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Generic Drug Claims Completely Preemped under Mensing and Bartlett

Posted in Recent Cases

In Strayhorn v. Wyeth Pharms., Inc., decided this Monday, the Sixth Circuit affirmed the complete dismissal of claims against makers of generic drugs under the Supreme Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  Judge Gilman’s opinion reads those cases as broadly holding that state law failure-to-warn claims based on generic drugs are preempted by the FDA’s requirement that the labels on generic drugs conform to the labels on the brand-name drugs.  Disregarding plaintiffs’ “most artful efforts to dress up a relatively simple failure-to-warn claim in a great variety of tort and contract causes of action,” the opinion held that each of those claims was preempted because for requiring a change to either the drug or the label—a “course of action . . . available to a generic manufacturer under federal law.”  It also rejected plaintiffs’ argument that advertising and promotional materials are not part of a drug’s label.  Finally, the decision dismissed claims against the brand-name manufacturers because the plaintiffs only purchased the generic version.

In her dissent, Judge Stranch disagreed with the majority’s characterization of state law, believing that Tennessee courts might find that brand-name drug manufacturers have a duty to warn consumers that purchase generic drugs.  She also criticized the catch-22 result that the majority’s decision produced, which precludes customers from suing both generic and brand-name manufacturers in these circumstances.