Zantac MDL Adds to Manufacturers’ Troubles

Gavel (Johnson & Johnson $37 million verdict)

Recently, contamination triggered widespread recalls of Zantac heartburn medication. As a result, the drug’s manufacturers now face a growing number of legal and financial troubles.

Zantac Recall and Lawsuit Background

Laboratory testing recently found a cancer-causing substance in Zantac (ranitidine) heartburn medication. Animal testing has linked the contaminant, n-nitrosodimethylamine (NDMA), to several forms of cancer.

The U.S. Food and Drug Administration (FDA) investigated the issue. The agency responded by enacting new testing requirements for the drug. At this time, all contaminated lots of the drug have been recalled. If manufacturers find contamination in the future, those lots will also be recalled.

Learn more about the Zantac recall here >>>
Learn more about the Zantac lawsuits here >>>

Zantac Manufacturer Reports Losses After Recall

Several companies manufacture Zantac and generic ranitidine. One of those manufacturers recently reported multi-million dollar losses associated with the drug.

Sanofi took a $186 million Zantac loss in the wake of its October recalls. The company also reported a 12.8% decrease in sales quarter-to-quarter. Several other global manufacturers recalled their own Zantac products. But none (aside from Sanofi) have announced the financial impact of the recalls. Given the 16 million-plus yearly prescriptions for Zantac and ranitidine, the other manufacturers likely suffered substantial losses as well.

JPML Forms Zantac MDL

In addition to their financial troubles, Zantac manufacturers must deal with new developments on the legal front. Days ago, more than 140 Zantac lawsuits were merged into multidistrict litigation (MDL). The U.S. Judicial Panel on Multidistrict Litigation (JPML) assigned the MDL to the Southern District of Florida. U.S. District Judge Robin Rosenberg will preside.

Creation of the Zantac MDL will substantially simplify the process of trying hundreds, if not thousands, of related cases. It will likely be months or years before we see the first Zantac lawsuit go to trial, though.

Plaintiffs Claim Zantac Forms Carcinogen In The Human Body

In crafting a case for legal damages from NDMA-contaminated Zantac, legal teams had a couple of options. They could focus on either of two possible sources for the carcinogen:

Contamination
The carcinogen may have been introduced in a raw material prior to arriving in the manufacturer’s hands. Manufacturers were unaware of the potential for NDMA contamination. So they did not test the final product for the carcinogen. Consumers were then unintentionally exposed to NDMA.

Conversion
Ranitidine, the active ingredient in Zantac is a volatile compound. Ranitidine can break down in the stomach, releasing NDMA as a byproduct.

The U.S. Food and Drug Administration (FDA) confirmed the contamination of certain Zantac products with NDMA. But, FDA officials disagreed with the theory of conversion. According to the agency, ranitidine does not form NDMA in the “normal human stomach.”

Despite the FDA’s statement on the topic, plaintiffs’ legal team focused their allegations on the conversion of Zantac to NDMA. According to some reports, the legal team chose this argument deliberately. They wanted to differentiate Zantac lawsuits from those of similarly contaminated valsartan. For reference, valsartan lawsuits have blamed a manufacturing defect for the NDMA contamination.

Valsartan, a blood pressure medication, has recently been recalled due to NDMA contamination. Learn more here >>>

Only time will tell if focusing on ranitidine conversion in the stomach will prove a successful strategy for the plaintiffs. In the meantime, you can learn more about Zantac, NDMA, and NDMA-related recalls here.

Authored by Katy Moncivais, Ph.D.Medical Editor
Photo of Katy Moncivais, Ph.D.
Katy Moncivais holds a Ph.D. in Biomedical Engineering from The University of Texas at Austin. She’s an experienced Regenerative Medicine Consultant with a demonstrated history of working in the hospital & healthcare industry. Skilled in adult stem cells, medical devices, biomechanics, bacterial and mammalian cell culture, and regenerative medicine, she provides guidance on an array of topics affecting consumers. In her role at ConsumerSafety.org, Dr. Moncivais works alongside the writing and research staff to help deliver fact-based news stories to consumers. Her unique professional history alongside her rigorous educational background allows her to contribute to a variety of consumer-focused topics with a fresh perspective. In addition, Dr. Moncivais reviews portions of medically driven content to ensure scientific accuracy.
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