Marcia Boumil


The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label—does preempt state law as to claims that challenge the warnings that accompany generic drugs.

In each of these cases, the underlying issue has been whether the federal regulatory process leading to FDA approval of drugs and medical devices “preempt” state laws as to the safety issues addressed through the approval process. Thus, to summarize the applicable law prior to Bartlett, the Court had upheld failure-to-warn claims against the brand (preemption denied) but denied failure-to-warn claims against the generic (preemption upheld); the Court has also denied device manufacturers’ liability for most product liability-related claims (preemption upheld) pursuant to a specific statutory provision. By a vote of 5-4, Bartlett has now denied liability of generic manufacturers on the basis of design-defect. Following the Supreme Court opinion, however, the FDA set forth its agenda, which includes proposing a rule that would allow generic drug makers to revise their drug labels. If created and adopted, this rule could again alter the landscape of liability for generic manufacturers. Further, the related issue (which is still unresolved by the high court and is the subject of a split among the circuit courts) is whether FDA approval of medical devices preempts all state law actions, thus insulating device manufacturers from product liability claims under all circumstances. This Article will address each of these issues, as well as the related issue of whether off-label use of FDA-approved medical devices give rise to liability.