The Valsartan litigation centers around the FDA recalls of Valsartan, a commonly-prescribed generic blood pressure medication, in 2018 and 2019. Other batches of “sartan” medications, Losartan and Irbesartan, were subsequently added to the FDA recall list.  As of late 2019, there were over 1,150 individual recalls, making this the largest Class 1 drug recall to date.

The recalled Valsartan contained nitrosamine impurities that failed to meet FDA safety standards, including Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4aminobutyric acid (NMBA).  NDMA, NDEA, and NMBA are recognized as carcinogens or probable carcinogens by the FDA, International Agency for Research on Cancer, the EPA, and others.

Lieff Cabraser partner Rachel Geman serves on the Plaintiffs’ Economic Reimbursement Steering Committee in the Valsartan litigation, which seeks compensation for plaintiffs’ losses and injuries relating to defendants’ misconduct and misrepresentations in the  manufacture, testing, distribution, labeling, marketing, and sale of Valsartan throughout the United States.  She is proposed co-lead counsel for the medical monitoring class as well.

The defendants include Active Pharmaceutical Ingredient (API) manufacturers, wholesalers, and retail pharmacies.

The court denied, in good part, and granted, in part, defendants’ multiple motions to dismiss in a series of rulings in 2020 and 2021, and also found the claims were not preempted.

In November 2021, various classes of plaintiffs, including the economic loss classes and the medical monitoring classes, sought class certification.  Class certification and expert-related briefing will continue through the spring of 2022.