Article by Elizabeth J. Cabraser
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.
About the Author
Elizabeth J. Cabraser. Partner at Lieff, Cabraser, Heimann & Bernstein, LLP in San Francisco.
Citation
84 Tul. L. Rev. 1275 (2010)