A resident of Tennessee has filed a new valsartan lawsuit that seeks refunds for individuals who purchased heart and blood pressure medications tainted with a cancer-causing chemical.
The class action filing came just days before the U.S. Food & Drug Administration (FDA) expanded the ongoing valsartan recall to include additional generic medications.
Valsartan is the generic name for Diovan, a medication indicated to treat heart failure and high blood pressure.
The FDA began recalling generic versions of Diovan over the summer, after the Zhejiang Huahai Pharmaceutical Company announced that its valsartan active pharmaceutical ingredient (API) was tainted with N-nitrosodimethylamine (NDMA), a known human carcinogen.
Prior to the announcement, the Chinese manufacturer provided API for roughly half of the generic valsartan drugs sold in the United States.
Zhejiang Huahai Pharmaceuticals is the only defendant named in a Valsartan class action lawsuit filed in the U.S. District Court, Eastern District of Tennessee, on October 16th. (Case No. 1:18-cv-00247)
“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 complaint states. “These medications are worthless because they are contaminated with carcinogenic and harmful N-nitrosodimethylamine and are not fit for human consumption.”
The compliant is just the latest Valsartan lawsuit filed against the Chinese company in the United States. In addition to Zehjiang Huahai, other filings name various generic drug makers, distributors, and retailers as defendants.
Earlier this month, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation seeking centralization of all federally-filed Valsartan recall claims in a single jurisdiction, specifically the U.S. District Court, District of New Jersey. The plaintiffs’ motion noted that at least 11 Valsartan lawsuits had been filed in federal courts around the country. However, they predicted that the number of filings would grow significantly in the near future.
Valsartan has been recalled in the United States, Europe, and Canada in the wake of Zhejiang Huahai’s disclosure. Late last week, CNN reported that even more valsartan products had been added to the FDA’s recall.
NDMA has been declared a probable human carcinogen by the U.S. Environmental Protection Agency (EPA), after studies involving animals linked the chemical to tumors of the liver, respiratory tract, kidneys and blood vessels.
The FDA’s scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there might be one additional case of cancer over the lifetimes of those 8,000 people.
It’s likely that tainted valsartan has been in circulation for at least 4 years, as the FDA suspects that problem originated with a modification to Zehjiang Huahai’s production method that occurred in 2014.
The FDA banned the company’s drug products and API from entering the United States, following an agency inspection that uncovered several problems at its factory in Zinhai, China.