As every school child knows, or at least every law student in the United States knows, Daubert was a Bendectin case. The plaintiff claimed that his mother’s use of Bendectin, a prescription anti-nausea medication, during pregnancy caused him to be born with a major limb reduction defect.
Filed in 1984, the Daubert case was pending, in summer 1989, before Judge Earl Ben Gilliam, in the Southern District of California. A trial date was approaching, and a deadline for motions for summary judgment. The first Daubert motion was filed in August 1989, in Daubert v. Merrell Dow Pharmaceuticals, Inc.[1] It was a motion for summary judgment, not a motion specifically to exclude plaintiffs’ expert witness’s proffered testimony.
By the time of the first Daubert motion, the plaintiff was relying upon the anticipated testimony of John Davis Palmer, M.D. For the time, John Davis Palmer was not an unlikely expert witness. Although Palmer practiced internal medicine, he had a doctorate in pharmacology. Palmer, however, had no experience studying Bendectin, and no real expertise in epidemiology. He had never designed or published an epidemiologic study, and he had never done any kind of research on Bendectin. The standard for qualifying an expert witness, even in federal court, has always been very low, and thus not an effective way to police the quality of scientific evidence.
Palmer was a rather late substitute for expert witnesses previously listed by the plaintiff. Alan Kimball Done, a pediatrician, had been the main warhorse of the Bendectin plaintiffs, but he was withdrawn by plaintiff’s counsel after he was found to have committed perjury about his academic credentials in another Bendectin case.[2]
Plaintiff also needed to drop another expert witness, William Griffith McBride, who had been a star in plaintiff’s counsel’s stable. McBride helped show the teratogenicity of thalidomide in the early 1960s,[3] and his work in the Bendectin litigation gave these dodgy cases some patina of respectability. In 1988, however, McBride was accused of fraud, for which he would eventually lose his medical license.[4] McBride also chose, rather improvidently, to sue journalists, journals, and Merrell Dow executives, for reporting his rather extensive fees, only to lose that litigation.[5] When plaintiff’s counsel withdrew McBride, plaintiff was left with only Dr. Palmer to serve as plaintiff’s sole expert witness on both general and specific causation.
At the time that the first Daubert motion was filed, manufacturer Merrell Dow had voluntarily withdrawn Bendectin from the market, without any suggestion from the FDA that this action was necessary or in the public interest. The manufacturer had also enjoyed considerable success in court. The company had tried a case that consolidated the general causation claims of over 800 plaintiffs, to a defense jury verdict, in 1985, before Chief Judge Carl Rubin, of the Southern District of Ohio.[6] Despite some isolated trial losses, the company was vindicated in three federal circuits at the time its lawyers filed the “Daubert” motion.[7] The First, Fifth, and District of Columbia Circuits of the United States Court of Appeals, had all held that the plaintiffs’ case was legally insufficient to sustain a verdict against the defendant, or that the expert testimony involved was inadmissible.
In the Daubert case, Merrell Dow Pharmaceuticals was represented by the law firm Dickson, Carlson & Campillo. The important task of drafting the motion for summary judgment landed on the desk of a first year associate, Pamela Yates, who is now a partner at Arnold & Porter. Given that Merrell Dow had succeeded in other appellate courts, the task may have seemed straight forward, but the legal theories were actually all over the map.
The first Daubert motion was not styled as a motion to exclude expert witness opinion testimony, but rather as a motion for summary judgment, pursuant to Federal Rule of Civil Procedure 56, on the issue of causation. Merrell Dow’s supporting brief did not clearly invoke the distinction between general and specific causation, which distinction was not widely drawn until later in the 1990s. The supporting brief implicitly addressed both general and specific causation.
At the time that the first Daubert motion was made, there was no clear consensus of precedent that identified the source of support for a trial court’s ruling peremptorily on a weak evidentiary display on the causation issue. The evidence supporting the defense expert witnesses’ opinion that Bendectin had not been shown to cause birth defects generally and limb reduction defects specifically was strong. For all major congenital defects, there had been no change in overall incidence for the years in which Bendectin was marketed. Such an ecological argument usually has no validity, but in the case of Bendectin, for several years, roughly half of all pregnant women used the medication. When the medication was abruptly withdrawn,[8] not because of the science but because of the cost of the litigation, the rate of birth defects remained unaffected. The great majority of birth defects have no known cause, and there was no scientific consensus that Bendectin caused birth defects; indeed by 1989, the nearly universal consensus was that Bendectin did not cause birth defects.[9]
There were also many analytical epidemiologic studies, which both individually or in combination failed to support a conclusion of causation.
In the face of the defense’s affirmative evidence, the plaintiff relied upon a potpourri of evidence:
1) chemical structure activity analysis;
2) in vitro (test tube) studies;
3 ) in vivo studies (animal teratology) studies; and
4) reanalysis of epidemiology studies.
Plaintiff’s lead counsel Barry Nace[10] had concocted this potpourri approach, which he called “mosaic theory,” and which might more aptly be called the tsemish or the shmegegge theory.[11] Whatever Nace called it, he fed it to his expert witness to argue that:
“Like the pieces of a mosaic, the individual studies showed little or nothing when viewed separately from one another, but they combined to produce a whole that was greater than the sum of its parts: a foundation for Dr. Done’s opinion that Bendectin caused appellant’s birth defects.”[12]
Although philosopher Harry Frankfurt had not yet written his seminal treatise on the subject, most courts saw that this was bullshit, which tends to result “whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”[13]
In addition to favorable opinions from the First, Fifth, and District of Columbia Circuits, Merrell Dow had a favorable Zeitgeist working in its favor. The plaintiff-friendly influential judge, Judge Jack Weinstein, had rolled up his sleeves and taken a hard look at the plaintiffs’ scientific evidence in the Agent Orange litigation. Judge Weinstein found that evidence wanting in an important opinion in 1985.[14] Although the alleged causal agent in Agent Orange was not Bendectin, Judge Weinstein recognized that epidemiological studies were, in a similar medico-legal context, “the only useful studies having any bearing on causation.[15] Judge Weinstein relied heavily upon Federal Rule of Evidence Rule 703, which governed what inadmissible studies expert witnesses could rely upon, to whittle down the reliance list of plaintiffs’ expert witnesses before declaring their opinions too fragile to support a reasonable jury’s verdict in favor of plaintiffs.
More generally, discerning members of the legal system were reaching the end of their tolerance for the common law laissez-faire approach to expert witness evidence. In 1986, the Department of Justice issued a report that explicitly called for meaningful judicial gatekeeping of expert witnesses.[16] And in that same year, 1986, Judge Patrick Higginbotham wrote an influential opinion, in which he warned that expert witness opinion testimony was out of control, with expert witnesses becoming mouth pieces for the lawyers and advocates of policy beyond their proper role. Judge Higginbotham observed that trial judges (with support from appellate court judges) had a duty to address the problem by policing the soundness of opinions proffered in litigation, and to reject the system’s reliance upon expert witnesses simply because they “say[] it is so:”[17]
“we recognize the temptation to answer objections to receipt of expert testimony with the short hand remark that the jury will give it ‘the weight it deserves’. This nigh reflective explanation may be sound in some cases, but in others it can mask a failure by the trial judge to come to grips with an important trial decision. Trial judges must be sensitive to the qualifications of persons claiming to be experts … . Our message to our able trial colleagues: It is time to take hold of expert testimony in federal trials.”[18]
Although Merrell Dow had a substantial tailwind behind its motion for summary judgment, there was no one clear theory upon which it could rely. Some of the Bendectin appellate court opinions were based upon the insufficiency of the plaintiffs’ expert witness evidence, on the basis of the entire record after trial. The evidence in Daubert was virtually the same if not more restricted than what was of record in some of those appellate court cases. The ecological evidence was clear.
Some of the judgments relied upon by Merrell Dow were based upon the Frye test, and some were based upon Rule 703, which addresses what kinds of otherwise inadmissible evidence expert witnesses may rely upon in formulating their opinions. Finally, some courts, such as Fifth Circuit in In Re Air Crash Disaster at New Orleans, were beginning to see Rule 702 as the source of their authority to control wayward expert witness opinion testimony.
Merrell Dow advanced multiple lines of analyses to show that plaintiffs cannot establish causation based upon the then current scientific record. The first Daubert motion had no clear line of authority, and so, understandably, it cast a wide net on all available potential legal rules and doctrines to oppose the plantiff’s potpourri Bendectin causation theory. The motion harnessed precedents based upon sufficiency of the plaintiffs’ proffered expert witness, Federal Rules 702 and 703, as well as the 1923 Frye case.[19]
The cases that invoked Frye doctrine presented several interpretative problems. Frye was a criminal case that prohibited expert witnesses from testifying about their interpretations of the output of a mechanical device. The Frye case’s insistence upon general acceptance, when imported into a causation dispute in a tort case, was ambiguous as to what exactly had to be generally accepted: the specific causal claim, or the method used to reach the causal claim, or the method used as applied to the facts of the case. Furthermore, Frye’s requirement of general acceptance was not explicitly incorporated into either Rule 702 or 703, when promulgated in 1975.[20]
Merrell Dow had ample evidence that there was no general acceptance of the plaintiff’s causal claim, but its counsel also showed that by applying generally accepted methodology, scientists could not reach the plaintiff’s causal conclusion, and no scientist outside of the litigation had done so. In particular, there was general acceptance of the propositions that non-human in vivo and in vitro teratology experiments have little if any predictive ability for human outcomes. Because randomized controlled trials were never an option for testing human teratogenicity, observational epidemiology was required, and the available studies were largely exonerative. Only by post-publication data dredging and manipulation was plaintiffs’ expert witness Palmer (following what Shann Swan had done in previous cases) able to raise questions about possible associations. Plaintiff’s expert witness Palmer could not show that these manipulations were a generally accepted method for interpreting or re-analyzing published studies.
In its last point, the first Daubert motion also maintained that the standard for medical causation required that the relevant relative risk exceed two.[21] As noted, the brief did not distinguish general from specific causation, a distinction that had not entered the legal lexicon fully in 1989. The brief’s citation to swine-flu cases, however, clarifies the nature of Merrell Dow’s argument. In the swine-flu litigation, the United States government assumed liability for adverse effects of a vaccine for swine flu. The government recognized that within a certain time window after vaccination, patients had more than a doubled risk of Guillain-Barré syndrome (GBS), an autoimmune neurological condition. The government refused compensation for claimants outside that window. Merrell Dow relied heavily upon one swine flu case, Cook v. United States, which articulated and applied the principle:
“Wherever the relative risk to vaccinated persons is greater than two times the risk to unvaccinated persons, there is a greater than 50% chance that a given GBS case among vaccinees of that latency period is attributable to vaccination, thus sustaining plaintiff’s burden of proof on causation.”[22]
In other words, the government had conceded that the swine-flu vaccine could cause GBS in some temporal situations, but not others. The magnitude of the causal association had been quantified in relative risk terms by epidemiologic studies. Only for those claimants vaccinated in time windows with relative risks greater than two could courts conclude that GBS was, more likely than not, caused by vaccination.
Unlike the federal government in the swine-flu GBS litigation, Merrell Dow was not, however, conceding general causation for any exposure scenarios. The first Daubert motion can only be read to deny general causation, but to explain further that even if the court were to assume, arguendo, that Bendectin causes limb reduction deficits based upon Palmer’s schmegegge and Swan’s re-jiggered risk ratios, that there would still be no proper inference that Bendectin more likely than not caused Jason Daubert’s birth defects.
In response to these arguments, the plaintiff’s counsel argued their mosaic, potpourri, schmegegge theories. Although plaintiffs were down to Dr. Palmer, they filed transcripts and affidavits from a host of other expert witnesses, from previous Bendectin cases.
As for the legal rules of decision, Barry Nace, on behalf of plaintiffs, argued that Rule 703 had “absorbed” the Frye rule. Having been shown to be qualified under the minimal standard of Rule 702, these expert witnesses then satisfied Rule 703 by relying upon “scientific evidence” of the sort that experts in their field rely upon, even if other scientists would not rely upon such evidence in support of a conclusion. Otherwise those expert witnesses were unrestrained by the law, and they were free to assess their relied upon facts and data as sufficient to show that Bendectin probably causes birth defects and that Bendectin caused Jason Daubert’s birth defects. Nace argued that as long as expert witnesses, properly qualified, offered relevant opinions, based upon “things of science,” they could opine that the earth was flat, and it was for the jury to sort out whether to believe them.
Judge Earl Gilliam found Nace’s position untenable, and granted summary judgment later in 1989.[23] Interestingly Judge Gilliam’s opinion in the district court never cited Federal Rule of Evidence 702. Instead, the opinion pointed to Rule 703, as restricting evidence, even if “science,” unless the proponent showed that the underlying principle had gained general acceptance in the relevant field.[24] Opinions not based upon facts or data “of a type reasonably relied upon by experts in the particular field” would be confusing, misleading, and unhelpful, and thus inadmissible. The reference to helpfulness might perhaps be taken as an implicit invocation of Rule 702.
Judge Gilliam had the benefit of the Circuit decisions in Brock, Richardson, and Lynch, with their various holdings of insufficiency or inadmissibility of plaintiffs’ expert witness evidence. In particular, Judge Gilliam cited Brock for the proposition that trial courts must “critically evaluate the reasoning process by which the experts connect data to their conclusions in order for courts to consistently and rationally resolve the disputes before them.”[25] Following Judge Weinstein on Agent Orange, and the previous federal decisions on Bendectin, Judge Gilliam observed that causation in the Bendectin cases could be established, under the circumstances of plaintiffs’ evidentiary display, only through reliance upon epidemiologic evidence. Dr. Done’s schmeggege, concocted as it was by Barry Nace, would not get plaintiffs to a jury.
Judge Gilliam went further to point out that some of plaintiffs’ proffer did not even purport to claim causation. Shanna Swan’s prior testimony asserted that Bendectin was “associated” with limb reduction. Jay Glasser, a specialist in biostatistics, epidemiology and biometry had opined that “Bendectin is within a reasonable degree of epidemiological certainty associated with congenital disorders, including limb defects.” Dr. Johannes Thiersch, a specialist in pathology and pharmacology, proclaimed that “structure analysis” was “of great interest.”[26] In other words, there was a good deal of true, true, but immaterial opinion in what Mr. Nace had thrown over the transom, in opposition to the motion for summary judgment.
Nace appealed, and the Daubert case was argued to the Ninth Circuit in 1991. In a short opinion by Judge Kozinski, the appellate court affirmed the judgment below.[27] The affirmance did not mention Rule 702; rather it relied upon the decisions of other Circuits, in which the plaintiffs’ evidentiary display had been found insufficient to sustain a reasonable jury verdict.
Judge Kozinski’s opinion tilted towards Rule 703 and the Frye standard in citing to cases that stated, based upon Frye, that expert witnesses must use generally accepted techniques from the scientific community. As a legal determination, the determination of general acceptance vel non was a legal determination reviewable de novo. For its de novo decision on general acceptance, the Ninth Circuit relied upon the cases coming from the First, Fifth, and District of Columbia Circuits,[28] and of course, the record below.
By 1991, another Circuit, the Third, had weighed in on the same evidentiary display, when it reversed summary judgment for Merrell Dow, and remanded for reconsideration under the Third Circuit’s approach to Rule 702. Judge Kozinski declared that the Third Circuit’s approach was not followed in the Ninth Circuit, and proceeded to ignore the DeLuca case.[29]
Judge Kozinski treated the insufficiency and the invalidity of the Nace/Done schmeggege theory as legal precedent, and thus the court’s opinion gave very little attention by way of expository description or explanation of the problems with the four factors (in vitro, in vivo, structure analysis, and re-analysis of epidemiologic studies). As Judge Kozinski put the matter:
“For the convincing reasons articulated by our sister circuits, we agree with the district court that the available animal and chemical studies, together with plaintiffs’ expert reanalysis of epidemiological studies, provide insufficient foundation to allow admission of expert testimony to the effect that Bendectin caused plaintiffs’ injuries.”[30]
And thus, summary judgment was proper in Daubert. Judge Kozinksi, like Judge Gilliam in the district court, never reached the specific causation argument that involved risk ratios less than two.
Some of the Circuit court cases relied upon by Judge Kozinski delved into the invalidity of these methods for determining the causes of human birth defects. The Lynch decision explored in some detail the Shanna Swan made-for-litigation rejiggering of a study based upon data from the Metropolitan Atlanta Congenital Defects Program, which included a challenge to whether it could be reasonably relied upon (Rule 703), as well as its pretense to support a scientific conclusion (Rule 702).[31] Later commentators would skirt the validity issue by asserting that re-analysis, in the abstract, is not impermissible or invalid, without addressing the specific issues discussed in the reported decisions. Other commentators have misrepresented Swan’s re-analysis as a meta-analysis, which it was not.
Some commentators have complained that the defense in Daubert made too much of the lack of statistical significance. Their complaint, in the abstract, might have some salience. In some contexts, an isolated and elevated risk ratio greater or less than one may well have important information, even if the p-value is a bit above 0.05. The lack of statistical significance at the conventional five percent, however, conveys important information about the finding’s imprecision, especially when there was a large dataset to evaluate. In 1994, a meta-analysis was published that found a summary estimate of all birth defects in the available epidemiologic studies to be an odds ratio of 0.95 (95% C.I., 0.88-1.04), and the summary estimate for limb reduction defects to be an odds ratio 1.12 (95% C.I., 0.83-1.48).[32]
[1] Defendant’s Memorandum of Points and Authorities in Support of Its Motion for Summary Judgment on the Issue of Causation, Daubert v. Merrell Dow Pharms., Inc., Case No. 84-2013-G(I) (S.D. Cal. Aug. 2, 1989). The motion was made in a companion case before Judge Gilliam as well, Schuller v. Merrell Dow Pharms., Inc., Case No. 84-2929-G(I). The first Daubert motion may not have been the first one drafted. The linked brief is the first one as filed.
[2] See Oxendine v. Merrell Dow Pharms., Inc., 563 A.2d 330 (D.C. Ct. App. 1989).
[3] William Griffith McBride, Thalidomide and Congenital Abnormalities, 278 LANCET 1358 (1961).
[4] William Griffith McBride, McBride criticizes inquiry, 336 NATURE 614 (1988); Norman Swan, Disciplinary tribunal for McBride, 299 BRIT. MED. J. 1360 (1989); G. F. Humphrey, Scientific fraud: the McBride case, 32 MED. SCI. LAW 199 (1992); Mark Lawson, McBride found guilty of fraud, 361 NATURE 673 (1993); Leigh Dayton, Thalidomide hero found guilty of scientific fraud, NEW SCI. (Feb.27, 1993); William McBride: alerted the world to the dangers of thalidomide in fetal development, 362 BRIT. MED. J. k3415 (2018).
[5] McBride v. Merrell Dow & Pharms., Inc., 800 F.2d 1208 (D.C. Ct. App. 1986). McBride ultimately failed against all his litigation targets.
[6] See In Re Richardson-Merrell. Inc. Bendectin Prods. Liab. Litig., 624 F.Supp. 1212 (S.D. Ohio 1985); aff’d sub nom. In re Bendectin Litig., 857 F.2d 290 (6th Cir. 1988); cert. denied, 488 US 1006 (1989).
[7] Brock v. Merrell Dow Pharmaceuticals Inc., 874 F.2d 307 (5th Cir. 1989); Richardson y. Richardson-Merrell, 857 F.2d 823 (D.C. Cir. 1988); Lynch v. Merrell-National Labs., 830 F.2d 1190 (1st Cir. 1987) (affirming grant of summary judgment).
[8] US Food & Drug Admin., Determination That Bendectin Was Not Withdrawn from Sale for Reasons of Safety or Effectiveness, 64 FED. REG. 43190–1 (1999).
[9] Brief at 3-4.
[10] Barry Nace was one of the lead plaintiffs’ counsel in the Bendectin litigation, and he represented the Daubert family. Nace was also formerly President of the lawsuit industry’s principal lobbying organization, the American Trial Lawyers Association (now the AAJ). See also In re Barry J. Nace, A Member of the Bar of the District of Columbia Court of Appeals (Bar Registration No. 130724), No. 13–BG–1439, Slip op. (Sept. 4, 2014), available at <https://www.dccourts.gov/sites/default/files/pdf-opinions/13-BG-1439.pdf>, last visited on Feb. 8, 2026.
[11] See Michael D. Green, Pessimism about Milward, 3 WAKE FOREST J. L & POL’Y 41, 63 (2013) (paraphrasing Nace as describing the mosaic theory as “[d]amn brilliant, and I was the one who thought of it and fed it to Alan [Done].”).
[12] Id. at 61 (2013) (citing Oxendine v. Merrell Dow Pharm., Inc., 506 A.2d 1100, 1110 (D.C. 1986).
[13] Harry Frankfurt, ON BULLSHIT 63 (2005).
[14] In re “Agent Orange” Prod. Liab. Litig., 611 F. Supp. 1223 (E.D.N.Y. 1985), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).
[15] Id. at p. 1231.
[16] United States Dep’t of Justice, Tort Policy Working Group, Report of the Tort Policy Working Group on the causes, extent and policy implications of the current crisis in insurance availability and affordability at 35 (Report No. 027-000-01251-5) (Wash. DC 1986), available at https://archive.org/details/micro_IA41152903_0369.
[17] In Re Air Crash Disaster at New Orleans, 795 F.2d 1230, 1233-34 (5th Cir. 1986).
[18] Id. at 1233-34.
[19] The Brief, at 2, cited United States v. Kilgus, 571 F.2d 508, 510 (9th Cir. 1987) (citing Frye).
[20] An Act to Establish Rules of Evidence for Certain Courts and Proceedings. Pub. L. 93–595, 88 Stat. 1926 (1975).
[21] Brief at 17.
[22] 545 F.Supp. 306, 308 (N.D. Cal. 1982). See generally Richard E. Neustadt & Harvey V. Fineberg, THE SWINE FLU AFFAIR: DECISION-MAKING ON A SLIPPERY DISEASE (Nat’l Acad. Sci. 1978).
[23] Daubert v. Merrell Dow Pharms., Inc., 727 F.Supp. 570 (S.D. Cal. 1989).
[24] Id. at 571, citing United States v. Kilgus, 571 F.2d 508, 510 (9th Cir.1978).
[25] Id. at 572 (citing Brock, 874 F.2d at 310).
[26] Id. at 574. The use of “association” was at best ambiguous, because it begged the question whether it as an association that was “clear cut” (reasonably free from bias and confounding), and beyond that which we would care to attribute to chance.
[27] Daubert v. Merrell Dow Pharms., Inc., 951 F.2d 1128 (9th Cir. 1991).
[28] Brock v. Merrell Dow Pharms., Inc., 874 F.2d 307, modified, 884 F.2d 166 (5th Cir.1989), cert. denied, 494 U.S. 1046 (1990); Richardson v. Richardson–Merrell, Inc., 857 F.2d 823 (D.C.Cir.1988), cert. denied, 493 U.S. 882 (1989); Lynch v. Merrell–National Labs., 830 F.2d 1190 (1st Cir.1987).
[29] DeLuca v. Merrell Dow Pharmaceuticals, Inc., 131 F.R.D. 71 (D.N.J.) (granting summary judgment), rev’d and remanded, 911 F.2d 941 (3d Cir.1990). On remand, the district court entered summary judgment on the alternative reasoning of Rule 702, as interpreted by the Third Circuit. DeLuca v. Merrell Dow Pharms., Inc., 791 F.Supp. 1042, 1048 (D.N.J. 1992) (re-entering summary judgment after considering Rule 702), aff’d, 6 F.3d 778 (3d Cir.1993) (per curiam), cert. denied, 510 U.S. 1044 (1994).
[30] Daubert v. Merrell Dow Pharms., Inc., 951 F.2d 1128, 1131 (9th Cir. 1991).
[31] Lynch v. Merrell–National Labs., 830 F.2d 1190, 1194-95 (1st Cir.1987).
[32] Paul M. McKeigue, Steven H. Lamm, Shai Linn & Jeffrey S. Kutcher, Bendectin and Birth Defects: I. A Meta-Analysis of the Epidemiologic Studies, 50 TERATOLOGY 27 (1994). This meta-analysis made no correction for multiple comparisons in examining many different types of birth defects.
