Daubert v. Merrell-Dow
The plaintiff in this case, heard in Federal District Court in San Diego, California, was a pregnant woman who took Bendectin, a Merrell-Dow Pharmaceutical Company product that had been prescribed for many years to relieve nausea that occurred during pregnancy. Mrs Daubert had given birth twice to children both of whom were born with birth defects. After the second child was born, she sued Merrell-Dow, claiming that Bendectin caused the birth defects. This type of civil case is called a tort, specifically a toxic tort. In a civil suit for toxic tort, the plaintiff alleges that a substance, such as a pharmaceutical, is the cause of a harm that is suffered by someone who ingests the substance. Since the biochemical causes of birth defects are not fully understood, there was no direct way for Daubert to establish directly that Bendectin was the cause of the defects. Instead, the plaintiff resorted to epidemiology, the study of the cause and effects of disease on large populations. The plaintiff and defendant both retained statisticians to determine whether the instances of birth defects among women who took Bendectin during pregnancy were statistically significantly greater than birth defects in the general population. The plaintiff’s experts concluded that there was a significant increase in birth defects among Bendectin users’ babies, whereas the defendant’s experts concluded that any increase was not statistically significant. The defendant also argued that the plaintiff’s experts did not use methods that were generally accepted by the scientific community in reaching their conclusions; that is they argued that the plaintiff had failed to meet the Frye standard for the admissibility of their statistical evidence. The court agreed with Merrell-Dow and, upon a motion for summary judgment, found for Merrell-Dow. Daubert appealed and eventually the United States Supreme Court heard the case. The Court ruled that the trial judge had used the wrong standard of admissibility in reaching his ruling. The Supreme Court concluded that the Federal Courts could not use the Frye rule anymore in deciding questions about the admissibility of scientific or technical evidence, and that the doctrine of general acceptance espoused in Frye was not the proper yardstick. Instead, the Supreme Court ruled that courts must use the Federal Rules of Evidence in determining the standard for the evaluation of the admissibility of scientific or technical evidence. The Court drew particular attention to FRE 702, reproduced below:
In interpreting the Federal Rule 702 as well as other relevant rules, the Court indi cated that the judge must be the “gatekeeper” who decides when scientific evidence is admissible. In doing so, the court must use rational criteria for determining whether evidence is reliable and valid. The Court went so far as to suggest several criteria that a judge could use in the gatekeeper role. These were not meant to be exhaustive, but only suggestions.
• Falsifiability—If the underlying theory or principle behind a novel technique has been repeatedly tested to see if it is false and in all cases the theory is verified, this can be a good measure of validity. This is not amenable to all principles and proper research designs must be implemented for this to be a valid criterion.
• Knowledge of error rates—If the error rates of the results of a technique are known or can be estimated, then a judge could presumably make some determination as to the reliability and validity of a technique. For some techniques, there is little or no quantifiable data available to determine an error rate.
• Peer review—Certainly a technique or method or principle that has survived the peer review process and has been found worthy of publication, has demon strated some level of scientific validity. This is tempered, however, by the issue of the quality and scholarliness of the journals in the applicable field.
• General acceptance—The Supreme Court never meant to discard general acceptance as an acceptable criterion for determining scientific validity. The Court concluded that this should not be the only criterion and that there exist other, perhaps better ones. The Court did not however, seek to define what it meant by general acceptance.
In addition, the Court’s decision mandated that scientific techniques must be based on scientific principles, not speculation, and that the scientific basis for the principles had to be demonstrated. It should be noted that the Supreme Court sent the case back to the trial court for retrial and instructed the court that they must use the Federal Rules of Evidence in evaluating if Daubert’s statistical evidence should be admitted. At the second trial the judge ruled on a motion for directed verdict by Merrell-Dow, that the statistical evidence proffered by Daubert didn’t meet the requirements of the Federal Rules and he once again, directed the jury to find for Merrell-Dow. Even though they won the case, Merrell-Dow shortly thereafter removed Bendectin from the marketplace.
