The Daubert Standard
Frye Under Fire
The FDA approved Bendectin in 1956 as an anti-nausea drug to combat morning sickness. Numerous human studies had found no link between the use of the drug and birth defects. Nevertheless, several lawsuits began working their way through the courts beginning in the late 1970s.
One of the lawsuits was from the parents of Jason Daubert and Eric Schuller, both born with birth defects to mothers who had taken Bendectin while pregnant. Daubert’s and Schuller’s lawyers presented research from animal studies, chemical structure analyses, and reanalysis of previously published human statistical studies to support their claim.
In 1991, both the trial court and the Ninth Circuit Court of Appeals ruled in favor of Merrell Dow, the drug’s manufacturer, citing Frye v. United States. The science presented by the families’ lawyers did not meet the general acceptance test: the scientific results were unpublished, were not peer reviewed, and “generated solely for use in litigation.”
Two years later, the U.S. Supreme Court agreed to hear the case. It had been 70 years since the courts had taken a serious look at the admissibility of scientific evidence. Scientists were eager to offer their advice.
Friends of the Court
A Who’s Who of individual scientists and scientific organizations filed 22 amicus (friend of the court) briefs to support both sides of the case. Very few of them weighed in on the issue at hand—did Bendectin cause birth defects? Rather, they offered their opinions on scientific knowledge, the scientific method, scientific validity, and the peer review process.
Eminent scientists led by Harvard paleontologist Stephen Jay Gould called it a “grave mistake” to dismiss research just because it had not been peer reviewed. This, in part, would “sanction a stifling and repressive scientific orthodoxy.” On the other side, equally prestigious scientists stressed the importance of peer review, arguing that research “must rest on a foundation reflecting the generally accepted standards.”
Oral arguments were held March 30, 1993. After working under the Frye test for the past seven decades, science in the courtroom was about to get a makeover.
A New Standard
The Supreme Court announced its decision on June 28, 1993. The Frye standard was out, replaced by the Federal Rules of Evidence that had been adopted in 1975. The Supreme Court decision gave the trial judge a gatekeeper role to decide what constitutes “good science,” and the justices offered the following guidelines:
1) whether the theory or technique in question can be (and has been) tested to see if it can be falsified,
2) whether it has been subjected to peer review and publication,
3) its known or potential error rate and the existence and maintenance of standards controlling its operation, and
4) whether it has attracted widespread acceptance within a relevant scientific community.
The court made clear that this list is “flexible” and that the decision to admit or reject scientific evidence must be made “solely on principles and methodology, not on the conclusions that they generate.”
The Daubert case was sent back to the Ninth Circuit, which, in 1995, using the new Daubert test, again sided with Merrell Dow. The federal Daubert standard has been adopted in 39 states (including Kansas), with seven states still using the Frye test. Missouri, along with three other states, follow a hybrid of the two.
By 1983, Merrell Dow had pulled Bendectin from the market as sales dropped and legal fees mounted. In 2013, the pharmaceutical company Duchesnay reintroduced the drug on the market under the brand name Diclegis.