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

The Lobby – Cut on the Bias

July 6th, 2020

When ordinary citizens hear about lobbies, they think about highly paid former elected officials pressing the interests of manufacturing and service industries in the federal and various state capitals. Of course, there are such lobbyists, but the description misses one of the most powerful groups, the plaintiffs’ mass tort trial bar, the largest rent-seeking group in the United States. When the plaintiffs’ lawyers’ interests are aligned with a group of scientists and physicians who have for decades pressed the interests of labor unions for more and more compensation, and have delivered scientific studies calculated to support their pro-compensation goals, the lobby deserves special attention as “The Lobby.”

Francis Douglas Kelly Liddell was the anti-Selikoff, and he frequently drew the ire, wrath, and barbs of The Lobby. Unlike Selikoff, Liddell had a first-rate education in mathematics (B.A., M.A., Trinity College, Cambridge University), and he had 21 years of hands-on pneumoconiosis research as a Scientific Officer and then Director of the Statistics Department of the National Coal Board, and then Head of the Medical Service’s Medical Statistics Branch.[1]

McGill University recruited Liddell in 1969 to its Medical School’s Department of Epidemiology. In Montreal, Liddell led the statistical analyses for epidemiologic studies of the Quebec chrysotile miners and millers. He helped develop the methodology that underlies the ILO system for evaluating chest radiographs for pneumoconiosis. Although Liddell retired in 1992, as an Emeritus Professor, he remained active in lecturing and publishing, and in his professional associations, Royal Statistical Society and later in the American Statistical Association. Liddell’s careful statistical work, and the much lower risks found in the Canadian chrysotile mining cohorts put him at odds with Selikoff and The Lobby.

In 1997, Liddell had had enough of The Lobby’s insinuations, slanders, and bent science. He did what rarely happens in the scientific world; he called them out for what they were doing:

“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”[2]

Since Liddell wrote in 1997, The Lobby has grown and insinuated itself into the International Agency for Research on Cancer, and into a variety of domestic advisory boards to regulatory agencies. The Lobby has learned to use the language and hand waving of the “moral panic,” whenever an expert who has had any connections to regulated industries. Members of The Lobby, however, seem to think that they have no conflicts of interest, despite their deep positional and financial connections to the unregulated lawsuit industry. Asserting conflicts of interest thus becomes an asymmetric weapon to advance pro-compensation and environmental “friendly” conclusions.

Early last month, a group of admittedly pro-manufacturing industry organizations[3] submitted their counter to The Lobby’s purity tests that keep defense expert witnesses and consultants from serving on advisory boards. The organizations wrote to the EPA Administrator, to object to the asymmetry of interest alignments among the Ad Hoc Peer Reviewers for the March 2020 Draft Risk Evaluation for Asbestos, from the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).

While the assertion of conflicts of interest for actual research tends to be overwrought, at least when the methods and data are transparent, the conflicts identified in the letter to the EPA have the real potential to skew an opinion-laden, policy document. The reality is that any such EPA risk assessment will be used as a cudgel in tort and environmental litigation, restrictive regulations, and legislative campaigns to “ban” asbestos. The organizations’ complaints are well justified.

The three committee members at issue are Henry Anderson, Steven Markowitz, and Marty Kanarek. All three are card-carrying members of The Lobby.  Markowitz and Anderson are tied to a lobby group, the Asbestos Disease Awareness Organization (ADAO), which advocates a universal ban on asbestos, notwithstanding that this may require relocating 7+ billion people to another planet. Markowitz, Anderson, and Kanarek all testify for the asbestos lawsuit industry. Anderson has been testifying in asbestos personal injury cases, for over 35 years, after he served a brief training in the Mt. Sinai catechism, on New York’s Upper East Side. Indeed, in the mid-1980s, New Jersey plaintiffs’ lawyers regularly called Anderson as an expert witness to give the party line. Markowitz has also trained in the Mt. Sinai catechism, but now is at Queens College, in Queens, New York. Markowitz has not testified for as long as Anderson, but then he has not lived as long. In any event, Markowitz has almost certainly made up in volume for what he has lost in time.

The organizations complaining about Anderson, Markowitz, and Kanarek as peer reviewers correctly point out that these physicians are advocates and highly compensated expert witnesses for the asbestos lawsuit industry. The letter to the EPA also points out that they have been purveyors of dubious opinions on “each and every exposure,” which have been found to be unreliable and not well supported.[4] Certainly less biased experts could be found, and if not, then the Peer Review committee could be balanced with experts who have more balanced views. Inquiring minds wonder how the peer review committee ever became so unbalanced, but I suspect that asymmetrical evaluation of conflicts of interest had a lot to do with it.[5]

[1]  James Hanley, Corbett McDonald, and Margaret R. Becklake, “In Memoriam 2003: Francis Douglas Kelly Liddell.”

[2]  F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997).

[3]  The U.S. Chamber of Commerce, U.S. Chamber Institute for Legal Reform, American Property Casualty Insurance Association, American Tort Reform Association, Aerospace Industries Association, Coalition for Litigation Justice, International Association of Defense Counsel, National Federation of Independent Business Small Business Legal Center, Product Liability Advisory Council, Inc., and Washington Legal Foundation.

[4]  See, e.g., In re W.R. Grace & Co., 355 B.R. 462, 482 (Bankr. D. Del. 2006) (“Dr. Anderson’s analysis is unreliable. Dr. Anderson’s opinion, therefore, does not satisfy Daubert and its progeny and is not admissible. We exclude this evidence.”), appeal den., 2007 WL 1074094 (D. Del. Mar. 26, 2007); In re Matter of New York City Asbestos Litig., 48 Misc. 3d 460, 483-484 (Sup. Ct. N.Y. Cty. 2015) (“For all of these reasons, Markowitz’s opinions, either individually or collectively, do not establish that asbestos contained in friction products can cause mesothelioma, and as he conceded, he could identify no study to support his proposition that there is an increased risk of contracting mesothelioma from exposure to auto brakes, clutches, or gaskets or that there is an increased risk of mesothelioma from the use of friction products or work on friction materials in the automobile industry…. Markowitz not only cited no study to support his opinion, but he also conceded that numerous studies contradict it.”), aff’d sub nom., Juni v. A.O. Smith Water Prods. Co., 32 N.Y.3d 1116, 116 N.E.3d 75 91 N.Y.S.3d 784 (2018).

[5]  “Disappearing Conflicts of Interest” (Oct. 29, 2017) (discussing Steven Markowitz); “The Mt. Sinai Catechism” (June 7, 2013) (discussing Markowitz’ s publications that followed up on Selikoff’s insulator cohort).

Ingham v. Johnson & Johnson – A Case of Meretricious Mensuration?

July 3rd, 2020

There are a few incontrovertible facts underlying the Ingham fiasco. First, only God can make asbestos; it is not a man-made substance. Second, “asbestos” is not a mineralogical or geological term. The word asbestos developed in an industrial context to designate one of six different minerals that occurred in a fibrous habit, and which had commercial application. Five of the six asbestos minerals are double-chain silicates in the amphibole family: actinolite, anthophyllite, crocidolite, grunerite (known by its non-mineralogical name, amosite, from Amosa, “asbestos mines of South Africa), and tremolite. The sixth asbestos mineral is a serpentine family silicate: chrysotile.

Many other minerals occur in fibrous habit, but not all fibrous minerals are asbestos. Of the minerals designated as asbestos, some refer to minerals that occur in fibrous and non-fibrous habits: actinolite, anthophyllite, grunerite, and tremolite. An analytical report that found one of these minerals could not automatically be interpreted as having “asbestos.” The fibrous nature of the mineral would have to be ascertained as well as its chemical an structural nature.

The asbestos mineral crocidolite is known as riebeckite when non-fibrous; and chrysotile is the fibrous form that comes from a group of serpentine minerals, including non-fibrous lizardite and antigorite.[1]

The term “asbestiform” is often used to distinguish the fibrous habit of those asbestos minerals that can occur in fibrous or non-fibrous form. The term, however, is also used to refer to any inorganic fiber, natural or synthetic that resembles the long, thin habit of the asbestos minerals.[2]

What is a fiber?

The asbestos minerals were commercially useful in large part because of their fibrous habit, which allowed them to be woven into cloth or used as heat-resistant binders in insulation materials. Fibers were very long, thin structures with aspect ratios in the hundreds or thousands. Some of the fibers can fracture into long, thin fibrils. Some of the asbestos minerals can appear in their non-fibrous habit as small cleavage fragments, which may have aspect ratios ranging from 1 to 10. The EPA’s counting protocols count fragments with aspect ratios of 3 or greater as “fibers,” but that does not mean that there is strong evidence that amphibole cleavage fragments with aspect ratios of 3 cause cancer.

According to Johnson & Johnson’s principal brief, the plaintiffs’ expert witness William Longo counted any amphibole particle long and thin enough to satisfy a particular regulatory definition of “fiber” set out by the Environmental Protection Agency (EPA).[3]

Unfortunately, in its opening brief, J&J never explained clearly what separates the asbestiform from the non-asbestiform in the counting process. The appeal presents other potential problems. From a review of the appellants’ briefs, it seems unclear whether J&J disputed Longo’s adherence to the EPA definition of asbestiform. In any event, J&J appears not to have challenged the claim that any “asbestiform” fiber as defined by regulatory agencies can cause cancer. Moreover, plaintiffs’ expert witness, Dr. Jacqueline Moline, opined that cleavage fragments, or non-asbestiform amphiboles cause cancer.[4] This opinion seems highly dubious,[5] but there was NO appellate point in the defendants’ appellate brief to allege error in admitting Moline’s testimony. In addition, the appellate court’s opinion stated plaintiffs’ position that each and every exposure was a substantial causal factor without any suggestion that there was a challenge to the admissibility of this opinion.

What was the estimated exposure?

The plaintiffs’ expert witnesses appeared to be wildly inconsistent in their quantitative estimations of asbestos exposure from the ordinary use of J&J’s talcum powder. According to J&J’s appellate brief:

“Dr. Longo testified that plaintiffs’ use of the Powders would have exposed them to levels of asbestos at least ‘10 to 20 times above’ the amount in every day air that you breathe’. Tr. 1071. He put these exposure levels in the ‘same category’ as occupational levels. Tr. 1073.”[6]

There are many estimates of the ambient asbestos levels in “every day air,” but one estimate on the high side was given by the National Research Council, in 1984, as 0.0004 fibers/cm3.[7] Using Longo’s upper estimate of 20 times the “every day” level yields exposures of 0.008 f/cm3, a level that is well below the current permissible exposure level set by the U.S. Occupational Safety and Health Administration. Historically, workers in occupational cohorts experienced asbestos exposures at or even above 50 f/cm3.[8]

David Egilman also gave inflated exposure estimates that he equated with “occupational exposure” to the plaintiffs. Egilman opined, based upon Longo’s simulation study, a NIOSH study that counted all fibers, and a published study of another talc product, that the amount of asbestos dust released during personal use of J&J’s product was as high as 2.2 f/cm3, during the application process. These estimates were not time-weighted averages, and the estimates, such as they are, would be many orders of magnitude lower if they were analyzed as part of an eight-hour work day. Nonetheless, Egilman concluded that the plaintiffs’ exposures to J&J’s talc products more than doubled their ovarian cancer risk over baseline.[9]

In my previous post on Ingham, I noted how scientifically ignorant and irresponsible Egilman’s testimony was with respect to equating talc and anthopyllite.[10]  The Missouri Court of Appeals presented Egilman’s opinion as though it were well supported, and gave perfunctory consideration to J&J’s complaint about this testimony:

“Plaintiffs concede that Dr. Egilman’s intensity values for diapering came from a test that counted all types of fibers released by a sample of the Powders, including fibers that are not asbestos (principally talc fibers). RB124.  Suggesting that any of those fibers was asbestos would be speculative; assuming all of them were, as Dr. Egilman did, is absurd. Plaintiffs respond with the radical (and scientifically false) assertion that talc fibers are ‘chemically identical’ to anthophyllite asbestos fibers and therefore equivalent. Id. But plaintiffs never argued at trial, much less proved, that talc is identical to asbestos. Indeed, their own expert, Dr. Longo, distinguished between anthophyllite fibers and talc. See Tr.1062.”[11]

We should all sympathize with a litigant that has been abused by absurd opinion testimony. The Court of Appeals took a more insouciant approach:

“Defendants maintain Dr. Egilman’s measurements ‘lacked a reasonable factual basis’ for several reasons. However, their arguments are insufficient to render Dr. Egilman’s testimony inadmissible. ‘[Q]uestions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissbility and should be left for the jury’s consideration.’  Primrose Operating Co. v. Nat’l Am. Ins. Co., 382 F.3d 546, 562 (5th Cir. 2004) (alterations in original) (internal quotations omitted). The problems Defendants cite with Dr. Egilman’s testimony go to the weight of his testimony, not its admissibility.”[12]

Curiously, the Missouri Court of Appeals cited a federal court decision that applied an incorrect standard for evaluating the admissibility of expert witness opinion testimony.[13] It is inconceivable that the validity of the expert witness’s bases, and his inferences therefrom, are beyond the judicial gatekeeper’s scrutiny. If Egilman consulted a mercator projection map, from which he concluded the world was flat, would the Court of Appeals from the “Show Me” state shrug and say show it to the jury?

Perhaps even more remarkable than Longo’s and Egilman’s meretricious mensuration was Egilman’s opinion that personal use of talc more than doubled the plaintiffs’ risk of ovarian cancer. In the meta-analyses of studies of occupational asbestos exposure, the summary risk estimates were well below two.[14]

[1]  SeeSerpentine subgroup,” in Wikipedia.

[2]  Lester Breslow, et al., Asbestiform Fibers: Nonoccupational Health Risks at 7 (Nat’l Research Council 1984).

[3]  Appellants’ Brief at 38, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (Sept. 6, 2019) (Tr. 1171-73).

[4]  Respondents’ Brief at 37, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (Dec. 19, 2019) (Tr.5.3369).

[5]  See, e.g., John F. Gamble & Graham W. Gibbs, “An evaluation of the risks of lung cancer and mesothelioma from exposure to amphibole cleavage fragments,” 52 Regulatory Toxicol. & Pharmacol. S154 (2008).

[6]  Appellants’ Brief at 52.

[7]  Lester Breslow, et al., Asbestiform Fibers: Nonoccupational Health Risks at 3 (Nat’l Research Council 1984).

[8]  Irving John Selikoff, “Statistical Compassion,” 44 J. Clin. Epidemiol. 141S, 142S (1991).

[9]  Ingham v. Johnson & Johnson, Slip op. at 52-53, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (June 23, 2020) (Slip op.).

[10]  See “Ingham v. Johnson & Johnson – Passing Talc Off As Asbestos,” (June 26, 2020).

[11]  Appellants’ Reply Brief at 43, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (Mar. 3, 2020)

[12]  Slip op. at 53.

[13]  SeeJudicial Dodgers – Weight not Admissibility” (May 28, 2020) (collecting authorities).

[14]  See M. Constanza Camargo, Leslie T. Stayner, Kurt Straif, Margarita Reina, Umaima Al-Alem, Paul A. Demers, and Philip J. Landrigan, “Occupational Exposure to Asbestos and Ovarian Cancer: A Meta-analysis,” 119 Envt’l Health Persp. 1211 (2011); Alison Reid, Nick de Klerk, and Arthur W Musk, “Does Exposure to Asbestos Cause Ovarian Cancer? A Systematic Literature Review and Meta-Analysis,” 20 Cancer Epidemiol., Biomarkers & Prevention 1287 (2011).

Ingham v. Johnson & Johnson – Passing Talc Off As Asbestos

June 26th, 2020

In talc exposure litigation of ovarian cancer claims, plaintiffs were struggling to show that cosmetic talc use caused ovarian cancer, despite missteps by the defense.[1] And then lawsuit industrialist Mark Lanier entered the fray and offered a meretriciously beguiling move: Stop trying talc cases and start trying asbestos cases.

The Ingham appellate decision this week from the Missouri Court of Appeals appears to be a superficial affirmation of the Lanier strategy.[2] The court gave defendants some relief on jurisdictional issues, but largely affirmed the admissibility of Lanier’s expert witnesses on medical causation, both general and specific.[3]

After all, asbestos is an established cause of ovarian cancer. Or is it?

In 2006, the Institute of Medicine (now the National Academy of Medicine) addressed extra-pulmonary cancers caused by asbestos, without ever mentioning ovarian carcinoma.[4] Many textbooks and reviews found themselves unable to conclude that asbestos of any type caused ovarian cancer throughout the 20th century and a decade into the 21st century. The world of opinions changed, however, in 2011, when a working group of the International Agency for Research on Cancer (IARC) met in Lyon, France, and issued its support for the general causation claim in a suspect document published in 2012.[5] The IARC has strict rules that prohibit anyone who has any connection with manufacturing industry from serving on its working groups, but the Agency allows consultants and contractors for the lawsuit industry to serve without limitation. The 2011 working group on fibers and dusts thus sported lawsuit industry acolytes such as Peter F. Infante, Jonathan Samet, and Philip J. Landrigan.

Given the composition of this working group, no one was surprised by its finding:

“The Working Group noted that a causal association between exposure to asbestos and cancer of the ovary was clearly established, based on five strongly positive cohort mortality studies of women with heavy occupational exposure to asbestos (Acheson et al., 1982; Wignall & Fox, 1982; Germani et al., 1999; Berry et al., 2000; Magnani et al., 2008). The conclusion received additional support from studies showing that women and girls with environmental, but not occupational exposure to asbestos (Ferrante et al., 2007; Reid et al., 2008, 2009) had positive, though non-significant, increases in both ovarian cancer incidence and mortality.”[6]

The herd mentality is fairly strong in the world of occupational medicine, but not everyone concurred. A group of Australian asbestos researchers (Reid, et al.) without lawsuit industry credentials published another meta-analysis in 2011, as well.[7] Although the Australian researchers reported an increased summary estimate of risk, they were careful to point out that this elevation may have resulted from disease misclassification:

“In the studies that did not examine ovarian cancer pathology, or confirmed cases of mesothelioma from a cancer or mesothelioma registry, misclassification of the cause of death in some cases is likely to have occurred, given that misclassification was reported in those studies that did reexamine cancer pathology specimens. Misclassification may result in an underestimate of peritoneal mesothelioma and an overestimate of ovarian cancer or the converse. Among women, peritoneal mesothelioma may be more likely to be classified as ovarian, colon, or stomach cancer, rather than a rare occupational cancer.”[8]

The authors noted that Irving Selikoff had first reported that a significant number of peritoneal cancers, likely mesothelial in origin, have been misclassified as ovarian cancers. Studies that relied upon death certificates only might thus be very misleading. Supporting the danger of misclassification, the Reid study reported that:

“Only the meta-analysis of those studies that reported ovarian cancer incidence (i.e., those studies that did not rely on cause of death certification to classify their cases of ovarian cancer) did not observe a significant excess risk.”[9]

Reid also reported the absence of other indicia of causation:

“No study showed a statistically significant trend  of ovarian cancer with degree of asbestos exposure. In addition, there was no evidence of a significant trend across studies as grouped exposure increased.”[10]

Other scientists and physicians have acknowledged the controversial nature of the IARC’s determination. In 2011, pathologist Samuel Hammar, who has testified regularly for the lawsuit industry, voiced concerns about the diagnostic accuracy of ovarian cancer cases in asbestos studies:

“It has been difficult to draw conclusions on the basis of epidemiologic studies of ovarian cancers because, histologically, their distinction between peritoneal mesothelioma and carcinomatous peritonei (including primary peritoneal serous papillary adenocarcinoma) is difficult. Ovarian tumors tend to grow by extension and uncommonly metastasize through the bloodstream, which is similar to tumors of mesothelial origin … .”[11]

In 2014, a working group of the Finnish Institute of Occupational Health noted that “despite the conclusions by IARC and the support from recent studies, the hypothesis that asbestos is [a] cause of ovarian cancer remains controversial.”[12] The same year, 2014, the relevant chapter in a leading textbook by Dr. Victor L. Roggli and colleagues opined that:

“the balance of the evidence available at present does not support an association between asbestos exposure and cancers of the female reproductive system.”[13]

Two years later, a text by Dr. Dorsett D. Smith cited “the lack of certainty of the pathologic diagnosis of ovarian cancer versus a peritoneal mesothelioma in epidemiologic studies” as making the epidemiology uninterpretable and any conclusions impossible.[14]

Against this backdrop of evidence, I took a look at what Johnson & Johnson had to say about the occupational asbestos epidemiology in its briefs, in section “B. Studies on asbestos and ovarian cancer.”[15] The defense acknowledged that plaintiffs’ expert witnesses Drs. Jacqueline Moline and Dean Felsher focused on the IARC conclusion, and on studies of heavy occupational exposure. J & J recited without comment or criticism what plaintiffs’ expert witnesses had testified, much of which was quite objectionable.[16]

For instance, Moline and Felsher both reprised the scientifically and judicially debunked views that there is “no known safe level of exposure,” from which they inferred the non-sequitur that “any amount above ordinary background levels – could cause ovarian cancer.”[17] From ignorance, nothing derives but conjecture.

Another example was Felsher’s testimony that asbestos can make the body of an ovarian cancer patient therapy-resistant. In response to these and other remarkable assertions, J & J countered with only the statement that their expert witness, Dr. Huh, “did not agree that all of this was true in the context of ovarian cancer.”[18]

Huh, indeed; that the defense expert witness disagree with some of what plaintiffs’ witnesses claimed hardly frames an issue for exclusion of any expert witness’s opinion. Even more disturbing, there is no appellate point that corresponds to a motion to exclude Dr Moline’s testimony.

The Egilman Challenge

There was a challenge to the testimony of another expert witness, David Egilman, a frequent testifier for Mark Lanier and other lawsuit industrialists. One of the challenges that the defendants made on appeal to the admissibility of Dr. David Egilman’s testimony was his use of a 1972 NIOSH study that apparently quantified exposure in terms of fibers per cubic centimeter, without specifying whether all fibers in the measurement were asbestos fibers, as opposed to non-asbestos fibers, including talc fibers.

The Missouri Court of Appeals rejected this specificc challenge in part because Egilman had explained that:

“whether the 1972 NIOSH study identified fibers specifically as ‘asbestos’ was inconsequential, as the only other possible fiber that could be present in a talc sample is a ‘talc fiber, which is chemically identical to anthophyllite asbestos and structurally the same’.”[19]

Talc typically crystallizes in small plates, but it can occur occasionally as fibers. Egilman, however, equated a talc fiber as chemically and structurally identical to an anthophyllite fiber.

Does Egilman’s opinion hold water?

No, Egilman has wet himself badly (assuming the Missouri appellate court quoted testimony accurately).

According to the Mineralogical Society of America’s Handbook of Mineralogy (and every other standard work on mineralogy I reviewed), anthophyllite and talc, whether in fibrous habit or not, are two different minerals, with very different chemical formulae, crystal chemistry, and structure.[20] Anthophyllite has the chemical formula: (Mg;Fe2+)2(Mg;Fe2+)5Si8O22(OH)2 and is an amphibole double chain silicate. Talc, on the other hand, is a phyllosilicate, a hydrated magnesium silicate with the chemical formula Mg3Si4O10(OH)2. Talc crystallizes in the triclinic class, although sometimes monoclinic, and crystals are platy and very soft.

If the Missouri Court of Appeals characterized Egilman’s testimony correctly on this point, then Egilman gave patently false testimony. Talc and anthophyllite are different chemically and structurally.

[1]  SeeThe Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations”; “The Slemp Case, Part 2 – Openings”; “ Slemp Trial Part 3 – The Defense Expert Witness – Huh”; “Slemp Trial Part 4 – Graham Colditz”; “ Slemp Trial Part 5 – Daniel W. Cramer”; “Lawsuit Magic – Turning Talcum into Wampum”; “Talc Litigation Supported by Slippery Expert Witness” (2017).

[2]  Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (June 23, 2020) (Slip op.).

[3]  Cara Salvatore, “Missouri Appeals Court Slashes $4.7B Talc Verdict Against J&J,” Law360 (June 23, 2020).

[4]  Jonathan M. Samet, et al., Asbestos: Selected Cancers Effects (I.O.M. Committee on Asbestos 2006).

[5]  International Agency for Research on Cancer, A Review of Human Carcinogens, Monograph Vol. 100, Part C: Arsenic, Metals, Fibres, and Dusts (2012).

[6]  Id. at 256. Some members followed up their controversial finding with an attempt to justify it with a meta-analysis; see M. Constanza Camargo, Leslie T. Stayner, Kurt Straif, Margarita Reina, Umaima Al-Alem, Paul A. Demers, and Philip J. Landrigan, “Occupational Exposure to Asbestos and Ovarian Cancer: A Meta-analysis,” 119 Envt’l Health Persp. 1211 (2011).

[7]  Alison Reid, Nick de Klerk, and Arthur W Musk, “Does Exposure to Asbestos Cause Ovarian Cancer? A Systematic Literature Review and Meta-Analysis,” 20 Cancer Epidemiol., Biomarkers & Prevention 1287 (2011) [Reid].

[8]  Reid at 1293, 1287.

[9]  Id. at 1293.

[10]  Id. at 1294.

[11]  Samuel Hammar, Richard A. Lemen, Douglas W. Henderson & James Leigh, “Asbestos and other cancers,” chap. 8, in Ronald F. Dodson & Samuel P. Hammar, eds., Asbestos: Risk Assessment, Epidemiology, and Health Effects 435 (2nd ed. 2011) (internal citation omitted).

[12]  Finnish Institute of Occupational Health, Asbestos, Asbestosis and Cancer – Helsinki Criteria for Diagnosis and Attribution 60 (2014) (concluding that there was an increased risk in cohorts of women with “relatively high asbestos exposures”).

[13]  Faye F. Gao and Tim D. Oury, “Other Neoplasia,” chap. 8, in Tim D. Oury, Thomas A. Sporn & Victor L. Roggli, eds., in Pathology of Asbestos-Associated Diseases 177, 188 (3d ed. 2014).

[14]  Dorsett D. Smith, The Health Effects of Asbestos: An Evidence-based Approach 208 (2016).

[15]  Brief of Appellants Johnson & Johnson and Johnson & Johnson Consumer Inc., at 29, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (filed Sept. 6, 2019) [J&J Brief].

[16]  Id. at 30.

[17]  See Mark A. Behrens & William L. Anderson, “The ‘Any Exposure’ Theory: An Unsound Basis for Asbestos Causation and Expert Testimony,” 37 SW. U. L. Rev. 479 (2008); William L. Anderson, Lynn Levitan & Kieran Tuckley, “The ‘Any Exposure’ Theory Round II — Court Review of Minimal Exposure Expert Testimony in Asbestos and Toxic Tort Litigation Since 2008,” 22 Kans. J. L. & Pub. Pol’y 1 (2012); William L. Anderson & Kieran Tuckley, “The Any Exposure Theory Round III: An Update on the State of the Case Law 2012 – 2016,” Defense Counsel J. 264 (July 2016); William L. Anderson & Kieran Tuckley, “How Much Is Enough? A Judicial Roadmap to Low Dose Causation Testimony in Asbestos and Tort Litigation,” 42 Am. J. Trial Advocacy 38 (2018).

[18]  Id. at 30.

[19]  Slip op. at 54.

[20]  John W. Anthony, Richard A. Bideaux, Kenneth W. Bladh, and Monte C. Nichols, Handbook of Mineralogy (Mineralogical Soc’y of America 2001).

Legal Remedies for Suspect Medical Science in Products Cases – Part Two

June 3rd, 2020

The Federal Multi-District Silicosis Proceedings Before Judge Janis Jack

One of the most significant developments in the role of scientific and medical evidence gatekeeping under Rule 702, and the Supreme Court’s decision in Daubert,[1] was the 2005 opinion of Judge Janis Graham Jack in the multi-district silicosis litigation.[2] Judge Jack’s lengthy opinion addresses a variety of procedural issues, including subject matter jurisdiction over some of the cases, but Her Honor’s focus was “whether the doctors who diagnosed Plaintiffs with silicosis employed a sufficiently reliable methodology for their testimony to be admissible” and “whether Plaintiffs’ counsel should be sanctioned for submitting unreliable diagnoses and failing to fully comply with discovery orders.”  Judge Jack held that thousands of diagnoses of silicosis were radically flawed and could not be treated as proper science or medicine, and she imposed sanctions against plaintiffs’ lawyers in the cases over which she had subject matter jurisdiction.

In summary, Judge Jack held that to pass the minimum reliability analysis under Daubert, a diagnosis of silicosis requires:

“(1) an adequate exposure to silica dust with an appropriate latency period,

(2) radiographic evidence of silicosis, and

(3) the absence of any good reason to believe that the radiographic findings are the result of some other condition (i.e., a differential diagnosis).

* * * * *

As discussed above, these three criteria are universally accepted, as demonstrated by learned treatises and experts in the field.  It is the implementation of these criteria in these cases which ranged from questionable to abysmal.”[3]

With respect to the first criterion, evidence of “adequate exposure to silica dust with an appropriate latency period,” the court concluded that “[t]he ‘exposure histories’ (or ‘work histories’) were virtually always taken by people with no medical training, who had significant financial incentives to find someone positive for exposure to silica (or asbestos, depending on which type of suit the employing law firm was seeking to file).”[4]  The court went on to state that:

“[t]hese ‘histories’ were devoid of meaningful details, such as the duration and intensity of exposure, which are critical to determining whether someone has sufficient exposure, dosage and latency to support a reliable diagnosis.”[5]

Judge Jack, who had been a registered nurse before going to law school and becoming a lawyer, was clearly concerned that the medical “histories were taken by receptionists [at medical screening companies allied with plaintiffs’ counsel] with no medical training.”[6]  The head of one of the screening companies “testified that the doctors who worked for his screening company simply relied upon the abbreviated work histories that [the screening company] supplied them.”[7]  As a former nurse, Judge Jack was probably more than a little put off by the screening company executive’s explanation that “to ask the doctor to take a work history in our field would be like asking [the defense attorney questioning him] to wash my car.  I mean it’s . . . very beneath him.”[8]  Judge Jack rejected this approach entirely, and found that legitimate doctors would find it necessary to take the occupational history themselves:

“This type of thorough, detailed, physician-guided work/exposure history is the kind of history that experts in the field of occupational medicine insist upon when diagnosing silicosis.  It is therefore the type of history required by the Federal Rules for these diagnoses to be admissible.  Cf. Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198 (5th Cir. 1996)… .”[9]

The second required predicate for an admissible diagnosis of silicosis was an appropriate radiographic finding – a so-called “B-read,” which is simply the interpretation of a physician, who has passed a certifying proficiency examination given by the National Institute of Occupational Health, for evaluating chest films for pneumoconiosis, using a standardized scale and notations.  Judge Jack discerned, contrary to the approach taken by some of the plaintiffs’ lawyers and certain doctors, that a positive B-read was not “a talisman that would dispel any doubts about the diagnoses as a whole.”[10]  A positive B-read simply is not sufficient alone to support a silicosis diagnosis.

Judge Jack noted that a consensus report of the American College of Occupational and Environmental Medicine rejected the use of a B-read alone as sufficient to support a diagnosis of pneumoconiosis, and emphasized the views of one testifying physician that the “ILO guidelines, by their express terms, [were] ‘not supposed to be used for designation of disease or determining compensation.’ ”[11] But even apart from rejecting the concept that a positive B-read was by itself a sufficient basis for a diagnosis of silicosis, Judge Jack fundamentally criticized the manner in which the X-rays at issue were conducted.

The B-reader system was not originally established for use in litigation, but as part of a coal workers’ surveillance program to determine whether a worker should be transferred to a low-dust environment.  And under this surveillance program, the worker is not transferred until at least two B-readers agree on a positive read.  But in most of these MDL cases, a single positive B-read was deemed sufficient by plaintiffs’ hired witnesses to establish a diagnosis of silicosis.[12]

Judge Jack also stressed that the methodology followed by the B-readers did “not correspond to the ILO’s recommended methodology for applying the ILO classification system, because according to ILO guidelines:

“When classifying radiographs for epidemiological purposes it is essential that the reader does not consider any information about the individuals concerned other than the radiographs themselves.  Awareness of supplementary details specific to the individuals themselves can introduce bias into the results.”[13]

In the cases before her, Judge Jack found that it was obvious that the so-called B-reader was “acutely aware of the precise disease he is supposed to be finding on the X-rays.  In these cases, the doctors repeatedly testified that they were told to look for silicosis, and the doctors did as they were told.”[14] Business pressures had obviously corrupted the diagnostic process, and resulted in improbable consistency in finding silicosis in whomever plaintiffs’ lawyers signed up for litigation.

This corrupt consistency, and obediency to retaining plaintiffs’ counsel, which led to Judge Jack’s approval of the testimony from the hearings that advanced the notion that some degree of blinding is needed to assure the integrity of the diagnostic process. When the radiographic films come from a mass screening, the readers should be confronted with films known to be negative through multiple, independent evaluations.

The third criterion given by Judge Jack for an admissible diagnosis of silicosis, was a proper “differential diagnosis,” which consisted of a showing of “the absence of any good reason to believe that the positive radiographic findings are the result of some other condition.”[15]

One of the physicians whose diagnoses were challenged claimed that this ruling out of other explanations for a radiographic pattern was not required for diagnosing silicosis, but Judge Jack found that this self-serving opinion was contradicted by the major textbooks in the field, by the physicians who showed up to testify in the hearings, and even by the plaintiffs’ own briefs. Judge Jack adverted to the language of Daubert to note that one factor to be considered in the “reliability” of an expert witness’s opinion was its general acceptance in the relevant scientific community.[16] The self-validating views of plaintiffs’ expert witnesses simply were not generally accepted in any legitimate segment of the medical profession. And thus Judge Jack found that, in the MDL cases, the plaintiffs’ expert witnesses’ failure to exclude other alternative causes of the radiographic findings clearly was not generally accepted in the field of occupational medicine, and that their opinions did not satisfy the requirements of Rule 702.[17] A proper differential diagnosis required what was lacking across the board in the cases, namely “a thorough occupational/exposure history and medical history,” as well as a social history that included travel destinations.[18]

In addition to Judge Jack’s carefully reasoned conclusions about the diagnostic “process” used by the challenged expert witnesses, Her Honor was presented with additional evidence of the egregious infirmity of the challenged diagnoses:

– The willingness of one doctor to render opinions on 1,239 plaintiffs in the MDL when he was admittedly not a qualified B-reader, not an expert in silicosis treatment, not qualified to read X-rays or CT scans, did no physical examinations, simply took whatever histories had been given to him by the plaintiffs’ lawyers, and spent a negligible amount of time reviewing each of the plaintiffs’ files.  The doctor testified that his practice consists almost entirely of litigation consulting and that he charges $600 per hour for that work.

– Another doctor’s abandonment of about 3,700 diagnoses under the scrutiny generated by the hearings before Judge Jack.

– The fact that 1,587 claimants who had previously been listed as having asbestosis, with no reference to silica disease, had their diagnoses changed to silicosis, with no reference to asbestos disease.  These diagnoses were produced rapidly and in large groups.

– The fact that a purported epidemic of silicosis apparently began abruptly in early 2001, when plaintiffs’ lawyers turned their attention to this alternative to asbestos litigation, and the fact that many of the silicosis claimants were recycled asbestosis clients of the plaintiffs’ firms.

The specific facts before Judge Jack may seem extreme, but the same or similar abuses have been commonplace in asbestos litigation for a long time before they were outed in the silicosis MDL.  The crucial holdings of In re Silica go beyond the serious depravity of the expert witnesses involved.

Raymark v. Stempel

In 1990, one now defunct asbestos product manufacturer, Raymark Industries, Inc. (“Raymark”), deluged with dubious lawsuits, brought RICO and other claims against medical professionals, lawyers, and claimants.[19]  Raymark based its allegations on deceptions that led it to settle an asbestos personal injury class action.

In ruling upon defendants’ motions to dismiss, the district court found that defendant medical screeners had disregarded standards set by the American Thoracic Society and reported that workers had asbestos-related “injuries” even thought the radiographic interpretations had no clinical significance.  The court stated that the screening program had produced a “steady flow of faulty claims” and was a “fraud on the court.”[20]  The court thus refused to dismiss Raymark’s claims based on common law fraud and RICO violations.[21]

Owens Corning Fiberglass Bankruptcy Proceedings

The efforts to curtail frivolous asbestos claims also include the motion by Credit Suisse in the Owens Corning bankruptcy for leave to file an adversary complaint against certain physicians who reported chest radiographs as positive for asbestos-related diseases.  This motion was granted conditionally on the agreement of Credit Suisse to indemnify Owens Corning for any potential ensuing liability, but then was withdrawn when Credit Suisse declined to provide such assurance.

[1]  Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).

[2]  In re Silica Products Liab.Litig., 398 F.Supp. 2d 563 (S.D.Tex. 2005) (“In re Silica”).

[3]  In re Silica. at 622 (internal citations and footnote omitted).

[4]  In re Silica, at 622 -23.

[5]  Id.

[6]  Id.

[7]  Id.

[8]  Id.

[9]  In re Silica, at 623-34.

[10]  In re Silica, at 625 – 26.

[11]  Id. at 626 – 27 (internal quotes omitted).

[12]  Id. at 626.

[13]  Id.

[14]  Id. at 627.

[15]  Id. at 629.

[16]  Id. at 629 – 30 (citing Daubert, 509 U.S. at 593-94; Pipitone v. Biomatrix, Inc., 288 F.3d 239, 246 (5th Cir. 2002) (upholding admissibility under Rule 702 when a physician’s “elimination of various alternative causes. . . .were [sic] based on generally accepted diagnostic principles related to these conditions”).

[17]  Id. at 629 – 30.

[18]  Id. at 630 – 32 (coccidioidomycosis is endemic to some parts of the United States and resembles silicosis radiographically).

[19]  Raymark Indus., Inc. v. Stemple, 1990 WL 72588 (D. Kan., May 30, 1990).

[20]  1990 WL 72588 at *2, *8, *18, *22.

[21] See Nathan Schachtman, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Sem. Roentgenology 140 (1992) (discussing Semple in greater detail). It is unclear how Stemple was ultimately resolved.  The court’s docket does not indicate whether this case was dismissed, voluntarily, involuntarily, as a result of settlement, or otherwise.  The clerk of the court reported that this case was sealed under court order.