Is Ozempic Facing a Lawsuit? Mapping the 2026 Litigation Landscape

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> Reviewed by FormBlends Medical Team · Last updated May 2026 · 13 sources cited

Key Takeaways

• Ozempic and the broader GLP-1 class are named in a federal multidistrict litigation (MDL No. 3094) consolidated in the Eastern District of Pennsylvania, focused on gastroparesis claims.
• Separate lawsuits address NAION vision loss, intestinal obstruction, and ileus, generally filed under failure-to-warn and design-defect theories.
• No bellwether trials had concluded as of May 2026; the litigation is in pretrial discovery, expert-evidence review, and class-certification motions.
• The FDA has independently updated GLP-1 labeling for ileus (September 2023) and is reviewing the NAION signal from a 2024 JAMA Ophthalmology study.
• Pending lawsuits do not change the drugs' FDA approval status or prescription availability.

Direct answer

Yes, Ozempic is facing several lawsuits as of May 2026. The largest is a federal multidistrict litigation, MDL No. 3094, consolidating gastroparesis cases against Novo Nordisk and Eli Lilly in the Eastern District of Pennsylvania. Additional suits target NAION vision loss, ileus, and intestinal obstruction. No verdicts have been entered; the cases are in pretrial proceedings, and the drugs remain FDA-approved and prescribable.

Table of contents

1. The three lawsuit categories in plain terms
2. MDL No. 3094: the gastroparesis litigation
3. NAION vision-loss suits and the JAMA Ophthalmology signal
4. Ileus and intestinal-obstruction cases
5. What the FDA has done independently of the litigation
6. What a failure-to-warn case actually requires
7. Where compounded semaglutide fits
8. What this means for patients currently on Ozempic
9. The defense view: why Novo Nordisk and Lilly are contesting
10. What to watch over the next 12 months
11. FAQ
12. Sources

The three lawsuit categories in plain terms

Three distinct theories drive most of the active GLP-1 product-liability docket.

1. Gastroparesis claims. Plaintiffs allege the labels did not adequately warn that GLP-1 receptor agonists can cause delayed gastric emptying severe enough to be classified as gastroparesis, with persistent vomiting, malnutrition, or hospitalization.
2. NAION claims. Plaintiffs allege the label did not warn of an increased risk of nonarteritic anterior ischemic optic neuropathy, a form of sudden, often permanent vision loss.
3. Ileus and obstruction claims. Plaintiffs allege the drugs caused bowel obstruction, paralytic ileus, or other severe gastrointestinal stoppage events, sometimes requiring emergency surgery.

Each category has its own evidentiary record, expert disputes, and likely outcomes. Bundling them as one "Ozempic lawsuit" obscures the differences.

MDL No. 3094: the gastroparesis litigation

The largest pending matter is captioned In re: Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation, MDL No. 3094. The Judicial Panel on Multidistrict Litigation consolidated the cases in February 2024 and transferred them to the Honorable Karen S. Marston in the Eastern District of Pennsylvania.

What a multidistrict litigation actually is

An MDL is not a class action. Each plaintiff retains an individual case. The MDL handles common pretrial issues, including discovery, expert-witness disputes (Daubert motions), and selection of "bellwether" cases for early trials. Bellwether verdicts often shape settlement discussions for the remaining inventory.

The named defendants

The MDL names Novo Nordisk, the manufacturer of Ozempic, Wegovy, Rybelsus, Saxenda, and Victoza, and Eli Lilly, the manufacturer of Mounjaro, Zepbound, and Trulicity. Both companies are contesting the cases.

The plaintiffs' theory

Plaintiffs argue that:

• Delayed gastric emptying is a known mechanism of GLP-1 drugs.
• In some patients, the delay progresses to gastroparesis with chronic vomiting, weight loss, and hospitalization.
• The labels did not adequately warn of this severity or duration, including the risk that symptoms might persist after discontinuation.
• Patients who would have declined or paused treatment had they known are entitled to compensation.

The defense theory

Novo Nordisk and Eli Lilly argue that:

• The labels disclosed delayed gastric emptying and gastrointestinal adverse events.
• Gastroparesis as a discrete diagnosis is rare and not consistently established by plaintiffs' medical records.
• Underlying conditions, especially diabetes itself, are well-documented causes of gastroparesis independent of medication.
• Plaintiffs' general-causation experts rely on associations rather than reliable proof that the drugs cause persistent gastroparesis.

Procedural posture as of May 2026

The MDL is in the Daubert phase, where the court evaluates whether plaintiffs' expert witnesses meet federal admissibility standards on general causation. Pretrial bellwether selection follows the resolution of those motions. No trial verdicts have been entered.

NAION vision-loss suits and the JAMA Ophthalmology signal

NAION cases form a distinct branch of the litigation. The scientific anchor is a July 2024 study published in JAMA Ophthalmology by Hathaway, Shah, Wang, and colleagues at Harvard Medical School and Massachusetts Eye and Ear. The study reported that semaglutide patients had elevated hazard ratios for NAION compared with matched controls, with a particularly notable signal in the obesity-treatment cohort.

NAION is a sudden vision-loss condition caused by reduced blood flow to the optic nerve. The visual deficit is typically permanent. The condition is rare in the general population.

The cases generally allege:

• The label did not warn of NAION risk.
• The mechanism, possibly related to rapid changes in metabolic state or hemodynamics, was foreseeable.
• Patients with vascular risk factors should have received targeted warnings.

The defense response references the limits of the underlying epidemiology: the JAMA Ophthalmology paper is a single retrospective cohort, NAION is rare in absolute terms, and association alone is not causation. Replication studies have produced mixed signals through early 2026.

Ileus and intestinal-obstruction cases

The ileus and intestinal-obstruction docket overlaps with the broader gastrointestinal litigation. Plaintiffs allege that the slowed gastric and intestinal motility caused by GLP-1 receptor agonists led to:

• Paralytic ileus requiring hospitalization.
• Small-bowel obstruction in some cases, occasionally requiring surgery.
• Severe, sustained symptoms in patients without a clear alternative cause.

The FDA added ileus as a postmarketing adverse reaction to the semaglutide label in September 2023. Plaintiffs argue the warning came too late; defendants argue the underlying clinical mechanism was disclosed in the original labeling.

What the FDA has done independently of the litigation

It is important to separate FDA action from court action.

Date	FDA action	Drug or class
September 2023	Added ileus as a postmarketing adverse reaction	Semaglutide (Ozempic and Wegovy labels)
2023-2024	Issued safety communications on compounded semaglutide	Compounded products
July 2024	Began review of NAION signal following JAMA Ophthalmology publication	GLP-1 class review
October 2024	Removed tirzepatide from drug shortage list	Mounjaro, Zepbound
February 2025	Removed semaglutide from drug shortage list	Ozempic, Wegovy, Rybelsus

FDA labeling decisions follow agency review, not court rulings. A jury verdict against a manufacturer can trigger label discussion, but it is the agency, not the jury, that changes the label.

What a failure-to-warn case actually requires

The legal theory at the center of most GLP-1 lawsuits is failure to warn. To prevail, a plaintiff must generally show four things:

1. Duty. The manufacturer owed a duty to warn about the risk.
2. Breach. The label or other communication failed to provide an adequate warning given what the manufacturer knew or should have known.
3. Causation. The drug caused the plaintiff's injury (general causation) and caused this particular plaintiff's injury (specific causation).
4. Damages. The plaintiff suffered a compensable harm.

The most contested element in pharmaceutical product-liability cases is usually causation. The "learned intermediary" doctrine, applied in most US states, also lets manufacturers argue that adequate warnings to prescribers, rather than directly to patients, can satisfy the duty.

Where compounded semaglutide fits

The MDL is focused on FDA-approved brand-name products and their manufacturers. Compounded semaglutide is a separate legal territory. Through 2023, 2024, and 2025, Novo Nordisk filed several lawsuits in state and federal court against compounding pharmacies, telehealth platforms, and medical spas, alleging trademark infringement, false advertising, and unlawful marketing of compounded GLP-1 products.

Those cases differ from the gastroparesis MDL in plaintiff, defendant, and theory. Compounded semaglutide is not FDA-approved. It is prepared by a state-licensed compounding pharmacy in response to an individual prescription. Compounded products are not interchangeable with brand-name Ozempic.

What this means for patients currently on Ozempic

If you are taking Ozempic or another GLP-1 medication, the lawsuits do not change your prescription's legal status. The medication remains FDA-approved and available. Several practical points are worth noting:

• Pending litigation does not constitute a recall.
• If you experience severe, persistent gastrointestinal symptoms, sudden vision loss, or signs of intestinal obstruction, contact your clinician and seek emergency care if indicated.
• Document symptoms and clinical visits. If you later choose to consult an attorney, contemporaneous records are more useful than after-the-fact recollection.
• Discuss any treatment changes with the prescribing clinician. Abruptly stopping a GLP-1 medication can cause appetite rebound and metabolic changes.

FormBlends does not provide legal advice. Questions about whether a particular case might be pursued belong with a licensed attorney in your jurisdiction.

The defense view: why Novo Nordisk and Lilly are contesting

For balance, the defendants' core arguments deserve a fair statement.

Argument 1: The labels disclosed the gastrointestinal risks. The semaglutide and tirzepatide labels included warnings about nausea, vomiting, abdominal pain, and delayed gastric emptying. Defendants argue these warnings put prescribers on notice of the underlying risk that, in severe cases, can manifest as gastroparesis.

Argument 2: Causation is hard to prove in patients with diabetes. Diabetic gastroparesis is well-documented in the literature, with longstanding diabetes recognized as a major cause. Disentangling drug-caused from disease-caused gastroparesis in any individual plaintiff is technically difficult.

Argument 3: NAION is rare and the epidemiology is single-source. The JAMA Ophthalmology study is one retrospective cohort. The class label change for NAION would normally require replication, dose-response evidence, and a plausible mechanism, which are still under review.

Argument 4: The learned intermediary doctrine. Manufacturers argue that they communicated risks through the FDA-approved label and direct-to-prescriber materials, which is sufficient under the laws of most US states.

None of these arguments mean the cases will fail; they explain why the manufacturers are not settling quickly.

What to watch over the next 12 months

The MDL calendar will drive most public news.

• Daubert rulings. The court's ruling on plaintiffs' general-causation experts will shape what cases can proceed.
• Bellwether selection. A small pool of representative cases will be chosen for early trials.
• FDA NAION review. Any label change driven by the agency would precede court rulings.
• State-court tracks. Some cases filed in state courts will move independently of the MDL.
• Compounding enforcement. Litigation between Novo Nordisk and compounding-related defendants will continue after the FDA shortage list resolution.

Compounded medication note for this topic

For Is Ozempic Facing a Lawsuit? Mapping the 2026 Litigation Landscape, keep the pharmacy distinction clear: when compounded semaglutide or tirzepatide is prescribed, it is prepared for an individual patient by a licensed 503A compounding pharmacy. Compounded preparations are not FDA-approved drug products and are not interchangeable with Ozempic, Wegovy, Mounjaro, or Zepbound.

The practical question is not whether a compounded medication is a brand substitute. It is whether the prescription, pharmacy label, concentration, follow-up plan, and adverse-event support are clear enough for your specific medical history.

FAQ

Is Ozempic facing a lawsuit in 2026? Yes. The drug is named in a consolidated federal multidistrict litigation (MDL No. 3094) and in separate suits for NAION vision loss, ileus, and intestinal obstruction. Both Novo Nordisk and Eli Lilly are defendants in the MDL because it covers the GLP-1 class.

What court hears the Ozempic gastroparesis cases? The Judicial Panel on Multidistrict Litigation consolidated the cases in the United States District Court for the Eastern District of Pennsylvania in February 2024, before Judge Karen S. Marston.

What is MDL No. 3094? The formal caption is In re: Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation. It is a federal consolidation of individual cases for common pretrial proceedings, not a class action.

Has Novo Nordisk lost any of the Ozempic lawsuits? No. No bellwether trials had concluded as of May 2026. The MDL is in the pretrial Daubert phase.

Is Wegovy in the lawsuits too? Yes. Wegovy contains semaglutide, the same active ingredient as Ozempic, and is included in MDL No. 3094 alongside Mounjaro, Zepbound, Trulicity, and other GLP-1 receptor agonists.

What is the NAION Ozempic lawsuit? NAION is a sudden vision-loss condition. After the July 2024 JAMA Ophthalmology study from Massachusetts Eye and Ear reported elevated risk among semaglutide patients, plaintiffs began filing failure-to-warn lawsuits. The cases are distinct from the gastroparesis MDL.

Should I stop Ozempic because of the lawsuits? Treatment decisions should follow clinical guidance, not litigation news. Discuss any concerns with the prescribing clinician. Abrupt discontinuation has its own metabolic consequences.

Has the FDA recalled Ozempic? No. Ozempic has not been recalled. The FDA updated semaglutide labeling for ileus in September 2023 based on its own postmarketing review.

How long will the MDL take? Pharmaceutical MDLs of this size typically run several years. The pretrial phase alone can take 18 to 36 months, and bellwether trials often span an additional year or more.

Can I join the Ozempic lawsuit? Joining product-liability litigation is a legal decision that belongs with a licensed attorney in your state. FormBlends does not refer patients to litigation counsel and does not provide legal advice.

Sources

1. Judicial Panel on Multidistrict Litigation. In re: Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Products Liability Litigation. MDL No. 3094. Transfer Order. February 2024.
2. US District Court for the Eastern District of Pennsylvania. Case management orders, MDL No. 3094. 2024-2026 docket.
3. Hathaway JT, Shah MP, Hathaway DB, et al. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmology. 2024.
4. US Food and Drug Administration. Ozempic Prescribing Information. Postmarketing adverse reactions update, September 2023.
5. US Food and Drug Administration. Wegovy Prescribing Information. Current label.
6. US Food and Drug Administration. Drug Shortages Database. Semaglutide resolution, February 2025.
7. US Food and Drug Administration. Drug Shortages Database. Tirzepatide resolution, October 2024.
8. Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. 2021.
9. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022.
10. Sodhi M, Rezaeianzadeh R, Kezouh A, Etminan M. Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. JAMA. 2023.
11. Restatement (Third) of Torts: Products Liability. Section 6 (prescription drugs and the learned intermediary doctrine).
12. Federal Rules of Evidence. Rule 702 (testimony by expert witnesses) and the Daubert standard.
13. Novo Nordisk. Annual Report 2024. Litigation disclosures.

Footer disclaimers

Platform Disclaimer. FormBlends is a digital health platform connecting patients with independent licensed clinicians and US-based pharmacies. We do not manufacture, prescribe, or dispense medication. Nothing on this page is legal advice. Questions about pending litigation belong with a licensed attorney in your jurisdiction.

Compounded Medication Notice. Compounded semaglutide and tirzepatide are not FDA-approved. They are prepared by state-licensed compounding pharmacies in response to individual prescriptions. Compounded preparations are not interchangeable with FDA-approved Ozempic, Wegovy, Mounjaro, or Zepbound and have not been reviewed for safety and efficacy in the same manner.

Results Disclaimer. Individual treatment outcomes vary. Litigation discussed on this page describes pending allegations, not adjudicated facts. References to clinical trials reflect group-level results that may differ from any single patient's experience.

Trademark Notice. Ozempic, Wegovy, Rybelsus, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Mounjaro, Zepbound, and Trulicity are registered trademarks of Eli Lilly and Company. FormBlends is not affiliated with, endorsed by, or sponsored by either manufacturer.