By Edward P. Richards and Charles Walter, 17 IEEE Engineering In Medicine And Biology Magazine, (March-April 1998) #2 p 124-125.
Since the United States Supreme Court's 1993 decision in the Daubert case, federal judges have been looking more carefully at the scientific basis of the expert testimony presented in their courtrooms. Medical device litigation, especially that over the alleged harm caused by breast implants, has been at the center of this rethinking of the role of the court in assessing scientific evidence. Cases that were about to settle for a total of more than $4 billion are now being seen as potentially groundless. One judge in Oregon dismissed a group of breast implant cases, finding there was no scientific basis for the plaintiff's claims. Another court, overseeing a large group of cases, has appointed an independent panel of experts to determine if the plaintiff's experts will be allowed to testify.
As in the Oregon breast implant cases, the exclusion of a plaintiff's expert witness often means the court must also dismiss the plaintiff's case. Plaintiff's have appealed these decisions, arguing that since the trial court's exclusion of their expert's testimony ends their case, the appeals courts should strictly review the correctness of the trial court's decision. In GE v. Joiner, decided December 1997, the United States Supreme Court established the proper standard for appellate review of decisions by trial courts to exclude evidence.
The plaintiff in the Daubert case argued that her baby's birth defects had been caused by the drug Bendectin, which she took to control nausea of pregnancy. The defense experts testified that none of the more than 30 published studies, involving more than 130,000 patients, showed any evidence that Bendectin caused birth defects. The plaintiff's sought to admit the testimony of experts who relied on animal studies and a reevaluation of the epidemiological studies to prove that Bendectin did cause birth defects. The judge dismissed the plaintiff's claims, ruling that their expert testimony did not meet the legal standard for admissibility.
The standard that the trial court applied was called the "Frye test", first laid down in the Frye case in 1923. When the Circuit court of appeals affirmed the trial court's ruling, it stated "... that expert opinion based on a scientific technique is inadmissible unless the technique is "generally accepted" as reliable in the relevant scientific community. ... The court declared that expert opinion based on a methodology that diverges "significantly from the procedures accepted by recognized authorities in the field ... cannot be shown to be 'generally accepted as a reliable technique."
The plaintiffs appealed, arguing that when the Federal Rules of Evidence (FRE) were revised, they abandoned the Frye test. The United States Supreme Court agreed, finding that the FRE were intended to broaden the scope of admissible evidence, relying on judges and attorneys to assure the reliability of the evidence presented to the jury. The Court held that while general acceptance by the scientific community could be considered in evaluating expert testimony, it was only one of several factors that the trial court must consider.
The Court proposed that judges should recognize that science is a process in which theories are proposed, debated, and accepted or rejected over a period of time. The Court suggested that trial judges should look to factors such as whether the expert's theories had been published in peer-reviewed journals, whether they relied on accepted methods of analysis, and whether they properly reflected the underlying data they were based on.
The Supreme Court reversed the trial court's exclusion of evidence in Daubert and sent the case back to the Circuit court to be reconsidered. Applying the standards established by the Supreme Court's ruling, the Circuit court reevaluated trial court's exclusion of the plaintiff's proffered testimony. The Circuit court found that trial court's reasoning under the Frye standard also included sufficient justification to exclude the evidence under the Daubert test. The Circuit court then reinstated the trial courts exclusion of the evidence.
At least in theory, Daubert shifted the decision on the reliability of scientific evidence from the scientific community to the judge. In practice, the change was less dramatic. Under the Frye rule the judge had to determine whether the testimony was consistent with generally accepted scientific standard. This required looking at many of the same factors that were required under the Daubert decision. The major change was that the judge was given latitude to accept testimony that was determined to be reliable, even if it was not generally accepted.
The problem is that few judges have the necessary scientific background to make these decisions. They are dependent on the attorneys in the cases before them to present the necessary factual information for them to decide whether the evidence is reliable under the Daubert standard. Unfortunately, neither side in litigation has an interest in an impartial presentation of evidence - the job of the advocate is to present the facts in a way that is most beneficial to his/her side. While some judges are experimenting with court-appointed neutral experts, in most cases the judges still evaluate the scientific evidence themselves.
Trial judges have great discretion in their decisions about how cases are tried in their courts. Appellant courts generally will not overrule a trial judge's decision on a procedural matter unless the court abused its discretion. While this is a difficult standard to quantify, it usually requires the appealing party to show that some rule or precedent case clearly holds that the judge must rule a given way and has no discretion to rule differently. This is a very hard standard to meet.
Some appellant courts were concerned that the "abuse of discretion" standard, combined with the uncertainty of a lay judge's review of scientific evidence, gave trial judges too much power to dispose of cases before their courts. The G.E. v. Joiner case arose when the 11th Circuit Court of Appeals reviewed a trial court's exclusion of the plaintiff's evidence in a toxic exposure case. Applying what it called a "particularly stringent standard of review to the trial judge's exclusion of expert testimony," the appeals court reversed the trial judge's exclusion of the plaintiff's expert testimony. The defendant appealed to the United States Supreme Court on the grounds that applications of the Daubert standard must be governed by the same standards of review as other procedural rulings by the trial judge.
Plaintiff was an electrician who worked with electrical transformers. Plaintiff was exposed to transformer oils containing PCBs and their breakdown products in the workplace. He developed oat cell cancer of the lung and sued GE, the transformer manufacturer. He was also a smoker and had a history of cancer in his family. His claim was not that the exposure caused the cancer, but that the PCBs "promoted" his cancer, causing it to manifest sooner.
Plaintiff's experts based their testimony on animal studies involving different cancers and dosages, and on epidemiologic studies of PCB exposure in the workplace. The experts were unable to convince the court that there was a reasonable basis for extrapolating from the animal studies to the plaintiff's cancer. The epidemiologic studies actually found there was no association between PCBs in the workplace and plaintiff's cancer. Plaintiff's experts maintained that they had reinterpreted the data in these studies and that their analysis did show an association between the PCBs and cancers such as plaintiff's. The court did not find this reanalysis persuasive and rejected the testimony.
"The District Court ruled that there was a genuine issue of material fact as to whether Joiner had been exposed to PCBs. But it nevertheless granted summary judgment for petitioners because (1) there was no genuine issue as to whether Joiner had been exposed to furans and dioxins, and (2) the testimony of Joiner's experts had failed to show that there was a link between exposure to PCBs and small cell lung cancer. The court believed that the testimony of respondent's experts to the contrary did not rise above "subjective belief or unsupported speculation."
The 11th Circuit reversed: "because the Federal Rules of Evidence governing expert testimony display a preference for admissibility, we apply a particularly stringent standard of review to the trial judge's exclusion of expert testimony.". Applying that standard, the Court of Appeals held that the District Court had erred in excluding the testimony of Joiner's expert witnesses. The District Court had made two fundamental errors. First, it excluded the experts' testimony because it "drew different conclusions from the research than did each of the experts." The Court of Appeals opined that a district court should limit its role to determining the "legal reliability of proffered expert testimony, leaving the jury to decide the correctness of competing expert opinions."
In a opinion by Chief Justice Rhenquist, joined in by 7 other justices, with a concurrence and dissent by Justice Stevens, the court reversed the Circuit court and ruled that the trial court's exclusion of the evidence was proper. The majority opinion saw this as a simple case of trial court discretion. Rejecting the "stringent" standard imposed by the Circuit court, it ruled that the proper standard was the usual "abuse of discretion review."
Applying this standard to the trial court's exclusion of the plaintiff's evidence, the Supreme Court found that the trial court conducted a proper Daubert analysis and gave clear reasons for its rejection of the specific studies relied on by plaintiff's experts. The Supreme Court also accepted the trial court's rejection of the reanalysis of the published epidemiologic studies.
Justice Breyer filed a concurring opinion, agreeing with the majority's ruling, but recognizing the difficulties faced by judges evaluating evidence under the Daubert standard. Justice Breyer stressed that judges should use the devices provided by the Federal Rules of Civil Procedure and Evidence to avail themselves of expert help and to use pretrial conferences to examine witnesses and narrow the scientific issue before the court.
Justice Stevens dissented, finding that the Daubert analysis should be restricted to the methodology used, not the conclusion drawn. In his view, Daubert does reach conclusions drawn by experts, as long as they rely on methodologically sound studies. Thus, if the epidemiologic studies were properly done, then the plaintiff's expert should be allowed to testify that he reached a different conclusion than the authors of the study. In this case, Justice Stevens would have allowed the plaintiff's expert to testify that PCB exposure promoted the plaintiff's cancer, even though the epidemiologic studies relied on by the expert found no statistical association between exposures such as the plaintiff's and oat cell lung cancer.
Daubert established the factors to be considered by a trial court when it evaluates the admission of expert testimony. GE v. Joiner establishes that these rulings will be difficult to overturn on appeal. While the GE case involved the exclusion of evidence, the rule would be the same for admitting evidence: if the trial court finds that the evidence is reliable and relevant and admits it, the appeals court will have little latitude to reverse the finding and exclude the evidence. Justice Breyer recognized that evaluating evidence is a difficult task and encouraged judges to get help, neither opinion effectively deals with the problem described by the Circuit court in its reevaluation of the Daubert case:
"The task before us is more daunting still when the dispute concerns matters at the very cutting edge of scientific research, where fact meets theory and certainty dissolves into probability. As the record in this case illustrates, scientists often have vigorous and sincere disagreements as to what research methodology is proper, what should be accepted as sufficient proof for the existence of a "fact," and whether information derived by a particular method can tell us anything useful about the subject under study."
"Our responsibility, then, unless we badly misread the Supreme Court's opinion, is to resolve disputes among respected, well-credentialed scientists about matters squarely within their expertise, in areas where there is no scientific consensus as to what is and what is not "good science," and occasionally to reject such expert testimony because it was not "derived by the scientific method." Mindful of our position in the hierarchy of the federal judiciary, we take a deep breath and proceed with this heady task."
In our next Law and Engineering article we will return to the review of scientific evidence by trial judges and propose guidelines that we believe can make this process more reliable.
1. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 125 L. Ed. 2d 469, 113 S. Ct. 2786 (1993)
2. GE v. Joiner, 1997 U.S. LEXIS 7503, 66 U.S.L.W. 4036 (U.S. 1997)
3. Frye v. United States, 293 F. 1013 (1923).
4. Daubert v. Merrell Dow Pharmaceuticals, 43 F.3d 1311 (9th Cir. Cal. 1995).
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