No. 92-102

WILLIAM DAUBERT, et ux., etc., et al., PETITIONERS v. MERRELL DOW PHARMACEUTICALS, INC. on writ of certiorari to the united states court of appeals for the ninth circuit [June 28, 1993]

Justice Blackmun delivered the opinion of the Court.

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 anti nausea 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. [n.1] Doctor Lammstated 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. [n.2] 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; andthe "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.' " 727 F. Supp. 570, 572 (SD Cal. 1989), quoting United States v. Kilgus, 571 F. 2d 508, 510 (CA9 1978). 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. 727 F. Supp., at 575. 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. Ibid. 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. Ibid.

The United States Court of Appeals for the Ninth Circuit affirmed. 951 F.2d 1128 (1991). 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. 951 F. 2d, at 1129-1130. 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.' " Id., at 1130, quoting United States v. Solomon, 753 F. 2d 1522, 1526 (CA9 1985).

The court emphasized that other Courts of Appealsconsidering the risks of Bendectin had refused to admit reanalyses of epidemiological studies that had been neither published nor subjected to peer review. 951 F. 2d, at 1130-1131. 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." Id., at 1130. 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." Id., at 1131. The court concluded that petitioners' evidence provided an insufficient foundation to allow admission of expert testimony that Bendectin caused their injuries and, accordingly, that petitioners could not satisfy their burden of proving causation at trial.

We granted certiorari, ___ U. S. ___ (1992), in light of sharp divisions among the courts regarding the proper standard for the admission of expert testimony. Compare, e. g., United States v. Shorter, 257 U. S. App. D.C. 358, 363-364, 809 F. 2d 54, 59-60 (applying the "general acceptance" standard), cert. denied, 484 U.S. 817 (1987), with DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F. 2d 941, 955 (CA3 1990) (rejecting the "general acceptance" standard).  Next Page ->


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