Zantac Side Effects Led To Kidney Cancer, Gallbladder Removal: Lawsuit

In a recently filed lawsuit, a D.C. woman indicates she developed kidney cancer and had to have her gallbladder removed due to side effects of Zantac, which exposed her to cancer-causing chemicals during 18 years of taking the popular heartburn drug.

Robin S. McKinney filed the complaint (PDF) in the U.S. District Court for the District of Columbia on March 5, pursuing damages from Boehringer Ingelheim, Sanofi US Services, Inc., Chattem, Inc. Pfizer, Inc. and GlaxoSmithKline, LLC, who manufactured and sold brand-name Zantac at various times without warning about the potential risks.

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 active ingredient in the pill, ranitidine, produces large amounts of a cancer-causing chemical, known as N-Nitrosodimethylamine, or NDMA.

McKinney indicates she was unaware of the presence of NDMA in Zantac, and took the drug almost daily for 18 years. According to the lawsuit, she was diagnosed with kidney cancer in 2018, and had her gallbladder removed as a result of the Zantac side effects that resulted from her exposure to NDMA.

“Plaintiff regularly ingested Zantac since 2002, ingesting the drug 5-7 times a week on average,” the lawsuit states. “As a direct and proximate result of ingesting Zantac, Plaintiff developed kidney cancer and painful gall bladder stones and complications and underwent surgery in 2018 to have half of her left kidney and gall bladder removed.”

The public was not informed about the high levels of NDMA produced by Zantac until a year later, in September 2019, when the 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.

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

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.

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.