Lawyers blaming heart abnormalities on the painkillers Darvon and Darvocet and their generic equivalents are trying to jumpstart their cases on appeal after a federal judge dismissed the vast majority of the actions.
In a petition filed before the U.S. Court of Appeals for the Sixth Circuit, plaintiffs’ attorney Louis Bograd wrote that the cases raised an issue of first impression: Can patients bring their state law claims against a generic manufacturer that, by continuing to sell an “unreasonably dangerous prescription drug,” violated the federal misbranding statute?
In so arguing, Bograd, senior litigation counsel at the Center for Constitutional Litigation, an appellate law firm in Washington, hopes to revive the multidistrict litigation over the painkillers, which were pulled from the market in 2010 due to potentially fatal heart rhythm abnormalities.
“Nothing changed between the date when the FDA ordered the drug pulled and the dates when various plaintiffs were taking the product,” he said. “There was plenty of information that should have led a responsible drug manufacturer to pull the drug earlier.”
The plaintiffs filed their brief on October 9. The drug companies are set to file their response on November 12.
Attorneys for the brand name companies—Mary Larimore, a partner at Ice Miller in Indianapolis, for Eli Lilly and Co., or Gina Saelinger, a partner at Ulmer & Berne in Cincinnati who represents Xanodyne Pharmaceuticals Inc.—did not return calls for comment.
Mark Cheffo, a New York partner at Quinn, Emanuel, Urquhart & Sullivan, lead counsel for the generic manufacturers, called plaintiffs’ appeal “another effort to create a loophole where none exists.”
“Since Mensing, plaintiffs have attempted to artificially constrict the scope and holding of Mensing and to create exceptions to Mensing,” he wrote in an email to The National Law Journal, referring to the U.S. Supreme Court’s decision in Pliva v. Mensing.
U.S. District Judge Danny Reeves in Frankfort, Ky., who is overseeing the multidistrict litigation, tossed nearly all of the 200 cases last year based on the U.S. Supreme Court’s decision in Pliva v. Mensing.
That 2011 ruling found that generic pharmaceutical manufacturers couldn’t be held liable for failing to warn about risks associated with their products if they relied on federally approved labeling used by the brand-name companies. Reeves also found that most patients didn’t take the brand-name drugs.
Briefing before the Sixth Circuit had been held up pending the ruling in Mutual Pharmaceutical Co. v. Bartlett, in which the U.S. Supreme Court found on June 24 that Pliva’s holding applied to design-defect claims.
In his brief, Bograd latched onto a footnote in Bartlett indicating that generic companies could be liable if, under the Food, Drug and Cosmetic Act’s misbranding statute, they failed to pull a federally approved drug from the market that was later found to be “dangerous to health.”
“This is an issue the Supreme Court expressly identified as something they had not held pre-empted in Bartlett and Mensing,” Bograd said. “It’s therefore a live and viable legal theory until somebody tells us otherwise, and it’s also one that applies to every single one of the Darvon plaintiffs.”
He also cited the Sixth Circuit’s March 13 decision in Fulgenzi v. Pliva, which found that generic companies could be liable if they didn’t change the labeling of a drug after the FDA required the brand name companies to do so. In 2009, the FDA ordered the warning labels on Darvon and Darvocet updated, but the cases allege that the generic manufacturers hadn’t done so at the time the plaintiffs were prescribed the drugs.
“Where the plaintiffs took the drug after the relevant date, those cases are no-brainers,” he said.
Contact Amanda Bronstad at firstname.lastname@example.org.