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The U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear oral arguments late next month over whether to centralize and consolidate all valsartan recall lawsuits filed throughout the federal court system, and whether the proceedings should include both economic loss class actions and personal injury claims.
There are currently at least 12 product liability and class action lawsuits pending on the federal court system stemming from recent recalls for generic valsartan tablets, which have been distributed in recent years with a cancer-causing impurity, N-nitrosodimethylamine (NDMA), which may increase the risk of liver cancer, kidney cancer, bladder cancer, stomach cancer and other digestive tract cancers.
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.
In a Hearing Order (PDF) issued on December 13, the JPML indicated that it will hear oral arguments about the motion on January 31, at the Wilkie D. Ferguson Jr. U.S. Courthouse in Miami, Florida.
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.
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.
As more individuals discover that they may have received contaminated pills, a growing number of valsartan lawsuits are likely to be filed by individuals nationwide, including claims that individuals may have avoided a cancer diagnosis if NDMA has not been in the generic hypertension drugs.