Class Action Lawsuit Over Recalled Valsartan Filed By Healthcare Insurance Company

A Delaware-based health insurer has filed a class action lawsuit against several drug manufacturers involved with recent valsartan recalls, indicating the insurers were forced to pay for drugs contaminated with cancer-causing impurities. 

A complaint (PDF) filed by MSP Recovery Claims, Series LLC, appears to be the first brought by a health insurer over the valsartan recalls. The case was filed in the U.S. District Court for the Southern District of Florida on December 14, naming Zhejiang Huahai Pharmaceutical Co., Prinston Pharmaceutical, Inc. Solco Healthcare, and Teva Pharmaceuticals as defendants.

The claim seeks class action status on behalf of similar healthcare insurers, pursuing recovery for payments that allegedly were unlawfully induced by the defendants, who were all forced to issue valsartan recalls in recent months due to the presence of N-nitrosodimethylamine (NDMA), which is a known carcinogen.

“Since at least 2014, the Valsartan Defendants have manufactured or sold hundreds of millions of dollars in worthless, adulterated generic Valsartan—a widely-popular prescription drug mainly used to treat high blood pressure and congestive heart failure,” the lawsuit states. “This is no minor contamination. Nitrosamines such as NDMA are well-known to be carcinogenic and have been used widely in cancer research for that very reason.”

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, 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.

In addition to the complaint filed by MSP, a number of other valsartan recall class action lawsuits have been filed nationwide by individuals, with many seeking damages for the cost of future medical monitoring for individuals who may face a continuing risk of developing cancer.

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.