TORTINI

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

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 MayoStatistical 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 (2nd ed. 2011). A new edition is due out presently.

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 13th 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.

  1. 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.”

  1. 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.

  1. 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]

  1. 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.

  1. 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.

  1. 5G and COVID-19

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

  1. 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.

  1. 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. SeeThe 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 HydroxychloroquineForbes (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).

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 23rd 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 quadrillionStatistical 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] SeeCounsel’s liability for excessive costs,” 28 U.S. Code § 1927.

A TrumPence for Your Thoughts

November 21st, 2020

Trigger Warning: Political Rant

“Let them call me rebel and welcome, I feel no concern from it; but I should suffer the misery of devils, were I to make a whore of my soul by swearing allegiance to one whose character is that of a sottish, stupid, stubborn, worthless, brutish man.”

Thomas Paine, “The Crisis, Number 1” (Dec. 23, 1776), in Ian Shapiro & Jane E. Calvert, eds., Selected Writings of Thomas Paine 53, 58 (2014).

♂, ♀, ✳, †, ∞

Person, woman, man, camera, TV

Back on October 20, 2020, televangelist Pat Robertson heard voices in his head, and interpreted them to be the voice of god, announcing the imminent victory of Donald Trump. How Robertson knows he was not hearing the devil, he does not say. Even gods get their facts and predictions wrong sometimes. We should always ask for the data and the analysis.

Trump’s “spiritual advisor,” mega-maga-church pastor and televangelist, Paula White, violated the ban on establishment of religion, and prayed for Trump’s victory.[1] Speaking in tongues, White made Trump seem articulate. White wandered from unconstitutional into blatantly criminal territory, however, when she sought intervention of foreign powers in the election, by summoning angels from Africa and South America to help Trump win the election.  Trump seemed not to take notice that these angels were undocumented, illegal aliens. In the end, the unlawful aliens proved ineffective. Our better angels prevailed over Ms. White’s immigrant angels. Now ICE will now have to track these angels down and deport them back to their you-know-what countries of origin.

How did we get to this place? It is not that astute observers on the left and the right did not warn us.

Before Trump was elected in 2016, Justice Ruth Bader Ginsburg notoriously bashed Donald Trump, by calling him a “faker”:

“He has no consistency about him. He says whatever comes into his head at the moment. He really has an ego … How has he gotten away with not turning over his tax returns? The press seems to be very gentle with him on that.”[2]

Faker was a fitting epithet that captured Trump’s many pretensions. It is a word that has a broader meaning in the polyglot world of New York City, where both Justice Ginsburg and Donald Trump were born and grew up. The word has a similar range of connotations as trombenik, “a lazy person, ne’er-do-well, boastful loudmouth, bullshitter, bum.” Maybe we should modify trombenik to Trumpnik?

Justice Ginsburg’s public pronouncement was, of course, inappropriate, but accurate nonetheless. She did something, however, that Trump has never done in his public persona; she apologized:

“‘On reflection, my recent remarks in response to press inquiries were ill-advised and I regret making them’, Ginsburg said in a statement Thursday morning. ‘Judges should avoid commenting on a candidate for public office. In the future I will be more circumspect’.”[3]

Of course, Justice Ginsburg should have been more circumspect, but her disdain for Trump was not simply an aversion to his toxic politics and personality. Justice Ginsburg was a close friend of Justice Antonin Scalia, who was one of the most conservative justices on the Supreme Court bench. Ginsburg and Scalia could and did disagree vigorously and still share friendship and many common interests. Scalia was not a faker; Trump is.

Other conservative writers have had an equal or even a greater disdain for Trump. On this side of the Atlantic, principled conservatives rejected the moral and political chaos of Donald Trump. When Trump’s nomination as the Republican Party candidate for president seemed assured in June 2016, columnist George Will announced to the Federalist Society that he had changed his party affiliation from Republican to unaffiliated.[4]

On the other side of the Atlantic, conservative thinkers such as the late Sir Roger Scruton rolled their eyes at the prospect of Donald Trump’s masquerading as a conservative.[5] After Trump had the benefit of a few months to get his sea legs on the ship of state, Sir Roger noted that Trump was nothing more than a craven opportunist:

“Q. Does ‘Trumpism’ as an ideology exist, and if it does, is it conservative, or is it just opportunism?

A. It is opportunism. He probably does have conservative instincts, but let’s face it, he doesn’t have any thoughts that are longer than 140 characters, so how can he have a real philosophy?”[6]

Twitter did, at some point, double the number of characters permitted in a tweet, but Trump simply repeated himself more.

In the United States, we have had social conservatives, fiscal conservatives, classic liberal conservatives, and more recently, we have seen neo-cons, theo-cons, and Vichy cons. I suppose there have always been con-cons, but Trump has strongly raised the profile of this last subgroup. There can be little doubt that Donald John Trump has always been a con-con. Now we have Banana Republicans who have made a travesty of the rule of law. Four years in, we are all suffering from what Barak Obama termed “truth decay.”

Cancel culture has always been with us. Socrates, Jesus, and Julius Caesar were all canceled, with extreme prejudice. In the United States, Senator Joseph McCarthy developed cancel culture into a national past time. In this century, the Woke Left has weaponized cancel culture into a serious social and intellectual problem. Now, Donald Trump wants to go one step further and cancel our republican form of democracy. Trump is attempting in plain sight to cancel a national election he lost.

Yes, I have wandered from my main mission on this blog to write about tort law and about how the law handles scientific and statistical issues. My desultory writings on this blog have largely focused on evidence in scientific controversies that find their way into the law. Our political structures are created and conditioned by our law, and our commitment to the rule of law, and the mistreatment of scientific issues by political actors is as pressing a concern, to me at least, as mistreatment of science by judges or lawyers. Trump has now made the post-modernists look like paragons of epistemic virtue. As exemplified in the political response to the pandemic, this political development has important implications for the public acceptance of science and evidence-based policies and positions in all walks of life.

Another blogger whose work on science and risk I respect is David Zaruk, who openly acknowledges that Donald Trump is an “ethically and intellectually flawed train wreck of a politician.”[7] Like Trump apologists James Lindsay and Ben Shapiro, however, Zaruk excuses the large turnout for Trump because Trump voters:

“are sick to death of being told by smug, arrogant, sanctimonious zealots how to think, how to feel and how to act. Nobody likes to be fixed and especially not by self-righteous, moralising mercenaries.”

But wait:  Isn’t this putative defense itself a smug, arrogant, sanctimonious, and zealous lecture that we should somehow be tolerant of Trump and his supporters? What about the sickness unto death over Trump’s endless propagation of lies and fraud? Trump has set an example that empowers his followers to do likewise. Zaruk’s reductionist analysis ignores important determinants of the vote. Many of the Trump voters were motivated by the most self-righteous of all moralizing mercenaries – leaders of Christian nationalism.[8] Zaruk’s acknowledgement of Trump’s deep ethical and intellectual flaws, while refraining from criticizing Trump voters, fits the pattern of the Trump-supporting mass social media that engages in the rhetoric of gas-lighting “what-about-ism.”[9]

Sure, no one likes to be told that they are bereft of moral, practical, and political judgment, but voting for Trump is complicit in advancing “a deeply ethically and intellectually flawed” opportunist. Labeling all of Trump’s opponents as “smug, arrogant, sanctimonious zealots” is really as empty as Trump’s list of achievements. Furthermore, Zaruk’s animadversions against the Woke Left miss the full picture of who is criticizing Trump and his “base.” The critique of Trump has come not just from so-called progressives but from deeply conservative writers such as Will and Scruton, and from pragmatic conservative political commentators such as George Conway, Amanda Carpenter, Sarah Longwell, and Charles Sykes. There is no moral equivalency between the possibility that the Wokies will influence a Biden administration and the certainty that truly deplorable people such as Bannon, Gingrich, Giuliani, Navarro, et alia, will both influence and control our nation’s policy agenda.

Of course, Trump voters may honestly believe that a Democratic administration will be on the wrong side of key issues, such as immigration, abortion, gun control, regulation, taxation, and the like. Certainly opponents of the Democratic positions on these issues could seek an honest broker to represent their views. Trump voters, however, cannot honestly endorse the character and morality of Mr. Trump, his cabinet, and his key Senate enablers. Trump has been the Vector-in-Chief of contagion and lies. As for Trump’s evangelical Christian supporters, they have an irreconcilable problem with our fundamental prohibition against state establishment of religion.

It has been a difficult year for Trump. He has had the full 2020 experience. He developed COVID, lost his job, and received an eviction notice. And now he finds himself with electicle dysfunction. Trump has long been a hater and a denier. Without intending to libel his siblings, we can say that hating and denying are in his DNA. Trump hates and denies truth, evidence, valid inference, careful analysis and synthesis. He is the apotheosis of what happens when a corrupt, small-minded business man surrounds himself with lackies, yes-people, and emotionally damaged, financially dependent children.

Trump declared victory before the votes could be tallied, and he announced in advance, without evidence, that the election was rigged but only if it turned out with the “appearance” of his losing. After the votes were tallied, and he had lost by over 5,000,000 votes, and he lost the Electoral College by the same margin he labeled a “landslide” for him four years earlier, he claimed victory, contrary to the evidence, just as he said he would. Sore loser. Millions of voting Americans, to whom Zaruk would give a moral pass, do not see this as a problem.

In The Queen’s Gambit, a Netflix series, the stern, taciturn janitor of a girls’ orphanage, Mr. Shaibel, taught Beth Harmon, a seven year old, how to play chess. In one of their early games, Beth has a clearly lost position, and Mr. Shaibel instructs her, “now you resign.” Beth protests that she still has moves she can make before there is a checkmate, but Mr. Shaibel sternly repeats himself, “no, now you resign.” Beth breaks into tears and runs out of the room, but she learned the lesson and developed the resiliency, focus, and sportsmanship to play competitive chess at the highest level. If only Mr. Shaibel could have taught our current president this lesson, perhaps he would understand that the American electorate, both the self-styled progressives and conservatives who care about decency and morality, have united in saying to him, “now you resign.”

Dr. Mary Trump, the President’s niece, has written an unflattering psychological analysis of Trump. It does not take a Ph.D. in clinical psychology to see the problem. Donald Trump and his family do not have a dog. Before Donald Trump, James K. Polk (11th president) was the last president not to have a dog in the White House (March 4, 1845 – March 4, 1849). Polk died three months after leaving office.

I suppose there are some good people who do not like dogs, but liking and caring for dogs, and being open to their affection back, certainly marks people as capable of empathy, concern, and love. I could forgive the Obamas for never having had dogs before moving into the Whitehouse; they were a hard working, ambitious two career couple, living in a large city. They fixed their omission shortly upon Obama’s election. The absence of dog from the Trump White House speaks volumes about Trump. In a rally speech, he mocked: “Can you imagine me walking a dog?” Of course, he would not want to walk a dog down a ramp. How interesting that of all the criticisms lodged against Trump, the observation that he lacked canine companionship struck such a nerve that he addressed the matter defensively in one of his rallies. And how sad that he could not imagine his son Barron walking a dog. It was probably Barron’s only hope of having another living creature close to him show concern. Of course, Melania could walk the dog, which would allow her to do something useful and entertaining (besides ignoring the Christmas decorations), especially in her high-heel dog-walking shoes.

Saturday, November 7, 2020. O joy, o rapture! People danced in the streets of the Upper East. Cars honked horns. People hung out their windows and banged pots. Grown men and women shed tears of joy and laughter. A beautiful New York day, VD Day, not venereal disease day, but victory over Donald. Trump can begin to plan for the Trump Presidential Lie-brary and adult book store.

But wait. Trump legal advisor Harmeet Dhillon tells Lou Dobbs on the Fox News Channel: “We’re waiting for the United States Supreme Court – of which the president has nominated three justices – to step in and do something. And hopefully Amy Coney Barrett will come through.” Well, that was not a terribly subtle indication of the corruption in Trump’s soul and on his legal team. Americans now know all about loyalty oaths to the leader, and the abdication of principles. Fealty to Trump is the only principle; just read the Republican Party Platform.

Former White House chief strategist Steven Bannon was not to be out done in his demonstrations of fealty. Bannon called for Dr. Anthony Fauci and FBI Director Christopher Wray to be beheaded “as a warning to federal bureaucrats. You either get with the program or you are gone.” Bannon, of course, was not in a principal-agent relationship with Trump, as was Dhillon, but given that Trump has an opinion about everything on Twitter-Twatter, and that he was silent about Bannon’s call for decapitations, we have to take his silence as tacit agreement.

It does seem that many Republicans are clutching at straws to hang on. Fraud claims require pleading with particularity, and proof by clear and convincing evidence. Extraordinary claims require extraordinary evidence. First and second order hearsay will not suffice. Surely, Rudy the Wanker knows this; indeed, when he has appeared in court, he has readily admitted that he is not pursuing a fraud case.[10] In open court, Guiliani, with a straight face, told a federal judge that his client was denied the opportunity to ensure opacity at the polls.[11]

Under the eye of Newt Gingrich, former Republican Speaker of the House, poll workers should be jailed, and Attorney General William P. Barr should step in to the fray. Never failing to disappoint, Bully Barr obliged. Still, the Republican attempt to win by litigation, a distinctly un-conservative approach, has been failing.[12]

How will we know when our national nightmare is over? There will not be the usual concession speech. Look for Trump’s announcement of his candidacy for the 2024 presidential election.

Donald J. Trump Foundation, Trump Airlines, Trump Magazine, Trump Steaks, Trump Vodka, Trump Mortgage, Trump: The Game, Trump University, GoTrump.com, Trump Marriage #1, Trump Marriage #2, Trump Taj Mahal, Trump Plaza Hotel and Casino, Plaza Hotel, Trump Castle Hotel and Casino, Trump Hotels and Casino Resorts, Trump Entertainment Resorts, Trumpnet – all failures – are now gone. Soon Trump himself will be gone as well.


Post-Script

A dimly lit room filled with coffins. Spider webs stretch across the room. Rats scurry across the floor. Slowly, the tops of the coffins are pushed open from within in, by arms of skeletons. The occupants of the coffins, skeleton, slowly get up and start talking.

Skeleton one: COVID, COVID, COVID, COVID, COVID, COVID, that’s all everyone wants to talk about.

Skeleton two: It’s no big deal; we were going to die anyway. Well at some point.

Skeleton three: And besides, now we are immune. Ha, ha, ha!

Skeleton four: Hey, look at us; we’re rounding the corner.

All, singing while dancing in a circle conga line:

We’ll be coming around the corner when he’s gone (toot, toot)

We’ll be coming around the corner when he’s gone (toot, toot)

We’ll be coming around the corner, we’ll be coming around the corner

We’ll be coming around the corner when he’s gone (toot, toot).


[1]  Wyatte Grantham-Philips, “Pastor Paula White calls on angels from Africa and South America to bring Trump victory,” USA TODAY (Nov. 5, 2020).

[2]  John Kruzel, “Justice Ruth Bader Ginsburg has taken to bashing Donald Trump in recent days,” (July 12, 2016).

[3]  Jessica Taylor, “Ginsburg Apologizes For ‘Ill-Advised’ Trump Comments,” Nat’l Public Radio (July 14, 2016).

[4]  Maggie Haberman, “George Will Leaves the G.O.P. Over Donald Trump,” N.Y. Times (June 25, 2016).

[5]  Roger Scruton, “What Trump Doesn’t Get About Conservatism,” N.Y. Times (July 4, 2018).

[6]  Tom Szigeti, “Sir Roger Scruton on Trump: ‘He doesn’t have any thoughts that are longer than 140 characters’,” Hungary Today (June 8, 2017).

[7]  David Zaruk, “The Trump Effect: Stop Telling me What to Think!,” RiskMonger (Nov. 5, 2020).

[8]  See Katherine Stewart, The Power Worshippers: Inside the Dangerous Rise of Religious Nationalism (2020).

[9]  See Amanda Carpenter, Gaslighting America – Why We Love It When Trump Lies to Us 2018.

[10]  Lisa Lerer, “‘This Is Not a Fraud Case’: Keep an eye on what President Trump’s lawyers say about supposed voter fraud in court, where lying under oath is a crime,” (Nov. 18, 2020).

[11]  Gail Collins, “Barr the Bad or Rudy the Ridiculous?” N.Y. Times (Nov. 18, 2020).

[12]  Jim Rutenberg, Nick Corasaniti and Alan Feuer, “With No Evidence of Fraud, Trump Fails to Make Headway on Legal Cases,” N.Y. Times (Nov. 7, 2020); Aaron Blake, “It goes from bad to worse for the Trump legal team,” Wash. Post (Nov. 13, 2020); Alan Feuer, “Trump Loses String of Election Lawsuits, Leaving Few Vehicles to Fight His Defeat,” N.Y. Times (Nov. 13, 2020); Jon Swaine & Elise Viebeck, “Trump campaign jettisons major parts of its legal challenge against Pennsylvania’s election results,” Wash. Post (Nov. 15, 2020).

The Knowledge Remedy Proposal

November 14th, 2020

Alexandra D. Lahav is the Ellen Ash Peters Professor of Law at the University of Connecticut School of Law. This year’s symposium issue of the Texas Law Review has published Professor Lahav’s article, “The Knowledge Remedy,” which calls for the imposition of a duty to conduct studies by defendants, to provide evidence relevant to plaintiffs’ product liability claims. Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020) [cited as Lahav].

Professor Lahav’s advocated reform is based upon the premises that (1) the requisite studies needed for causal assessment “are too costly for plaintiffs to fund,” (2) are not done by manufacturers, or (3) are not done in good faith, and (4) are not conducted or adequately funded by government. Lahav believes that plaintiffs are injured by exposure to chemicals but they cannot establish causation in court because the defendant “hid its head in the sand,” or worse, “engaged in misconduct to prevent or hide research into its products.”[1] Lahav thus argues that when defendants have been found to have engaged in misconduct, courts should order them to fund studies into risks posed by their products.

Lahav’s claims are either empty or non-factual. The suggestion that plaintiffs are injured by products but cannot “prove” causation begs the question how she knows that these people were injured by the products at issue. In law professors’ language, Lahav has committed the fallacy of petitio principia.

Lahav’s poor-mouthing on behalf of claimants is factually unsupported in this article. Lahav tells us that:

“studies are too expensive for individuals or even groups to fund.”

This is assertion is never backed up with any data or evidence about the expense involved. Case-control studies for rare outcomes suffer from potential threats to their validity, but they can be assembled relatively quickly and inexpensively. Perhaps a more dramatic refutation of Lahav’s assertions come from the cohort studies done in administrative databases, such as the national healthcare databases of Denmark or Sweden, or the Veterans’ Administration database in the United States. These studies involve querying existing databases for the exposures and outcomes of interest, with appropriate controls; such studies are frequently of as high quality and validity as can be had in observational analytical epidemiology.

There are, of course, examples of corporate defendants’ misconduct in sponsoring or conducting studies. There is also evidence of misconduct in plaintiffs’ sponsorship of studies,[2] and outright fraud.[3] And certainly there is evidence of misconduct or misdirection in governmentally funded and sponsored research, sometimes done in cahoots with plaintiffs’ counsel.[4]

Perhaps more important for the intended audience of the Texas Law Review, Lahav’s assertion is demonstrably false. Plaintiffs, plaintiffs’ counsel, and plaintiffs’ advocacy groups have funded studies, often surreptitiously, in many litigations, including those involving claims of harm from Bair Hugger, asbestos, silicone gel breast implants, welding fume, Zofran, isotretinoin, and others. Lahav’s repetition of the claim does not make it true.[5] Plaintiffs and their proxies, including scientific advocates, can and do conduct studies, very much with a view toward supporting litigation claims. Mass tort litigation is a big business, often run by lawyer oligarchs of the plaintiffs’ bar. Ignorantia facti is not an excuse for someone who argues for a radical re-ordering of an already fragile litigation system.

Lahav also complains that studies take so long that the statute of limitations will run on the injury claims before the scientific studies can be completed. There is a germ of truth in this complaint, but the issue could be resolved with minor procedural modifications. Plaintiffs could be allowed a procedure to propound a simple interrogatory to manufacturing firms to ask whether they believe that causality exists between their product and a specific kind of harm, or whether a claimant should reasonably know that such causality exists to warrant pursuing a legal claim. If the manufacturers answer in the negative, then the firms would not be able to assert a limitations defense for any injury that arose on or before the date of its answer. Perhaps the court could allow the matter to stay on its docket and require that the defendant answer the question annually. Plaintiffs and their proxies would be able to sponsor studies necessary to support their claims, and putative defendants would be on notice that such studies are underway.

Without any serious consideration of the extant regulations, Lahav even extends her claims of inadequate testing and lax regulation to pharmaceutical products, which are subject to extensive requirements of showing safety and efficacy, both before and after approval for marketing. Lahav’s advocacy ignores that an individual epidemiologic study rarely “demonstrates” causation, and many such studies are required before the scientific community can accept the causal hypothesis as “disproven.” Lahav’s knowledge remedy is mostly an ignorance ruse.


[1]  Lahav at 1361.

[2]  For a recent, egregious example, see In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) (uncovering dark data and dark money behind April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019)). See also In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657);  “April Fool – Zambelli-Weiner Must Disclose” (April 2, 2020); “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[3]  See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”) (emphasis added).

[4]  See, e.g., Robert M. Park, Paul A. Schulte, Joseph D. Bowman, James T. Walker, Stephen C. Bondy, Michael G. Yost, Jennifer A. Touchstone, and Mustafa Dosemeci, “Potential Occupational Risks for Neurodegenerative Diseases,” 48 Am. J. Ind. Med. 63, 65 (2005).

[5]  Lahav at 1369-70.

Hacking at the “A” Cell

November 10th, 2020

At the heart of epidemiologic studies and clinical trials is the contingency table. The term, contingency table, was introduced by Karl Pearson in the early 20th century as a way to explore the independence, vel non, in a multivariate model. The simplest version of the table is the “2 by 2” table that is at the heart of case-control and other studies:

  Cases (with outcome of interest) Controls (without outcome of interest)  
Exposure of Interest Present                A                  B A + B

Marginal total of all exposed

Exposure of Interest Absent                C                  D C + D

Marginal total of all non-exposed

  A + C

Marginal total of cases

B + D

Marginal total of controls

A + B + C + D

Total observed in study

 

A measure of association between the exposure of interest and the outcome of interest can be shown in the odds ratio (OR), which can be assessed for random error on the assumption of no association.

OR = (A/C)/(B/D) = A*D/B*C

The measurement of the OR turns on faithfully applying the same method of counting cases regardless of exposure status. When investigators expand the “A” cell by loosening their criteria for exposure, we say that they have engaged in “hacking the A cell.”

Something akin to hacking the A cell occurred in the large epidemiologic study, known as  “Yale Hemorrhagic Stroke Project (HSP),” which was the center piece of the plaintiffs’ case in In re Phenylpropanolamine Products Liability Litigation. Although the HSP was sponsored by manufacturers, it was conducted independently without any manufacturer oversight beyond the protocol. The FDA reviewed the HSP results, and ultimately the HSP was published in the New England Journal of Medicine.[1]

The HSP was challenged in a Rule 702 hearing in the Multi-District Litigation (MDL). The MDL judge, Judge Rothstein, conducted hearings and entertained extensive briefings on the reliability of plaintiffs’ expert witnesses’ opinions, which were based largely upon the HSP. The hearings, however, could not go beyond doubts raised by the published paper, and Judge Rothstein permitted plaintiffs’ expert witnesses’ proffered testimony based upon the study, finding that:

“The prestigious NEJM published the HSP results, further substantiating that the research bears the indicia of good science.”[2]

The HSP study was subjected to much greater analysis in litigation.  After the MDL concluded its abridged gatekeeping process, the defense successfully sought the underlying data to the HSP. These data unraveled the HSP paper by showing that the study investigators had deviated from the protocol in a way to increase the number of exposed cases (A cell), with the obvious result of increasing the OR reported by the study.

Both sides of the PPA litigation accused the other side of “hacking at the A cell,” but juries seemed to understand that the hacking had started before the paper was published. A notable string of defense verdicts ensued. After one of the early defense verdicts, plaintiffs’ counsel challenged the defendant’s reliance upon underlying data that went behind the peer-reviewed publication.  The trial court rejected the request for a new trial, and spoke to the significance of challenging the superficial significance of peer review of the key study relied upon by plaintiffs in the PPA litigation:

“I mean, you could almost say that there was some unethical activity with that Yale Study.  It’s real close.  I mean, I — I am very, very concerned at the integrity of those researchers. Yale gets — Yale gets a big black eye on this.”[3]

Today we can see the equivalent of “A” cell hacking in a rather sleazy attempt by the Banana Republicans to steal a presidential election they lost. Cry-baby conservatives are seeking recounts where they lost, but not where they won. They are challenging individual ballots on the basis of outcome. They are raising speculative questions about the electoral processes of entire states, even where the states in question have handed them notable wins down ballot.


[1]  Walter N. Kernan, Catherine M. Viscoli, Lawrence M. Brass, Joseph P. Broderick, Thomas Brott, Edward Feldmann, Lewis B. Morgenstern,  Janet Lee Wilterdink, and Ralph I. Horwitz, “Phenylpropanolamine and the Risk of Hemorrhagic Stroke,” 343 New Engl. J. Med. 1826 (2000). SeeMisplaced Reliance On Peer Review to Separate Valid Science From Nonsense” (Aug. 14, 2011).

[2]  In re Phenylpropanolamine Prod. Liab. Litig., 289 F. 2d 1230, 1239 (2003) (citing Daubert II for the proposition that peer review shows the research meets the minimal criteria for good science).  There were many layers of peer review for the HSP study, all of which proved ultimately ineffectual compared with the closer scrutiny that the HSP received in litigation where underlying data were produced.

[3]  O’Neill v. Novartis AG, California Superior Court, Los Angeles Cty., Transcript of Oral Argument on Post-Trial Motions, at 46 -47 (March 18, 2004) (Hon. Anthony J. Mohr).

Tort Law – Theory versus Practice

November 5th, 2020

The Journal of Tort Law was founded, in 2006, by Jules Coleman as a scholarly forum for exchange of heterodox views of tort law.  Under its current Editor In Chief, Christopher Robinette, the journal has continued its exploration of tort theory and philosophy of law. Practitioners can sharpen their practice considerably by understanding the deep structure, theory, and philosophy of tort law, but it seems equally clear that theorists can and must pay attention to what actually happens in tort litigation. Professor Robinette should thus be commended for featuring a symposium in the pages of the journal on “What Practitioners Can Teach Academics about Tort Litigation.”

A passage from Immanuel Kant’s The Critique of Pure Reason (1781) is often paraphrased as “theory without practice is empty and practice without theory is blind.”  Yogi Berra gets credit for the deeper insight that “in theory, there is no difference between theory and practice, but in practice, there is.” Professor Robinette has empowered Yogi’s world view by turning over the pages of the forthcoming issue of the Journal of Tort Law to practitioners, who offer their views on what is actually going on in tort law.

Earlier this week, the various symposium contributions to “What Practitioners Can Teach Academics about Tort Litigation” appeared online as “in press” articles at the Journal of Tort Law. The contributors come from various subdisciplines of tort law, and from differing perspectives of lawyers for pursuers and defenders. This issue will be, I believe, perfect pandemic reading. Here are the symposium articles:

Nathan A. Schachtman, “Products Liability Law – Lessons from the Military and Industrial Contexts

Malcolm E. Wheeler & Theresa Wardon Benz, “Litigation Financing: Balancing Access with Fairness,”

Paul Figley, “Defending Government Tort Litigation: Considerations for Scholars,”

Victor E. Schwartz, “Expert Testimony Needs Judges to Act as “Gatekeepers”: The Maryland Court of Appeals Teaches Why

Thomas E. Albro & Thomas M. Hendell, “What Practitioners can Teach Academics about Tort Litigation – The Plaintiff’s Perspective in Medical Malpractice Litigation”

Scott B. Cooper, “What Practitioners can Teach Academics about Tort Litigation: Auto Accidents from the Plaintiff’s Counsel

Daniel E. Cummins, “Fighting the Good Fight: The Insurance Defense Litigator

Sara M. Peters, “Shifting the Burden of Proof on Causation: The One Who Creates Uncertainty Should Bear Its Burden

As for my contribution, I can say it is a better and more succinct article for my having received suggestions from the editor, Professor Robinette. One of the casualties of page limitations, however, was my failure to acknowledge other lawyers who commented on early drafts, or who pointed me to pertinent briefs. Thank you John Garde, Kirk Hartley, Timothy Kapshandy, Michael Pichini, Robert Pisani, David Speziali, and John Ulizio, for reading drafts, listening to rants, or providing briefs. My article is better for your help, but like Donald Trump, you bear no responsibilities for any errors.

Regressive Methodology in Pharmaco-Epidemiology

October 24th, 2020

Medications are rigorously tested for safety and efficacy in clinical trials before approval by regulatory agencies such as the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA). The approval process, however, contemplates that more data about safety and efficacy will emerge from the use of approved medications in pharmacoepidemiologic studies conducted outside of clinical trials. Litigation of safety outcomes rarely arises from claims based upon the pivotal clinical trials that were conducted for regulatory approval and licensing. The typical courtroom scenario is that a safety outcome is called into question by pharmacoepidemiologic studies that purport to find associations or causality between the use of a specific medication and the claimed harm.

The International Society for Pharmacoepidemiology (ISPE), established in 1989, describes itself as an international professional organization intent on advancing health through pharmacoepidemiology, and related areas of pharmacovigilance. The ISPE website defines pharmacoepidemiology as

“the science that applies epidemiologic approaches to studying the use, effectiveness, value and safety of pharmaceuticals.”

The ISPE conceptualizes pharmacoepidemiology as “real-world” evidence, in contrast to randomized clinical trials:

“Randomized controlled trials (RCTs) have served and will continue to serve as the major evidentiary standard for regulatory approvals of new molecular entities and other health technology. Nonetheless, RWE derived from well-designed studies, with application of rigorous epidemiologic methods, combined with judicious interpretation, can offer robust evidence regarding safety and effectiveness. Such evidence contributes to the development, approval, and post-marketing evaluation of medicines and other health technology. It enables patient, clinician, payer, and regulatory decision-making when a traditional RCT is not feasible or not appropriate.”

ISPE Position on Real-World Evidence (Feb. 12, 2020) (emphasis in original).

The ISPE publishes an official journal, Pharmacoepidemiology and Drug Safety, and sponsors conferences and seminars, all of which are watched by lawyers pursuing and defending drug and device health safety claims. The endorsement by the ISPE of the American Statistical Association’s 2016 statement on p-values is thus of interest not only to statisticians, but to lawyers and claimants involved in drug safety litigation.

The ISPE, through its board of directors, formally endorsed the ASA 2016 p-value statement on April 1, 2017 (no fooling) in a statement that can be found at its website:

The International Society for Pharmacoepidemiology, ISPE, formally endorses the ASA statement on the misuse of p-values and accepts it as an important step forward in the pursuit of reasonable and appropriate interpretation of data.

On March 7, 2016, the American Statistical Association (ASA) issued a policy statement that warned the scientific community about the use P-values and statistical significance for interpretation of reported associations. The policy statement was accompanied by an introduction that characterized the reliance on significance testing as a vicious cycle of teaching significance testing because it was expected, and using it because that was what was taught. The statement and many accompanying commentaries illustrated that p-values were commonly misinterpreted to imply conclusions that they cannot imply. Most notably, “p-values do not measure the probability that the studied hypothesis is true, or the probability that the data were produced by random chance alone.” Also, “a p-value does not provide a good measure of evidence regarding a model or hypothesis.” Furthermore, reliance on p-values for data

interpretation has exacerbated the replication problem of scientific work, as replication of a finding is often confused with replicating the statistical significance of a finding, on the erroneous assumption that replication should lead to studies getting similar p-values.

This official statement from the ASA has ramifications for a broad range of disciplines, including pharmacoepidemiology, where use of significance testing and misinterpretation of data based on P-values is still common. ISPE has already adopted a similar stance and incorporated it into our GPP [ref] guidelines. The ASA statement, however, carries weight on this topic that other organizations cannot, and will inevitably lead to changes in journals and classrooms.

There are points of interpretation of the ASA Statement, which can be discussed and debated. What is clear, however, is that the ASA never urged the abandonment of p-values or even of statistical significance. The Statement contained six principles, some of which did nothing other than to attempt to correct prevalent misunderstandings of p-values. The third principle stated that “[s]cientific conclusions and business or policy decisions should not be based only on whether a p-value passes a specific threshold.” (emphasis added).

This principle, as stated, thus hardly advocated for the abandonment of a threshold in testing; rather it made the unexceptional point that the ultimate scientific conclusion (say about causality) required more assessment than only determining whether a p-value passed a specified threshold.

Presumably, the ISPE’s endorsement of the ASA’s 2016 Statement embraces all six of the articulated principles, including the ASA’s fourth principle:

4. Proper inference requires full reporting and transparency

P-values and related analyses should not be reported selectively. Conducting multiple analyses of the data and reporting only those with certain p-values (typically those passing a significance threshold) renders the reported p-values essentially uninterpretable. Cherry-picking promising findings, also known by such terms as data dredging, significance chasing, significance questing, selective inference, and “p-hacking,” leads to a spurious excess of statistically significant results in the published literature and should be vigorously avoided. One need not formally carry out multiple statistical tests for this problem to arise: Whenever a researcher chooses what to present based on statistical results, valid interpretation of those results is severely compromised if the reader is not informed of the choice and its basis. Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted, and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”

The ISPE’s endorsement of the ASA 2016 Statement references the ISPE’s own

Guidelines for Good Pharmacoepidemiology Practices (GPP),” which were promulgated initially in 1996, and revised as recently as June 2015. Good practices, as of 2015, provided that:

“Interpretation of statistical measures, including confidence intervals, should be tempered with appropriate judgment and acknowledgements of potential sources of error and limitations of the analysis, and should never be taken as the sole or rigid basis for concluding that there is or is not a relation between an exposure and outcome. Sensitivity analyses should be conducted to examine the effect of varying potentially critical assumptions of the analysis.”

All well and good, but this “good practices” statement might be taken as a bit anemic, given that it contains no mention of, or caution against, unqualified or unadjusted confidence intervals or p-values that come from multiple testing or comparisons. The ISPE endorsement of the ASA Statement now expands upon the ISPE’s good practices to include the avoidance of multiplicity and the disclosure of the full extent of analyses conducted in a study.

What happens in the “real world” of publishing, outside the board room?

Last month, the ISPE conducted its (virtual) 36th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. The abstracts and poster presentations from this Conference were published last week as a Special Issue of the ISPE journal. I spot checked the journal contents to see how well the presentations lived up to the ISPE’s statistical aspirations.

One poster presentation addressed statin use and skin cancer risk in a French prospective cohort.[1]  The authors described their cohort of French women, who were 40 to 65 years old, in 1990, and were followed forward. Exposure to statin medications was assessed from 2004 through 2014. The analysis included outcomes of any skin cancer, melanoma, basal-cell carcinoma (BCC), and squamous-call carcinoma (SCC), among 66,916 women. Here is how the authors describe their findings:

There was no association between ever use of statins and skin cancer risk: the HRs were 0.96 (95% CI = 0.87-1.05) for overall skin cancer, 1.18 (95% CI = 0.96-1.47) for melanoma, 0.89 (95% CI = 0.79-1.01) for BCC, and 0.90 (95% CI = 0.67-1.21) for SCC. Associations did not differ by statin molecule nor by duration or dose of use. However, women who started to use statins before age 60 were at increased risk of BCC (HR = 1.45, 95% CI = 1.07-1.96 for ever vs never use).

To be fair, this was a poster presentation, but this short description of findings makes clear that the investigators looked at least at the following subgroups:

Exposure subgroups:

  • specific statin drug
  • duration of use
  • dosage
  • age strata

and

Outcome subgroups:

  • melanoma
  • basal-cell carcinoma
  • squamous-cell carcinoma

The reader is not told how many specific statins, how many duration groups, dosage groups, and age strata were involved in the exposure analysis. My estimate is that the exposure subgroups were likely in excess of 100. With three disease outcome subgroups, the total subgroup analyses thus likely exceeded 300. The authors did not provide any information about the full extent of their analyses.

Here is how the authors reported their conclusion:

“These findings of increased BCC risk in statin users before age 60 deserve further investigations.”

Now, the authors did not use the phrase “statistically significant,” but it is clear that they have characterized a finding of “increased BCC risk in statin users before age 60,” and in no other subgroup, and they have done so based upon a reported nominal “HR = 1.45, 95% CI = 1.07-1.96 for ever vs never use.” It is also clear that the authors have made no allowance, adjustment, modification, or qualification, for the wild multiplicity arising from their estimated 300 or so subgroups. Instead, they made an unqualified statement about “increased BCC risk,” and they offered an opinion about the warrant for further studies.

Endorsement of good statistical practices is a welcome professional organizational activity, but it is rather meaningless unless the professional societies begin to implement the good practices in their article selection, editing, and publishing activities.


[1]  Marie Al Rahmoun, Yahya Mahamat-Saleh, Iris Cervenka, Gianluca Severi, Marie-Christine Boutron-Ruault, Marina Kvaskoff, and Agnès Fournier, “Statin use and skin cancer risk: A French prospective cohort study,” 29 Pharmacoepidemiol. & Drug Safety s645 (2020).

Two Schools of Thought for Warning Standards

September 19th, 2020

In products liability litigation over designs and warnings, a supplier or manufacturer is typically held to the knowledge and expertise of an expert in the relevant field. Experts, especially in the early days of understanding a newly identified putative risk, may disagree on the quality and quantity of evidence in support of the claimed risk. And of course they may dispute whether the claimed risk exists at all, or the criteria by which the risk should be established. Unfortunately, the law offers little help in answering the obvious question of which expert or group of experts, and which criteria, of all the experts and criteria in the world, are the appropriate reference standards. The point of adverting to experts is, no doubt, that the law knows nothing about causal claims unless there is admissible and sufficient evidence of the risk, typically from a qualified expert, serving as an expert witness, who proffers an opinion about causal claim.

The standard formulation evades the necessity of confronting the epistemic standard for knowledge of the risk by pointing to some expert’s or group of experts’ opinion. Rather than looking directly at whether the causal claim is “true, justified belief,” the law asks whether expert witnesses hold such opinions. This maneuver has several inherent risks of its own. First, it transmutes factfinding into an exercise in the sociology or sampling of expert witnesses. In the case of claims that involve long latencies between the exposure to the putative risk and the manifestation of harm, this sociological exercise becomes one of intellectual history. One of the reasons that the Frye standard was so difficult in practice was its insistence that courts ascertain whether a particular claim or a use of scientific device was “generally accepted.” The assessment of the relevant expert’s knowledge of risk has generally not gone well in litigation contexts. Second, the maneuver of looking to experts’ opinions introduces a different kind of risk; that is, the maneuver risks diluting the standard for warning, “knowledge and expertise” to subjective opinion, hunches, conjecture, and the like.

An analogue of the standard for warning of risks may be found in the law of medical malpractice. Historically, American law relied heavily upon generally held opinions as the measure of knowledge, which were incorporated into standards of reasonable professional care. The law that governs litigation over the quality of medical care in many states resolves this issue by providing a defense under the “Two Schools of Thought Doctrine.”[1] A physician does not deviate from the standard of care simply because many or even most physicians reject the approach he or she took in the care and treatment of the aggrieved patient’s problem. As long as a substantial minority of physicians would have concurred in the judgment of the defendant physician, the claim of malpractice fails.

Pennsylvania confronted the nose-counting problem in Jones v. Chidester, by passing the buck to the jury. The Pennsylvania Supreme Court held that a physician would escape liability if his medical treatment received the support of a “considerable number” of medical experts.[2] The court allocated to the jury the factual determination how many recognized and respected medical experts were needed to create a “school of thought,” but it left completely unclear how a jury would make such a determination.[3]

The law’s lassitude in relying upon professional custom and opinion, rather than whether the custom had sound evidentiary and methodological foundations, might be taken as deference to, and protection of, the medical profession. Or, less charitably, this reliance might be taken as intellectual laziness to avoid engagement with the intellectual basis for the custom or the school of thought. Indeed, the continuing validity of the “nose-counting” approach may certainly be questioned in the era of “evidence-based medicine,” which rejects custom as the basis for medical interventions in favor of the novelty of evidence itself.[4]

If the Two Schools Doctrine should be good law, it has obvious implications for the standard of design or warning in products cases, as well as for the standard of causation. How can a judge or jury impose liability upon a manufacturer for failing to warn about a risk that “a school of thought” among scientists believes is not a risk? An even more extreme disparity arises when the jury or judge comes to the belief that a manufacturer deserves to be punished for failing to warn about supposed risks when many scientists and even regulators do not believe exist.

It is a mystery.


[1]        See, e.g., MacDonald v. United States, 767 F. Supp. 1295, 1308 (M.D. Pa. 1991) (outlining the history and development of the two-schools doctrine under Pennsylvania law); Young v. United States, 574 F. Supp. 571, 581 (D. Del. 1983) (holding that medical profession’s acceptance of alternative appropriate remedies is a complete defense to claim of negligence for failing to use another remedy);  Scheuler v. Strelinger, 204 A.2d 577, 204 A.2d 577, 585  (1964).

[2]        Jones v. Chidester, 531 Pa. 31, 610 A.2d 964, 967 (1992).

[3]        See, e.g., Dailey, “The Two Schools of Thought and Informed Consent Doctrine in Pennsylvania,” 98 Dickenson L. Rev. 713 (1994); Douglas Rader Brown, “Panacea or Pandora’s Box: The ‘Two Schools of Medical Thought’ Doctrine after Jones v. Chidester, 610 A.2d 964 (Pa. 1992),” 44 J. Urban & Contemp. Law 223 (1993).

[4]           See Terence M. Davidson & Christopher P. Guzelian, “Evidence-Based Medicine (EBM): The (Only) Means for Distinguishing Knowledge of Medical Causation from Expert Opinion in the Courtroom,” 47 Trial & Insur. Prac. L. J. 741 (2012) (discussing the advent of evidence-based medicine and its implications for medical education an practice).

The Defenestration of Sir Ronald Aylmer Fisher

August 20th, 2020

Fisher has been defenestrated. Literally.

Sir Ronald Fisher was a brilliant statistician. Born in 1890, he won a scholarship to Gonville and Caius College, in Cambridge University, in 1909. Three years later, he gained first class honors in Mathematics, and he went on to have extraordinary careers in genetics and statistics. In 1929, Fisher was elected to the Royal Society, and in 1952, Queen Bessy knighted him for his many contributions to the realm, including his work on experimental design and data interpretation, and his bridging the Mendelian theory of genetics and Darwin’s theory of evolution. In 1998, Bradley Efron described Fisher as “the single most important figure in 20th century statistics.[1] And in 2010, University College, London, established the “R. A. Fisher Chair in Statistical Genetics” in honor of Fisher’s remarkable contributions to both genetics and statistics. Fisher’s college put up a stained-glass window to celebrate its accomplished graduate.

Fisher was, through his interest in genetics, also interested in eugenics through the application of genetic learning to political problems. For instance, he favored abolishing extra social support to large families, in favor of support proportional to the father’s wages. Fisher also entertained with some seriousness grand claims about the connection between rise and fall of civilizations and the loss of fertility among the upper classes.[2] While a student at Caius College, Fisher joined the Cambridge Eugenics Society, as did John Maynard Keynes. For reasons having to do with professional jealousies, Fisher’s appointment at University College London, in 1933, was as a professor of Eugenics, not Statistics.

After World War II, an agency of the United Nations, the United Nations Educational, Scientific and Cultural Organization (UNESCO) sought to forge a scientific consensus against racism, and Nazi horrors.[3] Fisher participated in the UNESCO commission, which he found to be “well-intentioned” but errant for failing to acknowledge inter-group differences “in their innate capacity for intellectual and emotional development.”[4]

Later in the UNESCO report, Fisher’s objections are described as the same as those of Herman Joseph Muller, who won the Nobel Prize for Medicine in 1946, The report provides Fisher’s objections in his own words:

“As you ask for remarks and suggestions, there is one that occurs to me, unfortunately of a somewhat fundamental nature, namely that the Statement as it stands appears to draw a distinction between the body and mind of men, which must, I think, prove untenable. It appears to me unmistakable that gene differences which influence the growth or physiological development of an organism will ordinarily pari passu influence the congenital inclinations and capacities of the mind. In fact, I should say that, to vary conclusion (2) on page 5, ‘Available scientific knowledge provides a firm basis for believing that the groups of mankind differ in their innate capacity for intellectual and emotional development,’ seeing that such groups do differ undoubtedly in a very large number of their genes.”[5]

Fisher’s comments may not be totally anodyne by today’s standards, but he had also commented that that:

“the practical international problem is that of learning to share the resources of this planet amicably with persons of materially different nature, and that this problem is being obscured by entirely well-intentioned efforts to minimize the real differences that exist.”[6]

Fisher’s comments seem to reflect his beliefs in the importance of the genetic contribution to “intelligence and emotional development,” which today retain both their plausibility and controversial status. Fisher’s participation in the UNESCO effort, and his emphasis on sharing resources peacefully, seem to speak against malignant racism, and distinguish him from the ugliness of the racism expressed by the Marxist statistician (and eugenicist) Karl Pearson.[7]

Cancel Culture Catches Up With Sir Ronald A. Fisher

Nonetheless the Woke mob has had its daggers out for Sir Ronald, for some time. Back in June of this year, graffiti covered the walls of Caius College, calling for the defenestration of Fisher.  A more sedate group circulated a petition for the removal of the Fisher window.[8] Later that month, the university removed the Fisher window, literally defenestrating him.[9]

The de-platforming of Fisher was not contained to the campus of a college in Cambridge University.  Fisher spent some of his most productive years, outside the university, at the Rothamsted Experimental Station.  Not to be found deficient in the metrics of social justice, Rothamsted Research issued a statement, on June 9, 2020, concerning its most famous resident scientist:

“Ronald Aylmer Fisher is often considered to have founded modern statistics. Starting in 1919, Fisher worked at Rothamsted Experimental Station (as it was called then) for 14 years.

Among his many interests, Fisher supported the philosophy of eugenics, which was not uncommon among intellectuals in Europe and America in the early 20th Century.

The Trustees of the Lawes Agricultural Trust, therefore, consider it appropriate to change the name of the Fisher Court accommodation block (opened in 2018 and named after the old Fisher Building that it replaced) to ‘AnoVa Court’, after the analysis of variance statistical test developed by Fisher’s team at Rothamsted, and which is widely used today. Arrangements for this change of name are currently being made.”

I suppose that soon it will verboten to mention Fisher’s Exact Test.

Daniel Cleather, a scientist and self-proclaimed anarchist, goes further and claims that the entire enterprise of statistics is racist.[10] Cleather argues that mathematical models of reality are biased against causal explanation, and that this bias supports eugenics and politically conservative goals. Cleather claims that statistical methods were developed “by white supremacists for the express purpose of demonstrating that white men are better than other people.” Cleather never delivers any evidence, however, to support his charges, but he no doubt feels strongly about it, and feels unsafe in the presence of Fisher’s work on experimental methods.

It is interesting to compare the disparate treatment that other famous scholars and scientists are receiving from the Woke. Aristotle was a great philosopher and “natural philosopher” scientist. There is a well-known philosophical society, the Aristotlean Society, obviously named for Aristotle, as is fitting. In the aftermath of the killings of George Floyd, Breonna Taylor and Ahmaud Arbery, the Aristotlean Society engaged in this bit of moral grandstanding, of which The Philosopher would have likely disapproved:

A statement from the Aristotelian Society

“The recent killings of George Floyd, Breonna Taylor and Ahmaud Arbery have underlined the systemic racism and racial injustice that continue to pervade not just US but also British society. The Aristotelian Society stands resolutely opposed to racism and discrimination in any form. In line with its founding principles, the Society is committed to ensuring that all its members can meet on an equal footing in the promotion of philosophy. In order to achieve this aim, we will continue to work to identify ways that we can improve, in consultation with others. We recognise it as part of the mission of the Society to actively promote philosophical work that engages productively with issues of race and racism.”

I am sure it occurred to the members of the Society that Aristotle had expressed a view that some people were slaves by nature.[11] Today, we certainly do not celebrate Aristotle for this view, but we have not defenestrated him for a view much more hateful than any expressed by Sir Ronald. My point is merely that the vaunted Aristotelian Society is well able to look at the entire set of accomplishments of Aristotle, and not throw him out the window for his views on slavery. Still, if you have art work depicting Aristotle, you may be wise to put it out of harms way.

If Aristotle’s transgressions were too ancient for the Woke mob, then consider those of Nathan Roscoe Pound, who was the Dean of Harvard Law School, from 1916 to 1936. Pound wrote on jurisprudential issues, and he is generally regarded as the founder of “sociological jurisprudence,” which seeks to understand law as influenced and determined by sociological conditions. Pound is celebrated especially by the plaintiffs’ bar, for his work for National Association of Claimants‘ Compensation Attorneys, which was the precursor to the Association of Trial Lawyers of America, and the current, rent-seeking, American Association for Justice. A group of “compensation lawyers” founded the Roscoe Pound –American Trial Lawyers Foundation (now the The Pound Civil Justice Institute) in 1956, to build on Pound’s work.

Pound died in 1964, but he lives on in the hearts of social justice warriors, who seem oblivious of Pound’s affinity for Hitler and Nazism.[12] Pound’s enthusiasm was not a momentary lapse, but lasted a decade according to Daniel R. Coquillette, professor of American legal history at Harvard Law School.[13] Although Pound is represented in various ways as having been a great leader throughout the Harvard Law School, Coquillette says that volume two of his history of the school will address the sordid business of Pound’s Nazi leanings. In the meanwhile, no one is spraying graffiti on Pound’s portraits, photographs, and memorabilia, which are scattered throughout the School.

I would not want my defense of Fisher to be taken as a Trumpist “what-about” rhetorical diversion. Still, the Woke criteria for defenestrations seem, at best, to be applied inconsistently. More important, the Woke seem to have no patience for examining the positive contributions made by those they denounce. In Fisher’s (and Aristotle’s) case, the balance between good and bad ideas, and the creativity and brilliance of his important contributions, should allow of people of good will to celebrate his many achievements, without moral hand waving. If the Aristotelian Society can keep its name, the Cambridge should be able to keep its stained-glass window memorial to Fisher.


[1]        Bradley Efron, “R. A. Fisher in the 21st century,” 13 Statistical Science 95, 95 (1998).

[2]        See Ronald A. Fisher, The Genetical Theory of Natural Selection 228-55 (1930) (chap. XI, “Social Selection of Fertility,” addresses the “decay of ruling classes”).

[3]        UNESCO, The Race Concept: Results of an Inquiry (1952).

[4]        Id. at 27 (noting that “Sir Ronald Fisher has one fundamental objection to the Statement, which, as he himself says, destroys the very spirit of the whole document. He believes that human groups differ profoundly “in their innate capacity for intellectual and emotional development.”)

[5]        Id. at 56.

[6]        Id. at 27.

[7]        Karl Pearson & Margaret Moul, “The Problem of Alien Immigration into Great Britain, Illustrated by an Examination of Russian and Polish Jewish Children, Part I,” 1 Ann. Human Genetics 5 (1925) (opining that Jewish immigrants “will develop into a parasitic race. […] Taken on the average, and regarding both sexes, this alien Jewish population is somewhat inferior physically and mentally to the native population.” ); “Part II,” 2 Ann. Human Genetics 111 (1927); “Part III,” 3 Ann. Human Genetics 1 (1928).

[8]        “Petition: Remove the window in honour of R. A. Fisher at Gonville & Caius, University of Cambridge.” See Genevieve Holl-Allen, “Students petition for window commemorating eugenicist to be removed from college hall; The petition surpassed 600 signatures in under a day,” The Cambridge Tab (June 2020).

[9]        Eli Cahan, “Amid protests against racism, scientists move to strip offensive names from journals, prizes, and more,” Science (July 2, 2020); Sam Kean “Ronald Fisher, a Bad Cup of Tea, and the Birth of Modern Statistics: A lesson in humility begets a scientific revolution,” Distillations (Science History Institute) (Aug. 6, 2019). Bayesians have been all-too-happy to throw shade at Fisher. See Eric-Jan Wagenmakers & Johnny van Doorn, “This Statement by Sir Ronald Fisher Will Shock You,” Bayesian Spectacles (July 2, 2020).

[10]      Daniel Cleather, “Is Statistics Racist?Medium (Mar. 9, 2020).

[11]      Aristotle, Politics, 1254b16–21.

[12]      James Q. Whitman, Hitler’s American Model: The United States and the Making of Nazi Race Law 15 & n. 39 (2017); Stephen H. Norwood, The Third Reich in the Ivory Tower 56-57 (2009); Peter Rees, “Nathan Roscoe Pound and the Nazis,”  60 Boston Coll. L. Rev. 1313 (2019); Ron Grossman, “Harvard accused of coddling Nazis,” Chicago Tribune (Nov. 30, 2004).

[13]      Garrett W. O’Brien, “The Hidden History of the Harvard Law School Library’s Treasure Room,” The Crimson (Mar. 28, 2020).

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.