Pharmaceutical MDL-3163 Actively Recruiting Eastern District of Pennsylvania

Ozempic Vision Loss Lawsuit (NAION / Sudden Blindness)

New federal litigation alleging GLP-1 receptor agonist drugs like Ozempic, Wegovy, and Mounjaro caused non-arteritic anterior ischemic optic neuropathy (NAION) — sudden, typically irreversible vision loss. Created December 2025 after Harvard study found 4-7x higher risk.

Last Updated: May 1, 2026
16 min read
JPML Data Verified
8 sources cited

Key Takeaways

  • MDL created December 15, 2025 — one of the newest federal MDLs
  • Harvard/JAMA study found 4.28x higher risk for diabetics, 7.64x higher for weight loss patients
  • June 2025: European Medicines Agency confirmed NAION as "very rare" side effect
  • Same judge as MDL-3094 (GI claims) — Judge Karen S. Marston
  • Vision loss is typically sudden, painless, and permanent

May 2026 Updates Latest

86 cases now pending (86 total filed), up from 73 in April — growth continues as more NAION patients file claims in the Eastern District of Pennsylvania. Science Day is now less than one month out, set for June 2, 2026, when Judge Karen Marston will hear non-adversarial scientific presentations from both sides on the link between semaglutide-class drugs and non-arteritic anterior ischemic optic neuropathy. The hearing is widely viewed as the gating event before any case-management or bellwether-selection schedule is set.

U.S. FDA has still NOT added a NAION warning to GLP-1 drug labels — a regulatory gap that remains central to plaintiffs' failure-to-warn theory. Plaintiffs continue to rely on the JAMA Ophthalmology study showing semaglutide patients experienced NAION at over 7x the rate of patients on other medications. Co-Lead Counsel Parvin Aminolroaya (Seeger Weiss) continues to lead the plaintiffs' executive committee, with discovery and bellwether selection expected to follow Science Day.

86
Pending Actions
4.28x
Risk (Diabetics)
7.64x
Risk (Weight Loss)
Dec 2025
MDL Created

Case Growth Tracking

Newly formed MDL tracking case filings since creation in December 2025.

Dec 25
21
Jan 26
30
Feb 26
37
Mar 26
54
Apr 26
73
May 26
86

Source: JPML MDL Statistics Reports

Key Facts (May 2026)

Pending Actions 86 cases (newly formed MDL)
MDL Created December 15, 2025
Key Defendants Novo Nordisk Inc./A/S, Eli Lilly and Company
Presiding Judge Hon. Karen S. Marston (E.D. Pennsylvania)
Alleged Injury NAION — sudden, permanent vision loss
Key Study Harvard/Mass Eye & Ear (JAMA Ophthalmol. July 2024)
EMA Label Status June 2025: NAION added as "very rare" side effect
FDA Label Status No NAION warning (as of May 2026)
Can You Still File? Yes, lawsuits are actively being filed

Harvard JAMA Ophthalmology Study (July 2024)

Researchers at Massachusetts Eye and Ear (Harvard Medical School) observed three NAION cases in one week — all in patients taking semaglutide. The subsequent study of 16,827 patients found significantly elevated risk:

4.28x
Higher risk for Type 2 diabetes patients
8.9% vs 1.8% cumulative incidence
7.64x
Higher risk for weight loss patients
6.7% vs 0.8% cumulative incidence

Source: Hathaway JT, et al. JAMA Ophthalmol. 2024;142(8):732-739 (PMID: 38958939)

1 What Is NAION?

Non-arteritic anterior ischemic optic neuropathy (NAION) is the most common cause of sudden optic nerve blindness in adults. It occurs when blood flow to the front of the optic nerve is disrupted, causing permanent damage — sometimes called a "stroke of the optic nerve."

How NAION Presents

  • Sudden, painless vision loss — often discovered upon waking
  • Usually affects one eye — can affect second eye in 15-25% of cases over 5 years
  • Vision loss is typically permanent — no effective treatment exists
  • Affects approximately 21,000 Americans annually
Known Risk Factors: Diabetes, hypertension, sleep apnea, "disc at risk" anatomy, age over 50. Many GLP-1 users have these pre-existing conditions, which defendants cite as confounding factors.

2 Why Two GLP-1 MDLs?

The JPML created a separate MDL for NAION claims rather than adding them to MDL-3094 (gastroparesis). Here's how they differ:

Factor MDL-3094 (GI) MDL-3163 (Vision)
Primary Injuries Gastroparesis, ileus, intestinal obstruction NAION, sudden vision loss, blindness
Case Count ~3,300+ cases ~54 cases
Established February 2024 December 2025
Expert Type Gastroenterology Ophthalmology, Neuro-ophthalmology
FDA Warning Oct 2025: Gastroparesis warning added No U.S. warning
Same Judge, Same Defendants: Both MDLs are before Judge Karen S. Marston in the Eastern District of Pennsylvania. Both involve Novo Nordisk and Eli Lilly. Coordination is expected on common legal issues.

3 Regulatory Status: EMA vs FDA

European Medicines Agency (June 2025)

The EMA's Pharmacovigilance Committee (PRAC) concluded that NAION is a "very rare" side effect of semaglutide. They recommended adding NAION to European drug labels and advising patients to stop the medication if NAION is confirmed.

U.S. FDA (As of March 2026)

NAION is NOT included in U.S. drug labels for Ozempic, Wegovy, or Rybelsus. The FDA is reportedly evaluating whether action is required. This regulatory gap is central to plaintiffs' failure-to-warn claims.

4 Scientific Evidence

Key Studies

Harvard/Mass Eye & Ear Study (July 2024)
16,827 patients — found 4.28x to 7.64x higher NAION risk
PMID: 38958939
Large Population Study (February 2025)
37.1 million patients — found modest but elevated risk (IRR 1.32)
PMID: 39976940
Danish-Norwegian Study (December 2024)
424,000+ patients — found 2.19x higher risk vs SGLT2 inhibitors

Proposed Mechanisms (Under Investigation)

  • • Rapid metabolic changes affecting optic nerve perfusion
  • • Enhanced sympathetic activity impacting vascular tone
  • • Pre-existing microvascular damage in diabetic patients

Dr. Joseph Rizzo at Harvard has received NIH funding to study GLP-1 receptors in optic nerve tissue.

5 Do You Qualify?

Eligibility for NAION Claims

  • Took a GLP-1 drug — Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, or similar
  • Diagnosed with NAION — Confirmed by ophthalmologist or neuro-ophthalmologist
  • Sudden vision loss — Typically painless, often discovered upon waking
  • Medical documentation — Prescription records, eye exam records, diagnosis confirmation
Have GI Injuries Instead? If you experienced gastroparesis, intestinal obstruction, or other GI injuries from GLP-1 drugs, see MDL-3094.

6 Frequently Asked Questions

Is NAION vision loss permanent?
Yes, in most cases. There is currently no effective treatment to restore vision lost to NAION. Some patients experience limited spontaneous improvement, but most have permanent visual impairment.
Why hasn't the FDA added a warning?
The FDA is reportedly still evaluating the evidence. The European Medicines Agency acted faster, adding NAION as a "very rare" side effect in June 2025. This regulatory gap is central to plaintiffs' failure-to-warn claims.
What if I have both GI and vision problems?
"Combination" cases alleging both injuries may have claims in both MDLs. Judge Marston will coordinate case-by-case determination of which MDL handles which claims. Consult with an attorney about your specific situation.
Are Mounjaro and Zepbound included?
Yes. The MDL includes claims against both Novo Nordisk (Ozempic, Wegovy, Rybelsus) and Eli Lilly (Mounjaro, Zepbound). Note that tirzepatide (Mounjaro/Zepbound) is a dual GIP/GLP-1 receptor agonist, not a pure GLP-1.
When will there be trials?
MDL-3163 was just created in December 2025. Early case management orders are expected in 2026. Bellwether trials are likely years away. The related MDL-3094 (GI claims) may have bellwethers in mid-2026.

7 Key Timeline

Jul 2024
Harvard JAMA Study Published

Research showing 4-7x higher NAION risk sparks litigation

Jan 2025
EMA Launches Review

European regulators begin investigating NAION-semaglutide link

Jun 2025
EMA Confirms Link

NAION added to European drug labels as "very rare" side effect

Nov 2025
New Jersey MCL Granted

State-level consolidation of NAION and GI claims

Dec 2025
MDL-3163 Created

Federal NAION cases consolidated before Judge Marston in E.D. Pennsylvania

Sources & References

8 official sources cited

• JPML Transfer Order MDL-3163 (December 15, 2025)

• Hathaway JT, et al. "Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide." JAMA Ophthalmol. 2024;142(8):732-739 (PMID: 38958939)

• Cai CX, et al. "Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy." JAMA Ophthalmol. 2025;143(4):304-314 (PMID: 39976940)

• European Medicines Agency — Wegovy Product Information (June 2025 PRAC decision)

• American Academy of Ophthalmology — "What Is Ischemic Optic Neuropathy?"

• FDA DailyMed — Ozempic Prescribing Information (October 2025)

• JPML MDL Statistics Report (March 2026)

• U.S. District Court, Eastern District of Pennsylvania — MDL-3163 docket

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