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Big Blue versus Asbestos Fiber Type Egalitarianism

July 16th, 2020

The differential potency for causing mesothelioma among asbestos varieties is well established. In the year 2000, John Hodgson of the Epidemiology and Medical Statistics Unit, in the British Health and Safety Executive, published an analysis of the relative potency for different asbestos minerals. The published analysis showed that the estimated ratio of excess mesothelioma mortality for the same exposure in fiber/milliliter – years was 1:100:500 for chrysotile, amosite and crocidolite, respectively.[1] The analysis was recently updated by David Garabrant, who charitably considered some mixed exposure cohorts as chrysotile only,[2] with the result of slightly less extreme relative risks for amosite and crocidolite.[3]

The lawsuit industry’s expert witnesses have long been afraid to acknowledge the differential potency of chrysotile (with or without tremolite contamination) and the commercial amphibole fibers, amosite and crocidolite.[4] Why? First, by lumping the fiber types together, they obtain risk ratios for mesothelioma for all workers, regardless of the nature of their specific exposures. Their quest to seek compensation and obtain bans of all asbestos works better by simplification and exaggeration of risk. Second, they knew in the early days of the asbestos litigation in the United States that the South African amphibole suppliers were beyond the reach of courts and litigants in American courts. They were alert to the litigation risk that the Canadian mining companies would escape liability because the overwhelming bulk of the risk derived from South African amphibole fiber. Later cases involved chrysotile-only products that did not cause the level of exposures seen from friable insulation and cloth materials. A differential in risk for low-exposure chrysotile products raised serious questions whether such products could contribute substantially to a given case of mesothelioma, for which there was also exposure to amosite and crocidolite. Interestingly, some companies, concerned about losing contribution from low-exposure chrysotile products, took similar positions. Third, the exaggerated risks of all fibers helps advance their “each and every fiber” (or cumulative) causation theory, which they invoke to claim that even fleeting exposures from asbestos-containing products are “substantial contributing factors.” Consider how that argument goes when one product is akin to drinking 750 ml. of whiskey, and another is the equivalent of 1.5 ml. A man drinks a fifth of whiskey at one bar, and a thimble full of whiskey at the second. Most juries can see that the thimble was not substantial factor in contributing to the man’s drunkenness. Still, if you were the company that sold the whole bottle, you would love to have the thimble seller pay a 50% share; no? If you were the drunkard, and the seller of the bottle of whiskey was now a “bankruptcy trust,” obtaining a pro-rate share against the thimble seller would be lovely.

The extent to which crocidolite asbestos contributed to the horrific burden of mesothelioma was muddled by the writings of Irving John Selikoff. Before Selikoff wrote anything about any asbestos type and cancer, in 1960, in a remarkable case series, Christopher Wagner and colleagues showed a strong relationship between mesothelioma and crocidolite (blue) asbestos. Selikoff may not have had any first-hand knowledge of the unique potency of “big blue,” but he had been a regular testifier in workman’s compensation cases for UNARCO (Union Asbestos & Rubber Company) workers throughout the 1950s.[5]

In a 1965 volume, which Selikoff edited, of proceedings of a 1965 conference, which which Selikoff chaired, Selikoff presented United States Department of Commerce statistics that showed for six years reported (1957-1962), crocidolite imports exceeded amosite imports.[6] In that same year, 1965, in a prominent article in the New England Journal of Medicine, Selikoff played down the role in causing mesotheliomas in the United States.[7]

“Crocidolite is a relative newcomer to the American asbestos-industry scheme. Thus, American imports of crocidolite (none is mined here) were less than 500 tons in 1935 and had reached a level of only 20,000 tons even in 1962. In contrast, chrysotile, the type of asbestos fiber widely used in the American asbestos industry, was imported at a level of 165,000 tons in 1935 and 650,000 tons in 1962.5”

Selikoff thus chose to paint the mesothelioma problem as a dichotomy between blue asbestos and chrysotile, while leaving amosite out of the analysis completely. Indeed, the word “amosite” (or the word grunerite) does not appear in the New England Journal of Medicine article .

Aside from misleadingly framing the South Africa experience as limited to blue asbestos, and the United States experience as somehow limited to chrysotile, Selikoff presented the import statistics for amosite and crocidolite in a rather confusing way. In 1972, Selikoff presented a more revealing set of statistics about amphibole fiber imports, in the context of discussing whether amosite was carcinogenic (despite testifying in the UNARCO cases two decades earlier):

“Few data exist concerning the comparative neoplastic potential of the several kinds of asbestos in man. Some information is available for chrysotile,4 crocidolite,5 and anthophyllite.6 However, there has been no evidence to indicate whether or not the amosite variety is also carcinogenic.”[8]

Selikoff went on, in this 1972 article, to present more complete data on fiber type consumption in the United States, although still only estimates:

The 1972 article raises interesting questions about Selikoff’s own testimony in the 1950s New Jersey workman’s compensation cases on behalf of UNARCO workers.  Table 1, reproduced above from Selikoff’s 1972 article, also throws considerable doubt upon generalizations about what fiber types were commercially used by insulators and others throughout the 20th century, in the United States. We can see that for 1920 and 1925, there is an “other” category, which could be virtually anything, and no data about South African fibers, which could mean none or it could mean simply no data available. In 1930, 1935, and 1940, there are data for crocidolite and amosite combined. Throughout the 1930s, the “other” category grew considerably, introducing serious ambiguity and doubt into Selikoff’s argument. Selikoff’s 1965 article in the New England Journal of Medicine gave a distorted view of the supply issue, but to my knowledge, it has never been corrected.

From Table 1, above, we see crocidolite and amosite data segregated for the first time in 1945. And for that year, the supply of crocidolite (8,700 tons) was almost twice that of amosite (4,500 tons). There was certainly no warrant for claiming that insulators and American factory workers had no amosite or crocidolite exposure before and after World War II.

While these confusions were being put forward, other countries were acting to control the occupational hazards of asbestos by differentially banning crocidolite, and imposing stricter controls on chrysotile. Selikoff led the United States in a different direction. The photograph and text below is from the May 1966 issue of the Port of Houston Magazine, showing how blue asbestos was continuing to invade the United States, while Selikoff and many of his colleagues were pointing to chrysotile.

Port of Houston Magazine 21 (May 1966)

In a 1968 conference presentation, with the benefit of hindsight, Selikoff addressed the issue of the forseeability of widespread asbestos disease:

“At the outset of this presentation, I questioned whether asbestos might properly be included as an unanticipated environmental hazard. Yet the less iconoclastic among us might have countered with: it must have been-we could not have knowingly allowed this to come to pass! Surely the explanation lies in the length of the period that elapses between exposure and disease which kept us from really knowing the problem until now.

Perhaps so. Indeed, I do not share the demonological theory of industrial hygiene history, in which industry is seen as callously exchanging human disease for profits. Rather, I would say industry shared the ignorance and lethargy of us all. The answer will come in these next several years. We have some reason for optimism. First, we have the law of averages on our side-sooner or later, some important environmental hazard is bound to be controlled. I suspect asbestos will be one. We have reason to believe that the dose-disease relationship is on our side-to the present, disease has been uncommon except with significant exposure. And our data suggest further that such significant exposure can be prevented, that we can learn to live and work with asbestos. All it will take is the doing -but herein lies another tale.”[9]

Selikoff’s position was especially generous to manufacturers who had used crocidolite after 1960, when Wagner alerted the community to para-occupational mesothelioma cases from blue asbestos exposure. Selikoff’s dismissal of the problem of blue asbestos as somehow a problem of English workers allowed the reality of blue asbestos use to be ignored, and then hidden with the myth of equal potency among all asbestos types. Twenty years after Selikoff’s New England Journal of Medicine article, no less an authority than Dr. Harriet Hardy would refer to mesothelioma as

 “A fatal malignancy [mesothelioma] associated with inhalation of a single form (crocidolite) of asbestos invaded the chest wall (pleura) and/or the abdominal wall.”[10]

It is time to acknowledge the harm caused by asbestos fiber type egalitarianism.

[1]  John T. Hodgson & Andrew A. Darnton, “The quantitative risks of mesothelioma and lung cancer in relation to asbestos exposure,” 14 Ann. Occup. Hygiene 565 (2000).

[2]  Misty J Hein, Leslie T Stayner, Everett Lehman & John M Dement, “Follow-up study of chrysotile textile workers: cohort mortality and exposure-response,” 64

Occup. & Envt’l Med. 616 (2007).

[3]  David H. Garabrant & Susan T. Pastula, “A comparison of asbestos fiber potency and elongate mineral particle (EMP) potency for mesothelioma in humans,” 361 Toxicology & Applied Pharmacol. 127 (2018) (“relative potency of chrysotile:amosite:crocidolite was 1:83:376”). See also D. Wayne Berman & Kenny S. Crump, “Update of Potency Factors for Asbestos-Related Lung Cancer and Mesothelioma,” 38(S1) Critical Reviews in Toxicology 1 (2008).

[4]  “Playing Hide the Substantial Factors in Asbestos Litigation” (Sept. 27, 2011); “Selikoff and the Mystery of the Disappearing Amphiboles” (Dec. 10. 2010).

[5]  “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014); “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

[6]  App. 3, Statistical Tables – Asbestos, prepared by T. May, United States Bureau of Mines, in I.J. Selikoff & J. Churg, eds., “Biological Effects of Asbestos,” 132 Ann. N.Y. Acad. Sci. at 753, Table 17 (1965).

[7]  Irving J. Selikoff, Jacob Churg, and E. Cuyler Hammond, Relation Between Exposure to Asbestos and Mesothelioma, 272 New Engl. J. Med. 560 (1965).

[8]  Irving John Selikoff, E. Cuyler Hammond & Jacob Churg, “Carcinogenicity of Amosite Asbestos,” 25 Arch. Envt’l Health 183, 183 (1972). The article contains no disclosure of conflicts of interest, despite Selikoff’s testifying role in UNARCO and other asbestos cases for claimants.

[9]  Irving John Selikoff, “Asbestos” 11 Environment 3, 7 (Mar. 1969) (presented at the Symposium on “Unanticipated Environmental Hazards Resulting from Technological Intrusions,” held by the American Association for the Advancement of Science Committee on Science in the Promotion of Human Welfare and the Scientists’ Institute for Public Information, at Dallas, Texas, on Dec. 28, 1968).

[10]  Harriet Hardy, M.D., Challenging Man-Made Disease:  The Memoirs of Harriet L. Hardy, M.D. 95 (1983). See also “Harriet Hardy’s Views on Asbestos Issues” (Mar. 13, 2013).

Posted in Asbestos, Historian Testimony, State of the Art | Comments Off on Big Blue versus Asbestos Fiber Type Egalitarianism

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).

Posted in Asbestos, Conflicts of Interest | Comments Off on The Lobby – Cut on the Bias

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]  See “Serpentine 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]  See “Judicial 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).

Posted in Asbestos, Expert Witnesses, Rule 702 | Comments Off on Ingham v. Johnson & Johnson – A Case of Meretricious Mensuration?

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]  See “The 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).

Posted in Asbestos, Causation, Conflicts of Interest, Rule 702 | Comments Off on Ingham v. Johnson & Johnson – Passing Talc Off As Asbestos

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.

Posted in Asbestos, Expert Witnesses, Rule 702, Silica | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part Two

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

June 2nd, 2020

Expert witness opinions about the nature and cause of plaintiffs’ medical conditions, are the linchpin of mass tort cases involving claims of bodily injury from allegedly harmful products.  The quality of these expert witness opinions has long been the subject of debate, but the explosion of products liability cases has brought increasing scrutiny, especially in cases involving asbestos, silica, and pharmaceutical claims.[1]

Courts, Congress, and commentators have raised concerns about the scientific and medical validity of the opinions offered in support of certain product liability claims, whether certain of the individuals who offer such opinions have a proper degree of independence from the lawyers representing the plaintiffs, and whether there is any way to address these questions apart from a rejection of the individual claims in which the bogus opinions are offered.  Famously, Judge Janis Jack of the United States District Court for the Southern District of Texas addressed these issues in a lengthy decision in which she excoriated physicians, medical screeners, and plaintiffs’ lawyers who she concluded had transgressed basic ground rules of medical and legal propriety in connection with silicosis claims.[2]

The stakes generated by the availability of these medical/technical opinions are especially high in mass torts that involve medical assessments of thousands of claimants.  The pendency of asbestos claims has driven well over 100 companies into bankruptcy, and with that example, any industry facing a substantial wave of repetitive liability claims must be concerned about how to respond to what it believes are false or unfounded claims. Clients ask whether there are remedies for the promotion of false, fraudulent, or just inadequate medical science under the banner of seeking compensation in products liability cases. The answers remain less than clear.

Some Past Attempts to Remedy the Harm from Dubious Science in Products Cases

GAF’s Litigation against the Asbestos Lawsuit Industry

On January 10, 2001, G-I Holdings Inc., the successor to GAF Corporation (“GAF”), filed suit against a group of asbestos personal injury lawyers who it alleged had “orchestrated a scheme to inundate the judicial system with hundreds of thousands of asbestos cases without regard to their merit.”[3] Among the allegations were claims that the plaintiffs’ firms had “suborned perjury and fabricated evidence” and “induced expert witnesses to provide false and misleading testimony, all for the purpose of extracting unwarranted and inflated settlements, judgments and, correspondingly, attorneys’ fees, from GAF and other asbestos defendants.”  The complaint alleged that, in 1978, a group of

“approximately 125 plaintiffs’ asbestos contingency fee attorneys banded together to form and fund the Asbestos Litigation Group (“ALG”) in order to further their scheme of promoting asbestos litigation.”  GAF asserted that “acting jointly through the ALG, and through less formal asbestos-related organizations, defendants, upon information and belief, solicited tens of thousands of asbestos claimants and sued manufacturers without regard for, or in conscious disregard of, the merits of their claims against particular individual defendants such as GAF. . . . .pursuant to agreements with each network [of local counsel] member, a share of the fees . . . .is typically channeled back to the referring ALG member, and ultimately to the ALG, to be invested  in future claimant solicitations, including mailed advertisements in newsletters.  This has resulted in the filing of further claims, thereby continuing the scheme, and increasing the network, which spirals ever larger.”

GAF’s complaint specifically included claims relating to the alleged “fabricat[ion]” of “medical evidence.”  In this regard, GAF alleged, upon information and belief, that the plaintiffs’ lawyers had:[4]

  1. . . . .induced medical “experts” to testify falsely. As set forth in the “Toxic Justice” report, [the plaintiffs’ law firm] paid off what one of the firm’s paralegals described as “whore docs” i.e., doctors who for money eagerly attributed virtually any lung abnormality to asbestos exposure, regardless of what medical evidence actually showed.

And GAF complained that:

  1. . . . . these practices induced false and misleading testimony to be given by expert witnesses in support of claims brought against GAF and others, which resulted in GAF’s payment of inflated verdicts and settlements in a number of cases.

While much of GAF’s complaint did not focus specifically on the quality of the medical evidence, it is nonetheless instructive as an overall perspective on the factual framework within which these medical issues arise. GAF’s complaint understandably focused heavily on defendant’s Baron & Budd’s memorandum, entitled “Preparing for Your Deposition.”  GAF alleged that this

“memorandum, apparently created for use in preparing asbestos plaintiffs for deposition, improperly exhorts witnesses to testify in a pre-scripted manner, regardless of the truth.”

For particularity’s sake, GAF alleged, with extensive quotations from the Baron & Budd memorandum, that the memorandum told

“witnesses to identify only those products listed on the Work History Sheets prepared by Baron & Budd (lest the witness identify the product of a bankrupt entity from whom no damages or attorneys’ fees could be collected). . . .and to memorize the product names provided by Baron & Budd on the “Work History Sheets” and to testify that they actually saw those names on containers where they worked. . . .”[5]

The complaint alleges that the memorandum gave further improper instructions to plaintiffs about their testimony, including directions to omit any mention of exposures resulting “from the replacement or removal of old product that could not be identified by brand”; making false claims of “equal exposure to all products”; denying “that they ever saw any warnings or had knowledge concerning the harmful effects of asbestos.”

GAF alleged a variety of other concerted actions to file false asbestos claims.  These activities allegedly included withholding “from production in discovery death certificates for asbestos claimants that did not support the conclusion that the individual had died as a result of an asbestos-related disease”; conducting “periodic in-house training sessions to teach other attorneys and/or paralegals how to prepare all asbestos claimants to give scripted testimony in their depositions. . . . .without regard for whether or not the testimony was true”; participating in a scheme to falsify Court records to indicate that complaints were filed before the running of the statute of limitations; and submitting affidavits containing false information concerning the identity of products.

The complaint also contained a number of allegations to the effect that the defendant law firms had “used their considerable resources and power in an attempt to intimidate and deter GAF (and others) from exercising their constitutionally protected rights to petition Congress in support of legislation that would establish a fair and efficient administrative facility for resolving legitimate asbestos claims without the years of delay and wasteful fees and transaction costs that are characteristic of the current system.  Defendants have waged a full-scale, multi-front war against those seeking passage of a Congressional bill entitled the “Fairness in Asbestos Compensation Act.”

The suit pled claims under the Racketeer Influenced and Corrupt Organizations Act (“RICO”),[6] and under numerous other headings of state, and federal, law.[7]  The lawsuit industry defendants brought a series of motions to dismiss on the pleadings, with successive amended complaints filed, until there was nothing left of GAF’s complaint.[8]  For example, part of the case – relating to the Baron & Budd memorandum discussed above — pleaded fraud based on information and belief.  Judge Sweet dismissed that aspect of the fraud claims on the grounds that Federal Rule of Civil Procedure 9(b) requires that allegations of fraud be pleaded with specificity and that the plaintiff must provide a statement of facts upon which the belief of the existence of fraud is founded.  Judge Sweet concluded that GAF had repeatedly failed to meet this requirement.

Federal and State Prosecutions against Physicians and Screening Companies

After Judge Jack’s exposé of fraudulent and false diagnoses in the silicosis MDL, various news media reported that the United States Attorney’s office in the Southern District of New York was investigating possible criminal charges against the physicians and lawyers who orchestrated the screenings. Historically, there has been little interest among prosecutors in the questionable activities of screening physicians, with some notable exceptions.  In 1990, the United States Attorney’s office, for the Eastern District of Philadelphia, filed a civil RICO against several Philadelphia-area physicians for their role in submitting false and fraudulent Medicare claims.[9]  As pleaded by the government, the fraudulent scheme consisted of soliciting industrial workers for “free” lung screening, at the behest of lawyer clients, for asbestos-related diseases.  The physicians conducted radiologic and pulmonary function examinations, and submitted requests to Medicare for reimbursement of inflated costs for these services and falsely stated that the services were reasonably medically necessary because of diagnoses of chronic obstructive pulmonary disease.[10]  This matter appears to have been resolved before trial, although the docket fails to reveal the exact nature of the resolution.

The false claim problem continues, although the silicosis screenings have abated, and most asbestos plaintiffs’ lawyers have shifted their efforts to the high-yield mesothelioma and lung cancer cases, for which diagnostic accuracy is not typically the dominant issue. Some within the lawsuit industry appear to continue the practice of referring clients to friendly physicians for an examination that will form the basis of a lawsuit, with the consulting physician in turn filing a request for reimbursement with the claimant’s private or public health insurer.  For most insurers, such a claim for reimbursement impliedly represents that the services were reasonably medically necessary, and sometimes the services may well be necessary.  At other times, the services are redundant and provided only for purposes of preparing the examining physician to serve as an expert witness.  In a case I tried early in my career, the testifying expert witness first saw the plaintiff two weeks before trial for no purpose other than to serve as a witness.  The plaintiff had a regular treating physician, and had been examined by another testifying witness, but the plaintiff’s lawyer wanted to have a second testifying witness for trial.  The “Saturday-night” expert witness conducted his examination, and then requested reimbursement for the examination from the plaintiff’s health insurer, and indicated the name of the plaintiff’s counsel as the “referring physician” on the insurance forms.  The trial judge remarkably would not permit cross-examination of the testifying expert witness on the fraud, and suggested that such cross-examination was prohibited by the collateral source rule!  The health insurance industry will occasionally act vigilantly to enforce a lien against a tort recovery, but there has been little evidence of civil or criminal litigation arising from the practice of billing insurers for examinations by physicians who are essentially expert witnesses and not treating physicians.

The Pennsylvania Silicosis Litigation Cock Up

In February 2002, Texas invaded Pennsylvania. No conventional weapons were fired. The Texans took up positions in mobile vans in motel parking lots across eastern Pennsylvania. Without prescriptions, physicians’ orders, or regulatory approval, the Texans directed unlawful X-ray radiation at Pennsylvania workers in the hopes of creating evidence to be used in lawsuits for silicosis. To help establish their litigation beachhead, the Texans hired local mercenaries – a New Jersey company in the business of providing mobile X-ray screenings. Dozens of silicosis lawsuits were created and filed in Philadelphia as a result of the invasion.

On January 25, 2007, the Commonwealth of Pennsylvania, through its Department of Environmental Protection (DEP), responded by fining the New Jersey company, MOST Health Services, Inc. The DEP found that MOST violated Pennsylvania law by conducting X-ray screenings without physician or regulatory approval. For having unlawfully exposed 161 persons to ionizing radiation, DEP assessed a civil penalty of $80,500.00, against MOST. The DEP did not charge the plaintiffs’ lawyers with any violation of Commonwealth regulations.

MOST’s participation in unlawful litigation screenings was not a momentary lapse in judgment. Back in 2000, defense counsel in asbestos cases compelled the testimony of MOST principal Kenneth Warner, who acknowledged then that MOST had not been in the practice of complying with screening regulations. Mr. Warner, however, claimed that the company was in the process of filing appropriate applications to comply.

Workers were invited to the February 2002 MOST screenings by their unions, but the invitation letters were written by Texas lawyers. To participate in the screenings, the workers had to sign a retainer agreement to engage the Texas-based law firm. The workers were told that “legal ethics” required that they hire the sponsoring law firm to represent them before “the attorneys can provide [them] with medical tests.”

Of course, the law in no state permits attorneys to provide medical tests, and especially not X-rays. DEP, like most other states’ regulatory agencies, has promulgated comprehensive regulations that govern virtually every aspect of the use of medical radiation. In Pennsylvania, anyone proposing a “healing arts screening” with X-rays must submit, in advance, a comprehensive, written proposal with details of the proposed screening, the description of the population to be examined, the qualifications of the radiation technician and operator, the quality control to be used, the qualifications of the supervising physician, and the identity and qualifications of the physician who will interpret the radiographs.

The MOST screenings, commissioned by the Texas lawyers, were never authorized by the DEP. No physician was present on site. None of the workers presented prescriptions or physicians’ orders before being unlawfully exposed to radiation. The identity of the physician slated to receive the chest radiographs was never disclosed to DEP.

Ultimately, the films created by MOST were sent to a West Virginia physician, well known and well compensated in dust-disease litigation. This off-site physician diagnosed virtually all of the workers with either asbestosis or silicosis, and a majority of litigants with both asbestosis and silicosis, although he never examined the workers, never interviewed them, and never reviewed their medical records.

In December 2005, the defendants in the silicosis cases that arose from the MOST screenings moved to dismiss on grounds that the claims were the direct result of unlawful activities that violated Pennsylvania public policy. The trial court denied the motion without opinion. Despite the obvious conspiracy between the plaintiffs’ lawyers and MOST to violate Pennsylvania health regulations, no disciplinary actions were brought against the plaintiffs’ lawyers in the cases.

The Pennsylvania fine against MOST seems to have been an exceptional finding. Although the predatory screening practices decried in federal Judge Janis Graham Jack’s now judicial opinion, In re Silica Products Liability Litigation, no other states to my knowledge have taken action against the conspiracies among lawyers, physicians, and mobile screening companies, to violate state health regulations. These conspiracies thrived for some time, in part because of the entrepreneurial enthusiasm of the conspirators, and the failure of courts, bar associations, adversary counsel, state and federal regulators, and medical societies to condemn the screening practices. In the context of silicosis litigation, the “red flags of fraud,” go beyond the manufacturing of diagnoses for money; they mark as dubious the entire enterprise of suing sand suppliers for failure to warn about hazards that were well known to government, industry, labor, and academia from the 1930s, forward.

[1]  The following commentary flows from a joint project that the late R. Nicholas (Nick) Gimbel and I worked on some years ago. Nick’s illness and tragic death prevented us from publishing this work, but I believe it still bears some sort of public airing. Nick Gimbel and I presented some of this commentary in a paper, “Legal Remedies to Address Suspect Medical Science in Product Liability Cases,” for Mealey’s Advanced Insurance Coverage Conference, in Philadelphia, Pennsylvania (Jan. 23, 2006).

[2]  In re Silica Products Liability Litigation, 398 F.Supp. 2d 563 (S.D.Tex. 2005) (“In re Silica”). Although Judge Jack’s deconstruction of the silicosis “epidemic” is famous among defense counsel, Her Honor’s work has been met with willful ignorance by the lawsuit industry. See, e.g., David Michaels, “Deadly Dust,” chap. 8, in The Triumph of Doubt: Dark Money and the Science of Deception (2020) (exhibiting amnesia about one of the largest litigation frauds in the 21st century, so far.)

[3]  For a more complete, scholarly exposition of this case, see Lester Brickman, “Civil RICO: An Effective Deterrent to Fraudulent Asbestos Litigation?” 40 Cardozo L. Rev. 2301, 2344-2402 (2019).

[4]  Fourth Amended Complaint dated August 19, 2002.

[5]  Fourth Amended Complaint, ¶ 61.

[6]   18 U.S.C. § 1961, et seq.

[7]  Other claims in the GAF complaint asserted tortious interference with contract and economic advantage, breach of contract, common law fraud and falsification of documents.  Claims that were dismissed include malicious interference with GAF’s right to petition Congress, violation of 15 U.S.C. § 1 (antitrust laws) and fraudulent inducement.

[8]  See G-I Holdings, Inc. v. Baron & Budd, No. 01-Civ. 0216, 2005 WL 1653623 (S.D.N.Y.); G-I Holdings, Inc. v. Baron & Budd, No. 01-Civ. 0216, 2004 WL 638141 (S.D.N.Y. Mar. 30, 2004);  G-I Holdings, Inc. v. Baron & Budd, 2004 WL 540456 (S.D.N.Y. Mar. 17, 2004); G-I Holdings, Inc. v. Baron & Budd, 2004 WL 374450 (S.D.N.Y. Feb. 27, 2004); G-I Holdings, Inc. v. Baron & Budd, 218 F.R.D. 409 (S.D.N.Y. 2003); G-I Holdings, Inc. v. Baron & Budd, 213 F.R.D. 146 (S.D.N.Y. 2003); G-I Holdings, Inc. v. Baron & Budd, 01 Civ. 0216, 2002 WL 31251702 (S.D.N.Y. Oct. 8, 2002); G-I Holdings, Inc. v. Baron & Budd, 238 F.Supp.2d 521 (S.D.N.Y. 2002); and G-I Holdings, Inc. v. Baron & Budd, 179 F.Supp.2d 233 (S.D.N.Y. 2001).

[9]  U.S. v. MRS Diagnostics, Inc., Civil Action No. 90-3517 (E.D.Pa. May 23, 1990), Complaint.

[10]  Id. at Complaint para. 1(a)-(i).

Posted in Asbestos, Scientific Misconduct, Silica | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part One

Everything She Just Said Was Bullshit

September 26th, 2019

At this point, most products liability lawyers have read about the New Jersey verdicts returned earlier this month against Johnson & Johnson in four mesothelioma cases.[1] The Middlesex County jury found that the defendant’s talc and its supposed asbestos impurities were a cause of all four mesothelioma cases, and awarded compensatory damages of $37.3 million, in the cases.[2]

Johnson & Johnson was prejudiced by having to try four cases questionably consolidated together, and then hobbled by having its affirmative defense evidence stricken, and finally crucified when the trial judge instructed the jury at the end of the defense lawyer’s closing argument: “everything she just said was bullshit.”

Judge Ana C. Viscomi, who presided over the trial, struck the entire summation of defense lawyer Diane Sullivan. The action effectively deprived Johnson & Johnson of a defense, as can be seen from the verdicts. Judge Viscomi’s egregious ruling was given without explaining which parts of Sullivan’s closing were objectionable, and without giving Sullivan an opportunity to argue against the sanction.

During the course of Sullivan’s closing argument, Judge Viscomi criticized Sullivan for calling the plaintiffs’ lawyers “sinister,” and suggested that her argument was defaming the legal profession in violation of the Rules of Professional Conduct.[3] Sullivan did use the word “sinister” several times, but in each instance, she referred to the plaintiffs’ arguments, allegations, and innuendo about Johnson & Johnson’s action. Judge Viscomi curiously imputed unprofessional conduct to Sullivan for referring to plaintiffs’ counsel’s “shows and props,” as a suggestion that plaintiffs’ counsel had fabricated evidence.

Striking an entire closing argument is, as far as anyone has determined, unprecedented. Of course, Judge Haller is fondly remembered for having stricken the entirety of Vinny Gambini’s opening statement, but the good judge did allow Vinny’s “thank you” to stand:

Vinny Gambini: “Yeah, everything that guy just said is bullshit… Thank you.”

D.A. Jim Trotter: “Objection. Counsel’s entire opening statement is argument.”

Judge Chamberlain Haller: “Sustained. Counselor’s entire opening statement, with the exception of ‘Thank you’ will be stricken from the record.”

My Cousin Vinny (1992).

In the real world of a New Jersey courtroom, even Ms. Sullivan’s expression of gratitude for the jury’s attention and service succumbed to Judge Viscomi’s unprecedented ruling,[4] as did almost 40 pages of argument in which Sullivan carefully debunked and challenged the opinion testimony of plaintiffs’ highly paid expert witnesses. The trial court’s ruling undermined the defense’s detailed rebuttal of plaintiffs’ evidence, as well as the defense’s comment upon the plaintiffs’ witnesses’ lack of credibility.

Judge Viscomi’s sua sponte ruling appears even more curious given what took place in the aftermath of her instructing the jury to disregard Sullivan’s argument. First, the trial court gave very disparate treatment to plaintiffs’ counsel. The lawyers for the plaintiffs gave extensive closing arguments that were replete with assertions that Johnson & Johnson and Ms. Sullivan were liars, predators, manipulators, poisoners, baby killers, and then some. Sullivan’s objections were perfunctorily overruled. Second, Judge Viscomi permitted plaintiffs’ counsel to comment extensively upon Ms. Sullivan’s closing, even though it had been stricken. Third, despite the judicial admonition about the Rules of Professional Conduct, neither the trial judge nor plaintiffs’ counsel appear to have filed a disciplinary complaint against Ms. Sullivan. Of course, if Judge Viscomi or the plaintiffs’ counsel thought that Ms. Sullivan had violated the Rules, then they would be obligated to report Ms. Sullivan for misconduct.

Bottom line: these verdicts are unsafe.

[1]  The cases were tried in a questionable consolidation in the New Jersey Superior Court, for Middlesex County, before Judge Viscomi. Barden v. Brenntag North America, No. L-1809-17; Etheridge v. Brenntag North America, No. L-932-17; McNeill-George v. Brenntag North America, No. L-7049-16; and Ronning v. Brenntag North America, No. L-6040-17.

[2]  Bill Wichert, “J&J Hit With $37.3M Verdict In NJ Talc Case,” Law360 (Sept. 11, 2019).

[3]  Amanda Bronstad, “J&J Moves for Talc Mistrial After Judge Strikes Entire Closing Argument,” N.J.L.J. (Sept. 10, 2019) (describing Judge Viscomi as having admonished Ms. Sullivan to “[s]top denigrating the lawyers”; J&J’s motion for mistrial was made before the case was submitted to the jury).

[4]  See Peder B. Hong, “Summation at the Border: Serious Misconduct in Final Argument in Civil Trials,” 19 Hamline L. Rev. 179 (1995); Ty Tasker, “Stick and Stones: Judicial Handling of Invective in Advocacy,” 42 Judges J. 17 (2003); Janelle L. Davis, “Sticks and Stones May Break My Bones, But Names Could Get Me a Mistrial: An Examination of Name-Calling in Closing Argument in Civil Cases,” 42 Gonzaga L. Rev. 133 (2011).

Posted in Asbestos, Trial Procedure | Comments Off on Everything She Just Said Was Bullshit

Sophisticated Intermediary Defense in Asbestos Cases – Use With Discretion

May 20th, 2019

“Discretion is the better part of valor.” Shakespeare, King Henry the Fourth.

A recent asbestos case illustrates the perils of improvidently asserting a sophisticated intermediary defense, when the alleged injury is mesothelioma, and the years of exposure reach back to the 1940s. In Sawyer v. Union Carbide Corp., Foster Wheeler LLC, pleaded sophisticated intermediary and superseding cause defenses “pro forma,” in a mesothelioma case that involved asbestos exposure from 1948 through the 1970s.[1] Plaintiff moved for partial summary judgment on these two defenses, but rather than withdraw the defenses, Foster Wheeler attempted to present evidentiary support in the form of the employer’s (purchaser’s) knowledge of asbestos hazards. The employer was the Bethlehem Steel Company, at the Bethlehem Steel Sparrows Point Shipyard.

Foster Wheeler certainly was able to show that Bethlehem Steel was aware of the hazards of asbestosis, going back to 1948. If the plaintiff’s alleged injury had been asbestosis, the employer’s knowledge should have sufficed. The injury alleged, however, was mesothelioma. Evidence that the Maritime Commission had warned Bethlehem Steel about the hazards of asbestosis, and to maintain a threshold limit value of 5 million particles per cubic foot, was not particularly germane or helpful in avoiding mesothelioma among employees.

Moving forward two decades, Foster Wheeler was able to show that Bethlehem Steel’s Medical Director, Dr. Paul J. Whitaker, was well aware of the connection between asbestos exposure and mesothelioma, in 1968.[2] This evidence, however, left two decades of exposure, from 1948 to 1968, in which Foster Wheeler had not shown its purchaser was aware of the risk of mesothelioma.

The trial court in Sawyer, however, did not focus on the differential between an asbestosis and a mesothelioma hazard. Instead of noting the lack of knowledge with respect to mesothelioma, the trial court insisted that the supplier must have subjective awareness of the purchaser’s actual knowledge of the relevant hazards. Even the overwhelming evidence of Bethlehem’s awareness of asbestosis hazards throughout the plaintiff’s employment was thus, questionably, deemed irrelevant.

According the trial court, the sophisticated intermediary defense focuses on what “focuses on what the product manufacturer knew and the reasonableness of its reliance on the employer prior to and during the time the workers were exposed.”[3] The Sawyer court took this focus to require a showing that the defendant had actual awareness of the intermediary’s knowledge of the dangers of asbestos exposure. According to the decision, Foster Wheeler failed to establish a basis for having such actual knowledge of Bethlehem Steel’s knowledge.

The Sawyer court’s insistence upon actual awareness is not supported by its citation to the Restatement (Second) of Torts. The relevant provision for sales of products to be used by a third party states that[4]:

“One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier

  • knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
  • has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
  • fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous.”

The Restatement’s articulated standard does not call for the seller’s subjective awareness as a necessary condition. Having a reason to believe the user will realize its dangerous condition seems eminently satisfied by a generalized, reasonable belief that purchasers are sophisticated with respect to the product’s use. Foster Wheeler might have improved its evidentiary showing in opposition to plaintiff’s motion, however, by adverting to its own knowledge that there was a prevalent regulatory scheme, including the Walsh-Healy Act, which covered the safety of workers in the use of asbestos. As noted above, this knowledge would not have implicated the hazard of mesothelioma or the means to avoid it in purchasers’ workplaces.

The Sawyer decision offered virtually no support for the proposition that the seller, wishing to avail itself of the sophisticated intermediary defense, must have actual knowledge of the buyer’s awareness of the relevant hazard. Failure to warn liability for a product’s harm is predicated upon negligence law. Almost all civilized jurisdictions require plaintiff to show negligence in such cases.[5] The test for non-obviousness such that a warning might be required under the law is an objective one, which does not turn on the user’s actual knowledge of the hazard.[6]

Although standing on the sophisticated intermediary defense may have been improvident in Sawyer, there are many cases that cry out for dismissal on the strength of the defense. The facts of silica cases, for example, are radically different from early exposure asbestos cases because of the wide diffusion and general equality of knowledge of silica hazards throughout industry, labor, and government.[7]  The dangers of occupational exposure to crystalline silica were so well known that the New York Court of Appeals recognized, seventy years ago, that “[i]t is a matter of common knowledge that it is injurious to the lungs and dangerous to health to work in silica dust.”[8] This pervasiveness of knowledge about the potential hazards of industrial silica exposure has been the basis for many dispositive rulings in silica cases, even when the sellers lacked subjective awareness of the buyer’s state of mind.[9]

Product liability is defined and bounded by the scope of an essential need for warnings in the face of imbalances in knowledge between seller and buyer. When the rationale is not or cannot be satisfied, ignoring the sophisticated intermediary’s knowledge is little more than creating a “duty to pay.” In the context of industrial sales of materials and products to large, sophisticated buyers, the law recognizes that warnings are often unnecessary and even counter-productive when hazards of the materials or products are known to the buyers as well as, if not better than, to the sellers. The so-called sophisticated intermediary defense thus reflects nothing more than the rational limits of liability in situations when the chattel is widely known to be hazardous, and the seller can reasonably rely upon the intermediary to be aware of the hazard and to protect down-stream users, typically employees of the purchaser.

Because of the shift in knowledge about the causal relationship between amphibole asbestos and mesothelioma, asbestos product cases would appear unlikely applications for sophisticated intermediary defenses, at least until the knowledge of mesothelioma hazards became widely prevalent. Because of the  change in the state of the art with respect to asbestos hazards, asbestos cases involve substantial factual and legal differences from other hazardous material cases. The singular facts of some of the asbestos cases include an extreme imbalance between supplier and some purchasers in their respective knowledge of asbestos hazards. Accordingly, jurisdictions that have embraced the sophisticated intermediary defense have thus treated asbestos cases, with pre-OSHA exposures, differently from other occupational exposure cases.[10]

The OSH Act of 1970, which created OSHA, was fueled in large part by wide-spread awareness and concern about asbestos exposure and occupational cancers, such as mesothelioma. In asbestos cases involving only post-1969 asbestos exposures, courts have upheld the applicability of the sophisticated intermediary defense. Thus a federal trial court in Kentucky, applying Indiana law, granted summary judgment to a respirator manufacturer, on the basis of the sophisticated intermediary defense, in a post-OSHA asbestos lung cancer case.[11] Similarly, a Virginia state trial court, notwithstanding the application of Virginia law in the Willis and Oman federal cases upheld the sophisticated intermediary defense as a complete legal defense for asbestos sales after 1970.[12] The decisions in these asbestos cases with only post-1970 asbestos exposure emphasized the equality of knowledge of asbestos hazards, which distinguished them from earlier asbestos cases involving companies such as Johns-Manville, which had been found to suppress or hide information from purchasers and workers.[13]

[1] Sawyer v. Union Carbide Corp., Civil No. CCB-16-118, 2019 U.S. Dist. LEXIS 72215 at *33; 2019 WL 1904882 (D. Md. April 29, 2019).

[2] Sawyer at *36.

[3] Sawyer at *36 (quoting Willis v. Raymark Indus., Inc., 905 F.2d 793, 797 (4th Cir. 1990)).

[4]  § 388 Chattel Known to Be Dangerous for Intended Use, Restatement (Second) of Torts (1965).

[5] Under New York law, for instance, the duty to warn in strict liability is identical in nature and scope as the duty in negligence. Martin v. Hacker, 83 N.Y. 1, 8 n.1 (1993). New York law acknowledges that there is no meaningful distinction between negligent and strict liability failure to warn claims. See Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir. 1991) (New York law) (“Failure to warn claims purporting to sound in strict liability and those sounding in negligence are essentially the same.”). See also Rainbow v. Albert Elia Bldg. Co., 49 A.D.2d 250 (4th Dept. 1974) (distinguishing manufacturing and design defects, and permitting “reasonableness” defenses, including state-of-the-art defenses, to the latter in strict products liability), aff’d, 56 N.Y.2d 550 (1981). On the equivalence between negligence and product liability for failure to warn, New York law is aligned with the law of most states. See Restatement (Third) of Torts: Products Liability § 2, and comment I (1998); Restatement (Second) of Torts § 388 & comment n (1965); Restatement (First) of Torts § 388, comment 1 (1934).

[6] The standard for the open and obvious defense, which is many respects is a variant of the sophisticated intermediary defense, is an objective one, based on what would be obvious to the ordinary person. See Plante v. Hobart Corp., 771 F.2d 617, 620 (1st Cir. 1985) (“Where the danger involved in using a product is obvious and apparent, discernible by casual inspection, a supplier is not negligent in failing to warn of that danger.”); Fleck v. KDI Sylvan Pools, Inc., 981 F.2d 107, 119 (3d Cir. 1992) (“[W]hether a danger is open and obvious is an objective inquiry, not dependent upon the actual knowledge of the user or his actual awareness of the danger.”); Glittenberg v. Doughboy, 491 N.W.2d 208, 213 (Mich. 1992) (“Determination of the ‘obvious’ character of a product- connected danger is objective.”).

[7] See Linda Regis, “Frame the Sandbox to Sandblasting: Regulation of Crystalline Silica,” 17 Pace Envt’l L. Rev. 207, 208 n. 8 (1999); Richard Ausness, “Learned Intermediaries and Sophisticated Users: Encouraging the Use of Intermediaries to Transmit Product Safety Information,” 46 Syracuse L. Rev. 1185, 1205-07 (1996); Kenneth Willner, “Failures to Warn and the Sophisticated User Defense,” 74 Va. L. Rev. 579 (1988); Victor Schwartz & Russell Driver, “Warnings in the Workplace: The Need for a Synthesis of Law and Communication Theory,” 52 U. Cin. L. Rev. 38 (1983).

[8] Sadowski v. Long Island RR., 292 N.Y. 448, 456 (1944) (emphasis added). A few years later, the United States Supreme Court concurred and quoted Sadowski. Urie v. Tompkins, 337 U.S. 163, 190 (1949).

[9] See, e.g., Goodbar v. Whitehead Bros., 591 F. Supp. 552 (W.D. Va. 1984), aff’d sub nom. Beale v. Hardy, 769 F.2d 213 (4th Cir. 1985); Smith v. Walter C. Best, Inc., 927 F.2d 736 (3d Cir. 1990) (applying Ohio law in a silica foundry case); Bergfeld v. Unimin Corp., 319 F.3d 350 (8th Cir. 2003) (applying Iowa law to affirm summary judgment); Haase v. Badger Mining Corp., 266 Wis. 2d 970 (Wis. Ct. App. 2003), aff’d, 274 Wis. 2d 143 (2004); Damond v. Avondale Industries, 718 So. 2d 551 (La. App. 1998) (affirming summary judgment for a silica supplier on a worker’s claims for silicosis from sandblasting, which if not done carefully, can be an extremely hazardous); Cowart v. Avondale Indus., 792 So. 2d 73 (La. Ct. App. 2001) (holding that the sophisticated user defense was dispositive in a foundry workplace, which was sophisticated about the potential hazards of its silica use); Bates v. E.D. Bullard Co., 76 So.3d 111 (La.App. 2011) (affirming summary judgment for silica suppliers); Phillips v. A.P. Green Refractories Co., 428 Pa. Super. 167, 630 A.2d 874 (1993), aff’d on other grounds, Phillips v. A-Best Products Co., 542 Pa. 124, 665 A.2d 1167 (1995) (lack of proximate cause for claimed failure to warn).

[10] Virginia law, which governed the Willis case cited by the Sawyer court is illustrative. Compare Oman v. Johns-Manville Corp., 764 F.2d 224 (4th Cir. 1985) (applying Virginia law, which embraces § 388, but refusing to apply the doctrine because the employer was unaware of asbestos hazards during plaintiffs’ employment before 1964), cert. denied sub nom. Oman v. H.K. Porter, 474 U.S. 970 (1985), with Beale v. Hardy, 469 F.2d 213 (4th Cir. 1985) (holding that Section 388 was a complete defense in silicosis cases under Virginia law). Michigan, another industrialized state with well-developed case law, also illustrates the disparate treatment of asbestos cases. Compare Russo v. Abex Corp., 670 F. Supp. 206, 208 (E.D. Mich. 1987) (holding that “asbestos-containing product manufacturers have an absolute duty to warn because of the unique and patent dangers of asbestos”) with Jodway v. Kennametal, Inc., 207 Mich. App. 622, 525 N.W.2d 883 (Mich. Ct. App. 1994) (applying Section 388 in hard-metal (cobalt) lung disease case); Kudzia v. Carboloy Division, 190 Mich. App. 285, 475N.W.2d 371 (1991) (same), aff’d, 439 Mich. 923, 479 N.W.2d 679 (1992); Tasca v. GTE Products Corp., 175 Mich. App. 617, 438 N.W.2d 625 (Mich. Ct. of App. 1989) (same). See also Antcliff v. State Employees Credit Union, 414 Mich. 624, 640 (1982); Ross v. Jaybird Automation, Inc., 172 Mich. App. 603, 607 (1988); Rasmussen v. Louisville Ladder Co., Inc., 211 Mich. App. 541, 547-48 (1995); Portelli v. I.R. Construction Products Co., 218 Mich. App. 591, 599 (1996); Mills v. Curioni, 238 F. Supp. 876, 894-96 (E.D. Mich. 2002).

[11] Triplett v. Minnesota Mining & Mfg. Co., 422 F. Supp. 2d 779 (W.D. Ky. 2006).

[12] Bean v. Asbestos Corporation, Ltd., 1998 WL 972122 (Va. Cir. Ct. 1998).

[13] See also Gottschall v. General Electric Co., 2011 U.S. Dist. LEXIS 151563 (E.D. Pa. Dec. 8, 2011) (MDL 875) (California law; granting summary judgment when the Navy’s knowledge of asbestos hazards was equal to that of defendant), rev’d, No. 14-15379, 14-15380, 2016 U.S. App. LEXIS 17248 (9th Cir. 2016).

Posted in Asbestos, Learned and sophisticated intermediary, Sophisticated User | Comments Off on Sophisticated Intermediary Defense in Asbestos Cases – Use With Discretion

Apportionment and Pennsylvania’s Fair Share Act

March 14th, 2019

In 2011, Pennsylvania enacted the Fair Share Act, which was remedial legislation designed to mitigate the unfairness of joint and several liability in mass, and other, tort litigation by abrogating joint and several liability in favor of apportionment of shares among multiple defendants, including settled defendants.1

Although the statute stated the general rule in terms of negligence,2 the Act was clearly intended to apply to actions for so-called strict liability:3

“(1) Where recovery is allowed against more than one person, including actions for strict liability, and where liability is attributed to more than one defendant, each defendant shall be liable for that proportion of the total dollar amount awarded as damages in the ratio of the amount of that defendant’s liability to the amount of liability attributed to all defendants and other persons to whom liability is apportioned under subsection.”

The intended result of the legislation was for courts to enter separate and several judgments against defendants held liable in the amount apportioned to each defendant’s liability.4 The Act created exceptions for for intentional torts and for cases in which a defendant receives 60% or greater share in the apportionment.5

In Pennsylvania, as in other states, judges sometimes fall prey to the superstition that the law, procedural and substantive, does not apply to asbestos cases. Roverano v. John Crane, Inc., is an asbestos case in which the plaintiff claimed his lung cancer was caused by exposure to multiple defendants’ products. The trial judge, falling under the sway of asbestos exceptionalism, refused to apply Fair Share Act, suggesting that “the jury was not presented with evidence that would permit an apportionment to be made by it.”

The Roverano trial judge’s suggestion is remarkable, given that any plaintiff is exposed to different asbestos products in distinguishable amounts, and for distinguishable durations. Furthermore, asbestos products have distinguishable, relative levels of friability, with different levels of respirable fiber exposure for the plaintiff. In some cases, the products contain different kinds of asbestos minerals, which have distinguishable and relative levels of potency to cause the plaintiff’s specific disease. Asbestos cases, whether involving asbestosis, lung cancer, or mesothelioma claims, are more amenable to apportionment of shares among co-defendants than are “red car / blue car” cases.

Pennsylvania’s intermediate appellate court reversed the trial court’s asbestos exceptionalism, and held that upon remand, the court must:

“[a]pply a non-per capita allocation to negligent joint tortfeasors and strict liability joint tortfeasors; and permit evidence of settlements reached between plaintiffs and bankrupt entities to be included in the calculation of allocation of liability.”

Roverano v. John Crane, 2017 Pa. Super. 415, 177 A.3d 892 (2017).

The Superior Court’s decision did not sit well with the litigation industry, which likes joint and several liability, with equal shares. Joint and several liability permits plaintiffs’ counsel to extort large settlements from minor defendants who face the prospect of out-sized pro rata shares after trial, without the benefit of reductions for the shares of settled bankrupt defendants. The Roverano plaintiff appealed from the Superior Court’s straightforward application of a remedial statute.

What should be a per curiam affirmance of the Superior Court, however, could result in another act of asbestos exceptionalism by Pennsylvania Supreme Court. Media reports of the oral argument in Roverano suggest that several of the justices invoked the specter of “junk science” in apportioning shares among asbestos co-defendants.6 Disrespectfully, Justice Max Baer commented:

“Respectfully, your theory is interjecting junk science. We’ve never held that duration of contact corresponds with culpability.”7

The Pennsylvania Justices’ muddle can be easily avoided. First, the legislature clearly expressed its intention that apportionment be permitted in strict liability cases.

Second, failure-to-warn strict liability cases are, as virtually all scholars and most courts recognize, essentially negligence cases, in any event.8

Third, apportionment is a well-recognized procedure in the law of Torts, including the Pennsylvania law of torts. Apportionment of damages among various causes was recognized in the Restatement of Torts (Second) Section 433A (Apportionment of Harm to Causes), which specifies that:

(1) Damages for harm are to be apportioned among two or more causes where

(a) there are distinct harms, or

(b) there is a reasonable basis for determining the contribution of each cause to a single harm.

Restatement (Second) of Torts § 433A(1) (1965) [hereinafter cited as Section 433A].

The comments to Section 433A suggest a liberal application for apportionment. The rules set out in Section 433A apply “whenever two or more causes have combined to bring about harm to the plaintiff, and each has been a substantial factor in producing the harm … .”

Id., comment a. The independent causes may be tortious or innocent, “and it is immaterial whether all or any of such persons are joined as defendants in the particular action.” Id. Indeed, apportionment also applies when the defendant’s conduct combines “with the operation of a force of nature, or with a pre-existing condition which the defendant has not caused, to bring about the harm to the plaintiff.” Just as the law of grits applies in everyone’s kitchen, the law of apportionment applies in Pennsylvania courts.

Apportionment of damages is an accepted legal principle in Pennsylvania law. Martin v. Owens-Corning Fiberglas Corp., 515 Pa. 377, 528 A.2d 947 (1987). Courts, applying Pennsylvania law, have permitted juries to apportion damages between asbestos and cigarette smoking as causal factors in plaintiffs’ lung cancers, based upon a reasonable basis for determining the contribution of each source of harm to a single harm.9

In Parker, none of the experts assigned exact mathematical percentages to the probability that asbestos rather than smoking caused the lung cancer. The Court of Appeals noted that on the record before it:

“we cannot say that no reasonable basis existed for determining the contribution of cigarette smoking to the cancer suffered by the decedent.”10

The Pennsylvania Supreme Court has itself affirmed the proposition that “liability attaches to a negligent act only to the degree that the negligent act caused the employee’s injury.”11 Thus, even in straight-up negligence cases, causal apportionment must play in a role, even when the relative causal contributions are much harder to determine than in the quasi-quantitative setting of an asbestos exposure claim.

Let’s hope that Justice Baer and his colleagues read the statute and the case law before delivering judgment. The first word in the name of the legislation is Fair.

1 42 Pa.C.S.A. § 7102.

2 42 Pa.C.S.A. § 7102(a)

3 42 Pa.C.S.A. § 7102(a)(1) (emphasis added).

4 42 Pa.C.S.A. § 7102(a)(2).

5 42 Pa.C.S.A. § 7102 (a)(3)(ii), (iii).

7 Id. (quoting Baer, J.).

8 See, e.g, Restatement (Third) of Torts: Products Liability § 2, and comment I (1998); Fane v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir. 1991) (“Failure to warn claims purporting to sound in strict liability and those sounding in negligence are essentially the same.”).

9 Parker v. Bell Asbestos Mines, No. 86-1197, unpublished slip op. at 5 (3d Cir., Dec. 30, 1987) (per curiam) (citing Section 433A as Pennsylvania law, and Martin v. Owens-Corning Fiberglas Corp. , 515 Pa. 377, 528 A.2d 947, 949 (1987))

10 Id. at 7.

11 Dale v. Baltimore & Ohio RR., 520 Pa. 96, 106, 552 A.2d 1037, 1041 (1989). See also McAllister v. Pennsylvania RR., 324 Pa. 65, 69-70, 187 A. 415, 418 (1936) (holding that plaintiff’s impairment, and pain and suffering, can be apportioned between two tortious causes; plaintiff need not separate damages with exactitude); Shamey v. State Farm Mutual Auto. Ins. Co., 229 Pa. Super. 215, 223, 331 A.2d 498, 502 (1974) (citing, and relying upon, Section 433A; difficulties in proof do not constitute sufficient reason to hold a defendant liable for the damage inflicted by another person). Pennsylvania law is in accord with the law of other states as well, on apportionment. See Waterson v. General Motors Corp., 111 N.J. 238, 544 A.2d 357 (1988) (holding that a strict liability claim against General Motors for an unreasonably dangerous product defect was subject to apportionment for contribution from failing to wear a seat belt) (the jury’s right to apportion furthered the public policy of properly allocating the costs of accidents and injuries).

Posted in Apportionment, Asbestos, Causation, Trial Procedure | Comments Off on Apportionment and Pennsylvania’s Fair Share Act

Selikoff Timeline & Asbestos Litigation History

December 20th, 2018

This post has been updated here.

Posted in Asbestos, Expert Witnesses, Historian Testimony | Comments Off on Selikoff Timeline & Asbestos Litigation History

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