DAUBERT ET UX., INDIVIDUALLY AND AS GUARDIANS AD LITEM FOR DAUBERT, ET AL. v. MERRELL DOW PHARMACEUTICALS, INC.
No. 92-102
Supreme Court of the United States
Argued March 30, 1993-Decided June 28, 1993
509 U.S. 579
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.*
*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 Associatiоn 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 Dеfense 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
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.
I
Petitioners 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 divеrsity 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.
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
The United States Court of Appeals for the Ninth Circuit affirmed. 951 F. 2d 1128 (1991). Citing Frye v. United States, 54 App. D. C. 46, 47, 293 F. 1013, 1014 (1923), the court stated that expert opinion based on a scientific technique is inadmissible unless the technique is “generally accepted” as reliable in the relevant scientific community. 951 F. 2d, at 1129-1130. The court declared that expert opinion based on a methodology that diverges “significantly from the procedures accepted by recognized authorities in the field... cannot be shown to be ‘generally accepted as a reliable technique.‘” Id., at 1130, quoting United States v. Solomon, 753 F. 2d 1522, 1526 (CA9 1985).
The court emphasizеd that other Courts of Appeals considering the risks of Bendectin had refused to admit reanalyses of epidemiological studies that had been neither published nor subjected to peer review. 951 F. 2d, at 1130-1131. Those courts had found unpublished reanalyses “particularly problematic in light of the massive weight of the original published studies supporting [respondent‘s] position, all of which had undergone full scrutiny from the scientific community.” Id., at 1130. Contending that reanalysis is generally accepted by the scientific community only when it is subjected to verification and scrutiny by others in the field, the Court of Appeals rejected petitioners’ reanalyses as “unpublished, not subjected to the normal peer review process and generated solely for use in litigation.” Id., at 1131. The
We granted certiorari, 506 U. S. 914 (1992), in light of sharp divisions among the courts regarding the proper standard for the admission of expert testimony. Compare, e. g., United States v. Shorter, 257 U. S. App. D. C. 358, 363-364, 809 F. 2d 54, 59-60 (applying the “general acceptance” standard), cert. denied, 484 U. S. 817 (1987), with DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F. 2d 941, 955 (CA3 1990) (rejecting the “general acceptance” standard).
II
A
In the 70 years since its formulation in the Frye case, the “general acceptance” test has been the dominant standard for determining the admissibility of novel scientific evidence at trial. See E. Green & C. Nesson, Problems, Cases, and Materials on Evidence 649 (1983). Although under increasing attack of late, the rule continues to be followed by a majority of courts, including the Ninth Circuit.3
The Frye test has its origin in a short and citation-free 1923 decision concerning the admissibility of evidence derived from a systolic blood pressure deception test, a crude precursor to the polygraph machine. In what has become a famous (perhaps infamous) passage, the then Court of Appeals for the District of Columbia described the device and its operation and declared:
“Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages
is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general аcceptance in the particular field in which it belongs.” 54 App. D. C., at 47, 293 F., at 1014 (emphasis added).
Because the deception test had “not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made,” evidence of its results was ruled inadmissible. Ibid.
The merits of the Frye test have been much debated, and scholarship on its proper scope and application is legion.4
We interpret the legislatively enacted Federal Rules of Evidence as we would any statute. Beech Aircraft Corp. v. Rainey, 488 U. S. 153, 163 (1988).
“All rеlevant evidence is admissible, except as otherwise provided by the Constitution of the United States, by Act of Congress, by these rules, or by other rules prescribed by the Supreme Court pursuant to statutory authority. Evidence which is not relevant is not admissible.”
“Relevant evidence” is defined as that which has “any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.”
Frye, of course, predated the Rules by half a century. In United States v. Abel, 469 U. S. 45 (1984), we considered the pertinence of background common law in interpreting the Rules of Evidence. We noted that the Rules occupy the field, id., at 49, but, quoting Professor Cleary, the Reporter,
“‘In principle, under the Federal Rules no common law of evidence remains. “All relevant evidence is admissible, except as otherwise provided....” In reality, of course, the body of common law knowledge continues to exist, though in the somewhat altered form of a source of guidance in the exercise of delegated powers.‘” Id., at 51-52.
We found the common-law precept at issue in the Abel case entirely consistent with Rule 402‘s general requirement of admissibility, and considered it unlikely that the drafters had intended to change the rule. Id., at 50-51. In Bourjaily v. United States, 483 U. S. 171 (1987), on the other hand, the Court was unable to find a particular common-law doctrine in the Rules, and so held it superseded.
Here there is a specific Rule that speaks to the contested issue.
“If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.”
Nothing in the text of this Rule establishes “general acceptance” as an absolute prerequisite to admissibility. Nor does respondent present any clear indication that Rule 702 or the Rules as a whole were intended to incorporate a “general acceptance” standard. The drafting history makes no mention of Frye, and a rigid “general acceptance” requirement would be at odds with the “liberal thrust” of the Federal Rules and their “general approach of relaxing the traditional barriers to ‘opinion’ testimony.” Beech Aircraft Corp. v. Rainey, 488 U. S., at 169 (citing Rules 701 to 705). See also Weinstein, Rule 702 of the Federal Rules of Evidence is
B
That the Frye test was displaced by the Rules of Evidence does not mean, however, that the Rules themselves place no limits on the admissibility of purportedly scientifiс evidence.7 Nor is the trial judge disabled from screening such evidence. To the contrary, under the Rules the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.
The primary locus of this obligation is Rule 702, which clearly contemplates some degree of regulation of the subjects and theories about which an expert may testify. “If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue” an expert “may testify thereto.” (Emphasis added.) The subject of an expert‘s testimony must
That these requirements are embodied in Rule 702 is not surprising. Unlike an ordinary witness, see
C
Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to
Ordinarily, a key question to be answered in determining whether a theory or technique is scientific knowledge that will assist the trier of fact will be whether it can be (and has been) tested. “Scientific methodology today is based on generating hypotheses and testing them to see if they can be falsified; indeed, this methodology is what distinguishes science from other fields of human inquiry.” Green 645. See also C. Hempel, Philosophy of Natural Science 49 (1966) (“[T]he statements constituting a scientific explanation must be capable of empirical test“); K. Popper, Conjectures and Refutations: The Growth of Scientific Knowledge 37 (5th ed. 1989) (“[T]he criterion of the scientific status of a theory is its falsifiability, or refutability, or testability“) (emphasis deletеd).
Another pertinent consideration is whether the theory or technique has been subjected to peer review and publication. Publication (which is but one element of peer review) is not a sine qua non of admissibility; it does not necessarily correlate with reliability, see S. Jasanoff, The Fifth Branch: Science Advisors as Policymakers 61-76 (1990), and in some instances well-grounded but innovative theories will not have been published, see Horrobin, The Philosophical Basis of Peer Review and the Suppression of Innovation, 263 JAMA 1438 (1990). Some propositions, moreover, are too particular, too new, or of too limited interest to be published. But submission to the scrutiny of the scientific community is a component of “good science,” in part because it increases the likelihood that substantive flaws in methodоlogy will be detected. See J. Ziman, Reliable Knowledge: An Exploration
Additionally, in the case of a particular scientific technique, the court ordinarily should consider the known or potential rate of error, see, e. g., United States v. Smith, 869 F. 2d 348, 353-354 (CA7 1989) (surveying studies of the error rate of spectrographic voice identification technique), and the existence and maintenance of standards controlling the technique‘s operation, see United States v. Williams, 583 F. 2d 1194, 1198 (CA2 1978) (noting professional organization‘s standard governing spectrogrаphic analysis), cert. denied, 439 U. S. 1117 (1979).
Finally, “general acceptance” can yet have a bearing on the inquiry. A “reliability assessment does not require, although it does permit, explicit identification of a relevant scientific community and an express determination of a particular degree of acceptance within that community.” United States v. Downing, 753 F. 2d, at 1238. See also 3 Weinstein & Berger ¶ 702[03], pp. 702-41 to 702-42. Widespread acceptance can be an important factor in ruling particular evidence admissible, and “a known technique which has been able to attract only minimal support within the community,” Downing, 753 F. 2d, at 1238, may properly be viewed with skepticism.
The inquiry envisioned by Rule 702 is, we emphasize, a flexible one.12 Its overarching subject is the scientific valid-
Throughout, a judge assessing a proffer of expert scientific testimony under Rule 702 should also be mindful of other applicable rules.
III
We conclude by briefly addressing what appear to be two underlying concerns of the parties and amici in this case. Respondent expresses apprehension that abandonment of “general acceptance” as the exclusive requirement for admission will result in a “free-for-all” in which befuddled juries are confounded by absurd and irrational pseudoscientific as-
Petitioners and, to a greater extent, their amici exhibit a different concern. They suggest that recognition of a screening role for the judge that allows for the exclusion of “invalid” evidence will sanction a stifling and repressive scientific orthodoxy and will be inimical to the search for truth. See, e. g., Brief for Ronald Bayer et al. as Amici Curiae. It is true that open debate is аn essential part of both legal and scientific analyses. Yet there are important differences between the quest for truth in the courtroom and the quest
IV
To summarize: “General acceptance” is not a necessary precondition to the admissibility of scientific evidence under the Federal Rules of Evidence, but the Rules of Evidence-especially Rule 702-do assign to the trial judge the task of ensuring that an expert‘s testimony both rests on a reliable foundation and is relevant to the task at hand. Pertinent evidence based on scientifically valid principles will satisfy those demands.
The inquiries of the District Court and the Court of Apрeals focused almost exclusively on “general acceptance,” as gauged by publication and the decisions of other courts. Ac-
It is so ordered.
CHIEF JUSTICE REHNQUIST, with whom JUSTICE STEVENS joins, concurring in part and dissenting in part.
The petition for certiorari in this case presents two questions: first, whether the rule of Frye v. United States, 54 App. D. C. 46, 293 F. 1013 (1923), remains good law after the enactment of the Federal Rules of Evidence; and second, if Frye remains valid, whether it requires expert scientific testimony to have been subjected to a peer review process in order to be admissible. The Court concludes, correctly in my view, that the Frye rule did not survive the enactment of the Federal Rules of Evidence, and I therefore join Parts I and II-A of its opinion. The second question presented in the petition for certiorari necessarily is mooted by this holding, but the Court nonetheless proceeds to construe Rules 702 and 703 very much in the abstract, and then offers some “general observations.” Ante, at 593.
“General observations” by this Court customarily carry great weight with lower federal courts, but the ones offered here suffer from the flaw common to most such observations-they are not applied to deciding whether particular testimony was or was not admissible, and therefore they tend to be not only general, but vague and abstract. This is particularly unfortunate in a case such as this, where the ultimate legal question depends on an appreciation of one or more bodies of knowledge not judicially noticeаble, and subject to different interpretations in the briefs of the parties and their amici. Twenty-two amicus briefs have been filed in the case, and indeed the Court‘s opinion contains no fewer than 37 citations to amicus briefs and other secondary sources.
But even if it were desirable to make “general observations” not necessary to decide the questions presented, I cannot subscribe to some of the observations made by the Court. In Part II-B, the Court concludes that reliability and relevancy are the touchstones of the admissibility of expert testimony. Ante, at 590-592.
Questions arise simply from reading this part of the Court‘s opinion, and countless more questions will surely arise when hundreds of district judges try to apply its teaching to particular offers of expert testimony. Does all of this dicta apply to an expert seeking to testify on the basis of “technical or other specialized knowledge“-the other types of expert knowledge to which Rule 702 applies-or are the “general observations” limited only to “scientific knowledge“? What is the difference between scientific knowledge and technical knowledge; does Rule 702 actually contemplate that the phrase “scientific, technical, or other specialized knowledge” be broken down into numerous subspecies of expertise, or did its authors simply pick general descriptive language covering the sort of expert testimony which courts have customarily received? The Court speaks of its confidence that federal judges can make a “preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.” Ante, at 592-593. The Court then states that a “key question” to be answered in deciding whether something is “scientific knowledge” “will be whether it can be (and has been) tested.” Ante, at 593. Following this sentence are three quotations from treatises, which not only speak of empirical testing, but one of which states that the “‘criterion of the scientific status of a theory is its falsifiability, or refutability, or testability.‘” Ibid.
I defer to no one in my confidence in federal judges; but I am at a loss to know what is meant when it is said that the scientific status of a theory depends on its “falsifiability,” and I suspect some of them will be, too.
I do not doubt that Rule 702 confides to the judge some gatekeeping responsibility in deciding questions of the admissibility of proffered expert testimony. But I do not think
Notes
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).
