When American companies make generic prescription drugs, they may use active pharmaceutical ingredients (APIs) manufactured overseas, where standards may be lower. The complaint for this class action alleges that Mylan Pharmaceuticals, Mylan NV, and Rite Aid Corporation sold medicines containing valsartan contaminated with N-nitrosodiethylamine (NDEA).
The class for this action is all persons in the US who bought or paid for medications containing valsartan that was contaminated with NDEA. A New York subclass has also been proposed for those who bought the medications in New York.
At issue is a drug generically called valsartan, which is given to patients with high blood pressure or congestive heart failure. It’s made by a number of companies, among them Mylan.
In July 2018, when the Food and Drug Administration (FDA) announced a voluntary recall of certain brands of drugs containing valsartan. The valsartan at issue came from a Chinese company, Zhejiang Huahai Pharmaceuticals, and it contained a different contaminant, N-nitrosodimethylamine (NDMA). Both NDMA and NDEA are classified as probably human carcinogens.
Because the contamination seemed to be widespread, the FDA began testing and evaluating drugs containing valsartan. The recall eventually expanded to valsartan made in India as well. According to the complaint, that’s when the FDA found NDEA was also present in some drugs.
However, the complaint claims that Mylan dragged its feet in recalling its valsartan drugs. Other companies, like Camber Pharmaceuticals, reacted sooner, issuing a recall in August 2018 and pointing to certain labs in India as the source of contamination.
The complaint claims that Mylan profited from this delay, because patients who had been getting the drugs from companies like Camber switched to Mylan’s version, thinking it was not contaminated. Also, the complaint claims that the price of the drug more than doubled during this time, creating an additional windfall for Mylan.
Mylan did not recall its own valsartan drugs until November 2018. Shortly before this, the FDA sent the company a Warning Letter, setting forth “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
The violations cited in the letter included a failure to “clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals…” It also said that Mylan did not “follow written procedures for production and process control” of the drugs. It cited multiple Mylan sites at which the violations had occurred, and other warnings the FDA had provided since 2015.
In short, the complaint alleges that Mylan had ample earlier warnings that its drugs may have been contaminated. The complaint alleges breaches of warranty, violations of New York’s General Business Law, gross negligence, and fraud, among other things.