A federal judge in Florida has turned down a motion by several drug makers to dismiss a class action alleging that plaintiffs consumed doses of the heartburn drug Zantac containing cancer-causing impurities.
Judge Robin Rosenberg of the Southern District of Florida denied the motion by GlaxoSmithKline, Sanofi, Pfizer and Boehringer Ingelheim on Oct. 6 to dismiss the lawsuit. The defendants argued the plaintiffs had failed to prove they consumed Zantac doses with levels of the impurity N-Nitrosodimethylamine (NDMA) that significantly increased cancer risks.
Rosenberg, however, found that the plaintiffs’ arguments were adequate to support their claims of carcinogen exposure.
The lawsuit was filed in the wake of an April 2020 decision by the U.S. Food and Drug Administration requesting makers of prescription and over-the-counter drugs containing ranitidine, which is better known by the brand name Zantac, to pull the products from the market. The FDA took the action after investigating NDMA levels in ranitidine drugs.
“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA said in a news release.
Despite the judge’s ruling, the pharmaceutical companies are standing by the safety of their medicines.
“We remain confident in the strength of our defenses in this litigation,” a Sanofi spokesperson said in an email to the Florida Record. “In particular, as both FDA and the European Medicines Agency have recently published, the weight of the scientific evidence does not support the plaintiffs’ claims that Zantac causes cancer.”
In its investigation, the FDA said many of the samples it initially studied did not contain unacceptable levels of NDMA, but the agency also noted that it could not be sure of how long those samples were stored.
The plaintiffs argue that NDMA levels found in the drug can cause potentially deadly diseases, including bladder, breast, colorectal, kidney, lung, pancreatic and prostate cancers. They are seeking monetary damages for financial losses and medical monitoring.