Order Requires Valsartan Recall Lawsuits To Provide Product Identification for Specific Generic Drug Makers Named

Court established a process that requires plaintiffs to establish they used specific versions of recalled pills made by each manufacturer named in a Valsartan lawsuit.

The U.S. District Judge presiding over all federal Valsartan lawsuits has approved a new process that requires plaintiffs to establish that they used specific versions of the recalled blood pressure drug that were made by each generic manufacturer named as a defendant in their complaint.

A number of different generic drug manufacturers have collectively been named as defendants in more than 1,300 product liability lawsuits filed since a series of Valsartan recalls were issued in 2018, following the discovery that certain versions of the pills were distributed with high levels of N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and other known carcinogens being.

Plaintiffs pursuing the Valsartan recall lawsuits allege that the contaminants caused them to develop colorectal cancer, intestinal cancer, liver cancer, gastric cancer, esophageal cancer, prostate cancer, bladder cancer and other forms of cancer linked to the carcinogens.

Since there are common questions of fact and law shared among the claims being pursued against different drug makers throughout the federal court systems, a Valsartan lawsuit MDL, or multidistrict litigation, has been established in the U.S. District Court for the District of New Jersey, where U.S. District Judge Renee M. Bumb is presiding over coordinated discovery and preparing several groups of claims for bellwether trials.

Although Valsartan settlements have been reached to resolve claims brought against certain manufacturers, there remain others who have failed to reach resolutions for large numbers of claims. 

To help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the lawsuits, Judge Bumb has indicated the first trials will begin later this year. However, the Court has now established a process to make sure defendant manufacturers are dismissed from claims where plaintiffs are unable to establish that they used specific recalled versions of the drug.

Valsartan Show Cause Procedures

Following a case management conference earlier this month, the parties submitted a joint proposal (PDF) for a process to establish product identification for each manufacturer defendant, which Judge Bumb has agreed to adopt.

According to an order (PDF) issued on March 14, if a manufacturer is named as a defendant in a case where the plaintiff has failed to provide documentary evidence identifying that their product was used, they can file a notice of the deficiency. If the dispute is not resolved within 30 days, the defendant can place the issue on the agenda for the next case management conference before Judge Bumb, and if a case appears on the agenda for two conferences, the defendant can request an Order to Show Cause why the case should not be dismissed.

In advance of a case management conference set for March 28, the Defendants submitted a letter (PDF) identifying at least 43 pending claims where product liability issues remain unresolved with at least one of the named generic manufacturers.

Valsartan Recall Lawsuit Bellwether Trials

The attempt to remove improper defendants from pending lawsuits comes as the parties make final preparations for the first Valsartan recall bellwether trial set to begin in September 2025, involving a claim brought by Gaston J. Roberts, an Alabama man who developed liver cancer after using recalled versions of the drug.

While the outcome of the trial will not have any binding impact on other remaining Valsartan claims, it will be closely watched and could help the remaining parties reach Valsartan cancer settlements.

Following the bellwether trial process, if additional agreements are not reached to resolve large numbers of claims, it is expected that Judge Bumb may begin remanding them back to U.S. District Courts nationwide for individual trial dates throughout the federal court system in the coming years.