Zantac Class Action Lawsuit Claims Manufacturers Exposed Public To Unsafe Levels Of Cancer-Causing Agent

Several drug manufacturers face a Zantac class action lawsuit, which alleges consumers were defrauded for years into by buying a heartburn medication that contained high amounts of cancer-causing agents.

The complaint (PDF) was filed earlier this month by John Scholl, Ryan Dahl and Brad Hoag, in the U.S. District Court for the District of Minnesota, seeking class action status to pursue damages against Sanofi-Aventis, Sanofi US Services Inc. Chattem, Inc. and Boehringer Ingelheim Pharmaceuticals as defendants.

Zantac (ranitidine) has been a top selling heartburn and acid reflux drug since it was introduced in the early 1980s, but most versions have been removed from the market over the past few months, after a series of Zantac recalls were issued by different drug makers following the discovery that “unacceptable” levels of N-Nitrosodimethylamine (NDMA) were found in all versions of the medication.

The plaintiffs say the makers knew about the potential link between Zantac and cancer-causing chemicals, yet deceived the public for decades about presence of NDMA from the very beginning, withholding information from consumers, the medical community, and federal regulators.

“Both Sanofi and Boehringer knew or had reason to know that Zantac exposes users to unsafe levels of the carcinogen NDMA. During the period that Sanofi and Boehringer manufactured and distributed Zantac, numerous scientific studies were published showing, among other things, that ranitidine (the generic bioequivalent of Zantac) forms NDMA when placed in drinking water and that a person who consumes ranitidine has a 400-fold increase of NDMA concentration in their urine,” the lawsuit states. “Despite the weight of scientific evidence showing that Zantac exposed users to unsafe levels of the carcinogen NDMA, neither Sanofi nor Boehringer disclosed this risk to consumers on the drug’s label—or through any other means. Had Defendants disclosed that Zantac results in unsafe levels of NDMA in the human body, no person, let alone a reasonable person, would have purchased and consumed Zantac.”

The Zantac problems were not discovered by the public until September 2019, when the online pharmacy Valisure filed a Citizens Petition with the FDA, calling for all versions of Zantac to be recalled from the market, after testing confirmed that NDMA was created due to the inherent structure of the active pharmaceutical ingredient in the heartburn drug, ranitidine.

Valisure’s testing indicated Zantac contained up to 29,000 times the levels of NDMA the FDA considered permissible. While the FDA has questioned some of Valisure’s procedures, the agency conducted its own testing and agreed that the levels of NDMA were still excessively high.

Since the information was publicly released, dozens of Zantac cancer lawsuits have been filed by individuals throughout the United States, each involving similar allegations that plaintiffs developed kidney cancer, stomach cancer, bladder cancer, colorectal cancer, esophageal cancer or other cancers along the digestive tract, as ranitidine contained in Zantac broke down into NDMA inside the body.

As lawyers continue to investigate potential Zantac claims over the coming months and years, it is widely expected that thousands of lawsuits will be brought throughout the federal court system.