Exposure to high levels of the cancer causing chemical N-Nitrosodimethylamine (NDMA) in Zantac caused a Kentucky man to develop colorectal cancer that has spread to his liver, according to a recently filed lawsuit against several major manufacturers of the popular heartburn drug.

The complaint (PDF) was filed by Christopher Wamble in the U.S. District Court for the Western District of Kentucky on January 23, indicating that the drug makers knew or should have known about that Zantac generates high levels of the carcinogen for decades, yet consumers and regulators have only recently learned about the risk.

Wamble indicates that he used versions of Zantac (ranitidine) over a period of nine years before his cancer diagnosis, presenting claims against Boehringer Ingelheim, Sanofi US Services, Inc., Chattem, Inc., Pfizer, Inc. and GlaxoSmithKline, LLC, as defendants. By the time he discovered he had colorectal cancer from Zantac, it had already metastasized to his liver according to the lawsuit, lowering his chances of survival.

Zantac (ranitidine) was one of the best selling drugs in history, becoming the first medication to surpass $1 billion in annual sales in 1988, and it continued to be widely used, both over-the-counter and as generic ranitidine, until most versions were pulled from the market last year, when it was discovered that the inherent structure of the active pharmaceutical ingredient in the pill produces large amounts of NDMA.

“To be clear, this is not a contamination case—the levels of NDMA that researchers are seeing in Zantac is not the product of some manufacturing error,” the lawsuit states. “The high levels of NDMA observed in Zantac is a function of the ranitidine molecule and the way it breaks down in the human digestive system.”

Wamble’s complaint is one of dozens of similar Zantac cancer lawsuits filed in recent weeks, each involving nearly identical allegations that exposure to NDMA produced by the heartburn drug resulted in various forms of cancer along the digestive tract, including colon cancer, rectal cancer (known collectively as colorectal cancer), esophageal cancer, stomach cancer, bladder cancer, liver cancer, kidney cancer and other diseases.

While multiple manufacturers have issued Zantac recalls since September 2019, many consumers remain unaware that cancer diagnosed in recent years may have been caused by the heartburn drug, which has been on the market since 1986.

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.

To deal with the growing number of complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments later this month to determine whether the claim should be centralized before one judge for coordinated discovery and pretrial proceedings.

All parties have agreed that the claims should be consolidated as part of a federal MDL, or multidistrict litigation, to avoid duplicative discovery, conflicting pretrial rulings and to serve the convenience of common witnesses and parties, as well as the judicial system.

Tags: Cancer, Colorectal Cancer, Drug Recall, Heartburn, Heartburn Drug, Zantac