TORTINI

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

The Advocates’ Errors in Daubert

December 28th, 2018

Over 25 years ago, the United States Supreme Court answered a narrow legal question about whether the so-called Frye rule was incorporated into Rule 702 of the Federal Rules of Evidence. Plaintiffs in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), appealed a Ninth Circuit ruling that the Frye rule survived, and was incorporated into, the enactment of a statutory evidentiary rule, Rule 702. As most legal observers can now discern, plaintiffs won the battle and lost the war. The Court held that the plain language of Rule 702 does not memorialize Frye; rather the rule requires an epistemic warrant for the opinion testimony of expert witnesses.

Many of the sub-issues of the Daubert case are now so much water over the dam. The case involved claims of birth defects from maternal use of an anti-nausea medication, Bendectin. Litigation over Bendectin is long over, and the medication is now approved for use in pregnant women, on the basis of a full new drug application, supported by clinical trial evidence.

In revisiting Daubert, therefore, we might imagine that legal scholars and scientists would be interested in the anatomy of the errors that led Bendectin plaintiffs stridently to maintain their causal claims. The oral argument before the Supreme Court is telling with respect to some of the sources of error. Two law professors, Michael H. Gottesman, for plaintiffs, and Charles Fried, for the defense, squared off one Tuesday morning in March 1993. A review of Gottesman’s argument reveals several fallacious lines of argument, which are still relevant today:

A. Regulation is Based Upon Scientific Determinations of Causation

In his oral argument, Gottesman asserted that regulators (as opposed to the scientific community) are in charge of determining causation,1 and environmental regulations are based upon scientific causation determinations.2 By the time that the Supreme Court heard argument in the Daubert case, this conflation of scientific and regulatory standards for causal conclusions was fairly well debunked.3 Gottesman’s attempt to mislead the Court failed, but the effort continues in courtrooms around the United States.

B. Similar Chemical Structures Have the Same Toxicities

Gottesman asserted that human teratogenicity can be determined from similarity in chemical structures with other established teratogens.4 Close may count in horseshoes, but in chemical structural activities, small differences in chemical structures can result in huge differences in toxicologic or pharmacologic properties. A silly little methyl group on a complicated hydrocarbon ring structure can make a world of difference, as in the difference between estrogen and testosterone.

C. All Animals React the Same to Any Given Substance

Gottesman, in his oral argument, maintained that human teratogenicity can be determined from teratogenicity in non-human, non-primate, murine species.5 The Court wasted little time on this claim, the credibility of which has continued to decline in the last 25 years.

D. The Transposition Fallacy

Perhaps of greatest interest to me was Gottesman’s claim that the probability of the claimed causal association can be determined from the p-value or from the coefficient of confidence taken from the observational epidemiologic studies of birth defects among children of women who ingested Bendectin in pregancy; a.k.a. the transposition fallacy.6

All these errors are still in play in American courtrooms, despite efforts of scientists and scientific organizations to disabuse judges and lawyers. The transposition fallacy, which has been addressed in these pages and elsewhere at great length seems especially resilient to educational efforts. Still, the fallacy was as well recognized at the time of the Daubert argument as it is today, and it is noteworthy that the law professor who argued the plaintiffs’ case, in the highest court of the land, advanced this fallacious argument, and that the scientific and statistical community did little to nothing to correct the error.7

Although Professor Gottesman’s meaning in the oral argument is not entirely clear, on multiple occasions, he appeared to have conflated the coefficient of confidence, from confidence intervals, with the posterior probability that attaches to the alternative hypothesis of some association:

What the lower courts have said was yes, but prove to us to a degree of statistical certainty which would give us 95 percent confidence that the human epidemiological data is reflective, that these higher numbers for the mothers who used Bendectin were not the product of random chance but in fact are demonstrating the linkage between this drug and the symptoms observed.”8

* * * * *

“… what was demonstrated by Shanna Swan was that if you used a degree of confidence lower than 95 percent but still sufficient to prove the point as likelier than not, the epidemiological evidence is positive… .”9

* * * * *

The question is, how confident can we be that that is in fact probative of causation, not at a 95 percent level, but what Drs. Swan and Glassman said was applying the Rothman technique, a published technique and doing the arithmetic, that you find that this does link causation likelier than not.”10

Professor Fried’s oral argument for the defense largely refused or failed to engage with plaintiffs’ argument on statistical inference. With respect to the “Rothman” approach, Fried pointed out that plaintiffs’ statistical expert witness, Shanna swan, never actually employed “the Rothman principle.”11

With respect to plaintiffs’ claim that individual studies had low power to detect risk ratios of two, Professor Fried missed the opportunity to point out that such post-hoc power calculations, whatever validity they might possess, embrace the concept of statistical significance at the customary 5% level. Fried did note that a meta-analysis, based upon all the epidemiologic studies, rendered plaintiffs’ power complaint irrelevant.12

Some readers may believe that judging advocates speaking extemporaneously about statistical concepts might be overly harsh. How well then did the lawyers explain and represent statistical concepts in their written briefs in the Daubert case?

Petitioners’ Briefs

Petitioners’ Opening Brief

The petitioners’ briefs reveal that Gottesman’s statements at oral argument represent a consistent misunderstanding of statistical concepts. The plaintiffs consistently conflated significance probability or the coefficient of confidence with the civil burden of proof probability:

The crux of the disagreement between Merrell’s experts and those whose testimony is put forward by plaintiffs is that the latter are prepared to find causation more probable than not when the epidemiological evidence is strongly positive (albeit not at a 95% confidence level) and when it is buttressed with animal and chemical evidence predictive of causation, while the former are unwilling to find causation in the absence of an epidemiological study that satisfies the 95% confidence level.”13

After giving a reasonable fascimile of a definition of statistical significance, the plaintiffs’ brief proceeds to confuse the complement of alpha, or the coefficient of confidence (typically 95%), with probability that the observed risk ratio in a sample is the actual population parameter of risk:

But in toxic tort lawsuits, the issue is not whether it is certain that a chemical caused a result, but rather whether it is likelier than not that it did. It is not self-evident that the latter conclusion would require eliminating the null hypothesis (i.e. non-causation) to a confidence level of 95%.3014

The plaintiffs’ brief cited heavily to Rothman’s textbook, Modern Epidemiology, with the specious claim that the textbook supported the plaintiffs’ use of the coefficient of confidence to derive a posterior probability (> 50%) of the correctness of an elevated risk ratio for birth defects in children born to mothers who had taken Bendectin in their first trimesters of pregnancy:

An alternative mechanism has been developed by epidemiologists in recent years to give a somewhat more informative picture of what the statistics mean. At any given confidence level (e.g. 95%) a confidence interval can be constructed. The confidence interval identifies the range of relative risks that collectively comprise the 95% universe. Additional confidence levels are then constructed exhibiting the range at other confidence levels, e.g., at 90%, 80%, etc. From this set of nested confidence intervals the epidemiologist can make assessments of how likely it is that the statistics are showing a true association. Rothman, Tab 9, pp. 122-25. By calculating nested confidence intervals for the data in the Bendectin studies, Dr. Swan was able to determine that it is far more likely than not that a true association exists between Bendectin and human limb reduction birth defects. Swan, Tab 12, at 3618-28.”15

The heavy reliance upon Rothman’s textbook at first blush appears confusing. Modern Epidemiology makes one limited mention of nested confidence intervals, and certainly never suggests that such intervals can provide a posterior probability of the correctness of the hypothesis. Rothman’s complaints about reliance upon “statistical significance,” however, are well-known, and Rothman himself submitted an amicus brief16 in Daubert, a brief that has its own problems.17

In direct response to the Rothman Brief,18 Professor Alvin Feinstein filed an amicus brief in Daubert, wherein he acknowledged that meta-analyses and re-analyses can be valid, but these techniques are subject to many sources of invalidity, and their employment by careful practitioners in some instances should not be a blank check to professional witnesses who are supported by plaintiffs’ counsel. Similarly, Feinstein acknowledged that standards of statistical significance:

should be appropriately flexible, but they must exist if science is to preserve its tradition of intellectual discipline and high quality research.”19

Petitioners’ Reply Brief

The plaintiffs’ statistical misunderstandings are further exemplified in their Reply Brief, where they reassert the transposition fallacy and alternatively state that associations with p-values greater than 5%, or 95% confidence intervals that include the risk ratio of 1.0, do not show the absence of an association.20 The latter point was, of course irrelevant in the Daubert case, in which plaintiffs had the burden of persuasion. As in their oral argument through Professor Gottesman, the plaintiffs’ appellate briefs misunderstand the crucial point that confidence intervals are conditioned upon the data observed from a particular sample, and do not provide posterior probabilities for the correctness of a claimed hypothesis.

Defense Brief

The defense brief spent little time on the statistical issue or plaintiffs’ misstatements, but dispatched the issue in a trenchant footnote:

Petitioners stress the controversy some epidemiologists have raised about the standard use by epidemiologists of a 95% confidence level as a condition of statistical significance. Pet. Br. 8-10. See also Rothman Amicus Br. It is hard to see what point petitioners’ discussion establishes that could help their case. Petitioners’ experts have never developed and defended a detailed analysis of the epidemiological data using some alternative well-articulated methodology. Nor, indeed, do they show (or could they) that with some other plausible measure of confidence (say, 90%) the many published studies would collectively support an inference that Bendectin caused petitioners’ limb reduction defects. At the very most, all that petitioners’ theoretical speculations do is question whether these studies – as the medical profession and regulatory authorities in many countries have concluded – affirmatively prove that Bendectin is not a teratogen.”21

The defense never responded to the specious argument, stated or implied within the plaintiffs’ briefs, and in Gottesman’s oral argument, that a coefficient of confidence of 51% would have generated confidence intervals that routinely excluded the null hypothesis of risk ratio of 1.0. The defense did, however, respond to plaintiffs’ power argument by adverting to a meta-analysis that failed to find a statistically significant association.22

The defense also advanced two important arguments to which the plaintiffs’ briefs never meaningfully responded. First, the defense detailed the “cherry picking” or selective reliance engaged in by plaintiffs’ expert witnesses.23 Second, the defense noted that plaintiffs’ had a specific causation problem in that their expert witnesses had been attempting to infer specific causation based upon relative risks well below 2.0.24

To some extent, the plaintiffs’ statistical misstatements were taken up by an amicus brief submitted by the United States government, speaking through the office of the Solicitor General.25 Drawing upon the Supreme Court’s decisions in race discrimination cases,26 the government asserted that epidemiologists “must determine” whether a finding of an elevated risk ratio “could have arisen due to chance alone.”27

Unfortunately, the government’s brief butchered the meaning of confidence intervals. Rather than describe the confidence interval as showing what point estimates of risk ratios are reasonable compatible with the sample result, the government stated that confidence intervals show “how close the real population percentage is likely to be to the figure observed in the sample”:

since there is a 95 percent chance that the ‘true’ value lies within two standard deviations of the sample figure, that particular ‘confidence interval’ (i.e., two standard deviations) is therefore said to have a ‘confidence level’ of about 95 percent.” 28

The Solicitor General’s office seemed to have had some awareness that it was giving offense with the above definition because it quickly added:

“While it is customary (and, in many cases, easier) to speak of ‘a 95 percent chance’ that the actual population percentage is within two standard deviations of the figure obtained from the sample, ‘the chances are in the sampling procedure, not in the parameter’.”29

Easier perhaps but clearly erroneous to speak that way, and customary only among the unwashed. The government half apologized for misleading the Court when it followed up with a better definition from David Freedman’s textbook, but sadly the government lawyers were not content to let the matter sit there. The Solicitor General offices brief obscured the textbook definition with a further inaccurate and false précis:

if the sampling from the general population were repeated numerous times, the ‘real’ population figure would be within the confidence interval 95 percent of the time. The ‘real’ figure would be outside that interval the remaining five percent of the time.”30

The lawyers in the Solicitor General’s office thus made the rookie mistake of forgetting that in the long run, after numerous repeated samples, there would be numerous confidence intervals, not one. The 95% probability of containing the true population value belongs to the set of the numerous confidence intervals, not “the confidence interval” obtained in the first go around.

The Daubert case has been the subject of nearly endless scholarly comment, but few authors have chosen to revisit the parties’ briefs. Two authors have published a paper that reviewed the scientists’ amici briefs in Daubert.31 The Rothman brief was outlined in detail; the Feinstein rebuttal was not substantively discussed. The plaintiffs’ invocation of the transposition fallacy in Daubert has apparently gone unnoticed.


1 Oral Argument in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court no. 92-102, 1993 WL 754951, *5 (Tuesday, March 30, 1993) [Oral Arg.]

2 Oral Arg. at *6.

3 In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y.1984) (“The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one.”), aff’d in relevant part, 818 F.2d 145 (2d Cir. 1987), cert. denied sub nom. Pinkney v. Dow Chemical Co., 484 U.S. 1004 (1988).

4 Org. Arg. at *19.

5 Oral Arg. at *18-19.

6 Oral Arg. at *19.

7 See, e.g., “Sander Greenland on ‘The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics’” (Feb. 8, 2015) (noting biostatistician Sander Greenland’s publications, which selectively criticize only defense expert witnesses and lawyers for statistical misstatements); see alsoSome High-Value Targets for Sander Greenland in 2018” (Dec. 27, 2017).

8 Oral Arg. at *19.

9 Oral Arg. at *20

10 Oral Arg. at *44. At the oral argument, this last statement was perhaps Gottesman’s clearest misstatement of statistical principles, in that he directly suggested that the coefficient of confidence translates into a posterior probability of the claimed association at the observed size.

11 Oral Arg. at *37.

12 Oral Arg. at *32.

13 Petitioner’s Brief in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court No. 92-102, 1992 WL 12006442, *8 (U.S. Dec. 2, 1992) [Petitioiner’s Brief].

14 Petitioner’s Brief at *9.

15 Petitioner’s Brief at *n. 36.

16 Brief Amici Curiae of Professors Kenneth Rothman, Noel Weiss, James Robins, Raymond Neutra and Steven Stellman, in Support of Petitioners, 1992 WL 12006438, Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. S. Ct. No. 92-102 (Dec. 2, 1992).

18 Brief Amicus Curiae of Professor Alvan R. Feinstein in Support of Respondent, in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court no. 92-102, 1993 WL 13006284, at *2 (U.S., Jan. 19, 1993) [Feinstein Brief].

19 Feinstein Brief at *19.

20 Petitioner’s Reply Brief in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court No. 92-102, 1993 WL 13006390, at *4 (U.S., Feb. 22, 1993).

21 Respondent’s Brief in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court No. 92-102, 1993 WL 13006277, at n. 32 (U.S., Jan. 19, 1993) [Respondent Brief].

22 Respondent Brief at *4.

23 Respondent Brief at *42 n.32 and 47.

24 Respondent Brief at *40-41 (citing DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941, 958 (3d Cir. 1990)).

25 Brief for the United States as Amicus Curiae Supporting Respondent in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court No. 92-102, 1993 WL 13006291 (U.S., Jan. 19, 1993) [U.S. Brief].

26 See, e.g., Hazelwood School District v. United States, 433 U.S. 299, 308-312

(1977); Castaneda v. Partida, 430 U.S. 482, 495-499 & nn.16-18 (1977) (“As a general rule for such large samples, if the difference between the expected value and the observed number is greater than two or three standard deviations, then the hypothesis that the jury drawing was random would be suspect to a social scientist.”).

27 U.S. Brief at *3-4. Over two decades later, when politically convenient, the United States government submitted an amicus brief in a case involving alleged securities fraud for failing to disclose adverse events of an over-the-counter medication. In Matrixx Initiatives Inc. v. Siracusano, 131 S. Ct. 1309 (2011), the securities fraud plaintiffs contended that they need not plead “statistically significant” evidence for adverse drug effects. The Solicitor General’s office, along with counsel for the Food and Drug Division of the Department of Health & Human Services, in their zeal to assist plaintiffs disclaimed the necessity, or even the importance, of statistical significance:

[w]hile statistical significance provides some indication about the validity of a correlation between a product and a harm, a determination that certain data are not statistically significant … does not refute an inference of causation.”

Brief for the United States as Amicus Curiae Supporting Respondents, in Matrixx Initiatives, Inc. v. Siracusano, 2010 WL 4624148, at *14 (Nov. 12, 2010).

28 U.S. Brief at *5.

29 U.S. Brief at *5-6 (citing David Freedman, Freedman, R. Pisani, R. Purves & A. Adhikari, Statistics 351, 397 (2d ed. 1991)).

30 U.S. Brief at *6 (citing Freedman’s text at 351) (emphasis added).

31 See Joan E. Bertin & Mary S. Henifin, Science, Law, and the Search for Truth in the Courtroom: Lessons from Dauburt v. Menell Dow,” 22 J. Law, Medicine & Ethics 6 (1994); Joan E. Bertin & Mary Sue Henifin, “Scientists Talk to Judges: Reflections on Daubert v. Merrell Dow,” 4(3) New Solutions 3 (1994). The authors’ choice of the New Solutions journal is interesting and curious. New Solutions: A journal of Environmental and Occupational Health Policy was published by the Oil, Chemical and Atomic Workers International Union, under the control of Anthony Mazzocchi (June 13, 1926 – Oct. 5, 2002), who was the union’s secretary-treasurer. Anthony Mazzocchi, “Finding Common Ground: Our Commitment to Confront the Issues,” 1 New Solutions 3 (1990); see also Steven Greenhouse, “Anthony Mazzocchi, 76, Dies; Union Officer and Party Father,” N.Y. Times (Oct. 9, 2002). Even a cursory review of this journal’s contents reveals how concerned, even obsessed, the union was interested and invested in the litigation industry and that industry’s expert witnesses. 

 

The American Statistical Association Statement on Significance Testing Goes to Court – Part I

November 13th, 2018

It has been two and one-half years since the American Statistical Association (ASA) issued its statement on statistical significance. Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The American Statistician 129 (2016) [ASA Statement]. When the ASA Statement was published, I commended it as a needed counterweight to the exaggerated criticisms of significance testing.1 Lawyers and expert witnesses for the litigation industry had routinely poo-poohed the absence of statistical significance, but over-endorsed its presence in poorly designed and biased studies. Courts and lawyers from all sides routinely misunderstand, misstated, and misrepresented the meaning of statistical significance.2

The ASA Statement had potential to help resolve judicial confusion. It is written in non-technical language, which is easily understood by non-statisticians. Still, the Statement has to be read with care. The principle of charity led me to believe that lawyers and judges would read the Statement carefully, and that it would improve judicial gatekeeping of expert witnesses’ opinion testimony that involved statistical evidence. I am less sanguine now about the prospect of progress.

No sooner had the ASA issued its Statement than the spinning started. One scientist, and an editor PLoS Biology, blogged that “the ASA notes, the importance of the p-value has been greatly overstated and the scientific community has become over-reliant on this one – flawed – measure.”3 Lawyers for the litigation industry were even less restrained in promoting wild misrepresentations about the Statement, with claims that the ASA had condemned the use of p-values, significance testing, and significance probabilities, as “flawed.”4 And yet, no where in the ASA’s statement does the group suggest that the the p-value was a “flawed” measure.

Criminal Use of the ASA Statement

Where are we now, two plus years out from the ASA Statement? Not surprisingly, the Statement has made its way into the legal arena. The Statement has been used in any number of depositions, relied upon in briefs, and cited in at least a couple of judicial decisions, in the last two years. The empirical evidence of how the ASA Statement has been used, or might be used in the future, is still sparse. Just last month, the ASA Statement was cited by the Washington State Supreme Court, in a ruling that held the death penalty unconstitutional. State of Washington v. Gregory, No. 88086-7, (Wash. S.Ct., Oct. 11, 2018) (en banc). Mr. Gregory, who was facing the death penalty, after being duly convicted or rape, robbery, and murder. The prosecution was supported by DNA matches, fingerprint identification, and other evidence. Mr. Gregory challenged the constitutionality of his imposed punishment, not on per se grounds of unconstitutionality, but on race disparities in the imposition of the death penalty. On this claim, the Washington Supreme Court commented on the empirical evidence marshalled on Mr. Gregory’s behalf:

The most important consideration is whether the evidence shows that race has a meaningful impact on imposition of the death penalty. We make this determination by way of legal analysis, not pure science. At the very most, there is an 11 percent chance that the observed association between race and the death penalty in Beckett’s regression analysis is attributed to random chance rather than true association. Commissioner’s Report at 56-68 (the p-values range from 0.048-0.111, which measures the probability that the observed association is the result of random chance rather than a true association).[8] Just as we declined to require ‘precise uniformity’ under our proportionality review, we decline to require indisputably true social science to prove that our death penalty is impermissibly imposed based on race.

Id. (internal citations omitted).

Whatever you think of the death penalty, or how it is imposed in the United States, you will have to agree that the Court’s discussion of statistics is itself criminal. In the above quotation from the Court’s opinion, the Court badly misinterpreted the p-values generated in various regression analyses that were offered to support claims of race disparity. The Court’s equating statistically significant evidence of race disparity in these regression analyses with “indisputably true social science” also reflects a rhetorical strategy that imputes ridiculously high certainty (indisputably true) to social science conclusions in order to dismiss the need for them in order to accept a causal race disparity claim on empirical evidence.5

Gregory’s counsel had briefed the Washington Court on statistical significance, and raised the ASA Statement as excuse and justification for not presenting statistically significant empirical evidence of race disparity.6 Footnote 8, in the above quote from the Gregory decision shows that the Court was aware of the ASA Statement, which makes the Court’s errors even more unpardonable: 

[8] The most common p-value used for statistical significance is 0.05, but this is not a bright line rule. The American Statistical Association (ASA) explains that the ‘mechanical “bright-line” rules (such as “p < 0.05”) for justifying scientific claims or conclusions can lead to erroneous beliefs and poor decision making’.”7

Conveniently, Gregory’s counsel did not cite to other parts of the ASA Statement, which would have called for a more searching review of the statistical regression analyses:

“Good statistical practice, as an essential component of good scientific practice, emphasizes principles of good study design and conduct, a variety of numerical and graphical summaries of data, understanding the phenomenon under study, interpretation of results in context, complete reporting and proper logical and quantitative understanding of what data summaries mean. No single index should substitute for scientific reasoning.”8

The Supreme Court of Washington first erred in its assessment of what scientific evidence requires in terms of a burden of proof. It then accepted spurious arguments to excuse the absence of statistical significance in the statistical evidence before it, on the basis of a distorted representation of the ASA Statement. Finally, the Court erred in claiming support from social science evidence, by ignoring other methodological issues in Gregory’s empirical claims. Ironically, the Court had made significance testing the end all and be all of its analysis, and when it dispatched statistical significance as a consideration, the Court jumped to the conclusion it wanted to reach. Clearly, the intended message of the ASA Statement had been subverted by counsel and the Court.

2 See, e.g., In re Ephedra Prods. Liab. Litig., 393 F.Supp. 2d 181, 191 (S.D.N.Y. 2005). See alsoConfidence in Intervals and Diffidence in the Courts” (March 4, 2012); “Scientific illiteracy among the judiciary” (Feb. 29, 2012).

5 Moultrie v. Martin, 690 F.2d 1078, 1082 (4th Cir. 1982) (internal citations omitted) (“When a litigant seeks to prove his point exclusively through the use of statistics, he is borrowing the principles of another discipline, mathematics, and applying these principles to the law. In borrowing from another discipline, a litigant cannot be selective in which principles are applied. He must employ a standard mathematical analysis. Any other requirement defies logic to the point of being unjust. Statisticians do not simply look at two statistics, such as the actual and expected percentage of blacks on a grand jury, and make a subjective conclusion that the statistics are significantly different. Rather, statisticians compare figures through an objective process known as hypothesis testing.”).

6 Supplemental Brief of Allen Eugene Gregory, at 15, filed in State of Washington v. Gregory, No. 88086-7, (Wash. S.Ct., Jan. 22, 2018).

7 State of Washington v. Gregory, No. 88086-7, (Wash. S.Ct., Oct. 11, 2018) (en banc) (internal citations omitted).

8 ASA Statement at 132.

Passing Hypotheses Off as Causal Conclusions – Allen v. Martin Surfacing

November 11th, 2018

The November 2018 issue of the American Bar Association Journal (ABAJ) featured an exposé-style article on the hazards of our chemical environment, worthy of Mother Jones, or the International Journal of Health Nostrums, by a lawyer, Alan Bell.1 Alan Bell, according to his website, is a self-described “environmental health warrior.” Channeling Chuck McGill, Bell also describes himself as a:

[v]ictim, survivor, advocate and avenger. This former organized crime prosecutor almost died from an environmentally linked illness. He now devotes his life to giving a voice for those too weak or sick to fight for themselves.”

Bell apparently is not so ill that he cannot also serve as “a fierce advocate” for victims of chemicals. Here is how Mr. Bell described his own “environmentally linked illness” (emphasis added):

Over the following months, Alan developed high fevers, sore throats, swollen glands and impaired breathing. Eventually, he experienced seizures and could barely walk. His health continued to worsen until he became so ill he was forced to stop working. Despite being examined and tested by numerous world-renowned doctors, none of them could help. Finally, a doctor diagnosed him with Multiple Chemical Sensitivity, a devastating illness caused by exposure to environmental toxins. The medical profession had no treatment to offer Alan: no cure, and no hope. Doctors could only advise him to avoid all synthetic chemicals and live in complete isolation within a totally organic environment.”

Multiple chemical sensitivity (MCS)? Does anyone still remember “clinical ecology”? Despite the strident advocacy of support groups and self-proclaimed victims, MCS is not recognized as a chemically caused illness by the World Health Organization, the American Medical Association, the American Academy of Allergy and Immunology, and the American College of Physicians.2 Double-blinded, placebo-controlled clinical trials have shown that putative MCS patients respond to placebo as strongly as they react to chemicals.3

Still, Bell’s claims must be true; Bell has written a book, Poisoned, about his ordeal and that of others.4 After recounting his bizarre medical symptoms, he describes his miraculous cure in a sterile bubble in the Arizona desert. From safe within his bubble, Bell has managed to create the “Environmental Health Foundation,” which is difficult if not impossible to find on the internet, although there are some cheesy endorsements to be found on YouTube.

According to Bell’s narrative, Daniel Allen, the football coach of the College of the Holy Cross was experiencing neurological signs and symptoms that could not be explained by physicians in the Boston area, home to some of the greatest teaching hospitals in the world. Allen and his wife, Laura, reached out Bell through his Foundation. Bell describes how he put the Allens in touch with Marcia Ratner, who sits on the Scientific Advisory Board of his Environmental Health Foundation. Bell sent the Allens to see “the world renown” Marcia Ratner, who diagnosed Mr. Allen with amyotrophic lateral sclerosis (ALS). Bell’s story may strike some as odd, considering that Ratner is not a physician. Ratner could not provide a cure for Mr. Allen’s tragic disease, but she could help provide the Allens with a lawsuit.

According to Bell:

Testimony from a sympathetic widow, combined with powerful evidence that the chemicals Dan was exposed to caused him to die long before his time, would smash their case to bits. The defense opted to seek a settlement. The case settled in 2009.5

The ABAJ article on the Allen case is a reprise of chapter 15 of Bell’s book “Chemicals Take Down a Football Coach.” Shame on the A.B.A. for not marking the article as unpaid advertising. More shame on the A.B.A. for not fact checking the glib causal claims made in the article, some of which have been the subject of a recently published “case report” in the red journal, the American Journal of Industrial Medicine, by Dr. Ratner and some, but not all, of the other expert witnesses for Mr. Allen’s litigation team.6 Had the editors of the ABAJ compared Mr. Bell’s statements and claims about the Allen case, they would have seen that Dr. Ratner, et al., ten years after beating back the defendants’ Daubert motion in the Allen case, described their literature review and assessment of Mr. Allen’s case, as merely “hypothesis generating”:

This literature review and clinical case report about a 45-year-old man with no family history of motor neuron disease who developed overt symptoms of a neuromuscular disorder in close temporal association with his unwitting occupational exposure to volatile organic compounds (VOCs) puts forth the hypothesis that exposure to VOCs such as toluene, which disrupt motor function and increase oxidative stress, can unmask latent ALS type neuromuscular disorder in susceptible individuals.”7

         * * * * * * *

In conclusion, this hypothesis generating case report provides additional support for the suggestion that exposure to chemicals that share common mechanisms of action with those implicated in the pathogenesis of ALS type neuromuscular disorders can unmask latent disease in susceptible persons. Further research is needed to elucidate these relationships.”8

So in 2018, the Allen case was merely a “hypothesis generating” case report. Ten years earlier, however, in 2008, when Ratner, Abou-Donia, Oliver, Ewing, and Clapp gave solemn oaths and testified under penalty of perjury to a federal district judge, the facts of the same case warranted a claim to scientific knowledge, under Rule 702. Judges, lawyers, and legal reformers should take note of how expert witnesses will characterize facile opinions as causal conclusions when speaking as paid witnesses, and as mere hypotheses in need of evidentiary support when speaking in professional journals to scientists. You’re shocked; eh?

Sometimes when federal courts permit dubious causation opinion testimony over Rule 702 objections, the culprit is bad lawyering by the opponent of the proffered testimony. The published case report by Ratner helps demonstrate that Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009), was the result of litigation overreach by plaintiffs’ counsel and their paid expert witnesses, and a failure of organized skepticism by defense counsel and the judiciary.

Marcia H. Ratner, Ph.D.

I first encountered Dr. Ratner as an expert witness for the litigation industry in cases involving manganese-containing welding rods. Plaintiffs’ counsel, Dickie Scruggs, et al., withdrew her before the defense could conduct an examination before trial. When I came across the Daubert decision in the Allen case, I was intrigued because I had read Ratner’s dissertation9 and her welding litigation report, and saw what appeared to be fallacies10 similar to those that plagued the research of Dr. Brad Racette, who also had worked with Scruggs in conducting screenings, from which he extracted “data” for a study, which for a while became the center piece of Scruggs’ claims.11

The Allen case provoked some research on my part, and then a blog post about that case and Dr. Ratner.12 Dr. Ratner took umbrage to my blog post; and in email correspondence, she threatened to sue me for tortious interference with her prospective business opportunities. She also felt that the blog post had put her in a bad light by commenting upon her criminal conviction for unlawful gun possession.13 As a result of our correspondence, and seeing that Dr. Ratner was no stranger to the courtroom,14 I wrote a post-script to add some context and her perspective on my original post.15

One fact Dr Ratner wished me to include in the blog post-script was that plaintiffs’ counsel in the Allen case had pressured her to opine that toluene and isocyanates caused Mr. Allen’s ALS, and that she had refused. Dr. Ratner of course was making a virtue of necessity since there was, and is, a mountain of medical opinion, authoritative and well-supportive, that there is no known cause of sporadic ALS.16 Dr. Ratner was very proud, however, of having devised a work-around, by proffering an opinion that toluene caused the acceleration of Mr. Allen’s ALS. This causal claim about accelerated onset could have been tested with an observational study, but the litigation claim about earlier onset was as lacking in evidential support as the more straightforward claim of causation.

Bell’s article in the ABAJ – or rather his advertisement17 – cited an unpublished write up of the Allen case, by Ratner, The Allen Case: Our Daubert Strategy, Victory, and Its Legal and Medical Landmark Ramifications, in which she kvelled about how the Allen case was cited in the Reference Manual on Scientific Evidence. The Manual’s citations, however, were about the admissibility of the industrial hygienist’s proffered testimony on exposure, based in turn on Mr. Allen’s account of acute-onset symptoms.18 The Manual does not address the dubious acceleration aspect of Ratner’s causal opinion in the Allen case.

The puff piece in the ABAJ caused me to look again at Dr. Ratner’s activities. According to the Better Business Bureau reports that Dr. Marcia Ratner is a medical consultant in occupational and environmental toxicology. Since early 2016, she has been the sole proprietor of a consulting firm, Neurotoxicants.com, located in Mendon, Vermont. The firm’s website advertises that:

The Principals and Consultants of Neurotoxicants.com provide expert consulting in neurotoxicology and the relationships between neurotoxic chemical exposures and neurodegenerative disease onset and progression.

Only Ratner is identified as working on consulting through the firm. According to the LinkedIn entry for Neurotoxicants.com, Ratner is the also founder and director of Medical-Legal Research at Neurotoxicants.com. Ratner’s website advertises her involvement in occupational exposure litigation as an expert witness for claimants.19 Previously, Ratner was the Vice President and Director of Research at Chemical Safety Net, Inc., another consulting firm that she had founded with the late Robert G. Feldman, MD.

Conflict of Interest

The authors of the published Allen case report gave a curious conflict-of-interest disclosure at the end of their article:

The authors have no current specific competing interests to declare. However, Drs. Ratner, Abou-Donia and Oliver, and Mr. Ewing all served as expert witnesses in this case which settled favorably for the patient over 10 years ago with an outcome that is a fully disclosed matter of public record. Drs. Ratner, Abou-Donia and Oliver and Mr. Ewing are occasionally asked to serve as expert witnesses and/or consultants in occupational and environmental chemical exposure injury cases.”20

The disclosure conveniently omitted that Dr. Ratner owns a business that she set up to provide medico-legal consulting, and that Dr. Oliver testifies with some frequency in asbestos cases. None of the authors was, or is, an expert in the neuroepidemiology of ALS. Dr. Ratner’s conflict-of-interest disclosure in the Allen case report was, however, better than her efforts in previous publications that touched on the subject matter of her commercial consulting practice.21


1 Alan Bell, “Devastated by office chemicals, an attorney helps others fight toxic torts,Am. Bar. Ass’n J. (Nov. 2018).

2 See, e.g., American Academy of Allergy, Asthma and Immunology, “Idiopathic environmental intolerances,” 103 J. Allergy Clin. Immunol. 36 (1999).

3 See Susanne Bornschein, Constanze Hausteiner, Horst Römmelt, Dennis Nowak, Hans Förstl, and Thomas Zilker, “Double-blind placebo-controlled provocation study in patients with subjective Multiple Chemical Sensitivity and matched control subjects,” 46 Clin. Toxicol. 443 (2008); Susanne Bornschein, Hans Förstl, and Thomas Zilker, “Idiopathic environmental intolerances (formerly multiple chemical sensitivity) psychiatric perspectives,” 250 J. Intern. Med. 309 (2001).

4 Poisoned: How a Crime-Busting Prosecutor Turned His Medical Mystery into a Crusade for Environmental Victims (Skyhorse Publishing 2017).

5 Steven H. Foskett Jr., “Late Holy Cross coach’s family, insurers settle lawsuit for $681K,” Telegram & Gazette (Oct. 1, 2009). Obviously, the settlement amount represented a deep compromise over any plaintiff’s verdict.

6 Marcia H. Ratner, Joe F. Jabre, William M. Ewing, Mohamed Abou-Donia, and L. Christine Oliver, “Amyotrophic lateral sclerosis—A case report and mechanistic review of the association with toluene and other volatile organic compounds,” 61 Am. J. Ind. Med. 251 (2018).

7 Id. at 251.

8 Id. at 258 (emphasis added).

9 Marcia Hillary Ratner, Age at Onset of Parkinson’s Disease Among Subjects Occupationally Exposed to Metals and Pesticides; Doctoral Dissertation, UMI Number 3125932, Boston University (2004). Neither Ratner’s dissertation supervisor nor her three readers were epidemiologists.

11 See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, Joel S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005).

13 See Quincy District Court News,” Patriot Ledger June 09, 2010 (reporting that Ratner pleaded guilty to criminal possession of mace and a firearm).

14 Ratner v. Village Square at Pico Condominium Owners Ass’n, Inc., No. 91-2-11 Rdcv (Teachout, J., Aug. 28, 2012).

17 Bell is a client of the Worthy Marketing Group.

18 RMSE3d at 505-06 n.5, 512-13 n. 26, 540 n.88; see also Allen v. Martin Surfacing, 2009 WL 3461145, 2008 U.S. Dist. LEXIS 111658, 263 F.R.D. 47 (D. Mass. 2008) (holding that an industrial hygienist was qualified to testify about the concentration and duration of plaintiffs’ exposure to toluene and isocyanates).

20 Id. at 259. One of the plaintiffs’ expert witnesses, Richard W. Clapp, opted out of co-author status on this publication.

21 See Marcia H. Ratner & Edward Fitzgerald, “Understanding of the role of manganese in parkinsonism and Parkinson disease,” 88 Neurology 338 (2017) (claiming no relevant conflicts of interest); Marcia H. Ratner, David H. Farb, Josef Ozer, Robert G. Feldman, and Raymon Durso, “Younger age at onset of sporadic Parkinson’s disease among subjects occupationally exposed to metals and pesticides,” 7 Interdiscip. Toxicol. 123 (2014) (failing to make any disclosure of conflicts of interest). In one short case report written with Dr. Jonathan Rutchik, another expert witness actively participated for the plaintiffs’ litigation industry in welding fume cases, Dr. Ratner let on that she “occasionally” is asked to serve as an expert witness, but she failed to disclose that she has a business enterprise set up to commercialize her expert witness work. Jonathan Rutchik & Marcia H. Ratner, “Is it Possible for Late-Onset Schizophrenia to Masquerade as Manganese Psychosis?” 60 J. Occup. & Envt’l Med. E207 (2018) (“The authors have no current specific competing interests to declare. However, Dr. Rutchik served as expert witnesses [sic] in this case. Drs. Rutchik and Ratner are occasionally asked to serve as expert witnesses and/or consultants in occupational and environmental chemical exposure injury cases.”)

Confounding in Daubert, and Daubert Confounded

November 4th, 2018

ABERRANT DECISIONS

The Daubert trilogy and the statutory revisions to Rule 702 have not brought universal enlightenment. Many decisions reflect a curmudgeonly and dismissive approach to gatekeeping.

The New Jersey Experience

Until recently, New Jersey law looked as though it favored vigorous gatekeeping of invalid expert witness opinion testimony. The law as applied, however, was another matter, with most New Jersey judges keen to find ways to escape the logical and scientific implications of the articulated standards, at least in civil cases.1 For example, in Grassis v. Johns-Manville Corp., 248 N.J. Super. 446, 591 A.2d 671, 675 (App. Div. 1991), the intermediate appellate court discussed the possibility that confounders may lead to an erroneous inference of a causal relationship. Plaintiffs’ counsel claimed that occupational asbestos exposure causes colorectal cancer, but the available studies, inconsistent as they were, failed to assess the role of smoking, family history, and dietary factors. The court essentially shrugged its judicial shoulders and let a plaintiffs’ verdict stand, even though it was supported by expert witness testimony that had relied upon seriously flawed and confounded studies. Not surprisingly, 15 years after the Grassis case, the scientific community acknowledged what should have been obvious in 1991: the studies did not support a conclusion that asbestos causes colorectal cancer.2

This year, however, saw the New Jersey Supreme Court step in to help extricate the lower courts from their gatekeeping doldrums. In a case that involved the dismissal of plaintiffs’ expert witnesses’ testimony in over 2,000 Accutane cases, the New Jersey Supreme Court demonstrated how to close the gate on testimony that is based upon flawed studies and involves tenuous and unreliable inferences.3 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.4

Cook v. Rockwell International

The litigation over radioactive contamination from the Colorado Rocky Flats nuclear weapons plant is illustrative of the retrograde tendency in some federal courts. The defense objected to plaintiffs’ expert witness, Dr. Clapp, whose study failed to account for known confounders.5 Judge Kane denied the challenge, claiming that the defense could:

cite no authority, scientific or legal, that compliance with all, or even one, of these factors is required for Dr. Clapp’s methodology and conclusions to be deemed sufficiently reliable to be admissible under Rule 702. The scientific consensus is, in fact, to the contrary. It identifies Defendants’ list of factors as some of the nine factors or lenses that guide epidemiologists in making judgments about causation. Ref. Guide on Epidemiolog at 375.).”6

In Cook, the trial court or the parties or both missed the obvious references in the Reference Manual to the need to control for confounding. Certainly many other scientific sources could be cited as well. Judge Kane apparently took a defense expert witness’s statement that ecological studies do not account for confounders to mean that the presence of confounding does not render such studies unscientific. Id. True but immaterial. Ecological studies may be “scientific,” but they do not warrant inferences of causation. Some so-called scientific studies are merely hypothesis generating, preliminary, tentative, or data-dredging exercises. Judge Kane employed the flaws-are-features approach, and opined that ecological studies are merely “less probative” than other studies, and the relative weights of studies do not render them inadmissible.7 This approach is, of course, a complete abdication of gatekeeping responsibility. First, studies themselves are not admissible; it is the expert witness, whose testimony is challenged. The witness’s reliance upon studies is relevant to the Rule 702 and 703 analyses, but admissibility is not the issue. Second, Rule 702 requires that the proffered opinion be “scientific knowledge,” and ecological studies simply lack the necessary epistemic warrant to support a causal conclusion. Third, the trial court in Cook had to ignore the federal judiciary’s own reference manual’s warnings about the inability of ecological studies to provide causal inferences.8 The Cook case is part of an unfortunate trend to regard all studies as “flawed,” and their relative weights simply a matter of argument and debate for the litigants.9

Abilify

Another example of sloppy reasoning about confounding can be found in a recent federal trial court decision, In re Abilify Products Liability Litigation,10 where the trial court advanced a futility analysis. All observational studies have potential confounding, and so confounding is not an error but a feature. Given this simplistic position, it follows that failure to control for every imaginable potential confounder does not invalidate an epidemiologic study.11 From its nihilistic starting point, the trial court readily found that an expert witness could reasonably dispense with controlling for confounding factors of psychiatric conditions in studies of a putative association between the antipsychotic medication Abilify and gambling disorders.12

Under this sort of “reasoning,” some criminal defense lawyers might argue that since all human beings are “flawed,” we have no basis to distinguish sinners from saints. We have a long way to go before our courts are part of the evidence-based world.


1 In the context of a “social justice” issue such as whether race disparities exist in death penalty cases, New Jersey court has carefully considered confounding in its analyses. See In re Proportionality Review Project (II), 165 N.J. 206, 757 A.2d 168 (2000) (noting that bivariate analyses of race and capital sentences were confounded by missing important variables). Unlike the New Jersey courts (until the recent decision in Accutane), the Texas courts were quick to adopt the principles and policies of gatekeeping expert witness opinion testimony. See Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706, 714, 724 (Tex.1997) (reviewing court should consider whether the studies relied upon were scientifically reliable, including consideration of the presence of confounding variables).  Even some so-called Frye jurisdictions “get it.” See, e.g., Porter v. SmithKline Beecham Corp., No. 3516 EDA 2015, 2017 WL 1902905 *6 (Phila. Super., May 8, 2017) (unpublished) (affirming exclusion of plaintiffs’ expert witness on epidemiology, under Frye test, for relying upon an epidemiologic study that failed to exclude confounding as an explanation for a putative association), affirming, Mem. Op., No. 03275, 2015 WL 5970639 (Phila. Ct. Com. Pl. Oct. 5, 2015) (Bernstein, J.), and Op. sur Appellate Issues (Phila. Ct. Com. Pl., Feb. 10, 2016) (Bernstein, J.).

3 In re Accutane Litig., ___ N.J. ___, ___ A.3d ___, 2018 WL 3636867 (2018); see N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses(Aug. 8, 2018).

2018 WL 3636867, at *20 (citing the Reference Manual 3d ed., at 597-99).

5 Cook v. Rockwell Internat’l Corp., 580 F. Supp. 2d 1071, 1098 (D. Colo. 2006) (“Defendants next claim that Dr. Clapp’s study and the conclusions he drew from it are unreliable because they failed to comply with four factors or criteria for drawing causal interferences from epidemiological studies: accounting for known confounders … .”), rev’d and remanded on other grounds, 618 F.3d 1127 (10th Cir. 2010), cert. denied, ___ U.S. ___ (May 24, 2012). For another example of a trial court refusing to see through important qualitative differences between and among epidemiologic studies, see In re Welding Fume Prods. Liab. Litig., 2006 WL 4507859, *33 (N.D. Ohio 2006) (reducing all studies to one level, and treating all criticisms as though they rendered all studies invalid).

6 Id.   

7 Id.

8 RMSE3d at 561-62 (“[ecological] studies may be useful for identifying associations, but they rarely provide definitive causal answers”) (internal citations omitted); see also David A. Freedman, “Ecological Inference and the Ecological Fallacy,” in Neil J. Smelser & Paul B. Baltes, eds., 6 Internat’l Encyclopedia of the Social and Behavioral Sciences 4027 (2001).

9 See also McDaniel v. CSX Transportation, Inc., 955 S.W.2d 257 (Tenn. 1997) (considering confounding but holding that it was a jury issue); Perkins v. Origin Medsystems Inc., 299 F. Supp. 2d 45 (D. Conn. 2004) (striking reliance upon a study with uncontrolled confounding, but allowing expert witness to testify anyway)

10 In re Abilifiy (Aripiprazole) Prods. Liab. Litig., 299 F. Supp. 3d 1291 (N.D. Fla. 2018).

11 Id. at 1322-23 (citing Bazemore as a purported justification for the court’s nihilistic approach); see Bazemore v. Friday, 478 U.S. 385, 400 (1986) (“Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.).

12 Id. at 1325.


Appendix – Some Federal Court Decisions on Confounding

1st Circuit

Bricklayers & Trowel Trades Internat’l Pension Fund v. Credit Suisse Sec. (USA) LLC, 752 F.3d 82, 85 (1st Cir. 2014) (affirming exclusion of expert witness whose event study and causal conclusion failed to consider relevant confounding variables and information that entered market on the event date)

2d Circuit

In re “Agent Orange” Prod. Liab. Litig., 597 F. Supp. 740, 783 (E.D.N.Y. 1984) (noting that confounding had not been sufficiently addressed in a study of U.S. servicemen exposed to Agent Orange), aff’d, 818 F.2d 145 (2d Cir. 1987) (approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 484 U.S. 1004 (1988)

3d Circuit

In re Zoloft Prods. Liab. Litig., 858 F.3d 787, 793, 799 (2017) (acknowledging that statistically significant findings occur in the presence of inadequately controlled confounding or bias; affirming the exclusion of statistical expert witness, Nicholas Jewell, in part for using an admittedly non-rigorous approach to adjusting for confouding by indication)

4th Circuit

Gross v. King David Bistro, Inc., 83 F. Supp. 2d 597 (D. Md. 2000) (excluding expert witness who opined shigella infection caused fibromyalgia, given the existence of many confounding factors that muddled the putative association)

5th Circuit

Kelley v. American Heyer-Schulte Corp., 957 F. Supp. 873 (W.D. Tex. 1997) (noting that observed association may be causal or spurious, and that confounding factors must be considered to distinguish spurious from real associations)

Brock v. Merrell Dow Pharms., Inc., 874 F.2d 307, 311 (5th Cir. 1989) (noting that “[o]ne difficulty with epidemiologic studies is that often several factors can cause the same disease.”)

6th Circuit

Nelson v. Tennessee Gas Pipeline Co., WL 1297690, at *4 (W.D. Tenn. Aug. 31, 1998) (excluding an expert witness who failed to take into consideration confounding factors), aff’d, 243 F.3d 244, 252 (6th Cir. 2001), cert. denied, 534 U.S. 822 (2001)

Adams v. Cooper Indus. Inc., 2007 WL 2219212, 2007 U.S. Dist. LEXIS 55131 (E.D. Ky. 2007) (differential diagnosis includes ruling out confounding causes of plaintiffs’ disease).

7th Circuit

People Who Care v. Rockford Bd. of Educ., 111 F.3d 528, 537-38 (7th Cir. 1997) (Posner, J.) (“a statistical study that fails to correct for salient explanatory variables, or even to make the most elementary comparisons, has no value as causal explanation and is therefore inadmissible in a federal court”) (educational achievement in multiple regression);

Sheehan v. Daily Racing Form, Inc., 104 F.3d 940 (7th Cir. 1997) (holding that expert witness’s opinion, which failed to correct for any potential explanatory variables other than age, was inadmissible)

Allgood v. General Motors Corp., 2006 WL 2669337, at *11 (S.D. Ind. 2006) (noting that confounding factors must be carefully addressed; holding that selection bias rendered expert testimony inadmissible)

9th Circuit

In re Bextra & Celebrex Marketing Celebrex Sales Practices & Prod. Liab. Litig., 524 F.Supp. 2d 1166, 1178-79 (N.D. Cal. 2007) (noting plaintiffs’ expert witnesses’ inconsistent criticism of studies for failing to control for confounders; excluding opinions that Celebrex at 200 mg/day can cause heart attacks, as failing to satisfy Rule 702)

Avila v. Willits Envt’l Remediation Trust, 2009 WL 1813125, 2009 U.S. Dist. LEXIS 67981 (N.D. Cal. 2009) (excluding expert witness’s opinion in part because of his failure to rule out confounding exposures and risk factors for the outcomes of interest), aff’d in relevant part, 633 F.3d 828 (9th Cir.), cert denied, 132 S.Ct. 120 (2011)

Hendricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1158 (E.D. Wash. 2009) (“In general, epidemiology studies are probative of general causation: a relative risk greater than 1.0 means the product has the capacity to cause the disease. “Where the study properly accounts for potential confounding factors and concludes that exposure to the agent is what increases the probability of contracting the disease, the study has demonstrated general causation – that exposure to the agent is capable of causing [the illness at issue] in the general population.’’) (internal quotation marks and citation omitted)

Valentine v. Pioneer Chlor Alkali Co., Inc., 921 F. Supp. 666, 677 (D. Nev. 1996) (‘‘In summary, Dr. Kilburn’s study suffers from very serious flaws. He took no steps to eliminate selection bias in the study group, he failed to identify the background rate for the observed disorders in the Henderson community, he failed to control for potential recall bias, he simply ignored the lack of reliable dosage data, he chose a tiny sample size, and he did not attempt to eliminate so-called confounding factors which might have been responsible for the incidence of neurological disorders in the subject group.’’)

Claar v. Burlington No. RR, 29 F.3d 499 (9th Cir. 1994) (affirming exclusion of plaintiffs’ expert witnesses, and grant of summary judgment, when plaintiffs’ witnesses concluded that the plaintiffs’ injuries were caused by exposure to toxic chemicals, without investigating any other possible causes).

10th Circuit

Hollander v. Sandoz Pharms. Corp., 289 F.3d 1193, 1213 (10th Cir. 2002) (affirming exclusion in Parlodel case involving stroke; confounding makes case reports inappropriate bases for causal inferences, and even observational epidemiologic studies must evaluated carefully for confounding)

D.C. Circuit

American Farm Bureau Fed’n v. EPA, 559 F.3d 512 (2009) (noting that in setting particulate matter standards addressing visibility, agency should avoid relying upon data that failed to control for the confounding effects of humidity)