In The Supreme Court of the United States
October Term, 1992
WILLIAM DAUBERT and JOYCE DAUBERT, Individually
and as Guardians Ad Litem for JASON DAUBERT,
and ANITA DE YOUNG, Individually, and as Guardian Ad Litem for ERIC SCHULLER, Petitioners
VS.
MERRELL DOW PHARMACEUTICALS, INC., Respondent.
On Petition for Writ of Certiorari to the United States Court of Appeals for the Ninth Circuit
PETITIONERS' BRIEF
STATEMENT OF THE CASE
"Based on my review of the scientific literature, I conclude that maternal use of Bendectin during the first trimester of pregnancy is not a risk factor for human birth defects in general, for limb reduction defects specifically, or for any other particular human birth defect."
This ultimate statement of opinion, standing alone, constituted admissible evidence, because Rules 704(a) and 705 of the Federal Rules of Evidence permit qualified experts to state their opinions on an ultimate issue of fact without disclosing the fasts or data underlying their opinions. Dr. Lamm did provide several paragraphs of elaboration about the sorts of inquiries into the available epidemiological data that had led him to his ultimate opinion that Bendectin use is not a risk factor. But neither the underlying data nor detail about those inquires was entered into evidence. They were not part of the admissible summary judgment record at all, but simply served to enhance the credibility of Dr. Lamm’s opinion. Dr. Lamm freely and informally referred to these outside sources as permitted by Rule 703 of the Federal Rules of Evidence, which (as the Ninth Circuit has expressly agreed with other circuits) functions as "the expert testimony exception to the hearsay rules." United States v. Unruh
As required, petitioners opposed summary judgment with affidavits from expert witnesses, skilled in several relevant scientific and medical disciplines. Merrell readily conceded that each of the eight experts was qualified to state an opinion concerning the effect of Bendectin on birth defects. One of petitioners’ experts, Dr. John Palmer, a medical professor and physician specializing in pharmacology, concluded:
I have also examined the medical records pertaining to the Daubert and Schuller children and it is my opinion within a reasonable degree of medical certainty that in each case the drug Bendectin was taken at the period of time so as to (affect) the cells that would produce the normal limb structure and that Bendectin did cause the limb defects in each of the children.
Under Fed. R. Evid. 704(a) and 705, this ultimate statement of opinion about causation from a qualified expert, standing alone, was sufficient to serve as admissible proof of causation.
The credibility of Dr. Palmer’s opinion was enhanced, however, by several pages of elaboration on his reasoning and on his consideration of data from four standard sources of information about whether particular substances cause birth defects: (1) in vitro animal tests on animal cells, (2) in vivo animal tests on live animals, (3) analysis of chemical structure, and (4) analysis of data contained in the same published epidemiological studies considered by Merrell’s experts. As with the sources of data contained in the same published epidemiological studies considered by Merrell’s experts. As with the sources of data relied on by Merrell’s experts. As with the sources of data relied on by Merrell's contrary expert, the sources relied on by Dr. Palmer were not themselves entered into evidence. Rather, Dr. Palmer referred to these outside sources pursuant to Fed. R. Evid. 703. Petitioners also submitted the affidavits of seven other concededly qualified experts drawn from a variety of fields related to birth defects, including teratology (the study of substances that produce malformations in human fetuses), pathology, chemistry, developmental biology, pharmacology, toxicology, embryology, dysmorphology and epidemiology. These seven affidavits demonstrated to the district court the evidence petitioners proposed to offer in order to enhance the credibility of Dr. Palmer’s ultimate opinion at trial.
The Ninth Circuit below, affirming the district court's grant of summary judgment. declined to review these legal arguments concerning Rule 703. Instead, it advanced its own ground for excluding petitioners' expert testimony -- the judge-made "Frye rule" -- and held that the exclusion of all of petitioners' expert testimony was proper because that testimony had failed to meet the strictures of Frye. As the Ninth Circuit explained the rule:
Expert opinion based on a scientific technique "is admissible if it is generally accepted as a reliable technique among the scientific community." United States v. Solomon. We impose this requirement because such evidence "creates a substantial danger of undue prejudice or of confusing the issues or of misleading the jury . . . because of its aura of special reliability and trustworthiness." United States v. Amarel. For expert opinion based on a given scientific methodology to be admissible, the methodology cannot diverge significantly from the procedures accepted by recognized authorities in the field. if it does so diverge, it cannot be shown to be 'generally accepted as a reliable technique,' Solomon, and a district court must exclude it.
The "methodology" that the Ninth Circuit found problematic under the Frye test was what the court called "the reanalysis methodology employed by plaintiffs' experts' in analyzing the epidemiological data contained in published studies. Rather than restating the published conclusion of each epidemiological study, plaintiffs' experts looked at the underlying data in the studies, applied less stringent certainty standards, and pooled data from various studies to minimize the effect of random variation affecting any one study. By so doing, plaintiffs' experts were able to offer an opinion contrary to that of the original authors of the studies. That is, through careful analysis of the original data in each study juxtaposed by consideration of the data in other studies, plaintiffs' experts were able to disagree with the original authors and conclude that the data on balance provided substantial evidence of causation. The Ninth Circuit did not rule against the legitimacy of this "reanalysis methodology." Rather, the court found Frye unsatisfied simply because plaintiffs' experts had not published their conclusions in peer-reviewed journals before submitting their affidavits in court:
"Plaintiffs argue that reanalysis is a generally accepted scientific technique, so it follows that their experts were basing their opinions on a permissible methodology. But the reanalysis of epidemiological studies is generally accepted by the scientific community only when it is subjected to verification and scrutiny by others in the field. Plaintiffs' reanalysis do not comply with this standard; they were unpublished, not subject to the normal peer review process, and generated solely for use in litigation. It does not suffice that the expert’s methodology meet some of the requirements imposed by the scientific community; it must meet all of the essential requirements. Selective borrowing from generally accepted scientific methodology does not satisfy Solomon’s rigorous standard."
RULES FOR GRANTING THE WRIT
1. This Court Should Resolve the Conflict over wheteher the Frye Rule has survived the enactment of the Federal Rules of Evidence
2. This Court Should Decide Whether the Lower Federal Courts Possess Inherent Judicial Power to Create Their Own Rules for Excluding Evidence
The Ninth Circuit's decision below stretches the concept of "inherent judicial power" well beyond the breaking point, trampling over Congress's express displacement of that power in Fed. R. Evid. 402. In so doing, the decision bypasses the procedural safeguards for evidence rulemaking set forth by Congress in 28 U.S.C. §§ 2071-2077, and it effects substantive revision of rights granted petitioners under state tort law in violation of this Court's Erie jurisprudence which must in this context supersede whatever inherent judicial power could otherwise be exercised. The instant case therefore presents this Court with an opportunity to speak with a united voice concerning the limits of inherent judicial power.
The Ninth Circuit has refused to recognize that its power to impose the Frye test has been displaced by enactment of the Federal Rules of Evidence and related procedural rulemaking requirements laid down by Congress. That refusal and the Ninth Circuit's imposition of the Frye test to significantly reduce the substantive scope of petitioners' tort remedies under California law in a diversity case reveal a fundamental lack of respect for the limits on inherent judicial power. Such disrespect provides common ground for the majority and dissenting Justices in Chambers and presents an important opportunity for this Court to underscore to the lower federal courts basic axioms regarding the limits of judicial power.
3. This Court Should Decide Whether the Lower Federal Courts May Delegate Control Over Admissibility of Scientific Expert Opinion Testimony to the Editors of Peer-Reviewed Journals
The final issue warranting review is the Ninth Circuit's use of the Frye rule to delegate control over admissibility of scientific expert opinion testimony to the editors of peer-reviewed journals. Under the decision below, if an expert witness wishes to rely upon his own analysis of data in a published scientific study, but after full study reaches a conclusion opposite that of the author of the study, he may offer his opinion only if that opinion 'is subjected to verification and scrutiny by others in the field" through the peer-review process and can convince the editors of a peer-review journal to publish the analysis. The court below regarded this as a wise requirement, on the basis that the peer review process "is one of the hallmarks of reliable scientific investigation" -- that "the science of publication, replication, and verification, the science of consensus and peer review" is "good science" and "'the best test of certainty we have." This requirement mandates that such opinions may be presented to a jury only if "accepted by recognized authorities in the field’, in accord with the central aim of the Frye rule of "assur[ing] that those most qualified to assess the general validity of a scientific method will have the determinative voice." United States v. Addison.
The Ninth Circuit's requirement that opinions be published in peer-reviewed journals before they can be presented at trial, and the concomitant delegation of substantial authority over evidence in federal trials to the private editors of these journals, is a blatant abuse of judicial power. There is absolutely no language in any relevant statute or rule authorizing such a requirement. To be sure, whether or not an expert's conclusions are peer-reviewed and published may well affect the credibility of his testimony. The Ninth Circuit urged an "added dose of skepticism" especially where studies are performed in anticipation of litigation. But our system of justice entrusts such practical grounds for skepticism of a witness's testimony to the jury -- not to judges, and not to private journalists anointed by judges -- and the Seventh Amendment bars the strange rule imposed by the court below.
As the Ninth Circuit below acknowledged , its decision is in conflict with the Third Circuit's decision in DeLuca v. Merrell Dow Pharmaceuticals, Inc., a conflict that independently merits this Court's review.' Lacking in any legal support, the rule imposed below is equally lacking in scientific support. The Ninth Circuit is profoundly mistaken in regarding the peer-reviewed publication process as built on a "search for truth," so that it may logically serve the truth-seeking function of the trial process. As a former editor of the Journal of the American Medical Association has remarked, "[p]eer review is far from being a ‘perfect sausage machine for grinding out the truth.’ . . . ‘Just because peer review is about a review of scientific data doesn't mean that it is itself a scientific process. . . . We need more realistic, human expectations.'" L.A. Times, I (quoting Elizabeth Knoll). The editor-in-chief of The New England Journal of Medicine agrees that "the peer review process is 'not meant to determine ultimate truth or falsity.' [I]ts main functions [are] 'to improve the quality of what is published' and 'to help editors decide what they want to publish in their journals . . . . " Ibid. (quoting Dr. Arnold S. Reiman). As numerous commentators have documented, neither the objectives of peer review nor its procedures are suited to the determination of truth. The Ninth Circuit's bizarre "publish-or-perish" edict for expert testimony is bad law and bad science, has no place in federal jurisprudence, and merits prompt review.