Litigation is growing over tainted blood pressure medications with a class-action lawsuit now filed in Florida against Walmart and three drug companies that span the supply chain.
In addition to the retailer, the lawsuit names Indian drugmaker Aurobindo, U.S. drugmaker ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals. It was filed in federal court in Florida against the four over the sale of irbesartan because the drug contained the impurity, N-nitrosodiethylamine (NDEA).
The FDA in October reported that India’s Aurobindo was recalling 22 batches of its irbesartan API because it was found to contain NDEA. Days later, Hauppauge, New York-based ScieGen and its distributor Westminster initiated a nationwide voluntary recall to the consumer level of all lots of unexpired irbesartan tablets because they had been made with the Aurobindo API and then shipped to Walmart.
The FDA learned this summer that the suspected carcinogen, as well as N-nitrosodimethylamine (NDMA), can show up in “sartan”-based drugs as a result of certain manufacturing processes.
According to the lawsuit, consumers were injured by paying the full purchase price of their medications containing the adulterated irbesartan and by paying for incidental medical expenses. Among other grounds, it names failure to warn, unjust enrichment and gross negligence.
“These medications are worthless because they are contaminated with carcinogenic and harmful NDEA and are thus not fit for human consumption,” the lawsuit says.
This Florida litigation is just one of a growing list of lawsuits filed since the global recall of a host of high blood pressure drugs began this summer when the FDA and EU learned that the valsartan API made by China’s Zhejiang Huahai Pharmaceuticals contained NDEA and NDMA. The Chinese company has disclosed (PDF) to the Shanghai Stock Exchange that it has been named in lawsuits in Missouri, New Jersey, Illinois and New York.
But as the recalls spread to other drugmakers and other blood pressure meds, the litigation can be expected to follow. Mylan and Teva last week began recalling valsartan products after Mylan reported NDEA was found in some of the API made at one of its Indian plants and which Teva used to make products.