By Amanda Bronstad, From The National Law Journal

A federal judge’s rare move has tossed out at least 750 failure-to-warn lawsuits filed against the makers of four diabetes drugs based on the federal preemption doctrine.

The decision found that drugmakers, which include Merck Sharp & Dohme Corp. and Eli Lilly and Co., were shielded from state law claims because the U.S. Food and Drug Administration would not have approved the changes to the product labels that the plaintiffs claimed were necessary. Plaintiffs allege that manufacturers failed to warn that taking the drug increased the risk of pancreatic cancer.

The decision issued on Monday throws out all the litigation over a class of Type 2 diabetes drugs known as incretin mimetics with the brand names Januvia, Janumet, Byetta and Victoza—about 750 federal lawsuits, according to the U.S. Judicial Panel on Multidistrict Litigation. About 300 state law cases in California also are expected to be thrown out.

Federal preemption decisions have been unusual since 2009, when the U.S. Supreme Court found in Wyeth v. Levine that federal regulatory approval of a drug didn’t shield manufacturers from state law claims without “clear evidence” that the FDA would “not have approved” changes to product labels.

But U.S. District Judge Anthony Battaglia of the Southern District of California, citing the “unprecedented facts of this case,” found this week that the makers of four drugs had established that the FDA would not have approved changes to their product labels warning patients of pancreatic cancer risks.

“The record establishes the FDA has specifically considered pancreatic cancer risk, commented publicly on the adequacy of drug labeling, and maintained its position that scientific evidence of a causal association between incretin mimetics and pancreatic cancer is indeterminate,” Battaglia wrote.

Paul Boehm, a partner at Williams & Connolly in Washington, D.C., who represented Merck Sharp & Dohme, a subsidiary of Merck & Co. Inc., which makes Janumet and Januvia, said the ruling was consistent with prior decisions interpreting Wyeth.

“The court acknowledged the FDA conducted an independent review on the scientific evidence on the very question that the plaintiffs claimed in this case,” he said.

A spokeswoman for O’Melveny & Myers, which represented Amylin Pharmaceuticals, a subsidiary of Bristol-Myers Squibb Co. that made Byetta with Eli Lilly, referred requests for comment to the drug’s distributor, AstraZeneca Pharmaceuticals LP, which didn’t respond. Eli Lilly was represented by Pepper Hamilton.

“We are pleased with the judge’s well-reasoned and thorough opinion,” Eli Lilly spokeswoman Candace Johnson wrote in an email.

DLA Piper partner Loren Brown, who represents Victoza manufacturer Novo Nordisk Inc., owned by Denmark’s Novo Nordisk A/S, did not respond to a request for comment.

The ruling is a blow to the plaintiffs’ bar, which touted the litigation as the latest to target diabetes drugs linked to cancer. The FDA approved all four drugs between 2005 and 2010.

Co-lead plaintiffs counsel Hunter Shkolnik of New York’s Napoli Shkolnik said he planned to appeal the decision to the U.S. Court of Appeals for the Ninth Circuit. He said Battaglia relied improperly on a 2014 article in the New England Journal of Medicine in which FDA officials stated that reports of a link between incretin mimetics and pancreatic cancer “are inconsistent with the current data.”

“What he misinterpreted is the FDA hasn’t determined that a stronger warning would not have been appropriate—all they did was reject a warning that was presented,” he said. “The court is suggesting that the FDA has to propose it. It’s wrong. It’s the manufacturer under Levine that must propose the stronger warning.”

Brian Depew, a partner at Los Angeles-based Engstrom, Lipscomb & Lack, lead counsel in the 300 additional incretin mimetic cases coordinated in Los Angeles Superior Court, said he also planned to appeal an anticipated preemption ruling from Los Angeles Superior Court Judge William Highberger, who joined Battaglia at a Sept. 11 hearing.

In addition to statements in the New England Journal of Medicine article, Battaglia cited the FDA’s rejection of a public citizen petition to withdraw Victoza from the market. Battaglia also wasn’t persuaded by plaintiffs’ arguments that the FDA hadn’t made a final conclusion as to the link to pancreatic cancer.

“The potential for the FDA to reach a different conclusion in the future in light of new scientific evidence or developments does not preclude a finding of preemption now,” he wrote.

For more on this story go to: http://www.nationallawjournal.com/id=1202742223967/In-Unusual-Ruling-Judge-Nixes-At-Least-750-Diabetes-Drug–Cases#ixzz3rIJEviiQ