Ozempic and Wegovy Lawsuit: Where the GLP-1 Litigation Stands

Nearly 4,000 lawsuits allege one of the most widely used drug classes in America caused permanent stomach paralysis or sudden vision loss — and not one of them has reached a jury yet. In September 2026, a single hearing will start to answer whether any of them ever will.

Quick answer: Lawsuits allege GLP-1 receptor agonist drugs — Ozempic, Wegovy, Rybelsus, Saxenda (Novo Nordisk) and Mounjaro, Zepbound (Eli Lilly) — caused severe gastroparesis or, in a separate, smaller docket, NAION vision loss, and that the manufacturers’ labels didn’t adequately warn about either risk for years. The gastrointestinal claims are consolidated as MDL No. 3094 (nearly 4,000 cases); the vision-loss claims are a separate proceeding, MDL No. 3163 (86 cases), created in December 2025. No trial, settlement, or bellwether date exists yet. A Rule 702 hearing scheduled for September 10-18, 2026 will decide whether the plaintiffs’ causation experts can even testify — a genuinely pivotal moment for the entire litigation.

What’s Actually Being Alleged

GLP-1 receptor agonists — a class of drugs originally developed for diabetes and increasingly prescribed for weight loss — work partly by slowing gastric emptying, a mechanism that is part of how they’re intended to function. Lawsuits allege that for some patients, this effect goes well beyond the intended, temporary slowing and progresses into gastroparesis — a severe, sometimes permanent condition in which the stomach cannot empty normally — and that the manufacturers knew or should have known about this risk long before their product labels adequately reflected it. A separate, much smaller set of claims alleges the same drugs caused NAION (non-arteritic anterior ischemic optic neuropathy), a form of sudden vision loss caused by reduced blood flow to the optic nerve.

Two Competing Manufacturers, One Consolidated Proceeding

This litigation has an unusual structure worth understanding on its own: it consolidates lawsuits against two direct competitors into the same federal proceeding, because their products share the same drug class and the same core allegation.

• Novo Nordisk — Ozempic, Wegovy, Rybelsus, Saxenda
• Eli Lilly — Mounjaro, Zepbound

All six drugs are GLP-1 receptor agonists, and claims against both companies proceed together in MDL No. 3094, before Judge Karen Spencer Marston in the U.S. District Court for the Eastern District of Pennsylvania — a genuinely different arrangement from most mass torts on this site, which typically involve a single manufacturer or a handful of nearly identical products from related companies rather than two competing drugmakers litigated side by side.

The Label History Behind the Failure-to-Warn Claim

The failure-to-warn theory rests on a label that changed gradually, not all at once — and the timing matters enormously to any individual claim:

• 2017 — Ozempic approved by the FDA with no gastroparesis warning.
• September 2023 — FDA adds a warning for ileus (a related bowel-motility condition), not gastroparesis specifically.
• January 2025 — FDA adds a warning for severe gastrointestinal adverse reactions, more broadly.
• October 2025 — the label is updated to state the drug “is not recommended in patients with severe gastroparesis,” the most direct gastroparesis-specific language added yet.

For NAION, the label cautions generally about vision changes and diabetic retinopathy, but plaintiffs allege it still does not specifically address NAION risk or recommend baseline and ongoing eye examinations for patients starting the drug. Someone diagnosed with gastroparesis or NAION before the relevant warning existed generally has a stronger argument that the label they and their physician actually relied on was inadequate at the time.

Two Separate MDLs, Not One

Unlike most mass torts, this litigation split into two distinct proceedings rather than combining both alleged injuries into one:

• MDL No. 3094 — the gastrointestinal injury docket (gastroparesis, ileus, intestinal obstruction), with nearly 4,000 pending cases.
• MDL No. 3163 — created in December 2025, specifically for NAION vision-loss claims, with 86 pending cases as of this writing.

Both are assigned to the same judge for efficiency, but they are functionally separate litigations with their own case schedules, and the vision-loss docket is meaningfully newer and less developed than the gastrointestinal one.

The September 2026 Hearing That Could Decide a Great Deal

A Rule 702 hearing — sometimes called a Daubert hearing — is scheduled for September 10 through 18, 2026, addressing general causation: whether GLP-1 drugs, as a class, can cause the injuries alleged at all, along with related warnings and preemption arguments. This is exactly the kind of hearing that has proven decisive elsewhere in mass tort litigation — see our guide to the NEC baby formula litigation for a recent example where a federal judge’s exclusion of plaintiffs’ causation experts ended multiple bellwether cases before they ever reached a jury. If the court here excludes the plaintiffs’ causation experts, it could foreclose large portions of this litigation in federal court; if the experts are permitted to testify, the case moves substantially closer to its first real trials. Exclusion isn’t necessarily permanent, either — our guide to the Tylenol autism and ADHD litigation covers a federal appeals court reversing a 2024 expert exclusion in 2026 and reviving a litigation that had already been dismissed entirely.

Where Things Stand

As of this writing: no trial has occurred, no settlement has been reached, and no bellwether trial date has been set. This is normal for a mass tort at this pretrial stage — see our explainer on how mass tort litigation actually works for why years typically pass between an MDL’s formation and its first trial — but it also means anyone evaluating a potential claim right now is doing so before the litigation’s central scientific and legal questions have been resolved by any court.

Practical Steps

1. Identify the exact drug, dosage and treatment dates — since the failure-to-warn theory depends heavily on when you were prescribed the drug relative to the label changes described above.
2. Get a documented diagnosis from the relevant specialist — a gastroenterologist for gastroparesis (often confirmed by a gastric emptying study), or an ophthalmologist for NAION.
3. Confirm which MDL, if either, your specific injury falls under, since gastrointestinal and vision-loss claims proceed on entirely separate tracks.
4. Don’t wait on the September 2026 hearing to consult an attorney, even though its outcome will affect the litigation broadly — your own state’s filing deadline runs independently of the MDL’s own schedule.
5. Don’t change or stop a prescribed medication based on litigation news — that decision belongs with your treating physician.
6. Consult an attorney experienced in pharmaceutical mass tort litigation specifically, given how early-stage and unsettled this particular litigation remains.

Sources & Further Reading

• U.S. District Court, Eastern District of Pennsylvania — docket for MDL No. 3094, In re: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Products Liability Litigation, and MDL No. 3163, the separate NAION proceeding created December 2025, both before Judge Karen Spencer Marston
• U.S. Food and Drug Administration — Ozempic prescribing information and label revision history, including the September 2023 ileus warning, January 2025 gastrointestinal warning, and October 2025 gastroparesis-specific language
• See our guides to how mass tort litigation actually works for what a Rule 702/Daubert hearing generally decides and why years of pretrial process is normal, and the NEC baby formula litigation for a recent, concrete example of causation experts being excluded before a bellwether trial ever reached a jury