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Reference Manual on Scientific Evidence v4.0

February 28th, 2021

The need for revisions to the third edition of the Reference Manual on Scientific Evidence (RMSE) has been apparent since its publication in 2011. A decade has passed, and the federal agencies involved in the third edition, the Federal Judicial Center (FJC) and the National Academies of Science Engineering and Medicine (NASEM), are assembling staff to prepare the long-needed revisions.

The first sign of life for this new edition came back on November 24, 2020, when the NASEM held a short, closed door virtual meeting to discuss planning for a fourth edition.[1] The meeting was billed by the NASEM as “the first meeting of the Committee on Emerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence.” The Committee members heard from John S. Cooke (FJC Director), and Alan Tomkins and Reggie Sheehan, both of the National Science Foundation (NSF). The stated purpose of the meeting was to review the third edition of the RMSE to identify “identify areas of science, technology, and medicine that may be candidates for new or updated chapters in a proposed new (fourth) edition of the manual.” The only public pronouncement from the first meeting was that the committee would sponsor a workshop on the topic of new chapters for the RMSE, in early 2021.

The Committee’s second meeting took place a week later, again in closed session.[2] The stated purpose of the Committee’s second meeting was to review the third edition of the RMSE, and to discuss candidate areas for inclusion as new and updated chapters for a fourth edition.

Last week saw the Committee’s third, public meeting. The meeting spanned two days (Feb. 24 and 25, 2021), and was open to the public. The meeting was sponsored by NASEM, FJC, along with the NSF, and was co-chaired by Thomas D. Albright, Professor and Conrad T. Prebys Chair at the Salk Institute for Biological Studies, and the Hon. Kathleen McDonald O’Malley, who sits on the United States Court of Appeals for the Federal Circuit. Identified members of the committee include:

Steven M. Bellovin, professor in the Computer Science department at Columbia University;

Karen Kafadar, Departmental Chair and Commonwealth Professor of Statistics at the University of Virginia, and former president of the American Statistical Association;

Andrew Maynard, professor, and director of the Risk Innovation Lab at the School for the Future of Innovation in Society, at Arizona State University;

Venkatachalam Ramaswamy, Director of the Geophysical Fluid Dynamics Laboratory of the National Oceanic and Atmospheric Administration (NOAA) Office of Oceanic and Atmospheric Research (OAR), studying climate modeling and climate change;

Thomas Schroeder, Chief Judge for the U.S. District Court for the Middle District of North Carolina;

David S. Tatel, United States Court of Appeals for the District of Columbia Circuit; and

Steven R. Kendall, Staff Officer

The meeting comprised five panel presentations, made up of remarkably accomplished and talented speakers. Each panel’s presentations were followed by discussion among the panelists, and the committee members. Some panels answered questions submitted from the public audience. Judge O’Malley opened the meeting with introductory remarks about the purpose and scope of the RMSE, and of the inquiry into additional possible chapters.

  1. Challenges in Evaluating Scientific Evidence in Court

The first panel consisted entirely of judges, who held forth on their approaches to judicial gatekeeping of expert witnesses, and their approach to scientific and technical issues. Chief Judge Schroeder moderated the presentations of panelists:

Barbara Parker Hervey, Texas Court of Criminal Appeals;

Patti B. Saris, Chief Judge of the United States District Court for the District of Massachusetts,  member of President’s Council of Advisors on Science and Technology (PCAST);

Leonard P. Stark, U.S. District Court for the District of Delaware; and

Sarah S. Vance, Judge (former Chief Judge) of the U.S. District Court for the Eastern District of Louisiana, chair of the Judicial Panel on Multidistrict Litigation.

  1. Emerging Issues in the Climate and Environmental Sciences

Paul Hanle, of the Environmental Law Institute moderated presenters:

Joellen L. Russell, the Thomas R. Brown Distinguished Chair of Integrative Science and Professor at the University of Arizona in the Department of Geosciences;

Veerabhadran Ramanathan, Edward A. Frieman Endowed Presidential Chair in Climate Sustainability at the Scripps Institution of Oceanography at the University of California, San Diego;

Benjamin D. Santer, atmospheric scientist at Lawrence Livermore National Laboratory; and

Donald J. Wuebbles, the Harry E. Preble Professor of Atmospheric Science at the University of Illinois.

  1. Emerging Issues in Computer Science and Information Technology

Josh Goldfoot, Principal Deputy Chief, Computer Crime & Intellectual Property Section, at U.S. Department of Justice, moderated panelists:

Jeremy J. Epstein, Deputy Division Director of Computer and Information Science and Engineering (CISE) and Computer and Network Systems (CNS) at the National Science Foundation;

Russ Housley, founder of Vigil Security, LLC;

Subbarao Kambhampati, professor of computer science at Arizona State University; and

Alice Xiang, Senior Research Scientist at Sony AI.

  1. Emerging Issues in the Biological Sciences

Panel four was moderated by Professor Ellen Wright Clayton, the Craig-Weaver Professor of Pediatrics, and Professor of Law and of Health Policy at Vanderbilt Law School, at Vanderbilt University. Her panelists were:

Dana Carroll, distinguished professor in the Department of Biochemistry at the University of Utah School of Medicine;

Yaniv Erlich, Chief Executive Officer of Eleven Therapeutics, Chief Science Officer of MyHeritage;

Steven E. Hyman, director of the Stanley Center for Psychiatric Research at Broad Institute of MIT and Harvard; and

Philip Sabes, Professor Emeritus in Physiology at the University of California, San Francisco (UCSF).

  1. Emerging areas in Psychology, Data, and Statistical Sciences

Gary Marchant, Lincoln Professor of Emerging Technologies, Law and Ethics, at Arizona State University’s Sandra Day O’Connor College of Law, moderated panelists:

Xiao-Li Meng, the Whipple V. N. Jones Professor of Statistics, Harvard University, and the Founding Editor-in-Chief of Harvard Data Science Review;

Rebecca Doerge, Glen de Vries Dean of the Mellon College of Science at Carnegie Mellon University, member of the Dietrich College of Humanities and Social Sciences’ Department of Statistics and Data Science, and of the Mellon College of Science’s Department of Biological Sciences;

Daniel Kahneman, Professor of Psychology and Public Affairs Emeritus at the Princeton School of Public and International Affairs, the Eugene Higgins Professor of Psychology Emeritus at Princeton University, and a fellow of the Center for Rationality at the Hebrew University in Jerusalem; and

Goodwin Liu, Associate Justice of the California Supreme Court.

The Proceedings of this two day meeting were recorded and will be published. The website materials are unclear whether the verbatim remarks will be included, but regardless, the proceedings should warrant careful reading.

Judge O’Malley, in her introductory remarks, emphasized that the RMSE must be a neutral, disinterested source of information for federal judges, an aspirational judgment from which there can be no dissent. More controversial will be Her Honor’s assessment that epidemiologic studies can “take forever,” and other judges’ suggestion that plaintiffs lack financial resources to put forward credible, reliable expert witnesses. Judge Vance corrected the course of the discussion by pointing out that MDL plaintiffs were not disadvantaged, but no one pointed out that plaintiffs’ counsel were among the wealthiest individuals in the United States, and that they have been known to sponsor epidemiologic and other studies that wind up as evidence in court.

Panel One was perhaps the most discomforting experience, as it involved revelations about how sausage is made in the gatekeeping process. The panel was remarkable for including a state court judge from Texas, Judge Barbara Parker Hervey, of the Texas Court of Criminal Appeals. Judge Hervey remarked that [in her experience] if we judges “can’t understand it, we won’t read it.” Her dictum raises interesting issues. No doubt, in some instances, the judicial failure of comprehension is the fault of the lawyers. What happens when the judges “can’t understand it”? Do they ask for further briefing? Or do they ask for a hearing with viva voce testimony from expert witnesses? The point was not followed up.

Leonard P. Stark’s insights were interesting in that his docket in the District of Delaware is flooded with patent and Hatch-Waxman Act litigation. Judge Stark’s extensive educational training is in politics and political science. The docket volume Judge Stark described, however, raised issues about how much attention he could give to any one case.

When the panel was asked how they dealt with scientific issues, Judge Saris discussed her presiding over In re Neurontin, which was a “big challenge for me to understand,” with no randomized trials or objective assessments by the litigants.[3] Judge Vance discussed her experience of presiding in a low-level benzene exposure case, in which plaintiff claimed that his acute myelogenous leukemia was caused by gasoline.[4]

Perhaps the key difference in approach to Rule 702 emerged when the judges were asked whether they read the underlying studies. Judge Saris did not answer directly, but stated she reads the reports. Judge Vance, on the other hand, noted that she reads the relied upon studies. In her gasoline-leukemia case, she read the relied-upon epidemiologic studies, which she described as a “hodge podge,” and which were misrepresented by the expert witnesses and counsel. She emphasized the distortions of the adversarial system and the need to moderate its excesses by validating what exactly the expert witnesses had relied upon.

This division in judicial approach was seen again when Professor Karen Kafadar asked how the judges dealt with peer review. Judge Saris seemed to suggest that the peer-reviewed published article was prima facie reliable. Others disagreed and noted that peer reviewed articles can have findings that are overstated, and wrong. One speaker noted that Jerome Kassirer had downplayed the significance of, and the validation provided by, peer review, in the RMSE (3rd ed 2011).

Curiously, there was no discussion of Rule 703, either in Judge O’Malley’s opening remarks on the RMSE, or in the first panel discussion. When someone from the audience submitted a question about the role of Rule 703 in the gatekeeping process, the moderator did not read it.

Panel Two. The climate change panel was a tour de force of the case for anthropogenic climate change. To some, the presentations may have seemed like a reprise of The Day After Tomorrow. Indeed, the science was presented so confidently, if not stridently, that one of the committee members asked whether there could be any reasonable disagreement. The panelists responded essentially by pointing out that there could be no good faith opposition. The panelists were much less convincing on the issue of attributability. None of the speakers addressed the appropriateness vel non of climate change litigation, when the federal and state governments encouraged, licensed, and regulated the exploitation and use of fossil fuel reserves.

Panel Four. Dr. Clayton’s panel was fascinating and likely to lead to new chapters. Professor Hyman presented on heritability, a subject that did not receive much attention in the RMSE third edition. With the advent of genetic claims of susceptibility and defenses of mutation-induced disease, courts will likely need some good advice on navigating the science. Dana Carroll presented on human genome editing (CRISPR). Philip Sabes presented on brain-computer interfaces, which have progressed well beyond the level of sci-fi thrillers, such as The Brain That Wouldn’t Die (“Jan in the Pan”).

In addition to the therapeutic applications, Sabes discussed some of potential forensic uses, such as lie detectors, pain quantification, and the like. Yaniv Erlich, of MyHeritage, discussed advances in forensic genetic genealogy, which have made a dramatic entrance to the common imagination through the apprehension of Joseph James DeAngelo, the Golden State killer. The technique of triangulating DNA matches from consumer DNA databases has other applications, of course, such as identifying lost heirs, and resolving paternity issues.

Panel Five. Professor Marchant’s panel may well have identified some of the most salient needs for the next edition of the RMSE. Nobel Laureate Daniel Kahneman presented some of the highlights from his forthcoming book about “noise” in human judgment.[5] Kahneman’s expansion upon his previous thinking about the sources of error in human – and scientific – judgment are a much needed addition to the RMSE. Along the same lines, Professor Xiao Li Meng, presented on selection bias, and how it pervades scientific work, and detracts from the strength of evidence in the form of:

  1. cherry picking
  2. subgroup analyses
  3. unprincipled handling of outliers
  4. selection in methodologies (different tests)
  5. selection in due diligence (check only when you don’t like results)
  6. publication bias that results from publishing only impressive or statistically significant results
  7. selection in reporting, not reporting limitations all analyses
  8. selection in understanding

Professor Meng’s insights are sorely lacking in the third edition of the RMSE, and among judicial gatekeepers generally.  All too often, undue selectivity in methodologies and in relied-upon data is treated by judges as an issue that “goes to the weight, not the admissibility” of expert witness opinion testimony. In actuality, the selection biases, and other systematic and cognitive biases, are as important as, if not more important than, random error assessments. Indeed a close look at the RMSE third edition reveals a close embrace of the amorphous, anything-goes “weight of the evidence” approach in the epidemiology chapter.  That chapter marginalizes meta-analyses and fails to mention systematic review techiniques altogether. The chapter on clinical medicine, however, takes a divergent approach, emphasizing the hierarchy of evidence inherent in different study types, and the need for principled and systematic reviews of the available evidence.[6]

The Committee co-chairs and panel moderators did a wonderful job to identify important new trends in genetics, data science, error assessment, and computer science, and they should be congratulated for their efforts. Judge O’Malley is certainly correct in saying that the RMSE must be a neutral source of information on statistical and scientific methodologies, and it needs to be revised and updated to address errors and omissions in the previous editions. The legal community should look for, and study, the published proceedings when they become available.

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[1]  See “Emerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence – Committee Meeting” (Nov. 24, 2020).

[2]  See “Emerging Areas of Science, Engineering, and Medicine for the Courts: Identifying Chapters for a Fourth Edition of The Reference Manual on Scientific Evidence – Committee Meeting 2 (Virtual)” (Dec. 1, 2020).

[3]  In re Neurontin Marketing, Sales Practices & Prods. Liab. Litig., 612 F. Supp. 2d 116 (D. Mass. 2009) (Saris, J.).

[4]  Burst v. Shell Oil Co., 104 F.Supp.3d 773 (E.D.La. 2015) (Vance, J.), aff’d, ___ Fed. App’x ___, 2016 WL 2989261 (5th Cir. May 23, 2016), cert. denied, 137 S.Ct. 312 (2016). See “The One Percent Non-solution – Infante Fuels His Own Exclusion in Gasoline Leukemia Case” (June 25, 2015).

[5]  Daniel Kahneman, Olivier Sibony, and Cass R. Sunstein, Noise: A Flaw in Human Judgment (anticipated May 2021).

[6]  See John B. Wong, Lawrence O. Gostin, and Oscar A. Cabrera, “Reference Guide on Medical Testimony,” Reference Manual on Scientific Evidence 723-24 (3ed ed. 2011) (discussing hierarchy of medical evidence, with systematic reviews at the apex).

Posted in Evidence, Expert Witnesses, Peer Review, Reference Manual on Scientific Evidence, Rule 702, Rule 703, Scientific Evidence | 129 Comments »

Larding Up the Literature

February 20th, 2021

Another bio-medical journal?

In October 2019, The Journal of Scientific Practice and Integrity published its inaugural volume one, number one issue, online. This journal purports to cover scientific integrity issues, which may well not be adequately covered in the major biomedical journals. There are reasons to believe, however, that this journal may be more of a threat to scientific integrity than a defender.

Thenew journal describes itself as:

“an interdisciplinary, peer-reviewed journal that publishes scholarly debate and original research on scientific practices that impact human and environmental health.”

The editorial board reads like a Who’s Who’s list of “political scientists” who testify a LOT for claimants, and who, when not working for the lawsuit industry, practice occupational and environmental medicine for the redistribution of wealth.

David Egilman, contemnor and frequent plaintiffs’ expert witness in personal injury litigation is editor in chief. Tess Bird, an Egilman protégé, is managing editor. Another Egilman protégé, Susana Rankin Bohme, an associate Director of Research at Corporate Accountability International, also sits on the editorial board. You may be forgiven for believing that this journal will be an Egilman vanity press. The editorial board also includes some high-volume testifying plaintiffs expert witnesses:

Peter Infante, of Peter F. Infante Consulting, LLC, Virginia

Adriane Fugh-Berman, of PharmedOut

Barry Castleman,

William E. Longo, President, MAS, LLC

David Madigan,

Michael R. Harbut,

David Rosner, and

Gerald Markowitz

The journal identifies the Collegium Ramazzini as one of its “partners.” Cue the “Интернационал”!

The first issue of this new journal features a letter[1] from the chief and managing editors, Egilman and Bird, which states wonderfully aspirational goals. The trick will be whether the journal can apply its ethical microscope to all actors in the world of scientific publishing, or whether this new journal is just not another lawsuit industry propaganda outlet.

Egilman’s previous editorial perch was at the International Journal of Occupational and Environmental Health, which was published by Maney Publishing. In 2015, the British company, the Taylor & Francis Group, acquired the IJOEH, with Maney’s other journals, and installed a new editor-in-chief, Andrew Maier. Egilman was cast out; hence the new journal.

Egilman’s new journal will feature among other types of articles, “reviews of legal testimony,” as a scholarly subject. It will be interesting to see whether such reviews assess the testimony of lawsuit industry witnesses, as well as manufacturing industry witnesses.

The new journal requires the use of the International Committee of Medical Journal Editors (ICMJE) conflict-of-interest and funding disclosure rules, and the use of the ICMJE form. Accordingly, authors “should” report all conflicts, including:

“[a]ny financial contributions, payments, or funding for the present work;

relevant financial activities outside of the submitted work;

any patents or copyrights broadly relevant to the work; and

any relationships that readers could perceive to influence the submitted work.”

There have been only two issues of Egilman’s new journal so far, but I decided to spot check compliance. The first article[2] I saw was by Colin Soskolne, who has testified for the lawsuit industry in a diacetyl case.[3] Oops; no disclosure.

Does Soskolne’s bias show? In the spot-checked article, authors Sokolne and Baur reprise a publication previously part of a 2018 Collegium Ramazzini convocation entitled “Corporate Influence Threatens the Public Health.” The aim of the convocation speakers was to press their claims that [manufacturing] corporate influence undermines scientific integrity through discernible methods, all by “those in the pay of industry”:

  • infiltrating journal editorial boards by scientists, with the resulting publication of poorly designed, biased research that foments doubt;
  • interfering with “the independent activities of IARC” and similar agencies;
  • blocking “much needed” regulation of “hazardous agents,” such as pesticides and polyfluoroalkyl substances (PFAS); and
  • promulgating causal criteria, which are baseless and which “block workers’ access to legal remedies for occupational illness and premature death.”[4]

There can be little doubt that Soskolne is not interested in messing with “those in the pay of the lawsuit industry.” Soskolne’s biases are fairly clear, clear enough for us to complain that he has not disclosed that he has been compensated by the lawsuit industry, and that he has deep positional conflicts as well. Ironically, he is writing in a journal that itself appears to lack “balance.” The editorial board of the journal for which Soskolne was writing is composed of many of “those in the pay of the lawsuit industry.”

Soskolne is keen to preserve the independence of IARC, but that perceived independence has become a sad, sick joke, with the exclusion of most anyone who has had any working relationship with manufacturing industry, while engaging many with deep ties to the lawsuit industry. Soskolne’s assessment of “much needed” regulation ultimately must be evaluated on the facts and data of each putative toxic substance. If the claim of harmful effects is correct, then regulation may well be “much needed.” If the claim is not correct, then regulation will be much “unneeded.” As for promulgating causal criteria, there is no doubt that the Soskolne, along with the editorial board of this new journal, would like to see the abrogation of causal criteria, so that workers have legal remedies ad libitum.

Soskolne and Baur provide their hit list of the methods of obfuscation or of techniques used to undermine science and policy.[5] There is precious little in their list, however, that is not common place among all journals that publish occupational and environmental epidemiology, including the journals that have been captured by the lawsuit industry’s scientists. Soskolne and Baur also provide a catalogue of how lawsuit industry scientists would subvert science and lock in their biased and selective interpretation of data:

  • elevate biological plausibility into sufficient basis for causal inference
  • conflate species and ignore species differences in order to allow animal studies to suffice for causal inference for humans
  • ignore substantial, relevant biological differences in even slight structural differences among various molecules to enable assertions of harm based upon similar molecular structure of a putative toxic substance

Soskolne ends with a quote from the “pink panthers,” two radical, labor historians, both editorial board members of this new journal, and who both have testified many times for the lawsuit industry:

“[A]s a society, we cannot entrust those with self-interest to be the judge and jury of what is and what is not a danger[;] … that can only lead to compromised science, a questionable decisionmaking process, and a potentially polluted world.”[6]

The pink panthers are, of course, correct, but we must understand that self-interest and conflict of interest can be, and are, both ideological, positional, as well as economic.

[1]  Tess Bird & David Egilman, “Letter from the Editors: An Introduction to the Journal of Scientific Practice and Integrity,” 1 J. Sci. Practice & Integrity 1 (2019).

[2]  Colin Soskolne & Xaver Baur, “How Corporate Influence Continues to Undermine the Public’s Health,” 1 J. Sci. Practice & Integrity 1 (2019), available at DOI: 10.35122/jospi.2019.878137 [cited as Soskolne & Baur]

[3]  See Watson v. Dillon Companies, 797 F. Supp. 2d 1138 (D. Colo. 2011) (addressing Soskolne’s testimony).
[4]  Soskolne & Baur at 1-2.

[5]  Soskolne & Baur at 3.

[6]  Soskolne & Baur at 4, quoting from Gerald Markowitz & David Rosner, “Monsanto, PCBs, and the creation of a ‘world-wide ecological problem’,” 39 J. Pub. Health Policy 463 (2018).

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Scientific Publishing | No Comments »

Dr. Harry Shubin – Asbestos Litigation Hall of Shame

February 19th, 2021

Many physicians took and failed the so-called B-reader examination for proficiency in using the International Labor Office’s grading schema of chest radiographs for pneumoconiosis. Famously, Irving Selikoff was someone who took but failed this examination, and he stopped serving as a clinical expert witness in asbestos cases. No one can say for sure whether there was cause and effect. In Philadelphia, South Jersey pulmonary physician, Dr. Joseph Sokolowski, was a frequent testifier for plaintiffs, despite his having failed the B-Reader examination three times. Sokolowski was conditionally fined and disqualified from testifying in Philadelphia because of his refusal to comply with compulsory process for his B-Reader test results.[1]

The only physician I encountered who lied outright about his B-reader examination results was the late Harry Shubin. Some people may know of Dr. Shubin only because of the “Harry Shubin, M.D. Statesman in Healthcare Administration Award,” presented by the American Academy of Medical Administrators. Indeed, Shubin had a long career in hospital administration. He was graduated from Temple School of Medicine in 1937, and went into family practice, at the age of 22. Later, he specialized in the treatment of tuberculosis and pulmonary disease.[2] Over his long career, he was a patron of the arts and of other charities in Philadelphia.

In 1955, Dr Shubin became the president of the American Academy of Tuberculosis Physicians.[3] In 1958, Shubin was elected head of staff at Pennsylvania General Hospital.[4] He later became the medical director of the Northern Division of Philadelphia General Hospital.

In 1962, along with 18 other physicians, Shubin purchased a 104-bed hospital, known as the Broad Street Hospital, at 739 South Broad Street, for which he would become medical director.[5] When the Jefferson Medical College sold its Barton Memorial Hospital for “diseases of the chest,” including silicosis and coal workers’ pneumoconiosis, at Broad and Fitzwater Streets, the South Broad Street Medical Center, Inc., bought it.  Shubin was the medical director.[6]

Shubin’s career as a medical director suffered in the ensuing decades.[7] In 1970, after a hearing, Dr. Shubin was disqualified by the U.S. Food & Drug Administration from receiving investigational products.[8] And then in 1981, his Center City Hospital, at 1829 Pine Street, closed, under pressure from both Blue Cross and the federal Health Systems Agency.[9]

Perhaps those setbacks explain Dr. Shubin’s foray into the lucrative world of expert witnessing in the asbestos litigation. Shubin started turning up as an expert witness for plaintiffs in hundreds of cases, in 1985. Dr. Peter Theodos, a prominent Philadelphia pulmonary physician had been designated to testify in these cases, but he died while the cases languished due to the huge backlog of asbestos cases in Philadelphia.

Shubin’s qualifications to replace Theodos were thin, Aside from an insignificant paper in a Pennsylvania Medicine,[10] Shubin had not written anything on asbestos or asbestos-related disease. Shubin was, however, a media hound, and in 1985, he was turning up at union halls and town hall meetings across Pennsylvania.[11]

Despite his lack of significant experience and expertise in asbestos-related disease, Shubin could put on a great show for uncritical Philadelphia juries. He was charming and persuasive. His years of public speaking on behalf of his beleaguered hospitals gave him confidence and skills of evasion in the witness box. When confronted with statements from Selikoff’s book or articles, Shubin would chuckle, smile knowingly, and say that he taught Selikoff everything about asbestos. His demeanor was avuncular and cherubic, which made cross-examination even more difficult.

Initially, Shubin testified that he was a B-reader, but after the defense verified his absence from the NIOSH list of certified B-readers, he “modified” his next trial’s testimony to state that he had started, but had not finished, the examination because of an eye problem.

After inquiring at NIOSH and learning that Shubin had finished the examination, defense counsel confronted Shubin yet again, only to have his tale embellished by a claim that he had withdrawn from the examination after finishing because of the eye problem, and wrote to NIOSH to ask that his examination not be evaluated.

In 1986, the leading asbestos plaintiffs’ firm was pushing one of its many cases to trial, with a Shubin report to support its claims.[12] Although the defense expert witnesses had given this plaintiff a clean bill of health, we had sufficient concerned about Shubin’s testimonial skills, that I decided to document Shubin’s perjury on the subject of his B-Reader status.

In 1986, the records’ custodian of B-Reader test results for NIOSH was Mitizie Martin, in Morgantown, West Virginia. After a good deal of procedural wrangling, I was able to obtain a court order that required plaintiffs’ counsel’s appearance for a deposition of Ms. Martin, in Morgantown. I noticed her deposition in all Philadelphia asbestos cases and gave all plaintiffs’ firms notice of the event. And so, in the first week of September, 1986, plaintiffs’ counsel, John DiDonato, and I were on board a small airplane for a bumpy ride to Morgantown, for Ms. Martin’s deposition.[13]

Martin was a wonderful witness. In 1986, she was Chief of the X-ray Receiving Center Section, Division of X-Ray Disease Studies, for NIOSH. She had been with NIOSH or its predecessor for 20 years.[14] Martin explained NIOSH’s role in teaching the A-Reader course, and in administering the B-Reader examination, along with the American College of Radiology, and its record retention policies.

Martin described the B-reader examination, which at the time required a showing of proficiency in interpreting 125 chest films for the presence and absence of various pneumoconiosis, according to the ILO scale.[15]

Finally, and most important, Martin authenticated the Shubin file, and laid a foundation for its admissibility at all future asbestos trials. Shubin had sought to become a B-Reader by taking the required test, in March 1982, in Orlando, Florida.[16] He completed but failed that examination in 1982, after which he wrote to Ms. Martin, to express his desire to take the test again. He made no mention of an eye problem; nor did he request that the 1982 results be disregarded. Martin wrote back to explain that he would have to wait a year before taking the examination again.[17]

Shubin waited three years, but he eventually signed up for, and took, the B-Reader examination a second time, in March 1985, on Kiawah Island, South Carolina. This second attempt resulted in a second failure, and a notification to Shubin that he had received a “failing grade, deficient in most categories.”[18] Shubin had thus taken the B-Reader examination twice, and failed both times. He had never abandoned the test; nor had he written to NIOSH to request a withdrawal from the examination, or to notify the agency of an eye-sight problem.[19]

My then colleague, Terri Keeley, was set to try the next-schedule case in which Dr. Shubin was supposed to have testified, in September 1986. Unsurprisingly, the case resolved. As soon as I received the transcript, I provided a copy gratis to every asbestos plaintiffs’ firm in Philadelphia. The result was that we never saw Dr. Shubin in an asbestos case again. Occasionally, we would receive a Dr. Shubin report, but a quick reminder of the procedural history behind Ms. Mitzie Martin’s deposition testimony sealed his effectual exclusion.

Remarkably, despite the notoriety he had gained in the Philadelphia asbestos litigation, Shubin showed up in the high-profile Paoli Railroad PCB case, as an expert witness on causation.[20] In the Paoli case, Shubin gave rather unscientific testimony that conflated general and specific causation, and assumed that PCBs caused individual plaintiffs’ disease because PCBs can cause disease.[21] As far I can determine, he was never confronted with his perjuries from the Philadelphia asbestos cases.

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[1]  Downing v. Johns-Manville Corp., Philadelphia Cty. Ct. C.P. 1981- 11- 3762, Order sur Motion to Compel Dr. Sokolowski to answer interrogatories and produce documents related to his failure of the B-Reader examination (Mar. 31, 1988).

[2]  “Harry Shubin Obituary,” Phila. Inq. at 25 (Mar. 7, 1997) (Dr. Shbuin died March 2, 1997).

[3]  “News from the Field,” 45 Am. J. Pub. Health 1399 (1955).

[4]  “Pennsylvania General Hospital,” Phila. Inq. at 29 (Mar. 25, 1958).

[5]  “Doctor-Owned Hospital Opens in South Philadelphia,” Phila. Daily News at p.19 (Feb. 5, 1962).

[6]  “Medical Center Sells Building,” Phila. Daily News at 57 (May 5, 1961).

[7]  Frank Dougherty, “11 Hospitals Cut from Blue Cross,” Phila. Daily News at p.3 (Nov. 14, 1972) (Broad Street Hospital cut).

[8]  Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (Mar. 16, 1970).

[9]  Phila. Inq. at 5 (Mar. 18, 1981) (Shubin, medical director).

[10]  Harry Shubin, “Asbestosis: inhalation disease of the lungs,” 88 Pa. Med. 54, 56, 58 (1985).

[11]  See, e.g., “Pat Purcell, Angry Man,” Pottsville Republican (Pottsville, PA) at p.1 (Mar. 14, 1987); Frank Scholz, “Help Coming for Asbestos Victims Living Here,” The Times-Tribune (Scranton, PA Sept. 15, 1985).

[12]  Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981). Years later, I met Mr. Nyman at my sister-in-law’s wedding, where he and his wife were dancing vigorously.

[13]  Deposition of Mitzie Martin, in Ove Nyman v. Johns-Mansville Corp., Phila. Cty. Ct. C.P. (April Term, 1981), taken on Sept. 5, 1986.

[14]  Id. at 3.

[15]  Id. at 7.

[16]  Id. at 12-13.

[17]  Id. at 14.

[18]  Id. at 14-15.

[19]  Id. at 16-19.

[20] In re Paoli R.R. Yard PCB Litig., 706 F. Supp. 358, 364-65 (E.D. Pa. 1988), rev’d, 916 F.2d 829, 840 (3d Cir. 1990), cert. denied, 111 S. Ct. 1584 (1991).

[21]  Susan R. Poulter, “Science and Toxic Torts: Is There a Rational Solution to the Problem of Causation?” 7 High Technology L.J. 189, 238 (1993).

Posted in Asbestos, Expert Witness Hall of Shame, Expert Witnesses | No Comments »

Lawsuit Industry Expert Witness Robert Neel Proctor’s Intimidation Tactics

December 25th, 2020

In his autobiography, Sir Karl Popper described one of the most curious and interesting confrontations in 20th century philosophy. While visiting Cambridge University to give a guest lecture, Popper was hectored by the renown chairman of the philosophy department, Ludwig Wittgenstein. While nervously playing with a fireplace poker and waving it about for emphasis, Wittgenstein challenged Popper to provide an example of a moral rule. Popper rejoined “Not to threaten visiting lecturers with pokers,” after which Wittgenstein threw down the poker and stormed out of the room.[1]

A more recent anecdote in this century gives rise to another moral rule, “thou shalt not bully graduate students working for your adversary.”

The law firm of Jones Day, representing tobacco mega-defendant R. J. Reynolds in personal injury lawsuits, was working with Associate Professor Gregg L. Michel, at the University of Texas. Michel needed research assistants to help with this litigation consulting work, and so in 2008, he reached out to J. Matthew Gallman, a professor of history at the University of Florida, to help line up some worker bees. Gallman helped Michel hire four master-level graduate students from Gallman’s department.

Tobacco lawsuit industry testifier Associate Professor Louis M. Kyriakoudes, at University of Southern Mississippi, learned of the arrangement from his involvement in tobacco litigation. Kyriakoudes shared the information with his fellow-traveling expert witness for tobacco plaintiffs, Robert Neel Proctor.

There was no impropriety in Michel’s hiring the graduate students to assist with his research. Parties are allowed to have consulting expert witness, if for no other reason than to test the accuracy of the other side’s expert witness’s opinions. The research assignment involved searching the archives of a local Pensacola newspaper, in the 1940s, for coverage of smoking’s ill health effects. According to Gallman, the students were “explicitly told not to be selective,” to favor one party or the other.

Proctor was, and still is, a highly paid expert witness for the tobacco lawsuit industry, that is the plaintiffs’ bar, and a regular feature of tobacco trials. After learning the names of the graduate students from his litigation work, Proctor in turn contacted Professor Vassiliki Betty Smocovitis, who held joint appointments in the University of Florida history and biology departments.[2]

In a fairly obvious effort to intimidate and harass the students, Proctor revealed the students’ names to Smocovitis, and pressed his tendentious, gratuitous opinion:

“In my view this is historical malpractice, and I would be very interested to know if the advisers of these students know what they have been doing.”

Smocovitis, who had never been involved in litigation as a partisan expert witness, dutifully carried out the inquiry for Proctor, only to find, unsurprisingly, that her colleagues did not believe that the students had done anything improper. According to her emails, Smocovitis reported back to Proctor that her departmental colleagues were indifferent or annoyed or both for her having bothered them with Proctor’s issue. She told Proctor that “I’m afraid that this is a case of ‘shoot the messenger’, so I can’t persist without alienating myself further,” She resisted Proctor’s importuning to raise the issue at a faculty meeting.

Lawyers at Jones Day sought emails of Proctor and Kyriakoudes from their university servers, and ultimately took depositions of Proctor and Kyriakoudes, the plaintiffs’ expert witnesses, and Smocovitis, in support of motions to sanction Proctor. Michel filed an affidavit in which he described how one of the four students had been led to believe by her departmental chairman, Joseph F. Spillane, that Proctor intended to publish her name.

Kyriakoudes, who dropped the dime on the graduate students, suggested in his deposition that Proctor’s intrusion into the University of Florida department was a “tactical mistake.” According the Chronicle of Higher Education, he testified that “[t]his whole business of getting involved in a department’s activities like this is just—it’s caused no end of trouble.”

In his own deposition, Proctor described the communications as:

“legitimate scholarly inquiry into the participation of historians in litigation.”

* * *

“I was simply raising an ethical issue that she might want to discuss.”

Sort of like Trump’s perfect conversation with President Volodymyr Zelensky. In Trumpian turn-around, Proctor complained that he was real victim of witness harassment and bullying by the defense counsel, in an effort to “silence him.” Ah, the flexibility of historical narrative!

What really seemed to irk Proctor was that any historian, even master-level graduate students, would disagree with him, or find historical evidence that embarrassed Proctor’s litigation positions. Proctor’s blindness to his own bad behavior in the recent past, certainly raises questions about his historical acumen.

Proctor’s play at grievance victimhood was amplified by the obsequious scholarship of Jon Wiener. In the pages of The Nation, Wiener incorrectly reported that “[n]othing improper was found, no witness tampering or intimidation, and the tobacco attorneys dropped the issue–for a while.”[3] In fact, as an historical matter, Wiener was quite wrong.

Judgment Day

The Jones Day lawyers’ motion claimed that Proctor’s improprieties was part of a pattern of behavior that stemmed from his “uncontrolled zeal to win.” Proctor, a paid advocate for the tobacco lawsuit industry, thought it was within his mandate to expose the connection between tobacco defense and historians. In doing so, he engaged in witness tampering and harassment. Proctor and his employers in the lawsuit industry responded with an attempt to portray Proctor’s ham-fisted inquiries as concern for the vulnerable graduate students who were not receiving “guidance,” which would impair their future careers.

The Motion contra Proctor came before Judge Williams Parsons, in the Volusia County Circuit Court.[4] Contrary to the Wiener report, Judge Parsons found that Proctor indeed had intended to harass and humiliate the students into abandoning their litigation support work. Judge Parsons described Proctor’s willingness to advance the plaintiffs’ case at the students’ expense as “appalling,” and “the lowest of the low.” The defense had sought Proctor’s exclusion, but Judge Parsons declined to impose this extreme sanction in favor of barring Proctor from having any contact with adversary expert witnesses or their assistants.

Conduct the following thought experiment. Imagine an historian who testifies for the defense in tobacco litigation finds out that Proctor had hired graduate students to help with research. The defense historian calls up the students’ supervisors to suggest that they are acting unethically and unprofessionally. Now close your eyes and listen to the outcry from the Wieners of the world, or from the American Historical Association! Even after the ugly facts were disclosed, there were some in in the academic historian establishment who rallied to Proctor’s defense, and tried to give Wiener cover for his mendacious coverage of the graduate student incident.[5]

Lancet-ing Adversary Expert Witnesses

Proctor’s attempt to exploit vulnerable history graduate students was not his first attempt to silence historians who disagree with him. Proctor, who has stridently criticized tobacco defense counsel for trying to “silence him,” has worked assiduously to try to silence historians who work for the other side. In a commentary piece in The Lancet, Proctor criticized colleagues who have worked on historical issues for tobacco companies’ legal defense.[6] Proctor substantively criticized his adversaries’ testimony, without providing much in the way of detail, and he implied that their work was ethically improper and rife with conflicts of interest. Perhaps more telling, Proctor himself gave conflicts disclosure that he had “worked on several occasions as an expert witness in plaintiff’s lawsuits,” without telling his readers that he was highly compensated for work.

Proctor’s one-sided analysis provoked spirited opposition from several distinguished medical historians who refused to be bullied or to acquiesce in his moral grandstanding. John C. Burnham, a Professor of History at The Ohio State, wrote a scathing letter to the Lancet’s editors, as well as opinion pieces in History News Network.[7] David Rothman, a professor at Columbia University, similarly took Proctor to task for his pretensions of doing “history” while testifying for the lawsuit industry.[8]

Perhaps the most telling rebuttal came from Professor Alan Blum, a physician and anti-tobacco activist. Dr. Blum, who is the Director of Center for the Study of Tobacco & Society, and a chaired professor at the University of Alabama, is a leading authority on the history of tobacco use and the depradations of the tobacco industry. Professor Blum found Proctor’s animadversions a bit too sanctimonious given that Proctor himself has been a compensated expert witness for the tobacco lawsuit industry.[9]

Conflicted Friends of the Court

The friend of the court brief, from disinterested third parties, is an important, potentially useful source of extra-record information and opinion for judges, both in trial and appellate courts. Historians can on occasion have important historical information, necessary for adjudication. For instance, in the theocratic zeal to strip women of their reproductive rights, historians have adduced important scholarship that abortion was lawful in all thirteen colonies at the time of the Constitutional ratification.  In the context of amicus briefs, historians of course can and do overstep their distinterested roles to act as legal advocates.[10]

Speaking of overstepping, Robert Proctor filed an amicus brief in Altria Group, Inc. v. Good, which involved a tobacco industry’s challenge to Federal Trade Commission control of advertising for “light” or “lowered tar” cigarettes.[11] Accompanying Proctor were four other signatories, Allan M. Brandt, David M. Burns, Jonathan M. Samet and David Rosner.

All except for Brandt had testified multiple times as expert witnesses. Brandt, Proctor, and Samet acknowledged having testified as expert witnesses in United States v. Philip Morris USA, Inc.[12] They all conveniently forgot to note that they were remunerated, and that they had testified against Philip Morris USA, Inc. Burns, who testified as an expert witness in United States v. Philip Morris USA, Inc., failed to mention his testimonial role in that case, as well as many other tobacco cases in support of the lawsuit industry. Rosner, who had not testified in tobacco cases, failed to mention his many paid testimonial adventures for the lawsuit industry.[13]

[1] Karl Popper, Unended Quest: An Intellectual Autobiography at 141-43 (rev. ed. 2005), first published as “Autobiography by Karl Popper,” in Paul Arthur Schlipp, ed., The Philosophy of Karl Popper (1974). The incident is the subject of a book-long inquiry. David Edmonds & John Eidinow, Wittgenstein’s Poker: The Story of a Ten-Minute Argument Between Two Great Philosophers (2001).

[2] Peter Schmidt, “Big Tobacco Strikes Back at Historian in Court,” The Chronicle of Higher Education (Nov. 8, 2009).

[3] Jon Wiener, “Big Tobacco and the Historians: A tale of seduction and intimidation,” The Nation (Feb. 25, 2010).

[4] Nathan Crabbe, “UF students caught in middle of tobacco case’s controversy,” The Gainesville Sun (Dec 8, 2009).

[5]  See “More debate over Jon Wiener’s tobacco exposé,” History News Network (Dec. 13, 2010).

[6] Robert N. Proctor, “Should medical historians be working for the tobacco industry?” 363 Lancet 1173 (2004).

[7] John C. Burnham, “Medical historians and the tobacco industry,” 364 Lancet 838 (2004); John C. Burnham, “In Defense of Historians as Expert Witnesses: A Rebuttal to Jon Wiener,” History News Network (Mar. 29, 2010).

[8] David Rothman, “Medical historians and the tobacco industry,” 364 Lancet 839 (2004). See also Patricia Cohen, “Historians for Hire in Industry Lawsuits,” N.Y. Times (June 13, 2003) (quoting David J. Rothman,  director of the Center for the Study of Science and Medicine at the Columbia College of Physicians and Surgeons, concludes, “To enter the courtroom is to do many things, but it is not to do history”).

[9] Alan Blum, “A Dissenting View of Robert Proctor by a Fellow Anti-Smoking Advocate,” History Network News (April 26, 2010).

[10] Nell Gluckman, “Why More Historians Are Embracing the Amicus Brief,” The Chronicle of Higher Education (May 3, 2017) (quoting Harvard history professor Tomiko Brown-Nagin’s observation that “[t]o be a legal advocate is freeing”; Brown-Nagin filed an amicus brief in the 2013 Supreme Court case involving racist policies at the University of Texas).

[11]  Amicus Brief of Allan M. Brandt, Robert N. Proctor, David M. Burns, Jonathan M. Samet & David Rosner, in Support of Petition for Certiorari, in Altria Group, Inc. v. Good, No. 07-562, 2008 WL 2472390, (U.S. Supreme Court June 18, 2008).

[12] United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D.D.C. 2006).

[13] “The Amicus Curious Brief” (Jan. 4, 2018) (describing Rosner and many other plaintiffs’ expert witnesses’ failure to disclose their testimonial conflicts of interest when writing and filing an amicus brief in litigation that directly affected the economic viability of their testimony in asbestos cases for the lawsuit industry).

Posted in Expert Witness Discovery, Expert Witnesses, Historian Testimony | Comments Off on Lawsuit Industry Expert Witness Robert Neel Proctor’s Intimidation Tactics

Historical Malfeasance from Lawsuit Industry Expert Witnesses

July 31st, 2020

“The slickest way in the world to lie is to tell the right amount of truth at the right time-and then shut up.”

― Robert A. Heinlein, Stranger in a Strange Land

Is David Rosner’s and Gerald Markowitz’s ToxicDocs Website Really A Scholarly Enterprise?

In past posts,[1] I have called attention to a project launched by historian David K. Rosner and others to provide a free, web-based database of industry “secret” documents that come out of litigation files. Rosner and his frequent co-author, Gerald Markowitz, organized a group of sycophantic, lawsuit industry acolytes – both lawsuit industry consultants and lawyer – to write endorsements in a special issue in the Journal of Public Health Policy.[2]

The ToxicDocs project has received a warm embrace from Rosner’s fellow travellers,[3] and perhaps more disturbing, funding, to the tune of almost half a million dollars, from the National Science Foundation.[4]

The Abstract for the National Science Foundation grant is both incredibly revealing, and concealing:

“This award supports a research infrastructure project called ToxicDoc. It will enable easy access and use of millions of documents for multi-disciplinary research. Recent class-action tort litigation has unearthed millions of previously secret internal records from private firms responsible for wide-scale introduction of toxic substances, such as asbestos and polychlorinated biphenyls (PCBs). These documents include memos between executives, unpublished scientific studies, planning documents for public relations campaigns, letters to policymakers, and trade association meeting minutes.

Although technically part of the public record, this material is extremely hard to access, even for scientific researchers. ToxicDocs will provide a critical intellectual resource for scholars in multiple fields examining health, toxics, and corporate action. Expected users include scholars in environmental and health history, critical legal studies, hazards geography, environmental health and environmental justice research.

*** Without taking any particular side, ToxicDocs will provide an empirical base for informed policy debates that are grounded in key historical records.” (emphasis added)

The project is, in my view, a great deception for several reasons.

First, despite the claims of novelty, the concept is a rehash of tobacco industry documents that have been up and running on the internet for many years.[5]

Second, many if not most of the documents are, and have been, in the public domain for a long time. There are many transcripts and documents that were offered in open judicial proceedings, without any protective or confidentiality orders.

Third, the database has been sanitized to protect against disclosure of the lawsuit industry’s misdeeds. You will not find the infamous Barron & Budd memorandum, which provided instructions to asbestos plaintiffs on how to lie at depositions. You will not find the secret correspondence between plaintiffs’ lawyers and their expert witnesses about how to abridge their historical researches to avoid unfavorable revelations. You will not find any evidence of the unlawful and unethical schemes, by the lawsuit industry, to conduct mass screenings and manufacturing of claims in various mass tort litigations, including the asbestos, silica, and welding litigations.

Fourth, the database is grossly incomplete because many correlative documents that modify, qualify, or even reverse the meaning of databased documents are absent. Rosner’s database is a sham because it is deceptively imbalanced and misleading in its content. Contrary to the abstract on the National Science Foundation’s website, ToxicDocs most definitely takes a “particular side,” invariably the side of the lawsuit industry.

Let me give you some examples of omissions, relating to Gerrit W.H. Schepers, who was a participant in developing knowledge about asbestos hazards, and a frequent testifier for the lawsuit industry on general and specific causation of asbestos diseases, as well as the historical development of knowledge of those diseases.

In ToxicDocs, you will find entries for some testimony about Schepers, extolling his writings on asbestos and his role at the Trudeau Institute, at Saranac Lake, New York, usually by lawsuit industry expert witnesses, such as Barry Castleman. You will find examples of people within manufacturing industrial concerns that criticize Schepers, especially after he entered the fray as a partisan testifying expert witness for the lawsuit industry. What you will not find in ToxicDocs are many examples of Schepers’ testimony, and specifically some of his more outlandish testimony.

Schepers testified frequently. Indeed, he testified so often that he came to see himself as seemingly a “performing seal” for the lawyers who called him.[6] As a testifying expert witness, Schepers was certainly as slippery as a seal.

The first time I went off to cross-examine Dr. Gerritt Schepers was in a New Jersey case, brought by an Owens-Corning Fiberglas plantworker, who worked on making OCF’s Kaylo insulation.[7] The plantworker had undeniable asbestos exposure from which he had developed peritoneal mesothelioma. During his years of employment, Owens-Corning had used both chrysotile and amosite in manufacturing Kaylo. The amosite supplier was in South Africa and judgment proof, but the plaintiff’s lawyer was able to sue Carey-Canada, Inc., a Canadian chrysotile mining company for its supply to the factory. One other chrysotile supplier had settled, and the third, Johns-Manville was in bankruptcy.  In this plantworker case, I represented Carey-Canada in what turned out to be one of its last cases in the United States, before filing for bankruptcy. After a hard fought trial, in which the plaintiff’s estate called Schepers and other expert witnesses, the Camden County jury returned a no-cause verdict on the mesothelioma claim. You will not find the trial transcript of Schepers’ testimony, whether direct or cross-examination, in ToxicDocs.

A year later, I saw Schepers again, in a New Jersey case.[8] He was again a paid expert witness, this time to testify about “state of the art,” and he was as wily as ever, in providing some wild testimony. Here is a flavor:

Q. Back in the 1950s Doctor Hueper 20 was fairly well regarded as an expert in industrial medicine?

A. No. No. No. No. He was a — he was a pathologist, epidemiologist, whose main focus was cancer, not all of the industrial medicine or hygiene, and his focus was almost singularly on the issue of relationship between industrial processes and cancer. That’s about the only way I can answer that question.

Q. All right. Was he regarded – was [sic] his opinions regarded — well regarded in the 1950s?

A. Oh, my goodness, some — some people thought that he was criminally irresponsible, and others thought he was a genius. I can’t answer that question.

Q. Did some think he was irresponsible because he rejected the association between smoking and lung cancer?

A. No. No. No. No. It is because he blamed everything, he blamed he just blamed everything as a cause. By then he got to the stage where you could get cancer from riding down the highway. You could get cancer from working with silica bricks, all things that are — you know, had been disproven, so forth.[9]

After this criminal indictment of Hueper, I chose to ratchet down the examination and ask about a less nefarious character:

Q. Let me though ask you about Doctor or Professor Philip Drinker. He was not a physician but he was an industrial hygienist.

A. No, he was an engineer.

Q. He was actually on the faculty of the Harvard School of Public Health?

A. Yes.

Q. And he was a well respected figure in industrial hygiene?

A. Yes. Yes.

Q. And, in fact, I believe that you had dedicated one of your books to him; is that correct?

A. Yes.[10]

An interesting colloquy, considering that Drinker is demonized by the ToxicDoc historians, and Drinker’s works are largely absent from the ToxicDoc database, as was my deposition transcript, and many others like it.

The Biological Action of Talc and Other Silicate Minerals

In 1973, Schepers published a written statement of his views on the carcinogenicity of talc, tremolite, chrysotile, and crocidolite.[11] Schepers’ paper, which was published in an Information Circular of the United States government, pronounced that the

“[p]roliferation of pleural mesothelium is a classical sequel to crocidolite exposure which leads to neoplasis (mesothelioma) in a high proportion of cases.”[12]

Indeed, the only suggestion of the cause of mesothelioma in this 1973 government publication by Schepers was crocidolite asbestos.[13]

A copy of Schepers’ 1973 paper is not in the ToxicDocs database.

Schepers’ Letter to Grover Wrenn

Three years later, on July 19, 1976, Schepers wrote to Grover Wrenn, who was, at the time, the Chief of the Division of Health Standards Development, in the Occupational Safety and Health Administration, within the Department of Labor, in Washington.

The subject of Schepers’ letter was “Scientific Data on Fibrous Minerals and Beryllium.” According to Schepers’ letter, he was following up on his recent meeting with Wrenn, by sending represents and copies of articles on asbestos and beryllium, which were under intense scrutiny from OSHA at the time.

In his letter to Wrenn, Schepers summarized his views at the time:

“As you can see, my researches cast considerable doubt on the proposition that [A]merican fibrous minerals are carcinogenic. I am not one of those who doubt the carcinogenicity of everything. To the contrary, I believe I have helped prove that some environmental pollutants are carcinogenic. For this reason, you may perhaps accept the credibility of my findings when I state that I could detect no evidence of carcinogenicity for either chrysotile, talc or fiberglass.”

Schepers’ letter to Grover Wrenn is not in ToxicDocs.

Schepers’ Letter to Navy Captain D. F. Hoeffler

By 1978, the Navy was up to its gunnels in asbestos claims, and Schepers sensed an opportunity. On March 10, 1978, Schepers wrote to Captain D.F. Hoeffler, who with the Medical Corps in the Bureau of Medicine and Surgery, in the Department of the Navy. His intent was clear; he was looking for consulting work in connection with lawsuits. His letter was a remarkable snap shot of what an ostensible expert on asbestos was thinking and writing about fiber type and cancer in 1978, and so I am reproducing the letter in full:

Dear Captain Hoeffler:

A multitude of duties and interruptions delayed my response to your telephone inquiry of a few weeks ago. You desired some details concerning my experience with the pneumoconioses. I had to dig through some boxes to get you this material and some we had to Xerox afresh.

Here is a CV and some reprints which will possibly be helpful. Since I have been involved with so many things my expertise with respect to asbestosis is somewhat hidden among the rest. For emphasis therefore let me summarize that my clinical and research involvement with asbestosis and thus also lung cancer spans some thirty years. I commenced this work in South Africa, where as a pulmonary medical director for the pneumoconiosis Bureau we researched the working conditions and health of all employee of that countries[sic] extensive crocidolite and amosite mines an industries. The fact that mesotheliomatosis can be associated with exposure was first discovered by me during 1949 at the Penge-Egnep mines in the Eastern Transvaal. It is also important to know that only one out of three persons who develop mesothelioma ever was exposed to asbestos dust. The Institute for Pneumoconiosis Research which I started there has abundant evidence about this.

In the USA I next studied the asbestos problem for the Quebec Government and the Johns Manville Company and also for various asbestos producing companies. This embraced research on human subjects, lung tissue and experimental animals. The net result of my fifteen years of work in this field here has been to convince me that chrysotile, which is the North American type of asbestos, is relatively innocuous as compared to the African and Russian varieties. I have never seen a case of lung cancer develop in any person exposed to chrysotile only. However I have seen plenty of lung cancers in asbestos workers. This is because most asbestos workers also are exposed to carcinogenic materials other than asbestos and all the cases with lung cancer also were chronic lung self-mutilators through cigarette smoking. In a rather major set of experiments of mine I exposed animals to the most potent known carcinogen (beryllium sulphate) and then exposed them to asbestos (chrysotile) dust. These animals had fewer cancers than those exposed to the beryllium sulphate. So chrysotile is not even a significant co-carcinogen. I reversed the order of the exposure, namely asbestos (chrysotile) first and then the BeSO4. The result was the same. The animals exposed only to chrysotile never developed any lung cancers.

I probably have the largest collection of asbestosis case materials, having been a consultant to hundreds of physicians. I have a very detailed knowledge of what various types of asbestos can an cannot do to the lungs. If my command of this subject can be of any cse [sic] to the Navy in the current law suit please feel to use my services as you deem fit.

Other reprints will be forwarded in separate packages as I locate them. I am still extricating myself from my recent move.

Sincerely,

Gerrit W. H. Schepers, MD, Sc.D.

Aside from implicating smoking as the overwhelming, most important cause of lung cancer, Schepers exculpated chrysotile (the North American asbestos fiber) from causing cancer. At the same time, he pointed the finger to asbestos mined in the Transvaal, which was mostly amosite but with some crocidolite, as the cause of mesothelioma.[14] Indeed, the Transvaal was the source of almost all of world’s supply of amosite and much of its crocidolite. Schepers dates his “discovery” to 1949, a full decade and some before the date typically given for the discovery by Christopher Wagner.[15] A search of Schepers’ publications fails to show that he ever published his “discovery,” even after he came to the United States in the early 1950s. At the time, American companies were importing considerable South African amphibole asbestos, which was used a wide variety of products, including asbestos-containing insulation.

A disinterested historian might have that this letter should have been included in a database of historical documents about who knew what and when, but…

Schepers’ Letter to Captain D. F. Hoeffler is not in ToxicDocs.  

This exercise about Schepers could and should be repeated on any number of other topics and writers. It is hard to escape the conclusion that ToxicDocs is not a true research historical archive. It is designed by, and for, historians who advocate for the lawsuit industry. As such, the database frames the issues of historical knowledge as manufacturing industry versus individuals, without a meaningful exploration of what labor unions and the government knew and did when they had control over exposures to various chemicals, dusts, and materials.

What a waste of taxpayers’ money!

[1]  “ToxicHistorians Sponsor ToxicDocs” (Feb. 1, 2018); “Creators of ToxicDocs Show Off Their Biases” (June 7, 2019);  “David Rosner’s Document Repository” (July 23, 2017).

[2]  David Rosner, Gerald Markowitz, and Merlin Chowkwanyun, “ToxicDocs (www.ToxicDocs.org): from history buried in stacks of paper to open, searchable archives online,” 39 J. Public Health Pol’y 4 (2018); Anthony Robbins & Phyllis Freeman, “ToxicDocs (www.ToxicDocs.org) goes live: A giant step toward leveling the playing field for efforts to combat toxic exposures,” 39 J. Public Health Pol’y 1 (2018); Robert N. Proctor, “God is watching: history in the age of near-infinite digital archives,” 39 J. Public Health Pol’y 24 (2018); Stéphane Horel, “Browsing a corporation’s mind,” 39 J. Public Health Pol’y 12 (2018); Christer Hogstedt & David H. Wegman, “ToxicDocs and the fight against biased public health science worldwide,” 39 J. Public Health Pol’y 15 (2018); Joch McCulloch, “Archival sources on asbestos and silicosis in Southern Africa and Australia,” 39 J. Public Health Pol’y 18 (2018); Sheldon Whitehouse, “ToxicDocs: using the US legal system to confront industries’ systematic counterattacks against public health,” 39 J. Public Health Pol’y 22 (2018); Elena N. Naumova, “The value of not being lost in our digital world,” 39 J. Public Health Pol’y 27 (2018); Nicholas Freudenberg, “ToxicDocs: a new resource for assessing the impact of corporate practices on health,” 39 J. Public Health Pol’y 30 (2018).

[3]  Pamela Aaltonen, APHA President, “Science and Industry: Let’s Agree on Goals and Shared Wins,” 109 Am. J. Pub. Health 949 (2019); Carla Cantor, “ToxicDocs Exposes Industry Misdeeds” Columbia Magazine (Summer 2019); Tik Root, “In ToxicDocs.org, a Treasure Trove of Industry Secrets,”  Undark (Jan. 10, 2018); Celeste Monforton, “Public health historians make open to us a treasure trove of industry documents,” Pump Handle (Jan. 26, 2018) (praise from SKAPP co-conspirator); Susan M. Reverby, “Historical Misfeasance: Immorality to Justice in Public Health,” 107 Am. J. Public Health 14 (2017); Merlin Chowkwanyun, “Big Data, Large-Scale Text Analysis, and Public Health Research,” 109 Am. J. Pub. Health S126 (2019) (the author is associated with the Center for the History and Ethics of Public Health, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University); Sheldon Krimsky & Carey Gillam, “Roundup litigation discovery documents: implications for public health and journal ethics,” 39 J. Public Health Policy 318 (2018); Xaver Baur, Colin L. Soskolne & Lisa A. Bero, “How can the integrity of occupational and environmental health research be maintained in the presence of conflicting interests?” 18 Envt’l Health 1 (2019); Gerald Markowitz & David Rosner, “Monsanto, PCBs, and the creation of a ‘world-wide ecological problem’,” 39 J. Public Health Policy 463 (2018).

[4]  “Columbia Professors Receive NSF Grant to Expand ToxicDocs Project” Ass’n Schools & Programs of Public Health (Aug. 16, 2018) (reporting that David Rosner and Merlin Chowkwanyun in Columbia’s department of sociomedical sciences received a grant of $457,649 from the National Science Foundation (NSF) for support of their ongoing ToxicDocs project).

[5]  The tobacco litigation has spawned several such on-line repositories: “Truth Tobacco Industry Documents Library,” Tobacco Archives,” and “Tobacco Litigation Documents.” Rosner’s efforts to create a public library of the documents upon which they rely in litigation harkens to earlier websites. See David Heath & Jim Morris, “Exposed: Decades of denial on poisons. Internal documents reveal industry ‘pattern of behavior’ on toxic chemicals,” Center for Public Integrity (Dec. 4, 2014). Even before the tobacco document repositories were online, lawsuit industry expert witness, David Egilman, sponsored a website (www.egilman.com), now defunct, on which he provided his references and materials upon which he relied in giving testimony.

[6]  Testimony of Gerrit Schepers at 49:9-12 (July 25, 1990), in Hill v. Carey-Canada, Inc., N.J. Super. Ct., Law Div. for Camden Cty., Docket-051429-84.

[7]  Id.

[8]  Deposition of Gerrit W. H. Schepers, in Hadcliff v. Eagle-Picher Inc., N.J. Super. Ct., Law Div. for Gloucester Cty., Docket W-023456-88 (June 14, 1991).

[9]  Id. at 234:19 – 235:15.

[10]  Id. at 236:1-17.

[11]  Gerrit W. H. Schepers, “The Biological Action of Talc and Other Silicate Minerals,” in Goodwin, Proceedings on the Symposium on Talc; U.S. Dep’t Interior Information Circular 8639 (1973).

[12]  Id. at 65.

[13]  Id. at 68.

[14]  James I. Phillips, David Rees, Jill Murray and John C.A. Davies, “Mineralogy and Malignant Mesothelioma: The South African Experience,” Chap. 1, in Carmen Belli & Santosh Anand, eds., Malignant Mesothelioma (2012). See also G.J. V. Clarence, “Amosite asbestos,” 33 Transactions Geol. Soc’y So. Africa 5 (1930); L. Reinecke & L. McClure, “Variations in the quality of amosite asbestos at Penge, Transvaal,” 37 Transactions Geol. Soc’y So. Africa 29 (1934); Bruce Cairncross & Roger Dixon, Minerals of South Africa; The Geological Society of South Africa (1995).

[15]  See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).

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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).

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

June 5th, 2020

 Legislative Initiatives – The Asbestos Fairness in Compensation Act

Over the years, Congress has considered various possible solutions to the problem of asbestos liability. One proposed reform bill, which bore the title “Asbestos Fairness in Compensation Act,” was specifically motivated by a concern about the quality of the expert opinions that fueled the asbestos litigation tsunami.[1] The Report by the Senate Judiciary Committee for this bill commented on its view of medical testimony in asbestos cases:

“Defendants’ rights are further compromised when courts lack the resources to monitor the medical evidence submitted by plaintiffs.  A study by neutral academics showed that forty-one (41 %) percent of audited claims of alleged asbestosis or pleural disease were found by trust physicians to have either no disease or a less severe disease than alleged by the plaintiffs’ experts (for example, pleural disease rather than asbestosis).”[2]

A key part of the bill sought to establish a process to ensure that claims would be based upon sound medical science.  As the Senate Report explained the legislative goal:

“4. Diagnostic and latency criteria

Asbestos claimants must meet diagnostic and latency criteria to be compensated by the Fund.  The diagnostic criteria should reflect the typical components of a true medical diagnosis by a claimant’s doctor, including an in-person physical examination (or pathology in the case where the injured person is deceased) and a review of the claimant’s medical, smoking and exposure history by the doctor diagnosing an asbestos-related disease.  These requirements ensure that the claimant will be given a meaningful diagnosis related to the claimant’s condition.  The diagnosis must also include consideration of other more likely causes of the condition to ensure that asbestos exposure was the cause of any claimed nonmalignant disease (as opposed to other industrial dust exposure) or a substantial contributing factor in causing a malignant disease….”[3]

A number of the bill’s specific provisions sought to limit payments to only claimants who could qualify under properly validated medical criteria. This bill, like all those before it, died on the Hill.

The Health Care Quality Improvement Act of 1986

In 1986, Congress passed the Health Care Quality Improvement Act (“HCQIA”)[4], which was prompted by concerns that fear of litigation would deter hospitals, physicians and others from carrying out peer review of unprofessional conduct and from providing candid assessments to peer review bodies.  The Act gave all participants in a qualifying “professional review action” immunity from being held liable in damages “under any law of the United States or of any State (or political subdivision thereof) with respect to the action.”[5]  One of the immunized entities is a “professional review body,” a term defined by HCQIA to mean “a health care entity and the governing body or any committee of a health care entity which conducts professional review activity, and includes any committee of the medical staff of such an entity when assisting the governing body in a professional review activity.”[6]  Moreover, another provision of the Act[7] provides immunity from damages to any person “providing information to a professional review body regarding the competence or professional conduct of a physician. . . .unless such information is false and the person providing it knew such information was false.”

The HCQIA has given rise to litigation over whether it protects professional review bodies from defamation cases involving litigation opinions. If medico-legal opinions are within the scope of the practice of medicine, then a potentially important method for curbing unscrupulous expert witnesses and false or exaggerated opinion testimony might consist of peer review actions through professional associations or state medical boards.

In Florida litigation, an intermediate appellate court held that the Florida Medical Association did not have immunity under the HCQIA for having provided procedures for pressing complaints against medical expert witnesses for unprofessional conduct.[8] The state law that might be invoked to curb meretricious testimony by licensed physicians, through professional associations or medical licensing boards, remains a hodge-podge.[9]

The American Bar Association’s Resolution Condemning Screenings and Calling For Impairment Criteria in Asbestos Litigation

Part of the impetus for federal legislative reform of asbestos litigation and its diagnostic gamesmanship came from an American Bar Association (ABA) recommendation of enacting impairment requirements for asbestos non-malignant personal injury cases.[10]  Acting upon concerns of court dockets backlogged by unimpaired and false-positive and bogus asbestosis cases, many of which arose out of mass screenings, the ABA urged that limitations rules be relaxed so as not to require the filing of unimpaired cases and that compensation be limited to cases that have demonstrable objective evidence of physical impairment due to asbestosis.  The ABA Report helped to instigate asbestos tort reform efforts in Congress, as well as several successful state legislative efforts.

State Tort Reform Acts for Reliable Diagnostic and Impairment Criteria in Asbestos and Silica Cases

While Congress floundered on litigation reform of the asbestos racket, several states enacted meaningful procedural and substantive changes to address some of the more abusive medical screening practices in asbestos and silica cases.  Texas, Georgia, Florida, and Ohio have enacted remedial legislation that requires a demonstration of objective pulmonary impairment.  In some instances, the tort reform measures specify that the diagnosing physician have a patient-physician relationship with the claimant.  This requirement was aimed at chilling the efforts of itinerant, out-of-state screening physicians, whose conduct came under scrutiny in In re Silica.[11]

Daubert, Its Progeny, and Amended Rule of Evidence 702

The Supreme Court’s opinion in Daubert was not only a watershed in the analysis of expert evidence generally but also reflected specific concerns about expert testimony in the area of product liability litigation. Daubert itself was a pharmaceutical product liability case, as were Joiner and Kumho Tire.  Medical causation is one of the key issues in every product liability case, and the pressure to produce an opinion, whether inculpatory or exculpatory, will occasionally distort a fragile epistemic foundation that will not support a conclusion with any certainty.  In In re Silica, the prospect of creating a mass tort out of whole cloth seems to have had just such a distorting influence.[12]

As noted by Judge Jack, in making the reliability inquiry, the trial judge has the responsibility “to make certain that an expert … employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”[13] Typically, this requirement of “intellectual rigor” means that physicians proffering a diagnosis for litigation purposes must employ the same standards and practices in reaching that diagnosis that they would use in their regular, non-litigation practice of medicine.

Judge Jack was not writing on a completely blank slate in finding the silicosis diagnoses to be bogus in the MDL cases. A few years earlier, the Fourth Circuit affirmed the exclusion of a physician expert witness who insisted upon a “hands-on” examination in his medical practice, but who did not bother to examine the plaintiff personally in a case involving a failed spinal fusion.[14] Standing alone, the physician expert witness’s failure to conduct a physical examination might not have required exclusion, but the deviation from his own established, non-litigation practice provided a persuasive showing that the expert witness “did not employ in the courtroom the same methods that he employs in his own practice,” which required exclusion.[15]

A similar example of gatekeeping occurred in Ingram v. Solkatronic Chemical, Inc.,[16] where the trial judge excluded the testimony of a medical expert witness who opined that plaintiff had been injured by exposure to arsine gas.  At his deposition, the expert witness “outlined his standard diagnostic protocol when called upon to evaluate a cause of a given physical ailment.”[17]  The witness’s own protocol included taking a medical history, performing a physical examination, and determining what tests were required.  This protocol starkly contrasted with the expert witness’s anemic litigation approach to diagnosis, which failed to include physical examinations or review of complete medical or occupational histories.  Finding that the expert’s procedures “depart[ed] from his own established diagnostic standards,” the court excluded his testimony.[18]

[1]  S. 852, 109th Congress, 1st Session, and Senate Judiciary Comm. Report (June 30, 2005).

[2]  Id. at 21.

[3]  Id. at 34.

[4]  42 U.S.C. §§ 11101, et seq.

[5]  42 U.S.C. § 11111(a)(1).

[6]  42 U.S.C. § 11151(11).

[7]  42 U.S.C. § 11111(a)(2)/

[8]  Fullerton v. The Florida Med. Ass’n, 938 So.2d 587 (Fla. D. Ct. App. 2006). See also Adam Liptak, “Doctor’s Testimony Leads To a Complex Legal Fight,” N.Y. Times (June 20, 2004).

[9]  See, e.g., Sandeep K. Narang & Stephan R. Paul, “Expert Witness Participation in Civil and Criminal Proceedings,” 139 Pediatrics e1 (2017); Robert A. Bitterman, “Halting inappropriate expert witness testimony – Part I: Professional associations’ efforts to police ‘experts’,” Relias Media (Jan. 1, 2007); Robert A. Bitterman, “Halting Inappropriate Expert Witness Testimony — Part II: Efforts of State Medical Boards and State Medical Societies to Police ‘Experts’,” Relias Media (Feb. 1, 2007); Robert A. Bitterman, “Halting inappropriate expert witness testimony ? Part III: Tort reform to prevent not-so-expert opinions,” Relias Media (Mar. 1, 2007).

[10]  See ABA Commission on Asbestos Litigation, Report to the House of Delegates (Report No. 302) (February 2003).

[11]  For discussion of some of the state legislative reform, see Mark A. Behrens, “What’s New in Asbestos Litigation?” 28 Rev. Litig. 501 (2009); Jeb Barnes, “Rethinking the Landscape of Tort Reform: Legislative Inertia and Court-Base Tort Reform in the Case of Asbestos,” 28 The Justice System J. 157 (2007); Jeb Barnes, Dust-Up: Asbestos Litigation and the Failure of Commonsense Policy Reform (2011).

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

[13]  Id. at 621, quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). 

[14]  Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 203 (4th Cir. 2001).

[15]  Id.

[16]  2005 WL 3544244 (N.D. Okla., Dec. 28, 2005),

[17]  Id. at *13.

[18]  Id. at *14.  See also Goebel v. Denver and Rio Grande Western Railroad Co., 346 F.3d 987, 998 (10th Cir. 2003) (upholding admissibility of opinion of medical expert witness who “followed ‘standard medical procedure in evaluating and diagnosing’ [plaintiff]”) (internal quotations omitted); Fitzgerald v. Smith & Nephew Richards, Inc., 1999 WL 1489199 (D. Md., Dec. 30, 1999), aff’d, 11 Fed. Appx. 335, 339 (4th Cir. 2001) (excluding opinion of medical expert who testified that clinical judgment requires personal contact with patient, but who failed to examine the plaintiff or review her complete medical history; finding that the expert “did not undertake his medical review and formulate his opinions with ‘intellectual rigor’”); Wooley v. Smith & Nephew Richards, Inc., 67 F. Supp. 2d 703, 709 (S.D. Tex. 1999) (excluding testimony of medical expert witness who had not examined plaintiff, and who relied on his review of medical records selected by  plaintiff’s counsel; concluding that “no expert orthopedic surgeon would attempt to make an accurate and complete diagnosis as to the probable cause of postoperative spinal injury without interviewing or examining the patient or considering the entirety of a patient’s records”).

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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

Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

May 13th, 2020

Explaining the denial of a Rule 702 motion in terms of the availability of cross-examination is just one among several dodges that judges use to avoid fully engaging with Rule 702’s requirements.[1] Another dodge involves shifting the burden of proof on admissibility from the proponent of the challenged expert witness to the challenger. This dodgewould appear to violate well-established law.

The Supreme Court, in deciding Daubert, made clear that the question whether an expert witness’s opinion was admissible was governed under the procedure set out in Federal Rule of Evidence 104(a).[2] The significance of placing the Rule 702 issues under the procedures set out in Rule 104(a) is that the trial judge must make the admissibility determination, and that he or she is not bound by the rules of evidence. The exclusion of the admissibility determination from the other rules of evidence means that trial judges can look at challenged expert witnesses’ relied-upon materials, and other facts, data, and opinions, regardless of these materials’ admissibility. The Supreme Court also made clear that the admissibility of an expert witness’s opinion testimony should be shown “by a preponderance of proof.”[3] Every court that has directly addressed the burden of proof issue in a Rule 702 challenge to expert witness testimony has clearly assigned that burden to the proponent of the testimony.[4]

Trial courts intent upon evading gatekeeping responsibility, however, have created a presumption of admissibility. When called upon to explain why they have denied Rule 702 challenges, these courts advert to the presumption as an explanation and justification for the denial.[5] Some courts even manage to discuss the burden of proof upon the proponent, and a presumption of admissibility, in almost the same breath.[6]

In his policy brief for amending Rule 702, Lee Mickus traces the presumption innovation to Borawick v. Shay, a 1995 Second Circuit decision that involved a challenge to hypnotically refreshed (or created) memory.[7] In Borawick, the Court of Appeals held that the plaintiff’s challenge turned upon whether Borawick’s testimony was competent or admissible, and that it did not involve the “the admissibility of data derived from scientific techniques or expert opinions.”[8] Nevertheless, in dicta, the court observed that “by loosening the strictures on scientific evidence set by Frye, Daubert reinforces the idea that there should be a presumption of admissibility of evidence.”[9]

Presumptions come in different forms and operate differently, and this casual reference to a presumption in dictum could mean any number of things. A presumption of admissibility could mean simply that unless there is a challenge to an expert witness’s opinion, the opinion is admissible.[10] The presumption could be a bursting-bubble (Thayer) presumption, which disappears once the opponent of the evidence credibly raises questions about the evidence’s admissibility. The presumption might be something that does not disappear, but once the admissibility is challenged, the presumption continues to provide some evidence for the proponent. And in the most extreme forms, the (Morgan) presumption might be nothing less than a judicially artful way of saying that the burden of proof is shifted to the opponent of the evidence to show inadmissibility.[11]

Although Borawick suggested that there should be a presumption, it did not exactly hold that one existed. A presumption in favor of the admissibility of evidence raises many questions about the nature, definition, and operation of the presumption. It throws open the question what evidence is needed to rebut the presumption. For instance, may a party whose expert witness is challenged not defend the witness’s compliance with Rule 702, stand on the presumption, and still prevail?

There is no mention of a presumption in Rule 702 itself, or in any Supreme Court decision on Rule 702, or in the advisory committee notes. Inventing a presumption, especially a poorly described one, turns the judicial discretion to grant or deny a Rule 702 challenge into an arbitrary decision.

Most importantly, given the ambiguity of “presumption,” a judicial opinion that denies a Rule 702 challenge by invoking a legal fiction fails to answer the question whether the proponent of the expert witness has carried the burden of showing that all the subparts of Rule 702 were satisfied by a preponderance of the evidence. While judges may prefer not to endorse or disavow the methodology of an otherwise “qualified” expert witness, their office requires them to do so, and not hide behind fictional presumptions.

1

[1]  “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020).

[2]  Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592 n.10 (1993).

[3]  Id., citing Bourjaily v. United States, 483 U. S. 171, 175-176 (1987).

[4]  Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir. 2010) (quoting Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir. 2006)); Beylin v. Wyeth, 738 F. Supp. 2d 887 (E.D. Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.); Pride v. BIC Corp., 218 F.3d 566, 578 (6th Cir. 2000); Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 742 (S.D. Ohio 2007).

[5]  See, e.g., Cates v. Trustees of Columbia Univ. in City of New York, No. 16CIV6524GBDSDA, 2020 WL 1528124, at *6 (S.D.N.Y. Mar. 30, 2020) (discussing presumptive admissibility); Price v. General Motors, LLC, No. CIV-17-156-R, 2018 WL 8333415, at *1 (W.D. Okla. Oct. 3, 2018) (“[T]here is a presumption under the Rules that expert testimony is admissible.”)(internetal citation omitted); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“The Second Circuit has made clear that Daubert contemplates liberal admissibility standards, and reinforces the idea that there should be a presumption of admissibility of evidence.”); Advanced Fiber Technologies (AFT) Trust v. J & L Fiber Services, Inc., No. 1:07-CV-1191, 2015 WL 1472015, at *20 (N.D.N.Y. Mar. 31, 2015) (“In assuming this [gatekeeper] role, the Court applies a presumption of admissibility.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *2 (S.D.N.Y. Jan. 22, 2015) (“[T]he court should apply ‘a presumption of admissibility’ of evidence” in carrying out the gatekeeper function.); Martinez v. Porta, 598 F. Supp. 2d 807, 812 (N.D. Tex. 2009) (“Expert testimony is presumed admissible”).

[6]  S.E.C. v. Yorkville Advisors, LLC, 305 F. Supp. 3d 486, 503-04 (S.D.N.Y. 2018) (“The party seeking to introduce the expert testimony bears the burden of establishing by a preponderance of the evidence that the proffered testimony is admissible. There is a presumption that expert testimony is admissible … .”) (internal citations omitted).

[7]  Borawick v. Shay, 68 F.3d 597, 610 (2d Cir. 1995), cert. denied, 517 U.S. 1229 (1996).

[8]  Id.

[9]  Id. (referring to Frye v. United States, 293 F. 1013 (D.C.Cir.1923)).

[10]  In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007) (Weinstein, J.) (“Since Rule 702 embodies a liberal standard of admissibility for expert opinions, the assumption the court starts with is that a well-qualified expert’s testimony is admissible.”).

[11]  See, e.g., Orion Drilling Co., LLC v. EQT Prod. Co., No. CV 16-1516, 2019 WL 4273861, at *34 (W.D. Pa. Sept. 10, 2019) (after declaring that “[e]xclusion is disfavored” under Rule 702, the court flipped the burden of production and declared the opinion testimony admissible, stating “Orion has not established that incorporation of the data renders Ray’s opinion unreliable.”).

Posted in Expert Witnesses, Rule 702 | Comments Off on Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions

May 11th, 2020

In my last post,[1] I praised Lee Mickus’s recent policy paper on amending Rule 702 for its persuasive force on the need for an amendment, as well as a source for helping lawyers anticipate common judicial dodges to a faithful application of the rule.[2] There are multiple dodges used by judicial dodgers, and it behooves litigants to recognize and anticipate them. In this post, and perhaps future ones, I elaborate upon the concerns that Mickus documents.

One prevalent judicial response to the Rule 702 motion is to kick the can and announce that the challenge to an expert witness’s methodological shenanigans can and should be addressed by crossexamination. This judicial response was, of course, the standard one before the 1993 Daubert decision, but Justice Blackmun’s opinion kept it alive in frequently quote dicta:

“Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.”[3]

Justice Blackmun, no doubt, believed he was offering a “helpful” observation here, but the reality is quite different. Traditionally, courts allowed qualified expert witnesses to opine with wild abandon, after showing that they had the very minimal qualifications required to do so in court. In the face of this traditional judicial lassitude, “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof” were all a litigant could hope to accomplish in litigation. Furthermore, the litany of remedies for “shaky but admissible evidence” fails to help lower court judges and lawyers sort shaky but admissible evidence from shaky and inadmissible evidence.

Perhaps even more to the point, cases at common law “traditionally” did not involve multivariate logistic regression, structural equation models, propensity score weighting, and the like. Juries did just fine on whether Farmer Brown had exercised due care when he ran over his neighbor’s cow with his tractor, or even when a physician opined that a child was born 350 days after the putative father’s death was sired by the testator and entitled to inherit from “dad.”

Mickus is correct that a trial judge’s comment that the loser of a Rule 702 motion is free to cross-examine is often a dodge, an evasion, or an outright failure to engage with the intricacies of a complex methodological challenge.[4] Stating that the “traditional and appropriate means of attacking shaky but admissible evidence” remain available is a truism, and might be offered as judicial balm to the motion loser, but the availability of such means is hardly an explanation or justification for denying the Rule 702 motion. Furthermore, Justice Blackmun’s observation about traditional means was looking back at an era when in most state and federal court, a person found to be minimally qualified, could pretty much say anything regardless of scientific validity. That was the tradition that stood in active need of reform when Daubert was decided in 1993.

Mickus is also certainly correct that the whole point of judicial gatekeeping is that the presentation of vive voce testimony before juries is not an effective method for revealing shaky, inadmissible opinion testimony. A few courts have acknowledged that cross-examination in front of a jury is not an appropriate justification for admitting methodologically infirm expert witness opinion testimony. In the words of Judge Jed Rakoff, who served on the President’s Council of Advisors on Science and Technology,[5] addressed the limited ability of cross-examination in the context of forensic evidence:

“Although effective cross-examination may mitigate some of these dangers, the explicit premise of Daubert and Kumho Tire is that, when it comes to expert testimony, cross-examination is inherently handicapped by the jury’s own lack of background knowledge, so that the Court must play a greater role, not only in excluding unreliable testimony, but also in alerting the jury to the limitations of what is presented.”[6]

Judge Rakoff’s point is by no means limited to forensic evidence, and it has been acknowledged more generally by Professor Daniel Capra, the Reporter to the Advisory Committee on Evidence Rules:

“the key to Daubert is that cross-examination alone is ineffective in revealing nuanced defects in expert opinion testimony and that the trial judge must act as a gatekeeper to ensure that unreliable opinions don’t get to the jury in the first place.”[7]

Juries do not arrive at the court house knowledgeable about statistical and scientific methods; nor are they prepared to spend weeks going over studies to assess their quality, and whether an expert witness engaged in cherry picking, misapplying methodologies, or insufficient investigation.[8] In discussing the problem of expert witnesses’ overstating the strength of their opinions, beyond what is supported by evidence, the Reporter stressed the limits and ineffectiveness of remedial adversarial cross-examination:

“Perhaps another way to think about cross-examination as a remedy is to compare the overstatement issue to the issues of sufficiency of basis, reliability of methodology, and reliable application of that methodology. As we know, those three factors must be shown by a preponderance of the evidence. The whole point of Rule 702 — and the Daubert-Rule 104(a) gatekeeping function — is that these issues cannot be left to cross-examination. The underpinning of Daubert is that an expert’s opinion could be unreliable and the jury could not figure that out, even given cross-examination and argument, because the jurors are deferent to a qualified expert (i.e., the white lab coat effect). The premise is that cross-examination cannot undo the damage that has been done by the expert who has power over the jury. This is because, for the very reason that an expert is needed (because lay jurors need assistance) the jury may well be unable to figure out whether the expert is providing real information or junk. The real question, then, is whether the dangers of overstatement are any different from the dangers of insufficient basis, unreliability of methodology, and unreliable application. Why would cross-examination be insufficient for the latter yet sufficient for the former?

It is hard to see any difference between the risk of overstatement and the other risks that are regulated by Rule 702. When an expert says that they are certain of a result — when they cannot be — how is that easier for the jury to figure out than if an expert says something like ‘I relied on four scientifically valid studies concluding that PCB’s cause small lung cancer’. When an expert says he employed a ‘scientific methodology’ when that is not so, how is that different from an expert saying “I employed a reliable methodology” when that is not so?”[9]

The Reporter’s example of PCBs and small lung cancer was an obvious reference to the Joiner case, in which the Supreme Court held that the trial judge had properly excluded causation opinions. The Reporter’s point goes directly to the cross-examination excuse for not shirking the gatekeeping function. In Joiner, the Court held that gatekeeping was necessitated when cross-examination was insufficient in the face of an analytical gap between methodology and conclusion.[10] Indeed, such gaps are or should be present in most well-conceived Rule 702 challenges.

The problem is not only that juries defer to expert witnesses. Juries lack the competence to assess scientific validity. Although many judges are lacking in such competence, at least litigants can expect them to read the Reference Manual on Scientific Evidence before they read the parties’ briefs and the expert witnesses’ reports. If the trial judge’s opinion evidences ignorance of the Manual, then at least there is the possibility of an appeal. It will be a strange day in a stranger world, when a jury summons arrives in the mail with a copy of the Manual!

The rules of evidence permit expert witnesses to rely upon inadmissible evidence, at least when experts in their field would do so reasonably. To decide whether the reliance is reasonable requires the decision maker go outside the “proofs” that would typically be offered at trial. Furthermore, the decision maker – gatekeeper – will have to read the relied-upon study and data to evaluate the reasonableness of the reliance. In a jury trial, the actual studies relied upon are rarely admissible, and so the jury almost never has the opportunity to read them to make its own determination of reasonableness of reliance, or of whether the study and its data really support what the expert witness draws from it.

Of course, juries do not have to write opinions about their findings. They need neither explain nor justify their verdicts, once the trial court has deemed that there is the minimally sufficient evidence to support a verdict. Juries, with whatever help cross-examination provides, in the absence of gatekeeping, cannot deliver anything approaching scientific due process of law.

Despite Supreme Court holdings, a substantially revised and amended Rule 702, and clear direction from the Advisory Committee, some lower courts have actively resisted enforcing the requirements of Rule. 702 Part of this resistance consists in pushing the assessment of the reliability of the data and assumptions used in applying a given methodology out of the gatekeeping column and into the jury’s column. Despite the clear language of Rule 702, and the Advisory Committee Note,[11] some Circuits of the Court of Appeals have declared that assessing the reliability of assumptions and data is not judges’ work (outside of a bench trial).[12]

As Seinfeld has taught us, rules are like reservations. It is not enough to make the rules, you have to keep and follow them. Indeed, following the rule is really the important part.[13] Although an amended Rule 702 might include a provision that “we really mean this,” perhaps it is worth a stop at the Supreme Court first to put down the resistance.

[1]  “Should Federal Rule of Evidence 702 Be Amended?” (May 8, 2020).

[2]  Lee Mickus, “Gatekeeping Reorientation: Amend Rule 702 to Correct Judicial Misunderstanding about Expert Evidence,” Washington Legal Foundation Critical Legal Issues Working Paper No. 217 (May 2020).

[3]  Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 596 (1993).

[4]  See, e.g., AmGuard Ins. Co. v. Lone Star Legal Aid, No. CV H-18-2139, 2020 WL 60247, at *8 (S.D. Tex. Jan. 6, 2020) (“[O]bjections [that the expert could not link her experienced-based methodology to her conclusions] are better left for cross examination, not a basis for exclusion.”); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“To the extent Defendant argues that Mr. McPartland’s conclusions are unreliable, it may attack his report through cross examination.”); Wright v. Stern, 450 F. Supp. 2d 335, 359–60 (S.D.N.Y. 2006) (“In a close case, a court should permit the testimony to be presented at trial, where it can be tested by cross-examination and measured against the other evidence in the case.”) (internal citation omitted). See also Adams v. Toyota Motor Corp., 867 F.3d 903, 916 (8th Cir. 2017) (affirming admission of expert testimony, reiterating the flexibility of the Daubert inquiry and emphasizing that defendant’s concerns could all be addressed with “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof”); Liquid Dynamics Corp. v. Vaughan Corp., 449 F.3d 1209, 1221 (Fed. Cir. 2006) (“The identification of such flaws in generally reliable scientific evidence is precisely the role of cross-examination.” (internal citation omitted)); Carmichael v. Verso Paper, LLC, 679 F. Supp. 2d 109, 119 (D. Me. 2010) (“[W]hen the adequacy of the foundation for the expert testimony is at issue, the law favors vigorous cross-examination over exclusion.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *6 (S.D.N.Y. Jan. 22, 2015) (“In light of the ‘presumption of admissibility of evidence,’ that opportunity [for cross-examination] is sufficient to ensure that the jury receives testimony that is both relevant and reliable.”) (internal citation omitted).

Even the most explicitly methodological challenges are transmuted into cross-examination issues by refusnik courts. For instance, cherry picking is reduced to a credibility issue for the jury and not germane to the court’s Rule 702 determination. In re Chantix Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1288 (N.D. Ala. 2012) (finding that an expert witness’s deliberate decision not to rely upon clinical trial data merely “is a matter for cross-examination, not exclusion under Daubert”); In re Urethane Antitrust Litig., 2012 WL 6681783, at *3 (D.Kan.) (“The extent to which [an expert] considered the entirety of the evidence in the case is a matter for cross-examination.”); Bouchard v. Am. Home Prods. Corp., 2002 WL 32597992, at *7 (N.D. Ohio) (“If the plaintiff believes that the expert ignored evidence that would have required him to substantially change his opinion, that is a fit subject for cross-examination.”). Similarly, courts have by ipse dixit made flawed application of what a standard methodological into merely a credibility issue to be explore by cross-examination rather than by judicial gatekeeping. United States v. Adam Bros. Farming, 2005 WL 5957827, at *5 (C.D. Cal. 2005) (“Defendants’ objections are to the accuracy of the expert’s application of the methodology, not the methodology itself, and as such are properly reserved for cross-examination.”); Oshana v. Coca-Cola Co., 2005 WL 1661999, at *4 (N.D. Ill.) (“Challenges addressing flaws in an expert’s application of reliable methodology may be raised on cross-examination.”).

[5]  President’s Council of Advisors on Science and Technology, Report to the President on Forensic Science in Criminal Courts: Ensuring Scientific Validity of Feature-Comparison Methods (Sept. 2016).

[6]  United States v. Glynn, 578 F. Supp. 2d 567, 574 (S.D.N.Y. 2008) (Rakoff, J.)

[7]  Daniel J. Capra, Reporter, Advisory Comm. on Evidence Rules, Minutes of Meeting at 23 (May 3, 2019) (comments of the Reporter).

[8]  Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702 at 50 (April 1, 2018) (identifying issues such as insufficient investigation, cherry-picking data, or misapplying standard methodologies, as examples of a “white lab coat” problem resulting from juries’ inability to evaluate expert witnesses’ factual bases, methodologies, and applications of methods).

[9]  Daniel J. Capra, Reporter, Advisory Comm. on Evidence Rules, Minutes of Meeting at 10-11 (Oct. 1, 2019) (comments of the Reporter on possible amendment of Rule 702) (internal citation to Joiner omitted).

[10]  Id. at 11 n.5.

[11]  See In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994) (calling for a close, careful analysis of the application of a proper methodology to every step in the case; “any step that renders the analysis unreliable renders the expert’s testimony inadmissible whether the step completely changes a reliable methodology or merely misapplies that methodology”).

[12]  See, e.g., City of Pomona v. SQM North Am. Corp., 750 F.3d 1036, 1047 (9th Cir. 2014) (rejecting the Paoli any-step approach without careful analysis of the statute, the advisory committee note, or Supreme Court decisions); Manpower, Inc. v. Ins. Co. of Pa., 732 F.3d 796, 808 (7th Cir. 2013) (“[t]he reliability of data and assumptions used in applying a methodology is tested by the adversarial process and determined by the jury; the court’s role is generally limited to assessing the reliability of the methodology – the framework – of the expert’s analysis”); Bonner v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir. 2001) (“the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination”).

[13]  Despite the clarity of the revised Rule 702, and the intent to synthesize Daubert, Joiner, Kumho Tire, and Weisgram, some courts have insisted that nothing changed with the amended rule. See, e.g., Pappas v. Sony Elec., Inc., 136 F. Supp. 2d 413, 420 & n.11 (W.D. Pa. 2000) (opining that Rule 702 as amended did not change the application of Daubert within the Third Circuit) (“The Committee Notes to the amended Rule 702 cite and discuss several Court of Appeals decisions that have properly applied Daubert and its progeny. Among these decisions are numerous cases from the Third Circuit. See Committee Note to 2000 Amendments to Fed. R.Evid. 702. Accordingly, I conclude that amended Rule 702 does not effect a change in the application of Daubert in the Third Circuit.”). Of course, if nothing changed, then the courts that take this position should be able to square their decisions with text of Rule 702, as amended in 2000.

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