Sanofi-Aventis U.S. LLC, Sanofi US Services Inc., and Chattem, Inc. have been hit with anotherproposed class action that claims the companies knowingly manufactured and sold Zantac contaminated with the probable carcinogen N-Nitrosodimethylamine (NDMA).
The lawsuit states that on September 9, 2019, independent pharmacy Valisure submitted a citizen petition to the FDA requesting the suspension of sales of ranitidine, the generic form of Zantac, due to “extremely high levels” of probable cancer-causing agent NDMA detected in the popular heartburn drug. According to the complaint, Valisure found that ranitidine “reacts with itself due to a molecular instability” and is capable of producing NDMA in excess of 3,000,000 ng per 150 mg tablet, or more than 31,000 times the maximum daily intake level recommended by the FDA.
Following Valisure’s petition, the FDA issued a MedWatch Alert and several recalls of certain lots of ranitidine, the suit says. On October 2, 2019, the agency reportedly revealed that “early, limited testing found unacceptable levels of NDMA in samples of ranitidine.”
The lawsuit argues that despite these concerns, Sanofi waited until October 18, 2019 to issue a voluntary recall of over-the-counter Zantac. The defendants, the case alleges, “knew or had reason to know” that taking Zantac would expose consumers to unsafe levels of NDMA yet failed to disclose the potential danger to buyers. According to the case, the defendants sold and distributed Zantac in “a false, deceptive and misleading manner” by failing to disclose that those who took the drug may be exposed to NDMA.