Court Fries Frye

By Vivian, Jesse C. | Drug Topics, September 6, 1993 | Go to article overview

Court Fries Frye


Vivian, Jesse C., Drug Topics


When is a fact scientifically valid? Or, more to the point, when will a court of law recognize a fact as scientifically sound? Those heady questions were the subject of a recent U.S. Supreme Court decision that should offer some new guidelines on how lawyers and judges interact with the scientific community to resolve legal disputes. The decision in Daubert v. Merrell Dow Pharmaceuticals (June 28, 1993) will make it easier to introduce newer and less well known scientific theories through "expert witnesses." The decision also grants authority to federal trial court judges to act as gatekeepers to exclude "junk science" from being considered by juries.

CASE FACTS: The case arose from a products liability claim by the parents of a child who suffers birth defects allegedly caused by the teratogenic effects of Bendectin (no longer marketed). The manufacturer was able to show that no peer-reviewed published epidemiological study ever established any link between human birth defects and the drug. Insofar as the Court was concerned, the vast weight of scientific opinion is that the drug is not teratogenic. Lawyers for the parents (the plaintiffs), however, submitted evidence to show that there are similarities in the chemical structures of the drug and other known teratogens. The plaintiffs evidence suggested there may be other scientifically valid methods of establishing a link between the drug and human birth defects.

LOWER COURT HOLDINGS: The trial court judge dismissed the case on the basis that these latter studies were not conducted in a manner of "general acceptance" to the relevant medical science community. That is, the opinions of the experts for the parents were not subjected to review in the scientific community and therefore could not be established as a "fact" admissible in court. Dismissal of the case was affirmed at the Court of Appeals level.

THE OLD STANDARD OF EVIDENCE: Both of these courts held that the evidence submitted by the plaintiffs would not be admissible during a trial, based on what is known as the Frye doctrine that originated from the case of Frye v. U.S. decided by the Supreme Court in 1923. Frye involved a question as to whether the results of a crude precursor to today's polygraph test should be admitted as relevant to determining the guilt or innocence of a criminal defendant. The results were not admitted because at the time, there was no "general acceptance" in the field of science as to whether a polygraph test was reliable. Accordingly, there has been a 50-year history in the courts of deciding the admissibility of evidence on questions involving scientific "facts," based on whether acknowledged experts in a particular field accept the results of various studies or tests. Often, this means that novel and nonaccepted studies, tests, and theories are excluded from the courtroom. …

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