Daubert v. Merrell Dow Pharmaceuticals, Inc ..., Exercises of Literature

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 ...

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Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) [edited]
1
Justice BLACKMUN delivered the opinion of the Court.
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.1 Doctor Lamm stated
that he had reviewed all the literature on Bendectin and human birth defects—more than 30 published studies
involving over 130,000 patients. No study had found Bendectin to be a human teratogen (i.e., a substance capable of
causing malformations in fetuses). 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.
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. These experts had concluded that Bendectin can cause birth defects. 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.’ ”. 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 is not admissible to establish causation. 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.
The United States Court of Appeals for the Ninth Circuit affirmed.. Citing Frye v. United States, 54 App.D.C. 46,
47, 293 F. 1013, 1014 (1923), the court stated that expert opinion based on a scientific technique is inadmissible
unless the technique is “generally accepted” as reliable in the relevant scientific community. The court declared that
expert opinion based on a methodology that diverges “significantly from the procedures accepted by recognized
authorities in the field ... cannot be shown to be ‘generally accepted as a reliable technique.’
….
We granted certiorari, in light of sharp divisions among the courts regarding the proper standard for the admission
of expert testimony.
….In the 70 years since its formulation in the Frye case, the “general acceptance” test has been the dominant
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Justice BLACKMUN delivered the opinion of the Court.

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. 1 Doctor Lamm stated that he had reviewed all the literature on Bendectin and human birth defects—more than 30 published studies involving over 130,000 patients. No study had found Bendectin to be a human teratogen ( i.e., a substance capable of causing malformations in fetuses). 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.

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. These experts had concluded that Bendectin can cause birth defects. 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.’ ”. 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 is not admissible to establish causation. 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.

The United States Court of Appeals for the Ninth Circuit affirmed.. Citing Frye v. United States, 54 App.D.C. 46, 47, 293 F. 1013, 1014 (1923), the court stated that expert opinion based on a scientific technique is inadmissible unless the technique is “generally accepted” as reliable in the relevant scientific community. The court declared that expert opinion based on a methodology that diverges “significantly from the procedures accepted by recognized authorities in the field ... cannot be shown to be ‘generally accepted as a reliable technique.’ …. We granted certiorari, in light of sharp divisions among the courts regarding the proper standard for the admission of expert testimony.

….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. Green & C. Nesson, Problems, Cases, and Materials on Evidence 649 (1983). Although under increasing attack of late, the rule continues to be followed by a ****2793** majority of courts, including the Ninth Circuit.^3

The merits of the Frye test have been much debated, and scholarship on its proper scope and application is legion. 587 *587 Petitioners’ primary attack, however, is not on the content but on the continuing authority of the rule. They contend that the Frye test was superseded by the adoption of the Federal Rules of Evidence. 5 We agree.

….

Here there is a specific Rule that speaks to the contested issue. Rule 702, governing expert testimony, provides:

“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.”

Nothing in the text of this Rule establishes “general acceptance” as an absolute prerequisite to admissibility. Nor does respondent present any clear indication that Rule 702 or the Rules as a whole were intended to incorporate a “general acceptance” standard. The drafting history makes no mention of Frye, and a rigid “general acceptance” requirement would be at odds with the “liberal thrust” of the Federal Rules and their “general approach of relaxing the traditional barriers to ‘opinion’ testimony.” Given the Rules’ permissive backdrop and their inclusion of a specific rule on expert testimony that does not mention “ ‘general acceptance,’ ” the assertion that the Rules somehow assimilated Frye is unconvincing. Frye made “general acceptance” the exclusive test for admitting expert scientific testimony. That austere standard, absent from, and incompatible with, the Federal Rules of Evidence, should not be applied in federal trials.

That the Frye test was displaced by the Rules of Evidence does not mean, however, that the Rules themselves place no limits on the admissibility of purportedly scientific evidence.^7 Nor is the trial judge disabled from screening such evidence. To the contrary, under the Rules the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.

The primary locus of this obligation is Rule 702, which clearly contemplates some degree of regulation of the subjects and theories about which an expert may testify. “ If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue” an expert “may testify thereto. ” (Emphasis added.) The subject of an expert’s testimony must be “scientific ... knowledge.”^8 The adjective “ scientific” implies a grounding in the methods and procedures of science. Similarly, the word “knowledge” connotes more than subjective belief or unsupported speculation. The term “applies to any body of known facts or to any body of ideas inferred from such facts or accepted as truths on good grounds.” Webster’s Third New International Dictionary 1252 (1986). Of course, it would be unreasonable to conclude that the subject of scientific testimony must be “known” to a certainty; arguably, there are no certainties in science. But, in order to qualify as “scientific knowledge,” an inference or assertion must be derived by the scientific method. Proposed testimony must be supported by appropriate validation— i.e., “good grounds,” based on what is known. In short, the requirement that an expert’s testimony pertain to “ scientific knowledge” establishes a standard of evidentiary reliability.

Additionally, in the case of a particular scientific technique, the court ordinarily should consider the known or potential rate of error, and the existence and maintenance of standards controlling the technique’s operation.

Finally, “general acceptance” can yet have a bearing on the inquiry. A “reliability assessment does not require, although it does permit, explicit identification of a relevant scientific community and an express determination of a particular degree of acceptance within that community.” Widespread acceptance can be an important factor in ruling particular evidence admissible, and “a known technique which has been able to attract only minimal support within the community,” may properly be viewed with skepticism.

The inquiry envisioned by Rule 702 is, we emphasize, a flexible one.^12 Its overarching subject is the scientific validity and thus the evidentiary relevance and reliability—of the principles that underlie a proposed submission. The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate….

We conclude by briefly addressing what appear to be two underlying concerns of the parties and amici in this case. Respondent expresses apprehension that abandonment of “general acceptance” as the exclusive requirement for admission will result in a “free-for-all” in which befuddled juries are confounded by absurd and irrational pseudoscientific assertions.In this regard respondent seems to us to be overly pessimistic about the capabilities of the jury and of the adversary system generally….

Petitioners and, to a greater extent, their amici exhibit a different concern. They suggest that recognition of a screening role for the judge that allows for the exclusion of “invalid” evidence will sanction a stifling and repressive scientific orthodoxy and will be inimical to the search for truth. See, e.g., Brief for Ronald Bayer et al. as Amici Curiae. It is true that open debate is an essential part of both legal and scientific analyses. Yet there are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly. The scientific project is advanced by broad and wide-ranging consideration of a multitude of hypotheses, for those that are incorrect will eventually be shown to be so, and that in itself is an advance. Conjectures that are probably wrong are of little use, however, in the project of reaching a quick, final, and binding legal judgment—often of great consequence—about a particular set of events in the past. We recognize that, in practice, a gatekeeping role for the judge, no matter how flexible, inevitably on occasion will prevent the jury from learning of authentic insights and innovations. That, nevertheless, is the balance that is struck by Rules of Evidence designed not for the exhaustive search for cosmic understanding but for the particularized resolution of legal disputes.

To summarize: “General acceptance” is not a necessary precondition to the admissibility of scientific evidence under the Federal Rules of Evidence, but the Rules of Evidence—especially Rule 702—do assign to the trial judge the task of ensuring that an expert’s testimony both rests on a reliable foundation and is relevant to the task at hand. Pertinent evidence based on scientifically valid principles will satisfy those demands….

End of Document