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Lawyers involved in the federal valsartan recall lawsuits are scheduled to meet for the first time next week with the U.S. District Judge recently appointed to preside over the federal litigation, at which time the parties will discuss how the growing litigation will move forward.
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.
In a case management order (PDF) issued on February 25, Judge Kugler indicated that an initial status conference will be held on Wednesday, March 27. At that time, it is expected that liaison counsel will be appointed, which Judge Kugler has requested attorneys for both sides confer and propose for the court’s approval. A liaison counsel for each side will perform administrative functions, including receiving orders and notices from the court, maintaining complete files and additional duties to be decided at the conference.
Both sides have also been instructed to present a position statement ahead of the conference, based on their preliminary understanding of the facts in the cases, as well as the important factual legal issues.
During the conference, it is also expected that the parties will discuss the appointment of valsartan recall lawyers to serve in other leadership roles in the litigation, the status of any state proceedings, the possibility of a Consolidated Master Amended Complaint and Short Form Complaints, direct filing, tolling agreements and the status of any motions and discovery already undertaken.
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 manufacturers 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.