Court Asked To Establish Valsartan Settlement Fund and Appoint Administrator

The U.S. District Judge presiding over all federal Valsartan lawsuits has been asked to approve the creation of a qualified settlement fund, as well as appoint a settlement administrator and custodian for funds that will be paid by certain generic manufacturers of the recalled hypertension drug, which has been linked to the development of cancers among former users.

There are currently more than 1,200 product liability lawsuits being pursued against various different manufacturers of generic valsartan pills, which were distributed with cancer-causing chemicals between 2015 and 2018, following changes to the drug’s manufacturing process.

Each of the lawsuits raise 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.

Given common questions of fact and law, all Valsartan cancer lawsuits have been consolidated for discovery and pretrial proceedings in the U.S. District Court for the District of New Jersey since 2019, where U.S. District Judge Renee M. Bumb is preparing a group of cases for early trial dates later this year.

While Valsartan settlements have been reached with certain manufacturers, Judge Bumb has indicated that a first round of Valsartan bellwether trials will begin in September 2025, involving claims against non-settling drug makers, to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the remaining litigation.

To help disburse the Valsartan lawsuit payouts as agreements are reached with drug makers, plaintiffs submitted a motion to establish a qualified settlement fund (PDF) on January 15, asking that the court authorize the creation of a trust agreement and appoint a fund administrator to oversee it.

The motion indicates plaintiffs will formally request the creation of the Valsartan settlement fund on February 18, but no details were provided in the filing about which manufacturers have reached agreements to settle Valsartan lawsuits or the average payouts former users may receive.

In May 2024, lawyers representing Hetero Drugs and certain plaintiffs submitted a letter (PDF) to Judge Bumb, indicating that an agreement had been reached to resolve most personal injury, economic loss and medical monitoring lawsuits involving Valsartan and other similar generic hypertension drugs manufactured by that specific pharmaceutical company.

However, the settlement with Hetero has still left the vast majority of the litigation unresolved, and the Court announced in October 2024 that Valsartan cancer lawsuits will start going before juries this year.

Judge Bumb has identified six bellwether lawsuits that will be used to test the strengths and weaknesses of various different types of claims, including two stomach cancer lawsuits, two colorectal cancer lawsuits, one prostate cancer lawsuit and one liver cancer lawsuit, which is scheduled to begin on September 8, 2025.