Bayer/Monsanto and Roundup Verdict of $2 Billion = Settlement

  • 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., 17th Floor

Los Angeles, CA 90024

Phone: (310) 207-3233

Email: rmccall@baumhedlundlaw.com

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

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Bayer’s Board Gets Vote of No Confidence Due To Monsanto Merger And Roundup Litigation MDL 2741 Docket

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.

_____________________________________________________________________________

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)

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

Mass Tort Nexus “CLE Immersion Course”

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

For class attendance information please contact Barbara Capasso at 954.383.3932 

  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 www.masstortnexus.com/news and sign up for free access.

 

Read More

False Narratives Opioids and Xarelto

Mass Tort Nexus is compiling an evidentiary package for law firms who intend to reject the current Xarelto settlement offer and prepare for trial. This article represents an extremely small segment of what any firm who prepares for trial will have at their disposal; however, we believe most everyone involved in Mass Torts might find the following topic interesting.

It is well known how Big Pharma allegedly promoted a false narrative regarding Opioids and the risk posed by these highly addictive drugs. Despite the fact that thousands of people were dying every year from opioid overdose, doctors seemed unaware that the narrative they had bought into was false.

What might the death toll ultimately be for the new anticoagulants?

We are aware that both the Xarelto primary defendants are also accused of being party to the opioid false narrative conspiracy in opioid litigation complaints.  If Big Pharma can keep doctors prescribing opioids like skittles for decades, despite the rising death toll, how hard could it be to keep doctors prescribing an anticoagulant with a few tweaks to the truth?

Why Did Doctors Prescribe Xarelto and Why do they Continue to Prescribe Xarelto?

The clinical trials for Xarelto did not prove the drug to be superior in efficacy to Warfarin, only “non inferior.” It was not a better drug from an efficacy stand point. Doctors had no reason to switch patients to Xarelto because it “worked better” than Warfarin.

Xarelto is exponentially more expensive that Warfarin, so doctors had to reason to switch patients to Xarelto based on cost.

What were the makers of Xarelto able to claim about their new (unproven in the general patient population) to convince them to switch patients to Xarelto?

  1. No Routine Blood Testing (monitoring.)
  2. No Dietary Restrictions.

What if these claims were false, patients do need routine blood monitoring while on Xarelto?

What if patients taking Xarelto do need to restrict their diet (not consume certain food products?)

Would doctors keep prescribing Xarelto? Probably not, if the arguably false narrative first presented to them was corrected (warned) as having been false. That said, once a claim is made, people, including doctors, are not likely to realize that the claim is no longer being made once they have bought into the claim, unless they are specifically informed that the claim might have been false.

The following will explain why the makers of Xarelto may have stopped claiming (in their television and print ads,) that patients taking Xarelto did not need routine blood testing nor adhere to any dietary restrictions.

We will first review Xarelto television spots beginning in 2013 and more recent ads. Then we will explain why the makers of Xarelto quit claiming that users of their product stopped claiming that:

  1. No Routine Blood Testing (monitoring) was needed.
  2. No dietary restrictions.

You may view a larger selection of ads than those provided below at: https://www.ispot.tv/brands/ISA/xarelto

2013: Xarelto Bob Ad  (both “no routine monitoring” and “no dietary restrictions claims made”.)

 

 

 

 

 

 

 

https://www.ispot.tv/ad/7dJt/xarelto-bob

Start at 16 Seconds, “Bob took Wafarin and made a monthly trip to the clintic to get his blood tested but not anymore.”

Start at  36 Seconds,   “Xarelto is the first and only once per day prescription blood thinner… That does not require rountine Blood Monitoring.”

Start at 57 Seconds, “and there’s no dietary restrictions…Bob can eat the health foods he likes. ”

2014 Mary Ad (both “no routine monitoring” and “no dietary restrictions claims made.”)

 

 

 

 

 

 

https://www.ispot.tv/ad/7pGC/xarelto-mary-song-by-arturo-cardelus

Start at 12 Seconds  “Which required monthly testing, but that’s history.”

Start at 56 Seconds “Plus with no Known Dietary Restrictions.”

2015  Arnold Palmer (they did not specifically say no routine testing and dietary restrictions, but they  implied the claims. )

 

 

 

 

 

 

https://www.ispot.tv/ad/AYGi/xarelto-game-plan-feat-chris-bosh-arnold-palmer-brian-vickers

Start at 29 Seconds (claims worked into general conversation)

article link: https://www.masstortnexus.com/News/366/Did-Xarelto-the-Drug-Arnold-Palmer-Promoted-Lead-to-His-Death?

2016: Jerry West (neither of the claims were made in this ad.)

 

 

 

 

 

 

https://www.ispot.tv/ad/ARh_/xarelto-high-risk-of-stroke-featuring-jerry-west

2017  Xarelto “Protect Themselves” ad feature authority figures  (neither of the claims were made in this ad.)

 

 

 

 

 

 

 

 

https://www.ispot.tv/ad/wtdp/xarelto-protect-themselves

2018  “Learn all you can ad” (we do not think irony was intended), (neither of the claims were made in this ad)

 

 

 

 

 

 

https://www.ispot.tv/ad/wPmP/xarelto-learn-all-you-can

So Why Did the Makers of Xarelto Quit Making Their “Claims to Fame?”

We will first address why the makers of Xarelto most likely stopped making the “no rountine blood testing (monitoring claim.) This answer to this one is easy; Because the FDA warned them about making this claim.

It is difficult to understand why the makers of Xarelto did not unilaterally determine (and warn that their original messaging no routine blood monitoring needed) might have been misleading based solely on the number of adverse events reported to the FDA since the product’s introduction.

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) print advertisement (K02XS121040 AF) (Print Ad) for XARELTO (rivaroxaban) tablets (Xarelto) submitted by Johnson & Johnson International, Inc. (Johnson & Johnson) on behalf of Janssen Pharmaceuticals, Inc. under cover of Form FDA 2253 and observed during routine surveillance in the January/February 2013 issue of WebMD magazine. The Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).

Background:

Below is the indication and summary of the most serious and most common risks associated with the use of Xarelto.1 According to its FDA-approved product labeling (PI), in pertinent part:

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

 The PI for Xarelto contains Boxed Warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural

hematoma. The PI also contains Contraindications regarding active pathological bleeding and severe hypersensitivity reaction to Xarelto, as well as Warnings and Precautions regarding the risk of bleeding, use in patients with renal impairment and hepatic impairment, use with P-gp and strong CYP3A4 inhibitors or inducers, and risk of pregnancy related hemorrhage. The most common adverse reactions with Xarelto were bleeding complications.

Minimization of Risk Information

 Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

• “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce

the risk of stroke—without routine blood monitoring.”

• “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly  minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims. We note that the Print Ad contains the statement, “Please see accompanying Medication Guide on the following pages” (emphasis original) at the bottom of the page, and that risk information is presented on an adjacent page, but this is not sufficient to mitigate the overall misleading presentation.

Misleading Claim

 The Print Ad includes the following claim (emphasis original):

• “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

Conclusion and Requested Action

For the reasons discussed above, the Print Ad misbrands Xarelto in violation of the FD&C Act, 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix). OPDP requests that Johnson & Johnson immediately cease the dissemination of violative promotional materials for Xarelto such as those described above. Please submit a written response to this letter on or before June 20, 2013, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Xarelto that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA# 215 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Xarelto comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

____________________________________________________________________________________

It is difficult to understand why the makers of Xarelto did not unilaterally determine (and warn that their original messaging (no routine blood monitoring needed) might have been misleading bases solely on the number of adverse events reported to the FDA since the products introduction.

 

 

 

 

 

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/59a37af8-d2bb-4dee-90bf-6620b1d5542f/state/analysis

 

 

 

 

 

 

https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/59a37af8-d2bb-4dee-90bf-6620b1d5542f/state/analysis

Having not corrected their prior claims (warned) related to the need for routine blood testing (monitoring) the makers of Xarelto did add the words underlined (below) to the label for Xarelto NDA -022406 in November of 2018. This statement in no way corrects the arguably false prior statements related to “No Routine Blood Testing” needed.  This statement simply warns that many of the common “blood monitoring tests used” are not recommended for individuals using Xarelto. A more accurate statement might have been: “These tests have no diagnostic value for individuals on Xarelto,” as the drug skews the test, and not in a predictable fashion, which would allow for adjustment of the test results.

Do these two statements seem the same to you?

  1. No Routine Blood Monitoring Needed with Xarelto.
  2. The test routinely used for anticoagulation monitoring has no diagnostic value for individuals taking Xarelto.

Which of the above two statements would likely increase revenues from the drug and which one would likely have the opposite effect?

11/07/2018 (SUPPL-29)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

… anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=287

“Now We Turn to “No Dietary Restrictions Necessary”

 06/28/2017 (SUPPL-23)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Risk of Bleeding

(additions underlined)

(excerpts)

5.6 Use with P-gp and Strong CYP3A4 Inhibitors or Inducers

(additions underlined)

Avoid concomitant use of XARELTO with known combined P-gp and strong CYP3A4 inhibitors.

Avoid concomitant use of XARELTO with drugs that are known combined P-gp and strong CYP3A4 inducers.

7 Drug Interactions

7.1 General Inhibition and Induction Properties

(additions underlined)

Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A4 inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A4 inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.

7.2 Drugs that Inhibit Cytochrome P450 3A4 Enzymes and Drug Transport Systems

Interaction with Combined P-gp and Moderate CYP3A4 Inhibitors in Patients with Renal Impairment

XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A4 inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk.

End excerpt

What is the significance of the above?

The inducers make the user more susceptible to clots (ischemic stroke, DVT, PE, etc.)

The inhibitors make the user more likely to bleed.

On a side note, the GI tract is significant to the actions of CYPE4A as well as P-gp. And if you remember from above, what was the most reported AE with Xarelto:

 

So what does the use of Strong and Moderate CYP34A and P-gp Inhibitors and Inducers have to do with dietary restrictions?

Most everyone is familiar with the fact that some drugs carry a warning about restricting grapefruit juice from your diet while on the given drug (i.e. statins).

The relation to the above and the “no dietary restrictions” claim, that the makers of Xarelto use to promote their drug (and then stopped making but did not correct the narrative) is simple. There are numerous foods which are CYP34A, and P-gp inhibitors and/or inducers. We provide a small sampling of foods and dietary supplements below.

The dietary restrictions associated with Warfarin restricted foods high in Vitamin K, like Kale (yummy Kale).

Xarelto Potential Food Restrictions

It is worth nothing that due to genetic differences, the strength of a given CYP34A and P-gp Inhibitor or Inducer necessary to interfere with a drug is not the same for everyone. Women as a general rule are more susceptible to the effects of CYP34A and P-gp Inhibitors or Inducers than men.

Grape Fruit Juice: Inhibits CYP34A and P-gp Seville Orange Juice CYP34A and P-gp
Lime Juice Inhibits CYP34A Lemon Juice Inhibits CYP34A
Pomegranate Juice Inhibits CYP34A Star Fruit Juice Inhibits CYP34A
Kiwi Juice Inhibits CYP34A Passion Fruit Juice Inhibits CYP34A
 St. John’s wort Induction of P-gp Ginkgo Biloba Induces P-gp

 In addition to food interactions Approximately 50% of prescription drugs either induce or inhibit CYP34A or P-gp.

While many drugs are deactivated by CYP3A4, there are also some drugs which are activated by the enzyme. Some substances, such as grapefruit juice and some drugs, interfere with the action of CYP3A4. These substances will therefore either amplify or weaken the action of those drugs that are modified by CYP3A4.

https://en.wikipedia.org/wiki/CYP3A4

So, what the Xarelto label (warnings) universally adequate in 2015, 2016 or today?

We think not!

Read More

Mass Tort Nexus: Xarelto Settlement Update

Xarelto Settlement: Power in Numbers

(April 23, 2019) As stated in previous Mass Tort Nexus articles, we are of the opinion that the current proposed Xarelto Settlement is “dead on arrival.” Based on our conversations with non-leadership firms, we are of the belief that there is an implacable intention to reject or recommend that their clients reject the current settlement offer.

Numerous additional firms have contacted Mass Tort Nexus since our first article was published related to the proposed settlement last week. Since that release, Mass Tort Nexus has received ongoing inquiries from firms asking the same basic question:

Do the leadership firms control enough of the client cases in the Xarelto litigation, to reach a settlement participation level acceptable to the defendant under the current proposal, without regard to the number of non-leadership firms that might reject the offer?

In order to provide an informed answer to this question Mass Tort Nexus conducted an analysis:

Mass Tort Nexus accessed the JMPL and the USDC ED Louisiana ECF links to determine how many cases are pending in MDL 2592. For this analysis we are not considering cases filed in other venues; however, there is no cause to believe that cases in other venues would be of sufficient volume to skew these findings.

According to the JPML, there are 23,866 cases pending in Xarelto MDL 2592 as of 04/15/2019. We believe no major change in these numbers has occurred in the three days that have elapsed between the latest JPML report and this analysis.

We will assume for arguments sake, that all the PSC members are going to accept the proposed Xarelto settlement. From a pure business perspective, the PSC members will be paid according to the work their firms have performed for the “common benefit”, which for many PSC firms may be a more significant sum than the fees they would earn from the clients they represent. Based on this reasoning, we will assume that all of the PSC member firms will accept the current settlement offer.

Mass Tort Nexus accessed Pacer to determine how many cases were on file for the Plaintiff Steering Committee (PSC) members.

The following are the result of that review:

PSC Member Firm MDL Cases
Ferrer Poirot 1,679
Beasley Allen 1,466
Morgan & Morgan 800
Levin Papantonio 650
Aylstock Witkin Kreis Overholtz 515
Schlicter, Bogard & Denton 118
Seeger Weiss 100
Nast Law 90
Ross Feller Casey 70
Levine Fish Bein & Berman 50
Weitz & Luxenberg P.C. 81
Goza & Honnold, L.L.C. 310
Total Client MDL Cases PSC Members 5,929 24.82%
Total Client Cases MDL Non-PSC Members 17,937 75.18%
Xarelto MDL 2592 23866
http://www.laed.uscourts.gov/case-information/mdl-mass-class-action/xarelto/contacts/plaintiffs-steering-committee
https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-April-15-2019.pdf

Based on the results of our findings, of cases filed by PSC members, “Leadership” represents 5,929 (24.82%) of the 23,866 Xarelto MDL 2592 cases on file, while non leadership firms represent 17,937 (75.18%) of the cases on file.

Therefore, the answer to the question “does leadership directly control enough of total number of Xarelto cases to meet the participation requirements by the defendant is NO, based on this informed analysis.

Based on information received from reliable sources, the “Participation Level” defendants require to “go through” with the current offer is 90%. Of course, the defendants would have the option of going through with the settlement at a participation level of less than 90% however, it would not make sense for a defendant in any mass litigation to move forward with a settlement, that left several thousand cases moving towards trial. The number of cases left unsettled is more important than the representation of that number as a percentage.

Note: Mass Tort Nexus’ analysis of the number of cases under the direct control of leadership did not include any cases filed by other firms, which may have subsequently been referred to leadership firms. Therefore, leadership may have direct control over a larger number of cases that cannot be confirmed through our analytical methodology. Without regard to the foregoing, Mass Tort Nexus was able to verify the number of cases on file by firms who have expressed an implacable intent to reject the current offer, and therefore, the conclusions reached through our analysis would not  impact the unknown variable arising from cases filed by non-leadership firms, that have been subsequently referred to leadership firms.

To complete our analysis, we calculated the number of cases that could reject the settlement offer and overall participation still reach a given percentage participation level.

 

Participation Level (PL) Maximum Rejections to Achieve PL
95% 1,193.3
90% 2,386.6
85% 3,579.9
80% 4,773.2
75% 5,966.5
70% 7,159.8
65% 8,353.1
60% 9,546.4
55% 10,739.7
50% 11933

 

Based on conversations with numerous firms with “small” to “large” dockets, in the Xarelto MDL (also verified in the same manner as MTN verified leaderships client numbers), Mass Tort Nexus is of the following opinion:

Firms that have expressed their position to be in absolute rejection of the current offer, (nothing can convince them to change their minds), that the hold outs from these firms along will prevent the participation level in the settlement from reaching 80%.

Firms that are leaning toward rejection but could possibly change their minds (if they split down the middle on their final decision, half going one way and half going the other) would likely prevent the settlement acceptance level form reaching 70%.

If additional firms that have not communicated with Mass Tort Nexus also add to the “implacable rejectors” count, reaching a participation percentage acceptable to defendants becomes even less probable.

Mass Tort Nexus would like to clarify past comments, as well as comments made in this article, and those that may be forthcoming in future coverage of the proposed Xarelto settlement. Our coverage of this issue is not intended to be a disparagement of the firms in leadership in the Xarelto MDL. Leadership did not make the current settlement offer, the defendants made the offer. When a defendant approaches leadership wishing to discuss settlement, leadership engages in the discussion. When defendants make an offer, leadership presents that offer to the non-leadership firms involved in the litigation (becoming the messenger.)  If the offer does not result in a consummated settlement, leadership will have to “go back to the table” with the defendants. Leadership can not be seen to have been the cause of the previous settlement offer “falling through” and retain the credibility with the defendants needed for additional rounds of negotiations.  It is never our intent to “shoot the messenger” even when our opinions differ from the message.

https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-April-15-2019.pdf

 

Read More

Analysis of Proposed Xarelto Settlement Discount Rates – Debunking Defendants Rationale

 

 

Analysis of Proposed Xarelto Settlement Discount Rates

Debunking Defendants Rationale

 This is a follow up to the Mass Tort Nexus article “Xarelto Settlement: Dead on Arrival” – link: Xarelto-Settlement-Dead-on-Arrival? April 15, 2019

 

(MASS TORT NEXUS MEDIA) This article is intended to address the Xarelto defendants’ contentions that certain settlement offer “discounts” are justified for client cases arising in 2015 and 2016 due to changes in the FDA label,  which the defendant contends brought warnings contained in the label into adequacy. This paper will also address defendant’s contention that cases arising under the laws of the States of Texas and Michigan merit a massive discount in settlement value (offers).

We will focus on the Xarelto label change from 11/07/2018, AND an additional label change was made on 01/15/2019 related to Eosinophilia, which could be relevant to many of the Xarelto cases already filed as well as give rise to a Xarelto Litigation II, that could involve more injured individuals than the current Xarelto Litigation. The relevance and significance of the 01/15/2019 “Eosinophilia” label change will be addressed by Mass Tort Nexus in the near future.

Mass Tort Nexus has also received information that there is an ongoing investigation related to Xarelto potentially causing kidney injury, which may or not be related to Eosinophilia. We will continue to provide more information related to this subject in future articles. Given the new Eosinophilia warning and the investigation related to Kidney injury, and the 11/07/2018 label change related to anticoagulation tests (and the possible impact on future Xarelto case trials) Mass Tort Nexus understands why the defendants might be eager to reach a settlement sooner rather than later. Conversely, there is no reason why plaintiffs’ firms should believe the defendants to be in a superior negotiating position, nor be willing to accept subpar settlements for their existing cases.

It is worth nothing that the 11/07/2018 label change (admission) by the defendant that the most commonly used anticoagulation tests are “not recommended” (in reality likely have no diagnostic value) would make it far more difficult for the defendants to prevail in future trials under the Learned Intermediary Doctrine, as doctors would be less likely to testify that, “they would still do everything exactly as they did when originally prescribing Xarelto.” Had the defendant revealed the foregoing before the prior bellwether trials, the outcome of those trials may have been very different.  It is not surprising that the defendants are eager to settled Xarelto cases without having to face another trial post the 11/07/2018 and 01/15/2019 label changes.

Had the defendants revealed the information related to the most common anticoagulation tests used as “not being recommended” prior to the bellwether trials, doctors testifying in support of a defendants “Learned Intermediary Defense” would likely face questions like these:

 Plaintiffs’ Counsel:  So, Dr. Smith, I see that you performed an INR test to make sure that my client was correctly anticoagulated, that their blood was not to thick or too thin, is that right?

Dr. Smith: Yes

Plaintiffs’ Counsel:  Were you aware that as of 11/07/2018 the defendants recommend that this test not be used and in fact, the literature shows that this test provides no diagnostic value when a person is taking Xarelto?

Dr. Smith: It unlikely that Dr. Smith will say he knew the above when he prescribed Xarelto as he would essentially be admitting to medical malpractice.

Plaintiffs’ Counsel:  So, Dr. Smith, would you still today, follow the same protocol when prescribing Xarelto and use an INR test to make sure the dose of Xarelto did not have the patient’s blood to thick (likely to clot) or too thin (likely to bleed).

Dr. Smith: Unlikely that Dr. Smith would say he would still do what the defendant now recommends he not do.

Plaintiffs’ Counsel:  Dr. Smith, just out of curiosity, do you think the words “No Routine Blood Testing Needed” mean the same thing as “The blood test routinely used don’t work”?

The same line of questioning could be used for doctors that treated a Xarelto bleed or clot.

The contention that any label change could render a product adequately warned for all circumstances and facts relevant to every possible client injury scenario is somewhat preposterous; however, we will address and rebut the defendant’s contentions more directly. Although the Xarelto warning label has been changed numerous times since 2016, we only need to review the label change made on 11/07/2018 (see below) to conclude that the label was not adequate in any clients case in which the referenced anticoagulation tests were used in the “dosing” of Xarelto or the treatment of any Xarelto related injury 11/07/2018.

 11/07/2018 Xarelto Label Change

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s029lbl.pdf

 5.0 Warnings and Precautions

 5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

… anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

Mass Tort Nexus Comment: The highlighted language above was added to the Xarelto FDA (U.S) 0n 11/07/2018, indicating that the use of PT, INR, aPTT anti-factor Xa (FXa) is not recommended. A more accurate statement (warning) would be that these tests have no diagnostic value and should not be used when evaluating dosing for individual patients nor treating bleeds and other conditions related to Xarelto, while the patient has Xarelto in their system.

 We will first address the 11/07/2018 label change as it related to the defendants contentions that the Xarelto label “adequately warned”  of the risks associated with label changes made in 2015 and 2016 as well as the justification (or lack thereof) for any discounts to base settlement offers arising therefrom.

Mass Tort Nexus opinion is as follows:

  1. At minimum, no discount is justified in any case arising before 11/07/2018, in which any of the anticoagulation tests now “not recommended” for use, where used by the prescribing physician immediately before and or any time after prescribing Xarelto, for use by the specific client. The doctor nor the patient were adequately warned with regard to these tests providing any diagnostic value that could serve to mitigate the risks associated with the use of Xarelto.  Additionally, for any client that presented at a medical facility (prior to 11/07/2018), with a Xarelto related injury which resulted in the use of the tests in the process of treating that injury, the warning label was not sufficient to mitigate the risks associated with the use of tests which the defendant now recommends not be used.
  2.  Today the warning label remains inadequate and no discount based on a contention that the warning label was brought into adequacy at any point in the past, is warranted. Until the defendants make further changes to the label including, but not limited to, giving the “anticoagulation” test “warning” greater prominence on the label as well as changing the “not recommended” portion of the statement to reflect a more truthful representation, that is less likely to be overlooked or misunderstood by prescribing physicians. An adequate warning would include information as to why the tests are not recommended (they likely have no diagnostic value).
  3.  It would be difficult for the defendants to argue that the fact that the most commonly used anticoagulation tests “are not recommended” for use in dosing Xarelto or treating a Xarelto injury, would not likely have impacted some doctors decision to prescribe the drug had they been previously warned prior to 11/07/2018. In reality, given the lack of prominence of the 11/07/2018 label change and the fact that no additional educational efforts are being made by defendants (that we are aware of), to insure that doctors are now aware that these tests are “not recommended” and in fact, likely have no diagnostic value, it is probable that the 11/07/2018 warning has not significantly decreased the risk posed Xarelto users, related to this new “warning.

 Before addressing Texas 82.007 and Michigan 600.2946, it is important to point out that one of the most Signiant claims made by the makers of Xarelto, in their effort to establish their product as being superior to Warfarin was that “no routine blood testing (anticoagulation tests) was needed” for patients using Xarelto. Patients taking Warfarin and other VKA’s (Vitamin K Antagonists) do require routine monitoring to insure their anticoagulation levels remain in a therapeutic range.

The “No Routine Blood Testing Needed” claim of the makers of Xarelto, made to the FDA and the public appears to have been very misleading. Mass Tort Nexus has yet to determine how the makers of Xarelto concluded that No Routine Blood Testing was needed for patients taking Xarelto. The 101,743 adverse event reports filed with the FDA related to Xarelto since 2011, is one indicator that “Routine Blood Testing” is needed to insure Xarelto user’s safety. If no Routine Blood Testing was needed, then why have Xarelto patients experienced such a high volume of bleeding and clotting events? The FDA warning letter sent to the makers of Xarelto (provided at the end of this document), is highly relevant to this topic.

If Xarelto was so well designed that a doctor could just assume that patients would be maintained with a therapeutic range (not too thin and likely to bleed or too thick and likely to clot), then why has the FDA received Xarelto 101,753 adverse event reports since 2011, many involving bleeding or clotting that might have been prevented with “routine testing’?

 

Texas and Michigan Cases

To the best of our knowledge, the defendant has yet to raise a defense under Texas 82.007 and Michigan 600.2946 in any case, much less prevail in arguments arising under these laws.

Neither Texas 82.007 nor Michigan 600.294 provide an absolute defense for drug manufacturers. Both state’s laws have language which provide a plaintiff with means, by which to overcome the presumption that these laws provide immunity for a given defendant. We will refer to the language in both States laws as the “savings clause” in the remainder of this article. We will also address each law separately with regard to the burden plaintiffs would face, in overcoming a defense raised under either Texas 82.007 or Michigan 600.294.

First, We Will review the “savings clause” for both Texas 82.007 and Michigan 600.2946 available to plaintiffs to overcome the presumption of drug manufacturer immunity arising under the two laws. See the relevant savings clauses and links to the entire statutes below:

Texas   82.007

(2)(b)  The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that:

(1)  the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury;

(3)(A) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;

(B)  the product was used as recommended, promoted, or advertised;  

Michigan 600.2946

(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted

http://www.legislature.mi.gov/(S(5z3q41uoys1lzoajegixoc5p))/mileg.aspx?page=GetObject&objectname=mcl-600-2946

As a preliminary point, if any discount was justified arising under Texas 82.007or Michigan 600.2946, it should be minimal in light of the fact that the defendant has neither raised a defense in any individual case (to the best of our knowledge), nor prevailed in such a defense. A small discount might be warranted to allow plaintiffs to avoid the cost of litigating any matter raised by defense in the unlikely event that the defendants are willing to incur the cost of litigating the matter themselves.

Secondly, if any discount arising under Texas 82.007 and Michigan 600.2946 was justified, cases arising under Texas 82.007 would warrant a less significant discount than those arising under Michigan 600.2946, for reasons we will address below.

It is worth noting that the defendants must affirmatively raise a defense under Texas 82.007 or Michigan 600.2946 and doing so may expose their clinical trials, communications with the FDA, (including warning letters related to their advertising, one of which we have included at the end of this document), to discovery and scrutiny they may wish to avoid. Mass Tort Nexus would be interested in any internal communications, as well as third party communications the defendants engaged in related to the death of Arnold Palmer (including communications with his family) as we have long held the opinion that Xarelto may have caused or contributed to the death of Xarelto’s most famous spokesperson.

Comment: Texas 82.007, does not require a showing that any information that may have been withheld or misrepresentation made to the FDA was “intentional.” Texas 82.007 does not require a plaintiff to plead nor show that the FDA would, and the drug would not have been approved, or the United States Food and Drug Administration would have withdrawn approval for the drug if the information were accurately submitted. Michigan 600.2946, does require plaintiffs to show and plead that any misrepresentations or withholding of information and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

Michigan 600.2946 obviously places a far more significant burden on a plaintiff seeking to rebut the presumption of immunity than does Texas 82.007. Pleading that a drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted, can be problematic in light of the SCOTUS decision Buckman v. Plaintiff Legal Committee: https://www.loc.gov/item/usrep531341/

The foregoing should not be interpreted as presenting an impossible burden for plaintiffs to overcome under Michigan 600.2946 as was shown in the Second Circuit decision in DESIANO v. WARNER-LAMBERT & CO. https://caselaw.findlaw.com/us-2nd-circuit/1209786.html. Also see TAYLOR v. SMITHKLINE BEECHAM Michigan Supreme Court decision https://caselaw.findlaw.com/mi-supreme-court/1355001.html. These two well-reasoned rulings and opinions make it clear that 1. Plaintiffs can meet the requirements set forth in Michigan 600.2946 to overcome the presumption of immunity without running afoul of Buckman. 2. Plaintiffs can prevail in overcoming a defense raised under Michigan 600.2946 as they did in DESIANO.

Notwithstanding the foregoing, the burden placed un plaintiffs under Michigan 600.2946 is still far greater than that placed on plaintiffs by Texas 82.007.  It appears that any defendant has a better chance of prevailing in raising a defense under Michigan 600.2946 than one raised under Texas 82.007 however, given the fact that Michigan has a population of 9,996,000,(3.05% percent of the U.S. population) while Texas has a population of 27,700,000 (8.45% percent of the U.S. population), would the defendants be willing to undertake the time and expense (and continued concern from the market) involved in raising a defense under Michigan 600.2946, which would not dispose of a significant number of cases, if they prevail given that there is no reason to believe that a disproportionate number of the total Xarelto cases on file arise under Michigan law. Additionally, would the defendant be likely to undertake the time and expense (and continued concern from the market) involved in raising a defense under Texas 82.007, with a far less likelihood of prevailing than in Michigan.

The plaintiff’s burden with overcoming a defense raised under Texas  82.007 is obviously less arduous that than the burden over overcoming a defense raised under Michigan 600.2946. Due to the foregoing, the defendant’s application of the same discount (if any is justified) to cases arising under Texas law to those arising under Michigan Law, is not justified.

 

Michigan and Texas Law and the 11/07/2018 Label Change

Texas 82.007 and Michigan 600.2946:

Texas 82.007: The defendants’ statements in the 11/07/2018 label change “not recommending” these tests are still arguably misleading given that the test apparently have no diagnostic value when a patient is taking Xarelto and more importantly represent important information previously withheld from the FDA and/or mispresenting to the FDA. A strict interpretation of C would not require a plaintiff to show that that the actions or inactions of the defendant were intentional. Arguably, the 11/07/2018 label change related to these tests could be rebut the presumption that the protection provided from Texas 82.007 is available to the defendant.

Michigan 600.2946: The same reasoning applied to the analysis of Texas  82.007 applies to Michigan 600.2946 in this matter with one exception, Michigan 600.2946 requires a showing that the defendants actions or inactions were intentional and a showing that the FDA would not have approved or would have withdrawn the approval for the product if not for the information withheld or misrepresentations made. MTN provides an analysis below aimed at showing what the defendants knew and when they knew it relevant to the warnings they neglected to add to their label until 11/07/2018.

Analysis

The following analysis is more relevant to Michigan 600.2946 than to Texas 82.007. There is a high degree of confidence that Plaintiffs would prevail in any defense raised under Texas 82.007.

In that overcoming a defense raised under Michigan 600.2946 requires a showing that the defendant intentionally made misrepresentations the FDA or intentionally withheld information from the FDA. Additionally, under Michigan 600.2946   plaintiffs must make a colorable argument that the FDA would not have approved the drug or would have later withdrawn approval, absent the misrepresentations or withheld information. The 11/07/2018 FDA label change related to anticoagulant testing would be an example of evidence plaintiffs might present to meet the requirements of Michigan 600.2946. In that Michigan’s law require plaintiffs show the offending actions or inactions of the defendant were intentional, demonstrating what the defendants knew (relevant to the referenced anticoagulation tests) and when they knew it would be important in overcoming a defense raised under Michigan 600.2946.

It should be noted that a defense raised under Michigan 600.2946 or Texas 82.007 exposes the defendant to broad discovery, through which plaintiffs would likely discover far more evidence to support their rebuttal arguments than can be discovered in the public domain.  For our instant purpose however, we will focus on determining when the defendant knew or should have known that the anticoagulation tests listed in the 11/07/2018 label change provide no diagnostic value for patients on Xarelto.

Mass Tort Nexus has conducted a review of the publicly available literature in order to establish what the defendant knew or should have know and when, related to anticoagulation testing with commonly used modalities and methods. We will not present a chronological listing (not exhaustive) of information in the public domain relevant to this topic.

 It should be noted that any information or data published in clinical literature must be developed over time (before it is reported). We can safely assume that any information reported in the medical literature in 2012 was known to the defendant at the time they sought the initial FDA approval for Xarelto, granted in July of 2011. If the defendants were to raise a defense under Michigan 600.2946 or Texas 82.007, plaintiffs would likely be allowed broad discovery which would reveal that the defendants possessed or should have possessed the information related to anticoagulation tests that they withheld from the FDA and prescribing physicians until 11/07/2018.

 No Exhaustive Review of the Literature

2012

The data below was taken from a presentation from Ohio Society of Pharmacist Association in 2012. Given the fact that the information below was reliant on clinical observations prior to the presentation of the below, it is likely that the defendant was aware of the issue related to INR testing, prior to seeking U.S. FDA approval (granted July 1, 2011)

Summary
• Dabigatran
– aPTT
• Appears to be a useful measure in hemorrhagic emergency
• Therapeutic ranges have not yet been established
– Ecarin clotting time
• Also useful in hemorrhagic emergency, but not widely available.
• Rivaroxaban and Apixaban
– Prothrombin time, but not INR
• Appears to be useful in hemorrhagic emergency
• Therapeutic ranges have not yet been established
– HepTest, PiCT, and chromagenic assay all appear to be
useful, but not commonly available

https://cdn.ymaws.com/www.ohioshp.org/resource/resmgr/annualmeetinghandouts/effects_of_new_oral_anticoag.pdf

 May 2012

Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories.

RXA plasma levels can be quantified accurately and precisely by a chromogenic anti-FXa assay on different coagulometers in different laboratories. Ingestion of 10mg RXA results in significant alterations of both PT- and aPTT-based coagulation assays.

https://www.ncbi.nlm.nih.gov/pubmed/21840043?dopt=Abstract

July 2012 Rivaroxaban: A practical Guide

INR testing should be preformed just before the next intake of Rivaroxaban on the INR measurement

http://www.uclmontgodinne.be/files/RivaroxabanPracticalGuide06072012.pdf

Thrombosis Journal 2013

https://thrombosisjournal.biomedcentral.com/articles/10.1186/1477-9560-11-11

Because rivaroxaban and other target-specific oral anticoagulants have different mechanisms of action from traditional anticoagulant agents, laboratory tests used for these traditional agents (such as PT/international normalized ratio [INR] or activated partial thromboplastin time) are not suitable for target-specific oral anticoagulants

Pub Med   May 2017

https://www.ncbi.nlm.nih.gov/pubmed/28476405

Direct factor Xa inhibitors such as rivaroxaban or apixaban may prolong prothrombin time (PT) and elevate international normalized ratio (INR). However, these tests are not reliable for assessing the anticoagulation effects of these agents such as rivaroxaban or apixaban may prolong prothrombin time (PT) and elevate international normalized ratio (INR). However, these tests are not reliable for assessing the anticoagulation effects of these agents.

See the warning letter sent from the FDA to the makers of Xarelto. Mass Tort Nexus believes more warning letters like this one exist and will continue our efforts to discover all relevant FDA communications. This warning letter is highly relevant to the prior subject matter of this article.

(FDA Link to June 6, 2013 Warning Letter to Johnson & Johnson Re: Xarelto Label is Below)

NDA 202439 XARELTO (rivaroxaban) tablets   

June 6, 2013

Johnson & Johnson International, Inc.

 

 

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) print advertisement (K02XS121040 AF) (Print Ad) for XARELTO (rivaroxaban) tablets (Xarelto) submitted by Johnson & Johnson International, Inc. (Johnson & Johnson) on behalf of Janssen Pharmaceuticals, Inc. under cover of Form FDA 2253 and observed during routine surveillance in the January/February 2013 issue of WebMD magazine. The Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).

Background:

Below is the indication and summary of the most serious and most common risks associated with the use of Xarelto.1 According to its FDA-approved product labeling (PI), in pertinent part:

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

 The PI for Xarelto contains Boxed Warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural

hematoma. The PI also contains Contraindications regarding active pathological bleeding and severe hypersensitivity reaction to Xarelto, as well as Warnings and Precautions regarding the risk of bleeding, use in patients with renal impairment and hepatic impairment, use with P-gp and strong CYP3A4 inhibitors or inducers, and risk of pregnancy related hemorrhage. The most common adverse reactions with Xarelto were bleeding complications.

Minimization of Risk Information

 Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

• “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce

the risk of stroke—without routine blood monitoring.”

• “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly  minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims. We note that the Print Ad contains the statement, “Please see accompanying Medication Guide on the following pages” (emphasis original) at the bottom of the page, and that risk information is presented on an adjacent page, but this is not sufficient to mitigate the overall misleading presentation.

Misleading Claim

 The Print Ad includes the following claim (emphasis original):

• “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

Conclusion and Requested Action

For the reasons discussed above, the Print Ad misbrands Xarelto in violation of the FD&C Act, 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix). OPDP requests that Johnson & Johnson immediately cease the dissemination of violative promotional materials for Xarelto such as those described above. Please submit a written response to this letter on or before June 20, 2013, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Xarelto that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA# 215 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Xarelto comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

 

Read More

Xarelto Settlement: Dead on Arrival?

April 15, 2019

(Mass Tort Nexus Media) Bayer and Johnson & Johnson both issued press releases on March 25th indicating to the public, as well as stockholders and analysts, that the companies had reached a settlement to resolve approximately 25,000 claims related to Xarelto. This announcement was arguably highly misleading, in that the agreement reached has not actually resulted in the settlement of a single Xarelto lawsuit (to the best of our knowledge) and certainly not 25,000 cases.

This was the headline in Reuters:  Bayer, J&J settle U.S. Xarelto litigation for $775 million,see Reuters.com/article/us-bayer-xarelto/bayer-jj-settle-us-xarelto-litigation-for-$775-million

At the time of press release, in which Bayer and Johnson & Johnson led the public and the market to believe they had resolved (settled) 25,000 pending Xarelto lawsuits, the overwhelming majority of firms representing those 25,000 clients had yet to receive significant details related to the proposed settlement, and of course had yet to present any offer to their individual clients, who would have to accept any offer made before a case could actually be settled.

Law Firms attending the Mass Torts Made Perfect conference in Las Vegas last week received more details related to the defendants proposed settlement and the reaction was not positive.

Large Scale Rejection of Proposed Settlement?

Mass Tort Nexus has spoken with a great a number of firms who were in attendance at MTMP, as well as numerous others since that time, and the clear indication that we have received would lead us to the conclusion that it is highly unlikely that the defendants proposed settlement will be accepted by enough firms (or rather their clients), to make going forward with the current proposed settlement anything other than a waste of time.

Law Firms that have been in contact with Mass Tort Nexus have indicated that they will fulfill their duty to present any offer made by defendants for their cases to the individual clients; however, they will not likely recommend that clients accept the offers made under the proposed settlement scheme. Many of the firms made colorful comments that we will not publish; however, there was a common theme among the comments:

“I would feel like I was selling out my clients if I recommend they accept the current offer the defendants have made.”

Others went as far as to say:

“I think it would be malpractice to recommend that clients accept the final amounts likely to be offered in this settlement scheme”

Dilemma for Bayer and Johnson & Johnson

The premature and arguably misleading public announcement, which would likely be considered official stock holder guidance, may create additional problems for the corporations already plagued by legal woes, which pose risks to their respective stock prices and stock holder value. If the proposed Xarelto settlement does fall through, as it appears will likely be the case, the companies will be faced with having to walk back previous positive news  “We have resolved the risk associated with the Xarelto litigation” to “not only have we not resolved the risk associated with the Xarelto litigation, but that risk may now be more significant than it was before we proposed a settlement, and many plaintiffs firms see it as more of an insult than an offer.”

If the proposed settlement was even close to something plaintiffs might except in significant numbers, Bayer and J&J might have been in a position to “tweak the settlement” and avoid having to deliver bad news to their stockholders and the public. Unfortunately for Bayer and J&J, the proposed settlement seems to be so far from “acceptable” that their only option may be to scrap the current proposed settlement and come back with another proposal, that will not be received with such strong resistance. If the two corporate giants have any hope of salvaging their messaging to the market, they will need to act quickly.

Proposed Settlement Appears to be a “Non-Starter” 

      

For now, it appears that there is no amount of lipstick that would make the proposed Xarelto settlement scheme attractive.  Most of the firms Mass Tort Nexus has spoken to have indicated that the defendants offer is not even a starting point.

 

 

 

 

MTN will provide more information in future articles about the proposed settlement, as well as the reasons a large number of firms do not feel the settlement is fair and just to their clients. At this point in time; however, it seems likely that the proposed Xarelto settlement is:

The Industry Comment

       XARELTO SETTLEMENT

Read More

Why Didn’t Bayer’s October 2018 Forecast Include Monsanto Roundup Litigation MDL 2741? Several billion possible reasons!

By Mark A. York (March 25, 2019)

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

 

Interim Report Third Quarter 2018

 

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.

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

[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)

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

Mass Tort Nexus “CLE Immersion Course”

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

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@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.

 

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Bayer AG Completes Monsanto Purchase – What’s Next On Litigation Docket?

Bayer now faces Roundup MDL 2741 along with Xarelto MDL 2592 and more than 30,000 plaintiffs

By Mark A. York (March 7, 2019)

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The integration of Monsanto into the Bayer AG Group was completed as of August 2018, which by chance coincided with the $289 million jury verdict against Monsanto on August 10, 2018 in a California trial over its Roundup “glyphosate” weed killer. The state court jury found that Monsanto’s Roundup was the cause of plaintiff R Johnson’s fatal diagnosis of non-hodgkins lymphoma.

As part of the deal completion, there were numerous requirements set by the US Department of Justice including the divestment by Bayer of certain Crop Science businesses to BASF Corp., which had sales volumes of around 2.2 billion euros. Bayer already became the sole owner of Monsanto Company on June 7, 2018, by becoming the sole Monsanto stock shareholder, resulting in Bayer assuming additional liabilities related to Monsanto’s Roundup litigation dockets across the United States.

The acquisition of Monsanto creates a market leading worldwide agriculture company, with Bayer assuming a much more direct access route to the highly coveted US farm and crop markets.

As part of the Bayer acquisition, they have inherited the Monsanto docket of Roundup litigation pending state and federal dockets across the USA. There is a current Monsanto Roundup trial underway in the US District Court in San Francisco that started February 25, 2019 in front of Judge Vince Chhabria, in the first Monsanto Roundup MDL 2740 bellwether trial. See Mass Tort Nexus Roundup Briefcase ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

Glyphosate, the active ingredient in Roundup, has been under scrutiny for years including when in 2015, the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, identified the ingredient as a “probable carcinogen.” Monsanto has adamantly denied those claims. Bayer now faces a flurry of back to back trial is state and federal courtrooms with the first trial having just started.

Monsanto Roundup Trial Schedule 2019-2020

02/25/2019  – Federal Court – Hardeman (underway)
03/18/2019  – CA JCCP – Pilliod (2 plaintiffs)
04/01/2019  – St. Louis City Court – Hall
04/22/2019  – St. Louis County Court – Gordon
05/25/2019  – Federal Court – Stevick or Gebeyehou
09/09/2019  – St. Louis County Court – 4 plaintiffs
01/21/2020  – St. Louis City Court – 10 plaintiffs
03/23/2020  – St. Louis City Court

The German parent entity Bayer AG, has started aggressively divesting assets including their animal products division, cutting consumer marketing group costs, closing several US manufacturing locations to the tune of more than $3 billion. Where Bayer decides to put the recently acquired cash remains to be seen, since they are also facing more than 20,000 lawsuits in the Xarelto MDL 2592 litigation.

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

MONSANTO ROUNDUP “GLYPHOSATE” MDL 2741

Bayer AG’s chief executive officer Werner Baumann, said this week the company might consider settling lawsuits over Monsanto’s glyphosate-containing weed-killers depending on how high court costs rise, but stressed it remained focused on defending the combined company against claims they cause cancer.

“If we can settle nuisances at some point where the defense costs in preparing cases are higher than potential settlement amounts, we will of course consider it from an economic standpoint,” CEO Werner Baumann told reporters when asked whether there was any scenario in which Bayer would consider settlement.

Baumann expressed confidence that Bayer could handle the litigation, and cited its “inexpensive” $12 million settlement of 4,000 lawsuits over its contraceptive Mirena device. Bayer also won five of six trials over its best-selling bloodthinner Xarelto, over which it faces 24,000 U.S. lawsuits. The sixth jury found in favor of a plaintiff, but a judge later overturned the decision.

“Due to our exposure as a pharmaceutical company, we have the experience to defend those (glyphosate) cases,” he said, also adding “the jury pool likely has grown more hostile” due to negative media coverage following the Johnson verdict.

Baumann said the company’s legal strategy had been revised following the integration of Bayer and Monsanto in mid-August. He declined to provide details, but recent court filings reveal some of the steps the company has taken.

Bayer recently added the attorneys from law firm Arnold & Portner, who won the Xarelto cases for the company to its glyphosate defense team.

As for the glyphosate verdict in California state court on August 10, 2018, Bayer believes that the jury’s decision is at odds with the weight of scientific evidence, decades of real world experience and the conclusions of regulators around the world that all confirm glyphosate is safe and does not cause non-Hodgkin’s lymphoma. The National Institutes of Health (NIH) recently reaffirmed glyphosate does not cause cancer. The U.S. Environmental Protection Agency (EPA), the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA) and other regulators around the world have also concluded that glyphosate can be used safely.

CEO Baumann had invited German media to visit Bayer’s new operations in the former research and development facilities of Monsanto in St. Louis, Missouri, when he made the statements on Monsanto litigation and bringing in the Bayer legal philosophy to support the ever-growing Roundup litigation in dockets across the country.

LITIGATION IMPACT ON BAYER EARNINGS

Shares in Bayer have lost 25 percent in value since Aug. 10, when a San Francisco jury awarded $289 million to Dewayne Johnson on grounds Monsanto failed to warn the school groundskeeper and other consumers of the cancer risks posed by glyphosate-based RoundUp and Ranger Pro.

Johnson has terminal non-Hodgkin’s lymphoma that he alleges was caused by the herbicides. The jury’s verdict is just the first step in this case, and it remains subject to post-trial motions in the trial court and to an appeal, as announced by Monsanto. As this case proceeds, Bayer believes courts ultimately will find that Monsanto and glyphosate were not responsible for Mr. Johnson’s illness.

Bayer denies that glyphosate causes cancer and says decades of scientific studies and real-world use have shown the chemical to be safe for human use.

The number of glyphosate cases that Bayer faces across the United States has jumped to more than 11,000, prompting concerns among investors about the impact of litigation costs on Bayer’s bottom line.

More recently, Bayer AG’s defense of Monsanto and its weed killer has taken a big hit after a major academic journal said Monsanto has improperly influenced study results related to a connection between cancer and glyphosate. . The journal, Critical Reviews in Toxicology a major toxicology peer review group that analyzes health risks of chemicals, now supports plaintiffs contentions that Monsanto ghost-wrote safety reviews into Roundup and its primary ingredient glyphosate and links to cancer.

Critical Review in Toxicology Issues Correction of Glyphosate-Monsanto “Roundup Study”

Sept. 27, 2018 – The academic journal Critical Reviews in Toxicology issued corrections yesterday for articles that were published in a 2016 supplemental issue dedicated to reviewing the safety of glyphosate, the active ingredient in Monsanto’s Roundup weed killer.

The corrections indicate that Monsanto did not fully disclose its involvement in the five articles published under the title, “An Independent Review of the Carcinogenic Potential of Glyphosate,” which concluded that glyphosate was not likely carcinogenic to humans. The review was written by expert panels overseen by Intertek, a consulting firm hired by Monsanto.

Critical Reviews in Toxicology’s publisher, Taylor & Francis, issued a rare “Expression of Concern” because the review authors failed to provide “an adequate explanation as to why the necessary level of transparency was not met on first submission.”

The journal’s correction bolsters what Roundup cancer attorneys have been saying for years: rather than informing consumers and the public about the link between Roundup and non-Hodgkin lymphoma, Monsanto ghostwrote science and engaged in deceptive PR campaigns to create the impression that its blockbuster Roundup herbicide is safe.

The law firm of Baum, Hedlund, Aristei & Goldman, which represents nearly 1,000 plaintiffs in Roundup cancer lawsuits, issued the following statement on the journal corrections:

“This decision confirms, as we have long contended based on the documentary evidence, that Monsanto made substantial contributions to these manuscripts. However, while some of Monsanto’s involvement in these publications has been acknowledged in the corrections, the investigation by Taylor & Francis fell far short of revealing the extent to which Monsanto violated scientific standards and ethics in this “independent” review.”

The corrections, incorporating apologies from several authors for their declaration failures, are a step in the right direction but do not go far enough to address what we know to be true based on the evidence.

For example:

  • Another correction states that Monsanto scientist William Heydens “pointed out some typographical errors.” Based on the documents we have, Heydens was far more involved in drafting, editing and organizing the reviews than the correction indicates. In an email correspondence with Dr. Ashley Roberts of Intertek, Heydens admits to writing “a draft introduction chapter” for the series of reviews, then asks Roberts “who should be the ultimate author” of the introduction chapter he ghostwrote. Dr. Heydens’ full involvement in these reviews remains uncorrected despite the fact that many of his edits and revisions can be found in the published final manuscript.
  • The reviews were conceived as part of a company plan to discredit IARC well before the agency came to its conclusion that glyphosate is a probable human carcinogen. One of the plan’s stated goals was to “orchestrate outcry with IARC decision, ”while another plan made clear that the company sought a “WHO Retraction” and made it a priority to “invalidate relevance of IARC.” A Monsanto “Post-IARC Meeting” details several scientists that Monsanto pegged as potential authors. The meeting presentation also asks the question, “How much writing can be done by Monsanto scientists to help keep costs down?” In an email under the subject “Post-IARC Activities to Support Glyphosate,” Monsanto executive Michael Koch wrote that the review on animal data cited by IARC should be “initiated by MON as ghost writers,” and “this would be more powerful if authored by non-Monsanto scientists (e.g., Kirkland, Kier, Williams, Greim and maybe Keith Solomon.)
  • The authors of these papers cited previous reviews that were ghostwritten by Monsanto. In an email discussing the plan for the review papers, Heydens wrote, “An option would be to add Greim and Kier or Kirkland to have their names on the publication, but we would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak. Recall that is how we handled Williams, Kroes & Munro, 2000.”

While we are pleased that the journal will take steps to correct some of the falsehoods in the original declaration of interest and acknowledgment, and we commend the authors who apologized for their violation of disclosure requirements, the scientific integrity of this “review” was compromised the day it was published and, therefore, a complete disclosure of Monsanto’s involvement, ghostwriting and payments to the experts undermining any assertions of their independence is necessary.

Our release of the Monsanto Papers and their part in the recent Monsanto verdict clearly put pressure on these authors to take at least these steps toward correcting the misleading impression that their reviews were free of Monsanto involvement and direction. It is a shame that Monsanto and now Bayer refuse to apologize for their role in this affair. We will continue to put pressure on Monsanto and Bayer to vindicate the rights of our clients.

Allegations of Ghostwriting Central to $289.2 Million Monsanto Roundup Verdict

Monsanto has long maintained that the 2016 glyphosate review in Critical Reviews in Toxicology was independent, and the original Declaration of Interest underscored the company’s claim:

“The Expert Panelists were engaged by, and acted as consultants to, Intertek, and were not directly contacted by the Monsanto Company. Funding for this evaluation was provided to Intertek by the Monsanto Company which is a primary producer of glyphosate and products containing this active ingredient. Neither any Monsanto company employees nor any attorneys reviewed any of the Expert Panel’s manuscripts prior to submission to the journal.”

But according to internal company documents obtained during the discovery phase of the Monsanto Roundup litigation, it is evident that “An Independent Review of the Carcinogenic Potential of Glyphosate” was anything but independent.

Allegations of ghostwriting scientific literature on glyphosate and Roundup were presented in the first Monsanto Roundup lawsuit to proceed to trial. The suit, filed by former California groundskeeper, Dewayne “Lee” Johnson, culminated in a $289.2 million verdict last month against Monsanto.

Internal company documents that are now part of the Monsanto Papers show that Monsanto scientist and executive William Heydens did not just review the glyphosate review; Heydens actually drafted and edited the work without disclosing his or his company’s involvement.

In an email communication between Heydens and Dr. Ashley Roberts, Heydens wrote:

“OK, I have gone through the entire document and indicated what I think should stay, what can go, and in a couple spots I did a little editing. I took a crack at adding a little text: on page 10 to address John’s comments about toxicologists’ use of Hill’s criteria…”

Heydens also argued with one of the paper’s authors, Dr. John Acquavella, about statements he wanted to include about IARC. In the comments of a draft of the paper, Acquavella deemed the statements “inflammatory” and “not necessary,” to which Heydens said, “I would ignore John’s comment.”

During a deposition, Heydens admitted that draft manuscripts of the glyphosate review were sent to him, and that he read “parts of them” before the paper was published. When asked whether or not he made dozens of edits to the manuscript, Heydens said, “I don’t recall.”

“Although I’m glad the journal is now on record finding that they were misled when publishing these articles, a retraction is more than warranted for this situation,” said Nathan Donley, a senior scientist at the Center for Biological Diversity. Donley was one of four scientists to send a letter to the editors of Critical Reviews in Toxicology last year asking for a retraction.

“Furthermore, the journal appears to be allowing the phrase ‘an independent review’ to remain in the title of the issue. There is nothing independent about this review by any stretch of the imagination.”

Reviews Updated with New Acknowledgments and Declaration of Interest Sections

Several of the authors issued apologies in the updated Declaration of Interest sections of three of the five review papers, including:

  • Keith R. Solomon (has worked as consultant for Monsanto)
  • David Brusick (has worked as consultant for Monsanto)
  • Marilyn Aardema
  • Larry Kier (has worked as consultant for Monsanto)
  • David Kirkland (has worked as consultant for Monsanto)
  • Gary Williams (has worked as consultant for Monsanto)
  • John Acquavella (former Monsanto employee, has worked as consultant for Monsanto)
  • David Garabrant
  • Gary Marsh
  • Tom Sorahan (former Monsanto employee, has worked as consultant for Monsanto)
  • Douglas L. Weed (has worked as consultant for Monsanto)

2003 De Roos Pesticide Non-Hodgkin’s Lymphoma Study

In this study, researchers analyzed data that was originally gathered by the National Cancer Institute (NCI) in the 1980s. As part of its investigation into the association between pesticide exposure and non-Hodgkin’s lymphoma in men, the NCI conducted three case control studies; one in Nebraska, one in Iowa and Minnesota, and one in Kansas. In case control studies, individuals with a disease, the cases, are compared to subjects without the disease, the controls. The goal is to determine if the cases were exposed to certain substances much more frequently than the controls. Researchers can use the data to estimate how much exposure to the substance increases the risk of acquiring the disease.

De Roos and his group, which included a number of scientists who had been involved in the three original studies, wanted to explore the effect of exposure to multiple pesticides (the pesticide group includes insecticides and herbicides like Roundup) on NHL risk. The researchers analyzed data from 870 cases and 2,569 controls. Men in both groups were interviewed about their exposure to agricultural pesticides and other risk factors for NHL. Forty-seven insecticides and herbicides were examined.

De Roos reported that nine pesticides, including glyphosate, were associated with increased incidence of non-Hodgkin’s lymphoma. It is significant that only nine of the 47 pesticides were linked to NHL. This, says De Roos, suggests that the findings for these pesticides were not simply the result of recall bias (inaccuracies in the recall of the subjects interviewed) or bias related to the selection of the 47 pesticides analyzed in the study. In other words, the association of these nine pesticides with NHL did not just happen by chance or because of a fault with the way the study was conducted. The high toxicity of these pesticides can be seen in the fact that four of them (fonofos, chlordane, dieldrin and copper acetoarsenite) have since been banned in the United States. A fifth, diazinon, used to be a popular insecticide, but can no longer be purchased by consumers due its health risks to humans, particularly children. Yet another (atrazine) was banned in the European Union. This is the exclusive “club” of which glyphosate was discovered to be a member.

When De Roos restricted her analysis to just these nine “potentially carcinogenic” pesticides, she discovered a significant trend. The more of these pesticides a subject used, the more the NHL incidence increased. Subjects who used five or more of the nine pesticides were “twice as likely to be NHL cases than controls.” It turned out that glyphosate was a special ingredient in this “stew” of highly toxic pesticides. When De Roos removed it and repeated the analysis with just eight pesticides, the trend towards increasing NHL incidence when an increased number of pesticides was used disappeared.

De Roos makes an important point at the conclusion of this study. For regulatory purposes, government agencies necessarily focus on pesticides individually. But risks to the public are often amplified by exposure to multiple pesticides. Protecting public health must involve an assessment of pesticides not just individually, but as they are used in possible combination with other pesticides.

Summary Information

Title
Integrative assessment of multiple pesticides as risk factors for non-Hodgkin’s lymphoma among men

Authors
A J De Roos1, S H Zahm1, K P Cantor1, D D Weisenburger2, F F Holmes3, L F Burmeister4, A Blair1

  1. Division of Cancer Epidemiology and Genetics, National Cancer Institute, USA
  2. University of Nebraska Medical Center, Omaha, NE, USA
  3. Kansas University Medical Center, Kansas City, KS, USA
  4. University of Iowa College of Medicine, Iowa City, IA, USA

Journal
Occupational and Environmental Medicine and Chemical Toxicology; 60 (9), September 2003

HOW MONSANTO MANIPULATED THE SYSTEM

Newly-released emails written by executives at Monsanto Co. show that Monsanto employees ghostwrote articles for independent scientists. Leading up to a regulatory hearing on the safety of glyphosate, Monsanto employees were looking for scientific studies showing that Roundup is safe.

Monsanto executive William “Bill” Heydens, Regulatory Product Safety Assessment Lead, instructed his staff to ghostwrite portions of a scientific article, planning to have scientists “just sign their names” to the study.

“Monsanto tells us that Roundup is safe because scientists say it is safe.  But apparently scientists sign their names, while Monsanto signs the checks,” says Kara Cook-Schultz, Toxics Director at U.S. PIRG. “This calls into question multiple studies written, or possibly ghostwritten, by agricultural scientists.”

Click here to see the actual unsealed documents with Heyden’s brazen ghost-writing plan.

 

Also included in the email chain is evidence showing that Monsanto regularly works together with other international chemical companies—such as Syngenta and Dow—to publish scientific papers. Christophe Gustin, Monsanto’s Crop Protection Regulatory Affairs Lead at Monsanto Europe, asked for Syngenta and Dow’s sign-off prior to hiring a scientist to publish the results of internal, unpublished studies on Roundup.

Court records show that Monsanto was tipped off by the US EPA, of a determination  by the International Agency for Research on Cancer, part of the World Health Organization, that glyphosate was a probable carcinogen. The WHO cited direct research linking glyphosate to non-Hodgkin’s lymphoma. The unreleased study results and findings were illegally handed over to Monsanto by US EPA deputy division director Jess Rowland as soon as it came across his desk. That led the company to prepare a public relations assault on the finding well in advance of its publication. Monsanto executives, in their internal email traffic, also said Mr. Rowland had promised to beat back an effort by the Department of Health and Human Services to conduct its own review.

People should know that there are superb scientists in the world who would disagree with Monsanto and some of the regulatory agencies’ evaluations, and even E.P.A. has disagreement within the agency

People should know that there are superb scientists in the world who would disagree with Monsanto and some of the regulatory agencies’ evaluations, and even E.P.A. has disagreement within the agency.

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

Mass Tort Nexus “CLE Immersion Course”

March 8-11, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@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.

 

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Monsanto-Bayer Facing Over 11,000 Lawsuits Over Roundup Cancer Risk As New Federal Trial Starts

How Will Bayer Address Over 11,000 Lawsuits Linked To Roundup Cancer Risk?

By Mark A. York (February 28, 2019)

(MASS TORT NEXUS MEDIA) The troubles keep mounting for German pharmaceutical giant Bayer since it acquired Monsanto last June for $62.5 billion, as they now face thousands of lawsuits in state and federal courts.

In a just started bellwether trial in the Monsanto Roundup MDL 2741 federal litigation, plaintiff Edwin Hardeman, 70, the second plaintiff to go to trial against Monsanto, is claiming agribusiness giant Monsanto’s weed killer causes cancer. He claims his decades-long use of the weedkiller on his 56-acre Sonoma County property is linked to his diagnosis of non-Hodgkin’s lymphoma in 2015

Last August, a California state court jury concluded that Roundup presented a “substantial danger” to terminally ill 46-year-old Dewayne “Lee” Johnson, and awarded him $289 million in damages. Lee Johnson became sick with non-Hodgkin’s lymphoma after using the spray for more than two years as a groundskeeper.

Hardeman’s trial is before a different judge and may be more significant. U.S. 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). Six others trials are scheduled to begin this year as well.

Glyphosate, the active ingredient in Roundup, has been under scrutiny for years including when in 2015, the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, identified the ingredient as a “probable carcinogen.” Monsanto has adamantly denied those claims.

The lawsuits pose a threat to Monsanto and its corporate parent, German chemical giant Bayer, which last year merged in the $60 billion deal with Monsanto. While Monsanto doesn’t break out sales of glyphosate, the product delivered $4.8 billion in revenue in 2015. In its last earnings report before Bayer acquisition, Monsanto said profits in its agricultural productivity division soared 30 percent due to “improved pricing” on glyphosate.

The Lee Johnson verdict award was seen as a positive step in the ever-growing litigation against Monsanto-Bayer, however that $289 million verdict was in California state court, and not the more restrictive US District Court in San Francisco where Judge Chhabria has bifurcated the trial, as well as prohibited admission of documents and research data that reflects badly on Monsanto.

The jury awarded Mr. Johnson, a school groundskeeper more than $289 million in damages after he claimed Monsanto’s best-selling weedkiller Roundup gave him cancer, and now the controversial ingredient – glyphosate — has been detected in popular kids’ breakfast cereals, including Cheerios, Lucky Charms and Quaker Old Fashioned Oats, according to an activist group.

Edwin Hardeman, 70, is the second plaintiff to go to trial claiming agribusiness giant Monsanto’s weed killer causes cancer. He claims decades-long use of the weedkiller on his 56-acre Sonoma County property is linked to his diagnosis of non-Hodgkin’s lymphoma in 2015. Hardeman’s trial is before a different judge and may be more significant for the overall litigation, due to this being a bellwether trial, the results may set the stage for how the other cases are addressed in dockets across the country.

The outcome of bellwether cases help attorneys on both sides decide whether to continue fighting in court including at ongoing bellwether trials or look toward settlement.  A jury verdict in favor of Hardeman and the other test plaintiffs would give their attorneys a strong bargaining position in any settlement talks for the remaining cases before Chhabria.

Lab tests conducted by the Environmental Working Group (EWG), a nonprofit advocacy group that specializes in toxic chemicals and corporate accountability, indicated almost three-fourths of the 45 food products tested detected high levels of glyphosate, which has been identified as a “probable carcinogen” by the World Health Organization in 2015.

Popular children items, including General Mills’ Cheerios Toasted Whole Grain Oat Cereal, Lucky Charm’s, Kellogg’s Cracklin’ Oat Bran and Quaker’s Old Fashioned Oats, all had levels exceeding EWG’s safety guidelines.

But makers of the foods EWG tested said they and their suppliers operate within U.S. government safety guidelines and dismissed the group’s findings as irrelevant.

Since the state court verdict won by Lee Johnson showed that juries can hold Monsanto liable, the Roundup litigation has made national headlines, and Bayer has been flooded with thousands of other lawsuits.

A Bayer spokesperson has stated that it would like “to emphasize once again that we disagree with the verdict in the Johnson case. We have therefore filed an appeal, and we will continue to defend ourselves vigorously in all the other proceedings as well.”

Bayer added that glyphosate, which is the controversial active ingredient in Roundup, “is a safe product” and “that has been proven by numerous scientific studies and the independent assessments of regulatory authorities throughout the world over a period of more than 40 years.”

However, glyphosate has been under scrutiny for years, including in 2015, the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, identified the ingredient as a “probable carcinogen.”

Bayer stock has fallen more than 27 percent since the first courtroom defeat in August, and the boardroom must be concerend about additional plaintiff verdicts in the future and how this will affect their stock proces. How Bayer begins to view the Monsanto merger and the tag-along liabilities of thousands of Roundup lawsuits may force Bayer to begin settlement discussions in earnest. The German parent entity Bayer AG, has started aggressively divesting assets including their animal products division, cutting consumer marketing group costs, closing several US manufacturing locations to the tune of more than $3 billion. Where Bayer decides to put the recently acquired cash remains to be seen, since they are also facing more than 20,000 lawsuits in the Xarelto MDL 2592 litigation.

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

The Xarelto lawsuits are pending in federal and state courts across the country where the blockbuster blood-thinner drug Xarelto is alleged to have injured and/or killed thousands while Bayer withheld and manipulated drug dangers and clinical study results.

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

Mass Tort Nexus “CLE Immersion Course”

March 8-11, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

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FDA STATEMENT ON BAYER ESSURE SAFETY OVERSIGHT AFTER BAYER STOPS U.S. SALES

 

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

For Immediate Release

December 20, 2018

FDA Statement

When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions and also support regulatory actions that reduce any potential risks to patients. We’ve taken a series of such steps with respect to Essure, a permanent birth control device. The product has been the focus of several important FDA safety actions. We’re announcing some additional steps today to make sure the FDA continues to evaluate the product’s long-term safety profile past its scheduled discontinuation from the U.S. market following a series of earlier regulatory actions that we took apply significant new requirements on its use. This includes the agency’s decision to take the step of making Essure a restricted device.

In July, citing the declining annual number of implantations, the manufacturer of the device, Bayer, announced that Essure will no longer be sold or distributed in the U.S. after Dec. 31, 2018. At that time, I stressed that, even when Essure is no longer sold, the FDA would remain vigilant in its oversight of the device. This includes requiring that Bayer complete the postmarket surveillance study that we ordered in February 2016. I also affirmed that we’d continue to actively communicate with patients and physicians as new information about the device becomes available or as the FDA takes additional regulatory steps.

Today, I’m providing an update on new steps to revise and strengthen the manufacturer’s postmarket study, to make sure we continue to collect long-term safety information following the discontinuation of the product to better evaluate the safety profile of the device when used in the real world.

As part of the revised protocol for the postmarket surveillance study, the FDA has worked with Bayer to see that the manufacturer implements several approved modifications to the study that we believe will strengthen the evidence collected.

First and foremost, women in the study will be followed for five years, rather than the three years that was initially required. This significant extension follows the FDA’s request that the company go beyond the three-year period provided for by law. This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.

Second, we’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.

The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results. Since FDA’s 2016 decision to order Bayer to conduct the postmarket study and then to add a boxed warning and Patient Decision Checklist to the labeling, sales of Essure declined by 70 percent. Earlier this year, the FDA decided to restrict the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and that give patients the opportunity to sign an acknowledgement of understanding before implantation. In view of this decline in sales and the manufacturer’s decision to discontinue sales and distribution at the end of this year, we recognize that Bayer is having challenges reaching the study’s initial sample size that relied on enrolling patients who were newly implanted with Essure until May 2020. We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment.

For the past several years, the FDA has been monitoring the progress of an Essure post-approval study that was mandated to gather long-term data on pregnancies occurring in patients who may have received a transvaginal ultrasound in order to confirm that Essure was properly placed in a woman’s fallopian tubes and could be relied upon to prevent pregnancy. The FDA’s Center for Devices and Radiological Health conducted an  analysis of an ongoing post-approval study data to gain a fuller understanding of device removals over time; they also completed their extensive evaluation into a significant collection of medical device reports submitted in 2017 and the first half of 2018 that mentioned issues involving potential device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure. CDRH also spent the past several months actively evaluating more than 15,000 medical device reports submitted to FDA in 2017 through June 2018 on the Essure device. (The majority of these reports referenced an instance in which the device was removed from a patient, and most came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer.) CDRH is providing some important new information about the removals of the Essure device learned from this analysis on our website.

Based on this information, the FDA instructed Bayer to extend the postmarket surveillance study from three years to five years to capture longer term information about device removals. We believe it’s important to continue closely monitoring device removals in the postmarket surveillance study to gain greater knowledge of this issue.

Following Essure’s removal from the market, the FDA is committed to continuing to monitor women who have the device implanted. In addition to the post-market surveillance study, the agency will continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. This follows previous actions the FDA has taken, including requiring Bayer to add a boxed warning to the labeling of Essure and issue a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks and the sales restriction that FDA placed on the product.

I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.

We’re also advancing new ways to solidify our monitoring systems to achieve our new goal to consistently be the first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

As we announced when we issued our Medical Device Safety Action Plan in April, we’re working to implement an active surveillance system to help us detect device safety signals faster, including for devices related to women’s health. We’re implementing active surveillance capabilities as part of our National Evaluation System of health Technology, which will leverage a wide range of data systems that could provide real-time information on device safety signals from electronic health information, such as registries and electronic medical records. We’re also continuing our ongoing efforts to strengthen our Coordinated Registry Networks (CRN), which link different real-world data sources to generate clinical evidence about medical devices used by patients.

We’re especially focused on addressing clinical questions for device therapies that address conditions that are unique to women, such as treatment of uterine fibroids, pelvic floor disorders, female sterilization (including the Essure device) and long-acting reversible contraception. To advance these goals, the FDA partnered with the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine and others on this effort, which is known as the Women’s Health Technologies CRN, or WHT-CRN. Once fully implemented, the WHT-CRN can be used to answer crucial questions on medical devices for women’s health to help supplement the evidence we’re gathering from postmarket studies and medical device reports. It could also help us detect safety issues with medical devices faster, enabling us to take actions — like the implementation of special controls — sooner.

We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them. The FDA will continue to collect and review reports of adverse events associated with device removal and is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.

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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.

To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

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