A new valsartan recall class action lawsuit was filed in the U.S. District Court for the District of Massachusetts on Nov. 7, 2018.

Plaintiff Veronica L. brings her legal case against Camber Pharmaceuticals Inc., Hetero USA Inc., and Hetero Drugs Limited. Veronica is a U.S. citizen that resides in the state of Massachusetts. She seeks to represent a group of people like herself that paid for a generic version of the drug in her valsartan recall class action lawsuit.

Valsartan treats high blood pressure and helps prevent myocardial infarction—physical risks that are significant.

According a report on the valsartan recall class action lawsuit appearing in Law360, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of products containing this generic hypertensive medication because of possible contamination with what the regulatory agency has defined as a probable human carcinogen.

This contamination was with N-nitrosodimethylamine—otherwise known as NDMA.

The valsartan recall class action lawsuit indicates that the defendants all worked together to manufacture, sell, and distribute the high-blood pressure medication. Hetero Drugs Limited is the manufacturing plant in India and has a stateside component located in New Jersey and known as Hetero USA Inc. Camber Pharmaceuticals Inc. is the New Jersey-based distributor that has reportedly agreed to recall all unexpired valsartan drug products in August 2018.

The valsartan recall class action lawsuit paints a picture of willful disregard for standard safety procedures on the part of the India manufacturing plant that allegedly allowed the contamination to go undiscovered for years until random testing revealed it this past summer.

According to the Law360 article, Camber distributors and Hetero Drugs ignored blatant problems and, when an inspection was scheduled by the FDA towards the end of the year in 2016, plant employees were seen on security footage attempting to shred manufacturing documentation.

The inspection of the plant allegedly uncovered wholly unacceptable manufacturing equipment that was not cleaned or maintained according to standards methods of protocol. The protocol is purportedly outlined in the FDA’s best practices information, and Veronica alleges that failure to adhere to this protocol led to the NDMA contamination.

Veronica claims in her valsartan recall class action lawsuit that the document shredding by plant employees indicated a desire to conceal mismanagement and manipulate evidence. Her case alleges federal breach of warranty, fraud, negligence and unjust enrichment.

She is also bringing to bear in the claim all applicable state consumer protection laws that may have been violated. Since the suit is a class action, the proposed Class is any consumer of a generic valsartan product purchased in the U.S. since 2012.

To date, no adverse medical events have been reported as a direct consequence of the NDMA contamination.

The pharmaceutical company, according to Law360, is encouraging all patients currently taking the drug to consult with their personal physicians and find and start an alternative drug before stopping any current treatment regimen.

The Valsartan Recall Class Action Lawsuit is Case No. 1:18-cv-12339 in the U.S. District Court for the District of Massachusetts.