Federal preemption has long been a hot button issue in pharmaceutical drug cases, with consumer advocates arguing that drug companies should be held to the sometimes higher state standards. However, the U.S. Supreme Court appears to have reversed the federal preemption stance it took in Wyeth v. Levine. In Wyeth, the Court held that the negligence claim against the pharmaceutical company was not preempted by federal regulations and that the drug company was liable for its failure to provide adequate warning of its drug’s dangers.
However, in Pliva v. Mensing, No. 09-993, the Supreme Court ruled that a pharmaceutical manufacturer could not be sued under state law for failing to warn consumers about its drug’s risks. This decision seems to go against the Court’s ruling in Wyeth just two years ago; both lawsuits deal with federal preemption issues and involve states setting higher safety regulations than the Food and Drug Administration (FDA). Yet in Wyeth, the Court held the drug company responsible, while in Pliva, the Court ruled the pharmaceutical lawsuit was barred under federal preemption.
Yet on closer inspection, there appear to be some key differences between the facts surrounding the drug warning labels in Wyeth and Pliva. The main issue in both the Wyeth and the Pliva pharmaceutical cases involved an FDA regulation referred to as “changes being effected” (CBE). Under the CBE regulation, a drug manufacturer may modify its warning label without prior FDA approval if the modifications will improve the drug’s safety. Under CBE regulations, the FDA approval comes after the warning changes, not before; however, the assumption is that the warning changes in such matters are so important to consumer safety that the FDA will eventually approve those changes.