Lawsuit claims Zantac use led to bladder cancer, multiple surgeries

by Jeffrey Nadrich Managing Partner, Nadrich & Cohen, LLP

A lawsuit filed in federal court in Pennsylvania on October 9 alleges that Zantac use led to a Pennsylvania man developing bladder cancer and needing multiple surgeries. The lawsuit names Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi US Services, Inc., Chattem, Inc., and GlaxoSmithKline, LLC as defendants.

The plaintiff is a Pennsylvania man who took 150 mg per day of Zantac from “as early as 2010” through 2019 and developed bladder cancer which necessitated three surgeries and continued monitoring to date.

NDMA

The lawsuit focuses on N-Nitrosodimethylamine (NDMA), which it refers to as a “known potent carcinogen.” The complaint notes that NDMA was once a byproduct of rocket fuel production but its only use today is to induce tumors in animals for lab experiments.

Zantac “produces staggering amounts of NDMA when it is digested by the human body. The U.S. Food and Drug Administration’s (“FDA”) allowable daily limit of NDMA is 92 ng (nanograms). In a single dose of Zantac, researchers are discovering levels in excess of 3 million ng per day in some cases,” according to the complaint.

The complaint claims that “the high levels of NDMA observed in Zantac are a function of the ranitidine molecule as it is broken down in the human digestive system.”

The complaint states that NDMA is “a member of N-nitrosamines, a family of potent carcinogens,” and that the “dangers that NDMA poses to human health have long been recognized.”

The complaint notes that a 1979 news article noted that NDMA had caused cancer in almost every lab animal tested.

The complaint states that NDMA is classified as a probable human carcinogen by the Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC). The complaint notes that the World Health Organization “has stated that scientific testing indicates that NDMA consumption is positively associated with either gastric or colorectal cancer and suggests that humans may be especially sensitive to the carcinogenicity of NDMA.”

The lawsuit notes that kidney, bladder, liver, lung, pancreas and stomach cancers were seen in animal studies investigating oral administration of NDMA.

“In addition, NDMA breaks down into various derivative molecules that, themselves, are associated with causing cancer. In animal studies, derivatives of NDMA induced cancer in the stomach and intestine (including colon),” the complaint states.

The complaint notes that EPA cancer guidelines generally assume that what causes tumors in animals might cause tumors in humans.

The complaint cites several studies dating back to 1995 finding an association between NDMA and cancer.

How Zantac becomes NDMA inside the body

The complaint claims that the NDMA levels produced by Zantac are “inherent to the molecular structure of ranitidine, the active ingredient in Zantac.” Ranitidine molecules contain a nitrite and a dimethylamine group “which are well known to combine to form NDMA. Thus, ranitidine produces NDMA by ‘react[ing] with itself,’ which means that every dosage and form of ranitidine, including Zantac, exposes users to NDMA,” the complaint states.

The complaint states that DMA and a nitoroso source reacting and forming NDMA is “well characterized in the scientific literature,” citing an example from 2003 where “alarming levels of NDMA in drinking water” were “specifically linked to the presence of ranitidine.”

“Recent testing of NDMA levels in ranitidine batches are so high that the nitroso for NDMA likely comes from no other source than the ranitidine molecule itself,” the complaint claims.

The complaint notes that the results of tests by testing lab Valisure showed that while NDMA was not detected in control tablets, up to 304,500 ng of NDMA was detected in a single dose of Zantac which was exposed to “biologically relevant conditions” involving simulated gastric fluid and sodium nitrite. This is over 3,300 times the FDA daily limit for NDMA intake.

The complaint states that antacid drugs “are known to increase stomach pH and thereby increase the growth of nitrite-reducing bacteria which further elevates levels of nitrite.” The complaint claims that existing research demonstrates ranitidine forms NDMA in the human stomach by interacting with acids and nitrites.

The complaint also notes that Valisure “identified a possible enzymatic mechanism for the liberation of ranitidine’s DMA group via the human enzyme” DDAH, adding that “liberated DMA can lead to the formation of NDMA when exposed to nitrite present on the ranitidine molecule, nitrite freely circulating in the body, or other potential pathways.”

The complaint cites a 2016 Stanford University study which found that healthy people who ingested 150 mg Zantac tablets “produced roughly 400 times elevated amounts of NDMA in their urine (over 47,000 ng) in the proceeding 24 hours after ingestion.”

Complaint claims defendants knew of NDMA defect, failed to test or warn

The complaint states that “the weight of scientific evidence showed that Zantac exposed users to unsafe levels of NDMA” during the time the defendants manufactured and sold Zantac in the U.S., yet the defendants failed to warn consumers of this risk on the drug’s label or report the risk to the FDA.

“Going back as far as 1981, two years before Zantac entered the market, research showed elevated rates of NDMA, when properly tested. This was known or should have been known by Defendants,” the complaint states.

The complaint states that a 1981 GlaxoSmithKline study studied and listed many metabolites of ranitidine in urine but there was no indication NDMA was looked for, claiming this omission “serves as a tacit admission that the manufacturer was avoiding detection of a carcinogen in their product.”

The complaint claims that GlaxoSmithKline published a flawed in study in 1987 which removed all gastric samples containing ranitidine out of concern these samples would contain “high concentrations of N-nitroso compounds being recorded.”

“So, without the chemical being present in any sample, any degradation into NDMA could not, by design, be observed,” the complaint states.

The complaint notes that several alternatives to Zantac exist which do not pose the same NDMA risk.

Lawsuit seeks punitive damages

The complaint states that the defendants’ conduct “was done with reckless disregard for human life, oppression, and malice. Defendants were fully aware of the safety risks of Zantac, particularly the carcinogenic potential of Zantac as it transforms into NDMA within the chemical environment of the human body. Nonetheless, Defendants deliberately crafted their label, marketing, and promotion to mislead consumers.”

The complaint argues that this decision was done with the intent of turning a profit by convincing consumers Zantac was safe. The complaint claims the defendants were successful in turning a profit via a misleading label and “through a comprehensive scheme of selective misleading research and testing, false advertising, and deceptive omissions.”

The complaint argues that, for these reasons, punitive damages against the defendants are warranted.

Causes of action

The lawsuit seeks to recover damages based on numerous causes of action, including:

Strict liability – design defect: The complaint argues that Zantac is defective by design because it is inherently dangerous when manufactured and used as intended.

Strict liability – failure to warn: The complaint argues the defendants knew Zantac contained NDMA and posed a cancer risk yet failed to warn the public about this.

Negligence: The complaint argues that the defendants had a duty to exercise reasonable care in the labeling of Zantac and failed to uphold this duty when they failed to warn about the NDMA in Zantac on Zantac’s label.

Breach of express and implied warranties: The complaint argues that the defendants expressly and impliedly warranted that Zantac was safe when it was, in fact, not.

About the author

Jeffrey Nadrich is the managing partner of Nadrich & Cohen, LLP, a California personal injury law firm which is investigating Zantac cancer claims.