Massive Valsartan Recall Sparks New Lawsuit Filing in New Jersey

Published on September 6, 2018 by Sandy Liebhard

A new class action lawsuit has been filed against Teva Pharmaceuticals by consumers who accuse the company of marketing generic versions of valsartan contaminated with a cancer-causing chemical.

Valsartan Lawsuit Allegations

The complaint, which was filed in the U.S. District Court, District of New Jersey, on August 31^st, also names Prinston Pharmaceutical, doing business as Solco Healthcare, and Huahai U.S. Inc. as defendants. The valsartan lawsuit seeks class action status on behalf of all individuals in the United States who purchased products manufactured by or for the defendants after January 2012. (Case 3:18-cv-13447)

Valsartan is a medication used to treat high blood pressure and heart failure. Teva and other defendants named in the lawsuit announced valsartan recalls after testing conducted by the U.S. Food & Drug Administration (FDA) detected N-nitrosodimethylamine (NDMA), a chemical that has been linked to liver damage and cancer, in the active ingredient used in various generic drug makers’ products.

The active ingredient that sparked the valsartan recalls was manufactured by China-based Zhejiang Huahai Pharmaceuticals.  The recalls now involve multiple generic drug makers and 2,300 valsartan batches sold in 22 countries.

According to the valsartan class action lawsuit, evidence suggests that the NDMA contamination behind the valsartan recalls dates back to at least 2012. However, the defendants expressly warranted that their valsartan products were fit for ordinary use as an FDA-approved generic pharmaceutical equivalent to Diovan, the brand-name version of the drug.

“However, for years, Defendants willfully ignored warnings signs regarding the operating standards at the Zhejiang Huahai Pharmaceuticals (“ZHP”) manufacturing plant in China, and continued to allow ZHP to manufacture their Valsartan products for sale to consumers in the United States even after Defendants knew or should have known that their Valsartan products manufactured by ZHP contained or likely contained NDMA and/or other impurities,” the lawsuit charges.

NDMA: What’s the Risk?

The U.S. Environmental Protection Agency (EPA) has designated NDMA a probable human carcinogen.

Consuming up to 96 nanograms NDMA/day is considered reasonably safe. However, according to the FDA, the levels of NDMA detected in the recalled batches of valsartan exceed acceptable levels.

The agency estimates that there would be 1 additional case of cancer if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the entire 4 years that the tainted drugs were likely on the market.

Individuals with recalled valsartan in their possession should contact their doctor for a medication switch. The FDA has cautioned that valsartan patients should not stop taking their medication before contacting their doctor, as doing so could lead to serious adverse events.

It should also be noted that not all generic valsartan products currently on the market are included in the recall. The FDA has posted an updated  list of products included in the valsartan recall, as well as a list of products not included in the recall, on its website.