GLP-1 Vision Suits Grow While U.S. Labels Stay Quiet

Federal court in Philadelphia listed 216 pending GLP-1 vision-loss lawsuits on Sept. 1, 2026, all alleging a rare optic-nerve stroke called NAION. The claims name Novo Nordisk’s Ozempic, Wegovy and Rybelsus and Eli Lilly’s Mounjaro, Zepbound and Trulicity.

No jury has heard one of those cases. U.S. prescribing information still does not name the condition, even as regulators in Europe, the United Kingdom and Australia already tell patients it is a very rare risk.

Two GLP-1 Files in One Philadelphia Court

The vision cases are not riding inside the much larger stomach-injury docket. The Judicial Panel on Multidistrict Litigation opened MDL 3163 on Dec. 15, 2025, for claims that the drugs caused non-arteritic anterior ischemic optic neuropathy, a sudden, usually permanent loss of sight in one eye. Judge Karen S. Marston of the Eastern District of Pennsylvania drew that file and still runs MDL 3094, the gastrointestinal track opened in February 2024.

Eli Lilly asked the panel to pull the eye cases into their own proceeding. Novo Nordisk backed centralization. Plaintiffs opposed it. The split keeps NAION science in front of eye specialists instead of folding it into gastroparesis fights, and it leaves Marston coordinating both.

THE TWO FEDERAL DOCKETS

The panel’s Sept. 1, 2026, report put the stomach file 13th among 166 active MDLs. The vision file is smaller, and it is growing fast. It held 110 actions on June 1, 2026, and 216 three months later, a gain of 106 cases. More suits sit in New Jersey state court, which the federal count does not include. No trial verdict or global settlement had been announced in either docket by Sept. 27, 2026.

The U.S. Label Still Skips NAION

That silence on the American package insert is the failure-to-warn theory. Plaintiffs say the companies knew, or should have known, about an added NAION risk and sold the shots as routine tools for blood sugar and weight. One July complaint against Eli Lilly put it in the file as an effort to make the drugs look like “magic pills.”

Europe moved first. On June 6, 2025, the European Medicines Agency’s safety committee called NAION a very rare side effect of semaglutide, meaning it may affect up to 1 in 10,000 people taking the drug. The committee pointed to large studies in adults with type 2 diabetes that showed about a twofold rise in risk, or about one extra case per 10,000 person-years of treatment. If NAION is confirmed, it said, semaglutide should be stopped.

The World Health Organization issued an alert on June 27, 2025. Britain’s medicines regulator followed on Feb. 5, 2026, and told clinicians to send sudden vision loss to an ophthalmologist without delay. The Yellow Card scheme had three reports suggestive of NAION with semaglutide from 2018 through Aug. 1, 2025. Australia went wider on July 23, 2026, with class-wide warnings after 36 reports of optic ischaemic neuropathy: 23 with semaglutide, 10 with tirzepatide, three with liraglutide, and none with dulaglutide.

WHO WARNS PATIENTS ABOUT NAION

Australia’s own advisory committee said in October 2025 that the signal looked stronger for semaglutide than for dulaglutide or tirzepatide, then the regulator still put NAION into post-market language across the class. The wording for semaglutide is the firmest, including a stop-if-confirmed line and a note that people with a crowded optic disc, a “disc at risk,” already sit at higher risk whether or not they take a GLP-1 drug.

What the Eye Studies Found

The paper that opened this fight came from neuro-ophthalmologists at Mass Eye and Ear. In July 2024, JAMA Ophthalmology reported a matched cohort of 16,827 patients and a higher NAION rate after a semaglutide prescription. Among people with type 2 diabetes, 17 events occurred on semaglutide versus six on other diabetes drugs, a hazard ratio of 4.28. Among people treated for overweight or obesity, 20 events occurred versus three, a hazard ratio of 7.64. Over 36 months, cumulative incidence reached 8.9% versus 1.8% in the diabetes pair and 6.7% versus 0.8% in the weight pair. It was one hospital’s referral stream, and later reviewers treated those shares as a starting signal, not a national rate.

Bigger datasets came in lower. A 2025 JAMA Ophthalmology analysis of 43,620 new semaglutide users in an insurance file put incidence at 14.5 per 100,000 person-years and called the added risk modest. A Veterans Health Administration study of 102,361 people with type 2 diabetes, including 11,478 who started semaglutide and 90,883 who started an SGLT2 inhibitor, found 173 NAION events. Incidence was 123 per 100,000 person-years on semaglutide and 67 on the comparison drugs, a 2.33-fold hazard over a median 2.1 years. The overlap-weighted risk was 0.29% versus 0.13%, a difference of 0.16 percentage points. The authors still told clinicians to counsel patients on a rare, serious vision-loss event.

Novo Nordisk leans on randomized trials. A pooled analysis of placebo-controlled studies of semaglutide and liraglutide covered 96,829 participants and 205,777 participant-years. Ophthalmologists confirmed three NAION cases among 64,917 people on a GLP-1 drug and five cases among 31,912 on placebo, about three versus six events per 100,000 participant-years. Nils Ekström, senior manager for medical affairs at Novo Nordisk in Sweden, said a similar in-house pool “identified only a few ophthalmologist-confirmed cases of NAION” and that “the available data do not support a causal link between semaglutide and NAION.” He also pointed to FOCUS, a five-year randomized trial built to watch eye events on semaglutide.

Those trial counts are small harvests for a 1-in-10,000 event, which is why observational files and spontaneous reports still drive the label fight. The American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society, reviewing more than 40 studies in May 2026, put the pooled relative risk for semaglutide at about twofold. They also noted that NAION already affects 2.3 to 10.2 people per 100,000 per year in the general population, that a 1.2-million-patient Military Health System analysis found no added risk, and that no mechanism has been proven. Some lab work even hints GLP-1 activity could protect nerve tissue.

U.S. labels already talk about a different eye problem. The current Ozempic insert carries a diabetic retinopathy complications warning drawn from a two-year trial in which those events occurred in 3.0% of patients on the drug and 1.8% on placebo, with a larger gap among people who already had retinopathy (8.2% versus 5.2%). That is a complication tied to rapid sugar change, and it is not NAION. Wegovy’s insert uses the same retinopathy frame. Neither names ischemic optic neuropathy.

Weight-Loss Use Hit 11 Percent of Adults

The people who live with that gap are not a niche clinic list. Gallup found that 11 percent of U.S. adults were taking a GLP-1 medicine for weight loss in 2026, up from 3 percent in 2024, and that 15 percent had used one at some point. The poll ran May 28 to June 5, 2026, among 5,065 adults in the Gallup Panel.

GALLUP GLP-1 USE FOR WEIGHT LOSS

• Current use: 11 percent of U.S. adults in 2026.
• Ever used: 15 percent of U.S. adults.
• Current use in 2024: 3 percent of U.S. adults.

Diabetes already raises the baseline odds of NAION, with or without a shot. Sleep apnea, overnight low blood pressure, and a small optic-nerve cup do too. A lawsuit count of 216 federal eye cases, set beside that uptake, is a thin slice of users. It is also a thick enough file to change how a primary-care visit starts, because the American insert still does not give the sentence Europe prints.

Some late-stage obesity-drug trials now list NAION as a rare eye problem reported with similar medicines and tell volunteers to report sudden vision changes at once. That research-consent line is ahead of the commercial U.S. label for Ozempic. The mismatch is the practical harm even if most patients never meet an eye-stroke diagnosis.

A Stroke of the Optic Nerve

NAION is a drop in blood flow to the optic nerve. Sight usually goes in one eye, without pain, and there is no treatment shown to bring acuity back. Patients often notice it on waking. Jay Vandergriff, who is suing, described the first moment on Christmas Day in 2024 as an “eraser smear” he tried to wipe off his glasses after presents were opened, then realized the smear was in the eye.

That is the clinical picture the docket is built on. It is also why eye doctors keep repeating the same instruction, which does not depend on who wins in Philadelphia.

IF SIGHT DROPS WITHOUT PAIN

• The pattern: Sudden, painless loss, typically in one eye, sometimes first noticed in the morning.
• The action: Same-day emergency or ophthalmology care, not a wait-and-see message to the clinic portal.
• The drug question: If NAION is confirmed, Europe’s label says stop semaglutide; U.S. eye groups want a shared decision that weighs diabetes and heart risk too.
• The fellow eye: People who have already had NAION in one eye should talk through risk to the other eye before starting a GLP-1 drug.

Larry Frohman, M.D., executive vice president of the North American Neuro-Ophthalmology Society, said patients with other risk factors should work with their physicians to cut those risks where they can, and that sudden, painless vision loss is a reason to see an ophthalmologist promptly.

Eye Doctors Refuse a Blanket Stop

On Sept. 22, 2026, the Academy and NANOS restated the May review for a public that had just watched a new wave of suit coverage. They still do not recommend stopping semaglutide as a default. They do not want extra eye exams solely to grade NAION risk before a first dose. Patients with diabetes should keep the diabetic eye schedule they already have.

People with diabetes are known to be at higher risk to develop NAION regardless of medication use, so more research is necessary to confirm what role semaglutide medications have in this occurrence, if at all.

Raj Maturi, M.D., clinical spokesperson, American Academy of Ophthalmology, Sept. 22, 2026

Maturi listed overnight low blood pressure, untreated sleep apnea, and a very small optic-nerve cup as risks an ophthalmologist can walk through. For anyone already on semaglutide with no symptoms, he said, questions belong with the prescribing clinician before a dose is dropped.

WHERE EXPERTS DISAGREE

• EMA: List NAION as very rare and stop semaglutide if the diagnosis is confirmed.
• AAO and NANOS: About a twofold relative risk is possible, causation is unproven, and a blanket stop can be riskier than the eye event for people with hard-to-control diabetes, severe obesity, or heart disease.
• Novo Nordisk: Pooled randomized trials do not show extra NAION on semaglutide or liraglutide, and the company is defending the U.S. personal-injury suits as without merit.

That split is why the U.S. label has not copied Europe. It is also why the lawsuits have a cleaner warning theory here than in countries where the insert already carries the sentence. The stomach MDL is tangled in preemption arguments over nausea language the FDA already blessed. The vision MDL does not have that problem, because NAION is not on the U.S. insert at all.

No Bellwether Date Is on the Calendar

Marston has moved the gastrointestinal file through threshold fights first. On Aug. 15, 2025, she held that a gastroparesis claim needs a gastric emptying study from the time of diagnosis, which knocked out symptom-only theories. Expert and summary-judgment briefing on label adequacy, preemption, and general causation ran through summer 2026. A Rule 702 hearing filled Courtroom 16B from Sept. 14 to 18, 2026. No ruling was on the court’s MDL page as of Sept. 27, 2026, and no bellwether trial date has been set.

The vision docket is earlier. A Science Day on June 2, 2026, walked the judge through the ophthalmology evidence. In late September 2026 the parties were still arguing how plaintiff fact sheets should work, the paperwork that standardizes each filer’s medical story. New complaints were still landing after the Sept. 1, 2026, tally of 216.

THE VISION DOCKET SO FAR

1. July 2024: Mass Eye and Ear study in JAMA Ophthalmology reports higher NAION rates after semaglutide prescriptions.
2. June 6, 2025: EMA concludes NAION is a very rare semaglutide side effect and says to stop the drug if it is confirmed.
3. Dec. 15, 2025: The judicial panel opens MDL 3163 in Philadelphia before Judge Marston.
4. Feb. 5, 2026: The U.K. regulator tells clinicians to refer sudden vision loss urgently.
5. June 2, 2026: Science Day on the NAION evidence.
6. July 23, 2026: Australia extends NAION language across the GLP-1 class.
7. Sept. 1, 2026: The panel lists 216 pending federal vision-loss actions.
8. Sept. 22, 2026: AAO and NANOS tell patients not to stop on the basis of the suits alone.

Until a U.S. label change or a verdict, the warning a patient hears still depends on which country’s insert came with the pen, and on whether the prescriber has read the eye papers the lawsuits now recite. Judge Marston had posted no ruling on the September expert hearing by Sept. 27, 2026, and no bellwether date is on the calendar.

Disclaimer: This article is news reporting and analysis of court filings, regulator alerts, and published studies. It is for information only and is not medical, legal, or insurance advice, and it is not a recommendation to start, stop, or switch any GLP-1 medicine. Readers who have questions about Ozempic, Wegovy, Mounjaro, or related drugs should talk with their own physician or an ophthalmologist before changing a prescription, and anyone who thinks they may have a legal claim should consult a licensed attorney in their state. Case counts, labels, and study findings reflect the sources dated in the piece and can change as courts rule and agencies update product information.