GLP-1 receptor agonist drugs — including Novo Nordisk's Ozempic, Wegovy, and Rybelsus, and Eli Lilly's Mounjaro and Zepbound — have generated over $40 billion in annual sales while allegedly causing severe gastrointestinal injuries that manufacturers failed to adequately disclose. Over 3,100 lawsuits are consolidated in MDL 3094 in the Eastern District of Pennsylvania, with a separate NAION vision-loss MDL (3163) established in December 2025.
JPML establishes MDL 3163 for NAION vision-loss claims against Novo Nordisk. Approximately 29 cases consolidated with rapid growth expected. Expert discovery ongoing in the GI MDL; bellwether trials expected mid-2026.
filingMDL judge rules that gastroparesis plaintiffs must have a properly performed gastric emptying study confirming delayed emptying at time of diagnosis. May narrow plaintiff pool but strengthens remaining cases.
filingFDA updates Ozempic label to state drug is "not recommended in patients with severe gastroparesis" and adds intestinal obstruction warning — the first explicit gastroparesis language on the label.
regulatoryJAMA Ophthalmology study finds semaglutide users face dramatically elevated NAION risk (8.9% vs 1.8% in diabetic patients). EMA requires European label update in August 2024; Novo Nordisk does not update U.S. labels.
scientificThe JPML consolidates GLP-1 GI injury cases into MDL 3094 in the Eastern District of Pennsylvania before Judge Karen S. Marston. Thousands of cases are transferred.
filingSodhi et al. publish landmark JAMA study finding GLP-1 agonists associated with 3.67x gastroparesis risk, 4.22x bowel obstruction risk, and 9.09x pancreatitis risk among weight-loss patients. Triggers wave of lawsuits.
scientificFDA updates Ozempic labeling to add ileus as a post-marketing adverse reaction. This is the first official acknowledgment of severe GI motility effects beyond nausea and vomiting.
regulatoryEli Lilly's Mounjaro (tirzepatide) approved for type 2 diabetes. Later approved as Zepbound for weight loss in November 2023. The dual GIP/GLP-1 agonist produces even greater weight loss than semaglutide.
product-launchFDA approves higher-dose semaglutide (Wegovy 2.4mg) for chronic weight management. Sales explode as social media drives demand for the "skinny shot." Off-label Ozempic prescriptions for weight loss also surge.
product-launchFDA approves semaglutide injection (Ozempic) for type 2 diabetes. Label includes thyroid cancer Black Box Warning and GI side effects but does not name gastroparesis.
product-launchTakeda's Actos bladder cancer MDL produced a $9 billion jury verdict (later reduced) — a comparable pharmaceutical failure-to-warn case involving a diabetes drug with cancer risks the manufacturer concealed.
Merck's Vioxx global settlement of $4.85 billion for cardiovascular injuries from a drug with suppressed safety data — the gold standard comparable for pharmaceutical failure-to-warn mass tort settlements.
Bayer/J&J settled Xarelto GI bleeding claims for $775 million — a comparable pharmaceutical MDL involving GI side effects of a blockbuster drug.
PPI kidney injury settlements averaged $300,000 per claim — a comparable pharmaceutical GI drug mass tort. GLP-1 gastroparesis claims are expected to settle in a similar or higher range.
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