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The U.S. Supreme Court’s 2011 decision in PLIVA v. Mensing left consumers of generic drugs without a remedy for failure-to-warn claims. The Court held that FDA regulations made it impossible for a generic drug manufacturer unilaterally to enhance its warning label. Because of this impossibility, the Court held that the FDA regulations preempt state failure-to-warn claims. The FDA regulations do not, however, preempt brand name drug consumers’ claims against brand name drug manufacturers. Accordingly, consumers stand in starkly different positions depending on whether they consumed a brand name or a generic drug. This Note argues that the FDA should amend its regulations to allow all manufacturers unilaterally to enhance their warning labels. This would allow both generic and brand name consumers to recover from the manufacturer that produced the inadequately-labeled drug that was consumed.


File nameDate UploadedVisibilityFile size
7 Sep 2022
520 kB



  • Subject
    • Administrative Law

    • Consumer Protection Law

    • Food and Drug Law

    • Health Law and Policy

  • Journal title
    • Boston College Law Review

  • Volume
    • 53

  • Issue
    • 5

  • Pagination
    • 1967

  • Date submitted

    7 September 2022