Recalled Valsartan Tablets Contained “Acutely Toxic” Impurities, Class Action Lawsuit Claims

Rite Aid, Teva Pharmaceuticals and Zhejiang Huahai Pharmaceuticals face another class action lawsuit over recalled valsartan, indicating that consumers were exposed to cancer-causing impurities contained in pills distributed in recent years, which have left them requiring a lifetime of medical monitoring. 

In a complaint (PDF) filed earlier this month in the U.S. District Court for the Eastern District of New York, Gerald Nelson seeks class action status to pursue damages for himself and other consumers who purchased valsartan tablets containing ingredients manufactured by Teva and Zhejiang, which were contaminated with N-nitrosodimethylamine (NDMA) and and N-Nitrosodiethylamine (NDEA), which are both known carcinogens.

The lawsuit notes that Nelson and other consumers were sold the drugs under the pretense that they were virtually identical generic copy of Diovan, the original brand name version of the hypertension drug. However, Diovan has never been found to be contaminated with NDMA or NDEA, which the FDA and other investigators now indicate was an impurity caused by the manufacturing process used by the generic drug makers.

“Exposure to NDMA, such as through the contaminated valsartan medications, can cause liver damage and cancer in humans,” Nelson’s lawsuit states. “NDEA, like NDMA is a probable human carcinogen, and is acutely toxic when consumed orally.”

The first valsartan problems surfaced on July 5, after European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers. Since that time, the recall has been expanded several times, impacting a variety of manufacturers of the generic drug.

In September 2018, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals (ZHP) in China, which manufactured many of the ingredients that contained NDMA as a by-product of manufacturing problems.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.

The plaintiffs in this and similar valsartan class action lawsuits filed in recent months have not been diagnosed with cancer, but say they paid for drugs that were essentially worthless for years, and must now undergo medical monitoring for the rest of their lives due to their exposure to cancer-causing agents.

For individuals diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, valsartan injury lawsuits are also being reviewed by product liability lawyers.