A woman has filed a valsartan impurities class action lawsuit after the generic medication made in China was found to contain possible human carcinogens.

Plaintiff Loren L. is among thousands of patients who take valsartan for high blood pressure, congestive heart failure or the prevention of heart attack and stroke.

In July 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several brands of valsartan, including those made by Zhejiang Huahai Pharmaceutical Co., Ltd at a manufacturing facility in China. The company says that test results found valsartan impurities that include an organic chemical known as N-nitrosodimethylamine (NDMA).

NDMA is a known animal carcinogen and a suspected human carcinogen and is a byproduct of manufacturing processes.

In September 2018, the FDA found valsartan impurities also included N-nitrosodithylamine (NDEA), another known animal and suspected human carcinogen.

In order to protect U.S. patients, the FDA stopped valsartan imports from Zhejiang until the company is able to determine how the valsartan became contaminated and how to fix its quality control systems.

Valsartan Impurities Introduced in Manufacturing

The FDA’s investigation determined that the valsartan impurities were introduced because of a 2012 change in the manufacturing process. The change was initiated six years prior to the discovery of the valsartan impurities, which means “it is highly likely that additional batches, not tested by the FDA and not identified in any recall, were contaminated by NDMA and/or NDEA,” according to Loren’s complaint.

The FDA sent a letter to Zhejiang in August 2018 that stated FDA investigators found the following problems at the manufacturing facility that led to the contamination with NDMA and/or NDEA:

• The control system designed to evaluate changes that might affect the production and quality control of intermediate or active pharmaceutical ingredients (APIs) is inadequate;
• Validation of production processes and cleaning procedures is inadequate;
• Zhejiang’s quality unit has no written procedures, no authority, and no responsibility in ensuring the quality and purity of the valsartan meets specifications. There is no procedure in place to investigate all deviations in quality.
• The quality unit fails to always fulfill its responsibilities to release or reject the active pharmaceutical ingredient;
• Cleaning procedures do not include details to allow operators to clean each type of equipment in a reproducible and complete manner;
• Schedules and procedures for preventive maintenance of manufacturing equipment are not adequate or do not exist at all;
• Products needed for the operation of equipment, including lubricants, heating fluids, and coolants are not always food-grade quality substances;
• The ongoing testing program to monitor the continual quality of the active pharmaceutical ingredients, to confirm appropriate storage temperatures and conditions, and to establish re-testing dates is inadequate;
• Deviations in production are not always reported, and critical deviations are not always investigated, nor are any conclusions recorded.

The valsartan impurities lawsuit alleges that Zhejiang knew or should have known the risk of adverse health effects possibly experienced by patients who ingested the contaminated medication, but failed to provide adequate warnings to the medical community and consumers.

The Valsartan Impurities Lawsuit is Case No. 1:18-cv-00247 in the U.S. District Court for the Eastern District of Tennessee, Chattanooga Division.