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The U.S. District Judge presiding over all federal valsartan recall lawsuits has approved new procedures that allow the direct filing of new cases into the recently established multidistrict litigation (MDL) in New Jersey federal court, where all of the claims have been consolidated for pretrial proceedings.
There are currently about 50 product liability lawsuits filed against various generic drug manufacturers and distributors, each raising similar claims that versions of the hypertension drug valsartan were distributed for years with cancer-causing impurities, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which appear to be a by-product of the generic drug manufacturing process.
Many of the complaints involve allegations that users of the recalled valsartan drugs developed liver cancer, kidney cancer, bladder cancer, stomach cancer and other digestive tract cancers, pursuing damages against Zhejiang Huahai Pharmaceutical Company of China, which manufactured much of the tainted pharmaceutical ingredients, as well as other defendants.
Given common questions of fact and law presented in lawsuits filed in various different U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings lawsuit early last month, which resulted in the transfer of cases pending throughout the federal court system to U.S. District Judge Robert B. Kugler in the District of New Jersey. The process is designed to reduce duplicative discovery, avoid conflicting pretrial schedules and serve the convenience of the parties, witnesses and the judicial system.
To avoid the delay associated with transferring cases from different federal district courts, Judge Kugler issued a case management order (PDF) on April 9, outlining the process for the direct filing of future cases directly into the valsartan MDL.
The first valsartan problems surfaced in July, when European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals (ZHP) in China, tested positive for NDMA.
The FDA followed with its own recall announcement the following week, indicating 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 ZHP, 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 valsartan pills, a growing number of lawsuits are likely to be filed by individuals nationwide.
Following coordinated discovery and any early “bellwether” trials held in the MDL, if the generic drug makers fail to negotiate valsartan settlements or another resolution for the litigation, each individual case may ultimately be remanded back to the U.S. District Court where it was originally filed for a future trial date.