Class Action Claims Sanofi Knew ‘For Years’ of Zantac NDMA Contamination

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French pharmaceutical giant Sanofi is among the defendants in a proposed class action lawsuit that claims the company fraudulently concealed the presence of the carcinogen N-nitrosodimethylamine (NDMA) in Zantac.

Zantac, the over-the-counter brand name of the drug ranitidine, is designed to treat heartburn and other ailments, the case begins. Filed in New Jersey federal court, the lawsuit alleges Sanofi and its co-defendants were aware for years that their product could contain unsafe levels of cancer-causing NDMA yet failed to include a warning on Zantac’s label or otherwise notify the public and the FDA as required by law.

Although Zantac, the rights to which Sanofi obtained from co-defendant Boehringer Ingelheim Pharmaceuticals in 2017, had for years been widely prescribed to millions with ulcers, heartburn and other illnesses, several studies have since confirmed the presence of NDMA in ranitidine, the lawsuit states. Online pharmacy Valisure, for instance, ran tests on the drug and found that it contained over 3 million nanograms (ng) of NDMA, which, according to the lawsuit, is 26,000 times the FDA’s allowable daily limit of 96 ng. According to the case, the pharmacy subsequently reported its findings to the FDA along with a citizen petition to recall the drug.

In September 2019, the FDA notified the public of the dangers of ranitidine, which, according to the lawsuit, led some companies to issue recalls while several countries halted sales of the drug entirely. Sanofi, however, failed to immediately do so, the lawsuit says.

Though Sanofi eventually issued a recall in October 2019, the company waited until after Zantac’s negative effects were publicized by the FDA and the media, the complaint states. The case contends that Sanofi’s recall fails to atone for years of concealing the dangers of Zantac from consumers, especially when safer alternatives were available. From the complaint:

“Sanofi’s recall is far from an adequate response. The problem is that Sanofi knew its drug posed a risk to consumers and it chose not to disclose that information. This is when safer alternatives existed, which without a doubt patients would have taken to avoid unnecessary risks to their health. But Sanofi put profits above the safety of its consumers and kept that information from them.”

The lawsuit looks to represent a class covering all persons in the United States who bought Zantac over the counter.