Scientific Evidence in the Courtroom -- The Death of the Frye Rule Legal Issues in Medicine, Volume 330, Number 14: pp. 1018-1021. April 7, 1994.
In one of the most anticlimactic cases in recent years, the Supreme Court ruled on the last day of its 1992-1993 term that federal judges should admit all relevant scientific testimony and evidence that is “reliable”1. The result was so uncontroversial that both sides in the case said they were satisfied; because the result was also so vague, it will probably be years before its effect can be accurately ascertained. The facts of the case, Daubert v. Merrell Dow Pharmaceuticals, Inc., are somewhat more interesting than its prosaic legal conclusion.
Bendectin, an antinausea drug prescribed to a total of 33 million pregnant women over a period of 27 years, was withdrawn from the U.S. market in 1983 by its manufacturer, Merrell Dow Pharmaceuticals (formerly Richardson Merrell, now Marion Merrell Dow). The stated reason for the withdrawal was lawsuits alleging teratogenic effects of the drug. Thirty-eight cases had come to trial by 1993; the company won judgments in 36 (6 of which were appealed), and lost 2, both of which are being appealed2. About 30 other cases are currently pending. At one point, in 1984, the company offered to settle all pending cases involving Bendectin, then numbering about 700, for $120 million3. This settlement, although agreed to by many of the plaintiffs involved, was ultimately voided, and a trial proceeded on behalf of 1100 voluntary plaintiffs in 19853. A jury returned a verdict in favor of the company, which was sustained on appeal3.
The Case of Jason Daubert and Eric Schuller
Plaintiffs Jason Daubert and Eric Schuller both suffered limb-reduction birth defects, and it was alleged that these defects resulted from their mothers’ having taken Bendectin during pregnancy. They and their parents sued Merrell in California state court, after which Merrell had the suits removed to federal court on the basis of diversity of citizenship, since Merrell is not incorporated in California. After extensive discovery but before trial, Merrell asked for summary judgment on the grounds that the plaintiff had not presented any admissible evidence that Bendectin causes birth defects -- a necessary element of the lawsuit. To prevail, the plaintiffs had the burden of proving not only that Merrell had breached a duty to them and harmed them but also that Bendectin was more likely than not to have caused their specific injuries. Merrell submitted an affidavit from physician and epidemiologist Steven H. Lamm, which stated, among other things, that he had reviewed the entire published literature on Bendectin and human birth defects, which amounted to more than 30 published studies involving 130,000 people, and that none of these studies found Bendectin to be a human teratogen4.
The plaintiffs did not contest this conclusion but instead offered to have eight experts (three physicians, two epidemiologists, a biologist, a pharmacologist, and a veterinarian) testify that Bendectin is a human teratogen. The trial court was unimpressed, ruling that chemical, in
vitro, and animal studies are insufficient to demonstrate that Bendectin causes birth defects in the face of “the overwhelming body of contradictory epidemiological evidence”4,5. The plaintiffs’ epidemiologic evidence was rejected because it was limited to a “recalculation” of data reported in published studies (with the use of a P value greater than 0.05), and this recalculation was “never published or subjected to peer review”4. The trial court granted Merrell summary judgment (which dismissed the case), concluding that the plaintiffs’ scientific evidence was inadmissible because it was “not sufficiently established to have general acceptance” in the scientific field to which it belonged4.
The Ninth Circuit Court of Appeals affirmed the dismissal, noting that although an epidemiologic evaluation based on a reanalysis of data is a legitimate scientific method, it is “generally accepted by the scientific community only when it is subjected to verification and scrutiny by others in the field”6. The plaintiffs’ reanalyses did not qualify because “they were unpublished, not subjected to the normal peer review process and generated solely for use in litigation”6. The Supreme Court agreed to take the case because of the conflict among federal courts concerning the requirement of general acceptance for admitting scientific evidence.
The Supreme Court Opinion
Justice Harry Blackmun wrote the opinion of the Court, much of which was unanimous and a portion of which was supported by seven of the nine justices. The Court was well aware of the perceived importance of its opinion, evidenced in part by 22 amicus curiae briefs. One brief was submitted jointly by the New England Journal of Medicine, the Journal of the American Medical Association, and the Annals of Internal Medicine7. Although it took no position on whether Bendectin causes birth defects, the brief argued that “peer-review and publication of scientific data and conclusions, simply put, are the only available non-biased checks on scientific opinion available to the courts and should, therefore, be employed to the extent feasible”7.
Justice Blackmun noted that the Court had to navigate between two opposite hazards. The first was that abandonment of the general-acceptance requirement could result in a free-for-all in which befuddled juries would be confounded by absurd and “irrational pseudoscientific assertions”1. The second was that adherence to the general-acceptance requirement could “sanction a stifling and repressive scientific orthodoxy . . . inimical to the search for truth”1. The Court’s mandate, however, was not to write an ideal rule governing the admission of scientific evidence. The legal question in Daubert was a much narrower one: Did the Federal Rules of Evidence supersede the 1923 Frye rule, sometimes referred to simply as the general-acceptance rule1?
The Frye rule was enunciated by a federal court of appeals in a criminal case in which the defendant sought to present evidence that a crude “deception test” measuring systolic blood pressure (the precursor to the modern polygraph test) showed that he was telling the truth8. In affirming its decision to exclude the evidence, the court 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 acceptance in the particular field in which it belongs8.
It was the general-acceptance principle of the Frye rule that the lower courts in Daubert relied on to rule the plaintiffs’ epidemiologic reanalysis inadmissible. The Supreme Court ruled that the lower courts had erred in relying on the Frye rule, which has been superseded by the Federal Rules of Evidence, as all nine justices agreed. Those rules were first drafted by the American Law Institute in 1942 and revised twice before being used as a basis for the current rules by an advisory committee appointed by Chief Justice Earl Warren in 1965. The advisory committee’s own draft was published in 1969 and promulgated by the Supreme Court in 1972. Congress deferred the effective date of the Supreme Court’s rules until it enacted them. The President signed them into law in January 19759.
The Federal Rules of Evidence, which apply to all federal courts and have been adopted by most states as well, are liberal. They basically provide that unless there is some specific exception, “all relevant evidence is admissible.” Rule 702 governs the admissibility of scientific evidence:
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 otherwise1.
As the Court correctly and unequivocally noted, “nothing in the text of this Rule establishes ‘general acceptance’ as an absolute prerequisite to admissibility,” and accordingly, the adoption of Rule 702 eliminated Frye’s reliance on general acceptance as the exclusive requirement for admissibility1.
Tests of Admissibility
The Frye rule was too restrictive. The Court, however, did hold that Rule 702 requires that all scientific testimony be not only “relevant” but also “reliable”1. To qualify for the adjective “scientific,” the Court concluded, the testimony must be grounded in “the methods and procedures of science” and be more than simply subjective belief or unsupported speculation1. Moreover, because the expert witness (unlike the ordinary witness) “is permitted wide latitude to offer opinions, including those that are not based on first-hand knowledge or observation,” the Court concluded that the Federal Rules of Evidence require that “the expert’s opinion will have a reliable basis in the knowledge and experience of his discipline”1.
All this is, of course, still a bit vague, and Justice Blackmun lost the support of two of his colleagues (Chief Justice William Rehnquist and Justice John Paul Stevens) when he offered four “pertinent considerations” for federal trial judges to take into account when deciding whether scientific evidence is reliable. First, is the hypothesis set forward by the scientific expert falsifiable or testable? Second, has the theory or technique been subjected to peer review and publication? Although publication in a peer-reviewed journal is relevant, because
it increases the likelihood of detecting substantive flaws in the scientific method used, publication is not required, because “it does not necessarily correlate with reliability.” Third, what is the potential rate of error in the method used? Fourth, has the method or theory gained general acceptance, which “can be an important fact in ruling particular evidence admissible”1?
Justice Blackmun concluded the opinion by noting that science and law both attempt to find truth but that there are important differences in their methods and goals. In Justice Blackmun’s words, “Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly”1. The Federal Rules of Evidence were designed to promote “a quick, final, and binding legal judgment . . . about a particular set of events in the past . . . not for the exhaustive search for cosmic understanding”1.
Daubert’s Strength and Weakness
The great strength of the ruling in Daubert is its firm rejection of any one test, such as publication in a peer-reviewed journal, for the admissibility of scientific evidence. Peer review is not infallible, and although one hopes that peer review will “screen out work that is clearly invalid and greatly improve the chances that published work is valid, it cannot guarantee scientific validity”10. There is always some danger that lack of a simple exclusionary test will permit the admission of pseudoscience as evidence. But there are generic safeguards against the likelihood that any specific piece of evidence will automatically win the day in the courtroom. All expert witnesses providing scientific evidence are subject to cross-examination under oath, the defense may present its own experts to refute the evidence, and the judge may appoint independent experts to evaluate the evidence for the jury. The judge should also carefully instruct the jury on the burden of proof11. Moreover, a judge can refuse to admit even admissible evidence if its probative value is substantially outweighed by the dangers of prejudging, confusing, or misleading the jury or just wasting time9. Finally, a judge can override the jury’s verdict and a verdict can be overturned on appeal. Of course, none of this is quick, and the Daubert case may lend support to the growing use of alternative methods (other than litigation) for resolving disputes, such as mediation and arbitration.
The primary weakness of the Supreme Court opinion is its vagueness. What is perhaps most remarkable is that the Court failed even to attempt to apply either its ruling or its suggested considerations for admissibility to the scientific evidence presented by the plaintiffs in Daubert. Since the lawyers for both parties have said they are satisfied with the decision, each party must think it has won -- that is, the plaintiffs must believe their evidence will be admitted and they will have a trial, and the defendant must believe the Ninth Circuit Court of Appeals will rule the evidence inadmissible again, this time under the new standard. We will have to wait to find out who is right, and this makes the Court’s emphasis on the speed of the legal process ring somewhat hollow.
Because of the vagueness of the new admissibility rule, judges will probably play a more important part in evaluating the relevance and reliability of scientific evidence under Daubert than they have in the recent past. Judges in many ways have the same flexibility in admitting or excluding scientific evidence as the editors of peer-reviewed journals have in
accepting or rejecting manuscripts. Evidence that was found admissible under Frye will continue to be admissible. Evidence based on DNA studies, for example, previously found admissible by most courts under either Frye or Rule 702, will continue to be admissible in these courts, as well as in all federal courts and all state courts that have adopted the Federal Rules of Evidence12. Justice Blackmun’s considerations will also encourage judicial training sessions on scientific methodology, and at least some judges are likely to require lengthy pretrial hearings on the admissibility of scientific evidence. Since Rule 702 applies not only to scientific knowledge but also to “technical” and “other specialized knowledge,” it governs the testimony of other expert witnesses as well as that of scientists -- for example, bankers and businesspeople testifying on property values9.
To the extent that physicians testify as epidemiologists, the evidence they provide will be governed by Daubert13. For example, in one case decided on the basis of Daubert, the trial judge found the testimony of an obstetrician-gynecologist that Retin-A (tretinoin) was a teratogen inadmissible because he had no specialized training in embryology, teratology, or genetics; his theory had been neither tested nor published; and his analogies were unsupported by actual studies14. To the extent that the practice of medicine is seen as more an art than a science, and medical judgment as critical to assessing prudent conduct, Rule 703 (which governs the basis of opinion provided as expert testimony) will continue to be of most interest to physicians who testify as expert witnesses. Rule 703 permits experts, such as physicians, to base their opinions on firsthand observation, a hypothetical question, or the expert’s experience outside the courtroom (including statements from patients and their relatives, results of laboratory tests, reports from nurses, and the like). If that experience is “of a type reasonably relied upon by . . . [other physicians] in forming opinions or inferences,” it can be used without the facts or data themselves being admitted into evidence9.
Juries, Science, and Justice
It is a truism that “error is inherent in research, and [scientific] validity is always conditional”10. Science advances incrementally by establishing “facts” and is able to do so “because scientists operate within a framework of incremental adjustments and carefully bounded negotiations among communities who share a commitment to closure”15. Legal fact finding in the adversary system, however, treats every fact as “equally contingent,” and each party has “every incentive to overstate the weakness in the other’s case”15. The difference between these two approaches can make it difficult to evaluate scientific opinion in the courtroom. Proposed solutions to this problem have included the establishment of a separate “science court” to hear disputes over scientific fact, the use of blue-ribbon juries to hear complex cases, the appointment of experts by judges, and the resolution of conflicts by mediation or arbitration outside the courtroom11,15.
Alternatives to trial by jury have historically been proposed by American corporations, physicians, and others who do not trust juries to treat them fairly. This distrust seems misplaced. Merrell, for example, has won virtually all its jury-decided Bendectin cases, even though each involved a suit against a large corporation, brought on behalf of a seriously injured newborn. Likewise, an Institute of Medicine study found that in cases involving a clear violation of published contraindications to the use of oxytocin that resulted in severe
injury, juries found in favor of plaintiffs almost 90 percent of the time; when a contraindication was not clear, plaintiffs were successful only 15 percent of the time, “lending credence to the juries’ ability to distinguish a clear violation of the standard of care”16.
Both judges and juries are educable and able to deal with scientific facts and opinions. Both do require education. In Daubert the Supreme Court has decided it meant what it said when it adopted Rule 702: juries should be trusted to evaluate all relevant and reliable scientific evidence, and judges should exclude only evidence that fails to meet the twin tests of relevance and reliability.
1. Daubert v. Merrell Dow Pharmaceuticals, Inc., 113 S.Ct. 2786 (1993).
2. Tanouye E. Suits involving defunct Bendectin chill development of pregnancy medications. Wall Street Journal. June 22, 1993:B1.
3. Nausea: the massed legal attack. In: Huber PW. Galileo’s revenge: junk science in the courtroom. New York: BasicBooks, 1991:111-29.
4. Daubert v. Merrell Dow Pharmaceuticals, Inc., Schuller v. Merrell Dow Pharmaceuticals, Inc., 727 F. Supp. 570 (S.D. Cal. 1989).
5. Richardson v. Richardson-Merrell, 857 F.2d 823 (D.C. Cir. 1988).
6. Daubert v. Merrell Dow Pharmaceuticals, Inc., 951 F.2d 1128 (9th Cir. 1991).
7. Brief of the New England Journal of Medicine, Journal of the American Medical Association, and Annals of Internal Medicine as amici curiae in support of the Respondent in Daubert v. Merrell Dow Pharmaceuticals, Inc., No. 92-102, Jan. 19, 1993.
8. United States v. Frye, 293 F. 1013 (D.C. Cir. 1923).
9. Green ED, Nesson CR, eds. Federal rules of evidence: with selected legislative history and new cases and problems. Boston: Little, Brown, 1986.
10. Relman AS, Angell M. How good is peer review? N Engl J Med 1989;321:827-829. [Medline]
11. Foster KR, Bernstein DE, Huber PW. Science and the toxic tort. Science 1993;261:1509, 1614-1509, 1614. [Medline]
12. Annas GJ. Setting standards for the use of DNA-typing results in the courtroom -- the state of the art. N Engl J Med 1992;326:1641-1644. [Medline]
13. Gold JA, Zaremski MJ, Lev ER, Shefrin DH. Daubert v. Merrell Dow: the Supreme Court tackles scientific evidence in the courtroom. JAMA 1993;270:2964-2967. [CrossRef][Medline]
14. Chikovsky v. Ortho Pharmaceutical Corp., 832 F. Supp. 341 (S.D. Fla. 1993).
15. Jasanoff S. What judges should know about the sociology of science. Jurimetrics 1992;32:345-59.
16. Daniels S, Andrews L. The shadow of the law: jury decisions in obstetrics and gynecology cases (in) Institute of Medicine. Vol. II. Medical liability and the delivery of obstetrical care. Washington, D.C.: National Academy Press, 1989:161-93.
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