GLP-1 NAION Lawsuits: What MDL 3163 Shows

Non-arteritic anterior ischemic optic neuropathy, or NAION, is an eye condition that may cause loss of vision. Federal lawsuits alleging that GLP-1 receptor agonist medicines caused NAION are consolidated as MDL No. 3163 in the Eastern District of Pennsylvania before Judge Karen S. Marston. The Judicial Panel on Multidistrict Litigation created the docket on December 15, 2025 with 21 actions from three districts and reported 247 actions pending as of October 1, 2026. The documents reviewed for this article contain no trial verdict, no approved settlement and no court finding that any GLP-1 medicine caused a plaintiff’s NAION.

What MDL 3163 covers

The Panel’s transfer order states that the litigation “consists of 21 actions pending in three districts,” in the District of New Jersey, the Eastern District of Pennsylvania and the Northern District of Texas. It describes the claims this way: plaintiffs allege that their use of Eli Lilly’s or Novo Nordisk’s GLP-1 RA drugs, “specifically, Ozempic, Wegovy, Saxenda, and Trulicity,” caused them to suffer from NAION.

The order says the actions involve common questions of fact about the development, manufacture, testing, regulatory history, promotion and labeling of the products, and about their capacity to cause NAION. It records that plaintiffs bring substantially identical claims for failure to warn, design defect and breach of warranties. Centralization under 28 U.S.C. section 1407 sends the cases to one judge for coordinated pretrial proceedings. It does not decide the merits of any claim.

The Panel’s October 1, 2026 statistics report lists 247 actions pending in MDL 3163 and 247 filed in total. That is an increase from the 21 actions named in the transfer order. The report also lists a separate proceeding, MDL No. 3094, with 4,025 actions pending, also in the Eastern District of Pennsylvania before Judge Marston. The two dockets are distinct. MDL 3094 covers other products liability claims involving the same drug class; the analysis in this article is limited to MDL 3163 and the NAION claims.

What is established versus what is alleged

Established by the documents reviewed here: the Panel created MDL 3163 on December 15, 2025; the transferee court is the Eastern District of Pennsylvania; Judge Marston presides; the docket had 247 pending actions as of October 1, 2026; and the transfer order identifies Ozempic, Wegovy, Saxenda and Trulicity as the products named in the actions.

Established as a regulatory action, outside the United States: in June 2025 the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that NAION is a very rare side effect of semaglutide, the active substance in Ozempic, Rybelsus and Wegovy. The committee put the frequency at up to 1 in 10,000 people taking semaglutide. It reported that several large epidemiological studies suggest an approximately two-fold increase in the risk of developing NAION for adults with type 2 diabetes exposed to semaglutide, corresponding to about one additional case per 10,000 person-years of treatment.

Alleged, and not decided: that any GLP-1 medicine caused an individual plaintiff’s NAION; that the manufacturers failed to warn patients and prescribers adequately; that the products were defectively designed; and that the manufacturers breached warranties. Those are the claims asserted in the pleadings. A regulatory conclusion by an EU committee is not a finding by a US court, and it does not bind the MDL.

The scope point matters. The EMA review concerned semaglutide. The transfer order names four products and two manufacturers. The documents reviewed here do not show that the EMA reviewed every medicine named in the order, and they do not show a US agency conclusion that any of those medicines causes NAION.

What the US labels say

The prescribing information retrieved for this article does not list NAION. The Ozempic label record effective January 30, 2026 lists diabetic retinopathy complications as a warning at section 5.3 and does not contain the term NAION. The Mounjaro label record effective August 27, 2026 lists diabetic retinopathy complications at section 5.7 and does not contain the term. The Zepbound label record effective August 28, 2026 lists diabetic retinopathy complications at section 5.8 and does not contain the term.

Those records show what the FDA-approved labeling said on those dates. They do not show that the FDA examined the NAION question and rejected a warning, and they do not resolve whether any medicine caused an individual’s injury. A label can omit a risk that later evidence establishes, and a label warning does not by itself prove causation. The EMA’s 2025 conclusion is a regulatory assessment based on non-clinical studies, clinical trials, post-marketing surveillance and medical literature; it is not a US court judgment.

Key dates

• June 2-5, 2025: the EMA’s Pharmacovigilance Risk Assessment Committee meets and concludes that NAION is a very rare side effect of semaglutide medicines.
• December 15, 2025: the Judicial Panel on Multidistrict Litigation files the transfer order creating MDL No. 3163, covering 21 actions from three districts, and assigns it to Judge Karen S. Marston in the Eastern District of Pennsylvania.
• January 30, 2026: the Ozempic label record retrieved for this article takes effect; it lists diabetic retinopathy complications but not NAION.
• August 27 and 28, 2026: the Mounjaro and Zepbound label records retrieved for this article take effect; neither contains the term NAION.
• October 1, 2026: the Panel’s statistics report lists 247 actions pending in MDL No. 3163 and 247 filed in total.

Where the claims stand procedurally

MDL 3163 is in pretrial proceedings before Judge Marston. The Panel’s report lists every action filed in the docket as still pending, which means no action in the docket had been terminated as of October 1, 2026. The transfer order and the report contain no trial date, no bellwether trial selection, no verdict and no settlement.

A multidistrict proceeding is not a class action. Each plaintiff keeps an individual case, and common pretrial issues are coordinated. A nationwide resolution would require its own court-approved settlement or a series of individual resolutions. Background on that distinction appears in the guide to MDLs and class actions, alongside the pharmaceutical lawsuits section and the related article on the GLP-1 gastrointestinal-injury litigation.

What this does not establish

Nothing in the documents reviewed shows that a court has determined that Ozempic, Wegovy, Saxenda, Trulicity or any other GLP-1 medicine caused a plaintiff’s NAION. The transfer order decides where the cases will be heard, not who should win.

Nothing in the documents reviewed shows an approved settlement, a verdict or a compensation fund for these claims. The fact that a docket exists does not mean that any claim has value or that any reader is eligible for compensation.

The EMA’s conclusion is a regulatory action in the European Union. It is not a US court ruling, it is not an FDA action, and it does not establish what happened in any individual case. The US label records reviewed here do not contain the term NAION, which means the US labeling and the EU assessment differ on the question as of the dates examined.

Frequently asked questions

What is NAION?

NAION stands for non-arteritic anterior ischemic optic neuropathy. The European Medicines Agency describes it as an eye condition that may cause loss of vision. Its public communication states that patients who experience sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide should contact a doctor without delay.

Which medicines are named in MDL 3163?

The transfer order names Ozempic, Wegovy, Saxenda and Trulicity. It identifies Eli Lilly and Novo Nordisk as the defendant companies. The order does not name every GLP-1 medicine on the market, and the docket is separate from MDL 3094, which covers other injury claims involving the same drug class.

Did the FDA add NAION to the US labels?

The Ozempic, Mounjaro and Zepbound label records retrieved for this article do not contain the term NAION. By contrast, the EMA recommended in June 2025 that the EU product information for semaglutide medicines be updated to list NAION as a very rare side effect. The documents reviewed do not show a US regulatory conclusion equivalent to the EMA’s.

Has a court decided that a GLP-1 medicine caused NAION?

No. The transfer order centralizes the claims for pretrial proceedings and makes no causation finding. The Panel’s October 1, 2026 report lists the actions as pending, and the documents reviewed contain no verdict.

Is there a settlement in MDL 3163?

No approved settlement appears in the documents reviewed. The Panel’s report lists 247 actions pending as of October 1, 2026, and neither the transfer order nor the report announces a settlement.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending, Report Date 10/1/2026” (link, accessed 2026-10-19)
2. U.S. Judicial Panel on Multidistrict Litigation: “Transfer Order, In re: Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation, MDL No. 3163 (J.P.M.L. December 15, 2025)” (link, accessed 2026-10-19)
3. European Medicines Agency: “PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy” (link, accessed 2026-10-19)
4. European Medicines Agency: “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 June 2025” (link, accessed 2026-10-19)
5. U.S. Food and Drug Administration, openFDA: “Prescribing Information for Ozempic (semaglutide), label record effective January 30, 2026” (link, accessed 2026-10-19)
6. U.S. Food and Drug Administration, openFDA: “Prescribing Information for Mounjaro (tirzepatide), label record effective August 27, 2026” (link, accessed 2026-10-19)
7. U.S. Food and Drug Administration, openFDA: “Prescribing Information for Zepbound (tirzepatide), label record effective August 28, 2026” (link, accessed 2026-10-19)

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