Zantac Class Action Lawsuit Filed Over Cancer Risk

Two plaintiffs have filed a class action lawsuit over allegations the heartburn drug Zantac exposes users to high levels of a probable human carcinogen, putting them at risk of developing cancer.

Plaintiffs Byron Gilks and Craig Siemms filed the Zantac class action lawsuit on April 29 in the Ontario Superior Court of Justice. They claim that the defendants knew or should have known that Zantac was unsafe for ingestion yet continued to market the drug.

Zantac means the drug products have ranitidine hydrochloride as their active pharmaceutical ingredient. Zantac is a drug that is used to treat certain gastrointestinal conditions such as heartburn, acid indigestion, gastroesophageal reflux disease, and ulcers of the stomach. In Canada, Zantac is sold over the counter in tablet form or as a prescription in various dosages.

Health Canada first approved Zantac for an original market date of Dec. 31, 1982, and the drug has been marketed, distributed and sold in Canada since that date. Zantac was originally only available in Canada as a prescription until 1997 when it was also marketed and sold in Canada as an over-the-counter drug.

According to the Zantac class action lawsuit, the ingestion of Zantac exposes users to high levels of N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

However, the defendants allegedly never disclosed the serious health risk posed by Zantac to Canadian consumers, health care providers or to Health Canada.

NDMA has reportedly been classified as a probable carcinogen by the International Agency for Research on Cancer. The World Health Organization has similarly found 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 plaintiffs assert that every dosage of Zantac exposes users to high levels of NDMA. According to the Zantac cancer class action lawsuit, the high levels of NDMA are inherent to the molecular structure of ranitidine, the active ingredient in Zantac.

Users of the heartburn drug were allegedly exposed to NDMA because ranitidine forms NDMA in the body when ingested. NDMA was present in the ranitidine used to manufacture Zantac, and NDMA forms when Zantac is exposed to high temperatures, according to the Zantac class action lawsuit.

The plaintiffs assert that the defendants should have been aware of numerous scientific studies showing that ranitidine poses a significant health risk to consumers. The Zantac cancer class action lawsuit points to scientific studies dating back to 1983 that indicate that ranitidine may pose a cancer risk. Despite their awareness of these studies, the defendants allegedly failed to disclose that Zantac exposes users to NDMA.

“Meanwhile, the Defendants profited handsomely from the sale of Zantac products in Canada,” the Zantac class action lawsuit says.

The defendants named in the Zantac class action lawsuit include GlaxoSmithKline, Pfizer, Johnson & Johnson, and Sanofi.

According to the Zantac class action lawsuit, there have been warnings and recalls in the United States, Canada and elsewhere over concerns of serious health risks associated with Zantac.

In September 2019, Health Canada reportedly requested companies to stop distributing ranitidine drugs such as Zantac in Canada. Numerous companies that manufactured or marketed ranitidine drugs in Canada subsequently recalled the products, including Sanofi which controlled the rights to over-the-counter Zantac in Canada.

Plaintiff Byron of Alberta says he has purchased over-the-counter and prescription Zantac for more than three decades. He began taking a prescription version of Zantac in the 1980s, but switched to over-the-counter Zantac, which he allegedly took regularly over the last few years until he learned in November that Zantac had been recalled because it contains NDMA.

Plaintiff Craig of Ontario says he has taken over-the-counter Zantac on a daily basis for more than 25 years. He has now stopped taking the drug due to the Zantac recall.

Byron and Craig claim that, due to the defendants’ acts and omissions, they have suffered loss, damage and/or injury.

“The risks associated with the use of Zantac, including the risk of developing cancer, were in the exclusive knowledge and control of the Defendants,” the Zantac class action lawsuit states.

“The extent of the risks was not known to, and could not have been known by, the Class Members, their physicians or other health providers, or Health Canada.”

Class Members of the proposed Zantac cancer class action lawsuit include Canadian consumers who purchased and/or ingested Zantac.

The defendants have been hit with more than one Zantac cancer class action lawsuit following the Zantac recall. Zantac class action lawsuits are currently pending in Montreal and British Columbia.

A U.S. Zantac cancer lawsuit was recently filed in Georgia federal court.

Have you ever taken the heartburn drug Zantac? Do you think the alleged cancer risk should’ve been disclosed to consumers and health providers? Tell us your thoughts in the comment section below! 

The plaintiffs are represented by Charles M. Wright, Daniel E.H. Bach, Anthony O’Brien, and James E. Boyd of Siskinds LLP.

The Zantac Cancer Class Action Lawsuit is Byron Gilks, et al. v. GlaxoSmithKline Inc., et al., Case No. CV-20-00001660-00CP, in the Ontario Superior Court of Justice, Canada.

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