Prescription drug warning labels are regulated by both state products liability law and federal regulations imposed by the Food, Drug, and Cosmetic Act. Often, federal law acts as a minimum standard to which states may add stricter labeling requirements. Occasionally, however, state and federal labeling requirements place a prescription drug manufacturer in a position where compliance with state products liability law causes it to violate federal regulations and vice versa. When this occurs, a decision must be made as to whether state or federal drug labeling requirements prevail. Historically, courts have taken the position that state products liability law preempted federal regulations absent clear Congressional intent for federal law to preempt state law. This began to change in 2001, when manufacturers began to prevail using the defense of federal preemption. In 2009, in Wyeth v. Levine, the Supreme Court finally settled the issue of federal preemption in the context of prescription drugs. The Court developed a "clear evidence" standard, which weighed heavily in favor of state law failure-to-warn claims. In light of the Supreme Court's decision in Levine, the Seventh Circuit overruled the district court's holding in Mason v. SmithKline Beecham and held that the plaintiffs' state law failure-to-warn claims were not preempted by FDA regulations. This Note analyzes the Seventh Circuit's adoption of the presumption against preemption in the context of prescription drugs and argues that Congress should enact an express preemption clause for prescription drugs similar to the Medical Device Amendment of 1976.
Amanda N. Hart,
Federal Preemption of State-Law Failure-to-Warn Claims: Has the Presumption Against Preemption Gone Too Far?,
Seventh Circuit Rev.
Available at: https://scholarship.kentlaw.iit.edu/seventhcircuitreview/vol6/iss1/10