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

RESPONDENT'S (MERRELL DOW) BRIEF IN OPPOSITION - Excerpts

I. INTRODUCTION

Persistence in the pursuit of righteousness is a virtue; in the pursuit of heresy, it is obstinacy. Via their Petition, Petitioners join a long line of litigants who have repeatedly and unsuccessfully invited this Court to over turn the teaching Frye v. United States, ("Frye"), and its progeny which protect judicial fact finders from scientific shamans who, in the guise of their purported expertise, are willing to testify to virtually any conclusion to suit the needs of the litigant with resources sufficient to pay their retainer.

In the opinion below ("Opinion"),' the Ninth Circuit Court of Appeals, per Circuit Judge Kozinski, rejected the Petitioners' pleas to be permitted to swim upstream against an overwhelming scientific torrent of consensus that Bendectin does not cause limb reduction birth defects, and affirmed the granting of the motion for summary judgment made by Respondent Merrell Dow Pharmaceuticals Inc. ( "Merrell Dow.") As it has consistently in the past, not only in the context of the Bendectin litigation, but in others as well, this Court should deny the Petition simply because the rule in Frye protects the process from becoming a spectacle in which paid experts are willing to mouth any expedient phrase, without regard to universally recognized scientific truths. In any event review of this case is not appropriate. since under Frye or any other standard, Petitioners' motion would be denied, and the result would therefore be the same.

In a Bendectin case the reasons for denying Supreme Court review are infinitely more convincing than in Christophersen. Bendectin, an anti-nausea medicine prescribed for use during pregnancy, is perhaps the most thoroughly investigated drug in history, at least with respect to whether it causes limb reduction birth defects. As the Opinion noted, and as Petitioners do not dispute, thirty published studies, involving over 130,000 patients, have concluded that there is no epidemiological evidence supporting a statistically significant association between Bendectin and birth defects. Further time and time again federal and state appellate tribunals have affirmed trial court and jury determinations that Bendectin is not a teratogen.'

II.

THE OPINION DOES NOT OFFEND ANY LIMITATION ON INHERENT JUDICIAL POWER REGARDING THE ADMISSIBILITY OF EXPERT TESTIMONY.

The Petition conjures up the specter of a judiciary run amok, capriciously ignoring the Federal Rules of evidence and arbitrarily erecting artificial barriers to the admission of scientifically supportable expert testimony. In so doing, Petitioners misconstrue the Opinion, misread the Federal Rules of Evidence, and misunderstand the fundamental role of the trial judge in safeguarding a lay jury from the indefensible speculations of practitioners of mercenary science.

Contrary to the Petitioners' explicit assertion, the Federal Rules of Evidence did not abrogate the common law of evidence. Instead, they expressly recognize, through Rule 104(a), Federal Rules of Evidence, the duty of the trial judge to regulate the admission of evidence. In the exercise of that authority, the trial court neither abuses its inherent judicial power, nor ignores the substantive rights of litigants in diversity cases.

III.

THE OPINION'S INSISTENCE ON PEER REVIEW DOES NOT ABUSE JUDICIAL AUTHORITY.

The Petition criticizes the Opinion for a supposed judicially imposed requirement that renegade reanalysis of epidemiological data be subjected to peer review as a predicate to admissibility. In the unique circumstances of the Bendectin litigation, this condition is one of the few barriers that protects a jury from the unprincipled opinions of any venal technocrat willing to trade his credentials and opinions for whatever fee the market will bear. Especially when a disputed expert opinion bucks a nearly universal scientific consensus, the insistence upon peer review preserves the integrity both of the trial and the science there presented.

Focus on what the Bendectin litigation is, and what it is not. The controversy surrounding Bendectin does not pit two schools of reputable scientific thought against one another equally supported by independent sets of data, separately derived by disinterested observers. Rather, on one side of the Bendectin Armageddon is an array of independent scientific investigators who, via epidemiology. have scrutinized from 1976 to the present whether Bendectin causes limb reduction birth defects; without exception thew investigators, despite every incentive to find a fink between this popularly prescribed drug and birth defects, found absolutely none. This side of the struggle has consistently published, subjecting all of the data to the strictest standards of peer review. Lined up against these forces are a combination of doctors (medical and otherwise), veterinarians, and one epidemiologist, whose sole common denominator is that they have been retained by plaintiffs' attorneys representing clients alleging injuries due to exposure to Bendectin." None of their work has been published, or subjected to peer review; furthermore, all of their data is produced through unreliable scientific technique, which often cannot be replicated, performed at the request of litigants whose undisputed interest lies in finding a causative link between Bendectin and congenital abnormalities.

Under these circumstances, peer review and publication insulate the jury from the expert opinion formulated solely to. satisfy the interests of those who paid for it. This protection is necessary because of the aura of apparent objectivity that surrounds scientific inquiry. Testimony that claims a scientific basis may carry undue weight with the trier of fact. Sterling v. Velsicol Chemical Corp., 855 F.2d 1188, 1208 (6th Cir. 1988); United States v. Brown. 557 E2d 541, 556 (6th Cir. 1977).

Petitioners suggest that far from being salutary, peer review is actually a device through which small-minded, conceited and jealous journal editors unfairly regulate the dissemination of scientific investigation. Before neither the District Court, nor the Ninth Circuit did Petitioners make any showing that the research upon which their champions rely suffered this fate. Instead, Petitioners apparently feel it is appropriate for this Court to judicially notice that peer review is the functional equivalent of some scholarly inquisition to bum the heretic and reward the devout.

In fact, peer review is far from an elitist barrier to the free flow of important scientific insights. It is considered vital to both scientific integrity and progress (Lock, "The State of Peer Review," Peer Review and Scientific Publishing, Council of Biology Editors, Inc., p. 30 (1990)). One author has written that it would be hard to imagine how society would get along without peer review. Relman, "How Good Is Peer Review," New England Journal of medicine. Vol. 32 1. No. 12, p. 827 at 829. Stephen Lock, the editor of the British Medical Journal, explained the role of peer review in the field of scientific inquiry in A Difficult Balance. Editorial Peer Review in Medicine (1985). He emphasizes that in order to be reliable, empirical observations and scientific theories must survive critical study in testing by other competent and disinterested people, and that publication plays a key part in this role. Id., 1. Through the rigors of peer review, diagnostic standards for causation have been embraced by the scientific community. Included in these standards are such inquiries as: "Do other investigators consistently find the same result?" and "Does the association make epidemiological sense?"

The antithesis of these rigorous epidemiological standards is. Dr. Lock has noted, a phenomenon called "pathological science," which has as it- hallmark features present in the proffered testimony of the Petitioners' experts. Id., 76-77. Among these characteristics are whether many measurements are necessary because of the very low statistical significance of the results, and whether the ratio of supporters to critics gradually falls to nil over time. Only through extensive, result-oriented reanalysis of published epidemiological data are the Petitioners' experts able to fashion any epidemiological inference regarding causation. Petitioners acknowledge that there are no peer reviewed published supporters of the hypothesis that Bendectin causes limb reduction defects.

Dr. Lock should not be understood as advocating the perfection of editorial peer review. However, he does maintain that it plays an essential role in medicine and science, since it is the best way of distinguishing between the promising and the meretricious.

When confronted with a battle of peer reviewed vs. nonpeer reviewed experts, most courts choose the former and dismiss the latter. Consider, for example, In Re Air Crash Disaster at New Orleans La., 795 F.2d 1230 (5th Cir. 1986), a wrongful death action in which the verdict for the plaintiff was reversed because of the inherently incredible testimony of an economist on the issue of an anticipated inheritance:

We know from our judicial experience that many such able persons present studies and express opinions that they might not be willing to express in an article submitted to a refereed journal of their discipline or in other contexts subject to peer review. We think that is one important signal, along with many others, that ought to be considered in deciding whether to accept expert testimony. Second, the professional expert is now commonplace. That a person spends substantially all of his time consulting with attorneys and testifying is not a disqualification. But experts whose opinions are available to the highest bidder have no place testifying in a court of law, before a jury, and with the imprimatur of the trial judge's decision that he is an "expert".

CONCLUSION

The Petition should be denied. The energies of this Court should only be marshalled to consider issues of broad application. The stage on which the Bendectin litigation is played out is peculiar to itself; no other theater presents a drama where the line between fact and illusion is so clearly drawn. Only Bendectin plaintiffs and their expert footmen resist that concurrence of the scientific community that Bendectin does not cause limb reduction birth defects. The Circuits uniformly require that expert testimony satisfy a threshold of reliability; no matter how that threshold is articulated, the expert testimony proffered by Petitioners cannot pass muster. Rules relied upon in Bendectin litigation are sound in that context, but not necessarily so in all others. Scrutiny by this Court of these issues is unwarranted.