JPML creates a second GLP-1 MDL for vision loss claims

The U.S. Judicial Panel on Multidistrict Litigation created a second federal GLP-1 multidistrict litigation on December 15, 2025, consolidating lawsuits that allege the drugs caused non-arteritic anterior ischemic optic neuropathy, or NAION, a form of sudden and usually permanent vision loss ^[2]. The new proceeding, MDL No. 3163, was centralized in the Eastern District of Pennsylvania before U.S. District Judge Karen S. Marston ^[1][2].

The Panel declined requests to fold the vision cases into the existing gastrointestinal-injury MDL and instead set up a separate docket, concluding that NAION is a distinct injury warranting its own centralized proceeding ^[1]. Judge Marston already oversees MDL 3094, the GLP-1 gastrointestinal litigation established in February 2024, which covers claims of gastroparesis, ileus and intestinal obstruction ^[2]. The two MDLs involve the same defendants — Novo Nordisk Inc./A/S and Eli Lilly and Company — but different medical specialties, with ophthalmology and neuro-ophthalmology experts central to the NAION cases ^[2]. Claims in MDL 3163 include failure to warn, design defect and breach of warranty ^[1]. None of those allegations has been proven; much of the detailed reporting here comes from plaintiffs' law firm sites, which are attorney advertising ^[2][5].

The vision docket has grown quickly but remains far smaller than the GI litigation. JPML statistics list 21 pending actions in December 2025, rising to 216 by September 1, 2026 ^[2]. As of the same date, MDL 3094 had 4,022 pending actions, for a combined federal total of 4,238 ^[3][5]. Parallel state consolidations exist in New Jersey, where separate multicounty litigations handle GI injuries (MCL 643) and NAION claims (MCL 644) ^[4].

What the science shows

NAION happens when blood flow to the front of the optic nerve is disrupted. It is typically painless, often noticed on waking, usually affects one eye, and has no proven treatment to reverse the damage ^[1][2]. About 21,000 Americans are diagnosed each year, and known risk factors include diabetes, high blood pressure, sleep apnea and age over 50 — conditions common among GLP-1 users, which manufacturers cite as confounding factors ^[2].

The litigation grew out of a July 2024 JAMA Ophthalmology study from Massachusetts Eye and Ear of 16,827 patients, which reported 4.28 times higher NAION risk in type 2 diabetes patients prescribed semaglutide (8.9% versus 1.8% cumulative incidence) and 7.64 times higher risk in weight-loss patients (6.7% versus 0.8%) ^[2][5]. Later, larger studies found smaller effects: a February 2025 analysis of 37.1 million patients reported an incidence rate ratio of 1.32, a Danish-Norwegian study of more than 424,000 patients found 2.19 times the risk versus SGLT2 inhibitors ^[2], and a VA study in JAMA Network Open of 588,168 patients found a 35% higher three-year risk — 39 per 10,000 GLP-1 users versus 29 per 10,000 SGLT2 users ^[5].

Regulators have split. In June 2025, the European Medicines Agency's pharmacovigilance committee concluded NAION is a "very rare" side effect of semaglutide and recommended adding it to European labels ^[2]. Australia added NAION warnings to product information for Ozempic, Wegovy, Mounjaro, Saxenda and Trulicity in July 2026 ^[5]. As of September 2026, US labels for Ozempic, Wegovy and Rybelsus still contained no NAION warning ^[2] — the gap at the center of plaintiffs' failure-to-warn theory.

Why it matters for patients

A separate MDL means vision-loss claims will be litigated on their own scientific record, with their own experts and timeline, rather than moving at the pace of the much larger GI docket ^[1][2]. For patients, the practical takeaway is that the absolute risk reported in the largest studies is low but the injury is serious and generally irreversible ^[2][5], and that US prescribing information does not yet mention it even though European and Australian labels do ^[2][5]. Whether FDA will act is not yet known; sources say the agency is reportedly still evaluating the evidence ^[2].

What happens next

Judge Marston held a Science Day on June 2, 2026 ^[2][5]. On July 2, 2026, she ordered the litigation to first address general causation and federal preemption rather than proceed straight to pilot cases ^[5]. A September 2026 case management order set fact discovery against Lilly for December 18, 2026, and Novo Nordisk for February 26, 2027; plaintiffs' general causation expert reports March 26, 2027; defense reports April 23; depositions by June 4; and expert challenges and summary judgment motions due July 2, 2027 ^[5]. Bellwether trial dates have not been set ^[2].