Product News and Recalls

Zantac Carcinogen Lawsuits Consolidated into Multidistrict Litigation

Zantac lawsuits consolidated into MDLAs the number of lawsuits filed over NDMA contaminated Zantac continues to grow, over 140 such suits have been sent to a federal judge to be heard as a multidistrict litigation. The MDL will be the first for U.S. District Judge Robin Rosenberg who serves as a judge for the Southern District of Florida. In selecting Judge Rosenberg, the Judicial Panel on Multidistrict Litigation called her “an able jurist who has not yet had the opportunity to preside over an MDL.”

The lawsuits stem from the discovery of NDMA, or N-nitrosodimenthylamine, in batches of ranitidine. Ranitidine is the generic form of Zantac and the main active ingredient in the drug. Investigators initially suspected the contamination was a result of a production fault or some other error originating out of two Indian pharmaceutical suppliers. The discovery led to a global recall of Zantac while investigators continued researching the matter. That investigation took an interesting twist, however, when it was discovered that the source of the NDMA contamination in Zantac might have actually been Zantac itself.

Tests conducted by a California-based laboratory showed that Zantac can produce the carcinogen on its own when it is exposed to heat. The higher the level of heat, the more NDMA is produced. And, while the heat of storage units and shipping containers are certainly the kinds of environments were NDMA production might flourish, the director of the lab that made the discovery fears that Zantac might produce NDMA at any temperature, albeit at a slower rate. “The more you heat it, the more NDMA you generate,” he said in an interview. “I am worried that if it just sits at home at room temperature it could gradually generate NDMA.”

Zantac is a wildly popular heartburn medication and a big seller for GlaxoSmithKline. Given the amount of the drug that might be in medicine cabinets across the country, the Zantac MDL could very quickly turn into a massive case.