TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses

August 8th, 2018

The United States Supreme Court’s decision in Daubert is now over 25 years old. The idea of judicial gatekeeping of expert witness opinion testimony is even older in New Jersey state courts. The New Jersey Supreme Court articulated a reliability standard before the Daubert case was even argued in Washington, D.C. See Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991). Articulating a standard, however, is something very different from following a standard, and in many New Jersey trial courts, until very recently, the standard was pretty much anything goes.

One counter-example to the general rule of dog-eat-dog in New Jersey was Judge Nelson Johnson’s careful review and analysis of the proffered causation opinions in cases in which plaintiffs claimed that their use of the anti-acne medication isotretinoin (Accutane) caused Crohn’s disease. Judge Johnson, who sits in the Law Division of the New Jersey Superior Court for Atlantic County held a lengthy hearing, and reviewed the expert witnesses’ reliance materials.1 Judge Johnson found that the plaintiffs’ expert witnesses had employed undue selectivity in choosing what to rely upon. Perhaps even more concerning, Judge Johnson found that these witnesses had refused to rely upon reasonably well-conducted epidemiologic studies, while embracing unpublished, incomplete, and poorly conducted studies and anecdotal evidence. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div., Atlantic Cty. Feb. 20, 2015). In response, Judge Johnson politely but firmly closed the gate to conclusion-driven duplicitous expert witness causation opinions in over 2,000 personal injury cases. “Johnson of Accutane – Keeping the Gate in the Garden State” (Mar. 28, 2015).

Aside from resolving over 2,000 pending cases, Judge Johnson’s judgment was of intense interest to all who are involved in pharmaceutical and other products liability litigation. Judge Johnson had conducted a pretrial hearing, sometimes called a Kemp hearing in New Jersey, after the New Jersey Supreme Court’s opinion in Kemp v. The State of New Jersey, 174 N.J. 412 (2002). At the hearing and in his opinion that excluded plaintiffs’ expert witnesses’ causation opinions, Judge Johnson demonstrated a remarkable aptitude for analyzing data and inferences in the gatekeeping process.

When the courtroom din quieted, the trial court ruled that the proffered testimony of Dr., Arthur Kornbluth and Dr. David Madigan did not meet the liberal New Jersey test for admissibility. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div. Atlantic Cty. Feb. 20, 2015). And in closing the gate, Judge Johnson protected the judicial process from several bogus and misleading “lines of evidence,” which have become standard ploys to mislead juries in courthouses where the gatekeepers are asleep. Recognizing that not all evidence is on the same analytical plane, Judge Johnson gave case reports short shrift.

[u]nsystematic clinical observations or case reports and adverse event reports are at the bottom of the evidence hierarchy.”

Id. at *16. Adverse event reports, largely driven by the very litigation in his courtroom, received little credit and were labeled as “not evidentiary in a court of law.” Id. at 14 (quoting FDA’s description of FAERS).

Judge Johnson recognized that there was a wide range of identified “risk factors” for irritable bowel syndrome, such as prior appendectomy, breast-feeding as an infant, stress, Vitamin D deficiency, tobacco or alcohol use, refined sugars, dietary animal fat, fast food. In re Accutane, 2015 WL 753674, at *9. The court also noted that there were four medications generally acknowledged to be potential risk factors for inflammatory bowel disease: aspirin, nonsteroidal anti-inflammatory medications (NSAIDs), oral contraceptives, and antibiotics. Understandably, Judge Johnson was concerned that the plaintiffs’ expert witnesses preferred studies unadjusted for potential confounding co-variables and studies that had involved “cherry picking the subjects.” Id. at *18.

Judge Johnson had found that both sides in the isotretinoin cases conceded the relative unimportance of animal studies, but the plaintiffs’ expert witnesses nonetheless invoked the animal studies in the face of the artificial absence of epidemiologic studies that had been created by their cherry-picking strategies. Id.

Plaintiffs’ expert witnesses had reprised a common claimants’ strategy; namely, they claimed that all the epidemiology studies lacked statistical power. Their arguments often ignored that statistical power calculations depend upon statistical significance, a concept to which many plaintiffs’ counsel have virulent antibodies, as well as an arbitrarily selected alternative hypothesis of association size. Furthermore, the plaintiffs’ arguments ignored the actual point estimates, most of which were favorable to the defense, and the observed confidence intervals, most of which were reasonably narrow.

The defense responded to the bogus statistical arguments by presenting an extremely capable clinical and statistical expert witness, Dr. Stephen Goodman, to present a meta-analysis of the available epidemiologic evidence.

Meta-analysis has become an important facet of pharmaceutical and other products liability litigation[1]. Fortunately for Judge Johnson, he had before him an extremely capable expert witness, Dr. Stephen Goodman, to explain meta-analysis generally, and two meta-analyses he had performed on isotretinoin and irritable bowel outcomes.

Dr. Goodman explained that the plaintiffs’ witnesses’ failure to perform a meta-analysis was telling when meta-analysis can obviate the plaintiffs’ hyperbolic statistical complaints:

the strength of the meta-analysis is that no one feature, no one study, is determinant. You don’t throw out evidence except when you absolutely have to.”

In re Accutane, 2015 WL 753674, at *8.

Judge Johnson’s judicial handiwork received non-deferential appellate review from a three-judge panel of the Appellate Division, which reversed the exclusion of Kornbluth and Madigan. In re Accutane Litig., 451 N.J. Super. 153, 165 A.3d 832 (App. Div. 2017). The New Jersey Supreme Court granted the isotretinoin defendants’ petition for appellate review, and the issues were joined over the appropriate standard of appellate review for expert witness opinion exclusions, and the appropriateness of Judge Johnson’s exclusions of Kornbluth and Madigan. A bevy of amici curiae joined in the fray.2

Last week, the New Jersey Supreme Court issued a unanimous opinion, which reversed the Appellate Division’s holding that Judge Johnson had “mistakenly exercised” discretion. Applying its own precedents from Rubanick, Landrigan, and Kemp, and the established abuse-of-discretion standard, the Court concluded that the trial court’s ruling to exclude Kornbluth and Madigan was “unassailable.” In re Accutane Litig., ___ N.J. ___, 2018 WL 3636867 (2018), Slip op. at 79.3

The high court graciously acknowledged that defendants and amici had “good reason” to seek clarification of New Jersey law. Slip op. at 67. In abandoning abuse-of-discretion as its standard of review, the Appellate Division had relied upon a criminal case that involved the application of the Frye standard, which is applied as a matter of law. Id. at 70-71. The high court also appeared to welcome the opportunity to grant review and reverse the intermediate court reinforce “the rigor expected of the trial court” in its gatekeeping role. Id. at 67. The Supreme Court, however, did not articulate a new standard; rather it demonstrated at length that Judge Johnson had appropriately applied the legal standards that had been previously announced in New Jersey Supreme Court cases.4

In attempting to defend the Appellate Division’s decision, plaintiffs sought to characterize New Jersey law as somehow different from, and more “liberal” than, the United States Supreme Court’s decision in Daubert. The New Jersey Supreme Court acknowledged that it had never formally adopted the dicta from Daubert about factors that could be considered in gatekeeping, slip op. at 10, but the Court went on to note what disinterested observers had long understood, that the so-called Daubert factors simply flowed from a requirement of sound methodology, and that there was “little distinction” and “not much light” between the Landrigan and Rubanick principles and the Daubert case or its progeny. Id at 10, 80.

Curiously, the New Jersey Supreme Court announced that the Daubert factors should be incorporated into the New Jersey Rules 702 and 703 and their case law, but it stopped short of declaring New Jersey a “Daubert” jurisdiction. Slip op. at 82. In part, the Court’s hesitance followed from New Jersey’s bifurcation of expert witness standards for civil and criminal cases, with the Frye standard still controlling in the criminal docket. At another level, it makes no sense to describe any jurisdiction as a “Daubert” state because the relevant aspects of the Daubert decision were dicta, and the Daubert decision and its progeny were superseded by the revision of the controlling statute in 2000.5

There were other remarkable aspects of the Supreme Court’s Accutane decision. For instance, the Court put its weight behind the common-sense and accurate interpretation of Sir Austin Bradford Hill’s famous articulation of factors for causal judgment, which requires that sampling error, bias, and confounding be eliminated before assessing whether the observed association is strong, consistent, plausible, and the like. Slip op. at 20 (citing the Reference Manual at 597-99), 78.

The Supreme Court relied extensively on the National Academies’ Reference Manual on Scientific Evidence.6 That reliance is certainly preferable to judicial speculations and fabulations of scientific method. The reliance is also positive, considering that the Court did not look only at the problematic epidemiology chapter, but adverted also to the chapters on statistical evidence and on clinical medicine.

The Supreme Court recognized that the Appellate Division had essentially sanctioned an anything goes abandonment of gatekeeping, an approach that has been all-too-common in some of New Jersey’s lower courts. Contrary to the previously prevailing New Jersey zeitgeist, the Court instructed that gatekeeping must be “rigorous” to “prevent[] the jury’s exposure to unsound science through the compelling voice of an expert.” Slip op. at 68-9.

Not all evidence is equal. “[C]ase reports are at the bottom of the evidence hierarchy.” Slip op. at 73. Extrapolation from non-human animal studies is fraught with external validity problems, and such studies “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (internal quotations omitted).

Perhaps most chilling for the lawsuit industry will be the Supreme Court’s strident denunciation of expert witnesses’ selectivity in choosing lesser evidence in the face of a large body of epidemiologic evidence, id. at 77, and their unprincipled cherry picking among the extant epidemiologic publications. Like the trial court, the Supreme Court found that the plaintiffs’ expert witnesses’ inconsistent use of methodological criteria and their selective reliance upon studies (disregarding eight of the nine epidemiologic studies) that favored their task masters was the antithesis of sound methodology. Id. at 73, citing with approval, In re Lipitor, ___ F.3d ___ (4th Cir. 2018) (slip op. at 16) (“Result-driven analysis, or cherry-picking, undermines principles of the scientific method and is a quintessential example of applying methodologies (valid or otherwise) in an unreliable fashion.”).

An essential feature of the Supreme Court’s decision is that it was not willing to engage in the common reductionism that has “all epidemiologic studies are flawed,” and which thus privileges cherry picking. Not all disagreements between expert witnesses can be framed as differences in interpretation. In re Accutane will likely stand as a bulwark against flawed expert witness opinion testimony in the Garden State for a long time.


1 Judge Nelson Johnson is also the author of Boardwalk Empire: The Birth, High Times, and Corruption of Atlantic City (2010), a spell-binding historical novel about political and personal corruption.

2 In support of the defendants’ positions, amicus briefs were filed by the New Jersey Business & Industry Association, Commerce and Industry Association of New Jersey, and New Jersey Chamber of Commerce; by law professors Kenneth S. Broun, Daniel J. Capra, Joanne A. Epps, David L. Faigman, Laird Kirkpatrick, Michael M. Martin, Liesa Richter, and Stephen A. Saltzburg; by medical associations the American Medical Association, Medical Society of New Jersey, American Academy of Dermatology, Society for Investigative Dermatology, American Acne and Rosacea Society, and Dermatological Society of New Jersey, by the Defense Research Institute; by the Pharmaceutical Research and Manufacturers of America; and by New Jersey Civil Justice Institute. In support of the plaintiffs’ position and the intermediate appellate court’s determination, amicus briefs were filed by political action committee the New Jersey Association for Justice; by the Ironbound Community Corporation; and by plaintiffs’ lawyer Allan Kanner.

3 Nothing in the intervening scientific record called question upon Judge Johnson’s trial court judgment. See, e.g., I.A. Vallerand, R.T. Lewinson, M.S. Farris, C.D. Sibley, M.L. Ramien, A.G.M. Bulloch, and S.B. Patten, “Efficacy and adverse events of oral isotretinoin for acne: a systematic review,” 178 Brit. J. Dermatol. 76 (2018).

4 Slip op. at 9, 14-15, citing Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991) (“We initially took that step to allow the parties in toxic tort civil matters to present novel scientific evidence of causation if, after the trial court engages in rigorous gatekeeping when reviewing for reliability, the proponent persuades the court of the soundness of the expert’s reasoning.”).

5 The Court did acknowledge that Federal Rule of Evidence 702 had been amended in 2000, to reflect the Supreme Court’s decision in Daubert, Joiner, and Kumho Tire, but the Court did not deal with the inconsistencies between the present rule and the 1993 Daubert case. Slip op. at 64, citing Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 320-21, 320 n.8 (3d Cir. 2003).

6 See Accutane slip op. at 12-18, 24, 73-74, 77-78. With respect to meta-analysis, the Reference Manual’s epidemiology chapter is still stuck in the 1980s and the prevalent resistance to poorly conducted, often meaningless meta-analyses. SeeThe Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence” (Nov. 14, 2011) (The Reference Manual fails to come to grips with the prevalence and importance of meta-analysis in litigation, and fails to provide meaningful guidance to trial judges).

Failed Gatekeeping in Ambrosini v. Labarraque (1996)

December 28th, 2017

The Ambrosini case straddled the Supreme Court’s 1993 Daubert decision. The case began before the Supreme Court clarified the federal standard for expert witness gatekeeping, and ended in the Court of Appeals for the District of Columbia, after the high court adopted the curious notion that scientific claims should be based upon reliable evidence and valid inferences. That notion has only slowly and inconsistently trickled down to the lower courts.

Given that Ambrosini was litigated in the District of Columbia, where the docket is dominated by regulatory controversies, frequently involving dubious scientific claims, no one should be surprised that the D.C. Court of Appeals did not see that the Supreme Court had read “an exacting standard” into Federal Rule of Evidence 702. And so, we see, in Ambrosini, this Court of Appeals citing and purportedly applying its own pre-Daubert decision in Ferebee v. Chevron Chem. Co., 552 F. Supp. 1297 (D.D.C. 1982), aff’d, 736 F.2d 1529 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984).1 In 2000, the Federal Rule of Evidence 702 was revised in a way that extinguishes the precedential value of Ambrosini and the broad dicta of Ferebee, but some courts and commentators have failed to stay abreast of the law.

Escolastica Ambrosini was using a synthetic progestin birth control, Depo-Provera, as well as an anti-nausea medication, Bendectin, when she became pregnant. The child that resulted from this pregnancy, Teresa Ambrosini, was born with malformations of her face, eyes, and ears, cleft lip and palate, and vetebral malformations. About three percent of all live births in the United States have a major malformation. Perhaps because the Divine Being has sovereign immunity, Escolastica sued the manufacturers of Bendectin and Depo-Provera, as well as the prescribing physician.

The causal claims were controversial when made, and they still are. The progestin at issue, medroxyprogesterone acetate (MPA), was embryotoxic in the cynomolgus monkey2, but not in the baboon3. The evidence in humans was equivocal at best, and involved mostly genital malformations4; the epidemiologic evidence for the MPA causal claim to this day remains unconvincing5.

At the close of discovery in Ambrosini, Upjohn (the manufacturer of the progestin) moved for summary judgment, with a supporting affidavit of a physician and geneticist, Dr. Joe Leigh Simpson. In his affidavit, Simpson discussed three epidemiologic studies, as well as other published papers, in support of his opinion that the progestin at issue did not cause the types of birth defects manifested by Teresa Ambrosini.

Ambrosini had disclosed two expert witnesses, Dr. Allen S. Goldman and Dr. Brian Strom. Neither Goldman nor Strom bothered to identify the papers, studies, data, or methodology used in arriving at an opinion on causation. Not surprisingly, the district judge was unimpressed with their opposition, and granted summary judgment for the defendant. Ambrosini v. Labarraque, 966 F.2d 1462, 1466 (D.C. Cir. 1992).

The plaintiffs appealed on the remarkable ground that Goldman’s and Strom’s crypto-evidence satisfied Federal Rule of Evidence 703. Even more remarkably, the Circuit, in a strikingly unscholarly opinion by Judge Mikva, opined that disclosure of relied-upon studies was not required for expert witnesses under Rules 703 and 705. Judge Mikva seemed to forget that the opinions being challenged were not given in testimony, but in (late-filed) affidavits that had to satisfy the requirement of Federal Rule of Civil Procedure 26. Id. at 1468-69. At trial, an expert witness may express an opinion without identifying its bases, but of course the adverse party may compel disclosure of those bases. In discovery, the proffered expert witness must supply all opinions and evidence relied upon in reach the opinions. In any event, the Circuit remanded the case for a hearing and further proceedings, at which the two challenged expert witnesses, Goldman and Strom, would have to identify the bases of their opinions. Id. at 1471.

Not long after the case landed back in the district court, the Supreme Court decided Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). With an order to produce entered, plaintiffs’ counsel could no longer hide Goldman and Strom’s evidentiary bases, and their scientific inferences came under judicial scrutiny.

Upjohn moved again to exclude Goldman and Strom’s opinions. The district court upheld Upjohn’s challenges, and granted summary judgment in favor of Upjohn for the second time. The Ambrosinis appealed again, but the second case in the D.C. Circuit resulted in a split decision, with the majority holding that the exclusion of Goldman and Strom’s opinions under Rule 702 was erroneous. Ambrosini v. Labarraque, 101 F.3d 129 (D.C. Cir. 1996).

Although issued two decades ago, the majority’s opinion remains noteworthy as an example of judicial resistance to the existence and meaning of the Supreme Court’s Daubert opinion. The majority opinion uncritically cited the notorious Ferebee6 and other pre-Daubert decisions. The court embraced the Daubert dictum about gatekeeping being limited to methodologic consideration, and then proceeded to interpret methodology as superficially as necessary to sustain admissibility. If an expert witness claimed to have looked at epidemiologic studies, and epidemiology was an accepted methodology, then the opinion of the expert witness must satisfy the legal requirements of Daubert, or so it would seem from the opinion of the U.S. Court of Appeals for the District of Columbia.

Despite the majority’s hand waving, a careful reader will discern that there must have been substantial gaps and omissions in the explanations and evidence cited by plaintiffs’ expert witnesses. Seeing anything clearly in the Circuit’s opinion is made difficult, however, by careless and imprecise language, such as its descriptions of studies as showing, or not showing “causation,” when it could have meant only that such studies showed associations, with more or less random and systematic error.

Dr. Strom’s report addressed only general causation, and even so, he apparently did not address general causation of the specific malformations manifested by the plaintiffs’ child. Strom claimed to have relied upon the “totality of the data,” but his methodologic approach seems to have required him to dismiss studies that failed to show an association.

Dr. Strom first set forth the reasoning he employed that led him to disagree with those studies finding no causal relationship [sic] between progestins and birth defects like Teresa’s. He explained that an epidemiologist evaluates studies based on their ‘statistical power’. Statistical power, he continued, represents the ability of a study, based on its sample size, to detect a causal relationship. Conventionally, in order to be considered meaningful, negative studies, that is, those which allege the absence of a causal relationship, must have at least an 80 to 90 percent chance of detecting a causal link if such a link exists; otherwise, the studies cannot be considered conclusive. Based on sample sizes too small to be reliable, the negative studies at issue, Dr. Strom explained, lacked sufficient statistical power to be considered conclusive.”

Id. at 1367.

Putting aside the problem of suggesting that an observational study detects a “causal relationship,” as opposed to an association in need of further causal evaluation, the Court’s précis of Strom’s testimony on power is troublesome, and typical of how other courts have misunderstood and misapplied the concept of statistical power. Statistical power is a probability of observing an association of a specified size at a specified level of statistical significance. The calculation of statistical power turns indeed on sample size, the level of significance probability preselected for “statistical significance, an assumed probability distribution of the sample, and, critically, an alternative hypothesis. Without a specified alternative hypothesis, the notion of statistical power is meaningless, regardless of what probability (80% or 90% or some other percentage) is sought for finding the alternative hypothesis. Furthermore, the notion that the defense must adduce studies with “sufficient statistical power to be considered conclusive” creates an unscientific standard that can never be met, while subverting the law’s requirement that the claimant establish causation.

The suggestion that the studies that failed to find an association cannot be considered conclusive because they “lacked sufficient statistical power” is troublesome because it distorts and misapplies the very notion of statistical power. No attempt was made to describe the confidence intervals surrounding the point estimates of the null studies; nor was there any discussion whether the studies could be aggregated to increase their power to rule out meaningful associations.

The Circuit court’s scientific jurisprudence was thus seriously flawed. Without a discussion of the end points observed, the relevant point estimates of risk ratios, and the confidence intervals, the reader cannot assess the strength of the claims made by Goldman and Strom, or by defense expert Simpson, in their reports. Without identifying the study endpoints, the reader cannot evaluate whether the plaintiffs’ expert witnesses relied upon relevant outcomes in formulating their opinions. The court viewed the subject matter from 30,000 feet, passing over at 600 mph, without engagement or care. A strong dissent, however, suggested serious mischaracterizations of the plaintiffs’ evidence by the majority.

The only specific causation testimony to support plaintiff’s claims came from Goldman, in what appears to have been a “differential etiology.” Goldman purported to rule out a genetic cause, even though he had not conducted a critical family history or ordered a state-of-the-art chromosomal study. Id. at 140. Of course, nothing in a differential etiology approach would allow a physician to rule out “unknown” causes, which, for birth defects, make up the most prevalent and likely causes to explain any particular case. The majority acknowledged that these were short comings, but rhetorically characterized them as substantive, not methodologic, and therefore as issues for cross-examination, not for consideration by a judicial gatekeeping. All this is magical thinking, but it continues to infect judicial approaches to specific causation. See, e.g., Green Mountain Chrysler Plymouth Dodge Jeep v. Crombie, 508 F. Supp. 2d 295, 311 (D.Vt. 2007) (citing Ambrosini for the proposition that “the possibility of uneliminated causes goes to weight rather than admissibility, provided that the expert has considered and reasonably ruled out the most obvious”). In Ambrosini, however, Dr. Goldman had not ruled out much of anything.

Circuit Judge Karen LeCraft Henderson dissented in a short, but pointed opinion that carefully marshaled the record evidence. Drs. Goldman and Strom had relied upon a study by Greenberg and Matsunaga, whose data failed to show a statistically significant association between MPA and cleft lip and palate, when the crucial issue of timing of exposure was taken into consideration. Ambrosini, 101 F.3d at 142.

Beyond the specific claims and evidence, Judge Henderson anticipated the subsequent Supreme Court decisions in Joiner, Kumho Tire, and Weisgram, and the year 2000 revision of Rule 702, in noting that the majority’s acceptance of glib claims to have used a “traditional methodology” would render Daubert nugatory. Id. at 143-45 (characterizing Strom and Goldman’s methodologies as “wispish”). Even more importantly, Judge Henderson refused to indulge the assumption that somehow the length of Goldman’s C.V. substituted for evidence that his methods satisfied the legal (or scientific) standard of reliability. Id.

The good news is that little or nothing in Ambrosini survives the 2000 amendment to Rule 702. The bad news is that not all federal judges seem to have noticed, and that some commentators continue to cite the case, as lovely.

Probably no commentator has promiscuously embraced Ambrosini as warmly as Carl Cranor, a philosopher, and occasional expert witness for the lawsuit industry, in several publications and presentations.8 Cranor has been particularly enthusiastic about Ambrosini’s approval of expert witness’s testimony that failed to address “the relative risk between exposed and unexposed populations of cleft lip and palate, or any other of the birth defects from which [the child] suffers,” as well as differential etiologies that exclude nothing.9 Somehow Cranor, as did the majority in Ambrosini, believes that testimony that fails to identify the magnitude of the point estimate of relative risk can “assist the trier of fact to understand the evidence or to determine a fact in issue.”10 Of course, without that magnitude given, the trier of fact could not evaluate the strength of the alleged association; nor could the trier assess the probability of individual causation to the plaintiff. Cranor also has written approvingly of lumping unrelated end points, which defeats the assessment of biological plausibility and coherence by the trier of fact. When the defense expert witness in Ambrosini adverted to the point estimates for relevant end points, the majority, with Cranor’s approval, rejected the null findings as “too small to be significant.”11 If the null studies were, in fact, too small to be useful tests of the plaintiffs’ claims, intellectual and scientific honesty required an acknowledgement that the evidentiary display was not one from which a reasonable scientist would draw a causal conclusion.


1Ambrosini v. Labarraque, 101 F.3d 129, 138-39 (D.C. Cir. 1996) (citing and applying Ferebee), cert. dismissed sub nom. Upjohn Co. v. Ambrosini, 117 S.Ct. 1572 (1997) See also David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89Notre Dame L. Rev. 27, 31 (2013).

2 S. Prahalada, E. Carroad, M. Cukierski, and A.G. Hendrickx, “Embryotoxicity of a single dose of medroxyprogesterone acetate (MPA) and maternal serum MPA concentrations in cynomolgus monkey (Macaca fascicularis),” 32 Teratology 421 (1985).

3 S. Prahalada, E. Carroad, and A.G. Hendrick, “Embryotoxicity and maternal serum concentrations of medroxyprogesterone acetate (MPA) in baboons (Papio cynocephalus),” 32 Contraception 497 (1985).

4 See, e.g., Z. Katz, M. Lancet, J. Skornik, J. Chemke, B.M. Mogilner, and M. Klinberg, “Teratogenicity of progestogens given during the first trimester of pregnancy,” 65 Obstet Gynecol. 775 (1985); J.L. Yovich, S.R. Turner, and R. Draper, “Medroxyprogesterone acetate therapy in early pregnancy has no apparent fetal effects,” 38 Teratology 135 (1988).

5 G. Saccone, C. Schoen, J.M. Franasiak, R.T. Scott, and V. Berghella, “Supplementation with progestogens in the first trimester of pregnancy to prevent miscarriage in women with unexplained recurrent miscarriage: a systematic review and meta-analysis of randomized, controlled trials,” 107 Fertil. Steril. 430 (2017).

6 Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1535 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984).

7 Dr. Strom was also quoted as having provided a misleading definition of statistical significance: “whether there is a statistically significant finding at greater than 95 percent chance that it’s not due to random error.” Ambrosini at 101 F.3d at 136. Given the majority’s inadequate description of the record, the description of witness testimony may not be accurate, and error cannot properly be allocated.

8 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 320, 327-28 (2006); see also Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 238 (2d ed. 2016).

9 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 320 (2006).

10 Id.

11 Id. ; see also Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 238 (2d ed. 2016).