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Jun 26, 2013

Higgins Comments on High Court's Generic-Drug Liability Ruling


Angela Higgins’ commentary on the significance of the U.S. Supreme Court’s June 24 ruling in Mutual Pharmaceutical Co. Inc. v. Bartlett was included in a Law 360 article (Lawyers React To High Court’s Generic-Drug Liability Ruling) regarding the significance of the ruling, which prohibits a user of a generic drug from bringing a state-law design defect claim against the manufacturer because the manufacturer cannot change a generic drug's design under federal law. Angela commented:

While Bartlett is expressly limited to the generic drug context, it presents a tantalizing glimpse of the Court’s potential receptiveness to similar arguments regarding supposed feasible safer alternative design in the context of branded pharmaceuticals.  The Court noted that redesign of the generic drug was not possible for two reasons, the first being requirements that the generic be equivalent to the branded drug, but the second, and more interesting to branded manufacturers, being that an alteration to the chemical composition of the drug results in an entirely different drug that would require new FDA approval.  Slip Op. at 10-11. 

Additional comments from attorneys across the country are available online to Law360 suBaker Sterchiibers.