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Hundreds of Januvia, Victoza, Byetta Lawsuits Reinstated by Appeals Court Ruling

A federal appeals court has revived more than 700 Byetta lawsuitsJanuvia lawsuitsJanumet lawsuits, and Victoza lawsuits, overturning a prior decision to dismiss the claims brought by individuals who developed pancreatic cancer following use of the diabetes drugs. 

Byetta, Victoza, Januvia and Janumet are all part of a popular class of diabetes medications, known as increatin mimetics, which have been linked to an increased risk of pancreatitis. Plaintiffs maintain that the drug makers knew this may result in the development of pancreatic cancer in many cases, yet failed to warn consumers and the medical community.

Given similar questions of fact and law raised in cases filed throughout the federal court system, the litigation was centralized before U.S. District Judge Anthony Battaglia in the Southern District of California in 2013.

Following coordinated discovery and pretrial proceedings, Judge Battaglia granted a motion for summary judgment filed by the drug makers in 2015, finding that the claims were pre-empted by federal law, since he believed there was sufficient evidence to establish that the FDA would not have approved any request by the drug makers to add pancreatic cancer warnings to the drug labels.

Plaintiffs appealed that decision to the U.S. Court of Appeals for the Ninth Circuit, which issued an opinion (PDF) on December 6, which reverses the Judge Battaglia’s ruling and reinstates the lawsuits. The ruling also overturned a discovery decision by Judge Battaglia, which found that some of plaintiffs’ requests for documents from the drug makers were unduly burdensome, and also rejected a decision that disqualified some of the testimony by one of the plaintiffs’ expert witnesses.

“The plaintiffs sought the ‘source files’ for each pancreatic cancer event known to the defendants,” the opinion states. “Such files have been produced in pharmaceutical litigation of this sort, it is undisputed that the defendants already maintained these databases, and here, the volume of the requested data was limited.”

The appeals court overturned the decision to grant summary judgment and remanded the litigation back to Judge Battaglia for further proceedings.

Following any additional discovery permitted under the ruling, it is expected that Judge Battaglia will schedule a series of early trial dates involving the different medications, which are known as “bellwether” trials because they are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

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