Zhejiang Huahai Pharmaceuticals is facing a new valsartan lawsuit alleging contaminated medication stocks caused them to develop stomach cancer.

The claim was filed by a resident from California, who alleges the contaminated generic valsartan stock they were prescribed was ineffective in their purpose and put them at an increased risk of cancer.

Plaintiff Kevork A. had been prescribed generic valsartan to treat high blood pressure in October 2015, which was is a typical treatment purpose for this medication. Valsartan is part of the angiotensin II receptor agonists, and reduces constrictions in the blood vessels easing circulation.

Valsartan is manufactured and produced by various generic manufacturers including Major Pharmaceuticals and Teva Pharmaceuticals, but certain generic stocks may be contaminated with NDMA.

Kevork took the hypertension medication according to prescription instructions until June 2018. Around that time, doctors diagnosed him with stomach cancer. According to the valsartan lawsuit, Kevork was diagnosed with the disease on May 22, 2018, allegedly as a result of ingesting contaminated medication stock.

Kevork opted to file legal action after discovering the reported NDMA contamination in certain generic valsartan stocks, which reportedly occurred during the manufacturing process in a Huahai Pharmaceuticals plant in China.

Overview of Valsartan Contamination

The alleged contamination was first reported in May 2018, when the European Medicines Agency  announced that NDMA (N-nitrosodimethylamine) had contaminated certain valsartan stocks sourced from a Huahai Pharmaceuticals plant.

NDMA is a yellow, odorless liquid that is often produced as a byproduct of a manufacturing process. It is classified as a human carcinogen and has been linked to liver damage in humans.

According to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, the NDMA contamination was most likely caused by changes made in the plant’s manufacturing process back in 2012. This means that contaminated valsartan stocks may have been on the market for several years, which led the FDA to release its own warning.

In July 2018, the FDA announced it had contacted three generic valsartan manufacturers to ask them to voluntarily recall their stocks from the United States market and asked pharmacists to purge their inventories.

The FDA is currently conducting an ongoing investigation of the NDMA contamination, including the risk patients are facing and preventative measures that can be taken in the future.

It is important to note that not all valsartan medications have been recalled, with the contaminated products produced or distributed by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceutical Industries. A more detailed list of recalled products can be reviewed on the FDA’s website.

At all times relevant, Kevork and prescribing physicians had relied on the marketing materials provided by Huahai Pharmaceuticals and other generic manufacturers that produced the allegedly contaminated valsartan stocks. Kevork states they would not have agreed to take valsartan if the NDMA contamination had been disclosed.

Kevork is seeking a multitude of damages in his lawsuit, including negligence and failure to warn. In addition, Kevork is also seeking compensation for all past and future medical expenses related to stomach cancer allegedly caused by the contaminated valsartan.

This Valsartan Lawsuit is Case No. 1:19-at-121, in the U.S. District Court for the Eastern District of California.