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Pernicious Probabilities in the Supreme Court

December 11th, 2020

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

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

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

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

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

On the Democratic side of the 2016 and 2020 elections, there was a dramatic change in the line-up. In 2016, candidate Hilary Clinton inspired many feminists because of her XX 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 quadrillion” Statistical Modeling, Causal Inference, and Social Science (Dec. 8, 2020).

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

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

Posted in Cognitive Biases, statistical evidence | Comments Off on Pernicious Probabilities in the Supreme Court

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.

Posted in Cognitive Biases, Rule 702, Scientific Misconduct, Underlying Data | Comments Off on The Knowledge Remedy Proposal

Is Your Daubert Motion Racist?

July 17th, 2020

In this week’s New York Magazine, Jonathan Chait points out there is now a vibrant anti-racism consulting industry that exists to help white (or White?) people to recognize the extent to which their race has enabled their success, in the face of systematic inequalities that burden people of color. Chait acknowledges that some of what this industry does is salutary and timely, but he also notes that there are disturbing elements in this industry’s messaging, which is nothing short of an attack on individualism as racist myth that ignores that individuals are subsumed completely into their respective racial group. Chait argues that many of the West’s most cherished values – individualism, due process, free speech and inquiry, and the rule of law – are imperiled by so-called “radical progressivism” and “identity politics.”[1]

It is hard to fathom how anti-racism can collapse all identity into racial categories, even if some inarticulate progressives say so. Chait’s claim, however, seems to be supported by the Smithsonian National Museum of African American History & Culture, and its webpages on “Talking about Race,” which provides an extended analysis of “whiteness,” “white privilege,” and the like.

On May 31, 2020, the Museum’s website published a graphic that presented its view of the “Aspects & Assumptions of Whiteness and White Culture in the United States,” which made many startling claims about what is “white,” and by implication, what is “non-white.” [The chart is set out below.] I will leave it to the sociologists, psychologists, and anthropologists to parse the discussion of “white-dominant culture,” and white “racial identity,” provided in the Museum’s webpages. In my view, the characterizations of “whiteness” were overtly racist and insulting to all races and ethnicities. As Chait points out, with an abundance of irony, Donald Trump would seem to be the epitome of non-white, by his disavowal of the Museum’s identification of white culture’s insistence that “hard work is the key to success.”

The aspect of the graphic summary of whiteness, which I found most curious, most racist, and most insulting to people of all colors and ethnicities, is the chart’s assertion that white culture places “Emphasis on the Scientific Method,” with its valuation of “[o]bjective, rational linear thinking; “[c]ause and effect relationships”; and “[q]uantitative emphasis.” The implication is that non-whites do not emphasize or care about the scientific method. So scientific method, with its concern over validity of inference, and ruling out random and systematic errors, is just white privilege, and a microaggression against non-white people.

Really? Can the Smithsonian National Museum of African American History & Culture really mean that scientific punctilio is just another manifestation of racism and cultural imperialism. Chait seems to think so, quoting Glenn Singleton, president of Courageous Conversation, a racial-sensitivity training firm, who asserts that valuing “written communication over other forms” is “a hallmark of whiteness,” as is “scientific, linear thinking. Cause and effect.”

The Museum has apparently removed the graphic from its website, in response to a blitz of criticism from right-wing media and pundits.[2]  According to the Washington Post, the graphic has its origins in a 1978 book on White Awareness.[3] In response to the criticism, museum director Spencer Crew apologized and removed the graphic, agreeing that “it did not contribute to the discussion as planned.”[4]

The removal of the graphic is not really the point. Many people will now simply be bitter that they cannot publicly display their racist tropes. More important yet, many people will continue to believe that causal, rational, linear thinking is white, exclusionary, and even racist. Something to remember when you make your next Rule 702 motion.

   

[1]  Jonathan Chait, “Is the Anti-Racism Training Industry Just Peddling White Supremacy?” New York Magazine (July 16, 2020).

[2]  Laura Gesualdi-Gilmore “‘DEEPLY INSULTING’ African American museum accused of ‘racism’ over whiteness chart linking hard work and nuclear family to white culture,” The Sun (Jul 16 2020); “DC museum criticized for saying ‘delayed gratification’ and ‘decision-making’ are aspects of ‘whiteness’,” Fox News (July 16, 2020) (noting that the National Museum of African American History and Culture received a tremendous outcry after equating the nuclear family and self-reliance to whiteness); Sam Dorman, “African-American museum removes controversial chart linking ‘whiteness’ to self-reliance, decision-making The chart didn’t contribute to the ‘productive conversation’ they wanted to see,” Fox News (July 16, 2020); Mairead McArdle, “African American History Museum Publishes Graphic Linking ‘Rational Linear Thinking,’ ‘Nuclear Family’ to White Culture,” Nat’l Rev. (July 15, 2020).

[3]  Judy H. Katz, White Awareness: Handbook for Anti-Racism Training (1978).

[4]  Peggy McGlone, “African American Museum site removes ‘whiteness’ chart after criticism from Trump Jr. and conservative media,” Wash. Post (July 17, 2020).

Posted in Causation, Cognitive Biases, Rule 702, Scientific Evidence | Comments Off on Is Your Daubert Motion Racist?

ACGIH TLVs Lack Scientific Integrity & Transparency – The Mica NIC

June 2nd, 2020

The American Conference of Governmental Industrial Hygienists (ACGIH®) is a non-profit corporation established in 1938, to advance occupational and environmental health.  The corporation’s motto, included in its logo, hubristically announces:  “Defining the Science of Occupational and Environmental Health.”

Philosophers of science may demur from “the” in “the Science,” as well as from the intellectual arrogance in suggesting that this private organization has any such ability to commandeer the complex social nature of scientific knowledge. And yet, in the small area of setting permissible exposure limits to potential environmental or occupational toxic substances, the ACGIH is in the business of “defining” safety. Starting in 1941, the group started to review and recommend “exposure limits.” In 1956, the group coined (literally and figuratively) the term “threshold limit values” (TLVs®), and started to publish documentation for its recommended values.

From the beginning, the ACGIH has asserted that TLVs® are not standards; rather they are guidelines for use, with other information, in determining safe levels of workplace and environmental exposure. The ACGIH maintains that its TLVs are based upon published, peer-reviewed scientific studies in industrial hygiene, toxicology, occupational medicine, and epidemiology, without consideration for economic or technical feasibility.

Beginning in the 1980s, “the Lobby”[1] started to throw brushback pitches at the ACGIH to bully the organization out of positions that the Lobby thought were too comforting to manufacturing industry.[2]  The result was a dramatic shift in the ACGIH’s perspective. The bullying created a “white-hat” bias that operates as a one-way ratchet to push the ACGIH always to lower TLVs, regardless whether there was a scientific warrant for doing so. Efforts to curb ACGIH overreach by litigation have generally failed. The TLVs have becoming increasingly controversial and non-evidence-based.[3]

What follows is what a hypothetical stakeholder might submit in response to a recent ACGIH Notice of Intended change for its TLV for mica dust. Like other mineral dusts, mica when inhaled in large quantities over long time periods, causes a pneumoconiosis. Documenting a “reasonable safe” level requires studies with adequate quantification of exposure. I will leave the reader to decide whether the ACGIH has that evidence in hand, based upon the following.

[1]  F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997); see “The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013).

[2]  Barry I. Castleman & Grace E. Ziem, “Corporate influence on threshold limit values,” 13 Am. J. Indus.  Med. 531 (1988); Grace Ziem & Barry I. Castleman, “Threshold limit values: historical perspectives and current practice,” 31 J. Occup. Med. 910 (1989); S.A. Roach & S.M. Rappaport, “But they are not thresholds:  a critical analysis of the documentation of Threshold Limit Values,” 17 Am. J. Indus. Med. 727 (1990).

[3]  Philip E. Karmel, “The Threshold Limit Values Controversy,” N.Y. L. J. (Jan. 3, 2008).

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

These comments are in response to the proposed change in the ACGIH® TLV® for Mica, as explained in the ACGIH “Mica: TLV® Chemical Substances Draft Documentation, Notice of Intended Change” (“NIC”).  For the reasons stated below, the change in the Mica TLV-TWA (time-weighted average) in the NIC is not warranted and the existing Mica TLV should not be changed.

The ACGIH® TLVs® are important non-governmental standards, largely because a number of government entities incorporate TLVs by reference into regulations and thus give TLVs the force of law.[4]  For example, some states and Canadian provinces simply adopt TLVs as state or provincial occupational exposures levels, and some states have established “maximum allowable ambient concentrations” or similar limits on “toxic air contaminants” based entirely or in part on TLVs.  The U.S. Mine Safety and Health Administration (MSHA) uses the 1973 ACGIH TLV for crystalline silica (quartz) as a legally enforceable permissible exposure level.[5]  The U.S. Occupational Health and Safety Administration (OSHA) Hazard Communication Standard requires that ACGIH TLVs be disclosed in required Safety Data Sheets.  The process by which the ACGIH develops TLVs is critically important, and furthermore, given the regulatory and legal significance of the ACGIH TLVs, the ACGIH has the burden to support proposed changes in TLVs by an adequate process, which includes transparency and evidence sufficient to support any proposed change.

The flaws in the ACGIH TLV setting process are well known and the subject of several publications, most recently in paper titled “142 ACGIH Threshold Limit Values® established from 2008-2018 lack consistency and transparency.”

The following specific comments address the ACGIH’s process disclosed in the ACGIH’s NIC in support of its proposed change for the TLV-TWA for mica, which illustrate the process problem — the ACGIH NIC for the proposed Mica TLV-TWA change does not support the change proposed by the ACGIH.   Again, the ACGIH TLVs have regulatory and legal significance; therefore, the ACGIH should not make TLV changes arbitrarily and capriciously.  Instead, the changes should be made pursuant to a transparent process, and the ACGIH should support the proposed changes with the weight of the available evidence, and the evidence in support of and the reasons for the proposed change should be publicly disclosed.  It has not done that in this case, and its own NIC makes it clear that it has not:

  1. There is no evidence that “mica is an important cause of disabling occupational pneumoconiosis” as stated in the NIC. 

The NIC provides no citation or other supporting evidence for this conclusion; it merely states the conclusion as “fact” and a premise for the proposed change.[6] The NIC fails to estimate the number of workers currently potentially exposed to mica in the U.S. (or elsewhere), what industries these workers work in, what forms of mica these workers may be exposed to, what levels of respirable mica these workers may be exposed to, and to what extent pneumoconiosis caused by the inhalation of respirable mica exists.[7]

  1. The NIC proposes to materially lower the TLV for mica, but, other than noting that there are “nine different major species”, does not adequately address the mineralogical differences between the different species of mica, makes no attempt to assess the potential adverse health effects for the different species of mica, does not examine the “dose-response” data (as inadequate as it is) for the different species of mica, and so on. 

The “Chemical and Physical Properties” section of the NIC suggests the wide variety of materials that fall within the general term “mica”.  In spite of this, the ACGIH appears to have ignored differences and concluded that the TLV for “mica” as a general category of substances should be applicable to all forms of mica, with no support for this conclusion in the NIC.[8]

  1. The human studies (sic) cited in the NIC are inadequate to support a decision to change the mica TLV and do not support the mica TLV proposed.

The first cited study involved four employees in a muscovite milling plant, with an alleged exposure to respirable mica (as muscovite) dust between 1.86 and 5.77 mg/m3.

The second cited study involved a (one) South African man who worked in a mica milling factory.  As noted in the NIC, “[q]uantitative exposure data were not reported.”

The third cited study involved a (one) 65-year old who worked in the rubber industry for 40 years, where he was exposed to numerous dusts, including mica.  There was no exposure data reported.

The fourth study involved a (one) 62-year old woman allegedly exposed to “pure mica” for seven years; no quantitative exposure data were available.

The NIC cites the case of a worker who bagged mica flake for 36 years.  In this case, there were, apparently, two dust samples taken – one at the time of a medical exam of the worker at age 54, total dust of 0.2 mg/m3 — and one taken 17 years earlier – 0.7 mg/m3.  The bulk mica samples disclosed 7.1% to 8.4% silica (presumably, respirable crystalline silica as quartz).  The reference to the silica content of the “bulk samples” suggests that there was no analysis of the material collected in the two air samples taken.

The NIC cites the case of two British men who worked as “grinders of imported muscovite,” one starting in 1957. The “workplace dust concentrations were not quantified.”

The next paper cited in the NIC was from 1940 and involved employees who were exposed to the dust caused by “mica-scrap” grinding.  There was actually an attempt to quantify mica exposures (the data from before 1940), but it was done by particle count.  The NIC notes that the available information regarding mica health effects may be “limited by potential uncertainty converting from mppcf (million particles per cubic foot) to mg/m3 (which might not apply to all dust exposure scenarios).”  The difficulties associated with converting from mppcf to mg/m3 are well known in the cases of minerals far more extensively studied than mica (e.g., crystalline silica as quartz).  In addition to the conversion factor issue, there are other concerns raised by relying upon a paper published in 1940 to support a TLV today, such as, the quality of the sampling, the quality of the chest x-rays, and issues with the classification of the chest x-rays.  With that said, the NIC noted that “[n]one of the workers exposed at less than 10 mppcf (1.8 mg/m3), irrespective of employment duration, developed pneumoconiosis.”

The remaining studies cited in the NIC are similar.  But, to close this section of the comments, I will refer to the last study, a study of 71 South African workers employed in mica milling.  Twelve personal and static samples were taken during the course of the study.  The results of the personal samples indicated a range of respirable dust (or was it mica?) between 0.4 to 1.68 mg/m3.  The radiologic examination disclosed that 19 of the 71 workers had changes consistent with one or more of asbestos, silica and/or mica.  “The specific dust concentrations to which the individuals presenting with lung changes were exposed were not reported.”

The ACGIH is proposing a reduction in the mica TLV based on the studies as described in the NIC.  We submit that this is a process and transparency problem – there is simply no way to conclude that a reduction in the mica TLV is warranted based on the Human Studies (the “evidence”) cited in the NIC.  In most cases, the Human Studies are simply case reports involving one, two, or a few people, with no quantitative exposure data.  The studies with exposure data are inadequate, i.e., date from before 1940, and among other things measured exposure as mppcf, with one study literally including two samples.  Given the legal and regulatory significance of ACGIH TLVs, the evidence cited in support of the change in the mica TLV, and the reasonable conclusion that can be drawn from the evidence cited, should exceed some threshold and meet some burden.  The evidence in the NIC is grossly insufficient to support the proposed change.

  1. The NIC for mica does not disclose any evidence to support the proposed TLV of a TWA of 0.1 mg/m3. 

The comparison to OSHA’s notice of proposed rulemaking for occupational exposure to respirable crystalline silica (RCS) is instructive.  The supporting documentation sets forth a preliminary quantitative risk assessment outlining life-time risks for various disease end points associated with occupational exposure to RCS at various levels.  The preliminary quantitative risk assessment disclosed all of the underlying studies and methodology, sufficient to allow a reader to understand the basis for the risk assessment conclusions and agree or disagree with the conclusions.  Based on the risks (and other factors not considered by the ACGIH) set forth in the documentation, OSHA proposed a PEL (permissible exposure level) for RCS.

By contrast, the ACGIH simply contends for its proposed mica TLV: “Consequently, a TLV-TWA of 0.1 mg/m3 measured as respirable fraction (containing no asbestos and <1% crystalline silica) is recommended.”  The materials preceding “[c]consequently”, which in normal reading would be expected to support the conclusion following, are not a risk assessment or anything similar to one, and in no way even superficially support the conclusion – the recommendation – stated.[9]  Therefore, the ACGIH proposed a TLV-TWA of 0.1. The NIC materials do not support a TLV of 0.1 mg/m3, any more than they support a TLV of 0.0001 or 10.  It cannot be stated too emphatically that the NIC is devoid of any evidence to support any TLV, including the recommended TLV-TWA of 0.1 mg/m3.

Of course, the ACGIH TLV process is not a federal rulemaking.  And readers should be aware of the ACGIH Position Statement regarding TLVs (“TLVs … are not quantitative levels of risk at different exposure levels…”). But the same Position Statement notes that “TLVs®…represent conditions under which ACGIH® believes that nearly all workers may be repeatedly exposed without adverse health effects.”  So, presumably, the ACGIH concluded that its proposed mica TLV was that level, and yet there is simply no evidence in the NIC to support that conclusion.  Given the regulatory and legal significance of TLVs, the process of establishing TLVs should have some basis in science and evidence.

References

ACGIH® TLV/BEI® Position Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-position-statement

ACGIH® TLV/BEI® Policy Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-policy-statement

30 C.F.R. § 56.5001 (MSHA exposure to airborne contaminants)

29 C.F.R. § 1910.1200 (OSHA Hazard Communications)

D. Davies & R. Cotton, “Mica pneumoconiosis,” 40 Br. J. Indus. Med. 22 (1983)

Subhabrata Moitra, “Mica pneumoconiosis: a neglected occupational lung disease – letter,” 6 The Lancet Respir. Med. e39 (2018), available at: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30178-4/fulltext

Notice of Proposed Rule Making (NPRM) for Occupational Exposure to Respirable Crystalline Silica, 56 Fed. Reg. 56273 (Sept. 12, 2013)

Knut R. Skulburg, “Mica pneumoconiosis – a literature review,” 11 Scand. J. Work & Envt’l Health 65 (1985)

Carl J. Smith & Thomas A. Perfetti, “142 ACGIH Threshold Limit Values® (TLV®s) established from 2008-2018 lack consistency and transparency,” 3 Toxicol. Research & Application 1 (2019)

[4] ACGIH states that TLVs are not intended to be legal standards, but the ACGIH recognizes the broad use of TLVs and should reasonably anticipate that TLVs will be used in ways beyond the scope of the legal disclaimers that the ACGIH publishes.

[5] 30 C.F.R. 56.5001

[6] The problems cited by Moitra — illegally operated mica mines exploiting vulnerable populations to work without protections in India and some African countries — speak to the need to eliminate illegal mining and protect vulnerable populations from exploitation, not the adequacy or inadequacy of any TLV.

[7] By comparison, see the OSHA documentation for the NPRM for Occupational Exposure to Respirable Crystalline Silica published September 12, 2013.  The citation to the 1985 Skulberg article (in “Major Sources of Exposure”) is inadequate on its face in 2020; the article summarizes world mica use from 1905-1981, and provides no information regarding use post-1981.  Likewise, the citation to the “Campaign for Safe Cosmetics” does not provide information on occupational exposure.

[8] The case of crystalline silica again provides a useful contrast.  There is no ACGIH TLV for “crystalline silica,” which as a general term includes many polymorphs.

[9] Actually, the materials that precede “consequently” explicitly refute the conclusion stated by the ACGIH (the TLV-TWA of 0.1 mg/m3) — “the published literature has established an association between mica exposure and pneumoconiosis typically at concentrations in the range of 1-6 mg/m3,”  and “no cases were observed among workers exposed to mica dusts at concentrations of 1.8 mg/m3 or less….”

Posted in Cognitive Biases, Scientific Evidence | Comments Off on ACGIH TLVs Lack Scientific Integrity & Transparency – The Mica NIC

Counter Cancel Culture – The NAS Conference on Irreproducibility

February 9th, 2020

“The meaning of the world is the separation of wish and fact.”  Kurt Gödel

Back in October 2019, David Randall, the Director of Research, of the National Association of Scholars, contacted me to ask whether I would be interested in presenting at a conference, to be titled “Fixing Science: Practical Solutions for the Irreproducibility Crisis.” David explained that the conference would be aimed at a high level consideration of whether such a crisis existed, and if so, what salutary reforms might be implemented.

As for the character and commitments of the sponsoring organizations, David was candid and forthcoming. I will quote him, without his permission, and ask his forgiveness later:

“The National Association of Scholars is taken to be conservative by many scholars; the Independent Institute is (broadly speaking) in the libertarian camp. The NAS is open to but currently agnostic about the degree of human involvement in climate change. The Independent Institute I take to be institutionally skeptical of consensus climate change theory–e.g., they recently hosted Willie Soon for lecture. A certain number of speakers prefer not to participate in events hosted by institutions with these commitments.”

To me, the ask was for a presentation on how the so-called replication crisis, or the irreproducibility crisis, affected the law. This issue was certainly one I have had much occasion to consider. Although I am aware of the “adjacency” arguments made by some that people should be mindful of whom they align with, I felt that nothing in my participation would compromise my own views or unduly accredit institutional positions of the sponsors.

I was flattered by the invitation, but I did some due diligence on the sponsoring organizations. I vaguely recalled the Independent Institute from my more libertarian days, but the National Association of Scholars (NAS, not to be confused with Nathan A. Schachtman) was relatively unknown to me. A little bit of research showed that the NAS had a legitimate interest in the irreproducibility crisis. David Randall had written a monograph for the organization, which was a nice summary of some of the key problems. The Irreproducibility Crisis of Modern Science: Causes, Consequences,and the Road to Reform (2018).

On other issues, the NAS seemed to live up to its description as “an organization of scholars committed to higher education as the catalyst of American freedom.” I listened to some of the group’s podcasts, Curriculum Vitae, and browsed through its publications. I found myself agreeing with many positions articulated by or through the NAS, and disagreeing with a few positions very strongly.

In looking over the list of other invited speakers, I saw great diversity of view points and approaches, One distinguished speaker, Daniele Fanelli, had criticized the very notion that there was a reproducibility crisis. In the world of statistics, there were strong defenders of statistical tests, and vociferous critics. I decided to accept the invitation, not because I was flattered, but because the replication issue was important, and I believed that I could add something to the discussion before an audience of professional scientists, statisticians, and educated lay persons. In writing to David Randall to accept the invitation, I told him that with respect to the climate change issues, I was not at all put off by healthy skepticism in the face all dogmas. Every dogma will have its day.

I did not give any further consideration to the political aspect of the conference until early January, when I received an email from a scientist, Lenny Teytelman, Ph.D., the C.E.O. of a company protocols.io, which addresses reproducibility issues. Dr Teytelman’s interest in improving reproducibility seemed quite genuine, but he wrote to express his deep concern about the conference and the organizations that were sponsoring it.

Perhaps a bit pedantically, he cautioned me that the NAS was not the National Academy of Sciences, a confusion that never occurred to me because the National Academies has been known as the National Academies of Science, Engineering and Medicine for several years now. Dr. Teytelman’s real concern seemed to be that the NAS is a “‘politically conservative advocacy group’.” (The internal scare quotes were Teytelman’s, but I was not afraid.) According to Dr. Teytelman, the NAS sought to undermine climate science and environmental protection by advancing a call for more reproducible science. He pointed me to what he characterized as an exposé on NAS, in Undark,1 and he cautioned me that the National Association of Scholars’ work is “dangerous.” Finally, Dr. Teytelman urged me to reconsider my decision to participate in the conference.

I did reconsider my decision, but reaffirmed it in an email I sent back to Dr. Teytelman. I realized that I could be wrong, in which case, I would eat my words, confident that they would be most digestible:

Dear Dr Teytelman,

Thank you for your note. I was aware of the piece on Undark’s website, as well as the difference between the NAS and the NASEM. I don’t believe anyone involved in science education would likely to be confused between the two organizations. A couple of years ago, I wrote a teaching module on biomedical causation for the National Academies. This is my first presentation at the request of the NAS, and frankly I am honored by the organization’s request that I present at its conference.

I have read other materials that have been critical of the NAS and its publications on climate change and other issues. I know that there are views of the organization from which I would dissent, but I do not see my disagreement on some issues as a reason not to attend, and present at a conference on an issue of great importance to the legal system.

I am hardly an expert on climate change issues, and that is my failing. Most of my professional work involves health effects regulation and litigation. If the NAS has advanced sophistical arguments against a scientific claim, then the proper antidote will be to demonstrate its fallacious reasoning and misleading marshaling of evidence. I should think, however, as someone interested in improving the reproducibility of scientific research, you will agree that there is much common ground for discussion and reform of scientific practice, on a broader arrange [sic] of issues than climate change.

As for the political ‘conservatism’, of the organization, I am not sure why that is a reason to eschew participation in a conference that should be of great importance to people of all political views. My own politics probably owe much to the influence of Michael Oakeshott, which puts me in perhaps the smallest political tribe of any in the United States. If conservatism means antipathy to post-modernism, identity politics, political orthodoxies, and assaults on Enlightenment values and the Rule of Law, then count me in.

In any event, thanks for your solicitude. I think I can participate and return with my soul intact.

All the best.

Nathan

To his credit, Dr. Teytelman tenaciously continued. He acknowledged that the political leanings of the organizers were not a reason to boycott, but he politely pressed his case. We were now on a first name basis:

Dear Nathan,

I very much applaud all efforts to improve the rigour of our science. The problem here is that this NAS organization has a specific goal – undermining the environmental protection and denying climate change. This is why 7 out of the 21 speakers at the event are climate change deniers. [https://docs.google.com/spreadsheets/d/136FNLtJzACc6_JbbOxjy2urbkDK7GefRZ/edit?usp=sharing] And this isn’t some small fringe effort to be ignored. Efforts of this organization and others like them have now gotten us to the brink of a regulatory change at the United States Environmental Protection Agency which can gut the entire EPA (see a recent editorial against this I co-authored). This conference is not a genuine effort to talk about reproducibility. The reproducibility part is a clever disguise for pushing a climate change denialism agenda.

Best,

Lenny

I looked more carefully at Lenny’s spreadsheet, and considered the issue afresh. We were both pretty stubborn:

Dear Lenny,

Thank you for this information. I will review with interest.

I do not see that the conference is primarily or even secondarily about climate change vel non. There are two scientists, Trafimow and Wasserstein with whom I have some disagreements about statistical methodology. Tony Cox and Stan Young, whatever their political commitments or views on climate change may be, are both very capable statisticians, from whom I have learned a great deal. The conference should be a lively conversation about reproducibility, not about climate change. Given your interests and background, you should go.

I believe that your efforts here are really quite illiberal, although they are in line with the ‘cancel culture’, so popular on campuses these days.

Forty three years ago, I entered a Roman Catholic Church to marry the woman I love. There were no lightning bolts or temblors, even though I was then and I am now an atheist. Yes, I am still married to my first wife. Although I share the late Christopher Hitchins’ low view of the Catholic Church, somehow I managed to overcome my antipathy to being married in what some would call a house of ill repute. I even manage to agree with some Papist opinions, although not for the superstitious ‘reasons’ Papists embrace.

If I could tolerate the RC Church’s dogma for a morning, perhaps you could put aside the dichotomous ‘us and them’ view of the world and participate in what promises to be an interesting conference on reproducibility?

All the best.

Nathan

Lenny kindly acknowledged my having considered his issues, and wrote back a nice note, which I will quote again in full without permission, but with the hope that he will forgive me and even acknowledge that I have given his views an airing in this forum.

Hi Nathan,

We’ll have to agree to disagree. I don’t want to give a veneer of legitimacy to an organization whose goal is not improving reproducibility but derailing EPA and climate science.

Warmly,

Lenny

The business of psychoanalyzing motives and disparaging speakers and conference organizers is a dangerous business for several reasons. First motives can be inscrutable. Second, they can be misinterpreted. And third, they can be mixed. When speaking of organizations, there is the further complication of discerning a corporate motive among the constituent members.

The conference was an exciting, intellectually challenging event, which took place in Oakland, California, on February 7 and 8. I can report back to Lenny that his characterizations of and fears about the conference were unwarranted. While there were some assertions of climate change skepticism made with little or no evidence, the evidence-based presentations essentially affirmed climate change and sought to understand its causes and future course in a scientific way. But climate change was not why I went to this conference. On the more general issue of reform of scientific procedures and methods, we had open debates, some agreement on important principles, and robust and reasoned disagreement.

Lenny, you were correct that the NAS should not be ignored, but you should have gone to the meeting and participated in the conversation.

1 Michael Schulson, “A Remedy for Broken Science, Or an Attempt to Undercut It?” Undark (April 18, 2018).

Posted in Cognitive Biases, Conflicts of Interest, Scientific Evidence, Scientific Misconduct, statistical evidence | Comments Off on Counter Cancel Culture – The NAS Conference on Irreproducibility

Some High-Value Targets for Sander Greenland in 2018

December 27th, 2017

A couple of years ago, Sander Greenland and I had an interesting exchange on Deborah Mayo’s website. I tweaked Sander for his practice of calling out defense expert witnesses for statistical errors, while ignoring whoopers made by plaintiffs’ expert witnesses. See “Significance Levels Made a Whipping Boy on Climate-Change Evidence: Is p < 0.05 Too Strict?” Error Statistics (Jan. 6, 2015).1 Sander acknowledged that he received a biased sample of expert reports through his service as a plaintiffs’ expert witness, but protested that defense counsel avoided him like the plague. In an effort to be helpful, I directed Sander to an example of bad statistical analysis that had been proffered by Dr Bennett Omalu, in a Dursban case, Pritchard v. Dow Agro Sciences, 705 F. Supp. 2d 471 (W.D. Pa. 2010), aff’d, 430 F. App’x 102, 104 (3d Cir. 2011).2

Sander was unimpressed with my example of Dr. Omalu; he found the example “a bit disappointing though because [Omalu] was merely a county medical examiner, and his junk analysis was duly struck. The expert I quoted in my citations was a full professor of biostatistics at a major public university, a Fellow of the American Statistical Association, a holder of large NIH grants, and his analysis (more subtle in its transgressions) was admitted” (emphasis added). Sander expressed an interest in finding “examples involving similarly well-credentialed, professionally accomplished plaintiff experts whose testimony was likewise admitted… .”

Although it was heartening to read Sander’s concurrence in the assessment of Omalu’s analysis as “junk,” Sander’s rejection of Dr. Omalu as merely a low-value target was disappointing, given that Omalu also has a master’s degree in public health, from the University of Pittsburgh, where he claims he studied with Professor Lew Kuller. Omalu has also gained some fame and notoriety for his claim to have identified the problem of chronic traumatic encephalopathy (CTE) among professional football players. After all, even Sander Greenland has not been the subject of a feature-length movie (Concussion), as has Omalu.

I lost track of our exchange in 2015, until recently I was reminded of it when reading an expert report by Professor Martin Wells. Unlike Omalu, Wells meets all the Greenland criteria for high-value targets. He is not only a full, chaired professor but also the statistics department chairman at an ivy-league school, Cornell University. Wells is a fellow of both the American Statistical Association and the Royal Statistical Society, but most important, Wells is a frequent plaintiffs’ expert witness, who is well known to Sander Greenland. Both Wells and Greenland served, side by side, as plaintiffs’ expert witnesses in the pain pump litigation.

So here is the passage in the Wells’ report that is worthy of Greenland’s attention:

“If a 95% confidence interval is specified, the range encompasses the results we would expect 95% of the time if samples for new studies were repeatedly drawn from the same population.”

In re Testosterone Replacement Therapy Prods. Liab. Litig., Declaration of Martin T. Wells, Ph.D., at 2-3 (N.D. Ill., Oct. 30, 2016). Unlike the Dursban litigation involving Bennett Omalu, where the “junk analysis” was excluded, in the litigation against AbbVie for its manufacture and selling of prescription testosterone supplementation, Wells’ opinions were not excluded or limited. In re Testosterone Replacement Therapy Prods. Liab. Litig., No. 14 C 1748, MDL No. 2545, 2017 WL 1833173 (N.D. Ill. May 8, 2017) (denying Rule 702 motions).

Now this statement by Wells surely offends the guidance provided by Greenland and colleagues.3 And it was exactly the sort of misrepresentation that led to a confabulation of the American Statistical Association, and that Association’s consensus statement on statistical significance.4

And here is another example, which occurs not in a distorting litigation forum, but on the pages of an occupational health journal, where the editor in chief, Anthony L. Kiorpes, ranted about the need for better statistical editing and writing in his own journal. See Anthony L Kiorpes, “Lies, damned lies, and statistics,” 33 Toxicol. & Indus. Health 885 (2017). Kiorpes decried he misuse of statistics:

“I am not implying that it is the intent of the scientists who publish in these pages to mislead readers by their use of statistics, but I submit that the misuse of statistics, whether intentional or otherwise, creates confusion and error.”

Id. at 885. Kiorpes then proceeded to hold himself up as Exhibit A to his screed:

“Remember that p values are estimates of the probability that the null hypothesis (no difference) is true.”

Id. Uggh; we seem to be back sliding after the American Statistical Association’s consensus statement.

“Almost all scientists have stated (or have been tempted to state) something like ‘the mean of Group A was greater than that of Group B, but the difference was not statistically significant’. With very few exceptions (which I will mention below), this statement is nonsense.”

* * * * *

“What the statistics are indicating when the p-value is greater than 0.05 is that there is ‘no difference’ between group A and group B.”

Id. at 886.

Let’s hope that this gets Sander Greenland away from his biased sampling of expert witnesses, off the backs of defense expert witnesses, and on to some of the real culprits out there, in the new year.

1 See also “Sander Greenland on ‘The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics’” (Feb. 8, 2015).

2 See also “Pritchard v. Dow Agro – Gatekeeping Exemplified” (Aug. 25, 2014); “Omalu and Science — A Bad Weld” (Oct. 22, 2016); Brian v. Association of Independent Oil Distributors, No. 2011-3413, Westmoreland Cty. Ct. Common Pleas, Order of July 18, 2016 (excluding Dr. Omalu’s testimony on welding and solvents and Parkinson’s disease).

3 See, e.g., Sander Greenland, Stephen J. Senn, Kenneth J. Rothman, John B. Carlin, Charles Poole, Steven N. Goodman, and Douglas G. Altman, “Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations,” 31 Eur. J. Epidem. 337 (2016).

4 Ronald L. Wasserstein & Nicole A. Lazar, “American Statistical Association Statement on statistical significance and p values,” 70 Am. Statistician 129 (2016)

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Rule 702, statistical evidence | Comments Off on Some High-Value Targets for Sander Greenland in 2018

Alabama Justice and Fundamental Fairness

November 20th, 2017

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

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

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

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

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

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

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

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

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

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

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

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

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

Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

January 11th, 2017

Science necessarily involves a willingness to follow evidence to whatever conclusions are warranted, if conclusions properly can be had. When it comes to vaccination conspiracies, Democrats have it in their political DNA to distrust pharmaceutical companies that research, develop, and manufacture vaccines. The current Republican party, which has been commandeered by theocrats and populists, see vaccination as federal government aggrandizement, and resist vaccination policy as contrary to God’s will. Science is often the loser in the cross-fire.

And so we now have the public spectacle of watching the left and the right join in similar scientific apostasies. Consider how both McCain and Obama both suggested that vaccines and autism were related in the 2008 election. (Although both candidates were to some extent slippery in their suggestions, which might have been appropriate given how little they knew about the controversies.) And consider Michelle Bachmann was converted to a similar view about the HPV vaccine on the basis of a woman’s anecdote about her child. And then on the far left, you have the uplifting story of Robert F. Kennedy Jr, and his brief on how thimerosal supposedly causes autism.

So it should be no surprise that Donald Trump, a Birther, a Mirther, a mid-night Twitterer, should embrace the anti-vaccination movement. Trump has made it clear that he rejects evidence-based policy, and so no one should expect him to embrace a scientific policy that is driven by high-quality scientific evidence. According to Kennedy, Trump wants Kennedy to head up a “commission on vaccine safety and scientific integrity.” Michael D. Shear, Maggie Haberman & Pam Belluckjan, “Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety,” N.Y. Times (Jan. 10, 2017); Domenico Montanaro, “Despite The Facts, Trump Once Again Embraces Vaccine Skeptics,” National Public Radio (Jan. 10, 2017).

Who needs the National Academy of Medicine when you can put a yutzball lawyer in charge of a “commission”?

Some of the media refer to Robert F. Kennedy Jr. as a vaccine skeptic, but their terminology is grossly inaccurate and misleading. Kennedy is a vaccine denier; he has engaged in a vitriolic campaign against the safety and efficacy of vaccines. He has aligned himself with the most extreme deniers of science, medicine, and public safety, including the likes of Andrew Wakefield and Jenny McCarthy. Kennedy has not merely engaged hyperbolic rhetoric against vaccines, he has used his radio show on the lawsuit industry’s Ring of Fire, to advance his campaign against public health as well as to shill for the lawsuit industry on other issues. See “RFK, Jr.: Science Shows That Autism — Mercury Link Exists – PT. ½,” Ring of Fire (Mar 8, 2011).

Kennedy should not be characterized as a skeptic, when he is a shrill ideologue, for whom science has no method that he is bound to respect. Back in July 2005, Kennedy published an article, “Deadly Immunity,” in both Rolling Stone and on Slate’s website. The article was a hateful screed against Big Pharma and government health agencies for an alleged conspiracy to hide the autism risks of thimerosal preservatives in vaccines. Several years later, on January 16, 2011, Salon retracted the article. See “https://en.wikipedia.org/wiki/Deadly_Immunity” entry in Wikipedia. See also Phil Plait, “Robert F. Kennedy Jr.: Anti-Vaxxer,” Slate (June 5 2013) (describing Kennedy as a full-blown anti-vaccination conspiracy theorist); Rahul K. Parikh, M.D., “Inside the vaccine-and-autism scare: A pediatrician traces the rise of the anti-vaccine movement that falsely linked thimerosal with autism and turned parents away from the most lifesaving medicine in history,” Salon (Sept. 22, 2008); Keith Kloor, “Is Robert F. Kennedy Jr. Anti-Science?” Discover Magazine (June 1, 2013); Steven Novella, “RFK Jr.s Autism Conspiracy Theory,” (Jun 20 2007).

Back in 2008, President Obama apparently considered Robert Kennedy for a cabinet-level position, but on sober reflection, thought better of it. See Steven Novella, “Politics and Science – The RFK Jr. Test,” (Nov. 07 2008). The Wall Street Journal, joined by many others, are now urging Trump to think harder and better about the issue, perhaps with some evidence as well. See Alex Berezow & Hank Campbell, “Ignore Anti-Vaccine Hysteria, Mr. Trump: Robert F. Kennedy Jr.’s conspiracy theories have no place in the White House,” Wall Street J. (Jan. 10, 2017).

Posted in Causation, Cognitive Biases, Conflicts of Interest, Evidence, Public Nuisances, Scientific Evidence, Scientific Misconduct | Comments Off on Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

Art Historian Expert Testimony

August 15th, 2016

Art appraisal and authentication is sometimes held out as a non-technical and non-scientific area of expertise, and as such, not subject to rigorous testing.[1] But to what extent is this simply excuse mongering for an immature field of study? The law has seen way too much of this sort of rationalization in criminal forensic studies.[2] If an entire field of learning suffers from unreliability because of its reliance upon subjective methodologies, lack of rigor, inability or unwillingness to use measurements, failure to eliminate biases through blinding, and the like, then do expert witnesses in this field receive a “pass” under Rule 702, simply because they are doing reasonably well compared with their professional colleagues?

In the movie Who the Fuck is Jackson Pollack, the late Thomas Hoving was interviewed about the authenticity of a painting claimed to have been “painted” by Jackson Pollack. Hoving “authoritatively,” and with his typical flamboyance, averred that the disputed painting was not a Pollack because the work “did not sing to me like a Pollack.” Hoving did not, however, attempt to record the notes he heard; nor did Hoving speak to what key Pollack usually painted in.

In a recent case of defamation and tortious interference with prospective business benefit, a plaintiff sued over the disparagement of a painting’s authenticity and provenance. As a result of the defendants’ statements that the painting at issue was not created by Peter M. Doig, auction houses refused to sell the painting held by plaintiff. In litigation, the plaintiff proffered an expert witness who opined that the painting was, in fact, created by Doig. The defendants challenged plaintiff’s expert witness as not reliable or relevant under Federal Rule of Evidence 702. Fletcher v. Doig, 13 C 3270, 2016 U.S. Dist. LEXIS 95081 (N.D. Ill. July 21, 2016).

Peter Bartlow, the plaintiff’s expert witness on authenticity, was short on academic credentials. He had gone to college, and finished only one year of graduate study in art history. Bartlow did, however, have 40 years in experience in appraisal and authentication. Fletcher, at *3-4. Beyond qualifications, the defendants complained that Bartlow’s method was

(1) invented for the case,

(2) was too “generic” to establish authenticity, and

(3) failed to show that any claimed generic feature was unique to the work of the artist in question, Peter M. Doig.

The trial court rebuffed this challenge by noting that Peter Bartlow did not have to be an expert specifically in Doig’s work. Fletcher at *7. Similarly, the trial court rejected the defendants’ suggestion that the disputed work must exhibit “unique” features of Doig’s ouevre. Bartlow had made a legally sufficient case for his opinions based upon a qualitative analysis of 45 acknowledged works, using specific qualitative features of 11 known works. Id. At *10. Specifically, Bartlow compared types of paint, similarities in styles, shapes and positioning, and “repeated lineatures” by superimposing lines from known paintings to the questioned ones. Id. With respect to the last of these approaches, the trial court found that Bartlow’s explanation that the approach of superimposing lines to show similarity was simply a refinement of methods commonly used by art appraisers.

By comparison with Thomas Hoving’s subjective auditory methodology, as explained in Who the Fuck, Bartlow’s approach was positively brilliant, even if the challenged methodologies left much to be desired. For instance, Bartlow compared one disputed painting with 45 or so paintings of accepted provenance. No one tested Bartlow’s ability, blinded to provenance, to identify true and false positives of Doig paintings. See “The Eleventh Circuit Confuses Adversarial and Methodological Bias, Manifestly Erroneously” (June 6, 2015); see generally Christopher Robertson & Aaron Kesselheim, Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law (2016).

Interestingly, the Rule 702 challenges in Fletcher were in a case slated to be tried by the bench. The trial court thus toasted the chestnut that trial courts have even greater latitude in admitting expert witness opinion testimony in bench trials, in which “the usual concerns of [Rule 702] – keeping unreliable testimony from the jury – are not present.” Fletcher at *3 (citing Metavante Corp. v. Emigrants Savings Bank, 619 F.3d 648, 670 (7th Cir. 2010)). Citing Seventh Circuit precedent, the trial court, in Fletcher, asserted that the need to rule on admissibility before trial was lessened in a bench trial. Id. (citing In re Salem, 465 F.3d 767, 777 (7th Cir. 2006)). The courts that have taken this position have generally failed to explain why the standard for granting or denying a Rule 702 challenge should be different in a bench trial. Clearly, a bench trial can be just as much a waste of time, money, and energy as a jury trial. Even more clearly, judges can be, and are, snookered by misleading expert witness opinions, and they are also susceptible to their own cognitive biases and the false allure of unreliable opinion testimony, built upon invalid inferences. Men and women do not necessarily see more clearly when wearing black robes, but they can achieve some measure of objectivity by explaining and justifying their gatekeeping opinions in writing, subject to public review, comment, and criticism.

[1] See, e.g. Lees v. Carthage College, 714 F.3d 516, 525 (7th Cir. 2013) (holding that an expert witness’s testimony on premises security involved non-scientific expertise and knowledge that did “not easily admit of rigorous testing and replication”).

[2] See, e.g., National Academies of Science, Strengthening Forensic Science in the United States: A Path Forward (2009).

Posted in Cognitive Biases, Expert Witnesses, Historian Testimony, Rule 702 | Comments Off on Art Historian Expert Testimony

The LoGiudice Inquisitiorial Subpoena & Its Antecedents in N.Y. Law

July 14th, 2016

The plaintiffs’ bar’s inquisition into funding has been a recurring theme in the asbestos and other litigations.[1] It is thus interesting to compare the friendly reception Justice Moulton gave plaintiffs’ subpoena in LoGiudice[2] with the New York courts’ relatively recent hostility toward a defendant’s subpoena to Mt. Sinai School of Medicine.

A few years ago, Justice Sherry Heitler quashed a defendant’s attempt to subpoena information from the archives of a deceased, former faculty member of the Mount Sinai School of Medicine (“Mt. Sinai”), in Reyniak v. Barnstead Internat’l, No. 102688-08, 2010 NY Slip Op 50689, 2010 WL 1568424 (N.Y. Sup. Ct. Apr. 6, 2010). In a cursory opinion, Justice Heitler cited institutional expense, chilling of research, and scholars’ fears that their unpublished notes, ideas, and observations would become public as a result of litigation. Heitler relied upon and followed an earlier New York state court’s decision that adopted a rather lopsided “balancing” analysis, which permitted the New York courts to ignore the legitimate needs of defendants for access to underlying data.[3]

Remarkably, Justice Heitler failed to cite a federal appellate court’s subsequent decision, which upheld the tobacco companies’ subpoena to Mount Sinai.[4] Her opinion also ignored the important context of the asbestos litigation, in which Selikoff, long since deceased, played a crucial role in fomenting and perpetuating litigation, with tendentious publications and pronouncements. Some might say, “manufacturing certainty.” Perpetuating the Litigation Industry’s Selikoff mythology, Justice Heitler described Selikoff as a ground breaking asbestos researcher, but she either ignored, or was ignorant of, his testimonial adventures, his attempts to influence litigation with ex parte meetings with presiding judges, and his other questionable litigation-related conduct.

Selikoff’s participation in litigation was not always above board.  His supposedly ground-breaking work was funded by the insulator’s union, which also sought him out as a testifying expert witness. Among his many testimonial adventures,[5] Selikoff testified as early as 1966 that asbestos causes colorectal cancer, and that it caused a specific claimant’s colorectal cancer. See “Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966) (thanking Selikoff for his having given testimony to support an insulator’s claim that asbestos caused his colorectal cancer). To be sure, Selikoff made his litigation claims in the scientific literature as well, but without any acknowledgement of his involving in litigation involving this very issue, and his funding by the asbestos union.[6]

Given the dubious provenance of many of Selikoff’s opinions,[7] the disparate treatment of the subpoenas in LoGuidice and Reyniak is irreconcilable. The inflated prestige of Selikoff and Mount Sinai blinded the New York state trial courts to Selikoff’s role in litigation and his biased assessments in science. The judicial hypocrisy may well be the consequence of how the academic community has promoted Selikoff’s reputation, while working assiduously to undermine the reputations of anyone who has been connected with the defense of occupational disease claims. Consider, for instance, how Labor (Marxist) historians have railed against the role that Dr. Anthony Lanza played in personal injury litigation following the Gauley Bridge tunnel construction.  See Jock McCulloch and Geoffrey Tweedale, “Anthony J. Lanza, Silicosis and the Gauley Bridge ‘Nine’,” 27 Social History of Medicine 86 (2013). While these historians deplore Lanza, however, they laud Selikoff. See “British Labor Historians Belaboring American Labor History – Gauley Bridge” (Oct. 14, 2013). Politics and occupational disease litigation are like that.

[1] See In re All Litigation filed by Maune, Raichle, Hartley, French & Mudd LLC v. 3M Co., No. 5-15-0235, Ill. App., 5th Dist.; 2016 Ill. App. Unpub. LEXIS 1392 (June 30, 2016); “Engineers for Automakers Must Unredact Agendas in Madison County Asbestos Litigation,” Madison County Record (July 2016); Lynn A. Lenhart, “Meeting Agendas Between Non-Party Consultant and Counsel for Asbestos Friction Clients Not Privileged” (July 5, 2016).  See also Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013), aff’d, 2013 WL 2435565 (N.Y. App. Div., 1st Dep’t June 6, 2013); “A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013).

[2] LoGiudice v. American Talc Co., No. 190253/2014, 2016 N.Y. Misc. LEXIS 2360, (N.Y. Sup., N.Y. Cty., June 20, 2016).

[3] See In re R.J. Reynolds Tobacco Co., 136 Misc 2d 282, 285, 518 N.Y.S.2d 729 (Sup. Ct., N.Y. Cty. 1987); see also In re New York County Data Entry Worker Prod. Liab.Litig., No. 14003/92, 1994 WL 87529 (N.Y. Sup. Ct. N.Y. Cty. Jan 31, 1994) (denying discovery because “special circumstances,” vaguely defined were absent).

[4] Mount Sinai School of Medicine v. The American Tobacco Co., 866 F.2d 552 (2d Cir. 1889).

[5] “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

[6] See, e.g., Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for his causal conclusion between asbestos and all gastrointestinal cancers).movie Her trailer

[7] See generally “Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas” (Oct. 4, 2014); “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014).

Posted in Asbestos, Cognitive Biases, Conflicts of Interest, Expert Witness Discovery | Comments Off on The LoGiudice Inquisitiorial Subpoena & Its Antecedents in N.Y. Law

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