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State-Law Design-Defect Claims Against Generic Drug Manufacturers Are Preempted

BY Wendy S. Dowse
September 26, 2013

In 2011, the U.S. Supreme Court held that federal law prohibits generic pharmaceutical manufacturers from independently changing the labeling of their drugs ' the labeling must be the same as the labeling for the brand-name drug to which the generic is equivalent. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2574-77 (2011). State-law claims based on the failure to provide different warnings for generic drugs conflict with this “federal duty of 'sameness'” and are therefore preempted. Id. at 2575.

Although attempts to avoid Mensing have been largely unsuccessful, in Bartlett v. Mutual Pharm. Co., the First Circuit held that a design-defect claim against a generic manufacturer was not preempted under Mensing because it could simply “choose not to make the drug at all.” 678 F.3d 30, 37 (1st Cir. 2012). In June, the Supreme Court reversed, holding that “state-law design-defect claims ' that place a duty on [generic] manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling.” Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2479 (2013).

This article discusses Mensing and Bartlett and their potential impact. For an analysis of the other related decisions, see “Recent Developments Since Pliva v. Mensing” in the September issue of this newsletter (http://bit.ly/17Rqoyu).

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