Valsartan Class Action Lawsuit Filed Against Manufacturers Over Cancer Risks

Following a recent string of massive recalls involving generic valsartan, a class action lawsuit has been been filed against several drug manufacturers and pharmacies, seeking compensation for consumers who paid for the contaminated pills, believing them to be safe.

Elizabeth and John Duffey filed the complaint (PDF) in the U.S. District Court for the Southern District of New York on August 16, seeking class action status against Solco Healthcare, Prinston Pharmaceutical, Walgreens, and Throgg Neck Pharmacy.

Duffey took valsartan pills made and distributed by the defendants for years before recent recalls were issued, due to contamination with the impurity N-nitrosodimethylamine (NDMA), which has been linked a risk of liver cancer, kidney cancer and other types of cancer.

The initial valsartan recall was announced by the European Medicines Agency (EMA) on July 5, after batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA. That initial recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada.

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.

The agency determined that a number of manufacturers have been distributing the contaminated pills for years. Like the EMA, the FDA also noted NDMA has been linked to cancer risks in animal studies and that the U.S. Environmental Protection Agency (EPA) determined that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion.

“Plaintiffs and the Class were injured by the full purchase price of their valsartan-containing medications,” the lawsuit states. “These medications are worthless, as they are contaminated with carcinogenic and harmful NDMA and are not fit for human consumption.”

The complaint estimates that hundreds of thousands of consumers nationwide were exposed to the contaminated pills before they were recalled and seeks class action status. The lawsuit presents claims of breach of warranty, unjust enrichment, fraud, fraudulent concealment, strict products liability, gross negligence, negligence, battery and violation of New York’s General Business Law.

While this class action seeks to represent patients who have not yet been diagnosed with cancer, a number of consumers who have been diagnosed with liver cancer, kidney cancer, lung cancer or suffered an acute liver injury in recent years are now reviewing whether they may be eligible for compensation through a valsartan lawsuit against the manufacturers of the generic drug, with lawyers providing free consultations and case evaluations for individuals nationwide.