A proposed class action lawsuit has been filed in New York’s Southern District over the possible contamination of heartburn treatment drug Zantac with dangerous levels of the probable carcinogen N-nitrosodimethylamine (NDMA).
Filed against drug manufacturer Sanofi U.S. LLC; distributor Chattem, Inc.; and retailers CVS Health Co. and Dollar Tree Stores, Inc., the lawsuit claims the defendants allowed the over-the-counter medicine to be sold to consumers despite knowing that it presented a safety risk and was essentially “worthless.” The case charges the apparent NDMA contamination stemmed from Sanofi’s manufacturing process for Zantac, which has since been recalled by the FDA.
According to the lawsuit, the FDA announced in September 2019 that NDMA, a nitrosamine the case says can cause liver damage and cancer, had been detected in some ranitidine medicines, including Zantac. Further testing revealed that “unacceptable levels” of the contaminant had been found in the drug, the lawsuit states.
Following these announcements, Sanofi failed to issue a recall for Zantac despite several other manufacturers initiating recalls of their own ranitidine medications, the lawsuit alleges. Further, CVS and Dollar Tree, the case states, continued to sell the drug in the face of safety concerns.
According to the lawsuit, which echoes claims presented in a prior suit filed in California, Zantac contains between 2.5-3.3 million nanograms of NDMA per tablet. The FDA’s daily intake limit for the substance is set at 96 nanograms, according to the lawsuit.
The case contends that consumers who purchased Zantac were damaged in the full amount of the purchase price of the medication. The lawsuit looks to represent classes of consumers nationwide and a New York-only subclass consisting of those who purchased Zantac.