Valsartan Lawsuit Claims Consumers Should Be Reimbursed For Buying Contaminated Drugs

A class action lawsuit has been filed on behalf of consumers purchased certain generic valsartan drugs in recent years, indicating that that the manufacturer of ingredients used in the pills should be forced to reimburse consumers who received a useless drug that had to be recalled due to contamination with a cancer-causing impurity. 

The complaint (PDF) was filed by Loren Lewis in the U.S. District Court for the Eastern District of Tennessee on October 16, naming Zhejiang Huahai Pharmaceutical Company as the defendant.

The lawsuit seeks class action status on behalf of those who purchased recalled valsartan, which were removed from the market in recent months after U.S. and European regulators warned that they may be contaminated with N-nitrosodimethylamine (NDMA), a known human carcinogen.

“Plaintiff and the putative class members were injured by paying the full purchase price of their valsartan-containing medications and paying for incidental medical expenses,” the lawsuit states. “These medications are worthless because they are contaminated with carcinogenic and harmful N-nitrosodimethylamine and are not fit for human consumption.”

The impurity 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 plaintiffs developed cancer or suffered physical injuries from the recalled drugs, but instead says consumers paid premium prices for subpar drugs for years, after being told they were the equivalent to the popular brand name product.

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.

Late last month, 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 being reviewed by product liability lawyers.