David Frederick. Photo: Diego M. Radzinschi/ALM

A federal appeals court has revived more than 750 lawsuits filed over four diabetes drugs after finding that a San Diego judge misapplied a 2011 U.S. Supreme Court opinion relating to federal pre-emption.

In a Dec. 6 unpublished memorandum, the U.S. Court of Appeals for the Ninth Circuit punted on a key issue in the case: whether the manufacturers of the drugs, under the Supreme Court's 2009 holding in Wyeth v. Levine, could provide “clear evidence” that the Food and Drug Administration would “not have approved” changes to the drugs' labeling that plaintiffs alleged were necessary to warn of links to pancreatic cancer.

Kannon Shanmugam, a Washington, D.C., partner at Williams & Connolly who argued for the drug manufacturers, had insisted the makers of the drugs had done extensive research to disprove such a link.

But the panel vacated and remanded a 2015 summary judgment decision in the case after finding that U.S. District Judge Anthony Battaglia of the Southern District of California had misapplied the Supreme Court's holding in Buckman v. Plaintiffs' Legal Committee, which found that state law claims alleging “fraud on the FDA” were pre-empted by federal law. Under that holding, Battaglia had barred new safety information that plaintiffs had sought to introduce to defeat summary judgment, and struck the plaintiffs' regulatory expert who was set to testify about that information.

“First, we disagree with the district court's characterization of the plaintiffs' state-law claims as 'fraud-on-the-FDA type allegations,'” the panel wrote. “Neither Buckman's holding nor what the district court termed the 'policy underlying Buckman' can be read to preclude discovery of evidence relevant to the plaintiffs' state-law failure-to-warn claims.”

The panel found Battaglia shouldn't have barred the new safety information or the plaintiffs' expert.

The ruling was a big win for plaintiffs, represented by David Frederick of Kellogg, Hansen, Todd, Figel & Frederick in Washington, D.C., in the the litigation over incretin-based therapies, the latest series of diabetes drugs to face multidistrict litigation. Frederick, who argued successfully for the plaintiff in Wyeth v. Levine, faced a similar dispute over the “clear evidence” standard in an MDL involving osteoporosis drug Fosamax, in which the U.S. Court of Appeals for the Third Circuit revived 5,000 cases this year.

He and his colleague, Derek Ho, also have fought dismissals of MDLs involving Zoloft and Lipitor based on expert evidence standards. Ho is scheduled to argue before the Fourth Circuit next month in the Lipitor MDL.

The Ninth Circuit ruling also “should have an impact” on 300 additional lawsuits over the same drugs that Los Angeles Superior Court Judge William Highberger tossed on similar grounds, according to lead plaintiffs counsel Brian Depew of Engstrom, Lipscomb & Lack.

The defendants are Merck Sharp & Dohme Corp., Eli Lilly and Co., Novo Nordisk Inc. and Amylin Pharmaceuticals. Representatives of Merck, Lilly and Amylin did not respond to requests for comment.

“The company stands firmly behind the safety of Victoza, an FDA-approved diabetes medicine with a strong safety profile, as confirmed in numerous clinical trials and real-world observational studies conducted over the past two decades,” wrote Novo Nordisk spokesman Ken Inchausti. “We are disappointed by the U.S. Court of Appeals for the Ninth Circuit's ruling, and will continue to vigorously defend the company against the plaintiffs' claims.”

The ruling is a big loss for Shanmugam, coming off a string of Supreme Court victories this year. Shanmugam declined to comment.

David Frederick. Photo: Diego M. Radzinschi/ALM

A federal appeals court has revived more than 750 lawsuits filed over four diabetes drugs after finding that a San Diego judge misapplied a 2011 U.S. Supreme Court opinion relating to federal pre-emption.

In a Dec. 6 unpublished memorandum, the U.S. Court of Appeals for the Ninth Circuit punted on a key issue in the case: whether the manufacturers of the drugs, under the Supreme Court's 2009 holding in Wyeth v. Levine, could provide “clear evidence” that the Food and Drug Administration would “not have approved” changes to the drugs' labeling that plaintiffs alleged were necessary to warn of links to pancreatic cancer.

Kannon Shanmugam, a Washington, D.C., partner at Williams & Connolly who argued for the drug manufacturers, had insisted the makers of the drugs had done extensive research to disprove such a link.

But the panel vacated and remanded a 2015 summary judgment decision in the case after finding that U.S. District Judge Anthony Battaglia of the Southern District of California had misapplied the Supreme Court's holding in Buckman v. Plaintiffs' Legal Committee, which found that state law claims alleging “fraud on the FDA” were pre-empted by federal law. Under that holding, Battaglia had barred new safety information that plaintiffs had sought to introduce to defeat summary judgment, and struck the plaintiffs' regulatory expert who was set to testify about that information.

“First, we disagree with the district court's characterization of the plaintiffs' state-law claims as 'fraud-on-the-FDA type allegations,'” the panel wrote. “Neither Buckman's holding nor what the district court termed the 'policy underlying Buckman' can be read to preclude discovery of evidence relevant to the plaintiffs' state-law failure-to-warn claims.”

The panel found Battaglia shouldn't have barred the new safety information or the plaintiffs' expert.

The ruling was a big win for plaintiffs, represented by David Frederick of Kellogg, Hansen, Todd, Figel & Frederick in Washington, D.C., in the the litigation over incretin-based therapies, the latest series of diabetes drugs to face multidistrict litigation. Frederick, who argued successfully for the plaintiff in Wyeth v. Levine, faced a similar dispute over the “clear evidence” standard in an MDL involving osteoporosis drug Fosamax, in which the U.S. Court of Appeals for the Third Circuit revived 5,000 cases this year.

He and his colleague, Derek Ho, also have fought dismissals of MDLs involving Zoloft and Lipitor based on expert evidence standards. Ho is scheduled to argue before the Fourth Circuit next month in the Lipitor MDL.

The Ninth Circuit ruling also “should have an impact” on 300 additional lawsuits over the same drugs that Los Angeles Superior Court Judge William Highberger tossed on similar grounds, according to lead plaintiffs counsel Brian Depew of Engstrom, Lipscomb & Lack.

The defendants are Merck Sharp & Dohme Corp., Eli Lilly and Co., Novo Nordisk Inc. and Amylin Pharmaceuticals. Representatives of Merck, Lilly and Amylin did not respond to requests for comment.

“The company stands firmly behind the safety of Victoza, an FDA-approved diabetes medicine with a strong safety profile, as confirmed in numerous clinical trials and real-world observational studies conducted over the past two decades,” wrote Novo Nordisk spokesman Ken Inchausti. “We are disappointed by the U.S. Court of Appeals for the Ninth Circuit's ruling, and will continue to vigorously defend the company against the plaintiffs' claims.”

The ruling is a big loss for Shanmugam, coming off a string of Supreme Court victories this year. Shanmugam declined to comment.