With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety.
What can manufacturers of glucagon-like peptide 1 receptor (GLP-1) weight-loss drugs learn from our unique mass tort litigation history and how they can successfully defend themselves in future litigation?
Our analysis indicates there is a significant likelihood that GLP-1 may become the next major mass tort in the U.S. This prediction is supported by the rapid growth in prescriptions, the rising number of lawsuits and the recent MDL consolidation of Ozempic lawsuits.
The GLP-1 agonist market refers to the pharmaceutical sector focused on drugs that mimic the action of the hormone glucagon-like peptide-1 (GLP-1). GLP-1 agonists are a type of medication used primarily to treat type 2 diabetes, although their efficacy in managing obesity is widely known. These drugs work by stimulating insulin secretion, suppressing glucagon secretion, slowing gastric emptying, and promoting satiety.
The market for GLP-1 agonists has been expanding rapidly due to the increasing prevalence of diabetes and obesity worldwide, as well as the growing recognition of the importance of managing these conditions effectively to prevent further health-related complications. Key players in the GLP-1 agonist market include pharmaceutical companies that develop and manufacture these drugs.
The sharp increase in GLP-1 agonist prescriptions, especially for off-label weight loss, underscores this trend. Ozempic now claims an estimated 40% of the U.S. GLP-1 agonist market, with 38% of users primarily seeking weight loss. This widespread use raises the likelihood of adverse events and ensuing lawsuits. The number of lawsuits against GLP-1 manufacturers is growing, with over fifty stomach paralysis lawsuits filed in federal court by early 2024 with many more expected. Efforts to consolidate these lawsuits into an MDL, supported by at least one manufacturer, may signal the potential onset of mass tort litigation.
Plaintiffs’ claims in these early stages include the allegation that manufacturers provided insufficient warnings about side effects. Various media outlets, always on the hunt for a good story, report in detail on these potentially serious adverse events including gastroparesis, gallbladder issues, and links to suicidal thoughts, underscoring the risks manufacturers could be facing. These conditions, real or perceived, will be argued to not only impair quality of life but also pose life-threatening risks. Plaintiffs’ counsels are poised to leverage these compelling claims, emphasizing to a jury the profound impact on individuals’ health and well-being. Furthermore, significant marketing and promotional efforts by GLP-1 manufacturers for off-label weight loss use have allegedly downplayed these risks.
In 2020, the FDA stepped in and ordered a revision to Ozempic’s warning label to include references to additional, potentially significant side effects from using this medication. FDA regulatory updates come at a pivotal time for this potential mass tort, as the legal landscape surrounding agency authority is undergoing significant changes. Historically, the FDA has relied on the Chevron deference, a legal doctrine that compels courts to defer to agency interpretations of ambiguous statutes. However, the recent Supreme Court decision overturning Chevron may increase judicial scrutiny of FDA decisions on drug approvals and safety warnings. This raises broader questions about congressional intent and specificity in statutes and agency discretion under vague laws. Without Chevron, challenges to FDA determinations and approvals for drugs like Ozempic may rise, particularly concerning safety warnings and approval processes. The absence of Chevron could bolster claims that the FDA inadequately regulated or warned against off-label uses of GLP-1 medications. Courts are increasingly likely to scrutinize FDA decisions, potentially further reshaping drug regulation and related litigation.
How’d we get here?
In the last five years, the use of GLP-1 drugs has surged in the U.S., marking a notable change in the medical environment for conditions like obesity and diabetes. Five years ago, the use of GLP-1s was relatively minimal, with only a handful of patients being prescribed these drugs. Today, there are millions of Americans using them. The significant rise in GLP-1 drug usage mirrors a broader trend in pharmaceutical market dynamics. Specifically, approximately 12% of U.S. adults have utilized these medications, with 6% currently using them, driven by their efficacy in managing conditions like diabetes and promoting substantial weight loss. This surge in demand is exemplified by the soaring sales figures of Ozempic and other leading drugs, projecting the GLP-1 market to grow to $71 billion by 2032.
This evolving environment of pharmaceutical use and market growth has intersected with a notable increase in mass tort litigation within the U.S. legal system. This trend reflects our unique legal mechanisms such as class actions under Rule 23 of the Federal Rules of Civil Procedure, facilitating consolidated litigation through multidistrict litigation (MDL). Contingency fee arrangements are another, perhaps more significant underlying reason as the common use of contingency fee arrangements in the U.S. incentivizes plaintiffs’ attorney to take on what are (at least initially), complex, but always high-stakes mass tort cases in the hopes of following precedent and securing large settlements or judgments. Another factor is the broad scope of U.S. product liability laws, which are often perceived as more favorable to plaintiffs.
These legal frameworks have paved the way for extensive and long-running mass tort litigations in the U.S., with asbestos litigation standing out as one of the most notable examples. Asbestos litigation is the longest-running mass torts in U.S. legal history, involving hundreds of thousands of claims against manufacturers, and their insurers, directly related to various diseases including ovarian cancer and mesothelioma, alleged to be asbestos-related. The asbestos-related talc litigation, which emerged in the early 2000s, is rapidly evolving into a prominent aspect of asbestos lawsuits in the U.S., involving claims from plaintiffs in diverse jurisdictions, including internationally. Other significant mass tort cases in the U.S. over the past twenty years include Vioxx; transvaginal mesh; and the ongoing opioid epidemic litigation.
These now well-established precedents influence the handling and resolution of current and nascent mass tort litigation, shaping legal strategies, settlement negotiations, and regulatory responses. The current nascent litigation against manufacturers in the GLP-1 agonist space shares similarities with these precedent-setting mass tort cases and could be headed in the same direction.
The first lawsuit related to GLP-1 induced stomach paralysis was filed in August 2023. By February 2024, at least 55 lawsuits were consolidated into an MDL in the Eastern District of Pennsylvania. Plaintiffs in these cases generally allege that the drug manufacturers failed to adequately warn both doctors and patients about the potential risks of severe gastrointestinal side effects and other complications. In response to these lawsuits, the FDA updated the warning label for Ozempic to acknowledge risks of intestinal blockage.
Current defense strategies in play.
The manufacturer of Ozempic has publicly stated that it stands behind the safety and efficacy of its GLP-1 drugs when used as indicated and according to the approved labeling. The company has acknowledged the possibility of gastrointestinal side effects associated with Ozempic usage but emphasizes that these are typically mild to moderate in nature and of short duration. Generally, manufacturers primary defense asserts they sufficiently alerted consumers to the potential side effects through its warning label. Additionally, at least one manufacturer has supported the creation of the MDL that has consolidated the lawsuits, indicating its intention to vigorously defend against the claims.
Leveraging the MDL process to streamline pretrial proceedings and efficiently manage the large volume of similar cases is a sensible approach. The manufacturer’s defense focuses on emphasizing the safety and efficacy of GLP-1 drugs when used as directed, while also asserting that adequate warnings about potential side effects were provided to consumers. The company’s support for MDL consolidation indicates a strategy of centralized and coordinated defense against the lawsuits.
As this litigation continues to unfold, some additional key defense strategies may include:
- Emphasizing the rigorous clinical trial data and FDA approval process for all GLP-1 medications, including Ozempic.
- Vigorously challenging the scientific validity of plaintiffs’ claims and expert testimony.
- Meaningfully exploring opportunities for early settlement of claims to avoid protracted litigation.
- Coordinating a clear, unified, and well-communicated defense strategy and leadership across multiple cases and jurisdictions.
How can we as defense lawyers implement best practices to defend against and mitigate future lawsuits, including those involving similar medications with FDA approval and a history of rigorous clinical study?
Below are some potential cost-effective strategies manufacturers should consider to mitigate future risk:
- Mindfully Leverage Data and TechnologyManufacturers in the GLP-1 space should leverage their investments in artificial intelligence (AI), machine learning, and data analytics to gain deeper insights into the side effect profiles of their medications. This strategy will help identify, better anticipate and address potential legal issues before they escalate into further lawsuits. For example, employing AI to efficiently meta-analyze key datasets including clinical trials, electronic health records, and insurance claims to better identify potential side effects that may not be evident in smaller-scale studies.Additionally, automating data analysis through AI potentially reduces the burden on allocating resources for data analysts. This could also serve to minimize the risks of human error (critical in the drug industry) and lowers overall costs. The decrease in costs can be reinvested into other areas, ensuring optimal drug quality and safety.
- Purposefully Enhance Transparency and CommunicationManufacturers should continue to prioritize transparency regarding the potential side effects of all GLP-1 medications, including Ozempic, by proactively communicating this information to both patients and healthcare providers. A culture of transparency will help manage expectations and potentially reduce risk.By transparently sharing information about the potential risks and side effects of their drugs, manufacturers enable patients to make informed decisions about treatment options. When patients are well-informed about potential risks, they are less likely to feel misled and more prepared to manage side effects, reducing the likelihood of legal action.
- Explore (Really Explore) Alternative Dispute Resolution (ADR)Manufacturers should explore alternative dispute resolution methods, including mediation and arbitration, to resolve the current GLP-1 lawsuits in a more cost-effective manner, rather than relying exclusively on litigation.Mediation involves a neutral third-party facilitating discussions to help disputing parties reach a mutually acceptable solution, aiming for a win-win outcome. With over 80% of disputes in mediation resulting in satisfactory outcomes, this approach is often faster and less costly than litigation.Given the current scale of GLP-1 litigation, estimates suggest that the number of lawsuits could reach into the thousands. ADR can handle large volumes of cases more efficiently than traditional court systems, significantly reducing the costs involved.
- Strengthen PharmacovigilanceManufacturers should further strengthen their post-marketing surveillance and pharmacovigilance efforts to quickly identify and address any emerging safety concerns with their medications. This could also help mitigate the risk of future lawsuits.Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse drug effects to ensure medication safety and efficacy. Manufacturers should develop risk management plans, implement regular safety updates, and conduct surveillance studies to monitor drug profiles throughout their lifecycle.
- Focus on FDA Regulation ComplianceManufacturers should work even more collaboratively with regulatory bodies including the FDA and healthcare professionals to advocate for policy changes that support the development and commercialization of innovative diabetes treatments, while also ensuring appropriate safety measures are in place. By implementing some or all these strategies, manufacturers can potentially reduce the overall costs of defending against the current GLP-1/Ozempic lawsuits and, more importantly, take proactive steps to prevent similar issues from arising in the future.
Why it matters.
Is GLP-1 agonist litigation the next “big one”? Hard to say. Maybe not in terms of risk per case but could it come close in terms of the quantity of the cases yet-to-be brought? The rapidly-evolving medical landscape of diabetes and obesity management medications that are so wildly popular right now in the GLP-1 agonist space stands as not only a beacon of innovation, offering hope for improved outcomes and quality of life for millions of people worldwide, but also as an opportunity for manufacturers to assess, plan, and execute a concise, thoughtful, and engaged legal strategy that gets their legal defense ducks in a row now, to better prepare for what may be coming.
Dino Haloulos, Of Counsel in Foley Mansfield’s New York office, specializes in highly focused, high-risk complex commercial litigation in legal arenas including insurance and mass toxic tort defense, personal injury, products liability, general liability, and premises liability.
Jarif H. Khan is a summer associate in Foley Mansfield’s New York office.