This blog provides an update on the ongoing semaglutide lawsuit, outlining recent legal actions, key medical findings, and other important things to know.

What are semaglutides?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, initially developed to treat type 2 diabetes and reduce the risk of cardiovascular complications. The drug mimics the naturally occurring GLP-1 hormone, which is released from the intestines after a meal to lower blood glucose levels. Because GLP-1 degrades quickly, semaglutide has been modified to last longer in the bloodstream, making it effective as a once-weekly injection. Beyond its original purpose, semaglutide has shown potential as a weight loss treatment, leading to its expanded use among obese patients.

What is the semaglutide lawsuit?

The ongoing lawsuits allege that manufacturers of semaglutide drugs failed to warn patients about severe side effects, including gastroparesis, intestinal blockages, and other gastrointestinal complications. Many of these side effects can require hospitalization and cause long-term medical problems for patients. The first lawsuit, filed on August 2, 2023, centers on claims of inadequate warnings provided by the drug manufacturers.

What injuries have been linked to semaglutide medications?

Injuries linked to semaglutide medications are primarily gastrointestinal, but also include other serious complications. Many of these conditions require hospitalization and ongoing medical care, which can lead to recurring expenses for patients, potentially over a lifetime. Reported injuries include:

  • Gastroparesis
  • Bowel obstruction
  • Persistent vomiting
  • New suicidal thoughts
  • Surgical gallbladder removal
  • Pancreatic cancer
  • Non-arteritic anterior ischemic optic neuropathy (NAION)
  • Deep vein thrombosis (DVT)
  • Death

Who are the defendants in the semaglutide lawsuit?

The main defendants in the lawsuit are Novo Nordisk and Eli Lilly. Novo Nordisk initially developed semaglutide in 2012 and has since expanded its consumer base with the drugs Ozempic, Wegovy, Rybelsus, and Saxenda. Eli Lilly is the sole maker and provider of Mounjaro, another GLP-1 RA drug.

What are the latest updates on the semaglutide lawsuit?

October 2024: FDA Issues Warning and Judge Denies Plaintiffs’ Request
In early October, the FDA issued a warning about the use of unapproved versions of GLP-1 drugs for weight loss. These drugs are sometimes compounded by pharmacies to create customized medications and “can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.”

In a separate development, MDL Judge Marston denied the plaintiffs’ request to compel the defendants to release specific marketing materials early in the case. A key issue is whether Ozempic’s warning labels adequately notified users of the drug’s potential risks and side effects. The plaintiffs argued that the drug’s aggressive and “unprecedented” marketing campaign overshadowed critical safety information on the warning labels, and sought access to marketing materials from specific periods. However, after reviewing arguments from both sides and holding multiple hearings, the judge declined to grant the plaintiffs’ request at this stage of the proceedings.

September 2024: The Role of Marketing Materials in Ozempic Litigation and Safety Warnings
Defendants are opposing the plaintiffs’ request for marketing discovery, claiming it’s unnecessary due to the court’s bifurcation order, which focuses on label adequacy and preemption based solely on the printed label and FDA communications. Plaintiffs argue that marketing materials and promotional content are part of the drug’s “label” under FDA rules, crucial for assessing risks like gastroparesis. They cite legal precedents, including In re Fosamax, which states that a drug’s label includes all prescriber-facing materials. Plaintiffs maintain that without this discovery, the court can’t fully evaluate the adequacy of the warnings.

This dispute over the inclusion of marketing materials is central to evaluating whether Novo Nordisk adequately warned consumers, as highlighted by the recent lawsuit filed by a Kentucky woman who developed gastroparesis after using Ozempic from January to April 2024. The plaintiff alleges that Novo Nordisk failed to warn users about serious gastrointestinal risks, despite being aware of them, and misled consumers by emphasizing weight loss benefits in its marketing. The plaintiff is seeking compensatory and punitive damages, accusing the company of reckless promotion without adequate safety warnings.

In addition, a recent study raised concerns about a possible link between GLP-1 receptor agonists and an increased risk of suicidal thoughts, particularly when combined with antidepressants or benzodiazepines. This research has prompted discussions about the need for an Ozempic suicide warning.

August 2024: Cost-Sharing Protocols and New Study Highlights Increased Risk of Blood Clots
MDL Judge Marston established cost-sharing protocols under Case Management Order Number 17, outlining how plaintiff lawyers must share litigation expenses. This collaboration, involving dozens of law firms, anticipates millions of dollars in costs over several years before cases go to trial. Settlement provisions were also included, allowing plaintiff lawyers to receive a percentage of each settlement.

A recent article in the Endocrine Journal found that people who use semaglutide drugs are at a 266% increased risk of blood clots, including deep vein thrombosis (DVT). Patients with DVT are at risk of pulmonary embolisms, which can be fatal.

July 2024: Predicted Focus on Aggressive Marketing Tactics while New Study Reveals Increased Risk of Vision Loss
A 19-page discovery order, filed on July 31, 2024, outlines the documents Novo Nordisk is required to produce for the lawsuit. Both parties must meet and confer to identify custodians holding relevant information. The focus is expected to center on Novo Nordisk’s marketing practices, particularly due to their aggressive and unconventional tactics in promoting Ozempic. Notably, Judge Marston, with prior experience prosecuting off-label marketing cases, has suggested that this area warrants further investigation.

A Case Management Order also requires plaintiffs in the Ozempic lawsuit to submit a Plaintiff Fact Sheet after filing a complaint. This sheet provides basic information to the defendant and is part of Case Management Order Number 12, filed on July 14, 2024.

A new study published in the Journal of the American Medical Association (JAMA) also highlighted an increased risk of vision loss associated with semaglutide. In a pool of 16,827 patients, those taking semaglutide were found to be over four times more likely to develop Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) compared to those taking other medications. This is a significant finding, as vision loss is not currently a listed side effect of semaglutide drugs.

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