The Frye rule was reviewed by the U.S. Supreme Court in the Daubert case. [Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) .] This was a case brought by two children born with birth defects that they claimed were caused by an anti- nausea drug, Bendectin. The only such drug approved by the FDA (Food and Drug Administration) for pregnant women, it had been given to more than 17,500,000 women before being taken off the market. Plaintiffs’ attorneys argued that thousands of children were born with birth defects to mothers who had taken Bendectin and this proved that Bendectin caused birth defects. Although extensive studies had not shown Bendectin to have any teratogenic effects, plaintiffs had “experts” who disagreed with these studies, based on their own unpublished and unreviewed work. Using these experts, plaintiffs had filed many cases against the manufacturer, Merrell Dow Pharmaceuticals.

The Daubert case turned on whether Bendectin, a anti- nausea drug for pregnant women, caused non-specific birth defects. As with all cases involving non-specific birth defects, the key scientific issue is sorting the defects allegedly caused by the teratogen from the high (1-6%, depending on severity) background level of birth defects. All of the formal scientific studies had shown no correlation between Bendectin intake by a pregnant woman and birth defects in her child. The plaintiffs had an expert who was qualified by training and experience - the main standard pre- Daubert - but whose methods of analysis of the data were not accepted by other scientists and had not been subjected to peer review in the literature. The trial court excluded the evidence, holding that the federal rules required the judge to act as a "gatekeeper" to prevent the jury from hearing unreliable evidence or evidence whose value was outweighed by its prejudicial nature. Prejudice jury was especially important in the Daubert case because of the emotional appeal of a birth injured baby plaintiff. The judge knew that if there was any evidence to support the plaintiff's case, it would be very difficult for the jury to find against the plaintiff. This created a special duty to assure that the plaintiff's evidence was scientifically valid.

Plaintiffs had not been successful in any of the Bendectin lawsuits at the time of the Daubert case, but the costs of defense were so high that Merrell Dow had taken the drug off the market. It was assumed by plaintiffs that they would eventually get a substantial settlement from Merrell Dow, either because they would finally win one of the cases, or just to end the defense costs. In the Daubert case, the trial judge determined that plaintiff’s experts were not credible because their evidence did not meet the Frye test requirements of general acceptability. Such a finding is critical to the defense because it stops the lawsuit before the costs are too high, plus it eliminates any chance of a sympathy verdict from the jury.

The plaintiffs appealed, claiming that the revised federal rules of evidence abolished the Frye rule and allowed the presentation of evidence that was not generally accepted by the medical or scientific community. The appeals court upheld the trial judge’s decision and the plaintiffs appealed to the U.S. Supreme Court.