Zantac Resulted In Bladder Cancer Diagnosis, Multiple Surgeries and Chemotherapy, Lawsuit Alleges

A recently filed product liability lawsuit indicates that side effects of Zantac caused a man to develop bladder cancer, resulting in multiple surgical procedures and harsh chemotherapy treatments for the cancer, which may have been avoided if the drug maker had disclosed problems with the heartburn drug.

David S. Sebag filed the complaint (PDF) in the U.S. District Court for the Southern District of Florida on April 6, naming Sanofi, Sanofi-Aventis, Chattem, Incl., Boehringer Ingelheim, GlaxoSmithKline and Pfizer as defendants

According to the complaint, the drug manufacturers knew or should have known that the active ingredient in Zantac, ranitidine, produces high levels of N-Nitrosodimethylamine (NDMA), a cancer-causing agent. However, rather than warning consumers, regulators and the medical community, the pharmaceutical companies continued to promote drug as safe.

Sebag indicates he began taking Zantac in the mid-1990s, due to acid indigestion, heartburn, and stomach pain. Following years o Zantac use, Sebag was diagnosed with noninvasive stage 1 bladder cancer in 2005.

“As a result thereof, Plaintiff was required to undergo numerous bladder surgeries between 2005 and 2017, followed by courses of chemotherapy treatments, as well as any and all of their sequelae and attendant pain, suffering, and emotional distress,” the lawsuit states. “The injuries and damages sustained by Plaintiff were caused by Defendants’ Ranitidine products, including Zantac, and their unlawful conduct with respect to Zantac’s design, manufacture, marketing and sale.”

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.