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A product liability lawsuit filed against several drug manufacturers indicates the side effects of Zantac caused bladder cancer for a Colorado man, alleging that the active ingredient in the widely used heartburn drug converts to a known human human carcinogen.
The complaint (PDF) was filed last week by Allan Mark Blake in the U.S. District Court for the District of Colorado, naming several different manufacturers of the ranitidine-based drug as defendants, including Boehringer Ingelheim, Sanofi US, Pfizer, GlaxoSmithKline and Chattem, Inc.
According to allegations raised in the Zantac bladder cancer lawsuit, the drug makers knew or should have known for decades that ranitidine in Zantac exposes consumers to excessive amounts of the chemical byproduct N-nitrosodimethylamine (NDMA), which is a probable carcinogen.
Zantac (ranitidine) has been on the market for decades, and is widely used by millions of Americans for treatment of heart burn and acid reflux. However, in recent weeks, multiple manufacturers have issued Zantac recalls, after testing confirmed the active ingredient may convert to NDMA when exposed to high temperatures, such as in a car or inside the human stomach.
NDMA is a chemical byproduct, which has been linked to reports of kidney cancer, stomach cancer, bladder cancer, small intestine cancer, liver cancer and other digestive tract cancers.
According to the lawsuit, Blake began using prescription Zantac in 1996. Over time, he switched to over-the-counter Zantac, taking it about four times per week through 2019. Following nearly three decades of use, Blake indicates he was diagnosed with bladder cancer in 2018, and blames the diagnosis on Zantac use.
The lawsuit indicates the manufacturers knew as far back as 1981, two years before Zantac was approved for sale, that it released elevated levels of NDMA. However, it was sold for all this time with no warning.
“During the time that Defendants manufactured and sold Zantac in the United States, the weight of scientific evidence showed that Zantac exposed users to unsafe levels of NDMA,” the lawsuit notes. “Defendants failed to disclose this risk to consumers on the drug’s label—or through any other means—and Defendants failed to report these risks to the FDA.”
While the FDA’s permissible daily intake limit for NDMA is 96 ng, an online pharmacy, Valisure, recently determined that some Zantac tablets contain up to 3,000,000 ng of NDMA; 29,000 times the daily limit. Following the findings, a Citizens Petition was filed that calls for the drug to be recalled from the market, and the FDA has issued warnings about the potential risk of Zantac NDMA contamination, indicating that the agency is continuing to investigate the issue.
The bladder cancer case filed by Blake joins a number of recently filed class action lawsuits, which seek damages for all purchasers of the recalled heartburn drug. It is also one of the first of what is expected to be hundreds, if not thousands, of individual Zantac cancer lawsuits that are likely to be filed in the coming months and years, alleging that a diagnosis could have been avoided if other available heartburn drugs had been used.