1. NDMA Contamination and Cancer Risk
- Core Allegation: Plaintiffs allege that Zantac (ranitidine) is inherently unstable and can break down into N-Nitrosodimethylamine (NDMA), a probable human carcinogen, especially when exposed to heat, humidity, or during digestion.
- Cancer Claims: Lawsuits link long-term Zantac use to cancers such as bladder, stomach, esophageal, liver, colorectal, prostate, and kidney cancer.
- Scientific Dispute: The admissibility and sufficiency of scientific evidence connecting Zantac to cancer is a central issue. Courts have recently excluded some expert testimony, challenging plaintiffs’ ability to prove causation. E.g., In re Zantac (ranitidine) Litigation, No. N22C-09-101 (Del. 7/10/2025).
2. Failure to Warn and Concealment
- Failure to Warn: Plaintiffs claim manufacturers failed to adequately warn the public and healthcare professionals about the risk of NDMA contamination and its potential to cause cancer.
- Alleged Concealment: There are allegations that drugmakers, including GSK and Sanofi, were aware of NDMA risks for decades but concealed this information from regulators and consumers, prioritizing profits over safety.
- Labeling Issues: Original product labels did not mention NDMA or cancer risks, and manufacturers are accused of delaying recalls and downplaying adverse event reports.
3. Regulatory and Legal Actions
- FDA Recall: The FDA ordered all ranitidine-based products, including Zantac, off the U.S. market in April 2020 due to NDMA contamination concerns.
- Multidistrict Litigation (MDL): Thousands of cases have been consolidated in federal and state courts, with Delaware and Florida being major jurisdictions for ongoing litigation.
- Dismissals and Appeals: In December 2022, a federal judge dismissed many Zantac cases for insufficient evidence of causation, but appeals and state-level cases continue.
4. Manufacturer and Shareholder Lawsuits
- Manufacturer Liability: Major pharmaceutical companies named include Sanofi, GlaxoSmithKline (GSK), Pfizer, Boehringer Ingelheim, and others.
- Shareholder Claims: GSK shareholders have also sued the company, alleging it concealed knowledge of NDMA risks, especially after large settlements with affected consumers.
- Whistleblower Allegations: Whistleblowers and independent labs like Valisure claim drugmakers had knowledge of NDMA risks since the 1980s but failed to disclose them.
5. Ongoing Litigation and Settlements
- Current Status: As of July 2025, tens of thousands of cases remain active, with some consolidated in Delaware and ongoing appeals regarding the admissibility of scientific evidence.
- No Universal Settlement: There have been some settlements, but no universal resolution or bellwether trial verdicts have been reached yet.
These issues collectively define the complex and ongoing nature of the Zantac litigation in the United States.
