The end of an ERA: junk science departs products liability.

• Author: Riley, Suzanne E.

"I see Nobody on the road," said Alice.

"I only wish I had such eyes," the king remarked in a fretful tone. "To be able to see Nobody! And at that distance too! Why, it's as much as I can do to see real people in this light!

- Through the Looking Glass, by Lewis Carroll

"JUNK SCIENCE" is the label courts, counsel and expert witnesses have given to novel scientific theories that are not based on sound foundation. Junk science involves theories that are tested and accepted in the courtroom, not the laboratory.(1) Just as Alice led the king to believe she saw someone on the road when there was no one there, junk science "experts" lead people to believe a valid scientific theory exists when in reality it does not. As products liability expert Peter Huber explains, junk science is "a hodgepodge of biased data, spurious inference, and logical legerdemain, patched together by researchers whose enthusiasm for discovery and diagnosis far outstrips their skill."(2)

For almost a century courts have struggled to determine on what basis they should admit novel scientific theories into evidence. In 1923, the District of Columbia Court of Appeals established the first admissibility test for such theories. In Frye v. United States,(3) the court stated that novel scientific evidence is admissible if it is based on a principle that is generally accepted in the relevant scientific community. The test became known as the "general acceptance," or Frye, test.

In 1975, Congress enacted the Federal Rules of Evidence, which were thought to relax the standards for expert scientific evidence. Believing the Frye test to be too rigid, many courts began to use the new Federal Rules to determine the admissibility of novel scientific evidence.(4) But the adoption of the Federal Rules only led to confusion among the courts as to which test - Frye, he Federal Rules, or a combination - should determine admissibility.(5)

In 1993, the U.S. Supreme Court addressed this confusion in Daubert v. Merrell Dow Pharmaceuticals Inc.(6) a product liability case, and held that the Federal Rules, in particular Rule 702, supersede the Frye test. The Court went further, however, and set forth a non-inclusive list of factors for courts to consider when determining admissibility.

SOME HISTORY

1. Frye Test

   In Frye, a criminal case, the court found expert evidence derived from a systolic blood pressure deception test, which was a crude precursor of the modern lie detector test, to be inadmissible because the evidence was based on experimental studies that had not been recognized by scientific authorities. The court stated, "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 belongs."

   Although Frye was a criminal case and the court did not rely on any authority to establish its test of general acceptance, the majority of jurisdictions adopted the Frye test for civil, particularly products liability, litigation.(7) Yet the Frye test proved not to be the ideal solution for determining the admissibility of novel scientific evidence, and problems arose over the years.

   Some courts felt the Frye test had become too vague and subject to abuse by the courts.(8) Because of its yielding nature, it did not afford consistent results, and the emphasis on acceptance by a relevant scientific community, a form of "nose-counting," often led to the exclusion of valid scientific theories. Yet in some instances the nose-counting emphasis allowed in junk science, as scientific communities emerged that consisted entirely of scientists working for attorneys.(9) A small group of scientists, all practicing junk science, could accept one of their peer's work, and then that work could be deemed admissible under the Frye test. Many courts turned to the Federal Rules, believing they would yield more consistent results.

2. Federal Rules of Evidence

   Federal Rules 402, 702 and 703 are particularly pertinent to the issue of admissibility of novel scientific evidence.

   Rule 402, entitled "Relevant Evidence Generally Admissible; Irrelevant Evidence Inadmissible," states when evidence is generally admissible, while Rules 702 ("Testimony by Experts") and 703 ("Bases of Opinion Testimony by Experts") specifically address expert testimony. The texts of the rules are:

   [Rule 402]

   All relevant evidence is admissible, except as otherwise provided by the Constitution of the United States, by Act of Congress, by these rules, or by other rules prescribed by the Supreme Court pursuant to statutory authority. Evidence which is not relevant is not admissible.

   [Rule 702]

   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 otherwise.

   [Rule 703]

   The facts or data in the particular case upon which an expert bases an opinion or inference may be those perceived by or made known to the expert at or before the hearing. If of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject, the facts or data need not be admissible in evidence.

   Although the Federal Rules solved the problems some courts had with the Frye test, they ultimately caused more confusion and conflict. As a result, the general trend among the jurisdictions was to allow novel expert scientific theories into evidence.(10)

   DAUBERT: SOLVING THE CONFLICT

   Daubert was a products liability case involving allegations of limb reduction birth defects caused by a mother's ingestion of Bendectin, an anti-nausea prescription drug manufactured by Merrell Dow Pharmaceuticals. Bendectin was taken by pregnant women to help prevent morning sickness. Minor children who suffered from serious limb reduction birth defects and their parents sued Merrell Dow, alleging that Bendectin was a teratogen, a substance that causes malformations in fetuses.

   The suit initially was brought in state court, but Merrell Dow removed to federal court on diversity grounds. After extensive discovery, Merrell Dow moved for summary judgment, asserting that the plaintiffs were unable to produce admissible evidence to prove that Bendectin caused birth defects in human beings. After reviewing the plaintiffs, eight expert witnesses and their testimony, the district court granted summary judgment.(11)

   The court determined that none of the evidence offered by the eight experts was admissible. Quoting United States v. Kilgus,(12) the court stated that scientific evidence is admissible only if the principle on which it is based is "sufficiently established to have general acceptance in the field to which it belongs." Relying on the Frye test, it held that the plaintiffs' expert scientific evidence was not generally accepted within the relevant scientific community because the experts did not base their opinions on data generally accepted when studying the effects of Bendectin on human beings.

   The experts based their conclusions on three grounds. First, they stated that in vitro animal studies demonstrated a connection between Bendectin and animal...