A judicial panel has agreed to centralize all federally-filed valsartan cancer lawsuits related to recent generic drug recalls in the U.S. District Court, District of New Jersey, for the purpose of coordinated discovery and other pretrial proceedings.
Valsartan is the generic version of Diovan, an angiotensin II receptor blocker (ARB) used to treat heart failure and high blood pressure.
Generic drug makers in the United States, Canada, and Europe announced valsartan recalls last year, after tests detected trace amounts of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in the imported ingredients used to manufacture the following generic ARBs.
Animal studies suggest exposure to NDMA or NDEA can cause cancer in humans.
According to the U.S. Food & Drug Administration, the compounds appear to be byproducts of a manufacturing method Zhejiang Huahai and Hetero Labs began using in 2014. Consequently, contaminated ARBs may have been in circulation for at least four years.
According to a Transfer Order issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 14th, there are currently about 40 valsartan lawsuits pending in federal courts throughout the country.
The cases include 17 personal injury lawsuits that allege ingestion of tainted valsartan medications caused cancer. The remaining are consumer class actions that seek compensation for economic damages allegedly incurred as a result of valsartan purchases.
Valsartan lawsuit defendants currently include Zhejiang Huahai Pharmaceutical Co., Ltd., U.S. affiliates Prinston Pharmaceutical Inc., and Solco Healthcare U.S., LLC, among others.
Certain plaintiffs and defendants sought to limit the proposed multidistrict litigation to consumer class actions. Nevertheless, the JPML chose to consolidate valsartan cancer lawsuits in the same proceeding.
“The core factual issues in the personal injury actions will be the same as in the consumer class actions – in particular, the cause of the alleged impurities; the nature and extent of the health risks posed by the NDMA and NDEA levels at issue; defendants’ knowledge of the alleged impurities; and the impact of any findings made by the FDA,” the Panel wrote. “Additionally, there is significant overlap in defendants in the consumer class actions and personal injury actions. Thus, discovery undoubtedly will overlap among these actions.”
In choosing the District of New Jersey, the JPML pointed out that 12 valsartan lawsuits were already pending in that jurisdiction. Because many of the defendants maintain headquarters in the state, it’s likely that many common documents and witnesses are located there as well.