Plaintiffs Experts Latest Pathological Theories

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1 Plaintiffs Experts Latest Pathological Theories Kurt B. Gerstner Campbell Campbell Edwards & Conroy, P.C. One Constitution Center Boston, MA (617)

2 Kurt B. Gerstner is a shareholder and a trial lawyer at Campbell Campbell Edwards & Conroy PC in its Boston office. He supervises his firm s asbestos practice in Massachusetts, Rhode Island, Connecticut, Maine, New York and Pennsylvania. He has been practicing law for 30 years and has extensive experience defending product liability, toxic tort and other negligence actions. He has been specially admitted to represent clients in 16 states. He has been a frequent speaker at programs throughout the United States and in Korea. He holds leadership positions in DRI and the International Association of Defense Counsel.

3 Plaintiffs Experts Latest Pathological Theories Table of Contents I. New Theories on Migration of Asbestos Fibers in the Body II. The Gold Standard for Understanding Disease Causation Plaintiffs Experts Latest Pathological Theories Gerstner 465

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5 Plaintiffs Experts Latest Pathological Theories Although asbestos litigation has existed for decades, it remains a very dynamic and fluid practice area. The parties involved in this litigation continue to change as entire industries have gone bankrupt because of staggering litigation costs and new defendants and industries have been made defendants under new theories of liability. The applicable law has evolved as courts have tried to manage ever expanding dockets of asbestos cases and new issues have been presented for judicial scrutiny. Medical science related to disease processes and asbestos continue to evolve, as have theories and opinions of plaintiffs experts in asbestos litigation. For all of these reasons it is imperative that lawyers involved in defending asbestos litigation matters remain aware of evolving theories and opinions being presented by plaintiffs experts. This presentation will discuss several new or evolving theories/opinions being presented by several plaintiffs experts in the field of pathology. One concerns the migration of asbestos fibers in the body and what, if anything, is now understood from studying fiber burdens in different tissue in the body. The other concerns the understanding of asbestos fibers role in disease causation and whether molecular and cellular science has now developed sufficiently that it can be considered the gold standard in concluding that certain asbestos fibers cause disease, supplanting the role of epidemiology in understanding disease causation. Has medical science developed so far that these plaintiffs experts are presenting valid opinions that are supported by new science? Or are these really old theories and opinions recast as something new without widespread support in the medical and scientific community? I. New Theories on Migration of Asbestos Fibers in the Body Steven H. Dikman, M.D. (pathologist) and Ronald Gordon, Ph.D. (electron microscopist) of Mt. Sinai Hospital in New York have been working on an asbestos fiber migration study for the past decade. Dr. Dikman characterized their working hypothesis as follows: Hypothesis is that the distribution of asbestos fibers varies over a period of time, that it migrates from lung to regional lymph nodes, and perhaps elsewhere in the body. (Williams v. A.P. Green Industries, Inc., Dep. Dikman, Aug. 6, 2002, at 21). Dr. Dikman later refined his description of the working hypothesis to state: [W]e are looking to see if we can document a change in quantity of asbestos in lung tissue and migration of asbestos to extrapulmonary sites, specifically lymph nodes. (Wood v. A.P. Green Services, Inc., Dep. Dikman, April 5, 2004, at 15.) In describing the study, Dr. Dikman stated that he and Dr. Gordon selected patients with lung cancer who had been exposed to asbestos in their lifetimes (the study group) to compare with lung cancer patients who had not been exposed to asbestos (the control group). (It appears that the focus later changed to patients with mesothelioma. See below.) To be included in the study his office needed to have at least two biopsy or tissue specimens taken at different time periods from the same patient, e.g. one tissue sample taken during a biopsy and a later tissue sample taken from a subsequent biopsy or autopsy. Not all patients in the study were patients at Mt. Sinai Hospital. Some could have come from referrals to his office from other hospitals. Some could have come as referrals by attorneys. He did not plan to document the referral source of the patients in the paper on the study. Drs. Dikman and Gordon did not notify Mt. Sinai patients, referring hospitals or referring attorneys that the patients might be included in the study. Plaintiffs Experts Latest Pathological Theories Gerstner 467

6 Other criteria to be included in the patient study group was to have a certain level of demographic data about the patient available. This included a documented history of significant occupational or household asbestos exposure with data about the types of jobs the patient performed and the duration of asbestos exposure. (Id. at 21). To be in the control group the patient needed to have no significant occupational or household exposure to asbestos. Significant occupational or household asbestos exposure for purposes of the study was not specifically defined. Determination of whether a patient had a significant household or occupational exposure to asbestos came from whatever patient histories were available through their treating physicians. Dr. Dikman was not certain how those histories were obtained in the individual cases. (Id. at 23) He did not know if there was a standard for obtaining an exposure history. The clinical physicians at Mt. Sinai treating these patients were not aware of this study and there was no questionnaire or standard form of information to be obtained. Dr. Dikman went back to speak with some of the treating physicians to obtain more details of the patients exposure history if the treating physicians had that information available. For purposes of his study he said: Well, some of these patients have expired, so it s hard to get it [more information] from the patient, but we use the best data we have available. (Id. at 25). Dr. Dikman did not know how the work or occupational histories were taken for patients that were referred from sources other than Mt. Sinai treating physicians. (Id. at 27.) For patients referred by attorneys he could be relying on the occupational history provided by the attorney as well as by the treating physician. He does not know how histories taken by attorneys were obtained or whether they were shown any documents by the attorneys in conjunction with their histories being taken. (Id.) As of 2004, Drs. Dikman and Gordon were focusing primarily on lymph node tissue but Dr. Dikman thought they might look at some pleural specimens as well. He anticipated that lymph node and pleural specimens would be included in the study. For this research Dr. Dikman was reviewing all of the tissue and Dr. Gordon was doing the electron microscopy and handling other technical aspects of the analysis. Both Drs. Dikman and Gordon did the analysis of the tissue digestion studies. As part of this study they did not limit themselves to particular types of asbestos fibers. They looked at all fibers but in fiber counts they restrict it to fibers of a certain length. (Id. at 32.) In 2001 Dr. Dikman testified that he expected this study to be completed later that year. In each subsequent year he continued to predict that it would be completed and published shortly. That paper still has not been completed and published in any peer review publication. A poster/abstract related to this study was first presented at the American Thoracic Society meeting in Attached is a copy of the poster summarizing data from 100 of the cases that Drs. Dikman and Gordon have studied. By the time that poster was created the experimental group had evolved into patients with a diagnosis of mesothelioma. Drs. Gordon and Dikman have now analyzed just over 200 cases for this study. But Dr. Gordon has testified that they lost the data files from most of the cases from which this poster was created. He has the data only for the cases added since (Stites v. Aeroquip-Vickers, Inc., Dep. Gordon, April 23, 2012, at ) That is approximately 31 to 32 cases. (Id.) Even though he no longer has data for the majority of the cases from his initial poster, Dr. Gordon has not yet decided whether to disregard those earlier cases in his study analysis. (Id. at 35). Drs. Gordon and Dikman have also created a second poster containing a summary of the background data for 28 additional cases that had been added to the study since 2009 up to the time of the second presen- 468 Asbestos Medicine Seminar November 2012

7 tation. That poster was presented at the American Thoracic Society meeting in 2010 or (Id. at 38) That poster information also has not been published although he hopes to complete it and submit it for publication to the American Journal of Industrial Medicine. (Id.) He may no longer have a copy of that second poster. (Id. at 40) Dr. Gordon testified that of the 100 cases noted in their initial poster, probably 75 percent of those cases came from law firms. (Id. at 155) He confirmed that the Asbestos History Occupation information came from either the law firms or from the patient histories. (Id. at 156) They used the information that was available; there was no consistent asbestos occupational history. (Id.) They had no medical records or employment records to confirm histories provided by lawyers. (Id. at 157). Drs. Dikman and Gordon believe that their study has revealed new information about the significance of fiber burden analyses. As part of the Background portion of their poster, Drs. Dikman and Gordon state: In this presentation we hope to show that examination of asbestos fiber burdens in paratracheal and parabronchial lymph nodes in conjunction with lung parenchyma burdens provide a more accurate assessment of past exposure and risk of mesothelioma than lung burdens alone. We also will give further evidence that exposures to only chrysotile are associated with the development of mesotheliomas. Dr. Mary Beth Beasley will comment on their study and the conclusions they have reached. II. The Gold Standard for Understanding Disease Causation Eugene Mark, M.D. is a pathologist at Massachusetts General Hospital. He appears frequently as an expert witness for plaintiffs in asbestos litigation. Dr. Mark holds the opinion that there is no safe level of asbestos and that every occupational or household exposure to asbestos of any type or fiber, including chrysotile, causes the development of mesothelioma. He supports his opinions in a variety of ways. Q. Okay. What studies are there that say that chrysotile without tremolite causes mesothelioma? A. One can think about that in six manners. One is mining studies. Two is worker studies. Three is molecular studies. Four is historical studies. Five is government regulation studies. Six is epidemiologic studies. There might be additional avenues to explore, but those would be six avenues that one could explore to prove or to give evidence of my statement. (Stites v. 3M Company, Dep. Mark, May 2, 2012, at 25). Despite his reference to epidemiological studies as support for his opinions in some contexts, he has referred to molecular science as the gold standard for determining disease causation: I meant that molecular science being the gold standard for our understanding of the development of disease, including tumors, that chrysotile alone or chrysotile admixed can be studied in various manners and can produce cellular abnormalities, genomic abnormalities, tissue abnormalities, and that those abnormalities can be followed at the genomic level over time, and that those studies can show the development of increasingly abnormal clones of cells that eventuate in the diffuse malignant mesothelioma, and that those studies or clones can be initiated by chrysotile as well as other asbestos fiber types. (Id. at 32.) Dr. Mark states that he is basing this opinion primarily on animal studies and cellular studies. Plaintiffs Experts Latest Pathological Theories Gerstner 469

8 They re mostly animal studies, but some of them are cellular studies. I don t remember whether the cellular studies might have been taken from humans. On the other hand, there are human studies that can show not at the molecular level but at the ultrastructural level the presence, migration and cellular changes due to chrysotile as well as other fiber types. (Id.) By the cellular studies, I mean taking human tissue and examining it, usually from biopsy material, and then looking at the asbestos and looking at the cells. And that would be cellular and tissues being both human cells and human tissues. (Id. at 35). He does not identify any leading cellular studies but references work done by Dr. Craighead, a French book called The Pathology of Malignant Mesothelioma and publications by Dr. Pass. (Id. at 35-36). Dr. Mark appears to be referring to studies where chrysotile and other fibers were injected into animals and the animals later developed mesothelioma. But there are also animal studies where other substances that are not known to be carcinogenic in humans were injected into animals and the animals also developed mesothelioma following those injections. For this and other reasons animal studies have been criticized as not being directly related to human populations. Dr. Pass and others have examined changes in genes and DNA that have been associated with the development of mesothelioma. They have been trying to determine how asbestos fibers might cause changes to occur to genes and DNA in cells and they have formed hypotheses about what might be occurring to cause these cellular changes. Researchers have also posed hypotheses related to the relationships between different fiber types and cellular mutations. Even today, none of these studies appears to be conclusive or to extend beyond the stage of hypotheses. They are still subject to considerable criticism and debate within the scientific community. Dr. Mary Beth Beasley will discuss and evaluate Dr. Mark s recent characterization of these studies as the gold standard for understanding disease causation. 470 Asbestos Medicine Seminar November 2012

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