MDL Track
MDL 3163
E.D. Pa.
GLP-1 receptor agonist NAION/vision-loss track
54 pending
Pharmaceutical · litigation and safety scrutiny around semaglutide products and non-arteritic anterior ischemic optic neuropathy
Defendant
Novo Nordisk A/S
MDL / Track
MDL 3163
E.D. Pa.
Judge
Judge Karen S. Marston
Plaintiffs
~87 pending (54 per JPML March 2, 2026 report plus 33 new filings tracked)
Bellwether / Trial
No verdicts yet
Settlement Status
No settlement
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Case overview
The Judicial Panel on Multidistrict Litigation created MDL 3163 in December 2025 to consolidate federal lawsuits alleging GLP-1 receptor agonists caused non-arteritic anterior ischemic optic neuropathy (NAION), assigning the docket to Judge Karen S. Marston in the Eastern District of Pennsylvania. As of July 2026, approximately 146 actions are pending against Novo Nordisk (Ozempic, Wegovy) and Eli Lilly (Mounjaro, Zepbound), with plaintiffs alleging failure to warn, design defect, and breach of warranties. The court held a Science Day on June 2, 2026, and bellwether trials are tentatively scheduled for late 2026 or early 2027.
Causation Theory
Plaintiffs' causation theory centers on semaglutide's effects on fluid regulation and vasculature, including changes in intracranial pressure or blood flow patterns that may compromise circulation to the optic nerve. The July 2024 JAMA Ophthalmology study by Mass Eye and Ear researchers found diabetic patients prescribed semaglutide had approximately four times the risk of NAION compared to other diabetes medications. A May 2026 PLOS Medicine meta-analysis of observational studies found semaglutide use associated with a 2.17-fold increased hazard of NAION (95% CI 1.73–2.74), and a 2025 Veterans Health Administration study reported a 2.33-fold higher risk (95% CI 1.54–3.54) compared to SGLT2 inhibitors. In June 2025, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee concluded NAION is a "very rare" side effect of semaglutide, recommending label updates and discontinuation upon diagnosis.
Case Management Orders
Litigation status
MDL 3163, the standalone NAION vision-loss docket, is in early pretrial coordination before Judge Karen S. Marston in the Eastern District of Pennsylvania. The JPML created the MDL on December 15, 2025, rejecting Eli Lilly's bid to fold claims into the gastrointestinal MDL 3094. A Science Day proceeding has been held to address causation evidence.
MDL Track
MDL 3163
E.D. Pa.
GLP-1 receptor agonist NAION/vision-loss track
54 pending
State Court Activity
Numerous cases pending in New Jersey state court, Novo Nordisk's headquarters jurisdiction
MDL 3163 Leadership
Plaintiff Leadership
Co-Chair, Plaintiffs' Executive Committee & Federal–State Court Liaison
Co-Lead Counsel for Plaintiffs
Member, Plaintiffs' Executive Committee
Geographic exposure
Estimated 15 million U.S. adults have used GLP-1 drugs. NAION incidence among semaglutide users: 14.5–123 per 100,000 person-years across studies. Absolute risk estimate: ~0.29% cumulative risk over ~2 years per VHA data.
MDL 3163 (In re: GLP-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation) assigned to Judge Karen S. Marston. Docket grew from 21 actions at transfer order (Dec. 15, 2025) to 146 pending actions as of July 1, 2026. Science Day held June 2, 2026.
MHRA Drug Safety Update (Feb. 5, 2026): semaglutide SmPC and PIL updating to include NAION risk. Commission on Human Medicines PEAG endorsed ~2-fold relative risk finding. Three Yellow Card reports through Aug. 1, 2025; ~10.2 million semaglutide packs dispensed in prior 5 years.
EMA PRAC concluded June 2025 that NAION is 'very rare side effect' of semaglutide, recommending label updates. Estimated incidence: ~1 additional case per 10,000 person-years of treatment; roughly two-fold relative risk vs. non-users.
Retrospective cohort study of 102,361 Veterans with T2D (11,478 semaglutide initiators; 90,883 SGLT2i initiators). Semaglutide associated with 2.33-fold higher NAION hazard (HR 2.33; 95% CI 1.53–3.54; P<0.001). Incidence rate: 123 per 100,000 person-years vs. 67 for SGLT2i. Cumulative risk: 0.29% semaglutide vs. 0.12% SGLT2i over median 2.1 years follow-up (medRxiv preprint, 2025).
Retrospective study of 37.1 million T2D patients including 810,390 new semaglutide users. Self-controlled case-series showed increased NAION risk (meta-analysis IRR 1.32; 95% CI 1.14–1.54; P<0.001). Incidence rate 14.5 per 100,000 person-years. Published JAMA Ophthalmology 2025.
Two-year SOL for product liability claims, tolled by discovery rule until patient knew or should have known of injury and causal link to GLP-1. Patients with 2023–2025 vision loss dates potentially viable pending medical record review for date of physician-causation attribution.
Key defendants
Novo Nordisk A/S
Role: Manufacturer
Primary defendant in MDL 3163 (In Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation), consolidated in E.D. Pa. before Judge Karen Marston. Core exposure on failure-to-warn for Ozempic/Wegovy NAION risk. EMA June 2025 labeling change for NAION as 'very rare' adverse reaction strengthens causation arguments.
Novo Nordisk Inc.
Role: Manufacturer
U.S. subsidiary named in MDL 3163 and New Jersey MCL applications. Same litigation posture as parent—early pretrial proceedings with focus on prescriber information and FDA FAERS data on vision loss reports.
Eli Lilly and Company
Role: Manufacturer
Named defendant in MDL 3163 for Trulicity, Mounjaro, Zepbound. Lilly urged JPML to consolidate NAION cases into existing gastroparesis MDL rather than separate MDL; panel rejected this. Lower case volume than Novo Nordisk in NAION track but same failure-to-warn theory.
| Defendant | Role | Intelligence Note |
|---|---|---|
| Novo Nordisk A/S | Manufacturer | Primary defendant in MDL 3163 (In Re: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy Products Liability Litigation), consolidated in E.D. Pa. before Judge Karen Marston. Core exposure on failure-to-warn for Ozempic/Wegovy NAION risk. EMA June 2025 labeling change for NAION as 'very rare' adverse reaction strengthens causation arguments. |
| Novo Nordisk Inc. | Manufacturer | U.S. subsidiary named in MDL 3163 and New Jersey MCL applications. Same litigation posture as parent—early pretrial proceedings with focus on prescriber information and FDA FAERS data on vision loss reports. |
| Eli Lilly and Company | Manufacturer | Named defendant in MDL 3163 for Trulicity, Mounjaro, Zepbound. Lilly urged JPML to consolidate NAION cases into existing gastroparesis MDL rather than separate MDL; panel rejected this. Lower case volume than Novo Nordisk in NAION track but same failure-to-warn theory. |
Timeline
JAMA Study Links Semaglutide to NAION
Hathaway et al. publish retrospective cohort study in JAMA Ophthalmology finding semaglutide users had approximately fourfold higher risk of non-arteritic anterior ischemic optic neuropathy compared to matched controls, with higher risk in obesity-treated patients. Study becomes central scientific anchor for litigation.
EMA Confirms NAION as Semaglutide Adverse Reaction
European Medicines Agency Pharmacovigilance Risk Assessment Committee concludes NAION is 'very rare possible adverse reaction' to semaglutide medicines, recommends label updates.
New Jersey NAION Consolidation Petitioned
Over 30 plaintiffs seek multicounty litigation designation in Middlesex County, New Jersey state court for Ozempic/Wegovy vision loss claims.
MDL 3163 First Status Conference
Judge Marston holds initial status conference for NAION MDL. Case management order establishes discovery and expert disclosure timelines. In re: GLP-1 RAs NAION Products Liability Litigation, MDL No. 3163, E.D. Pa.
UK MHRA Issues NAION Safety Update
UK Medicines and Healthcare products Regulatory Agency publishes safety update aligned with EU assessment, advising semaglutide may very rarely be associated with NAION and that product information would be updated.
MDL 3163 Science Day Held
Judge Marston holds formal Science Day, an educational session where parties present medical and scientific background on NAION and GLP-1 drugs without cross-examination. Foundational order entered establishing procedures. In re: GLP-1 RAs NAION Products Liability Litigation, MDL No. 3163, E.D. Pa.
Statute of limitations
NAION cases centralized in MDL 3163, In Re: Semaglutide (Ozempic, Wegovy) Products Liability Litigation, S.D. Fla., per JPML 2025 order. Discovery accrual likely runs from NAION diagnosis date or July 2024 Harvard/JAMA Ophthalmology study publication establishing semaglutide-NAION association. EMA concluded June 2025 that NAION should be listed as very rare adverse reaction for semaglutide products. Exclude MDL 3094 (GI track) per guidance. No federal preemption holding in NAION track.
Florida
4 years from discovery
Rule: Fla. Stat. § 95.11(3)(a) products liability; discovery rule applies
Discovery: Accrues when plaintiff knew or should have known of injury and its likely cause; NAION diagnosis date or July 2024 Harvard/JAMA study publication may trigger
MDL 3163 centralized in S.D. Fla. per JPML 2025 order; early pretrial proceedings as of March 2026
Pennsylvania
2 years from discovery
Rule: 42 Pa. C.S. § 5524(2); discovery rule applies
Discovery: Accrues when plaintiff discovers or reasonably should discover injury and causal connection; NAION cases may accrue at diagnosis or regulatory recognition
MDL 3094 (GI track) presided over by Judge Karen S. Marston in E.D. Pa.; NAION cases now in MDL 3163 (S.D. Fla.) per JPML 2025 order
California
2 years from discovery
Rule: Cal. Code Civ. Proc. § 340.3; discovery rule applies
Discovery: Accrues when plaintiff suspects or should suspect injury caused by defendant's conduct
Large plaintiff pool; EMA August 2024 labeling change for NAION risk may support discovery arguments
Texas
2 years from discovery
Rule: Tex. Civ. Prac. & Rem. Code § 16.003; discovery rule applies
Discovery: Accrues when injury becomes inherently undiscoverable and not discoverable by reasonable diligence; NAION sudden onset favors plaintiffs
New York
3 years from discovery
Rule: N.Y. C.P.L.R. § 214(5); discovery rule applies
Discovery: Accrues when plaintiff discovers or should have discovered injury and its cause; July 2024 study date critical for recent users
Federal filings from N.Y. transferred to MDL 3163 (S.D. Fla.)
New Jersey
2 years from discovery
Rule: N.J. Stat. § 2A:14-2; discovery rule applies
Discovery: Accrues when plaintiff knows or reasonably should know of injury and its cause
Multicounty litigation (MCL) application pending for NAION claims against Novo Nordisk; state court alternative to federal MDL 3163
| State | SOL | Rule | Discovery Rule | Notes |
|---|---|---|---|---|
| Florida | 4 years from discovery | Fla. Stat. § 95.11(3)(a) products liability; discovery rule applies | Accrues when plaintiff knew or should have known of injury and its likely cause; NAION diagnosis date or July 2024 Harvard/JAMA study publication may trigger | MDL 3163 centralized in S.D. Fla. per JPML 2025 order; early pretrial proceedings as of March 2026 |
| Pennsylvania | 2 years from discovery | 42 Pa. C.S. § 5524(2); discovery rule applies | Accrues when plaintiff discovers or reasonably should discover injury and causal connection; NAION cases may accrue at diagnosis or regulatory recognition | MDL 3094 (GI track) presided over by Judge Karen S. Marston in E.D. Pa.; NAION cases now in MDL 3163 (S.D. Fla.) per JPML 2025 order |
| California | 2 years from discovery | Cal. Code Civ. Proc. § 340.3; discovery rule applies | Accrues when plaintiff suspects or should suspect injury caused by defendant's conduct | Large plaintiff pool; EMA August 2024 labeling change for NAION risk may support discovery arguments |
| Texas | 2 years from discovery | Tex. Civ. Prac. & Rem. Code § 16.003; discovery rule applies | Accrues when injury becomes inherently undiscoverable and not discoverable by reasonable diligence; NAION sudden onset favors plaintiffs | — |
| New York | 3 years from discovery | N.Y. C.P.L.R. § 214(5); discovery rule applies | Accrues when plaintiff discovers or should have discovered injury and its cause; July 2024 study date critical for recent users | Federal filings from N.Y. transferred to MDL 3163 (S.D. Fla.) |
| New Jersey | 2 years from discovery | N.J. Stat. § 2A:14-2; discovery rule applies | Accrues when plaintiff knows or reasonably should know of injury and its cause | Multicounty litigation (MCL) application pending for NAION claims against Novo Nordisk; state court alternative to federal MDL 3163 |
Live intelligence
AI litigation brief
Ozempic NAION remains early-stage / active mdl with 84 current signals in the accepted feed.
Overview
MDL 3163, the standalone NAION vision-loss docket, is in early pretrial coordination before Judge Karen S. Marston in the Eastern District of Pennsylvania. The JPML created the MDL on December 15, 2025, rejecting Eli Lilly's bid to fold claims into the gastrointestinal MDL 3094. A Science Day proceeding has been held to address causation evidence.
Key developments
Trajectory
Court filings and press coverage are both active in MDL 3163, pointing to sustained litigation pressure rather than a one-off headline cycle. 6 live sources are contributing current context.
Editorial intelligence
MDL 3163 should stay on the lead docket watch because it is the primary consolidation vehicle for Ozempic NAION.
Generated Aug 12, 2026, 2:00 AM UTC
84 events detected
Google News (13)
Australian regulator warns of ‘rare but severe’ eye disorder linked to GLP-1 drugs like Ozempic - The Guardian
Rare eye disorder linked to Ozempic-like medications - abc.net.au
Rare eye disorder linked to Ozempic-like medications - ABC News & Headlines – Australian Broadcasting Corporation
Georgia woman part of lawsuit claiming link between GLP-1 weight loss drugs and blindness - WSB-TV
Ozempic Blindness: Should You Worry? - GoodRx
Parker Waichman LLP files lawsuits alleging Ozempic causes NAION - scanx.trade
Parker Waichman LLP Files Lawsuits on behalf of Georgia and California Residents Alleging Development of Irreversible Eye Condition, NAION, after taking Ozempic - PR Newswire
Parker Waichman LLP Files Lawsuit on behalf of Ohio Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Ozempic - PR Newswire
Research Links Ozempic to Vision Loss as GLP-1 Lawsuits Increase - The Legal Examiner
Research Links GLP-1s to Vision Loss as Lawsuits Increase - The Legal Examiner
Parker Waichman LLP Files Lawsuit on behalf of Pennsylvania Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Wegovy - PR Newswire
Parker Waichman LLP Files Lawsuit on behalf of Florida Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Ozempic and Mounjaro - PR Newswire
Parker Waichman LLP Files Lawsuit on behalf of Florida Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Ozempic - PR Newswire
Clinics in dermatology • Narla RR • PMID 42562129 • Journal Article.
Ophthalmology • Lao KC • PMID 42556433 • Journal Article.
The British journal of ophthalmology • Gao B • PMID 42547311 • Journal Article.
Retina (Philadelphia, Pa.) • Batool S • PMID 42468029 • Journal Article.
BMC ophthalmology • Magliyah MS • PMID 42432542 • Journal Article.
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket filed in JPML: Plaintiffs are suing Defendants because they failed to provide adequate warnings regarding the risk of permanent vision loss associated with their medications. Plaintiffs claim that the use of Ozempic and Mounjaro led to the development of non-arteritic anterior ischemic optic neuropathy (NAION). Th
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Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19532352.), filed by THERESA ODINO. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/10/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19532202.), filed by EARNEST SIMONS. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/10/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19532156.), filed by DIANE TOTHEROW. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/10/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19532106.), filed by STEWART FISCHER. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/10/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19531655.), filed by JIMI SPINKS. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/10/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19531563.), filed by MARK FRANK. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/10/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT JOHN WENDELL LANDRY, JR. against All Defendants ( Filing fee $ 405 receipt number APAEDC-19526747.), filed by JOHN WENDELL LANDRY, JR.. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(ORENT, JONATHAN) (Entered: 08/07/2026)
Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation
PACER docket entry from PAED: COMPLAINT against NOVO NORDISK A/S, NOVO NORDISK INC., ( Filing fee $ 405 receipt number APAEDC-19524089.), filed by BRIDGET LARSON-HILL. (Attachments: # 1 Civil Cover Sheet, # 2 Designation Form)(Nigh, Daniel) (Entered: 08/06/2026)
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LexGenius Ranking
92Score
Court, news, and regulatory activity are elevated
Monitoring
Live
monitoring
Last: Aug 12, 2026, 2:00 AM UTC
Next: —
Source Monitoring
PACER
PACER
Google News
FAERS
PubMed
Event feed
84
events detected
AI Brief
Ozempic NAION remains early-stage / active mdl with 84 current signals in the accepted feed.
Overview
MDL 3163, the standalone NAION vision-loss docket, is in early pretrial coordination before Judge Karen S. Marston in the Eastern District of Pennsylvania. The JPML created the MDL on December 15, 2025, rejecting Eli Lilly's bid to fold claims into the gastrointestinal MDL 3094. A Science Day proceeding has been held to address causation evidence.
Key developments
PACER court filing on Dec 31: Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Products Liability Litigation. ‖ The Guardian news on Jul 24: Australian regulator warns of ‘rare but severe’ eye disorder linked to GLP-1 drugs like Ozempic - The Guardian. ‖ FAERS FDA alert on Jun 30: FAERS Filing 26942960: Optic ischaemic neuropathy. ‖ PubMed research on Aug 6: Integrating GLP-1 Receptor Agonists Into Dermatology Practice: Safety and Monitoring Strategies..
Generated Aug 12, 2026, 2:00 AM UTC
Tracked MDLs
MDL 3163
E.D. Pa.
GLP-1 receptor agonist NAION/vision-loss track