Generic Preemption: Applying Conflict Preemption after Wyeth v. Levine
Hannah B. Murray
affiliation not provided to SSRN
May 20, 2009
Michigan Telecommunications and Technology Law Review, Vol. 16, p. 255, Fall 2009
Despite the much-awaited Supreme Court decision in Wyeth v. Levine, preemption for generic pharmaceuticals still exists. Levine addressed conflict preemption of state failure-to-warn claims. After reviewing the federal law governing pharmaceutical warning labels, the Court found that pharmaceutical companies could modify their branded drug warning labels to meet obligations presented by state law. Consequently, conflict preemption does not apply.
In contrast, generic drugs must adopt the identical label employed by their branded counterparts. The FDA does not allow the generic drug label to deviate from the branded competitor’s at any point during the approval process or thereafter. As a result, the generic manufacturer is not at liberty to make changes to its product’s warning label. State tort failure-to-warn claims pose an impossible situation – the generic manufacturer cannot comply with both the federal requirements to mirror the branded drug’s label and a state obligation to enhance or modify the label. Further, Congress eliminated much of the clinical testing requirements for generic drugs as a measure to ensure that they remain low cost options for consumers.
Exposing generic drugs to tort liability under state law might serve to push generic manufacturers to conduct or support safety and efficacy testing. Conducting this type of research would certainly increase costs and drug prices, frustrating the purpose of Congress to promote generic drugs. Conflict preemption applies when it is impossible to comply with both state and federal duties under law or when state law stands as an obstacle to accomplishing the purposes of Congress. Conflict preemption applies to generic manufacturers sued under state failure-to-warn claims, but a change in the law is needed to ensure generic warning labels are adequate and that consumers injured by generic drugs are not left without any compensation for their pain, suffering, and medical bills.
Number of Pages in PDF File: 23
Keywords: preemption pharmaceutical generic drug
Date posted: May 21, 2009 ; Last revised: June 2, 2013