Valsartan Lawsuit Claims Manufacturers Deceived Consumers Over Drugs’ Safety

A Massachusetts woman has filed a class action lawsuit against manufacturers of recalled valsartan pills, alleging that contaminated versions of the generic blood pressure drug were sold to hundreds of thousands of patients, which were essentially useless because they contained cancer-causing impurities. 

The complaint (PDF) was filed by Veronica Longwell in the U.S. District Court for the District of Massachusetts on November 11, naming Camber Pharmaceuticals, Inc. and Hetero Drugs, Limited as defendants.

The valsartan lawsuit seeks class action status on behalf of all individuals who purchased generic pills distributed in recent years with a chemical impurity known as N-nitrosodimethylamine (NDMA), which is a known human carcinogen.

The chemical byproduct is believed to have resulted from the generic drug manufacturing process, as the name-brand Diovan did not have such carcinogencic impurities.

The lawsuit does not claim that Longwell developed cancer or suffered physical injuries from the recalled valsartan, but instead says consumers paid premium prices for subpar drugs for years, after being told they were the equivalent to Diovan. The lawsuit indicates that the defendants knew or should have known about the problem since at least 2012.

“Plaintiff and Class Members paid for all or part of their Valsartan prescriptions that were illegally introduced into the market by Defendants and which were not fit for their ordinary use,” the lawsuit states. “Defendants have been unjustly enriched through the sale of these adulterated drugs since at least 2012.”

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.

As consumers nationwide continue to face concerns about the safety of pills they have taken in recent years, a number of valsartan recall class action lawsuits have been filed nationwide, seeking damages for the cost of the recalled drugs and medical monitoring.

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