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

Since 2019, all Valsartan lawsuits filed throughout the federal court system have been centralized in the U.S. District Court for the District of New Jersey, for coordinated discovery and pretrial proceedings, since they each involve common questions of fact and law.

While the litigation was originally assigned to U.S. District Judge Robert B. Kugler, and the first Valsartan trial was expected to begin in March 2024, to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims, the litigation has been delayed following the judge's sudden retirement earlier this year.

In April, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order reassigning the Valsartan MDL to U.S. District Judge Renee M. Bumb, who will meet with lawyers involved in the cases on July 23, 2024.

In advance of this scheduled conference, the parties filed a joint status report (PDF) on July 9, to help bring Judge Bumb up to speed about developments in the litigation, key rulings that have occurred in the past, and a number of matters still actively pending after Judge Kugler's retirement.

The report notes that there are currently more than 1,200 personal injury claims pending in the MDL, involving plaintiffs who developed cancers after using valsartan or similar blood pressure drugs, such as losartan, irbesartan or combination therapies.

One of the key issues brought up by plaintiffs in the report is the rescheduling of the first Valsartan lawsuit bellwether trial, which was previously scheduled to begin on March 18. Plaintiffs recommend that the trial be rescheduled for fall of this year.

In the coming months, the report notes that Judge Bumb will have to make key decisions that could affect the entire litigation, including the scope of issues that will be determined at trial, decisions on depositions, exhibits to be submitted at trial and other issues.

Last month, the parties announced a Valsartan settlement agreement had been reached to resolve all claims involving one of the generic manufacturers involved in the litigation, Hetero Labs, resolving personal injury, economic loss and medical monitoring claims.

Details on the proposed settlement have not been released, but lawyers indicate the only Hetero Valsartan lawsuits that would remain unresolved are those associated with economic loss lawsuits linked to losartan, a similar hypertension drug from the same class of medications. Hetero is the only manufacturer involved in the settlement agreement, which has not yet been finalized.

Plaintiffs also indicated last month that they are preparing a motion calling for the preliminary approval of a Valsartan class action settlement agreement. However, the most recent status report indicates that negotiations to settle other Valsartan lawsuits have stalled, though defendants say they believe progress is being made.

"It is Plaintiffs' position that in practice, the settlement discussions with the Special Masters have unfortunately not advanced, and appointed settlement counsel has not been involved in the settlement discussions that have advanced (with the exception of Hetero), and litigation counsel has handled or led the settlement negotiations that have advanced, including for Plaintiffs where co-lead counsel has been leading the settlement negotiations," the report states. "It is Defendants' position that discussions with the Special Masters have made limited progress, but Defendants do not agree that they have not advanced."

Even if the Hetero Valsartan settlement agreement is finalized, it would still leave hundreds of lawsuits pending against other manufacturers, which will likely face future bellwether trials to help the parties gauge the average payout juries may award for individuals diagnosed with various forms of cancer. However, if those drug makers fail to settle the remaining Valsartan claims or otherwise resolve the litigation, hundreds of individual cases may later be remanded back to different U.S. District Courts nationwide for separate trial dates in the future.