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The widow of a West Virginia man has filed a wrongful death lawsuit against the makers of Zantac, indicating he developed esophageal cancer due to NDMA produced by the recalled heartburn drug.
Sonja O’Neal filed the complaint (PDF) in the U.S. District Court for the District of New Jersey on January 10, seek damages from Boehringer Ingelheim, Chattem, Sanofi-Aventis and Sanofi U.S. for the 2018 death of her husband, Richard O’Neal.
For years, Zantac (ranitidine) has been one of the best selling drugs in the U.S., including prescription versions, as well as over-the-counter and generic equivalents. However, most versions of Zantac have been removed from the market over the past few months, after it was discovered that ranitidine contained in the drug may produce high levels of the human carcinogen N-Nitrosodimethylamine (NDMA).
O’Neal indicates her husband regularly used Zantac from about 2003 until his death in January 2018. He was first diagnosed with esophageal cancer in December 2017, but had no way of knowing the disease might be linked to side effects of Zantac, since the warning labels failed to disclose users may be exposed to NDMA and a risk of cancer.
“Plaintiff did not discover, and could not have discovered through the exercise of reasonable diligence, that high levels of the carcinogen NDMA was produced by Zantac ingestion,” according to the wrongful death lawsuit.
The case joins dozens of similar Zantac 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. However, O’Neal’s lawsuit indicates manufacturers were likely aware even before medication first went on sale.
“Specifically, questions were raised as to whether ranitidine ingestion can lead to the formation of highly carcinogenic NDMA within the human body,” the lawsuit notes. “As time went on, the scientific evidence establishing that NDMA is formed from ranitidine, in the body, and in other conditions, continued to pile up.”
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.
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 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.