Sixth Circuit Dismisses Claims of Those Harmed By Generic Drugs in In re Darvocet

July 10, 2014

Recently, the Sixth Circuit Court of Appeals gave a temporary victory to drug manufacturers when it upheld a motion to dismiss the plaintiffs' case, stating that they had not met the necessary elements to survive the motion.

pills-1111305-m.jpgIn In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, the plaintiffs sought to hold Darvocet's manufacturer, Eli Lilly and Company, responsible for damage caused by the generic drug based on a misrepresentation legal theory. The painkiller Darvocet was first patented in 1957, and other manufacturers began to market generic versions after 1984. Darvocet had a troubled history, having been withdrawn from the UK market in 2005. The federal Food and Drug Administration (FDA) eventually requested that it be removed from U.S. markets in 2010. The plaintiffs in In re Darvocet claimed to have ingested Darvocet shortly before the FDA's request. They argued that manufacturers continued to market generic Darvocet even after they knew or should have known that the risks of the drugs exceeded their benefits. The plaintiffs sought to hold one or more brand names responsible, alleging that the brand name manufacturers made misrepresentations that led the plaintiffs' physicians to prescribe generic versions of Darvocet.

The United States Supreme Court then issued a ruling in Mutual Pharmacy Co. v. Bartlett (2013) that state design defect claims based on the adequacy of the drug's warnings were preempted by federal law. Included was a footnote that stated that this ruling did not address state design defect claims that "parallel" the federal misbranding statute. The plaintiffs in In re Darvocet therefore brought their claims against the brand name manufacturers based on the theory of parallel misbranding.

The Sixth Circuit's decision did not involve whether parallel misbranding claims should be recognized. Instead, it noted that the plaintiffs had failed to plead the elements necessary to survive a motion to dismiss, which involved: (1) alleging a cause of action for branding under state law; (2) identifying new and scientifically significant information that had not come before the FDA; and (3) demonstrating that the FDA would have found the drug misbranded in light of that new information. The Sixth Circuit determined that the second element had not been met, since the plaintiffs had failed to demonstrate that the generic manufacturers had access to a 2009 study on the drugs' dangers before the FDA could review it.

The Court also noted that the lawsuits originated in 22 different states, not all of which had laws that recognized the plaintiffs' misrepresentation claims. Therefore, the Court ended up dismissing 67 of 68 cases, remanding just one that involved use of a brand name drug.

While this was undoubtedly a setback for plaintiffs in In re Darvocet, it leaves open the possibility that another plaintiff could successfully plead a parallel misbranding cause of action.

Miller & Falkner is an Indiana and Kentucky plaintiffs law firm. Located in Louisville, Kentucky, the firm provides representation in the areas of personal injury and employment law. If you need a Kentucky or Indiana personal injury attorney, contact us today for a free consultation.

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