Daubert v. Merrell Dow Pharmaceuticals, Inc.

Citations: 951 F.2d 1128; 91 Daily Journal DAR 15720; 91 Cal. Daily Op. Serv. 9905; 34 Fed. R. Serv. 1145; 1991 U.S. App. LEXIS 29497; 1991 WL 269803Docket: No. 90-55397

Court: Court of Appeals for the Ninth Circuit; December 19, 1991; Federal Appellate Court

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Plaintiffs Jason Daubert and Eric Schuller, who have limb reduction birth defects, claim these conditions resulted from their mothers' use of Bendectin, an anti-nausea medication, during pregnancy. They seek damages from Merrell Dow Pharmaceuticals, the drug's manufacturer. The plaintiffs primarily rely on expert opinions derived from animal testing, chemical analyses, and a reanalysis of epidemiological studies to establish causation. In contrast, Merrell Dow presented an affidavit from a physician and epidemiologist who reviewed over 30 studies involving more than 130,000 patients, concluding no significant association between Bendectin and birth defects was found, a point the plaintiffs did not contest. The district court ruled that the plaintiffs failed to prove causation and granted Merrell Dow's motion for summary judgment.

Expert testimony based on scientific techniques must be generally accepted within the scientific community to be admissible, as established in relevant case law. This requirement aims to prevent undue prejudice or jury confusion. The reliability of the scientific method used is reviewed de novo by appellate courts, without regard to individual trial judges’ discretion. If a methodology diverges significantly from established procedures in the field, it cannot be deemed reliable and must be excluded from evidence. Precedent indicates that the issue of Bendectin's role in causing limb reduction defects is not novel, as multiple circuits have addressed the need for rigorously analyzed epidemiological studies to establish a connection between the drug and the defects.

Three circuit courts determined that plaintiffs could not establish a causal link between Bendectin and birth defects based on the evidence presented to the district court, specifically citing deficiencies in animal and chemical studies. These courts emphasized that plaintiffs' experts acknowledged the necessity of epidemiological data for verification. They rejected the plaintiffs' reliance on reanalyses of epidemiological studies, as these analyses were unpublished and lacked peer review, undermining their scientific validity. The original studies supporting the defendant had undergone rigorous scrutiny, contrasting with the unverified methodologies of the plaintiffs.

Plaintiffs contended that their reanalysis was a generally accepted scientific method, yet it failed to meet essential standards of verification and peer review, as outlined by relevant scientific literature. The courts expressed skepticism towards the reanalysis methodologies used by the plaintiffs' experts, asserting that credible scientific evidence must be published, replicated, and peer-reviewed to be considered reliable.

Consequently, the district court was affirmed in its exclusion of the plaintiffs' expert testimony regarding Bendectin's alleged role in causing their injuries, as it lacked an adequate foundation. The appeals court noted that if essential evidence is excluded, the review of summary judgment becomes moot. Furthermore, while the Third Circuit left open the possibility for admissible expert testimony based on reanalyses, it diverged from established precedent, which mandates strict scrutiny of studies generated for litigation. Overall, the courts concluded that the plaintiffs did not meet the burden of proof for causation, consistent with the principles of reliable scientific inquiry.