Abstract: 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.
BCLR Releases Vol. LIV No. 2
Boston College Law Review is pleased to announce the publication of our March 2013 issue. • Jeremy Waldron, Separation of […]
BCLR Elects New Board of Editors
On March 22, 2013, the membership of the Boston College Law Review elected a new Board of Editors for the […]
BCLR Editors Win Student Writing Competitions
Two members of the Boston College Law Review‘s Executive Board, Laura Kaplan and Michael Palmisciano, recently won national writing competitions […]