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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.

Posted in Expert Witnesses, Rule 702, Uncategorized | Comments Off on Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions

Should Federal Rule of Evidence 702 Be Amended?

May 8th, 2020

Almost 27 years have passed since the United States Supreme Court issued its opinion in Daubert.[1] The holding was narrow. The Court reminded the Bar that Federal Rule of Evidence 702 was a statute, and that courts were thus bound to read it as a statute. The plain language of Rule 702 had been adopted by the Court in 1972, and then enacted by Congress, to be effective on July 1, 1975. Absent from the enacted Rule 702 was the “twilight zone” test articulated by a lower federal court in 1923.[2] In the Daubert case, the defense erroneously urged the application of the twilight zone test. In the post-modern way, the plaintiffs urged the application of no test.[3] The Court held simply that the twilight zone test had not been incorporated in the statutory language of Rule 702. Instead, the Court observed that the plain language of the statute imposed “helpfulness” and epistemic requirements for admitting expert witness opinion testimony.

It took another two Supreme Court decisions to flesh out the epistemic requirements for expert witnesses’ opinions,[4] and a third decision in which the Court told the Bench and Bar that the requirements of Rule 702 are “exacting.”[5] After the Supreme Court had added significantly to Rule 702’s helpfulness and knowledge requirements, the Advisory Committee revised the rule in 2000, to synthesize and incorporate these four Supreme Court decisions, and scholarly thinking about the patho-epistemology of expert witness opinion testimony. The Committee revised Rule 702 again in 2011, but only on “stylistic” issues, without any intent to add to or subtract from the 2000 rule.

Not all judges got the memo, or bothered to read and implement the revised Rule 702, in 2000. At both the District Court and the Circuit levels, courts persisted, and continue to persist, in citing retrograde decisions that predate the 2000 amendment, and even predate the 1993 decision in Daubert. Even the Supreme Court, in a 2011 opinion that did not involve the interpretation of Rule 702, was misled by a Solicitor General’s amicus brief, into citing one of the most anti-science, anti-method, post-modern, pre-Daubert, anything-goes decisions.[6] The judicial resistance to Rule 702 is well documented in many scholarly articles,[7] by the Reporter to the Advisory Committee,[8] and in the pages of this and other blogs.

In 2015, when evidence scholar David Bernstein argued that Rule 702 required amending,[9] I acknowledged the strength of his argument, but resisted because of what I perceived to be the danger of opening up the debate in Congress.[10] Professor Bernstein and lawyer Eric Lasker detailed and documented the many judicial dodges and evasions engaged in by many judges intent upon ignoring the clear requirements of Rule 702.

A paper published this week by the Washington Legal Foundation has updated and expanded the case for reform made by Professor Bernstein five years ago. In his advocacy paper, lawyer Lee Mickus has collated and analyzed some of the more recent dodges, which will depress the spirits of anyone who believes in evidence-based decision making.[11] My resistance to reform by amendment is waning. The meaning and intent of Rule 702 has been scarred over by precedent based upon judicial ipse dixit, and not Rule 702.

Mickus’s paper, like Professor Bernstein’s articles before, makes a persuasive case for reform, but this new paper does not evaluate the vagaries of navigating an amendment through the Advisory Committee, the Supreme Court, and Congress. Even if the reader is not interested in the amendment process, the paper can be helpful to the advocate in anticipating dodgy rule denialism.

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

[2]  Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923).

[3]  See “The Advocates’ Errors in Daubert” (Dec. 28, 2018).

[4]  General Electric Co. v. Joiner, 522 U.S. 136 (1997); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).

[5]  Weisgram v. Marley Co., 528 U.S. 440, 455 (2000) (Ginsberg, J.) (unanimous decision).

[6] Matrixx Initiatives, Inc. v. Siracusano, 563 US 27, 131 S.Ct. 1309, 1319 (2011) (citing Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262, 298 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986)).  See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; “Part 2”; “Part 3”; “Part 4”; “Part 5”; and “Part 6”.

[7]  David E. Bernstein & Eric Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 Wm. & Mary L. Rev. 1 (2015); David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2014).

[8]  See Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702 at 52 (April 1, 2018) (“[T]he fact remains that some courts are ignoring the requirements of Rule 702(b) and (d). That is frustrating.”).

[9]  David E. Bernstein & Eric Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 Wm. & Mary L. Rev. 1 (2015).

[10]  “On Amending Rule 702 of the Federal Rules of Evidence” (Oct. 17, 2015).

[11]  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).

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Dark Money, Scott Augustine, and Hot Air

April 11th, 2020

Fraud by the litigation industry takes many different forms. In the massive silicosis litigation unleashed in Mississippi and Texas in the early 2000s, plaintiffs’ lawyers colluded with physicians to concoct dubious diagnoses of silicosis. Fraudulent diagnoses of silicosis led to dismissals of thousands of cases, as well as the professional defrocking of some physician witnesses.[1] For those trying to keep up with lawsuit industry’s publishing arm, discussion of the Great Silicosis Fraud is completely absent from David Michaels’ recent book, The Triumph of Doubt.[2] So too is any mention of “dark money” that propelled the recently concluded Bair Hugger litigation.

Back in 2017, I wrote about the denial of a Rule 702 motion in the Bair Hugger litigation.[3] At the time, I viewed the trial court’s denial, on the facts of the case, to be a typical failure of gatekeeping.[4] Events in the Bair Hugger cases were only warming up in 2017.

After the court’s ruling, 3M took the first bellwether case to trial and won the case with jury, on May 30, 2018. Perhaps this jury verdict encouraged the MDL trial judge to take 3M’s motion for reconsideration of the Rule 702 motion seriously. In July 2019, the MDL court granted 3M’s motion to exclude the opinion testimony of plaintiffs’ general causation and mechanism expert witnesses, Drs. Jarvis, Samet, Stonnington, and Elghobashi.[5] Without these witnesses, over 5,000 plaintiffs, who had been misled about the merits of their cases, were stranded and set up for dismissal. On August 2, 2019, the MDL cases were dismissed for want of evidentiary support on causation. On August 29, 2019, plaintiffs filed a joint notice of appeal to the Eight Circuit.

The two Bair Hugger Rule 702 federal court decisions focused (or failed to focus) on scientific considerations. Most of the story of “dark money” and the manufacturing of science to support the litigation were suppressed in the Rule 702 motion practice, and in the federal jury trial. In her second Rule 702 reconsideration opinion, the MDL judge did mention undisclosed conflicts of interest by authors of the key studies relied upon by plaintiffs’ witnesses.[6]

To understand how the Bair Hugger litigation got started, and to obtain a full understanding of the nature of the scientific evidence was, a disinterested observer will have to read the state court decisions. Defendant 3M moved to exclude plaintiffs’ causation expert witnesses, in its Minnesota state court cases, under the so-called Frye standard. In response, the state judge excluded plaintiffs’ witnesses for advancing a novel scientific theory that lacked acceptance in the relevant scientific community. The Minnesota Court of Appeals affirmed, with a decision that talked rather more freely about the plaintiffs’ counsel’s dark money. In re 3M Bair Hugger Litig., 924 N.W.2d 16 (Minn. App. 2019) [cited as Bair Hugger].

As the Minnesota Court of Appeals explained, a forced-air warming device (FAWD) is a very important, useful device to keep patients’ body temperatures normal during surgery. The “Bair Hugger” is a FAWD, which was invented in 1987, by Dr. Scott Augustine, an anesthesiologist, who at the time was the chief executive officer of Augustine Medical, Inc. Bair Hugger at 19.

In the following 15 years, the Bair Hugger became the leading FAWD in the world. In 2002, the federal government notified Augustine that it was investigating him for Medicare fraud. Augustine resigned from the company that bore his name, and the company purged the taint by reorganizing as Arizant Healthcare Inc. (Arizant), which continued to make the Bair Hugger. In the following year, 2003, Augustine pleaded guilty to fraud and paid a $2 million fine. His sentence included a five-year ban from involvement in federal health-care programs.

During the years of his banishment, fraudfeasor Augustine developed a rival product and then embarked upon a global attack on the safety of his own earlier invention, the Bair Hugger. In the United Kingdom, his claim that the Bair Hugger increased risks of surgical site infections attacks was rejected by the UK National Institute for Health and Clinical Excellence. A German court enjoined Augustine from falsely claiming that the Bair Hugger led to increased bacterial contamination.[7] The United States FDA considered and rejected Augustine’s claims, and recommended the use of FAWDs.

In 2009, Augustine began to work as a non-testifying expert witness with the Houston, Texas, plaintiffs’ law firm of Kennedy Hodges LLP. A series of publications resulted in which the authors attempted to raise questions about the safety of the Bair Hugger. By 2013, with the medical literature “seeded” with several studies attacking the Bair Hugger, the Kennedy Hodges law firm began to manufacture law suits against Arizant and 3M (which had bought the Bair Hugger product line from Arizant in 2010). Bair Hugger at 20.

The seeding studies were marketing and litigation propaganda used by Augustine to encourage the all-too-complicit lawsuit industry to ramp up production of complaints against 3M over the Bair Hugger. Several of the plaintiffs’ studies included as an author a young statistician, Mark Albrecht, an employee of, or a contractor for, Augustine’s new companies, Augustine Temperature Management and Augustine Medical. Even when disclosures were made, they were at best “anemic”:

“The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.”[8]

Some of these studies generally included a disclosure that Albrecht was funded or employed by Augustine, but they did not disclose the protracted, bitter feud or Augustine’s confessed fraudulent conduct. Another author of some of the plaintiffs’ studies included David Leaper, who was a highly paid “consultant’’ to Augustine at the time of the work on the study. None of the studies disclosed Leaper’s consultancy for Augustin:

  1. Mark Albrecht, Robert Gauthier, and David Leaper, “Forced air warming, a source of airborne contamination in the operating room?” 1 Orthopedic Rev. (Pavia) e28 (2009)
  2. Mark Albrecht, Robert L. Gauthier, Kumar Belani, Mark Litchy, and David Leaper, “Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room,” 39 Am. J. Infection Control 321 (2011)
  3. P.D. McGovern, Mark Albrecht, Kumar Belani, C. Nachtsheim, “Forced-air warming and ultra-clean ventilation do not mix,” 93 J. Bone & Joint Surg. – British 1537 (2011)
  4. K.B. Dasari, Mark Albrecht, and M. Harper, “Effect of forced-air warming on the performance of operating-theatre laminar-flow ventilation,” 67 Anaesthesia 244 (2012)
  5. Mike Reed, Oliver Kimberger, Paul D. McGovern, and Mark C. Albrecht, “Forced-Air Warming Design: Evaluation of Intake Filtration, Internal Microbial Buildup, and Airborne-Contamination Emissions,” 81 Am. Ass’n Nurse Anesthetists 275 (2013)
  6. Kumar Belani, Mark Albrecht, Paul McGovern, Mike Reed, and Christopher Nachtsheim, “Patient warming excess heat: the effects on orthopedic operating room ventilation performance,” 117 Anesthesia & Analgesia 406 (2013)

In one study, Augustine’s employee Mark Albrecht conducted the experiment with one of the authors, but was not listed as an author although he wrote an early draft of the study. Augustine provided all the equipment used in the experiment. The published paper failed to disclose any of these questionable activities:

  1. A.J. Legg & A.J. Hammer, “Forced-air patient warming blankets disrupt unidirectional flow,” 95 Bone & Joint J. 407 (2013)

Another study had more peripheral but still questionable involvement of Augustine, whose company lent the authors equipment used to conduct the study, without proper acknowledgment and disclosure:

  1. A.J. Legg, T. Cannon, and A. J. Hamer, “Do forced-air warming devices disrupt unidirectional downward airflow?” 94 J. Bone & Joint Surg. – British 254 (2012)

In addition to the defects in the authors’ disclosures, 3M discovered that two of the studies had investigated whether the Bair Hugger spread bacteria in the surgical area. Although the experiments found no spread with the Bair Hugger, the researchers never publicly disclosed their exculpatory evidence.[9]

Augustine’s marketing campaign, through these studies, ultimately fell flat at the FDA, which denied his citizen’s petition and recommended that surgeons continue to use FAWDs such as the Bair Hugger.[10] Augustine’s proxy litigation war against 3M also fizzled, unless the 8th Circuit revives his vendetta. Nonetheless, the Augustine saga raises serious questions about how litigation funding of “scientific studies” will vex the search for the truth in pharmaceutical products litigation. The Augustine attempt to pollute the medical literature was relatively apparent, but dark money from undisclosed financiers may require greater attention from litigants and from journal editors.

[1]  In re Silica Products Liab. Litig., MDL No. 1553, 398 F. Supp. 2d 563 (S.D.Tex. 2005).

[2]  David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020).

[3]  In re Bair Hugger Forced Air Warming, MDL No. 15-2666, 2017 WL 6397721 (D. Minn. Dec. 13, 2017).

[4]  “Gatekeeping of Expert Witnesses Needs a Bair Hug” (Dec. 20, 2017).

[5]  In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., MDL No. 15-2666, 2019 WL 4394812 (D. Minn. July 31, 2019). See Joe G. Hollingsworth & Caroline Barker, “Exclusion of Junk Science in ‘Bair Hugger’ MDL Shows Daubert Is Still Breathing,” Wash. Leg. Foundation (Jan 23, 2020); Christine Kain, Patrick Reilly, Hannah Anderson and Isabelle Chammas, “Top 5 Drug And Medical Device Developments Of 2019,” Law360 (Jan. 9, 2020).

[6]  In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., 2019 WL 4394812, at *10 n.13 (D. Minn. July 31, 2019) (observing that “[i]n the published study, the authors originally declared no conflicts of interest”).

[7]  Dr. Augustine has never been a stranger to the judicial system. See, e.g., Augustine Medical, Inc. v. Gaymar Industries, Inc., 181 F.3d 1291 (Fed. Cir. 1999); Augustine Medical, Inc. v. Progressive Dynamics, Inc., 194 F.3d 1367 (Fed. Cir. 1999); Cincinnati Sub-Zero Products, Inc. v. Augustine Medical, Inc., 800 F. Supp. 1549 (S.D. Ohio 1992).

[8]  P.D. McGovern, Mark Albrecht, Kumar Belani, and C. Nachtsheim, “Forced-air warming and ultra-clean ventilation do not mix,” 93 J. Bone & Joint Surg. – British 1537, 1544 (2011).

[9]  See https://www.truthaboutbairhugger.com/truth-science-behind-claims-3m-bair-hugger-system-look-augustine-connections-research-studies/.

[10]  William Maisel, “Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers”; Center for Devices and Radiological Health, U.S. Food and Drug Administration (Aug. 30, 2017).

Posted in Conflicts of Interest, Expert Witnesses, Rule 702, Scientific Misconduct, Scientific Publishing | Comments Off on Dark Money, Scott Augustine, and Hot Air

April Fool – Zambelli-Weiner Must Disclose

April 2nd, 2020

Back in the summer of 2019, Judge Saylor, the MDL judge presiding over the Zofran birth defect cases, ordered epidemiologist, Dr. Zambelli-Weiner to produce documents relating to an epidemiologic study of Zofran,[1] as well as her claimed confidential consulting relationship with plaintiffs’ counsel.[2]

This previous round of motion practice and discovery established that Zambelli-Weiner was a paid consultant in advance of litigation, that her Zofran study was funded by plaintiffs’ counsel, and that she presented at a Las Vegas conference, for plaintiffs’ counsel only, on [sic] how to make mass torts perfect. Furthermore, she had made false statements to the court about her activities.[3]

Zambelli-Weiner ultimately responded to the discovery requests but she and plaintiffs’ counsel withheld several documents as confidential, pursuant to the MDL’s procedure for protective orders. Yesterday, April 1, 2020, Judge Saylor entered granted GlaxoSmithKline’s motion to de-designate four documents that plaintiffs claimed to be confidential.[4]

Zambelli-Weiner sought to resist GSK’s motion to compel disclosure of the documents on a claim that GSK was seeking the documents to advance its own litigation strategy. Judge Saylor acknowledged that Zambelli-Weiner’s psycho-analysis might be correct, but that GSK’s motive was not the critical issue. According to Judge Saylor, the proper inquiry was whether the claim of confidentiality was proper in the first place, and whether removing the cloak of secrecy was appropriate under the facts and circumstances of the case. Indeed, the court found “persuasive public-interest reasons” to support disclosure, including providing the FDA and the EMA a complete, unvarnished view of Zambelli-Weiner’s research.[5] Of course, the plaintiffs’ counsel, in close concert with Zambelli-Weiner, had created GSK’s need for the documents.

This discovery battle has no doubt been fought because plaintiffs and their testifying expert witnesses rely heavily upon the Zambelli-Weiner study to support their claim that Zofran causes birth defects. The present issue is whether four of the documents produced by Dr. Zambelli-Weiner pursuant to subpoena should continue to enjoy confidential status under the court’s protective order. GSK argued that the documents were never properly designated as confidential, and alternatively, the court should de-designate the documents because, among other things, the documents would disclose information important to medical researchers and regulators.

Judge Saylor’s Order considered GSK’s objections to plaintiffs’ and Zambelli-Weiner’s withholding four documents:

(1) Zambelli-Weiner’s Zofran study protocol;

(2) Undisclosed, hidden analyses that compared birth defects rates for children born to mothers who used Zofran with the rates seen with the use of other anti-emetic medications;

(3) An earlier draft Zambelli-Weiner’s Zofran study, which she had prepared to submit to the New England Journal of Medicine; and

(4) Zambelli-Weiner’s advocacy document, a “Causation Briefing Document,” which she prepared for plaintiffs’ lawyers.

Judge Saylor noted that none of the withheld documents would typically be viewed as confidential. None contained “sensitive personal, financial, or medical information.”[6]  The court dismissed Zambelli-Weiner’s contention that the documents all contained “business and proprietary information,” as conclusory and meritless. Neither she nor plaintiffs’ counsel explained how the requested documents implicated proprietary information when Zambelli-Weiner’s only business at issue is to assist in making lawsuits. The court observed that she is not “engaged in the business of conducting research to develop a pharmaceutical drug or other proprietary medical product or device,” and is related solely to her paid consultancy to plaintiffs’ lawyers. Neither she nor the plaintiffs’ lawyers showed how public disclosure would hurt her proprietary or business interests. Of course, if Zambelli-Weiner had been dishonest in carrying out the Zofran study, as reflected in study deviations from its protocol, her professional credibility and her business of conducting such studies might well suffer. Zambelli-Weiner, however, was not prepared to affirm the antecedent of that hypothetical. In any event, the court found that whatever right Zambelli-Weiner might have enjoyed to avoid discovery evaporated with her previous dishonest representations to the MDL court.[7]

The Zofran Study Protocol

GSK sought production of the Zofran study protocol, which in theory contained the research plan for the Zofran study and the analyses the researchers intended to conduct. Zambelli-Weiner attempted to resist production on the specious theory that she had not published the protocol, but the court found this “non-publication” irrelevant to the claim of confidentiality. Most professional organizations, such as the International Society of Pharmacoepidemiology (“ISPE”), which ultimately published Zambelli-Weiner’s study, encourage the publication and sharing of study protocols.[8] Disclosure of protocols helps ensure the integrity of studies by allowing readers to assess whether the researchers have adhered to their study plan, or have engaged in ad hoc data dredging in search for a desired result.[9]

The Secret, Undisclosed Analyses

Perhaps even more egregious than withholding the study protocol was the refusal to disclose unpublished analyses comparing the rate of birth defects among children born to mothers who used Zofran with the birth defect rates of children with in utero exposure to other anti-emetic medications.  In ruling that Zambelli-Weiner must produce the unpublished analyses, the court expressed its skepticism over whether these analyses could ever have been confidential. Under ISPE guidelines, researchers must report findings that significantly affect public health, and the relative safety of Zofran is essential to its evaluation by regulators and prescribing physicians.

Not only was Zambelli-Weiner’s failure to include these analyses in her published article ethically problematic, but she apparently hid these analyses from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, which specifically inquired of Zambelli-Weiner whether she had performed such analyses. As a result, the PRAC recommended a label change based upon Zambelli-Weiner’s failure to disclosure material information. Furthermore, the plaintiffs’ counsel represented they intended to oppose GSK’s citizen petition to the FDA, based upon the Zambelli-Weiner study. The apparently fraudulent non-disclosure of relevant analyses could not have been more fraught for public health significance. The MDL court found that the public health need trumped any (doubtful) claim to confidentiality.[10] Against the obvious public interest, Zambelli-Weiner offered no “compelling countervailing interest” in keeping her secret analyses confidential.

There were other aspects to the data-dredging rationale not discussed in the court’s order. Without seeing the secret analyses of other anti-emetics, readers were deprive of an important opportunity to assess actual and potential confounding in her study. Perhaps even more important, the statistical tools that Zambelli-Weiner used, including any measurements of p-values and confidence intervals, and any declarations of “statistical significance,” were rendered meaningless by her secret, undisclosed, multiple testing. As noted by the American Statistical Association (ASA) in its 2016 position statement, “4. Proper inference requires full reporting and transparency.”

The ASA explains that the proper inference from a p-value can be completely undermined by “multiple analyses” of study data, with selective reporting of sample statistics that have attractively low p-values, or cherry picking of suggestive study findings. The ASA points out that common practices of selective reporting compromises valid interpretation. Hence the correlative recommendation:

“Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”[11]

The Draft Manuscript for the New England Journal of Medicine

The MDL court wasted little time and ink in dispatching Zambelli-Weiner’s claim of confidentiality for her draft New England Journal of Medicine manuscript. The court found that she failed to explain how any differences in content between this manuscript and the published version constituted “proprietary business information,” or how disclosure would cause her any actual prejudice.

Zambelli-Weiner’s Litigation Road Map

In a world where social justice warriors complain about organizations such as Exponent, for its litigation support of defense efforts, the revelation that Zambelli-Weiner was helping to quarterback the plaintiffs’ offense deserves greater recognition. Zambelli-Weiner’s litigation road map was clearly created to help Grant & Eisenhofer, P.A., the plaintiffs’ lawyers,, create a causation strategy (to which she would add her Zofran study). Such a document from a consulting expert witness is typically the sort of document that enjoys confidentiality and protection from litigation discovery. The MDL court, however, looked beyond Zambelli-Weiner’s role as a “consulting witness” to her involvement in designing and conducting research. The broader extent of her involvement in producing studies and communicating with regulators made her litigation “strategery” “almost certainly relevant to scientists and regulatory authorities” charged with evaluating her study.”[12]

Despite Zambelli-Weiner’s protestations that she had made a disclosure of conflict of interest, the MDL court found her disclosure anemic and the public interest in knowing the full extent of her involvement in advising plaintiffs’ counsel, long before the study was conducted, great.[13]

The legal media has been uncommonly quiet about the rulings on April Zambelli-Weiner, in the Zofran litigation. From the Union of Concerned Scientists, and other industry scolds such as David Egilman, David Michaels, and Carl Cranor – crickets. Meanwhile, while the appeal over the admissibility of her testimony is pending before the Pennsylvania Supreme Court,[14] Zambelli-Weiner continues to create an unenviable record in Zofran, Accutane,[15] Mirena,[16] and other litigations.

[1]  April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019).

[2]  See In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657) [cited as In re Zofran].

[3]  “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[4]  In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) [Order].

[5]  Order at n.3

[6]  Order at 3.

[7]  See In re Zofran, 392 F. Supp. 3d at 186.

[8]  Order at 4. See also Xavier Kurz, Susana Perez-Gutthann, the ENCePP Steering Group, “Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP),” 27 Pharmacoepidemiology & Drug Safety 245 (2018).

[9]  Order at note 2 (citing Charles J. Walsh & Marc S. Klein, “From Dog Food to Prescription Drug Advertising: Litigating False Scientific Establishment Claims Under the Lanham Act,” 22 Seton Hall L. Rev. 389, 431 (1992) (noting that adherence to study protocol “is essential to avoid ‘data dredging’—looking through results without a predetermined plan until one finds data to support a claim”).

[10]  Order at 5, citing Anderson v. Cryovac, Inc., 805 F.2d 1, 8 (1st Cir. 1986) (describing public-health concerns as “compelling justification” for requiring disclosing of confidential information).

[11]  Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The American Statistician 129 (2016)

See also “The American Statistical Association’s Statement on and of Significance” (March 17, 2016).“Courts Can and Must Acknowledge Multiple Comparisons in Statistical Analyses” (Oct. 14, 2014).

[12]  Order at 6.

[13]  Cf. Elizabeth J. Cabraser, Fabrice Vincent & Alexandra Foote, “Ethics and Admissibility: Failure to Disclose Conflicts of Interest in and/or Funding of Scientific Studies and/or Data May Warrant Evidentiary Exclusions,” Mealey’s Emerging Drugs Reporter (Dec. 2002) (arguing that failure to disclose conflicts of interest and study funding should result in evidentiary exclusions).

[14]  Walsh v. BASF Corp., GD #10-018588 (Oct. 5, 2016, Pa. Ct. C.P. Allegheny Cty., Pa.) (finding that Zambelli-Weiner’s and Nachman Brautbar’s opinions that pesticides generally cause acute myelogenous leukemia, that even the smallest exposure to benzene increases the risk of leukemia offended generally accepted scientific methodology), rev’d, 2018 Pa. Super. 174, 191 A.3d 838, 842-43 (Pa. Super. 2018), appeal granted, 203 A.3d 976 (Pa. 2019).

[15]  In re Accutane Litig., No. A-4952-16T1, (Jan. 17, 2020 N.J. App. Div.) (affirming exclusion of Zambelli-Weiner as an expert witness).

[16]  In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396 (S.D.N.Y. 2016) (excluding Zambelli-Weiner in part).

Posted in Conflicts of Interest, Data Sharing, Expert Witness Discovery, Expert Witness Hall of Shame, Expert Witnesses, Scientific Misconduct, Scientific Publishing, statistical evidence, Trial Procedure, Underlying Data | Comments Off on April Fool – Zambelli-Weiner Must Disclose

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