Zantac Exposed Users to Unsafe Levels of Carcinogen NDMA, Lawsuit Alleges

According to allegations raised in a product liability lawsuit recently filed by a woman from Indiana, exposure to the heartburn drug Zantac caused the development of uterine cancer, due to high levels of the carcinogen N-nitrosodimenthylamine (NDMA) produced by the active ingredient.

The complaint (PDF) was filed by Pamila Wilbanks in the U.S. District Court for the Southern District of Florida on July 14, indicating that Zantac exposed users to unsafe and dangerous levels of the cancer-causing chemical byproduct since it was first introduced in the 1980s, as ranitidine contained in the pills may convert to NDMA during storage or inside the human body.

Zantac (ranitidine) has been marketed for decades as a safe and effective treatment for heartburn, which was sold both as a prescription and over-the-counter treatment. However, after it was discovered late last year that pills contained high levels of NDMA, Zantac recalls have been issued for most versions of the drug.

NDMA used to be a chemical biproduct of making rocket fuel in the early 1990s. However, today, its only use is to cause cancer in animals as part of laboratory experiments.

According to Wilbanks’ lawsuit, she used Zantac regularly from the 1980s to early 2020. She was diagnosed with uterine cancer and underwent a hysterectomy in 2018, and now blames the cancer and her resulting infertility on the failure of Zantac manufacturers to sell a safe product.

The lawsuit presents claims against various makers of Zantac, including Pfizer, Boehringer Ingelheim, Chattem, Inc., Sanofi, Sanofi-Aventis, and GlaxoSmithKline, alleging that the pharmaceutical companies knew, or should have known, that Zantac exposed users to high levels of NDMA, yet failed to warn consumers, doctors or regulators.

“Defendants negligently and/or recklessly failed to disclose their knowledge that their ranitidine products, including Zantac, contained unsafe levels of NDMA that could cause cancer, from Plaintiffs treating physicians, hospitals, pharmacies, the FDA, the public in general and/or the medical community,” the lawsuit notes. “In omitting and inadequately providing critical safety information regarding the use of ranitidine products, including Zantac, in order to induce their purchase and use, Defendants engaged in and continue to engage in conduct likely to mislead consumers including Plaintiff.”

While FDA standards have established that maximum human daily exposure to NDMA should be only 96 nanograms, testing has found that some 150 mg Zantac pills contain more than 3 million nanograms of NDMA. Exposure to the Zantac ingredient has been linked to reports of breast cancer, kidney cancer, leukemia and other cancers, raising widespread concerns among long-term users of the drug.

Wilbanks’ lawsuit joins hundreds of other Zantac lawsuits filed in recent months, each claiming that exposure to NDMA produced by the ingredient ranitidine 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.