Mounjaro Lawsuit Claims Lack of Label Warnings Led to Gastroparesis Injuries

Side effects of Mounjaro caused cyclical vomiting that required emergency medical treatment, lawsuit claims.

An Alabama woman has filed a lawsuit against Eli Lilly, claiming that the drug maker has failed to adequately warn patients and the medical community about the risk that Mounjaro may cause severe gastroparesis, or stomach paralysis.

The complaint (PDF) was brought by Karen Stacey on September 13 in the U.S. District Court for the Eastern District of Pennsylvania, joining a growing number of complaints filed over gastrointestinal problems linked to Mounjaro (tirzepatide) and similar drugs, which belong to a popular new class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists.

Mounjaro is approved for treatment of type-2 diabetes, and has been marketed as a direct competitor to the blockbuster treatment Ozempic, which is another GLP-1. Both drugs work by delaying gastric emptying, which has also been shown to promote weight loss among users, leading to the widespread use of the medications as diet drugs in recent years.

Although the medications have been promoted as safe and effective, with few serious side effects disclosed on the drug label, hundreds of consumers are now pursuing Mounjaro gastroparesis lawsuits and Ozempic lawsuits, indicating that the manufacturers placed a desire for profits before consumer safety by minimizing the risk of severe gastroparesis injuries.

Stacey, 46, indicates that she used Mounjaro from August 2022 until April 2023, as prescribed by her physician.

During that time Stacey developed gastrointestinal injuries, including gastroparesis, which led to constant nausea, extreme constipation, malnutrition and cyclical vomiting so severe that she required emergency medical treatment.

“The Prescribing Information for Mounjaro discloses ‘Warnings and Precautions’ and ‘Adverse Reactions’ but does not adequately warn of the risk of gastroparesis and its sequelae like cyclical vomiting and delayed emptying lasting a year,” Stacey’s lawsuit states. “The Mounjaro label lists nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain as common adverse reactions, but it does not indicate a severity of symptoms. Even though the label warns about the risk of severe gastrointestinal disease, gastroparesis is not specifically mentioned.”

Stacey presents claims of failure to warn, breach of warranty, fraudulent concealment, fraudulent misrepresentation, and seeks both compensatory and punitive damages.

September 2024 Mounjaro Lawsuits Update

There are currently more than 800 product liability lawsuits filed against Eli Lilly and other manufacturers of GLP-1 medications throughout the federal court system, which are all centralized before Judge Karen S. Marston in the Eastern District of Pennsylvania for coordinated pretrial proceedings.

As part of the management of the MDL, Judge Marston has indicated that before any individual cases are prepared for trial, the Court will address a number of “cross cutting” issues that are likely to impact large numbers of claims. Therefore, early discovery and motions will focus on addressing whether the claims are preempted by federal law, and whether plaintiffs must provide specific diagnostic testing to establish their gastroparesis injury.

The court is then expected to establish a bellwether program, where the parties will select a small group of representative claims that will go through case-specific discovery and be prepared for the first federal trial dates. While the outcomes in these claims will not be binding on other claimants, the average lawsuit payouts may impact the amount of Ozempic and Mounjaro settlements the drug makers may later need to offer to avoid the need for each individual case to go before separate juries in future years.