Sanofi and other drug manufacturers were recently hit with a Zantac and bladder cancer lawsuit from a man who allegedly developed the disease after taking the drug.

Plaintiff Lazaro F. claims that he took Zantac for 11 years. After taking the drug for over a decade, Lazaro reportedly developed bladder cancer. He claims that his cancer was a direct result of exposure to N-nitrosodimethylamine (NDMA), a carcinogen, through taking contaminated Zantac.

In September 2019, the U.S. Food and Drug Administration (FDA) announced that Zantac and generic ranitidine were contaminated with low levels of NDMA. Testing of the antacid medication reportedly revealed NDMA levels far above the FDA’s daily allowable limit of 96 nanograms. According to Lazaro, a single dose of Zantac contains over 3 million nanograms of NDMA.

Although NDMA has been linked to other drug recalls due to contamination, like the valsartan NDMA recall, Lazaro argues that this is not the case with Zantac. Instead, he claims that the nature of NDMA leads to “the production of staggering amounts of NDMA when it is digested by the human body.”

“To be clear, this is not a contamination case—the levels of NDMA that researchers are seeing in Zantac is not the product of some manufacturing error,” the Zantac lawsuit argues. “The high levels of NDMA observed in Zantac is a function of the ranitidine molecule and the way it breaks down in the human digestive system.”

In his claims against Boehringer Ingelheim, Sanofi, Pfizer, and other drug manufacturers, Lazaro claims that the companies failed to warn consumers about the risks for cancer allegedly associated with their drugs.

The Zantac and Bladder Cancer Lawsuit is Case No. 1:20-cv-20392-KMW, in the U.S. District Court for the Southern District of Florida.

Link Between Zantac and Bladder Cancer

Zantac is taken for GERD and heartburn.

Since the FDA announced the NDMA detected in Zantac and generic ranitidine medications, numerous drug manufacturers have announced voluntary recalls of their ranitidine medications. The FDA has announced these recalls as they are initiated.

Several plaintiffs like Lazaro have taken legal action against Zantac manufacturers despite these recalls. For example, Sanofi was faced with a Zantac class action lawsuit from a Chicago woman alleging that she would not have purchased the medication if she was aware that she would be exposed to NDMA. Based on a lack of warning, the woman allegedly took Zantac four times a week for the past four years.

The U.S. Judicial Panel on Multidistrict Litigation was scheduled to rule on a potential MDL on Jan. 30. The panel’s decision will determine whether or not pending cases surrounding Zantac and ranitidine are consolidated into an MDL.

If the pending litigation surrounding Zantac and bladder cancer is consolidated, 22 proposed class actions and 73 individual lawsuits may be resolved in a quicker fashion than if they were each tried individually.

Manufacturers like Sanofi and Pfizer said that the legal disputes will be “complex and hard-fought” in their November 2019 response to the MDL application.

The Zantac MDL is In re: Zantac (Ranitidine) Products Liability Litigation, MDL number 2924, before the U.S. Judicial Panel on Multidistrict Litigation.