Sanofi-Aventis Zantac/Generics Produce NDMA in the Body Class Action

Zantac is a brand-name form of ranitidine, a stomach-acid reduction drug. The complaint for this class action alleges that certain companies involved in the making or marketing of Zantac—Sanofi-Aventis US, LLC, Sanofi US Services, Inc., Chattem, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., and GlaxoSmithKline, LLC (GSK)—have been continuing to put out the drug despite knowing that it is defective and produces NDMA, a dangerous substance, in the body.

The class for this action is all individuals in Massachusetts who, within the statute of limitations, paid any amount of money out of pocket for generic ranitidine for personal or household use.

Interestingly, the complaint brings suit on behalf of “hundreds of thousands of consumers who paid for generic ranitidine products … that were unsafe, dangerous, or defective….” although the defendants are not those involved with the generic drugs but those involved with the branded drug Zantac. 

The complaint says that “Defendants should have known[] that generic equivalents of their Zantac products would perpetuate the same unsafe, dangerous, or defective condition giving rise to NDMA in Defendants’ branded Zantac products.” It claims that the Zantac companies “owed a duty” to consumers to ensure that Zantac was not unsafe, dangerous, or defective. 

Zantac, or ranitidine, is used to treat acid indigestion, heartburn, sour stomach, and gastroesophageal reflux disease. What’s the problem with it? Apparently, when digested by the body, “the inherently unstable drug molecule breaks down and produces high quantities of NDMA in the human body.”

NDMA is N-Nitrosodimethylamine, a substance that the World Health Organization (WHO) International Agency for Research on Cancer (IARC) classifies as a probable carcinogen. The Environmental Protection Agency (EPA) classifies it similarly as well. 

The Food and Drug Administration (FDA) has announced an “interim permissible intake limit” of 96 nanograms (ng) of NDMA per day. However, tests of ranitidine have shown that one dose of ranitidine can create 26,000 times that much when exposed to stomach acid. 

The complaint alleges that the defendants in this case should have known “that any deficiencies in the labeling, manufacturing, or design for their branded Zantac drug products would foreseeably be perpetuated for any generic ranitidine products that were required [by the FDA] to be the ‘same’ as” the branded Zantac product. 

Also, it says, the defendants “had an ongoing duty to update their branded Zantac labeling to adequately disclose the risk of NDMA.” If the companies had done that, the changes would have required that the makers of the generic forms of the drug would have had to change their labels as well. 

The counts include recklessness, reckless misrepresentation/omission, and fraudulent concealment and include a request for medical monitoring. 

Article Type: Lawsuit
Topic: medical
Tags: Cancer Risk, Pharmaceuticals