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All but one of 68 Darvon/Darvocet claims dismissed by court

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All but one of 68 Darvon/Darvocet claims dismissed by court

A federal appeals court on Friday affirmed dismissal of all but one of 68 claims filed by plaintiffs in 22 states against both generic and brand-name manufacturers for personal injuries related to the use of the drug propoxyphene, which was sold under the brand names Darvocet and Darvon.

The U.S. Food and Drug Administration announced withdrawal of propoxyphene, which was used to treat mild to moderate pain, in November 2010, stating there was data showing that, even at recommended does, it increased the risk for serious abnormal heart rhythms that have been linked to adverse effects including sudden death.

The drug's manufacturer, Newport, Kentucky-based Xanodyne Pharmaceuticals Inc., agreed to withdraw the drug at the FDA's request, and its generic manufacturers agreed to voluntarily remove their products as well

The 68 plaintiffs in In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation had all taken the drug before its 2010 withdrawal, according to Friday's ruling by the 6th U.S. Circuit Court of Appeals in Cincinnati.

The three sets of claims against the generic manufacturers were for wrongful marketing, failure-to-warn and various remaining state law claims, including breached express and implied warranty, fraud, misrepresentation and consumer protection. Claims against the drug's brand manufacturers were for failure to state a claim, according to the appellate ruling.

The plaintiffs' claims were consolidated by the Judicial Panel on Multidistrict Litigation in 2011 in the U.S. District Court in Lexington, Kentucky. The District Court dismissed all the claims, and the plaintiffs appealed.

The appeals court upheld dismissal of all but one of the claims. In the wrongful marketing claim against the generic manufacturing firms, for example, the unanimous three-judge panel of the 6th Circuit said such claims are pre-empted under two U.S. Supreme Court rulings.

The high court's 2011 ruling in Pliva v. Mensing held that cases against generic manufacturers could not go forward because it is impossible for them to comply simultaneously with the state duty to adequately warn and “their federal duty of sameness,” the federal law that requires generic drug labels to be the same as their branded counterpart.

Also cited was the Supreme Court's June 2013 ruling in Bartlett v. Mutual Pharmaceutical Co., in which the high court held that state law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by the Pliva ruling.

“Plaintiffs' wrongful marketing claim stacks assumptions into a house of cards,” says the appellate ruling. “It asks us to assume that parallel misbranding claims survive Mensing and Bartlett preemption. … At a minimum the house collapses based on their deficient pleading,” said the ruling.

The one claim the appeals court reinstated and remanded to the District Court concerned the issue of whether a brand name drug manufacturer had been identified in the lawsuit.