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The fact that Zantac exposed users to cancer-causing chemicals for decades before the consumers and the medical community were warned about the problems represents one of the largest cases of medical fraud in history, according to allegations raised in a recently filed a product liability lawsuit.
The complaint (PDF) was filed last week by Kathrin Davis in the U.S. District Court for the Southern District of Florida, accusing several drug manufacturers of hiding problems with Zantac for years, including information that the active ingredient ranitidine is inherently unstable and may convert to high levels of the carcinogen N-Nitrosodimethylamine (NDMA), especially when stored at high temperatures or as it travels through the body.
Davis indicates she was exposed to the chemicals for years before she was diagnosed with colon cancer, pursuing damages from various manufacturers and distributors of the popular heartburn drug, including GlaxoSmithKline, Pfizer, Boehringer Ingelheim, Sanofi and Chattem, Inc.
Zantac (ranitidine) was a one of the top selling heartburn and acid reflux medication on the market in the United States for decades, widely available both as a prescription and over-the-counter treatment. However, since September 2019, Zantac recalls have been issued for all versions of the ranitidine-based drug, after an independent pharmacy discovered that pills from multiple lots, across multiple manufacturers, contained extremely high levels of NDMA, which may increase the risk of colon cancer, breast cancer, kidney cancer, bladder cancer and other injuries.
While FDA standards limit the safe daily exposure to NDMA at only 96 nanograms, testing has found that some 150 mg Zantac OTC pills contain more than 3 million nanograms of NDMA.
Davis’s lawsuit notes the manufacturers knew or should have known about the Zantac problems with NDMA since before the drug was first approved for sale.
“This case involves perhaps one of the most sinister public-health frauds of modern times,” the lawsuit states. “Each Defendant knew or should have known at all times it sold Zantac that the drug has the critical and deleterious defect of producing high quantities of NDMA in the human body when ingested. The dangers of NDMA have been publicly known for over 40 years, well before Zantac hit the market.”
Davis notes she did not learn about the presence of NDMA in Zantac until recalls were issued late last year.
The case joins hundreds of other Zantac lawsuits filed in recent months, each claiming that exposure to NDMA in Zantac caused cancer among long-term users.
As Zantac recall lawyers continue to review and file claims in the coming weeks and months, the size and scope of the litigation is expected to continue to increase, likely involving tens of thousands of complaints filed nationwide.
To deal with the increasing complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation recently ordered all Zantac claims be centralized and consolidated in the U.S. District Court for the Southern District of Florida, where the litigation will be overseen by U.S. District Judge Robin L. Rosenberg during coordinated discovery and pretrial proceedings.