Ozempic Lawsuits: Where the Two Federal MDLs Stand in 2026

The Ozempic lawsuits are product-liability claims against Novo Nordisk and Eli Lilly alleging that GLP-1 drugs caused serious injuries the labels did not adequately warn about. They sit in two separate federal multidistrict litigations (MDLs) before the same judge, Karen S. Marston of the Eastern District of Pennsylvania. MDL 3094 covers gastrointestinal injuries — mostly gastroparesis (stomach paralysis), plus ileus and gallbladder injuries — and held 4,022 pending cases out of 4,056 total filed as of the Judicial Panel on Multidistrict Litigation’s September 1, 2026 report ^[1]. MDL 3163 covers vision loss from non-arteritic anterior ischemic optic neuropathy (NAION) and held 216 pending cases, also as of September 1, 2026 ^[1]. No settlements have been announced in either docket as of September 2026 ^[2][10]. All injury claims remain allegations; none has been proven at trial.

Here is how the two dockets compare:

	MDL 3094 (GI injuries)	MDL 3163 (NAION vision loss)
Pending actions (Sept 1, 2026)	4,022 [1]	216 [1]
Total actions filed	4,056 [1]	216 [1]
Created	February 2024 [2]	December 15, 2025 [13]
Presiding judge	Karen S. Marston [1]	Karen S. Marston [1]
Main alleged injuries	Gastroparesis, ileus, gallbladder [2]	NAION, sudden vision loss [13]
Settlements announced	None [2][10]	None [2][10]

What is an MDL, and what is a bellwether trial?

An MDL groups lawsuits sharing common facts so one judge can handle pretrial work for all of them. The JPML said centralizing the GLP-1 cases serves the convenience of the parties and witnesses, eliminates duplicative discovery, and avoids inconsistent pretrial rulings on issues such as preemption and expert admissibility ^[13].

A bellwether trial is a representative case tried early so both sides can see how a jury responds to the evidence. Bellwether outcomes are not binding on other claims ^[9]. If the cases do not settle, each one goes back to the district where it was originally filed for its own trial ^[9].

What is MDL 3094 about, and who is being sued?

MDL 3094 was created by the JPML in February 2024 and was first assigned to Judge Pratter; it is now before Judge Marston ^[2]. The defendants are Novo Nordisk (maker of Ozempic, Wegovy, Rybelsus, Victoza and Saxenda) and Eli Lilly (maker of Mounjaro, Zepbound and Trulicity) ^[2][10].

The core allegation is failure to warn — that the manufacturers knew or should have known about the risks and made misleading or incomplete safety representations ^[10]. Per one tracker’s breakdown, about 75% of complaints allege gastroparesis, about 18% allege ileus, and about 8% allege gallbladder injuries ^[2]. The first stomach paralysis lawsuit was filed on August 2, 2023 by a Louisiana plaintiff ^[10][12].

What did the August 15, 2025 gastroparesis ruling decide?

Judge Marston had directed the parties to prioritize three cross-cutting issues: whether the claims are preempted by federal law, whether plaintiffs need specific diagnostic testing, and whether there is sufficient general causation evidence linking the drugs to the injuries ^[9].

On August 15, 2025, she ruled on the diagnostic question: any plaintiff claiming gastroparesis must show the diagnosis was based on a properly performed gastric emptying study — scintigraphy, a breath test, or a wireless motility capsule ^[14]. The same order granted defense motions to exclude the opinions of two plaintiffs’ experts, Drs. Raines and Siegel, on that issue ^[14]. Also on August 15, 2025, the court granted the defense motion to dismiss in part and denied it in part, and allowed plaintiffs to file an amended master complaint ^[14].

Where does MDL 3094 stand as of September 2026?

The docket has grown fast: 1,331 cases were pending in January 2025, 2,947 in December 2025, and 4,022 by September 2026 ^[2]. Case Management Order 29, issued December 16, 2025, set the 2026 schedule for the remaining causation and preemption issues ^[9]. Expert depositions were to be completed by April 10, motions to exclude expert opinions were due April 28, and summary judgment motions were due April 30, 2026 ^[9]. Reply briefs on summary judgment were due July 24, 2026, and the summary judgment process was still playing out in late August 2026 ^[9][10].

A litigation tracker expects the first bellwether trials possibly in late 2026 and considers a mass settlement unlikely before late 2027 ^[2]. Those are tracker expectations, not court-set dates.

What does the Ozempic label say about stomach risks?

The label states the mechanism plainly: “Semaglutide causes a delay of early postprandial gastric emptying” ^[6]. Section 5.7, Severe Gastrointestinal Adverse Reactions, appears on the label’s recent-major-changes list with a date of 10/2025 ^[6][2]. It says Ozempic is not recommended in patients with severe gastroparesis ^[6][2]. In clinical trials, severe gastrointestinal reactions were reported by 0.4% of patients on the 0.5 mg dose and 0.8% on the 1 mg dose, versus 0% on placebo ^[6].

The postmarketing section lists ileus, intestinal obstruction, and severe constipation including fecal impaction, and notes that because these reports are voluntary, frequency cannot be reliably estimated and causality is not established ^[6]. Ileus was added to the Ozempic label in September 2023 based on postmarketing reports; the Mounjaro label added ileus in July 2023 ^[12].

Delayed gastric emptying is how the drug works — an intended effect described on the label ^[2][6]. Plaintiffs argue the labels did not adequately warn that this effect could persist or progress to severe, persistent gastroparesis ^[2].

What does the JAMA 2023 study behind the gastroparesis claims show?

The study often cited in the litigation is a 2023 research letter in JAMA by Sodhi et al. It followed 613 semaglutide users, 4,144 liraglutide users, and 654 bupropion-naltrexone users; everyone had an obesity diagnosis code, and people with diabetes were excluded ^[5]. Gastroparesis rates per 1,000 person-years were 9.1 for semaglutide, 7.3 for liraglutide, and 3.1 for bupropion-naltrexone ^[5].

The adjusted hazard ratios compare GLP-1 agonists combined (semaglutide plus liraglutide) against bupropion-naltrexone — not semaglutide alone ^[5]:

Outcome	Adjusted HR, GLP-1 agonists vs bupropion-naltrexone	95% CI
Gastroparesis	3.67	1.15–11.90 [5]
Bowel obstruction	4.22	1.02–17.40 [5]
Pancreatitis	9.09	1.25–66.00 [5]
Biliary disease	1.50	0.89–2.53 [5]

The study has real limits. The semaglutide arm was small — 613 users with a median follow-up of 0.6 years, only 4 gastroparesis events, and 0 bowel obstruction events ^[5]. The confidence intervals are wide; for pancreatitis it runs from 1.25 to 66.00 ^[5]. The biliary disease interval crosses 1, meaning that result is not statistically significant, and outcomes were identified by ICD-9 or ICD-10 diagnosis codes recorded in a health claims database ^[5].

The defense has also raised federal preemption and the reliability of plaintiffs’ general causation experts — the cross-cutting issues Judge Marston directed the parties to address ^[9] — and the summary judgment process was still playing out in late August 2026 ^[10].

What is the FDA warning letter to Novo Nordisk about?

On March 5, 2026, the FDA sent Novo Nordisk a warning letter following an inspection from January 13 to February 7, 2025 at Novo Nordisk Inc. ^[15][11]. The letter concerns adverse-event reporting procedures, not any conclusion that a drug caused an injury. The FDA found that the company’s written procedures allowed adverse events judged “unrelated” by the reporter to be rejected and not reported, contrary to the rule requiring serious, unexpected events to be reported within 15 calendar days ^[15].

Examples in the letter include a death report in a semaglutide patient that was invalidated over a missing patient identifier the FDA later found in source documents, a suicide report that was not investigated, and a stroke report in a liraglutide patient that was rejected because the patient said it was unrelated to the drug ^[15][11]. The FDA called Novo’s corrective response inadequate and gave the company 15 business days to respond ^[11]. Novo Nordisk said the letter concerns regulatory compliance and makes no conclusions about the quality or safety of its medicines ^[11].

What is MDL 3163, the vision-loss MDL?

The JPML created MDL 3163 by transfer order dated December 15, 2025, starting with 21 actions pending in three districts plus nine related potential tag-along actions ^[13]. The named products are Ozempic, Wegovy, Saxenda and Trulicity, and the claims include failure to warn, design defect, and breach of warranties ^[13].

Eli Lilly had asked to fold the NAION cases into MDL 3094, while plaintiffs wanted the District of New Jersey ^[13]. The panel cited substantial overlap — the same defendants, largely the same counsel, and some plaintiffs alleging both GI injuries and NAION — in assigning the docket to Judge Marston, but kept it separate to make case tracking easier and to let the judge set the level of coordination between the two proceedings ^[13].

The docket has grown from 21 cases in December 2025 to 86 in May 2026 and 216 by September 2026 ^[3]. A Science Day — non-adversarial scientific presentations from both sides — was scheduled for June 2, 2026 ^[3]. A special master for discovery was appointed by August 2026, and the litigation is still in its early stages ^[10]. In parallel, New Jersey granted a multicounty litigation in November 2025 and appointed leadership for both sides in June 2026 ^[3][10]. Per a tracker, the FDA had added no NAION warning to US GLP-1 labels as of September 2026 ^[3].

What is NAION, and what does the evidence show?

NAION is a loss of blood flow to the front of the optic nerve. It causes sudden, painless vision loss, often noticed on waking, usually in one eye; the second eye is affected in 15–25% of cases over five years ^[3][4]. The vision loss is usually permanent, and there is no proven treatment ^[3][4].

The study that sparked the litigation was published in JAMA Ophthalmology in July 2024 by Hathaway et al. at Mass Eye and Ear. Among 16,827 patients, the study found semaglutide patients experienced NAION at more than four times the rate of other medications in patients with type 2 diabetes (4.28 times higher, with cumulative incidence of 8.9% versus 1.8%) and more than seven times the rate in patients taking it for weight loss (7.64 times higher, with cumulative incidence of 6.7% versus 0.8%) ^[3].

In Europe, the EMA’s safety committee concluded on June 6, 2025 that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people taking it ^[7]. The EMA said large studies suggest roughly a two-fold risk increase in adults with type 2 diabetes, corresponding to about one extra case per 10,000 person-years of treatment, and recommended updating the product information and stopping semaglutide if NAION is confirmed ^[7].

What did the US veterans study find?

A study of 102,361 US veterans with type 2 diabetes compared 11,478 who started semaglutide with 90,883 who started an SGLT2 inhibitor ^[8]. Over a maximum of 7.5 years, 173 NAION events occurred — 30 in the semaglutide group and 143 in the SGLT2i group, or 123 versus 67 per 100,000 person-years ^[8].

The overlap-weighted hazard ratio was 2.33 (95% CI, 1.54–3.54). Over a median of 2.1 years, the weighted risk was 0.29% for semaglutide initiators versus 0.13% for SGLT2i initiators — a difference of 0.16 percentage points ^[8]. The authors wrote that while the absolute risk is low, counseling patients about this potential complication may be warranted ^[8].

What settlement figures are being advertised?

Some law firm estimates cited by Drugwatch put typical settlement payouts at $400,000 to $700,000, with lower estimates around $250,000 and some as high as $1 million ^[10]. Drugwatch describes these figures as speculative, and no global settlement has been announced as of September 2026 ^[10]. A litigation tracker reports an analyst estimate that combined liability across both MDLs could exceed $2 billion ^[2]. None of these numbers comes from the court or from any actual settlement.

Does the litigation cover compounded semaglutide?

The MDLs focus on brand-name products from Novo Nordisk and Eli Lilly ^[2]. Compounded semaglutide is a separate issue. On March 3, 2026, the FDA announced 30 warning letters to telehealth companies over misleading claims about compounded GLP-1 products, including claims implying sameness with FDA-approved drugs ^[16]. Compounded drugs are not FDA-approved and are not the same as generics, which are FDA-approved ^[16].

Sources

1. United States Judicial Panel on Multidistrict Litigation. MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending. September 1, 2026.
2. MDL Update. Ozempic & Wegovy Lawsuit: Gastroparesis Claims | MDL-3094. September 1, 2026.
3. MDL Update. Ozempic Vision Loss Lawsuit | MDL-3163. September 1, 2026.
4. Levin Law. Federal Court Creates New MDL for Ozempic and Other GLP-1 Drugs Linked to Vision Loss (NAION). December 17, 2025.
5. JAMA. Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss.
6. National Library of Medicine DailyMed. OZEMPIC - semaglutide injection, solution.
7. European Medicines Agency. PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy.
8. JAMA Ophthalmology. New-Onset Nonarteritic Anterior Ischemic Optic Neuropathy and Initiators of Semaglutide in US Veterans With Type 2 Diabetes.
9. AboutLawsuits.com. Link Between Gastroparesis and Ozempic, Other GLP-1 Medications To Be Reviewed by MDL Court in 2026.
10. Drugwatch. Ozempic Lawsuit: September 2026 Blindness and Gastroparesis Claims.
11. Healio. FDA issues warning letter to Novo Nordisk for improper reporting of GLP-1 adverse events.
12. MedPage Today. FDA Adds Intestinal Blockage Reports to Ozempic Labeling. September 28, 2023.
13. United States Judicial Panel on Multidistrict Litigation. In re: GLP-1 RAs Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation, MDL No. 3163 Transfer Order. December 15, 2025.
14. govinfo. 24-3094 - Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation, Document in Context.
15. US Food and Drug Administration. Novo Nordisk Inc. Warning Letter 717576. March 5, 2026.
16. US Food and Drug Administration. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s.