Schedule Leading to Valsartan Lawsuit Bellwether Trial in September 2025 Outlined by MDL Judge

First Valsartan bellwether trial will involve a liver cancer lawsuit filed by an Alabama man exposed to contaminated versions of the hypertension drug.

The final steps needed to prepare the first Valsartan bellwether lawsuit for trial in September 2025 have been outlined in the federal multidistrict litigation (MDL), where hundreds of similar claimants are eagerly watching to see how juries may respond to certain evidence and testimony that contaminants in the recalled blood pressure drug caused the development of cancer.

There are currently more than 1,300 Valsartan cancer lawsuits pending in the federal court system, each involving similar allegations that changes in the generic drug manufacturing process caused cancer-causing chemicals to form in the pills.

The litigation emerged after a series of Valsartan recalls were issued in late 2018, following the discovery of high levels of N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and other contaminants. 

These known human carcinogens can form as unintended byproducts during pharmaceutical manufacturing when ingredients are exposed to certain conditions, such as high temperatures or specific solvents. However, if quality control systems fail, the contamination may go undetected, allowing contaminated pills to enter the drug supply.

Studies have linked long-term exposure to NDMA and NDEA to an increased risk of several cancers, and plaintiffs are now pursuing damages from the generic Valsartan manufacturers, alleging that their diagnoses of liver cancer, kidney cancer, colorectal cancer, stomach cancer, prostate cancer, bladder cancer and other malignancies were the direct result of the chemicals passing through their digestive system.

Given common questions of fact and law raised throughout the litigation, all Valsartan lawsuits are currently consolidated before U.S. District Judge Renee M. Bumb in the District of New Jersey. There, Judge Bumb has been presiding over coordinated discovery and pretrial proceedings, focusing on preparing several groups of representative claims for early bellwether trials.

Although several Valsartan settlements have been reached with some generic drug manufacturers, others have failed to reach agreements to resolve large numbers of claims, which would place a heavy burden on the federal court system if they all eventually went to trial.

Judge Bumb has indicated that a series of early test cases should give the parties a good sense of how juries are likely to respond to evidence and expert testimony that would be repeated in courtrooms nationwide, which may promote additional Valsartan settlement agreements.

First Valsartan Lawsuit Trial Schedule

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, Gaston Roberts, who developed liver cancer after using recalled versions of the drug.

On July 9, retired Judge Thomas L. Vanaskie, who has been appointed as a Special Master in the litigation, issued an order (PDF) establishing an amended case management schedule, indicating that all parties had met and conferred, agreeing with the schedule.

The order calls for final responses to summary judgment and expert witness dismissal motions to be submitted this week, by July 17, and any motions in limine must be filed by July 21. 

Judge Vanaskie also ordered the parties to submit a joint final pretrial order by August 11, and to file pretrial briefs by August 14. Witness and exhibit lists will be due by August 26, before a pretrial video conference on August 28. The trial is scheduled to begin on September 8.

After the outcome of the trial, if the parties have still failed to reach a settlement, they and the court have selected a second group of Valsartan lawsuits to be prepared for additional bellwether trials.

Should additional agreements not be 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.