Mylan Pharmaceuticals, Inc and Rite Aid named in class action lawsuit over sale of valsartan contaminated with a carcinogenic and liver-damaging impurity

This is a class action lawsuit pertaining to Mylan and Rite Aid’s manufacturing, distribution, and sale of valsartan-containing generic prescription medications contaminated with N-nitrosodiethylamine (NDEA), a carcinogenic and liver-damaging impurity.

NDEA is classified as a probable human carcinogen. Animal studies have revealed the carcinogenic nature of the compound. On July 13, 2018, the U.S. Food & Drug Administration (“FDA”) announced a voluntary recall of several brands of valsartan-containing generic medications. The recall traced back to a Chinese company, Zhejiang Huahai Pharmaceuticals, which supplied the active pharmaceutical ingredient, valsartan, to American subsidiaries, as well as other companies. The recall was due to the presence of N-nitrosodimethylamine (NDMA) in the recalled valsartan products. The FDA’s notice states that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” Several subsequent recalls were made.

As alleged, Mylan failed to promptly recall its valsartan-containing medications for over four months after the initial recall was announced, and over three months after labs in India were implicated. The Mylan Defendants failed to do so despite knowing that their valsartan containing medication were also likely contaminated. It took the Mylan Defendants another two weeks to recall all non-expired lots of the medication due to the presence of NDEA.

Plaintiff and the Class were injured by the full purchase price of their valsartan containing medications. These medications are worthless, as they are contaminated with carcinogenic and harmful NDEA, and therefore and are not fit for human consumption. Indeed, Plaintiff has been instructed to immediately stop using the medication, and has been instructed to return the remaining medication for another, non-contaminated brand. Plaintiff and the Class are further entitled to statutory damages, damages for the injury sustained in consuming high levels of acutely-toxic NDEA, and for damages related to Defendants’ conduct.

COMPLAINT