Skip to main content


On May 2, 2012, the U.S. Court of Appeals for the First Circuit held in Bartlett v. Mutual Pharmaceutical Co. that the Federal Food, Drug, and Cosmetic Act (FDCA) does not preempt design defect claims against generic manufacturers. The court reasoned that, by not manufacturing the drug, a generic manufacturer could avoid state design defect liability without violating the federal requirement that a generic drug remain “the same” as a listed brand-name drug. This Comment argues that, in so holding, the First Circuit misconstrued Supreme Court precedent and contravened the objectives of the Hatch-Waxman Amendments. It further argues that, on review, the Supreme Court should hold that the FDCA preempts design defect claims against generic manufacturers. Finally, this Comment proposes that Congress enact a federal damages remedy to give injured consumers some relief.


File nameDate UploadedVisibilityFile size
7 Sep 2022
173 kB



  • Subject
    • Conflict of Laws

    • Consumer Protection Law

    • Food and Drug Law

    • Health Law and Policy

  • Journal title
    • Boston College Law Review

  • Volume
    • 54

  • Issue
    • 6

  • Pagination
    • E. Supp. 1

  • Date submitted

    7 September 2022

  • Keywords