Wrongful Death Lawsuit Brought Against Makers of Recalled Zantac

The family of an Indiana woman who died from breast cancer in May 2018 has filed a wrongful death lawsuit against the makers of Zantac, alleging that more than 30 years of using the heartburn drug caused her to develop breast cancer. According to the lawsuit, the death of the plaintiff’s mother, Teresa Tedesco, from breast cancer occurred as a result of exposure to the cancer-causing chemical N-Nitrosodimethylamine (NDMA) in Zantac, which has since been recalled by the FDA. If you or someone you love has been diagnosed with breast cancer or another type of cancer allegedly caused by NDMA-contaminated Zantac, contact an experienced Zantac cancer lawyer as soon as possible to discuss your legal options. You may be eligible for compensation through a Zantac injury lawsuit.

Drug Makers Accused of Knowing About NDMA Contamination

The latest Zantac wrongful death lawsuit was filed this week by Guy Tedesco in the U.S. District Court for the Southern District of Florida, on behalf of himself and his mother. It names as defendants various manufacturers of prescription and over-the-counter Zantac, including Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Sanofi US Services and Chattem, and alleges, among other things, that the drug makers have known for years that ranitidine, the active pharmaceutical ingredient in Zantac, produces high levels of NDMA and therefore poses a potential cancer risk for users. According to the complaint, prior to her death in May 2018, Teresa Tedesco took Zantac for more than three decades, unaware that ranitidine-based drugs may contain high levels of the cancer-causing chemical NDMA.

High Levels of NDMA Found in Ranitidine (Zantac)

Zantac has been on the market in the United States since the 1980s, but it wasn’t until last year that longtime Zantac users were warned that the heartburn drug may contain potentially dangerous levels of NDMA possibly linked to higher rates of cancer. In June 2019, the independent pharmacy Valisure notified the FDA that it had 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,” which the pharmacy linked to the “inherent instability” of the ranitidine molecule. In September 2019, Valisure filed a petition with the FDA asking the agency to recall all drug products containing ranitidine. Over the next few months, the pharmaceutical drug industry saw wave after wave of Zantac and ranitidine recalls over NDMA contamination concerns.

FDA Recalls All Ranitidine (Zantac) Medications

On April 1, 2020, the FDA called for the immediate removal of all prescription and OTC ranitidine drugs from the market in the U.S., as part of an ongoing investigation into NDMA contamination in ranitidine (Zantac) medications. These medications have been used by millions of people nationwide to prevent and treat heartburn, acid reflux, gastroesophageal reflux disease (GERD) and other stomach acid-related conditions and the fact that the drugs could be contaminated with NDMA means millions of people may now be at risk for cancer. “The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” the FDA reported upon announcing the Zantac recall.

Lawsuits Alleging Link Between NDMA Exposure and Cancer

NDMA is a carcinogenic (cancer-causing) chemical that has recently been detected in several different medications in addition to Zantac, including the blood pressure drugs valsartan, losartan and irbesartan, and the diabetes drug metformin. Prolonged exposure to NDMA has been associated with many kinds of cancer, including breast cancer, kidney cancer, bladder cancer, testicular cancer, stomach cancer and colorectal cancer. A growing number of lawsuits filed in the wake of the widespread Zantac recalls allege that the makers of Zantac knew or should have known that their drug products could expose users to toxic NDMA and put them at risk for cancer, yet failed to adequately warn consumers or the medical community about this risk.

“During the time that Defendants manufactured and sold Zantac in the United States, the weight of scientific evidence showed that Zantac exposed users to unsafe levels of NDMA. Defendants failed to disclose this risk to consumers on the drug’s label—or through any other means—and Defendants failed to report these risks to the FDA,” Guy Tedesco’s wrongful death lawsuit states. “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.”