PASADENA – California’s Ninth Circuit Court of Appeals has vacated a district court’s decision granting summary judgment to Merck Sharp & Dohme Corp.

The class action suit alleges that the pharmaceutical company had failed to warn consumers of the potential to develop pancreatic issues, including cancer, as a result of taking certain drugs for type 2 diabetes.

According to the Ninth Circuit’s unpublished opinion, filed Dec. 6, the district court misapplied Supreme Court case Buckman Co. v. Plaintiffs’ Legal Committee in circumscribing discovery and deeming new evidence irrelevant to its determination that the plaintiffs’ state-law claims were preempted by federal law.

The district court had deemed the plaintiffs’ claims “fraud-on-the-FDA type allegations” of the sort that are preempted by Buckman but the circuit court disagreed with the characterization. 

“The plaintiffs asserted common law failure-to-warn claims arising from a state-law duty that paralleled an FDCA-imposed duty,” the opinion said. “The plaintiffs did argue that it would not be unduly burdensome to produce the data they requested because the defendants were required to collect and submit it to the FDA, but the duty the plaintiffs claim the defendants breached was the parallel common law duty to warn, not a duty arising from the FDCA.”

The court further found the district court had misapplied Buckman in its rejection of “new safety information” the plaintiffs uncovered during discovery. The opinion pointed to the district court’s statement that it is unclear whether the FDA had been aware of the plaintiffs’ new information, or whether it would have changed its conclusions. 

“Uncertainty about whether the FDA considered the ‘new safety information’ and whether it would have altered the FDA’s conclusion establishes that a disputed issue of material fact should have prevented entry of summary judgment on the defendants’ preemption claim,” reads the Ninth Circuit’s opinion.

The circuit court also found the district court had erred in disqualifying the plaintiffs’ expert, who had done consulting work involving the defendant. According to the Ninth Circuit’s opinion, the defendants did no more than show that he had done this work and that “Dr. Alexander Fleming’s exposure to confidential information could not be ‘entirely documented’ by discoverable information such as meeting minutes.” As such, found the Ninth Circuit, “the defendants did not meet their burden of showing ‘specific and unambiguous’ disclosures required to trigger disqualification.”

The appeal was heard before Circuit Judges Susan Graber, Mary H. Murguia and Morgan Christen.

Want to get notified whenever we write about Merck Sharp & Dohme ?
Next time we write about Merck Sharp & Dohme, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.

Organizations in this Story

Merck Sharp & Dohme




More News