FDA Cites 'Systemic Failures' in Novo Nordisk's Reporting of Ozempic Deaths

The FDA issued a warning letter to Novo Nordisk on March 5, 2026, citing "systemic failures" in the company's adverse event reporting for its semaglutide and liraglutide drugs — including at least two unreported patient deaths and a suicide case that had still not been submitted to the FDA as of the letter's date. The violations, uncovered during a January–February 2025 inspection of Novo Nordisk's Plainsboro, New Jersey facility, affected the company's "entire product portfolio," according to the agency.

The letter lands as GLP-1 litigation accelerates: MDL-3094 now carries 3,363 pending cases — a 153% increase since January 2025 — with expert discovery due March 27 and first bellwether trials expected mid-2026. A USA TODAY investigation published March 17 found that more than 600 deaths and 50,000 adverse event reports have been submitted to the FDA's FAERS database for semaglutide drugs since 2020.

What the FDA Found

The warning letter details five specific cases where Novo Nordisk's internal procedures prevented adverse events from reaching the FDA. The violations fall into two categories: flawed written procedures and failure to investigate reportable events.

On procedures, the FDA found that Novo Nordisk's internal protocol allowed adverse drug experiences to be rejected if the reporter believed events were unrelated to the drug — directly contradicting FDA regulations requiring all serious and unexpected events to be reported regardless of suspected causality. In one case, a consumer taking liraglutide suffered a disabling stroke, but the report was cancelled because the consumer said it was unrelated.

In another case, a male patient who died while receiving semaglutide had his report invalidated because call-center contractors claimed the patient identifier was missing — when FDA inspectors found the identifier in the source documents.

The FDA also found that cases sat in "medical review" far beyond Novo Nordisk's own 10-day internal deadline. A consumer who reported suicidal ideation on semaglutide in December 2024 wasn't reviewed until February 2025 — only after FDA inspectors flagged it during the inspection.

"Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA," the agency wrote.

Three Warning Letters in Six Months

The March 2026 letter is the third FDA warning to Novo Nordisk in six months. In September 2025, the FDA cited a promotional video featuring Oprah Winfrey as "false or misleading" for understating safety risks. In November 2025, a separate letter flagged manufacturing issues at a contract facility producing semaglutide.

The pattern matters for litigation. Lead plaintiffs' attorney Jonathan Orent told USA TODAY that the warning letter "gives me tremendous comfort both that we're right, but also that the government is actually now doing something about these problems." He compared the reporting failures to "the opioid days," noting that expert witnesses reviewing the case had "not seen anything quite that bad."

Novo Nordisk responded that the letter "does not make any conclusions about the quality or safety of our medicines" and that the company plans to "address the requests in the warning letter expeditiously and holistically."

What This Means for GLP-1 Litigation

Strengthening Failure-to-Warn Claims

The warning letter provides plaintiffs' attorneys with a critical piece of evidence: documentation that Novo Nordisk had institutional procedures that systematically prevented adverse events from reaching the FDA. This isn't a case of isolated reporting lapses — the FDA found that the company's written protocols were themselves the problem.

For the 3,363 cases in MDL-3094 alleging gastroparesis, bowel obstruction, and other GI injuries, the letter supports the argument that the company knew about adverse events and failed to ensure they were properly reported. Expert discovery is due March 27, with summary judgment motions due April 16 — timing that allows plaintiffs to incorporate the warning letter into their filings.

A Second Front: Vision Loss Claims

Beyond the GI injury cases, a second GLP-1 MDL was created in December 2025 for vision loss claims. MDL-3163, also assigned to Judge Karen S. Marston in the Eastern District of Pennsylvania, consolidates claims that GLP-1 drugs caused NAION — non-arteritic anterior ischemic optic neuropathy, a sudden, painless form of vision loss sometimes called "eye stroke."

A July 2024 study in JAMA Ophthalmology found that semaglutide users faced a 4.28x increased risk of NAION among diabetics and a 7.64x increased risk among weight-loss patients. The MDL had 37 pending cases as of February 2026 and is growing rapidly.

The Prescription Records Question

For firms building GLP-1 cases, the warning letter underscores why complete prescription histories are essential. Establishing drug exposure requires pharmacy records showing the specific drug, dosage, and dates of use; physician notes documenting the prescribing decision; and insurance or medical records showing continuity of use. Cases involving compounded semaglutide typically do not qualify for the MDL — only name-brand prescriptions are covered.

The Bottom Line

The FDA's warning letter to Novo Nordisk documents what plaintiffs' attorneys have alleged for months: that the company's adverse event reporting was systematically inadequate. With more than 31 million Americans taking GLP-1 drugs and litigation growing at 153% year-over-year, the letter provides a regulatory foundation for failure-to-warn claims that will be tested in bellwether trials later this year.

For firms handling GLP-1 cases, the immediate priority is building complete prescription and medical histories that document drug exposure, adverse event onset, and the timeline connecting the two. The warning letter strengthens the legal theory — but individual case outcomes still depend on the medical evidence.

Sources: FDA Warning Letter, USA TODAY Investigation, MDL Update — MDL-3094, JAMA Ophthalmology — NAION Study, KFF Health Tracking Poll, Reuters — MDL-3163.