Bladder Cancer Lawsuit Filed Over Zantac Contamination

A Rhode Island man has filed a product liability lawsuit against Sanofi, GlaxoSmithKline and other drug manufacturers, alleging that Zantac contamination resulted in his development of bladder cancer from exposure to N-Nitrosodimethylamine (NDMA) produced by the recalled heartburn medication.

The complaint (PDF) was filed by Michael Lane in the U.S. District Court for the District of Rhode Island on February 28, indicating that his bladder cancer diagnosis came after he regularly took brand-name Zantac pills at least five times per week between 2014 and 2019, when nearly all versions of the drug were removed from the market in the U.S.

Defendants named in the lawsuit include pharmaceutical companies that held the U.S. rights to Zantac at various times, including Sanofi US Services, Inc., Boehringer Ingelheim, Chattem, Inc. Pfizer and GlaxoSmithKline, indicating that consumers were not adequately informed that the active ingredient ranitidine produces high levels of NDMA inside the body or during storage.

As a result of the Zantac contamination, Lane indicates that he was diagnosed with bladder cancer in October 2019, the same month most versions of the heartburn drug were pulled from the market due to cancer concerns.

Zantac (ranitidine) was introduced nearly 30 years ago, and became the first medication to surpass $1 billion in annual sales in 1988, amid aggressive marketing that established it as a safe and effective treatment for acid reflux and heartburn.

“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,” Lane’s lawsuit states. “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.”

Lane indicates that if the drug makers had warned that contamination of Zantac would result in exposure to NDMA, he never would have taken the drug and could have avoided the cancer diagnosis.

Bladder cancer is one of the most common forms of cancer in the U.S., impacting nearly 70,000 adults each year. Symptoms include bloody urine, painful urination and pelvic pain. While usually caught in its early stages, and often easily treatable, bladder cancer is known to have a high rate of recurrence, meaning those who have survived bladder cancer need follow-up testing for years.

Lane states that he did not learn about the link between Zantac and bladder cancer until weeks before his diagnosis, in September 2019, when a news article was published that indicated high levels of NDMA was found in Zantac. Although the FDA has determined that the safe daily level of NDMA is only 96ng, testing conducted by the independent pharmacy Valisure detected that Zantac contamination may exposure users to more than 3,000,000ng from each 150mg pill.

This cases joins dozens of Zantac lawsuits filed in recent weeks that involve former users who indicate they have already been diagnosed with cancer following years of exposure to ranitidine. In addition to bladder cancer, lawsuits allege that plaintiffs have also developed stomach cancer, colorectal cancer, esophageal cancer, liver cancer, kidney cancer and other cancers along the digestive tract.

To deal with the increasing complaints being filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation recently ordered that all Zantac cases 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.