Zantac Lawsuit Alleges Carcinogenic Byproduct Caused Bladder Cancer And Kidney Cancer Diagnosis

Just one day before federal regulators ordered all Zantac products removed from the market, a Pennsylvania man filed a product liability lawsuit alleging that carcinogenic byproducts of Zantac caused bladder cancer and kidney cancer, following years of exposure to the widely used heartburn drug.

Donald Leon filed the complaint (PDF) in the U.S. District Court for the Southern District of Florida on March 30, indicating that Boehringer Ingelheim, Sanofi US Services, Inc. Pfizer, Inc., and GlaxoSmithKline, LLC knew or should have known that Zantac produced high levels of N-Nitrosodimethylamine (NDMA), a cancer-causing agent.

According to the lawsuit, Leon used Zantac from about 2001 through 2019, taking about 600 mg per week. As a result of the long-term exposure to the Zantac chemical byproduct NDMA, Leon indicates that he was diagnosed with bladder cancer and kidney cancer in April 2018.

“Based on prevailing scientific evidence, exposure to Zantac (and the attendant NDMA) can cause bladder cancer and kidney cancer in humans. Plaintiff’s cancers were caused by ingestion of Zantac,” the lawsuit states. “Had any Defendant warned Plaintiff that Zantac could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac.”

Zantac (ranitidine) has been a top selling heartburn drug for decades, becoming the first medication to surpass $1 billion in annual sales in 1988, amid aggressive marketing which established it as a safe and effective treatment for acid reflux and heartburn.

According to allegations raised in a growing number of Zantac lawsuits filed in recent months, various manufacturers of Zantac and generic ranitidine have known that the active pharmaceutical ingredient was inherently unstable, and exposure users to dangerously high high levels of the chemical byproduct NDMA, which is toxic and increases the risk of bladder cancer, kidney cancer, colorectal cancer, stomach cancer and other cancers along the digestive tract.

The public was not informed about the Zantac carcinogenic byproduct 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.

On April 1, after months of removing batches of Zantac as they tested positive for high levels of NDMA, the FDA called for a nationwide Zantac recall, determining that all versions of the heartburn drug pose a risk to the public. The decision came after the FDA determined that levels of NDMA increase in Zantac over time while it is stored, particularly if it is stored in higher than average temperatures.

As Zantac injury lawyers continue to review and file claims in the coming weeks and months, the size and scope of the litigation is expected to continue to increase, likely involving thousands of complaints filed nationwide.

To deal with the increasing complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation recently 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.