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For decades, drug makers have failed to disclose the risk of cancer from Zantac, according to allegations raised in a product liability lawsuit filed by an Ohio man who claims that NDMA exposure while using the popular heartburn drug resulted in his pancreatic cancer diagnosis.
The complaint (PDF) was filed by Randy J. Wright in the U.S. District Court for the Northern District of Ohio on January 29, naming Boehringer Ingelheim, Sanofi U.S., Chattem, Inc., Pfizer, Inc. and GlaxoSmithKline as defendants.
Wright indicates he began using over-the-counter Zantac in 1996, and used the heartburn and acid reflux drug on a daily basis. However, he was unaware ranitidine in the drug produces high levels of the carcinogenic chemical N-Nitrosodimethylamine (NDMA), which he indicates resulted in his diagnosis of pancreatic cancer in 2019.
“Based on prevailing scientific evidence, exposure to Zantac (and the attendant NDMA) can cause pancreatic cancer in humans,” the lawsuit states. “Had any Defendant warned Plaintiff that Zantac could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac.”
Pancreatic cancer is a rare form of cancer with attacks the pancreas. There are fewer than 200,000 pancreatic caner diagnoses in the U.S. each year. However, it is hard to detect in its early stages, because there are few to no symptoms. As a result, it is often at an advanced stage when diagnosed and the overall one-year survival rate us only 20%, with a five-year survival rate of 7%.
Rather than warning about the pancreatic cancer risk from Zantac, which may have resulted in closer monitoring and testing for former users, the drug maker engaged in an aggressive marketing campaign for years, according to the lawsuit.
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 pill produces large amounts of NDMA.
This case joins dozens of Zantac lawsuits filed in recent weeks that involve former users who indicate they have already been diagnosed with cancer following years of exposure to ranitidine.
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 heard oral arguments on January 30 to determine whether the claim should be centralized before one judge for coordinated discovery and pretrial proceedings. A decision is pending.
All parties have agreed 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.