A St. Louis man filed a class action lawsuit against a number of drug companies for manufacturing and distributing certain blood pressure and heart failure medications containing the active ingredient valsartan that may have been contaminated with a probable carcinogen.
James Jones filed the lawsuit in the U.S. District Court for the Eastern District of Missouri two months after the Food and Drug Administration (FDA) informed the public about the issue and announced the first wave of recalls of drugs that contained valsartan.
Companies named in the lawsuit are Zhejiang Huahai Pharmaceutical Co. Ltd., Prinston Pharmaceuticals, Solco Healthcare U.S. LLC, and Huahai US Inc.
Valsartan is used to treat high blood pressure and congestive heart failure. It is sometimes combined with other medications. The recall involved various generic versions of the drug.
The recall was initiated after the drugs were found to contain an impurity known as N-nitrocodimethylamine (NDMA) in levels that exceeded those considered acceptable for public safety. NDMA is sometimes found in water supplies and food and is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen. The FDA said the impurity may have been in the drugs for as long as four years.
The FDA launched an investigation that led to an expanded recall as well as the identification of another “unexpected impurity” that is also a potentially cancer-causing chemical – N-Nitrosodiethylamine, or NDEA.
Jones and the putative class members are suing on 10 counts that include strict products liability, failure to warn, breach of contract, fraudulent concealment and negligence. The class seeks equitable and economic relief for the cost of the contaminated drugs and incidental medical expenses.
St. Louis Record