Lawsuit Alleges Novo Nordisk Downplayed Ozempic Gastroparesis Risks

Warning label failed to mention that symptoms of nausea and vomiting could be signs of gastroparesis from Ozempic, increasing the risk of severe injury.

A West Virginia man says Ozempic gastroparesis injuries experienced by himself and a growing number of other users of the popular diabetes and weight loss treatment could have avoided if the manufacturer had come clean about the fact that gastrointestinal side effects may be signs of the more severe stomach paralysis injury.

Ozempic (semaglutide) has become one of the most widely used prescription medications on the market in the United States since it was introduced by Novo Nordisk for treatment of type 2 diabetes in December 2017. As a result of the benefits the drug provides promoting weight loss, it has been widely used off-label as a diet drug.

The medication is part of a new class of drugs, known as glucagon-like peptide-1 receptor agonists (GLP-1 RA), which also includes Wegovy, Mounjaro, Zepbound and Trulicity. The drugs promote weight loss by delaying gastric emptying, which in return, makes users feel fuller for extended periods.

Ozempic Gastroparesis Risks

Although the drug warning label does indicate that some users experience nausea and vomiting, Novo Nordisk failed to adequately disclose that these symptoms may be signs of gastroparesis from Ozempic, which is a much more severe injury with long-term consequences, which was not mentioned at all on the label or prescribing information.

In October 2023, a study found that Ozempic triples the risk of the stomach paralysis among users when compared to users of non-injectable weight loss drugs. The research compared the gastrointestinal side effects of Ozempic and other injectable GLP-1 agonists like liraglutide (Victoza and Saxenda) against those experienced by users of Contrave (bupropion-naltrexone), an oral weight management medication.

The findings indicated that about 1% of Ozempic users developed stomach paralysis, compared to 0.7% of liraglutide users and around 0.3% of those on Contrave. The study highlighted that injectable semaglutide and liraglutide were significantly more likely to cause stomach paralysis and bowel obstruction than Contrave.

As a result of an alleged failure to warn about the severity of these side effects, Novo Nordisk now faces a rapidly growing number of Ozempic lawsuits filed throughout the federal court system, which is ultimately expected to involve tens of thousands of lawsuits that may be brought in the coming months and years, as lawyers continue to review and investigate claims.

A complaint (PDF) filed by Gregory H. Mann on July 15, in the U.S. District Court for the Eastern District of Pennsylvania, alleges that the drugmaker Novo Nordisk intentionally played down Ozempic gastroparesis risks on the labels warning and when representing the drug to federal regulators, in order to increase profits.

Mann, 61, indicates he used Ozempic from March 2021 to May 2023 on instructions from his physician. As, a result, Mann indicates that he experienced several gastrointestinal side effects,including nausea, vomiting and diarrhea, which were later diagnosed as a gastroparesis injury, the lawsuit claims.

While the warning label lists some of the symptoms of gastroparesis, such as nausea and vomiting, as common adverse reactions, it fails to include these in the “Warnings and Precautions” section, and never warned the patient, or medical community, that these could be signs of a more serious condition.

“Defendants acknowledge that gastrointestinal events are well known side effects of the GLP-1RA class of drugs,” Mann’s lawsuit states. “However, Defendants have downplayed the severity of the gastrointestinal events caused by their GLP-1RAs, never, for example, warning of the risk of gastroparesis (paralyzed stomach) and its sequalae.”

Mann presents claims of failure to warn and strict products liability, and seeks both compensatory and punitive damages.

July 2024 Ozempic Gastroparesis Lawsuit Update

Given common questions of fact and law raised in complaints like Mann’s, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Ozempic and other GLP-1 lawsuits earlier this year, transferring complaints filed throughout the federal court system to U.S. District Judge Gene E. K. Pratter in the U.S. District Court for the Eastern District of Pennsylvania. However, Judge Pratter passed away of May 17, and the litigation was just recently reassigned to District Judge Karen S. Marston.

In a pretrial order issued on July 14, Judge Marson authorized the direct filing of new Ozempic lawsuits in the federal MDL, which will avoid delays associated with transferring claims from various different federal district courts nationwide.

As the litigation continues to grow, it is expected that the Court will establish a bellwether program, by working with plaintiffs and defendants to determine what Ozempic lawsuits are representative of the greater litigation, and then sending them through case-specific fact discovery before scheduling a series of early test trials, which will help the parties gauge how juries may respond to certain evidence and testimony that would be repeated in potentially hundreds of trials.

Following coordinated discovery and any early bellwether cases, if the parties are unable to negotiate Ozempic gastroparesis settlements or another resolution for the litigation, Judge Marston may later remand each claim back to the U.S. District Court where it was originally filed for trial.