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Propoxyphene is a pain reliever that was used in the United States to treat mild to moderate pain until November 2010, when drugs such as Darvon and Darvocet that contained propoxyphene were taken off the market because of the FDA’s safety concerns. The FDA action came nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it.

The public interest group Public Citizen had petitioned the FDA to ban the drug back in 1978 and again in 2006. Following the 2006 petition, the FDA took the matter to an expert advisory committee, which in July 2009 voted to ban the drug. However, the FDA overruled the panel, and instead asked Darvon/Darvocet maker Xanodyne Pharmaceuticals Inc. to conduct studies of the drug’s effects on the heart. The results of those studies led to the FDA finally banning the drug. “The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities,” John Jenkins, MD, director of the FDA’s office of new drugs at the Center for Drug Evaluation and Research, said when the drug was finally banned.

Teva Pharmaceuticals held the rights to generic versions of the propoxyphene products Darvocet and Darvon. To date, more than forty actions have been filed in California state courts alleging injuries related to the ingestion of propoxyphene, an ingredient found in the Darvocet and Darvon pain medications, as well as in their generic brand counterparts. There are additional propoxyphene cases pending in multidistrict litigation in the Eastern District of Kentucky. See In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., 780 F.Supp.2d 1379 (E.D.Ky.2011

Last October, a group of attorneys responsible for many of the propoxyphene actions in California state courts filed a petition asking the California Judicial Council to establish a coordinated proceeding for all California propoxyphene actions. Soon after the request was filed, Teva removed the cases to federal court under the “mass action” provision of the Class Action Fairness Act (CAFA). CAFA provides federal courts with jurisdiction over “mass actions” if the actions meet all of the statutory requirements. CAFA defines a mass action as: “any civil action – in which monetary relief claims of 100 or more persons are proposed to be tried jointly on the ground that the plaintiffs’ claims involve common questions of law or fact.” The federal district court held that CAFA did not apply, and ordered the case back to state court. Teva appealed and a split panel of the Ninth Circuit Court of Appeals has now affirmed the district court’s decision.

Meanwhile, in the Kentucky cases, 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. 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 and 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.

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.