Status of Valsartan Recall Claims to be Reviewed at Case Management Conference

Lawyers involved in the federal valsartan recall lawsuits are scheduled to meet this week with the U.S. District Judge presiding over the litigation, during a case management conference where the parties are expected to discuss procedures designed to advance claims brought by individuals nationwide who received versions of the blood pressure drug that were contaminated with cancer-causing chemicals.

There are currently about five dozen product liability lawsuits pending in the federal court system against various generic drug manufacturers and distributors, each raising similar claims that generic valsartan pills 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 drug manufacturing process.

As lawyers continue to review and file valsartan claims for individuals diagnosed with liver cancer, kidney cancer, bladder cancer, stomach cancer and other digestive tract cancers, it is widely expected that several thousands cases will ultimately be brought by individuals nationwide.

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Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug.

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Given common questions of fact and law presented in complaints filed in various different U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings in February 2019, 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.

A case management conference is scheduled for Wednesday, June 26, at which time the parties are expected to discuss the status of the litigation, filing of short-firm complaints, and standardized formats for the exchange of information about each claim, known as Plaintiff Fact Sheets.

On June 24, plaintiffs and defendants each filed statements outlining proposed agenda items of the upcoming conference. In the Plaintiffs’ letter (PDF), they indicated that the proposed Plaintiffs’ Fact Sheet (PFS) form submitted by Defendants would be overly burdensome, and that the issue is expected to be a significant part of this conference and the next.

“Plaintiffs will be providing a response, but there will be many issues to be discussed between the parties,” the letter states. “The parties have conferred and jointly agree that the conference at the end of July 2019 should be targeted to address disputes.”

The Defendants’ statement (PDF) indicates they hope to iron out disagreements and finalize the standardized fact sheets before the July 24 conference, which will help facilitate the exchange of information about each of the valsartan recall claims.

Once approved, Plaintiffs Fact Sheets would need to be submitted by each plaintiff, providing case-specific details about problems they have experienced after taking the recalled hypertension drugs.

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.

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