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A California woman says she developed breast cancer from side effects of Zantac, alleging in a recently filed lawsuit that makers of the recalled heartburn drug failed to disclose the risk users face from carcinogenic chemicals produced by the active pharmaceutical ingredient.
The complaint (PDF) was filed by Marina Golden in California Superior Court for Los Angeles County on April 19, presenting claims against various manufacturers and retailers, including Sanofi-Aventis, Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Amerisource Health Services, Mylan Pharmaceuticals, Par Pharmaceutical, Inc., L. Perrigo Company, Taro Pharmaceuticals, Teva Pharmaceuticals, Wockhardt USA, LLC, Zydus Pharmaceuticals, CVS Pharmacy, Inc., The Kroger Co., Walgreen Co., Walmart Inc, Albertsons Companies, Inc. and Rite Aid.
Golden indicates she took prescription Zantac at 300 mg strength from 1981 until the late 80s, then switched to the over-the-counter 150 mg version which she used until 2017. Following years of exposure to the active ingredient ranitidine, which has recently been found to release high levels of the cancer-causing chemical byproduct N-nitrosodimethylamine (NDMA), Golden was diagnosed with breast cancer in 2014.
All versions of Zantac and generic ranitidine were recalled from the market last year, after federal health officials concluded there was no way to confirm whether pills may be contaminated with NDMA released when the bottles are stored or transported under certain conditions.
“Plaintiff has been diagnosed with breast cancer because of ingesting carcinogenic Ranitidine-Containing Drugs due to Defendants’ willful misconduct and gross dereliction of duty,” the lawsuit states. “Had she known that Ranitidine-Containing Drugs would wreak such havoc to her body, Plaintiff would not have purchased or ingested any Ranitidine-Containing Drug.”
The case presents similar allegations to those raised in thousands of Zantac lawsuits filed throughout the U.S. court system over the past year, alleging that long-term users of the medication faced an unreasonable risk of developing breast cancer, prostate cancer, pancreatic cancer, stomach cancer and other injuries.
Most of the litigation is currently pending in the federal court system, where claims brought in U.S. District Courts nationwide are currently centralized before U.S. District Judge Robin L. Rosenberg in the Southern District of Florida. However, like Golden’s complaint, a growing number of cases are also being filed in various state courts, including California, Tennessee, New Jersey and other venues.
Zantac Cancer Risks
It is widely expected Zantac cancer litigation may become one of the largest active pharmaceutical mass tort claims over the next few years, given the widespread use of the heartburn and acid reflux drug for decades before it was removed from the market late last year.
Public concerns about Zantac cancer risk first emerged in September 2019, when an online pharmacy discovered each pill may expose users to levels of NDMA drastically higher than permissible and safe. The FDA has previously found the daily safe limit for NDMA exposure is only 96 nanograms (ng). However, pills tested by the independent pharmacy found users may be exposed to more than 3 million nanograms from each Zantac pill.
Investigations have confirmed the problems were not caused by contamination or changes in the manufacturing process, but appear to be part of the inherent molecular structure of the active pharmaceutical ingredient in Zantac, ranitidine.
Plaintiffs allege the manufacturers of Zantac knew or should have known about these problems for decades, yet aggressively marketed and sold brand-name prescription, generic and over-the-counter versions of Zantac for years, without warning users it may cause them to develop cancer.
Golden’s lawsuit presents claims of design defect, failure to warn, negligent misrepresentation, fraudulent concealment, and negligence on behalf of the manufacturers and the retailers. She seeks both compensatory and punitive damages.