Recalled Valsartan Side Effects Caused Liver Cancer, Lawsuit Alleges

According to a product liability lawsuit filed against a number of generic drug manufacturers, side effects of recalled valsartan pills caused a Tennessee woman to develop liver cancer, which was allegedly caused by carcinogenic impurities that contaminated the raw ingredients in the blood pressure medication.

The complaint (PDF) was brought by Karen Brackman in the U.S. District Court for the Middle District of Tennessee on April 10, naming Zhejiang Huahai Pharmaceutical Co., Prinston Pharmaceutical, Inc. and Solco Healthcare as defendants.

Brackman indicates that she began taking generic valsartan in February 2015, for the treatment of high blood pressure, and continued to use the pills until July 2018, when it was discovered that the drugs were distributed with a carcinogenic byproduct of the manufacturing process for years.

In April 2018, Brackman indicates that she was diagnosed with liver cancer, which she indicates is one of a number of malignancies linked to the chemicals N-nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA) found in recalled valsartan pills distributed by the defendants.

“Plaintiff would not have consented to taking valsartan, had Plaintiff known of or been fully and adequately informed by Defendants of the true increased risks and serious dangers of taking the drug, which was rendered unreasonably dangerous by the presence of NDMA and/or NDEA,” Brackman’s lawsuit indicates. “Plaintiff and Plaintiff’s physicians chose to take and prescribe valsartan based on the risks and benefits disclosed to them by Defendants but would have made a difference choice, had the true risks and benefits been provided.”

Brackman presents claims of manufacturing defect, failure to warn, design defect, negligence, breach of warranty, fraud, negligent misrepresentation, and breach of consumer protection statutes. She seeks both compensatory and punitive damages.

The case joins a growing number of valsartan recall lawsuits filed in recent months by individuals who indicate they were left with liver cancer, kidney cancer, bladder cancer, gastric cancer and other injuries following exposure to the tainted drugs.

In addition, a number of valsartan class action claims are pursuing damages for users of the medications who have not been diagnosed with cancer, but seek reimbursement for the cost of what were essentially worthless drugs, and funding for medical monitoring they may require for the rest of their lives due to their exposure to cancer-causing agents.