A second class action lawsuit was filed against manufacturers and distributors of a high blood pressure drug that was found to be contaminated with a probable cancer-causing impurity.
The lawsuit was filed in Boston federal court against New Jersey-based Camber Pharmaceuticals Inc., and Hetero Drugs Ltd. Hetero is based in India but makes the drug ingredient, valsartan, with its partner, Hetero USA Inc., also based in New Jersey. The lawsuit claims poor safety procedures at the India plant should have tipped the companies off years ago that the drugs could be contaminated. Instead, the companies “willfully ignored warning signs.”
In July, the Food and Drug Administration (FDA) announced a recall of several drugs containing the drug ingredient valsartan, used to treat high blood pressure and heart failure, because testing revealed the drug was contaminated with N-nitrocodimethylamine (NDMA), an impurity classified by the Environmental Protection Agency (EPA) as a probable carcinogen. After closer inspection, the agency said the impurity may have been in the drugs for as long as four years.
The lawsuit claims that Hetero may have tried to prevent FDA investigators from finding out about potential dangers at its India plant as employees there were seen on video shredding documents days before regulators inspected the plant in December 2016.
During the inspection, FDA investigators discovered that manufacturing records were incomplete and equipment was not properly cleaned or maintained to prevent contamination. As a result, the lawsuit claims, the India plant introduced NDMA into valsartan. Had Camber and Hetero followed FDA guidelines regarding best practices, the lawsuit claims, they “would have found the NDMA contamination almost immediately.”
In October, a St. Louis man filed a class action lawsuit in the U.S. District Court for the Eastern District of Missouri against a number of drug companies for manufacturing and distributing valsartan tainted with NDMA. His lawsuit named Zhejiang Huahai Pharmaceutical Co. Ltd., Prinston Pharmaceuticals, Solco Healthcare U.S. LLC, and Huahai US Inc.