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 medications, including at least two unreported patient deaths and a suicide case that had not been submitted to the agency as of the letter's date. The violations, identified 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 regulatory action arrives as GLP-1 litigation continues to expand: MDL-3094 holds 3,363 pending cases, representing a 153% increase since January 2025. Expert discovery closed on March 27, with initial bellwether trials scheduled for mid-2026. A USA TODAY investigation published March 17 identified more than 600 deaths and 50,000 adverse event reports submitted to the FDA's FAERS database for semaglutide medications since 2020.

What the FDA Found

The warning letter details five specific instances where Novo Nordisk's internal procedures prevented adverse event reports from reaching the FDA. The violations involve flawed written procedures and failures to investigate reportable events.

Regarding procedures, the FDA determined that Novo Nordisk's internal protocol allowed adverse drug experiences to be rejected if the reporter believed events were unrelated to the drug, contradicting FDA regulations requiring all serious, unexpected events to be reported regardless of initial causality impressions. In one case, a patient taking liraglutide suffered a disabling stroke, but the report was closed because the patient initially believed it was unrelated.

In another instance, a male patient who died while receiving semaglutide had his report invalidated because call-center contractors claimed the patient identifier was missing, even though FDA inspectors identified the identifier in the source documents.

The FDA also found that adverse event files remained in "medical review" past Novo Nordisk's 10-day internal deadline. A consumer report of suicidal ideation on semaglutide received in December 2024 was not reviewed until February 2025, following questions from FDA inspectors.

"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 stated.

Warning Letter History

The March 2026 letter is the third FDA warning issued to Novo Nordisk in six months. In September 2025, the FDA cited a promotional video featuring Oprah Winfrey as misleading for minimizing safety risks. In November 2025, a separate letter identified manufacturing deficiencies at a contract production facility.

Plaintiffs' counsel noted to USA TODAY that the findings provide regulatory corroboration for failure-to-warn arguments in the MDL.

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."

Impact on GLP-1 Litigation

Strengthening Failure-to-Warn Claims

The warning letter provides plaintiffs' attorneys with evidence that institutional procedures prevented adverse event reports from reaching the FDA. The findings focus directly on written company protocols.

For the 3,363 cases in MDL-3094 alleging gastroparesis, bowel obstruction, and related GI injuries, the letter supports claims regarding adverse event reporting and knowledge. Expert discovery closed March 27, and summary judgment briefing concludes in late April.

Parallel Vision Loss Litigation

In addition to GI claims, a second GLP-1 MDL was created in December 2025 for vision loss injuries. MDL-3163, 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 condition causing sudden, permanent vision loss.

A July 2024 study in JAMA Ophthalmology found that semaglutide users experienced a 4.28x increased risk of NAION among diabetic patients and a 7.64x increased risk among weight-loss patients.

Evidentiary Requirements for Prescription Verification

Establishing drug exposure requires verified pharmacy fill logs confirming the exact medication, dosage, and dispensing timeline. Physician progress notes and health insurance claims substantiate continuous use. Claims involving compounded semaglutide generally do not meet MDL inclusion criteria, which require name-brand products.

Next Steps for Law Firms

Summary

The FDA's warning letter to Novo Nordisk establishes a regulatory record regarding adverse event reporting practices. With over 31 million Americans taking GLP-1 medications and litigation volume increasing, the findings will be evaluated during upcoming bellwether proceedings.

Firms handling GLP-1 inventories should secure complete pharmacy dispensing logs and specialty medical records to document exposure and injury onset.

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