March 03, 2009

Supreme Court Decides Wyeth v. Levine

In 2000, a health care worker injected Wyeth's medication, Phenergan, into Donna Levine by "IV push" administration. The placement of the IV was incorrect and medication entered Levine's artery, resulting in gangrene and the eventual amputation of Levine's forearm. Levine brought claims against Wyeth, arguing that the medication's label was defective because it failed to instruct clinicians to use IV drip, rather than IV push, to administer Phenergan. A jury awarded Levine damages. On appeal, the trial court and appellate state courts in Vermont denied Wyeth's argument that Levine's state law claims were preempted by FDA regulations governing the labeling of medications. The Supreme Court agreed. It held that conflict preemption did not bar Levine's claims under either of the two theories advanced by Wyeth. First, the Court determined that it would not have been "impossible" for Wyeth to comply with both federal and state laws because Wyeth could have altered Phenergan's label under the changes being effected ("CBE") regulations that allow manufacturers to change medication labels to add or strengthen specified statements. According to the Court, the manufacturer bears the responsibility for its label "at all times." There were also no indications that the FDA would have rejected a change to Phenergan's label. Second, the Court concluded that the state law claims based on Phenergan's warnings would not result in an "obstacle" to Congressional purposes and objectives. In doing so, the Court rejected the notion that FDA sets both a "ceiling and a floor" by approving a medication's label and held that the FDA's statement to such effect in a preamble to a 2006 regulation was not entitled to deference.

Justice Stevens delivered the opinion of the court in which Justices Kennedy, Souter, Ginsburg and Breyer joined. Justices Breyer and Thomas filed concurring opinions. Justice Alito filed a dissenting opinion in which Chief Justice Roberts and Justice Scalia joined.

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