MDL Sought for Valsartan Recall Lawsuits Over NDMA Contamination

With a growing number of valsartan lawsuits being pursued throughout the federal court system by individuals who received recalled versions of the generic hypertension drug, a motion has been filed with the U.S. Judicial Panel on Multidistrict (JPML) seeking to centralize the litigation before one judge for coordinated pretrial proceedings. 

Each of the complaints raise similar allegations against Zhejiang Huahai Pharmaceutical Company and a number of generic drug distributors, claiming that valsartan pills were sold for years with a cancer-causing impurity, known as N-nitrosodimethylamine (NDMA), which may increase the risk of liver cancer, kidney cancer, bladder cancer, stomach cancer and other digestive tract cancers.

There are currently at least 10 Valsartan class action complaints pending in the federal court system, as well as one individual lawsuit, each of which present similar questions of fact and law about the problems that resulted in the distribution of contaminated valsartan for years.

In a motion to transfer (PDF) filed with the U.S. JPML last week, plaintiff Robert Kruk called for the establishment of a federal calsartan recall MDL, or multidistrict litigation. The requests seeks to centralize the cases in the District of New Jersey, where one judge will coordinate pretrial proceedings to prevent duplicative discovery into common issues in the cases, avoid contradictory pretrial rulings from different judges and serve the convenient of common witnesses, parties and the judicial system.

“Each Scheduled Action arises from a common factual core: the plaintiff purchased

Valsartan, only to discover after the Recall that the purchased Valsartan was contaminated by NDMA, a dangerous carcinogen,” the motion states. “Thus, each action depends on establishing on the fact that the purchased Valsartan was in fact contaminated by NDMA. ”

In addition to the pending valsartan cases, the motion indicates that the federal court system has only seen a small sample of the lawsuits that will eventually be filed.

“It is reasonable to expect that more cases will be filed as the public becomes increasingly aware that a generic drug meant to treat heart disease – the leading cause of death for Americans – has been contaminated with a carcinogen, possibly for years,” according to the motion.

The first valsartan problems surfaced in July, when European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA.

The FDA followed with its own recall announcement the following week, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers. Since that time, the recall has been expanded several times, impacting a variety of manufacturers of the generic drug.

Late last month, 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.

As more individuals discover that they may have received contaminated pills, a growing number of valsartan recall lawsuits are likely to be filed, including claims that individuals may have avoided a cancer diagnosis if NDMA has not been in the generic hypertension drugs.