Parties Propose Schedules for Second Wave of Valsartan Bellwether Lawsuits

With more than 1,300 valsartan lawsuits being pursued in the federal court system, each involving allegations that former users of recalled versions of the blood pressure drug developed various forms of cancer, lawyers submitted letters to the court last week outlining their respective proposals for a second wave of bellwether trials, in the event settlements are not reached after initial cases go before juries later this year.

The litigation emerged after a series of Valsartan recalls were issued by a number of different generic drug makers in 2018, after it was discovered that cancer-causing chemicals had contaminated certain versions of the hypertension treatment following changes to the manufacturing process.

Each lawsuit raises similar allegations that high levels of N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and other contaminants in the recalled pills caused former users to develop liver cancer, colorectal cancer, stomach cancer, prostate cancer, bladder cancer, esophageal cancer and various other malignancies.

While Valsartan settlements have been reached with some generic drug manufacturers, since others have failed to reach agreements to resolve large numbers of claims, the U.S. District Judge presiding over the litigation plans to move forward with several waves of early “bellwether” trials. These trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Given common questions of fact and law raised in complaints brought throughout the federal court system after the recall, all Valsartan lawsuits are currently consolidated in the District of New Jersey before U.S. District Judge Renee M. Bumb, who has been presiding over coordinated discovery and pretrial proceedings, which have focused on preparing several groups of representative claims for early bellwether trials.

Following some Valsartan settlements by certain manufacturers, Judge Bumb has called for a series of bellwether trials to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, in hopes of resolving the rest of the claims.

The first Valsartan bellwether trial over the recalled blood pressure drug is currently expected to begin in September 2025, involving a claim brought by an Alabama man who developed liver cancer after using recalled versions of the drug.

However, if that trial fails to drive the parties to reach a settlement, the special master presiding over the claims, retired Judge Thomas Vanaskie, indicated in late December that the parties and Court have selected a second group of Valsartan lawsuits that will be prepared for additional bellwether trials, if needed.

In a letter (PDF) submitted last week, representatives for the plaintiffs called on the Court combine claims brought by four individuals into one bellwether trial for the first case in the second wave, where a single jury could be convened to hear the evidence and determine the amount of damages each plaintiff should receive.

In a separate letter (PDF) submitted on February 14, the drug makers voiced their opposition to this proposal, calling for the second wave of bellwether trials to begin in November 2025, involving only one plaintiff.

Valsartan Settlement Fund Established

The proposals come days before the court agreed to establish a Valsartan settlement fund to administer agreements reached with certain drug manufacturers to resolve claims involving their products.

Last year, the India-based generic manufacturers Hetero Drugs, Ltd and Hetero Labs, Ltd announced that they had reached an agreement to resolve most personal injury claims, economic loss and medical monitoring lawsuits involving chemical contaminants in their versions of Valsartan, as well as the similar blood pressure drugs Irbesartan and Losartan.

In an order (PDF) issued on February 19, Judge Bumb created a qualified settlement fund and appointed a fund administrator, who was granted the authority to conduct any necessary steps to disburse individual payouts to claimants who agreed to settle their lawsuit. However, the settlements will leave hundreds of claims involving other generic manufacturers unresolved.

While the outcome of these bellwether trials will not have any binding impact on other remaining claims, they will be closely watched and could help the remaining parties reach valsartan cancer settlements. However, if additional agreements are not reached following the two waves of bellwether trials, Judge Bumb may begin remanding large numbers of claims back to U.S. District Courts nationwide for individual trial dates throughout the federal court system.