A lawsuit brought by 10 Connecticut residents accuses the former makers of Zantac of turning a blind eye to the danger posed by ranitidine, the generic active ingredient in the popular heartburn drug that was pulled off the market by the FDA in April 2020. 

The plaintiffs in the product liability lawsuit, filed in Connecticut Superior Court on August 29, allege that they developed bladder, breast, prostate or other cancers because of long-term usage of Zantac or its generic, over-the-counter equivalent ranitidine, which transforms over time and at temperatures above room temperature into a potentially-carcinogenic compound known as NDMA, Law360.com reports. According to the complaint, the plaintiffs purchased Zantac products as early as 2000. 

Former Zantac makers Boehringer Ingelheim, GlaxoSmithKline, Pfizer, and Sanofi are accused of distributing the products without a warning. Three Boehringer Ingelheim entities are Connecticut-based. 

"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 public," the complaint said per Law360. "Defendants concealed the Zantac-NDMA link from consumers in part by not reporting it to the [FDA], which relies on drug manufacturers to bring new information about an approved drug like Zantac to the agency's attention."

According to the complaint, the plaintiffs said they would have taken safer alternatives to Zantac, a drug that formerly produced over $1 billion in sales annually, had they known about the risk of ranitidine, and are seeking punitive and compensatory damages.

Federal Zantac lawsuits consolidated in multidistrict litigation (MDL) were dismissed in December 2022 after a U.S. District Judge in Florida overseeing the MDL ruled that plaintiffs’ expert witnesses used unreliable scientific methodologies linking NDMA to cancer. U.S. District Judge Robin Rosenberg’s ruling dismissed more than 150,000 claims in the MDL. 

Despite Judge Rosenberg’s ruling, the dismissal of the MDL does not apply to Zantac lawsuits filed at the state level. Furthermore, the plaintiffs in the Conn. suit argue that both the Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC), a World Health Organization (WHO) sub-entity, have labeled NDMA as a probable human carcinogen. The WHO itself has stated that conclusive evidence proves that high levels of NDMA are highly carcinogenic. 

The FDA’s allowable safe limit for NDMA consumption is 96 nanograms. The plaintiffs’ complaint says that a single dose of Zantac contains 3 million micrograms of the compound. The plaintiffs also state that derivatives of NDMA are also carcinogenic. Levels of NDMA can be very high in the body if ranitidine is taken alongside nitrate-containing foods such as cured meats. 

A Zantac trial scheduled for July in California settled before the trial date. To date, no Zantac cases have gone to trial. 

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