Decision Author: Robert L. Brent
Many publications, including The Scientist, and reports by individual authors have commented on the implications of the recent United States Supreme Court decision on the proper standard for admissibility of scientific evidence in the courtroom (F. Hoke, The Scientist, June 13, 1994, page 1; June 27, 1994, page 1). The decision of the court involved the evaluation of expert scientific and medical testimony provided in a product liability lawsuit involving the drug Bendectin, Daubert v. Merrell Dow Pharmaceuticals Inc. (951 F.2d 1128, 1131 [9th Cir. 1992] vacated ___U.S.___, U.S.L.W. 4805, June 28, 1993). Legal interpretations of the Daubert decision by plaintiff attorneys and defense attorneys reflect a bias, since each group views the decision as favorable to them.
The entire Bendectin litigation assault was the prototype of non-meritorious litigation. Bendectin was the only medication approved by the Food and Drug Administration for the treatment of nausea and vomiting during pregnancy.
Millions of pregnant women took Bendectin during their pregnancy. There are numerous cohort and case control studies, two meta analyses, as well as animal studies and in vitro studies, all of which indicate that the clinical use of Bendectin presents no measurable increased risk of birth defects in the exposed population (R.L. Brent, Reproductive Toxicology, 9:337-49, 1995). Expert witnesses for the plaintiff have testified numerous times, but have not subjected the basis of their testimony to peer review. It is important to understand that there is no scientific basis for testifying "with a reasonable degree of medical certainty" that Bendectin causes congenital malformations as a general thesis or in an individual congenital malformation lawsuit.
There are some issues that are important to physicians and scientists in the Daubert decision. In 1989, the U.S. District Court for Southern California dismissed a Bendectin malformation lawsuit because the court concluded that the expert witnesses' conclusion that Bendectin causes birth defects was not valid (Daubert v. Merrell Dow Pharmaceuticals Inc., 727 F. Supp. 570, S.D. Cal. 1989). The U.S. Court of Appeals for the Ninth Circuit in San Francisco upheld the lower court's summary judgment -- that the standard of the scientific community, reliance on peer review, should outweigh other considerations in evaluating the admissibility of evidence.
In 1993, the Supreme Court remanded the case back to the San Francisco appeals court with the instruction that the judges should take a more active "gatekeeping role" in screening courtroom science. Judges were to act independently in assessing evidence, using only relevance and reliability as their guides. In other words, the judge determines only whether the expert's underlying reasoning or methodology is scientifically sound, but the judge should not focus on the conclusion of the expert witness. On Jan. 7, 1995, a three- judge appeals panel found that the plaintiff's scientists used unacceptable and non-peer-reviewed methodology in an effort to demonstrate that Bendectin caused human congenital malformations (Daubert v. Merrell Dow Pharmaceuticals Inc., WL 1736, 9th Cir. 1995).
I disagree with two components of the Supreme Court's decision: the Court's opinion of the qualifications of (1) judges and (2) expert witness. What the Supreme Court is saying is that they do not think the judge has the authority to summarily dismiss the conclusions of an expert, but the judge does have the authority to invalidate an expert witness's testimony because the basis of his or her conclusion is faulty. The conclusion of the Supreme Court seems to be a compromise so that both the plaintiffs and the defendants gain something from this decision.
The difficulty that I see with the Supreme Court decision is that it acts as if all judges are the same, both in their qualifications and their ability to understand a complicated issue. There are judges who are willing to study the issues and know as much about the science at the end of a trial as do the attorneys for both sides and the expert witnesses.
In the Daubert case, the judges who dismissed the case based their decision on the fact that they understood quite clearly that the conclusions and scientific basis of the plaintiffs' experts' opinions were wrong. Unfortunately, there are judges who have neither the capacity nor the interest to judge the scientific basis of an expert's opinion. A few judges may not comprehend a complicated medical issue. The Supreme Court's decision discounts the variability in qualifications and competence of judges who participate in various medicolegal cases. It is possible that the liberal guidelines sanctioned by the Supreme Court will induce many trial judges to admit most scientific evidence and allow the jury to make the final decision as to its importance.
In most other countries, judges adjudicate complicated cases similar to the Bendectin litigation, because they believe that many juries would have difficulty in evaluating such complex issues. Judges who understand the judicial aspects of the case, and who are willing to study and learn, can provide the kind of traditional evaluation that is necessary in these complicated cases and could render appropriate decisions.
With regard to the qualifications of the experts, the court was impressed with the qualifications of the plaintiff's experts. Apparently, the court based their opinion on the scientific training or publications of the plaintiff's experts. But scientists know there are two other important components to providing expertise to the courts. The first is that the scientist should be an expert and respected in the area about which he or she is testifying. The second component is that the scientist must avoid becoming a partisan in the courtroom (R.L. Brent, Pediatrics, 70:754-62, 1982). His or her ethical behavior should reflect the highest standards of the scientific community. The experts either lacked knowledge of the science pertaining to the Bendectin litigation or functioned as partisans. Their qualifications should not have been impressive to the Supreme Court. The Court did not do their homework.
Bendectin litigation is the epitome of non-meritorious litigation, and the issues involved explain in part the epidemic of litigation brought before juries in our country. A lawsuit is filed because it may be won, regardless of whether or not it has merit (R.L. Brent, Teratology, 16:1-14, 1977).
There are a few drastic changes that could eliminate the negligence -- litigation crisis and the excessive amount of non- meritorious litigation in the U.S. The first suggestion is to eliminate the contingency-fee system for attorney compensation, a system that is practically nonexistent in the rest of the world. The second is to adjudicate cases involving complicated scientific matters before designated judges with the work ethic and intelligence that was exemplified by the judges in California who rendered the Daubert decision. The third suggestion is to eliminate the concept of plaintiff and defense expert witnesses and rely on expert scientific panels that are "friends of the court" (R.L. Brent, Journal of Pediatrics, 71:288-98, 1967).
These three suggestions would make fundamental changes in the management of negligence lawsuits, and therefore it is unlikely that any of these suggestions are going to be adopted for a long time in the U.S., because the members of the law profession will not permit their adoption by state and federal legislatures.
As citizens and scientists we must realize and recognize that the only area of litigation over which science and medicine could have legitimate impact is the performance of expert witnesses. Most non-meritorious cases would not proceed if the attorneys could not find a physician or scientist who is willing to say that a non-meritorious case has merit. Therefore, while we may be displeased with some attorneys and blame them for the epidemic of litigation, the fact is that scientists and physicians have an important part in promoting these non-meritorious actions. Since we do not have any influence in modifying the legal system and, therefore, it is unlikely that the contingency fee will be eliminated and the system of expert witnesses will be drastically changed, we should put all our efforts and energies into raising the quality of expert-witness testimony (R.L. Brent, Pediatrics, 82:511-3, 1988).
We must strengthen the guidelines of universities and professional organizations in the U.S. to train and encourage scientists and physicians to perform as scholars and to monitor their contributions to the courts. We should expect them to behave as scholars in the courtroom, and if they do not provide competent and scholarly testimony, they should be criticized or expelled by their universities or their professional scientific and medical organizations.
Robert L. Brent is distinguished professor and Louis and Bess Stein Professor of Pediatrics, Radiology, and Pathology at Jefferson Medical College in Philadelphia and head of the laboratory of clinical and environmental teratology in the department of medical cell biology at the A.I. duPont Institute Children's Hospital in Wilmington, Del.