High, Low and Right-Sided Colonics – Ridding the Courts of Junk Science

Not surprisingly, many of Selikoff’s litigation- and regulatory-driven opinions have not fared well, such as the notions that asbestos causes gastrointestinal cancers and that all asbestos minerals have equal potential and strength to cause mesothelioma.  Forty years after Selikoff testified in litigation that occupational asbestos exposure caused an insulator’s colorectal cancer, the Institute of Medicine reviewed the extant evidence and announced that the evidence was  “suggestive but not sufficient to infer a causal relationship between asbestos exposure and pharyngeal, stomach, and colorectal cancers.” Jonathan Samet, et al., eds., Institute of Medicine Review of Asbestos: Selected Cancers (2006).[1] The Institute of Medicine’s monograph has fostered a more circumspect approach in some of the federal agencies.  The National Cancer Institute’s website now proclaims that the evidence is insufficient to permit a conclusion that asbestos causes non-pulmonary cancers of gastrointestinal tract and throat.[2]

As discussed elsewhere, Selikoff testified as early as 1966 that asbestos causes colorectal cancer, in advance of any meaningful evidence to support such an opinion, and then he, and his protégées, worked hard to lace the scientific literature with their pronouncements on the subject, without disclosing their financial, political, and positional conflicts of interest.[3]

With plaintiffs’ firm’s (Lanier) zealous pursuit of bias information from the University of Idaho, in the LoGuidice case, what are we to make of Selikoff’s and his minions’ dubious ethics of failed disclosure. Do Selikoff and Mount Sinai receive a pass because their asbestos research predated the discovery of ethics? The “Lobby” (as the late Douglas Liddell called Selikoff and his associates)[4] has seriously distorted truth-finding in any number of litigations, but nowhere are the Lobby’s distortions more at work than in lawsuits for claimed asbestos injuries. Here the conflicts of interests truly have had a deleterious effect on the quality of civil justice. As we saw with the Selikoff exceptionalism displayed by the New York Supreme Court in reviewing third-party subpoenas,[5] some courts seem bent on ignoring evidence-based analyses in favor of Mount Sinai faith-based initiatives.

Current Asbestos Litigation Claims Involving Colorectal Cancer

Although Selikoff has passed from the litigation scene, his trainees and followers have lined up at the courthouse door to propagate his opinions. Even before the IOM’s 2006 monograph, more sophisticated epidemiologists consistently rejected the Selikoff conclusion on asbestos and colon cancer, which grew out of Selikoff’s litigation activities.[6] And yet, the minions keep coming.

In the pre-Daubert era, defendants lacked an evidentiary challenge to the Selikoff’s opinion that asbestos caused colorectal cancer. Instead of contesting the legal validity or sufficiency of the plaintiffs’ general causation claims, defendants often focused on the unreliability of the causal attribution for the specific claimant’s disease. These early cases are often misunderstood to be challenges to expert witnesses’ opinions about whether asbestos causes colorectal cancer; they were not.[7]

Of course, after the IOM’s 2006 monograph, active expert witness gatekeeping should eliminate asbestos gastrointestinal cancer claims, but sadly they persist. Perhaps, courts simply considered the issue “grandfathered” in from the era in which judicial scrutiny of expert witness opinion testimony was restricted. Perhaps, defense counsel are failing to frame and support their challenges properly.  Perhaps both.

Arthur Frank Jumps the Gate

Although ostensibly a “Frye” state, Pennsylvania judges have, when moved by the occasion, to apply a fairly thorough analysis of proffered expert witness opinion.[8] On occasion, Pennsylvania judges have excluded unreliably or invalidly supported causation opinions, under the Pennsylvania version of the Frye standard. A recent case, however, tried before a Workman’s Compensation Judge (WCJ), and appealed to the Commonwealth Court, shows how inconsistent the application of the standard can be, especially when Selikoff’s legacy views are at issue.

Michael Piatetsky, an architect, died of colorectal cancer. Before his death, he and his wife filed a worker’s compensation claim, in which they alleged that his disease was caused by his workplace exposure to asbestos. Garrison Architects v. Workers’ Comp. Appeal Bd. (Piatetsky), No. 1095 C.D. 2015, Pa. Cmwlth. Ct., 2016 Pa. Commw. Unpub. LEXIS 72 (Jan. 22, 2016) [cited as Piatetsky]. Mr. Piatetsky was an architect, almost certainly knowledgeable about asbestos hazards generally.  Despite his knowledge, Piatetsky eschewed personal protective equipment even when working at dusty work sites well marked with warnings. Although he had engaged in culpable conduct, the employer in worker compensation proceedings does not have ordinary negligence defenses, such as contributory negligence or assumption of risk.

In litigating the Piatetsky’s claim, the employer dragged its feet and failed to name an expert witness.  Eventually, after many requests for continuances, the Workers’ Compensation Judge barred the employer from presenting an expert witness. With the record closed, and without an expert witness, the Judge understandably ruled in favor of the claimant.

The employer, sans expert witness, had to confront claimant’s expert witness, Arthur L. Frank, a minion of Selikoff and a frequent testifier in asbestos and many other litigations. Frank, of course, opined that asbestos causes colon cancer and that it caused Mr. Piatetsky’s cancer. Mr. Piatetsky’s colon cancer originated on the right side of his colon. Dr. Frank thus emphasized that asbestos causes colon cancer in all locations, but especially on the right side in view of one study’s having concluded “that colon cancer caused by asbestos is more likely to begin on the right side.” Piatetsky at *6.

On appeal, the employer sought relief on several issues, but the only one of interest here is the employer’s argument “that Claimant’s medical expert based his opinion on flimsy medical studies.” Piatetsky at *10. The employer’s appeal seemed to go off the rails with the insistence that the Claimant’s medical opinion was invalid because Dr. Frank relied upon studies not involving architects. Piatetsky at *14. The Commonwealth Court was able to point to testimony, although probably exaggerated, which suggested that Mr. Piatetsky had been heavily exposed, at least at times, and thus his exposure was similar to that in the studies cited by Frank.

With respect to Frank’s right-sided (non-sinister) opinion, the Commonwealth Court framed the employer’s issue as a contention that Dr. Frank’s opinion on the asbestos-relatedness of right-sided colon cancer was “not universally accepted.” But universal acceptance has never been the test or standard for the rejection or acceptance of expert witness opinion testimony in any state.  Either the employer badly framed its appeal, or the appellate court badly misstated the employer’s ground for relief. In any event, the Commonwealth Court never addressed the relevant legal standard in its discussion.

The Claimant argued that the hearing Judge had found that Frank’s opinion was based on “numerous studies.” Piatetsky at *15. None of these studies is cited to permit the public to assess the argument and the Court’s acceptance of it. The appellate court made inappropriately short work of this appellate issue by confusing general and specific causation, and invoking Mr. Piatetsky’s age, his lack of family history of colon cancer, Frank’s review of medical records, testimony, and work records, as warranting Frank’s causal inference. None of these factors is relevant to general causation, and none is probative of the specific causation claim.  Many if not most colon cancers have no identifiable risk factor, and Dr. Frank had no way to rule out baseline risk, even if there were an increased risk from asbestos exposure. Piatetsky at *16. With no defense expert witness, the employer certainly had a difficult appellate journey. It is hard for the reader of the Commonwealth Court’s opinion to determine whether the case was poorly defended, poorly briefed on appeal, or poorly described by the appellate judges.

In any event, the right-sided ruse of Arthur Frank went unreprimanded.  Intellectual due process might have led the appellate court to cite the article at issue, but it failed to do so.  It is interesting and curious to see how the appellate court gave a detailed recitation of the controverted facts of asbestos exposure, while how glib the court was when describing the scientific issues and evidence.  Nonetheless, the article referenced vaguely, which went uncited by the appellate court, was no doubt the paper:  K. Jakobsson, M. Albin & L. Hagmar, “Asbestos, cement, and cancer in the right part of the colon,” 51 Occup. & Envt’l Med. 95 (1994).

These authors 24 observed versus 9.63 expected right-sided colon cancers, and they concluded that there was an increased rate of right-sided colon cancer in the asbestos cement plant workers.  Notably the authors’ reference population had a curiously low rate of right-sided colon cancer.  For left-sided colon cancer, the authors 9.3 expected cases but observed only 5 cases in the asbestos-cement cohort.  Contrary to Frank’s suggestion, the authors did not conclude that right-sided colon cancers had been caused by asbestos; indeed, the authors never reached any conclusion whether asbestos causes colorectal  cancer under any circumstances.  In their discussion, these authors noted that “[d]espite numerous epidemiological and experimental studies, there is no consensus concerning exposure to asbestos and risks of gastrointestinal cancer.” Jakobsson at 99; see also Dorsett D. Smith, “Does Asbestos Cause Additional Malignancies Other than Lung Cancer,” chap. 11, in Dorsett D. Smith, The Health Effects of Asbestos: An Evidence-based Approach 143, 154 (2015). Even this casual description of the Jakobsson study will awake the learned reader to the multiple comparisons that went on in this cohort study, with outcomes reported for left, right, rectum, and multiple sites, without any adjustment to the level of significance.  Risk of right-sided colon cancer was not a pre-specified outcome of the study, and the results of subsequent studies have never corroborated this small cohort study.

A sane understanding of subgroup analyses is important to judicial gatekeeping. SeeSub-group Analyses in Epidemiologic Studies — Dangers of Statistical Significance as a Bright-Line Test” (May 17, 2011).  The chapter on statistics in the Reference Manual for Scientific Evidence (3d ed. 2011) has some prudent caveats for multiple comparisons and testing, but neither the chapter on epidemiology, nor the chapter on clinical medicine[9], provides any sense of the dangers of over-interpreting subgroup analyses.

Some commentators have argued that we must not dissuade scientists from doing subgroup analysis, but the issue is not whether they should be done, but how they should be interpreted.[10] Certainly many authors have called for caution in how subgroup analyses are interpreted[11], but apparently Expert Witness Arthur Frank, did not receive the memo, before testifying in the Piatetsky case, and the Commonwealth Court did not before deciding this case.


[1] As good as the IOM process can be on occasion, even its reviews are sometimes less than thorough. The asbestos monograph gave no consideration to alcohol in the causation of laryngeal cancer, and no consideration to smoking in its analysis of asbestos and colorectal cancer. See, e.g., Peter S. Liang, Ting-Yi Chen & Edward Giovannucci, “Cigarette smoking and colorectal cancer incidence and mortality: Systematic review and meta-analysis,” 124 Internat’l J. Cancer 2406, 2410 (2009) (“Our results indicate that both past and current smokers have an increased risk of [colorectal cancer] incidence and mortality. Significantly increased risk was found for current smokers in terms of mortality (RR 5 1.40), former smokers in terms of incidence (RR 5 1.25)”); Lindsay M. Hannan, Eric J. Jacobs and Michael J. Thun, “The Association between Cigarette Smoking and Risk of Colorectal Cancer in a Large Prospective Cohort from the United States,” 18 Cancer Epidemiol., Biomarkers & Prevention 3362 (2009).

[2] National Cancer Institute, “Asbestos Exposure and Cancer Risk” (last visited July 10, 2016) (“In addition to lung cancer and mesothelioma, some studies have suggested an association between asbestos exposure and gastrointestinal and colorectal cancers, as well as an elevated risk for cancers of the throat, kidney, esophagus, and gallbladder (3, 4). However, the evidence is inconclusive.”).

[3] Compare “Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966) (thanking Selikoff for testifying in a colon cancer case) with, Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for his causal conclusion between asbestos and all gastrointestinal cancers, with no acknowledgment of his role in litigation or his funding from the asbestos insulators’ union).

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

[5]

SeeThe LoGiudice Inquisitiorial Subpoena & Its Antecedents in N.Y. Law” (July 14, 2016).

[6] See, e.g., Richard Doll & Julian Peto, Asbestos: Effects on health of exposure to asbestos 8 (1985) (“In particular, there are no grounds for believing that gastrointestinal cancers in general are peculiarly likely to be caused by asbestos exposure.”).

[7] See Landrigan v. The Celotex Corporation, Revisited” (June 4, 2013); Landrigan v. The Celotex Corp., 127 N.J. 404, 605 A.2d 1079 (1992); Caterinicchio v. Pittsburgh Corning Corp., 127 NJ. 428, 605 A.2d 1092 (1992). In both Landrigan and Caterinicchio, there had been no challenge to the reliability or validity of the plaintiffs’ expert witnesses’ general causation opinions. Instead, the trial courts entered judgments, assuming arguendo that asbestos can cause colorectal cancer (a dubious proposition), on the ground that the low relative risk cited by plaintiffs’ expert witnesses (about 1.5) was factually insufficient to support a verdict for plaintiffs on specific causation.  Indeed, the relative risk suggested that the odds were about 2 to 1 in defendants’ favor that the plaintiffs’ colorectal cancers were not caused by asbestos.

[8] See, e.g., Porter v. Smithkline Beecham Corp., Sept. Term 2007, No. 03275. 2016 WL 614572 (Phila. Cty. Com. Pleas, Oct. 5, 2015); “Demonstration of Frye Gatekeeping in Pennsylvania Birth Defects Case” (Oct. 6, 2015).

[9] John B. Wong, Lawrence O. Gostin & Oscar A. Cabrera, “Reference Guide on Medical Testimony,” in Reference Manual for Scientific Evidence 687 (3d ed. 2011).

[10] See, e.g., Phillip I. Good & James W. Hardin, Common Errors in Statistics (and How to Avoid Them) 13 (2003) (proclaiming a scientists’ Bill of Rights under which they should be allowed to conduct subgroup analyses); Ralph I. Horwitz, Burton H. Singer, Robert W. Makuch, Catherine M. Viscoli, “Clinical versus statistical considerations in the design and analysis of clinical research,” 51 J. Clin. Epidemiol. 305 (1998) (arguing for the value of subgroup analyses). In United States v. Harkonen, the federal government prosecuted a scientist for fraud in sending a telecopy that described a clinical trial as “demonstrating” a benefit in a subgroup of a secondary trial outcome.  Remarkably, in the Harkonen case, the author, and criminal defendant, was describing a result in a pre-specified outcome, in a plausible but post-hoc subgroup, which result accorded with prior clinical trials and experimental evidence. United States v. Harkonen (D. Calif. 2009); United States v. Harkonen (D. Calif. 2010) (post-trial motions), aff’d, 510 F. App’x 633 (9th Cir. 2013) (unpublished), cert. denied, 134 S. Ct. 824, ___ U.S. ___ (2014); Brief by Scientists And Academics as Amici Curiae In Support Of Petitioner, On Petition For Writ Of Certiorari in the Supreme Court of the United States, W. Scott Harkonen v. United States, No. 13-180 (filed Sept. 4, 2013).

[11] SeeSub-group Analyses in Epidemiologic Studies — Dangers of Statistical Significance as a Bright-Line Test” (May 17, 2011) (collecting commentary); see also Lemuel A. Moyé, Statistical Reasoning in Medicine:  The Intuitive P-Value Primer 206, 225 (2d ed. 2006) (noting that subgroup analyses are often misleading: “Fishing expeditions for significance commonly catch only the junk of sampling error”); Victor M. Montori, Roman Jaeschke, Holger J. Schünemann, Mohit Bhandari, Jan L Brozek, P. J. Devereaux & Gordon H Guyatt, “Users’ guide to detecting misleading claims in clinical research reports,” 329 Brit. Med. J. 1093 (2004) (“Beware subgroup analysis”); Susan F. Assmann, Stuart J. Pocock, Laura E. Enos, Linda E. Kasten, “Subgroup analysis and other (mis)uses) of baseline data in clinical trials,” 355 Lancet 1064 (2000); George Davey Smith & Mathias Egger, “Commentary: Incommunicable knowledge? Interpreting and applying the results of clinical trials and meta-analyses,” 51 J. Clin. Epidemiol. 289 (1998) (arguing against post-hoc hypothesis testing); Douglas G. Altman, “Statistical reviewing for medical journals,” 17 Stat. Med. 2662 (1998); Douglas G. Altman, “Commentary:  Within trial variation – A false trail?” 51 J. Clin. Epidemiol. 301 (1998) (noting that observed associations are expected to vary across subgroup because of random variability); Christopher Bulpitt, “Subgroup Analysis,” 2 Lancet: 31 (1988).

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