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Manufacturing Consent

December 2nd, 2017

David Michaels along with other “political” scientists, and the lawsuit industry, have worked assiduously over the last several decades to delegitimize discussion, debate, and controversy over scientific claims.1 Their key goals have been to attempt to disqualify manufacturing industry and any scientist with the slightest manufacturing industry contact. Their attempts to disqualify other interlocutors is, however, highly asymmetrical. If those with connections to manufacturing industry criticize studies or causal conclusions, then we hear that the criticism is corrupt. If those with connections to manufacturing industry embrace studies that show favored associations, or causal conclusions, then we hear that the embrace of advocacy positions was an “admission,” reluctantly given but “forced” by overwhelming evidence. In other words, the attempts to disqualify interlocutors are made only when the speakers articulate criticism of the claims of advocacy science.

David Zaruk has argued that the techniques used to squelch criticism of advocacy science bear an uncanny resemblance to the techniques used by fascists generally. See David Zaruk, “Ten Practices Linking Environmentalism with Fascism,” Riskmonger (Dec. 2, 2017). Although Zaruk’s argument may appear hyperbolic, there is no denying that advocacy scientists (not merely in the field of environmentalism) have used the rhetorical devices that are used by intellectual bullies everywhere. In the case of advocacy scientists, one of their key maneuvers has been to privilege advocacy scientists who speak for their favored positions, for the lawsuit industry, and for self-styled public interest groups by ignoring their potential conflicts of interest, while diminishing the substantive content of all “opposition” voices by pejoratively characterizing their opponents’ motivation as “manufacturing doubt.” Of course, the deepest irony is that before there was manufacturing doubt, there was manufacturing consent.2 The unkindest thing that can, and must be said, of the current enthusiasm for attacking dissident scientists is not that the attacks are fascist, but that they are unscientific.

The likes of David Michaels have sought to manufacture consent on various health effects issues, by selectively and asymmetrically accusing scientists of conflicts of interest, or trying to pervert the course of science. These attacks on “dissidents” assume the truth of the contested causal conclusions, and then proceed to call out the dissidents for casting doubt on the “truth” in favor of falsehood. What this mobbing of dissidents ignores is the basic normative structure of science, which requires doubt.

One of the first sociologists of science, Robert Merton, described four institutional imperatives of science: universality, communitarianism, disinterestedness, and “organized skepticism.”3 Scientists are committed to methodologies and an institutional ethos that require searching scrutiny of claims to scientific knowledge. The scientific advocates who would silence criticism with accusations of “manufacturing doubt” ignore the epistemic importance of dissent and disagreement in science. The prevalent attempts to squelch dissent as “manufacturing doubt” is thus unscientific and dangerous.4

1 See, e.g., David Michaels, Doubt is Their Product: How Industry’s War on Science Threatens Your Health (2008); David Michaels, “Manufactured Uncertainty: Protecting Public Health in the Age of Contested Science and Product Defense,” 1076 Ann. N.Y. Acad. Sci. 149 (2006); David Michaels, “Mercenary Epidemiology – Data Reanalysis and Reinterpretation for Sponsors with Financial Interest in the Outcome,” 16 Ann. Epidemiol. 583 (2006); David Michaels & Celeste Monforton, “Manufacturing Uncertainty: Contested Science and the Protection of the Public’s Health and Environment,” 95 Amer. J. Public Health S39 (2005); David Michaels, “Doubt is their Product,” 292 Sci. Amer. 74 (June 2005).

2 See generally Edward S. Herman & Noam Chomsky, Manufacturing Consent (1988).

3 Robert K. Merton, “The Normative Structure of Science,” in Robert K. Merton, The Sociology of Science: Theoretical and Empirical Investigations, chap. 13, at 267, 270 (1973).

4 See Inmaculada de Melo-Mmartín and Kristen Intemann, “Who’s afraid of dissent? Addressing concerns about undermining scientific consensus in public policy developments,” 22 Persp. on Science 593 (2014).

Posted in Causation, Public Nuisances, Scientific Evidence | Comments Off on Manufacturing Consent

Copywrongs in the Academic-Publishing Industrial Complex

December 1st, 2017

Works of the United States government, including works prepared by its officers and employees, do not qualify for copyright protection. 17 U.S.C. § 105. Such works are in the “public domain,” and may be freely distributed. Works in the public domain thus include academic papers written by governmental scientists and published in proprietary academic journals. The journals cannot acquire a copyright in what was in the public domain ab initio.

And yet, proprietary journals routinely charge customers for works in the public domain. There appears to be no meaningful regulation of the academic publishing world, where publishers sometimes commandeer $60 or more per article, and charge yet again for access to supplementary data and materials. Charging fees such as these for what belongs to the public is worse than ludicrous; it’s piracy! See Ryan Merkley, “You Pay to Read Research You Fund. That’s Ludicrous,” Wired (April 18, 2016).

In an era when publishers complain and sue over unauthorized distribution of articles, it is remarkable that publishers are so cavalier about their own copywrongs. Paywall Watch is a website that has set its mission to call out proprietary academic publishers for improperly charging money to distribute articles that are in the public domain. See Dalmeet Singh Chawla, “Website Flags Wrongly Paywalled Papers,” The Scientist (May 31, 2017). From a casual review of the Paywall Watch website, there appear to be many offending instances of publisher piracy.

In addition to overt copywrongs, there is the more prevalent issue raised by publishers profiteering from selling papers based upon federally funded research. Federal regulations and Executive Orders direct federal agencies to ensure that taxpayers do not pay twice for federally funded research, even research conducted by non-governmental employees. See “Expanding Public Access to the Results of Federally Funded Research,” (Feb. 22, 2013); Office of Science and Technology Policy, “Memorandum on Public Access” (2013). Despite President Obama’s support, powerful congressional patrons of the Academic-Publishing complex, from both sides of the aisle, have shilled for protectionist legislation. See “Beware the Academic-Publishing Complex!” (Jan. 11, 2012) (discussing Congresswoman Carolyn Maloney’s efforts to press special interest legislation for Elsevier). Compliance with the federal open-access mandate is poor.

* * * * * * *

A group of authors, led by scientists from Divisions of the National Institute for Occupational Safety and Health, in Cincinnati, Ohio, recently published an epidemiologic study of cancer outcomes in workers exposed to polychlorinated biphenyls (PCBs). Avima M. Ruder, Misty J. Hein, Nancy B. Hopf, and Martha A. Waters, “Cancer incidence among capacitor manufacturing workers exposed to polychlorinated biphenyls,” 60 Am. J. Indus. Med. 198 (2017) [cited below as Ruder]. The NIOSH authors published their study in the “Red Journal,” the American Journal of Industrial Medicine, edited by Steven B. Markowitz and Rodney Ehrlich, who are well-known in lawsuit industry circles.

Ruder’s article contained a clear disclaimer:

“This article is a U.S. Government work and is in the public domain in the USA.”

Ruder’s publisher, John Wiley & Sons, blithely ignored the disclaimer and hid the article behind a paywall (at the relatively low, one-time price of $38.00, U.S.). And that is too bad because Ruder’s work has generally shown that there is not much to the claim that PCBs cause lung cancer, a claim that caused quite a stir in the United States Supreme Court, twenty years ago. See General Electric Co. v. Joiner, 522 U.S. 136 (1997). Ruder and colleagues found a slightly raised incidence of lung cancer, risk ratio 1.16, but they readily acknowledged that without smoking history data, this small risk could not be interpreted causally. Ruder at 205 (2017); see also Avima M. Ruder, Misty J. Hein, Nancy B. Hopf, and Martha A. Waters, “Mortality among 24,865 workers exposed to polychlorinated biphenyls (PCBs) in three electrical capacitor manufacturing plants: A ten-year update,”217 Internat’l J. Hyg. & Envt’l Health 176 (2014). In a previous analysis of lung cancer mortality in the full cohort, the elevation had disappeared when short-term workers (fewer than 90 days on the job) were removed from the analysis. The long-term workers, with obviously much greater potential for cumulative and peak exposures, showed a lung cancer standardized mortality ratio of 0.99, ever so slightly less lung cancer than expected among non-exposed workers. Ruder at 205. See “How Have Important Rule 702 Holdings Held Up With Time?” (Mar. 20, 2015); “The Joiner Finale.”

Posted in Scientific Evidence | Comments Off on Copywrongs in the Academic-Publishing Industrial Complex

Alabama Justice and Fundamental Fairness

November 20th, 2017

Judges from Alabama get a bad rap. Like Job, Roy Moore cannot seem to catch a break, despite his professions of great faith. Still Moore ought to be more liberal, given that he, and all of us, are descended from a transgendered woman. After all, Eve was made from a male rib, the tissue of which carried a Y chromosome:

“And the rib, which the LORD God had taken from man, made he a woman, and brought her unto the man.”

Genesis 2:22. Even if Eve magically ended up with two X chromosomes, certainly Judge Moore must accept that the result was part of a cosmic sex change operation. Moore might prefer Lillith, who was built female from the ground up, as his female progenitor.

But Alabama is not so bad, really. My Cousin Vinny got a fair trial for Bill Gambini and Stanley Rothenstein in Beechum County, Alabama. Vinny was surprised by the prosecutor’s generosity in turning over his file, based upon a casual oral request, but as his fiancée Mona Lisa Vito pointed out, the prosecutor had to do this; it’s the law. Brady v. Maryland, 373 U.S. 83 (1963), requires prosecutors to disclose to defense counsel any evidence that could reasonably be construed to favor the defendant.

Actually, Alabama law interpets Brady in the typical fashion to require the prosecutor to disclose only exculpatory evidence. Alabama Rules of Criminal Procedure Rule 16. And Judge Chamberlain Haller, who presided over State v. Gambini, was a stickler for the rules.

And Beechum County prosecutor, Jim Trotter III, was a decent sort. Not only did he offer Vinny his hunting lodge as a quiet place to prepare for trial, Trotter turned over his entire case file upon a casual oral request, without delay. When the evidence appeared to exclupate Gambini and Rothenstein, Trotter withdrew the charges. Outside of Beechum County, that sort of thing happens mostly in movies; in the real world, it is dog eat dog.

The recently publicized case of Wilbert Jones is probably a more typical case. Jones was duly convicted on the testimony of the woman he supposedly raped. The identification, which was the only inculpatory evidence, was shaky, but it was sufficient for one Louisiana jury. What the jury did not hear, however, was that there was another man, who fit the description of the rapist, and who had committed similar crimes in the vicinity. The prosecutor did not think to share that information with Jones’s counsel. When later challenged about the prosecution’s failure to disclose the information, the prosecutors argued that the information was not exculpatory, and would not have made a difference in any event to the “hanging” jury that heard the case. A federal judge, hearing Jones’s petition for the writ of habeas corpus, disagreed, and vacated Jones’s conviction. Jacey Fortin, “Louisiana Man Freed After 45 Years as Conviction is Tossed Out,” N.Y. Times (Nov. 17, 2017). Despite having their conviction vacated, the Louisiana prosecutors have vowed to appeal the decision and retry the case.

Chief Judge Janet DiFiore, of the New York Court of Appeals, is also a stickler for the rules, much like Judge Haller of Beechum County, Alabama. Recently Her Honor issued a new rule that requires trial judges to order, in each case, the prosecution to review their files and disclose all favorable (exculpatory) evidence, at least 30 days before trial. Imagine that; New York prosecutors have to be ordered to comply with the constitutional requirement of disclosure, set out in Brady! See Alan Feuer & James C. McKinley, “Rule Would Push Prosecutors to Release Evidence Favorable to Defense,” N.Y. Times (Nov. 8, 2017); Emmet G. Sullivan, “How New York Courts Are Keeping Prosecutors in Line,” Wall St. J., at A11 (Nov. 18, 2017). See also Andrew Cohen, “Prosecutors Shouldn’t Be Hiding Evidence From Defendants,” The Atlantic (May 13, 2013).

The news media accounts of Chief Judge DiFiore’s newly promulgated rule quotes Innocence Project founder Barry Scheck as stating that the new New York rule is a “big deal.” The New York rule strikes me as a “raw deal,” which leaves to prosecutors to dole out what they think is exculpatory, on the eve of trial. Murder suspects in Beechum County, Alabama, get much better treatment from the likes of Prosecutor Jim Trotter.

The problem, even under the new New York rule, is that prosecutors are advocates and constitutionally incapable of looking at their files from the defense perspective to determine fairly what must be disclosed. Allowing prosecutors to decide what is exculpatory or not is bad policy, bad law, and bad human psychology. The better view would be to require prosecutors to turn over their complete file well in advance of trial, to permit defense counsel to prepare an effective defense.

Criminal trials, like civil trials, end with each side’s lawyer arguing that all the admitted evidence at trial favors his or her side. From the prosecutor’s perspective, none of the evidence exculpates the defendant, or even creates the slightest smidgeon of doubt. How schizophrenic must prosecutors be in order to step inside the psyche of the adversary, before trial, to see the potential inferences and potential for arguments that they will vehemently reject at trial, as utterly implausible and too farfetched to create reasonable doubt?

The entire system of permitting prosecutors to decide the disclosure issue, ex parte, and without supervision, violates the spirit and mandate of Brady. Whatever we may think of Alabama Judge Roy Moore, we could all use some of that Beechum County sense of fair play and due process.

Posted in Cognitive Biases, Trial Procedure | Comments Off on Alabama Justice and Fundamental Fairness

Mississippi High Court Takes the Bite Out of Forensic Evidence

November 3rd, 2017

The Supreme Court’s 1993 decision in Daubert changed the thrust of Federal Rule of Evidence 702, which governs the admissibility of expert witness opinion testimony in both civil and criminal cases. Before Daubert, lawyers who hoped to exclude opinions lacking in evidentiary and analytical support turned to the Frye decision on “general acceptance.” Frye, however, was an outdated rule that was rarely applied outside the context of devices. Furthermore, the meaning and application of Frye were unclear. Confusion reigned on whether expert witnesses could survive Frye challenges simply by adverting to their claimed use of a generally accepted science, such as epidemiology, even though their implementation of epidemiologic science was sloppy, incoherent, and invalid.

Daubert noted that Rule 702 should be interpreted in the light of the “liberal” goals of the Federal Rules of Evidence. Some observers rejoiced at the invocation of “liberal” values, but history of the last 25 years has shown that they really yearned for libertine interpretations of the rules. Liberal, of course, never meant “anything goes.” It is unclear why “liberal” cannot mean restricting evidence not likely to advance the truth-finding function of trials.

Criminal versus Civil

Back on April 27, 2009, then President Barack Obama announced the formation of the President’s Council of Advisors on Science and Technology (PCAST). The mission of PCAST was to advise the President and his administration on science and technology, and their policy implications. Although the PCAST was a new council, presidents have had scientific advisors and advisory committees back to Franklin Roosevelt, in 1933.

On September 20, 2016, PCAST issued an important report to President Obama, Report to the President on Forensic Science in Criminal Courts: Ensuring Scientific Validity of Feature-Comparison Methods. Few areas of forensic “science,” beyond DNA matching, escaped the Council’s withering criticism. Bite-mark evidence in particular received a thorough mastication.

The criticism was hardly new. Seven years earlier, the National Academies of Science issued an indictment that forensic scientists had largely failed to establish the validity of their techniques and conclusions, and that the judiciary had “been utterly ineffective in addressing this problem.”1

The response from Obama’s Department of Justice, led by Loretta Lynch, was underwhelming.2 The Trump response was equally disappointing.3 The Left and the Right appear to agree that science is dispensable when it becomes politically inconvenient. It is a common place in the community of evidence scholars that Rule 702 is not applied with the same enthusiasm in criminal cases, to the benefit of criminal defendants, as the rule is sometimes, sporadically and inconsistently applied in civil cases. The Daubert revolution has failed the criminal justice system perhaps because courts are unwilling to lift the veil on forensic evidence, for fear they may not like what the find.4

A Grudging Look at the Scientific Invalidity of Bite Mark Evidence

Sherwood Brown was convicted of a triple murder in large measure as a result of testimony from Dr. Michael West, a forensic odontologist. West, as well as another odontologist, opined that a cut on Brown’s wrist matched the shape of a victim’s mouth. DNA testing authorized after the conviction, however, rendered West’s opinions edentulous. Samples from inside the female victim’s mouth yielded male DNA, but not that of Mr. Brown.5

Did the PCAST report leave an impression upon the highest court of Mississippi? The Supreme Court of Mississippi vacated Brown’s conviction and remanded for a new trial, in an opinion that a bitemark expert might describe as reading like a bite into a lemon. Brown v. State, No. 2017 DR 00206 SCT, Slip op. (Miss. Sup. Ct. Oct. 26, 2017). The majority could not bring themselves to comment upon the Dr. West’s toothless opinions. Three justices would have kicked the can down to the trial judge by voting to grant a new hearing without vacating Brown’s convictions. The decision seems mostly predicated on the strength of the DNA evidence, rather than the invalidity of the bite mark evidence. Mr. Brown will probably be vindicated, but bite mark evidence will continue to mislead juries, with judicial imprimatur.

1 National Research Council, Committee on Identifying the Needs of the Forensic Sciences Community, Strengthening Forensic Science in the United States: A Path Forward 53 (2009).

2 See Jordan Smith, “FBI and DoJ Vow to Continue Using Junk Science Rejected by White House Report,” The Intercept (Sept. 23, 2016); Radley Balko, “When Obama wouldn’t fight for science,” Wash. Post (Jan. 4, 2017).

3 See Radley Balko, “Jeff Sessions wants to keep forensics in the Dark Ages,” Wash. Post (April 11, 2017); Jessica Gabel Cino, “Session’s Assault on Forensic Science Will Lead to More Unsafe Convictions,” Newsweek (April 20, 2017).

4 See, e.g., Paul C. Giannelli, “Forensic Science: Daubert’s Failure,” Case Western Reserve L. Rev. (2017) (“in press”).

Posted in Expert Witnesses, Frye, Rule 702 | Comments Off on Mississippi High Court Takes the Bite Out of Forensic Evidence

Disappearing Conflicts of Interest

October 29th, 2017

As the story of who funded the opposition research into Trumski and the Russian micturaters unfolds, both sides of the political spectrum seem obsessed with who funded the research. Funny thing that both sides had coins in the fountain. Funding is, in any event, an invalid proxy for good and sufficient reason. The public should be focused on the truth or falsity of the factual claims. The same goes in science, although more and more, science is evaluated by “conflicts of interest” (COIs) rather than by the strength of evidence and validity of inferences.

No one screams louder today about COIs than the lawsuit industry and its scientist fellow travelers. Although I believe we should rid ourselves of this obsession with COIs, to the extent we must put up with it, the obsession should at least be symmetrical, complete, and non-hypocritical.

In an in-press publication, Morris Greenberg has published an historical account of the role that the U.K. Medical Research Council had in studying asbestos health effects.1 Greenberg often weighs in on occupational disease issues in synch with the litigation industry, and so no one will be entirely surprised that Greenberg suspects undue industry influence (not the lawsuit industry, but an industry that actually makes things). Greenberg may be right in his historical narrative and analysis, but my point today is different. What was interesting about Greenberg’s paper was the disclosure at its conclusion, by the “American Journal of Industrial Medicine editor of record”:

“Steven B. Markowitz declares that he has no conflict of interest in the review and publication decision regarding this article.”

Markowitz’s declaration is remarkable in the era when the litigation industry and its scientific allies perpetually have their knickers knotted over perceived COIs. Well known to the asbestos bar, Markowitz has testified with some regularity for plaintiffs’ lawyers and their clients. Markowitz is also an editor in chief of the “red” journal,” the American Journal of Industrial Medicine. Many of the associate editors are regular testifiers for the lawsuit industry, such as Arthur L. Frank and Richard A. Lemen.

Even more curious is that Steven Markowitz, along with fellow plaintiffs’ expert witness, Jacqueline M. Moline, recently published a case report about mesothelioma occuring in an unusual exposure situation, in the red journal. This paper appeared online in February 2017, and carried a disclosure that “[t]he authors have served as expert witnesses in cases involving asbestos tort litigation.2” A bit misleading given how both appear virtually exclusively for claimants, but still a disclosure, whereas Markowitz, qua editor of Greenberg’s article, claimed to have none.

Markowitz, as an alumnus of the Mount Sinai School of Medicine, is, of course, a member of the secret handshake society of the litigation industry, the Collegium Ramazzini. At the Collegium, Markowitz proudly presents his labor union consultancies, but these union ties are not disclosed in Markowitz’s asbestos publications.

Previously, I blogged about Markowitz’s failure to make an appropriate COI disclosure in connection with an earlier asbestos paper.3 See “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013). At the time, there appeared to be no disclosure of litigation work, but I was encouraged to see, upon checking today, that Markowitz’s disclosure for his 2013 paper now reveals that he has received fees for expert testimony, from “various law firms.” A bit thin to leave out plaintiffs’ law firms, considering that the paper at issue is used regularly by Markowitz and other plaintiffs’ expert witnesses to advance their positions in asbestos cases. A more complete disclosure might read something like: “Markowitz has been paid to consult and testify in asbestos personal injury by plaintiffs’ legal counsel, and to consult for labor unions. In his testimony and consultations, he relies upon this paper and other evidence to support his opinions. This study has grown out of research that was originally funded by the asbestos workers’ union.”

Or we could just evaluate the study on its merits, or lack thereof.

1 Morris Greenberg, “Experimental asbestos studies in the UK: 1912-1950,” 60 Am. J. Indus. Med. XXX (2017) (doi: 10.1002/ajim.22762).

2 Steven B. Markowitz & Jacqueline M. Moline, “Malignant Mesothelioma Due to Asbestos Exposure in Dental Tape,” 60 Am. J. Indus. Med. 437 (2017).

Posted in Asbestos, Conflicts of Interest, Expert Witnesses | Comments Off on Disappearing Conflicts of Interest

Johnson & Johnson Leaves Them in the Dust – Echeverria Verdict Unraveled

October 24th, 2017

It was a tough week for the talc litigation industry. On October 17, the Missouri Court of Appeals reversed a large verdict for plaintiffs because a St. Louis trial court unconstitutionally had asserted personal jurisdiction over Johnson & Johnson. In essence, the Missouri appellate court just said no to forum shopping. Fox v. Johnson & Johnson, Mo. Ct. App., No. ED104580 (Oct. 17, 2017). And on Friday, October 20, a California trial court, on sober second thought, granted judgment notwithstanding the verdict, and in the alternative, a new trial in the recent Escheverria case, which had resulted in plaintiffs’ awards approaching half a billion dollars. See Orders regarding Defendants Combined Motion for New Trial and Judgment Notwithstanding the Verdict, Echeverria v. Johnson & Johnson, Inc., Case No. BC628228, JCCP No. 4872, Calif. Super. Ct., Los Angeles Cty. (Oct. 20, 2017) [cited below as Echeverria op.] See also Daniel Siegal, “J&J Wins Battle Against $417M Talc Award, But War Not Over,” Law360 (Oct. 23, 2017).

The trial court issued an opinion, over 50 pages long, which carefully reviewed the parties’ contentions. Only some of the issues considered by the trial court are discussed below.

Differential Etiology

Differential etiology resembles the biological process of solid waste management; both employ the process of elimination.

Most diseases in humans have a large “idiopathic” or “cause unknown” component. The differential methodology purports to take all the known causes and rule out the ones that are improbable in a given case. As a matter of logic, this is what is known as an iterative disjunctive syllogism. If you start with:

A or B or C.

And you show not B;

and then, not C.

you are left with A.

This argument is, of course, a perfectly valid syllogism. If the premises are true, then the conclusion must be true. The problem is that the initial premise, to be accurate for many if not most human chronic diseases, must include a disjunct, U, or “cause unknown.” And once U is added to the first line of the syllogism, rarely is there a way to exclude it.

Sometimes the “cause unknown” component may be very small. For instance, in human malignant mesothelioma, the overwhelming majority of occupational cases do have a known cause: amphibole asbestos. When sufficient amphibole asbestos fiber exposure has been shown, there is usually no serious issue of individual attribution left for debate. The base rate of (idiopathic) mesothelioma is very low, and the relative risk from occupational amphibole asbestos exposure is extraordinarily large.

Ovarian cancer, which is the subject of the Escheverria case, is a very different story. The rate of idiopathic cases – no known causes – is much higher, and may even make up a majority of cases. The so-called differential etiology method never gets down to a conclusion that it is the talc (assuming arguendo that talc causes ovarian cancer). You always have talc or unknown cause in the conclusion.

In Escheverria, the plaintiffs’ lawyers called only one expert witness on specific causation, Echeverria’s treating physician, Dr. Annie Yessaian (“Yessaian”). Yessaian advanced a “differential etiology” analysis, which she claimed allowed her to conclude that talc was “more probable than not” a cause of plaintiff’s ovarian cancer. Echeverria op. at 5. Upon careful review, the trial court realized that Yessaian had never properly applied the iterative disjunctive syllogism, or differential etiology, to reach a valid conclusion. Despite a good deal of hand waving, Yessaian never ruled out other causes of the plaintiff’s ovarian cancer. Echeverria op. at 30.

The plaintiff’s menarche was at age 11, and so she had had a large number of ovulatory cycles. She was obese, and over 60 years old at the time of diagnosis. Yessaian did not rule these factors out; rather she testified without foundation that these factors were “less likely than not” causes of plaintiff’s ovarian cancer1. Echeverria op. at 31. The trial court noted that these potential causes had never been eliminated from the list of differentials; Yessaian had simply “discounted” them by ipse dixit. As for the “U,” or unknown causes that are clearly at play in many if not most ovarian cancers, Yessaian admitted that Escheverria’s cancer “probably” resulted from some unknown risk factor; but then, out of thin air, she testified that the probability of idiopathic causation was less than 50%. The trial court concluded that Yessian’s ruling in and ruling out decisions were ultimately nothing more than conjecture, and the plaintiff had never properly shown specific causation. Id. at 26-27, 31.

Relative Risk Less than Two

Yessaian’s specific causation opinion cratered further as a result of her inability to identify any specific biomarker or “fingerprint” of causation. The plaintiffs’ expert witnesses had argued that chronic inflammation is the mechanism by which talc causes ovarian cancer, but there was no histopathologic evidence of inflammation in association with ovarian tissue that had given rise to the cancer.

The relative risk argument is one way to attribute specific causation, and circumvent idiopathic causes by quantifying the contribution of the specific causal factor (again assuming it really is such) vis-a-vis the baseline risk of disease from unknown causes. The plaintiff, however, had called an expert witness on epidemiology, Jack Siemiatycki, who had explained that a risk ratio of 2.0 is “the point at which the probability of causation, which is the probability that a given agent causes a specific disease, exceeds 50 percent ….” Escheverria op. at 5. The defense epidemiologic expert, Dr. Douglas Weed, similarly testified and elaborated on the concept of probability of causation and attributable risk.2

The plaintiffs’ counsel attempted to extricate themselves from this arithmetic quagmire by arguing that there was “multiple causation,” and interaction among causes. Escheverria op. at 41-42. Yessaian, however, had disavowed even the most obvious concurrent causes (ovulatory cycles and age), and put all her markers down on talc. There was no evidence of multiple causation to muck up the analysis. Of course, the talc epidemiologic studies were all multivariate analyses that measured associations of talc and ovarian cancer in the presence of co-variates, such as age at menarche, and age at diagnosis.

Furthermore, Yessian was constrained by her acknowledgement that histologic type of ovarian cancer is highly relevant, and that none of the studies of serous ovaran cancer (the type diagnosed in Ms. Escheverria) reported out risk ratios in excess of 2.0. Escheverria op. at 28-29. Yessaian could not escape the inexorable math, and testimony about probability of causation from Jack Siemiatycki. Id at 29.3

Their case in extremis, the plaintiffs’ counsel argued4 that epidemiologic studies were not needed to prove causation, which might be true in a case involving a known mechanism with highly specific biomarkers to identify the causal mechanism that had taken place in the claimant. Having cited and relied extensively upon epidemiologic studies, Yessaian was hoisted with own her petard; the trial court found the assertion that there was an alternative path to specific causation to be absent from the record and quite incredible.

State of the Art

The duty to warn is constrained by what is known or should have been known at the time of marketing, what lawyers sometimes call “state of the art.” The trial court reasoned that since Eva Echeverria developed her serous ovarian cancer in 2007, the relevant scientific state of knowledge was censored at the time of plaintiff’s diagnosis. Any warning given after 2007 could not have prevented plaintiffs’ disease. (In truth, the relevant censoring date was likely well before 2007, but an earlier date would not have made a difference in the judicial outcome.)

There was no serious claim that the defendants had “secret” knowledge other than what was known in the scientific community. Plaintiffs’ expert witness on epidemiology, Jack Siemiatycki, co-chaired the IARC working group that concluded and published in 2007, that talc was a possible cause of ovarian cancer, a finding that rejected a higher classification, such as “probable” or “known.” IARC Monograph for Carbon Black, Titanium Dioxide & Talc, vol 93 (2010); Robert Baan, et al., “Carcinogenicity of carbon black, titanium dioxide, and talc,” 7 Lancet Oncology 295 (2006)5. In Escheverria, Siemiatycki testified in accordance with his public scientific work, and his service on the IARC working group, and he conceded that in 2007, there was no known causal connection between talc and human ovarian cancer. Notably, the defense lawyers failed to convert this state-of-the-art issue into a dispositive judgment because they had failed to ask for a binding jury instruction on the issue. Escheverria op. at 32.

For the trial court, the absence of scientific knowledge up to and including 2007, the year of Escheverria’s diagnosis, was also relevant to the existence vel non of malice that would support the imposition of punitive damages. Looking at the evidence in the light most favorable to the plaintiff, the trial court found that there was a scientific debate whether talc causes ovarian cancer, which debate would not allow the imputation of scienter to the defendants to permit the jury to infer that the defendants had acted with malice. Escheverria op. at 35. Given that no one in the medical or scientific community had asserted a relevant causal conclusion in or before 2007, the trial court’s conclusion is unassailable. The court’s analysis, however, begs the question why a lay jury is permitted to find any breach of a duty to warn, in the face of an engaged scientific community that uniformly refused to advance a causal conclusion in the relevant time frame.

New Trial on General and Specific Causation

The trial court did not belabor the analysis of general causation beyond pointing out that there were substantial uncertainties for many of the Bradford Hill considerations, such as consistency, strength, and exposure-response. With respect to specific causation, all the problems discussed on the motion for judgment notwithstanding the verdict were also relevant to finding that the plaintiff failed to establish specific causation by a preponderance of the evidence. Escheverria op. at 40.

The trial court identified several grounds for the grant of a new trial, but one ground involved improper argument by plaintiffs’ counsel, who has repeatedly resorted to the same argument in previous cases. Forewarned, the defense sought a ruling in limine to exclude all evidence of lobbying and communications with federal agencies over regulations and regulatory classifications of talc. In a pretrial ruling, the trial court permitted the use of company documents about attempts to influence the National Toxicology Program (NTP) and the IARC for the limited purpose of notice to defendants that scientific organizations were considering whether to label talc as a carcinogen. Escheverria op. at 45.

Perhaps the trial court was being charitable in assessing what the lobbying evidence would be used for, but the plaintiffs did not need evidence of lobbying to prove “notice.” Early, often, and deliberately, the plaintiffs’ lawyers used evidence of lobbying for purposes well beyond the permissible, limited relevancy of notice. Escheverria’s counsel, Allen Smith argued, in opening and in closing that the defendants had “fended off” the National Toxicology Program (NTP), and that “if Johnson & Johnson would have just stayed out of it, let the scientists do their work at the U.S. government, the NTP would have listed talc as a carcinogen as far back as 2000.” So lobbying activities were not used as evidence of notice at all, but rather for arguing an inference of malice and outrageous misconduct from the prevention of regulation. Escheverria op. at 46.

Predictable.

1 Yessaian did advert to a study that she interpreted as failing to establish an association between obesity and ovarian cancer, but for the other risk factors of age and ovulatory cycles, the plaintiff’s expert witness offered no basis at all.

2 The trial court studiously avoided reference to the defense expert witness on epidemiology. See “Echeverria Talc Trial – Crossexamination on Alleged Expert Witness Misconduct” (Oct. 21, 2017).

3 citing well-known relative risk of two cases, Daubert v. Merrell Dow Pharms., Inc., 43 F. 3d 1311, 1321 (9th Cir. 1995); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Prac. & Prod. Liab. Litig., 185 F. Supp. 3d 786, 791-92; Marder v. G.D. Searle & Co., 630 F. Supp. 1087, 1092 (D.Md. 1986), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987) (per curiam).

4 citing the dubious In re Neurontin Marketing, Sales Practices & Prods. Liab. Litig., 612 F. Supp. 2d 116, 132 (D. Mass. 2009), aff’d, 712 F.3d 21 (1st Cir. 2013).

5 Unfortunately, even the IARC classification of “probably” carcinogenic to humans is actually fairly meaningless exercises in semantics, not science. A close reading of the IARC Preamble definition of probable reveals that probable does not mean greater than 50%: “The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.”

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Echeverria Talc Trial – Crossexamination on Alleged Expert Witness Misconduct

October 21st, 2017

In a post-trial end-zone victory dance in Echeverria v. Johnson & Johnson, plaintiffs’ lawyer, Allen Smith proffered three explanations for the jury’s stunning $417 million verdict in his talc ovarian cancer case.1 One of the explanations asserted was Smith’s boast that he had adduced evidence that Johnson & Johnson’s expert witness on epidemiology, Douglas Weed, a former National Cancer Institute epidemiologist and physician, had been sanctioned in another, non-talc case in North Carolina, for lying under oath about whether he had notes to his expert report in that other case.2 Having now viewed Dr. Weed’s testimony3, through the Courtroom Video Network, I can evaluate Smith’s claim.

Weed’s allegedly perjurious testimony took place in Carter v. Fiber Composites LLC, 11 CVS 1355, N.C. Super. Ct., where he served as a party expert witness. In April 2014, Weed gave deposition testimony in the discovery phase of the Carter case. Although not served personally with a lawful subpoena, defense counsel had agreed to accept a subpoena for their expert witness to appear and produce documents, as was the local custom. In deposition, plaintiffs’ counsel asked Dr. Weed to produce any notes he created in the process of researching and writing his expert witness report. Dr. Weed testified that he had no notes. 

The parties disputed whether Dr. Weed had complied with a subpoena served upon defense counsel. The discovery dispute escalated and Dr. Weed obtained legal counsel, and submitted a sworn affidavit that denied the existence of notes. Plaintiffs’ counsel pressed on Dr. Weed’s understanding that he had no “notes.” In an Order, dated May 6, 2014, the trial court directed Dr. Weed to produce everything in his possession. In response to the order, Weed produced his calendar and a thumb drive with “small fragments of notes,” “inserts,” and “miscellaneous items.”

The North Carolina court did not take kindly to Dr. Weed’s confusion about whether his report “segments” and “inserts” were notes, or not. Dr. Weed viewed the segments and inserts to have been parts of his report, and later included within his report without any substantial change. The court concluded, however, that although Dr. Weed did not violate any court order, his assertion, in deposition, in an affidavit, and through legal counsel, was unreasonable, and directly related to his credibility in the Carter case. See Order Concerning Plaintiffs’ Motion for Sanctions Against Defendants and Non-Party Witness for Defendants (June 22, 2015) (Forrest D. Bridges, J.).

The upshot was that Dr. Weed and his counsel had provided false information to the court, on the court’s understanding of what had been requested in discovery. In the court’s view, Dr. Weed’s misunderstanding may have been understandable as a non-lawyer, but it was not reasonable for him to persist and have his counsel argue that there were no notes. The trial court specifically did not find that Dr. Weed had lied, as asserted by Allen Smith, but found that Weed’s conduct was undertaken intentionally or with reckless disregard of the truth, and that his testimony was an unacceptable violation of the oath to tell the whole truth. The trial court concluded that it could not sanction Dr. Weed personally, but its order specified that as a sanction, the plaintiffs’ counsel would be permitted to cross-examine Dr. Weed with the court’s findings and conclusions in the Carter case. Id. Not surprisingly, defense counsel withdrew Dr. Weed as an expert witness.

In the Echeverria case, the defense counsel did not object to the cross-examination; the video proceedings did not inform the viewers whether there had been a prior motion in limine concerning this examination. Allen Smith’s assertion about the North Carolina court’s findings was thus almost true. A cynic might say he too had not told the whole truth, but he did march Dr. Weed through Judge Bridges’ order of June 2015, which was displayed to the jury.

Douglas Weed handled the cross-examination about as well as possible. He explained on cross, and later on redirect, that he did not regard segments of his report, which were later incorporated into his report as served, to be notes. He pointed out that there was no information in the segments, which differed from the final report, or which was not included in the report. Smith’s cross-examination, however, had raised questions not so much about credibility (despite Judge Bridges’ findings), but about whether Dr. Weed was a “quibbler,” who would hide behind idiosyncratic understandings of important words such as “consistency.” Given how harmless the belatedly produced report fragments and segments were, we are left to wonder why Dr. Weed persisted in not volunteering them.

Smith’s confrontation of Dr. Weed with the order from the Carter case came at the conclusion of a generally unsuccessful cross-examination. Unlike the Slemp case, in which Smith appeared to be able to ask unfounded questions without restraint from the bench, in Echeverria, Smith drew repeated objections, which were frequently sustained. His response often was to ask almost the same question again, drawing the same objection and the same ruling. He sounded stymied and defeated.

Courtroom Video Network, of course, does not film the jurors, and so watching the streaming video of the trial offers no insights into how the jurors reacted in real time to Smith’s cross-examination. If Weed’s testimony was ignored or discredited by Smith’s cross-examination on the Carter order, then the Escheverria case cannot be considered a useful test of the plaintiffs’ causal claim. Dr. Weed had offered important testimony on methodological issues for conducting and interpreting studies, as well as inferring causation.

One of the peculiarities of the Slemp case was that the defense offered no epidemiologist in the face of two epidemiologists offered by the plaintiff. In Escheverria, the defense addressed this gap and went further to have its epidemiologist address the glaring problem of how any specific causal inference can be drawn from a risk ratio of 1.3. Dr. Weed explained attributable risk and probability of causation, and this testimony and many other important points went without cross-examination or contradiction. And yet, after finding general causation on a weak record, the jury somehow leaped over an insurmountable epistemic barrier on specific causation.

1 Amanda Bronstad, “New Evidence Seen as Key in LA Jury’s $417M Talc Verdict,” Law.com (Aug. 22, 2017).

3 The cross-examination at issue arose about one hour, nine minutes into Smith’s cross-examination, on Aug. 15, 2017.

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Statistical Gobbledygook Goes to the Supreme Court

October 20th, 2017

Back in July, my summer slumber was rudely interrupted by an intemperate, ad hominem rant from statistican Sander Greenland. Greenland’s rant concerned my views of the the Supreme Court’s decision in Matrixx Initiatives v. Siracusano, 563 U.S. 27 (2011).

Greenland held forth, unfiltered, on Deborah Mayo’s web blog, where he wrote:

“Glad to have finally flushed out Schachtman, whose blog did not allow my critical dissenting comments back when this case first hit. Nice to see him insult the intellect of the Court too, using standard legal obfuscation of the fact that the Court is entitled to consider science, ordinary logic, and common sense outside of that legal framework to form and justify its ruling – that reasoning is what composes the bulk of the opinion I linked. Go read it and see what you think without the smokescreen offered by Schachtman.”

“A megateam of reproducibility-minded scientists look to lowering the p-value,” Error Statistics (July 25, 2017).

Oh my! It is true that my blog does not have comments enabled, but as I have written on several occasions, I would gladly welcome requests to post opposing views, even those of Sander Greenland. On Deborah Mayo’s blog, I had the opportunity to explain carefully why Greenland has been giving a naïve, mistaken characterization of the holding of Matrixx Initiatives, in his expert witness reports for plaintiffs’ counsel, as well as in his professional publications. Ultimately, Greenland ran out of epithets, lost his enthusiasm for the discussion, and slunk away into cyber-silence.

I was a bit jarred, however, by Greenland’s accusation that I had insulted the Court. Certainly, I did not use any of the pejorative adjectives that Greenland had hurled at me; rather, I simply have given legal analysis of the Court’s opinions and a description of the legal, scientific, and statistical errors therein.1 And, to be sure, other knowledgeable writers and evidence scholars, have critiqued the Court’s decision and some of the pronouncements of the parties and the amici in Matrixx Initiatives2.

This week, John Pfaff, a professor at Fordham Law School, published an editorial in the New York Times, to argue that “The Supreme Court Justices Need Fact-Checkers,” N.Y. Times (Oct. 18, 2017). No doubt, Greenland would consider Pfaff’s editorial to be “insulting” to the Court, unless of course, Greenland thinks criticism can be insulting only if it challenges views he wants to see articulated by the Court.

In support of his criticism of the Court, Pfaff adverted to the Chief Justice’s recent comments in the oral argument of a gerrymandering case, Gill v. Whitford. In a question critical of the gerrymander challenge, Chief Justice Roberts described the supporting evidence:

“it may be simply my educational background, but I can only describe as sociological gobbledygook.”

Oral Argument before the U.S. Supreme Court at p.40, in Gill v. Whitford, No. 16-1161 (Oct. 3, 2017). The Chief Justice’s dismissive comments about gobble may well have been provoked by an amicus brief filed on behalf of 44 election law, scientific evidencce, and empirical legal scholars, who explored the legal and statistical basis for striking down the Wisconsin gerrymander. See Brief of Amici Curiae, of 44 Election Law, Scientific Evidence, and Empirical Legal Scholars, filed in Gill v. Whitford, No. 16-1161 (Sept. 1, 2017).

As with Greenland’s obsequious respect for the Matrixx Initiatives opinion, no one is likely to have been misled by Chief Justice Roberts’ false modesty. John Roberts was graduated summa cum laude from Harvard College in three years, although with a major in a “soft” discipline, history. He went on to Harvard Law School, where he was the managing editor of the Harvard Law Review, and was graduated magna cum laude. As a lawyer, Roberts has had an extraordinarily successful career. And yet, the Chief Justice went out of his way to disparage the mathematical and statistical models used to show gerrymandering in the Gill case, as “gobbledygook.” Odds are that the Chief Justice was thus not deprecating his own education; yet, inquiring minds might wonder whether that education was deficient in mathematics, statistics, and science.

Policy is a major part of the court’s docket now, whether the Justices likes it or not. The Justices cannot avoid adapting to the technical requirements of scientific and statistical issues, and they cannot simply dismiss evidence they do not understand as “gobbledygook.” Referencing a recent ProPublica report, Professor Pfaff suggests that the Supreme Court might well employ independent advisors to fact check their use of descriptive statistics3. 

The problem identified by Pfaff, however, seems to implicate a fundamental divide between the “two cultures” of science and the humanities. See C.P. Snow, The Rede Lecture 1959. Perhaps Professor Pfaff might start with his own educational institution. The Fordham University School of Law does not offer a course in statistics and probability; nor does it require entering students to have satisfied a requirement of course work in mathematics, science, or statistics. The closest offering at Fordham is a course on accounting for lawyer, and the opportunity to take a one-credit course in “quantitative methods” at the graduate school.

Fordham School of Law, of course, is hardly alone. Despite cries for “relevancy” and experiential learning in legal education, some law schools eschew courses in statistics and probability for legal applications, sometimes on the explicit acknowledgement that such courses are too “hard,” or provoke too much student anxiety. The result, as C.P. Snow saw over a half century ago, is that lawyers and judges cannot tell gobbledygook from important data analysis, even when it smacks them in the face.

1 With David Venderbush of Alston & Bird LLP, I published my initial views of the Matrixx case, in the the form of a Washington Legal Foundation Legal Backgrounder, available at the Foundation’s website. See Schachtman & Venderbush, “Matrixx Unbounded: High Court’s Ruling Needlessly Complicates Scientific Evidence Principles,” 26 (14) Legal Backgrounder (June 17, 2011). I expanded on my critique in several blog posts. See, e.g., “Matrixx Unloaded” (Mar. 29, 2011); “The Matrixx Oversold” (Apr. 4, 2011); “The Matrixx – A Comedy of Errors” (Apr. 6, 2011); “De-Zincing the Matrixx” (Apr. 12, 2011); “Siracusano Dicta Infects Daubert Decisions” (Sept. 22, 2012).

2 See David Kaye, “The Transposition Fallacy in Matrixx Initiatives, Inc. v. Siracusano: Part I” (Aug. 19, 2011), and “The Transposition Fallacy in Matrixx Initiatives, Inc. v. Siracusano: Part II” (Aug. 26, 2011); David Kaye, “Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety & Liability Reporter 1007 (Sept. 12, 2011).

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Love that Hormesis to Pieces

October 12th, 2017

Hermann Joseph Muller was an American biologist who won the Nobel Prize in 1946, for Physiology or Medicine, for his work on fruit fly genetics. In his Nobel Prize speech, Muller opined that there was no threshold dose for radiation-induced mutagenesis. Muller’s speech became a locus of support for what later became known as the “linear no threshold” (LNT) theory of carcinogenesis.

Muller was an ardent eugenicist, although of the communist, not the Nazi, variety.1 After 1932, Muller’s political enthusiasms took him to the Soviet Union, where Muller blithely ignored murderous purges and famines, in order to pursue his scientific interests for the greater glory of the Proletarian Dicatorship.2 Muller became enamored of a People’s eugenics program. On May 5, 1936, Muller wrote to “Comrade Stalin,” “[a]s a scientist with confidence in the ultimate Bolshevik triumph throughout all possible spheres of human endeavor,” to offer the brutal dictator “a matter of vital importance arising out of my own science – biology, and, in particular, genetics.”3

Comrade Stalin was underwhelmed by Muller’s offer, and threw his lot in with Trofim Lysenko. A disheartened Muller managed to extricate himself from the Soviet fatherland, but not so much from its politics and ideology4. After returning to the United States, he remained active in noteworthy liberal and progressive political activities. Alas, he also seemed to remain a Communist fellow traveler, who found time to criticize only the Soviet embrace of Lysenkoism and its treatment of dissident geneticists (such as himself), with nary a mention of Ukrainian farmers, political dissidents, or the Soviet subjugation of eastern and central Europe.5

In retreating from his Soviet homeland, Muller did not abandon his eugenic vision for the United States. In 1966, Muller urged the immediate establishment of sperm banks for “outstanding men,” such as himself, to make deposits for use in artificial insemination6

**********************************

Back in a 1976, George E. P. Box outlined his notion that all models are wrong even though some may be useful7. The LNT model, as devised by Muller and embraced by regulatory agencies around the world, has long since lost its usefulness in describing and predicting biological phenomena. LNT is scientific in the sense that it is testable and falsifiable; LNT has been tested and falsified. Muller’s model ignores relevant biological processes of tolerance, defense, and adaptation8. 

The resilience of the LNT seems to be due to the advocacy of scientists and regulators who find the simplistic LNT model to be useful in ensuring regulation of, and compensation for, low-dose exposures. The perpetual machine litigation created with asbestos comes to mind. Other “political scientists” come to mind as well. Theory and data are often in tension, but at the end of any debate, scientists are obligated to “save the phenomena.” Fortunately, there are scientists who are challenging the dominance of the LNT model, and who are pointing out where the model just does not fit the data9.

In the United States, Muller’s theories were subjected to some real-world tests. In May 1947, Muller warned of the possible evolution of evil monsters born to Japanese survivors of Hiroshima and Nagasaki, on the basis of his assessment that the atomic bombs had produced countless mutants. Later that year, however, Austin Brues, director of the Argonne National Laboraty, published his findings of children born to Hiroshima survivors, who had no more mutations than baseline expectation10.

Notwithstanding the shaky evidentiary foundations of Muller’s views, his prestige as a Nobel laureate encouraged the adoption and promotion of the LNT model by the National Academy of Sciences’ Biological Effects of Atomic Radiation (BEAR) I Genetics Panel. Edward J. Calabrese, a prominent toxicologist in the Department of Environmental Health Sciences, School of Public Health and Health Sciences, University of Massachusetts, has taken pains, on multiple occasions, to trace the genealogy of this error. His most recent, and most succinct effort, is a worthwhile read for policy makers, judges, and lawyers who want to understand the historical dimension of the LNT model11. A fuller bibliography is set out as an appendix to this post.

 

1 Herman Joseph Muller, Out of the Night – a Biologist’s View of the Future (1935).

2 Elof Alex Carlson, Genes, Radiation, and Society: The Life and Work of H.J. Muller (1981).

3 John Glad, “Hermann J. Muller’s 1936 Letter to Stalin,” 43 The Mankind Quarterly 305 (2003).

4 See, e.g., Peter J. Kuznick, Beyond the Laboratory: Scientists as Political Activists in 1930’s America 121 (1987).

5 Hermann J. Muller, “The Crushing of Genetics in the USSR,” 4 Bull. Atomic Scientists 369 (1948). Some have attempted to protect Muller’s conduct by arguing that he testified before the House Un-American Activities Committee, where he was critical of Soviet restrictions on secondary education. See Thomas D. Clark, Indiana University: Midwestern Pioneer 310 (1977). Given Muller’s privileged position to observe first hand what had happened to Ukrainian farmers and others, this coming forward on Soviet education seems feeble indeed.

6 See “Sperm Banks Urged by Nobel Laureate,” N.Y. Times (Sept. 13, 1966).

7 See George E. P. Box, “Science and Statistics,” 71 J. Am. Stat. Ass’ 791 (1976); George E. P. Box, “Robustness in the strategy of scientific model building,” in R. L. Launer & G.N. Wilkinson, Robustness in Statistics at 201–236 (1979); George E. P. Box & Norman Draper, Empirical Model-Building and Response Surfaces at 74 (1987) (“Remember that all models are wrong; the practical question is how wrong do they have to be to not be useful.”).

8 See, e.g., Adam D. Thomas, Gareth J. S. Jenkins, Bernd Kaina, Owen G. Bodger, Karl-Heinz Tomaszowski, Paul D. Lewis, Shareen H. Doak, and George E. Johnson, “Influence of DNA Repair on Nonlinear Dose-Responses for Mutation,” 132 Toxicol. Sci. 87 (2013).

9 See, e.g., Bill Sacks & Jeffry A. Siegel, “Preserving the Anti-Scientific Linear No-Threshold Myth: Authority, Agnosticism, Transparency, and the Standard of Care,” 15 Dose-Response: An Internat’l J. 1 (2017); Charles L. Sanders, Radiobiology and Radiation Hormesis: New Evidence and its Implications for Medicine and Society (2017).

10 William Widder, “Probe Effects of Atom Bomb: Study Betrays No Evidence of Mutations,” Greensburg Daily News (Greensburg, Indiana) at 22 (Mon, Nov. 24, 1947).

11 Edward J.Calabrese, “The Mistaken Birth and Adoption of the LNT: An Abridged Version,” 15 Dose-Response: An Internat’l J. (2017).

Appendix

Edward J.Calabrese & Linda A. Baldwin, “Chemical hormesis: its historical foundations as a biological hypothesis,” 19 Human & Experimental Toxicol. 2 (2000)

Edward J. Calabrese and Linda A. Baldwin, “Hormesis: U-shaped dose responses and their centrality in toxicology,” 22 Trends Pharmacol. Sci. 285 (2001)

Edward J.Calabrese, “Hormesis: a revolution in toxicology, risk assessment and medicine: Re-framing the dose–response relationship,” 5 Eur. Mol. Bio. Org. Reports S37 (2004)

Edward J. Calabrese & Robyn Blain, “The occurrence of hormetic dose responses in the toxicological literature, the hormesis database: an overview,” 202 Toxicol. & Applied Pharmacol. 289 (2005);

Edward J. Calabrese, “Pain and U-shaped dose responses: occurrence, mechanisms and clinical Implications,” 38 Crit. Rev. Toxicol. 579 (2008)

Edward J. Calabrese, “Neuroscience and hormesis: overview and general findings,” 38 Crit. Rev. Toxicol. 249 (2008)

Edward J. Calabrese, “Linear No Threshold (LNT) – The New Homeopathy,” 31 Envt’l Toxicol. & Chem. 2723 (2012)

Edward J. Calabrese, “Muller’s Nobel Prize Lecture: When Ideology Prevailed over Science,” 126 Toxicol. Sci. 1 (2012)

Edward J. Calabrese, “How the U.S. National Academy of Sciences misled the world community on cancer risk assessment: new findings challenge historical foundations of the linear dose response, 87 Arch. Toxicol. 2063 (2013)

Edward J. Calabrese, “On the origins of the linear no-threshold (LNT) dogma by means of untruths, artful dodges and blind faith,” 142 Envt’l Research 432 (2015)

Edward J. Calabrese, “An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment,” 89 Arch. Toxicol. 647 (2015)

Edward J. Calabrese, “LNTgate: How scientific misconduct by the U.S. NAS led to governments adopting LNT for cancer risk assessment,” 148 Envt’l Research 535 148 (2016)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 1. The Russell-Muller debate,” 154 Envt’l Res. 435 (2017)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 2. How a mistake led BEIR I to adopt LNT,” 154 Envt’l Res. 452 (2017)

Posted in Causation, Historian Testimony, Scientific Evidence | Comments Off on Love that Hormesis to Pieces

Multiplicity in the Third Circuit

September 21st, 2017

In Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283 (W. D. Pa.), plaintiffs claimed that their employer’s reduction in force unlawfully targeted workers over 50 years of age. Plaintiffs lacked any evidence of employer animus against old folks, and thus attempted to make out a statistical disparate impact claim. The plaintiffs placed their chief reliance upon an expert witness, Michael A. Campion, to analyze a dataset of workers agreed to have been the subject of the R.I.F. For the last 30 years, Campion has been on the faculty in Purdue University. His academic training and graduate degrees are in industrial and organizational psychology. Campion has served an editor of Personnel Psychology, and as a past president of the Society for Industrial and Organizational Psychology. Campion’s academic website page notes that he manages a small consulting firm, Campion Consulting Services1.

The defense sought to characterize Campion as not qualified to offer his statistical analysis2. Campion did, however, have some statistical training as part of his master’s level training in psychology, and his professional publications did occasionally involve statistical analyses. To be sure, Campion’s statistical acumen paled in comparison to the defense expert witness, James Rosenberger, a fellow and a former vice president of the American Statistical Association, as well as a full professor of statistics in Pennsylvania State University. The threshold for qualification, however, is low, and the defense’s attack on Campion’s qualifications failed to attract the court’s serious attention.

On the merits, the defense subjected Campion to a strong challenge on whether he had misused data. The defense’s expert witness, Prof. Rosenberger, filed a report that questioned Campion’s data handling and statistical analyses. The defense claimed that Campion had engaged in questionable data manipulation by including, in his RIF analysis, workers who had been terminated when their plant was transferred to another company, as well as workers who retired voluntarily.

Using simple z-score tests, Campion compared the ages of terminated and non-terminated employees in four subgroups, ages 40+, 45+, 50+, and 55+. He did not conduct an analysis of the 60+ subgroup on the claim that this group had too few members for the test to have sufficient power3. Campion found a small z-score for the 40+ versus <40 age groups comparison (z =1.51), which is not close to statistical significance at the 5% level. On the defense’s legal theory, this was the crucial comparison to be made under the Age Discrimination in Employment Act (ADEA). The plaintiffs, however, maintained that they could make out a case of disparate impact by showing age discrimination at age subgroups that started above the minimum specified by the ADEA. Although age is a continuous variable, Campion decided to conduct z-scores on subgroups that were based upon five-year increments. For the 45+, 50+, and 55+ age subgroups, he found z-scores that ranged from 2.15 to 2.46, and he concluded that there was evidence of disparate impact in the higher age subgroups4. Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283, 2015 WL 4232600, at *11 (W.D. Pa. July 13, 2015) (McVerry, S.J.)

The defense, and apparently the defense expert witnesses, branded Campion’s analysis as “data snooping,” which required correction for multiple comparisons. In the defense’s view, the multiple age subgroups required a Bonferroni correction that would have diminished the critical p-value for “significance” by a factor of four. The trial court agreed with the defense contention about data snooping and multiple comparisons, and excluded Campion’s opinion of disparate impact, which had been based upon finding statistically significant disparities in the 45+, 50+, and 55+ age subgroups. 2015 WL 4232600, at *13. The trial court noted that Campion, in finding significant disparities in terminations in the subgroups, but not in the 40+ versus <40 analysis:

“[did] not apply any of the generally accepted statistical procedures (i.e., the Bonferroni procedure) to correct his results for the likelihood of a false indication of significance. This sort of subgrouping ‘analysis’ is data-snooping, plain and simple.”

Id. After excluding Campion’s opinions under Rule 702, as well as other evidence in support of plaintiffs’ disparate impact claim, the trial court granted summary judgment on the discrimination claims. Karlo v. Pittsburgh Glass Works, LLC, No. 2:10–cv–1283, 2015 WL 5156913 (W. D. Pa. Sept. 2, 2015).

On plaintiffs’ appeal, the Third Circuit took the wind out of the attack on Campion by holding that the ADEA prohibits disparate impacts based upon age, which need not necessarily be on workers’ being over 40 years old, as opposed to being at least 40 years old. Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 66-68 (3d Cir. 2017). This holding took the legal significance out of the statistical insignificance of Campion’s comparison 40+ versus <40 age-group termination rates. Campion’s subgroup analyses were back in play, but the Third Circuit still faced the question whether Campion’s conclusions, based upon unadjusted z-scores and p-values, offended Rule 702.

The Third Circuit noted that the district court had identified three grounds for excluding Campion’s statistical analyses:

(1) Dr. Campion used facts or data that were not reliable;

(2) he failed to use a statistical adjustment called the Bonferroni procedure; and

(3) his testimony lacks ‘‘fit’’ to the case because subgroup claims are not cognizable.

849 F.3d at 81. The first issue was raised by the defense’s claims of Campion’s sloppy data handling, and inclusion of voluntarily retired workers and workers who were terminated when their plant was turned over to another company. The Circuit did not address these data handling issues, which it left for the trial court on remand. Id. at 82. The third ground went out of the case with the appellate court’s resolution of the scope of the ADEA. The Circuit did, however, engage on the issue whether adjustment for multiple comparisons was required by Rule 702.

On the “data-snooping” issue, the Circuit concluded that the trial court had applied “an incorrectly rigorous standard for reliability.” Id. The Circuit acknowledged that

“[i]n theory, a researcher who searches for statistical significance in multiple attempts raises the probability of discovering it purely by chance, committing Type I error (i.e., finding a false positive).”

849 F.3d at 82. The defense expert witness contended that applying the Bonferroni adjustment, which would have reduced the critical significance probability level from 5% to 1%, would have rendered Campion’s analyses not statistically significant, and thus not probative of disparate impact. Given that plaintiffs’ cases were entirely statistical, the adjustment would have been fatal to their cases. Id. at 82.

At the trial level and on appeal, plaintiffs and Campion had objected to the data-snooping charge on ground that

(1) he had engaged in only four subgroups;

(2) virtually all subgroups were statistically significant;

(3) his methodology was “hypothesis driven” and involved logical increments in age to explore whether the strength of the evidence of age disparity in terminations continued in each, increasingly older subgroup;

(4) his method was analogous to replications with different samples; and

(5) his result was confirmed by a single, supplemental analysis.

Id. at 83. According to the plaintiffs, Campion’s approach was based upon the reality that age is a continuous, not a dichotomous variable, and he was exploring a single hypothesis. A.240-241; Brief of Appellants at 26. Campion’s explanations do mitigate somewhat the charge of “data snooping,” but they do not explain why Campion did not use a statistical analysis that treated age as a continuous variable, at the outset of his analysis. The single, supplemental analysis was never described or reported by the trial or appellate courts.

The Third Circuit concluded that the district court had applied a ‘‘merits standard of correctness,’’ which is higher than what Rule 702 requires. Specifically, the district court, having identified a potential methodological flaw, did not further evaluate whether Campion’s opinion relied upon good grounds. 849 F.3d at 83. The Circuit vacated the judgment below, and remanded the case to the district court for the opportunity to apply the correct standard.

The trial court’s acceptance that an adjustment was appropriate or required hardly seems a “merits standard.” The use of a proper adjustment for multiple comparisons is very much a methodological concern. If Campion could reach his conclusion only by way of an inappropriate methodology, then his conclusion surely would fail the requirements of Rule 702. The trial court did, however, appear to accept, without explicit evidence, that the failure to apply the Bonferroni correction made it impossible for Campion to present sound scientific argument for his conclusion that there had been disparate impact. The trial court’s opinion also suggests that the Bonferroni correction itself, as opposed to some more appropriate correction, was required.

Unfortunately, the reported opinions do not provide the reader with a clear account of what the analyses would have shown on the correct data set, without improper inclusions and exclusions, and with appropriate statistical adjustments. Presumably, the parties are left to make their cases on remand.

Based upon citations to sources that described the Bonferroni adjustment as “good statistical practice,” but one that is ‘‘not widely or consistently adopted’’ in the behavioral and social sciences, the Third Circuit observed that in some cases, failure to adjust for multiple comparisons may “simply diminish the weight of an expert’s finding.”5 The observation is problematic given that Kumho Tire suggests that an expert witness must use “in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150, (1999). One implication is that courts are prisoners to prevalent scientific malpractice and abuse of statistical methodology. Another implication is that courts need to look more closely at the assumptions and predicates for various statistical tests and adjustments, such as the Bonferroni correction.

These worrisome implications are exacerbated by the appellate court’s insistence that the question whether a study’s result was properly calculated or interpreted “goes to the weight of the evidence, not to its admissibility.”6 Combined with citations to pre-Daubert statistics cases7, judicial comments such as these can appear to be a general disregard for the statutory requirements of Rules 702 and 703. Claims of statistical significance, in studies with multiple exposure and multiple outcomes, are frequently not adjusted for multiple comparisons, without notation, explanation, or justification. The consequence is that study results are often over-interpreted and over-sold. Methodological errors related to multiple testing or over-claiming statistical significance are commonplace in tort litigation over “health-effects” studies of birth defects, cancer, and other chronic diseases that require epidemiologic evidence8.

In Karlo, the claimed methodological error is beset by its own methodological problems. As the court noted, adjustments for multiple comparisons are not free from methodological controversy9. One noteworthy textbook10 labels the Bonferroni correction as an “awful response” to the problem of multiple comparisons. Aside from this strident criticism, there are alternative approaches to statistical adjustment for multiple comparisons. In the context of the Karlo case, the Bonferroni might well be awful because Campion’s four subgroups are hardly independent tests. Because each subgroup is nested within the next higher age subgroup, the subgroup test results will be strongly correlated in a way that defeats the mathematical assumptions of the Bonferroni correction. On remand, the trial court in Karlo must still make his Rule 702 gatekeeping decision on the methodological appropriateness of whether Campion’s properly considered the role of multiple subgroups, and multiple anaslyses run on different models.

1 Although Campion describes his consulting business as small, he seems to turn up in quite a few employment discrimination cases. See, e.g., Chen-Oster v. Goldman, Sachs & Co., 10 Civ. 6950 (AT) (JCF) (S.D.N.Y. 2015); Brand v. Comcast Corp., Case No. 11 C 8471 (N.D. Ill. July 5, 2014); Powell v. Dallas Morning News L.P., 776 F. Supp. 2d 240, 247 (N.D. Tex. 2011) (excluding Campion’s opinions), aff’d, 486 F. App’x 469 (5th Cir. 2012).

2 See Defendant’s Motion to Bar Dr. Michael Campion’s Statistical Analysis, 2013 WL 11260556.

3 There was no mention of an effect size for the lower aged subgroups, and a power calculation for the 60+ subgroup’s probability of showing a z-score greater than two. Similarly, there was no discussion or argument about why this subgroup could not have been evaluated with Fisher’s exact test. In deciding the appeal, the Third Circuit observed that “Dr. Rosenberger test[ed] a subgroup of sixty-and-older employees, which Dr. Campion did not include in his analysis because ‘[t]here are only 14 terminations, which means the statistical power to detect a significant effect is very low’. A.244–45.” Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 82 n.15 (3d Cir. 2017).

4 In the trial court’s words, the z-score converts the difference in termination rates into standard deviations. Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283, 2015 WL 4232600, at *11 n.13 (W.D. Pa. July 13, 2015). According to the trial court, Campion gave a rather dubious explanation of the meaning of the z-score: “[w]hen the number of standard deviations is less than –2 (actually–1.96), there is a 95% probability that the difference in termination rates of the subgroups is not due to chance alone” Id. (internal citation omitted).

5 See 849 F.3d 61, 83 (3d Cir. 2017) (citing and quoting from Paetzold & Willborn § 6:7, at 308 n.2) (describing the Bonferroni adjustment as ‘‘good statistical practice,’’ but ‘‘not widely or consistently adopted’’ in the behavioral and social sciences); see also E.E.O.C. v. Autozone, Inc., No. 00-2923, 2006 WL 2524093, at *4 (W.D. Tenn. Aug. 29, 2006) (‘‘[T]he Court does not have a sufficient basis to find that … the non-utilization [of the Bonferroni adjustment] makes [the expert’s] results unreliable.’’). And of course, the Third Circuit invoked the Daubert chestnut: ‘‘Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but

admissible evidence.’’ Daubert, 509 U.S. 579, 596 (1993).

6 See 849 F.3d at 83 (citing Leonard v. Stemtech Internat’l Inc., 834 F.3d 376, 391 (3d Cir. 2016).

7 See 849 F.3d 61, 83 (3d Cir. 2017), citing Bazemore v. Friday, 478 U.S. 385, 400 (1986) (‘‘Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.’’).

8 See Hans Zeisel & David Kaye, Prove It with Figures: Empirical Methods in Law and Litigation 93 & n.3 (1997) (criticizing the “notorious” case of Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986), for its erroneous endorsement of conclusions based upon “statistically significant” studies that explored dozens of congenital malformation outcomes, without statistical adjustment). The authors do, however, give an encouraging example of a English trial judge who took multiplicity seriously. Reay v. British Nuclear Fuels (Q.B. Oct. 8,1993) (published in The Independent, Nov. 22,1993). In Reay, the trial court took seriously the multiplicity of hypotheses tested in the study relied upon by plaintiffs. Id. (“the fact that a number of hypotheses were considered in the study requires an increase in the P-value of the findings with consequent reduction in the confidence that can be placed in the study result … .”), quoted in Zeisel & Kaye at 93. Zeisel and Kaye emphasize that courts should not be overly impressed with claims of statistically significant findings, and should pay close attention to how expert witnesses developed their statistical models. Id. at 94.

9 See David B. Cohen, Michael G. Aamodt, and Eric M. Dunleavy, Technical Advisory Committee Report on Best Practices in Adverse Impact Analyses (Center for Corporate Equality 2010).

10 Kenneth J. Rothman, Sander Greenland, and Timoth L. Lash, Modern Epidemiology 273 (3d ed. 2008); see also Kenneth J. Rothman, “No Adjustments Are Needed for Multiple Comparisons,” 1 Epidemiology 43, 43 (1990)

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