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2024-04-18| In-Depth

The Legal Battlefield of Weight-Loss Drugs: Eli Lilly and Novo Nordisk on the Defensive

by Bernice Lottering
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Lawsuits against Eli Lilly and Novo Nordisk surge over undisclosed weight loss drug side effects, as the companies seemingly shift blame to compounding firms.

The lawsuits against Eli Lilly and Novo Nordisk highlight concerns over inadequate reporting of side effects associated with GLP-1 medications like Mounjaro and Ozempic. Despite being widely prescribed for managing blood sugar levels and demonstrating significant weight loss benefits, these drugs have been linked to undisclosed side effects leading to hospitalizations and surgeries. The lack of sufficient warning about these risks has resulted in numerous product liability lawsuits and the consolidation of over 72 lawsuits into multidistrict litigation, aiming to streamline proceedings and address alleged shortcomings in reporting. However, in addition to facing lawsuits for inadequate reporting of side effects, Eli Lilly and Novo Nordisk have initiated legal actions against compounding pharmacies, which some view as attempts to deflect accountability for the adverse effects onto these companies.

Lawsuits Against Eli Lilly and Novo Nordisk for Inadequate Reporting of Side Effects

Mounjaro (tirzepatide), from Eli Lilly, rivals Novo Nordisk’s Ozempic (semaglutide), both widely-used GLP-1 treatments for diabetes. Commonly prescribed for managing blood sugar levels in people with Type II diabetes, these GLP-1 RA medications have also demonstrated significant weight loss benefits. However, although these products demonstrate efficacy, they have been reported to induce undisclosed side effects, resulting in hospitalizations and surgeries. The lack of adequate warning about these risks has sparked numerous product liability lawsuits, yet no recall has been initiated despite numerous adverse events reported. Individuals prescribed Novo Nordisk’s Ozempic, Wegovy, Rybelsus, or Eli Lilly’s Trulicity and Mounjaro were allegedly not sufficiently informed about potential side effects, including gastroparesis, intestinal obstruction, and other gastrointestinal injuries.

In February a federal panel combined over 72 lawsuits against Novo Nordisk and Eli Lilly into multidistrict litigation (MDL) streamlining the process under one judge and jurisdiction for discovery and motion hearings. Plaintiff attorneys expect to file around 10,000 related lawsuits as part of the MDL. Supporters of multidistrict litigation contend that consolidation streamlines proceedings and prevents conflicting rulings by different judges. The lawsuits allege inadequate warning about severe side effects linked to drugs like Ozempic and Mounjaro, asserting that the seriousness of the side effects were understated, despite the warnings on the labels. Ozempic lawsuits claim that Novo Nordisk didn’t include gastroparesis warnings in its prescription information until September 2023, despite FDA approval in 2017. While other side effects were warned about, the risk of severe gastroparesis wasn’t publicly addressed. Similarly, Mounjaro gained FDA approval in Q2 of 2022, and subsequent use of Mounjaro prescriptions for chronic weight management and cosmetic weight loss showed a rapid incline, but the related extent of side effects were not openly acknowledged. To meet this specific demand, Eli Lilly developed Zepbound, an alternative tirzepatide medication for weight loss, which was FDA-approved in November 2023, and just like Mounjaro, Zepbound also appears to minimally describe the severity of the gastrointestinal-related side effects. 

Two recent studies, published by the BMJ and Frontiers, respectively, reveal concerning associations between GLP-1 receptor agonist drugs like Mounjaro and dangerous side effects, including gastrointestinal problems and adverse psychiatric events, underscoring the need for further understanding of potential risks of these drugs. The complete range of potential side effects associated with these medications remains unknown, and caution appears to have not been thoroughly exercised. 

The Pharma Giants’ Lawsuits Against Compounding Pharmacies

In September 2023, Eli Lilly initiated legal action against numerous compounding pharmacies, accusing them of Federal Food, Drug, and Cosmetic Act (FDCA) violations for selling modified versions of tirzepatide not yet approved by the FDA. Compounded medications are custom-made by pharmacists to meet specific patient needs and are not subject to the same FDA approval process as mass-produced drugs. In June of 2023, Novo Nordisk asserted that certain pharmacies were producing versions of Ozempic and Wegovy without semaglutide, the key active ingredient in GLP-1 drugs. They took legal action against the spas and clinics that failed to inform patients about the use of compounded versions, claiming that some companies are using semaglutide sodium or semaglutide acetate in their knockoffs, which lack proven safety and efficacy. Adverse event reports were received by the agency after patients used these compounded versions. 

The legal offensive of these pharma giants against compounding pharmacies traces back to the companies’ efforts to protect their patented medications, particularly Ozempic and Mounjaro. These moves might be seen as an effort to deflect accountability for the side effects of these GLP-1 medications onto compounding companies, in response to the current lawsuits that both Novo Nordisk and Eli Lilly are on the defensive for. Subsequently, a federal judge in Florida dismissed Lilly’s lawsuit against a Miami compounding pharmacy, asserting that Lilly can’t “use state law as a back door to privately enforce” the FDCA. This ruling closely follows another dismissal by a different Florida judge a few months prior, involving a separate case brought by Lilly against another compounding pharmacy.

Whilst Eli Lilly’s lawsuits have been dismissed, Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of semaglutide treatments Ozempic and Wegovy. Under permanent injunction orders, the sellers will cease using company trademarks and will disclose for 12 months that compounded versions of the drugs lack FDA-approved safety and efficacy standards. The legal actions against Lilly and Novo Nordisk raise doubts about the puzzling origins of these side effects. Despite the producers of GLP-1 medications attributing the adverse effects to compounded products, the timeline of patient reporting and MDL proceedings suggest otherwise.

Navigating the Legal Landscape of Big Pharma

The MDL lawsuits against Novo Nordisk and Eli Lilly have revealed an aspect of turmoil within the weight loss industry. To this end, Novo Nordisk has supported the creation of the MDL while consistently asserting that the claims lacked merit. Conversely, Eli Lilly, involved in a smaller portion of the lawsuits, has resisted inclusion in the MDL. The legal battles between pharmaceutical giants like Eli Lilly and Novo Nordisk and compounding pharmacies highlight the complex landscape surrounding the production and distribution of medications like Mounjaro and Ozempic. Despite efforts to hold compounding pharmacies accountable, the origins of adverse effects remain uncertain, with MDL and ongoing studies underscoring the need for further understanding and caution in the use of GLP-1 receptor agonist drugs.

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