The numerous stocks of blood pressure medicine valsartan have been recalled due to a reported NDMA contamination, which patients claim renders the medication useless for its intended purpose and may increase the risk of cancer.

This has already spurred legal action from the public, with one of the most recent valsartan lawsuits filed by a woman from Massachusetts alleging the medication failed in its purpose to treat hypertension.

Plaintiff Veronica L. says she purchased the blood pressure medicine valsartan at different times including March 2018, April 2018, and June 2019. The medicine purchased each time was allegedly manufactured by the generic pharmaceutical companies Camber Pharmaceuticals Inc. and Hetero USA Inc.

In each of these occasions, the generic valsartan stocks were reportedly sourced from Zhejiang Huahai Pharmaceuticals and were allegedly contaminated with NDMA (N-nitrosodimethylamine).

What is Valsartan?

Valsartan is the generic equivalent of the very popular and more expensive Diovan, and is part of the angiotensin II receptor agonist drug family. This medication works by reducing the constriction in blood vessels, which allows for easier circulation.

Valsartan is a popular treatment choice for hypertension and high blood pressure, which can lead to heart failure and other serious cardiovascular problems if not treated. This makes valsartan vital for some patients, which makes the alleged NDMA contamination all the more troubling.

Veronica opted to file legal action soon after discovering this information and is seeking to represent other consumers who purchased potentially contaminated stocks of the blood pressure medicine valsartan. Veronica alleges that their money was wasted on medications that were unusable and should not have been sold to begin with.

Overview of Valsartan NDMA Contamination

NDMA is considered a potential human carcinogen and is a byproduct of a manufacturing process, which reportedly stemmed from a change in how Zhejiang Huahai conducted its manufacturing process in one of their plants in China.

This contamination was first reported in May 2018 by the European Medicines Agency, which stated that the NDMA impurity was found in valsartan medication sourced from Huahai Pharmaceuticals.

European health officials had reportedly started recalling valsartan stocks that potentially contained NDMA, with the United Kingdom also telling pharmacies that valsartan and valsartan HCTZ should be pulled from their shelves.

The FDA first announced the valsartan NDMA contamination in July 2018, stating it had asked three generic valsartan manufacturers to voluntarily recall their products. The FDA also asked pharmacies to purge their inventory of contaminated stock and return them to their manufacturers.

The FDA is currently investigating the potential causes of the NDMA contamination and what steps can be taken to prevent it in the future. The NDMA contamination was reportedly caused by a change in the manufacturing process in the plant in China in 2012, which means contaminated valsartan medication could have been on the market for at least several years.

Veronica alleges that she and other patients would not have purchased their respective valsartan medications if they had known about the alleged NDMA contamination. Her class action valsartan lawsuit is seeking to represent a nationwide class, as well as a subclass for patients from New Jersey or Massachusetts, who had purchased generic valsartan since at least January 2012.

This Blood Pressure Medicine Valsartan Lawsuit is Case No. 1:19-cv-07463, in the U.S. District Court of Massachusetts.