Weight Drug Suits Highlight Need For Legal Work On Safety

Gregg Goldfarb | February 21, 2025 | Mass Tort

The following article appeared on February 21, 2025 on Law360 UK.

The Rise of GLP-1 Agonists

The rapid ascent of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) — such as Novo Nordisk’s Ozempic and Wegovy, and Eli Lilly & Co.’s Mounjaro and Zepbound — has revolutionized diabetes management and weight loss.

However, this surge has triggered legal disputes over which claims ought to be included in the In Re: Glucagon-like Peptide-1 Receptor Agonists Products Liability Litigation, in the U.S. District Court for the Eastern District of Pennsylvania. Eye injuries and deep vein thrombosis were excluded from this multidistrict litigation (MDL) in December 2024.

There are also ongoing battles over who can produce compounded versions of the drugs while they remain in shortage. The FDA ruled in December that state-licensed pharmacies could only compound GLP-1 drug tirzepatide until this month.

The continuing legal disputes, alongside concerns over off-label promotion of the drugs for weight loss, underscore the legal profession’s responsibility to protect patient safety amid a rapidly shifting pharmaceutical landscape.

As Side Effects Pile Up, MDL Remains Narrowly Focused

The initial claims against GLP-1 RA manufacturers focused on gastrointestinal side effects, including stomach paralysis and intestinal obstruction. However, numerous GLP-1 RA users have reported additional side effects, including deep vein thrombosis and blood clot-related injuries, since plaintiffs’ claims were organized in the MDL before U.S. District Judge Gene Prater.

Judge Prater passed away in May 2024. This prompted the transfer of the MDL to U.S. District Judge Karen Marston, also of the Eastern District of Pennsylvania But despite petitions from users of GLP-1 RA drugs claiming injuries beyond those covered in the first lawsuits, the Judicial Panel on Multidistrict Litigation declined to add new types of injuries to the MDL in a December ruling, citing their potential to make the MDL “procedurally and substantively unwieldy.”[1]

That means plaintiffs with nongastrointestinal claims will need to pursue justice through another avenue, while the more than 1,300 plaintiffs with gastrointestinal injuries proceed with the original MDL. Science may be on the side of those with other claims. An independent Danish study published in December examined data from more than 400,000 Danes with type 2 diabetes, and found that Ozempic users were twice as likely to develop nonarteritic anterior ischemic optic neuropathy, a condition that reduces blood flow to the optic nerve and causes vision loss.

While the rare eye disease affected roughly 60 to 70 people per year before Ozempic hit the market in 2018, Denmark now sees up to 150 cases per year.[2]

An older study, published in 2021 in the Endocrine Journal, found that semaglutide — the active ingredient in Ozempic — increased the likelihood of developing deep vein thrombosis by 266% in patients with type 2 diabetes.[3]

Compounded Drugs: Access Versus Safety

While the GLP-1 RA MDL in Pennsylvania seeks to hold drugmakers accountable for undisclosed side effects, the
issue of drug compounding is pitting the original GLP-1 manufacturers against compounding pharmacies that
produce analogues of the in-demand medications.

Such pharmacies are legally allowed to make versions of GLP-1 RA drugs so long as they remain on the FDA’s shortage list — a mechanism of pharmaceutical law designed to ensure that patients can get the drugs they need when original manufacturers are overwhelmed by demand. Eli Lilly’s tirzepatide-based drugs Zepbound and Mounjaro, respectively for weight loss and diabetes management, both went on the FDA shortage list in December
2022.

Last October, Eli Lilly asked the FDA to remove the drugs from the shortage list, on the basis that the company had
caught up to demand.

With billions of dollars on the line, the drug compounders fought back, filing an October lawsuit in the U.S. District Court for the Northern District of Texas — Outsourcing Facilities Association v. FDA — that claimed that Eli Lilly was only able to catch up with demand by the fall of 2024 due to the compounders’ efforts to supplement supply.

Compounders even argued that the FDA’s removal of the drugs from its shortage list would “destroy their revenues” due to a substantial investment in developing copies of the drugs in accordance with state regulations. Some compounding pharmacies believe that they represent as much as 30% of the current GLP-1 RA market.

While compounding pharmacies argue that efforts by Eli Lilly and Novo Nordisk to remove their diabetes and weight loss drugs from the FDA shortage list amount to little more than a ploy to increase market share, the drugmakers contend that compounders aren’t capable of safely duplicating their in-demand medications. Novo Nordisk asked the FDA to ban semaglutide compounding in October on such grounds.[4]

Regarding tirzepatide injections — Eli Lilly’s Mounjaro and Zepbound — it seems the drug compounders are producing GLP-1 RA analogues on borrowed time. In late December, the FDA issued a declaratory order stating that the tirzepatide shortage had been resolved, allowing state-licensed pharmacists and physicians to continue compounding until Feb. 18, with a March 19 deadline for outsourcing facilities.[5]

However, the same directive indicated that injection forms of semaglutide, dulaglutide and liraglutide remain in shortage — meaning compounders can still produce their own versions of Ozempic, Wegovy, Victoza, Saxenda and Trulicity until further notice.

The intersection of drug shortages and the rise of compounded versions of GLP-1 agonists presents a complex dilemma. While compounding pharmacies have played a role in mitigating shortages by providing more affordable alternatives, concerns about the safety and efficacy of these compounded medications persist.

This scenario highlights the tension between ensuring drug availability and maintaining rigorous safety standards. For patients — particularly those from underserved communities — compounded drugs have offered a more accessible option. However, the lack of FDA approval and potential quality control issues necessitate a cautious approach.

Legally, this raises questions about the extent to which compounding pharmacies can be held liable for adverse outcomes, and the responsibilities of original manufacturers in ensuring their products are not misrepresented or inappropriately replicated.

Off-Label Promotion and Ethical Implications

The aggressive marketing strategies employed to promote GLP-1 agonists for weight loss — prior to obtaining formal regulatory approval for such indications — raise significant ethical and legal questions. While off-label prescribing is a common practice — and one allowed by the FDA — the deliberate promotion of drugs for unapproved uses can be construed as prioritizing market expansion over patient welfare.

Dr. Robert Klitzman of Columbia University stated:

“The high costs of anti-obesity drugs and the need for lifelong use pose significant financial challenges, which could
worsen health disparities,” Columbia University Master of Science in Bioethics program director Dr. Robert Klitzman
told Columbia Psychiatry News in October. “There’s also a risk that the excitement about these new medications
might overshadow crucial public health efforts focused on prevention and lifestyle changes.”[6]

This practice not only contravenes regulatory standards, but also erodes public trust in the pharmaceutical industry. As legal professionals, we must advocate for marketing practices that are not only legally compliant but also ethically sound, ensuring that patient health remains paramount.

The Path Forward: Balancing Innovation, Safety, and Access

The ongoing legal battles surrounding GLP-1 agonists serve as a microcosm of the broader challenges in the pharmaceutical landscape. As we navigate these complexities, it is imperative to foster a legal and regulatory environment that encourages innovation, while steadfastly safeguarding patient health and ensuring equitable access to lifesaving medications.

This necessitates a collaborative approach, engaging stakeholders across the spectrum — from manufacturers and healthcare providers to regulators and legal professionals — to develop solutions that are both effective and ethically sound. By doing so, we can aspire to a healthcare system that truly serves the best interests of all patients.

The legal battles over GLP-1 drugs underscore a broader tension in healthcare: innovation versus accountability. While these drugs have undeniably improved lives, the costs — in terms of safety, access and ethical compromise — are equally undeniable.

As practitioners, we must advocate for accountability not only from manufacturers but also from regulators and the broader healthcare ecosystem. By addressing these challenges head-on, we can ensure that innovation serves its intended purpose: improving patient outcomes without compromising safety.