Gastric Emptying Study Will Be Required in Ozempic Gastroparesis Lawsuits: MDL Order

Court indicates most cases will survive the ruling, as many plaintiffs suffer long-term stomach paralysis from Ozempic or other GLP-1s, and can still be tested.

The U.S. District Judge presiding over all federal Ozempic lawsuits, Wegovy lawsuits, Mounjaro lawsuits and other claims involving side effects of GLP-1 medications has issued a critical ruling clearing the litigation to move forward, as long as plaintiffs diagnosed with gastroparesis are able to provide evidence of a gastric emptying study to support their diagnosis.

Novo Nordisk and Eli Lilly face more than 2,400 product liability lawsuits brought throughout the federal court system over the past few years, each indicating that the manufacturers failed to provide adequate warning that the diabetes and weight loss drugs could cause severe gastrointestinal problems, including gastroparesis, bowel obstructions and other painful side effects.

The medications at issue in the litigation all belong to a popular new class of drugs, known as glucagon-like peptide-1 (GLP-1) receptor agonists, which also includes Victoza, Rybelsus and Trulicity.

While the drugs were originally developed to treat type 2 diabetes, use of the treatments has exploded in popularity over the past few years, due to their weight loss benefits. However, a growing number of users are now filing lawsuits against the drug makers, alleging that they withheld critical safety information and warnings, particularly about the risk that users may be left with devastating stomach paralysis injuries.

Given common questions of fact and law raised in complaints filed in U.S. District Courts nationwide, all Ozempic gastroparesis lawsuits have been centralized into a multidistrict litigation (MDL) in the Eastern District of Pennsylvania, where U.S. District Judge Karen Marston is overseeing pretrial proceedings, coordinated discovery, and plan to prepare a group of representative claims to serve as early test “bellwether” trials.

These trials will allow both sides and the court to see how juries will respond to evidence and testimony likely to be repeated throughout the litigation. However, before scheduling those bellwether trials, Judge Marston required the parties to address certain “cross-cutting” issues, which would have widespread implications on the litigation.

Early in the litigation, the parties were directed to prioritize discovery and motions on three key issues, including whether claims are preempted by federal law, whether plaintiffs are required to present specific diagnostic testing evidence and whether there is sufficient general causation evidence linking Ozempic and the gastrointestinal injuries.

Ozempic Lawsuits Require Gastric Study

Judge Marston decided the issue of diagnostic testing in a court order (PDF) issued on August 15, indicating all plaintiffs pursuing a gastroparesis lawsuit against the makers of Ozempic or other GLP-1 medications must have their gastroparesis verified through a gastric emptying study.

Plaintiffs had argued that there were additional ways to diagnose stomach paralysis, and that the requirement was too restrictive, as many doctors probably diagnosed the condition without requiring one of those methods.

However, in an accompanying memorandum (PDF) explaining her decision, the judge said she did not believe the ruling would have a large effect on the litigation, as most of the injuries reported are persistent gastroparesis, which could still be diagnosed through a scintigraphy, breath test, or wireless motility capsule (WMC). Therefore, she has granted plaintiffs leave to file amended complaints once they have undergone the proper testing.

“[T]he Court recognizes that given this ruling, some Plaintiffs in this MDL will be unable to prove that they suffered from gastroparesis because their diagnosis was not based on a properly performed gastric emptying study. Although unfortunate, it would be perhaps more unjust to hold Defendants potentially liable for damages based on an unreliable diagnosis.”

— U.S. District Judge Karen Marston

Once the other cross-cutting issues have been resolved, the Court is expected to move forward in scheduling those early bellwether trials. While the outcomes of those early test trials will not be binding on other GLP-1 lawsuits, they will be closely watched and may help the parties negotiate Ozempic gastroparesis settlements to resolve a large number of claims in the future.

If the cases have not been resolved following the bellwether trials, Judge Marston would then likely remand the claims back to their courts of origin in preparation for individual trial dates.