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Several plaintiffs have joined in a class action lawsuit over the recently discovered Zantac cancer risk, indicating that drug makers should be required to pay for medical monitoring for former users who may have been exposed for years to carcinogenic chemicals produced by the widely used heartburn drug.
The complaint (PDF) was filed last week in the U.S. District Court for the Southern District of Ohio, seeking damages for 13 plaintiffs and all other individuals who took Zantac or one if its generic equivalents for an extended period of time.
Plaintiffs seek class action status for Zantac users nationwide, indicating that they now require medical monitoring for the rest of their lives due to the risk that the drug may cause them to develop a variety of cancers along the digestive tract, including bladder cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer, kidney cancer and other injuries.
The lawsuit alleges that the drug makers Sanofi, Sanofi-Aventis, Chattem, Boehringer Ingelheim, and GlaxoSmithKline all knew or should have known that the active ingredient in Zantac, ranitidine, may convert to high levels of the chemical N-Nitrosodimethylamine (NDMA) during storage or inside the body. Rather than warning about the cancer risk, the drug makers continued to aggressively market the acid reflux treatment for years, causing users nationwide to face a continuing risk that they may be diagnosed with cancer.
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 is not a contamination case—the levels of NDMA that researchers are seeing in Zantac is not the product of some manufacturing error. The high levels of NDMA produced by Zantac are not caused by a manufacturing defect but are inherent to the molecular structure of ranitidine, the active ingredient in Zantac,” the lawsuit states. “As a result, anyone who has taken Zantac is a potential class participant because of the metabolic breakdown in the body, which creates NDMA.”
This case joins dozens of individual 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.
The Zantac class action claim seeks damages for individuals who have not yet developed cancer, but will now be required to spend money on future medical monitoring. In addition, the plaintiffs indicate that the drug makers should reimburse former users for the money they spent on a drug that ended up endangering their lives.
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 next week 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.