Colon Cancer Resulted from 10 Years of Exposure to NDMA in Zantac, Lawsuit Alleges

Following use of the recalled heartburn drug Zantac for ten years, a Florida woman indicates she developed colon cancer due to exposure to high levels of the carcinogen N-Nitrosodimethylamine (NDMA) created by the medication.

The complaint (PDF) filed by Cynthia Minkley in the U.S. District Court for the Southern District of Florida on January 7, alleging that NDMA in Zantac is a function of the ranitidine molecule in the widely used heartburn and acid reflux drug, and the way it breaks down in the human digestive system.

Minkley indicates the drug makers Boehringer Ingelheim, Sanofi, Pfizer and GlaxoSmithKline knew Zantac exposed users to levels of NDMA, yet failed to disclose the potential cancer risk or report the problem to consumers, doctors or regulators.

“(NDMA”) is a potent carcinogen. It used to be a chemical biproduct of making rocket fuel in the early 1900s but, today, its only use is to induce tumors in animals as part of laboratory experiments,” the lawsuit notes. “Its only function is to cause cancer. It has no business being in a human body.”

About 200,000 Americans are diagnosed with colon cancer every year. It is highly treatable, particularly when discovered in its earliest stages.

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, due to concerns about the risk of cancer from NDMA produced by Zantac.

The case filed by Minkley joins dozens of similar Zantac cancer lawsuits filed in recent months, 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, 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. According to the lawsuit, Minkley tooktwice that amount daily for a decade. 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.