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Motion to Dismiss Valsartan Contamination Claims Will Not Be Addressed by MDL Court

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The U.S. District Judge presiding over all valsartan contamination lawsuits is refusing to entertain motions to dismiss a specific sub-set of claims at this time, indicating that the parties would be better served on focusing their energy discovery to determine how and why generic versions of the blood pressure pills became contaminated with cancer-causing impurities.

There are currently more than 100 product liability lawsuits pending in the federal court system against various generic drug manufacturers and distributors, each raising similar claims that problems with the manufacturing process resulted in pills being contaminated with known human carcinogens, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).

As individuals diagnosed with liver cancer, kidney cancer, stomach cancer and other gastrointestinal tract cancers continue to contact lawyers and review new valsartan claims, the size of the litigation is expected to grow rapidly in the coming months and year.

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. In addition to individual cancer claims, a number of valsartan recall class action lawsuits are also centralized as part of the federal multidistrict litigation (MDL).

In a letter (PDF) sent to the Court on July 31, attorneys representing the generic drug makers advised Judge Kugler that they intended to file a motion to dismiss the class action cases, arguing that plaintiffs have shown no injury.

The valsartan class action lawsuits seek damages for individuals who received the contaminated medication, but have not been diagnosed with cancer, seeking damages for medical monitoring. The class action claims also point out that they were essentially buying an unapproved and worthless drug, since the impurities made generic valsartan pills into new drugs not approved by the FDA.

In a letter in opposition (PDF) sent to the Court on August 8, plaintiffs attorneys indicated that entertaining the motions at this time would only be a distraction, as it would not change the scope of discovery the parties are engaged in, even if the drug makers were successful with the motion.

Judge Kugler sent a short response letter (PDF) on August 15, indicating that the requested permission to file motions to dismiss at this time were denied, and could be reconsidered at a later and more appropriate time.

“Even were the outcome of the proposed motions favorable to defendants, it is not likely the scope of discovery would change,” he wrote. “We all need to focus on the current important issues: how and why the contamination occurred and what the defendants knew about it.”

Judge Kugler cautioned the parties that he would not be “sidetracked by extraneous issues”, and promised no unsupportable valsartan claims would be permitted to go to trial.

At a recent status conference, plaintiffs’ attorneys informed the court that they anticipate more than 2,000 valsartan contamination cases will eventually will be filed on behalf of individuals nationwide.

As part of the coordinated pretrial proceedings, it is expected that Judge Kugler will establish a “bellwether” process where a representative group claims will be prepared for early trial dates in the MDL, to help the parties gauge how juries may respond to evidence and testimony that will be repeated throughout the litigation, and promote potential valsartan settlements with the manufacturers and distributors of the contaminated pills.

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