Cite as: 531 U. S. 341 (2001)
Opinion of the Court
Irving L. Gornstein argued the cause for the United States as amicus curiae urging reversal. With him on the brief were Solicitor General Waxman, Assistant Attorney General Ogden, Deputy Solicitor General Kneedler, Douglas N. Letter, Peter J. Smith, Margaret Jane Porter, and Patricia J. Kaeding.
Michael D. Fishbein argued the cause for respondent. With him on the brief were Arnold Levin, Sandra L. Duggan, and John J. Cummings III.*
Chief Justice Rehnquist delivered the opinion of the Court.
Respondent represents plaintiffs who claim injuries resulting from the use of orthopedic bone screws in the pedicles of their spines. Petitioner is a consulting company that assisted the screws' manufacturer, AcroMed Corporation, in navigating the federal regulatory process for these devices. Plaintiffs say petitioner made fraudulent representations to the Food and Drug Administration (FDA or Administration) in the course of obtaining approval to market the screws. Plaintiffs further claim that such representations were at least a "but for" cause of injuries that plaintiffs sustained from the implantation of these devices: Had the representations not been made, the FDA would not have approved the devices, and plaintiffs would not have been injured. Plaintiffs sought damages from petitioner under state tort law.
*Briefs of amici curiae urging reversal were filed for the Medical Device Manufacturers Association by Daniel G. Jarcho, Donald R. Stone, and Larry R. Pilot; for Medtronic Sofamor Danek, Inc., by James M. Beck and Stephen S. Phillips; for Pharmaceutical Research and Manufacturers of America by Bert W. Rein, Daniel E. Troy, and Jennifer A. Shah; for the Product Liability Advisory Council, Inc., by Malcolm E. Wheeler; and for the Washington Legal Foundation by Daniel J. Popeo and Richard A. Samp.
Briefs of amici curiae urging affirmance were filed for the Association of Trial Lawyers of America by Jeffrey Robert White and Frederick M. Baron; and for Public Citizen by Allison M. Zieve, Brian Wolfman, and Alan Morrison.
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