Recalled Zantac Had “Staggeringly High Levels” Of Cancer-Causing NDMA: Lawsuit

According to a recently filed product liability lawsuit, recalled Zantac pills have exposed users to massive amounts of the chemical N-Nitrosodimethylamine (NDMA) for decades, which allegedly caused a Tennessee man to develop bladder cancer.

The complaint (PDF) was filed by Carl Williams in the U.S. District Court for the Middle District of Florida on May 1, indicating that exposure to “staggeringly high levels” of NDMA produced by ranitidine, the active ingredient in Zantac.

Williams indicates he began using the popular heartburn drug in about 1990, and continued to take 150 mg of Zantac per day for nearly three decades, resulting in his bladder cancer diagnosis in August 2019.

The very next month, in September 2019, the independent pharmacy Valisure announced it detected high NDMA levels across multiple versions of Zantac tested, indicating that ranitidine contained in the pills may produce the cancer-causing chemical byproduct when stored at high levels or inside the body.

According to the lawsuit filed against Boehringer Ingelheim, Sanofi US Services, Chattem, Inc., Pfizer, Inc. and GlaxoSmithKline, the drug makers knew or should have known about the Zantac NDMA problems, yet continued to market and sell the drug to consumers without warnings or information about the potential cancer risks.

“Zantac (chemically known as ranitidine), the popular antacid medication used by millions of people every day, leads to the production of staggering amounts of NDMA when it is digested by the human body,” according to the complaint. “The U.S. Food and Drug Administration’s (‘FDA’) allowable daily limit of NDMA is 92 ng (nanograms) and yet, in a single dose of Zantac, researchers are discovering over 3 million ng.”

Following the discovery of high levels of NDMA, most versions of Zantac were recalled late last year, and the FDA issued recommendations last month that no ranitidine-based drugs should still be sold, since it could not be determined how long or under what conditions pills have been stored before they reach consumers.

Exposure to high levels of NDMA has been linked to reports of breast cancer, testicular cancer, kidney cancer, bladder cancer, colorectal cancer, stomach cancer and other injuries, which a growing number of Zantac lawsuits now allege was not adequately disclosed to users of the medication.

“Had any Defendant warned Plaintiff that Ranitidine under brand name Zantac could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac,” Williams’ lawsuit states. “After being diagnosed with cancer, Plaintiff investigated what could have caused his cancer, but to no avail until recently when he heard about the connection of Zantac to NDMA and cancer.”

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.