If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. This impossibility indicates that conflict preemption applies and the generic manufacturer ought not to be liable for claims arising under state tort law. This situation is distinct from branded pharmaceutical manufacturers who do have the ability to control and modify their safety labels. Part I begins by examining the doctrine of preemption, considering state tort liability and federal preemption theories. Part II reviews recent Supreme Court jurisprudence relevant to pharmaceutical preemption. Part III then looks at how generic drugs fit into the preemption landscape and concludes that preemption applies to generic drugs. Finally, Part IV evaluates the implications of preemption within the generic drug context.
Hannah B. Murray,
Generic Preemption: Applying Conflict Preemption after Wyeth v. Levine,
Mich. Telecomm. & Tech. L. Rev.
Available at: http://repository.law.umich.edu/mttlr/vol16/iss1/7