Source: http://www.forensic-psych.com/articles/caseDaubertvMerrellDow.php
Timestamp: 2019-04-20 08:25:21+00:00

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DAUBERT et ux., individually and as guardians and litem for DAUBERT, et al. v. MERRELL DOW PHARMACEUTICALS, INC.
Petitioners, two minor children and their parents, alleged in their suit against respondent that the children's serious birth defects had been caused by the mothers' prenatal ingestion of Bendectin, a prescription drug marketed by respondent. The District Court granted respondent summary judgment based on a well credentialed expert's affidavit concluding, upon reviewing the extensive published scientific literature on the subject, that maternal use of Bendectin has not been shown to be a risk factor for human birth defects. Although petitioners had responded with the testimony of eight other well credentialed experts, who based their conclusion that Bendectin can cause birth defects on animal studies, chemical structure analyses, and the unpublished "reanalysis" of previously published human statistical studies, the court determined that this evidence did not meet the applicable "general acceptance" standard for the admission of expert testimony. The Court of Appeals agreed and affirmed, citing Frye v. United States, 54 App. D. C. 46, 47, 293 F. 1013, 1014, for the rule that expert opinion based on a scientific technique is inadmissible unless the technique is "generally accepted" as reliable in the relevant scientific community.
Held: The Federal Rules of Evidence, not Frye, provide the standard for admitting expert scientific testimony in a federal trial. Pp. 4-17.
(a) Frye's "general acceptance" test was superseded by the Rules' adoption. The Rules occupy the field, United States v. Abel, 469 U.S. 45, 49, and, although the common law of evidence may serve as an aid to their application, id., at 51-52, respondent's assertion that they somehow assimilated Frye is unconvincing. Nothing in theRules as a whole or in the text and drafting history of Rule 702, which specifically governs expert testimony, gives any indication that "general acceptance" is a necessary precondition to the admissibility of scientific evidence. Moreover, such a rigid standard would be at odds with the Rules' liberal thrust and their general approach of relaxing the traditional barriers to "opinion" testimony. Pp. 4-8.
(b) The Rules--especially Rule 702--place appropriate limits on the admissibility of purportedly scientific evidence by assigning 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. The reliability standard is established by Rule 702's requirement that an expert's testimony pertain to "scientific . . . knowledge," since the adjective "scientific" implies a grounding in science's methods and procedures, while the word "knowledge" connotes a body of known facts or of ideas inferred from such facts or accepted as true on good grounds. The Rule's requirement that the testimony "assist the trier of fact to understand the evidence or to determine a fact in issue" goes primarily to relevance by demanding a valid scientific connection to the pertinent inquiry as a precondition to admissibility. Pp. 9-12.
(c) Faced with a proffer of expert scientific testimony under Rule 702, the trial judge, pursuant to Rule 104(a), must make a preliminary assessment of whether the testimony's underlying reasoning or methodology is scientifically valid and properly can be applied to the facts at issue. Many considerations will bear on the inquiry, including whether the theory or technique in question can be (and has been) tested, whether it has been subjected to peer review and publication, its known or potential error rate, and the existence and maintenance of standards controlling its operation, and whether it has attracted widespread acceptance within a relevant scientific community. The inquiry is a flexible one, and its focus must be solely on principles and methodology, not on the conclusions that they generate. Throughout, the judge should also be mindful of other applicable Rules. Pp. 12-15.
951 F. 2d 1128, vacated and remanded.
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.
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.  Doctor Lammstated 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.  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; andthe "reanalysis" of previously published epidemiological (human statistical) studies.
The merits of the Frye test have been much debated, and scholarship on its proper scope and application is legion.  Petitioners' primary attack, however, is not onthe content but on the continuing authority of the rule. They contend that the Frye test was superseded by the adoption of the Federal Rules of Evidence.  We agree.
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 scientific evidence.  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.
Rule 702 further requires that the evidence or testimony "assist the trier of fact to understand the evidence or to determine a fact in issue." This condition goes primarilyto relevance. "Expert testimony which does not relate to any issue in the case is not relevant and, ergo, non helpful." 3 Weinstein & Berger ¶ 702, p. 702-18. See also United States v. Downing, 753 F. 2d 1224, 1242 (CA3 1985) ("An additional consideration under Rule 702--and another aspect of relevancy--is whether expert testimony proffered in the case is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute"). The consideration has been aptly described by Judge Becker as one of "fit." Ibid. "Fit" is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes. See Starrs, Frye v. United States Restructured and Revitalized: A Proposal to Amend Federal Evidence Rule 702, and 26 Jurimetrics J. 249, 258 (1986). The study of the phases of the moon, for example, may provide valid scientific "knowledge" about whether a certain night was dark, and if darkness is a fact in issue, the knowledge will assist the trier of fact. However (absent creditable grounds supporting such a link), evidence that the moon was full on a certain night will not assist the trier of fact in determining whether an individual was unusually likely to have behaved irrationally on that night. Rule 702's "helpfulness" standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.
Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a),  whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue.  This entails 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. We are confident that federal judges possess the capacity to undertake this review. Many factors will bear on the inquiry, and we do not presume to set out a definitive checklist or test. But some general observations are appropriate.
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, pp. 702-41 to 702-42. Widespread acceptance can be an important factor in ruling particular evidence admissible, and "a known technique that has been able to attract only minimal support within the community," Downing, supra, at 1238, may properly be viewed with skepticism.
The inquiry envisioned by Rule 702 is, we emphasize, a flexible one.  Its overarching subject is the scientific validity--and thus the evidentiary relevance and reliability--of the principles that underlie a proposed submission. The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate.
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 assertions. In this regard respondent seems to us to be overly pessimistic about the capabilities of the jury, and of the adversary system generally. Vigorous cross examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence. See Rock v. Arkansas, 483 U.S. 44, 61 (1987). Additionally, in the event the trial court concludes that the scintilla of evidence presented supporting a position is insufficient to allow a reasonable juror to conclude that the position more likely than notis true, the court remains free to direct a judgment, Fed. Rule Civ. Proc. 50 (a), and likewise to grant summary judgment, Fed. Rule Civ. Proc. 56. Cf., e.g., Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F. 2d 1349 (CA6) (holding that scientific evidence that provided foundation for expert testimony, viewed in the light most favorable to plaintiffs, was not sufficient to allow a jury to find it more probable than not that defendant caused plaintiff's injury), cert. denied, 506 U. S. ___ (1992); Brock v. >Merrell Dow Pharmaceuticals, Inc., 874 F. 2d 307 (CA5 1989) (reversing judgment entered on jury verdict for plaintiffs because evidence regarding causation was insufficient), modified, 884 F. 2d 166 (CA5 1989), cert. denied, 494 U.S. 1046 (1990); Green 680-681. These conventional devices, rather than wholesale exclusion under an uncompromising "general acceptance" test, are the appropriate safeguards where the basis of scientific testimony meets the standards of Rule 702.
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.
For example, Shanna Helen Swan, who received a master's degree in biostatics 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. App. 113-114, 131-132. Stewart A. Newman, who received his master's and a doctorate in chemistry from Columbia University and the University of Chicago, respectively, is a professor at New York Medical College and has spent over a decade studying the effect of chemicals on limb development. App. 54-56. The credentials of the others are similarly impressive. See App. 61-66, 73-80, 148-153, 187-192, and Attachment to Petitioners' Opposition to Summary Judgment, Tabs 12, 20, 21, 26, 31, 32.
For a catalogue of the many cases on either side of this controversy, see P. Gianelli & E. Imwinkelried, Scientific Evidence § 1-5, pp. 10-14 (1986 & Supp. 1991).
See, e.g., Green, Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and BendectinLitigation, 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 Alphonso Frye is Sixty Five Years Old; Should He Retire?," 16 W. 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); Gianelli, 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).
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), cert. denied, 439 U.S. 1117 (1979) (Frye is superseded by the Rules of Evidence), with Christopherson v. Allied Signal Corp., 939 F. 2d 1106, 1111, 1115-1116 (CA5 1991) (en banc) (Frye and the Rules coexist), cert. denied, ___ U. S. ___ (1992), 3 J. Weinstein & M. Berger, Weinstein's Evidence ¶ 702, pp. 702-36 to 702-37 (1988) (hereinafter Weinstein & Berger) (Frye is dead), and M. Graham, Handbook of Federal Evidence § 703.2 (2d ed. 1991) (Frye lives). See generally P. Gianelli & E. Imwinkelried, Scientific Evidence § 1-5, pp. 28-29 (1986 & Supp. 1991) (citing authorities).
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 judge made rule affecting substantive rights, would violate the doctrine of ErieR. Co. v. Tompkins, 304 U.S. 64 (1938).
The Chief Justice "do[es] not doubt that Rule 702 confides to the judge some gatekeeping responsibility," post, at 4, 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.
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.
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, A Unified Theory of Scientific Evidence, 56 Ford. L. Rev. 595, 599 (1988). 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 to evidentiary reliability--that is, trustworthiness. Cf., e. g., Advisory Committee's Notes on Fed. Rule Evid. 602 (" `[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 the Rules of Evidence (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.
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, well established 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 Fed. Rule Evid. 201.
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 1238-1239 (on which our discussion draws in part); 3 Weinstein & Berger ¶ 702, 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.
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).
Chief Justice Rehnquist , with whom Justice Stevens 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 12.
"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 or not 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 anappreciation of one or more bodies of knowledge not judicially noticeable, 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 less than 37 citations to amicus briefs and other secondary sources.
The various briefs filed in this case are markedly different from typical briefs, in that large parts of them do not deal with decided cases or statutory language--the sort of material we customarily interpret. Instead, they deal with definitions of scientific knowledge, scientific method, scientific validity, and peer review--in short, matters far afield from the expertise of judges. This is not to say that such materials are not useful or even necessary in deciding how Rule 703 should be applied; but it is to say that the unusual subject matter should cause us to proceed with great caution in deciding more than we have to, because our reach can so easily exceed our grasp.
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 9. Federal Rule of Evidence 402 provides, as the Court points out, that "[e]vidence which is not relevant is not admissible." But there is no similar reference in the Rule to "reliability." The Court constructs its argument by parsing the language "[i]f 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 . . . ." Fed. Rule Evid. 702. It stresses that the subject of the expert's testimony must be "scientific . . . knowledge," and points out that "scientific" "implies a grounding in the methods and procedures of science," and that the word "knowledge" "connotes more than subjective belief or unsupported speculation." Ante, at 9. From this it concludes that "scientific knowledge" must be "derived by the scientific method." Ante, at 10. Proposed testimony, we are told, must be supported by "appropriate validation." Ante, at 10. Indeed, in footnote 9, the Court decides that "[i]n a case involving scientific evidence, evidentiary reliability will be based upon scientific validity." Ante, at 10, n. 9 (emphasis in original).
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 12. 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 12. Following this sentence are three quotations from treatises, which speak not only 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," ante, pp. 12-13.
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 saidthat 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 it imposes on them either the obligation or the authority to become amateur scientists in order to perform that role. I think the Court would be far better advised in this case to decide only the questions presented, and to leave the further development of this important area of the law to future cases.

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