TORTINI

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

California Roasts Fear-Mongering Industry

June 16th, 2019

A year ago, California set out to create an exemption for coffee from its Proposition 65 regulations. The lawsuit industry, represented by the Council for Education and Research on Toxics (CERT) had been successfully deploying Prop 65’s private right of action provisions to pick the pockets of coffee vendors. Something had to give.

In 2010, Mr. Metzger, on behalf of CERT, sued Starbucks and 90 other coffee manufacturers and distributors, claiming they had failed to warn consumers about the cancer risks of acrylamide. CERT’s mission was to shake down the roasters and the vendors because coffee has minor amounts of acrylamide in it. Acrylamide in very high doses causes tumors in rats[1]; coffee consumption by humans is generally regarded as beneficial.

Earlier last year a Los Angeles Superior Court ordered the coffee companies to put cancer warnings on their beverages. In the upcoming damages phase of the case, Metzger sought as much as $2,500 in civil penalties for each cup of coffee the defendants sold over at least a decade. Suing companies for violating California’s Proposition 65 is like shooting fish in a barrel, but the State’s regulatory initiative to save California from the embarrassment of branding coffee a carcinogen was a major setback for CERT.

And so the Office of Environmental Health Hazard Assessment (OEHHA) began a rulemaking largely designed to protect the agency from the public relations nightmare created by the application of the governing statute and regulations to squeeze the coffee roasters and makers.[2] The California’s agency’s proposed regulation on acrylamide in coffee resulted in a stay of CERT’s enforcement action against Starbucks.[3] CERT’s lawyers were not pleased; they had already won a trial court’s judgment that they were owed damages, and only the amount needed to be set. In September 2018, CERT filed a lawsuit in Los Angeles Superior Court against the state of California challenging OEHHA’s proposed rule, saying it was being rammed through the agency on the order of the Office of the Governor in an effort to kill CERT’s suit against the coffee companies. Or maybe it was simply designed to allow people to drink their coffee without the Big Prop 65 warning.

Earlier this month, after reviewing voluminous submissions and holding a hearing, the OEHHA announced its ruling that Californians do not need to be warned that coffee causes cancer. Epistemically, coffee is not known to the State of California to be hazardous to human health.[4] According to Sam Delson, a spokesperson for the OEHHA, “Coffee is a complex mixture of hundreds of chemicals that includes both carcinogens and anti-carcinogens. … The overall effect of coffee consumption is not associated with any significant cancer risk.” The regulation saving coffee goes into effect in October 2019. CERT, no doubt, will press on in its litigation campaign against the State.

CERT is the ethically dodgy organization founded by C. Sterling Wolfe, a former environmental lawyer; Brad Lunn; Carl Cranor, a philosophy professor at University of California Riverside; and Martyn T. Smith, a toxicology professor at University of California Berkeley.[5] Metzger has been its lawyer for many years; indeed, Metzger and CERT share the same office. Smith has been the recipient of CERT’s largesse in funding toxicologic studies. Cranor and Smith have both testified for the lawsuit industry.

In the well-known Milward case,[6] both Cranor and Smith served as paid expert witnesses for plaintiff. When the trial court excluded their proffered testimonies as unhelpful and unreliable, their own organization, CERT, came to the rescue by filing an amicus brief in the First Circuit. Supporting by a large cast of fellow travelers, CERT perverted the course of justice by failing to disclose the intimate relationship between the “amicus” CERT and the expert witnesses Cranor and Smith, whose opinions had been successfully challenged.[7]

The OEHHA coffee regulation shows that not all regulation is bad.


[1]  National Cancer Institute, “Acrylamide and Cancer Risk.”

[2]  See Sam Delson, “Press Release: Proposed OEHHA regulation clarifies that cancer warnings are not required for coffee under Proposition 65” (June 15, 2018).

[3]  Council for Education and Research on Toxics v. Starbucks Corp., case no. B292762, Court of Appeal of the State of California, Second Appellate District.

[4]  Associated Press, “Perk Up: California Says Coffee Cancer Risk Insignificant,” N.Y. Times (June 3, 2019); Sara Randazzo, “Coffee Doesn’t Warrant a Cancer Warning in California, Agency Says; Industry scores win following finding on chemical found in beverage,” W.S.J. (June 3, 2019); Editorial Board, “Coffee Doesn’t Kill After All: California has a moment of sanity, and a lawyer is furious,” Wall.St.J. (June 5, 2019).

[5]  Michael Waters, “The Secretive Non-Profit Gaming California’s Health Laws,” The Outline (June 18, 2018); Beth Mole, “The secretive nonprofit that made millions suing companies over cancer warnings,” Ars Technica (June 6, 2019); NAS, “Coffee with Cream, Sugar & a Dash of Acrylamide” (June 9, 2018); NAS, “The Council for Education & Research on Toxics” (July 9, 2013); NAS, “Sand in My Shoe – CERTainly” (June 17, 2014) (CERT briefs supported by fellow-travelers, testifying expert witnesses Jerrold Abraham, Richard W. Clapp, Ronald Crystal, David A. Eastmond, Arthur L. Frank, Robert J. Harrison, Ronald Melnick, Lee Newman, Stephen M. Rappaport, David Joseph Ross, and Janet Weiss, all without disclosing conflicts of interest).

[6]  Milward v. Acuity Specialty Products Group, Inc., 664 F. Supp. 2d 137, 148 (D.Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. den. sub nom. U.S. Steel Corp. v. Milward, 565 U.S. 1111 (2012), on remand, Milward v. Acuity Specialty Products Group, Inc., 969 F.Supp. 2d 101 (D.Mass. 2013) (excluding specific causation opinions as invalid; granting summary judgment), aff’d, 820 F.3d 469 (1st Cir. 2016).

[7]  NAS, “The Council for Education & Research on Toxics” (July 9, 2013) (CERT amicus brief filed without any disclosure of conflict of interest). The fellow travelers who knowingly or unknowingly aided CERT’s scheme to pervert the course of justice, included some well-known testifiers for the lawsuit industry: Nicholas A. Ashford, Nachman Brautbar, David C. Christiani, Richard W. Clapp, James Dahlgren, Devra Lee Davis, Malin Roy Dollinger, Brian G. Durie, David A. Eastmond, Arthur L. Frank, Frank H. Gardner, Peter L. Greenberg, Robert J. Harrison, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, Melissa A. McDiarmid, Myron Mehlman, Ronald L. Melnick, Mark Nicas, David Ozonoff, Stephen M. Rappaport, David Rosner, Allan H. Smith, Daniel Thau Teitelbaum, Janet Weiss, and Luoping Zhang. See also NAS, “Carl Cranor’s Conflicted Jeremiad Against Daubert” (Sept. 23, 2018); Carl Cranor, “Milward v. Acuity Specialty Products: How the First Circuit Opened Courthouse Doors for Wronged Parties to Present Wider Range of Scientific Evidence” (July 25, 2011).

 

 

History of Silicosis Litigation

January 31st, 2019

“Now, Silicosis, you’re a dirty robber and a thief;
Yes, silicosis, you’re a dirty robber and a thief;
Robbed me of my right to live,
and all you brought poor me is grief.
I was there diggin’ that tunnel for just six bits a day;
I was diggin’ that tunnel for just six bits a day;
Didn’t know I was diggin’ my own grave,
Silicosis was eatin’ my lungs away.”

Josh White, “Silicosis Is Killin’ Me (Silicosis Blues)” (1936)

Recently, David Rosner, labor historian, social justice warrior, and expert witness for the litigation industry, gave the Fielding H. Garrison Lecture, in which he argued for the importance of the work that he and his comrade-in-arms, Gerald Markowitz, have done as historian expert witnesses in tort cases.1 Although I am of course grateful for the shout out that Professor Rosner gives me,2 I am still obligated to call him on the short-comings of his account of silicosis litigation.3 Under the rubric of “the contentious struggle to define disease,” Rosner presents a tendentious account of silicosis litigation, which is highly misleading, for what it says, and in particular, for it omits.

For Rosner’s self-congratulatory view of his own role in silicosis litigation to make sense, we must imagine a counterfactual world that is the center piece of his historical narrative in which silicosis remains the scourge of the American worker, and manufacturing industry is engaged in a perpetual cover up.

Rosner’s fabulistic account of silicosis litigation and his role in it falls apart under even mild scrutiny. The hazards of silica exposure were known to Josh White and the entire country in 1936. Some silicosis litigation arose in the 1930s against employers, but plaintiffs were clearly hampered by tort doctrines of assumption of risk, contributory negligence, the fellow-servant rule. To my knowledge, there were no litigation claims against remote suppliers of silica before the late 1970s, when courts started to experiment with hyperstrict liability rules.

Eventually, the litigation industry, buoyed by its successes against asbestos-product manufacturers turned their attention to silica sand suppliers to foundries and other industrial users. Liability claims against remote suppliers of a natural raw material such as silica sand, however, made no sense in terms of the rationales of tort law. There was no disparity of information between customer and supplier; the customer, plaintiffs’ employer was not only the cheapest and most efficient cost and risk avoider, the employer was the only party that could control the risk. Workers and their unions were well aware of the hazards of working in uncontrolled silica-laden workplaces.

Although employer compliance with safety and health regulations for silica exposure has never been perfect, the problem of rampant acute silicosis, such as what afflicted the tunnel workers memorialized by Josh White, is a thing of the past in the United States. The control of silica exposures and the elimination of silicosis are rightly claimed to be one of the great public health achievements of the 20th century. See Centers Disease Control, “Ten Great Public Health Achievements — United States, 1900-1999,” 48 Morbidity & Mortality Weekly Report 241 (April 02, 1999).

Interestingly, after World War II, silicosis has been a much greater problem in the communist countries, such as China, the countries that made up the Soviet Union. Rosner and Markowitz, however, like the leftist intellectuals of the 1950s who could not bring themselves to criticize Stalin, seem blind to the sorry state of workplace safety in communist countries. Their blindness vitiates their historical project, which attempts to reduce occupational diseases and other workplace hazards to the excesses of corporate capitalism. A fair comparison with non-capitalist systems would reveal that silicosis results from many motives and conditions, including inattention, apathy, carelessness, concern with productivity, party goals, and labor-management rivalries. In the case of silicosis, ignorance of the hazards of silica is the least likely explanation for silicosis cases arising out of workplace exposures after the mid-1930s.

In the United States, silicosis litigation has been infused with fraud and deception, not by the defendants, but by the litigation industry that creates lawsuits. Absent from Rosner’s historical narratives is any mention of the frauds that have led to dismissals of thousands of cases, and the professional defrocking of any number of physician witnesses.  In re Silica Products Liab. Litig., MDL No. 1553, 398 F.Supp. 2d 563 (S.D.Tex. 2005).

Nor does Rosner deign to discuss the ethical and legal breaches committed by the plaintiffs’ counsel in conducting radiographic screenings of workers, in the hopes of creating lawsuits. With the help of unscrupulous physicians, these screenings were unnaturally successful not only in detecting silicosis that did not exist, but in some cases, in transmuting real asbestosis into silicosis.4

Many silicosis cases in recent times were accompanied by more subtle frauds, which turned on the “failure-to-warn” rhetoric implicit in the Restatement (Second) of Torts § 402A. Consider the outbreak of silicosis litigation in western Pennsylvania, in the mid-1980s. Many of the men who claimed to have silicosis had significant silica exposure at the Bethlehem and U.S. Steel foundries in the Johnstown areas. Some of the claimants actually had simple silicosis, although discovery of these claimants’ workplace records revealed that they had been non-compliant with workplace safety rules.

The Johnstown, Cambria County, cases were not the result of unlawful medical screenings, paid for by plaintiffs’ lawyers and conducted by physicians of dubious integrity and medical acumen. Instead, the plaintiffs’ lawyers found their claimants as a result of the claimants’ having had previous workers’ compensation claims for silicosis, which resulted after the workers were diagnosed by employer medical screening programs.

Cambria County Courthouse in Ebensburg, PA (venue for an outbreak of silicosis litigation in the 1980s and early 1990s5)

The first of the foundrymen’s cases was set for trial in 1989, 30 years ago, in Cambria County, Pennsylvania. The silica cases were on the docket of the President Judge, the Hon. Joseph O’Kicki, who turned out to be less than honorable. Just before the first silica trial, Judge O’Kicki was arrested on charges of corruption, as well as lewdness (for calling in his female staff while lounging in chambers in his panties).

As a result of O’Kicki’s arrest, the only Cambria Country trial we saw in 1989 was the criminal trial of Judge O’Kicki, in Northampton County. In April 1989, a jury found O’Kicki guilty of bribery and corruption, although it acquitted him on charges of lewdness.6 Facing a sentence of over 25 years, and a second trial on additional charges, O’Kicki returned to the land of his forebears, Slovenia, where he lived out his days and contributed to the surplus population.7

Whatever schadenfreude experienced by the defendants in the Cambria County silicosis litigation was quickly dispelled by the assignment of the silica cases to the Hon. Eugene Creany, who proved to be an active partisan for the plaintiffs’ cause. Faced with a large backlog of cases created by the rapacious filings of the Pittsburgh plaintiffs’ lawfirms, and Judge O’Kicki’s furlough from judicial service, Judge Creany devised various abridgements of due process, the first of which was to consolidate cases. As a result, the first case up in 1990 was actually three individual cases “clustered” for a single jury trial: Harmotta, Phillips, and Peterson.8 To poke due process in both eyes, Judge Creany made sure that one of the “clustered” cases was a death case (Peterson).

Jury selection started in earnest on April 2, 1990, with opening statements set for April 4. In between, the defense made the first of its many motions for mistrial, when defense lawyers observed one of the plaintiffs, Mr. Phillips, having breakfast with some of the jurors in the courthouse cafeteria. Judge Creany did not seem to think that this pre-game confabulation was exceptional, and admonished the defense that folks in Cambria County are just friendly, but they are fair. Trial slogged on for four weeks, with new abridgments of due process almost every day, such as forcing defendants, with adverse interests and positions, into having one direct- and one cross-examination of each witness. The last motion for mistrial was provoked by Judge Creany’s walking into the jury room during its deliberations, to deliver doughnuts.

At the end of the day, in May 1990, the jury proved to be much fairer than the trial judge. Judge Creany instructed the jury that “silica was the defect,” and on other novel points of law. Led by its foreman, a union organizer for the United Mine Workers, the jury returned a defense verdict in the Peterson case, which involved a claim that Mr. Peterson’s heart attack death case was caused by his underlying silicosis. In the two living plaintiffs’ cases, the jury found that the men had knowingly assumed the risk of silicosis, but at the judge’s insistence, the jury proceeded to address defendants’ liability, and to assess damages, in the amount of $22,500, in the two cases.

Pennsylvania’s appellate courts took a dim view of plaintiffs’ efforts to hold remote silica suppliers responsible for silicosis arising out of employment by large, sophisticated steel manufacturers. The Superior Court, Pennsylvania’s intermediate appellate court, reversed and remanded both plaintiffs’ verdicts. In Mr. Harmotta’s case, the court held that his action was collaterally estopped by a previous workman’s compensation judge’s finding that he did not have silicosis. In Mr. Phillip’s case, the court addressed the ultimate issue, whether a remote supplier to a sophisticated intermediary can be liable for silicosis that resulted from the intermediary’s employment and use of the supplied raw material. In what was a typical factual scenario of supply of silica to foundry employers, the Superior Court held that there was no strict or negligence liability for the employees’ silicosis.9 The Pennsylvania Supreme Court declined to hear Harmotta’s appeal on collateral estoppels, but heard an appeal in Phillips’ case. The Supreme Court pulled back from the sophisticated intermediary rationale for reversal, and placed its holding instead on the obvious lack of proximate cause between the alleged failure to warn and the claimed harm, given the jury’s special finding of assumed risk.10

One of plaintiffs’ counsel’s principal arguments, aimed at the union organizer on the jury, was that even if a warning to the individual plaintiffs might not have changed their behavior, a warning to the union would have been effective. The case law involving claims against unions for failing to warn have largely exculpated unions and taken them out of the warning loop. Given this case law, plaintiffs’ argument was puzzling, but the puzzlement turned to outrage when we learned after the first trial that Judge Creany had been a union solicitor, in which role, he had regularly written to U.S. Steel in Johnstown, to notify the employer when one of the local union members had been diagnosed with silicosis.

The next natural step seemed to list Judge Creany as a percipient fact witness to the pervasive knowledge of silicosis among the workforce and especially among the union leadership. Judge Creany did not take kindly to being listed as a fact witness, or being identified in voire dire as a potential witness. Still, the big lie about failure to warn and worker and labor union ignorance had been uncovered. Judge Creany started to delegate trials to other judges in the courthouse and to bring judges in from neighboring counties. The defense went on win the next dozen or so cases, before the plaintiffs’ lawyers gave up on their misbegotten enterprise of trying to use Pennsylvania’s hyperstrict liability rules to make remote silica suppliers pay for the fault of workers and their employers.

You won’t find any mention of the Cambria County saga in Rosner or Markowitz’s glorified accounts of silicosis litigation. The widespread unlawful screenings, the “double dipping” by asbestos claimants seeking a second paycheck for fabricated silicosis, the manufactured diagnoses and product identification do not rent space in Rosner and Markowitz’s fantastical histories.


2 See, e.g., Nathan A. Schachtman, “On Deadly Dust and Histrionic Historians: Preliminary Thoughts on History and Historians as Expert Witnesses,” 2 Mealey’s Silica Litigation Report Silica 1, 2 (November 2003); Nathan Schachtman & John Ulizio, “Courting Clio:  Historians and Their Testimony in Products Liability Action,” in: Brian Dolan & Paul Blanc, eds., At Work in the World: Proceedings of the Fourth International Conference on the History of Occupational and Environmental Health, Perspectives in Medical Humanities, University of California Medical Humanities Consortium, University of California Press (2012); Schachtman, “On Deadly Dust & Histrionic Historians 041904,”; How Testifying Historians Are Like Lawn-Mowing Dogs” (May 15, 2010)A Walk on the Wild Side (July 16, 2010); Counter Narratives for Hire (Dec. 13, 2010); Historians Noir (Nov. 18, 2014); Succès de scandale – With Thanks to Rosner & Markowitz” (Mar. 26, 2017). And of course, I have experienced some schadenfreude for when one of the Pink Panthers was excluded in a case in which he was disclosed as a testifying expert witness. Quester v. B.F. Goodrich Co., Case No. 03-509539, Court of Common Pleas for Cuyahoga Cty., Ohio, Order Sur Motion to Exclude Dr. Gerald Markowitz (Sweeney, J.).

3 “Trying Times” is the sixth Rosnowitz publication to point to me as a source of criticism of the Rosner-Markowitz radical leftist history of silicosis in the United States. See David Rosner, “Trying Times: The Courts, the Historian, and the Contentious Struggle to Define Disease,” 91 Bull. History Med. 473, 491-92 & n.32 (2017); Previously, Rosner and Markowitz have attempted to call me out in four published articles and one book. See D. Rosner & G. Markowitz, “The Trials and Tribulations of Two Historians:  Adjudicating Responsibility for Pollution and Personal Harm, 53 Medical History 271, 280-81 (2009); D. Rosner & G. Markowitz, “L’histoire au prétoire.  Deux historiens dans les procès des maladies professionnelles et environnementales,” 56 Revue  D’Histoire Moderne & Contemporaine 227, 238-39 (2009); David Rosner, “Trials and Tribulations:  What Happens When Historians Enter the Courtroom,” 72 Law & Contemporary Problems 137, 152 (2009); David Rosner & Gerald Markowitz, “The Historians of Industry” Academe (Nov. 2010); and Gerald Markowitz and David Rosner, Deceit and Denial: The Deadly Politics of Industrial Pollution at 313-14 (U. Calif. rev. ed. 2013). 

4 Nathan A. Schachtman, “State Regulators Impose Sanction Unlawful Screenings 05-25-07,” Washington Legal Foundation Legal Opinion Letter, vol. 17, no. 13 (May 2007); “Silica Litigation – Screening, Scheming, and Suing,” Washington Legal Foundation Critical Legal Issues Working Paper (December 2005); Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Seminars in Roentgenology140 (1992).

5 by Publichall – own work, CC BY-SA 3.0.

6 Assoc’d Press, “Pennsylvania County Judge Guilty of Corruption,” (April 18, 1989).

7 U.P.I., “Facing Prison, Convicted Judge Skips Bail,” (Mar. 8, 1993); “Judge O’kicki Declared Fugitive; May Be In Slovenia,” The Morning Call (April 20, 1993).

8 Harmotta v. Walter C. Best, Inc., Cambria Cty. Ct. C.P. No. 1986-128; Phillips v. Walter C. Best, Inc., Cambria Cty. Ct. C.P. No. 1987-434(b)(10); Peterson v. Walter C. Best, Inc., Cambria Cty. Ct. C.P. No. 1986-678.

9 Phillips v. A.P. Green Co., 428 Pa. Super. 167, 630 A.2d 874 (1993).

10 Phillips v. A-Best Products Co., 542 Pa. 124, 665 A.2d 1167 (1995).

Carl Cranor’s Conflicted Jeremiad Against Daubert

September 23rd, 2018

Carl Cranor’s Conflicted Jeremiad Against Daubert

It seems that authors who have the most intense and refractory conflicts of interest (COI) often fail to see their own conflicts and are the most vociferous critics of others for failing to identify COIs. Consider the spectacle of having anti-tobacco activists and tobacco plaintiffs’ expert witnesses assert that the American Law Institute had an ethical problem because Institute members included some tobacco defense lawyers.1 Somehow these authors overlooked their own positional and financial conflicts, as well as the obvious fact that the Institute’s members included some tobacco plaintiffs’ lawyers as well. Still, the complaint was instructive because it typifies the abuse of ethical asymmetrical standards, as well as ethical blindspots.2

Recently, Raymond Richard Neutra, Carl F. Cranor, and David Gee published a paper on the litigation use of Sir Austin Bradford Hill’s considerations for evaluating whether an association is causal or not.3 See Raymond Richard Neutra, Carl F. Cranor, and David Gee, “The Use and Misuse of Bradford Hill in U.S. Tort Law,” 58 Jurimetrics 127 (2018) [cited here as Cranor]. Their paper provides a startling example of hypocritical and asymmetrical assertions of conflicts of interests.

Neutra is a self-styled public health advocate4 and the Chief of the Division of Environmental and Occupational Disease Control (DEODC) of the California Department of Health Services (CDHS). David Gee, not to be confused with the English artist or the Australian coin forger, is with the European Environment Agency, in Copenhagen, Denmark. He is perhaps best known for his precautionary principle advocacy and his work with trade unions.5

Carl Cranor is with the Center for Progressive Reform, and he teaches philosophy at one of the University of California campuses. Although he is neither a lawyer nor a scientist, he participates with some frequency as a consultant, and as an expert witness, in lawsuits, on behalf of claimants. Perhaps Cranor’s most notorious appearance as an expert witness resulted in the decision of Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012). Probably less generally known is that Cranor was one of the founders of an organization, the Council for Education and Research on Toxics (CERT), which recently was the complaining party in a California case in which CERT sought money damages for Starbucks’ failure to label each cup of coffee sold as known to the State of California as causing cancer.6 Having a so-called not-for-profit corporation can also be pretty handy, especially when it holds itself out as a scientific organization and files amicus briefs in support of reversing Daubert exclusions of the founding members of the corporation, as CERT did on behalf of its founding member in the Milward case.7 The conflict of interest, in such an amicus brief, however, is no longer potential or subtle, and violates the duty of candor to the court.

In this recent article on Hill’s considerations for judging causality, Cranor followed CERT’s lead from Milward. Cranor failed to disclose that he has been a party expert witness for plaintiffs, in cases in which he was advocating many of the same positions put forward in the Jurimetrics article, including the Milward case, in which he was excluded from testifying by the trial court. Cranor’s lack of candor with the readers of the Jurimetrics article is all the more remarkable in that Cranor and his co-authors give conflicts of interest outsize importance in substantive interpretations of scholarship:

the desired reliability for evidence evaluation requires that biases that derive from the financial interests and ideological commitments of the investigators and editors that control the gateways to publication be considered in a way that Hill did not address.”

Cranor at 137 & n.59. Well, we could add that Cranor’s financial interests and ideological commitments might well be considered in evaluating the reliability of the opinions and positions advanced in this most recent work by Cranor and colleagues. If you believe that COIs disqualify a speaker from addressing important issues, then you have all the reason you need to avoid reading Cranor’s recent article.

Dubious Scholarship

The more serious problem with Cranor’s article is not his ethically strained pronouncements about financial interests, but the dubious scholarship he and his colleagues advance to thwart judicial gatekeeping of even more dubious expert witness opinion testimony. To begin with, the authors disparage the training and abilities of federal judges to assess the epistemic warrant and reliability of proffered causation opinions:

With their enhanced duties to review scientific and technical testimony federal judges, typically not well prepared by legal education for these tasks, have struggled to assess the scientific support for—and the reliability and relevance of—expert testimony.”

Cranor at 147. Their assessment is fair but hides the authors’ cynical agenda to remove gatekeeping and leave the assessment to lay juries, who are less well prepared for the task, and whose function ensures no institutional accountability, review, or public evaluation.

Similarly, the authors note the temporal context and limitations of Bradford Hill’s 1965 paper, which date and limit the advice provided over 50 years ago in a discipline that has changed dramatically with the advancement of biological, epidemiologic, and genetic science.8 Even at the time of its original publication in 1965, Bradford Hill’s paper, which was based upon an informal lecture, was not designed or intended to be a definitive treatment of causal inference. Cranor and his colleagues make no effort to review Bradford Hill’s many other publications, both before and after his 1965 dinner speech, for evidence of his views on the factors for causal inference, including the role of statistical testing and inference.

Nonetheless, Bradford Hill’s 1965 paper has become a landmark, even if dated, because of its author’s iconic status in the world of public health, earned for his showing that tobacco smoking causes lung cancer,9 and for advancing the role of double-blind randomized clinical trials.10 Cranor and his colleagues made no serious effort to engage with the large body of Bradford Hill’s writings, including his immensely important textbook, The Principles of Medical Statistics, which started as a series of articles in The Lancet, and went through 12 editions in print.11 Hill’s reputation will no doubt survive Cranor’s bowdlerized version of Sir Austin’s views.

Epidemiology is Dispensable When It Fails to Support Causal Claims

The egregious aspect of Cranor’s article is its bill of particulars against the federal judiciary for allegedly errant gatekeeping, which for these authors translates really into any gatekeeping at all. Cranor at 144-45. Indeed, the authors provide not a single example of what was a “proper” exclusion of an expert witness, who was contending for some doubtful causal claim. Perhaps they have never seen a proper exclusion, but doesn’t that speak volumes about their agenda and their biases?

High on the authors’ list of claimed gatekeeping errors is the requirement that a causal claim be supported with epidemiologic evidence. Although some causal claims may be supported by strong evidence of a biological process with mechanistic evidence, such claims are not common in United States tort litigation.

In support of the claim that epidemiology is dispensable, Cranor suggests that:

Some courts have recognized this, and distinguished scientific committees often do not require epidemiological studies to infer harm to humans. For example, the International Agency for Research on Cancer (IRAC) [sic], the National Toxicology Program, and California’s Proposition 65 Scientific Advisory Panel, among others, do not require epidemiological data to support findings that a substance is a probable or—in some cases—a known human carcinogen, but it is welcomed if available.”

Cranor at 149. California’s Proposition 65!??? Even IARC is hard to take seriously these days with its capture by consultants for the litigation industry, but if we were to accept IARC as an honest broker of causal inferences, what substance “known” to IARC to cause cancer in humans (Category I) was branded as a “known carcinogen” without the support of epidemiologic studies? Inquiring minds might want to know, but they will not learn the answer from Cranor and his co-authors.

When it comes to adverting to legal decisions that supposedly support the authors’ claim that epidemiology is unnecessary, their scholarship is equally wanting. The paper cites the notorious Wells case, which was so roundly condemned in scientific circles, that it probably helped ensure that a decision such as Daubert would ultimately be handed down by the Supreme Court. The authors seemingly cannot read, understand, and interpret even the most straightforward legal decisions. Here is how they cite Wells as support for their views:

Wells v. Ortho Pharm. Corp., 788 F.2d 741, 745 (11th Cir. 1986) (reviewing a district court’s decision deciding not to require the use of epidemiological evidence and instead allowing expert testimony).”

Cranor at 149-50 n.122. The trial judge in Wells never made such a decision; indeed, the case was tried by the bench, before the Supreme Court decided Daubert. There was no gatekeeping involved at all. More important, however, and contrary to Cranor’s explanatory parenthetical, both sides presented epidemiologic evidence in support of their positions.12

Cranor and his co-authors similarly misread and misrepresent the trial court’s decision in the litigation over maternal sertraline use and infant birth defects. Twice they cite the Multi-District Litigation trial court’s decision that excluded plaintiffs’ expert witnesses:

In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 449, 455 (E.D. Pa. 2014) (expert may not rely on nonstatistically significant studies to which to apply the [Bradford Hill] factors).”

Cranor at 144 n.85; 158 n.179. The MDL judge, Judge Rufe, decidedly never held that an expert witness may not rely upon a statistically non-significant study in a “Bradford Hill” analysis, and the Third Circuit, which affirmed the exclusions of the plaintiffs’ expert witnesses’ testimony, was equally clear in avoiding the making of such a pronouncement.13

Who Needs Statistical Significance

Part of Cranor’s post-science agenda is to intimidate judges into believing that statistical significance is unnecessary and a wrong-headed criterion for judging the validity of relied upon research. In their article, Cranor and friends suggest that Hill agreed with their radical approach, but nothing could be further from the truth. Although these authors parse almost every word of Hill’s 1965 article, they conveniently omit Hill’s views about the necessary predicates for applying his nine considerations for causal inference:

Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Cranor’s radicalism leaves no room for assessing whether a putative association is “beyond what we would care to attribute to the play of chance,” and his poor scholarship ignores Hill’s insistence that this statistical analysis be carried out.14

Hill’s work certainly acknowledged the limitations of statistical method, which could not compensate for poorly designed research:

It is a serious mistake to rely upon the statistical method to eliminate disturbing factors at the completion of the work.  No statistical method can compensate for a badly planned experiment.”

Austin Bradford Hill, Principles of Medical Statistics at 4 (4th ed. 1948). Hill was equally clear, however, that the limits on statistical methods did not imply that statistical methods are not needed to interpret a properly planned experiment or study. In the summary section of his textbook’s first chapter, Hill removed any doubt about his view of the importance, and the necessity, of statistical methods:

The statistical method is required in the interpretation of figures which are at the mercy of numerous influences, and its object is to determine whether individual influences can be isolated and their effects measured.”

Id. at 10 (emphasis added).

In his efforts to eliminate judicial gatekeeping of expert witness testimony, Cranor has struggled with understanding of statistical inference and testing.15 In an early writing, a 1993 book, Cranor suggests that we “can think of type I and II error rates as “standards of proof,” which begs the question whether they are appropriately used to assess significance or posterior probabilities.16 Indeed, Cranor goes further, in confusing significance and posterior probabilities, when he described the usual level of alpha (5%) as the “95%” rule, and claimed that regulatory agencies require something akin to proof “beyond a reasonable doubt,” when they require two “statistically significant” studies.17

Cranor has persisted in this fallacious analysis in his writings. In a 2006 book, he erroneously equated the 95% coefficient of statistical confidence with 95% certainty of knowledge.18 Later in this same text, Cranor again asserted his nonsense that agency regulations are written when supported by “beyond a reasonable doubt.”19 Given that Cranor has consistently confused significance and posterior probability, he really should not be giving advice to anyone about statistical or scientific inference. Cranor’s persistent misunderstandings of basic statistical concepts do, however, explain his motivation for advocating the elimination of statistical significance testing, even if these misunderstandings make his enterprise intellectually unacceptable.

Cranor and company fall into a similar muddle when they offer advice on post-hoc power calculations, which advice ignores standard statistical learning for interpreting completed studies.20 Another measure of the authors’ failed scholarship is their omission of any discussion of recent efforts by many in the scientific community to lower the threshold for statistical significance, based upon the belief that the customary 5% p-value is an order of magnitude too high.21

 

Relative Risks Greater Than Two

There are other tendentious arguments and treatments in Cranor’s brief against gatekeeping, but I will stop with one last example. The inference of specific causation from study risk ratios has provoked a torrent of verbiage from Sander Greenland (who is cited copiously by Cranor). Cranor, however, does not even scratch the surface of the issue and fails to cite the work of epidemiologists, such as Duncan C. Thomas, who have defended the use of probabilities of (specific) causation. More important, however, Cranor fails to speak out against the abuse of using any relative risk greater than 1.0 to support an inference of specific causation, when the nature of the causal relationship is neither necessary nor sufficient. In this context, Kenneth Rothman has reminded us that someone can be exposed to, or have, a risk, and then develop the related outcome, without there being any specific causation:

An elementary but essential principle to keep in mind is that a person may be exposed to an agent and then develop disease without there being any causal connection between the exposure and the disease. For this reason, we cannot consider the incidence proportion or the incidence rate among exposed people to measure a causal effect.”

Kenneth J. Rothman, Epidemiology: An Introduction at 57 (2d ed. 2012).

The danger in Cranor’s article in Jurimetrics is that some readers will not realize the extreme partisanship in its ipse dixit, and erroneous, pronouncements. Caveat lector


1 Elizabeth Laposata, Richard Barnes & Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa L. Rev. 1 (2012).

2 The American Law Institute responded briefly. See Roberta Cooper Ramo & Lance Liebman, “The ALI’s Response to the Center for Tobacco Control Research & Education,” 98 Iowa L. Rev. Bull. 1 (2013), and the original authors’ self-serving last word. Elizabeth Laposata, Richard Barnes & Stanton Glantz, “The ALI Needs to Implement Modern Conflict of Interest Policies,” 98 Iowa L. Rev. Bull. 17 (2013).

3 Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965).

4 Raymond Richard Neutra, “Epidemiology Differs from Public Health Practice,” 7 Epidemiology 559 (1996).

7From Here to CERT-ainty” (June 28, 2018).

8 Kristen Fedak, Autumn Bernal, Zachary Capshaw, and Sherilyn A Gross, “Applying the Bradford Hill Criteria in the 21st Century: How Data Integration Has Changed Causal Inference in Molecular Epidemiology,” Emerging Themes in Epidemiol. 12:14 (2015); John P. A. Ioannides, “Exposure Wide Epidemiology, Revisiting Bradford Hill,” 35 Stats. Med. 1749 (2016).

9 Richard Doll & Austin Bradford Hill, “Smoking and Carcinoma of the Lung,” 2(4682) Brit. Med. J. (1950).

10 Geoffrey Marshall (chairman), “Streptomycin Treatment of Pulmonary Tuberculosis: A Medical Research Council Investigation,” 2 Brit. Med. J. 769, 769–71 (1948).

11 Vern Farewell & Anthony Johnson,The origins of Austin Bradford Hill’s classic textbook of medical statistics,” 105 J. Royal Soc’y Med. 483 (2012). See also Hilary E. Tillett, “Bradford Hill’s Principles of Medical Statistics,” 108 Epidemiol. Infect. 559 (1992).

13 In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of biostatistician Nichols Jewell’s dodgy opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully).

14 See Bradford Hill on Statistical Methods” (Sept. 24, 2013).

16 Carl F. Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law at 33-34 (1993) (arguing incorrectly that one can think of α, β (the chances of type I and type II errors, respectively and 1- β as measures of the “risk of error” or “standards of proof.”); see also id. at 44, 47, 55, 72-76. At least one astute reviewer called Cranor on his statistical solecisms. Michael D. Green, “Science Is to Law as the Burden of Proof is to Significance Testing: Book Review of Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law,” 37 Jurimetrics J. 205 (1997) (taking Cranor to task for confusing significance and posterior (burden of proof) probabilities).

17 Id. (squaring 0.05 to arrive at “the chances of two such rare events occurring” as 0.0025, which impermissibly assumes independence between the two studies).

18 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 100 (2006) (incorrectly asserting that “[t]he practice of setting α =.05 I call the “95% rule,” for researchers want to be 95% certain that when knowledge is gained [a study shows new results] and the null hypothesis is rejected, it is correctly rejected.”).

19 Id. at 266.

21 See, e.g., John P. A. Ioannidis, “The Proposal to Lower P Value Thresholds to .005,” 319 J. Am. Med. Ass’n 1429 (2018); Daniel J. Benjamin, James O. Berger, Valen E. Johnson, et al., “Redefine statistical significance,” 2 Nature Human Behavior 6 (2018).

The Expert Witness Who Put God on His Reference List

August 28th, 2018

And you never ask questions
When God’s on your side”

                                Bob Dylan, “With God on Our Side” 1963.

Cases involving claims of personal injury have inspired some of the most dubious scientific studies in the so-called medical literature, but the flights of fancy in published papers are nothing compared with what is recorded in the annals of expert witness testimony. The weaker the medical claims, the more outlandish is the expert testimony proffered. Claims for personal injury supposedly resulting from mold exposure are no exception to the general rule. The expert witness opinion testimony in mold litigation has resulted in several commentaries1 and professional position papers,2 offered to curb the apparent excesses.

Ritchie Shoemaker, M.D., has been a regular expert witness for the mold lawsuit industry. Professional criticism has not deterred Shoemaker, although discerning courts have put the kibosh on some of Shoemaker’s testimonial adventures.3

Shoemaker cannot be everywhere, and so in conjunction with the mold lawsuit industry, Shoemaker has taken to certifying new expert witnesses. But how will Shoemaker and his protégées overcome the critical judicial reception?

Enter Divine Intervention

Make thee an ark of gopher wood; rooms shalt thou make in the ark, and shalt pitch it within and without with pitch.4

Some say the age of prophets, burning bushes, and the like is over, but perhaps not so. Maybe God speaks to expert witnesses to fill in the voids left by missing evidence. Consider the testimony of Dr. Scott W. McMahon, who recently testified that he was Shoemaker trained, and divinely inspired:

Q. Jumping around a little bit, Doctor, how did your interest in indoor environmental quality in general, and mold in particular, how did that come about?

A. I had — in 2009, I had been asked to give a talk at a medical society at the end of October and the people who were involved in it were harassing me almost on a weekly basis asking me what the title of my talk was going to be. I had spoken to the same society the previous four years. I had no idea what I was going to speak about. I am a man of faith, I’ve been a pastor and a missionary and other things, so I prayed about it and what I heard in my head verbatim was pediatric mold exposure colon the next great epidemic question mark. That’s what I heard in my head. And so because I try to live by faith, I typed that up as an email and said this is the name of my topic. And then I said, okay, God, you have ten weeks to teach me about this, and he did. Within three, four weeks maybe five, he had connected me to Dr. Shoemaker who was the leading person in the world at that time and the discoverer of this chronic inflammatory response.

*****

I am a man of faith, I’ve been a pastor and everything. And I realized that this was a real entity.

*****

Q. And do you attribute your decision or the decision for you to start Whole World Health Care also to be a divine intervention?

A. Well, that certainly started the process but I used my brain, too. Like I said, I went and I investigated Dr. Shoemaker, I wanted to make sure that his methods were real, that he wasn’t doing, you know, some sort of voodoo medicine and I saw that he wasn’t, that his scientific practice was standard. I mean, he changes one variable at a time in tests. He tested every step of the way. And I found that his conclusions were realistic. And then, you know, over the last few years, I’ve 1 gathered my own data and I see that they confirm almost every one of his conclusions.

Q. Doctor, was there anything in your past or anything dealing with your family in terms of exposure to mold or other indoor health issues?

A. No, it was totally off my radar.

Q. *** I’m not going to go into great detail with respect to Dr. Shoemaker, but are you Shoemaker certified?

A. I am.

Deposition transcript of Dr. Scott W. McMahon, at pp.46-49, in Courcelle v. C.W. Nola Properties LLC, Orleans Parish, Louisiana No. 15-3870, Sec. 7, Div. F. (May 18, 2018).

You may be surprised that the examining lawyer did not ask about the voice in which God spoke. The examining lawyer seems to have accepted without further question that the voice was that of an adult male voice. Still did the God entity speak in English, or in tongues? Was it a deep, resonant voice like Morgan Freeman’s in Bruce Almighty (2003)? Or was it a Yiddische voice like George Burns, in Oh God (1977)? Were there bushes burning when God spoke to McMahon? Or did the toast burn darker than expected?

Some might think that McMahon was impudent if not outright blasphemous for telling God that “He” had 10 weeks in which to instruct McMahon in the nuances of how mold causes human illness. Apparently, God was not bothered by this presumptuousness and complied with McMahon, which makes McMahon a special sort of prophet.

Of course, McMahon says he used his “brain,” in addition to following God’s instructions. But really why bother? Were there evidentiary or inferential gaps filled in by the Lord? The deposition does not address this issue.

In federal court, and in many state courts, an expert witness may base opinions on facts or data that are not admissible if, and only if, expert witnesses “in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject.5

Have other expert witnesses claimed divine inspiration for opinion testimony? A quick Pubmed search does not reveal any papers by God, or papers with God as someone’s Co-Author. It is only a matter of time, however, before a judge, some where, takes judicial notice of divinely inspired expert witness testimony.


1 See, e.g., Howard M. Weiner, Ronald E. Gots, and Robert P. Hein, “Medical Causation and Expert Testimony: Allergists at this Intersection of Medicine and Law,” 12 Curr. Allergy Asthma Rep. 590 (2012).

2 See, e.g., Bryan D. Hardin, Bruce J. Kelman, and Andrew Saxon, “ACOEM Evidence-Based Statement: Adverse Human Health Effects Associated with Molds in the Indoor Environment,” 45 J. Occup. & Envt’l Med. 470 (2003).

3 See, e.g., Chesson v. Montgomery Mutual Insur. Co., 434 Md. 346, 75 A.3d 932, 2013 WL 5311126 (2013) (“Dr. Shoemaker’s technique, which reflects a dearth of scientific methodology, as well as his causal theory, therefore, are not shown to be generally accepted in the relevant scientific community.”); Young v. Burton, 567 F. Supp. 2d 121, 130-31 (D.D.C. 2008) (excluding Dr. Shoemaker’s theories as lacking general acceptance and reliability; listing Virginia, Florida, and Alabama as states in which courts have rejected Shoemaker’s theory).

4 Genesis 6:14 (King James translation).

5 Federal Rule of Evidence. Bases of an Expert.