Recalled Valsartan Side Effects Caused Bladder Cancer, Lawsuit Claims

According to allegations raised in a recently filed product liability lawsuit, side effects of recalled valsartan caused a Louisiana man to develop bladder cancer after ingesting tainted versions of the generic hypertension for more than a year. 

Michael Patrick Slavich filed the complaint (PDF) last week in the U.S. District Court for the Eastern District of Louisiana, indicating that Zhejiang Huahai Pharmaceutical Co., Ltd., Huahai US, Inc. Prinston Pharmaceutical, Inc. and Solco Healthcare U.S., LLC sold and distributed generic valsartan pills that contained cancer-causing impurities.

The valsartan lawsuit indicates Slavich began taking the drug in 2016, for treatment of hypertension. In January 2018, he was diagnosed with bladder cancer, which he claims was a direct result of the recalled valsartan side effects.

About six months after Slavich was diagnosed with bladder cancer, the FDA and regulators in Europe began a series of valsartan recalls, after confirming that certain generic ingredients were contaminated with an impurity known as N-nitrosodimethylamine (NDMA), which is believed to be a byproduct of the manufacturing process used by Zhejiang Huahai and some other generic manufacturers.

NDMA is a known human carcinogen, which has been linked to the development of several types of cancer, including liver cancer, colorectal cancer, stomach cancer and bladder cancer.

“The Adulterated Valsartan purchased and consumed by Plaintiff was included in the Lots subject to the Recall on or about July 13, 2018,” Slavich’s lawsuit states. “Prior to the recall, Plaintiff was never made aware that the Valsartan he was consuming on a daily basis was adulterated and contained the dangerous carcinogen, NDMA.”

The lawsuit notes that Diovan, the original brand name drug off which other valsartan generics are based, never contained NDMA during the manufacturing process. Slavich indicates this makes the recalled valsartan adulterated products, since generic pharmaceuticals are supposed to be identical to the original brands in safety, quality and other factors.

In September, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals (ZHP) in China, which manufactured many of the ingredients that contained NDMA as a by-product of manufacturing problems.

Growing Valsartan Litigation

Slavich’s complaint is one of a growing number of lawsuits over recalled valsartan filed in recent months.

The claims have been brought against Zhejiang Huahai Pharmaceutical Company of China, which manufactured the tainted pharmaceutical ingredients, as well as a number of different generic drug manufacturers and distributors, each raising similar allegations that the defendants knew or should have known for years that they were selling defective and unreasonably dangerous versions of the blood pressure drug.

Given common questions of fact and law presented in claims pending in several different U.S. District Courts, a motion was filed with the U.S. JPML in late October, calling for the establishment of a federal valsartan recall MDL, or multidistrict litigation. The request seeks to centralize the cases before one judge in New Jersey, to reduce duplicative discovery, avoid contradictory pretrial rulings and serve the convenience of common witnesses, parties and the judicial system.