A new product liability lawsuit filed in federal court in Alabama alleges that side effects of the popular heartburn drug Zantac exposed an Alabama man to carcinogenic chemicals for years, ultimately leading to his prostate cancer diagnosis. Based on recent testing by an independent laboratory and widespread drug recalls affecting nearly every version of Zantac and ranitidine, the brand-name drug and its generic equivalent may contain an impurity that could increase the risk of cancer in users. If you have been diagnosed with prostate cancer, stomach cancer, bladder cancer or another type of cancer following use of the popular heartburn drug Zantac, contact our consumer advocates at Leading Justice to find out if you may be entitled to financial compensation through a Zantac lawsuit.
Regular Zantac Users May Face Increased Cancer Risk
Zantac is one of the most widely used heartburn drugs in the United States. In 1988, amid aggressive marketing tactics that established the drug as a safe and effective treatment for heartburn, acid reflux and other conditions in which the stomach produces too much acid, Zantac became the first medication to surpass $1 billion in annual sales. Zantac has been available on the market in the U.S. for decades and is prescribed more than 15 million times a year. Sadly, regular users of Zantac and ranitidine are just now finding out that the medications they have taken for years to treat heartburn and acid reflux may expose them to high levels of the cancer-causing chemical N-Nitrosodimethylamine (NDMA). This potential cancer risk has resulted in dozens of lawsuits being filed against the makers of brand-name Zantac and generic ranitidine drugs.
This latest Zantac lawsuit was filed by Virgil Beck in the U.S. District Court for the Northern District of Alabama on March 11. Named as defendants in the lawsuit are drug manufacturers Boehringer Ingelheim, Pfizer, Sanofi and GlaxoSmithKline. Beck claims in his complaint that the drug makers knowingly distributed brand-name Zantac pills that contained toxic levels of the carcinogenic chemical N-Nitrosodimethylamine (NDMA) for decades without warning users about the potential for NDMA exposure to cause cancer. According to Beck’s lawsuit, he took the popular ranitidine-based drugs for about 26 years prior to being diagnosed with prostate cancer, completely unaware that the medication he took daily to prevent heartburn could put him at risk for cancer.
What is NDMA?
NDMA is an organic chemical that has been classified as a probable human carcinogen, meaning the substance could cause cancer in humans, based on results from laboratory tests. According to the Agency for Toxic Substances and Disease Registry (ATSDR), NDMA was once used to make rocket fuel, but this use was stopped after “unusually high levels of this compound were found in air, water, and soil samples collected near a rocket fuel manufacturing plant.” Today, NDMA is produced in the United States only for use as a research chemical, to induce cancer in animal test subjects. However, NDMA sometimes occurs unexpectedly as a chemical byproduct of certain manufacturing processes, which is how consumers may come to be exposed to the carcinogenic chemical in taking certain pharmaceutical drugs.
Carcinogenic Impurity Found in Popular Medications
Since 2018, the FDA has been investigating the presence of NDMA and other potentially harmful impurities in popular blood pressure and heart failure drugs, including valsartan, losartan and irbesartan. The FDA issued widespread recalls for those medications after finding that they contained “unacceptable levels of nitrosamines” like NDMA. The first warning about the potential risk of NDMA exposure from Zantac and generic ranitidine drugs came in September 2019, when the FDA reported the presence of low levels of NDMA in batches of ranitidine medications, including the brand-name heartburn drug Zantac. The FDA warning came on the heels of a petition filed by the independent pharmacy Valisure, which called for a recall of all products containing ranitidine.
According to the Valisure website, “Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule. This means that all manufacturers, brand or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.” In its petition to the FDA, the pharmacy states that “Valisure tests all batches of all its medications for quality and consistency issues and through such tests detected extremely high levels of N-Nitrososdimethylamine (‘NDMA’), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”
Zantac Cancer Litigation Continues to Grow
Beck’s case joins a growing number of Zantac lawsuits filed in recent weeks on behalf of plaintiffs who have been diagnosed with prostate cancer, bladder cancer, colorectal cancer, stomach cancer, esophageal cancer and other types of cancer after years of exposure to ranitidine. Each Zantac lawsuit involves similar claims that plaintiffs could have avoided a cancer diagnosis had they been properly warned about the potential for side effects of Zantac to increase the risk of cancer. “Based on prevailing scientific evidence, exposure to Zantac (and the attendant NDMA) can cause prostate cancer in humans,” Beck’s lawsuit states. “Had any Defendant warned Plaintiff that Zantac could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac.”