Product liability math works differently than regular math. In the case of Bayer and the Monsanto Roundup herbicide litigation, jury verdicts of $78 million and $80 million somehow adds up to $40 billion.

By Mark A. York (April 30, 2019)

(MASS TORT NEXUS MEDIA) The Monsanto glyphosate legal drama may be about to hit the agriculture firm’s new owners Bayer where it hurts the most-“The Boardroom.” This is where the executive suite is being forced to address the claims that they neither recognized nor took into account the enormous legal risks associated with the Monsanto takeover and the Roundup Litigation.

Bayer’s board received a vote of no confidence at the German company’s annual  meeting, last Friday April 26, 2019, coming from major financial inverstor widespread concerns over the Bayer purchase of  Monsanto last year, the major stakeholders in Bayer made it clear how unhappy they are.

What Would Settlement Cost?

Analysts at Liberum, an investment bank with offices in New York and London, figure a settlement cost of $11 billion — an average of $1 million for each of the 11,200 people who are suing over Roundup — sounds conservative.

While $1 million is far less than the recent jury awards, it’s high by the standards of other notorious product liability cases. Merck settled suits over its Vioxx painkiller for an average of $184,000 per plaintiff, and American Home Products paid $422,000 per person to settle claims over the diet drug fen-phen.

See Federal Jury Verdict Forms of March 19, 2019 Trial Findings Re: “Monsanto Roundup Caused Plaintiff’s Cancer”

Roundup MDL 2741 Federal Trial Jury Instructions of March 19, 2019

Roundup MDL 2741 Federal Trial Jury Verdict Form of March 19, 2019

Bayer bought Monsanto as part of its reinvention as a life-science firm with a focus on health and agriculture. At the time the deal was proposed in 2016, the competitive landscape of the agricultural-science space was shifting dramatically—Dow and DuPont were merging, and so were ChemChina and Syngenta. Bayer wanted to become a bigger player in seeds and genetically modified crops, and Monsanto offered just that.

Bayer’s share price has fallen by around two-fifths thanks to two jury verdicts in the U.S. that Monsanto’s glyphosate-based weedkiller, Roundup, was responsible for causing plaintiffs’ cancer. There are still 13,400 cases to go, and the liability costs could end up being astronomical. Some disgruntled Bayer investors say the management and supervisory boards should go—they’ve recommended that shareholders vote against ratifying the board’s actions, which would effectively be a vote of no confidence.

Bayer Chief Executive Werner Baumann has nine months to prove he shouldn’t be kicked out as a result of last year’s Monsanto acquisition, a corporate law expert warned Tuesday.

Professor Christoph Schalast, a mergers and acquisition specialist at the Frankfurt School of Finance and Management, said Friday’s unprecedented rebuke of Bayer’s management was in part caused by Baumann’s overconfidence in the company’s handling of glyphosate lawsuits that have already lopped two-fifths off Bayer’s value. The nine-month timescale he laid out refers to the timing of when Bayer sets the agenda for its next annual general meeting, after which dissident shareholders can file counter motions against management.

Baumann, for his part, has insisted that “management acted conscientiously” in assessing the liability risk around Monsanto.

There have so far been two multi-million-dollar verdicts in the U.S. that held Monsanto liable for plaintiffs’ cancers, on the basis that those cancers were caused by years of using the glyphosate-based weedkiller Roundup. There are another 13,400 such claims waiting in the wings. Bayer’s shareholders do not believe the company adequately assessed this financial risk when buying Monsanto for $63 billion last year in an effort to become a leading player in agriculture.

Extraordinary pressure

At Bayer’s annual general meeting last week, 55.5% of investors voted against “discharging”—or ratifying—the board of management’s actions over the past year. This does not have direct legal implications, but it certainly sent a message.

Ordinarily, German shareholders discharge management by 90% or more, and anything less is seen as a stain on management’s reputation. Deutsche Bank’s co-CEOs were forced out several years ago after 39% of investors refused to back them in such a vote. Baumann now has the distinction of being the first CEO of a DAX-listed company to have a majority of investors vote against him.

Just as unusually, many of those voting against Baumann and his team said they did not want Bayer’s management to go just yet, due to the added chaos that would introduce into the situation. As Janne Werning of shareholder Union Investment put it to the Financial Times, management now gets a “second chance to get to grips with the risks and take the company back on to a path of stable growth.”

Schalast said Baumann’s situation was not directly comparable with that of ousted Deutsche Bank chiefs Anshu Jain and Jürgen Fitschen, because their defenestration was the result of generally poor performance at the bank.

“It is the one deal. That’s why [Baumann] is under such strong pressure,” said Schalast. “[The AGM vote] is a wake-up call for both the supervisory board and board of management, but [Baumann] is in the spotlight.”

Germany has a two-tier system for boards of directors in corporations, with the supervisory board being responsible for monitoring the board of management. Immediately following Friday’s vote, Bayer’s supervisory board—which itself only won 66% approval from shareholders—expressed its support for Baumann. However, supervisory board chair Werner Wenning is known to see Baumann as his protégé, so this support is less than surprising.

Bayer’s route to change

If the board of management does not prove in the next nine months that it is capable of getting a handle on the legal situation in the U.S., Schalast said, shareholders will need to apply pressure to the supervisory board. This may involve calling for a new supervisory board member who has expertise in U.S. litigation of the sort Monsanto faces.

“If they want a change and the supervisory board is not open to such a change, then they have to vote in a new supervisory board,” Schalast said, explaining that in Germany supervisory boards are generally responsive to pressure from shareholders, to whom they are ultimately responsible. “You usually talk to them and they resign and then you have the possibility to vote for a new member,” he said. “If that doesn’t happen, then you need an extraordinary general assembly.”

Investor pressure could be accelerated if there are more major verdicts that go against Bayer/Monsanto, Schalast said.

A Bayer spokesperson said shareholders’ decision not to discharge management was “a new situation for us,” but highlighted the fact that investors had also said “there is no real alternative to the current management.”

“There was nobody who asked the board or the CEO to step down,” said the spokesperson. “There is no real basis for speculation about Mr. Baumann’s future as CEO.”

BAYER FINANCIAL DISCLOSURE OCTOBER 2018

Why is there no mention of Monsanto Roundup MDL 2741?

Bayer Interim Financial Report Third Quarter 2018

(Excerpt from Official Bayer Report)

 Explanatory Notes

Legal Risks

Product-related litigation

Mirena™: As of January 30, 2018, lawsuits from approximately 2,900 users of Mirena™, a levonorgestrel-releasing intrauterine system providing long-term contraception, had been served upon Bayer in the United States (excluding lawsuits no longer pending). Plaintiffs allege personal injuries resulting from the use of Mirena™, including perforation of the uterus, ectopic pregnancy or idiopathic intracranial hypertension, and seek compensatory and punitive damages. Plaintiffs claim, inter alia, that Mirena™ is defective and that Bayer knew or should have known of the risks associated with it and failed to adequately warn its users. Additional lawsuits are anticipated. In April 2017, most of the cases pending in U.S. federal courts in which plaintiffs allege idiopathic intracranial hypertension were consolidated in a multidistrict litigation (“MDL”) proceeding for common pre-trial management. As of January 30, 2018, lawsuits from approximately 400 users of Mirena™ alleging idiopathic intracranial hypertension had been served upon Bayer in the United States. Another MDL proceeding concerning perforation cases has, in the meantime, been dismissed. The Second Circuit Court of Appeals affirmed the perforation MDL district court’s summary judgment order of 2016 dismissing approximately 1,230 cases pending before that court. In August 2017, Bayer reached an agreement in principle with plaintiffs’ counsel leadership for global settlement of the perforation litigation, for a total amount of US$12.2 million. As of January 30, 2018, a total of approximately 4,000 cases would be included in the settlement. The idiopathic intracranial hypertension MDL proceeding is not included in the settlement.

As of January 30, 2018, five Canadian lawsuits relating to Mirena™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

        XARELTO LITIGATION

Xarelto™: As of January 30, 2018, U.S. lawsuits from approximately 22,000 recipients of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Xarelto™, including cerebral, gastrointestinal or other bleeding and death, and seek compensatory and punitive damages. They claim, amongst other things, that Xarelto™ is defective and that Bayer knew or should have known of these risks associated with the use of Xarelto™ and failed to adequately warn its users. Additional lawsuits are anticipated. Cases pending in U.S. federal courts have been consolidated in an MDL for common pre-trial management. In May, June and August 2017, the first three MDL trials resulted in complete defense verdicts; plaintiffs have appealed all three verdicts. In January 2018, after the first trial to proceed in Pennsylvania state court had initially resulted in a judgment in favor of the plaintiff, the trial judge vacated the jury’s verdict and granted judgment in favor of Bayer. Further Pennsylvania state court trials are currently scheduled for the first and second quarters of 2018. Bayer anticipates that additional trials will be scheduled.

As of January 30, 2018, ten Canadian lawsuits relating to Xarelto™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Essure™: As of January 30, 2018, U.S. lawsuits from approximately16,100 users of Essure™, a medical device offering permanent birth control with a nonsurgical procedure, had been served upon Bayer. Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated.

As of January 30, 2018, two Canadian lawsuits relating to Essure™ seeking class action certification had been served upon Bayer. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

Class actions over neonicotinoids in Canada: Proposed class actions against Bayer were filed in Quebec and Ontario (Canada) concerning crop protection products containing the active substances imidacloprid and clothianidin (neonicotinoids). Plaintiffs are honey producers, who have filed a proposed nationwide class action in Ontario and a Quebec-only class action in Quebec. Plaintiffs claim for damages and punitive damages and allege Bayer and another crop protection company were negligent in the design, development, marketing and sale of neonicotinoid pesticides. The proposed Ontario class action is in a very early procedural phase. In Quebec, the plaintiff sought authorization (certification) of a class for which a motion was heard in November 2017. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

INSURANCE COMPANY PAYS THE BILLS

In connection with the above-mentioned proceedings, Bayer is insured against statutory product liability claims against Bayer to the extent customary in the respective industries and has, based on the information currently available, taken appropriate accounting measures for anticipated defense costs. However, the accounting measures relating to Essure™ claims exceed the available insurance coverage.

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SHOULD BAYER HAVE INSERTED ROUNDUP MDL LITIGATION HERE?

https://www.masstortnexus.com/News/4362/Monsanto-Bayer-Facing-Over-11-000-Lawsuits-Over-Roundup-Cancer-Risk-As-New-Federal-Trial-Starts

Link to US District ND California Monsanto MDL 2741 litigation case outline and case related orders: https://www.cand.uscourts.gov/VC/roundupmdl

1. Pretrial order no. 70: Final Juror Questionnaire (.pdf, 224 KB)264502/05/2019
2. Pretrial order no. 71: Re Motion to Amend PTO 50 (.pdf, 72 KB)265102/06/2019
3. Pretrial order no. 72: Procedure for Certain Motions to Remand (.pdf, 31 KB)266302/07/2019
4. Pretrial order no. 73: Re Caselaw on Statute of Limitations (.pdf, 53 KB)267102/07/2019
5. Pretrial order no. 74: Tentative View on Monsanto’s Specific Causation Experts(.pdf, 104 KB)268202/11/2019
6. Pretrial order no. 75: Discussion of Expert Witnesses at Feb. 13, 2019, Hearing (.pdf, 69 KB)269102/12/2019
7. Pretrial order no. 76: Re Missing Submissions (.pdf, 71 KB)269902/12/2019
8. Pretrial order no. 77: Court’s Proposed Phase 1 Jury Instructions (.pdf, 154 KB)270602/12/2019
9. Pretrial order no. 78: Guidance for the Parties re Motions in Limine (.pdf, 113 KB)270702/12/2019
10. Pretrial order no. 79: Confidentiality of Juror Questionnaires (.pdf, 62 KB)275802/13/2019
11. Pretrial order no. 80: Tentative Juror Excusals (.pdf, 70 KB)276902/15/2019
12. Pretrial order no. 81: Ruling on Motions in Limine (.pdf, 119 KB)277502/18/2019
13. Pretrial order no. 82: Parties’ Proposed Voir Dire Questions (.pdf, 104 KB)277602/18/2019
14. Pretrial order no. 83: Time Limits for Trial (.pdf, 68 KB)279002/21/2019
15. Pretrial order no. 84: Ruling on Deposition Objections for Drs. Turk, Turley, and Ye(.pdf, 81 KB)279702/23/2019
16. Pretrial order no. 85: Denying Monsanto’s Motion for Summary Judgment on Specific Causation (.pdf, 195 KB)279902/24/2019
17. Pretrial order no. 86: Remaining Summary Judgment Arguments (.pdf, 73 KB)280002/24/2019
18. Pretrial order no. 87: Order to Show Cause Re Sanctions (.pdf, 78 KB)280202/25/2019
19. Pretrial order no. 88: Deposition Designations for Dr. Matthew Ross (.pdf, 85 KB)281002/25/2019
20. Pretrial order no. 89: Initial Ruling on Deposition Designations for Dr. William Reeves(.pdf, 50 KB)281202/25/2019
21. Pretrial order no. 90: Ruling on Deposition Objections for Dr. Goldstein (.pdf, 72 KB)281702/26/2019
22. Pretrial order no. 91: Order Sanctioning Mr. Hardeman’s Counsel (.pdf, 117 KB)282802/26/2019
23. Pretrial order no. 92: Evidentiary Rulings on Dr. Portier’s Direct Testimony (.pdf, 112 KB)282902/26/2019
24. Pretrial order no. 93: Further Order re Reeves Deposition Designations (.pdf, 90 KB)283002/27/2019
25. Pretrial Order no. 94: Order Regarding Opening Statement Slides (.pdf, 47 KB)283102/26/2019
26. Pretrial order no. 95: Ruling on Deposition Objections for Dr. Blair (.pdf, 72 KB)283702/27/2019
27. Pretrial order no. 96: Evidentiary Rulings on Dr. Portier’s Testimony on Cross-Examination (.pdf, 128 KB)283802/27/2019
28. Pretrial order no. 97: Evidentiary Rulings on Dr. Portier’s Re-Direct and Re-Cross Testimony (.pdf, 118 KB)286102/28/2019
29. Pretrial order no. 98: Initial Rulings on Deposition Designations for Dr. Reeves(.pdf, 101 KB)286703/01/2019
30. Pretrial order no. 99: Order re Dr. Weisenburger’s Testimony (.pdf, 56 KB)287703/02/2019
31. Pretrial order no. 100: Ruling on Monsanto’s Deposition Designations for Dr. Reeves(.pdf, 98 KB)289403/04/2019
32. Pretrial order no. 101: Order re Monsanto’s Motion for Summary Judgment on Non-Causation Grounds (.pdf, 146 KB)293703/07/2019
33. Pretrial order no. 102: Court’s Draft Phase 1 Instructions (.pdf, 173 KB)294003/07/2019
34. Pretrial order no. 103: Order re Monsanto’s Proposed Questions for Drs. Arber and Levine(.pdf, 107 KB)294103/07/2019
35. Pretrial order no. 104: Scope of Dr. Arber’s Testimony (.pdf, 97 KB)294203/08/2019
36. Pretrial order no. 105: Order re Authentication of Mr. Hardeman’s Medical Records(.pdf, 106 KB)295803/11/2019
37. Pretrial order no. 106: Court’s Revised Phase 1 Instructions (.pdf, 178 KB)295903/11/2019
38. Pretrial order no. 107: Order re Final Jury Instructions (.pdf, 97 KB)296103/12/2019Pretrial order no. 108: Final Phase 1 Instructions (.pdf, 177 KB)296303/12/2019
39. Pretrial order no. 109: Final Verdict Form (.pdf, 80 KB)296403/12/2019
40. Pretrial order no. 110: Order re Plaintiff’s Expert James Mills (.pdf, 104 KB)297903/13/2019
41. Pretrial order no. 111: Order Requesting Further Information on Drs. Benbrook and Mills(.pdf, 86 KB)298203/13/2019
42. Pretrial order no. 112: Order re Design Defect Jury Instruction (.pdf, 88 KB)298303/13/2019
43. Pretrial order no. 113: Order Denying Monsanto’s Motion for a Directed Verdict(.pdf, 102 KB)298403/13/2019
44. Pretrial order no. 114: Outstanding Evidentiary Issues from PTO 81 (.pdf, 90 KB)298703/13/2019
45. Pretrial order no. 115: Order re Phase 2 Opening Statements (.pdf, 97 KB)299903/14/2019
46. Pretrial order no. 116: Order re Design Defect Claim (.pdf, 92 KB)305103/18/2019
47. Pretrial order no. 117: Ruling on Deposition Designations for Mark Martens (.pdf, 91 KB)308203/18/2019
48. Pretrial order no. 118: Ruling on Phase 2 Deposition Designations for Dr. Reeves(.pdf, 103 KB)309303/19/2019
49. Pretrial order no. 119: Ruling on Initial Phase 2 Deposition Designations for Dr. Farmer(.pdf, 100 KB)309403/20/2019
50. Pretrial order no. 120: Ruling on Phase 2 Designations for Dr. Heydens (.pdf, 74 KB)310803/20/2019
51. Pretrial order no. 121: Order re Rowland and Housenger Evidence (.pdf, 84 KB)312103/21/2019
52. Pretrial order no. 122: Ruling on Phase 2 Designations for Dr. Portier (.pdf, 85 KB)314003/22/2019

[End of Bayer-Mosanto Docket in MDL 2741]

March 6, 2019 https://www.masstortnexus.com/mass-torts-news/bayer-ag-completes-monsanto-purchase-whats-next-on-litigation-dockets/

___________________________________________________________________________

Patent Disputes

Adempas™: In January 2018, Bayer filed patent infringement lawsuits in a U.S. federal court against Alembic Pharmaceuticals Limited, Alembic Global Holding SA, Alembic Pharmaceuticals, Inc. and INC Research, LLC (together “Alembic”), against MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. (together “MSN”) and against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (together “Teva”). In December 2017, Bayer had received notices of an Abbreviated New Drug Application with a paragraph IV certification (“ANDA IV”) pursuant to which Alembic, MSN and Teva each seek approval of a generic version of Bayer’s pulmonary hypertension drug Adempas™ in the United States.

Betaferon™ / Betaseron™: In 2010, Bayer filed a complaint against Biogen Idec MA Inc. in a U.S. federal court seeking a declaration by the court that a patent issued to Biogen in 2009 is invalid and not infringed by Bayer’s production and distribution of Betaseron™, Bayer’s drug product for the treatment of multiple sclerosis. Biogen is alleging patent infringement by Bayer through Bayer’s production and distribution of Betaseron™ and Extavia™ and has sued Bayer accordingly. Bayer manufactures Betaseron™ and distributes the product in the United States. Extavia™ is also a drug product for the treatment of multiple sclerosis; it is manufactured by Bayer, but distributed in the United States by Novartis Pharmaceuticals Corporation, another defendant in the lawsuit. In 2016, the U.S. federal court decided a disputed issue regarding the scope of the patent in Biogen’s favor. Bayer disagrees with the decision, which may be appealed at the conclusion of the proceedings in the U.S. federal court.

Damoctocog alfa pegol (BAY 94‑9027, long-acting recombinant factor VIII): In August 2017, Bayer filed a lawsuit in a U.S. federal court against Nektar Therapeutics (“Nektar”), Baxalta Incorporated and Baxalta U.S., Inc. (together “Baxalta”) seeking a declaration by the court that a patent by Nektar is invalid and not infringed by Bayer’s drug candidate BAY 94‑9027 for the treatment of hemophilia A. In September 2017, Baxalta and Nektar filed a complaint in a different U.S. federal court against Bayer alleging that BAY 94‑9027 infringes seven other patents by Nektar. Regarding the complaint by Bayer, Nektar and Baxalta gave Bayer a covenant not to make any claims against Bayer for infringement of that patent. Bayer amended the complaint to now seek a declaration by the court that the seven other patents by Nektar are not infringed by BAY 94‑9027. The patents are part of a patent family registered in the name of Nektar and further comprising European patent applications with the title “Polymer-factor VIII moiety conjugates” which are at issue in a lawsuit Bayer filed against Nektar in 2013 in the district court of Munich, Germany. In this proceeding, Bayer claims rights to the European patent applications based on a past collaboration between Bayer and Nektar in the field of hemophilia. However, Bayer believes that the patent family does not include any valid patent claim relevant for Bayer’s drug candidate BAY 94‑9027 for the treatment of hemophilia A.

Nexavar™: In 2015, Bayer filed patent infringement lawsuits in a U.S. federal court against Mylan Pharmaceuticals Inc. and Mylan Inc. (together “Mylan”). In 2014 and 2015, Bayer had received notices of an ANDA IV application pursuant to which Mylan seeks approval of a generic version of Bayer’s cancer drug Nexavar™ in the United States. In October 2017, Bayer reached agreement with Mylan to settle this patent dispute. Under the settlement terms, Mylan will obtain a license to sell its generic version of Nexavar™ in the United States at a date after the expiration of the patent for the active ingredient expiring in January 2020. In 2016, Bayer had received another notice of such an ANDA IV application by Teva Pharmaceuticals USA, Inc. Bayer filed a patent infringement lawsuit against Teva in the same U.S. federal court. In January 2018, Bayer reached agreement with Teva to settle this patent dispute. Under the settlement terms, Teva will obtain a license to sell its generic version of Nexavar™ in the United States at a date after the expiration of the patent for the active ingredient expiring in January 2020.

Stivarga™: In 2016, Bayer filed patent infringement lawsuits in a U.S. federal court against Apotex, Inc. and Apotex Corp. (together “Apotex”) and against Teva. Bayer had received notices of an ANDA IV application pursuant to which Apotex and Teva each seek approval of a generic version of Bayer’s cancer drug Stivarga™ in the United States.

Xarelto™: In 2015, Bayer and Janssen Pharmaceuticals filed a patent infringement lawsuit in a U.S. federal court against Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc. (together “Aurobindo”), Breckenridge Pharmaceutical Inc. (“Breckenridge”), Micro Labs Ltd., Micro Labs USA Inc. (together “Micro Labs”), Mylan, Prinston Pharmaceutical Inc. (“Prinston”), Sigmapharm Laboratories, LLC (“Sigmapharm”), Torrent Pharmaceuticals, Limited and Torrent Pharma Inc. (together “Torrent”). Bayer had received notices of an ANDA IV application by Aurobindo, Breckenridge, Micro Labs, Mylan, Prinston, Sigmapharm and Torrent, each seeking approval to market a generic version of Xarelto™, an oral anticoagulant for the treatment and prevention of blood clots, in the United States. In 2016, Bayer received another notice of such an ANDA IV application by InvaGen Pharmaceuticals, Inc. (“InvaGen”). Bayer and Janssen Pharmaceuticals filed a patent infringement lawsuit against InvaGen in the same U.S. federal court.

Bayer believes it has meritorious defenses in the above ongoing patent disputes and intends to defend itself vigorously.

Further Legal Proceedings

Trasylol™ / Avelox™: A qui tam complaint relating to marketing practices for Trasylol™ (aprotinin) and Avelox™ (moxifloxacin) filed by a former Bayer employee is pending in the United States District Court in New Jersey. The U.S. government has declined to intervene at the present time.

Newark Bay Environmental Matters: In the United States, Bayer is one of numerous parties involved in a series of claims brought by federal and state environmental protection agencies. The claims arise from operations by entities which historically were conducted near Newark Bay or surrounding bodies of water, or which allegedly discharged hazardous waste into these waterways or onto nearby land. Bayer and the other potentially responsible parties are being asked to remediate and contribute to the payment of past and future remediation or restoration costs and damages. In 2016, Bayer learned that two major potentially responsible parties had filed for protection under Chapter 11 of the U.S. Bankruptcy Code. While Bayer remains unable to determine the extent of its liability for these matters, this development is likely to adversely affect the share of costs potentially allocated to Bayer.

In the Lower Passaic River matter, a group of more than sixty companies including Bayer is investigating contaminated sediments in the riverbed under the supervision of the United States Environmental Protection Agency (EPA) and other governmental authorities. Future remediation will involve some form of dredging, the nature and scope of which are not yet defined, and potentially other tasks. The cost of the investigation and the remediation work may be substantial if the final remedy involves extensive dredging and disposal of impacted sediments. In the Newark Bay matter, an unaffiliated party is currently conducting an investigation of sediments in Newark Bay under EPA supervision. The investigation is in a preliminary stage. Bayer has contributed to certain investigation costs in the past and may incur costs for future investigation and remediation activities in Newark Bay.

Bayer has also been notified by governmental authorities acting as natural resource trustees that it may have liability for natural resource damages arising from the contamination of the Lower Passaic River, Newark Bay and surrounding water bodies. Bayer is currently unable to determine the extent of its liability.

Asbestos: A further risk may arise from asbestos litigation in the United States. In many cases, the plaintiffs allege that Bayer and co-defendants employed third parties on their sites in past decades without providing them with sufficient warnings or protection against the known dangers of asbestos. Additionally, a Bayer affiliate in the United States is the legal successor to companies that sold asbestos products until 1976. Union Carbide has agreed to indemnify Bayer for this liability. Bayer believes it has meritorious defenses and intends to defend itself vigorously.

There is no official reference to Monsanto Roundup MDL 2741, even though an August 2018 verdict award for the plaintiff in California State Court was for more than $280 million, and showed that non-hodgkins lymphoma was caused by use of Monsanto Roundup herbicide containing Glyphosate. f

https://www.reuters.com/article/us-bayer-glyphosate-lawsuit/bayer-shares-slide-after-latest-roundup-cancer-ruling-idUSKCN1R02O3

Bayer Legal Disclaimer October 2018: Cautionary Statements Regarding Forward-Looking Information

Certain statements contained in this communication may constitute “forward-looking statements.” Actual results could differ materially from those projected or forecast in the forward-looking statements. The factors that could cause actual results to differ materially include the following: the risk that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected timeframes (or at all) and to successfully integrate the operations of Monsanto Company (“Monsanto”) into those of Bayer Aktiengesellschaft (“Bayer”); such integration may be more difficult, time-consuming or costly than expected; revenues following the transaction may be lower than expected; operating costs, customer loss and business disruption (including difficulties in maintaining relationships with employees, customers, clients or suppliers) may be greater or more significant than expected following the transaction; the retention of certain key employees at Monsanto; the parties’ ability to meet expectations regarding the accounting and tax treatments of the merger; the impact of refinancing the loans taken out for the transaction; the impact of indebtedness incurred by Bayer in connection with the transaction and the potential impact on Bayer’s rating of indebtedness; the effects of the business combination of Bayer and Monsanto, including the combined company’s future financial condition, operating results, strategy and plans; other factors detailed in Monsanto’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) for the fiscal year ended August 31, 2017, and Monsanto’s other filings with the SEC, which are available at http://www.sec.gov and on Monsanto’s website at www.monsanto.com; and other factors discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. Bayer assumes no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.

BAYER LITIGATION DOCKETS IN MDL’s ARE STILL GROWING

ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California) Mass Tort Nexus Briefcase

XARELTO-(rivaroxaban)-MDL-2592-(USDC-ED-Louisiana) Mass Tort Nexus Briefcase

XARELTO-Case-No-2349–Philadephia-Court-of-Common-Pleas-Complex-Litigation-(PA-State-Court) Mass Tort Nexus Briefcase)

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https://www.fda.gov/ as of April 26, 2019

 FDA has announced the launch of a newly redesigned FDA public access website. They have made changes to provide a more modern and customer friendly access for the public. The new FDA website launch was completed April 26, 2019.

PRODUCTS THE FDA REGULATES

Food – Drugs – Medical Devices – Radiation-Emitting Products – Vaccines, Blood, and Biologics – Animal and Veterinary – Cosmetics and Tobacco Products

____________________________________________________________

The FDA public website receives nearly 5 million visitors—consumers, health professionals, scientists/researchers, and industry stakeholders each month. It serves as the face of the agency and a critical vehicle for meeting FDA’s mission, as it’s home to agency policy and perspectives and information about recalls, safety alerts and important regulatory actions. Ensuring that this content is easy to find is a top priority.

The FDA has attempted to make the FDA.gov website more user friendly, by redesigning not only the functionality, but the way it looks as well. The new FDA site is cleaner and the overall layout is less distracting and the content is much more contemporary.

The goals for the new FDA.gov website include:

https://www.fda.gov/

• Remodeled webpages that can be viewed on any internet-ready device
• Easier access to popular content
• Updated navigation based on data and audience behavior
• Easier to find FDA content in search results
• Better consistency of FDA content across web and social channels

The FDA.gov website refresh centers around the migration to a new web content management system (WCMS). The current WCMS is end-of-life and we are replacing it with a new modern publishing platform.

Here are some of the things we are doing to improve FDA.gov:

• Using data to archive and expire webpages that aren’t being used, consolidating similar content/renaming page titles to reduce redundancy so it’s easier for online audiences to find what they are looking for.
• Adding stronger and more relevant metadata to the webpages to optimize them for search and social media.
• Updating FDA.gov’s design to provide more visuals and interactive content. Overall the site will have a more modern look-and-feel. FDA content will appear consistently regardless of web and social channels.
• Upgrading to a modern publishing platform ensures that our content is accessible anywhere, anytime and on any device.

WHAT THE FDA DOES AND LINKS TO RESOURCES.GOV

• FDA Mission
• FDA’s Regulatory Responsibilities: Laws and Regulations
• Product Approval
• Recalls, News, and Events
• Guidance Documents, Rulemaking, and Freedom of Information

FDA Mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

FDA’s Regulatory Responsibilities: Laws and Regulations

• Laws enforced by FDA
• What does FDA regulate?
• FDA 101: An overview of FDA’s regulatory and research activities
• FDA regulations: 21 CFR, Food and Drugs

Product Approval

• Approvals of FDA-regulated products
• Is It Really “FDA-Approved?”

Recalls, News, and Events

• Recalls, market withdrawals, and safety alerts
• FDA news and events

Guidance Documents, Rulemaking, and Freedom of Information

• Search for FDA guidance documents
• FDA rules and regulations
• FDA Dockets: Comment on rulemaking, administrative proceedings
• Freedom of Information

Navigating The New FDA Site

Being a large and diverse agency with aesthetics apart, just keeping track of pathways and names is overwhelming in such a complex website, and it is easy to lose track of what needs to be updated.  The FDA stated that one of the goals was to make the site more friendly to consumers and it has improved. The former site ran banner photos of some topical interest, the new site landing pages feature a topic with a photo array focused on a feature topic. To get to the information, you need to click on the box announcing the feature, not the photos. Key to success for this approach will be topics that change out frequently as well as the topics themselves. This month’s is about children and allergy relief, timely given the time of year and the number of children, but perhaps not as serious as the recall of blood pressure medications.

Each FDA division – Drugs, Food, Medical Devices has “featured information” that generally mirrors the FDA landing page (though stylistically there is not consistency across all divisions in terms of layout). For FDA to achieve its consumer friendly goal here they will have to work at providing information that is of interest to consumers and not necessarily just focus on that information FDA wants most to talk about.

Longer, Less Crowded Landing Page – It used to be when you went to FDA’s landing page, you had a LOT of information crammed into the screen offering you pathways in a bunch of different directions at once – from links to speeches to advisory committee information to meetings information to the latest press releases, etc. All of that is still on the landing page, but it is more coherently laid out. That means that there is less splashed in your face on the screen, but the content has been elongated – and you now have to scroll down to find all the bits and pieces. That may not be entirely apparent to some. As you scroll down, you come to additional featured topics beyond the main one mentioned above. Right now one of them includes a link to information about the revamp of the site; a link to information about combatting opioids and one on FDA fostering drug competition. As noted above, these topics fall a little more into the category of things FDA may want to say versus the things we want to hear more about from a consumer perspective. As you scroll down, you come to press announcements (where curiously the title of the section is in smaller type than the titles of the most recent press releases). Scrolling down further takes you past many of the links that were formerly crammed into the landing square of the old site. It is almost all still there, just there more for your leisurely scrolling rather than in your face. But not everything is on the landing page. For that you need the next section.

Menu Function is Key – In the upper right hand corner is the Menu Function. You are going to need this as it is the key to providing you a one-size fits all access to various divisions of the agency. It takes you to a site-map-lite that is actually very helpful if there are some specific things you want to look up. Most notably on the left side are a list of “featured links”. These are vital. They take you not only to guidance documents, but also one is the link that gets you to Advisory Committee information — to the page that is set up for each committee containing such information as the committee roster and meeting notices as well as documents related to specific meetings. To the right of this menu you will also find access to the FDA’s divisions, though it is not called that – instead it is called “Products”. Under that heading you will not see links to “CDER”, “CBER” or the others and where is the Office of Prescription Drug Promotion? Actually CDER, CBER and the others are there, but they are not called that. They are under their generic names (haha) – Drugs, Food, Medical Devices, Radiation-Emitting Products, etc. FDA may want to consider adding the acronyms here. These pages are generally laid out in similar fashion to the initial agency landing page, with a heading that is meant to cover topical information, prompting the user to scroll down to find the bits desired. Here you will find a link as you travel down the page to the Warning and Untitled Letters issued (still only one issued this year so far). The link to the Office of Prescription Drug Promotion exists but not on this page – it is under the About FDA Tab, and then drilling down through organizational structure through CDER there before you find it – here.

Finding Specifics Related to Function in the About FDA Link – One thing you don’t see when you go to the Drug page or the Food page or any of the other division pages is a map for getting to where you want to go within that division (hence the lack of an OPDP link from the Drugs Page). To find that level of detail – to find a specific office that does a specific function, you may have to either conduct a Search (which can offer up a messy slew of links) or go to the About FDA link mentioned above. Here’s the thing – that is in very small letters at the very bottom of the landing page. It is a small, obscure link to an important function. Overall, navigation of the site is less confusing now that everything is removed from a single frame shot. The order of things as you scroll down is pretty logical, though the demarcation of sections is subtle. Of note, if you have links to FDA materials at any site, some of the material may have shifted.

MENTOR WORLDWIDE (J&J) ON FDA RADAR OVER TEXTURED IMPLANTS AND CANCER: IS THIS AN EMERGING MASS TORT? 

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

By Mark A. York (May 8, 2019)

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

In addition to the warning notice to Mentor Worldwide in March 2018 (above), the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. The FDA shas  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

In the U.S. and Canada, regulators did not impose any consequences after manufacturers lost track of most of the participants in a large-population health study within three years, although a 10-year study was ordered as a condition of allowing silicone implants back on the market.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Typical Breast Implants Placement

Silicone Breast Implant History

History that breast implants have caused serious health problems, but for most of the public, that problem is assumed to be a historical reference, because those implants were removed from the market, so the current implants on the market must be very safe.

While the FDA now openly mentions problems that often occur in many women with breast implants, such as leaking and rupturing, they fail to warn the public about the more dangerous connection to auto-immune disorders.

The FDA actually allowed implants to be put onto the market for over 40 years without formally approving them, so it’s not a best practice to trust what the FDA says.

The lawsuits in the 1990’s involved 450,000 US women who sued  Dow Corning, one of the world’s largest manufacturers of silicone implants.

While Dow Corning never admitted that their implants were dangerous, they paid out enormous amounts to the victims. Their implants of the 1970’s had a very thin outer shell, and had a high leakage rate. Many women even lost their lives from illness caused by these implants, while waiting for a legal resolution of their lawsuits against Dow.

It was disclosed that Dow Corning knew for a very long time that their implants were toxic, yet covered it up for as long as they could.

In their own animal studies, researchers found that silicone could easily leak into the body, and caused tumours in up to 80% of the rats that were being tested on, see Fig. 7. The numbers were so alarming that the FDA, instead of being concerned, called these studies “erroneous,” which basically means they ‘must’ have been incorrect. The FDA then approved the Dow Corning implants, despite protests from some staff members that there were troubling warning signs.

We’ve also heard about the now infamous French PIP implant scandal which hit worldwide news recently. These implants (which were found to contain toxic chemicals used in mattresses and not approved for human use) are now banned, and women in the UK were offered free treatment to have them removed.

Shocking Ingredients Found In Dow Silicone Implants

When women are told that their implants contain silicone or saline, they often don’t tend to ask if anything else is being used alongside it. They certainly aren’t told this by the surgeons, who more than likely don’t even know themselves.

Check out the long list of alarming ingredients used in Dow’s silicone implants which came out during their court case when they were forced to disclose what was in their dangerous implants:

• Methyl ethyl ketone (neurotoxin)
• Cyclohexanone (neurotoxin)
• Isopropyl Alcohol
• Denatured Alcohol
• Acetone (used in nail polish remover and is a neurotoxin)
• Urethane
• Polyvinyl chloride (neurotoxin)
• Amine
• Toulene
• Dicholormethane (carcinogen)
• Chloromethane
• Ethyl acetate (neurotoxin)
• Silicone
• Sodium fluoride
• Lead Based Solder
• Formaldehyde
• Talcum powder
• Oakite (cleaning solvent)
• Methyl 2- Cynanoacrylates
• Ethylene Oxide (Carcinogen)
• Xylene (neurotoxin)
• Hexon
• 2-Hedanone
• Thixon-OSN-2
• Stearic Acid
• Zinc Oxide
• Naptha (rubber solvent)
• Phenol (neurotoxin)
• Benzene (carcinogen/neurotoxin)
• Lacquer thinner
• Epoxy resin
• Epoxy hardener
• Printing Ink
• Metal cleaning acid
• colour pigments as release agents
• heavy metals such as aluminium (neurotoxin linked to Alzheimer’s and auto immune disorders)
• Platinium
• Silica * (2)

What’s In Implants Today?

The current problem is we just don’t know. Its very difficult to find out exactly what is in current implants today. There nothing that shows a full ingredient list. Plastic surgeons state they have ‘never seen a full list’ and implant websites, do not disclose what is in their products.

Some scientists have been taking an in-depth look at the platinum, a toxic salt, found in silicone implants and its connection to ill health. However, after looking at this list above, it seems ludicrous to suggest that one individual ingredient would be the sole cause of these health problems. It’s clear that breast implants are completely toxic.

Its important to know that saline implants ALL have silicone outer shells, so these too can leak silicone and other ingredients into the body, either through rupturing or when the textured surface flakes off.

Types of Breast Implants Used Today

Silicone Implants

Many women opt out of having silicone implants due to the Dow Corning Lawsuit. But a growing number of women are now choosing to have them again due to the implant’s ability to look more natural than other types. These implants have an elastic type envelope which is pre-filled with a sticky, clear, jelly-like form of silicone. There are a few varieties of shapes to choose from, with smooth or textured surfaces.

With the FDA allowing silicone implants to come back on the market, it is very concerning to know that statistics show (according to Nancy Bruning, author of Breast Implants — Everything You Need To Know) that almost half of all women who have this type of implant will experience a rupture within 6-10 years, and one in five women were found to have silicone migrate to other parts of their bodies.

According to Dr Susan Kolb, world expert on breast implants, silicone implants should be completely avoided.

Saline implants – silicone outer shell, saline liquid inserted during surgery by surgeon

Saline Implants

Saline implants are commonly thought to be safer, yet they have their own problems. Saline implants have a silicone shell filled with a saline water, which is salt based and ‘sterile.’ Some types are inserted empty which the surgeon will inflate during surgery with this saline liquid. There is another type of saline implant, which also has a silicone shell, but the inside contains a gel like texture. There are smooth surface saline implants and textured surface saline implants.

According to research experts, 60% of women with these types of implants have complications within four years, and one out of five require additional surgery within three years.  This seems to be a cause for concern, since patients are commonly told that implants either never need to be removed or should be removed every ten years.

Possible Side Effects

This is what your surgeon does not tell you:

• tenderness, lumpiness, or discomfort around the implants
• change in the shape of your breast(s)
• change in the consistency of your breast, such as increased softness
• change in the way your breast moves – all of these symptoms may be a sign your implant has ruptured.
• hardening of breast tissue
• muscle pain
• pain and swelling of the joints
• pain in the soft tissues
• a burning sensation of pain
• tightness, redness, or swelling of the skin
• swollen glands or lymph nodes
• unusual, extreme, or unexplained fatigue
• swelling of the hands and feet
• unusualhair loss
• rashes
• skin thickening or hardening
• dry eyes, mouth, or vagina
• loss of memory, mental confusion, or ‘fogginess’
• autoimmune disorders such as fibromyalgia, rheumatoid arthritis, scleroderma, multiple chemical sensitivity disorder, cancer, and biotoxicity problems.

Above is an excerpt from Breast Implants – All You Need To Know by Nancy Bruning.

A ruptured silicone implant. The red is tissue that had to be removed from the patient. The sticky consistency on the right is what comes out when ruptures and leakage occur.

Breast Implants Can Cause Cancer

It might not surprise some of you reading this to learn that there is a link between cancer and implants. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants.

French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

Suicide Risk

Another little known factor about breast implants is that there is a connection between suicide. While this connection might be more about the woman’s mental status prior to having the surgery (perhaps she suffered from low self esteem and thought implants would make her much happier), it could also be because of the stressful impact the implants have on the body and its many important systems. As we have seen above, implants are linked to neurological disorders, amongst other concerns.

Women who have implants are at least 3 (some sources say 4) times more likely to commit suicide than those who do not have them.

The American Society of Plastic Surgeons (ASPS) reported that 329,396 women have undergone breast augmentation in the United States, an increase of 55% between 2000 and 2006, making it the most frequent US surgical cosmetic procedure for 2006 (ASPS, 2007). Although many studies have explored psychological aspects of this type of surgery, the consistently dramatic increase in numbers of breast augmentations, some that result in adverse psychological outcomes, remains a serious concern for health care providers. Surprisingly, very little is known about either the psychological characteristics of cosmetic surgery patients or the psychological impact of the surgical procedures. This literature review focuses on psychological issues in relation to breast augmentation procedures, including recent suicide findings related to this procedure. Conclusion of this review supports the necessity by health care providers to consistently screen patients for psychological disorders, such as Body Dysmorphic Disorder (BDD), prior to conducting cosmetic surgical procedures, specifically breast augmentation. See https://www.ncbi.nlm.nih.gov/pubmed/19499438, Psychological Issues Associated With Breast Augmentation Issues Ment Health Nurs. 2009 Jun;30(6):377-82

Mammograms Can Rupture Breast Implants

Mammogram on a patient without implants 

If you have implants, you need to be aware that having mammograms can actually do serious damage to them. Because the procedure involves intense squashing down of the breast tissue, this has been known to cause ruptures, and if the implants do begin to leak, what is inside them will likely leak into your body.

It must be said that there is also alarming information that mammograms are not safe to have, even if you don’t have implants.

Is There A Safe Implant?

If you choose to get implants, then according to breast implant expert Dr. Susan Kolb, the safest type is the saline implant that has a smooth surface and does not have a valve. This is because the textured implants have been found to have particles flake off into the person’s body which can then attack the immune system. If there is a valve, as mentioned previously, a systemic fungal infection can ensue.  But even with this type, problems can happen in the future and lead to drastic complications, and it now seems to be leading toward Breast Implant Litigation Round II.

As discussed in the article What You Need To Know About Breast Implants, the authors wrote about the concerns with breastfeeding and toxicity:

According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding. Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue. A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.

THE FAILS AGAIN

The FDA has also posted an unusually blunt warning on its website. It advises patients that the risk of complications is high and says flatly:  “You should assume that you will need to have additional surgeries.”

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

A Clear Example of What Can Go Wrong

Please check out Susan’s experience that really turned into an utter nightmare for her, which is still affecting her health today. Below is a picture of her implants that she had recently removed.

Susan’s implants which were moved back in April this year. The one on the left was so ‘jelly like’ it had to be scraped off her ribs. The right one, although looks quite normal, actually had a small rupture too. The red tissue is what the surgeon also had to remove to ensure all the silicone was gone.

To access information on Breast Implants II and the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

May 31 – June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Barbara Capasso at 954.530.9892 or Barbara@masstortnexus.com.

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• Pilliod v. Monsanto Co. RG17862702, California Superior Court, County of Alameda (Oakland)

(MASS TORT NEXUS MEDIA) Combine the $2 billion verdict of May 13, 2019 and the two previous jury awards of $159 million in damages and you get major legal and financial issues for Bayer and the board of directors.

The Monsanto Roundup MDL 2741 May trial, initially set for next week was stopped by Judge Chhabria, who vacated the May 20, 2019 bellwether trial date, in the case of, Stevick v. Monsanto  where plaintiff Elaine Stevick, asserts that Roundup caused non-Hodgkin lymphoma. Federal Judge Vince Chhabria is overseeing thousands of Roundup lawsuits and has deemed Hardeman’s case and two others “bellwether trials” in ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

The numbers being discussed between Bayer corporate and their now very concerned board of directors for a global settlement are between $3 billion and $5 billion, which may be a low number after the $2 billion Pilliod jury award.

Here is the breakdown of the Pilliod vs. Monsanto trial verdict in the Alameda County Superior Court, Oakland, CA

$2.055 billion total verdict

 $55,206,172.80 compensatory damages and $2 billion punitive damages

Alva Pilliod

Compensatory:

Past economic – $47,296.01

Past non-economic loss – $8M

Future non-economic loss – $10M

——————————————-

$18,047,296.10

Punitive damages – $1 billion

Alberta Pilliod

Compensatory:

Past economic – $201,166.76

Past non-economic – $8M

Future economic  – $2,957,710

Future non-economic – $26M

——————————————-

$37,158,876.70

Punitive damages – $1 billion

 Monsanto Hit with Historic $2.055 Billion Verdict Losing Third Roundup Trial

Baum Hedlund Firm Press Conference on Verdict:  https://www.facebook.com/BaumHedlund/

 May 13, 2019  An Alameda jury in the case of Pilliod et al. v. Monsanto Company (Case No. RG17862702, JCCP No. 4953) returned a verdict today of $2.055 billion in favor of a husband and wife with non-Hodgkin lymphoma, ordering Monsanto to pay $55 million in compensatory damages and $2 billion in punitive damages ($1 billion each for Mr. and Mrs. Pilliod) for failing to warn consumers that exposure to Roundup weed killer causes non-Hodgkin lymphoma (NHL).

The verdict is the third in a row against Monsanto (now Bayer). Combined with the first two legal defeats (the Johnson v. Monsanto verdict of $289.2M and the Hardeman v. Monsanto verdict of $80M), verdicts against Monsanto in the Roundup cancer litigation now stand at $2.424 billion with 13,400 cases still pending in state and federal courts. (Johnson’s verdict was later reduced to $78.5M but his verdict is on appeal.)

A press conference on today’s landmark verdict will be held at the offices of Audet & Partners in San Francisco at 4:30 p.m. Plaintiffs Alva and Alberta Pilliod and their legal team will give statements on the verdict. A Q&A with the attorneys will follow. Details can be found below. We will also live stream this from our Facebook page.

Monsanto Loses Third Straight Roundup Cancer Trial

Alva and Alberta Pilliod, a Livermore, California couple in their 70s, used Monsanto’s Roundup weed killer together for more than 30 years to landscape their home and other properties. They were both diagnosed with the same type of NHL, diffuse large B-cell lymphoma (DLBCL), associated with Roundup exposure. In 2011, Alva was diagnosed with systemic NHL in many of his bones, which spread to his pelvis and spine. Alberta was diagnosed with NHL brain cancer in 2015.

In their Roundup cancer lawsuit, the couple attributed their cancer diagnoses on exposure to Roundup and its active ingredient, glyphosate, and accused Monsanto of fraudulently representing that Roundup is safe despite scientific evidence linking exposure to NHL.

At trial, attorneys for the Pilliods, Michael Miller of the Miller Firm and R. Brent Wisner of Baum, Hedlund, Aristei & Goldman, showed jurors a trove of internal Monsanto documents they say demonstrate the agrochemical giant’s manipulation of scientific literature, including ghostwriting several review papers on glyphosate published in scientific journals and cited in Environmental Protection Agency (EPA) regulatory reviews.

The jury also saw documents showing Monsanto’s efforts to influence EPA and other regulatory agencies, as well as evidence that Monsanto ran a public relations campaign to plant favorable stories in Reuters and other media outlets to defend its products and discredit scientists who determined glyphosate was linked to cancer.

During closing arguments, Wisner told the jury that Roundup was “born in fraud” because the agrochemical received EPA approval in 1974 based on studies conducted at Industrial Bio-Test Laboratories (IBT). A subsequent EPA review of the data found that IBT routinely falsified data. Three IBT executives were later convicted of fraud. According to Wisner, from that point on, Monsanto repeatedly refused to conduct studies on glyphosate and Roundup, even after the EPA and its own toxicologist told Monsanto that it needed to conduct more studies to address safety concerns.

After approximately 7 weeks of trial proceedings, the jury found that exposure to Roundup caused the Pilliods to develop NHL and that Monsanto failed to warn of this severe health hazard. Importantly, the jury also found that Monsanto acted with malice, oppression or fraud and should be punished for its conduct.

Since the Monsanto acquisition last summer and two negative jury verdicts, Bayer has lost more than $30 billion in shareholder value.

Monsanto Co. continues to refuse to warn consumers of the dangers of its multi-billion-dollar product Roundup despite the world’s foremost authority on cancer—the International Agency for Research on Cancer (IARC)—listing glyphosate as a probable carcinogen in 2015.

Monsanto Bad Conduct Is Revealed

* Monsanto never conducted epidemiology studies for Roundup and its other formulations made with the active ingredient glyphosate to evaluate the cancer risks for users.

* Monsanto was aware that the surfactants in Roundup were much more toxic than glyphosate alone.

* Monsanto spent millions of dollars on covert public relations campaigns to finance ghostwritten studies and articles aimed at discrediting independent scientists whose work found dangers with Monsanto’s herbicides.

* When the US Agency for Toxic Substances and Disease Registry sought to evaluate glyphosate toxicity in 2015, Monsanto engaged the assistance of EPA officials to delay that review.

* Monsanto enjoyed a close relationship with certain officials within the Environmental Protection Agency (EPA), who have repeatedly backed Monsanto’s assertions about the safety of its glyphosate products.

* The company internally had worker safety recommendations that called for wearing a full range of protective gear when applying glyphosate herbicides, but did not warn the public to do the same.

Pilliod v. Monsanto Trial Transcripts

Pilliod v. Monsanto Trial Exhibits

Pilliod v. Monsanto Jury Instructions

Attorneys React to Verdict Against Monsanto

After the verdict, co-lead trial counsel R. Brent Wisner thanked the jury for dutifully listening to scientific evidence and testimony over the course of several weeks. “They were given an incredibly difficult task having to analyze the highly-complex scientific issues in this case,” said Wisner. “They took detailed notes, asked incredibly thoughtful questions and in the end, came to understand that the science shows there are serious health hazards associated with Roundup and that Monsanto did nothing to warn people about the risk.”

“The jury saw for themselves internal company documents demonstrating that, from day one, Monsanto has never had any interest in finding out whether Roundup is safe,” Wisner said. “Instead of investing in sound science, they invested millions in attacking science that threatened their business agenda.”

Wisner also thanked everyone on the trial team, calling the victory a “true team effort that would not have been possible without the tenacity and resolve of everyone who worked on the case.”

Michael Miller, who served with Wisner as co-lead trial counsel added: “Unlike the first two Monsanto trials, where the judges severely limited the amount of plaintiffs’ evidence, we were finally allowed to show a jury the mountain of evidence showing Monsanto’s manipulation of science, the media and regulatory agencies to forward their own agenda despite Roundup’s severe harm to the animal kingdom and humankind.”

Roundup Cancer Attorneys in Pilliod v. Monsanto

A team of attorneys from three law firms represented the Pilliods in this trial: Michael Miller, Curtis G. Hoke, David J. Dickens and Jeffrey Travers of The Miller Firm of Orange, Virginia; R. Brent Wisner, Michael L. Baum and Pedram Esfandiary of Baum, Hedlund, Aristei & Goldman of Los Angeles, California; and Mark Burton of Audet & Partners of San Francisco, California.

The Miller Firm and Baum, Hedlund, Aristei & Goldman co-tried the case of Dewayne “Lee” Johnson v. Monsanto Co., the first Monsanto Roundup lawsuit to proceed to trial. The case resulted in a $289.2 million jury verdict last August. The judge later upheld the jury’s verdict but reduced the punitive damages award, bringing the total award to $78.5 million.

Baum Hedlund partner, R. Brent Wisner, was also part of the Hardeman trial team (the second Roundup trial) conducted by Aimee Wagstaff of Andrus Wagstaff and Jennifer Moore of Moore Law in U.S. District Court for the Northern District of California (federal court). Mr. Wisner presented one of the key fact witnesses (Dr. Christopher Portier) and he cross-examined most of the corporate witnesses in Hardeman v. Monsanto Co. Wisner is also administrator and co-lead counsel for the Roundup Products Cases JCCP 4953 (known as the Roundup Judicial Council Coordination Proceedings or simply Roundup JCCP) before the California Superior Court for the County of Alameda (where he Pilliod trial occurred).

Baum Hedlund managing partner, Michael Baum, and a team working under him assisted the Hardeman trial team as members of the MDL Executive Committee by presenting and preparing experts, corporate testimony and documents for Hardeman v. Monsanto Co. Mr. Baum is also a member of the Executive Committee for the Monsanto Roundup MDL (federal multi-district litigation). Mr. Miller is a co-leader of the Roundup MDL Executive Committee.

Pilliod v. Monsanto Docket History and Links

Alva and Alberta Pilliod v. Monsanto Co. (Case No. RG17862702, JCCP No. 4953) is the first Roundup non-Hodgkin lymphoma lawsuit from the California Roundup Judicial Council Coordination Proceedings (JCCP) to go to trial. Hundreds of lawsuits filed in California state courts are consolidated in the Roundup JCCP before Judge Winifred Smith for the Superior Court of Alameda County.

Pilliod v. Monsanto Co. is the third Roundup cancer case to go before a jury. The first Monsanto Roundup trial, Dewayne “Lee” Johnson v. Monsanto Co., resulted in a $289.2 million jury verdict last August. The judge later upheld the jury’s verdict but reduced the punitive damages award, bringing the total award to $78.5 million. The second case, Edwin Hardeman v. Monsanto Co., resulted in an $80 million jury verdict against the agrochemical company.

Plaintiffs in the litigation against Monsanto (now Bayer) allege that exposure to Roundup weed killer caused them to develop non-Hodgkin lymphoma.

Quick link to Pilliod trial transcripts

Quick link to Pilliod trial exhibits

Quick link to Pilliod trial press release

Jury Instructions

Alberta Pilliod verdict form

Alva Pilliod verdict form

Looking for unsealed Monsanto emails, communications, studies and other memoranda? Visit the Monsanto Papers page.

Alva Pilliod and his wife, Alberta, are in their 70s and have been married for nearly 50 years. They started using Roundup in the 1970s and continued using the weed killer until only a few years ago. The Livermore couple has two children and four grandchildren.

Alva suffers from non-Hodgkin lymphoma in his bones that spread to his pelvis and spine. He was diagnosed in 2011. Alberta was diagnosed with non-Hodgkin lymphoma brain cancer in 2015.

Attorneys for the Pilliods asked Judge Ioana Petrou (the previous presiding judge who has since been appointed to the First District Court of Appeal) to expedite the trial due to their advanced ages and cancer diagnoses. Judge Petrou granted their trial preference. The presiding judge for this trial is now Judge Winifred Smith.

The Miller Firm senior partner Michael J. Miller and Baum, Hedlund, Aristei & Goldman attorney R. Brent Wisner are co-lead trial counsel for the Pilliods. The Miller Firm and Baum, Hedlund, Aristei & Goldman co-tried the Johnson case last year.

Pilliod v. Monsanto Company Trial Transcripts

Day 1: 3/28/2019 – Plaintiff opening statement by R. Brent Wisner. Defense opening statement by Tarek Ismail.

Day 2: 4/2/2019 – Dr. Christopher Portier 402 Hearing (short hearing out of the presence of the jury to determine the admissibility of evidence). Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner.

Dr. Christopher Portier testimony (jury present). Direct examination by R. Brent Wisner.

Dr. Portier holds a Ph.D. in Biostatistics (with a minor in Epidemiology). For over three decades, Dr. Portier held prominent leadership positions in the U.S. government that combined the disciplines of toxicology, statistics and epidemiology, including:

• Associate Director of the National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program and thus the nation’s chief toxicologist, among other roles at NIEHS.
• Director of the National Center for Environmental Health, Center for Disease and Prevention.
• Director of the Agency for Toxic Substances and Disease Registry (ATSDR).

Expert Report of Dr. Portier

Day 3: 4/3/2019 – Dr. Christopher Portier testimony (continued). Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner.

Day 4: 4/4/2019 – Dr. Charles Jameson testimony. Direct examination by R. Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by R. Brent Wisner. Recross-examination by Tarek Ismail.

Dr. Jameson worked for the National Institutes of Health’s National Cancer Institute (NCI) as a senior chemist for the NCI’s Rodent Bioassay Program where he served as chief chemist, directing all chemistry activities and participating in the development of all two-year rodent bioassays while also serving as secretary for the NCI’s Chemical Selection Working Group. He also served as program leader for the National Toxicology Program at the NIH’s National Institute of Environmental Health Sciences (NIEHS) for 12 years.

Expert Report of Dr. Jameson

Day 5: 4/8/2019 – Dr. Beate Ritz, Chair of the Epidemiology Department at UCLA, direct examination by Michael Miller. Cross-examination by Kelly Evans. Redirect examination by Michael Miller. Recross-examination by Kelly Evans. Further redirect examination by Michael Miller.

Mark Martens video testimony (taken on April 7, 2017 in Washington, D.C.).  Mr. Martens is a former Monsanto executive, Toxicology Agriculture Research & Development Director for Monsanto Europe.

Dr. Ritz is a professor of Epidemiology at the University of California, Los Angeles. She holds doctoral degrees in Medicine and Epidemiology and is the author of numerous toxicology publications, lectures and presentations. Dr. Ritz engaged in a systematic review of the literature in this case, utilized the Bradford Hill Criteria and concluded that “to a reasonable degree of scientific certainty, glyphosate causes NHL. Furthermore, to a reasonable degree of scientific certainty, glyphosate-based formulations, including Roundup, cause NHL.”

Dr. Ritz Expert Report

Day 6: 4/9/2019 – Dr. Dennis Weisenburger direct examination by Michael Miller. Cross-examination by Tarek Ismail.

Dr. Weisenburger specializes in the studies of the hematopoietic and immune systems, with a special interest in non-Hodgkin lymphoma. His study of the pathological mechanisms by which NHL develops began in the 1980s when he was directing large epidemiologic studies related to NHL.

Over the last four decades, Dr. Weisenburger has published over 300 papers on NHL in peer-reviewed journals, and over 50 papers on the epidemiology of NHL, including studies on glyphosate and NHL. In his expert report, Dr. Weisenburger concluded that to “a reasonable degree of medical certainty that glyphosate and GBFs [glyphosate-based formulations] (including Roundup) can cause NHL in humans exposed to these chemicals in the workplace or environment.”

Dr. Weisenburger Expert Report

Day 7: 4/10/2019 – Dr. Dennis Weisenburger cross-examination by Tarek Ismail (resumed). Redirect examination by Michael Miller. Recross-examination by Tarek Ismail. Further re-direct examination by Michael Miller. Further recross-examination by Tarek Ismail.

Mark Martens video testimony (resumed).

William Reeves video testimony. Mr. Reeves is Global Health and Safety Issues Management Lead at Bayer Crop Science.

Day 8: 4/11/2019 – Dr. William Robert Sawyer, toxicologist, direct examination by Brent Wisner. Cross-examination by Kelly Evans. Redirect examination by Brent Wisner.

William Reeves video testimony (resumed)

Day 9: 4/15/19 – William Reeves video testimony (resumed)

William Heydens video testimony (Monsanto Regulatory Product Safety Assessment Lead)

Michael Koch video testimony (Product Safety Team Lead, Bayer Crop Science)

Day 10: 4/16/19 – Michael Koch video testimony (resumed)

William Pease, direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr. Redirect examination by Brent Wisner.

Dr. Pease, toxicologist and assistant adjunct professor at the School of Public Health, University of California at Berkeley. In the early 90s he was a Research Toxicologist at UC Berkeley, where he coordinated the school’s Environmental Health Policy Program and conducted research on the impacts of pesticide use in California. Dr. Pease served as the co-chair of the Human Health Committee of CalEPA’s Comparative Risk Project, organizing its risk assessment and risk ranking process.

Michael Koch video testimony (resumed)

Aaron Blair video testimony. Dr. Blair currently serves as an advisor on the Chlordecone Scientific Committee (Institute National du Cancer, France), Pesticide Advisory Committee (Carex Canada), and Independent Advisory Board for Exposure Assessment (Institute of Occupational Medicine, Scotland). He has authored/coauthored more than 500 papers on occupational and environmental causes of cancer, other diseases, and epidemiologic methodology.

Daniel Goldstein video testimony. Dr. Goldstein works for Monsanto as Monsanto Lead Medical Sciences and Outreach.

Day 11: 4/17/2019 – Charles Benbrook, scientist and agricultural economist, direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr. Redirect by Brent Wisner.

Kavitha Raj video testimony. Dr. Kavitha Raj is the treating physician for Mr. and Mrs. Pilliod.

Day 12: 4/18/2019 – Kavitha Raj video testimony (resumed)

Alberta Pilliod direct examination by Brent Wisner. Cross-examination by Eugene Brown, Jr.

Alva Pilliod direct examination by Brent Wisner

Michael Pilliod direct examination by Michael Miller

Alberta and Alva Pilliod are the plaintiffs in this case. Michael Pilliod is their son.

James Rubenstein video testimony

Dr. Rubenstein, attending physician in hematology and oncology from the University of California San Francisco, was Alberta Pilliod’s treating physician.

Day 13: 4/22/2019 – Neel Gupta video testimony. Dr. Gupta is Alberta Pilliod’s physician.

Chadi Nabhan direct examination by Michael Miller. Voir dire examination by Tarek Ismail. Direct examination by Michael Miller.

Dr. Chadi Nabhan is a board-certified clinical medical oncologist and past Assistant Professor of Medicine at the University of Chicago. Currently, Dr. Nabhan serves as Medical Director of Cardinal Health. His clinical practice and academic research for the past 17 years has focused on lymphomas.

Expert Report of Dr. Nabhan

Day 14: 4/23/2019 – Alberta Pilliod 402 hearing (out of the presence of the jury). Direct examination by Brent Wisner. Cross-examination by Tarek Ismail. Redirect examination by Brent Wisner.

Chadi Nabhan testimony (continued). Direct examination by Michael Miller. Cross-examination by Tarek Ismail. Redirect examination by Michael Miller. Recross-examination by Tarek Ismail.

Direct examination of James Mills by Michael Miller. Cross-examination by Tarek Ismail.

Mr. Mills is a forensic economist.

Video testimony of Samuel Murphey. Mr. Murphey is Head of Global Issues Management, Bayer Crop Science.

Video testimony of James Guard. Mr. Guard is Global Roundup Lawn & Garden Lead, Bayer Crops Science.

Plaintiffs rest.

Day 15: 4/25/2019 – Proceedings without jury present.

Day 16: 4/27/2019 – Testimony of defense expert witness, Celeste Bello.

Direct examination by Tarek Ismail. Voir dire examination by Brent Wisner. Direct examination resumed by Tarek Ismail. Cross-examination by Brent Wisner. Redirect examination by Tarek Ismail. Recross-examination by Brent Wisner.

Dr. Bello is a hematologist and oncologist at the Moffitt Cancer Center.

Day 17: 4/30/2019 – Testimony of defense expert witness, Robert Phalen.

Direct examination by Kelly Evans. Voir dire examination by Brent Wisner. Direct examination resumed by Kelly Evans. Cross-examination by Brent Wisner. Redirect examination Kelly Evans. Recross-examination by Brent Wisner.

Dr. Phalen is an associate professor in industrial hygiene and safety at the University of Houston, Clear Lake.

Day 18: 5/1/2019 – Testimony of defense expert witness, Lorelei Mucci.

Direct examination by Kelly Evans. Voir dire examination by Michael Miller. Direct examination resumed by Kelly Evans. Cross-examination by Michael Miller. Redirect examination by Kelly Evans. Recross-examination by Michael Miller.

Dr. Mucci is an Associate Professor of Epidemiology at Harvard T.H. Chan School of Public Health and Assistant Professor of Medicine at Harvard Medical School.

Day 19: 5/6/2019 – Testimony of defense expert witness, Alexandra Levine.

Direct examination by Tarek Ismail. Voir dire examination by Michael Miller. Direct examination resumed by Tarek Ismail. Cross-examination by Michael Miller. Redirect examination by Tarek Ismail. Recross-examination by Michael Miller.

Dr. Levine is a professor in City of Hope’s Hematologic Malignancies and Stem Cell Transplantation Institute.

Defendant rests.

Day 20: 5/7/2019 – Proceedings without jury present.

Pilliod v. Monsanto Company Trial Exhibits

Plaintiffs’ Trial Exhibits

The jury in Bayer AG’s third Roundup weedkiller trial was urged by a plaintiffs’ lawyer to consider socking the company with $1 billion in damages as punishment for covering up the health risks of the herbicide for decades.

The aggressive demand on behalf an elderly couple who claim they got cancer from exposure to Roundup shows that plaintiffs are becoming bolder after winning the first two trials against Bayer, which together yielded $159 million in damages.

The couple’s attorney said the billion-dollar request is roughly based on the gross profit of $892 million recorded in 2017 by the agricultural-chemicals division of Monsanto, which was making Roundup long before Bayer acquired the company last year.

“That is a number that changes things,” lawyer Brent Wisner said Wednesday at the close of a trial in state court in Oakland, California. He also asked the jury to award about $55 million to compensate Alva and Alberta Pilliod for economic damages like hospital bills and noneconomic losses such as pain and suffering.

Investors have been closely watching developments in the costly Roundup litigation, and Bayer fell as much as 2.6% Thursday in Frankfurt. The shares have fallen about 40 percent since the $63 billion Monsanto purchase was completed in June.

Wisner argued that Monsanto’s internal data and documents reveal its “manipulation and fabrication of science,” just like other defective products that got to market based on fraudulent representations that they were safe.

An attorney for the company sought Wednesday to poke holes in the Pilliods’ efforts to show that they wouldn’t have developed non-Hodgkin lymphoma if they hadn’t used Roundup for landscaping their properties over a period of 30 years.

Tarek Ismail told the jury that’s an impossible, illogical conclusion given that Alva Pilliod’s weakened immune system greatly increased his risk of developing cancer. Digging into Pilliod’s medical history, Ismail cited 22 different types of skin cancers starting in his 20s, five brain infections starting in the late 1970s caused by herpes, other viral infections and colitis.

“You put this picture together and what do you see?” Ismail asked. “How anyone can stand here and deny this evidence of a weakened immune system is incredible.”

Alberta Pilliod, who Ismail said started smoking before she was 20 years old, similarly suffered from conditions that increased her risk of developing non-Hodgkins lymphoma, the lawyer said. He highlighted testimony from a doctor for the couple to argue her cancerous tumor wasn’t a type associated with exposure to herbicides, “full stop.”

Bayer Chief Executive Officer Werner Baumann faces increased shareholder pressure over the litigation it inherited from Monsanto. The agrochemical giant that operates out of St. Louis is the named defendant in U.S. lawsuits over Roundup filed by 13,400 people, a number that jumps by thousands with each passing quarter.

Why Bayer Shares Are Facing Such Trials Over Roundup: QuickTake

Bayer denies that Roundup causes cancer and the company has been holding out hope for a court win that would give Baumann some breathing space as the company hones its legal response to the swelling wave of litigation. A third loss, however, could force the company to accelerate talks on a global settlement, which analysts have said could top $5 billion. The judge in San Francisco handling the federal suits canceled a trial scheduled for May 20 to allow for confidential negotiations.

Plaintiffs’ lawyers, meanwhile, are honing their own arguments. In Oakland, Wisner presented evidence previous juries hadn’t seen, and portrayed internal emails and company advertising as evidence of glib disregard for consumer safety.

He played a video of an advertisement for Roundup showing a suburban man in shorts and a short-sleeved shirt killing weeds using the company’s “one-touch wand” to a soundtrack invoking the Old West. He pointed to Monsanto’s own exposure studies recommending that the herbicide be applied with chemical boots and overalls.

“That’s deliberate and knowing disregard for human safety, and it directly links to the Pilliods,” Wisner said.

An award of $1 billion would be vulnerable to a legal challenge by Bayer because courts have generally held that punitive damages shouldn’t be more than 10 times higher than compensatory damages.

The Alameda County Court case is Pilliod v. Monsanto Co. RG17862702, California Superior Court, County of Alameda (Oakland).

Mass Tort Nexus wants to thank Robin McCall and the Baum Hedlund firm for sharing their comments immediately after the trial verdict was announced.

Contact: Robin McCall, Media Relations

Baum, Hedlund, Aristei & Goldman, PC

Los Angeles – Sacramento – San Francisco

10940 Wilshire Blvd., 17^th Floor

Los Angeles, CA 90024

Phone: (310) 207-3233

Email: rmccall@baumhedlundlaw.com

Web:  https://www.baumhedlundlaw.com/pilliod-v-monsanto-trial/

SUPREME COURT OF THE UNITED STATES

MERCK SHARP & DOHME CORP. v. ALBRECHT ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 17–290. Argued January 7, 2019—Decided May 20, 2019
Petitioner Merck Sharp & Dohme Corp. manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. However, the mechanism through which Fosamax treats and prevents osteoporosis may increase the risk that patients will suffer “atypical femoral fractures,” that is, a rare type of complete, low-energy fracture that affects the thigh bone. When the Food and Drug Administration first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculativerisk of atypical femoral fractures associated with the drug. But stronger evidence connecting Fosamax to atypical femoral fractures developed after 1995. And the FDA ultimately ordered Merck to add a warning about atypical femoral fractures to the Fosamax label in 2011. Respondents are more than 500 individuals who took Fosamax andsuffered atypical femoral fractures between 1999 and 2010. Respondents sued Merck seeking tort damages on the ground that statelaw imposed upon Merck a legal duty to warn respondents and their doctors about the risk of atypical femoral fractures associated withusing Fosamax. Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-empted by federal law. Merck conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010, but Merck asserted that the FDA would have rejected that attempt.In particular, Merck claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk ofatypical femoral fractures associated with the drug. The District Court agreed with Merck’s pre-emption argument and
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
Syllabus
granted summary judgment to Merck, but the Third Circuit vacatedand remanded. The Court of Appeals recognized that its pre-emption analysis was controlled by this Court’s decision in Wyeth v. Levine, 555 U. S. 555, which held that a state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. The Court of Appeals, however,suggested that the “clear evidence” standard had led to varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d 268, 284.
Held:
1. “Clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change tothe drug’s label to include that warning. Pp. 9–15.
(a)
The Wyeth Court undertook a careful review of the history of federal regulation of drugs and drug labeling and found both a reluctance by Congress to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associatedwith their drugs and an insistence by Congress that drug manufacturers bear the responsibility for the content of their drug labels. Accordingly, this Court held in Wyeth that “absent clear evidence that the FDA would not have approved a change” to the label, the Court“will not conclude that it was impossible . . . to comply with both federal and state requirements.” 555 U. S., at 571. Applying that ruleto the facts of that case, the Court said that Wyeth’s evidence of preemption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. And second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. Pp. 10–13.
(b)
Thus, in a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfystate law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning. These conclusions flow from this Court’s precedents on impossibility pre-emption and the statutory and regulatory scheme thatthe Court reviewed in Wyeth. See 555 U. S., at 578. In particular,this Court has refused to find clear evidence of impossibility wherethe laws of one sovereign permit an activity that the laws of the othersovereign restrict or even prohibit. And as explained in Wyeth, FDA
Cite as: 587 U. S. ____ (2019) 3
Syllabus
regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” 21 CFR §314.70(c)(6)(iii)(A). Pp. 13–14.
(c) The only agency actions that can determine the answer to thepre-emption question are agency actions taken pursuant to the FDA’s congressionally delegated authority. The Supremacy Clause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And pre-emption takes place “ ‘only when and if [the agency] is acting within the scope of its congressionally delegated authority.’ ” New York v. FERC, 535 U. S. 1, 18 (some alterations omitted). P 15.
2. The question of agency disapproval is primarily one of law for a judge to decide. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped toevaluate the nature and scope of an agency’s determination, and are better suited to understand and to interpret agency decisions in light of the governing statutory and regulatory context. While contested brute facts will sometimes prove relevant to a court’s legal determination about the meaning and effect of an agency decision, such factual questions are subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury. Pp. 15–17.
852 F. 3d 268, vacated and remanded.
BREYER, J., delivered the opinion of the Court, in which THOMAS, GINSBURG, SOTOMAYOR, KAGAN, and GORSUCH, JJ., joined. THOMAS, J., filed a concurring opinion. ALITO, J., filed an opinion concurring in thejudgment, in which ROBERTS, C. J., and KAVANAUGH, J., joined.
_________________

Cite as: 587 U. S. ____ (2019) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in thepreliminary print of the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in orderthat corrections may be made before the preliminary print goes to press.
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE BREYER delivered the opinion of the Court. When Congress enacted the Federal Food, Drug, and
Cosmetic Act, ch. 675, 52 Stat. 1040, as amended, 21
U. S. C. §301 et seq., it charged the Food and Drug Administration with ensuring that prescription drugs are “safefor use under the conditions prescribed, recommended, orsuggested” in the drug’s “labeling.” §355(d). When the FDA exercises this authority, it makes careful judgmentsabout what warnings should appear on a drug’s label for the safety of consumers.
For that reason, we have previously held that “clear evidence” that the FDA would not have approved a changeto the drug’s label pre-empts a claim, grounded in statelaw, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.See Wyeth v. Levine, 555 U. S. 555, 571 (2009). We here determine that this question of pre-emption is one for a judge to decide, not a jury. We also hold that “clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justificationsfor the warning required by state law and that the FDA, in
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
Opinion of the Court
turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.
I The central issue in this case concerns federal preemption, which as relevant here, takes place when it is“‘impossible for a private party to comply with both stateand federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated withdrugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulatesthe information that appears on brand-name prescriptiondrug labels. The alleged conflict between state and federallaw in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certainassociated risks.
A The FDA regulates the safety information that appearson the labels of prescription drugs that are marketed in the United States. 21 U. S. C. §355(b)(1)(F); 21 CFR§201.57(a) (2018). Although we commonly understand a drug’s “label” to refer to the sticker affixed to a prescription bottle, in this context the term refers more broadly to the written material that is sent to the physician whoprescribes the drug and the written material that comeswith the prescription bottle when the drug is handed to the patient at the pharmacy. 21 U. S. C. §321(m). These (often lengthy) package inserts contain detailed information about the drug’s medical uses and health risks. §355(b)(1)(F); 21 CFR §201.57(a).
Cite as: 587 U. S. ____ (2019) 3
Opinion of the Court
FDA regulations set out requirements for the content, the format, and the order of the safety information on the drug label. §201.57(c). Those regulations require druglabels to include, among other things: (1) prominent “boxed” warnings about risks that may lead to death or serious injury; (2) contraindications describing any situation in which the drug should not be used because the riskof use outweighs any therapeutic benefit; (3) warnings and precautions about other potential safety hazards; and
(4) any adverse reactions for which there is some basis to believe a causal relationship exists between the drug and the occurrence of the adverse event. Ibid.
As those requirements make clear, the category inwhich a particular risk appears on a drug label is anindicator of the likelihood and severity of the risk. The hierarchy of label information is designed to “preventoverwarning” so that less important information does not “overshadow” more important information. 73 Fed. Reg. 49605–49606 (2008). It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.” Id., at 2851.
Prospective drug manufacturers work with the FDA to develop an appropriate label when they apply for FDA approval of a new drug. 21 U. S. C. §§355(a), 355(b),355(d)(7); 21 CFR §314.125(b)(6). But FDA regulationsalso acknowledge that information about drug safety may change over time, and that new information may requirechanges to the drug label. §§314.80(c), 314.81(b)(2)(i). Drug manufacturers generally seek advance permissionfrom the FDA to make substantive changes to their druglabels. However, an FDA regulation called the “changesbeing effected” or “CBE” regulation permits drug manufacturers to change a label without prior FDA approval if the change is designed to “add or strengthen a . . . warning”where there is “newly acquired information” about the
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Opinion of the Court
“evidence of a causal association” between the drug and a risk of harm. 21 CFR §314.70(c)(6)(iii)(A).
B Petitioner Merck Sharp & Dohme manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. App. 192; In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F. 3d 268, 271, 274–275 (CA3 2017). Fosamax belongs to a classof drugs called “bisphosphonates.” Fosamax and other bisphosphonates work by affecting the “bone remodeling process,” that is, the process through which bones are continuously broken down and built back up again. App.102, 111. For some postmenopausal women, the two parts of the bone remodeling process fall out of sync; the body removes old bone cells faster than it can replace them.That imbalance can lead to osteoporosis, a disease that is characterized by low bone mass and an increased risk ofbone fractures. Fosamax (like other bisphosphonates)slows the breakdown of old bone cells and thereby helps postmenopausal women avoid osteoporotic fractures. Id., at 102. However, the mechanism through which Fosamax decreases the risk of osteoporotic fractures may increase therisk of a different type of fracture. Id., at 400–444, 661–
663. That is because all bones—healthy and osteoporoticalike—sometimes develop microscopic cracks that are not due to any trauma, but are instead caused by the mechanical stress of everyday activity. Id., at 102. Those so-called “stress fractures” ordinarily heal on their own through the bone remodeling process. But, by slowing the breakdown of old bone cells, Fosamax and other bisphosphonates may cause stress fractures to progress to complete breaks that cause great pain and require surgical intervention to repair. Id., at 106–109, 139, 144–145. When that rare type of complete, low-energy fracture
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affects the thigh bone, it is called an “atypical femoral fracture.” Id., at 101.
The Fosamax label that the FDA approved in 1995 did not warn of the risk of atypical femoral fractures. 852
F. 3d, at 274–275. At that time, Merck’s scientists were aware of at least a theoretical risk of those fractures. Indeed, as far back as 1990 and 1991, when Fosamax was undergoing preapproval clinical trials, Merck scientists expressed concern in internal discussions that Fosamaxcould inhibit bone remodeling to such a “‘profound’” degree that “inadequate repair may take place” and “‘microfractures would not heal.’” App. 111–113. When Merck applied to the FDA for approval of Fosamax, Merck brought those theoretical considerations to the FDA’s attention. 852 F. 3d, at 274–275. But, perhaps because the concerns were only theoretical, the FDA approved Fosamax’s label without requiring any mention of this risk. Ibid.
Evidence connecting Fosamax to atypical femoral fractures developed after 1995. Merck began receiving adverse event reports from the medical community indicating that long-term Fosamax users were suffering atypical femoral fractures. App. 122–125. For example, Merckreceived a report from a doctor who said that hospital staffhad begun calling atypical femoral fractures the “‘Fosamax Fracture’” because “‘100% of patients in his practice who have experienced femoral fractures (without being hit by a taxicab), were taking Fosamax . . . for over 5 years. ’” Id., at 126. Merck performed a statistical analysis of Fosamax adverse event reports, concluding that these reports revealed a statistically significant incidence offemur fractures. 3 App. in No. 14–1900 (CA3), pp. A1272– A1273, A1443. And about the same time, Merck began to see numerous scholarly articles and case studies documenting possible connections between long-term Fosamax use and atypical femoral fractures. App. 106–110, 116–
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122.
In 2008, Merck applied to the FDA for preapproval tochange Fosamax’s label to add language to both the “Adverse Reaction[s]” and the “Precaution[s]” sections of thelabel. Id., at 670. In particular, Merck proposed adding a reference to “‘low-energy femoral shaft fracture’” in theAdverse Reactions section, and cross-referencing a longerdiscussion in the Precautions section that focused on the risk of stress fractures associated with Fosamax. Id., at
728. The FDA approved the addition to the Adverse Reactions section, but rejected Merck’s proposal to warn of a risk of “stress fractures.” Id., at 511–512. The FDA explained that Merck’s “justification” for the proposedchange to the Precautions section was “inadequate,” because “[i]dentification of ‘stress fractures’ may not be clearly related to the atypical subtrochanteric fracturesthat have been reported in the literature.” Id., at 511. The FDA invited Merck to “resubmit” its application and to “fully address all the deficiencies listed.” Id., at 512; see 21 CFR §314.110(b). But Merck instead withdrew its application and decided to make the changes to the Adverse Reactions section through the CBE process. App.654–660. Merck made no changes to the Precautionssection at issue here. Id., at 274.
A warning about “atypical femoral fractures” did notappear on the Fosamax label until 2011, when the FDA ordered that change based on its own analyses. Id., at 246–252, 526–534. Merck was initially resistant to the change, proposing revised language that, once again,referred to the risk of “stress fractures.” Id., at 629–634. But the FDA, once again, rejected that language. And this time, the FDA explained that “the term ‘stress fracture’ was considered and was not accepted” because, “for most practitioners, the term ‘stress fracture’ represents a minorfracture and this would contradict the seriousness of the atypical femoral fractures associated with bisphosphonate
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use.” Id., at 566. In January 2011, Merck and the FDA ultimately agreed upon adding a three-paragraph discussion of atypical femoral fractures to the Warnings and Precautions section of the Fosamax label. Id., at 223–224. The label now refers to the fractures five times as “atypical” without using the term “stress fracture.” Ibid.
C The respondents here are more than 500 individuals who took Fosamax and who suffered atypical femoralfractures between 1999 and 2010. Brief for Respondents
7. Respondents, invoking federal diversity jurisdiction, filed separate actions seeking tort damages on the groundthat, during the relevant period, state law imposed uponMerck a legal duty to warn them and their doctors aboutthe risk of atypical femoral fractures associated with usingFosamax. Id., at 1. One respondent, for example, filed a complaint alleging that she took Fosamax for roughly 10years and suffered an atypical femoral fracture. One dayin 2009, when the respondent was 70 years old, she turned to unlock the front door of her house, heard a poppingsound, and suddenly felt her left leg give out beneath her.She needed surgery, in which doctors repaired her leg witha rod and screws. She explained she would not have usedFosamax for so many years if she had known that she might suffer an atypical femoral fracture as a result. See id., at 18–19.
Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-emptedby federal law. Both Merck and the FDA have long been aware that Fosamax could theoretically increase the riskof atypical femoral fractures. But for some period of timebetween 1995 (when the FDA first approved a drug label for Fosamax) and 2010 (when the FDA decided to requireMerck to add a warning about atypical femoral fracturesto Fosamax’s label), both Merck and the FDA were unsure
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whether the developing evidence of a causal link between Fosamax and atypical femoral fractures was strongenough to require adding a warning to the Fosamax druglabel. Merck conceded that the FDA’s CBE regulationwould have permitted Merck to try to change the label toadd a warning before 2010, but Merck asserted that the FDA would have rejected that attempt. In particular,Merck pointed to the FDA’s rejection of Merck’s 2008 attempt to amend the Fosamax label to warn of the risk of “stress fractures” associated with Fosamax. On that basis, Merck claimed that federal law prevented Merck from complying with any state-law duty to warn the respondents of the risk of atypical femoral fractures associatedwith Fosamax.
The District Court agreed with Merck’s pre-emption argument and granted summary judgment to Merck, In re Fosamax (Alendronate Sodium): Products Liability Litigation, 2014 WL 1266994, *17 (D NJ, Mar. 22, 2017), but theCourt of Appeals vacated and remanded, 852 F. 3d, at 302.The Court of Appeals concluded that its pre-emption analysis was controlled by this Court’s decision in Wyeth. Ibid. The Court of Appeals understood that case as making clear that a failure-to-warn claim grounded in state law is pre-empted where there is “‘clear evidence that the FDA would not have approved a change to the . . . label.’” Id., at 280 (quoting Wyeth, 555 U. S., at 571). The Court of Appeals, however, suggested that this statement had ledto varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d, at 284.
In attempting to do so itself, the Court of Appeals held that “the Supreme Court intended to announce a standard of proof when it used the term ‘clear evidence’ in Wyeth.” Ibid. That is, the Court of Appeals believed that “[t]heterm ‘clear evidence’ . . . does not refer directly to the typeof facts that a manufacturer must show, or to the circumCite
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stances in which preemption will be appropriate.” Id., at
285. “Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change.” Ibid. And in the Court of Appeals’ view, “for a defendant to establisha preemption defense under Wyeth, the factfinder must conclude that it is highly probable that the FDA would not have approved a change to the drug’s label.” Id., at 286. Moreover and importantly, the Court of Appeals also held that “whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury.” Ibid.
Merck filed a petition for a writ of certiorari. Merck’s petition asked the Court to decide whether Merck’s case and others like it “must . . . go to a jury” to determine whether the FDA, in effect, has disapproved a state-lawrequired labeling change. In light of differences and uncertainties among the courts of appeals and state supreme courts in respect to the application of Wyeth, we granted certiorari. See, e.g., Mason v. SmithKline Beecham Corp., 596 F. 3d 387, 391 (CA7 2010) (“The Supreme Court . . . did not clarify what constitutes ‘clear evidence’”); Reckis v. Johnson & Johnson, 471 Mass. 272, 286, 28 N. E. 3d 445, 457 (2015) (“Wyeth did not define ‘clear evidence’ . . . ” (some internal quotation marks omitted)).
II We stated in Wyeth v. Levine that state law failure-towarn claims are pre-empted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations when there is “clear evidence” that the FDA would not have approved the warning that state law requires. 555 U. S., at 571. We here decide that a judge, not the jury, must decide the pre-emption question. And we elaborate Wyeth’s requirements along the way.
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A We begin by describing Wyeth. In that case, the plaintiffdeveloped gangrene after a physician’s assistant injected her with Phenergan, an antinausea drug. The plaintiffbrought a state-law failure-to-warn claim against Wyeth,the drug’s manufacturer, for failing to provide an adequatewarning about the risks that accompany various methods of administering the drug. In particular, the plaintiff claimed that directly injecting Phenergan into a patient’s vein (the “IV-push” method of administration) creates a significant risk of catastrophic consequences. And those consequences could be avoided by introducing the druginto a saline solution that slowly descends into a patient’s vein (the “IV-drip” method of administration). A juryconcluded that Wyeth’s warning label was inadequate, and that the label’s inadequacy caused the plaintiff ’s injury.On appeal, Wyeth argued that the plaintiff ’s state-law failure-to-warn claims were pre-empted because it wasimpossible for Wyeth to comply with both state law dutiesand federal labeling obligations. The Vermont Supreme Court rejected Wyeth’s pre-emption claim. Id., at 563. We too considered Wyeth’s pre-emption argument, and we too rejected it. In rejecting Wyeth’s argument, we undertook a careful review of the history of federal regulation of drugs and drug labeling. Id., at 566–568. In doingso, we “assum[ed] that the historic police powers of theStates were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id., at 565 (internal quotation marks omitted). And we found nothing within that history to indicate that the FDA’s power to approve or to disapprove labeling changes, by itself, pre-empts state law.Rather, we concluded that Congress enacted the FDCA“to bolster consumer protection against harmful products;”that Congress provided no “federal remedy for consumersharmed by unsafe or ineffective drugs”; that Congress was
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“awar[e] of the prevalence of state tort litigation;” andthat, whether Congress’ general purpose was to protectconsumers, to provide safety-related incentives to manufacturers, or both, language, history, and purpose allindicate that “Congress did not intend FDA oversight to bethe exclusive means of ensuring drug safety and effectiveness.” Id., at 574–575 (emphasis added). See also id., at 574 (“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during theFDCA’s 70-year history”).
We also observed that “through many amendments tothe FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.” Id., at 570–571. A drug manufacturer “is charged both with crafting an adequate label and withensuring that its warnings remain adequate as long as the drug is on the market.” Id., at 571. Thus, when the risks of a particular drug become apparent, the manufacturerhas “a duty to provide a warning that adequately describe[s] that risk.” Ibid. “Indeed,” we noted, “prior to2007, the FDA lacked the authority to order manufacturers to revise their labels.” Ibid. And even when “Congressgranted the FDA this authority,” in the 2007 Amendments to the FDCA, Congress simultaneously “reaffirmed the manufacturer’s obligations and referred specifically to theCBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior toFDA approval.” Ibid.
In light of Congress’ reluctance to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associated with their drugs,and Congress’ insistence on requiring drug manufacturers to bear the responsibility for the content of their drug
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labels, we were unpersuaded by Wyeth’s pre-emption argument. In Wyeth’s case, we concluded, “when the riskof gangrene from IV-push injection of Phenergan becameapparent, Wyeth had a duty” under state law “to provide a warning that adequately described that risk, and the CBEregulation permitted it to provide such a warning beforereceiving the FDA’s approval.” Ibid.
At the same time, and more directly relevant here, we pointed out that “the FDA retains authority to rejectlabeling changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental application, just as it retains such authority in reviewing all supplemental applications.” Ibid. We then said that, nonetheless, “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with bothfederal and state requirements.” Ibid. (emphasis added).
We reviewed the record and concluded that “Wyeth has offered no such evidence.” Id., at 572. We said that Wyeth’s evidence of pre-emption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. We could find “no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of IV-push versus IV-drip administration”—the matter at issue in the case. Id., at 572 (internal quotation marks omitted). Second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. The “FDA had not made an affirmative decision to preserve” the warning asit was or “to prohibit Wyeth from strengthening its warning.” Id., at 572. For those reasons, we could not “credit Wyeth’s contention that the FDA would have prevented it from adding a stronger warning about the IV-push method
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of intravenous administration.” And we could not conclude that “it was impossible for Wyeth to comply withboth federal and state requirements.” Id., at 573. We acknowledged that meeting the standard we set forth would be difficult, but, we said, “[i]mpossibility preemption is a demanding defense.” Ibid.
B The underlying question for this type of impossibility pre-emption defense is whether federal law (includingappropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law. And, of course, in order to succeed with that defense the manufacturer must show that the answer to this question is yes. But in Wyeth, we confronted that question in the context of a particular setof circumstances. Accordingly, for purposes of this case,we assume—but do not decide—that, as was true of the warning at issue in Wyeth, there is sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamaxlabel. In a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that theFDA would not approve changing the drug’s label to include that warning.These conclusions flow from our precedents on impossibility pre-emption and the statutory and regulatory scheme that we reviewed in Wyeth. See 555 U. S., at 578. In particular, “it has long been settled that state laws thatconflict with federal law are without effect.” Mutual Pharmaceutical Co., 570 U. S., at 480. But as we have cautioned many times before, the “possibility of impossibil14
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ity [is] not enough.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 625, n. 8 (2011) (internal quotation marks omitted). Consequently, we have refused to find clear evidence of such impossibility where the laws of one sovereign permit an activity that the laws of the other sovereign restrict oreven prohibit. See, e.g., Barnett Bank of Marion Cty.,
N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, and n. 21 (1984).
And, as we explained in Wyeth, 555 U. S., at 571–573, federal law—the FDA’s CBE regulation—permits drugmanufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association,” without prior approval from the FDA. 21 CFR §314.70(c)(6)(iii)(A). Of course, the FDA reviews CBE submissions and can reject label changes even after themanufacturer has made them. See §§314.70(c)(6), (7). And manufacturers cannot propose a change that is not based on reasonable evidence. §314.70(c)(6)(iii)(A). But in the interim, the CBE regulation permits changes, so adrug manufacturer will not ordinarily be able to show thatthere is an actual conflict between state and federal law such that it was impossible to comply with both.
We do not further define Wyeth’s use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, as we shall discuss, infra, at 15–17, courts should treat the critical question not as a matter of fact for a jury but as a matter of law for thejudge to decide. And where that is so, the judge must simply ask himself or herself whether the relevant federal and state laws “irreconcilably conflic[t].” Rice v. Norman Williams Co., 458 U. S. 654, 659 (1982); see ibid. (“Theexistence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute”).
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We do note, however, that the only agency actions thatcan determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’scongressionally delegated authority. The SupremacyClause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And preemption takes place “‘only when and if [the agency] isacting within the scope of its congressionally delegatedauthority, . . . for an agency literally has no power to act,let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.’” New York v. FERC, 535 U. S. 1, 18 (2002) (some alterations omitted). Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labelingstandards, see, e.g., 21 U. S. C. §355(d); 21 CFR §§201.57,314.105; by formally rejecting a warning label that would have been adequate under state law, see, e.g., 21 CFR §§314.110(a), 314.125(b)(6); or with other agency actioncarrying the force of law, cf., e.g., 21 U. S. C. §355(o)(4)(A). The question of disapproval “method” is not now before us.And we make only the obvious point that, whatever the means the FDA uses to exercise its authority, those meansmust lie within the scope of the authority Congress has lawfully delegated.
III We turn now to what is the determinative questionbefore us: Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a questionof law, normally for a judge to decide without a jury?The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not ajury. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are
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not in dispute. Moreover, judges, rather than lay juries,are better equipped to evaluate the nature and scope of anagency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize itsconsidered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges arebetter suited than are juries to understand and to interpret agency decisions in light of the governing statutoryand regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agencyaction”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questionsrespecting the . . . terms of any agency action” and its“application” are “questions of law”). To understand the question as a legal question for judges makes sense giventhe fact that judges are normally familiar with principles of administrative law. Doing so should produce greateruniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.
We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drugconsumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision),the litigants may dispute whether the drug manufacturersubmitted all material information to the FDA.
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But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury.Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiaryfactual disputes” that are part and parcel of the broader legal question. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewherebetween a pristine legal standard and a simple historicalfact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circum-stances, “‘the fact/law distinction at times has turned on adetermination that, as a matter of the sound administration of justice, one judicial actor is better positioned thananother to decide the issue in question.’” Markman, 517
U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.
IV Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards wehave described in Part II of our opinion, we vacate its judgment and remand the case to that court for furtherproceedings consistent with this opinion.
It is so ordered.
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THOMAS, J., concurring
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE THOMAS, concurring. I join the Court’s opinion and write separately to explainmy understanding of the relevant pre-emption principles and how they apply to this case. The Supremacy Clause of the Constitution provides: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall bebound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” Art. VI, cl. 2.
Under this Clause, “[w]here state and federal law ‘directlyconflict,’ state law must give way.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 617 (2011). Although the Court has articulated several theories of pre-emption, Merck’s sole argument here is that state law is pre-empted because it is impossible for Merck to comply with federal and state law.I remain skeptical that “physical impossibility” is a proper test for deciding whether a direct conflict exists between federal and state law. But even under our impossibility precedents, Merck’s pre-emption defense fails.
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I As I have explained before, it is not obvious that the “‘physical impossibility’ standard is the best proxy for determining when state and federal laws ‘directly conflict’ for purposes of the Supremacy Clause.” Wyeth v. Levine, 555 U. S. 555, 590 (2009) (opinion concurring in judgment). Evidence from the founding suggests that, underthe original meaning of the Supremacy Clause, federal law pre-empts state law only if the two are in logical contradiction. See ibid.; Nelson, Preemption, 86 Va. L. Rev. 225, 260–261 (2000). Sometimes, federal law will logically contradict state law even if it is possible for a person to comply with both. For instance, “if federal law gives an individual the right to engage in certain behavior that state law prohibits, the laws would give contradictorycommands notwithstanding the fact that an individual could comply with both by electing to refrain from the covered behavior.” Wyeth, 555 U. S., at 590 (opinion of THOMAS, J.). Merck does not advance this logical-contradictionstandard, and it is doubtful that a pre-emption defense along these lines would succeed here. “To say, as thestatute does, that [Merck] may not market a drug withoutfederal approval (i.e., without [a Food and Drug Administration (FDA)] approved label) is not to say that federal approval gives [Merck] the unfettered right, for all time, to market its drug with the specific label that was federallyapproved.” Id., at 592. Nothing in the federal brand-name-drug “statutory or regulatory scheme necessarilyinsulates [Merck] from liability under state law simplybecause the FDA has approved a particular label.” Id., at
593. The relevant question would be whether federal law gives Merck “an unconditional right to market [a] federally approved drug at all times with the precise label initially approved by the FDA,” id., at 592, or whether it instead provides a federal floor that can be supplemented by difCite
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ferent state standards, see Brief for Cato Institute as Amicus Curiae 14, n. 4. Absent a federal statutory right tosell a brand-name drug with an FDA-approved label, FDA approval “does not represent a finding that the drug, aslabeled, can never be deemed unsafe by later federalaction, or as in this case, the application of state law.” Wyeth, supra, at 592 (opinion of THOMAS, J.).
II Applying the Court’s impossibility precedents leads tothe same conclusion. The question for impossibility iswhether it was “lawful under federal law for [Merck] to dowhat state law required of ” it. Mensing, 564 U. S., at 618. Because “[p]re-emption analysis requires us to compare federal and state law,” I “begin by identifying the [relevant] state tort duties and federal labeling requirements.” Id., at 611. Respondents’ claim here is “that state lawobligated Merck to add a warning about atypical femur fractures” to the Warnings and Precautions section of Fosamax’s label. In re Fosamax (Alendronate Sodium) Prods. Liability Litig., 852 F. 3d 268, 282 (CA3 2017).Under the Federal Food, Drug, and Cosmetic Act, a manufacturer of a brand-name drug “bears responsibility for thecontent of its label at all times.” Wyeth, 555 U. S., at 570– 571 (majority opinion). The manufacturer “is charged both with crafting an adequate label and with ensuringthat its warnings remain adequate as long as the drug is on the market.” Id., at 571. Generally, to propose labeling changes, the manufacturer can submit a Prior ApprovalSupplement (PAS) application, which requires FDA approval before the changes are made. 21 CFR §314.70(b)(2018). Alternatively, under the FDA’s Changes Being Effected (CBE) regulation, if the manufacturer would liketo change a label to “add or strengthen a contraindication,warning, precaution, or adverse reaction” “to reflect newlyacquired information,” it can change the label immediately
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upon filing its supplemental application with the FDA,without waiting for FDA approval. §314.70(c)(6)(iii); see Wyeth, supra, at 568. If the FDA later disapproves theCBE application, “it may order the manufacturer to cease distribution of the drug product(s)” with the new labeling.§314.70(c)(7).
Here, Merck’s impossibility pre-emption defense failsbecause it does not identify any federal law that “prohibited [it] from adding any and all warnings . . . that would satisfy state law.” Ante, at 13. By its reference to “the Laws of the United States,” the Supremacy Clause “requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text that was produced through the constitutionally required bicameral and presentmentprocedures.” Wyeth, supra, at 586 (opinion of THOMAS, J.).Merck’s primary argument, based on various agency communications, is that the FDA would have rejected a hypothetical labeling change submitted via the CBE process.But neither agency musings nor hypothetical future rejections constitute pre-emptive “Laws” under the SupremacyClause.
As the Court describes, in 2008 Merck submitted PAS applications to add certain language regarding fractures tothe Adverse Reactions and the Warnings and Precautions sections of Fosamax’s label. Ante, at 6. In 2009, the FDA sent Merck a “complete response” letter “agree[ing] thatatypical and subtrochanteric fractures should be added” tothe Adverse Reactions section. App. 510–511. But the letter said that Merck’s proposed Warnings and Precautions language, which focused on “the risk factors for stressfractures,” was “inadequate” because “[i]dentification of‘stress fractures’ may not be clearly related to the atypicalsubtrochanteric fractures that have been reported in theliterature.” Id., at 511. In accord with FDA regulations, the letter required Merck to take one of three actions: (1)
Cite as: 587 U. S. ____ (2019) 5
THOMAS, J., concurring
“[r]esubmit the application . . . , addressing all deficienciesidentified in the complete response letter”; (2) “[w]ithdraw the application . . . without prejudice to a subsequent submission”; or (3) “[a]sk the agency to provide . . . an opportunity for a hearing,” after which “the agency will either approve” or “refuse to approve the application.” 21 CFR §314.110(b); see App. 512. As this regulation suggests and the FDA has explained, complete response letters merely “infor[m] sponsors of changes that must be made before an application can be approved, with no implication as to the ultimate approvability of the application.” 73 Fed. Reg. 39588 (2008) (emphasis added). In other words, the 2009 letter neither marked “the consummation of the agency’s decisionmaking process” nor determined Merck’s “rights or obligations.” Bennett v. Spear, 520 U. S. 154, 178 (1997) (internal quotation marks omitted). Instead, it was “of a merely tentative or interlocutorynature.” Ibid. Therefore, the letter was not a final agencyaction with the force of law, so it cannot be “Law” with pre-emptive effect.
Merck’s argument that the 2009 letter and other agency communications suggest that the FDA would have denied a future labeling change fares no better: hypotheticalagency action is not “Law.” As Merck acknowledges, itcould have resubmitted its PAS applications, sought a hearing, or changed its label at any time through the CBE process. See Reply Brief 13. Indeed, when Merck instead decided to withdraw its PAS applications, it added atypical femoral fractures to the Adverse Reactions section through the CBE process. That process also enabledMerck to add language to the Warnings and Precautionssection, but Merck did not do so. If it had, it could have satisfied its federal and alleged state-law duties—meaning that it was possible for Merck to independently satisfyboth sets of duties. Merck’s belief that the FDA would have eventually rejected a CBE application does not make
6 MERCK SHARP & DOHME CORP. v. ALBRECHT
THOMAS, J., concurring
an earlier CBE change impossible. As the Court correctly explains, “‘the possibility of impossibility [is] not enough.’” Ante, at 13–14. The very point of the CBE process is that a manufacturer can “unilaterally” make a labeling changethat does not violate other federal law, Wyeth, 555 U. S., at 573; see id., at 570; e.g., 21 U. S. C. §352, at least until the FDA rules on its application.*
Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law.
—————— *In 2007, Congress “granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval,” but even after this amendment, brand-name-drug “manufacturers remain responsible for updating their labels.” Wyeth, 555 U. S., at 567–568; see 21 U. S. C. §355(o)(4). As I understand the Court’s opinion, if proper agencyactions pursuant to this amendment, or other federal law, “prohibited the drug manufacturer from . . . satisfy[ing] state law,” state law would be pre-empted under our impossibility precedents regardless of whetherthe manufacturer “show[ed] that it fully informed the FDA of the justifications for the warning required by state law.” Ante, at 13; see, e.g., Wyeth, 555 U. S., at 576; id., at 582 (BREYER, J., concurring). Of course, the only proper agency actions are those “that are set forth in, or necessarily follow from, the statutory text,” and they must have the force of law to be pre-emptive. Id., at 586 (opinion of THOMAS, J.). I am aware of no such agency action here that prevented Merck from complying with state law.
_________________
_________________
Cite as: 587 U. S. ____ (2019) 1
ALITO, J., concurring in judgment
SUPREME COURT OF THE UNITED STATES
No. 17–290
MERCK SHARP & DOHME CORP., PETITIONER v. DORIS ALBRECHT, ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT
[May 20, 2019]
JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE KAVANAUGH join, concurring in the judgment.
I concur in the judgment because I agree with the Court’s decision on the only question that it actually decides, namely, that whether federal law allowed Merck toinclude in the Fosamax label the warning alleged to be required by state law is a question of law to be decided by the courts, not a question of fact. I do not, however, jointhe opinion of the Court because I am concerned that itsdiscussion of the law and the facts may be misleading on remand.
I I begin with the law. The Court correctly notes that a drug manufacturer may prove impossibility pre-emption by showing that “federal law (including appropriate [Food and Drug Administration (FDA)] actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law.” Ante, at 13. But in expounding further on the pre-emption analysis,the Court provides a skewed summary. While dwelling on our decision in Wyeth v. Levine, 555 U. S. 555 (2009), see ante, at 9–14, the Court barely notes a statutory provisionenacted after the underlying events in that case that may have an important bearing on the ultimate pre-emption
2 MERCK SHARP & DOHME CORP. v. ALBRECHT
ALITO, J., concurring in judgment
analysis in this case.
Under 21 U. S. C. §355(o)(4)(A), which was enacted in 2007, Congress has imposed on the FDA a duty to initiatea label change “[i]f the Secretary becomes aware of new information, including any new safety information . . . that the Secretary determines should be included in the labeling of the drug.”* This provision does not relieve drugmanufacturers of their own responsibility to maintain their drug labels, see §355(o)(4)(I), but the FDA’s “actions,” ante, at 13, taken pursuant to this duty arguably affect the pre-emption analysis. This is so because, if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified. See United States v. Chemical Foundation, Inc., 272 U. S. 1, 14–15 (1926) (“The presumption of regularity supports the official acts of public officers and, in the absence of clear evidence to the contrary, courts presume that they have properly discharged their official duties”). The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention. Cf. ante, at 13 (“the drugmanufacturer [must] show that it fully informed the FDAof the justifications for the warning required by statelaw”). Nor does §355(o)(4)(A) require the FDA to communicate to the relevant drug manufacturer that a label change is unwarranted; instead, the FDA could simplyconsider the new information and decide not to act. Cf. ante, at 13 (“[T]he FDA, in turn, [must have] informed the drug manufacturer that the FDA would not approve ——————
*Prior to October 2018, §355(o)(4)(A)’s language contained slight differences not relevant here. See Substance Use–Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub. L. 115–271, §3041(b), 132 Stat. 3942–3943, effective Oct. 24, 2018.
Cite as: 587 U. S. ____ (2019) 3
ALITO, J., concurring in judgment
changing the drug’s label to include that warning”).
Section 355(o)(4)(A) is thus highly relevant to the preemption analysis, which turns on whether “federal law (including appropriate FDA actions) prohibited the drugmanufacturer from adding any and all warnings to thedrug label that would satisfy state law.” Ante, at 13 (emphasis added). On remand, I assume that the Court of Appeals will consider the effect of §355(o)(4)(A) on the preemption issue in this case.
Two other aspects of the Court’s discussion of the legal background must also

SCOTUS Fosamax Ruling (May 20, 2019)

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning

Small Win for Defendants

Defendants Won the argument that a Judge not a jury is the proper authority to decide impossibility preemption arguments arising under the FDCA (Food and Drug Cosmetics Act, Title 21). However, the win on this one issue is a hollow victory for defendants considering the entirety of SCOTUS order and opinion.

SCOTUS ruled that judges not juries are the proper authority to decide the issue however, SCOTUS also placed significant limits on what those lower court judges could and could not consider when ruling on impossibility pre-preemption arguments like those raise by Merck in the Fosamax Case.

JUSTICE THOMAS SUMMARY OF RULING

JUSTICE THOMAS, concurring:

I join the Court’s opinion and write separately to explain my understanding of the relevant pre-emption principles and how they apply to this case.

“Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law”

Big Win for Plaintiffs

SCOTUS ruled that Judges decide however, SCOTUS went much further and defined limits on what facts and information could be considered by lower court judges when making decisions related to impossibly preemption arguments like those raised by Merck in Fosamax.

SCOTUS opinion limits the clear and convincing evidence standards to OFFICAL Acts taken by the FDA which would in general rise1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

2. If the defendant did not ask to make the specific label change (which plaintiffs allege was needed) having provided the FDA all relevant information, and the FDA OFFICIALLY denied the label change, then no pre-emption exists.

Arguments that postulate “hypotheticals” (absent either of the above official actions (facts)) are not to be considered. Communications between the defendant and the FDA, Statements by the FDA that do not constitute an official act under the law, are not to be considered.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court heard arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse event being that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referred solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

SCOTUS RULED 9-0

Additional Concurring Opinion on the judgment only (Jury vs Judge only) from Justices Cavanaugh, Alito’s  and Chief Justice Roberts could be interpreted as allowing lower court Judges to consider other Official acts by the FDA other than those delineated above however, the additional opinion did not define what official acts other than the two discussed could be considered and inasmuch as these two official actions are constitute the limit of the powers relevant to such matters, delegated to the FDA by Congress, it is doubtful that a defendant could show a lower court Judge any other document (without posing hypotheticals) that would constitute an official action taken by the FDA that would have prevented the defendant from meeting its State Law duties (impossibility preemption).

In that the only powers delegated to the FDA by Congress (powers under the law) are those defined in the two types of actions listed above, relevant to the type of impossibility preemption arguments that were raised in Fosamax, based on unofficial actions, communications and statements from the FDA (and that defendants hoped to raise in numerous other cases) the Fosamax ruling taken in its entity, is a major blow to defendants hoping to open major cracks in Wyeth v Levine.

The central issue in this case concerns federal preemption, which as relevant here, takes place when it is “‘impossible for a private party to comply with both state and federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certain associated risks.

FOSAMAX HISTORY

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

MERCK SHARP & DOHME CORP. v. ALBRECHT Opinion of the Court(excerpt)

III

We turn now to what is the determinative question before us:

Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of law, normally for a judge to decide without a jury?

The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize its considered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agency action”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questions respecting the . . . terms of any agency action” and its “application” are “questions of law”). To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.

We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury. Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiary factual disputes” that are part and parcel of the broader legal question.  Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewhere between a pristine legal standard and a simple historical fact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circumstances, “‘the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.’” Markman, 517 U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.

 IV

Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion.

It is so ordered.

____________________________________________________________

How Big Pharma’s cadre of lobbyists and congressional insiders attempt to reap major dividends, as we address the Fosamax ruling remains to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is paying off very well.

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Does Bayer Now Have $10 Billion Or More Reasons To Settle?

Order Re: Roundup MDL 2741 PTO No. 147 Re: Remand of Cases (May 21, 2019)

(MASS TORT NEXUS MEDIA) Bayer AG and its recently acquired asset Monsanto Co., lost a recent California state court trial over the Roundup weedkiller in Oakland County, California when a jury awarded the plaintiffs $2.055 billion. They were ordered to pay the blockbuster verdict to a couple who successfully showed that Roundup use caused their non-Hodgkin’s lymphoma. The plaintiffs, Alva and Alberta Pilliod of Livermore, California, claimed they used Roundup once a week for nine months of the year over three decades, when they were both diagnosed with cancer in 2011 and 2015 respectively.

Now attention has moved from the state court Roundup docket to the US District Court in San Francisco, where Judge Vince Chhabria is handling the Monsanto Roundup Glyphosate MDL 2741. Judge Chhabria has entered an order setting a tentative plan in place to remand the federal cases back to their original courts of jurisdiction for trial. (see May 21, 2019 order excerpt below)

Among the financial and legal parties who are monitoring MDL 2741 the number attached to a full  settlement looks to be somewhere around $10 billion — an average of $1 million for each of the 11,200 people who are suing over Roundup, which may be a conservative estimate.

https://www.masstortnexus.com/Briefcases/Other-Mass-Litigations/116/ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California)

The tentative bench ruling by U.S. District Judge Vince Chhabria could help Bayer AG-owned Monsanto win future cases by trying them in agricultural states where farmers heavily depend on the company’s glyphosate-based herbicides Roundup and Ranger Pro, and where medical-causation laws favor the defendants.

Chhabria is now proposing  to send them back to their home districts for trial in phases, starting with 16 cases filed in California. Cases filed in other states would be transferred in subsequent phases.

Glyphosate is the most widely used agrichemical in history. Monsanto introduced it in 1974, and its use exploded in 1996 after Monsanto introduced “Roundup-ready” seeds engineered to resist the chemical. More than 2.6 billion pounds of glyphosate were spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey.

Roundup’s product label instructs users to wear protective clothing and equipment like goggles and long-sleeved shirts while spraying Roundup, and to not breathe it in. But because the first phase of the trial was limited to causation, the jury didn’t learn about the safety instructions included on the Roundup label.

The proposal comes after a federal jury awarded plaintiff Ed Hardeman $80 million in the first bellwether trial before Chhabria in San Francisco in March. Hardeman claimed decades of Roundup use had caused his non-Hodgkin lymphoma.

RELEVANT EXCERPTS FROM MAY 21, 20-19 REMAND ORDER

• The Court will decide all case-specific summary judgment motions. In addition, because Daubert motions relating to causation are so intertwined with summary judgment, the Court will decide those as well. Ninth Circuit law will govern the Daubert motions regardless of where the case originated.1 The courts that will eventually try the cases will be left with any other pretrial motions, including motions in limine, motions to bifurcate, and Daubert motions unrelated to summary judgment.
• The Court will then group the cases by their governing state law. The first group will likely be cases governed by California law. For this group, the Court’s prior summary judgment rulings will govern, at least absent intervening authority. Therefore, to obtain summary judgment in a particular case, Monsanto will need to identify a material difference between that case and the cases for which summary judgment has already been denied. Assuming summary judgment and Daubert motions are denied for a particular case, that case will be remanded to the multi-district litigation panel for transfer back to its original district in California.
• A similar process will take place for subsequent groups of cases, but with the parties also setting forth their positions on whether the law of the state relating to causation is materially different from California law.
•  Individual states may be grouped together if it is determined that the relevant law is the same.
• Absent extraordinary circumstances, all multi-plaintiff cases must be severed into separate, individual cases, both because it is not proper for those plaintiffs to be joined under Federal Rule of Civil Procedure 20 and because severance will facilitate implementation of the above-described plan.

IT IS SO ORDERED.

Date: May 21, 2019

VINCE CHHABRIA

United States District Judge

The World Health Organization’s International Agency for Research on Cancer (IARC) did deem Roundup a probable carcinogen in 2015—and though the evidence was mixed and partially based on animal studies, some scientific research has backed that classification. The Environmental Protection Agency’s official position is that “there are no risks to public health when glyphosate is used in accordance with its current label and that glyphosate is not a carcinogen,” with the EPA reiterating this stance at the end of April.

However, Monsanto has also faced accusations that it benefited from a cozy relationship with EPA officials and that it interferedwith supposedly independent scientific reviews that concluded Roundup is safe.

DEFENSE OPPOSES REMAND

Monsanto’s attorney Brian Stekloff, of Washington-based firm Wilkinson Walsh Eskovitz, opposed the plan in court Wednesday. Remanding California cases first likely means getting verdicts in those cases first, which Stekloff said would provide no new data about the litigation given Monsanto’s three trial losses in the state. Additional losses would further weaken the company’s bargaining position in court-ordered settlement discussions.

In addition to the $80 million Hardeman verdict, Monsanto has been ordered to pay $2 billion to a married couple and $289 million – later reduced to $78.5 million – to a school groundskeeper in state court trials in Oakland and San Francisco, respectively. All three plaintiffs alleged they developed non-Hodgkin lymphoma after using Roundup. The World Health Organization’s cancer agency declared Roundup’s main ingredient glyphosate a probable human carcinogen in 2015.

Chhabria rejected Stekloff’s argument by noting the California cases will be sent to federal courts spanning the entire state.

“California is a pretty diverse state,” the judge said. “It’s not like the Bay Area.”

Some observers contend Bay Area residents are too liberal to find for Monsanto.

In a follow-up question, Chhabria clarified Stekloff’s position. “You’d want to pick a state where you think the law on causation is different?” he asked. “More favorable to the defendants?”

“Correct,” Stekloff replied.

Earlier in Wednesday’s hearing, Stekloff said Monsanto wants to try cases in states where glyphosate is “used heavily in agriculture” and has a positive reputation.

Chhabria agreed to remand cases from one additional state during the first phase, but said he will revert to just California cases if the process becomes unwieldy.

Both parties can choose states for subsequent remands. Chhabria suggested they take turns for each remand phase and group states together based on similar laws on medical causation.

Chhabria split up the San Francisco bellwether trials into causation and liability phases to avoid biasing the jury against Monsanto, and Stekloff on Wednesday asked him to formally recommend that judges who get remanded cases also bifurcate their trials.

Chhabria demurred. But “[i]f somebody called me and asked me, I’d say aside from the misconduct in the opening statement, bifurcation worked well,” he said. “It’s a little more challenging for the judge, but I think it worked well.”

The judge recently sanctioned Hardeman’s two lead trial attorneys $500 each for presenting prohibited evidence in their opening statement to the jury.

Also Wednesday, Chhabria set a Feb. 10, 2020, trial date for the next bellwether case. Originally set for this month, Chhabria postponed it to prepare the remaining cases for summary judgment by late 2019.

He also appointed Kenneth Feinberg to mediate settlement discussions between Monsanto and the plaintiff’s MDL Executive Committee. Feinberg has served as Special Master of the September 11 Victim Compensation Fund and the Asbestos Personal Injury Litigation, and as administrator of the BP Deepwater Horizon Disaster Victim Compensation Fund.

Monsanto Bad Conduct Is Revealed At Trial

* Monsanto never conducted epidemiology studies for Roundup and its other formulations made with the active ingredient glyphosate to evaluate the cancer risks for users.

* Monsanto was aware that the surfactants in Roundup were much more toxic than glyphosate alone.

* Monsanto spent millions of dollars on covert public relations campaigns to finance ghostwritten studies and articles aimed at discrediting independent scientists whose work found dangers with Monsanto’s herbicides.

* When the US Agency for Toxic Substances and Disease Registry sought to evaluate glyphosate toxicity in 2015, Monsanto engaged the assistance of EPA officials to delay that review.

* Monsanto enjoyed a close relationship with certain officials within the Environmental Protection Agency (EPA), who have repeatedly backed Monsanto’s assertions about the safety of its glyphosate products.

* The company internally had worker safety recommendations that called for wearing a full range of protective gear when applying glyphosate herbicides, but did not warn the public to do the same.

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Federal judge rules Essure personal injury cases not headed back to state court due to no initial service on Bayer 

By Mark A. York (June 24, 2019)

(MASS TORT NEXUS MEDIA) A federal judge in Pennsylvania has limited tort and breach of warranty claims in the Bayer Essure litigation in recent rulings, as well as ruling that no service at start of certain state court cases, keeps them in the federal docket.

U.S. District Court ED Pennsylvania Judge John R. Padova excerpt: 

“Plaintiffs have filed a motion to remand all 24 cases to the Court of Common Pleas of Philadelphia County. They argue that defendant Bayer HealthCare LLC, which is a named defendant in each complaint but is not one of the removing defendants, is a citizen of Pennsylvania and that the Forum Defendant Rule therefore bars removal. The removing defendants counter that the Forum Defendant Rule does not bar removal in these cases because the sole Pennsylvania defendant – Bayer HealthCare, LLC – was not ‘properly joined and served’ as it was not served with the complaint prior to removal,” Padova later adding “that the plaintiffs could have prevented the consequence of his ruling by sending the complaint to all of its named defendants, simultaneously with its filing.”

Bayer Essure USDC ED Pennsylvania Order Denying Motion to Remand May 24, 2019 (Judge Padova)

Additional recent rulings by the same judge, which are favorable to Bayer, state that express pre-emption applied to many of the plaintiffs’ claims as well as those that failed to be filed within the statute of limitations.

The judge ruled on:

• Statute of limitations — whether time had run out on cases
• Discovery rule — an exception to the statute of limitations for tort claims that applies in certain cases
• Breach of warranty — refers to a company’s failure to live up to a claim made about a product
• Fraudulent concealment — when a company hides a fact that it had a duty to disclose

In a recent 60-page opinion, U.S. District Judge John Padova of the Eastern District of Pennsylvania weighed the claims of a dozen women suing Bayer over the device and determined that many should be dismissed at the summary judgment phase because they were not brought within the allowable time frame.

Padova commented that the ruling is meant to give guidance to the parties litigating over 1,000 defective device lawsuits in state and federal courts.

NO REMAND TO PHILLY COURT

Twenty-four personal injury cases filed against Bayer Pharmaceuticals from women who used its Essure birth control device will not be returning to the Philadelphia County Court of Common Pleas, per a recent federal court ruling.

In an order dated May 24, U.S. District Court for the Eastern District of Pennsylvania Judge John R. Padova disagreed with the plaintiffs’ assertion that a state court had subject matter jurisdiction over the disputes.

Essure are metal coils placed in a woman’s fallopian tubes, which serve as a blockage device for the tubes to prevent pregnancy.

“Essure is a Class III medical device that received Conditional Premarket Approval from the Food and Drug Administration (FDA) before it was marketed to the public. The complainants allege that, instead of working as intended, the Essure device ‘migrates from the fallopian tubes, perforates organs, breaks into pieces and/or corrodes. Each plaintiff had Essure implanted and, as a result, suffered severe and permanent injuries,” Padova previously said.

The plaintiffs brought a number of claims sounding in negligence against Bayer – specifically, negligent training, negligent risk management, breach of express warranty, negligent misrepresentation and negligent failure to warn, alleging the company failed to warn doctors, patients or the FDA about the supposed dangers of the Essure device.

Defendants Bayer Corporation, Bayer U.S. LLC, Bayer Essure Inc., and Bayer HealthCare Pharmaceuticals Inc. removed the cases to federal court, asserting jurisdiction based on diversity of citizenship. On Jan. 4, defendants filed their notices of removal with the state court.

Bayer asserted the cases were properly heard in federal court due to state law claims turning on construction of federal law, but the plaintiffs countered that the Forum Defendant Rule prohibits Bayer from removing based on diversity of citizenship.

“Plaintiffs have filed a motion to remand all 24 cases to the Court of Common Pleas of Philadelphia County. They argue that defendant Bayer HealthCare LLC, which is a named defendant in each complaint but is not one of the removing defendants, is a citizen of Pennsylvania and that the Forum Defendant Rule therefore bars removal. The removing defendants counter that the Forum Defendant Rule does not bar removal in these cases because the sole Pennsylvania defendant – Bayer HealthCare, LLC – was not ‘properly joined and served’ as it was not served with the complaint prior to removal,” Padova stated.

See https://www.masstortnexus.com/Briefcases/46/ESSURE-(Bayer)-Philadelphia-Court-of-Common-Pleas for related docket information.

“Plaintiffs maintain, however, that Bayer HealthCare, LLC was ‘properly joined and served’ because plaintiffs served it with the writs of summons. Thus, the primary question raised by plaintiffs’ motion is whether service with a writ of summons suffices to satisfy the ‘properly joined and served’ condition of the Forum Defendant Rule.”

Padova said that the plaintiffs could have prevented the consequence of his ruling by sending the complaint to all of its named defendants, simultaneously with its filing.

“While the rule we apply today encourages some level of gamesmanship because it arguably encourages defendants who have been served with writs of summons to strategically remove before a forum defendant is properly served with the complaint, we are confident that the rule’s effect in this regard will be slight,” Padova said.

In citing precedent from the U.S. Court of Appeals for the Third Circuit which concluded that the practical outcome of that interpretation of the Forum Defendant Rule is not “so outlandish as to constitute an absurd or bizarre result” – and thus, concluded that “a writ of summons does not suffice to satisfy the ‘properly joined and served’ condition of the Forum Defendant Rule, and thus the Forum Defendant Rule does not prohibit removal of this action to this court where Bayer HealthCare, LLC was not properly served with the complaint prior to removal.”

“For the foregoing reasons, we deny plaintiffs’ motion to remand,” Padova said.

U.S. District Court for the Eastern District of Pennsylvania cases 2:14-cv-07315 et al

Philadelphia County Court of Common Pleas cases 180202502 et al

Essure USDC ED Pennsylvania Ruling Barring Tort and Warranty Claims March 27, 2019 (Padova, J)

______________________________________________________

Opinion in Essure USDC ED Pennsylvania Ruling Barring Tort and Warranty Claims March 27, 2019 (Padova, J)

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

HELEN McLAUGHLIN                            CIVIL ACTION NO. 14-7315

BAYER ESSURE, INC., et al.

And Related Actions

1. 14-7316 (Ruble) NO. 16-3732 (Gross)
2. 14-7318 (Stelzer) NO. 16-3733 (Johnson)
3. 14-7317 (Strimel) NO. 16-3766 (Summerlin)
4. 15-0384 (Walsh) NO. 16-3767 (Rodvill)
5. 16-1458 (Dunstan) NO. 16-3769 (Quinton)
6. 16-1645 (Clarke) NO. 16-4081 (Bradford)

: NO. 16-1921 (Souto)                 NO. 17-2915 (Wistrom)

: NO. 16-2166 (Bailey)                 NO. 17-3968 (Bobo)

: NO. 16-2154 (Campos)             NO. 17-4417 (Guess)

: NO. 16-2717 (Bolds)                  NO. 17-4936 (Gonzalez)

: NO. 16-3049 (Tulgetske)            NO. 18-37 (Jenson)

: NO. 16-3409 (Abeyta)                NO. 18-836 (Morua)

: NO. 16-3589 (Burgis)                 NO. 18-837 (Galan)

: NO. 16-3710 (Dong)                  NO. 18-838 (Alfaro)

: NO. 16-3730 (Mantor)               NO. 18-908 (Archer)

: NO. 16-3731 (Olague)

MEMORANDUM

Opinion in Essure USDC ED Pennsylvania Ruling Barring Tort and Warranty Claims March 27, 2019 (Padova, J) (link is above)

Padova, J. March 27, 2019

Essure Statute of Limitations

Defendants in Essure personal injury cases have argues that the statute of limitations period in all Essure cases should begin on November 18, 2016, the date the FDA approved a black box warning (its strongest warning level) for Essure. In reality, the dates triggering Essure limitation periods will vary, with the beginning of each plaintiff’s limitation period will depend on the plaintiff’s individual claims and state law applicable to the particular case.

Bayer Stops USA Sales

Bayer announced in June 2018 that it would voluntarily discontinue U.S. sales of Essure by the end of this year “for business reasons” but earlier this month affirmed the safety profile of the device. Last week, Bayer took Netflix to task over the accuracy of its medical device documentary “The Bleeding Edge.” The tide was turning for Bayer at that point, sales were already down 70% after the 2016 FDA warning and the public became aware of the risks of using Essure.

Bayer received FDA approval to sell Essure in 2002 and promoted it as a quick and easy permanent solution to unplanned pregnancies. Essure consists of two thin-as-spaghetti nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman’s eggs.

Because of the reported complaints, the FDA added its most serious warning to the device in 2016 and ordered the company to conduct a 2,000-patient study. FDA Commissioner Scott Gottlieb said Friday, the agency would work with Bayer to continue the study, but noted “Bayer will not be able to meet its expected enrollment numbers” for new patients. The study was designed to follow patients for three years to better assess complications.

Gottlieb said the FDA will continue to monitor adverse events reported to its database after Essure is removed from the market.  He stated “I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so,” and added “Those who think it’s causing problems, such as persistent pain, should consult with their doctors,” with Gottlieb further noting that device removal “has its own risks.”

Essure’s original label warned that the device’s nickel can result in allergic reactions. Its current labeling lists hives, rash, swelling and itching as possible reactions.

But many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. Those problems are listed in the current FDA labeling for the device, with the qualifier: “It is unknown if these symptoms are related to Essure or other causes.”

Informational material Bayer supplied to doctors and patients lists potential problems and states the devices are meant to be permanent. It also says removal may require complicated surgery, including a hysterectomy, that might not be covered by insurance.

Bayer is currently facing more than 30,000 additional lawsuits over various products across the United States, as referenced in the Bayer 2018 Annual Report, see link: https://www.bayer.com/en/bayer-annual-report-2018.pdfx.

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Note: (Excerpts within this article include Penn Record materials and other online media sources)

Did Trump and Epstein Rape Two Underage Girls?

Before we address the question, Did Trump and Epstein Rape Two Underage Girls” we will first discuss Attorney General Bob Barr’s highly unusual decision to un-recuse himself from the Epstein case and actually take direct control over the case, despite have previously announced he was conflicted from having anything to do with the matter.

Why did Barr Un-Recuse?

Mass Tort Nexus researcher, Mark York, discovered a civil lawsuit filed in 2016 by Katie Johnson (now an adult), she accuses Trump and Epstein of committing multiple acts of sexual violence against herself (13 at the time) as well as a 12-year-old. (see excerpts below or download the complaint at:

Donald Trump – Jeffrey Epstein Federal Complaint (USDC California 2016) Re: Minor Sex Abuse

Given Epstein’s history of secretly taping famous people taking sexual advantage of young women procured by Epstein, if the allegations in the Johnson complaint are true, Trump has every reason to be concerned that tapes might exist which would prove Johnson’s allegations.

Would Bob Barr Obstruct Justice to protect Trump?

Evidence to date would suggest that Bob Barr is more than willing to pervert our justice system and even defy elected officials to protect his boss.

Would Trump ask Barr to Un-Recuse Himself?

The Presidents history (in his own words) related to Jeff Session’s recusal from the Russia Probe and subsequent refusal to un-recuse himself provide strong evidence that the President would ask an attorney general to un-recuse himself despite any previously addressed conflicts.

Why would Trump want his loyal Protector in Chief (Barr) in charge of the Epstein matter?

The remainder of this article will provide information on which the reader can draw their own conclusions as to why Trump may need Barr to interfere in the Epstein Case.

White House Initial Reactions to Epstein Indictment

Kellyanne Conway took the airways shortly after the new Epstein indictment was announced claiming that the president had not talked to nor seen Epstein in 10 to 15 years. If this claim was intended give the impression that the President and his hold friend had not cross paths in over a decade, the Lawsuit filed by Katie Johnson against Trump and Epstein in 2016 (co-defendants) accusing the pair of committing multiple acts of sexual violence against Johnson (then 13) and another girl (12 at the time) makes the statements made by Kellyanne Conway highly questionable. (see excerpts from complaint below)

Also See:

https://www.politico.com/story/2019/07/09/trump-jeffrey-epstein-kellyanne-conway-1402997

NOT FAKE NEW’s

After reading the excepts provided below from the Johnson complaint, you decide is Trump may need someone (Barr) to run interference on his behalf before the Epstein matter spills over and creates yet another potential reason Trump may have to be concerned about his future, not just as President but also as total loss of his choice of clothing (being restricted to a single orange jumpsuit).

Excerpts from Complaint:

FACTUAL ALLEGATIONS

The Plaintiff, Katie Johnson, alleges that the Defendants, Donald J. Trump and Jeffrey E. Epstein, did willfully and with extreme malice violate her Civil Rights under 18 U.S.C. ; 2241 by sexually and physically abusing Plaintiff Johnson by forcing her to engage in various perverted and depraved sex acts by threatening physical harm to Plaintiff Johnson and also her family. The Plaintiff, Katie Johnson, alleges that the Defendants, Donald J. Trump and Jeffrey E. Epstein, also did willfully and with extreme malice violate her Civil Rights under 42 U.S.C.; 1985 by conspiring to deny Plaintiff Johnson her Civil Rights by making her their sex slave.

The Plaintiff, Katie Johnson, alleges she was subject to extreme sexual and physical abuse by the Defendants, Donald J. Trump and Jeffrey E. Epstein, including forcible rape during a four month time span covering the months of June-September 1994 when Plaintiff Johnson was still only a minor of age 13.

The Plaintiff, Katie Johnson, alleges she was enticed by promises of money and a modeling career to attend a series of underage sex parties held at the New York City residence of Defendant Jeffrey E. Epstein and attended by Defendant Donald J. Trump.

On the first occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was forced to manually stimulate Defendant Trump with the use of her hand upon Defendant Trump’s erect penis until he reached sexual orgasm.

On the second occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was forced to orally copulate Defendant Trump by placing her mouth upon Defendant Trump’s erect penis until he reached sexual orgasm.

On the third occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson was forced to engage in an unnatural lesbian sex act with her fellow minor and sex slave, Maria Doe age 12, for the sexual enjoyment of Defendant Trump. After this sex act, both minors were forced to orally copulate Defendant Trump by placing their mouths simultaneously on his erect penis until he achieved sexual orgasm. After zipping up his pants, Defendant Trump physically pushed both minors away while angrily berating them for the “poor” quality of their sexual performance.

On the fourth and final sexual encounter with the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was tied to a bed by Defendant Trump who then proceeded to forcibly rape Plaintiff Johnson. During the course of this savage sexual attack, Plaintiff Johnson loudly pleaded with Defendant Trump to “please wear a condom”. Defendant Trump responded by violently striking Plaintiff Johnson in the face with his open hand and screaming that “he would do whatever he wanted” as he refused to wear protection. After achieving sexual orgasm, the Defendant, Donald J. Trump put his suit back on and when the Plaintiff, Katie Johnson, in tears asked Defendant Trump what would happen if he had impregnated her, Defendant Trump grabbed his wallet and threw some money at her and screamed that she should use the money “to get a fucking abortion”.

On the first occasion involving the Defendant, Jeffrey E. Epstein, the Plaintiff, Katie Johnson, was forced to disrobe into her bra and panties and to give a full body massage to Defendant Epstein while he was completely naked. During the massage, Defendant Epstein physically forced Plaintiff Johnson to touch his erect penis with her bare hands and to clean up his ejaculated semen after he achieved sexual orgasm.

On the second occasion involving the Defendant, Jeffrey Epstein, the Plaintiff, Katie Johnson, was again forced to disrobe into her bra and panties while giving Defendant Epstein a full body massage while he was completely naked. The Defendant, Donald J. Trump, was also present as he was getting his own massage from another minor, Jane Doe, age 13. Defendant Epstein forced Plaintiff Johnson to touch his erect penis by physically placing her bare hands upon his sex organ and again forced Plaintiff Johnson to clean up his ejaculated semen after he achieved sexual orgasm.

Shortly after this sexual assault by the Defendant, Jeffrey E. Epstein, on the Plaintiff, Katie Johnson, Plaintiff Johnson was still present while the two Defendants were arguing over who would be the one to take Plaintiff Johnson’s virginity. The Defendant, Donald J. Trump, was clearly heard referring to Defendant, Jeffrey E. Epstein, as a “Jew Bastard” as he yelled at Defendant Epstein, that clearly, he, Defendant Trump, should be the lucky one to “pop the cherry” of Plaintiff Johnson.

The third and final sexual assault by the Defendant, Jeffrey E. Epstein, on the Plaintiff, Katie Johnson, took place after Plaintiff Johnson had been brutally and savagely raped by Defendant Trump. While receiving another full body massage from Plaintiff Johnson, while in the nude, Defendant Epstein became so enraged after finding out that Defendant Trump had been the one to take Plaintiff Johnson’s virginity, that Defendant Epstein also violently raped Plaintiff Johnson.

After forcing Plaintiff Johnson to disrobe into her bra and panties, while receiving a massage from the Plaintiff, Defendant Epstein attempted to enter Plaintiff Johnson’s anal cavity with his erect penis while trying to restrain her. Plaintiff Johnson attempted to push Defendant Epstein away, at which time Defendant Epstein attempted to enter Plaintiff Johnson’s vagina with his erect penis. This attempt to brutally sodomize and rape Plaintiff Johnson by Defendant Epstein was finally repelled by Plaintiff Johnson but not before Defendant Epstein was able to achieve sexual orgasm. After perversely sodomizing and raping the Plaintiff, Katie Johnson, the Defendant, Jeffrey E. Epstein, attempted to strike her about the head with his closed fists while he angrily screamed at Plaintiff Johnson that he, Defendant Epstein, should have been the one who “took her cherry, not Mr. Trump”, before she finally managed to break away from Defendant Epstein.

The Plaintiff, Katie Johnson, was fully warned on more than one occasion by both Defendants, Donald J. Trump and Jeffrey E. Epstein, that were she ever to reveal any of the details of the sexual and physical abuse that she had suffered as a sex slave for Defendant Trump and Defendant Epstein, that Plaintiff Johnson and her family would be in mortal danger. Plaintiff Johnson was warned that this would mean certain death for herself and Plaintiff Johnson’s family unless she remained silent forever on the exact details of the depraved and perverted sexual and physical abuse she had been forced to endure from the Defendants.

MATERIAL WITNESSES

Tiffany Doe, a former trusted employee of the Defendant, Jeffrey E. Epstein, has agreed to provide sworn testimony in this civil case and any other future civil or criminal proceedings, fully verifying the authenticity of the claims of the Plaintiff, Katie Johnson. Witness Tiffany Doe was employed by the Defendant, Jeffrey E. Epstein, for more than 10 years as a party planner for his underage sex parties. Despite being subject to constant terroristic threats by Defendants Epstein and Trump to never reveal the details of these underage sex parties at which scores of teenagers, and pre-teen girls were used as sex slaves by Defendant Epstein and Defendant Trump, witness Tiffany Doe refuses to be silent any longer. She has agreed to fully reveal the extent of the sexual perversion and physical cruelty that she personally witnessed at these parties by Defendants Epstein and Trump.

Material witness Tiffany Doe fully confirms all of Plaintiff Katie Johnson’s allegations of physical and sexual abuse by Defendants Donald J. Trump and Jeffrey E. Epstein. Tiffany Doe was physically present at each of the four occasions of sexual abuse by Defendant Trump upon the person of Plaintiff Johnson, as it was her job to witness all of the sexual escapades of Defendant Epstein’s guests at these underage sex parties and later reveal all of the sordid details directly to Defendant Epstein. Defendant Epstein also demanded that Tiffany Doe tell him personally everything she had overheard at these parties explaining to her that “knowledge was king” in the financial world. As a result of these underage sex parties, Defendant Epstein was able to accumulate inside business knowledge that he otherwise would never have been privy to in order to amass his huge personal fortune.

Material witness Tiffany Doe will testify that she was also present or had direct knowledge of each of the three instances on which Defendant Jeffrey E. Epstein physically and sexually abused the Plaintiff, Katie Johnson. Tiffany Doe will testify to the fact that the Plaintiff, Katie Johnson, was extremely fortunate to have survived all of the physical and sexual horrors inflicted upon her by Defendants Epstein and Trump.

(end excerpts from Johnson Complaint)

Would Trump Do Such Things? 

“The fact that Donald Trump had a friendly relationship with Epstein — he told New York Magazine in 2002 that “(Epstein’s) a lot of fun to be with … It is even said that he likes beautiful women as much as I do, and many of them are on the younger side”

http://nymag.com/nymetro/news/people/n_7912/

Not Just Locker Room Talk

Is it Normal to Agree that your Daughter is a “Hot Piece of Ass? 

More Creepy Daddy Moments 

Do You Enjoy Kissing Your Daughter More than Kissing  your Wife?

Daddy Really Loves His Little Girl

Trump and Epstein Like Them Young

10 Creepy Things Donald Trump Has Said About Ivanka

Conclusion

Do you think Trump has a reason to want Bob Barr heading up the Epstein case?

Do you think Barr would be willing to run interference for Trump, even if it meant giving Epstein a break?

Do you think Trump might engage in the acts alleged in the Johnson Complaint?

Will Trump Supporters be OK with this?

More Background Information 

In case you have not been following the Epstien Case, the following should get you up to speed:

Other News and Links:

Donald Trump and Prince Andrew met up in London ahead of Jeffrey Epstein’s arrest on new sex trafficking charges

.@MotherJones' description of Trump's modeling agency is eerily similar to parts of Epstein's scheme as well.

Though there is less reporting on this, Trump seems to have illegally brought girls as young as 14 to the U.S. to work uncompensated. Sounds a lot like trafficking, no? pic.twitter.com/9ex97YM6B8

— Ian Madrigal – The Monopoly Man (@iansmadrig) November 30, 2018

By Mark A. York (July 11, 2019)

Past, Present and Future of Surgical Mesh With References

Abstract

Surgical mesh, in particular those used to repair hernias, have been in use since 1891. Since then, research in the area has expanded, given the vast number of post-surgery complications such as infection, fibrosis, adhesions, mesh rejection, and hernia recurrence. Researchers have focused on the analysis and implementation of a wide range of materials: meshes with different fiber size and porosity, a variety of manufacturing methods, and certainly a variety of surgical and implantation procedures. Currently, surface modification methods and development of nanofiber based systems are actively being explored as areas of opportunity to retain material strength and increase biocompatibility of available meshes. This review summarizes the history of surgical meshes and presents an overview of commercial surgical meshes, their properties, manufacturing methods, and observed biological response, as well as the requirements for an ideal surgical mesh and potential manufacturing methods.

Keywords: surgical mesh, hernia repair, abdominal wall reconstruction, biocompatibility

1. Introduction

A hernia is defined as a protrusion or projection (prolapse) of an organ through the wall of the cavity where it is normally contained [1]. There are many types of hernia, mostly classified according to the physical location, with the abdominal wall being the most susceptible site. Specifically, reports show that the most frequently seen hernia is the inguinal hernia (70–75% of cases), followed by femoral (6–17%) and umbilical (3–8.5%) hernias [2]. Hernias are also found in other sites such as the ventral or epigastric hernia, located between the chest cavity and the umbilicus.

Hernias can be uncomfortable and are sometimes accompanied by severe pain, which worsens during bowel movements, urination, heavy lifting, or straining [3]. Occasionally, a hernia can become strangulated, which occurs when the protruding tissue swells and becomes incarcerated. Strangulation will interrupt blood supply and can lead to infection, necrosis, and potentially life-threatening conditions [4].

Hernia repair is one of the most common surgical procedures performed globally. It is estimated that there are over 20 million hernia repair procedures per year worldwide [5]. The number of procedures has been increasing and is predicted to further increase due to several risk factors such as obesity and prior abdominal surgeries [6]. Hernia repairs provide an important revenue stream for hospitals, estimated at $48 billion/year in the United States [7].

The use of hernia mesh products to surgically repair or reconstruct anatomical defects has been widely adopted: in fact, more than 80% of hernia repairs performed in United Sates use mesh products [8]. The surgical mesh firmly reinforces the weakened area and provides tension-free repair that facilitates the incorporation of fibrocollagenous tissue [9]. However, there are many types of meshes and there is a strong controversy regarding optimum performance and success of surgical procedures. Researchers have investigated metals, composites, polymers and biodegradable biomaterials in their quest to attain the ideal surgical mesh and implantation procedure [10]. The sought-after characteristics are inertness, resistance to infection, the ability to maintain adequate long-term tensile strength to prevent early recurrence, rapid incorporation into the host tissue, adequate flexibility to avoid fragmentation, non-carcinogenic response and the capability to maintain or restore the natural respiratory movements of the abdominal wall [9].

Currently, utilized surgical meshes exhibit many but not all of the desired characteristics [8]. Therefore, current research efforts focus on providing potential solutions that range from the utilization of novel materials to new designs that could ameliorate existent shortcomings [11]. The aim of this review is to illustrate the current research in surgical meshes used for hernia repair. This review provides a perspective of existent commercial surgical meshes, their properties, manufacturing procedures, and observed biological responses. Furthermore, the article seeks to establish the requirements for an ideal surgical mesh and potential manufacturing procedures.

2. History

In 1890, Theodor Billroth suggested that the ideal way to repair hernias was to use a prosthetic material to close the hernia defect [12]. Many materials were used, but all failed due to infections, rejections, and recurrences [13]. Surgeons concluded that the main problem was built upon the multifilament suture material, which has been proven unsuitable in many other surgical procedures [14]. Surgeons became disenchanted with the popular cotton and silk sutures because of the frequently observed rejection syndrome and resultant endless recurring infections. The use of such sutures to secure mesh in place undoubtedly contributed to aggravate the existing bias against the surgical meshes [15].

In 1955, Dr. Francis Usher focused his attention on the materials that could solve existing problems. Nylon, Orlon, Dacron and Teflon were studied and were observed to have a variety of shortcomings such as: foreign body reaction, sepsis, rigidity, fragmentation, loss of tensile strength and encapsulation [16]. All of these precluded the acceptance of polymeric materials. After reading an article about a new polyolefin material (Marlex), which demonstrated remarkable properties, Usher started to develop a woven mesh [17]. Two years later, the marlex prostheses were implemented. These were made of large pores, which facilitated incorporation despite infections. The growth of tissue through its interstices was the main difference when compared to previous materials. After a few days of surgical incorporation, fibroblast activity was noticed to increase, more collagen was induced without giant cells, and the whole system gained strength [18]. Despite the numerous advantages of the woven and knitted polyethylene mesh, Usher continued the search for better systems. He soon found that knitted polypropylene had many more advantages: it could be autoclaved, had firm borders coupled with two-way stretching, and could be rapidly incorporated. Finally, in 1958, Usher published his surgical technique using a polypropylene mesh, and 30 years later the Lichtenstein repair (known today as “tension-free” mesh technique) was popularized for hernia repair [18]. Even when the benefits of meshes were accepted, the recollection of evidence-based cases was required to statistically quantify their advantages. In 2002, the European Union Hernia Trialists Collaboration, a group of surgical trialists who have participated in randomized trials of open mesh or laparoscopic groin hernia repair, analyzed 58 randomized controlled trials and concluded that the use of surgical meshes was superior to other techniques [19]. In particular, they noted fewer recurrences and less postoperative pain with mesh repair. These results were supported by other studies that demonstrated that hernia repair using surgical meshes reduced the risk of hernia recurrence compared to hernia reconstruction through other methods, in 2.7% vs. 8.2% in ventral hernia repair cases and by 50–75% of improvement through surgical meshes in inguinal repair [8].

Today, many surgeons agree that use of a prosthetic mesh is the preferred way to repair hernias. It should be emphasized that in the past, the success of repair was evaluated based on the strength and permanency of the mesh itself, not on the degree of scar tissue or other factors, which subsequently develop in and around the mesh [20]. The biocompatibility of the material has proven to be a strong contributor in the rejection of the prosthesis due to scar tissue developed by the immunological system. When a surgical mesh is implanted and lacks appropriate biocompatibility (either due to the material that it is made of or its structural design) the body responds by encapsulating the foreign system leading to the formation of a stiff scar which consequently results in poor tissue incorporation, causing hernia recurrence or infection of the mesh. A large percentage of meshes then have to be removed: approximately 69% of the explanted meshes are due to prosthesis infection [21].

Although the only treatment is surgery, there are new surgical procedures that ameliorate postoperative side effects such as the laparoscopic approach. Open surgery repair is performed by making an incision in the abdomen to identify and dissect the hernia sac through the subcutaneous tissues and fascia. Once the hernia sac is dissected away from any adjacent structures and examined for contents (intestine or any other tissues), these are inserted back into the peritoneal space, and hernia repair is carried out. Repair can be executed in two ways: (1) primary repair and (2) patch or mesh. The first involves sewing the tissue of the abdominal wall using sutures, while the second technique relies in the placement of a mesh to cover the hernia defect and reinforce surrounding tissue, fixing it with fibrin glue, staples or sutures.

In the case of a laparoscopic procedure, the surgeon starts by making several small incisions in the abdominal wall surrounding the hernia sac, in order to introduce surgical instruments and a laparoscope. In one of the incisions, carbon dioxide gas is introduced into the abdomen. The mesh or patch is then introduced, unrolled and fixed with staples or tacks. The procedure then continues with the release of the gas from the abdomen and closure of cutaneous incisions with sutures [22].

3. Current Research on Surgical Meshes

Most surgical meshes used currently are chemically and physically inert, nontoxic, stable and non-immunogenic. However, none of them are biologically inert, a property related to the mesh physiology and its role into the hernia repair process [23]. Implantation of any prosthetic material is quickly followed by an extraordinarily complex series of events that mark the initiation of the healing process [14]. As for the physiology of abdominal mesh implantation, perhaps the greatest concern, and hence the area that most research focuses on, is inflammation and wound healing [24]. The passive substrate of the biomaterials in conjunction with devitalized tissues can actively contribute to bacterial growth, resulting in infection, which delays the wound healing process [25].

The introduction of a foreign material into the body triggers a healing response characterized by one of three stereotypical reactions: (1) destruction or lysis, (2) inclusion or tolerance, and (3) rejection or removal. When an implant is introduced into the body, the immune system recognizes it as a foreign material and therefore attempts to destroy it [26]; immunosuppressive drugs must be administered to prevent the body from attacking it [27]. The rejection of an implant is primarily driven by the immune response of the T lymphocytes (T cells). The T cells are stimulated by the presence of an antigenic determinant on the foreign material. T cells are reproduced faster than the time required for immunosuppressants to interfere with its proliferation, therefore resulting in rejection of the implant given the large number of T cells attacking the foreign material [28].

Inflammation is the reaction of vascularized living tissue to injury and is the primary biological reaction to implanted medical devices. In the case of implanted meshes, the inflammatory response is presented in four stages that are related both temporally and hierarchically [29]. Immediately after implantation, prosthetics adsorb proteins, which create a coagulum around it [30]. Coagulums are composed of albumin, fibrinogen, plasminogen, complement factors and immunoglobulins [31]. Platelets adhere to the proteins releasing a host of chemoattractants that invite other cells such as polymorphonucleocytes (PMNs), fibroblasts, smooth muscle cells and macrophages to the area in a different sequence [32]. The chemotaxis process is defined as the movement of cells towards a preferred migration site triggered by a chemical stimulus [33]. The attraction of PMNs, also known as neutrophils, to the wound site is attributed to chemotaxis, and is observed as the first stage of biological response to the injured site. During the first stage or acute phase of inflammation, neutrophils phagocytize microorganisms. The neutrophil may also degenerate and die during this process, releasing its cytoplasmic and granular components near or over the surface of the prosthesis, which may also mediate the subsequent inflammatory response [34].

When the acute inflammatory response is unable to eliminate the injurious agent or restore injured tissue to its normal physiological state, the condition could progress into a state of chronic inflammation, known as second stage of inflammation. In this stage, monocytes that have migrated to the wound site during the acute inflammatory response rapidly differentiate into macrophages. In addition to macrophages, other primary cellular components such as plasma cells and lymphocytes actively contribute to the inflammatory process. Macrophages increasingly populate the area to consume foreign bodies as well as dead organisms and tissue [14].

In most of the cases where chronic inflammation is related to a medical device or biomaterial, the inflammation process will lead to an immune response or foreign body reaction, corresponding to the third stage of inflammation, where chronic inflammation macrophages fuse into a foreign body giant cell as a response to the presence of large foreign bodies [35]. Foreign body reaction is a complex defense reaction involving: foreign body giant cells, macrophages, fibroblast, and capillaries in varying amounts depending upon the form and topography of the implanted material [36].

The fourth stage of inflammation occurs in the wound healing phase and is characterized by the replacement of damaged tissue with various cells that specialize in secreting extracellular matrix materials to form a scar [14]. Wound healing and scar formation follow the initiation of inflammation, but their progression and the magnitude of scarring can be affected by the degree of persistent inflammatory activity as well as the severity of the primary injury [37].

Fibroblasts are cells that mediate the wound healing phase. These cells enter the wound site two to five days after the injury occurs, typically once the inflammatory phase has ended. Fibroblasts proliferate at the wound site, reaching peak levels after one to two weeks. The main function of fibroblasts is to synthesize extracellular matrix and collagen to maintain the structural integrity of connective tissues; at the end of the first week, these are the only cells in charge of collagen deposition. Cells involved in the regulation of inflammation, angiogenesis (formation of new blood vessels from preexisting vasculature) and further connective tissue reconstruction attach to, proliferate, and differentiate on the collagen matrix laid down by fibroblasts [26].

From a histological standpoint, the interaction between prosthesis and organism is characterized by three main aspects: size of tissue reaction; cell density; and fibroblastic activity. As mentioned, fibroblastic activity peaks one to two weeks post-wounding, usually on the 8th day for the intraperitoneal plane and on the 10th day for the extraperitoneal plane. The optimum quantity of fibroblasts needed for a successful integration of the mesh is achieved approximately two weeks after wounding. Further accumulation of fibroblasts will cause an inflammatory phase with increased fibrosis and faster prosthesis integration associated with paresthesia and pain. Furthermore, the inflammatory process could cause contraction and shrinkage of the mesh, resulting in adhesions and fistulas, leading to prosthesis rejection and eventually explantation [25].

The wound repair process described above creates a mesh integration due to the conformational changes of the proteins. This integration is progressive, starting from the prosthesis implantation that is accompanied by the foreign body reaction followed by the inclusion of the prosthesis, which occurs within the first two weeks. The process is finalized as the overall strength increases gradually, which last about 12 weeks and results in a relatively less elastic tissue that has only 70–80% of the strength of the native connective tissue [32].

Although integration and collagen deposition that result from the inflammatory response provide long-term strength, as pointed out, an aggressive integration could also be harmful to the tissue that surrounds the wound site causing a severe body reaction, inflammation, fibrosis, infection, and mesh rejection [23]. The fibrotic reaction generated by the body when a prosthetic material is introduced, such as in the case of surgical meshes for a hernia repair, is governed by the chemical nature of the material implanted and its physical characteristics. The integration and overall healing process of implantable surgical meshes is highly dependent upon the intrinsic mesh characteristics such as, the primary material, filament structure, tailored coatings, and pore size.

Research in abdominal wall repair has provided valuable information on the parameters, properties, and design of the meshes that influence the immune reaction of the body to the prosthesis as well as the optimal parameters to reduce fibrosis [38,39]. These factors are discussed below.

3.1. Elasticity and Tensile Strength

A deterioration of the tensile strength of the mesh or a strained mesh could potentially lead to hernia recurrence or a poor functional result. Hence, materials employed in surgical meshes must possess the minimum mechanical properties necessary to withstand the stresses placed on the abdominal wall. The maximum intra-abdominal pressure generated in a healthy adult occurs when coughing or jumping and is estimated to be approximately 170 mmHg. Given this information, the mesh used to repair abdominal hernias must withstand at least 180 mmHg (20 kPa) before failing [38].

The tension placed on the abdominal wall can be calculated using Laplace’s law relating the tension, pressure, thickness, and diameter of the abdominal wall. According to the thin-walled cylinder model, the total tensile strength is independent of the thickness of the layer. Hence, a physiological tensile strength of 16 N/cm is defined, using a pressure of 20 kPa (2 N/cm² as the maximum pressure to be experienced in the intra-abdominal wall), and 32 cm as the longitudinal diameter of the abdominal wall [39].

Studies over human abdominal walls have demonstrated that at the maximum tensile strength of 16 N/cm, the abdominal wall in males presents a natural mean distension of 23% ± 7% and 15% ± 5% when tissue is stretched in vertical and horizontal direction, respectively. In females, a distension of 32% ± 17% and 17% ± 5% in vertical and horizontal stretching has been observed [40].

3.2. Pore Size

Porosity plays a key role in the reaction of the tissue to the prostheses. Bacterial growth and cell proliferation are highly dependent upon porosity and pore size. Bacterial colonies are established principally in the spaces between pores and fibers. Macroporous meshes that have large pores have shown to facilitate entry of macrophages, fibroblasts and collagen fibers that will constitute the new connective tissue, integrate the prosthesis to the organism and prevent colonization of bacteria. Large pores have shown easy infiltration of immunocompetent cells, providing protection from infection [25]. Microporous meshes, with pores of <10 µm, have shown a higher rejection rate given that scar tissue rapidly bridges small pores resulting in minimum integration, these meshes are associated with chronic inflammation.

Although it would be helpful to classify pore size in a standard form, currently, there is not a formal classification. Earl and Mark proposed the following: very large pore: >2000 µm; large pore: 1000–2000 µm; medium pore: 600–1000 µm; small pore: 100–600 µm and microporous (solid) <100 µm [32,41].

3.3. Weight (Density)

Prostheses can be classified as: heavy-weight (HW), when they are above 80 g/m²; mediumweight (MW), between 50 and 80 g/m²; light-weight (LW), between 35 and 50 g/m²; and ultra-lightweight, below 35 g/m² [25]. While a heavy-weight mesh is produced with heavy materials, small pore size and high tensile strength, a light-weight is composed of thin filaments with large pores, generally larger than 1 mm. Given that light-weight meshes contain less material, results have shown that less pronounced foreign body reaction is to be expected. A decreased inflammatory response results in better tissue incorporation [42].

3.4. Constitution

Surgical meshes could be fabricated using monofilament or multifilament (twisted) systems. A surgical mesh formed of monofilament yarns provides satisfactory reinforcement ability, but with stiffness and limited pliability. In contrast, a surgical mesh formed of multifilament yarns is soft and pliable. However, multifilament yarns meshes tend to harbor infectious matter such as bacteria, increasing erosion rates by 20–30% [43]. Particularly, the small void areas or interstitial spaces between the multifilament yarns may promote the replication and breeding of such bacteria, which measures approximately 10 µm.

3.5. Material Absorption

Surgical meshes could be made from an absorbable or non-absorbable material. Non-absorbable meshes can withstand the mechanical requirements, are easy to shape intraoperative and have long-term stability. However, complications such as mesh stiffness over time, hernia recurrence, mesh erosion, and adhesions have been documented. On the other hand, absorbable meshes were developed to reduce these long-term complications. These meshes favor postoperative fibroblast activity. Nevertheless, after prosthesis absorption, the resulting scar tissue is not as strong as it was, and alone is insufficient to provide the needed strength and could result in hernia recurrence.

3.6. Commercially Available Surgical Meshes

The ideal mesh should be able to be held in situ by peripheral sutures, resist the possibility of loading under biaxial tension (coughing or lifting actions) without failure especially during the early postoperative period, and should promote a fast and organized response from fibrous tissue with minimal inflammation [3].

Given the difficulty to find a single surgical mesh that fulfills all of the “ideal” characteristics, there are more than 70 meshes for hernia repair available in the market. These are classified according to the composition or type of material as: (1) first generation (synthetic non-absorbable prosthesis), (2) second generation (mixed or composite prosthesis), and (3) third generation (biological prosthesis).

3.6.1. First Generation Meshes

First generation surgical meshes are predominantly based on polypropylene (PP) systems. In 1958, the first polypropylene mesh was used to repair an abdominal wall; it was a heavyweight mesh with small pores. Due to intense fibrotic reactions, the search for an “ideal” mesh continued. In 1998, a lightweight first generation mesh was introduced: this system had larger pores and smaller surface area [38,43]. First generation meshes are mostly classified into three categories: (1) macroporous meshes, (2) microporous meshes, and (3) macroporous meshes with multifilament or microporous components.

Macroporous prostheses are characterized by a pore size larger than 75 µm. Polypropylene has been the material of choice with several brand names such as: Marlex, Prolene^®, Prolite^®, Atrium^® and Trelex^®.

Microporous meshes have smaller pores, commonly less than 10 µm and commonly made from expanded polytetrafluoroethylene (e-PTFE) under the brand name Gore-Tex^® (AZ, USA).

Macroporous meshes with multifilament or microporous components contain plaited multifilamentary threads in their composition, the space between the threads is less than 10 µm and their pores are larger than 75 µm. Several systems are in the market such as: plaited polyester (PL) meshes (Mersilene^® and Parietex^®); plaited polypropylene (SurgiPro^®, Minneapolis, MN, USA), and perforated polytetrafluoroethylene (PTFE) (Mycromesh^® and MotifMesh^®) [25]. Table 1 shows the classification of commercially available first generation surgical meshes.

Table 1

Classification of commercially available first generation surgical meshes [38].

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PP: Polypropylene. POL: Polyester. e-PTFE: Expanded polytetrafluoroethylene. N.A, Information not available in literature. * Duplicated properties.

3.6.2. Second Generation Meshes

Despite the improvements made within the first generation meshes (Table 1), which include high tensile strength in order to support intra-abdominal pressure, several complications such as hernia recurrence, infection, and adhesions still prevailed. Therefore, second generation meshes were developed combining more than one synthetic material into their composition. Nearly all of these kinds of meshes continued to use PP, PL or e-PTFE but now in combination with each other and/or with other materials such as titanium (Ti), omega 3, poliglecaprone 25 (PGC-25) and polyvinylidene fluoride (PVDF) as composite systems.

The main advantage of these composite meshes relied in the fact that these could be employed in intraperitoneal spaces causing minimal adhesion formation to neighboring surfaces given that each side of the mesh is tailored to specific needs. These meshes therefore require a specific orientation during implantation; the visceral side has a microporous surface to prevent visceral adhesion, whereas the non-visceral side is often macroporous to allow parietal tissue ingrowth. There are two categories of composite meshes: absorbable and permanent (non-absorbable). Absorbable composite meshes require hydration prior to usage, are not amenable to modification, mitigate viscera-mesh related complications, and can aid in tissue ingrowth. Parietex^® is the first composite mesh to offer a resorbable collagen barrier on one side to limit visceral attachments combined with a three-dimensional polyester knit structure on the other side, to promote tissue ingrowth. Permanent composite meshes can be modified to fit specific applications and present less visceral adhesions and complications, taking advantage of the properties of both macro and micro porous meshes. Dual Mesh® (W.L. Gore & Associates, Inc., AZ, USA), Dulex^® and Composix^®(both manufactured by Bard Davol Inc., Providence, RI, USA)are some of the brand name meshes included in this category [42]. Table 2 lists some of the commercially available second generation surgical meshes.

Table 2

Classification of commercially available second generation surgical meshes [38].

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PP: Polypropylene. e-PTFE: Expanded polytetrafluoroethylene. POL: Polyester. PVDF: Polyvinylidene fluoride. PGC-25: poliglecaprone 25. N.A, Information not available in literature.

3.6.3. Third Generation Meshes

Even with the improvements made on the second generation meshes (Table 2) where composite systems were designed to maintain the mechanical stability of first generation meshes (Table 1) and reduce inflammation and infection risk by mesh surface modification, the problems encountered with second generation meshes, such as the prevalence of adhesions, led to the development of biologic prostheses. Biologic mesh materials are based on collagen scaffolds derived from donor sources and they represent the so-called third generation meshes. Dermis from human, porcine, and fetal bovine sources are decellularized to leave only the highly organized collagen sources in addition to the dermal products included in porcine small intestine submucosa and bovine pericardium. The concept of these surgical meshes is that they provide a matrix for native cells to populate and generate connective tissue that could replace the tissue in the hernia defect [25]. Table 3 lists some of the commercially available third generation surgical meshes.

Table 3

Classification of commercially available third generation surgical meshes [38].

N.A. Information not available in literature.

Third generation surgical meshes (Table 3) serve as biological scaffolds for repopulation and revascularization of host cells, showing a superior biocompatibility than first and second generations. These meshes do not trigger an inflammatory response from the body, though their high cost has hampered their wide acceptance.

3.7. Manufacturing Processes for Surgical Meshes

Surgical meshes are produced from different synthetic materials and in different mesh structures, the knitted structure being the most common [44]. Surgical filaments are mainly manufactured by extrusion processes and then knitted accordingly. As mentioned, meshes are typically manufactured from PL, PP, PTFE, e-PTFE, PVDF and composite materials (e-PTFE/PP) [45]. The knitting pattern can be significantly altered resulting in a broad range of properties. Thickness, pore size, tensile strength, flexural rigidity, and surface texture are highly dependent upon the knitting pattern; the resultant interplay among these characteristics imparts different performance [44]. These characteristics, besides altering the biocompatibility of the mesh given its affinity to cells, also dictate the mechanical properties of the mesh such as rigidity and deformation. Knitted meshes are a subset of the non-woven mesh configuration. However, there is much more order and consistency with pore size using a knitted design [46]. Knitting, by definition, is the construction of a fabric or cloth from the interlocking of threads through the formation of loops. Recent studies have been focused on treating the surgical mesh as a high-tech textile rather than as a prosthesis [44].

3.7.1. The Extrusion Process

Melt extrusion is the least expensive and simplest form of fiber extrusion [47]. This process consists of melting the polymer pellets through a combination of applied heat and friction. The molten polymer is then forced under high pressure through a small orifice or a “shower head” spinneret. The molten polymer flows out of the spinneret and freezes into a solid fiber, which is then typically reheated and drawn numerous times to further align the molecules and hence strengthen the fiber [48].

Most of the surgical meshes are made from filaments initially developed to be used for surgical sutures. Surgical sutures are made from polymers like PP [49], PL [50], e-PTFE [51] or PVDF [52] monofilaments and have been successfully used by the medical profession for decades. Filaments used for surgical sutures have to possess several characteristics such as [53]:

1. Ability to attach to needles by the usual procedure.
2. Capability to be sterilized using ethylene oxide or ultraviolet radiation.
3. Ability to pass easily through tissue.
4. Ability to resist breakdown without developing an infection.
5. Possess minimal reaction with tissue.
6. Maintain its in vivo tensile strength over extended periods.

Commonly, the monofilaments used for surgical meshes have diameters in the range of 100–300 microns [54]. Multifilaments have also gained attention and have been used to fabricate surgical meshes. Lubricants are commonly applied to these filaments before the yarns are knitted. Suitable lubricants can be either hydrophobic lubricants [55] or hydrophilic lubricants such as polyalky glycol [56].

3.7.2. The Knitting Process

During the knitting process, fibers or yarns are curved to follow a meandering path and not oriented unilaterally as in weaving; therefore, the resulting fabric tends to be much more flexible and elastic than woven fabrics. The basic structure of a knitted fabric consists of courses and wales. Courses are rows running across the width of the fabric, while wales are columns running across the length of the fabric. When the wales are perpendicular to the course of the fiber/yarn, this is called weft knitting. When the courses and wales are approximately parallel to the direction of the fiber/yarn, the process is known as warp knitting [57]. Figure 1 shows a warp structure.

Figure 1

Schematic of: (a) woven; and (b) warp knitted structures.

Warp knits and weft knits have been generated for use as implantable meshes to repair specific tissue sites and organs, such as those needed in hernia repair. Because of the looped stitches, the knitted structure is soft, flexible, and stretchable. It easily adapts to the movement of the human body [58], and has high elasticity, tensile strength, bursting strength and excellent porosity, which are key requirements for any implantable device that needs to mimic the biomechanical characteristics of the abdominal wall: tension of 16 N/cm with a 38% elasticity [38]. Given the interweaving, warp-knitted materials have a fixed structure that neither loosens nor peels off during cutting, regardless of the direction [55]. These material systems have been successfully commercialized and currently used worldwide. Table 4 lists some commercially available meshes classified according to the knitted technique, material, and type of filament.

Table 4

Classification of commercially available surgical meshes [59].

* Membrane/patch.

The most commonly used systems in the knitting manufacturing process are the Tricot [60] and Raschel knitting machines [61], which are used to create warp or weft knitting structures [62]. Warp knitted meshes are the most popular system used to repair hernia defects, and are manufactured using the Raschel machine with a basic configuration consisting of two bars where latch-type needles are collectively mounted (running the full knitting width of the machine) and guide bars to hold yarn beams individually. The needle bars follow up and down movements, while the guide bars move back and forth across the needles of each bar to form continuous loops. The warp knit fabric design and lapping sequence is controlled by the shagging or traverse motion of the guide bars [63].

In principle, the Tricot knitting machine is very similar to the Raschel knitting; the only difference is the use of spring beard or compound needles instead of the latch needles used in the Raschel knitting machine. In addition, Tricot sinkers not only performed the function of holding down the loops whilst the needles rise as Raschel sinkers, but also support the fabric loops. The small angle of fabric take-away and the type of knitting action in Tricots creates a gentle and lower tension on the knitted fabric, ideal for high-speed production of fine gauge [64].

A double Raschel warp knitting machine (DR 16 EEC/EAC) has 16 guide bars and enables the production of textiles with different yarn materials and counts. The machine is equipped with two different gauges, E18 and E30. This system allows the design of a mesh configuration that could be adjusted to match given design parameters such as size, shape, Young modulus, and porosity [65]. The ultimate mechanical properties of the meshes are determined by the intrinsic properties of the filaments and the final configuration of the knitted fabrics.

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4. Future Perspectives

Despite the clinical success and vast body of knowledge that has been gained regarding manufacturing of surgical meshes, material properties, and surgical procedures, it is obvious that the ideal mesh has not been developed. It is well known that meshes still suffer from contraction and/or infection after implantation [66]. Furthermore, adhesions between the visceral side of the mesh and adjacent organs still occur. These complications may have serious consequences, such as chronic pain, intestinal obstruction, bowel erosion, or hernia recurrence. All of these problems have opened a great number of opportunities to create a new generation of surgical meshes [67]. This new generation will have to show a better integration with the tissue of the abdominal wall, but no adhesions on the visceral side. Based on the ideas of van’t Riet [68], Ebersole [69] and Xu [70], new alternatives rely broadly on surface mesh modification by novel coatings to existent meshes and/or integration of nanofiber based systems.

4.1. Coatings

A variety of biocompatible and biodegradable natural and synthetic polymers are being investigated. Extensive research focuses in the development of a bi-layer composite hernia mesh in order to minimize the risk of infections and reduce adhesions on the visceral side [71,72]. Materials that had been studied are: Polylactic acid (PLLA) [20], oxygenated regenerated cellulose (ORC) [67], n-vinyl pyrrolydone (NVP) and n-butylmethacrylate (BMA) [67], polyglycolic acid (PGA) [73], carboxymethylcellulose (SCMC) [74], omega-3 fatty acid [75], messenchymal stem cells (RMSC) [76], human dermal (HDF) and rat kidney fibroblasts (RKF) [76], collagen [77,78,79], chitosan [80], nanocrystalline silver particles (NCSP) [81] and titanium [82,83]. Table 5 shows some of the properties that have made these materials attractive as active ingredients in surgical meshes [71,80,84,85,86].

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PLLA: Polylactic acid. PGA: Polyglycolic acid. ORC: Oxygenated regenerated cellulose. SCMC: Carboxymethylcellulose. NVP: N-vinyl pyrrolydone. BMA: N-butylmethacrylate. RMSC: Messenchymal stem cells. HDF: Human dermal. RKF: Rat kidney fibroblasts. NCSP: Nanocrystalline silver particles.

Most of the recently published literature still presents PP surgical meshes as the “gold standard” though with surface modifications made with materials mentioned in Table 5. Studies have primarily concentrated on: thickness and concentration of the materials used in the coating to be in contact with the visceral and/or abdominal side (Ex: 95% of oxidized collagen and 5% of chitosan) [26] and surface density (measured in g/m²). The following Table 6 presents a summary of the obtained results based on the inflammatory response and percentage of adhesion.

Table 6

Examples of surgical mesh coating parameters.

MBC: Modified bacterial cellulose. NCSP: Nanocrystalline silver particles.

In general, the new composite meshes show highly improved performance regarding peritoneal regeneration and visceral adhesion [84]. These studies have developed composite surgical meshes with high potential for adoption. Further studies with a focus on long-term adhesion and structural performance will complement obtained results.

4.2. Nanofibers

Nanofiber systems made from a large variety of materials have been explored extensively in the last decade. Scaffolds for tissue regeneration are strongly deemed as a potential application of these systems [87]. Mimicking the extracellular matrix (ECM) is vital to control cell behavior, such as adhesion, proliferation, migration, and differentiation. Tissue Engineering (TE) has been extensively explored to provide answers associated with current problems encountered in the interaction of the surgical meshes with the human body. One of the challenges of TE is to mimic the natural extracellular matrix (ECM) of the abdominal wall to promote an efficient integration. Researchers are actively exploring the implementation of nanofiber systems to effectively mimic the ECM [88,89,90].

Nanofibrous structures present several advantages, such as high specific surface area for cell attachment, higher microporous structure and a 3D micro environment for cell–cell and cell–biomaterial contact, these being associated with unique physical and mechanical properties. These structures when compared with commercial surgical meshes possess higher porosity and smaller pore size. These properties make nanofiber systems suitable for biomaterials used in wound care, drug delivery, and scaffolds for tissue regeneration [20,44,91].

Scaffolds for tissue engineering must possess a porous structure able to facilitate cell migration, a balance between surface hydrophilicity and hydrophobicity for cell attachment, mechanical properties comparable to natural tissue, and biocompatibility. Studies have shown that the abovementioned characteristics are also highly influenced by average diameter of the fibers and pore size. Effective cell attachment and proliferation has been observed in fiber systems with average diameters smaller than 1 µm and average pore size of 14 µm [92]. In commercially available meshes, even when it has been shown that cells are able to proliferate in micrometer/macrometer regimes, the cells in fact have difficulty attaching and proliferating. Cells are seen around the fibers whereas, on nanofiber based meshes, the cells attach to the fibers and quickly proliferate while making strong contact with underlying nanofibers, therefore promoting interlayer growth.

The application of nanofiber systems has been hampered due to its poor mechanical properties and nanofiber availability. Most of the available studies have focused on nanofibers prepared through solution processes. The properties of the developed fibers can be controlled by different parameters such as utilized solvent, concentration of polymer, processing methods, and ambient conditions. For example, in the case of nanofibers made of polypropylene (one of the highly used polymers for commercially available surgical meshes), decahydronaphthalene (decalin) and cyclohexane have been used as preferred solvents. Polypropylene nanofibers prepared with cyclohexane exhibited a rougher surface when compared to the fibers prepared with decalin, suggesting that the surface morphology of the nanofibers depend on the boiling point of each solvent [93]. When stress–strain behaviors of the nanofibers are investigated, a tensile strength of 61.4 ± 1.5 MPa with 35.2% ± 1.7% of strain, and a Young modulus of 174.6 ± 1.7 MPa was obtained for the decalin based nanofibers, whilst the cyclohexane nanofibers exhibit a tensile strength of 18.2 ± 1.1 MPa with 46.7% ± 1.2% of elongation and a Young modulus of 39.1 ± 1.4 MPa [94]. The abovementioned results were obtained from bundles of nanofibers rather than individual fibers, these properties are strongly dependent on fiber orientation within the tested sample, bonding between fibers, and slip of one fiber over another [94].

Regarding nanofiber availability, there are several methods to prepare nanofiber systems. These methods include wet chemistry, Electrospinning (ES) [95] and Forcespinning^® (FS) [96] techniques. Most of the available literature has used ES processes; these studies have proven the potential of these nanofiber systems towards solving many of the challenges encountered in TE. ES processes have been limited to laboratory-based research given the challenges associated with increasing yield and opportunity to work with melt based systems. FS, a technique that has been recently introduced is based on developing nanofibers through the application of centrifugal forces. The method has been proven effective to produce yields that could satisfy industry requirements (i.e., several hundred meters per minute) as well as to produce nanofibers from melt based systems therefore removing the requirement of a solvent and subsequently the potential contamination of the materials with toxic organic solvents, and cost associated with the solvent itself and solvent recovery procedures. Other scaffolds had been produced by 3D printing procedures. Such biomimetic scaffolds are promising techniques as they could allow precise control over the geometry and microstructure [46,97].

Table 7 presents a summary of recently published work regarding the manufacture of nanofiber based surgical meshes.

Table 7

Nanofiber based surgical meshes.

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PCL: Poly-ε-caprolactone. PDO: Polydioxanone. PLGA 8218: Polylactide-Co-Glycolide. PU: Polyurethane. PET: Polyethylene terephthalate.

Nanofiber systems are certainly showing a strong potential to be used in the next generation of surgical meshes, the increased availability (FS process) will certainly promote the development of practical applications. Nanofiber developed through the FS system have shown promising results regarding adhesion, growth, metabolic activity, proliferation, and viability of 3T3 cells [70,102]. It is expected that these systems will be used in combination with existent commercial meshes to satisfy other requirements such as mechanical strength needed to bear the intra-abdominal pressure exerted by human body and implantation requirements to mention some. Future studies in this area will include the effect of nanofiber morphology, mesh design (i.e., uniaxial aligned, radially aligned, orthogonally patterned) needed to improve structural properties, and in vivo testing.

In summary, this review synergistically complements recent reviews made in this important area. Table 8presents a comparative table with recent published reviews [38,103,104,105,106]. Besides having in common the history and present scenario, this review also presents information regarding manufacturing methods (manufacturing of these meshes has a strong influence in the medical results, therefore the ultimate functionality will be strongly dependent upon the manufacturing method) and future perspectives.

Table 8

Aspects related to hernia meshes compared in recently published reviews.

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5. Conclusions

Surgical meshes have become the system of choice for hernia repair. Even though it is not the optimum method, so far it is the one that has shown a lower rate of recurrence. Currently, there are more than 70 types of meshes commercially available. These are constructed from synthetic materials (absorbable, non-absorbable, or a combination of both) and animal tissue. Despite reducing rates of recurrence, hernia repair with surgical meshes still faces adverse effects such as infection, adhesion, and bowel obstruction. Most of these drawbacks are related to the chemical and structural nature of the mesh itself.

An optimum integration with the abdominal wall and negligible adhesion on the visceral side are the most important after sought features for the “ideal” mesh. A surgical mesh will trigger one of three different responses from the body: it may be integrated, encapsulated or degraded. In order to have a minimal inflammatory response to better integrate it to the body, it is highly important to improve biocompatibility.

To overcome this obstacle, researchers are actively exploring methods to improve biocompatibility, with the goal of developing a mesh that can be effectively incorporated with minimal inflammation and/or infection. Nanofibers have been recently considered as a strong potential intermediary structure to be used as a coating, given their ultralightweight quality, which could contribute to minimize the inflammatory response from the body and given its functional porosity, which could promote cell adhesion and proliferation.

Acknowledgments

The authors gratefully acknowledge support received by the National Science Foundation Partnership for Research and Education in Materials (PREM) award under Grant No. DMR-1523577: The University of Texas Rio Grande Valley–University of Minnesota Partnership for Fostering Innovation by Bridging Excellence in Research and Student Success. This work was also funded by Tecnológico de Monterrey—Campus Monterrey, through the Research group of Nanotechnology and Devices Design. Additional support was provided by Consejo Nacional de Ciencia y Tecnología (CONACYT), Project Number 242269, Mexico.

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Florida, Texas, Nevada, North Carolina, North Dakota, Tennessee, Massachusetts and others have their own Opioid Litigation in state courts across the country

By Mark A. York (July 15, 2019)

Live-video-opening-statements-for-oklahoma-opioid-trial vs. Johnson & Johnson

J&J defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

(MASS TORT NEXUS MEDIA) The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, fit in to the “opioid litigation solution” and if they will actually receive treatment services and assistance on a substantive level.

Johnson & Johnson used promotional gimmicks for its opioid painkillers that are similar to how criminal drug dealers try to boost sales, a pharmaceutical-industry critic told a judge hearing Oklahoma’s claim that the company helped fuel a crisis of addiction.

J&J’s use of coupons allowing patients to get free Duragesic pain patches was improper, said Andrew Kolodny, a Brandeis University professor and opioid researcher who testified at the trial Wednesday on behalf of the state, which says the company is liable under public-nuisance laws.

Closing arguments are underway today, July 15, 2019 in Oklahoma’s case against Johnson & Johnson alleging the consumer products giant and its subsidiaries helped fuel the state’s opioid crisis.

Each side had about two hours Monday to make their cases to Cleveland County District Judge Thad Balkman, who is expected to issue his ruling at a later date.

See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

https://kfor.com/2019/07/12/defense-rests-in-opioid-trial-closing-arguments-set-for-July 15th

Oklahoma Attorney General Mike Hunter has described consumer products giant Johnson & Johnson as the “kingpin” company that helped fuel the state’s opioid crisis during closing arguments in the state’s case against the drugmaker.

Oklahoma claims that J&J aggressively marketed opioids in the state in a way that overstated their effectiveness to treat chronic pain and understated the addiction risks.

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 2000 lawsuits against the opioid industry as a whole.

Bad Conduct of Opioid Big Pharma Outlined

In a June 2017 memo to Purdue officials, titled “Confidential Program Recommendation,” Matt Well, a founding partner of the Washington, D.C.-based public relations firm The Herald Group, details a campaign that included attacks on undisclosed attorneys general. The attacks were intended to deter other states from suing the company.

Link to Purdue Pharma Opioid Marketing Campaign Documents

“Our goal is to make state attorneys general think twice about joining the litigation,” Well wrote in the proposal.

Other recommendations included targeting outside law firms hired to help in the cases by calling into question the attorneys’ credibility and personal profit motive.

The final recommendation included working with journalists and placing stories in specific publications to tell what the firm labeled “the anti-story”. The anti-story refers to the public relations firm finding legal experts to talk to reporters or write op-eds for publications that slam lawsuits filed by states and shift the blame for the epidemic to victims in an attempt to sway public opinion to the company’s favor.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

KEY POINTS AT OKLAHOMA TRIAL 

• Lawyers for the state, including Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.
• The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic.
• J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

Lawyers for the state of Oklahoma on Monday urged a judge to hold Johnson & Johnson responsible for fueling the U.S. opioid epidemic, as the first trial nationally in litigation over the drug crisis came to an end.

Attorney General Mike Hunter, told a judge in Norman, Oklahoma that J&J knew opioids were addictive yet played down their dangers when promoting them, leading to an oversupply of pills that caused overdose deaths.

“This company went out and sponsored lies,” Brad Beckworth, a lawyer for the state, said in his closing argument.” They went out and said the risk of addiction was less than 1%.”

He urged Judge Thad Balkmanm, who presided over the multibillion-dollar nonjury trial, to find Johnson & Johnson liable for creating a public nuisance.

The case is one of around 2,000 actions by state and local governments accusing drug manufacturers of contributing to the opioid epidemic. Opioids were linked to a record 47,600 overdose deaths in 2017, according to the U.S. Centers for Disease Control and Prevention.

The Oklahoma trial is being closely watched by plaintiffs in other opioid lawsuits, particularly in 1,900 cases pending before a federal judge in Ohio who has been pushing for a settlement ahead of an October trial.

At trial, lawyers for Oklahoma argued that J&J, which sold the painkillers Duragesic and Nucynta, had since the 1990s marketed opioids as “safe and effective for everyday pain” while downplaying their addictive qualities.

The state has accused J&J of acting as the “kingpin” behind the epidemic and says the company was motivated to boost prescriptions not only because it sold painkillers but because it also grew and imported raw materials that opioid manufacturers like OxyContin maker Purdue Pharma LP used.

J&J denies causing the epidemic. Its lawyers have argued that its products made up a small share of opioids prescribed in Oklahoma and carried U.S. Food and Drug Administration-approved labels that warned of the addictive risks.

J&J, whose lawyers were expected to deliver their own closing arguments later on Monday, argues the state is seeking to stretch the bounds of a public nuisance statute in order to force J&J to pay up to $17.5 billion to remedy the crisis.

Purdue and Teva Pharmaceutical Industries Ltd were originally also defendants in the case. Purdue reached a $270 million settlement with the state in March and Teva settled for $85 million in June. Both deny wrongdoin

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

UP TO $500 BILLION SETTLEMENT?

The current “Opiate Prescription Litigation MDL 2804” is being compared to the 1998 Tobacco Litigation settlement where Big Tobacco paid a settlement of $200 billion to cities, states and other governmental entities. The Opioid Litigation is expected to reach settlement figures of 3 to 4 times that amount, projected to be at the $500 billion plus figure, due to the rampant corporate boardroom directed policies that flooded the US marketplace for the last 15 years. Corporate sales and marketing policies and lack of oversight, enabled hundreds of millions of opioid prescription drugs to reach all areas of the country, thereby causing in excess of 100 thousand deaths and unknown catastrophic economic damages in every corner of the United States.

INSURERS ARE FIGHTING BACK

In 2018 ravelers Insurance and St Paul Fire and Marine Insurance scored a legal victory when they were granted a declaratory judgment win related to defending Watson and it’s parent company Activis, Inc in the Orange County-Santa Clara County litigation, after the California Appellate Court declared the Traveller’s/St Paul  opioid coverage policy void due to the “Watson’s Deliberate Conduct” in relation to sales and marketing of opioid prescription drugs, which was determined to be improper. The decision also voided the Watson-Activis coverage in the City of Chicago vs. Watson et al, in Chicago federal court, see  California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense. This may be a trend for insurance carriers as they’ve filed other legal action to void coverage on behalf of opioid drug makers including Insys Therapeutics, Inc and defense of its Subsys fentanyl fast acting drug.

To access the most relevant and real time information on Mass Torts  sign up for:

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September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
2. To obtain our free newsletters that contains real time mass tort updates, visit com/news and sign up for free access.

Note: (Excerpts within this article include reference materials from CBS, ABC, NBC US Department of Ju

“Textured implants linked to rare form of cancer per FDA”

By Mark A. York (July 24, 2019)

(MASS TORT NEXUS MEDIA) A worldwide recall of breast implants by Allergan Inc. was issued Wednesday for textured models because of a link to a rare form of cancer. The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.

The FDA is not recommending women with the implants have them removed if they are not experiencing problems. The FDA had ruled earlier this year the implants could stay on the market.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

https://www.cbsnews.com/news/breast-implant-recall-allergan-recalls-textured-implant-linked-to-rare-cancer-today-2019-07-24/

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced in 2017.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.

Health authorities first linked textured implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.

As recently as May, the FDA said that the danger did not warrant a national ban on the devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implants not seen with other textured implants.

“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action,” said FDA deputy commissioner Amy Abernethy in a statement.

The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

In May, the country’s three largest breast implant manufacturers — Allergan, Sientra and Mentor — told CBS News textured implants have been extensively tested for safety and comply with FDA monitoring and that patient safety is their top priority.

___________________________________________________________

March 20, 2019   FDA NOTICE ON TEXTURED IMPLANTS

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End

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1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
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Note: (Excerpts within this article include network broadcast and print materials and other o

A Litigation Review by Mass Tort Nexus

July 30, 2019

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

By Mark A. York 

(Mass Tort Nexus Media) The  Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

What is the connection between textured breast implants and cancer?

Studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.

Breast Implants Can Cause Cancer

There is now a link between cancer and breast implants emerging in scientific and medical circles. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants. French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

 Silicone Breast Implant Lawsuit Not Preempted, Case to Proceed USDC ND Illinois Ruling

As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA.  We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.

^a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
^b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
^c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
^d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
^* Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)

These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs.  We excluded apparent duplicates.  The data is stratified by factors we considered in our analysis.

¹Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
^a Percentage in terms of the total 457 MDRs.
^b Percentage in terms of the total 573 MDRs.
^c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
^d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
^e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
^f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
^g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

History of Adverse Events Has Been Known 

The FDA has  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.

Background:

In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.

Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.

Current Breast Implant Lawsuits:

Silicone

• Weber v. Allergan (2012)
• Ebrahimi v. Mentor (2016)
• Mize v. Mentor | Nguyen v. Mentor (Spouse Plaintiff) (2017)
• Gravitt v. Mentor | Gravitt v. Mentor (Spouse Plaintiff) (2017)
• Skelton v. Allergan – BIA-ALCL (2018)
• Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
• Rea v. Allergan – BIA-ALCL (2018)
• Vieira et al v. Mentor Worldwide, LLC et al (2018)
• Sewell et al v. Mentor (2018)

Saline

• Laux v. Mentor (2015)
• Allergan Saline Lawsuits (2016)

Mentor Silicone Breast Implant Lawsuits:

Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants 

(September 28, 2016)

A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.

Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.

Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:

It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.

This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.

Rexina Mize, et al. v. Mentor Worldwide LLC

(February 2nd, 2017)

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.

Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.

From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:

Catherine Gravitt, et al. v. Mentor Worldwide LLC

(July 25th, 2017)

The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.“

In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”

Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson 

(April 27th, 2018)

The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.

They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.

Vieira et al v. Mentor Worldwide, LLC et al

(June 27th, 2018)

Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.

In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.

Allergan Silicone Breast Implant Lawsuits:

Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)

The case was filed in 2012 and is moving to trial in early 2018.

“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)

Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).

“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.

Vivian Skelton v. Allergan – BIA-ALCL

The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.

Rhea v. Allergan – BIA-ALCL

(May 8th, 2018)

Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.

From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:

Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.

Allergan Saline Lawsuits:

In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.

“I represent about 150 women,” said Attorney Chris Shakib.

Shakib, the lead attorney in the case, called his findings unbelievable.

For further information, see articles on this here (June 1st, 2016) and here (November 29th, 2016).

Mentor Saline Lawsuits:

Anita Laux v. Mentor Worldwide LLC

(December 29, 2015)

The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).

Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.

BIA-ALCL

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.¹ CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.

Risks:

“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18

Medical Device Reports (FDA)

Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.

As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:

• 87% (203 out of the 231 report) were with textured surfaces
• 12% (28 out of the 231 reports) were with smooth surfaces

Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.

Sample of the FDA Adverse Event Reports on BIA-ALCL:

Note: Parentheses represent redacted information to protect privacy.

1. Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
2. Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
3. Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
4. Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
5. On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
6. The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
7. It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.

Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.

BIA-ALCL Causation Theories:

The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.

Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.

Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.

The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.

It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.^1,2

Protocol: 

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

BIA-ALCL and Mammograms:

There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.

Resources:

• Facebook support group: ALCL in Women with Breast Implants BIA-ALCL and their advocacy website, BIAALCL.com
• Facebook support group: BIA-ALCL Clinician/Patient Discussion Group
• Dr. Mark Clemens YouTube: “Patient Education BIA-ALCL“
• Dr. Mark Clemens & American Society of Plastic Surgeons (ASPS): BIA-ALCL
• An excellent article on BIA-ALCL is “Rare cancer reignites debate over breast implants’ safety.”

Government Health Agencies and Other Sources

• FDA: BIA-ALCL
• FDA: BIA-ALCL Q&A
• Canadian Society of Plastic Surgery on ALCL
• Australia: TGA on Breast Implants and Anaplastic Large Cell Lymphoma
• UK: MHRA on Breast Implants and Anaplastic Large Cell Lymphoma

Science and Medical: 

Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).

Current Experts:

Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.

Educational Links:

What You Need to Know About Breast Implants (National Center For Health Research)

Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)

Safety – Junk Science, ‘New’ Cohesive Gel, and Toxicity for Silicone and Saline Implants

Breast Implants and Cancer (BIA-ALCL) and BIAALCL.com

Dr. Myhill –

Silicone Breast Implants and Injections

Chemical Poisoning – Diagnosis

Detoxification

Dr. Urzola –

Breast Implant Illness

“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)

Dr. Feng –

Breast Implant Removal: Basics I

Topic: Linda L. Haas, Feng Clinic CEO, answers basic scheduling questions from patients who have just started researching breast implant removal. Videos: Part I and Part II.

Breast Implant Removal: Basics II

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Note: (Excerpts within this article include other online media sources)

____________________________________________________________________________

Additional Resources On Breast Implant Complications and Adverse Events

Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.

Breast Implant Removal: Basics III

Topics: the aesthetics of the breast, muscle repair, mastopexies or breast lifts, fat transfer and who is a candidate. Video and Transcript.

Breast Implant Removal IV: Detoxification

Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.

Will I recover from breast implant illness without lymph node removal? (Video)

Is There A Connection Between Lyme Disease and Breast Implant Illness? (Video)

MTHFR and breast implants (Video)

Dr. Feng Webinars I-IV and YouTube Channel

Research articles and studies

Dr. Chun –

“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page

YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).

Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.

FDA Testimony

Dr. Kolb –

If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.

Doctors, are you listening?

Immune Protocol

Silicone Immune Treatment Protocol

Inositol for Silicone Detoxification Provided by Dr. Douglas Shanklin

Videos: Dr. Susan Kolb discusses silicone breast implants and saline breast implants

Book: The Naked Truth About Breast Implants: From Harm to Healing

Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.

Dr. Blais –

Breast Feeding

Truth on ‘Cohesive’ Gel Implant

Technology and composition of silicone breast implants

How do implants rupture and cause injury

Testimony to the FDA (2000) 

All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.

Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.

Dr. Brawer –

Case Report: Silicone is not fun in the sun (2018)

ASIA vs. the mechanisms of silicone toxicity (2017)

Vague Syndromes (2017)

Mechanisms of Breast Implant Toxicity (2017)

Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided (2017)

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity (2017)

Breast Implant Toxicity (2016)

Bones, Groans, and Silicone (2012)

Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000)

Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998)

Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Dr. Schoenfeld

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis (2018)

The ASIA syndrome: basic concepts (2017)

Autoimmune/Inflammatory syndrome induced by adjuvants (ASIA) and thyroid autoimmunity (2017)

Sjörgen’s Syndrome and Environmental Factors (2016)

Silicone and Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA). (2015)

Silicone implant incompatibility syndrome (SIIS). A frequent cause of ASIA (Schoenfeld’s syndrome). (2013)

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum (2013)

The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (2012)

’ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants (2010)

Fibrosarcoma after silicone breast augmentation: is there a connection? (1998)

Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation (1994)

Breast carcinoma occurring in association with silicone augmentation (1993)

Doctors Speak Out –

Dr. Bernard Patten, Dr. Al Levin, Dr. Robert Goldwyn,

Dr. Frank Vasey (the “Dark” side of silicone breast implants)

Dr. Stephen Edelson (goes into symptom mechanisms)

Dr. Britta Ostermeyer (on dangers of silicone implants)

Other Educational Videos –

Breast Implant Illness – Dr. Faria

Integrative en-block treatment – Dr. Hovsepian

Capsular contracture – ruptured breast implants – Dr. Cassileth

Silicone Toxicity and Detoxification – Dr. Jennings

Immune Response to Silicone (skip to 5:38 for the effects on children)

Dr. Urzola’s Live Feed on Breast Implant Illness (2017)

Other links:

National Birth Defect Registry

• Did you have breast implants while pregnant?
• Did you breastfeed with breast implants?
• Was your child born with a birth defect? Was your child born with a birth defect?

The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.

***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).

Petitions –

Breast Implant Petition

Request FDA Hearing

Medical Device Safety Act H.R. 2164

Surveys –

Dr. Victor Urzola’s Breast Implant Illness Data Collection Database

Dr. Yehuda Shoenfeld’s ASIA survey

PIP Implants Survey – if you have or had PIP, please fill out this survey

Concerns for estrogenicy of silicone breast implants

Allergan manufacturing patent

Method of making textured surface implants patent (Mentor)

UK MHRA PIP Implant Ingredient Analyses

Dr. Harbut response to FDA on platinum toxicity

Dr. Maharaj and Dr. Lykissa responses to FDA on platinum toxicity

Facebook Support Groups:

US: Breast Implant Illness – The Ticking Time Bomb

Breast Implant Illness and Breast Cancer Survivors Home

Canada: Breast Implant Failure and Illness – Canada

Australia: Breast Implant Illness – (Australia & New Zealand) Healing and Support

UK: UK Breast Implant Illness and Healing Support Group

ALCL: ALCL in Women with Breast Implants (BIA-ALCL)

For all medical devices: Medical Device Problems

Mothers: Breast Implants and Children

There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.

Personal Stories and Videos:

The Naked Truth // My Life with Breast Implants

Personal stories

Alex Chafen – Breast Implants, a Husband’s Perspective

Andrea Conti Cowder (Video and BII Story)

Pursuing Explantation – My path to health after breast implant illness

Beth Maturevich – Breast Implant Illness (Saline) Video

Raylene Hollrah – Diagnosed with ALCL, story

Implant Illness Awareness – Breast implants are not safe. We are the proof.

Mybreastimplantillness WordPress 

nothappywithmentor.blogspot.com

The faces of breast implant illness – Video

Jamee Cook –

Pursuing Explantation – My path to health after breast implant illness

YouTube channel on breast implant illness

Advocacy Groups:

US:

• FB: Breast Implant Victim Advocacy (BIVA)
• FB: Medical Device Problems
• FB: The Implant Truth Survivors Committee (Non-Profit)
• Breast Implant Info (Non-Profit)
• No Grit No Pearls.org (Non-Profit)
• BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)
• Breast Implant Petition

Canada:

• Breast Implant Failure
• Implant Awareness Society
• FB: Breast Implant Failure and Illness – Canada

Australia:

• FB: Breast Implant Illness – (Australia & New Zealand) Healing and Support
• FB: PIP Implant Rupture Support & Awareness Australia

Netherlands:

• SVS – Dutch breast implant advocacy with also an American site
• FB: Meldpunt Klachten Siliconen

UK:

• PIP Action Campaign
• FB: UK  PIP
• FB: UK Breast Implant Illness and Healing Support Group

Scotland:

• PIP Implants Scotland Campaign
• FB: PIP Implants Scotland
• FB: Breast implant illness and explant support group Scotland

Ireland FB Group: PIP Ireland

France:

• Prothese Mammaire Danger
• FB: Dans l’enfer des protheses mammaires
• PIP et Allergan
• FB: Association-PPP

Italy FB Page: Protesi PIP and Blog

Sweden:

• silikonimplantat
• Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”
• FB: Breast Implant Illness Sverige

Switzerland: Informationen zu Brustimplantaten

Venezuela FB Group: Protesis Mamarias PIP

Brasil: Breast Implants Illness (Doença Prótese Mamária) Brasil

Singapore FB Page: Implant Illness and Detox Singapore

South Africa: Breast Implant Illness – South Africa

Breast Implant Illness Websites:

Breast Implant Victim Advocacy (BIVA)

Breast Implant Failure

BIA-ALCL

BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)

Breast Implant Info (Non-Profit)

No Grit No Pearls.org (Non-Profit)

Toxic Discovery (Non-Profit)

Life Since Explant Club

Reversing Breast Implant Illness

Healing Breast Implant Illness

Discover Breast Implant Illness

Miss Diagnosed

BII Aware

Prothese Mammaire Danger

Fake Breasts Real Women

Breast implant illness websites and forums have been around since the late 90s and early 2000s:

Silicone Poison Report

Silicone Holocaust

Implant Information Network (founded in 2004)

Breast Implant Awareness – Humantics Foundation (founded in 2001)

Silicone Implants Survivors (forum since around 1999) and PS List

Silicone Hypersensitivity (owner passed away)

In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.

Breast Implant Manufacturer FDA Information:

Recalls

Allergan Natrelle Silicone & Allergan Silicone Timeline 

Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline

Mentor MemoryGel Silicone & Mentor Silicone Timeline

Mentor MemoryShape Silicone & Mentor Silicone Timeline

Sientra Silicone & FDA Timeline

Allergan Natrelle Saline & Saline Timeline

Mentor Saline & Saline Timeline

Ideal Saline & Saline Timeline

For more information on breast implant FDA links and how to do more FDA research, click here.

Books:

The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb

The D.I.R.T. Committee by Gail Hamilton

• Must read, especially if you had Dow
• D.I.R.T = Document Investigation & Review Team

The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet

Informed Consent by John A. Byrne

Dr. Andrew Hall Cutler:

• Hair Test Interpretation: Finding Hidden Toxicities
• FB: Andy Cutler Chelation Think Tank

Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.

Movies: Two Small Voices, Breast Men, Absolutely Safe

Press Articles & News:

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Mother feels she is dying after her 32E breast implants ‘poisoned’ her

Dr. Britta Ostermeyer testifies to FDA in 2000 on the dangers of silicone breast implants.

Safety of breast implants under review in South Korea after silicone gel found in breast milk

FDA panels put silicone breast implants back under microscope (2011)

The silicone implant scandal (2012)

Breast Implants: America’s Silent Epidemic

Breast Implant Illness by Maya

Sara-Jane Fitness Cover Story

The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.

The “Dark” Side of Silicone Breast Implants

Toxic Moldy Breast Implants

Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen

The Ill Effects of Breast Implants

Why are celebrities removing their breast implants?

Explant Breast Surgery: Why women are getting their breast implants removed

Devoted mother-of-four dies from heart failure after implants trigger dormant TB

46 cases of ALCL diagnosed in Australia & New Zealand

Australia’s health regulator has confirmed that women with breast implants have a much higher risk of cancer (7 News Sydney – Video)

Patients accuse breast implant manufacturer of fraud (2016 – Allergan)

Breast implant illness conference – Texas (7/16/16)

News Segment on a lady with breast implant illness & saline implants

Monsters Inside of Me – Discovery Channel on saline implants with mold

Mold and Breast Implant Illness – The Doctors (TV show)

2017 – Important Year for Breast Implant News –

Breast implant illness gains nationwide coverage and becomes a movement:

French court says German firm must compensate for faulty breast implants

Woman who beat breast cancer once says breast implants caused cancer again

Johnson & Johnson Unit Sued Over Leaking Breast Implants

Johnson & Johnson, Mentor Worldwide LLC Senior staff target Support Groups

Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness

Mother-of-two is left with ROTTING breasts after silicone implants leaked into her blood stream – as cosmetic procedures fall to a ten-year low in the UK 

Can implants kill you?

Phoenix Valley women speak out on breast implant illness: ‘I just had to get them out’

Doctor’s Breast Implant Illness Denial Elicits Strong Response

Breast Implants Cause Rare Form of Cancer, FDA says

9 deaths linked to rare cancer form breast implants

In the News: Breast Implants Linked to Rare Cancer (Diana Zuckerman)

Former Women’s IFBB Pro Jackie Paisley dies after long battle with illness (silicone toxicity)

Breast Implant Survey Suggests Doctors Divided on Safety

Nicola Robinson’s Deepest Regret (silicone breast implants)

Breast Implant Illness + 6 Other Breast Implant Dangers (Dr. Axe)

Playboy Models Claim Implants Caused Health Problems (The Doctors, show)

Former Playmate of the Year on removing breast implants: ‘I literally thought I was dying’ (AZ Family News)

Women complain that their breast implants made them sick (West Palm Beach – WPTV News)

Her Hidden Dangers (Illinois – 23WIFR News)

Breast implant patient’s life ‘could have been saved’ – Hairdresser Kandi du Cros died after breast implant operation flared up rare existing disease (BBC News)

2 Massachusetts Women, Thousands Nationwide Say Breast Implants Made Them Sick (CBS Boston News)

Women concerned about implants after learning they may be linked to rare cancer (Fox 59 Indianapolis News)

Caldwell woman diagnosed with cancer from her breast implants, insurance won’t pay to remove them (KIVI 6 On Your Side – ABC Idaho)

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ (NY Times)

DeLauro Statement on Breast Implants Connected to Lymphoma (United States Representative Rosa DeLauro)

Swedish breast implant illness news story: Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”

Danish: Johanna fik opereret brysterne større – aldrig har hun fortrudt noget så meget

Woman reveals danger of implants, horror of lawsuits – silicone poisoning brings on 20 year suit with Dow Chemicals (UB Media Biz)

Conflict of Interest: The FDA & Big Pharma – Does the FDA Work for Big Pharma? (Drug Watch)

Breast prostheses: For a national registry of complications (Dr. José Budo)

Colorado women claim breast implants made them sick (Denver 7 News)

Did breast implants make Valley woman sick? (ABC15 Arizona)

9 Investigates health concerns with silicone breast implants (WFTV9 Orlando, FL)

Brit Boob Implant Cancer Bombshell – Two breast surgery patients die from a ‘bombshell’ cancer linked to implants

Rare cancer reignites debate over breast implants’ safety

Silicone Breast Implants are back – This Time the Issue is Cancer

Sydney mother’s dire warning after breast implants almost ruined her life. (Australia News)

Dr. Robert Whitfield MD, FACS describes breast implant-related illness (The Plastic Surgery Channel)

The Explant Phenomenon (Huffington News)

Former ‘Playboy’ playmates have ‘toxic’ breast implants removed after they make them sick (Inside Edition)

Women say breast implants caused unexplained illness for years (WSB-TV Atlanta, GA)

Why scores of women are having their implants removed (Tucson News, AZ)

More Canadian women having their breast implants removed, surgeons say (CTV News)

2018

Women battling illness after breast implants urge awareness, education (CBS Miami)

The breast implants that may be linked to blood cancer: Linzy was baffled by her symptoms but doctors solved the mystery in time for her to make a full recovery (Daily Mail UK)

South Florida Woman: Breast implants ruined my life (West Palm Beach – WPTV News)

CBS 5 Investigates: Chemist claims breast implants make some women sick (CBS Arizona)

Why Kiwi women are getting their breast implants removed (New Zealand)

‘I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)

Facing unexplainable symptoms, metro women argue silicone breast implants made them sick (Fox 4 Kansas)

Arkansas women want doctors, FDA to recognize seriousness of ‘Breast Implant Illness’ (THV11 Arkansas)

My breast implants were killing me – how I took my life back (Elephant Journal)

Calls to ban textured breast implants after two die and 23 develop same type of cancer (My Vue News – UK)

Kiwi woman says seven-year illness caused by breast implants (Stuff – New Zealand)

Perth mum Ricci Jess reveals painful truth behind fake boobs (Perth Now – Australia) 

Explants: breast implants removal surgery grows among Perth women (Perth Now – Australia)

My breast implants nearly destroyed my life: how S Club 7’s Hannah Spearritt was left in agony following the boob job she craved (Daily Mail UK)

After 17 years with breast implants, Princeton woman leads calls for more education, safety (WFAA 8 ABC – North Texas)

Mount Pleasant woman says breast implants caused serious health problems (4News – Mount Pleasant, South Carolina)

Breast Implant Illness: What we don’t know can hurt us (Swaay)

Glamour model who got a boob job at 18 shares her plastic surgery nightmare that destroyed her kidneys and has left her on dialysis (Daily Mail Australia)

Facing health issues, Georgia woman has breast implants removed (Fox5 – Atlanta, Georgia)

Breast Implant Illness: Two metro women say implants caused years of complications (13 WHOtv – Iowa)

Breast Implant Illness: Woman claims implants made her sick (7 WJHG – Panama City Beach, Florida)

Former local 4 reporter says breast implants caused years of chronic fatigue, depression, hair loss (Click On Detroit – Michigan)

Auckland woman ‘s painful lesson about the dangers of breast implants (News Hub – NZ) 

What this yoga teacher learned from her mistake with breast implants (Charlotte Five)

Biocell textured breast implants under scrutiny as women complain of pain (CBC – Canada)

Breast implants reveal problems in tracking device safety (AP News) 

Breast Implant Injuries Kept Hidden As New Health Threats Surface (ICIJ)

Under the skin of ICIJ’s Implant Files (ICIJ)

Breast implants study reveals serious safety concerns (The Guardian)

The Implant Files reveal how breast implants linked to rare cancer set off alarm bells (ABC – Australia)

The Implant Files: Faulty breast implants leave women in limbo (Financial Review – Australia) 

Bare dager etter at hun opererte inn silikon i brystet, merket Karin Wenke Osthaug at noe var galt (Aftenpolten – Norway)

Cancer lié aux prothèses mammaires (LAGC) : l’inertie des autorités sanitaires (France Culture)

Temor, burocracia y dolor: hablan tres argentinas damnificadas por implantes mamarios (Perfil – Argentina)

British women are hit by new breast implant cancer scare seven years after PIP scandal as concerns grow over most commonly-used implant banned in France but still allowed in UK (Daily Mail – UK)

Rare form of Blood Cancer Linked to Certain Type of Breast Implants Used by Thousands of Women (People)

Breast Implants May Increase Your Risk of A Rare Type Of Cancer (Women’s Health)

Some medical devices deemed unsafe in other nations still sold in U.S. (NBC News)

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system (The Star)

My Breast Implants Made Me Sick – and Nobody Believed Me (Cosmopolitan)

Hidden dangers: patients, doctors not informed of defective implants (ICIJ)

Many Women Getting Breast Implants Removed In Light Of Health Concerns (CBS Philly)

Mother, 34, who was left ‘slowly dying’ by her ‘toxic’ C-cup breast implants has them removed after four years of agony (Daily Mail and The Sun)

Richmond woman warns of breast implant illness (K12 – Virginia)

As the Allergan breast implants disaster explodes, isn’t it time women say enough is enough? (Huffington Post – UK)

Allergan’s textured breast implants recalled by French authorities (NBC News)

Their response: “The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

By Mark A. York (August 8, 2019)

(MASS TORT NEXUS MEDIA) Opiate drugmaker stocks fell sharply after Bloomberg reported that a coalition of state attorneys general had demanded $45 billion from the three leading drug distributors in the U.S. to settle litigation over opioids.

According to Bloomberg, the counteroffer came after the distributors proposed a $10 billion settlement. The reported offers were made in negotiations between the National Association of Attorneys General andMcKesson (ticker: MCK), Cardinal Health (CAH), and AmerisourceBergen(ABC).

The report appears to be spooking investors. Shares of Cardinal were down 6.4% in afternoon trading, McKesson fell 5.9%, and AmerisourceBergen declined 6.1%.

Generic drugmakers also suffered large drops – . Teva Pharmaceutical Industries(TEVA) was down 8.7%, Mylan (MYL) was down 6.6%, and Endo International(ENDP) and Mallinckrodt (MNK)—which both released earnings Tuesday—were down 19% and 11.7%, respectively.

Those amounts appear to be far higher than investors expected. In a note Tuesday, Evercore ISI analyst Ross Muken wrote that investors he had spoken with had expected the distributors to pay $5 billion.

“Ohio Attorney General letter to Opiate MDL Judge Pollster citing caselaw”

The motion excludes state attorneys general, some of whom have brought lawsuits in state courts across the country, and sets up a procedure in which 24,500 cities, counties and other smaller governments could resolve their claims. It comes two days after Alabama Attorney General Steve Marshall voluntarily dismissed the state’s case in federal court and as Oklahoma Attorney General Mike Hunter is in the midst of the first opioid trial in the nation against manufacturer Johnson & Johnson.

Ohio AG Response

The Ohio AG wrote a letter to Federal Judge Dan Polster, where he challenged the legitimacy of the strategy pursued by private plaintiff attorneys, some of them veterans of the 1997 settlement between the states and the tobacco industry, who have signed up thousands of individual cities and counties as clients to try to pressure opioid manufacturers and distributors into a multibillion-dollar settlement. Private lawyers reaped some $14 billion in fees from the $260 billion tobacco settlement.

Yost criticized “the self-admitted power grab being made by unelected private attorneys to control the distribution of public moneys within the States.”

“The proposed negotiating class, and perhaps this very litigation, threatens the sovereignty of the States like nothing else in recent history,” he wrote. “It seeks to represent not a single political subdivision asserting parens patriae standing, but all of them. In other words, this motion seeks to permit the class to stand in the shoes of the States — nothing short of usurpation.”

Yost also criticized the allocation mechanism the lawyers have proposed. According to an “Allocation Map” the lawyers have placed online, Coshocton County, Ohio, would get $1.99 per capita or a total of $73,265 out of a $1 billion settlement, after lawyers claimed $100 million in fees.

“Distributing a few thousand dollars to local communities is meaningless.”  Ohio was among 27 states, including Texas and California, that filed a letter in June asking Judge Polster to delay any decision on a class.

See OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION

The motion also comes as U.S. District Judge Dan Polster of the Northern District of Ohio has pushed for global settlement talks while setting the first trial in the MDL for Oct. 21. In a brief supporting their motion a settlement class, which included 40 class representatives, including counties in California, Florida, Georgia, New Jersey and New York, and major cities such as Atlanta, Chicago, Denver, Los Angeles and San Francisco.

“This precise vehicle has never been used before, but we are very confident that this is a valid use of the procedure and that the court will, we are hopeful, welcome this as an opportunity to move the resolution of these cases forward,” said co-lead plaintiffs attorney Paul Hanly of Simmons Hanly Conroy in New York.

The federal litigation link is, Opiate Prescription MDL 2804, US District Court of Ohio link.

The move is also designed to provide some assurances to defendants—manufacturers and distributors of the prescription painkillers, as well as pharmacies—about the total scope of lawsuits that are out there.

The federal judge overseeing multidistrict litigation against opioid manufacturers and distributors left little doubt he supports a plan developed by private lawyers to assemble an unprecedented “negotiating class” consisting of every city and county in the U.S.

Rejecting complaints that the proposal would violate federal law and trample on states’ rights, U.S. District Judge Dan Aaron Polster repeatedly said “there has to be a vehicle” for resolving the nearly 2,000 cases by cities and counties that have been concentrated in his court. Along with hundreds of lawsuits still in state court and litigation by individual states, Indian tribes and other entities such as healthcare agencies and pension funds, Judge Polster said, the mass of litigation must be settled somehow.

“Everyone knows that trying 2,500 cases would sink the state and federal judiciaries, but also the amount of private resources would also be staggering and no one would want that,” the judge told lawyers for both sides during 1.5-hour hearing in Cleveland Tuesday morning.

A majority of state attorneys general as well as defendants including drug distributors are opposed to the proposal, under which Judge Polster would certify a procedure that specifying how funds from an opioid settlement are distributed to individual counties before any money is on the table. In filings with the court in late July, Ohio AG Dave Yost called the plan a “power grab” by private lawyers who represent most of the cities and counties in the litigation.

August 6, 2019 Development

“The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

Among other objections, critics of the plan say it would violate Rule 23 of the Federal Rules of Civil Procedure, which governs class actions, and U.S. Supreme Court decisions requiring class action lawyers to fairly represent both their own clients and so-called “absent” class members who aren’t participating in settlement negotiations or may not even be aware of the litigation.

In a back-and-forth exchange with Sonja Winner, a Covington Burling attorney representing McKesson, the judge dismissed the idea the proposal might violate the most important Supreme Court precedent, Amchem v. Windsor. In that 1997 decision, the court said any class action must satisfy Rule 23 requirements, including that the claims are typical across the entire class and the interests of absent class members are represented.

Winner said the proposed mechanism for allocating money under a settlement only reaches as far as the counties, leaving cities to negotiate their share of the money with the counties that theoretically represent them in the class. The conflict between the two groups would be fatal under Amchem, she said.

“I’m not worried about the Supreme Court — the issue is what I will do,” Judge Polster responded.

“I’ve got 2,000 cases. There has to be a vehicle for solving them as a group.”

According to a calculator the plaintiff lawyers have put online, Fremont County in Wyoming would get $98,000 of a hypothetical $1 billion settlement, while the town of DuBois would get nothing because its $98 payout would fall below a $500 minimum. Winner said that was typical of the uneven results that individual cities and counties might not be aware of before they are asked to decide whether to sign off on the settlement procedure or opt out.

The judge also brushed aside objections from other AG’s, who stated that the complex allocation formula would intrude on the power of the states to allocate money among their political subdivisions as they see fit. Judge Polster said he wouldn’t approve any language undermining state sovereignty, but went on to say he also won’t approve any settlement that directs all of the money into state treasuries, as some politicians demand.

He cited the 1997 tobacco settlement, in which little of the money paid over by cigarette companies actually went toward treating smoking-related disease. He said it was a “problem” that “in a number of states any money that the state AG obtains …goes into the general fund.”

Because the litigation in his court “encompasses the cities and counties,” any settlement “has to account for the matter of putting money into state general funds,” the judge said. “Because that idea isn’t going to fly.”

Clearly Judge Polster’s views on the opioid litigation have evolved since the early days, when he envisioned a swift settlement that included significant changes in how the industry does business. He repeatedly agreed with defendant companies that they have no incentive to settle unless plaintiff lawyers can offer them global peace, and that is impossible without the participation of the states and possibly even the federal government.

“Everybody understands no defendant is going to settle with the states alone and not the cities and counties,” or vice versa, he said. “That would be lunacy.”

The judge also told critics, including defendant companies, to come up with a better solution if they don’t like the one the plaintiff lawyers have proposed.

“Nobody has a monopoly on good ideas,” he said. “The more ideas floated, the better.”

He did recognize one glaring conflict of interest in the current proposal: Some of the same lawyers, most prominently Motley Rice, represent states and hundreds of members of the proposed class of cities and counties. He barred those lawyers from participating in the hearing or arguing in favor of the proposal.

“Those lawyers have a conflict at the moment because all or most of the state attorneys general are opposing this motion,” he said.

The judge also said that if he approves the mechanism, which seemed likely from his comments, he will appoint an independent representative on behalf of the tens of thousands of cities and counties that haven’t sued but could belong in the class. He also said he would limit settlement releases to claims under federal law and would have 13 nationwide “families” of defendants.

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

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How many billions is Bayer AG setting aside?

By Mark A. York (August 9, 2019)

(MASS TORT NEXUS MEDIA) The Bayer AG executive suite seems to be leaning toward settling the Monsanto (Bayer) Roundup MDL 2741 litigation, along with the thousands of cases in state courts around the country. A previous statement on settlement was, this is “financially reasonable” to review settlement of all litigation over the weedkiller Roundup, and is under review.

Bayer engaged additional senior defense counsel from Skadden, Arps and there is word of casual settlement discussions among people directly involved in the litigation. MDL Judge Chhabria has set a hard remand docket, and also appointed mediator Ken Feinberg to help move settlement along. How this all comes together in settlement discussions remains to be seen.

Is this where all plaintiff counsel remain together in forcing Bayer into high-value settlement, or where individual firms will attempt to carve out settlements based on their firm inventory?

The number of lawsuits from people in the U.S. who say the herbicide caused them to develop cancer rose by about 5,000 to 18,400. That is an enormous increase in lawsuits and there’s now an effort to make sure Bayer pays a premium settlement as the docket continues to grow.

BAYER IS SELLING ASSETS

Bayer is selling units to sharpen its focus after the $63 billion purchase of Monsanto, which saddled it with thousands of lawsuits claiming that the Roundup weedkiller it acquired in that deal causes cancer. The German giant agreed to unload its majority stake in a chemicals venture Wednesday in a deal valued at $3.9 billion, and two Roundup trials have been delayed as pressure builds to settle. Cash received from Bayer asset sales, may be going directly into the Roundup settlement fund.

Quarterly sales and earnings missed estimates and the German company questioned its ability to meet its full-year forecast. The shares fell 3.4 percent in Frankfurt.

Baumann has staked his credibility on last year’s $63 billion takeover of Monsanto Co., claiming the company is better off balancing its portfolio between agriculture and health care. But the surge in U.S. lawsuits alleging that Roundup — which Bayer inherited from Monsanto — causes cancer suggest settling the claims will become more much more expensive than previously thought.

“The jump in lawsuits is worrying,” said Mustaq Rahaman, a credit analyst at Bloomberg Intelligence. “This set of results will do little to stem calls for more dramatic action including a split.”

The chemicals and pharmaceutical giant said it would create a special committee of eight supervisory board members to monitor Roundup lawsuits and consult with management on legal strategies.

Bayer named U.S. lawyer John H. Beisner, an expert on mass tort and product litigation at Skadden, Arps, Slate, Meagher & Flom LLP, to advise the board on all Roundup legal matters, including trial tactics and mediation.

Bayer cited Mr. Beisner’s experience in negotiating high-profile settlements and said it looked forward to “constructively engaging in the mediation process.” A U.S. judge has provisionally appointed Kenneth Feinberg to serve as mediator in the consolidation of hundreds of Roundup cases filed in federal court. Mr. Feinberg has served as mediator in high-profile cases, including the Deepwater Horizon oil spill in the Gulf of Mexico in 2010.

U.S. hedge fund Elliott Management Corp., which owns some €1.1 billion ($1.25 billion) worth of Bayer shares, or about 2% of the company, backed Bayer’s latest steps. It said the new committee would provide “a new level of oversight and a fresh perspective to a litigation strategy in need of radical overhaul and help guide the company towards a rational, fair and swift settlement.”

U.S. Judge Vince Chhabria is handling the Roundup MDL 2471 lawsuits and has been moving the docket at a very fast pace, and denied Bayer’s Motion to Overturn the recent jury verdict, for case information see,  ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

Baumann said on a conference call that he is open to a settlement as long as it resolves all Roundup litigation. He repeated that the herbicide is safe, that the cases have no merit and that the company is “constructively engaging” with court-appointed mediator Ken Feinberg.

After the call, Bayer declined to say how much a “financially reasonable” sum would be or whether Baumann was referring only to the current load of cancer cases or the possibility of future Roundup suits tied to other ailments.

Bayer’s definition of what a reasonable settlement amount would be for all the Roundup cases isn’t likely to match up with estimates from lawyers for users of the weed-killer, said Carl Tobias, a professor at the University of Richmond’s law school who teaches about mass-tort litigation. “They aren’t going to like the numbers the plaintiffs are going to demand,” Tobias said. “Maybe Ken Feinberg can work something out.”

Bayer’s legal woes at the agricultural unit are being compounded by bad weather. In North America, heavy flooding has delayed planting season for farmers, while trade tensions with China hurt U.S. farmers’ ability to export soybeans, curbing demand for Bayer’s products. Just as Bayer reported earnings, U.S. President Donald Trump lashed out at China for what he said is an unwillingness to buy American agricultural products.

Bayer’s pesticide sales struggled in Europe too, due to unusually dry weather. Revenue at the crop science unit fell 3.1% after adjusting for currency and portfolio effects associated with the Monsanto takeover, Bayer said.

New Medicines

The Leverkusen, Germany-based company reiterated its annual financial forecast and its plan to defend itself in the Roundup litigation, while saying it will “constructively engage” in the mediation process ordered by a California judge. The company has aimed for about 46 billion euros ($51 billion) in revenue and profit of about 6.80 euros a share for this year.

Bayer’s other challenges include selling off its animal health division, rekindling growth at its ailing consumer-health division and coming up with promising new medicines for its pharma unit, where top-selling treatments Xarelto and Eylea both face losing patent protection next decade.

Bayer’s shares have plunged about 40% in the past 12 months amid concern over legal claims that Roundup and its main ingredient glyphosate can cause cancer. Activist shareholder Elliott Management Corp., which unveiled a $1.3 billion stake in last month, has said the company could unlock 30 billion euros in shareholder value with a settlement.

Still, some analysts say the company is right to spread its focus between different businesses to help manage the ebbs and flows of each unit.

“If Bayer just had the pharma business, the stock would be super risky, because the pharma business has some medium to long-term concerns,” said Dennis Berzhanin of Pareto Securities. “Yes, they’re having short-term problems right now with crop science, but it reduces the risk of the company in general and supports their growth going forward.”

YEARS OF BAD CONDUCT BY MONSANTO

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Selling Assets For Settlement?

Elanco Animal Health Inc., the business Eli Lilly & Co. listed last year, is aiming to reach an agreement soon, where they would combine with Bayer AG’s animal-health unit. The companies hope to announce a deal around the time of Elanco’s Aug. 13 earnings release, the people said, asking not to be identified as the discussions are private. Elanco, which has a market value of about $12.3 billion, plans to pay at least part of the acquisition cost using stock, the people said.

Elanco lost 4.2% Wednesday to close at $31.47. Bayer rose as much as 2.6% early Thursday in Frankfurt.

Bayer would get a significant minority stake in Elanco under the deal being discussed, according to another person. The companies are currently hammering out potential antitrust issues by identifying which businesses they will likely need to sell to gain regulatory approval, the person said.

While Bayer prefers a deal with Elanco, no final agreements have been reached and the talks could drag on or fall apart, the people said. Bayer may proceed with its previous plans for a broader auction process if it can’t agree on terms with Elanco by early September, one person said.

A deal between Elanco and Bayer would preempt a sale process that was expected to be one of Europe’s most hotly contested deal situations this year. It had attracted a flurry of initial interest from buyout firms ranging from KKR & Co. to Blackstone Group Inc. and CVC Capital Partners, which have increasingly been bidding against each other as they try to spend the record amounts of capital the industry has amassed.

Bayer said in a statement that it’s on track with plans to exit the animal-health business and its primary focus is on a sale. The German company also continues to consider all value-maximizing options, it said in the statement, declining to comment further.

Elanco has grown rapidly through at least 10 acquisitions since 2007, including the $5.4 billion takeover of Novartis AG’s animal-health unit. A representative for Elanco, which is based outside Indianapolis, declined to comment.

The sale of Bayer’s animal-health unit was expected to fetch as much as 8 billion euros ($9 billion). The process was initially slated to kick off in the second quarter, people with knowledge of the matter said in March, though Bayer has repeatedly pushed back the start of the auction.

The Bayer business offers medicine and antibiotics to farm animals and pets. The division’s best-selling product line is the Advantage flea, tick and worm treatments for small animals.

Monsanto (Bayer)  has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

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Note: (Excerpts within this article include print materials and other online media sources

Xarelto Proposed Settlement 

The death MDL settlements as we know and love them?

Foreword: Non leadership firms representing Xarelto plaintiffs facing potential dismissal from orders issued related to the proposed Xarelto settlement might find this article very beneficial.

Although it is still doubtful that the proposed Xarelto settlement will consummate, it appears that Judge Fallon is set to dismiss individual cases for failure to comply with orders arising from the proposed settlement. Such dismissals would arguably be ripe for appeal.

Spoiler Alert: MDL Judges arguably Lack Subject Matter Jurisdiction to issue orders arising from MDL settlements. Any case dismissed for failure to comply with an order issued absent jurisdiction over the subject matter giving rise to the order, would also be a juridical act undertaken without proper jurisdiction. Parties can not wave Subject Matter Jurisdiction, by act nor agreement. There is no time limit to file an appeal related to an order issued in the absence of jurisdiction over the Subject Matter. Orders issued lacking subject matter jurisdiction  are null from the onset and void on their face. Res Judicata does not apply to orders issued in want of jurisdiction over the subject matter.  See Citations of Relevant Law at the end of this article).

The Road to Hell and Good Intentions 

Certain well intended MDL Judges, including Judge Eldon Fallon have subscribed to the theory that “MDLs are Quasi Class Actions” and despite the fact the USC 1407 provides MDL judges with no jurisdiction to participate in MDL settlements, MDL judges could none the less exercised the powers of their court and involved themselves in MDL settlements, reasoning that MDLs are merely Quasi Class Actions. MDL judges ascribing to the “MDLs as Quasi Class Actions” theory have reasoned intra alia that  Federal Judges have jurisdiction over Class Action Settlements and therefore Federal Judges presiding over MDLs (Quasi Class Actions by their  reasoning) have the same jurisdiction as a Federal Judge Presiding over a Class Action, so long as they comply with the requirements of FRCP 23, in particular the requirements of FRCP 23(e) .

MDL Judges willing to arguably overstep their jurisdiction and exercise the power of their courts in MDL settlements, have justified doing so by  simultaneously complying with duties imposed under FRCP 23(e).

FRCP 23(e) requires Federal Judges presiding over Class Actions to conduct fairness hearings and approve any Class Settlement. These fairness hearings are intended in part to provide class action “absent plaintiff parties” protection from would be unscrupulous self-dealing lead class counsel.

Xarelto Settlement Where Activism turned to Tyranny 

Prior to the Xarelto Settlement, all MDL judges who have inserted themselves into MDL settlements have complied with FRCP 23(e) by conducting fairness hearings to allow parties not represented by plaintiffs leadership a voice before imposing any order related to the settlement that might negatively impact any absent plaintiffs case. Judge Fallon conducted extensive fairness hearings in the settlement of the Vioxx litigation. For reasons unknown to the author, Judge Fallon apparently does not view Xarelto plaintiffs as being deserving of the same protections provided Vioxx plaintiffs.

Although Quasi Class Actions do not actually exist, (MDLs are not Quasi Class Actions) and MDL judges arguably have no jurisdiction to involve themselves in MDL settlements, the Judicial Activism undertaken by Quasi Class Actions MDL judges has arguably been beneficial to defendants as well as plaintiffs desiring efficient mass settlement. Neither defendants nor plaintiffs have complained in the past however, Judge Fallon’s failure to conduct fairness hearings related to the proposed Xarelto Settlement may result in an end to the long running gravy train of MDL settlements achieved by activist MDL Judges willing to overstep their jurisdiction to assist parties in effectuating settlement.

In addition to failing to conduct fairness hearings related to the proposed Xarelto settlement, Judge Fallon also appears to be set to dismiss individual plaintiffs’ cases for failure to comply with orders arising from the settlement. These  orders were arguably issued absent jurisdiction over the subject matter. Any future order arising from the settlement orders, including an order dismissing a case for failing to comply with the settlement related orders, would also be issued without jurisdiction over the subject matter.

Appeals arising from the forgoing, may result in the creation of case law that puts an end to MDL judges inserting themselves into MDL settlements, making reaching mass settlement in MDLs a far more difficult task.

It should be noted I (John Ray) hold Judge Fallon in high esteem. I believe Judge Fallon is wise and fair minded. Despite the foregoing, even wise and fair-minded Judges can err.  I do not view Judge Fallon as a tyrant in general however, acts of tyranny are acts of tyranny, without regard to the general character of those that commit the acts.

Back Ground

MDL Judges presiding over Class Actions (FRCP 23) not only have jurisdiction over settlement, Judges presiding over Class Actions have a duty to insure than any proposed settlement is fair to all parties including “absent” parties. FRCP 23(e) Requires Judges presiding over Class Actions to conduct fairness hearings, and rule on the fairness of a class action settlement.

Rule 23(e) is the only safeguard provided to absent class members under Rule 23, protecting these vulnerable parties from self-dealing class action lead counsel that might be inclined to act to the common detriment of absent class members vs the common benefit of those absent parties.

Conversely USC 1407, passed by Congress in 1968, formerly codifying Multidistrict Litigation as a means by which very Federal Jurisdiction can be imposed, provided no jurisdiction for MDL judges to oversee, assist in, issue orders related to or arising from, mass settlement. Additionally, USC 1407, having extended no “settlement jurisdiction” to MDL judges also provided no protection from would be self-dealing lead counsel in MDLs that might act to the common detriment of absent plaintiffs (those not represented by leadership firms).

How Can This Be?

Common Misconception: MDL Judges Have Jurisdiction of the Subject Matter as Well as Personal Jurisdiction to oversee or enter orders to assist mass settlement.

Jurisdiction over the Subject Matter: Arguably does not exist!

Personal Jurisdiction: Arguably does not exist, except for cases that arose in the MDL Courts home State and then only if that court would otherwise have jurisdiction.

Wait a Second!

Wait a Second – MDL Judges frequently involve themselves in MDL mass settlements, how do they justify acting in excess of their Jurisdiction? How could the question of these judges jurisdiction over MDL settlement remained unresolved?

No party to an MDL to date,  has been so aggrieved by an MDL Judges overreach on settlement to force higher courts to deal with the issues. The Xarelto settlement is likely to change the foregoing.

The Birth of MDLs as Quasi Class Actions

Judge Jack B. Weinstein, presiding over the Zyprexa Litigation (MDL 1596), was the first MDL Judge (that we are aware of) to presume jurisdiction over settlement matters in Multidistrict Litigation under the “MDLs as Quasi Class Actions“ theory.

Weinstein reasoned that MDLs are “Quasi Class Actions” and cited (inter alia), his inherent authority under the “All Writs Act 28 U.S.C 1651” as providing him “inherent authority” over MDL settlements.

Judge Eldon Fallon, while presiding over the Vioxx Litigation, llowing Judge Weinstein’s Quasi Class Actions theory exerted his self-claimed inherent authority to wade into settlement of that litigation. Other MDL Judges (but not all) have also subscribed to Judge Weinstein’s “MDLs as Quasi Class Actions” theory.

Judge Eldon Fallon in Vioxx, as well as other “MDLs as Quasi Class Action  Judges” have reasoned that their involvement in MDL settlements is equitable, so long as the provisions of FRCP 23(e), are observed.  FRCP 23(e) is intended to provide protection from would be self-dealing lead Class Counsel. FRCP 23(e) obligates Federal Judges overseeing Class Actions to conduct fairness hearings (giving absent class members a chance to be heard) as well as rule on the fairness of any propose class settlement prior to approving the settlement and issuing any order related to the settlement that might negatively impact any individual plaintiff.

Judge Fallon in Vioxx as well as other “Quasi Class Action MDL judges” prior to the current Xarelto settlement have in fact held fairness hearings per FRCP 23(e) in all MDL mass settlements in which the court has involved itself via settlement related orders or other oversight.

Judge Fallon did not conduct fairness hearings before issuing orders related to the Xarelto settlement.

These “fairness hearings” are intended (according to “Quasi Class Action MDL judges”) to provide extend the protections provided absent parties in Class Action to absent parties in MDLs. In the MDL context “absent parties” would be all plaintiffs not represented by plaintiff’s leadership (retained by the leadership firms)

Why Do Xarelto Plaintiffs deserve Less Judicial protection than Vioxx Plaintiffs?

Only Judge Fallon could explain why he neglected to follow his own past reasoning (the requirement to conduct fairness hearings) and denied absent Xarelto Plaintiffs the same rights and protections as Vioxx plaintiffs.

Although the proposed Xarelto settlement is repeatedly referred to as a “Private Settlement” (extra udicial) reach by the parties, the label is inaccurate. The settlement was reached after negotiations between defense counsel and plaintiffs’ leadership. Plaintiffs leadership is not a party, nor do they represent any party (plaintiff) other than those retained by their respective firms.

Furthermore, the proposed Xarelto “Private Settlement” ceased to be Private (extrajudicial) the minute the “parties” crossed the threshold of the court seeking an order related to the settlement.

If the courts excuse for not conducting fairness hearings is “because this is a private settlement”, that dog simply won’t hunt.

Any contention that the court is acting under authority agreed to by the parties also fails. Plaintiff Leadership nor Defense Counsel all the “parties”. Plaintiff lead counsel can enter agreements binding on the clients retained by their firms (those parties) however, leadership does not represent all “parties” and therefore cannot stipulate to jurisdiction on behalf clients they do not represent. Additionally, issues related to subjected matter jurisdiction  cannot be waived by stipulation or agreement by the parties.

Jurisdiction Under the “All Writs Act”?

[A]ll courts established by Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law.”  28 U.S.C. § 1651(a).

In should be noted that Judge Weinstein, Judge Fallon  and “Quasi Class Action MDL Judges” never appear to claim to have  actual jurisdiction over MDL settlements, they instead cite their inherent authority, which would arise under the “All Writs Act”:

“All courts established by Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law.”  28 U.S.C. § 1651(a).”

The All Writs Act however, only provides “inherent authority” over subject matter for which the given Federal Court otherwise has jurisdiction. Absent Jurisdiction over the Subject Matter of MDL settlement, MDL Judges have no inherent authority  arising under 28 U.S.C. § 1651 related to the same subject matter (MDL settlements).

Judicial Activism Morphing into Tyranny

Judge Fallon, as well as other MDL judges who subscribe to the quasi-class action theory within the restraints of FRCP 23(e), have in the past been potentially guilty of well-intended judicial activism even when judicial acts arising from that activism may have strayed beyond their  jurisdiction.

The inherent problem always accompanying judicial activism is the risk of activism turning into tyranny.

Xarelto Plaintiffs aggrieved by the proposed settlement, with no forum in which to voice their grievances, while plaintiff leadership arguably acting to their common detriment and a court turning a deaf ear to their plight, might justifiably feel they are victims of judicial tyranny.

Many Judicial Scholars have expressed concern over the possible negative consequences of judicial activism. Many of the concerns expressed by these judicial scholars have now been realized in the proposed Xarelto Settlement.

The Author would argue that Judge Fallon’s failure to conduct fairness hearings, while issuing orders related to the Xarelto settlement, that may negatively impact individual plaintiffs, crossed the line from judicial activism to  judicial tyranny.

Don’t Take My Word for It

Due to the fact several members of Xarelto leadership directly threatening me and attempting to lead attorneys representing absent Xarelto plaintiffs (non-leadership) firms, to believe they are somehow at risk of ethical violations if they take the opinions of a non-lawyer (me) into consideration, I will provide the several links below to scholarly papers and articles written by judicial scholars who are actually attorneys. Draw your own conclusions.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

Elizabeth Chamblee Burch

https://www.amazon.com/Elizabeth-Chamblee-Burch/e/B00G61EI2I/ref=dp_byline_cont_ebooks_1

About Professor Burch: http://www.law.uga.edu/profile/elizabeth-chamblee-burch

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation is available for purchase on Amazon. Professor Burch has been conducing research related to MDL settlements for many years. Her most recent work “Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation” is an eye opening read even for those that believe they are already familiar with all of the “dirty little lies and secrets” of mass torts.

Other work by Professor Burch includes “Monopolies in Mass Torts”

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

You can obtain a copy of Monopolies in Mass Torts free at the link above. This paper is somewhat of a prequel to Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation. If you read the prequel you will want to buy the book.

DUBIOUS DOCTRINES: THE QUASI-CLASS ACTION  by Linda Mullenix

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

Note: This article written by Linda Mullenix in 2012 is as apt today as the day it was written.

About Professor Mullenix:  https://law.utexas.edu/faculty/linda-s-mullenix

Excepts:

In the past few years, the term ―quasi-class action has been appearing with increasing, uncritical frequency in a spate of federal court decisions. While it may be premature to characterize these sporadic references as a trend, it is perhaps soon enough to call attention to the misuse of loose labels that carry with them significant consequences. Before the quasi-class action gains any further traction, there are several valid reasons for definitively quashing this quasi

Before the inspired fabrication of the quasi-class action, global agreements accomplished under MDL auspices had to be settled pursuant to formal class requirements and due process protections. By engrafting the label quasi-class action onto MDL procedure, self-interested actors have created a perfect staging ground for negotiating back-room deals that carry a false aura of judicial legitimacy, liberated from the constraints of the formal class action rule.

MDL judges, in turn, by endorsing the concept of the quasi-class action have greatly expanded the scope of their authority and have become complicit in allowing private parties to accomplish the very backdoor settlements that the Supreme Court and federal courts have disallowed for decades. The quasi-class action, then, represents an ultimate, cynical expression of an aggregate claims-resolution model that enables self-interested actors to resolve claims in the actors‘ best interests rather than the interests of injured claimants.

At first blush, the sheer frequency of federal use of the term quasi-class action would seem to suggest that the quasi-class action is a well-recognized and well-established doctrine in federal jurisprudence. Since 1946, sixty-eight federal cases have cited the label. However, careful reading of this case law suggests an entirely different conclusion: the quasi-class action is a phantasm. None of these cases actually discussed the concept of the quasi-class action, and rarely-cited authority is inapposite or inaccurate.

Important Case Law

Although SCOTUS has yet to address the question : Does and MDL Judge (like a Class Action Judge) have jurisdiction over settlement, as the question has yet to be presented to SCOTUS, the high court has ruled on other questions in a manner which may be of value to any firm representing a plaintiff in the Xarelto litigation if said plaintiff case is dismissed or otherwise prejudiced by any of the orders related to or arising from the prosed Xarelto Settlement.

Lexecon v Milberg (Scotus)

https://www.oyez.org/cases/1997/96-1482

Note: Lexecon did not directly address the question of an MDL Judges jurisdiction over MDL settlement however, SCOTUS made it clear that USC 1407 does not extend an MDL judges jurisdiction beyond the exact language codified by Congress in 1407.

Federal Judges have broad discretion over many matters however, Federal Judges have no discretion in any matter (subject matter nor personal) beyond the specific grant of jurisdiction by Congress under which the court acts.

Question

May a federal district court conducting “pretrial proceedings” under 28 USC section 1407(a) invoke section 1404(a) to assign a transferred case to itself for trial?

No. In an opinion delivered by Justice David H. Souter, the Court held that a district court conducting pretrial proceedings pursuant to section 1407(a) has no authority to invoke section 1404(a) to assign a transferred case to itself for trial. The Court noted that the Panel’s section 1407(a) instructions are crouched in the word “shall,” which “creates an obligation impervious to judicial discretion.” Justice Souter wrote for the Court that, “the straightforward language imposing the Panel’s responsibility to remand… bars recognizing any self-assignment power in a transferee court.” The opinion was unanimous except insofar as Justice Antonin Scalia did not join Part II-C.

Lexecon Inc. was a defendant in a class action lawsuit. Under 28 USC section 1407(a), the lawsuit was transferred for pretrial proceedings to the District of Arizona. Section 1407(a) authorizes the Judicial Panel on Multidistrict Litigation to transfer civil actions with common issues of fact “to any district for coordinated or consolidated pretrial proceedings,” but provides that the Panel “shall” remand any such action to the original district “at or before the conclusion of such pretrial proceedings.” After claims against it were dismissed, Lexecon brought suit against Milberg Weiss Bershad Hynes & Lerach and others (Milberg) in the class action lawsuit in the Northern District of Illinois. Ultimately, the Panel, under section 1407(a), ordered the case transferred to the District of Arizona. Afterwards, Lexecon moved for the Arizona District Court to remand the case to Illinois. Milberg filed a countermotion requesting the Arizona District Court to invoke section 1404(a) to “transfer” the case to itself for trial. Ultimately, the court assigned the case to itself and the Court of Appeals affirmed its judgment.

AMCHEM PRODUCTS, INC., et al., PETITIONERS v. GEORGE WINDSOR et al.

Note: AMCHEM arose from the asbestos litigation, the ruling addressed attempts to settle cases filed in MDLs as well as cases filed in Class Actions. SCOTUS did not address the question of MDL Courts jurisdiction (nor lack thereof) over MDL settlement as this issue was not raised. SCOTUS ruling in AMCHEM did however make it clear that any mass tort judge, whether presiding over an MDL or a Class Action, has a duty to protect the interest of “absent plaintiffs”.

Excepts from AMCHEM

This case concerns the legitimacy under Rule 23 of the Federal Rules of Civil Procedure of a class action certification sought to achieve global settlement of current and future asbestos related claims. The class proposed for certification potentially encompasses hundreds of thousands, perhaps millions, of individuals tie d together by this commonality: each was, or some day may be, adversely affected by past exposure to asbestos products manufactured by one or more of 20 companies. Those companies, defendants in the lower courts, are petitioners here.

Rule 23(e), on settlement of class actions, reads in its entirety: “A class action shall not be dismissed or compromised without the approval of the court, and notice of the proposed dismissal or compromise shall be given to all members of the class in such manner as the court directs.” This prescription was designed to function as an additional requirement, not a superseding direction, for the “class action” to which Rule 23(e) refers is one qualified for certification under Rule 23(a) and (b). Cf. Eisen, 417 U. S., at 176-177 (adequate representation does not eliminate additional requirement to provide notice). Subdivisions (a) and (b) focus court attention on whether a proposed class has sufficient unity so that absent members can fairly be bound by decisions of class representatives. That dominant concern persists when settlement, rather than trial, is proposed.

The settling parties, in sum, achieved a global compromise with no structural assurance of fair and adequate representation for the diverse groups and individuals affected. Although the named parties alleged a range of complaints, each served generally as representative for the whole, not for a separate constituency. In another asbestos class action, the Second Circuit spoke precisely to this point:

[W]here differences among members of a class are such that subclasses must be established, we know of no authority that permits a court to approve a settlement without creating subclasses on the basis of consents by members of a unitary class, some of whom happen to be members of the distinct subgroups. The class representatives may well have thought that the Settlement serves the aggregate interests of the entire class. But the adversity among subgroups requires that the members of each subgroup cannot be bound to a settlement except by consents given by those who understand that their role is to represent solely the members of their respective subgroups.” In re Joint Eastern and Southern Dist. Asbestos Litigation, 982 F. 2d 721, 742-743 (CA2 1992), modified on reh’g sub nom. Inre Findley, 993 F. 2d 7 (CA2 1993).

The Third Circuit found no assurance here–either in the terms of the settlement or in the structure of the negotiations–that the named plaintiffs operated under a proper understanding of their representational responsibilities. See 83 F. 3d, at 630-631. That assessment, we conclude, is on the mark.

The argument is sensibly made that a nationwide administrative claims processing regime would provide the most secure, fair, and efficient means of compensating victims of asbestos exposure. Congress, however, has not adopted such a solution. And Rule 23, which must be interpreted with fidelity to the Rules Enabling Act and applied with the interests of absent class members in close view, cannot carry the large load CCR, class counsel, and the District Court heaped upon it. 

Subject Matter Jurisdiction Case Law 

Note: There are literally thousands of appellate rulings related to Lower Courts (Federal) issuing judgments and orders in excess of their jurisdiction. The citations below are merely examples of the vast number of rulings on the subject.

Void judgment is one entered by court that lacks the inherent power to make or enter the particular order involved, and it may be attacked at any time, either directly or collaterally; such a judgment would be a nullity, People v. Rolland 581 N.E.2d 907, Ill.App. 4 Dist. 1991)..

Invalidity need to appear on face of judgment alone that judgment or order may be said to be intrinsically void or void on its face, if lack of jurisdiction appears from the record, Crockett Oil Co. v. Effie, 374 S.W.2d 154 (Mo.App. 1964).

Note: MDL Court Judges imposing themselves into MDL settlements never seem to actually claim to have jurisdiction in the record, instead they  claim to have “inherent authority”. No authority exists absent jurisdiction.

Decision is void on the face of the judgment roll when from four comers of that roll, it may be determined that at least one of three elements of jurisdiction was absent: (1) jurisdiction over parties, (2) jurisdiction over subject matter, or (3) jurisdictional power to pronounce particular judgment that was rendered, B & C Investments, Inc. v. F & M Nat. Bank & Trust, 903 P.2d 339 (Okla. App. Div. 3, 1995).

A void judgment which includes judgment entered by a court which lacks jurisdiction over the parties or the subject matter, or lacks inherent Power to enter the particular judgment. or an order procured by fraud,can be attacked at any time, in any court, either directly or collaterally, provided that the party is properly before the court. Long v. Shorebank Development Corp., 182 F.3d 548 ( C.A. 7 Ill. 1999).

A void judgment is one which from its inception was a complete nullity and without legal effect, Lubben v. Selective Service System Local Bd. No. 2 7, 453 F.2d 645, 14 A.L.R. Fed. 298 (C.A. 1 Mass. 1972).

A void judgement is one which from its inception and forever continues to be absolutely null. without legal efficacy, ineffectual to bind the parties or to support a right, of no legal force and effect whatever, and incapable of enforcement in any manner or to any degree – Loyd v. Director, Dept. of Public Safety, 480 So. 2d 577 (Ala. Civ. App. 1985).

A judgment shown by evidence to be invalid for want of jurisdiction is a void judgment or at all events has all attributes of a void judgment, City of Los Angeles v. Morgan, 234 P.2d 319 (CaLApp. 2 Dist. 1491).

Res judicata consequences will not be applied to a void judgment which is one which from its inception is a complete nullity and without legal effect, Allcock v. Allcock 437 N.E. 2d 392 (Ill. App. 3 Dist. 1982).

Void judgment is one which has no legal force or effect whatever, it is an absolute nullity, its invalidity may be asserted by any person whose rights are affected at any time and at any place and it need not be attacked directly but may be attacked collaterally whenever and wherever it is interposed, City of Lufkin v. McVicker, 510 S.W. 2d 141 (Tex. Civ. App. – Beaumont 1973 1991)..

Disclaimer: The author of this article, John Ray, is not a lawyer. Nothing in this article should be taken as legal advice. The opinions expressed in this article are the opinions of the author. Publication of this article by any third party should not be considered an endorsement of nor agreement with the opinions expressed by the author.

Those Aggrieved by the Proposed Xarelto Settlement

May Still Get a Chance to be Heard

Thus far firms representing absent plaintiffs (those not represented by leadership) have yet to be given an opportunity to be heard by the court regarding any aspect of the proposed Xarelto settlement.  I previously addressed this issue in another article.

https://www.masstortnexus.com/mass-torts-news/xarelto-settlement-judicial-activism-vs-judicial-tyranny/

Due Process Refresher 

The Fifth and Fourteenth Amendments to the United States Constitution each contain a due process clause. Due process deals with the administration of justice and thus the due process clause acts as a safeguard from arbitrary denial of life, liberty, or property by the government outside the sanction of law. The Supreme Court of the United States interprets the clauses broadly, concluding that these clauses provide four protections: procedural due process (in civil and criminal proceedings), substantive due process.

The core of these requirements is notice and a hearing before an impartial tribunal.

Fuentes v. Shevin, 407 U.S. 67, 81 (1972). At times, the Court has also stressed the dignitary importance of procedural rights, the worth of being able to defend one’s interests even if one cannot change the result.

Mathews v. Eldridge, 424 U.S. 319, 333 (1976). “Parties whose rights are to be affected are entitled to be heard.” Baldwin v. Hale, 68 U.S. (1 Wall.) 223, 233 (1863).

Picking Up Where We Left Off

Without Regard to the points made in the prior article, even if the proposed Xarelto settlement agreement reaches the required participation numbers, it should not be a done deal. For Judge Fallon to grant specific common benefit fee requests, it will arguably be necessary to form a “Settlement Class Action” under FRCP 23. Once this occurs, his honor will not have the option of ignoring FRCP 23(e), the requirement to conduct fairness hearings before final approval of the settlement. This will be the time at which firms representing absent plaintiffs may get their chance to be heard and I believe these firms will have much to say.

If Judge Fallon allows the proposed Xarelto settlement to impact plaintiffs, without ever having engaged in any act to protect the rights of absent parties, this egregious failure may well define his legacy, overshadowing and otherwise admirable judicial career.

Note: Nothing would prevent a firm representing a non-settling client from moving to form a Class Action for non-settling plaintiffs, aggrieved by the settlement.

Due to the fact that the proposed Xarelto Settlement did not follow the “opt in” reasoning (see article by Judge Fallon below), the only way the necessity of creating a settlement class could be avoided would be if 100% of all Xarelto plaintiffs accepted the settlement. Even under this circumstance, jurisdictional issues would still exist. I will address this subject more thoroughly later in this article.  First, I will cover recent developments.

Latest Spin on the Xarelto Settlement

I have learned that leadership claims that 26,000 enrollment packages have been received by Brown Greer and they are very confident that they will reach 98% participation. MTN can not verify leaderships statements with Brown Greer as they seem to have been gagged by leadership. Regardless, the proposed settlement only covered 25,000 plaintiffs. The total number of complaints on file in the MDL and Philadelphia Court of Common Pleas has ballooned to over 31,339 plaintiffs since the proposed settlement was first announced. The foregoing begs the question “98% of what”.  26,000 is 82.96% of 31,339. If we take leadership at their word and believe 26,000 plaintiffs have accepted the settlement, then we must assume that the settlement is going to include more than 25,000 plaintiffs and base on “participation calculus” on the total number of cases on file, which is at least 31,339.

Settling 26,000 cases would leave 5339 remaining. I do not believe that the defendants can sell a settlement to their stockholders that leaves 5339 cases (unknown risks) unresolved.

A reliable source has informed me that the “98% participation claim” was based on 98% of the 70% of plaintiffs that have returned the enrollment package, not 98% of all plaintiffs. Maybe leadership is counting on using the “dismissal machine” they have arguably created in co-operation with defense, to get rid of the non-enrollers and therefore do not think these plaintiffs need be counted.

Though I can not verify the foregoing (Brown Greer gagged), I believe the 26,000-enrollment number may be significantly exaggerated or at minimum skewed. Leading non leadership firms to believe the proposed settlement will consummate would be a good way to get firms reluctant to encourage plaintiffs to except the settlement to change course. A self-fulfilling prophecy (stated as fact) if you will.

The Chance and Right to be Heard

I stated, in the previous article (link above) that Judge Fallon arguably lacks subject matter jurisdiction to issue orders related to an MDL settlement. I also stated that since Judge Fallon is an MDL judge that subscribes to the MDLs as Quasi  Class Actions theory and therefore should have held FRCP 23(e) fairness hearings before or currently with issuing in order related to settlement as His Honor did in Vioxx and other MDLs in the past.

Putting aside the above, absent Xarelto plaintiffs (those not represented by leadership firms) may still have a chance to be heard.

How an MDL Judge can properly involve  themselves in settlement:

1. Plaintiff Leadership and Defense reach a settlement agreement without seeking orders from the court.
2. Plaintiff Leadership presents the settlement to firms representing absent plaintiffs and if enough those plaintiffs opt into the settlement to meet the required participation threshold, then the settlement can be consummated (only for those that opted in).
3. Only after the foregoing, would it be proper for the court to become involved. Plaintiff Leadership and Defense can present the consummated agreement (with all opt ins) to the Judge and seek to form a Settlement Class Action (under FRCP 23).

Obviously the ship has sailed with regard to Judge Fallon conducting FRCP 23(3) fairness hearings before or concurrently with issuing orders related to settlement however, it would be inconceivable for His Honor to issue orders granting specific Leadership and PSC Firms common benefit fees without a “Settlement Class Action” being formed.

Why? Without a Settlement Class Action in place, Judge Fallon will have no control over or authority to grant any order related to the global proceeds of the mass settlement.

The Opportunity to Be Heard- Finally?

If the proposed Xarelto Settlement reaches the required participation numbers and is consummated, Judge Fallon will only be able to take control of the global proceeds (in order to grant common benefit fees) via a Settlement Class Action. This will be the point at which firms representing absent plaintiff firms will (as required FRCP 23(e) to be heard). If Judge Fallon neglects to conduct fairness hearings before granting fees, an appellate court is likely to overturn any order granting common benefit fees.

The link below is from a 9^th Circuit in the Hyundai Kia MDL. A settlement was reached in this MDL and a Settlement Class Action was granted by the MDL Judge. Suit was filed by firms representing absent plaintiffs related to the common benefit fees awarded arising from the settlement. The

https://www.consumerfinancialserviceslawmonitor.com/wp-content/uploads/sites/501/2019/06/In-re-Hyundai.pdf

Excerpts from Ruling:

On December 23, 2013, the settling parties sought preliminary approval of the nationwide class settlement and moved to certify a settlement class. The district court ordered multiple rounds of briefing concerning the fairness of the settlement, sufficiency of the class notice, the claims process, class certification, choice of law, and other issues. At four hearings held between December 2013 and August 2014, the parties addressed concerns raised by the court sua sponte as well as by objectors and other non-settling plaintiffs. In response to these concerns, the settling parties twice revised the settlement agreement and notice provisions.

After issuing several detailed written rulings, the district court granted preliminary approval of the settlement and certified the class for settlement purposes on August 29, 2014. The court appointed Hagens Berman and McCuneWright as settlement class counsel. In September and October 2014, the district court held four additional hearings, at which it requested that the parties make additional changes to the settlement notices and website, such as adding information about the Reimbursement Program, and rewording the notices to make them easier to understand.

A binding settlement must provide notice to the class in a “reasonable manner” and otherwise be “fair, reasonable, and adequate.” Fed. R. Civ. P. 23(e)(1), (2)

Before the district court approves a class settlement under Rule 23(e), it is “critical” that class members receive adequate notice. Hanlon, 150 F.3d at 1025. To satisfy Rule 23(e)(1), settlement notices must “present information about a proposed settlement neutrally, simply, and understandably.” Rodriguez v. W. Publ’g Corp., 563 F.3d 948, 962 (9th Cir. 2009). “Notice is satisfactory if generally describes the terms of the settlement in sufficient detail to alert those with adverse viewpoints to investigate and to come forward and be heard.’” Id. (quoting Churchill Vill., LLC v. Gen. Elec., 361 F.3d 566, 575 (9th Cir. 2004)).

Rule 23(e) ensures that unnamed class members are protected “from unjust or unfair settlements affecting their rights.” Amchem, 521 U.S. at 623 (1997).

Over the course of several years, the district court performed an admirable job of managing this complex litigation. After the settlement was announced, the district court held multiple status conferences and requested several rounds of briefing to ensure that all of the litigants’ concerns were heard and addressed.

Note: The 9^th circuit ruling leave little doubt that had the settlement court failed to comply with FRCP 23(e), that courts grant of attorney’s fees  to “Class Counsel”  would not have withstood appeal.

End Excerpts

Moving Forward -Two Possible Outcomes

1. Judge Fallon moves forward with a settlement class (if the settlement consummates) without the required FRCP 23 (e) fairness hearings, in which case any grant of common benefit fees arising from the court would likely be overturned on appeal.

2. Judge Fallon moves forward with a settlement class and does (as required) conduct fairness hearings per FRCP 23(e). Although belated, this would give firms representing absent class members to object to the terms of the settlement as well as any common benefit fees being awarded from the settlement proceeds. Even those plaintiffs that rejected the settlement or were subject to dismissal arising from a settlement related order would arguably have standing (the right to be heard).

1. Leadership Self-Dealing (subject of a future article).
2. Leadership Conclusion with defense to create a “dismissal machine.
3. Unwarranted Discounts.
4. Overly Complex processes created by settlement orders, leading to denial of due process.
5. Settlement related orders issued absent jurisdiction over the subject matter.

The article below, written by Judge Fallon

COMMON BENEFIT FEES IN MULTI-DISTRICT LITIGATION

https://judicialstudies.duke.edu/sites/default/files/centers/judicialstudies/mdl2014/Common_Benefit_Fees.pdf

By: The Honorable Eldon E. Fallon

Note:. In the article, Judge Fallon, as he has on numerous occasions, referred to “private mass tort settlements” as opt in (vs class actions which are opt outs). His Honors reference to these settlements as Opt In vs Opt Out seems to imply that his jurisdiction over settlement arises from the agreement of the parties that Opt In. By Implication this would mean that any party that does not opt in should not be negatively impacted by the given settlement. This has obviously not held true in the proposed Xarelto Settlement.

The following excerpt from the article by His Honor express the same view he expressed in Vioxx, which involved a settlement very similar to the proposed Xarelto Settlement (with 4 billion additional dollars for roughly the same number of plaintiffs) . In Vioxx, Judge Fallon conducted the Rule 23(e) hearing he references below to allow absent plaintiffs a voice in the settlement. I have yet to discern why His Honor believes Xarelto plaintiffs are less deserving of due process than Vioxx Clients.

Excerpt

The argument used by the courts supporting their equitable authority to review attorneys fees is that Rule 23 of the Federal Rules of Civil Procedure expressly provides that a district court presiding over a class action has a duty to scrutinize the attorneys fees of class counsel to assure that they are reasonable. The transferee judge in MDLs should have the same responsibility because MDLs are quasi class actions since their purpose and function is the same as the traditional class action namely efficiency and coordination before a single court. Furthermore, many MDLs contain multiple class actions along with the individual claims and it is not unusual to utilize the settlement class vehicle provided by Rule 23(e) to resolve the entire Thus Rule 23 is often an integral part of the MDL process.

End Excerpt

Has Judge Fallon Became to Chummy with Xarelto Leadership?

Just out of curiosity I have submitted a Form A0 10A to the Judicial Committee on Financial Disclosures, requesting Judge Fallon’s financial disclosures for 2013-2018. I already have copies of his disclosures through 2012 and His Honor discloses that his travel and other expenses are paid by third parties when he attended conferences 2012 and prior. I am curious to find out if MTMP paid Judge Fallon’s expenses when he attended MTMP conferences over the past few years. Paying for trips to lavish resorts in sin city for a Federal Judge before whom a firm currently has matters subject to litigation, is something I find worth exploring.

Required Reading for those wanting to improve their knowledge of all things MDL settlement.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

But this book, it may shock even the most cynical!

https://www.amazon.com/Mass-Tort-Deals-Bargaining-Multidistrict-ebook/dp/B07S7DMN7Z

By: Elizabeth Chamblee Burch

Elizabeth Chamblee Burch is the Fuller E. Callaway Chair of Law at the University of Georgia. Her teaching and research interests include mass torts, class actions, and civil procedure. She has been a Visiting Professor at Harvard Law School.

Other worthwhile reading authored by Professor Burch:

Monopolies in Multidistrict Litigation

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

Repeat Players in Multidistrict Litigation

https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?article=4737&context=clr

DISAGGREGATING

https://openscholarship.wustl.edu/cgi/viewcontent.cgi?article=6002&context=law_lawreview

Judging Multidistrict Litigation 

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1993&context=fac_artchop

Morphing Case Boundaries in Multidistrict Litigation Settlements

By: Margaret S. Thomas

http://law.emory.edu/elj/_documents/volumes/63/6/responses/thomas.pdf

About Professor Thomas: https://www.law.lsu.edu/directory/profiles/margaret-s-thomas/

Once Size Doesn’t Fit All: Multidistrict Litigation, Due Process and the Dangers of Procedural Collectivism

http://www.bu.edu/bulawreview/files/2015/02/REDISH.pdf

By: MARTIN H. REDISH & JULIE M. KARABA

Martin H. Redish is the Louis and Harriet Ancel Professor of Law and Public Policy at the Northwestern University Pritzker School of Law. Redish has written 19 books and over a hundred law review articles in the areas of civil procedure and constitutional law.

About Professor Redish: http://www.law.northwestern.edu/faculty/profiles/MartinRedish/

Julie Karaba (Siegal is) currently a Clerk for Chief Justice John Roberts, United States Supreme Court.

https://www.sesp.northwestern.edu/news-center/news/2018/03/sesp-alumna-to-clerk-for-chief-justice-of-the-united-states-john-g.-roberts,-jr..html

Judicial Review of Private Mass Tort Settlements

By: Jeremy T. Grabill

https://scholarship.shu.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1418&context=shlr

About Jeremy Grabill: https://www.phelps.com/jeremy-grabill

TAKING A SECOND LOOK AT MDL PRODUCT LIABILITY SETTLEMENTS: SOMEBODY NEEDS TO DO IT

https://kuscholarworks.ku.edu/bitstream/handle/1808/25557/Mueller_FINAL.pdf;jsessionid=DFE28872C148C01DAF73FED1CD91E292?sequence=1

By: Christopher B. Mueller

About Professor Mueller: https://lawweb.colorado.edu/profiles/profile.jsp?id=38

DUBIOUS DOCTRINES: THE QUASI-CLASS Action

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

By: Linda S. Mullenix

AGGREGATE LITIGATION AND THE DEATH OF DEMOCRATIC DISPUTE RESOLUTION

https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1063&context=nulr

Also by: Linda S. Mullenix

About Professor Mullenix: https://law.utexas.edu/faculty/linda-s-mullenix

Books by Professor Mullenix: https://www.amazon.com/Linda-S.-Mullenix/e/B001HML766

Managing Related Proposed Class Actions in Multidistrict Litigation

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

By: Catherine R. Borden

Government of the United States of America – Federal Judicial Center

GLOBAL SETTLEMENTS IN NON-CLASS MDL MASS TORTS

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

https://law.lclark.edu/live/files/25156-saackreadyforwebsitepdf

By: Amy L. Saack

About Amy Sacck: http://www.davisrothwell.com/attorney/amy-saack/

STANDARDS AND BEST PRACTICES FOR LARGE AND MASS-TORT MDLS

BOLCH JUDICIAL INSTITUTE, DUKE LAW SCHOOL

https://judicialstudies.duke.edu/wp-content/uploads/2018/10/standards_and_best_practices_for_large_and_mass-tort_mdls-Bolch-Judicial.pdf+

Disclaimer: The author of this article, John Ray, is not an attorney. Nothing in this article should be considered legal advice. The opinions expressed in this article are those of John Ray. Publication of this article by any third party should not be considered endorsement of nor agreement with the opinions expressed by the author.

Mass Tort Billionaires

What do they know that you don’t?

Fact: Mass Torts have made more plaintiff lawyers billionaires (or billionaire adjacent) than any other practice area.

Myth: Most Mass Tort billionaires made their money from the massive trial verdicts we here about in the news (RoundUp, Talcum Powder etc.).

Fact: The majority of Mass Tort billionaires (or billionaire adjacent) did not reach this lofty status from major trial verdicts, they built their practice over time, accumulating the knowledge and skills required to independently evaluate a mass tort litigation before taking a financial risk.

Most Successful Mass Tort Firms Learned by Trial and Error.

There is an easier way!

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error).  It is better to learn from the mistakes of others than to make those same mistakes yourself.

You may not be willing to take the risk required to become a “mass tort billionaire”, however, if you are interested in working smarter vs harder and reaching the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to get more information about the September Course . You may alson simply  call or email Barbara Capasso or Anne Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

How Most Lawyers Get Started in Mass Torts

One Lawyer, we will call him Mr. Mass Tort Big Bucks, gives another lawyer, we will call Mr. Mass Tort Outsider, an inside tip on a great new mass tort in which Mr. Big Bucks is involved. Mr. Outsider takes the tip and runs with it.

One of two things happen:

Scenario A: The litigation does South and Mr. Outsider thinks “Mass Torts is just a big gamble”, I am never doing that again.

Scenario B: The litigation pays off big and Mr. Outsider becomes overly optimistic, thinking, “Wow this Mass Tort thing is great”, I am going to bet on every new case that come along.

Neither Scenario Is Good for Mr. Outsider

In Scenario A, now “mass tort pessimistic” Mr. Outsider is likely to take him self out of the game (mass tort plaintiff law) that has created more plaintiff lawyer billionaires than any other practice area.

In Scenario B, now “mass tort overly optimistic” Mr. Outsider is likely to throw money at every mass tort litigation that comes along and is at risk of eventually losing his shirt.

1. Big Bucks, who is already sold on a litigation, is not an objective source of information.
2. Big Bucks can probably afford to lose money that Mr. Outsider may not be able to afford to lose.

Become a Mass Tort Insider!

Instead of relying on tips from other lawyers or the mass tort rumor mill, gain the “insider knowledge “that will allow you to evaluate mass tort litigation’s objectively. The next time you get a tip from another lawyer, have the information and knowledge that will allow you to do your homework before taking a leap into a mass tort litigation.

The course starts at the most basic level, discussing the difference between Class Actions and Multi-district Litigation and then progresses to providing the tools needed to evaluate the “metrics” relevant to all mass tort litigation’s which need to be considered before taking a financial risk. The basic metrics (below) are explained in detail before the course progresses to how firms can apply these metrics to make decisions and develop strategies that lead to success.

On the third day of the course, lead litigators step in and give presentations on various mass tort litigation’s in which they are currently involved. Course attendees will be armed with the knowledge developed in the first two days of the course, to ask the lead litigators informed questions and use the metrics and other information they have gained thus far in the course to make decisions about which litigation’s they may be interested in.

The relatively small class size allows course attendees to interact with the lead litigators in the classroom as well as during the outside activities “up close and personal”.

What do past course attendees have to say?

Visit our YouTube Channel to hear what other past attendees have to say about the course.

https://www.youtube.com/channel/UC8I9zGYo3YC5BhulgxthCOw/videos

This Week in Mass Torts Around The Country

Week of August 19, 2019

By Mark A. York

Mass Tort Opiate Litigation Update – Opioid Crisis:

> MDL Judge Appoints Negotiating Class Counsel (August 19, 2019)

Opiate MDL 2804 Order Appointing Interim Class Negotiating Counsel August 19, 2019

 Opiate MDL 2804 Judge Polster, seems to have decided to move forward on the unique class settlement format proposed by plaintiff’s leadership, which will ensure a re-energized opposition by numerous Attorney Generals from states across the country.   

See the Ohio AG’s July 23, 2019 letter to Judge Polster here “Ohio Attorney General letter to Opiate MDL Judge Pollster citing caselaw” where AG Yost expresses a high level of  concern, as well as intent to oppose the class certification settlement attempts.

The judge also brushed aside objections from other AG’s as well, who stated that the complex allocation formula would intrude on the power of the states to allocate money among their political subdivisions as they see fit. Judge Polster said he wouldn’t approve any language undermining state sovereignty, but went on to say he also won’t approve any settlement that directs all of the money into state treasuries, as some politicians demand.

See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

August 6, 2019 Opioid Developments

“The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

Opiate drugmaker stocks fell sharply after Bloomberg reported that a coalition of state attorneys general had demanded $45 billion from the three leading drug distributors in the U.S. to settle litigation over opioids.

According to Bloomberg, the counteroffer came after the distributors proposed a $10 billion settlement. The reported offers were made in negotiations between the National Association of Attorneys General andMcKesson (ticker: MCK), Cardinal Health (CAH), and AmerisourceBergen(ABC).

BREAKING: August 20, 2019 Endo and Allergan Pay $15M To Exit Opioid MDL Bellwether Trials

 (August 20, 2019) Endo Pharmaceuticals Inc. announced Tuesday August 20, 2019 that it will pay $10 million and donate up to $1 million in prescription drugs to exit the lead bellwether cases in the Opiate MDL 2804 litigation, which represents the most significant settlement so far in the Opioid MDL.

Endo announced said it had reached an agreement-in-principle to pay Cuyahoga and Summit counties $10 million to and provide them up to $1 million worth of two of its of its drug products free of charge.

Allergan has tentatively agreed to pay $5 million to resolve claims involving its branded opioids, though the deal does not resolve claims involving generic painkillers.

This Endo settlement is close on the heels of their similar settlement just before the June start date of the State of Oklahoma opioid trial, where Purdue Pharma and Endo settled before trial, leaving Johnson & Johnson as the lone defendant. The first MDL bellwether trial in front of Judge Polster is set to start October. 21^st and he seems set of making sure the trial moves forward or the opioid litigation is close to settling .

In addition to the $10 million payment, Endo said it would donate up to $1 million worth of its blood pressure drug Vasostrict and its emergency allergy treatment Adrenalin.

Local government plaintiffs in the MDL were discussing settlements that would involve noncash payments such as donations of prescription drugs, per a statement by Matthew J. Maletta, Endo’s chief legal officer, announced Tuesday, adding that the $10 million “approximates the estimated cost to Endo of proceeding through trial while the product portion of the settlement illustrates the importance of Endo’s critical care products.”

“It is important to note that the value of the settlement should not be extrapolated to any other opioid related cases or claims,” Maletta said.

This Endo settlement only relates to cases brought by the northern Ohio counties of Cuyahoga and Summit, the two plaintiffs at October’s bellwether trial.

Endo added , If there is eventually a global resolution of cases brought by other governments, this settlement stipulates that the two counties “will receive the value they would have receivedunder such resolution less the total value of the settlement in principle announced today.”

Endo halted sales of the oxymorphone painkiller Opana ER at the request of the U.S. Food and Drug Administration amid concern about abuse and a spike in injection-related diseases. In the MDL, the drugmaker made headlines when its local counsel, BakerHostetler, was disqualified based on conflict-of interest concerns.

Other companies still set to face trial on Oct. 21 include drugmakers Purdue Pharma LP, Teva Pharmaceutical Industries Ltd and Johnson & Johnson and drug distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp.

Docket Information:

>County of Cuyahoga v. Purdue Pharma LP et al., case number 1:17-op-45004, County of

>Summit et al. v. Purdue Pharma LP et al., case number 1:18-op-45090,

See In re: National Prescription Opiate Litigation, 17-md-02804, U.S. District Court for the Northern District of Ohio, Judge Polster

 Pfizer Named in Amended Opiate Complaints

Why adding Pfizer to Opiate Entity Complaints is a smart move in 2019.

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

On July 29, 2019 Summit County, Utah added more than 55 defendants to its opioid lawsuit, including members of the Sackler family, drugmaker Pfizer, pharmacy chains CVS and Walgreens and stores like Walmart, Costco and Smith’s Food and Drug. The Sacklers founded pharmaceutical giant Purdue Pharma. Pfizer attempted to dodge the litigation by working out a sweetheart marketing compliance deal with the Coty of Chicago and others at one point when the Opioid Litigation was just emerging. Most opiate plaintoffs may not have been aware that Pfizer insurance carriers revoked the coverage in certain opiate litigation dockets via filing successful Declaratory Judgment actions in last 2017, see link above to California Appeals Court ruling of November 2017.

Summit County Attorney Margaret Olson said the additions were prompted by the recent release of a trove of data from a Drug Enforcement Administration database.“It’s not a change in strategy, it would be a natural progression — an augmentation of our damage claim based upon additional facts we’ve gathered,” Olson said.

Pfizer Worked Early Opiate Deal With City of Chicago

In a surprising move, Pfizer (PFE) reached an agreement with the city of Chicago to follow a code of conduct for marketing opioids that officials hope will become standard practice for other companies.

The drug maker agreed last week to disclose in all promotional materials that opioids carry a risk of addiction and not to promote them for any unapproved uses. Moreover, Pfizer must make clear that there is insufficient research about the effectiveness of opioids if used beyond 12 weeks, a nod to concerns that the drugs are too often used on a long-term basis, which can lead to addiction.

The pact reflects an unusual development, however, because Pfizer agreed to cooperate with the city in a fight against several of its competitors. Two years ago, Chicago filed a lawsuit accusing five other drug makers of deceptively marketing opioids. Pfizer appears to have avoided being drawn into the litigation by providing city officials with documents and other evidence useful to the lawsuit.

NAS BABY PLAINTIFFS’ STATUS REPORT DATED August 19, 2019 Re: IN RESPONSE TO THIS COURT’S BENCH ORDER OF AUGUST 7, 2019

Link to: NAS Infant Status Report to Judge Polster Opiate MDL 2804 August 19, 2019

The NAS plaintiffs now seem to have gained traction within the MDL power structure and are able to secure the most tragically affected plaintiffs in this litigation a deserved place in the the far-flung settlement discussions. On August 7 the Court conducted a status conference where the Judge suggested potential issues that might be added to the class action complaints.

For more than a year, lead attorneys for the more than 35 NAS state class actions have sought to proceed with limited class discovery and access the ARCOS database.

The plaintiffs, represented by Counselors Scott Bickford and Kevin W. Thompson, did finally receive full access to all documents and databases requested at the end of July. Teams of attorneys are now reviewing 130 million pages of discovery responses, five hundred depositions, ARCOS data and thousands of files of redacted pleadings and pleading exhibits to buttress and streamline their causes of action and pare the discovery only to those areas not conducted by the parties to the MDL.

The transcript from the August 7 conference quotes Judge Polster as stating, “These cases, of course, are dramatically different from other cases in the MDL.” In the coming weeks, Plaintiffs will again request that they be granted leave to file amended complaints incorporating the recommendations by the Judge during the August 7 hearing.

In the meantime, the NAS representatives are moving forward with actions scheduled for next week before Judge Polster, as well as continuing to respond to the request from families confronting these issues. Their medical experts’ recent scientific confirmation of the teratogenic functions of prescription opioids in pregnancy women upon fetuses now links these cases clearly to legal precedent applied to accutane.

Please contact Stephen Wussow at Cooper Law Firm for more information about these issues, family referrals and the Opioid Justice Team at 504-399-0009 swussow@clfnola.com

Related materials >Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA

To access the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne-Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
2. To obtain our free newsletters that contains real time mass tort updates, visit com/news and sign up for 

Note: (Excerpts within this article include print materials and other online media sources

For more Mass Tort Nexus Information See: Mass Tort Nexus Newsletters and MDL Updates

“MORE BAD CONDUCT SHOWN IN OKLAHOMA OPIOID TRIAL”

By Mark A. York (August 26, 2019)

(MASS TORT NEXUS MEDIA) The first court verdict to come out of the massive litigation over the opioid crisis has resulted in a verdict against Johnson & Johnson for $550 MILLION at 4:05p.m. today, August 26, 2019 in one of the most important drug related lawsuits in U.S. history.

This is the first of several upcoming opioid lawsuits against a drugmaker to go to trial, and it could set a precedent for cases across the country. Depending on how the judge rules, it could give lawyers a new strategy for holding large corporations accountable.

For weeks, the state of Oklahoma has argued that Johnson & Johnson and its pharmaceutical subsidiary Janssen helped create a “public nuisance” by intensely marketing opioid painkillers while downplaying the risk of addiction.

“This is very personal to all of us,” said state attorney Reggie Whitten. “My partner lost a niece to this opioid epidemic. I lost my firstborn son to the opioid epidemic.”

The 2017 filing named multiple defendants. Purdue Pharma and Teva Pharmaceuticals USA settled out of court for a combined total of $355 million, without admitting wrongdoing.

But Johnson & Johnson and Janssen decided to go to trial.

“When you’re right, you fight,” said their attorney, Sabrina Strong, a partner at O’Melveny and Myers. “And that’s what you’re seeing here. We have sympathy for those who suffer from substance abuse. But Janssen did not cause the opioid crisis in this country.”

THIS TYPE OF COMMENTARY SEEMS TO BE A REPEAT OF J&J’s NOW OFT REPEATED CLAIM  “WE’VE DONE NOTHING WRONG” WHICH IS NOW PROVEN TO BE AN OUTRIGHT FALSE STATEMENT, WHETHER BY DEFENSE COUNSEL OR THE COMPANY PR MACHINE. JOHNSON & JOHNSON HAS BEEN SHOWN TO HAVE OUTRIGHT LIED, MISLED THE PUBLIC ANFD MANIPULATED SCIENCE AND MEDICAL INDUSTRY OPINIONS RELATED TO MANY COMPANY PHARMACEUTIAL PRODUCTS AND THE RELATED MARKETING CAMPAIGNS. 

J&J HISTORY OF BAD CONDUCT

Payments To Industry Insiders

Introduction of evidence in J&J Talc cancer trial in the last year, show that two individuals involved in the Cosmetic Industry Review (CIR), which has deemed talcum powder to be safe, which is data J&J has relied on in prior trials, had received payments from Johnson & Johnson for speeches and other engagements. This damaging information was discovered while cross-examining the group’s former director, Alan Andersen, who was a defense witness, and he was forced to disclose the prior unknown financial relationship of the CIR and Johnson & Johnson.

Bad Science

A major blow to J&J’s defense came when a defense witness, Senior Johnson & Johnson epidemiologist, Dr. Douglas Weed, was revealed to have been sanctioned for perjury in another trial in North Carolina, for lying under oath about whether he retained notes to his expert report, which plaintiffs attorneys were able to show.

“J&J presented these unbelievable and non-credible witnesses on an issue that is very important to our case,” Smith said. “Attempts to influence witnesses and alter facts, along with the fact other companies are warning of the cancer link and have been warning for eight to 12 months now. This was new evidence that proved very compelling to the jury as well as a reflection of J&J’s willingness to manipulate the trial process in their favor”, leading many to wonder what else J&J may have done.

In a post trial statement J&J declined to address the specifics of the case, stating: “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder. In April, the National Cancer Institute’s Physician Data Query Editorial Board wrote, ‘The weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.’ We are preparing for additional trials in the U.S. and we will continue to defend the safety of Johnson’s baby powder.”

In response, the Plaintiff team stated “The new evidence that came into the California case could play a role in the next talcum powder trial, which is set for Oct. 16 in Missouri, we certainly think it is evidence that should be presented, and we’ll make every attempt to do so,” Ted Meadows said.

Meanwhile, separate from the Oklahoma opioid trial,  reports are now official that the Department of Justice is pursuing a criminal probe into whether J&J lied about possible cancer risks in its talcum baby powder. The investigation follows a slew of talc-related lawsuits filed against the company, two of which recently resulted in multimillion-dollar plaintiff awards.

Now that ‘OPIOID BIG PHARMA” and their executive suites are being held accountable by the public and in both state and federal courts, there needs to be a formal accounting of how and why these “pharmaceutical titans” were able to develop dangerous drugs and then create horrendous off-label and life threatening marketing campaigns, all the while earning literally billions of dollars annually. At what point do the US consumers and general public say “enough is enough” and demand the corporate decision makers be held criminally liable as a regular part of the executive suite checks and balances oversight?

As long as the drug makers “cost of litigation” remains part of the risk management analysis in the year-end SEC filings, it’s likely that dangerous drugs and the bad conduct that often travels along, will remain a “cost of doing business” and the trail of destruction will continued to be ignored by the Alex Gorskys and Richard Sacklers of the drug industry.

Risperdal Off-Label Drug Marketing

Johnson & Johnson conducted a misleading marketing campaign for their anti-psychotic drug, Risperdal. Approved by the U.S. Food and Drug Administration (FDA) to treat adults with schizophrenia, Johnson & Johnson marketed the drug for use in children.

According to the U.S. Department of Justice, Johnson & Johnson, and their subsidiary, Janssen, were aware of the dangers the drug Risperdal posed when used by children. Even so, company representatives marketed the drug to mental health professionals who worked with children.

As a result of their misleading Risperdal marketing campaign, Johnson & Johnson was ordered in 2013 by the U.S. Department of Justice to pay a $2.2 billion fine.

Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults. It was not approved for use in children or adolescents until 13 years later, in 2006.

Evidence from lawsuits showed that pharmaceutical representatives from Johnson & Johnson had been pushing doctors (including the plaintiffs doctor) to prescribe Risperdal to children and teenagers even though it had not yet been tested on young people

Juries have found that Johnson & Johnson failed to adequately warn patients and doctors of harmful potential side effects, and verdicts against J&J and Risperdal marketing have been ongoing in courts for more than five years over this medication.

Johnson & Johnson paid the multi-billion dollar fine to the Department of Justice in criminal and civil fines as a result of the now proven illegally marketing of Risperdal for unapproved purposes, but are now denying in civil lawsuits that they were involved in anything improper in off-label marketing of Risperdal. Individual patients who were harmed by Risperdal, do not yet have a remedy other than filing a lawsuit against Johnson & Johnson.

Risperdal Male Breast Growth

 When used by children and adolescents, Risperdal has been known to cause male breast growth, also known as gynecomastia, due to the drug triggering the production of the hormone prolactin. For some patients who have suffered from gynecomastia as a Risperdal side effect, they have also dealt with decreased psychological and emotional well being as a result of physical changes.

Shareholders Sued J&J Over Off-Label Marketing and Bad Conduct–Complaint Attached

Johnson & Johnson says its opioid products account for less than one percent of the Oklahoma market. But the state disputes that.

Oklahoma Attorney General Mike Hunter told CBS News correspondent Omar Villafranca, “They made money whether they sold their drugs or when somebody else sold opioids, because they were supplying everybody else. And this ‘one percent’ thing, that’s a complete canard.”

If the judge rules against Johnson & Johnson, the “public nuisance” argument that was previously used successfully to fight Big Tobacco could possibly be used in opioid lawsuits set to go to trial in Ohio this fall.

https://www.law.du.edu/documents/corporate-governance/independent-director/johnsonjohnson/Opinion-In-re-Johnson-and-Johnson-10-cv-2033-D-NJ-Sept-29-2011.PDF

“Thousands of people being addicted to prescription opioids, thousands of people  dying, you’ve a public nuisance, you’ve got harm that’s occurring,” said Hunter.

Both sides in Oklahoma say they’ll appeal if the judge rules against them.

In addition to the cases in Ohio, suits were filed last week in West Virginia accusing Johnson & Johnson, as well as Teva, of misrepresenting the risks of their opioid products.

The J&J CEO Alex Gorsky approved bad conduct and medical industry manipulation dovetails perfectly along with the Purdue Pharma and Sackler Family marketing abuses, that were uncovered in a federal criminal indictment. The indictment of Purdue and company executives, was hushed up by a $650 million fine to the US Department of Justice in 2007, by none other than bad-conduct fixer Rudy Giuliani.

Many states including Masschusetts, (see complaint below) have decided to sue the Sackler family directly, to reclaim some of the billions the Sacklers earned over the many years the opioid crisis has killed thousands of people.

Related-Official Court Records: Purdue and Sackler Family Bad Conduct

Richard Sackler of Purdue Pharma Deposition Transcript Re: Oxycontin Train

https://www.documentcloud.org/documents/5745864-Purdue-Statement-in-Response-to-Leak-of-2015.html

State of Massachusetts vs. Purdue and The Sackler Family Amended-Complaint-2019-01-31.html

In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

he Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

As Purdue Pharma comes to grips with the fact that they are being designated as the primary litigation targets of states, counties and cities across the country for being the Opiate Big Pharma leader in creating the current opioid crisis in the United States, they may need to determine how they will pay the billions of dollars in jury verdicts and affiliated legal settlements resulting from the lawsuits that now number over 1,200 cases in state and federal courts.

The entire Sackler brothers’ Oxycontin marketing plan followed their previously proven drug marketing test drive of “Valium” – when Hoffman-LaRoche hired the Sacklers to market their new drug “diazepam” commonly known as Valium and its sister drug Librium.

While running the drug advertising company, Arthur Sackler became a publisher, starting a biweekly newspaper, the Medical Tribune, which eventually reached 600,000 physicians. He scoffed at suggestions that there was a conflict of interest between his roles as the head of a pharmaceutical-advertising company and the publisher of a periodical for doctors. Later it emerged that a company he owned, MD Publications, had paid the chief of the antibiotics division of the FDA, Henry Welch, nearly $300,000 in exchange for Welch’s help in promoting certain drugs. Sometimes, when Welch was giving a speech, he inserted a drug’s advertising slogan into his remarks. After the payments were discovered, Welch was forced to resign from the FDA.

When Purdue Pharma started selling its prescription opioid painkiller OxyContin in 1996, Dr. Richard Sackler asked people gathered for the launch party to envision natural disasters like an earthquake, a hurricane, or a blizzard. The debut of OxyContin, said Sackler — a member of the family that started and controls the company and then a company executive — “will be followed by a blizzard of prescriptions that will bury the competition.”

Five years later, as questions were raised about the risk of addiction and overdoses that came with taking OxyContin and opioid medications, Sackler outlined a strategy that critics have long accused the company of unleashing: divert the blame onto others, particularly the people who became addicted to opioids themselves.

“We have to hammer on the abusers in every way possible,” Sackler wrote in an email in February 2001. “They are the culprits and the problem. They are reckless criminals.”

Sackler’s comments at the party and his email are contained in newly public portions of a lawsuit filed by the state of Massachusetts against Purdue that alleges that the company, the Sackler family, and company executives misled prescribers and patients as they aimed to blanket the country with prescriptions for their addictive medications.

Addiction Recovery Issues

White drug users addicted to heroin, fentanyl and other opioids have had near-exclusive access to buprenorphine, a drug that curbs the craving for opioids and reduces the chance of a fatal overdose. That’s according to a study out Wednesday from the University of Michigan. It appears in JAMA Psychiatry.

“White populations are almost 35 times as likely to have a buprenorphine-related visit than black Americans,” said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School and the study’s lead author.

“This epidemic over the last few years has been framed by many as largely a white epidemic, but we know now that’s not true,” Lagisetty said.

What is true, Lagisetty added, is that most of the white patients either paid cash (40%) or relied on private insurance (35%) to fund their buprenorphine treatment. The fact that just 25% of the visits were paid for through Medicaid and Medicare “does highlight that many of these visits could be very costly for persons of low income,” Lagisetty said.

Doctors and nurse practitioners can demand cash payments because there’s a shortage of clinicians who can prescribe buprenorphine, according to Dr. Andrew Kolodny, co-director of Opioid Policy Research at Brandeis University’s Heller School for Social Policy and Management. Only about 5% of physicians have taken the special training required to prescribe buprenorphine.

“The few that are doing it are really able to name their price, and that’s what we’re seeing here and that’s the reason why individuals with more resources — who are more likely to be white — are more likely to access treatment with buprenorphine,” said Kolodny, who was not involved in the study.

Kolodny wants the federal government to eliminate the required special training for buprenorphine and a related cap on the number of patients a doctor can manage on the drug.

Some physicians who’ve studied racial disparities in addiction treatment say the root causes date to 2000, when buprenorphine was approved. At that time, proponents argued that buprenorphine was needed to help treat suburban youth, according to Dr. Helena Hansenat New York University. Those young patients didn’t see themselves as addicted to heroin in the same way as hard-core urban heroin users who went to methadone clinics for treatment.

“Buprenorphine was introduced as private-office treatment, for a private market with the means to pay,” said Hansen, an associate professor of psychiatry and anthropology. “So the unequal dissemination of buprenorphine for opioid dependence is not accidental.”

Hansen added that the fix must include universal access to treatment in a primary care setting, an end to the criminalization of opioid dependence (which puts more blacks in prison for drug use than whites) and more federal funding to expand access to buprenorphine for all patients.

Several leaders in the fight to reduce opioid overdose deaths say the study results are disturbing.

“It really demands for us to be looking at equitable treatment for addiction for African Americans as we do for white Americans,” said Michael Botticelli, director of the Grayken Center for Addiction at Boston Medical Center and the former director of the Office of National Drug Control Policy.

Botticelli identified key issues that may contribute to the racial treatment gap and deserve further investigation. For example, he wants to know if Medicaid reimbursement rates are simply too low to entice more doctors to work with low-income patients, or if there are too few inner-city doctors prescribing buprenorphine or if African Americans themselves are somehow reluctant to seek this form of treatment.

Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health, called the findings surprising and disturbing. Surprising because the disparity is so large, and disturbing because her agency has prioritized educating doctors about the value of prescribing buprenorphine.

Volkow also expressed disappointment that federal parity laws, which are supposed to guarantee equal access to all types of medications, don’t seem to be working for buprenorphine.

“We need to ensure that we have capacity to provide these treatments,” Volkow said, “because if you say you have to pay for them, but there are no services that can provide the treatments, then the issue of paying for them is secondary.”

Volkow has noted that fewer than half of Americans with an opioid use disorder have access to buprenorphine or two other medications used to treat opioid addiction: methadone and naltrexone. Volkow said she’s glad that the use of buprenorphine is on the rise, but the U.S. needs to understand why this lifesaving treatment isn’t benefiting all patients who need it.

Related materials >Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA

OPIOD LITIGATION UPDATE: FOR FEDERAL AND STATE COURT DOCKETS

To access the most relevant and real time information on the Opioid Litigation, Kevin Thompson (NAS Addicted Infant Litigation) and Steve New (Opioid Adult Injury Litigation) will be speaking at the Mass Tort Nexus Class September 13 – 16, 2019 in Fort Lauderdale, to attend follow the links below. 

Mass Tort Nexus “CLE Immersion Course”

September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne-Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
2. To obtain our free newsletters that contains real time mass tort updates, visit com/news and sign up for 

For more Mass Tort Nexus Information See: Mass Tort Nexus Newsletters and MDL Updates

Note: (Excerpts within this article include print materials and other online media sources)