Consumers suing drugmakers and others in a multidistrict litigation over a carcinogen found in heartburn medication Zantac fought in Florida federal court to keep their claims alive as the defendants argued their claims lacked specificity or an actual injury.
In a hearing before U.S. District Judge Robin L. Rosenberg on various motions to dismiss, the makers of Zantac told the court the consumers who used the drug or its generic equivalent ranitidine and have filed economic loss claims have not suffered any injury.
They bought a drug to treat a condition — in this case heartburn — and were not harmed, GlaxoSmithKline PLC attorney Lindsey Cohan of Dechert LLP told the court.
The suits accuse Sanofi SA, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc. and GlaxoSmithKline, as well as generic-drug makers, retailers, distributors and active pharmaceutical ingredient makers, of false advertising, failure to warn and other claims associated with the alleged discovery of the cancer-causing chemical nitrosodimethylamine, or NDMA, in the medication.
The U.S. Food and Drug Administration issued a warning in September 2019 that trace amounts of NDMA were found in Zantac and similar generic drugs. On April 1, 2020, it pulled all prescription and over-the-counter ranitidine drugs from the market over concerns that the drug, when stored at temperatures higher than room temperature, could result in exposure to unacceptable levels of the carcinogen.
The FDA has set an allowable daily limit of 96 nanograms of NDMA, but researchers have found more than 3 million nanograms in a dose of Zantac.