Three Years of Ozempic Use Led to Gastroparesis Diagnosis, Lawsuit Alleges

According to allegations raised in a recently filed product liability lawsuit against the Ozempic manufacturer Novo Nordisk, users and the medical community have not been adequately warned about the severity of gastrointestinal events that may be caused by the medication, which is now used by millions of Americans.

The complaint (PDF) was filed by Robbie Lewis in the U.S. District Court for the Eastern District of Pennsylvania on July 30, indicating that he is one of a rapidly growing number of former users of Ozempic who experienced severe abdominal pain, extreme nausea, vomiting and other complications, which ultimately resulted in a diagnosis of gastroparesis, or stomach paralysis.

Ozempic (semaglutide) was introduced by Novo Nordisk for treatment of type 2 diabetes in December 2017, and has been heavily marketed as a safe medication that also helps users lose weight. As a result of the benefits the drug provides promoting weight loss, it has also 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 Use Concerns

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, that Lewis points out is not mentioned at all on the label or prescribing information.

In October 2023, a study published in the Journal of the American Medical Association (JAMA) found that Ozempic triples the risk of gastroparesis when compared to individuals who received 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.

According to this recent complaint, Lewis, of Florida, was prescribed Ozempic by his doctor and used the injections from July 2020 until January 2023. The lawsuit claims that, as a result of Ozempic use, Lewis suffered gastroparesis, which led to sustained severe and permanent injuries, pain, suffering, emotional distress and medical expenses.

Lewis indicates he suffered severe abdominal pain, extreme nausea, severe vomiting and diarrhea, and needed emergency room treatment and hospitalization due to Ozempic side effects.

The lawsuit claims that Novo Nordisk knew or should have known about the risks of gastroparesis diagnosis for Ozempic users, but hid that knowledge from the public intentionally.

“From the date Novo Nordisk received FDA approval to market Ozempic until the present time, Novo Nordisk made, distributed, marketed, and/or sold Ozempic without adequate warning to Plaintiff’s prescribing physician(s) and/or Plaintiff that Ozempic was causally associated with and/or could cause gastroparesis and its sequelae,” the lawsuit states. “Defendants knew or should have known of the causal association between the use of GLP-1RAs and the risk of developing gastroparesis and its sequelae. Defendants’ actual and constructive knowledge derived from their clinical studies, case reports, and the medical literature, including the medical literature and case reports referenced in this Complaint.”

Lewis’s lawsuit presents claims of strict liability, negligent failure to warn, breach of warranty, fraudulent concealment, fraudulent misrepresentation, negligent misrepresentation, and seeks both compensatory and punitive damages for the injuries he suffered due to Ozempic side effects.

August 2024 Ozempic Lawsuits Update

Given common questions of fact and law raised in complaints similar to the one filed by Lewis throughout the federal court system, 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.

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.