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DAUBERT v. MERRELL DOW PHARMACEUTICALS, INC.
509 U.S. 579 (1993)
DAUBERT et ux., individually and as guardians AD LITEM FOR DAUBERT, et al.
v.
MERRELL DOW PHARMACEUTICALS, INC.
No. 92-102.
United States Supreme Court.
Argued March 30, 1993.
Decided June 28, 1993.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
Blackmun, J., delivered the opinion for a unanimous Court with respect to Parts I and II—A, and the opinion of the Court with respect to Parts II—B, II—C, III, and IV, in which White, O'Connor, Scalia, Kennedy, Souter, and Thomas, JJ., joined. Rehnquist, C. J., filed an opinion concurring in part and dissenting in part, in which Stevens, J., joined, post, p. 598.
Michael H. Gottesman argued the cause for petitioners. With him on the briefs were Kenneth J. Chesebro, Barry J. Nace, David L. Shapiro, and Mary G. Gillick.
Charles Fried argued the cause for respondent. With him on the brief were Charles R. Nesson, Joel I. Klein, Richard G. Taranto, Hall R. Marston, George E. Berry, Edward H. Stratemeier, and W. Glenn Forrester.*
Justice Blackmun, delivered the opinion of the Court.In this case we are called upon to determine the standard for admitting expert scientific testimony in a federal trial. IPetitioners Jason Daubert and Eric Schuller are minor children born with serious birth defects. They and their parents sued respondent in California state court, alleging that the birth defects had been caused by the mothers' ingestion of Bendectin, a prescription antinausea drug marketed by respondent. Respondent removed the suits to federal court on diversity grounds. After extensive discovery, respondent moved for summary judgment, contending that Bendectin does not cause birth defects in humans and that petitioners would be unable to come forward with any admissible evidence that it does. In support of its motion, respondent submitted an affidavit of Steven H. Lamm, physician and epidemiologist, who is a well-credentialed expert on the risks from exposure to various chemical substances.1 Doctor Lamm stated that he had reviewed all the literature on Bendectin and human birth defects—more than 30 published studies involving over 130,000 patients. No study had found Bendectin to be a human teratogen (i. e., a substance capable of causing malformations in fetuses). On the basis of this review, Doctor Lamm concluded that maternal use of Bendectin during the first trimester of pregnancy has not been shown to be a risk factor for human birth defects.
Petitioners did not (and do not) contest this characterization of the published record regarding Bendectin. Instead, they responded to respondent's motion with the testimony of eight experts of their own, each of whom also possessed impressive credentials.2 These experts had concluded that Bendectin can cause birth defects. Their conclusions were based upon "in vitro" (test tube) and "in vivo" (live) animal studies that found a link between Bendectin and malformations; pharmacological studies of the chemical structure of Bendectin that purported to show similarities between the structure of the drug and that of other substances known to cause birth defects; and the "reanalysis" of previously published epidemiological (human statistical) studies.The District Court granted respondent's motion for summary judgment. The court stated that scientific evidence is admissible only if the principle upon which it is based is "`sufficiently established to have general acceptance in the field to which it belongs.' " 727 F.Supp. 570, 572 (SD Cal. 1989), quoting United States v. Kilgus,571 F.2d 508, 510 (CA9 1978). The court concluded that petitioners' evidence did not meet this standard. Given the vast body of epidemiological data concerning Bendectin, the court held, expert opinion which is not based on epidemiological evidence
is not admissible to establish causation. 727 F. Supp., at 575. Thus, the animal-cell studies, live-animal studies, and chemical-structure analyses on which petitioners had relied could not raise by themselves a reasonably disputable jury issue regarding causation. Ibid. Petitioners' epidemiological analyses, based as they were on recalculations of data in previously published studies that had found no causal link between the drug and birth defects, were ruled to be inadmissible because they had not been published or subjected to peer review. Ibid.
* Briefs of amici curiae urging reversal were filed for the State of Texas et al. by Dan Morales, Attorney General of Texas, Mark Barnett, Attorney General of South Dakota, Marc Racicot, Attorney General of Montana, Larry EchoHawk, Attorney General of Idaho, and Brian Stuart Koukoutchos; for the American Society of Law, Medicine and Ethics et al. by Joan E. Bertin, Marsha S. Berzon, and Albert H. Meyerhoff; for the Association of Trial Lawyers of America by Jeffrey Robert White and Roxanne Barton Conlin; for Ronald Bayer et al. by Brian Stuart Koukoutchos, Priscilla Budeiri, Arthur Bryant, and George W. Conk; and for Daryl E. Chubin et al. by Ron Simon and Nicole Schultheis.Briefs of amici curiae urging affirmance were filed for the United States by Acting Solicitor General Wallace, Assistant Attorney General Gerson, Miguel A. Estrada, Michael Jay Singer, and John P. Schnitker; for the American Insurance Association by William J. Kilberg, Paul Blankenstein, Bradford R. Clark, and Craig A. Berrington; for the American Medical Association et al. by Carter G. Phillips, Mark D. Hopson, and Jack R. Bierig; for the American Tort Reform Association by John G. Kester and John W. Vardaman, Jr.; for the Chamber of Commerce of the United States by Timothy B. Dyk, Stephen A. Bokat, and Robin S. Conrad; for the Pharmaceutical Manufacturers Association by Louis R. Cohen and Daniel Marcus; for the Product Liability Advisory Council, Inc., et al. by Victor E. Schwartz, Robert P. Charrow, and Paul F. Rothstein; for the Washington Legal Foundation by Scott G. Campbell, Daniel J. Popeo, and Richard A. Samp; and for Nicolaas Bloembergen et al. by Martin S. Kaufman. Briefs of amici curiae were filed for the American Association for the Advancement of Science et al. by Richard A. Meserve and Bert Black; for the American College of Legal Medicine by Miles J. Zaremski; for the Carnegie Commission on Science, Technology, and Government by Steven G. Gallagher, Elizabeth H. Esty, and Margaret A. Berger; for the Defense Research Institute, Inc., by Joseph A. Sherman, E. Wayne Taff, and Harvey L. Kaplan; for the New England Journal of Medicine et al. by Michael Malina and Jeffrey I. D. Lewis; for A Group of American Law Professors by Donald N. Bersoff; for Alvan R. Feinstein by Don M. Kennedy, Loretta M. Smith, and Richard A. Oetheimer; and for Kenneth Rothman et al. by Neil B. Cohen. 1. Doctor Lamm received his master's and doctor of medicine degrees from the University of Southern California. He has served as a consultant in birth-defect epidemiology for the National Center for Health Statistics and has published numerous articles on the magnitude of risk from exposure to various chemical and biological substances. App. 34-44. 2. For example, Shanna Helen Swan, who received a master's degree in biostatistics from Columbia University and a doctorate in statistics from the University of California at Berkeley, is chief of the section of the California Department of Health and Services that determines causes of birth defects and has served as a consultant to the World Health Organization, the Food and Drug Administration, and the National Institutes of Health. Id., at 113-114, 131-132. Stuart A. Newman, who received his bachelor's degree in chemistry from Columbia University and his master's and doctorate in chemistry from the University of Chicago, is a professor at New York Medical College and has spent over a decade studying the effect of chemicals on limb development. Id., at 54-56. The credentials of the others are similarly impressive. See id., at 61-66, 73-80, 148-153, 187— 192, and Attachments 12, 20, 21, 26, 31, and 32 to Petitioners' Opposition to Summary Judgment in No. 84-——G(I) (SD Cal.). 3. For a catalog of the many cases on either side of this controversy, see P. Giannelli & E. Imwinkelried, Scientific Evidence § 1-5, pp. 10-14 (1986 and Supp. 1991). 4. See, e. g., Green, Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation, 86 Nw. U. L. Rev. 643 (1992) (hereinafter Green); Becker & Orenstein, The Federal Rules of Evidence After Sixteen Years—The Effect of "Plain Meaning" Jurisprudence, the Need for an Advisory Committee on the Rules of Evidence, and Suggestions for Selective Revision of the Rules, 60 Geo. Wash. L. Rev. 857, 876-885 (1992); Hanson, James Alphonzo Frye is Sixty-Five Years Old; Should He Retire?, 16 West. St. U. L. Rev. 357 (1989); Black, A Unified Theory of Scientific Evidence, 56 Ford. L. Rev. 595 (1988); Imwinkelried, The "Bases" of Expert Testimony: The Syllogistic Structure of Scientific Testimony, 67 N. C. L. Rev. 1 (1988); Proposals for a Model Rule on the Admissibility of Scientific Evidence, 26 Jurimetrics J. 235 (1986); Giannelli, The Admissibility of Novel Scientific Evidence: Frye v. United States, a Half-Century Later, 80 Colum. L. Rev. 1197 (1980); The Supreme Court, 1986 Term, 101 Harv. L. Rev. 7, 119, 125-127 (1987).
Indeed, the debates over Frye are such a well-established part of the academic landscape that a distinct term—"Frye -ologist"—has been advanced to describe those who take part. See Behringer, Introduction, Proposals for a Model Rule on the Admissibility of Scientific Evidence, 26 Jurimetrics J. 237, 239 (1986), quoting Lacey, Scientific Evidence, 24 Jurimetrics J. 254, 264 (1984). 5. Like the question of Frye `s merit, the dispute over its survival has divided courts and commentators. Compare, e. g., United States v. Williams,583 F.2d 1194 (CA2 1978) (Frye is superseded by the Rules of Evidence), cert. denied, 439 U.S. 1117 (1979), with Christophersen v. Allied-Signal Corp.,939 F.2d 1106, 1111, 1115-1116 (CA5 1991) (en banc) (Frye and the Rules coexist), cert. denied, 503 U.S. 912 (1992), 3 J. Weinstein & M. Berger, Weinstein's Evidence ¶ 702[03], pp. 702-36 to 702-37 (1988) (hereinafter Weinstein & Berger) (Frye is dead), and M. Graham, Handbook of Federal Evidence § 703.2 (3d ed. 1991) (Frye lives). See generally P. Giannelli & E. Imwinkelried, Scientific Evidence § 1-5, at 28-29 (citing authorities). 6. Because we hold that Frye has been superseded and base the discussion that follows on the content of the congressionally enacted Federal Rules of Evidence, we do not address petitioners' argument that application of the Frye rule in this diversity case, as the application of a judgemade rule affecting substantive rights, would violate the doctrine of Erie R. Co. v. Tompkins,304 U.S. 64 (1938). 7. The Chief Justice "do[es] not doubt that Rule 702 confides to the judge some gatekeeping responsibility," post, at 600, but would neither say how it does so nor explain what that role entails. We believe the better course is to note the nature and source of the duty. 8. Rule 702 also applies to"technical, or other specialized knowledge." Our discussion is limited to the scientific context because that is the nature of the expertise offered here. 9. We note that scientists typically distinguish between "validity" (does the principle support what it purports to show?) and "reliability"(does application of the principle produce consistent results?). See Black, 56 Ford. L. Rev., at 599. Although "the difference between accuracy, validity, and reliability may be such that each is distinct from the other by no more than a hen's kick," Starrs, Frye v. United States Restructured and Revitalized: A Proposal to Amend Federal Evidence Rule 702, 26 Jurimetrics J.249, 256 (1986), our reference here is toevidentiary reliability— that is, trustworthiness. Cf., e. g., Advisory Committee's Notes on Fed. Rule Evid. 602, 28 U. S. C. App., p. 755 ("`[T]he rule requiring that a witness who testifies to a fact which can be perceived by the senses must have had an opportunity to observe, and must have actually observed the fact' is a `most pervasive manifestation' of the common law insistence upon `the most reliable sources of information' " (citation omitted)); Advisory Committee's Notes on Art. VIII of Rules of Evidence, 28 U. S. C.App., p. 770 (hearsay exceptions will be recognized only "under circumstances supposed to furnish guarantees of trustworthiness"). In a case involving scientific evidence, evidentiary reliability will be based upon scientific validity. 10. Rule 104(a) provides:
"Preliminary questions concerning the qualification of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court, subject to the provisions of subdivision (b) [pertaining to conditional admissions]. In making its determination it is not bound by the rules of evidence except those with respect to privileges." These matters should be established by a preponderance of proof. See Bourjaily v. United States,483 U.S. 171, 175-176 (1987). 11. Although the Frye decision itself focused exclusively on "novel" scientific techniques, we do not read the requirements of Rule 702 to apply specially or exclusively to unconventional evidence. Of course, wellestablished propositions are less likely to be challenged than those that are novel, and they are more handily defended. Indeed, theories that are so firmly established as to have attained the status of scientific law, such as the laws of thermodynamics, properly are subject to judicial notice under Federal Rule of Evidence 201. 12. A number of authorities have presented variations on the reliability approach, each with its own slightly different set of factors. See, e. g., Downing, 753 F. 2d, at 1238-1239 (on which our discussion draws in part); 3 Weinstein & Berger ¶ 702[03], pp. 702-41 to 702-42 (on which the Downing court in turn partially relied); McCormick, Scientific Evidence: Defining a New Approach to Admissibility, 67 Iowa L. Rev. 879, 911-912 (1982); and Symposium on Science and the Rules of Evidence, 99 F. R. D. 187, 231 (1983) (statement by Margaret Berger). To the extent that they focus on the reliability of evidence as ensured by the scientific validity of its underlying principles, all these versions may well have merit, although we express no opinion regarding any of their particular details. 13. This is not to say that judicial interpretation, as opposed to adjudicative factfinding, does not share basic characteristics of the scientific endeavor: "The work of a judge is in one sense enduring and in another ephemeral. . . . In the endless process of testing and retesting, there is a constant rejection of the dross and a constant retention of whatever is pure and sound and fine." B. Cardozo, The Nature of the Judicial Process 178-179 (1921).
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