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The conflicting lines of authority, whether to use Frye, Federal Rule of Evidence 702, or a hybrid of the two, remained unreconciled until the Supreme Court granted review in Daubert v. Merrell Dow Pharmaceuticals, Inc. Interestingly, significant impetus for review of the case may have come from within the judicial rulemaking process. In June 1991, the Advisory Committee on Civil Rules of the Judicial Conference of the U.S. proposed amendments to both the Federal Rules of Civil Procedure and the Fed. R. Evid. The amendments included a revised Rule 702, which would have allowed the admission of expert testimony only if it was "reasonably reliable" and would "substantially assist the trier of fact to understand the evidence or to determine a fact in issue." The Committee Notes suggested that this revision was intended to limit the use, while increasing the utility and reliability, of expert testimony. The proposal contemplated that the courts should "reject testimony that is based upon premises lacking any significant support and acceptance within the scientific community." The Committee summary further indicated an intent to address unwarranted increases in litigation costs resulting from the use of unreliable expert testimony.

The Supreme Court's Order of April 22, 1993, adopted many of the civil rule amendments proposed by the Committee. These amendments were part of the comprehensive changes which became effective Dec. 1, 1993. The Court, however, granted certiorari in Daubert on October 13, 1992, and the proposed modification of Rule 702 did not emerge from the rulemaking process. Instead, the Court addressed the Committee's concerns in Daubert.

Daubert is now the best known of the many products liability cases involving the anti-nausea drug Bendectin. During the 1980s, approximately 1700 actions were brought alleging that the drug caused birth defects. Plaintiffs Jason Daubert and Eric Schuller were minor children born with serious birth defects. They sued Merrell Dow alleging that Bendectin caused their injuries.

Merrell Dow moved for summary judgment in the district court, arguing that Bendectin did not cause birth defects in humans and that petitioners could offer no admissible evidence to support theirclaim. Merrell Dow supported its motion with an affidavit of a physician whom Justice Blackmun, writing for the Court, described as a "well-credentialed expert on the risks of exposure to various chemical substances." The affidavit stated that none of the more than thirty published epidemiological studies involving over 130,000 patients had found Bendectin to be capable of causing malformations in fetuses and concluded that Bendectin was not a risk factor.

The plaintiffs did not dispute the description of the published research, but rather presented the testimony of eight experts whose credentials the court noted were also "impressive." The experts, testifying that Bendectin could cause birth defects, based their testimony on test tube and live animal studies suggesting causation, analyses of pharmacological similarities between Bendectin and other substances known to cause birth defects, and reanalyses of the published studies on Bendectin.

The district court examined plaintiffs' evidence under the Frye standard, which the 9th Circuit had reaffirmed in U.S. v. Kilgus. The court recognized the extensive body of generally accepted epidemiological data available on Bendectin. Consequently, it held that plaintiffs' test tube, live animal, and pharmacological studies, which were not based on epidemiological data, could not be admitted to prove causation. The court further held that plaintiffs' reanalyses of the published epidemiological studies were inadmissible because plaintiffs' experts had not published these studies and their peers had not reviewed them. Under the district court's analysis of the evidence, the plaintiffs offered no proof that Bendectin caused their birth defects and therefore it granted Merrell Dow's motion for summary judgment.

The 9th Circuit affirmed and discussed the Frye rule - that expert opinion based on a scientific technique is inadmissible unless the technique is generally accepted as reliable by the relevant scientific community. Evidence based on techniques that diverged significantly from techniques accepted by recognized authorities in the field, the court reasoned, could not meet the standard of general acceptance. The medical field generally accepted epidemiological studies to show causation of birth defects, and therefore the court did not permit other evidence of causation to be admitted. Thus, the 9th Circuit concluded that the district court properly excluded plaintiffs' test tube, live animal, and pharmacological studies, and had correctly excluded plaintiffs' evidence based on reanalyses of epidemiological data. While the medical community utilized reanalyses, such studies were generally accepted only after they were subjected to review by others in the field. The reanalyses in question had been prepared for the Daubert litigation and had not been reviewed by the scientific community. According to the 9th, it did not suffice that scientific proof met some of the requirements of the scientific community; the evidence had to meet all of the essential requirements and so upheld the exclusion of the reanalyses.

The Supreme Court granted review in Daubert to resolve the "sharp divisions regarding the proper standard for admission of expert testimony." The primary issue presented was whether the adoption of Fed.R. Evid. 702 eliminated the general acceptance test of Frye for the admission of scientific evidence. Secondarily, the Court was asked to consider whether, if Frye remained valid,Rule 702 required that expert scientific testimony undergo peer review to be admissible in evidence.

The Justices unanimously held that the adoption of the Fed.R. Evid. superseded Frye. Interpreting the legislatively-approved rules as it would any statute, the Court found that nothing in the text of Rule 702 required general acceptance as a foundation for the admission of scientific evidence, and there was no clear indication that the drafters intended the new rules to incorporate this standard. The Court construed the drafters' omission of any reference to the Frye test in either the text or the Committee Note as indicating that Frye was no longer good law. Moreover, in the Court's view, this rigid test was incompatible with the "liberal thrust" of the Fed.R. Evid. and henceforth should no longer be applied in federal trials.

In place of Frye, the majority articulated a two-part test, directing that "the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable." According to the Court, the primary source of this duty is the language of Rule 702, which first requires that the expert testimony convey "scientific knowledge." This characterization indicates that purported scientific testimony must be based on "scientific method or procedure" and comprise more than "subjective belief or unsupported speculation." Scientific testimony need not be certain, but must meet a standard of evidentiary reliability or trustworthiness. Rule 702's use of the term "knowledge" required that the testimony be supported by appropriate validation consisting of "good grounds based on what is known."

In addition, the majority explained, Rule 702 requires that there be a sufficient "fit" between the scientific testimony and the facts of the case so that the testimony will assist the trier in finding the facts. Displaying uncharacteristic whimsy, Justice Blackmun explained that absent an acceptable showing of such a nexus, evidence on the phases of the moon indicating that it was full on a certain night could not be received to show that a particular individual was behaving irrationally on that evening. He cautioned, however, that this relevance determination will not always present an obvious question, as the validity of scientific evidence can vary depending on the purpose for which it is used.

A court exercising its gatekeeping function regarding a proffer of expert scientific evidence must find that the proponent has established, by a preponderance of the evidence, the foundation facts. In making this preliminary determination, however, the court is not bound by the evidentiary rules. The Court identified some of the factors which bear on the determination as to whether the evidence is scientific, but did not attempt to provide a definitive checklist.

Ordinarily, a key question is whether the proffered theory or technique can be and has been tested. As the Court noted, "'scientific methodology today is based on generating hypotheses and testing them to see if they can be falsified.'" A second consideration is whether the theory or technique has been subjected to peer review and publication. Although publication is not necessary for admissibility, and in some instances may not ensure reliability, exposure to the review process supports admission because it increases the likelihood that the scientific community will detect any error that exists. For particular techniques, the district court should consider the known or potential rate of error and any professional standards that may be applicable. Lastly, the court may still consider the general acceptance of a technique by explicitly identifying a relevant scientific community and expressly determining the degree of acceptance in that community. "Widespread acceptance can be an important factor" in admitting evidence, and the district court may be properly skeptical of a known technique that has garnered only minimal support within the community.

The Daubert opinion emphasized that the district court should be flexible in conducting its inquiry and should focus on the principles and methodology that underlie the evidence, not on the conclusions they generate. The Court acknowledged its reliance on Downing and, in an obvious invitation to the lower courts to expand on the factors enumerated in the majority opinion, suggested that the approaches offered by the 3rd Circuit and a number of other sources on the reliability determination "may well have merit."

The majority cautioned that a district court considering a proffer must be mindful of other rules of evidence. Expert evidence based on otherwise inadmissible hearsay may be admitted pursuant to Rule 703 only if the underlying facts or data are of a type "reasonably relied upon by experts in the field in generating inferences or opinions upon the subject." Rule 706 authorizes the court to appoint an expert to assist with the case. In addition, the court may exclude evidence under Rule 403 "if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury." The majority noted that this provision allows judges greater control over experts than other witnesses, as "'expert evidence can be both powerful and quite misleading because of the difficulty in evaluating it.'"

Daubert concluded by responding to some of the policy concerns expressed by the opposing parties and numerous amici in the case. The Court stated that it did not expect that the abandonment of Frye would result in a free-for-all in which juries would beconfounded by "pseudoscientific" offerings. Merrell Dow was "overly pessimistic" about the ability of the jury to address scientific evidence, and the efficacy of the adversary system. At trial, vigorous cross-examination, introduction of opposing evidence, and careful jury instructions as to the burden of proof adequately address the potential problems presented by "shaky but admissible evidence." Moreover, if a court believes that the evidence is insufficient to support a favorable finding by a reasonable juror, the court may either direct a judgment at trial or grant summary judgment.

The Daubert majority was satisfied that these devices adequately insure the integrity of the truth-seeking process where scientific evidence is admitted in a case. Unlike scientific inquiry, legal fact finding is generally not subject to revision as additional data becomes available, but rather must settle issues within the constraints of a dispute resolution procedure. While the gatekeeping role played by a judge may occasionally result in the exclusion of valuable insights, the rules of evidence sanction this balance in order to resolve issues in the context of the legal process.

Justice Stevens joined Chief Justice Rehnquist in partial dissent. While agreeing that Frye did not survive the enactment of the Fed.R. Evid., these Justices disassociated themselves from the Court's effort to sketch the contours of the new test, calling the Court's observations "not only general, but vague and abstract." They expressed concern that the scientific subject matter of the briefs was outside the expertise of the judiciary. In particular, they questioned the competence of federal judges to decide in the first instance whether a scientific theory can be and has been tested. While not disputing the appropriateness of a gatekeeping function, they cautioned that amateur science was not within the jurisdiction of the courts.

While courts and commentators have debated at some length whether Daubert will affect the admissibility of various types of scientific evidence, Daubert did not contemplate a revolutionary change in the practice of the federal courts. In particular, the Court retained Frye's general acceptance standard as an "important factor" bearing on admissibility. Under the Court's formulation of the standard for Rule 702, district courts are free to retain all prior jurisprudence on the reliability of various scientific methods. At the same time, Daubert's emphasis that the inquiry it envisioned was to be "a flexible one" is calculated to allow the trial court to scrutinize the reliability of techniques that it views with skepticism, even when proponents have shown general acceptance. Daubert, however, also affords the district court the freedom to consider new methods of proof for which no such claim of acceptance can yet be made.

* The above material was excerpted, modified and otherwise prepared by the 'Lectric Law Library from "Novel Expert Evidence In Federal Civil Rights Litigation" a work by Gordon J. Beggs, Fair Employment Practices Clinic, Cleveland-Marshall College of Law.   Gordon Beggs. The original was found at www.wcl.american.edu

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