A federal judge issued a ruling over 300 pages long on Dec. 6 that dismisses tens of thousands of Zantac cancer lawsuits and claims because of weak evidence that the drug’s active ingredient–ranitidine–contained dangerously-high levels of a potentially cancer-causing contaminant. The order by Judge Robin Lee Rosenberg, who is overseeing a consolidation of approximately 2,450 Zantac lawsuits in multidistrict litigation (MDL) in United States District Court for the Southern District of Florida, issued a summary judgement for Zantac manufacturers, GlaxoSmithKline, Pfizer, Sanofi SA and Boehringer Ingelheim. The order also prevents more than 150,000 additional Zantac claims that were on the federal claims registry from advancing into the MDL.
However, Judge Rosenberg’s ruling does not affect Zantac lawsuits filed at the state level. Zantac plaintiffs who allege that they developed bladder; liver; pancreatic; stomach; and esophageal cancer because of frequent exposure to NDMA filed their lawsuits at the federal level, while Zantac claimants who developed other types of cancers filed their claims in state courts.
In 2019, an online pharmacy and independent laboratory testing company, Valisure, claimed in 2019 to have “discovered the link of Zantac and its generics (ranitidine) to the carcinogen NDMA during its routine testing of every batch of every medication.” Valisure consequently alerted the FDA of its findings that found N-Nitrosodimethylamine (NDMA), was the result of the ‘inherent instability’ of the ranitidine molecule, and filed a citizens petition with the FDA.
After conducting its own testing, the FDA recalled all ranitidine-containing products from the market on April 1, 2020. But Judge Rosenberg called into question the legitimacy of Valisure’s testing on NDMA. The judge said that Valisure heated ranitidine significantly above temperatures in the human body; used excessively-high amounts of sodium; and that legal products on the market such as heavily-processed meats expose consumers to roughly the equivalent amount of NDMA in Zantac.
Valisure’s testing revealed that a single dose of Zantac could contain levels of NDMA as high as 3 million nanograms, exceeding the FDA’s daily safe limit of 96 ng. Zantac MDL plaintiffs are likely to appeal the decision, thus, Zantac litigation could be ongoing for a long time to come.