Petitioners, two minor children and their parents, alleged in their suit against respondent that the children's serious birth defects had been caused by the mothers' prenatal ingestion of Bendectin, a prescription drug marketed by respondent. The District Court granted respondent summary judgment based on a well-credentialed expert's affidavit concluding, upon reviewing the extensive published scientific literature on the subject, that maternal use of Bendectin has not been shown to be a risk factor for human birth defects. Although petitioners had responded with the testimony of eight other well-credentialed experts, who based their conclusion that Bendectin can cause birth defects on animal studies, chemical structure analyses, and the unpublished "reanalysis" of previously published human statistical studies, the court determined that this evidence did not meet the applicable "general acceptance" standard for the admission of expert testimony. The Court of Appeals agreed and affirmed, citing Frye v. United States, 54 App. Held: The Federal Rules of Evidence, not Frye, provide the standard for admitting expert scientific testimony in a federal trial.
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Petitioners, two minor children and their parents, alleged in their suit against respondent that the children's serious birth defects had been caused by the mothers' prenatal ingestion of Bendectin, a prescription drug marketed by respondent. The District Court granted respondent summary judgment based on a well-credentialed expert's affidavit concluding, upon reviewing the extensive published scientific literature on the subject, that maternal use of Bendectin has not been shown to be a risk factor for human birth defects.
Although petitioners had responded with the testimony of eight other well-credentialed experts, who based their conclusion that Bendectin can cause birth defects on animal studies, chemical structure analyses, and the unpublished "reanalysis" of previously published human statistical studies, the court determined that this evidence did not meet the applicable "general acceptance" standard for the admission of expert testimony.
The Court of Appeals agreed and affirmed, citing Frye v. United States, 54 App. Held: The Federal Rules of Evidence, not Frye, provide the standard for admitting expert scientific testimony in a federal trial. The Rules occupy the field, United States v. Abel, U. Nothing in the Rules as a whole or in the text and drafting history of Rule , which specifically governs expert testimony, gives any indication that "general acceptance" is a necessary precondition to the admissibility of scientific evidence.
Moreover, such a rigid standard would be at odds with the Rules' liberal thrust and their general approach of relaxing the traditional barriers to "opinion" testimony.
The reliability standard is established by Rule 's requirement that an expert's testimony pertain to "scientific The Rule's requirement that the testimony "assist the trier of fact to understand the evidence or to determine a fact in issue" goes primarily to relevance by demanding a valid scientific connection to the pertinent inquiry as a precondition to admissibility. Many considerations will bear on the inquiry, including whether the theory or technique in question can be and has been tested, whether it has been subjected to peer review and publication, its known or potential error rate and the existence and maintenance of standards controlling its operation, and whether it has attracted widespread acceptance within a relevant scientific community.
The inquiry is a flexible one, and its focus must be solely on principles and methodology, not on the conclusions that they generate.
Throughout, the judge should also be mindful of other applicable Rules. That even limited screening by the trial judge, on occasion, will prevent the jury from hearing of authentic scientific breakthroughs is simply a consequence of the fact that the Rules are not designed to seek cosmic understanding but, rather, to resolve legal disputes.
With him on the briefs were Kenneth J. Chesebro, Barry J. Nace, David L. Shapiro, and Mary G. Charles Fried argued the cause for respondent. With him on the brief were Charles R.
Nesson, Joel 1. Klein, Richard G. Taranto, Hall R. Marston, George E. Berry, Edward H. Stratemeier, and W Glenn Forrester.
Bertin, Marsha S. Berzon, and Albert H. Chubin et al. Kilberg, Paul Blankenstein, Bradford R. Clark, and Craig A. Berrington; for the American Medical Association et al. Phillips, Mark D. Hopson, and Jack R. Kester and John W Vardaman, Jr. Dyk, Stephen A. Bokat, and Robin S. Schwartz, Robert P. Charrow, and Paul F. Campbell, Daniel J. Popeo, and Richard A. Samp; and for Nicolaas Bloembergen et al.
Briefs of amici curiae were filed for the American Association for the Advancement of Science et al. Gallagher, Elizabeth H. Esty, and Margaret A. Berger; for the Defense Research Institute, Inc. Sherman, E. Wayne Taff, and Harvey L. Kaplan; for the New England Journal of Medicine et al. In this case we are called upon to determine the standard for admitting expert scientific testimony in a federal trial. Petitioners Jason Daubert and Eric Schuller are minor children born with serious birth defects.
They and their parents sued respondent in California state court, alleging that the birth defects had been caused by the mothers' ingestion of Bendectin, a prescription antinausea drug marketed by respondent. Respondent removed the suits to federal court on diversity grounds. After extensive discovery, respondent moved for summary judgment, contending that Bendectin does not cause birth defects in humans and that petitioners would be unable to come forward with any admissible evidence that it does.
In support of its motion, respondent submitted an affidavit of Steven H. Lamm, physician and epidemiologist, who is a well-credentialed expert on the risks from exposure to various chemical substances.
No study had found Bendectin to be a human teratogen i. On the basis of this review, Doctor Lamm concluded that maternal use of Bendectin during the first trimester of pregnancy has not been shown to be a risk factor for human birth defects. Bersoff; for Alvan R. Feinstein by Don M.
Kennedy, Loretta M. Smith, and Richard A. Oetheimer; and for Kenneth Rothman et al. He has served as a consultant in birth-defect epidemiology for the National Center for Health Statistics and has published numerous articles on the magnitude of risk from exposure to various chemical and biological substances. Petitioners did not and do not contest this characterization of the published record regarding Bendectin.
Instead, they responded to respondent's motion with the testimony of eight experts of their own, each of whom also possessed impressive credentials. Their conclusions were based upon "in vitro" test tube and "in vivo" live animal studies that found a link between Bendectin and malformations; pharmacological studies of the chemical structure of Bendectin that purported to show similarities between the structure of the drug and that of other substances known to cause birth defects; and the "reanalysis" of previously published epidemiological human statistical studies.
The District Court granted respondent's motion for summary judgment. The court stated that scientific evidence is admissible only if the principle upon which it is based is "'sufficiently established to have general acceptance in the field to which it belongs. Kilgus, F. The court concluded that petitioners' evidence did not meet this standard. Given the vast body of epidemiological data concerning Bendectin, the court held, expert opinion which is not based on epidemiological evidence.
Stuart A. Newman, who received his bachelor's degree in chemistry from Columbia University and his master's and doctorate in chemistry from the University of Chicago, is a professor at New York Medical College and has spent over a decade studying the effect of chemicals on limb development.
The credentials of the others are similarly impressive. See id. Thus, the animal-cell studies, live-animal studies, and chemical-structure analyses on which petitioners had relied could not raise by themselves a reasonably disputable jury issue regarding causation. Petitioners' epidemiological analyses, based as they were on recalculations of data in previously published studies that had found no causal link between the drug and birth defects, were ruled to be inadmissible because they had not been published or subjected to peer review.
Citing Frye v. The court declared that expert opinion based on a methodology that diverges "significantly from the procedures accepted by recognized authorities in the field Solomon, The court emphasized that other Courts of Appeals considering the risks of Bendectin had refused to admit reanalyses of epidemiological studies that had been neither published nor subjected to peer review. Those courts had found unpublished reanalyses "particularly problematic in light of the massive weight of the original published studies supporting [respondent's] position, all of which had undergone full scrutiny from the scientific community.
Contending that reanalysis is generally accepted by the scientific community only when it is subjected to verification and scrutiny by others in the field, the Court of Appeals rejected petitioners' reanalyses as "unpublished, not subjected to the normal peer review process and generated solely for use in litigation. We granted certiorari, U. Compare, e. Shorter, U. Merrell Dow Pharmaceuticals, Inc. In the 70 years since its formulation in the Frye case, the "general acceptance" test has been the dominant standard for determining the admissibility of novel scientific evidence at trial.
See E. Nesson, Problems, Cases, and Materials on Evidence Although under increasing attack of late, the rule continues to be followed by a majority of courts, including the Ninth Circuit.
The Frye test has its origin in a short and citation-free decision concerning the admissibility of evidence derived from a systolic blood pressure deception test, a crude precursor to the polygraph machine. In what has become a famous perhaps infamous passage, the then Court of Appeals for the District of Columbia described the device and its operation and declared:.
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 belongs.
Because the deception test had "not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made," evidence of its results was ruled inadmissible.
The merits of the Frye test have been much debated, and scholarship on its proper scope and application is legion.
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)
In United States federal law, the Daubert standard is a rule of evidence regarding the admissibility of expert witness testimony. A party may raise a Daubert motion , a special motion in limine raised before or during trial , to exclude the presentation of unqualified evidence to the jury. Important appellate-level opinions that clarify the standard include Judge Kozinski 's opinion in Daubert on remand Daubert v. Merrell Dow Pharmaceuticals, Inc.