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According to allegations raised in a recently filed product liability lawsuit, side effects of Zantac caused an Illinois woman to develop gastric cancer after years of exposure to a known carcinogen produced by the active ingredient in the popular heartburn drug.
The complaint (PDF) was filed by Christine Erfft in the U.S. District Court for the District of New Jersey on February 14, indicating that the drug makers failed to disclose that Zantac contained high levels of N-Nitrosodimethylamine (NDMA), which is known to cause cancer.
Zantac (ranitidine) was one of the best selling drugs in history, becoming the first medication to surpass $1 billion in annual sales in 1988, and it continued to be widely used, both over-the-counter and as generic ranitidine, until most versions were pulled from the market last year, when it was discovered that the pill produces large amounts of NDMA.
Erfft indicates she developed gastric cancer following Zantac use for more than 18 years, presenting claims against various manufacturers of the brand-name drug, including Sanofi, Sanofi-Aventis U.S., Boehringer Ingelheim, Chattem and GlaxoSmithKline.
Rather than warning about the Zantac cancer risk, which may have resulted in closer monitoring and testing for former users, the lawsuit 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.
“Had Defendants provided adequate warnings and instructions and properly disclosed and disseminated the risks associated with their Zantac products, Plaintiff could have avoided the risk of developing injuries and could have obtained or used alternative medication,” according to the complaint.
While multiple manufacturers have issued Zantac recalls since September 2019, many consumers remain unaware that cancer diagnosed in recent years may have been caused by the heartburn drug, which has been on the market since 1986.
Erfft indicates she was diagnosed with gastric cancer from Zantac in June 2019, but the public was not informed about the high levels of NDMA produced by the medication until September 2019, when an independent pharmacy found that each pill may result in levels of exposure that are substantially higher than the permissible daily intake limit for NDMA set by the FDA.
The pharmacy Valisure conducted independent testing of pill, finding that 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,” Erfft’s lawsuit notes. “The high levels of NDMA observed in Zantac are a function of the ranitidine molecule and the way it breast down in the human digestive system.”
Erfft’s complaint is one of a growing number of Zantac lawsuits filed in recent months nationwide, each indicating that the manufacturers failed to provide adequate warning of the risks of NDMA exposure to consumers or the medical community.
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.