A federal appeals court on Friday upheld the dismissal of nearly all claims in 68 cases seeking to hold drug makers liable for injuries from the use of the prescription painkillers Darvon and Darvocet, which were pulled from the U.S. market in 2010.
The plaintiffs, who used generic versions of the drugs, had invoked design defect laws in 22 U.S. states in claiming that generic drug makers misbranded the drugs. Many also sought to hold brand-name drug makers liable for alleged misrepresentations made to prescribing doctors.
A three-judge panel of the 6th U.S. Circuit Court of Appeals in Cincinnati rejected claims in 67 of the cases. One lawsuit, by a Mississippi woman who said her husband’s use of the drugs led to cardiac failure, was allowed to proceed.
Friday’s decision largely upheld rulings by U.S. District Judge Danny Reeves in Lexington, Kentucky, who oversees nationwide litigation over the drug propoxyphene, including Darvon and Darvocet.
Among the defendants in the various cases were Eli Lilly & Co., which won regulatory approval for Darvon in 1957 and Darvocet in 1972, and generic drug makers such as Mylan Inc. and Teva Pharmaceutical Industries Ltd.
Louis Bograd, a lawyer at the Center for Constitutional Litigation who argued the plaintiffs’ appeals, said: “We are disappointed in the panel decision, and are considering our options.”
Lilly, in a statement, said it was pleased with the 6th Circuit’s “expansive decision.” Jay Lefkowitz, a partner at Kirkland & Ellis representing the generic drug makers, did not immediately respond to requests for comment.
The U.S. Food and Drug Administration in 2010 halted sales of products containing propoxyphene after a study by Xanodyne Pharmaceuticals Inc, which then held the rights to sell brand-name versions, suggested they might be linked to heart rhythm abnormalities.
Lawsuits ensued, but the plaintiffs suffered setbacks when the U.S. Supreme Court, in 2011 and 2013, shielded generic drug makers from state “failure-to-warn” claims and from state “design defect” claims that depended on the adequacy of a drug’s warnings.
In Friday’s decision, Circuit Judge Richard Suhrheinrich said the plaintiffs could not pursue misbranding claims against generic drug makers over propoxyphene, having failed to allege sufficient “new and scientifically significant information that was not before the FDA.”
He also said misrepresentation claims against the brand-name drug makers must be dismissed because courts in the 22 states would not recognize such claims under their respective laws.
The case is In re: Darvocet, Darvon, and Propoxyphene Products Liability Litigation, 6th U.S. Circuit Court of Appeals, No. 12-5368.
(Reporting by Jonathan Stempel in New York; editing by Matthew Lewis)