This is a class action lawsuit regarding Defendants’ manufacturing and distribution of Valsartan generic prescription medications contaminated with N-nitrosodimethylamine (“NDMA”), a carcinogenic and liver-damaging impurity.
Originally marketed under the brand name Diovan, Valsartan is a prescription medication mainly used for the treatment of high blood pressure and congestive heart failure. However, due to manufacturing defects originating from overseas laboratories in China, certain generic formulations have become contaminated with NDMA.
NDMA is a semi-volatile organic chemical. According to the U.S. Environmental Protection Agency, NDMA “is a member of N-ni-trosamines, a family of potent carcinogens.” While NDMA is not currently produced in the United States other than for research purposes, it was formerly used “in production of liquid rocket fuel,” among other uses. NDMA is listed as a “priority toxic pollutant” in federal regulations. See 40 CFR § 131.36. Exposure to NDMA, such as through the contaminated Valsartan medications, can cause liver damage and cancer in humans. NDMA is classified as a probable human carcinogen, and animal studies have shown that “exposure to NDMA has caused tumors primarily of the liver, respiratory tract, kidney and blood vessels.”
On July 13, 2018, the U.S. Food & Drug Administration (“FDA”) announced a voluntary recall of several brands of Valsartan, including those manufactured and distributed by Defendants. The recall was due to the presence of NDMA in the recalled 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.” The FDA is “investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and [determining] what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.”