Schachtman Law

TORTINI

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

Dr. Harry Shubin – Asbestos Litigation Hall of Shame

February 19th, 2021

Many physicians took and failed the so-called B-reader examination for proficiency in using the International Labor Office’s grading schema of chest radiographs for pneumoconiosis. Famously, Irving Selikoff was someone who took but failed this examination, and he stopped serving as a clinical expert witness in asbestos cases. No one can say for sure whether there was cause and effect. In Philadelphia, South Jersey pulmonary physician, Dr. Joseph Sokolowski, was a frequent testifier for plaintiffs, despite his having failed the B-Reader examination three times. Sokolowski was conditionally fined and disqualified from testifying in Philadelphia because of his refusal to comply with compulsory process for his B-Reader test results.[1]

The only physician I encountered who lied outright about his B-reader examination results was the late Harry Shubin. Some people may know of Dr. Shubin only because of the “Harry Shubin, M.D. Statesman in Healthcare Administration Award,” presented by the American Academy of Medical Administrators. Indeed, Shubin had a long career in hospital administration. He was graduated from Temple School of Medicine in 1937, and went into family practice, at the age of 22. Later, he specialized in the treatment of tuberculosis and pulmonary disease.[2] Over his long career, he was a patron of the arts and of other charities in Philadelphia.

In 1955, Dr Shubin became the president of the American Academy of Tuberculosis Physicians.[3] In 1958, Shubin was elected head of staff at Pennsylvania General Hospital.[4] He later became the medical director of the Northern Division of Philadelphia General Hospital.

In 1962, along with 18 other physicians, Shubin purchased a 104-bed hospital, known as the Broad Street Hospital, at 739 South Broad Street, for which he would become medical director.[5] When the Jefferson Medical College sold its Barton Memorial Hospital for “diseases of the chest,” including silicosis and coal workers’ pneumoconiosis, at Broad and Fitzwater Streets, the South Broad Street Medical Center, Inc., bought it. Shubin was the medical director.[6]

Shubin’s career as a medical director suffered in the ensuing decades.[7] In 1970, after a hearing, Dr. Shubin was disqualified by the U.S. Food & Drug Administration from receiving investigational products.[8] And then in 1981, his Center City Hospital, at 1829 Pine Street, closed, under pressure from both Blue Cross and the federal Health Systems Agency.[9]

Perhaps those setbacks explain Dr. Shubin’s foray into the lucrative world of expert witnessing in the asbestos litigation. Shubin started turning up as an expert witness for plaintiffs in hundreds of cases, in 1985. Dr. Peter Theodos, a prominent Philadelphia pulmonary physician had been designated to testify in these cases, but he died while the cases languished due to the huge backlog of asbestos cases in Philadelphia.

Shubin’s qualifications to replace Theodos were thin, Aside from an insignificant paper in a Pennsylvania Medicine,[10] Shubin had not written anything on asbestos or asbestos-related disease. Shubin was, however, a media hound, and in 1985, he was turning up at union halls and town hall meetings across Pennsylvania.[11]

Despite his lack of significant experience and expertise in asbestos-related disease, Shubin could put on a great show for uncritical Philadelphia juries. He was charming and persuasive. His years of public speaking on behalf of his beleaguered hospitals gave him confidence and skills of evasion in the witness box. When confronted with statements from Selikoff’s book or articles, Shubin would chuckle, smile knowingly, and say that he taught Selikoff everything about asbestos. His demeanor was avuncular and cherubic, which made cross-examination even more difficult.

Initially, Shubin testified that he was a B-reader, but after the defense verified his absence from the NIOSH list of certified B-readers, he “modified” his next trial’s testimony to state that he had started, but had not finished, the examination because of an eye problem.

After inquiring at NIOSH and learning that Shubin had finished the examination, defense counsel confronted Shubin yet again, only to have his tale embellished by a claim that he had withdrawn from the examination after finishing because of the eye problem, and wrote to NIOSH to ask that his examination not be evaluated.

In 1986, the leading asbestos plaintiffs’ firm was pushing one of its many cases to trial, with a Shubin report to support its claims.[12] Although the defense expert witnesses had given this plaintiff a clean bill of health, we had sufficient concerned about Shubin’s testimonial skills, that I decided to document Shubin’s perjury on the subject of his B-Reader status.

In 1986, the records’ custodian of B-Reader test results for NIOSH was Mitizie Martin, in Morgantown, West Virginia. After a good deal of procedural wrangling, I was able to obtain a court order that required plaintiffs’ counsel’s appearance for a deposition of Ms. Martin, in Morgantown. I noticed her deposition in all Philadelphia asbestos cases and gave all plaintiffs’ firms notice of the event. And so, in the first week of September, 1986, plaintiffs’ counsel, John DiDonato, and I were on board a small airplane for a bumpy ride to Morgantown, for Ms. Martin’s deposition.[13]

Martin was a wonderful witness. In 1986, she was Chief of the X-ray Receiving Center Section, Division of X-Ray Disease Studies, for NIOSH. She had been with NIOSH or its predecessor for 20 years.[14] Martin explained NIOSH’s role in teaching the A-Reader course, and in administering the B-Reader examination, along with the American College of Radiology, and its record retention policies.

Martin described the B-reader examination, which at the time required a showing of proficiency in interpreting 125 chest films for the presence and absence of various pneumoconiosis, according to the ILO scale.[15]

Finally, and most important, Martin authenticated the Shubin file, and laid a foundation for its admissibility at all future asbestos trials. Shubin had sought to become a B-Reader by taking the required test, in March 1982, in Orlando, Florida.[16] He completed but failed that examination in 1982, after which he wrote to Ms. Martin, to express his desire to take the test again. He made no mention of an eye problem; nor did he request that the 1982 results be disregarded. Martin wrote back to explain that he would have to wait a year before taking the examination again.[17]

Shubin waited three years, but he eventually signed up for, and took, the B-Reader examination a second time, in March 1985, on Kiawah Island, South Carolina. This second attempt resulted in a second failure, and a notification to Shubin that he had received a “failing grade, deficient in most categories.”[18] Shubin had thus taken the B-Reader examination twice, and failed both times. He had never abandoned the test; nor had he written to NIOSH to request a withdrawal from the examination, or to notify the agency of an eye-sight problem.[19]

My then colleague, Terri Keeley, was set to try the next-schedule case in which Dr. Shubin was supposed to have testified, in September 1986. Unsurprisingly, the case resolved. As soon as I received the transcript, I provided a copy gratis to every asbestos plaintiffs’ firm in Philadelphia. The result was that we never saw Dr. Shubin in an asbestos case again. Occasionally, we would receive a Dr. Shubin report, but a quick reminder of the procedural history behind Ms. Mitzie Martin’s deposition testimony sealed his effectual exclusion.

Remarkably, despite the notoriety he had gained in the Philadelphia asbestos litigation, Shubin showed up in the high-profile Paoli Railroad PCB case, as an expert witness on causation.[20] In the Paoli case, Shubin gave rather unscientific testimony that conflated general and specific causation, and assumed that PCBs caused individual plaintiffs’ disease because PCBs can cause disease.[21] As far I can determine, he was never confronted with his perjuries from the Philadelphia asbestos cases.

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[1] Downing v. Johns-Manville Corp., Philadelphia Cty. Ct. C.P. 1981- 11- 3762, Order sur Motion to Compel Dr. Sokolowski to answer interrogatories and produce documents related to his failure of the B-Reader examination (Mar. 31, 1988).

[2] “Harry Shubin Obituary,” Phila. Inq. at 25 (Mar. 7, 1997) (Dr. Shbuin died March 2, 1997).

[3] “News from the Field,” 45 Am. J. Pub. Health 1399 (1955).

[4] “Pennsylvania General Hospital,” Phila. Inq. at 29 (Mar. 25, 1958).

[5] “Doctor-Owned Hospital Opens in South Philadelphia,” Phila. Daily News at p.19 (Feb. 5, 1962).

[6] “Medical Center Sells Building,” Phila. Daily News at 57 (May 5, 1961).

[7] Frank Dougherty, “11 Hospitals Cut from Blue Cross,” Phila. Daily News at p.3 (Nov. 14, 1972) (Broad Street Hospital cut).

[8] Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (Mar. 16, 1970).

[9] Phila. Inq. at 5 (Mar. 18, 1981) (Shubin, medical director).

[10] Harry Shubin, “Asbestosis: inhalation disease of the lungs,” 88 Pa. Med. 54, 56, 58 (1985).

[11] See, e.g., “Pat Purcell, Angry Man,” Pottsville Republican (Pottsville, PA) at p.1 (Mar. 14, 1987); Frank Scholz, “Help Coming for Asbestos Victims Living Here,” The Times-Tribune (Scranton, PA Sept. 15, 1985).

[12] Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981). Years later, I met Mr. Nyman at my sister-in-law’s wedding, where he and his wife were dancing vigorously.

[13] Deposition of Mitzie Martin, in Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981), taken on Sept. 5, 1986.

[14] Id. at 3.

[15] Id. at 7.

[16] Id. at 12-13.

[17] Id. at 14.

[18] Id. at 14-15.

[19] Id. at 16-19.

[20] In re Paoli R.R. Yard PCB Litig., 706 F. Supp. 358, 364-65 (E.D. Pa. 1988), rev’d, 916 F.2d 829, 840 (3d Cir. 1990), cert. denied, 111 S. Ct. 1584 (1991).

[21] Susan R. Poulter, “Science and Toxic Torts: Is There a Rational Solution to the Problem of Causation?” 7 High Technology L.J. 189, 238 (1993).

Posted in Asbestos, Expert Witness Hall of Shame, Expert Witnesses | No Comments »

Carl Cranor’s Inference to the Best Explanation

February 12th, 2021

Carl Cranor pays me the dubious honor of quoting my assessment of weight of the evidence (WOE) pseudo-methodology as used by lawsuit industry expert witnesses, in one of his recent publications:

“Take all the evidence, throw it into the hopper, close your eyes, open your heart, and guess the weight. You could be a lucky winner! The weight of the evidence suggests that the weight-of-the-evidence (WOE) method is little more than subjective opinion, but why care if it helps you to get to a verdict!”[1]

Cranor’s intent was to deride my comments, but they hold up fairly well. I have always maintained that if were wrong, I would eat my words, but that they will be quite digestible. Nothing to eat here, though.

In his essay in the Public Affairs Quarterly, Cranor attempts to explain and support his advocacy of WOE in the notorious case, Milward, in which Cranor, along with his friend and business partner, Martyn Smith, served as partisan, paid expert witnesss.[2] Not disclosed in this article is that after the trial court excluded the opinions of Cranor and Smith under Federal Rule of Evidence 702, and plaintiff appealed, the lawsuit industry, acting through The Council for Education and Research on Toxics (CERT) filed an amicus brief to persuade the Court of Appeals to reverse the exclusion. The plaintiffs’ counsel, Cranor and Smith, and CERT failed to disclose that CERT was founded by the two witnesses, Cranor and Smith, whose exclusion was at issue.[3] Many of the lawsuit industry’s regular testifiers were signatories, and none raised any ethical qualms about the obvious conflict of interest, or the conspiracy to pervert the course of justice.[4]

Cranor equates WOE to “inference to the best explanation,” which reductively strips science of its predictive and reproducible nature. Readers may get the sense he is operating in the realm of narrative, not science, and they would be correct. Cranor goes on to conflate WOE methodology with “diagnostic induction,” and “differential diagnosis.”[5] The latter term is well understood in both medicine and in law to involve the assessment of an individual patient’s condition, based upon what is already known upon good and sufficient bases. The term has no accepted or justifiable meaning for assessing general causation. Cranor’s approach would pretermit the determination of general causation by making the disputed cause a differential.

Cranor offers several considerations in support of his WOE-ful methodology. First, he notes that the arguments for causal claims are not deductive. True, but indifferent as to his advocacy for WOE and inference to the best explanation.

Second, Cranor describes a search for relevant evidence once the scientific issue (hypothesis?) is formulated. Again, there is nothing unique about this described step, but Cranor intentionally leaves out considerations of validity, as in extrapolations between high and low dose, or between species. Similarly, he leaves out considerations of validity of study designs (such as whether any weight would be given to case studies, cross-sectional, or ecological studies) or of validity of individual studies.

Cranor’s third step is the formulation of a “sufficiently complete range of reasonable and plausible explanations to account for the evidence.” Again, nothing unique here about WOE, except that Cranor’s WOE abridges the process by ignoring the very real possibility that we do not have the correct plausible explanation available.

Fourth, according to Cranor, scientists rank, explicitly or implicitly, the putative “explanations” by plausibility and persuasiveness, based upon the evidence at hand, in view of general toxicological and background knowledge.[6] Note the absence of consideration of the predictive abilities of the competing explanations, or any felt need to assess the quality of evidence or the validity of study design.

For Cranor, the fifth consideration is to use the initial plausibility assessments, made on incomplete understanding of the phenomena, and on incomplete evidence, to direct “additionally relevant /available evidence to separate founded explanations from less well-founded ones.” Obviously missing from Cranor’s scheme is the idea of trying to challenge or test hypotheses severely to see whether withstand such challenges.

Sixth, Cranor suggests that “all scientifically relevant information” should be considered in moving to the “best supported” explanation. Because “best” is determined based upon what is available, regardless of the quality of the data, or the validity of the inference, Cranor rigs his WOE-ful methodology in favor of eliminating “indeterminate” as a possible conclusion.

In a seventh step, Cranor points to the need to “integrate, synthesize, and assess or evaluate,” all lines of “available relevant evidence.” There is nothing truly remarkable about this step, which clearly requires judgment. Cranor notes that there can be convergence of disparate lines of evidence, or divergence, and that some selection of “lines” of evidence may be endorsed as supporting the “more persuasive conclusion” of causality.[7] In other words, a grand gemish.

Cranor’s WOE-ful approach leaves out any consideration of random error, or systematic bias, or data quality, or study design. The words “bias” and “confounding” do not appear in Cranor’s essay, and he erroneously discusses “error” and “error rates,” only to disparage them as the machinations of defense lawyers in litigation. Similarly, Cranor omits any serious mention of reproducibility, or of the need to formulate predictions that have the ability to falsify tentative conclusions.

Quite stridently, Cranor insists that there is no room for any actual weighting of study types or designs. In apparent earnest, Cranor writes that:

“this conclusion is in accordance with a National Cancer Institute (NCI) recommendation that ‘there should be no hierarchy [among different types of scientific methods to determine cancer causation]. Epidemiology, animal, tissue culture and molecular pathology should be seen as integrating evidences in the determination of human carcinogenicity.”[8]

There is much whining and special pleading about the difficulty, expense, and lack of statistical power of epidemiologic studies, even though the last point is a curious backdoor endorsement of statistical significance. The first two points ignore the availability of large administrative databases from which large cohorts can be identified and studied, with tremendous statistical power. Case-control studies can in some instances be assembled quickly as studies nested in existing cohorts.

As I have noted elsewhere,[9] Cranor’s attempt to level all types of evidence starkly misrepresents the cited “NCI” source, which is not at all an NCI recommendation, but rather a “meeting report” of a workshop of non-epidemiologists.[10] The cited source is not an official pronouncement of the NCI, the authors were not NCI scientists, and the NCI did not sponsored the meeting. The meeting report appeared in the journal Cancer Research as a paid advertisement, not in the NCI’s Journal of the National Cancer Institute as a scholarly article:

“The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.”[11]

Tellingly, Cranor’s deception was relied upon and cited by the First Circuit, in its Milward, decision.[12] The scholarly fraud hit its mark. As a result of Cranor’s own dubious actions, the Milward decision has both both ethical and scholarship black clouds hovering over it. The First Circuit should withdraw the decision as improvidently decided.

The article ends with Cranor’s triumphant view of Milward,[13] which he published previously, along with the plaintiffs’ lawyer who hired him.[14] What Cranor leaves out is that the First Circuit’s holding is now suspect because of the court’s uncritical acceptance of Cranor’s own misrepresentations and CERT’s omissions of conflict-of-interest disclosures, as well as the subsequent procedural history of the case. After the Circuit reversed the Rule 702 exclusions, and the Supreme Court denied the petition for a writ of certiorari, the case returned to the federal district court, where the defense lodged a Rule 702 challenge to expert witness opinion that attributed plaintiff’s acute promyelocytic leukemia to benzene exposure. This specific causation issue was not previously addressed in the earlier proceedings. The trial court sustained the challenge, which left the plaintiff unable to show specific causation. The result was summary judgment for the defense, which the First Circuit affirmed on appeal.[15] The upshot of the subsequent proceedings, with their dispositive ruling in favor of the defense on specific causation, is that the earlier ruling on general causation is no longer necessary to the final judgment, and not the holding of the case when all the proceedings are considered.

In the end, Cranor’s WOE leaves us with a misdirected search for an “explanation of causation,” rather than a testable, tested, reproducible, and valid “inference of causation.” Cranor’s attempt to invoke the liberalization of the Federal Rules of Evidence ignores the true meaning of “liberal” in being free from dogma and authority. Evidence does not equal eminence, and expert witnesses in court must show their data and defend their inferences, whatever their explanations may be.

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[1] Carl F. Cranor, “How Courts’ Reviews of Science in Toxic Tort Cases Have Changed and Why That’s a Good Thing,” 31 Public Affairs Q. 280 (2017), quoting from Schachtman, “WOE-fully Inadequate Methodology – An Ipse Dixit by Another Name” (May 1, 2012).

[2] Milward v. Acuity Specialty Products Group, Inc., 639 F. 3d 11 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).

[3] See “The Council for Education and Research on Toxics” (July 9, 2013).

[4] Among the signatures were Nachman Brautbar, David C. Christiani, Richard W. Clapp, James Dahlgren, Arthur L. Frank, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, David Ozonoff, David Rosner, Allan H. Smith, and Daniel Thau Teitelbaum.

[5] Cranor at 286-87.

[6] Cranor at 287.

[7] Cranor at 287-88.

[8] Cranor at 290.

[9] “Cranor’s Defense of Milward at the CPR’s Celebration” (May 12, 2013).

[10] Michelle Carbone, Jack Gruber, and May Wong, “Modern criteria to establish human cancer etiology,” 14 Semin. Cancer Biol. 397 (2004).

[11] Michele Carbone, George Klein, Jack Gruber and May Wong, “Modern Criteria to Establish Human Cancer Etiology,” 64 Cancer Research 5518 (2004).

[12] Milward v. Acuity Specialty Products Group, Inc., 639 F. 3d 11, 17 (1st Cir. 2011) (“when a group from the National Cancer Institute was asked to rank the different types of evidence, it concluded that ‘[t]here should be no such hierarchy’.”), cert. denied, 132 S.Ct. 1002 (2012).

[13] Cranor at 292.

[14] See “Wake Forest Publishes the Litigation Industry’s Views on Milward” (April 20, 2013).

[15] Milward v. Acuity Specialty Products Group, Inc., 969 F. Supp. 2d 101 (D. Mass. 2013), aff’d sub nom. Milward v. Rust-Oleum Corp., 820 F.3d 469 (1st Cir. 2016).

Posted in Causation, Conflicts of Interest, Public Nuisances, Scientific Evidence, Scientific Misconduct, Systemic Bias | 1 Comment »

On Praising Judicial Decisions – In re Viagra

February 8th, 2021

We live in strange times. A virulent form of tribal stupidity gave us Trumpism, a personality cult in which it impossible to function in the Republican party and criticize der Führe. Even a diehard right-winger such as Liz Cheney, who dared to criticize Trump is censured, for nothing more than being disloyal to a cretin who fomented an insurrection that resulted in the murder of a Capital police officer and the deaths of several other people.[1]

Unfortunately, a similar, even if less extreme, tribal chauvinism affects legal commentary, from both sides of the courtroom. When Judge Richard Seeborg issued an opinion, early in 2020), in the melanoma – phosphodiesterase type 5 inhibitor (PDE5i) litigation,[2] I praised the decision for not shirking the gatekeeping responsibility even when the causal claim was based upon multiple, consistent statistically significant observational studies that showed an association between PDE5i medications and melanoma.[3] Although many of the plaintiffs’ relied-upon studies reported statistically significant associations between PDE5i use and melanoma occurrence, they also found similar size associations with non-melanoma skin cancers. Because skin carcinomas were not part of the hypothesized causal mechanism, the study findings strongly suggested a common, unmeasured confounding variable such as skin damage from ultraviolet light. The plaintiffs’ expert witnesses’ failure to account for confounding was fatal under Rule 702, and Judge Seeborg’s recognition of this defect, and his willingness to go beyond multiple, consistent, statistically significant associations was what made the decision important.

There were, however, problems and even a blatant error in the decision that required attention. Although the error was harmless in that its correction would not have required, or even suggested, a different result, Judge Seeborg, like many other judges and lawyers, tripped up over the proper interpretation of a confidence interval:

“When reviewing the results of a study it is important to consider the confidence interval, which, in simple terms, is the ‘margin of error’. For example, a given study could calculate a relative risk of 1.4 (a 40 percent increased risk of adverse events), but show a 95 percent ‘confidence interval’ of .8 to 1.9. That confidence interval means there is 95 percent chance that the true value—the actual relative risk—is between .8 and 1.9.”[4]

This statement about the true value is simply wrong. The provenance of this error is old, but the mistake was unfortunately amplified in the Third Edition of the Reference Manual on Scientific Evidence,[5] in its chapter on epidemiology.[6] The chapter, which is often cited, twice misstates the meaning of a confidence interval:

“A confidence interval provides both the relative risk (or other risk measure) found in the study and a range (interval) within which the risk likely would fall if the study were repeated numerous times.”[7]

and

“A confidence interval is a range of possible values calculated from the results of a study. If a 95% confidence interval is specified, the range encompasses the results we would expect 95% of the time if samples for new studies were repeatedly drawn from the same population. Thus, the width of the interval reflects random error.”[8]

The 95% confidence interval does represent random error, 1.96 standard errors above and below the point estimate from the sample date. The confidence interval is not the range of possible values, which could well be anything, but the range of reasonable compatible estimates with this one, particular study sample statistic.[9] Intervals have lower and upper bounds, which are themselves random variables, with approximately normal (or some other specified) distributions. The essence of the interval is that no value within the interval would be rejected as a null hypothesis based upon the data collected for the particular sample. Although the chapter on statistics in the Reference Manual accurately describes confidence intervals, judges and many lawyers are misled by the misstatements in the epidemiology chapter.[10]

Given the misdirection created by the Federal Judicial Center’s manual, Judge Seeborg’s erroneous definition of a confidence interval is understandable, but it should be noted in the context of praising the important gatekeeping decision in In re Viagra. Certainly our litigation tribalism should not “allow us to believe” impossible things.[11] The time to revise the Reference Manual is long overdue.

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[1] John Ruwitch, “Wyoming GOP Censures Liz Cheney For Voting To Impeach Trump,” Nat’l Pub. Radio (Feb. 6, 2021).

[2] In re Viagra (Sildenafil Citrate) and Cialis (Tadalafil) Prods. Liab. Litig., 424 F. Supp. 3d 781 (N.D. Cal. 2020) [Viagra].

[3] See “Judicial Gatekeeping Cures Claims That Viagra Can Cause Melonoma” (Jan. 24, 2020).

[4] Id. at 787.

[5] Federal Judicial Center, Reference Manual on Scientific Evidence (3rd ed. 2011).

[6] Michael D. Green, D. Michal Freedman, & Leon Gordis, “Reference Guide on Epidemiology,” in Federal Judicial Center, Reference Manual on Scientific Evidence 549 (3rd ed. 2011).

[7] Id. at 573.

[8] Id. at 580.

[9] Michael O. Finkelstein & Bruce Levin, Statistics for Lawyers 171, 173-74 (3rd ed. 2015). See also Sander Greenland, Stephen J. Senn, Kenneth J. Rothman, John B. Carlin, Charles Poole, Steven N. Goodman, and Douglas G. Altman, “Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations,” 31 Eur. J. Epidem. 337 (2016).

[10] See, e.g., Derek C. Smith, Jeremy S. Goldkind, and William R. Andrichik, “Statistically Significant Association: Preventing the Misuse of the Bradford Hill Criteria to Prove Causation in Toxic Tort Cases,” 86 Defense Counsel J. 1 (2020) (mischaracterizing the meaning of confidence intervals based upon the epidemiology chapter in the Reference Manual).

[11] See, e.g., James Beck, “Tort Pandemic Countermeasures? The Ten Best Prescription Drug/Medical Device Decisions of 2020,” Drug and Device Law Blog (Dec. 30, 2020) (suggesting that Judge Seeborg’s decision represented the rejection of plausibility and a single “association” as insufficient); Steven Boranian, “General Causation Experts Excluded In Viagra/Cialis MDL,” (Jan. 23, 2020).

Posted in Confounding, Reference Manual on Scientific Evidence, Rule 702, statistical evidence | No Comments »

American Law Institute – Medical Monitoring vs. Medical Mongering

February 5th, 2021

One of the key activities of the American Law Institute (ALI) has been the researching, writing, and publication of Restatements.[1] According to the ALI’s website, the basic idea was that the ALI “should address uncertainty in the law through a restatement of basic legal subjects that would tell judges and lawyers what the law was.” This self-appointed task has a huge influence on the development of the law in the United States, and indeed around the world, mostly for the better. Restatements can and often do reduce uncertainty and eliminate unnecessary complexity and obfuscation. The ALI also holds itself out “promote those changes which will tend better to adapt the laws to the needs of life.” The ALI has thus characterized its Restatements as having a “critical and constructive” goal as well as a clarifying and simplifying function.

This ambiguity in its mission statement makes ALI Restatement provisions occasionally controversial on occasion. Controversy can arise from the ALI’s addressing factual situations “not yet discussed by courts or dealt with by legislatures….” Perhaps more disconcerting, however, are situations that have been addressed by courts and legislatures at length, but where the ALI attempts to impose its policy judgments in place of those that carry the imprimatur of a majority of jurisdictions in the United States.

Take the ALI’s recently proposed “restatement” [sic] of medical monitoring law in the Restatement (Third) of Torts: Concluding Provisions:[2]

“A person can recover for medical monitoring expenses, even absent present bodily harm, if:

(a) an actor’s tortious conduct has exposed a person to a significant risk of serious future bodily harm;

(b) the exposure makes medical monitoring reasonable and necessary in order to prevent or mitigate the future bodily harm;

(c) the person has incurred the monitoring expense, will incur the monitoring expense, or would incur the monitoring expense if he or she could afford it; and;

(d) the actor’s liability is not indeterminate.”

Remarkably, the ALI has “restated” the law of medical monitoring to dispense with the requirement of present injury. The ALI Council Draft claims a slim majority of courts favor the abandonment of a present injury predicate, but the scholarship for this claim is shaky at best, as shown in an important recent article by Mark Behrens and Christopher Appel.[3]

Each subpart of the ALI’s proposed rule is problematic. Subpart (a) creates a requirement of “significant risk of serious future bodily harm.” Although there might be general agreement on what is serious bodily harm, the predicate of “significant risk” is incredibly vague. Risk is undefined, and by all rights should represent a cause ex ante, but the lawsuit industry often uses “risk” to connote a possible cause. At the very least, the ALI should clarify that the risk of subpart (a) is one that would pass muster as a general cause under the relevant substantive and evidentiary law. Furthermore, what might appear to be a “significant” risk, may be trivial. Consider an exposure to amphibole asbestos that doubled the risk of mesothelioma. If the baseline annual risk of mesothelioma were one in a million, the exposed claimant would consequently have a two in a million risk. A doubling of risk sounds significant and ominous, but the absolute annual attributable risk would be one in a million. The rule leaves open whether the significance of risk should be evaluated by subjective reactions of the jury, or some quantitative measure. If the latter, the rule leaves open whether the measure is relative or absolute risk.

Subpart (b) specifies that “the exposure makes medical monitoring reasonable and necessary in order to prevent or mitigate the future bodily harm.” Some medical monitoring regimens can allow for earlier interventions that are potentially curative, but others simply increase the time between diagnosis and death by moving up the diagnosis date. This subsection leaves open exactly what counts as mitigation of the future harm.

Subpart (c) ignores that many medical monitoring regimes are already a potential claimant’s personal responsibility, and they involve procedures that are covered by health insurance contracts. Given that any “significant risk” would not change the pre-existing need for such screening procedures as mammography in women, prostate-specific antigen in men, lung cancer screening in adults who have engaged in habitual tobacco self-abuse, and the like, this subpart leaves unclear why and how the burden paying for such routine screening should be shifted to the alleged tortfeasor.

Subpart (d) specifies that the rule would not apply if the defendant’s liability is indeterminate, presumably because of the number of potential claimants. Comment g to the Council’s draft provision attempts to explain:

“defendant whose conduct exposes a vast number of people to risk-creating agents or behaviors is not subject to liability for medical monitoring if the defendant is able to show that liability would be highly unpredictable and virtually unlimited.”[4]

Comment g goes on to suggest that the proposed rule would not apply if the liability it creates were:

“likely to exceed the defendant’s resources and insurance coverage and thereby meaningfully reduce monies available to those exposed persons who ultimately develop bodily harm.”[5]

What subpart (d) leaves unclear is how the defendant is suppose to satisfy this burden to prove “indeterminancy.” If the first case in court is one individual’s claim for medical monitoring costs, how does the defendant show that the aggregate liability will become indeterminate at some later date? Is the defendant suppose to present evidence of its insurance coverage, and perhaps interplead its carrier who had denied coverage? Comment g suggests a completely unworkable proof scheme for trial.

One of the key limitations on strict liability was its requirement of “physical harm.” As the Restatement (Second) of Torts made clear:

“harm implies a loss or detriment to a person, and not a mere change or alteration in some physical person, object, or thing. Physical changes or alterations may be either beneficial, detrimental, or of no consequence to a person. In so far as physical changes have a detrimental effect on a person that person suffers harm.”[6]

For this reason, juries are permitted to return no cause or no damage verdicts in cases brought by asbestos claimants with pleural plaques or pleural thickening without pulmonary impairment.[7]

Although not universal, the better rule, which the ALI should adopt, was articulated by the United States Supreme Court, in Metro-North Commuter Railroad v. Buckley,[8] when it rejected medical monitoring claims for asymptomatic asbestos claimants. In Buckley, the Court acknowledged[9] the obvious without relegating it to an affirmative defense: unlimited and unpredictable liability is sufficient reason in the abstract to going down the road of imposing medical monitoring liability.

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[1] See Am. L. Inst., Capturing the Voice of The American Law Institute: A Handbook for ALI Reporters and Those Who Review Their Work 3 (rev. ed. 2015).

[2] Restatement (Third) of Torts: Concluding Provisions, Council Draft No.

1, Medical Monitoring (Aug. 24, 2020); Restatement (Third) of Torts: Concluding Provisions, Prelim. Draft No. 1, Medical Monitoring (Feb. 3, 2020).

[3] Mark A. Behrens & Christopher E. Appel, “American Law Institute Proposes Controversial Medical Monitoring Rule in Final Part of Torts Restatement,” 87 Defense Counsel J. 1 (2021).

[4] Id. at cmt. g.

[5] Id.

[6] Restatement (Second) of Torts § 7 (1965).

[7] See, e.g., Caterinicchio v. Pittsburgh Corning Corp., 127 N.J. 428, 605 A.2d 1092 (1992) (rejecting claim that pleural thickening is an injury as a matter of law that requires the assessment of damages). See also James Beck & Mark Herrmann, “No Injury Cheat Sheet,” Drug & Device Law Blog (July 3, 2008).

[8] Metro-North Commuter R.R. v. Buckley, 521 U.S. 424, 433 (1997).

[9] Id. at 433 (quoting Consolidated Rail Corp. v. Gottshall, 512 U. S. 532, 557 (1994)). See also Herbert L. Zarov, Sheila Finnegan, Craig A. Woods, and Stephen J. Kane, “A Medical Monitoring Claim for Asymptomatic Plaintiffs: Should Illinois Take the Plunge?” 12 DePaul J. Health Care L. 1 (2009).

Posted in Medical monitoring, Risk and Risk Factor | 175 Comments »

Lawsuit Industry Advertising Indirectly Stimulates Adverse Event Reporting

February 4th, 2021

The lawsuit industry spends many millions of dollars each year to persuade people that they are ill from the medications they use, and that lawsuit industry lawyers will enrich them for their woes. But does the lawyer advertising stimulate the reporting of adverse events by consumers’ filing of MedWatch reports in the Federal Adverse Event Reporting System (FAERS)?

The question is of some significance. Adverse event reporting is a recognized, important component of pharmacovigilence. Regulatory agencies around the world look to an increased rate of reporting of a specific adverse event as a potential signal that there may be an underlying association between medication use and the reported harm. In the last two decades, pharmacoepidemiologists have developed techniques for mining databases of adverse event reports for evidence of a disproportionate level of reporting for a particular medication – adverse event pair. Such studies can help identify “signals” of potential issues for further study with properly controlled epidemiologic studies.[1]

One of the vexing misuses of pharmacovigilance techniques in the pharmaceutical products litigation is the use of adverse events reporting, either as case reports or in the form of disproportionality analyses to claim causal inference. In some litigations, lawsuit industry lawyers have argued that case reports, in the FAERS, standing alone support their claims of causation.[2] Desperate to make their case through anecdotes, plaintiffs’ counsel will sometimes retreat to the claim that they want to introduce the MedWatch reports in support of a lesser claim that the reports put the defendant on “notice.” Typically, the notice argument leaves open exactly what the content of the notice is, but the clear intent is to argue notice that (1) there is an increased risk, and (2) the defendant was aware of the increased risk.[3]

Standard textbooks on pharmacovigilance and pharmacoepidemiology, as well as regulatory agency guidance, emphatically reject the use of FAERS anecdotes or their transmogrification into disportionality analyses (DPAs) to support causal claims. The U.S. FDA’s official guidance on good pharmacovigilance practices, for example, elaborates on DPAs as an example of data mining, and instructs us that:

“[d]ata mining is not a tool for establishing causal attributions between products and adverse events.”[4]

The FDA specifically cautions that the signals detected by data mining techniques should be acknowledged to be “inherently exploratory or hypothesis generating.”[5] The agency exercises caution when making its own comparisons of adverse events between products in the same class because of the low quality of the data themselves, and uncontrollable and unpredictable biases in how the data are collected.[6] Because of the uncertainties in DPAs, the FDA urges “extreme causation” in comparing reporting rates, and generally considers DPA and similar analyses as “exploratory or hypothesis-generating.”[7]

The European Medicines Agency offers similar advice and caution:

“Therefore, the concept of SDR [Signal of Disproportionate Reporting] is applied in this guideline to describe a ‘statistical signal’ that has originated from a statistical method. The underlying principle of this method is that a drug–event pair is reported more often than expected relative to an independence model, based on the frequency of ICSRs on the reported drug and the frequency of ICSRs of a specific adverse event. This statistical association does not imply any kind of causal relationship between the administration of the drug and the occurrence of the adverse event.”[8]

Because the lawsuit industry frequently relies upon and over-endorses DPAs in its pharmaceutical litigations, inquiring minds may want to know whether the industry itself is stimulating reporting of adverse events through its media advertising.

Recently, two investigators published a study that attempted to look at whether lawsuit industry advertising was associated with stimulation of adverse event reporting in the FAERS.[9] Tippett and Chen conducted a multivariate regression analysis of FAERS reporting with independent variables of Google searches, attorney advertising, and FDA actions that would affect reporting over the course of a single calendar year (mid-2015 to mid-2016). The authors analyzed 412,901 adverse event reports to FAERS, involving 28 groups of drugs that were the subject of solicitous advertising.

The authors reported that they found associations (statistically significant, p < 0.05) for regression coefficients for FDA safety actions and Google searches, but not for attorney advertising. Using lag periods of one, two, three, and four weeks, or one or two months, between FAERS reporting and the variables did not result in statistically significant coefficients for lawyer advertising.

The authors variably described their finding as “preliminarily” supporting a claim that FAERS reporting is not stimulated by “direct attorney submission or drug injury advertising,” or as failing to find “a statistically significant relationship between drug injury advertising and adverse event reports.”[10] The authors claim that their analyses show that litigation advertisements “do not appear to have spurred patients, providers, attorneys, or other individuals to file a FAERS report, as shown in our regression and graphical results.”[11]

There are substantial problems with this study. For most of the 28 drugs and drug groups studied, attorneys made up a very small proportion of all submitters of adverse event reports. The authors present no pre-study power analysis for this aspect of their study. The authors do not tell us how many analyses they have done before the one presented in this journal article, but they do acknowledge having done “exploratory analyses.” Contrary to the 2016 guidance of the American Statistical Association,[12] they present no actual p-values, and they provide no confidence or prediction intervals for their coefficients. The study did not include local television advertising, and so the reported statistical non-significance of attorney advertising must be qualified to show the limitations of the authors’ data.

Perhaps the most serious problem with this observational study of attorney advertising and stimulated reporting is the way in which the authors framed their hypothesis. Advertising stimulates people to call the toll-free number to learn more how they too may hit the litigation jackpot. The point of attorney advertising is designed to persuade people to become legal clients, not to file MedWatch forms. In the following weeks and months that follow, paralegals interview the callers, collect information, and only then FAERs happen. Lag times of one to four weeks are generally irrelevant, as is the hypothesis studied and reported upon in this article.

After decades of working in this area, I have never seen an advertisement that encourages filing a MedWatch report, and the authors do not suggest otherwise. Advertising is only the initial part of a client intake mechanism that would result in the viewers’ making a telephone call, with a subsequent interview by lawfirm personnel, a review of the putative claim, and the viewers’ obtaining and signing retainer agreements and authorizations to obtain medical records. The scope of the study, which looked at FAERS filings and attorney advertisements after short lag periods could not detect an association given how long the recruitment takes.

The authors speculate, without evidence, that the lawsuit industry may discourage their clients from filing MedWatch reports and that the industry lawyers may hesitate to file the reports to avoid serving as a fact witness in their client’s case.[13] Indeed, the authors themselves adduce compelling evidence to the contrary, in the context of the multidistrict litigation over claimed harms from the use of testosterone therapies.

In their aggregate analysis of the 28 drugs and drug groups, the authors found that the lawsuit industry submitted only six percent of MedWatch reports. This low percentage would have been much lower yet but for the very high proportion (68%) of lawyer-submitted reports concerning the use of testosterone. The litigation-driven filings lagged the relevant attorney advertising by about six months, which should have caused the authors to re-evaluate their conclusions and their observational design that looked for correlations within one or two months. The testosterone data shows rather clearly that attorney advertising leads to recruitment of clients, which in turn leads to the filing of litigation-driven adverse event reports.

As the authors explain, attorney advertising and trolling for clients occurred in the summer of 2015, but FAERS reporting did not increase until an extreme burst of filings took place several months later. The authors’ graph tells the story even better:

So the correct conclusion is that attorney advertising stimulates client recruitment, which results in mass filings of MedWatch reports.

___________________________________________________________________

[1] Sean Hennessy, “Disproportionality analyses of spontaneous reports,” 13 Pharmacoepidemiology & Drug Safety 503, 503 (2004). See also “Disproportionality Analyses Misused by Lawsuit Industry” (Apr. 20, 2020).

[2] See, e.g., Fred S. Longer, “The Federal Judiciary’s Super Magnet,” 45 Trial 18, 18 (July 2009) (arguing that “adverse events . . . established a causal association between Piccolomal and liver disease at statistically significant levels”).

[3] See, e.g., Paul D. Rheingold, “Drug Products Liability and Malpractice Cases,” 17 Am. Jur. 1, Trials, Cumulative Supplement (1970 & Supp. 2019) (“Adverse event reports (AERs) created by manufacturers when users of their over-the-counter pain reliever experienced adverse events or problems, were admissible to show notice” of the elevated risk.).

[4] FDA, “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance for Industry” at 8 (2005) (emphasis added).

[5] Id. at 9.

[6] Id.

[7] Id. at 11.

[8] EUDRAVigilance Expert Working Group, European Medicines Agency, “Guideline on the Use of Statistical Signal Detection Methods in the EUDRAVigilance Data Analysis System,” at 3 (2006) (emphasis added). See also Gerald J. Dal Pan, Marie Lindquist & Kate Gelperin, “Postmarketing Spontaneous Pharmacovigilance Reporting Systems,” in Brian L. Strom & Stephen E. Kimmel and Sean Hennessy, Pharmacoepidemiology at 185 (6th ed. 2020).

[9] Elizabeth C. Tippett & Brian K. Chen, “Does Attorney Advertising Stimulate Adverse Event Reporting?” 74 Food & Drug Law J. 501 (2020) [Tippett].

[10] Id. at 502.

[11] Id.

[12] Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The Am. Statistician 129 (2016).

[13] Tippett at 591.

Posted in Causation, Confounding | 361 Comments »

Center for Truth in Science

February 2nd, 2021

The Center for Truth in Science

Well, now I have had the complete 2020 experience, trailing into 2021. CoVid-19, a.k.a. Trump flu happened. The worst for me is now mostly over, and I can see a light at the end of the tunnel. Fortunately it is not the hypoxemic end-of-life light at the end of the tunnel.

Kurt Gödel famously noted that the “the meaning of world is the separation of wish and fact.” The work of science in fields that touch on religion, politics, and other dogmas requires nothing less than separating wish from fact. Sadly, most people are cut off from the world of science by ignorance, lack of education, and social media that blur the distinction between wish and fact, and ultimately replace the latter with the former.

It should go without saying that truth is science and science is truth, but our current crises show that truth and science are both victims of the same forces that blur wish with fact. We might think that a center established for “truth in science” is as otiose as a center for justice in the law, but all the social forces at work to blur wish and fact make such a center an imperative for our time.

The Center for Truth in Science was established last year, and has already weighed in on important issues and scientific controversies that occupy American courtrooms and legislatures. Championing “fact-based” science, the Center has begun to tackle some of the difficult contemporary scientific issues that loom large on the judicial scene – talc, glyphosate, per- and polyfluoroalkyl substances, and other – as well as methodological and conceptual problems that underlie these issues. (Of course, there is no other kind of science than fact-based, but there are many pseudo-, non-fact based knock offs out there.) The Center has already produced helpful papers on various topics, with many more important papers in progress. The Center’s website is a welcomed resource for news and insights on science that matters for current policy decisions.

The Center is an important and exciting development, and its work promises to provide the tools to help us separate wish from fact. Nothing less than the meaning of the world is at stake.

Posted in Evidence, Scientific Evidence, Scientific Publishing, Uncategorized | Comments Off on Center for Truth in Science

Lawsuit Industry Expert Witness Robert Neel Proctor’s Intimidation Tactics

December 25th, 2020

In his autobiography, Sir Karl Popper described one of the most curious and interesting confrontations in 20th century philosophy. While visiting Cambridge University to give a guest lecture, Popper was hectored by the renown chairman of the philosophy department, Ludwig Wittgenstein. While nervously playing with a fireplace poker and waving it about for emphasis, Wittgenstein challenged Popper to provide an example of a moral rule. Popper rejoined “Not to threaten visiting lecturers with pokers,” after which Wittgenstein threw down the poker and stormed out of the room.[1]

A more recent anecdote in this century gives rise to another moral rule, “thou shalt not bully graduate students working for your adversary.”

The law firm of Jones Day, representing tobacco mega-defendant R. J. Reynolds in personal injury lawsuits, was working with Associate Professor Gregg L. Michel, at the University of Texas. Michel needed research assistants to help with this litigation consulting work, and so in 2008, he reached out to J. Matthew Gallman, a professor of history at the University of Florida, to help line up some worker bees. Gallman helped Michel hire four master-level graduate students from Gallman’s department.

Tobacco lawsuit industry testifier Associate Professor Louis M. Kyriakoudes, at University of Southern Mississippi, learned of the arrangement from his involvement in tobacco litigation. Kyriakoudes shared the information with his fellow-traveling expert witness for tobacco plaintiffs, Robert Neel Proctor.

There was no impropriety in Michel’s hiring the graduate students to assist with his research. Parties are allowed to have consulting expert witness, if for no other reason than to test the accuracy of the other side’s expert witness’s opinions. The research assignment involved searching the archives of a local Pensacola newspaper, in the 1940s, for coverage of smoking’s ill health effects. According to Gallman, the students were “explicitly told not to be selective,” to favor one party or the other.

Proctor was, and still is, a highly paid expert witness for the tobacco lawsuit industry, that is the plaintiffs’ bar, and a regular feature of tobacco trials. After learning the names of the graduate students from his litigation work, Proctor in turn contacted Professor Vassiliki Betty Smocovitis, who held joint appointments in the University of Florida history and biology departments.[2]

In a fairly obvious effort to intimidate and harass the students, Proctor revealed the students’ names to Smocovitis, and pressed his tendentious, gratuitous opinion:

“In my view this is historical malpractice, and I would be very interested to know if the advisers of these students know what they have been doing.”

Smocovitis, who had never been involved in litigation as a partisan expert witness, dutifully carried out the inquiry for Proctor, only to find, unsurprisingly, that her colleagues did not believe that the students had done anything improper. According to her emails, Smocovitis reported back to Proctor that her departmental colleagues were indifferent or annoyed or both for her having bothered them with Proctor’s issue. She told Proctor that “I’m afraid that this is a case of ‘shoot the messenger’, so I can’t persist without alienating myself further,” She resisted Proctor’s importuning to raise the issue at a faculty meeting.

Lawyers at Jones Day sought emails of Proctor and Kyriakoudes from their university servers, and ultimately took depositions of Proctor and Kyriakoudes, the plaintiffs’ expert witnesses, and Smocovitis, in support of motions to sanction Proctor. Michel filed an affidavit in which he described how one of the four students had been led to believe by her departmental chairman, Joseph F. Spillane, that Proctor intended to publish her name.

Kyriakoudes, who dropped the dime on the graduate students, suggested in his deposition that Proctor’s intrusion into the University of Florida department was a “tactical mistake.” According the Chronicle of Higher Education, he testified that “[t]his whole business of getting involved in a department’s activities like this is just—it’s caused no end of trouble.”

In his own deposition, Proctor described the communications as:

“legitimate scholarly inquiry into the participation of historians in litigation.”

* * *

“I was simply raising an ethical issue that she might want to discuss.”

Sort of like Trump’s perfect conversation with President Volodymyr Zelensky. In Trumpian turn-around, Proctor complained that he was real victim of witness harassment and bullying by the defense counsel, in an effort to “silence him.” Ah, the flexibility of historical narrative!

What really seemed to irk Proctor was that any historian, even master-level graduate students, would disagree with him, or find historical evidence that embarrassed Proctor’s litigation positions. Proctor’s blindness to his own bad behavior in the recent past, certainly raises questions about his historical acumen.

Proctor’s play at grievance victimhood was amplified by the obsequious scholarship of Jon Wiener. In the pages of The Nation, Wiener incorrectly reported that “[n]othing improper was found, no witness tampering or intimidation, and the tobacco attorneys dropped the issue–for a while.”[3] In fact, as an historical matter, Wiener was quite wrong.

Judgment Day

The Jones Day lawyers’ motion claimed that Proctor’s improprieties was part of a pattern of behavior that stemmed from his “uncontrolled zeal to win.” Proctor, a paid advocate for the tobacco lawsuit industry, thought it was within his mandate to expose the connection between tobacco defense and historians. In doing so, he engaged in witness tampering and harassment. Proctor and his employers in the lawsuit industry responded with an attempt to portray Proctor’s ham-fisted inquiries as concern for the vulnerable graduate students who were not receiving “guidance,” which would impair their future careers.

The Motion contra Proctor came before Judge Williams Parsons, in the Volusia County Circuit Court.[4] Contrary to the Wiener report, Judge Parsons found that Proctor indeed had intended to harass and humiliate the students into abandoning their litigation support work. Judge Parsons described Proctor’s willingness to advance the plaintiffs’ case at the students’ expense as “appalling,” and “the lowest of the low.” The defense had sought Proctor’s exclusion, but Judge Parsons declined to impose this extreme sanction in favor of barring Proctor from having any contact with adversary expert witnesses or their assistants.

Conduct the following thought experiment. Imagine an historian who testifies for the defense in tobacco litigation finds out that Proctor had hired graduate students to help with research. The defense historian calls up the students’ supervisors to suggest that they are acting unethically and unprofessionally. Now close your eyes and listen to the outcry from the Wieners of the world, or from the American Historical Association! Even after the ugly facts were disclosed, there were some in in the academic historian establishment who rallied to Proctor’s defense, and tried to give Wiener cover for his mendacious coverage of the graduate student incident.[5]

Lancet-ing Adversary Expert Witnesses

Proctor’s attempt to exploit vulnerable history graduate students was not his first attempt to silence historians who disagree with him. Proctor, who has stridently criticized tobacco defense counsel for trying to “silence him,” has worked assiduously to try to silence historians who work for the other side. In a commentary piece in The Lancet, Proctor criticized colleagues who have worked on historical issues for tobacco companies’ legal defense.[6] Proctor substantively criticized his adversaries’ testimony, without providing much in the way of detail, and he implied that their work was ethically improper and rife with conflicts of interest. Perhaps more telling, Proctor himself gave conflicts disclosure that he had “worked on several occasions as an expert witness in plaintiff’s lawsuits,” without telling his readers that he was highly compensated for work.

Proctor’s one-sided analysis provoked spirited opposition from several distinguished medical historians who refused to be bullied or to acquiesce in his moral grandstanding. John C. Burnham, a Professor of History at The Ohio State, wrote a scathing letter to the Lancet’s editors, as well as opinion pieces in History News Network.[7] David Rothman, a professor at Columbia University, similarly took Proctor to task for his pretensions of doing “history” while testifying for the lawsuit industry.[8]

Perhaps the most telling rebuttal came from Professor Alan Blum, a physician and anti-tobacco activist. Dr. Blum, who is the Director of Center for the Study of Tobacco & Society, and a chaired professor at the University of Alabama, is a leading authority on the history of tobacco use and the depradations of the tobacco industry. Professor Blum found Proctor’s animadversions a bit too sanctimonious given that Proctor himself has been a compensated expert witness for the tobacco lawsuit industry.[9]

Conflicted Friends of the Court

The friend of the court brief, from disinterested third parties, is an important, potentially useful source of extra-record information and opinion for judges, both in trial and appellate courts. Historians can on occasion have important historical information, necessary for adjudication. For instance, in the theocratic zeal to strip women of their reproductive rights, historians have adduced important scholarship that abortion was lawful in all thirteen colonies at the time of the Constitutional ratification. In the context of amicus briefs, historians of course can and do overstep their distinterested roles to act as legal advocates.[10]

Speaking of overstepping, Robert Proctor filed an amicus brief in Altria Group, Inc. v. Good, which involved a tobacco industry’s challenge to Federal Trade Commission control of advertising for “light” or “lowered tar” cigarettes.[11] Accompanying Proctor were four other signatories, Allan M. Brandt, David M. Burns, Jonathan M. Samet and David Rosner.

All except for Brandt had testified multiple times as expert witnesses. Brandt, Proctor, and Samet acknowledged having testified as expert witnesses in United States v. Philip Morris USA, Inc.[12] They all conveniently forgot to note that they were remunerated, and that they had testified against Philip Morris USA, Inc. Burns, who testified as an expert witness in United States v. Philip Morris USA, Inc., failed to mention his testimonial role in that case, as well as many other tobacco cases in support of the lawsuit industry. Rosner, who had not testified in tobacco cases, failed to mention his many paid testimonial adventures for the lawsuit industry.[13]

[1] Karl Popper, Unended Quest: An Intellectual Autobiography at 141-43 (rev. ed. 2005), first published as “Autobiography by Karl Popper,” in Paul Arthur Schlipp, ed., The Philosophy of Karl Popper (1974). The incident is the subject of a book-long inquiry. David Edmonds & John Eidinow, Wittgenstein’s Poker: The Story of a Ten-Minute Argument Between Two Great Philosophers (2001).

[2] Peter Schmidt, “Big Tobacco Strikes Back at Historian in Court,” The Chronicle of Higher Education (Nov. 8, 2009).

[3] Jon Wiener, “Big Tobacco and the Historians: A tale of seduction and intimidation,” The Nation (Feb. 25, 2010).

[4] Nathan Crabbe, “UF students caught in middle of tobacco case’s controversy,” The Gainesville Sun (Dec 8, 2009).

[5] See “More debate over Jon Wiener’s tobacco exposé,” History News Network (Dec. 13, 2010).

[6] Robert N. Proctor, “Should medical historians be working for the tobacco industry?” 363 Lancet 1173 (2004).

[7] John C. Burnham, “Medical historians and the tobacco industry,” 364 Lancet 838 (2004); John C. Burnham, “In Defense of Historians as Expert Witnesses: A Rebuttal to Jon Wiener,” History News Network (Mar. 29, 2010).

[8] David Rothman, “Medical historians and the tobacco industry,” 364 Lancet 839 (2004). See also Patricia Cohen, “Historians for Hire in Industry Lawsuits,” N.Y. Times (June 13, 2003) (quoting David J. Rothman, director of the Center for the Study of Science and Medicine at the Columbia College of Physicians and Surgeons, concludes, “To enter the courtroom is to do many things, but it is not to do history”).

[9] Alan Blum, “A Dissenting View of Robert Proctor by a Fellow Anti-Smoking Advocate,” History Network News (April 26, 2010).

[10] Nell Gluckman, “Why More Historians Are Embracing the Amicus Brief,” The Chronicle of Higher Education (May 3, 2017) (quoting Harvard history professor Tomiko Brown-Nagin’s observation that “[t]o be a legal advocate is freeing”; Brown-Nagin filed an amicus brief in the 2013 Supreme Court case involving racist policies at the University of Texas).

[11] Amicus Brief of Allan M. Brandt, Robert N. Proctor, David M. Burns, Jonathan M. Samet & David Rosner, in Support of Petition for Certiorari, in Altria Group, Inc. v. Good, No. 07-562, 2008 WL 2472390, (U.S. Supreme Court June 18, 2008).

[12] United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D.D.C. 2006).

[13] “The Amicus Curious Brief” (Jan. 4, 2018) (describing Rosner and many other plaintiffs’ expert witnesses’ failure to disclose their testimonial conflicts of interest when writing and filing an amicus brief in litigation that directly affected the economic viability of their testimony in asbestos cases for the lawsuit industry).

Posted in Expert Witness Discovery, Expert Witnesses, Historian Testimony | Comments Off on Lawsuit Industry Expert Witness Robert Neel Proctor’s Intimidation Tactics

Susan Haack on Judging Expert Testimony

December 19th, 2020

Susan Haack has written frequently about expert witness testimony in the United States legal system. At times, Haack’s observations are interesting and astute, perhaps more so because she has no training in the law or legal scholarship. She trained in philosophy, and her works no doubt are taken seriously because of her academic seniority; she is the Distinguished Professor in the Humanities, Cooper Senior Scholar in Arts and Sciences, Professor of Philosophy and Professor of Law at the University of Miami.

On occasion, Haack has used her background and experience from teaching about epistemology to good effect in elucidating how epistemiologic issues are handled in the law. For instance, her exploration of the vice of credulity, as voiced by W.K. Clifford,[1] is a useful counterweight to the shrill agnotologists, Robert Proctor, Naomi Oreskes, and David Michaels.

Professor Haack has also been a source of confused, fuzzy, and errant advice when it comes to the issue Rule 702 gatekeeping. Haack’s most recent article on “Judging Expert Testimony” is an example of some unfocused thinking about one of the most important aspect of modern litigation practice, admissibility challenges to expert witness opinion testimony.[2]

Uncontroversially, Haack finds the case law on expert witness gatekeeping lacking in “effective practical guidance,” and she seeks to offer courts, and presumably litigants, “operational help.” Haack sets out to explain “why the legal formulae” are not of practical use. Haack notes that terms such as “reliable” and “sufficient” are qualitative, and vague,[3] much like “obscene” and other adjectives that gave the courts such a difficult time. Rules with vague terms such as these give judges very little guidance. As a philosopher, Haack might have noted that the various judicial formulations of gatekeeping standards are couched as conclusions, devoid of explanatory force.[4] And she might have pointed out that the judicial tendency to confuse reliability with validity has muddled many court opinions and lawyers’ briefs.

Focusing specifically on the field of epidemiology, Haack attempts to help courts by offering questions that judges and lawyers should be asking. She tells us that the Reference Manual for Scientific Evidence is of little practical help, which is a bit unfair.[5] The Manual in its present form has problems, but ultimately the performance of gatekeepers can be improved only if the gatekeepers develop some aptitude and knowledge in the subject matter of the expert witnesses who undergoing Rule 702 challenges. Haack seems unduly reluctant to acknowledge that gatekeeping will require subject matter expertise. The chapter on statistics in the current edition of the Manual, by David Kaye and the late David Freeman, is a rich resource for judges and lawyers in evaluating statistical evidence, including statistical analyses that appear in epidemiologic studies.

Why do judges struggle with epidemiologic testimony? Haack unwittingly shows the way by suggestion that “[e]pidemiological testimony will be to the effect that a correlation, an increased relative risk, has, or hasn’t, been found, between exposure to some substance (the alleged toxin at issue in the case) and some disease or disorder (the alleged disease or disorder the plaintiff claims to have suffered)… .”[6] Some philosophical parsing of the difference between “correlation” and “increased risk” as two very different things might have been in order. Haack suggests an incorrect identity between correlation and increased risk that has confused courts as well as some epidemiologists.

Haack suggests asking various questions that are fairly obvious such as the soundness of the data, measurements, study design, and data interpretation. Haack gives the example of failing to ascertain exposure to an alleged teratogen during first trimester of pregnancy as a failure of study design that could obscure a real association. Curiously she claims that some of Merrell Dow’s studies of Bendectin did such a thing, not by citing to any publications but to the second-hand accounts of a trial judge.[7] Beyond the objectionable lack of scholarship, the example comes from a medication exposure that has been as exculpated as much as possible from the dubious litigation claims made of its teratogenicity. The misleading example begs the question why choose a Bendectin case, from a litigation that was punctuated by fraud and perjury from plaintiffs’ expert witnesses, and a medication that has been shown to be safe and effective in pregnancy?[8]

Haack balks when it comes to statistical significance, which she tells us is merely based upon a convention, and set “high” to avoid false alarms.[9] Haack’s dismissive attitude cannot be squared with the absolute need to address random error and to assess whether the research claim has been meaningfully tested.[10] Haack would reduce the assessment of random error to the uncertainties of eyeballing sample size. She tells us that:

“But of course, the larger the sample is, then, other things being equal, the better the study. Andrew Wakefield’s dreadful work supposedly finding a correlation between MMR vaccination, bowel disorders, and autism—based on a sample of only 12 children — is a paradigm example of a bad study.”[11]

Sample size was the least of Wakefield’s problems, but more to the point, in some study designs for some hypotheses, a sample of 12 may be quite adequate to the task, and capable of generating robust and even statistically significant findings.

Inevitably, Haack alights upon personal bias or conflicts of interest, as a subject of inquiry.[12] Of course, this is one of the few areas that judges and lawyers understand all too well, and do not need encouragement to pursue. Haack dives in, regardless, to advise asking:

“Do those who paid for or conducted a study have an interest in reaching a given conclusion (were they, for example, scientists working for manufacturers hoping to establish that their medication is effective and safe, or were they scientists working, like Wakefield, with attorneys for one party or another)?”[13]

Speaking of bias, we can detect some in how Haack frames the inquiry. Do scientists work for manufacturers (Boo!) or were they “like Wakefield” working for attorneys for a party? Haack cannot seem to bring herself to say that Wakefield, and many other expert witnesses, worked for plaintiffs and plaintiffs’ counsel, a.k.a., the lawsuit industry. Perhaps Haack included such expert witnesses as working for those who manufacture lawsuits. Similarly, in her discussion of journal quality, she notes that some journals carry advertisements from manufacturers, or receive financial support from them. There is a distinct lack of symmetry discernible in the lack of Haack’s curiosity about journals that are run by scientists or physicians who belong to advocacy groups, or who regularly testify for plaintiffs’ counsel.

There are many other quirky opinions here, but I will conclude with the obvious point that in the epidemiologic literature, there is a huge gulf between reporting on associations and drawing causal conclusions. Haack asks her readers to remember “that epidemiological studies can only show correlations, not causation.”[14] This suggestion ignores Haack’s article discussion of certain clinical trial results, which do “show” causal relationships. And epidemiologic studies can show strong, robust, consistent associations, with exposure-response gradients, not likely consistent with random variation, and these findings collectively can show causation in appropriate cases.

My recommendation is to ignore Haack’s suggestions and to pay closer attention to the subject matter of the expert witness who is under challenge. If the subject matter is epidemiology, open a few good textbooks on the subject. On the legal side, a good treatise such as The New Wigmore will provide much more illumination and guidance for judges and lawyers than vague, general suggestions.[15]

[1] William Kingdon Clifford, “The Ethics of Belief,” in L. Stephen & F. Pollock, eds., The Ethics of Belief 70-96 (1877) (“In order that we may have the to accept [someone’s] testimony as ground for believing what he says, we must have reasonable grounds for trusting his veracity, that he is really trying to speak the truth so far as he knows it; his knowledge, that he has had opportunities of knowing the truth about this matter; and his judgement, that he has made proper use of those opportunities in coming to the conclusion which he affirms.”), quoted in Susan Haack, “Judging Expert Testimony: From Verbal Formalism to Practical Advice,” 1 Quaestio facti. Internat’l J. Evidential Legal Reasoning 13, 13 (2020).

[2] Susan Haack, “Judging Expert Testimony: From Verbal Formalism to Practical Advice,” 1 Quaestio facti. Internat’l J. Evidential Legal Reasoning 13, 13 (2020) [cited as Haack].

[3] Haack at 21.

[4] See, e.g., “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions”; “Judicial Dodgers – Reassigning the Burden of Proof on Rule 702”; “Judicial Dodgers – Weight not Admissibility”; “Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent.”

[5] Haack at 21.

[6] Haack at 22.

[7] Haack at 24, citing Blum v. Merrell Dow Pharms., Inc., 33 Phila. Cty. Rep. 193, 214-17 (1996).

[8] See, e.g., “Bendectin, Diclegis & The Philosophy of Science” (Oct. 23, 2013).

[9] Haack at 23.

[10] See generally Deborah Mayo, Statistical Inference as Severe Testing: How to Get Beyond the Statistics Wars (2018).

[11] Haack at 23-24 (emphasis added).

[12] Haack at 24.

[13] Haack at 24.

[14] Haack at 25.

[15] David H. Kaye, David E. Bernstein & Jennifer L. Mnookin, The New Wigmore: A Treatise on Evidence: Expert Evidence (2^nd ed. 2011). A new edition is due out presently.

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Susan Haack on Judging Expert Testimony

Junk Science in 2020

December 17th, 2020

Exploring pathology can help us appreciate proper physiological function, and how normal functioning can be lost. In the realm of epistemology, studying error or patho-epistemology, can help us elucidate knowledge. To that end, Ross Pomeroy, at Real Clear Science, this week offers his views of the best of the worst of 2020 pseudo-science.[1] Admittedly, 2020 has been a bad year for epistemic virtue, but Pomeroy lists eight noteworthy instances of scientific junk. Not surprising, several of his eight examples come from the Trump epistemic swamp.

Next year, junk science is likely to be more bipartisan, with left-wing and right-wing nutjobs finding consensus in anti-vaccination make believe. On the left, chemophobia is leading to hyperventilation, without evidence, over whether chemicals such as Per- and polyfluoroalkyl substances (PFAS) will inhibit COVID-19 vaccine efficacy.[2] Congressman Dan Kildee (D-Mich.), who has tirelessly advocated against PFAS, pushed the Centers for Disease Control to investigate whether there was an interaction between PFAS exposure and COVID-19.[3] This bit of political pressure was then transformed into a hyperbolic statement by Philippe Grandjean, an adjunct professor of environmental health at the Harvard School of Public Health and testifier for the lawsuit industry,[4] that “[a]t this stage we don’t know if it [PFAS] will impact a corona vaccination, but it’s a risk.” How something that has unknown health effects is transmuted into a “risk” by Grandjean is a secret lost with the great alchemists of the 13^th century.[5]

And on the right, look for the leopard-skinned kraken-pot lawyer, Sidney Powell, to generate lies, conspiracies, and frauds about COVID-19 vaccines and vaccination.[6]

The numbering of junk science examples below is Pomeroy’s, and it is not clear whether the last, which was labeled number one, was supposed to be the worst, or whether number eight was. I have repeated Pomeroy’s list, in his order, with my musings.

Woke Science: Magic Amulets Prevent COVID-19

This exemplar of junk comes from researchers at the University of Pittsburgh’s departments of infectious disease and epidemiology, and was published online in October 2020, at the dubious journal, Science of the Total Environment.[7] The title of the article purports to ask a question:

“Can Traditional Chinese Medicine provide insights into controlling the COVID-19 pandemic: Serpentinization-induced lithospheric long-wavelength magnetic anomalies in Proterozoic bedrocks in a weakened geomagnetic field mediate the aberrant transformation of biogenic molecules in COVID-19 via magnetic catalysis”

Discerning editors and peer reviewers might have noticed that the authors omitted a question mark from their title, or that the content of the article was utterly bogus. A trip to the article online shows up a notice that the article has been removed:

“The publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.”

Inquiring minds are yearning to know the reason for the removal, but in the interim, several observers have noted that the paper in question had the aroma of a dogpile.[8] The article is so outlandish that some skeptical onlookers, such as Drs. Steven Novella[9] and Ivan Oransky, thought that the article might be a Sokal-style hoax.[10]

Alas, the authors were in earnest. COVID-19 is related to magnetic fields, but jade amulets can prevent the disease. Who would have thought? When Dr. Ivan Oransky wrote to confirm authorship of the publication,[11] his inquiry provoked a white-fragility accusation from Moses Turkle Bility, one of the authors!

“Dear Dr. Ivan Oransky, yes, I published that article, and I kindly suggest you read the article and examine the evidence provided. I also suggest you read the history of science and how zealots have consistently attempted to block and ridicule novel ideas that challenge the predominant paradigm from individuals that are deem not intelligent enough. I not surprised that this article has elicited angry responses. Clearly the idea that a black scientist can provide a paradigm shifting idea offends a lot of individuals. I’ll be very candid with you; my skin color has no bearing on my intelligence. If you have legitimate concerns about the article and wish to discuss, I’ll address; however, I will not tolerate racism or intellectual intolerance targeted at me.”

The ultimate Woke anti-racist brushback pitch in scientific discourse! Or maybe I am just “jaded.”

Maga-megachurch’s Air Filtration System Destroys 99.9% of COVID.

Owners of a megachurch claimed that their air filtration system killed 99.9% of the corona virus that causes COVID-19. Biblical miracles aside, the Arizona Attorney General thought this claim was a step too far and ordered the Phoenix church to stop advertising its air purification system.[12] Next you know, Arizona will ban claims of virgin birth.

Oleandrin

The transitive property of truth should validate the efficacy of oleandrin as a “miracle cure” for COVID-19. The CEO of MyPillow, Mike Lindell, supports Donald Trump, and Donald Trump supports Mike Lindell. Mike Lindell supports oleandrin, a plant-based toxin,[13] and so Trump supports oleandrin as well as a “miracle cure.” Or is it the transitive property of stupidity? In the meanwhile, the U.S. FDA rejected an application for permission to include oleandrin in supplements. On the other hand, Trump’s Secretary of Housing and Urban Development, Dr. Ben Carson has enthusiastically touted oleandrin, and he is a brain surgeon.[14]

Sodium Hypochlorite and Lysol, i.v., stat!

Back in April 2020, former President Trump told an anxious nation that he thought that the ideas of putting light down into the lungs, or maybe just disinfectant, would knock out the corona virus. Trump seemed to take credit for these ideas, which he found “pretty interesting.”[15] Main stream media struggled with how to let the American public know that their president was a moron.

Methanol for COVID.

Not a good idea, but apparently many Iranians thought it could not be worse than anything that President Hassan Rouhani had in store for them.

5G and COVID-19

OK, a bogus claim but maybe a good reason to delay upgrading your cell phone.

Face Masks Activate Corona Virus

COVID-19 brought out some of the most remarkable quacks. Take Judy Mikovits. Please. Mikovits was the intellectual powerhouse behind the docu-conspira-mentary, “Plandemic.” Good to know. Mikovits advanced the unfounded claim that wearing face masks activate the corona virus, that beaches have healing powers, and that a vaccine against COVID-19 will kill millions.[16] Good to know.

Hydroxychloroquine

Donald Trump has always been a snake-oil salesman, but with his endorsement of hydrochloroquine, at least he hawked an FDA-approved medication. The problem was that the indication for hydrochloroquine was malaria, not COVID-19.

Unlike his support for injecting bleach and Lysol, Trump had “expert support,” for his touting of hydrochloroquine, the Association of American Physicians & Surgeons (AAPS).[17] Despite its official sounding name, the AAPS was little more than a propaganda outlet for the debunked study by Didier Raoult. The International Society of Antimicrobial Chemotherapy (ISAC), which publishes the journal in which Raoult’s study appeared had issued a statement “of concern” about Raoult’s results. Trump, however, had no concern, perhaps because the AAPS also relied upon claims made by Vladimir Zelenko about 1,554 patients, for which he had “published no data, described no study design, and reported no analysis.”

But wait, Trump and the AAPS had more data. Since no quackfest would be complete without “evidence” from Mehmet Cengiz Öz, commonly known as Dr. Oz, the AAPS has dutifully reported that Oz had two patients to whom he gave HCQ, and both survived.[18] Notwithstanding Donald’s Trumping of hydroxychloroquine, the FDA revoked its emergency use authorization for the medication’s use as an anti-viral.[19] In the meanwhile, Trump and his administration wasted government resources by stockpiling an unproven, useless medication, while ignoring efficacious ones.[20]

[1] Ross Pomeroy, “The Biggest Junk Science of 2020,” Real Clear Science (Dec. 15, 2020).

[2] Oliver Milman, “Covid: chemicals found in everyday products could hinder vaccine: Researchers worry PFAS, commonly found in the bodies of Americans, will reduce the immunization’s effectiveness,” The Guardian (Nov. 17, 2020).

[3] Iris Myers, “CDC Investigates Potential Link Between ‘Forever Chemicals’ and Decreased Effectiveness of Covid-19 Vaccines,” Envt’l Working Group (Dec. 11, 2020).

[4] See, e.g., Maine People’s Alliance v. Holtrachem Mfr’g Co., 211 F. Supp. 2d 237 (D. Maine 2002); Sullivan v. Saint-Gobain Performance Plastics Corp., 431 F. Supp. 3d 448 (D. Vt. 2019); Food & Water Watch, Inc. v. U.S. EPA, case no. 17-cv-02162-EMC (N.D. Calif. Aug. 10, 2020).

[5] This hyperbole was rightly called out by Joseph Annotti and the Center for Truth in Science. See “Center for Truth in Science Responds to Concerns over PFAS Compounds and Vaccine Efficacy,” Center for Truth in Science (Dec. 16, 2020).

[6] Davey Alba & Sheera Frenkel, “From Voter Fraud to Vaccine Lies: Misinformation Peddlers Shift Gears,” N.Y. Times (Dec. 16, 2020).

[7] Moses Turkle Bility, Yash Agarwala, Sara Ho, Isabella Castronova, Cole Beattya, Shivkumar Biradara, Vanshika Narala, Nivitha Periyapatna, Yue Chen, Jean Nachega, “Can Traditional Chinese Medicine provide insights into controlling the COVID-19 pandemic: Serpentinization-induced lithospheric long-wavelength magnetic anomalies in Proterozoic bedrocks in a weakened geomagnetic field mediate the aberrant transformation,” Science of The Total Env’t, available at https://doi.org/10.1016/j.scitotenv.2020.142830 (online 8 October 2020, 142830).

[8] Shawna Williams, “Paper Proposing COVID-19, Magnetism Link to Be Retracted: The study, published in a peer-reviewed journal, has attracted widespread derision from researchers,” The Scientist (Nov. 4, 2020).

[9] Steven Novella, “Magic Amulets Do Not Prevent COVID,” The Ness (Nov. 03 2020).

[10] See, e.g., Jamie Lindsay & Peter Boyle, “The Conceptual Penis as a Social Construct,” 3 Cogent Social Sciences online (2017) (Peter Boghossian published under the pseudonym Peter Boyle), retracted (2017).

[11] Ivan Oransky, “Amulets may prevent COVID-19, says a paper in Elsevier journal. (They don’t),” Retraction Watch (Oct. 29, 2020).

[12] News Staff, “Arizona AG o)rders Glendale company, Phoenix church to stop advertising air purification system,” Arizona Family (June 26, 2020).

[13] Steven Novella, “Oleandra – The New COVID Snake Oil: Oleandrin is being promoted as the new COVID-19 snake oil – but it is a deadly toxin,” Science-Based Medicine (Aug. 19, 2020).

[14] Jonathan Swan, “Trump eyes new unproven coronavirus ‘cure’,” Axios (Aug. 16, 2020).

[15] William J. Broad & Dan Levin, “Trump Muses About Light as Remedy, but Also Disinfectant, Which Is Dangerous,” N.Y. Times (April 24, 2020).

[16] Angelo Fichera, Saranac Hale Spencer, D’Angelo Gore, Lori Robertson and Eugene Kiely, “The Falsehoods of the ‘Plandemic’ Video,” Fact Check (May 8, 2020); Stuart J.D. Neil & Edward M. Campbell, “Fake Science: XMRV, COVID-19, and the Toxic Legacy of Dr. Judy Mikovits,” 36 AIDS Research & Human Retroviruses 545 (2020); Martin Enserink & Jon Cohen, “Fact-checking Judy Mikovits, the controversial virologist attacking Anthony Fauci in a viral conspiracy video,” Science Mag. (May 8, 2020).

[17] “Hydroxychloroquine Has about 90 Percent Chance of Helping COVID-19 Patients,” AAPS (April 28, 2020).

[18] The HCQ issue is not the AAPS’s first quack attack. Those who follow the organization will sense déjà vu. The AAPS has held forth previously on abortion and breast cancer, vaccination and autism, HIV and AIDS, and Barak Obama and hypnotic induction. See “The Plague and Quackery Right & Left” (June 19, 2020).

[19] FDA Press Release, “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine” (June 15, 2020); Molly Walker, “HCQ No Longer Approved Even a Little for COVID-19 – Study after study showed no benefit, and now the FDA has had enough,” MedPage Today (June 15, 2020). The AAPS did not take the FDA’s rejection of hydroxychloroquine lying down. The Society sued the FDA to end “arbitrary” restrictions on its use. “AAPS Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine,” AAPS (June 2, 2020). The AAPS complaint is available at its website: http://aapsonline.org/judicial/aaps-v-fda-hcq-6-2-2020.pdf

[20] See Sheryl Gay Stolberg, “A Mad Scramble to Stock Millions of Malaria Pills, Likely for Nothing,” N.Y. Times (June 16, 2020) (quoting Trump’s Trade Advisor Peter Navarro); Philip Bump, “The rise and fall of Trump’s obsession with hydroxychloroquine – Forty days of promotion, hype – and eventual retreat,” Wash. Post (April 24, 2020); “Remarks by President Trump in a Roundtable with Restaurant Executives and Industry Leaders” (May 18, 2020); Andrew Solender, “All The Times Trump Has Promoted Hydroxychloroquine” Forbes (May 22, 2020). Curiously, the Administration has ignored the emerging potentially good news about the efficacy of dexamethasone in treating seriously ill COVID-19 patients, as shown in a randomized clinical trial, which is not yet peer reviewed and published. Benjamin Mueller & Roni Caryn Rabin, “Common Drug Reduces Coronavirus Deaths, Scientists Report,” N.Y. Times (June 16, 2020).

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Pernicious Probabilities in the Supreme Court

December 11th, 2020

Based upon Plato’s attribution,[1] philosophers credit pre-Socratic philosopher Heraclitus, who was in his prime about 500 B.C., for the oracular observation that πάντα χωρεῖ και οὐδε ν μένει, or in more elaborative English:

all things pass and nothing stays, and comparing existing things to the flow of a river, he says you could not step twice into the same river.

Time changes us all. Certainly 2016 is not 2020, and the general elections held in November of those two years were not the same elections, and certainly not the same electorate. No one would need a statistician to know that the population of voters in 2016 was different from that in 2020. Inevitably, some voters from 2016 died in the course of the Trump presidency; some no doubt died as a result of Trump’s malfeasance in handling the pandemic. Inevitably, some new voters came of age or became citizens and were thus eligible to vote in 2020, when they could not vote in 2016. Some potential voters who were unregistered in 2016 became new registrants. Non-voters in 2016 chose to vote in 2020, and some voters in 2016 chose not to vote in 2020. Overall, many more people turned out to vote in 2020 than turned out in 2016.

The candidates in 2016 and 2020 were different as well. On the Republican side, we had ostensibly the same candidate, but in 2020, Trump was the incumbent and had a record of dismal moral and political failures, four years in duration. Many Republicans who fooled themselves into believing that the Office of the Presidency would transform Trump into an honest political actor, came to realize that he was, and always has been, and always will be, a moral leper. These “apostate” Republicans effectively organized across the country, through groups like the Lincoln Project and the Bulwark, against Trump, and for the Democratic candidate, Joseph Biden.

In the 2016 election, Hilary Clinton outspent Donald Trump, but Trump used social media more effectively, with a big help from Vladimir Putin. In the 2020 election, Russian hackers did not have to develop a disinformation campaign; the incumbent president had been doing so for four years.

On the Democratic side of the 2016 and 2020 elections, there was a dramatic change in the line-up. In 2016, candidate Hilary Clinton inspired many feminists because of her XX 23^rd chromosomes. She also suffered significant damage in primary battles with social democrat Bernie Sanders, whose supporters were alienated by the ham-fisted prejudices of the Clinton-supporters on the Democratic National Committee. Many of Sanders’ supporters stayed home on election day, 2016. In 2020, Sanders and the left-wing of the Democratic party made peace with the centrist candidate Joseph Biden, in recognition that the alternative – Trump – involved existential risks to our republican democracy.

In 2016, third party candidates, from the Green Party and the Libertarian Party, attracted more votes than they did in 2020. The 2016 election saw more votes siphoned from the two major party candidates by third parties because of the unacceptable choice between Trump and Clinton for several percent of the voting public. In 2020, with Trump’s authoritarian kleptocracy fully disclosed to Americans, a symbolic vote for a third-party candidate was tantamount to the unacceptable decision to not vote at all.

In 2016, after eight years of Obama’s presidency, the economy and the health of the nation were good. In 2020, the general election occurred in the midst of a pandemic and great economic suffering. Many more people voted by absentee or mail-in ballot than voted in that manner in 2016. State legislatures anticipated the deluge of mail-in ballots; some by facilitating early counting, and some by prohibiting early counting. The Trump administration anticipated the large uptick in mail-in ballots by manipulating the Post Office’s funding, by anticipatory charges of fraud in mail-in procedures, and by spreading lies and disinformation about COVID-19, along with spreading the infection itself.

On December 8, 2020, without apparently tiring of losing so much, the Trump Campaign orchestrated the filing of the big one, the “kraken lawsuit.” The State of Texas filed a complaint in the United States Supreme Court, in an attempt to invoke that court’s original jurisdiction to adjudicate Texas’ complaint that it was harmed by voting procedures in four states in which Trump lost the popular vote. All four states had certified their results before Texas filed its audacious lawsuit. Legal commentators were skeptical and derisive of the kraken’s legal theories.[2] Even the stalwart National Review saw the frivolity.[3]

Charles J. Cicchetti[4] is an economist, who is a director at the Berkeley Research Group. Previously, Cicchetti held academic positions at the University of Southern California, and the Energy and Environmental Policy Center at Harvard University’s John F. Kennedy School of Government. At the heart of the kraken is a declaration from Cicchetti, who tells us under penalty of perjury, that he was “formally trained statistics and econometrics [sic][5] and accepted as an expert witness in civil proceedings.”[6] Declaration of Charles J. Cicchetti, Ph.D., Dec. 6, 2020, filed in support of Texas’ motion at ¶ 2.

Cicchetti’s declaration is not a model of clarity, but it is clear that he conducted several statistical analyses. He was quite transparent in stating his basic assumption for all his analyses; namely, the outcomes for the two Democratic candidates, Clinton and Biden, for the two major party candidates, Clinton versus Trump and Biden versus Trump, and for in-person and for mail-in voters were all randomly drawn from the same population. Id. at ¶ 7. Using a binomial model, Cicchetti calculated Z-scores for the observed disparities in rates, which was very good evidence to reject the “same population” assumptions.

Based upon very large Z-scores, Cicchetti rejected the null hypothesis of “same population” and of Biden = Clinton. Id. at ¶ 20. But nothing of importance follows from this. We knew before the analysis that Biden ≠ Clinton, and the various populations compare were definitely not the same. Cicchetti might have stopped there and preserved his integrity and reputation, but he went further.

He treated the four states, Georgia, Michigan, Pennsylvania, and Wisconsin, as independent tests, which of course they are not. All states had different populations from 2016 to 2020; all had no pandemic in 2016, and pandemic in 2020; all had been exposed for four years of Trump’s incompetence, venality, corruption, bigotry, and bullying. Cicchetti gilded the lily with the independence assumption, and came up with even lower, more meaningless probabilities that the populations were the same. And then he stepped into the abyss of the fallacy and non sequitur:

“In my opinion, this difference in the Clinton and Biden performance warrants further investigation of the vote tally particularly in large metropolitan counties within and adjacent to the urban centers in Atlanta, Philadelphia, Pittsburgh, Detroit and Milwaukee.”

Id. at ¶ 30. Cicchetti’s suggestion that there is anything amiss, which warrants investigation, follows only from a maga, mega-transposition fallacy. The high Z-score does not mean that observed result is not accurate or fair; it means only that the starting assumptions were outlandishly false.

Early versus Late Counting

Texas’ claim that there is something “odd” about the reporting before and after 3 a.m., on the morning after Election Day fares no better. Cicchetti tells us that “many Americans went to sleep election night with President Donald Trump (Trump) winning key battleground states, only to learn the next day that Biden surged ahead.” Id. at ¶ 7.

Well, Americans who wanted to learn the final count should not have gone to sleep, for several days. Again, the later counted mail-in votes came from a segment of the population that was obviously different from the in-person voters. Cicchetti’s statistical analysis shows that we should reject any assumption that they were the same, but who would make that assumption? These expected values for the mail-in ballots differed from the expected values for in-person votes; the difference was driven by Republican lies and disinformation about Covid-19, and by laws that prohibited early counting. Not surprisingly, the Trumpist propaganda had an effect, and there was a disparity between the rate at which Trump and Biden supporters voted in person, and who voted by mail-in ballot. The late counting and reporting of mail-in ballots was further ensured by laws in some states that prohibited counting before Election Day. Trump was never winning in the referenced “key battleground” states; he was ahead in some states, at 2:59 a.m., but the count changed after all lawfully cast ballots had been counted.

The Response to Cicchetti’s Analyses

The statistical “argument,” such as it is, has not fooled anyone outside of maga-land.[7] Cicchetti’s analysis has been derided as “ludicrous” and “incompetence, by Professors Kenneth Mayer and David Post. Mayer described the analysis as one that will be “used in undergraduate statistics classes as a canonical example of how not to do statistics.”[8] It might even make its way into a Berenstain Bear book on statistics. Andrew Gelman called the analysis “horrible,” and likened the declaration to the infamous Dreyfus case.[9]

The Texas lawsuit speaks volumes of the insincerity of the Trumpist Republican party. The rantings of Pat Robertson, asking God to intervene in the election to keep Trump in office, are more likely to have an effect.[10] The only issue the kraken fairly raises is whether the plaintiff, and plaintiff intervenor, should be be sanctioned for “multipl[ying] the proceedings in any case unreasonably and vexatiously.”[11]

[1] Plato, Cratylus 402a = A6.

[2] Adam Liptak, “Texas files an audacious suit with the Supreme Court challenging the election results,” N.Y. Times (Dec. 8, 2020); Jeremy W. Peters and Maggie Haberman, “17 Republican Attorneys General Back Trump in Far-Fetched Election Lawsuit,” N.Y. Times (Dec. 9, 2020); Paul J. Weber, “Trump’s election fight puts embattled Texas AG in spotlight,” Wash. Post (Dec. 9, 2020).

[3] Andrew C. McCarthy, “Texas’s Frivolous Lawsuit Seeks to Overturn Election in Four Other States,” Nat’l Rev. (Dec. 9, 2020); Robert VerBruggen, “The Dumb Statistical Argument in Texas’s Election Lawsuit,” Nat’l Rev. (Dec. 9, 2020).

[4] Not to be confused with Chicolini, Sylvania’s master spy.

[5] Apparently not formally trained in English.

[6] See, e.g., K N Energy, Inc. v. Cities of Alliance & Oshkosh, 266 Neb. 882, 670 N.W.2d 319 (2003), Center for Biological Diversity v. Pizarchik, 858 F. Supp. 2d 1221 (D. Colo. 2012), National Paint & Coatings Ass’n, v. City of Chicago, 835 F. Supp. 421 (N.D. Ill. 1993), National Paint & Coatings Ass’n, v. City of Chicago, 835 F. Supp. 414 (N.D. Ill. 1993); Mississippi v. Entergy Mississippi, Inc. (S.D. Miss. 2012); Hiko Energy, LLC v. Pennsylvania Public Utility Comm’n, 209 A.3d 246 (Pa. 2019).

[7] Philip Bump, “Trump’s effort to steal the election comes down to some utterly ridiculous statistical claims,” Wash. Post (Dec. 9, 2020); Jeremy W. Peters, David Montgomery, Linda Qiu & Adam Liptak, “Two reasons the Texas election case is faulty: flawed legal theory and statistical fallacy,” N.Y. Times (Dec. 10, 2020); David Post, “More on Statistical Stupidity at SCOTUS,” Volokh Conspiracy (Dec. 9, 2020).

[8] Eric Litke, “Lawsuit claim that statistics prove fraud in Wisconsin, elsewhere is wildly illogical,” PolitiFact ((Dec. 9, 2020).

[9] Andrew Gelman, “The p-value is 4.76×10^−264 1 in a quadrillion” Statistical Modeling, Causal Inference, and Social Science (Dec. 8, 2020).

[10] Evan Brechtel, “Pat Robertson Calls on God to ‘Intervene’ in the Election to Keep Trump President in Bonkers Rant” (Dec. 10, 2020).

[11] See “Counsel’s liability for excessive costs,” 28 U.S. Code § 1927.

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