On March 4, 2009, in Wyeth v. Levine, the United States Supreme Court rejected the viability of a preamble to a 2006 Food and Drug Administration (FDA) prescription drug-labeling regulation that purported to preempt state tort law, concluding that it “does not merit deference.” The Court upheld the verdict of a Vermont jury in favor of plaintiff Diana Levine against the manufacture of the prescription drug, on state tort law failure-to-warn theories, for an injury she had suffered nine years before, in April 2000. The injury resulted in the amputation of her right forearm and ended her career as a professional musician. Had the Supreme Court given deference to the FDA “Preamble,” and held Ms. Levine's claim to be preempted by the FDA's approval of the drug, her $6.77 million jury award would have been vacated, and she would have gone uncompensated for the loss of her arm and her livelihood. Far beyond the consequences to a single plaintiff, the claims of any thousands of prescription drug plaintiffs in cases pending across the country--representing billions of dollars in compensatory damages--would have then been dismissed. Dismissal would leave these plaintiffs without recourse and would immunize prescription drug manufacturers from financial accountability for the health, safety, and economic depredations of dangerous or improperly marketed drugs.. . .
The Defense of Preemption: A View from the Trenches
Most lawyers who have any familiarity with the law of federal preemption, and in particular the United States Supreme Court's cases involving the preemption of state tort requirements, would freely admit that the law is a muddle. Beginning with the Court's fractured 1992 decision in Cipollone v. Liggett Group, Inc., which was argued twice before it was decided, the Court has issued a series of decisions, some of them fractured and confusing, that have alternatively cheered and flummoxed the plaintiffs' bar as well as product manufacturers, transportation companies, and other businesses that regularly rely on the preemption defense. Unfortunately, these cases--which are among the most hotly contested of all cases on the Supreme Court's docket, judging by amicus participation--have produced significant confusion in the law of preemption generally. As someone who has participated in many of these cases over the years since Cipollone, my purpose is to offer a few observations drawn from my own experience about some of the major disputed issues in preemption law today, including the proper role of courts in resolving preemption cases. I also hope to make a few broader points about the preemption doctrine that are often overlooked in the acrimonious debate over tort cases.. . .