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

More Case Report Mischief in the Gadolinium Litigation

November 28th, 2014

The Decker case is one curious decision, by the MDL trial court, and the Sixth Circuit. Decker v. GE Healthcare Inc., ___ F.3d ___, 2014 FED App. 0258P, 2014 U.S. App. LEXIS 20049 (6th Cir. Oct. 20, 2014). First, the Circuit went out of its way to emphasize that the trial court had discretion, not only in evaluating the evidence on a Rule 702 challenge, but also in devising the criteria of validity[1]. Second, the courts ignored the role and the weight being assigned to Federal Rule of Evidence 703, in winnowing the materials upon which the defense expert witnesses could rely. Third, the Circuit approved what appeared to be extremely asymmetric gatekeeping of plaintiffs’ and defendant’s expert witnesses. The asymmetrical standards probably were the basis for emphasizing the breadth of the trial court’s discretion to devise the criteria for assessing scientific validity[2].

In barring GEHC’s expert witnesses from testifying about gadolinium-naive nephrogenic systemic fibrosis (NSF) cases, Judge Dan Polster, the MDL judge, appeared to invoke a double standard. Plaintiffs could adduce any case report or adverse event report (AER) on the theory that the reports were relevant to “notice” of a “safety signal” between gadolinium-based contrast agents in MRI and NSF. Defendants’ expert witnesses, however, were held to the most exacting standards of clinical identity with the plaintiff’s particular presentation of NSP, biopsy-proven presence of Gd in affected tissue, and documentation of lack of GBCA-exposure, before case reports would be permitted as reliance materials to support the existence of gadolinium-naïve NSF.

A fourth issue with the Decker opinion is the latitude it permitted the district court to allow testimony from plaintiffs’ pharmacovigilance expert witness, Cheryl Blume, Ph.D., over objections, to testify about the “signal” created by the NSF AERs available to GEHC. Decker at *11. At the same trial, the MDL judge prohibited GEHC’s expert witness, Dr. Anthony Gaspari, to testify that the AERs described by Blume did not support a clinical diagnosis of NSF.

On a motion for reconsideration, Judge Polster reaffirmed his ruling on grounds that

(1) the AERs were too incomplete to rule in or rule out a diagnosis of NSF, although they were sufficient to create a “signal”;

(2) whether the AERs were actual cases of NSF was not relevant to their being safety signals;

(3) Dr. Gaspari was not an expert in pharmacovigilance, which studied “signals” as opposed to causation; and

(4) Dr. Gaspari’s conclusion that the AERs were not NSF was made without reviewing all the information available to GEHC at the time of the AERs.

Decker at *12.

The fallacy of this stingy approach to Dr. Gaspari’s testimony lies in the courts’ stubborn refusal to recognize that if an AER was not, as a matter of medical science, a case of NSF, then it could not be a “signal” of a possible causal relationship between GBCA and NSF. Pharmacovigilance does not end with ascertaining signals; yet the courts privileged Blume’s opinions on signals even though she could not proceed to the next step and evaluate diagnostic accuracy and causality. This twisted logic makes a mockery of pharmacovigilance. It also led to the exclusion of Dr. Gaspari’s testimony on a key aspect of plaintiffs’ liability evidence.

The erroneous approach pioneered by Judge Polster was compounded by the district court’s refusal to give a jury instruction that AERs were only relevant to notice, and not to causation. Judge Polster offered his reasoning that “the instruction singles out one type of evidence, and adds, rather than minimizes, confusion.” Judge Polster cited the lack of any expert witness testimony that suggested that AERs showed causation and “besides, it doesn’t matter because those patients are not, are not the plaintiffs.” Decker at *17.

The lack of dispute about the meaning of AERs would have seemed all the more reason to control jury speculation about their import, and to give a binding instruction on AERs and their limited significance. As for the AER patients’ not being the plaintiffs, well, the case report patients were not the plaintiffs, either. This last reason is not even wrong[3]. The Circuit, in affirming, turned a blind eye to the district court’s exercise of discretion in a way that systematically increased the importance of Blume’s testimony on signals, while systematically hobbling the defendant’s expert witnesses.

[1] “THE STANDARD OF APPELLATE REVIEW FOR RULE 702 DECISIONS” (Nov. 12, 2014).

[2] “Gadolinium, Nephrogenic Systemic Fibrosis, and Case Reports” (Nov. 24, 2014).

[3] “Das ist nicht nur nicht richtig, es ist nicht einmal falsch!” The quote is attributed to Wolfgang Pauli in R. E. Peierls, “Wolfgang Ernst Pauli, 1900-1958,” 5 Biographical Memoirs Fellows Royal Soc’y 175, 186 (1960).

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The Shyster Files – Racketeering in Silicosis Litigation

November 26th, 2014

David Rosner and Gerald Markowitz trace the silicosis compensation issues back to debates at the 1935 National Silicosis Conference, where representatives of labor and management squared off on the appropriate criteria for compensation.

David Rosner & Gerald Markowitz, Deadly Dust: Silicosis and the On-Going Struggle to Protect Workers’ Health at 110-15 (Ann Arbor 2006). Labor’s representative argued that silicosis should be defined by inhaling silica dust, which would have made every case of respiratory disease compensable. A lawyer who represented industry, Alfred C. Hirth, argued that compensation should be tied to disability.

Although Hirth acknowledged that silicosis was an employer problem[1], Rosner and Markowitz give a typically uncharitable assessment of Hirth’s ideas, even though the labor view that any silica inhalation constituted silicosis was demonstrably wrong at the time, and more so today. The authors quote Hirth as decrying the “[i]gnorance and sensational journalism” that has given rise to the then “the popular belief … that to inhale silica is to have silicosis.” Plus ça change, plus c’est la même chose!

Rosner and Markowitz then hone in on one sentence in Hirth’s presentation, where he criticizes the:

“shyster lawyer and quack doctor, who have been with the United States always, but whom we hope we may someday exterminate.”

Deadly Dust at 113. Here they launch the charge that Hirth was an anti-semite because he was against shysters and quacks, and even hoped, not unreasonably, that someday we might be rid of them. The historians urge that we:

“Note the anti-Semitism implied by the use of shyster and the call for extermination, which echoed the views of the Nazi and the anti-Semites during the 1930s.”

Id. at 113n.19. Really?

Now when I first read this passage in Deadly Dust, I was puzzled. My grandmother, a sweet, charming Jewish lady, who could curse in several languages, including Yiddish, would regularly rant about the shysters about in the world. As far as I can recall, her usage was non-denominational, non-racial, non-ethnic. It was an equal opportunity epithet. So I decided to dig a little deeper into the alleged “implication” seen by Markowitz and Rosner. Everything I could find pointed to both Jewish hypersensitivity and linguistic ignorance in the authors of the Deadly Dust.

Fanciful Etymology

Here is what the venerable Oxford English Dictionary has to say about shyster:

“shyster slang. [Of obscure origin. It might be f. shy a. (sense 7, disreputable) + -ster; but this sense of the adj. is app. not current in the U.S.]

1. A lawyer who practises in an unprofessional or tricky manner; especially, one who haunts the prisons and lower courts to prey on petty criminals; hence, any one who conducts his business in a tricky manner.”

Nothing there to support the authors’ character assassination, but perhaps the English are just too polite? Here is the earthier, more down-to-Earth, American Heritage Dictionary (4th ed. 2000):

“shyster. NOUN: Slang An unethical, unscrupulous practitioner, especially of law.

ETYMOLOGY: Probably alteration of German Scheisser, son of a bitch, bastard, from scheissen, to defecate … .”

Now we are getting to fundamentals. The Merriam Webster dictionary is in line with the defecator, which accords with my sense of lawyers who file fraudulent lawsuits:

“a person who is professionally unscrupulous especially in the practice of law or politics : pettifogger. Origin of SHYSTER: probably from German Scheisser, literally, defecator. First Known Use: 1844”

The less venerable, crowd-sourced Wikipedia notes that

“Various false etymologies have suggested an anti-Semitic origin, but there is no proof for that.^[3]”

Wikipedia entry for “shyster” (citing Michael Quinion “Shyster” World Wide Words (19 May 2007).

“Shysters” in Court

My view of the usage and etymology of shyster would appear to have the highest judicial authority. When some puglistic contracts turned puglistic, Lennox Lewis sued Don King in cases that spanned the Atlantic Ocean. At some point, King, with his gloves off and his mouth open, called Judd Berstein, Lewis’s attorney, a “shyster lawyer.” Berstein claimed that these were fighting words, or at least suing words, but the House of Lords disagreed. Lennox Lewis v Don King, [2004] EWCA Civ1329 (House of Lords, Supreme Court of Judicature).

Burstein’s claim, in his action for libel, turned on the assertion that calling a Jewish lawyer a “shyster lawyer” was anti-semitic (and defamatory). The appellate court (Lord Chief Justice Mummery and the eponymously named Lord Justice Laws) noted, with apparent approval, that the court below had diligently searched but failed to find any support for Burstein’s claim:

“It seems clear from a web search of 900 dictionaries (including specifically American ones) that there is no support for the word ‘shyster’ having any anti-semitic connotations.”

Id. at para. 18.

Shysters to the Right of Me; Shysters to the Left

In playing the “shyster” card, Rosner and Markowitz protest too much. They are so intent upon painting industry as unreasonable, that they overlook that the litigious behavior of the shyster lawyers in the 1930s embarrassed labor. There were, to be sure, real cases of silicosis, with real impairment, and real disability, even if the diagnostic criteria and classification of silicosis were in flux. Liability was contested in many of the “real cases,” which made administrative compensation boards such as workman’s compensation courts more attractive to many in labor unions than were litigation solutions. Here is what one labor union publication of the time had to say about the explosion of silicosis litigation in the 1930s:

“It is estimated that today in the United States there are approximately $500,000,000 in damage suits pending against employers. Many of these are legitimate, many admittedly racketeering. But just as medical research has demonstrated that one disease can be cured by the injection of another into the system, so in the end this regretable [sic] racketeering in damage suits — this ambulance chasing and canvassing of hospital beds by shyster lawyers and quack doctors — may prove to be the beneficent agent that shall cure big business of the greed and insensitiveness that places profits above human lives.”

“Silicosis Prevention” 72 Internat’l Molders’ J. 1 (July 1936) (emphasis added) (republished from the American Federationist (June 1936)).

So everyone agreed that there were shysters out in the land, and in court. The difference between labor and management is that labor wanted to use the shysters and fraudulent lawsuits in the hope that they would pressure industry into providing safer workplaces. And industry somehow objected to being besmirched by the shysters.

[1] See Alfred C. Hirth, Silicosis as an Employer Problem (1935).

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History – Lies My Teacher Told Me

November 26th, 2014

James W. Loewen, a professor of history, has been one of the most untiring critics of how history is taught and practiced in the United States. A large part of his criticism derives from the overt politicization of the teaching of history, especially the heavy hand of school boards and textbook committees in their selection of “appropriate textbooks” for high school students. See James W. Loewen, Lies My Teacher Told Me: Everything Your American History Textbook Got Wrong (2007). The disgraceful “conservative” sanitizing of United States highschoolers’ history textbooks is almost equal to the heavy-handed Marxist bent of some University professors. The politicization of history may be unavoidable, but we should be alert to the intellectual depredations from the right and the left.

* * * * * *

I recently saw the self-styled social history of silicosis, Deadly Dust, by David Rosner and Gerald Markowitz, cited in a trial court brief. The cite was to the original edition, but it led me to read the “new and expanded” edition[1], published in 2006. Expanded, but not exactly super-sized, and with the same empty calories as before. The authors’ Preface to the second edition relays an air of excitement about recent (at the time of publication) media suggestions that silicosis may be the “new asbestosis.[2]” Of course, the authors were excited because the uptick in silicosis litigation around 2003, based almost exclusively upon fraudulent filings, brought them engagements as compensated expert witnesses for plaintiffs’ counsel.

The Preface also confesses that before their initial edition, the authors were ignorant about silicosis. And because they are so well read they assumed that their not having heard of silicosis meant that silicosis must have disappeared from the literature. Id. at xiii. This fallacious confusion between absence of evidence and evidence of absence pervades the entire book. Their first edition was written with this confirmation bias dominating their narrative:

“The book we wrote tells the story of a condition that dominated public health, medical, labor, and popular discourse on disease in the 1930s but that virtually vanished from popular and professional consciousness after World War II. How, we asked, could a chronic disease that took decades to develop and that was assumed to affect hundreds of thousands of American workers disappear from the literature and public notice in less than a decade? This question is the basis for Deadly Dust, and we believe that we answered it, providing a cultural, medical, and political model of how we, as a society, decide to recognize or forget about illness.”

Deadly Dust at xiv (emphasis added). The second edition is more of the same biased narrative.

Also clear from their Preface is the authors’ messianic complex. I now know why they have repeatedly attacked me for having criticized them: It is important for them to be seen as having been resistant victims of industry, indeed, especially if they are triumphant victims:

“We are particularly proud that lawyers for various industries have sought to get judges to exclude our book from court cases.”

Id. at xvi. Of course, from the lawyers’ perspective, a book such as Deadly Dust has many layers of evidentiary problems, running from authentication of documents, to multiple layers of hearsay, legal and logical relevancy, and rampant, subjective opinion spread throughout the narrative.

The “virtually vanished” phrase caused me to revisit[3] my previous quantitative assessment of discussions of silicosis in the popular and medical literature. The National Library of Medicine PubMed database is expanding back into the past, adding old journals and their articles to the database. Here is the most recent tally, by decade of articles with keyword “silicosis”:

Date Range Number of Articles from Keyword Search

1940 – 1949 119

1950 – 1959 1,436

1960 – 1969 1,868

1970 – 1979 1,176

1980 – 1989 940

1990 – 1999 883

2000 – 2009 860

2010 — present 498

The Rosner/Markowitz claim about silicosis “virtually vanishing” from professional discourse after World War II, is an assertion that is completely belied by the evidence. Google’s Ngram function further confirms the incorrectness of the fundamental premise of Deadly Dust:

Silicosis Ngram 1920 – 2010

The Google chart shows that although there was a peak around 1940, the level of referencing silicosis remained at or above the level for the mid-1930s until 1960, and never retreated to levels as low as for 1930-32.

This false premise, that silicosis vanished, or virtually vanished, from the medical literature, is the starting point for Rosner and Markowitz’ faux conspiracy charge against industry for suppressing discussion, when the reality was exactly the opposite. What follows from the false premise is a false set of conclusions.

[1] David Rosner & Gerald Markowitz, Deadly Dust: Silicosis and the On-Going Struggle to Protect Workers’ Health (Ann Arbor 2006).

[2] citing Jonathan Glater, “Suits on Silica Being Compared to Asbestos Cases,” New York Times (Sept. 6, 2003), C-1 (quoting one defense lawyer as saying that “I actually thought that we had made the world safe for sand.”).

[3] See Schachtman, “Conspiracy Theories: Historians, In and Out of Court” (April 17, 2013).

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Gadolinium, Nephrogenic Systemic Fibrosis, and Case Reports

November 24th, 2014

Gadolinium (Gd) is a rare earth element. In its ionic form (+3), gadolinium is known to be highly toxic to humans. Gadolinium is strongly paramagnetic, which makes it a valuable contrast agent in for magnetic resonance imaging (MRI). The gadolinium is administered intravenously in a chelated form before MRI. In its chelated form, the ion is escorted out of the body through the kidneys before exposure to free Gd ion occurs. Or that was the theory.

Nephrogenic systemic fibrosis (NSF) is a rare, painful, incurable progressive connective tissue disease. NSF manifests with skin thickening and fibrosis, tethering, which means it cannot be pulled away from body. Some patients may develop extracutaneous fibrosis of muscle, lymph nodes, pleura, and other internal organs. Elana J. Bernstein, Christian Schmidt-Lauber, and Jonathan Kay, “Nephrogenic systemic fibrosis: A systemic fibrosing disease resulting from gadolinium exposure,” 26 Best Practice & Research Clin. Rheum. 489, 489 (2012).

As a diagnostic entity, NSF is a relatively recent discovery. The first case was noted in 1997, in California. Within a few years, the differential diagnostic criteria to distinguish NSF from other fibrotic diseases were developed. Centers for Disease Control, “Fibrosing skin condition among patients with renal disease–United States and Europe, 1997–2002,” 51 MMWR Morbidity and Mortality Weekly Report 25 (2002). Physicians identified the condition among patients with renal insufficiency who had received MRI with a gadolinium-based contrast agent (GBCA). Given the rarity of both the exposure (GBCA and renal insufficiency) and the outcome (NSF), the relationship between NSF and the use of gadolinium-containing contrast agents for magnetic resonance imaging (MRI) was discovered largely from case reports. A case registry is maintained at Yale University, and has identified 380 cases to date. Shawn E. Cowper, “Nephrogenic Systemic Fibrosis” at the website for The International Center for Nephrogenic Systemic Fibrosis Research (ICNSFR) [last updated June 15, 2013).

The little epidemiology that exists on the subject generally has found that all “cases” had exposure to Gd[1]. Or almost all. There have been occasional cases found without reported exposure to GBCA. Indeed, one case of NSF without prior GBCA was reported last month in the dermatological literature. C. Ross, N. De Rosa, G. Marshman, D. Astill, “Nephrogenic systemic fibrosis in a gadolinium-naïve patient: Successful treatment with oral sirolimus,” Australas. J. Dermatol. (2014); doi: 10.1111/ajd.12176. [Epub ahead of print].

In litigation, the usual scenario is that plaintiffs and their counsel and expert witnesses want to offer case reports or case series as probative of a causal association between an exposure and a particular disease outcome. In the silicone gel breast implant litigation, women, who self-characterized themselves “victims,” shouted outside courtrooms, “We are the evidence.”

When the outcome in question has a baseline rate, and the exposure is widespread, this strategy is usually illegitimate and most courts have limited or prohibited the obvious attempt to prejudice the jury by the use of evidence that has little or no probative value.

The causal connection between NSF and GBCA, described above, was postulated on the basis of case reports, but this is not really a rejection of the general rule about case reports. NSF is an extremely rare outcome, and GBCA administered to patients with serious kidney insufficiency is a fairly rare exposure. In addition, gadolinium ion has a known human toxicity, and the connection between renal insufficiency and Gd toxicity is rather straightforward. The insufficiency of the kidney function results in longer “in residence” times for the GBCA, with the consequence that the gadolinium disassociates from its chelating agent, and the free Gd ion does its damage. Furthermore, biopsies of affected tissues show an uptake of gadolinium in NSF patients.

* * * * * * * *

GE Healthcare manufactures Omniscan, a GBCA, for use as an MRI-contrast medium. Given the recently discovered dangers of GBCAs in vulnerable patients, Omniscan has been a magnet for lawsuits, with the peak intensity of the litigation field in the MDL courtroom of federal district courtroom of Judge Dan Polster. Judge Polster tried the first Omniscan case, which resulted in a verdict for the plaintiff. GE appealed, complaining about several of Judge Polster’s rulings, including the uneven handling of case reports. Last month, the Sixth Circuit affirmed. Decker v. GE Healthcare Inc., ___ F.3d ___, 2014 FED App. 0258P, 2014 U.S. App. LEXIS 20049 (6th Cir. Oct. 20, 2014).

General causation between GBCAs and NSF was apparently not disputed in Decker. Although plaintiffs in the GBCA litigation established the causality of GABC in producing NSF, by case reports, Judge Polster refused to permit GEHC’s expert witnesses to testify about their reliance upon case reports of gadolinium-naïve cases of NSF; that is, the court disallowed testimony about reported cases that occurred in the absence of GBCA exposure[2]. Id. at *9. Judge Polster found that the reported gadolinium-naïve case reports were “methodologically flawed” because they did not adequately show that the NSF patients in question lacked Gd exposure, with tissue biopsy or other means. Id. at * 10. The district court speculated that there may have Gd exposure from a non-MRI procedure, but never explained what non-MRI procedure would involve internal administration of GBCA. Nor did the district court address the temporal relationship between this undocumented, conjectured non-MRI gadolinium-based imaging procedure and the onset of the reported patient’s NSF.

Before trial defendant GEHC moved for reconsideration of the district court’s previous decision on defensive use of gadolinium-naïve case reports, based upon on a then recent publication of a “purported” case of gadolinium-naïve NSF. Id. at *8. A quick read of the late-breaking case study shows that it was more than a “purported” case. A.A. Lemy, et al., “Revisiting nephrogenic systemic fibrosis in 6 kidney transplant recipients: a single-center experience,” 63 J. Am. Acad. Dermatol. 389 (2010). The cited paper by Lemy had diagnosed NSF in a patient without GBCA exposure, and mass spectrometry testing of affected tissue revealed no Gd. The district court, however, dismissed the Lemy case as irrelevant unless GEHC’s expert witnesses could demonstrate that Lemy’s patient number 5 and the plaintiff were so clinical similar that “it was probable that Mr. Decker’s NSF was not caused by his 2005 Omniscan [exposure].”

The Sixth Circuit affirmed this “tails they win; heads you lose” approach to gatekeeping as all within the scope of the district court’s exercise of discretion. Lemy’s case number 5 and Mr. Decker both had NSF, and yet the courts do not describe clinical varieties among NSF, which vary based upon their relatedness to gadolinium exposure. It would seem that the courts were imposing an extremely heavy burden on the defense to show that the gadolinium-naïve cases were absolutely free of Gd exposure, and that they resembled the particular plaintiff’s NSF diagnosis in every respect. Without any evidence of diagnostic disease criteria sensitivity and specificity, and positive predictive value for the criteria, the district and the appellate courts seem to have accepted glib demands for absolute identity between the plaintiff’s NSF manifestation and any candidate Gd-free NSF case. Given that there is clinical heterogeneity among Gd-NSF cases, and that causality was basically inferred from cases and case series, the courts’ reasoning seems strained.

The appellate court also seemed blithely unaware of the fallacious circularity of permitting a diagnostic entity to be defined based upon exposure, thereby preventing any fair test of the hypothesis that all NSF cases are caused by gadolinium. This fallacy was advanced in the silicone gel breast implant litigation, where the litigation industry shrank from claims that silicone caused classic connective tissue diseases, in the face of exculpatory epidemiologic studies. The claimants retreated to a claim that silicone caused a “new” disease that was defined by mostly vague, self-reported symptoms [so very different from NSF in this respect], in conjunction with silicone exposure. The court-appointed expert witnesses, however, would have none of these shenanigans:

“The National Science Panel concluded that they do not yet support the inclusion of SSRD [systemic silicone-related disease] in the list of accepted diseases, for 4 reasons. First, the requirement of the inclusion of the putative cause (silicone exposure) as one of the criteria does not allow the criteria set to be tested objectively without knowledge of the presence of implants, thus incurring incorporation bias (27).”

Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477, 2479 (2001) (citing David Sackett, “Bias in analytic research,” 32 J. Chronic Dis. 51 (1979)).

Of course, NSF does not share the dubious provenance of SSRD, or SAD [silicone-associated disorder] as it was sometimes known. Still, the analytic studies that have shown that NSF cases all, or mostly, had GBCA exposure, explicitly refrained from defining the NSF case as including gadolinium exposure.

Decker is thus a curious case. The trial and appellate court talked about preventing the defense expert witnesses from relying upon case reports that were “methodologically flawed,” but the courts never mentioned Federal Rule of Evidence 703, which should have been the basis for such selective pruning of the expert witnesses’ reliance materials. And then there is the matter that even if GEHC were correct about Gd-free NSF cases, the attributable risk for NSF to prior Gd exposure is almost certainly very high, and the debate over whether NSF is a “signature” disease was not likely going to affect the case outcome.

Decker can perhaps best be understood as a dispute about specific causation, with established general causation, in which the relative risk of NSF from GBCA exposure is extraordinarily high among patients with renal insufficiency. If there are other causes of NSF, they are considerably more rare than GBCA/renal insufficiency exposed cases. In the face of this very high attributable risk, GE’s expert witnesses’ discussions of an idiopathic or other cause was too speculative to pass muster under Rule 702.

[1] Elana J. Bernstein, Tamara Isakova, Mary E. Sullivan, Lori B. Chibnik, Myles Wolf & Jonathan Kay, “Nephrogenic systemic fibrosis is associated with hypophosphataemia: a case–control study,” 53 Rheumatology 1613 (2014); T.R. Elmholdt, M. Pedersen, B. Jørgensen, K. Søndergaard, J.D. Jensen, M. Ramsing, and A.B. Olesen, “Nephrogenic systemic fibrosis is found only among gadolinium-exposed patients with renal insufficiency: a case-control study from Denmark,” 165 Br. J. Dermatol. 828 (2011); P. Marckmann, “An epidemic outbreak of nephrogenic systemic fibrosis in a Danish hospital,” 66 Eur. J. Radiol. 187 (2008) (reporting all patients had gadodiamide-enhanced magnetic resonance imaging and severe renal insufficiency before onset of NSF); P. Marckmann, L. Skov, K. Rossen, J.G. Heaf, and H.S. Thomsen, “Case-control study of gadodiamide-related nephrogenic systemic fibrosis,” 22 Nephrol. Dialysis &Transplant. 3174 (2007) (all 19 cases in case-control study had prior exposure to gadolinium (Gd)-containing magnetic resonance imaging contrast agents); Centers for Disease Control, “Nephrogenic Fibrosing Dermopathy Associated with Exposure to Gadolinium-Containing Contrast Agents — St. Louis, Missouri, 2002–2006,” 56 MMWR Morbidity and Mortality Weekly Report (Feb. 23, 2007).

[2] T.A. Collidge, P.C. Thomson, P.B. Mark, et al., “Gadolinium-Enhanced MR Imaging and Nephrogenic Systemic Fibrosis: Retrospective Study of a Renal Replacement Therapy Cohort,” 245 Radiology 168-175 (2007); I.M. Wahba, E.L. Simpson, and K. White, “Gadolinium Is Not The Only Trigger For Nephrogenic Systemic Fibrosis: Insights From Two Cases And Review Of The Recent Literature,” 7 Am. J. Transplant. 1 (2007); A. Deng, D.B. Martin, et al., “Nephrogenic Systemic Fibrosis with a Spectrum of Clinical and Histopathological Presentation: A Disorder of Aberrant Dermal Remodeling,” 37 J. Cutan. Pathol. 204 (2009).

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Historians Noir

November 18th, 2014

David Rosner and Gerald Markowitz are two “labor” historians who make it their business to testify as historian expert witnesses in occupational and environmental disease cases. They apparently do not like lawyers who argue that they should have less business in the courts[1]. Rosner and Markowitz have obsessed about my article critical of their scholarship, and about historian witnesses, but rather than respond as scholars, they have responded largely ad hominem by suggesting that my criticisms were motivated by their testifying for the litigation industry. They have accused me of “attacking the messenger,” and they have responded by attacking the messenger. And their “attacks,” feeble though they may be, have come repetitively[2], suggesting some obsession and compulsion.

Last month[3], Professor Rosner gave a public lecture on his testimonial adventures as an historian expert witness, “Judging Science: The Historian, the Courts, & Discerning Responsibility for Environmental Pollution.” The lecture, given at Columbia University’s Heyman Center, lasted a little over an hour, exemplifies Rosner’s approach to “historifying,” as well as why courts should be wary of permitting such testimony. Here is how the Heyman Center’s website describes the talk:

“Over the past twenty years a vast public negotiation has taken place over the causes of, and responsibility for, disease. For the most part this discussion has flown under the radar of doctors, historians and public health professionals. This talk will look at a number of environmental pollution and public health cases over the course of the past two decades in which Professor Rosner has participated.”

Rosner begins by recounting his initial involvement in litigation, in Texas cases involving claims for silicosis. Rosner asserts that his involvement was necessitated by the defendants’ position that no one had ever heard of silicosis, and that silicosis had vanished from the medical literature after 1940. Rosner’s characterization of the claims and defenses of the Odessa sandblasting cases is, however, badly flawed, and his suggestion that silicosis had disappeared from the medical literature at the end of the 1930s is simply false.

According to Rosner (about 22:40 into the video), Histrionic Historians was an “attack” made in response to his, and his friend Gerald Markowitz’s, testimony in the Odessa, Texas case. Wrong. By the time Histrionic Historians was published, Rosner and Markowitz were listed as retained expert witnesses in hundreds if not thousands of cases, in the silicosis MDL, see In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005), and they were showing up in several other isolated cases around the country. One of the Odessa silicosis cases had gone up to the Texas Supreme Court, which reversed the judgment for plaintiff on the ground that the jury must consider the knowledge and role of the intermediary employer in the context of an occupational disease claim against a remote supplier. Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170 (Tex. 2004). The cases in front of Judge Jack were, of course, mostly fraudulent, and the liability in the remaining cases was almost tenuous to non-existent. In his Heyman Center lecture last month, Rosner suggests that my article was an attempt to “take back” from him and Markowitz, the narrative that had been historically controlled by industry (around 34:50 of the video). The fact is, however, that industry never controlled the silicosis narrative, which was played out in the 1930s by organized labor, government, academics, and industry. Histrionic Historians was only a preliminary essay designed to show that the Rosner narrative was false.

Towards the end of his lecture, Rosner attempts to describe the consequences of the workman’s compensation system. He argues that byssinosis, anthracosilicosis, and asbestosis were once considered “silicosis,” on the theory that silica was doing the damage, a stunning claim considering that byssinosis is caused by cotton dust, and does not involve any mineral dust of any kind. According to Rosner, the other pneumoconioses were “politically divided off of the silicosis issue” so that workers could regain the ability to sue, since workers could not sue for silicosis (due to statutory employer immunity). Video at 59:15-40. With no regard for the medical or scientific history of the knowledge of the various pneumoconioses, Rosner states that asbestosis and byssinosis were:

“in some sense created as clinical entities because of the political implications of being identified as silicosis after 1940. Silicosis was no longer compensable and so you had to find new definitions. It is a very interesting history of these disease that were once considered forms of silicosis.”

Video at 1:00:30-51. Very interesting, and entirely bogus. Asbestosis and silicosis were considered distinct diseases well before 1940, and medical science distinguished the two pneumoconioses as having different causes, different diagnostic criteria, and different sequelae. And neither asbestos nor cotton dust contains silica. A great example of the misinformation that historians unfamiliar with the relevant medical history can spout.

Historians’ Acting Badly

In response to a question from the audience, Professor Rosner recounts the events of an historical society meeting at which he and his colleagues learned that the President had been consulting for tobacco defendants in litigation. Apparently, this revelation almost led to fistfights in the halls. So much for diversity and tolerance! Video around 1:10:00. Rosner tells us that he is one of only about three historians who have decided to work for plaintiffs and labor unions. Video at 1:09:45.

Standards for Historian Testimony

Rosner criticizes the historians who testify for tobacco defendants on the grounds that they were not shown everything known (secretly) by the tobacco companies. These historian thus testified on only the public record, and their testimony was thus misleading. According to Rosner, you (the aspiring historian expert witness) “must see everything”; “you are entitled to see all the documents.” Otherwise, you are at risk of being given documents selectively by instructing counsel. Video at 1:11:10-29. There could be a semblance of a criterion in Rosner’s remarks for evaluating historian expert witness testimony. Rosner, understandably however, states that he does not know whether he wants the American Historian Association to become involved in policing historian witness testimony.

Historian Testimony – Beyond the Ken?

Rosner fielded a question from the audience about how courts viewed historian testimony. Of course, Rosner is not a lawyer, and his answer did not attempt to summarize the judicial antipathy towards historian testimony when not necessary. Instead, Rosner focused on his own niche of testifying in lead, asbestos, and silica cases, where courts have been more indulgent of permitting historian expert witness testimony. “They [the courts] are getting used to it,” Rosner reports. “Juries love” historian testimony because historians speak English, and “they understand it,” unlike the scientific testimony in the case. According to Rosner, historians are not pretending to have a special expertise that the jury cannot understand, and the materials relied upon do not require interpretation by an expert the way scientific studies do. Video at 1:12:24-14:04. Q.E.D.!

[1] 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,” Mealey’s Silica Litigation Report Vol. 2, No. 3 (Nov. 2003). See also “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).

[2] Four articles dwell on the issue. 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). To these publications, these “forensic historians” have added yet another recitation in an epilogue to a revised edition of one of their books. Gerald Markowitz and David Rosner, Deceit and Denial: The Deadly Politics of Industrial Pollution at 313-14 (U. Calif. rev. ed. 2013).

[3] October 22, 2014.

Posted in Historian Testimony | Comments Off on Historians Noir

Rhetorical Strategy in Characterizing Scientific Burdens of Proof

November 15th, 2014

The recent opinion piece by Kevin Elliott and David Resnik exemplifies a rhetorical strategy that idealizes and elevates a burden of proof in science, and then declares it is different from legal and regulatory burdens of proof. Kevin C. Elliott and David B. Resnik, “Science, Policy, and the Transparency of Values,” 122 Envt’l Health Persp. 647 (2014) [Elliott & Resnik]. What is astonishing about this strategy is the lack of support for the claim that “science” imposes such a high burden of proof that we can safely ignore it when making “practical” legal or regulatory decisions. Here is how the authors state their claim:

“Very high standards of evidence are typically expected in order to infer causal relationships or to approve the marketing of new drugs. In other social contexts, such as tort law and chemical regulation, weaker standards of evidence are sometimes acceptable to protect the public (Cranor 2008).”

Id.[1] Remarkably, the authors cite no statute, no case law, and no legal treatise for the proposition that the tort law standard for causation is somehow lower than for a scientific claim of causality. Similarly, the authors cite no support for their claim that regulatory pronouncements are judged under a lower burden. One only need consider the burden a sponsor faces in establishing medication efficacy and safety in a New Drug Application before the Food and Drug Administration. Of course, when agencies engage in assessing causal claims regarding safety, they often act under regulations and guidances that lessen the burden of proof from what we would be required in a tort action.[2]

And most important, Elliott and Resnik fail to cite to any work of scientists for the claim that scientists require a greater burden of proof before accepting a causal claim. When these authors’ claims of differential burdens of proof were challenged by a scientist, Dr. David Schwartz, in a letter to the editors, the authors insisted that they were correct, again citing to Carl Cranor, a non-lawyer, non-scientist:

“we caution against equating the standards of evidence expected in tort law with those expected in more traditional scientific contexts. The tort system requires only a preponderance of evidence (> 50% likelihood) to win a case; this is much weaker evidence than scientists typically demand when presenting or publishing results, and confusion about these differing standards has led to significant legal controversies (Cranor 2006).”

Reply to Dr. Schwartz. The only thing the authors added to the discussion was to cite to the same work by Carl Cranor[3], but change the date of the book.

Whence comes the assertion that science has a heavier burden of proof? Elliott and Resnik cite Cranor for their remarkable proposition, and so where did Cranor find support for the proposition at issue here? In his 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[4]. Cranor goes so far in his 1993 as to describe the usual level of alpha as the “95%” rule, and that regulatory agencies require something akin to proof “beyond a reasonable doubt,” when they require two “statistically significant” studies[5]. Thus Cranor’s opinion has its origins in his commission of the transposition fallacy[6].

Cranor has persisted in his fallacious analysis in his later books. In his 2006 book, he erroneously equates the 95% coefficient of statistical confidence with 95% certainty of knowledge[7]. Later in the text, he asserts that agency regulations are written when supported by “beyond a reasonable doubt.[8]”

To be fair, it is possible to find regulators stating something close to what Cranor asserts, but only when they themselves are committing the transposition fallacy:

“Statistical significance is a mathematical determination of the confidence in the outcome of a test. The usual criterion for establishing statistical significance is the p-value (probability value). A statistically significant difference in results is generally indicated by p < 0.05, meaning there is less than a 5% probability that the toxic effects observed were due to chance and were not caused by the chemical. Another way of looking at it is that there is a 95% probability that the effect is real, i.e., the effect seen was the result of the chemical exposure.”

U.S. Dep’t of Labor, Guidance for Hazard Determination for Compliance with the OSHA Hazard Communication Standard (29 CFR § 1910.1200) Section V (July 6, 2007).

And it is similarly possible to find policy wonks expressing similar views. In 1993, the Carnegie Commission published a report in which it tried to explain away junk science as simply the discrepancy in burdens of proof between law and science, but its reasoning clearly points to the Commission’s commission of the transposition fallacy:

“The reality is that courts often decide cases not on the scientific merits, but on concepts such as burden of proof that operate differently in the legal and scientific realms. Scientists may misperceive these decisions as based on a misunderstanding of the science, when in actuality the decision may simply result from applying a different norm, one that, for the judiciary, is appropriate. Much, for instance, has been written about ‘junk science’ in the courtroom. But judicial decisions that appear to be based on ‘bad’ science may actually reflect the reality that the law requires a burden of proof, or confidence level, other than the 95 percent confidence level that is often used by scientists to reject the possibility that chance alone accounted for observed differences.”

The Carnegie Commission on Science, Technology, and Government, Report on Science and Technology in Judicial Decision Making 28 (1993)[9].

Resnik and Cranor’s rhetoric is a commonplace in the courtroom. Here is how the rhetorical strategy plays out in courtroom. Plaintiffs’ counsel elicits concessions from defense expert witnesses that they are using the “norms” and standards of science in presenting their opinions. Counsel then argue to the finder of fact that the defense experts are wonderful, but irrelevant because the fact finder must decide the case on a lower standard. This stratagem can be found supported by the writings of plaintiffs’ counsel and their expert witnesses[10]. The stratagem also shows up in the writings of law professors who are critical of the law’s embrace of scientific scruples in the courtroom[11].

The cacophony of error, from advocates and commentators, have led the courts into frequent error on the subject. Thus, Judge Pauline Newman, who sits on the United States Court of Appeals for the Federal Circuit, and who was a member of the Committee on the Development of the Third Edition of the Reference Manual on Scientific Evidence, wrote in one of her appellate opinions[12]:

“Scientists as well as judges must understand: ‘the reality that the law requires a burden of proof, or confidence level, other than the 95 percent confidence level that is often used by scientists to reject the possibility that chance alone accounted for observed differences’.”

Reaching back even further into the judiciary’s wrestling with the issue of the difference between legal and scientific standards of proof, we have one of the clearest and clearly incorrect statements of the matter[13]:

“Petitioners demand sole reliance on scientific facts, on evidence that reputable scientific techniques certify as certain. Typically, a scientist will not so certify evidence unless the probability of error, by standard statistical measurement, is less than 5%. That is, scientific fact is at least 95% certain. Such certainty has never characterized the judicial or the administrative process. It may be that the ‘beyond a reasonable doubt’ standard of criminal law demands 95% certainty. Cf. McGill v. United States, 121 U.S.App. D.C. 179, 185 n.6, 348 F.2d 791, 797 n.6 (1965). But the standard of ordinary civil litigation, a preponderance of the evidence, demands only 51% certainty. A jury may weigh conflicting evidence and certify as adjudicative (although not scientific) fact that which it believes is more likely than not. ***”

The 95% certainty appears to derive from 95% confidence intervals, although “confidence” is a technical term in statistics, and it most certainly does not mean the probability of the alternative hypothesis under consideration. Similarly, the probability that is less than 5% is not the probability that the null hypothesis is correct. The United States Court of Appeals for the District of Columbia thus fell for the rhetorical gambit in accepting the strawman that scientific certainty is 95%, whereas civil and administrative law certainty is a smidgeon above 50%.

We should not be too surprised that courts have erroneously described burdens of proof in the realm of science. Even within legal contexts, judges have a very difficult time articulating exactly how different verbal formulations of the burden of proof translate into probability statements. In one of his published decisions, Judge Jack Weinstein reported an informal survey of judges of the Eastern District of New York, on what they believed were the correct quantizations of legal burdens of proof. The results confirm that judges, who must deal with burdens of proof as lawyers and then as “umpires” on the bench, have no idea of how to translate verbal formulations into mathematical quantities:

U.S. v. Fatico, 458 F.Supp. 388 (E.D.N.Y. 1978). Thus one judge believed that “clear, unequivocal and convincing” required a higher level of proof (90%) than “beyond a reasonable doubt,” and no judge placed “beyond a reasonable doubt” above 95%. A majority of the judges polled placed the criminal standard below 90%.

In running down Elliott, Resnik, and Cranor’s assertions about burdens of proof, all I could find was the commonplace error involved in moving from 95% confidence to 95% certainty. Otherwise, I found scientists declaring that the burden of proof should rest with the scientist who is making the novel causal claim. Carl Sagan famously declaimed, “extraordinary claims require extraordinary evidence[14],” but he appears never to have succumbed to the temptation to provide a quantification of the posterior probability that would cinch the claim.

If anyone has any evidence leading to support for Resnik’s claim, other than the transposition fallacy or the confusion between certainty and coefficient of statistical confidence, please share.

[1] The authors citation is to Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice (NY 2008). Professor Cranor teaches philosophy at one of the University of California campuses. He is neither a lawyer nor a scientist, but he does participate with some frequency as a consultant, and as an expert witness, in lawsuits, on behalf of claimants.

[2] See, e.g., In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y. 1984) (Weinstein, J.) (“The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one.”), aff’d 818 F.2d 145 (2d Cir. 1987) (approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988).

[3] Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice (NY 2006).

[4] Carl F. Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law at 33-34 (Oxford 1993) (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.

[5] Id. (squaring 0.05 to arrive at “the chances of two such rare events occurring” as 0.0025).

[6] 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). At least one other reviewer was not as discerning as Professor Green and fell for Cranor’s fallacious analysis. Steven R. Weller, “Book Review: Regulating Toxic Substances: A Philosophy of Science and Law,” 6 Harv. J. L. & Tech. 435, 436, 437-38 (1993) (“only when the statistical evidence gathered from studies shows that it is more than ninety-five percent likely that a test substance causes cancer will the substance be characterized scientifically as carcinogenic … to determine legal causality, the plaintiff need only establish that the probability with which it is true that the substance in question causes cancer is at least fifty percent, rather than the ninety-five percent to prove scientific causality”).

[7] Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 100 (2006) (incorrectly asserting, without further support, 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.”).

[8] Id. at 266.

[9] There were some scientists on the Commission’s Task Force, but most of the members were lawyers.

[10] Jan Beyea & Daniel Berger, “Scientific misconceptions among Daubert gatekeepers: the need for reform of expert review procedures,” 64 Law & Contemporary Problems 327, 328 (2001) (“In fact, Daubert, as interpreted by ‛logician’ judges, can amount to a super-Frye test requiring universal acceptance of the reasoning in an expert’s testimony. It also can, in effect, raise the burden of proof in science-dominated cases from the acceptable “more likely than not” standard to the nearly impossible burden of ‛beyond a reasonable doubt’.”).

[11] Lucinda M. Finley, “Guarding the Gate to the Courthouse: How Trial Judges Are Using Their Evidentiary Screening Role to Remake Tort Causation Rules,” 336 DePaul L. Rev. 335, 348 n. 49 (1999) (“Courts also require that the risk ratio in a study be ‘statistically significant,’ which is a statistical measurement of the likelihood that any detected association has occurred by chance, or is due to the exposure. Tests of statistical significance are intended to guard against what are called ‘Type I’ errors, or falsely ascribing a relationship when there in fact is not one (a false positive).” Finley erroneously ignores the conditioning of the significance probability on the null hypothesis, and she suggests that statistical significance is sufficient for ascribing causality); Erica Beecher-Monas, Evaluating Scientific Evidence: An Interdisciplinary Framework for Intellectual Due Process 42 n. 30, 61 (2007) (“Another way of explaining this is that it describes the probability that the procedure produced the observed effect by chance.”) (“Statistical significance is a statement about the frequency with which a particular finding is likely to arise by chance.″).

[12] Hodges v. Secretary Dep’t Health & Human Services, 9 F.3d 958, 967 (Fed. Cir. 1993) (Newman, J., dissenting) (citing and quoting from the Report of the Carnegie Commission on Science, Technology, and Government, Science and Technology in Judicial Decision Making 28 (1993).

[13] Ethyl Corp. v. EPA, 541 F.2d 1, 28 n.58 (D.C. Cir.), cert. denied, 426 U.S. 941 (1976).

[14] Carl Sagan, Broca’s Brain: Reflections on the Romance of Science 93 (1979).

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Rhetorical Strategy in Characterizing Scientific Burdens of Proof

THE STANDARD OF APPELLATE REVIEW FOR RULE 702 DECISIONS

November 12th, 2014

Back in the day, some Circuits of the United States Court of Appeal embraced an asymmetric standard of review of district court decisions concerning the admissibility of expert witness opinion evidence. If the trial court’s decision was to exclude an expert witness, and that exclusion resulted in summary judgment, then the appellate court would take a “hard look” at the trial court’s decision. If the trial court admitted the expert witness’s opinions, and the case proceeded to trial, with opponent of the challenged expert witness losing the verdict, then the appellate court would take a not-so “hard look” the trial court’s decision to admit the opinion. In re Paoli RR Yard PCB Litig., 35 F.3d 717, 750 (3d Cir.1994) (Becker, J.), cert. denied, 115 S.Ct.1253 (1995).

In Kumho Tire, the 11th Circuit followed this asymmetric approach, only to have the Supreme Court reverse and render. Unlike the appellate procedure followed in Daubert, the high Court took the extra step of applying the symmetrical standard of review, presumably for the didactic purpose of showing the 11th Circuit how to engage in appellate review. Carmichael v. Kumho Tire Co., 131 F.3d 1433 (11th Cir. 1997), rev’d sub nom. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 158-59 (1999).

If anything is clear from the Kumho Tire decision, courts do not have discretion to apply an asymmetric standard to their evaluation of a challenge, under Federal Rule of Evidence 702, to a proffered expert witness opinion. Justice Stephen Breyer, in his opinion for the Court, in Kumho Tire, went on to articulate the requirement that trial courts must inquire whether an expert witness ‘‘employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.’’ Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). Again, trial courts do not have the discretion to abandon this inquiry.

The “same intellectual rigor” test may have some ambiguities that make application difficult. For instance, identifying the “relevant” field or discipline may be contested. Physicians traditionally have not been trained in statistical analyses, yet they produce, and rely extensively upon, clinical research, the proper conduct and interpretation of which requires expertise in study design and data analysis. Is the relevant field biostatistics or internal medicine? Given that the validity and reliability of the relied upon studies come from biostatistics, courts need to acknowledge that the rigor test requires identification of the “appropriate” field — the field that produces the criteria or standards of validity and interpretation.

Justice Breyer did grant that trial courts must have some latitude in determining how to conduct their gatekeeping inquiries. Some cases may call for full-blown hearings and post-hearing proposed findings of fact and conclusions of law; some cases may be easily decided upon the moving papers. Justice Breyer’s grant of “latitude,” however, wanders off target:

“The trial court must have the same kind of latitude in deciding how to test an expert’s reliability, and to decide whether or when special briefing or other proceedings are needed to investigate reliability, as it enjoys when it decides whether that expert’s relevant testimony is reliable. Our opinion in Joiner makes clear that a court of appeals is to apply an abuse-of-discretion standard when it ‛review[s] a trial court’s decision to admit or exclude expert testimony’. 522 U. S. at 138-139. That standard applies as much to the trial court’s decisions about how to determine reliability as to its ultimate conclusion. Otherwise, the trial judge would lack the discretionary authority needed both to avoid unnecessary ‛reliability’ proceedings in ordinary cases where the reliability of an expert’s methods is properly taken for granted, and to require appropriate proceedings in the less usual or more complex cases where cause for questioning the expert’s reliability arises. Indeed, the Rules seek to avoid ‛unjustifiable expense and delay’ as part of their search for ‛truth’ and the ‛jus[t] determin[ation]’ of proceedings. Fed. Rule Evid. 102. Thus, whether Daubert ’s specific factors are, or are not, reasonable measures of reliability in a particular case is a matter that the law grants the trial judge broad latitude to determine. See Joiner, supra, at 143. And the Eleventh Circuit erred insofar as it held to the contrary.”

Kumho, 526 U.S. at 152-53.

Now the segue from discretion to fashion the procedural mechanism for gatekeeping review to discretion to fashion the substantive criteria or standards for determining “intellectual rigor in the relevant field” represents a rather abrupt shift. The leap from discretion to fashion procedure to discretion to fashion substantive criteria of validity has no basis in prior law, in linguistics, or in science. For instance, Justice Breyer would be hard pressed to uphold a trial court’s refusal to consider bias and confounding in assessing whether epidemiologic studies established causality in a given case, notwithstanding the careless language quoted above.

The troubling nature of Justice Breyer’s language did not go unnoticed at the time of the Kumho Tire case. Indeed, three of the Justices in Kumho Tire concurred to clarify:

“I join the opinion of the Court, which makes clear that the discretion it endorses—trial-court discretion in choosing the manner of testing expert 1reliability—is not discretion to abandon the gatekeeping function. I think it worth adding that it is not discretion to perform the function inadequately.”

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 158-59 (1999) (Scalia, J., concurring, with O’Connor, J., and Thomas, J.)

Of course, this language from Kumho Tire really cannot be treated as binding after the statute interpreted, Rule 702, was modified in 2000. The judges of the inferior federal courts have struggled with Rule 702, sometimes more to evade its reach than to perform gatekeeping in an intelligent way. Quotations of passages from cases decided before the statute was amended and revised should be treated with skepticism.

Recently, the Sixth Circuit quoted Justice Breyer’s language about latitude from Kumho Tire, in the Circuit’s decision involving GE Healthcare’s radiographic contrast medium, Omniscan. Decker v. GE Healthcare Inc., 2014 U.S. App. LEXIS 20049, at *29 (6th Cir. Oct. 20, 2014). Although the Decker case is problematic in many ways, the defendant did not challenge general causation between gadolinium and nephrogenic systemic fibrosis, a painful, progressive connective tissue disease, which afflicted the plaintiff. It is unclear exactly what sort of latitude in applying the statute, the Sixth Circuit was hoping to excuse.

Posted in Rule 702, Scientific Evidence | Comments Off on THE STANDARD OF APPELLATE REVIEW FOR RULE 702 DECISIONS

Teaching Statistics in Law Schools

November 12th, 2014

Back in 2011, I came across a blog post about a rumor of a trend in law school education to train law students in quantitative methods. Sasha Romanosky, “Two Law School Rumors” Concurring Opinions (Jan. 20, 2011). Of course, the notion that that quantitative methods and statistics would become essential to a liberal and a professional education reaches back to the 19th century. Holmes famously wrote that:

“For the rational study of the law the blackletter man may be the man of the present, but the man of the future is the man of statistics and the master of economics.”

Oliver Wendell Holmes, Jr., “The Path of Law” 10 Harvard Law Rev. 457 (1897). A few years later, H.G. Wells expanded the pre-requisite from lawyering to citizenship, generally:

“The great body of physical science, a great deal of the essential fact of financial science, and endless social and political problems are only accessible and only thinkable to those who have had a sound training in mathematical analysis, and the time may not be very remote when it will be understood that for complete initiation as an efficient citizen of one of the new great complex worldwide States that are now developing, it is as necessary to be able to compute, to think in averages and maxima and minima, as it is now to be able to read and write.”

Herbert George Wells, Mankind in the Making 204 (1903).

Certainly, there have been arguments made that statistics and quantitative analyses more generally should be part of the law school curriculum. See, e.g., Yair Listokin, “Why Statistics Should be Mandatory for Law Students” Prawfsblawg (May 22, 2006); Steven B. Dow, “There’s Madness in the Method: A Commentary on Law, Statistics, and the Nature of Legal Education,” 57 Okla. L. Rev. 579 (2004).

Judge Richard Posner has described the problem in dramatic Kierkegaardian terms of “fear and loathing.”Jackson v. Pollion, 733 F.3d 786, 790 (7th Cir. 2013). Stopping short of sickness unto death, Judge Posner catalogued the “lapse,” at the expense of others, in the words of judges and commentators:

“This lapse is worth noting because it is indicative of a widespread, and increasingly troublesome, discomfort among lawyers and judges confronted by a scientific or other technological issue. “As a general matter, lawyers and science don’t mix.” Peter Lee, “Patent Law and the Two Cultures,” 120 Yale L.J. 2, 4 (2010); see also Association for Molecular Pathology v. Myriad Genetics, Inc., ___ U.S. ___, 133 S.Ct. 2107, 2120, (2013) (Scalia, J., concurring in part and concurring in the judgment) (“I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief”); Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 599 (1993) (Rehnquist, C.J., concurring in part and dissenting in part) (‘‘the various briefs filed in this case … deal with definitions of scientific knowledge, scientific method, scientific validity, and peer review—in short, matters far afield from the expertise of judges’’); Marconi Wireless Telegraph Co. of America v. United States, 320 U.S. 1, 60–61 (1943) (Frankfurter, J., dissenting in part) (‘‘it is an old observation that the training of Anglo–American judges ill fits them to discharge the duties cast upon them by patent legislation’’); Parke–Davis & Co. v. H.K. Mulford Co., 189 F. 95, 115 (S.D.N.Y. 1911) (Hand, J.) (‘‘I cannot stop without calling attention to the extraordinary condition of the law which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions as these … . How long we shall continue to blunder along without the aid of unpartisan and authoritative scientific assistance in the administration of justice, no one knows; but all fair persons not conventionalized by provincial legal habits of mind ought, I should think, unite to effect some such advance’’); Henry J. Friendly, Federal Jurisdiction: A General View 157 (1973) (‘‘I am unable to perceive why we should not insist on the same level of scientific understanding on the patent bench that clients demand of the patent bar, or why lack of such understanding by the judge should be deemed a precious asset’’); David L. Faigman, Legal Alchemy: The Use and Misuse of Science in Law xi (1999) (‘‘the average lawyer is not merely ignorant of science, he or she has an affirmative aversion to it’’).

Of course, ignorance of the law is no excuse for the ordinary citizen[1]. Ignorance of science and math should be no excuse for the ordinary judge or lawyer.

In the 1960s, Michael Finkelstein introduced a course on statistics and probability into the curriculum of the Columbia Law School. The class has had an unfortunate reputation of being “difficult.” One year, when Prof. Finkelstein taught the class at Yale Law School, the students petitioned him not to give a final examination. Apparently, the students were traumatized by facing problems that actually have right and wrong answers! Michael O. Finkelstein, “Teaching Statistics to Law Students,” in L. Pereira-Mendoza, L.S. Kea, T.W.Kee, & W.K. Wong, eds., I Proceedings of the Fifth International Conference on Teaching Statistics at 505 (1998).

Law school is academia’s “last clear chance” to avoid having statistically illiterate lawyers running amok. Do law schools take advantage of the opportunity? For the most part, understanding statistical concepts is not required for admission to, or for graduation from, law school. Some law schools helpfully offer courses to address the prevalent gap in statistics education at the university level. I have collected some of the available law school offerings from law school websites, and collected below. If you know of any omissions, please let me know.

Law School Courses

Columbia Law School: Statistics for Lawyers (Schachtman)

Emory Law: Analytical Methods for Lawyers; Statistics for Lawyers (Joanna M. Shepherd)

Florida State College of Law: Analytical Methods for Lawyers (Murat C. Mungan)

Fordham University School of Law: Legal Process & Quantitative Methods

George Mason University School of Law: Quantitative Forensics (Kobayashi); Statistics for Lawyers and Policy Analysts (Dick Ippolito)

George Washington University Law School: Quantitative Analysis for Lawyers; The Law and Regulation of Science

Georgetown Law School: Analytical Methods (Joshua Teitelbaum); Analyzing Empirical Research for Lawyers (Juliet Aiken); Epidemiology for Lawyers (Kraemer)

Santa Clara University, School of Law: Analytical Methods for Lawyers (David Friedman)

Harvard Law School: Analytical Methods for Lawyers (Kathryn Spier); Analytical Methods for Lawyers; Fundamentals of Statistical Analysis (David Cope)

Loyola Law School: Statistics (Doug Stenstrom)

Marquette University School of Law: Quantitative Methods

Michigan State: Analytical Methods for Lawyers (Statistics) (Gia Barboza); Quantitative Analysis for Lawyers (Daniel Martin Katz)

New York Law School: Statistical Literacy

New York University Law School: Quantitative Methods in Law Seminar (Daniel Rubinfeld)

Northwestern Law School: Quantitative Reasoning in the Law (Jonathan Koehler); Statistics & Probability (Jonathan Koehler)

Notre Dame Law School: Analytical Methods for Lawyers (M. Barrett)

Ohio Northern University Claude W. Pettit College of Law: Analytical Methods for Lawyers

Stanford Law School: Statistical Inference in the Law; Bayesian Statistics and Econometrics (Daniel E. Ho); Quantitative Methods – Statistical Inference (Jeff Strnad)

University of Arizona James E. Rogers College of Law: Law, Statistics & Economics (Katherine Y. Barnes)

University of California at Berkeley: Quantitative Methods (Kevin Quinn); Introductory Statistics (Justin McCrary)

University of California, Hastings College of Law: Scientific Method for Lawyers (David Faigman)

University of California at Irvine: Statistics for Lawyers

University of California at Los Angeles: Quantitative Methods in the Law (Richard H. Sander)

University of Colorado: Quantitative Methods in the Law (Paul Ohm)

University of Connecticut School of Law: Statistical Reasoning in the Law

University of Michigan: Statistics for Lawyers

University of Minnesota: Analytical Methods for Lawyers: An Introduction (Parisi)

University of Pennsylvania Law School: Analytical Methods (David S. Abrams); Statistics for Lawyers (Jon Klick)

University of Texas at Austin: Analytical Methods (Farnworth)

University of Washington: Quantitative Methods In The Law (Mike Townsend)

Vanderbilt Law School: Statistical Concepts for Lawyer (Edward Cheng)

Wake Forest: Analytical Methods for Lawyers

Washington University St. Louis School of Law: Social Scientific Research for Lawyers (Andrew D. Martin)

Washington & Lee Law School: The Role of Social Science in the Law (John Keyser)

William & Mary Law School: Statistics for Lawyers

William Mitchell College of Law: Statistics Workshop (Herbert M. Kritzer)

Yale Law School: Probability Modeling and Statistics LAW 26403

[1] See Ignorantia juris non excusat.

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Expert Witness Mining – Antic Proposals for Reform

November 4th, 2014

Law Reviews and Altered States of Reality

In 2008, Justice Breyer observed wryly that “there is evidence that law review articles have left terra firma to soar into outer space”; and Judge Posner has criticized law review articles for the “silly titles, the many opaque passages, the antic proposals, the rude polemics, [and] the myriad pretentious citations.” In 2010, Justice Scalia, who was a law-review-producing law professor for the University of Virginia for several years, responded to a lawyer’s oral argument, in McDonald v. City of Chicago, by suggesting that the argument had no support in Supreme Court precedent, but the unsupported argument would make the lawyer the “the darling of the professoriate.” At the June 2011 Fourth Circuit Judicial Conference, Chief Justice Roberts opined that law reviews are generally not “particularly helpful for practitioners and judges.” In his words:

“Pick up a copy of any law review that you see and the first article is likely to be, you know, the influence of Immanuel Kant on evidentiary approaches in 18th-century Bulgaria, or something, which I’m sure was of great interest to the academic that wrote it, but isn’t of much help to the bar.”

See Debra Cassens Weiss, “Law Prof Responds After Chief Justice Roberts Disses Legal Scholarship” Am. Bar Ass’n J. (July 07, 2011). Lawyers would think the Justices view law review scholarship as a useless but generally harmless activity. Sometimes, however, law review articles can actually be harmful.

Selection Effects in the Retention and Presentation of Expert Witnesses

The complaints about law review scholarship are obviously based upon extremes and travesties. Interestingly, Judge Posner himself has been no slacker when it comes to producing law review articles with “antic proposals.” See, e.g., Richard A. Posner, “An Economic Approach to the Law of Evidence,” 51 Stan. L. Rev. 1477, 1541–42 (1999). In the tradition of non-traditional, rationalist proposals that ignore experience and make up something completely untested, Judge Richard Posner has advocated rule changes that would require lawyers

“to disclose the name of all the experts whom they approached as possible witnesses before settling on the one testifying. This would alert the jury to the problem of ‘witness shopping’.”

Posner, 51 Stan. L. Rev. at 1541. The point of Judge Posner’s radical reform is to alert triers of fact to whether the expert witness testifying is the first, or the umpteenth expert witness interviewed before a suitable opinion had been “procured,” so that the fact finder can draw the“ reasonable inference” that the case must be weaker than presented if the party went through so many expert witnesses before coming up with one who would testify in the case. If one party disclosed but one expert witness, the one that actually testified, and the other party disclosed X such witnesses (where X >1), then the fact finder could find in favor of the first party upon the basis of the so-called reasonable inference.

Posner’s proposal is at best a proxy for accuracy and validity in expert witness opinion testimony, and one for which Posner presents no evidence to support his hoped-for improvement in juridical accuracy. Not only does Judge Posner present no evidence that his proposed reform and suggested inference would be in the least bit reasonable and probative of the truth, he fails to address the obvious incentives that would be created by his proposal. Fearing the prejudicial inference from having consulted with “too many” expert witnesses, lawyers, operating under the Posner Rule, would have strong incentives to go to the expert witness “one-stop-shopping” mall, where they know they can obtain expert witnesses guaranteed to align themselves with the needed litigation positions and claims. The Posner Rule would also give a strong advantage to lawyers more skilled in vetting and selecting expert witnesses, to the detriment of less experienced lawyers. Of course, lawyers who are willing to go shopping at the meretricious mall or to employ a “cleaner” who brokers the selection without footprints might escape the bite of the Posner adverse inference.

Posner’s proposed rule ignores what is at the heart of identifying and selecting expert witnesses to testify. Obviously lawyers must identify potential witnesses with suitable expertise to address the issues raised by the litigation. Database searches, such as PubMed and Google Scholar searches for bio-medical experts, can go a long way towards identifying candidates, but interviews are important as well. Posner would chill lawyers’ effective representation by placing an adverse inference upon their diligence in any contact with the person other than the “one” who will be anointed to be the party’s designated testifier.

Meetings and interviews with prospective expert witnesses to ascertain whether the witness candidate has sufficient time and interest in fulfill the litigation assignment. Expertise in the area is hardly a guarantee that the candidate will be interested in answering the specific questions that are contested in the litigation. The lawyers must also ascertain whether the witness candidate has the stamina, patience, and aptitude for the litigation context. Not all real experts do, and the consequences of engaging an expert who does not have the qualities to make a good expert witness can be disastrous. Witness candidates must also be screened for their communication skills, their appearance, and even basic hygiene. The most brilliant expert who mumbles, or who is unkempt, is useless in litigation.

Lawyers must evaluate witness candidates for conflicts of interest, many of which are unknowable until there is a face-to-face meeting. Does the witness candidate have a significant other or child who works for the litigation industry (plaintiffs’ bar) or for the defendant industry under assault in the litigation at hand? Either way, the candidate may be compromised. Was the candidate mentored by an expert witness on the other side? Is the candidate on an editorial board with the adversary’s witnesses? Is the candidate close personal friends of the adversaries or their witnesses, such that he will be less than enthusiastic in showing the infirmities of the other side’s positions? Any of these questions could lead to answers that practically disqualify a witness candidate from consideration. Proceeding without such vetting could be catastrophic for the client and counsel. Burdening the vetting process with the threat of an adverse inference is deeply unfair to diligent counsel trying to represent and serve their clients.

And there are yet additional considerations that require exploration with any witness candidate. Expert witnesses are not equally able to deal with adverse authority in the form of a noted scientist who has taken a stand on the litigation issue, or a superficially appearing authoritative author who has published an adverse opinion. As well trained as they might be, some real experts are “sheep,” who are most comfortable following the herd, and not independent thinkers. Not all experts are willing or able to read studies as critically as needed for the litigation situation, which can sometimes be more demanding than the scientific arena. Lawyers charged with retaining expert witnesses must assess their clients’ positions and determine how well their expert witnesses will perform under all the circumstances of the case.

Professor Christopher Robertson proposes an even more radical reform of the law of expert witness by removing the selection and control of expert witnesses from parties and their counsel, completely. Robertson would somehow create a pool of expert witnesses on the issues in each case, and assign them to parties in a double-blinded randomized fashion. Christopher Tarver Robertson, “Blind Expertise,” 85 N.Y. Univ. L. Rev. 174, 211 (2010). Aside from depriving litigants of autonomy and control over their cases, this approach has even greater potential for generating false results. How do the expert witness come to be retained for this process? Any two expert witnesses may very well come to an incorrect analysis precisely because they do not have the benefit of each other’s report to develop the full range of data to be considered. What if the expert assigned to plaintiff concludes that there is no case, but the expert assigned to the defendant concludes that the plaintiff’s case is meritorious? Normally, plaintiffs’ expert witnesses must file their reports in advance of the defense witnesses, who then have the opportunity to rebut but also the benefit of all the data included. Simultaneous reports risk major omissions of data to be considered on both sides. The adversarial cauldron works to ensure completeness in what data and studies are considered.

Now comes Jonah Gelbach to attempt a probabilistic, theoretical defense of reforms in the Posner-Robertson mold. Jonah B. Gelbach, “Expert Mining and Required Disclosure,” 81 U. Chicago L. Rev. 131 (2014). Professor Gelbach is a well-trained economist, and a recently minted lawyer (Yale 2013), who is now an Associate Professor at the University of Pennsylvania Law School. Gelbach’s experience with the practice of law is limited to working as a law-school intern at David Rosen & Associates, in New Haven, Connecticut, before joining the Penn faculty. His proposals may need to be taken with a 100 grains of aspirin.

Although Gelbach disagrees with particulars of the Posner-Robertson proposals, Gelbach joins with them to opine that “[t]o the extent that additional fully disclosed expert testimony increases the fact finder’s information, we can expect a beneficial increase in accuracy.” Gelbach at 133. Gelbach’s dictum, however, is an ipse dixit, and he offers only a limited hypothetical case in which full disclosure of data should be required to solve the problem. And even in his hypothetical case, the disclosure of the identities of the testers is unnecessary to correct the error that Gelbach predicts. Gelbach’s call for the disclosure of consulting expert witnesses introduces only a collateral issue that has nothing to do with the accuracy of the scientific reasoning.

Gelbach analogizes “witness shopping” to data dredging and multiple testing, with a known inflation in the rate of false positive outcomes. If a party directs multiple to conduct single outcome measurements or tests, then that party can recreate the results of multiple testing without having to disclosure the number of independent tests. Gelbach’s argument is at its strongest for a simplistic model of a simple measurement, with errors normally distributed, with accuracy of the measurement tied to the outcome of the case. Gelbach at 136. Gelbach analogizes expert witness mining with data mining, and goes so far as to provide a calculation of false positive rates from multiple testing.

The sort of multiple testing Gelbach condemns is even more obvious when something other than random error is involved. Consider the need of litigants to have chest radiograph interpreted for the presence or absence of a pneumoconiosis in occupational dust disease litigation. Not only is there an intra-observer variability, there are potential or known subjective biases in radiograph interpretations. Gelbach need not worry about multiple testing because the need for economic efficiency already encourages many lawyers to employ radiologists who are must biased in favor of their clients’ positions. The bigger problem would be to encourage lawyers to obtain an honest second opinion, which might make them less strident about their litigation positions when discussing possible settlement.

Gelbach appears to believe that mandatory disclosure of the number of expert witnesses hired as well as the contents of the written and oral reports issued by the party’s nontestifying expert witnesses is needed to abate the potential harm from “expert mining.” By introducing the probabilistic modeling of Type I and Type II errors, however, Gelbach elevates proofiness over clear thinking about the issue. The simple solution to Gelbach’s soil measurement hypothetical is to require disclosure of all testing data, regardless whether conducted by expert witnesses designated as testifying or as consulting. All are agents of the party for purposes of creating data in the form of the hypothesized soil measurement. Indeed, Gelbach’s hypothetical envisions a technical laboratory that conducts such measurements, and the lab might not even be associated with a person designated to serve as an expert witness on the litigation issues.

Gelbach’s soil-measurement case is thus, for the most part, a straw-person case. In the vast majority of cases, multiple expert witness interviews leading up to selection and retention is, however, not at all like multiple testing, either in its ability to generate deliberate false positive or false negative opinions. The evidence remains what it is, and the parameter unchanged, whatever the qualitative judgments of the witness candidates. In most litigation contexts, the data upon which the expert witnesses will rely comes from published studies, and not from a single measurement under either side’s control and ability to resample many times through the agency of multiple expert witnesses. The Rules need to help the triers of fact discern the truth, not irrelevant proxies for the truth. If the triers of fact are incompetent to adjudge the actual evidence, then we may need to find triers who are competent.

The extension of the soil hypothetical to all of expert witness opinion testimony is unwarranted. Accuracy and validity of expert opinion is not “independent and identically distributed.” Truth and accuracy in scientific judgment as applied to litigation scientific questions are not random variables with known distributions.

A party may have to comb through dozens of potential expert witnesses before arriving at an expert witness with an appropriate, accurate answer to the litigation issue. When confronted with a pamphlet entitled “100 Authors against Einstein,” Albert Einstein quipped “if I were wrong, one would have been enough.” See Remigio Russo, 18 Mathematical Problems in Elasticity 125 (1996) (quoting Einstein). Legal counsel should not have their clients’ cause compromised because they had the misfortune of consulting the “100 Authors” before arriving at Einstein’s door. The Posner-Robertson-Gelbach proposals all suffer the same flaw: they defer unduly to conformism and ignore the truth, validity, and accuracy of procured opinions.

Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the number of speakers. The number of expert witness candidates who were interviewed or who offered preliminary opinions is irrelevant to the task assigned to the finder of fact in a case involving scientific evidence. The final, proffered opinion of the testifying expert witness is only as good as the evidence and analysis upon which it rests, which under the current rules, should be fully disclosed.

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