Recalled Valsartan Pills Not Properly Preserved for Litigation, Plaintiffs Claim

Plaintiffs attorneys involved in the federal valsartan litigation indicate that manufacturers have not properly preserved recalled pills, potentially spoiling or destroying important evidence about contaminated versions of the widely used blood pressure drug distributed throughout the U.S.

There are currently several hundred product liability lawsuits and class action claims pending throughout the federal court system, each involving similar allgations that recalled valsartan, losartan and irbesartan pills were contaminated with N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and other chemicals that are known to increase the risk of cancers.

Many of the complaints allege that individual users developed various cancers following long-term exposure to the chemicals, including liver cancer, stomach cancer, small intestine cancer, esophageal cancer, prostate cancer, pancreatic cancer and other cancers along the digestive tract.

Given common questions of fact and law raised in the lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) previously decided to consolidate and centralize all pretrial proceedings before U.S. District Judge Robert B. Kugler in the District of New Jersey, and it is widely expected that several thousand valsartan cancer claims may ultimately be presented in the coming months and years.

On January 14, attorneys representing plaintiffs sent a letter (PDF) to U.S. Magistrate Judge Joel Schneider, expressing concern about reports that recalled valsartan pills have been destroyed, and calling for the court to intervene.

“Plaintiffs were recently shocked when informed by Defendants that despite their litigation hold/preservation obligations, including but not limited to those imposed by this Court’s initial case management order, some or all of the Defendants had been destroying recalled pills,” the letter states. “The full extent of this potential spoliation issue is not yet known, and Plaintiffs request a complete accounting of all pills returned or held due to nitrosamine contamination (actual or potential), and what has been done with those pills. This is critical for the Plaintiffs and the Court to assess the extent and merits of the issue.”

Plaintiffs called for the court to issue an order to reiterating the drug makers’ obligations to preserve evidence.

In a response letter (PDF) sent on behalf of the Defendants, attorneys for the drug makers argue that the preservation requests by the Plaintiffs asks them to violate federal law, which has strict rules on the retrieval of recalled products and what should happen with the pills. The letter implies that Plaintiffs want every manufacturer, wholesaler and pharmacy to exert significant resources to preserve and store every valsartan pill, which plaintiffs deny.

The plaintiffs indicate that the drug makers are overreaching when claiming they would be forced to violate federal law, noting that courts routinely require stays of mandated government programs to prevent the destruction of evidence. They note that some Defendants and the FDA have already had communications that indicated pills were being preserved, or should be expected to be preserved due to the litigation.

On January 16, Magistrate Judge Schneider issued a new order (PDF) addressing a number of discovery issues, but did not directly address the preservation of the pills. However, the order reiterates that Defendants are required to give plaintiffs any communications with the FDA regarding the pills and recalls within seven days of them being sent or received.

The next status conference is set for January 28, where the issue is likely to be discussed.

Valsartan Litigation Status

The pills and communications will be a vital part of the discovery process of the litigation, and will likely play key roles as evidence if and when cases begin going to trial.

As part of the coordinated pretrial proceedings, it is expected Judge Kugler will establish a “bellwether” process, where the parties will use the fact sheet information about each valsartan cancer claim to select a representative group cases, which will be prepared for early trial dates in the MDL.

While the outcome of these early “bellwether” trials will not be binding on other plaintiffs, they are typically scheduled in complex pharmaceutical litigation to help the parties gauge how juries may respond to evidence and testimony which will be repeated throughout the litigation, and facilitate potential valsartan cancer settlements with the manufacturers and distributors of the contaminated pills.