Ozempic and Mounjaro injury lawsuits pass 4,000 cases with no trial date set
The GLP-1 stomach-injury litigation keeps growing past 4,000 cases, but the first trials and any settlements are still months or years away.
The federal litigation combining lawsuits over gastrointestinal injuries tied to GLP-1 medications has passed 4,000 pending cases, according to a litigation tracker's September 2026 update. The tracker counts 4,022 pending cases in MDL 3094, with 4,056 actions filed in total [1]. That is up from 3,928 in the Judicial Panel on Multidistrict Litigation's August 1, 2026 statistics report [1]. No trial date has been set.
The case is before Judge Karen S. Marston in the Eastern District of Pennsylvania and was created in February 2024 [1]. The tracker says the docket has grown 202% since January 2025, when it counted 1,331 pending cases, and that it continues to add hundreds of new filings each month [1].
The tracker says about 75% of complaints allege gastroparesis, also called stomach paralysis, 18% allege ileus, and 8% allege gallbladder injuries [1]. The lawsuits name Ozempic, Wegovy and Rybelsus (semaglutide, made by Novo Nordisk) and Mounjaro, Zepbound and Trulicity (made by Eli Lilly) [1]. Drugwatch reports that the pending cases cover Ozempic, Wegovy, Rybelsus, Mounjaro and Trulicity [2]. Mounjaro's active ingredient, tirzepatide, is a dual GIP/GLP-1 receptor agonist rather than a pure GLP-1 drug [1].
Plaintiffs argue the labels did not adequately warn that delayed stomach emptying — an intended effect of these drugs — could persist or progress to severe gastroparesis and intestinal blockages [1]. In October 2025, the FDA added language to the Ozempic label stating it "is not recommended in patients with severe gastroparesis" [1]. An earlier label update in 2023 added an ileus warning after the FDA received 33 blockage reports from semaglutide users, along with two deaths, according to Drugwatch [2].
An October 2023 research letter in JAMA, cited by both outlets, reported higher rates of gastrointestinal events among people using GLP-1 drugs for weight loss: 9.09 times the risk of pancreatitis, 4.22 times the risk of bowel obstruction and 3.67 times the risk of gastroparesis compared with people taking a different weight-loss drug [1]. Drugwatch describes the same study as finding gastroparesis risk three to four times higher and pancreatitis risk about nine times higher [2].
In August 2025, Judge Marston issued a 78-page ruling on how gastroparesis must be diagnosed in these cases, requiring objective diagnostic testing [1]. A Daubert deadline for challenges to expert testimony passed on April 28, 2026, and summary judgment briefing continued through July 2026 [1]. Bellwether trial selection is still tied to the outcome of those expert evidence rulings [1]. The tracker says first trials are possible in late 2026 but that mass settlements are considered unlikely before late 2027 [1]. No settlements, trials or verdicts have been announced [1][2].
A separate case, MDL 3163, handles vision-loss claims involving NAION, a form of sudden optic nerve damage. It was created in December 2025, has about 200 cases, and is also assigned to Judge Marston [1]. Legal analysts estimate total liability across both proceedings could exceed $2 billion [1].
Why it matters for patients
The litigation does not change what these drugs are approved for or what their labels currently say. It tracks serious gastrointestinal injuries that patients have reported and that courts are now sorting through case by case.
How a claim is evaluated depends heavily on medical records. Judge Marston's August 2025 ruling requires objective diagnostic testing for gastroparesis claims, and the National Institute of Diabetes and Digestive and Kidney Diseases defines diagnosis as a gastric emptying study showing more than 10% retention at four hours [1].
Most digestive side effects reported in trials were common and unpleasant rather than rare and severe. At the 1 mg Ozempic dose, Drugwatch lists nausea in 20.3% of patients, vomiting in 9.2%, diarrhea in 8.8%, abdominal pain in 5.7% and constipation in 3.1%, and lists symptoms such as persistent stomach pain, uncontrolled vomiting or vision changes as reasons to seek immediate care [2].
Because no settlement has been announced [1][2], anyone contacted about an active payout from these proceedings is ahead of the court record. Nothing about the case count tells an individual patient whether their own situation would qualify as a claim.
What happens next
The near-term milestone is the set of rulings on expert evidence, which the tracker says gates bellwether trial selection [1]. A trial date has not been reported. Summary judgment briefing ran through July 2026 [1]. If trials do begin, they would likely start in late 2026 at the earliest, with any broad settlement unlikely before late 2027 [1].
Sources
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