Prior to 1993, the legal rule in both state and federal courts regarding the admissibility of expert testimony was set forth in the case, Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), which held that expert opinion would be admissible even if the conclusion is somewhat novel so long as the scientific principle or discovery upon which the deduction is made is “sufficiently established to have gained general acceptance in th field.”  The Frye rule, however, was considered by some to be overly restrictive and had the effect of precluding testimony on cutting edge science.  In 1993, in keeping with the liberal intent of Rules 702 and 703 of the Federal Rules of Evidence, which were established in 1975 in part to codify and broaden the basis for admissibility of expert opinions, the Supreme Court issued a decision in Daubert, supra, which superseded the Frye Rule in federal courts.  In Daubert, the Supreme Court held that trial courts are to be gatekeepers, assessing the reliability of scientific evidence in court, and keeping out “junk science” based only on the “ipse dixit” (unsupported word) of an expert.  The Daubert Court provided flexible factors for assessing the reliability of scientific opinion (e.g, testability, peer review and publication, rate of error, general acceptance), but noted that the factors were neither exclusive nor dispositive.  The Daubert Court emphasized that the trial court’s role was to assess the reliability of the methodology, not the conclusion, of an expert’s opinion.   Thereafter, the Supreme Court issued two more landmark decisions on expert admissibility, General Electric v. Joiner, 522 U.S. 136 (1997)(holding that there cannot be “too great an analytical gap between the data and the opinion proferred”) and Kumho Tire v. Carmichael, 526 U.S. 137 (1999)(finding an expert’s methodology must be as rigorous as that of practitioners in the field, and applying Daubert to all experts, not just scientists). Together these cases, commonly called the “Daubert trilogy”, and the body of federal law based upon them, comprise the law regarding expert admissibility in federal courts.  Most state courts continue to follow the Frye rule; however, some states may adopt the Daubert rule.

The author uses as a case study for the real world application of the principles of Daubert, in a trial context, a pharmaceutical litigation regarding the drug Parlodel, with which the author has been involved for the past five years.  The Parlodel cases have been litigated in many federal courts and some state courts and have generated opposing decisions from courts based upon the same body of evidence and the same core of experts using the same methodology.  A general overview of the case and evidence is provided, along with commentary by scientists and legal scholars regarding the validity of such types of evidence, which is contrasted with the findings of various courts in the Parlodel litigation.  The author concludes that the broad discretion provided to trial judges by Daubert has resulted, in some cases, in the misapplication of the principles of Daubert by non-scientist judges to create an impossible standard for admissibility of expert testimony. The author further notes a disturbing trend in recent caselaw finding that the methodology of an expert as practiced in his or her field is not scientific enough in the legal context to pass muster under Daubert.  The author concludes that there is a need for greater communication between the legal and medical communities independent of the litigation context and associated financial ties to corporate sponsors.

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