Zantac Recall Lawsuits Mount, with New Bladder Cancer Filing in Federal MDL

Published on May 1, 2020 by Laurie Villanueva

Zantac lawsuits continue to mount in the federal multidistrict litigation now underway in the U.S. District Court, Northern District of Florida.

One of the most recent cases was filed on April 21st by a New York man who developed bladder cancer following years of Zantac use.  According to his complaint, Douglas Rochler took the popular heartburn medication an average of 4-to-5 times per week beginning in 2014 through September 2019. During that time, he was allegedly exposed to a “staggering” amount of Nitrosodimethylamine (NDMA), a probable human carcinogen. (Case No. Case 9:20-cv-80664)

“As a direct and proximate result of ingesting Zantac, Plaintiff developed bladder cancer and underwent multiple surgeries from June, 2017 through November, 2017, including a transurethral resection of his bladder tumor and radical cystectomy with neobladder,” his complaint states.

About the FDA’s Zantac Recall Order

Zantac (ranitidine) is one of the most popular antacids in the world.  But last month, the U.S. Food & Drug Administration (FDA) order pharmaceutical companies to remove all name-brand and generic versions of Zantac from the market after confirming that NDMA could increase in ranitidine over time.  The U.S. Environmental Protection Agency has classified NDMA as a probable human carcinogen based on animal tests suggested an association with cancer, including tumors of the liver, kidneys and gastrointestinal tract.

The FDA began investigating NDMA in Zantac last September, after the online pharmacy Valisure informed the agency that it had detected the chemical in every sample of Zantac and ranitidine it tested, and often at levels that far exceed the FDA’s recommended daily limit of 96 nanograms. Valisure also asserted that the instability of the ranitidine molecule produced NDMA when subjected to conditions that mimicked human digestion.

In January, Emery Pharma announced that its own tests suggested ranitidine produced NDMA when subjected to high temperatures typically encountered during shipment and storage.

Zantac Manufacturers Allegedly Knew of NDMA Risk

Rochler alleges that early in the drug’s development, the manufacturers of Zantac were aware ranitidine was highly likely to form NDMA after ingestion, especially when combined with other substances in the body, such as nitrates. This could occur in connection with a meal, one of the very events that would cause someone to take Zantac.

“Despite their knowledge that exposure to unsafe levels of NDMA could result in cancer, Defendants took no action to inform Plaintiff, Plaintiff’s physicians and/or the FDA of this known risk,” the complaint states. “Instead, Defendants continued to represent that their ranitidine products, including Zantac, had been tested and were found to be safe and effective for their indicated use in treating gastric ulcers, heartburn, acid indigestion, sour stomach, and other gastrointestinal conditions. Defendants promoted and marketed ranitidine products, including Zantac, as safe and effective for individuals such as Plaintiff throughout the United States, including New York.”

Rochler’s case is one of more than 220 Zantac lawsuits undergoing coordinated discovery and other pretrial proceedings before single judge in the Southern District of Florida. However, in light of Zantac’s widespread popularity prior to the recall, it’s likely that the litigation will eventually grow to include thousands of similar claims.

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