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,

v.

MERRELL DOW PHARMACEURICALS, INC., Respondent,

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

BRIEF AMICI CURIAE OF
RONALD BAYER, STEPHEN GOULD, GERALD HOLTON, PETER INFANTE, PHILIP LANDRIGAN, EVERETT MENDELSOHN, ROBERT MORRIS, HERBERT NEEDLEMAN, DOROTHY NELKIN, WILLIAM NICHOLSON, KATHLEEN JOY PROPERT, AND DAVID ROSNER,

The decision below adopts a rule of admissibility, derived from Frye v. United States, that is premised on a remarkable misunderstanding of the nature of scientific inquiry. The Ninth Circuit held that certain expert testimony from scientists of unchallenged qualification was wholly inadmissible because the methods of research and analysis employed by what the court referred to, without further elaboration, as the "scientific community." Yet the Ninth Circuit did not even purport to investigate the scientific methodology in question, nor did it survey the "scientific community" to determine just what the "consensus" was. Instead, the court below examined the conclusions reached by plaintiffs’ experts, and then blithely concluded that the methodology of these scientists’ studies was "problematic" – and therefore per se inadmissible – simply because their analyses had not been published in a peer-reviewed journal and because they reached a conclusion that contradicted what the court deemed to be a significant body of opposing evidence.

Judgements based on scientific evidence, whether made a laboratory or a courtroom, are undermined by a categorical refusal even to consider research or views that contradict someone’s notion of the prevailing "consensus" of scientific opinion. Science progresses as much or more by the replacement of old views as by the gradual accumulation of incremental knowledge. Automatically rejecting dissenting views that challenge the conventional wisdom is a dangerous fallacy, for almost every generally accepted view was once deemed eccentric or heretical. Perpetuating the reign of a supposed scientific orthodoxy in this way, whether in a research laboratory or in a courtroom, is profoundly inimical to the search for truth. A categorical refusal even to examine and search the truth. A categorical refusal even to examine and consider scientific evidence that conflicts with some ill-defined notion of majority opinion is a recipe for error in any forum.

Unable or unwilling to investigate scientific methodology and determine just what is orthodox and "generally accepted," the Ninth Circuit instead seized upon publication in a peer-reviewed scientific journal as the badge of respectability, the sine qua non of admissible "good science." The court thereby converted that editorial tool into something no scientist or journal editor ever meant it to be: a litmus test for scientific truth. This is not the way scientists work in their laboratories and symposia, and it is not the way that science should be used in the courtroom if the goal is to ensure the most accurate and valid judgments possible.

Expanding on the reasoning of Frye v. United States, the court below held that in order for a scientific opinion to be admissible, the methodology employed by the scientist to reach the opinion must meet "the essential requirements" imposed "by the scientific community." Without reference to any authority drawn from the scientific community, the Ninth Circuit then served up the bald assertion that the "requirements" of that community include publication of the expert’s study. It concluded that unless an expert scientific study reflects the "consensus" of the pertinent field and has been published in a peer-reviewed journal, then it is not "good science" and is per se inadmissible in a federal court.

Although the courts below purported to determine the admissibility of plaintiffs’ expert testimony by asking whether the methodology of the experts’ studies was "a generally accepted scientific technique", it is plain from the face of their opinions that the courts were in fact interested only in deciding whether those experts’ conclusions were generally accepted.

For example, with respect to one expert’s reanalysis of previously compiled epidemiological data about Bendectin, the Court of Appeals did not even purport to investigate the soundness or professionalism of the expert’s approach. Instead, it simply asserted, without reference to any authority drawn from the scientific community, that reanalysis is "generally accepted by the scientific community" only when it is subject to peer-review and published. In fact reanalysis is generally accepted as valid technique whether or not the specific reanalysis in question has been peer-reviewed and published. Indeed, the District Court noted without reservation or criticism that plaintiffs’ epidemiologists and biostatisticians based their opinions "on techniques that are generally and reasonably relied upon by biometrists, epidemiologists and biostatisticians."

Nor did the courts below question the soundness, quality, or professionalism of the animal studies, in vitro studies, and pharmacological and toxicological research on which plaintiffs’ experts relied. Significantly, the qualifications of plaintiffs’ expert scientific witnesses were not challenged by the defendant or by either court below.

Instead of directly evaluating the methodology of the research on which plaintiffs’ experts relied, the Ninth Circuit began with those experts’ conclusions and worked backwards. Thus, the Court of Appeals examined the result of one witness’s reanalysis of epidemiological data – the same published data relied upon by the defendant’s witness – and then opined that this reanalysis was "particularly problematic in light of the massive weight of the original published studies supporting the defendant’s posi5ion, all of which had undergone full scrutiny from the scientific community." This "massive weight" – which obviously relates to the conclusions reached by the studies, rather than to their methodology – was thought to flow from the fact that "no published epidemiological study had demonstrated a statistically significant association between Bendectin and birth defects."

While purporting to search for a "consensus" in the scientific community to justify its limits on the permissible scope of expert testimony, the Court of Appeals in fact searched only for a "consensus" in the legal community, by looking at how other courts have treated various forms of scientific evidence in Bendectin cases. Thus, the Ninth Circuit’s ruling of inadmissibility turned not on the methodology of the underlying research, nor on the caliber and nature of the experts’ analytical methods, not even on the nature of some supposed "consensus" in the scientific community, but on the fact that these experts; analyses had not been published, and on the fact that their conclusions contradicted what the Ninth Circuit took to be the conventional wisdom.

This myopic mode of decision-making – which refuses even to consider research that is deemed to be at odds with the prevailing wisdom – strikes amici as an unsound basis on which to predicate government action influenced by scientific testimony. As scientists, physicians, historians of science and sociologists of science who are members of the "scientific community", amici can assure the Court that this is not how scientists work in their pursuit of truth. Amici challenge the Ninth Circuit’s premise that the only "good science" is that which is "generally accepted" and published in peer-reviewed journals, and reject the notion that scientific analysis and conclusions that might diverge from what a court deems the published "consensus" are so unreliable as to be wholly unworthy of consideration. The quality of a scientific approach or opinion depends on the strength of its factual premises and on the depth and consistency of its reasoning, not on its appearance in a particular journal or on it popularity among other scientists. Even if it were possible to determine the existence and character of a "consensus," which is itself a task fraught with difficulty, prevailing views and conventional wisdom have all too often been consigned to the dust heap of the history of science. If the purpose of the Federal Rules of Evidence is to enable the fact0finder to make the most informed decision possible, by providing the assistance of qualified expert who possess "scientific, technical or other specialized knowledge [that] will assist the trier of fact to understand the evidence or to determine a fact in issue," Fed.R.Evid. 702, then it would be a grave mistake to require that all scientific analysis be supported by a consensus and published in a particular form in order to be considered.

SCIENTIFIC INQUIRY, LIKE THE FACT-FINDING PROCESS IN THE LAW, IS UNDERMINED BY A CATEGORICAL REFUSAL EVEN TO CONSIDER VIEWS OR ANALYSIS THAT CHALLENGE THE SUPPOSED CONVENTIONAL WISDOM.

The Ninth Circuit’s almost cursory conclusion that the only science worth considering is that which reflects some undefined "consensus" in the field is predicated on two fallacious assumptions about the nature of scientific inquiry.

First, the court below assumes that science always progresses by the continuous accumulation of objective, irrefutable truths, which are gradually incorporated into a consensus reflected in the scientific literature. This is incorrect. "[A] new theory, however special its range application, is seldom or never just an increment to what is already known. Its assimilation requires the reconstruction of prior theory and the reevaluation of prior fact, an intrinsically revolutionary process." Thus, "[s]cience advances primarily by replacement, not by addition." The conventional scientific wisdom is as often a stumbling-block as a stepping-stone to better understanding.

The Ninth Circuit’s second fallacy is the assumption that scientific truths, once discovered, are complete, universal immutable and eternal. The defendants have urged this Court that the expert testimony excluded here was inadmissible because it supposedly challenged "universally recognized scientific truths." Without passing judgment on the assertion that the safety of Bendectin rises to the level of a "universally recognized scientific truth," amici would remind the Court of Alfred North Whitehead’s dictum that "[t]here are no whole truths; all truths are half-truths. If is trying to treat them as whole truths that plays the devil.

With respect to epidemiology in particular, the eminent biostatician, Sir Austin Bradford Hill, has cautioned that "we can[not] usefully lay down some hard-and-fast rules of evidence that must be obeyed before we can accept cause and effect," because "[a]ll scientific work is incomplete – whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer on us a freedom to ignore the knowledge we already have, or to postpone action that it appears to demand at a given time."

These examples and a thousand more underscore the wisdom of Bertrand Russell’s "Seventh Commandment": "Do not fear to be eccentric in opinion, for every opinion now accepted was once eccentric." But the decision below is in fact even more dangerous than this suggests, for there was nothing "eccentric" about the reanalysis of epidemiological data or about the toxicological and pharmacological methodologies relied upon by the scientists whose testimony was excluded here. Neither court below purported to find anything unsound or unprofessional in the work of plaintiffs’ experts: these research techniques were deemed "problematic" because of the supposed "massive weight of the original published studies supporting the defendant’s position." Testimony based on such research may, of course, ultimately be rejected in favor of conflicting evidence. But in scientific inquiry, such a rejection should be a deliberative determination that the rejected view is incorrect, not a threshold assumption that the view is per se unworthy of consideration simply because it does not concur with someone’s idea of the majority position.

Indeed, we would think that the approach taken by the Ninth Circuit and promoted by the respondent is inimical to the search for truth in any discipline, not just in science. When a court is confronted by a body of legal scholarship, does it automatically refuse to consider the arguments and views of scholars whose position disagrees with the majority view in academe, or whose arguments are presented in an amicus brief rather than in a previously published law review article? When this Court must resolve a question of law on which the Courts of Appeals are divided 10 to 2, does it automatically dismiss the holdings of the courts in the minority without weighing their analysis? If a jury is asked to decide a question of fact on which qualified scientific testimony would be of assistance, we believe that the search for truth would be aided by allowing the jury to consider – as a practicing scientist would – all of the relevant evidence, not a just that which a particular judge deems to reflect the consensus of scientific opinion.

THE NINTH CIRCUIT’S ELEVATION OF PUBLICATION IN PEER-REVIEWED JOURNALS TO THE SINE QUA NON OF ADMISSIBLE. "GOOD SCIENCE" IS INSUPPORTABLE.

The Ninth Circuit’s test for whether scientific research meets its admissibility standards of "general acceptance" and "consensus" ultimately boils down to a requirement that the study or research on which a scientist would base her opinion have been published in a peer-reviewed journal. But the appearance of a study in a peer-reviewed journal does not necessarily mean that the study is generally accepted or even sound. Conversely, the fact that a study has not been published in a peer-reviewed journal does not mean that the study and any opinion based thereon are unreliable and would be of no help in resolving a question of fact.

The peer review process that precedes publication in many scientific journals is valuable, to be sure, but the Ninth Circuit is confused about the purpose and limits of that process. Peer review is a vital editorial tool whose: main functions," in the words of Dr. Arnold S. Relman, then editor-in-chief of the NEW ENGLAND JOURNAL OF MEDICINE, are "to improve the quality of what is published" and "to help editors decide what they want to publish in their journals." The Ninth Circuit has made a fetish of publication, even thought peer review takes place in many of publication, even though peer review takes place in many for a within the scientific community other than journals: peer review of papers submitted for presentation at conferences and meeting; review of grant applications; review by advisory committees. But "the peer review process is ‘not meant to determine ultimate truth or falsity.’" 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.’"

Whether a particular scientist’s research has been published in a peer-reviewed journal may be relevant to how much weight the study is accorded by other scientists or by a government decision-maker, be it a civil jury or a regulatory agency. But the Ninth Circuit has made peer review into something it never claimed to be: a Talisman of truth. It is unsurprising that the court below cites no scientific authority whatsoever for the outlandish proposition that unpublished studies are per se unreliable and unworthy of any consideration. For medical experts routinely rely on the unpublished (and sometimes even unwritten: observations and opinions of other experts in diagnosing, treating, and determining the cause of disease, just as research scientists rely on the as-yet unpublished work of their colleagues.

Moreover, federal regulations expressly authorize federal regulatory agencies to rely on unpublished scientific research in determining health hazards and in crafting safety standards to protect the public. Regulations promulgated under the Toxic Substances Control Act require manufacturers to submit to the Environmental Protection Agency lists of unpublished health and safety studies regarding toxic substances contained in their products, in order to assist the agency in assessing the health risks posed by the products. The Department of Agriculture requires that petitioners seeking reclassification of a genetically altered plant as a non-pest submit "copies of unpublished studies, or data from tests performed." These regulations reflect an understanding that the adoption of federal standards protecting the public health "cannot be postponed because definitive medical or scientific evidence is not currently available." Such pressing and important decisions must be based on "the best available evidence" including, if necessary, unpublished data and studies.

The Ninth Circuit has set a daunting task for federal judges by mandating that they apply a vague "general acceptance" standard to screen the testimony of all qualified scientific experts before admitting their testimony to a jury. It therefore comes as no surprise that the court below seized upon what it apparently took to be a quick and easy "Good Housekeeping Seal of Approval" for the scientific community – publication in a peer-reviewed journal. "Our society often wants to see peer review as a mechanical certification of truth for which no one has to take responsibility. No such mechanism is conceivable.

CONCLUSION

Although the "general acceptance" limitation on the admission of scientific evidence may have been intended to promote the ascertainment of truth and the achievement of justice in federal trials, amici believe that its application would have precisely the opposite effect. A jury, like a scientist, cannot reach the most accurate possible judgment on a scientific question if it is denied access to the relevant analysis f qualified scientists, simply because their studies have not yet been published or do not reflect some court’s notion of what is generally accepted in the particular "scientific community" defined by that court. Decision-makers forced to wear such arbitrary blinders will stumble and take many unnecessary and avoidable falls. The Ninth Circuit’s rule is predicated on a gross misunderstanding of scientific inquiry and Amici therefore urge this Court to reverse the judgment below.