Ozempic / GLP-1
OpenFILINGCausation
Plaintiffs allege GLP-1 receptor agonists cause severe gastroparesis (stomach paralysis), bowel obstruction, and pancreatitis. FDA added gastroparesis warning to labels in 2023. Studies show delayed gastric emptying is a known mechanism of GLP-1 drugs, with some patients experiencing permanent gastrointestinal damage.
Defendants
| Entity | Role | Note |
|---|---|---|
| Novo Nordisk | Manufacturer | Ozempic, Wegovy, Rybelsus (semaglutide) |
| Eli Lilly | Manufacturer | Mounjaro, Zepbound (tirzepatide) |
Litigation Timeline
Intelligence Signals
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances
Status: COMPLETED. Phase: NA. Conditions: Gastroparesis. Sponsor: Nils Vlaeminck. Interventions: Point-of-care gastric ultrasound
Status: RECRUITING. Phase: PHASE4. Conditions: Micronutrient Deficiencies. Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt. Interventions: Balance Tablet, Control (placebo)
Status: RECRUITING. Phase: PHASE4. Conditions: Semaglutide-Induced Gastric Motility, Anesthesia. Sponsor: Ain Shams University. Interventions: Itopride HCI 50 mg, Placebo
Status: COMPLETED. Phase: PHASE4. Conditions: Diabetes Mellitus, Type 2, Obesity, Gastroparesis. Sponsor: The Cleveland Clinic. Interventions: GLP-1 medication
Status: RECRUITING. Phase: N/A. Conditions: Full Stomach Status. Sponsor: Hospital Israelita Albert Einstein. Interventions: Ultrasonographic evaluation of gastric content
Abraham R et al.. Journal of neurogastroenterology and motility. 2026 Apr 30.
This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicaid, Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, drug coverage, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas, including the Medicare Drug Price Negotia
Derington CG et al.. JAMA network open. 2025 Oct 1.
Crisafulli S et al.. Annals of internal medicine. 2026 Jan.
Keng C et al.. Cureus. 2025 Dec.
Vlaeminck N et al.. Anaesthesia. 2026 Feb 3.
Triumbari EKA et al.. Clinical nuclear medicine. 2026 Feb 3.
Key Facts
- Status
- active
Geographic Exposure
Eligibility Criteria
- ✓Used Ozempic, Wegovy, Mounjaro, or other GLP-1 drug
- ✓Diagnosed with gastroparesis, bowel obstruction, or severe GI injury
- ✓Injury occurred during or after GLP-1 drug use
- ✓Required hospitalization or surgical intervention