Valsartan is used to treat high blood pressure and congestive heart failure. A number of drug makers offer generic versions of the drug, but the complaint for this class action alleges that some recent lots have been contaminated. It brings suit against Teva Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc., Major Pharmaceuticals, Zhejiang Huahai Pharmaceuticals, Ltd. (ZHP), Huahai U.S., Inc., and Rite Aid Corporation.
The class for this action is all persons in the US who bought drugs containing valsartan that are contaminated with NDMA or NDEA. There is also a subclass comprised of persons who bought the drugs in New York.
The complaint alleges that certain lots of valsartan have been found to be contaminated with N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), and that these substances can damage the liver or cause cancer.
The Environmental Protection Agency (EPA) calls NDMA “a member of N-ni-trosamines, a family of potent carcinogens.” It was formerly used to make liquid rocket fuel. Federal regulations classify it as a “priority toxic pollutant” and it has been shown to cause tumors in the liver, respiratory tract, kidneys, and blood vessels of animals.
The complaint says that NDEA “is a probable human carcinogen, and is acutely toxic when consumed orally.”
In July 2018, the Food and Drug Administration (FDA) recalled some brands of drugs containing valsartan because because they’d been contaminated with NDMA. The problem was traced back to ZHP, which made the active ingredient used to manufacture the drug. Drug manufacturers Teva and Major recalled products made with valsartan supplied by ZHP.
Over the next months, however, companies found that supplies from some sources in India were contaminated as well. Teva delayed, the complaint says, and only announced a recall in November of that year of drugs contaminated with NDEA. The complaint points out that Teva’s website contains claims about the quality and safety of its products, yet it did not recall its valsartan-containing medications until four months after the initial recall was announced and three months after labs in India were involved.
In November as well, the FDA sent ZHP a warning letter stating that ZHP had had previous knowledge of contamination in its active pharmaceutical ingredients (API) for valsartan. It cited “an unknown peak” that was detected of the valsartan API in June 2018, but the ZHP considered the problem to be “noise” and did not investigate far enough to find the problem, even after another complaint in September of that year.
The warning letter says that the contamination most likely dates back to November 2011, when the company changed its process for producing valsartan.
The complaint claims that the companies have breached warranties, violated laws against deceitful practices and fraudulent concealment, committed fraud, and have strict liability for their products, among other things.