Zantac Lawsuit Blames NDMA for Terminal Breast Cancer

Published on May 20, 2020 by Sandy Liebhard

The family of an Indiana woman who used Zantac for more than 30 years has filed a new lawsuit alleging a carcinogenic chemical produced by the drug was responsible for her death.

Zantac and Cancer: What’s the Problem?

According to a complaint filed in the U.S. District Court, Southern District of Florida, on May 12th, Teresa Tedesco began taking Zantac (ranitidine) in 1983 and continued using the drug through 2018, a period of approximately 32 years.  She was diagnosed with breast cancer in 2006, resulting in her death on May 12, 2018. (Case 9:20-cv-80778)

More than a year after her death, the online pharmacy Valisure reported that it had detected N-Nitrosodimethylamine (NDMA) – a known carcinogen — in every sample of Zantac it tested, including both name-brand and prescription versions, and often at levels well above the U.S. Food & Drug Administration’s (FDA) recommended daily limit of 96 nanograms. Valisure also suggested the contaminant resulted from the instability of the ranitidine molecule, which appeared to produce NDMA when subjected to conditions similar to human digestion.

Valisure’s discovery prompted some drug makers to voluntarily recall their Zantac and ranitidine products, while various retailers, including Wal-Mart, Rite-Aid, Walgreens, and CVS – removed the medications from their store shelves.

Earlier this year, Emery Pharma announced that its own Zantac tests indicated ranitidine produced NDMA when exposed to high temperatures typically encountered during shipment and storage. In April, the FDA confirmed that the amount of NDMA in ranitidine could increase over time and ordered pharmaceutical companies to recall any Zantac products remaining on the market.

Zantac Breast Cancer Allegations

According to the Tedesco family lawsuit, Zantac manufacturers have long known that ranitidine could expose users to dangerous levels of NDMA, but failed to disclose this risk on the product labels or through any other means.

“Going back as far as 1981, two years before Zantac entered the market, research showed elevated rates of NDMA, when properly tested. This was known or should have been known by the Defendants or any other maker or distributor of ranitidine-containing products,” the complaint states.

“Defendants concealed the Zantac–NDMA link from consumers in part by not reporting it to the FDA, which relies on drug manufacturers (or others, such as those who submit citizen petitions) to bring new information about an approved drug like Zantac to the agency’s attention.”

More than 230 Zantac lawsuits have been consolidated in the multidistrict litigation now underway in the Southern District of Florida. The docket includes both personal injury claims alleging cancer due to exposure to NDMA in ranitidine, as well as class action lawsuits that seek economic damages on consumers who purchases recalled Zantac. In light of the drug’s immense popularity, most legal experts believe the federal litigation will eventually grow to include hundreds – if not thousands – of additional Zantac lawsuits in the coming weeks and months.

While in-person court proceedings have been suspended due to the ongoing coronavirus pandemic, the Zantac litigation has continued to move forward to the extent possible through the use of video conferencing technology and other means.

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