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Boehringer Ingelheim faces a product liability lawsuit over the breast cancer side effects of Zantac, indicating that the drug maker failed to adequately warn consumers and the medical community that the heartburn drug may produce high levels of the cancer-causing chemical byproduct N-Nitrosodimethylamine (NDMA).
The complaint (PDF) was filed by Iris Crouse in Connecticut Superior Court on June 8, indicating that she and other consumers who used the popular heartburn drug were exposed to high levels of NDMA, which made Zantac “nothing more than a cancerous poison”.
Zantac (ranitidine) has been widely available for decades as both a prescription and over-the-counter treatment for heartburn and acid reflux. However, after it was discovered late last year that ranitidine is inherently unstable, and may convert to NDMA when stored at high temperatures or inside the body, Zantac recalls have been issued by manufacturers of all versions of the drug.
While FDA standards have established that maximum daily exposure to NDMA should be only 96 nanograms, testing has found that some 150 mg Zantac OTC pills contain more than 3 million nanograms of NDMA. Exposure to the known human carcinogen has been linked to reports of breast cancer, kidney cancer, leukemia and other cancers, raising widespread concerns among long-term users of Zantac.
Crouse, of Iowa, indicates that she took Zantac between 2009 and 2015, which the lawsuit claims led to the development of breast cancer. Her lawsuit claims neither she, nor the medical community, was warned that Zantac side effects may include NDMA exposure. In fact, the lawsuit claims Boehringer Ingelheim worked hard to conceal those problems.
“This case involves perhaps one of the most sinister and gravest public-health frauds in modern times,” according to the complaint. “Since its launch in 1983, every manufacturer of prescription and over-the-counter Zantac has aggressively pushed a poisonous pill into the stream of commerce, while knowing that, when ingested, every single tablet (or every single dose) of Zantac, produces levels of NDMA in amounts that exceed the U.S. Food and Drug Administration’s permissible daily limits for the carcinogen by thousands of times.”
The complaint joins hundreds of other Zantac lawsuits filed in recent months, each claiming that exposure to NDMA caused cancer among long-term users.
As Zantac cancer 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.