Zantac Exposure Over More Than Two Decades Resulted in Colon Cancer Diagnosis, Lawsuit Claims

Following years of regular exposure to cancer-causing chemicals in Zantac, a Georgia woman indicates in a recently filed product liability lawsuit that she developed colon cancer.

A complaint (PDF) was filed by Bobbie Serviss in the U.S. District Court for the Northern District of Georgia on February 28, indicating that the drug makers failed to disclose that the active ingredient in the widely used heartburn drug produces high levels of the chemical N-Nitrosodimethylamine (NDMA), which is a potent carcinogen.

Serviss indicates that she regularly used Zantac for 21 years, unaware that she was exposing herself to a chemical biproduct of making rocket fuel, which is only intended for use to induce tumors in animals as part of laboratory experiments.

As a result of the Zantac exposure, Serviss indicates that she was diagnosed with colon cancer in May 2018. However, it would be more than a year later before she discovered that there may be a connection between her use of Zantac and cancer diagnosis.

Zantac (ranitidine) was introduced nearly 30 years ago, and became the first medication to surpass $1 billion in annual sales in 1988, amid aggressive marketing that established it as a safe and effective treatment for acid reflux and heartburn. The brand name drug continued to be widely used by millions of Americans until most versions were pulled from the market last year, when it was discovered that the pill results in the production of large amounts of a cancer-causing chemical, known as N-Nitrosodimethylamine or NDMA.

The public was not informed about the high levels of NDMA produced by Zantac until September 2019, when an independent pharmacy, Valisure, conducted testing that found each pill may result in levels of exposure that are substantially higher than the permissible daily intake limit for NDMA set by the FDA.

Valisure indicates some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA. The daily limit deemed safe by the FDA is 96 ng.

Rather than warning about the Zantac cancer risk, which may have resulted in closer monitoring and testing for former users, the lawsuits indicates that the drug makers continued to engage in aggressive marketing campaigns designed to increase sales and further exposure users to a risk of colon cancer, gastric cancer, bladder cancer, pancreatic cancer, esophageal cancer and other injuries.

“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,” the lawsuit states. “Nonetheless, Defendants deliberately crafted their label, marketing, and promotion to mislead consumers.”

This cases joins dozens of Zantac exposure lawsuits filed in recent weeks that involve former users who indicate they have already been diagnosed with cancer following years of exposure to ranitidine.

To deal with the increasing complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation ordered all Zantac claims be centralized and consolidated in the U.S. District Court for the Southern District of Florida, where the litigation will be overseen by U.S. District Judge Robin L. Rosenberg during coordinated discovery and pretrial proceedings.