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Following the discovery that the popular heartburn drug Zantac produces high levels of a cancer-causing chemical, a Kentucky woman has filed a product liability lawsuit alleging she was diagnosed with stomach cancer and liver cancer following regular use of the drug for about eight years.
The complaint (PDF) was filed earlier this month by Vicki Sherbet in the U.S. District Court for the Eastern District of Kentucky, blaming the presence of N-Nitrosodimethylamine (NDMA) in Zantac for the development of her cancer.
Sherbet presents claims against various manufacturers of the brand-name drug, including Boehringer Ingelheim, Sanofi US, Chattem, Inc., Pfizer and GlaxoSmithKline as defendants, joining a growing number of lawsuits filed nationwide by former users who allege that the drug makers knew or should have known that Zantac causes cancer, yet failed to warn consumers or the medical community about the risk
Zantac (ranitidine) has been a top selling heartburn drug for decades, becoming the first medication to surpass $1 billion in annual sales in 1988, amid aggressive marketing which established it as a safe and effective treatment for acid reflux and heartburn. However, it now appears the drug makers have known for years that the active pharmaceutical ingredient is inherently unstable, and produces high levels of the chemical byproduct NDMA, which is considered a carcinogen.
The public was not informed about the high levels of NDMA produced by Zantac until September 2019, when an independent pharmacy, Valisure, conducted testing that found each pill may result in levels of exposure that are substantially higher than the permissible daily intake limit for NDMA set by the FDA.
Valisure indicates some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA. The daily limit deemed safe by the FDA is 96 ng.
“To be clear, this is not a contamination case – the levels of NDMA that researchers are seeing in Zantac is not the product of some manufacturing error,” the lawsuit notes. “The high levels of NDMA observed in Zantac is a function of the ranitidine molecule and the way it breaks down in the human digestive system.”
Rather than warning patients or the medical community about the Zantac cancer risk, which may have resulted in closer monitoring and testing for former users, the lawsuits indicates that the drug makers continued to engage in aggressive marketing campaigns designed to increase sales and further exposure users to a risk of gastric cancer, bladder cancer, pancreatic cancer, esophageal cancer and other injuries.
This cases joins dozens of Zantac lawsuits filed in recent weeks that involve former users who indicate they have already been diagnosed with cancer following years of exposure to ranitidine.
To deal with the increasing complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation ordered all Zantac claims be centralized and consolidated in the U.S. District Court for the Southern District of Florida, where the litigation will be overseen by U.S. District Judge Robin L. Rosenberg during coordinated discovery and pretrial proceedings.