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Following daily use of over-the-counter Zantac 150mg tablets for several years, an Ohio man indicates that he developed bladder cancer, alleging in a recently filed lawsuit that the active ingredient in Zantac converts to high levels of a cancer-causing chemical once inside the body.
Michael Combs and his wife, Deborah, filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on November 14, after he was diagnosed with bladder cancer following use of Zantac OTC 150mg from about 2014 through 2017.
The lawsuit blames the cancer diagnosis on the chemical by-product N-Nitrosodimethylamine (NDMA), which is a carcinogen recently detected in multiple versions of the popular ranitidine-based heartburn drug, leading to massive Zantac recalls by a number of different drug makers.
Combs is pursuing damages from manufacturers and distributors of Zantac OTC, including Boehringer Ingelheim, Chattem, Inc., Sanofi, and Sanofi-Aventis, indicating that he never would have taken the drug had he known it contained large amounts of a cancer-causing agent.
“Despite notice and knowledge that ranitidine products, including Zantac, contained unsafe levels of NDMA which can cause cancer and other severe health problems, Defendants continued to market and sell ranitidine products, including Zantac, without warning consumers, healthcare providers and/or the FDA of these significant risks,” according to the complaint. “Consumers, including Plaintiff, relied on the Defendants’ false representations and were mislead as to Zantac’s safety. Had Plaintiff known of the risks of cancer and other injuries associated with Zantac, Plaintiff would not have used the drug.”
The case joins a growing number of Zantac lawsuits filed in recent weeks by consumers diagnosed with bladder cancer, stomach cancer, colorectal cancer, esophageal cancer and other cancers along the digestive tract, alleging that ranitidine breaks down into NDMA inside the body.
While the FDA’s permissible daily intake limit for NDMA is 96 ng, the online pharmacy Valisure recently determined that some Zantac tablets contain up to 3,000,000 ng of NDMA; 29,000 times the daily limit.
In September, Valisure filed a Citizens Petition, which calls for the drug to be recalled from the market, leading the FDA has issued warnings about the potential risk of Zantac NDMA contamination, which the agency is continuing to investigate.
“Since the filing of Valisure’s Citizen Petition on September 9, 2019, virtually every health regulator throughout the world, with the exception of the U.S. FDA, has taken steps to remove Zantac and ranitidine from the marketplace,” according to the complaint. “In addition, many manufacturers, including the Boehringer and Sanofi Defendants, have also recalled the drug.”
Combs indicates that he did not discovery, and could not have discovered that high levels of NDMA were produced by Zantac, claiming that the drug makers fraudulently concealed the information and continued to sell the drug, without disclosing this information.
As lawyers continue to review and file claims for individuals diagnosed with cancer from Zantac, it is widely expected that hundreds, if not thousands, of similar product liability lawsuits will be filed in the coming months.