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Daubert v. Merrell Dow Pharms., Inc.

Supreme Court of the United States

March 30, 1993, Argued ; June 28, 1993, Decided

No. 92-102


 [1201]  [*582]  [***476]  [**2791]     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 [****7]  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. 2 Doctor Lamm stated that he had  [1202]  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.

 [****8]  [*583]   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. 3 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  [***477]  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  [**2792]  published epidemiological (human statistical) studies.

 [****9]   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  [*584]  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. [****10]  Ibid.

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509 U.S. 579 *; 113 S. Ct. 2786 **; 125 L. Ed. 2d 469 ***; 1993 U.S. LEXIS 4408 ****; 27 U.S.P.Q.2D (BNA) 1200; 61 U.S.L.W. 4805; 93 Cal. Daily Op. Service 4825; 93 Daily Journal DAR 8148; 23 ELR 20979; CCH Prod. Liab. Rep. P13,494; 7 Fla. L. Weekly Fed. S 632



Disposition: 951 F.2d 1128, vacated and remanded.


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Evidence, Rule Application & Interpretation, Relevance, Relevant Evidence, Testimony, Expert Witnesses, General Overview, Admissibility, Scientific Evidence, Civil Procedure, Judicial Officers, Judges, Standards for Admissibility, Procedural Matters, Preliminary Questions, Helpfulness, Examination, Summary Judgment, Entitlement as Matter of Law, Trials, Judgment as Matter of Law, Expert Witnesses