Bayer’s Legal Battles Continue: A $3.5 Million Verdict in Roundup Weedkiller Case

Daniela P on December 5, 2023

Bayer’s Legal Battles Continue: A $3.5 Million Verdict in Roundup Weedkiller Case

In a recent legal development, Bayer faced yet another setback in its ongoing litigation over the alleged carcinogenic effects of its Roundup weedkiller. A Philadelphia jury ordered the company to pay nearly $3.5 million to a woman who claimed the product caused her cancer. This verdict, smaller than Bayer’s previous trial losses, signals a continuing trend in the legal challenges the company faces.

Key Points: 

  • The Philadelphia Court of Common Pleas found Bayer liable, awarding $462,500 in compensatory and $3 million in punitive damages.  
  • Bayer contests the verdict, citing a conflict with scientific evidence and regulatory assessments.  
  • Recent months have seen Bayer hit with larger verdicts, including a staggering $1.56 billion in November.  
  • The plaintiff, like many in similar cases, alleged that non-Hodgkin lymphoma resulted from Roundup exposure.  
  • The company plans to be selective in settlements, with about $6.5 billion set aside for litigation. 

The verdict, which includes both compensatory and punitive damages, is the latest in a series of legal defeats for Bayer. The company, however, remains steadfast in its disagreement with the jury’s decision, pointing to the weight of scientific evidence that supports the safety of Roundup’s active ingredient, glyphosate. 

Bayer’s strategy in the face of these legal challenges has been marked by a combination of contestation and preparation. The company has not only vowed to appeal recent verdicts but also reassured investors of its financial preparedness to handle ongoing litigation. With approximately $6.5 billion reserved for such purposes, Bayer appears to be bracing for a prolonged legal battle. 

The plaintiff’s allegations, echoing those in numerous other cases, highlight a growing concern over the safety of Roundup, particularly regarding its potential link to non-Hodgkin lymphoma. This concern is compounded by conflicting scientific opinions and regulatory stances, with entities like the World Health Organization’s cancer research agency and the U.S. Environmental Protection Agency offering differing assessments of glyphosate’s safety. 

Bayer’s acquisition of Monsanto in 2018, which included Roundup, has since exposed the company to extensive legal scrutiny. With around 165,000 claims made against the product for personal injuries and over 50,000 claims still pending, Bayer’s legal journey seems far from over. 

This is the latest verdict in Philadelphia is more than just another legal setback for Bayer; it underscores the intricate and contentious nature of mass tort litigation in the pharmaceutical and agrochemical industries. For Bayer, navigating these legal challenges will require not only a robust legal strategy but also a careful consideration of the broader implications for its business and reputation. 

Understanding Suboxone Lawsuits: A Comprehensive Guide

Jennifer W on November 28, 2023

Suboxone Lawsuits: Navigating the Legal Landscape

The legal actions surrounding Suboxone, a medication prescribed for opioid addiction, have been marked by a series of lawsuits against its manufacturer, Indivior. These lawsuits allege that Indivior failed to adequately inform consumers and healthcare providers of the potential dental risks associated with Suboxone, such as tooth decay, oral infections, cavities, and tooth loss. Plaintiffs are seeking compensation for these alleged oversights.

Key Points: 

  • Legal Allegations Against Indivior: The lawsuits against Indivior, the manufacturer of Suboxone, claim that the company failed to adequately warn users and healthcare providers about the risk of serious dental problems associated with the use of Suboxone, including tooth decay, oral infections, cavities, and tooth loss. 
  • Current Status of Lawsuits: As of October 2023, Suboxone lawsuits are in the initial stages. Lawyers are actively accepting and investigating new cases, and there have been no jury trials scheduled or global settlements approved related to the dental issues allegedly caused by Suboxone. 
  • Significant Legal Developments: There have been several notable legal developments, including Indivior’s $385 million settlement in October 2023 to resolve monopoly accusations. Individual lawsuits, like those filed by Keith King and David Sorensen, specifically cite permanent dental damage from Suboxone. 
  • FDA’s Involvement and Warnings: In January 2022, the U.S. Food and Drug Administration (FDA) added warnings about potential dental problems to Suboxone’s prescribing information and patient medication guide, following the emergence of these lawsuits. 
  • Criteria for Filing a Lawsuit: The article suggests that individuals who have used prescription Suboxone and subsequently experienced severe dental issues may be eligible to file a lawsuit. Eligibility typically requires a history of prescribed Suboxone use and routine dental care prior to developing dental problems. 

Suboxone Lawsuits: Navigating the Legal Landscape 

As of October 2023, the Suboxone legal landscape is evolving. Lawsuits are at the preliminary stages, and legal representatives continue to review new cases. No jury trials have been scheduled, nor have any comprehensive settlements been approved concerning the dental issues related to Suboxone. 

Developments in Suboxone Litigation 

Significant developments in the Suboxone lawsuits include a $385 million settlement by Indivior in October 2023 to resolve monopoly accusations from other drug manufacturers. Additionally, individual lawsuits, like those filed by Keith King and David Sorensen in October and September 2023, respectively, allege permanent dental damage due to Suboxone use. Earlier, in August 2023, Indivior settled a federal antitrust lawsuit for $30 million, and in April 2023, the Federal Trade Commission distributed $369,000 from a $60 million class-action settlement concerning Suboxone. 

The Role of the FDA and Regulatory Actions on Suboxone 

In January 2022, the U.S. Food and Drug Administration (FDA) added warnings about dental problems to Suboxone’s prescribing information. This move followed previous legal challenges against Indivior and its former parent company, Reckitt Benckiser, for deceptive marketing practices, including misleading health plans and doctors about Suboxone’s safety and addiction potential. These cases resulted in substantial financial settlements, including a $600 million payment by Indivior in July 2019 and a $1.4 billion resolution by Reckitt Benckiser with the U.S. Department of Justice. 

Eligibility Criteria for Filing a Suboxone Lawsuit 

Potential plaintiffs in Suboxone lawsuits include individuals who have used prescription Suboxone and subsequently experienced severe dental issues. Eligibility for filing a lawsuit requires a history of prescribed Suboxone use and routine dental care prior to the onset of dental problems. Those affected are advised to seek legal consultation promptly due to varying state-specific filing deadlines. 

Overview of Suboxone Lawsuit Claims 

To initiate a Suboxone lawsuit, affected individuals should engage with experienced lawyers in mass tort and product liability. These legal professionals can guide clients through the litigation process, from filing lawsuits to negotiating settlements or preparing for jury trials. The complexity of these cases underscores the importance of selecting counsel with a track record of successfully litigating against multinational pharmaceutical companies. 

 

Tylenol Litigation Update: FDA’s Stance Reveals Complex Implications

Daniela P on September 11, 2023

FDA’s Response in Tylenol Autism/ADHD Litigation: An Overview 

In the unfolding Tylenol litigation, the U.S. Food and Drug Administration (FDA) has provided a nuanced response to inquiries concerning the potential risks associated with acetaminophen use during pregnancy. In late April 2023, the presiding Judge Cote solicited the agency’s perspective on whether warnings about the risk of autism and Attention-Deficit/Hyperactivity Disorder (ADHD) should be explicitly stated on acetaminophen labels for pregnant women. Although the FDA’s feedback was initially due by the end of July, the deadline was extended at the request of the U.S. Government to September 15th.

Ahead of schedule, on September 8th, the U.S. Attorney for the Southern District of New York, on behalf of the FDA, submitted a letter and an accompanying report. This submission occurred 11 days before the deadline for the parties to present their initial Daubert briefs, which are intended to challenge and aim to exclude their opponents’ general causation experts. 

The disclosure from the Department of Justice (DOJ) indicated that the FDA currently views the post-2015 scientific studies it has reviewed as inconclusive regarding causality. This perspective is seen as unfavorable by those who advocate for a definitive link between acetaminophen use during pregnancy and developmental disorders. 

However, there is an aspect of the FDA’s position that may be perceived positively by the plaintiffs. According to the DOJ letter, the FDA has chosen not to assert a position within the ongoing litigation, aiming not to impede Judge Cote’s evaluative process of expert testimony during the Daubert hearings. Notably, the FDA has refrained from commenting on potential alterations to the current warning labels, thus abstaining from influencing the judicial procedures directly. 

This development prompted Johnson & Johnson and Walmart to consider additional legal maneuvers, anticipating that Judge Cote might be persuaded to reassess her previous rulings that dismissed their preemption claims. In response to a subsequent request from Johnson & Johnson for a status conference to deliberate on the implications of the FDA’s stance, Judge Cote promptly declined, reasserting her focus on the upcoming September 19 Daubert motions. 

The future implications of the FDA’s position remain to be fully understood. Defendants are expected to leverage the FDA’s findings in the Daubert motions and may seek to inform juries of the agency’s stance in future bellwether trials. Conversely, the plaintiffs’ representatives are likely to contend that unless FDA officials are subject to deposition and cross-examination, the disclosure of the FDA’s views could unfairly prejudice the jury against the plaintiffs. 

Following the FDA’s response, the plaintiffs’ leadership has made public a previously submitted letter to the FDA, arguing that recent scientific studies do indeed establish a causal link. This public disclosure suggests an increased probability that subsequent filings from both parties, including the September 19 Daubert motions and the October 10 opposition briefs, may also enter the public domain rather than being filed confidentially. 

While the FDA’s current position on the recent studies does not endorse causality, the agency’s non-interventionist approach to the warning label debate and the Daubert process presents a complex tableau. The litigation community now eagerly awaits the impending exchange of Daubert motions, expert reports, and briefs due for submission on September 19, 2023. 

Tepezza Litigation Updates: Establishment of a Multidistrict Litigation

Jennifer W on August 19, 2023

Tepezza Litigation: MDL Establishment and Updated FDA Warnings 

Significant advancements have transpired in the ongoing Tepezza litigation. 

Formation of an MDL: On June 2, 2023, the Judicial Panel on Multidistrict Litigation (JPML) mandated the formation of multidistrict litigation (MDL) concerning Tepezza. The JPML selected the Honorable Judge Thomas Durkin of the Northern District of Illinois to preside over the MDL, which, as of August 15, 2023, comprises 46 individual cases. 

FDA Warning Label Update: After this, on July 24, the U.S. Food and Drug Administration (FDA) revised the warning label guidelines for Tepezza, mandating the inclusion of a warning pertaining to the risk of hearing impairment or hearing loss. This update reflects concerns regarding the potential adverse effects associated with the medication. 

Plaintiffs’ Allegations: The plaintiffs have presented allegations suggesting that Horizon Therapeutics, the manufacturer of Tepezza, was cognizant of the substantial risks associated with the drug, particularly in relation to hearing loss and tinnitus, but did not adequately communicate these risks to the FDA prior to or following the drug’s approval, nor did they sufficiently update the drug’s labeling to inform healthcare providers and patients. They contend that this omission constitutes a “failure to warn” and also assert that the drug possesses inherent safety issues, aligning with the “design defect” theory of liability. 

Horizon’s Stance: Horizon Therapeutics has countered, asserting that the warnings provided upon FDA approval in 2020 were adequate and that the subsequently identified concerns regarding hearing loss and tinnitus were not substantial enough to warrant an immediate change to the drug’s labeling. 

Impact of FDA Label Change: The FDA’s decision to modify the label on July 24, 2023, to include the exact warnings regarding hearing loss and the necessity for vigilant physician monitoring that the plaintiffs argued should have been included initially, is noteworthy. The revised labeling now clearly states the risks of severe hearing impairment, potentially altering the landscape of ongoing and future claims associated with the drug’s use. 

The updated label is available for review at: Tepezza Prescribing Information. 

The change in labeling is likely to have a dual effect: it may limit new “failure to warn” claims post-July 24, 2023, and it is expected to prompt more thorough discussions between physicians and patients about the risks associated with Tepezza. Moreover, this amendment fortifies the position of individuals who used Tepezza prior to these warnings, challenging Horizon’s defense against “failure to warn” claims before the label change. 

Horizon’s legal strategy regarding these preemption defenses remains unchanged as the briefing period continues. Upcoming oral arguments will be pivotal in discerning Judge Durkin’s perspective on these preemption issues and Horizon’s approach considering the updated warning. 

Progress Toward Bellwether Plan: According to a Joint Status Report filed on July 24th, the involved parties have expressed their intention to convene and forge a path toward a mutually agreeable Bellwether/Briefing Plan. This plan will encompass motions to dismiss and the initial selection of bellwether discovery cases. The subsequent status conference is scheduled with Judge Durkin on August 31, 2023. 

Amgen’s Proposed Acquisition of Horizon: In a related development, Amgen has expressed an intent to purchase Horizon for $27.8 billion (about $86 per person in the US). The transaction was initially deferred due to a lawsuit filed by the Federal Trade Commission (FTC) aimed at blocking the acquisition. Following a settlement with the FTC, the companies are now progressing toward finalizing the acquisition. The outcome of this purchase is anticipated to have a significant influence on the Tepezza litigation and its potential resolution. 

Potential Claimant Pool: Current data indicates that the pool of potential claimants is relatively limited, with only 14,500 patients having undergone treatment with Tepezza, as stated on the official product website. The treatment involves a series of infusions over approximately five months. The smaller number of potential claimants may influence the average settlement amount in any prospective collective settlement arrangement. 

Tylenol Litigation: Getting Closer to the Daubert Motions

William V on July 29, 2023

Judge Cote has largely ruled in plaintiffs’ favor to date on most of the defendants’ initial motions — e.g., denying Walmart’s preemption motion twice and J&J’s preemption motion, and various other motions to dismiss claims on other grounds. Most recently she denied J&J’s motion seeking her permission to file an immediate (interlocutory) appeal from her preemption ruling to the Second Circuit Court of Appeals.   
Plaintiffs’ leadership have filed amended master complaints against J&J and separately, against the various retail chain defendants who had manufactured and sold their own house brands of acetaminophen (i.e., Walmart, and other major retailers). These master complaints reflect the narrowing of plaintiffs’ causes of action in accordance with Judge Cote’s rulings.  

In further efforts to focus the litigation, parties have agreed to dismiss without prejudice complaints where Texas law clearly governs, since Cote previously dismissed certain claims against retailers under a Texas statutory “safe harbor” preemption clause for retailers. The parties asked Judge Cote to resolve the parties’ dispute over whether certain additional plaintiffs’ complaints are governed by Texas choice of law (and thus dismissible) or a different state’s law (and thus remaining viable).  

As previously written, she has also scheduled a “rocket docket” deadline, with special attention for Daubert motions to be filed on September 19th and a Daubert hearing on the motions during the week of December 4th. The parties will continue the process of exchanging initial and rebuttal expert reports in the weeks leading up to September 19, 2023. 

On July 28, 2023, the Department of Justice asked Judge Cote for a time extension until September 15th to respond to Cote’s unusual invitation to the federal government to weigh in on whether the label for acetaminophen should be changed to provide additional warnings of risk to pregnant women taking the drug. She likely granted the DOJ’s request to obtain a glimpse of how relevant regulatory agencies (especially the FDA) view this dispute in the context of their interpretation of public health and safety requirements.

Watch this space for links to the September 15th and 19th filings — to the extent they are public and not sealed.