TORTINI

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

The Unreasonable Success of Asbestos Litigation

July 25th, 2015

In asbestos litigation, the plaintiffs’ bar has apparently invented a perpetual motion machine that feeds on outrage that will never run out. Still, lawyers who have not filled their wallets with legal fees from asbestos cases sometimes attempt to replicate the machine. For the most part, the imitators have failed.

What accounts for the unreasonable success of asbestos litigation? Unlike pharmaceutical litigation, exposure does not require a prescription. Although asbestos insulators and applicators experienced the most exposure, other trades and occupations worked with, or near, asbestos materials. Anecdotal testimony of exposure suffices in almost every case. Add para-occupational exposure, and the sky’s the limit for the class of potential plaintiffs. See Lester Brickman, “Fraud and Abuse in Mesothelioma Litigation,” 88 Tulane L. Rev. 1071 (2014); Peggy Ableman, “The Garlock Decision Should be Required Reading for All Trial Court Judges in Asbestos Cases,” 37 Am. J. Trial Advocacy 479, 488 (2014).

Then there is the range of diseases and disorders attributable to asbestos. Excessive exposure to asbestos minerals cause non-malignant pleural plaques and thickening, as well as lung fibrosis, asbestosis. Some asbestos minerals cause mesothelioma, and despite a differential in potency among some of the minerals (between amosite and crocidolite), the general and specific causation of mesothelioma is often uncontested. Furthermore, lung cancer in the presence of asbestosis may be the result of interaction of asbestos exposure and cigarette smoking. Plaintiffs’ counsel and The Lobby have expanded the list of attributable diseases to include non-pulmonary cancers, only to find some defendants willing to pay money on these claims as well.

In addition to the ease of claiming, or manufacturing, exposure, and the willing cooperation of the occupational medical community in supporting medical causation, asbestos litigation is a lightning rod for moral outrage in the courtroom. Plaintiffs claim that “industry” knew about the hazards of asbestos, including its carcinogenicity, long before warnings appeared. Defending the knowledge claim requires nuanced explanation of shifting standards for establishing causality as epidemiology developed and was applied to putative asbestos-related cancer outcomes, as well as changing views about the latencies of asbestos-related diseases.

Every once in a while, plaintiffs’ and defense counsel[1], the media[2], the academy[3], and the insurance industry[4] ask whether “silica” is the next asbestos. Although the prospects have been, and remain, dim, plaintiffs’ counsel continue to try to build their litigation palace on sand, with predictably poor results. See Kimberley A. Strassel, “He Fought the Tort Bar — and Won,” Wall St. J. (May 4, 2009).

There are many serious disanalogies between asbestos and silica litigation. One glaring difference is the inability to summon any outrage over suppressed or nondisclosed knowledge of alleged silica cancer hazards. The silica cancer state of the art, written by those who are lionized in the asbestos litigation – Hueper, Schepers, and Hardy, along with NIOSH and the Surgeon General, all appropriately denied or doubted silica as a cause of lung cancer. See below. When the IARC shifted its views in the 1990s, under the weight of determined advocacy from some partisans in the occupational medicine community, and with the help from some rather biased reviews, industry promptly warned regardless of the lack of scientific support for the IARC’s conclusion. The manufacturing of faux consensus and certainty on silica and lung cancer is an important counter to the incessant media stories about the manufacturing of doubt on topics such as climate change.


[1] Robert D. Chesler, James Stewart, and Geoffrey T. Gibson, “Is Silica the Next Asbestos?” 176 N.J.L.J. 1 (June 28, 2004); Mark S. Raffman, “Where Will Silica Litigation Go?” 1 LJN Silica Legal News 1 (2005); Chris Michael Temple, “A Case for Why Silica Litigation Is Not the ‘Next Asbestos’,” LJN Product Liability Law & Strategy (2004).

[2] Jonathan D. Glater, “Suits on Silica Being Compared To Asbestos Cases,” N.Y. Times (Sept. 6, 2003).

[3] Michelle J. White, “Mass Tort Litigation: Asbestos,” in Jürgen Georg Backhaus, ed., Encyclopedia of Law and Economics 1 (2014); Melissa Shapiro, “Is Silica the Next Asbestos? An Analysis of the Silica Litigation and the Sudden Resurgence of Silica Lawsuit Filings,” 32 Pepperdine L. Rev. 4 (2005).

[4]Is silica the new asbestos?The Actuary (2005).


Historical Statements – – State-of-the-Art

Maxcy, ed., Rosenau Preventive Medicine and Hygiene 1051 (N.Y., 7th ed. 1951) (“Thus, there is no evidence that lung cancer is related in any way to silicosis.”)

May Mayers, “Industrial Cancer of the Lungs,” 4 Compensation Medicine 11, 12 (1952) (“Nevertheless, silicosis is not, apparently associated with, or productive of, lung cancer, whereas asbestosis very probably is.”) (Chief, Medical Unit, Division of Industrial Hygiene and Safety Standards, N.Y. Dep’t of Labor)

Geritt Schepers, “Occupational Chest Diseases,” Chap. 33, p. 455, ¶3, in A. Fleming, et al., eds., Modern Occupational Medicine (Phila. 2d ed. 1960) (“Lung cancer, of course, occurs in silicotics and is on the increase. Thus far, however, statistical studies have failed to reveal a relatively enhanced incidence of pulmonary neoplasia in silicotic subjects.”)

Spencer, Pathology of the Lung (1962) (“Silicosis and lung cancer inhaled silica, unlike asbestos, does not predispose to the development of lung cancer.”)

Wilhelm Hueper, Occupational and Environmental Cancers of the Respiratory System at 2-6 (N.Y. 1966) (“The bulk of the available epidemiologic evidence on the association of silicosis and lung cancer supports the view of a mere coincidental role of silicosis in this combination. *** From the evidence on hand, it appears that a well advanced silicosis does not seem to furnish a favorable soil for the development of cancer of the lung.”) (chief of the National Cancer Institute)

Harriet L. Hardy, “Current Concepts of Occupational Lung Disease of Interest to the Radiologist,” 2 Sem. Roentgenology 225, 231-32 (1967) (“cancer of the lung is not a risk for the silicotic. It is a serious risk following asbestos exposure and for hematite, feldspar, and uranium miners. This means that certain dusts and ionizing radiation alone or perhaps with cigarette smoke act as carcinogens.”)

Raymond Parkes, Occupational Lung Disorders 192 (London 1974) (“Bronchial carcinoma occasionally occurs in silicotic lungs but there is no evidence of a causal relationship between it and silicosis; indeed the incidence of lung cancer in miners with silicosis is significantly lower than in non-silicotic males.”)

Kaye Kilburn, Ruth Lilis, Edwin Holstein, “Silicosis,” in Maxcy-Rosenau, Public Health and Preventive Medicine, 11th ed., at 606 (N.Y. 1980) (“Lung cancer is apparently not a complication of silicosis.”)

Robert Jones, “Silicosis,” Chap. 16, in W. Rom, et al., eds., Environmental and Occupational Medicine 205 (Boston 1983) (“The weight of epidemiologic evidence is against the proposition that silicosis carries an increased risk of respiratory malignancy.”)

W. Keith C. Morgan & Anthony Seaton, eds., Occupational Lung Diseases 266 (1984) (“It is generally believed that silicosis does not predispose to lung cancer. * * * On balance, it seems unlikely that silicosis itself predisposes to lung cancer.”)

1 Anderson’s Pathology at 910b (1985) (“There is no evidence that silica increases the risk of lung cancer, nor does it enhance tobacco induced carcinogenesis.”)

U.S. Dep’t of Health and Human Services, The Health Consequences of Smoking – Cancer and Chronic Lung Disease in the Workplace: A Report of the Surgeon General at 348, Chapter 8 “Silica‑Exposed Workers” (1985) (“the evidence does not currently establish whether silica exposure increases the risk of developing lung cancer in men.”)

J. Cotes & J. Steel, Work-Related Lung Disorders 156 (Oxford 1987) (“The inhalation of silica dust does not contribute to malignancy.”)

NIOSH Silicosis and Silicate Disease Committee, “Diseases Associated With Exposure to Silica and Non-fibrous Silicate Minerals,” 112 Arch. Path. & Lab. Med. 673, 707 (1988) (“Epidemiologic studies have been conducted in an effort to assess the role of silica exposure in the pathogenesis of lung cancer. *** Thus, the results are inconclusive … .”)

Arthur Frank, “Epidemiology of Lung Cancer, in J. Roth, et al., Thoracic Oncology, Chap. 2, at p. 8 (Table 2-1), 11 (Phila. 1989) (omitting silica from list of lung carcinogens) (“The question of the relationship of coal mining to the development of lung cancer has been frequently considered. Most evidence points to cigarette smoking among coal miners as the major causative factor in the development of lung cancer, and neither a recent84 nor a British study of lung cancer among coal miners has found any relationship to occupational exposure.”)

Canadian Judges’ Reference Manual on Scientific Evidence

July 24th, 2015

I had some notion that there was a Canadian version of the Reference Manual on Scientific Evidence in the works, but Professor Greenland’s comments in a discussion over at Deborah Mayo’s blog drew my attention to the publication of the Science Manual for Canadian Judges [Manual]. See “‘Statistical Significance’ According to the U.S. Dept. of Health and Human Services (ii),Error Statistics Philosophy (July 17, 2015).

The Manual is the product of the Canadian National Judicial Institute (NJI), which is an independent, not-for-profit group that is committed to educating Canadian judges. The NJI’s website describes the Manual:

“Without the proper tools, the justice system can be vulnerable to unreliable expert scientific evidence.

* * *

The goal of the Science Manual is to provide judges with tools to better understand expert evidence and to assess the validity of purportedly scientific evidence presented to them. …”

The Chief Justice of Canada, Hon. Beverley M. McLachlin, contributed an introduction to the Manual, which was notable for its frank admission that:

[w]ithout the proper tools, the justice system is vulnerable to unreliable expert scientific evidence.

****

Within the increasingly science-rich culture of the courtroom, the judiciary needs to discern ‘good’ science from ‘bad’ science, in order to assess expert evidence effectively and establish a proper threshold for admissibility. Judicial education in science, the scientific method, and technology is essential to ensure that judges are capable of dealing with scientific evidence, and to counterbalance the discomfort of jurists confronted with this specific subject matter.”

Manual at 14. These are laudable goals, indeed.

The first chapter of the Manual is an overview of Canadian law of scientific evidence, “The Legal Framework for Scientific Evidence,” by Canadian law professors Hamish Stewart (University of Toronto), and Catherine Piché (University of Montreal). Several judges served as peer reviewers.

The second chapter, “Science and the Scientific Method,” contains the heart of what judges supposedly should know about scientific and statistical matters to serve as effective “gatekeepers.” Like the chapters in the Reference Manual on Scientific Evidence, this chapter was prepared by a scientist author (Scott Findlay, Ph.D., Associate Professor of Biology, University of Ottawa) and a lawyer author (Nathalie Chalifour, Associate Professor of Law, University of Ottawa). Several judges, and Professor Brian Baigrie (University of Toronto, Victoria College, and the Institute for the History and Philosophy of Science and Technology) provided peer review. The chapter attempts to cover the demarcation between science and non-science, and between scientific and other expert witness opinion. The authors describe “the” scientific method, hypotheses, experiments, predictions, inference, probability, statistics and statistical hypothesis testing, data reliability, and related topics. A subsection of chapter two is entitled “Normative Issues in Science – The Myth of Scientific Objectivity,” which suggests a Feyerabend, post-modernist influence at odds with the Chief Justice’s aspirational statement of goals in her introduction to the Manual.

Greenland noted some rather cavalier statements in Chapter two that suggest that the conventional alpha of 5% corresponds to a “scientific attitude that unless we are 95% sure the null hypothesis is false, we provisionally accept it.” And he pointed elsewhere where the chapter seems to suggest that the coefficient of confidence that corresponds to an alpha of 5% “constitutes a rather high standard of proof,” thus confusing and conflating probability of random error with posterior probabilities. Some have argued that these errors are simply an effort to make statistical concepts easier to grasp for lay people, but the statistics chapter in the FJC’s Reference Manual shows that accurate exposition of statistical concepts can be made understandable. The Canadian Manual seems in need of some trimming with Einstein’s razor, usually paraphrased as “Everything should be made as simple as possible, but no simpler.[1] The razor should certainly applied to statistical concepts, with the understanding that pushing to simplify too aggressively can sometimes result in simplistic, and simply wrong, exposition.

Chapter 3 returns to more lawyerly matters, “Managing and Evaluating Expert Evidence in the Courtroom,” prepared and peer-reviewed by prominent Canadian lawyers and judges. The final chapter, “Ethics of the Expert Witness,” should be of interest to lawyers and judges in the United States, where the topic is largely ignored. The chapter was prepared by Professor Adam Dodek (University of Ottawa), along with several writers from the National Judicial Institute, the Canadian Judicial Council, American College of Trial Lawyers, Environment Canada, and notably, Joe Cecil & the Federal Judicial Center.

Weighing in at 228 pages, the Science Manual for Canadian Judges is much shorter than the Federal Judicial Center’s Reference Manual on Scientific Evidence. Unlike the FJC’s Reference Manual, which is now in its third edition, the Canadian Manual has no separate chapters on regression, DNA testing and forensic evidence, clinical medicine and epidemiology. The coverage of statistical inference is concentrated in chapter two, but that chapter has no discussion of meta-analysis, systematic review, evidence-based medicine, confounding, and the like. Perhaps there will soon be a second edition of the Science Manual for Canadian Judges.


[1] See Albert Einstein, “On the Method of Theoretical Physics; The Herbert Spencer Lecture,” delivered at Oxford (10 June 1933), published in 1 Philosophy of Science 163 (1934) (“It can scarcely be denied that the supreme goal of all theory is to make the irreducible basic elements as simple and as few as possible without having to surrender the adequate representation of a single datum of experience.”).

Stanford Professor Smokes Out Tobacco Defense Expert Witnesses

July 18th, 2015

“Bullshit is unavoidable whenever circumstances require someone to talk without knowing what he is talking about.  Thus the production of bullshit is stimulated whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”

Harry Frankfurt, On Bullshit 63 (Princeton 2005)

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An in-press paper that attacks the ethics and motives of tobacco defense expert witnesses is making some ripples in the science and legal popular media. See, e.g., Tracie White, “Physicians testified for tobacco companies against plaintiffs with head, neck cancers, study finds,” ScienceDaily (July 17, 2015); Joyce E. Cutler, “Motives of Tobacco’s Experts Questioned by Study,” BNA Snapshot -Product Safety & Liability Reporter (July 20, 2015) [cited as Cutler]. The paper is now available in an in-press version. Robert K. Jackler, “Testimony by Otolaryngologists in Defense of Tobacco Companies 2009-2014,” The Laryngoscope (July 17, 2015) (in press) (doi: 10.1002/lary.25432). The paper is worth close study.

Dr. Robert Jackler, the Edward C. and Amy H. Sewall Professor in Otorhinolaryngology, at the Standford Medical School, has previously published his views of the tobacco industry’s role in obscuring medical research on the causal role of tobacco in human cancer.[1] In his most recent contribution, Jackler has reviewed tobacco companies’ expert witnesses’ testimonies to assess their consistency with what Jackler takes to be well-warranted scientific conclusions of known human cancer risks. From his one-sided review (of only defense witnesses) of a limited number of cases, Jackler concludes that tobacco defense expert witnesses were systematically biased in their under-estimation of the magnitude of tobacco-related risks, and their consistent inflation of non-tobacco risks, both in terms of their magnitude, prevalence, and scientific warrant of causality. Although one-sided in his review, Jackler does cite to transcripts that are available on-line from repositories at the University of California San Francisco Legacy Tobacco Documents Library. Disinterested observers can explore further the allegations and their merits by reading the primary documents.

The cases reviewed by Jackler included nine cases of upper aerodigestive-tract cancers (mostly larynx and esophagus), in which six defense otolaryngologists testified that tobacco played no role, or that there was no scientific basis for attributing individual cancers to tobacco. Jackler’s review interestingly identifies a tobacco defense strategy of “leveling” known causes with suspected causes and risk factors, to create a laundry list of differentials in a differential etiology for specific causation. Some of the risk factors that defense expert witnesses postulated included human papillomavirus (HPV), alcohol, mouthwash, heredity, asbestos, diesel fumes, gasoline fumes, salted fish, mouthwash, and urban living.

This epistemic dilution is indeed objectionable, but of course, it is the same epistemic bootstrapping that plaintiffs’ expert witnesses routinely use to place questionable, weakly supported differentials in their specific causation assessments. Consider the recent Tennessee appellate decision in Russell v. Illinois Central RR, in which the court rejected a defense challenge to the dodgy testimony of plaintiffs’ expert witness, Dr. Arthur Frank, that plaintiff’s throat cancer was caused by a etiological soup of asbestos, diesel fume, and environmental tobacco smoke. Russell v. Illinois Central RR, No. W2013-02453-COA-R3-CV, 2015 Tenn. App. LEXIS 520 (Tenn. App. June 30, 2015) (affirming judment for plaintiff in excess of $3 million).

Jackler notes that tobacco witnesses frequently raised the specter of “etiological soup.” Jackler at 3. For instance, some tobacco defense expert witnesses raised even possible asbestos exposure as a cause of laryngeal cancer, but Jackler is appropriately skeptical: “Although some studies suggest an additive effect with smoking, a meta-analysis concluded that the weight of the evidence does not support a causal association.” Jackler at 6 (citing H. Griffiths & N.C. Molony, “Does asbestos cause laryngeal cancer?” 28 Clin. Otolaryngol. & Allied Sci. 177 (2003); and Kevin Browne & J. Bernard L. Gee, “Asbestos exposure and laryngeal cancer,” 44 Ann. Occup. Hyg. 239 (2000). Jackler might be surprised by the stridency and the overreaching of a large segment of the occupational medicine community’s disagreement with his assessment.

Tobacco defense expert witnesses frequently raised diesel fume exposure as an alternative cause, but Jackler finds this testimony disingenuous. “The relationship of diesel fume exposure to laryngeal cancer has been discounted.” Jackler at 6 (citing J.E. Muscat & Ernst L. Wynder, “Diesel exhaust, diesel fumes, and laryngeal cancer,” 112 Otolaryngol. Head Neck Surg. 437 (1995)). So where is Jackler’s outrage against plaintiffs’ expert witness excesses, and the judicial acquiescence in accepting testimony such as that given by Dr. Arthur Frank in the Russell case.

Some of the risks, risk factors, and alternative causes invoked by the tobacco defense expert witnesses, as related by Dr. Jackler, did appear fantastical or false. Jackler, however, does not explore how the plaintiffs’ counsel addressed such over-reaching, or how the court responded to objections and challenges to the defense expert witness testimony. Plaintiffs’ counsel may have strategically allowed tobacco defense expert witnesses to overreach, in order to have a “harder” target on cross-examination.

Improper to Criticize Expert Witnesses

A spokesperson for Philip Morris, Bill Phelps, responded to Jackler’s critique by telling the BNA reporter that:

“We believe that out-of-court attempts to criticize experts for testifying on behalf of defendants in these cases have no place in our judicial system.”

Cutler. Phelps’ criticism is ambiguous between suggesting that any criticism of expert witnesses outside court is improper and suggesting that criticizing expert witnesses simply on the basis for testifying for the tobacco companies is improper.

If Phelps’s point was the latter, then it seems unexceptionable. Surely, the companies have a right to defend themselves, as long as they sponsor expert witness testimony in a responsible way. And certainly, any number of anti-tobacco scientists and physicians have resorted to bullying and name calling in efforts to chill scientists from speaking or testifying for tobacco companies, not by criticizing the substantive merits of testimony, but by asserting a contagious moral leprosy from merely having associated with tobacco companies.

Jackler comes very close to saying that physicians and scientists should not testify on behalf of tobacco companies. He casts aspersion on all tobacco defense expert witnesses by quoting others who state that “[t]he tobacco industry pays generously and gets its money worth.” Jackler at 7 (quoting L. Maggi, “Bearing Witness for Tobacco,” 21 J. Pub. Health Pol. 296 (2000). Jackler notes that “[u]nethical experts bias their testimony to bolster the position of the side who hired them.” Jackler at 7. But Jackler’s review is itself biased by his failure to examine the contentions and degrees of warrant of plaintiffs’ expert witnesses on any issues. Jackler does not articulate a view in his own voice, but states that “[s]ome medical ethicists question whether it could ever be ethical for a physician to testify on behalf of the tobacco industry.” Jackler at 7. Jackler’s implication begs the question whether plaintiffs, and their expert witnesses, are correct on all their medical claims, in every case.

The former point — that any out-of-court criticism of courtroom testimony — is wrong. Trenchant criticism of expert witness testimony is very much needed, and it is hard to see how it would not be helpful to public debate and to improvement of the judicial process. (Again, assuming that the critical discussions are fair and evidence-based.)

In an interview with the BNA, Jackler speculates:

“I think that these [tobacco defense] physicians testifying did so with the belief that their behavior would not become public. And this is an area where shedding light and creating dialogue will help to encourage people to behave ethically when giving their testimony.”

Cutler (quoting Jackler). If expert witnesses on either side think that they can escape critical scrutiny by advocating fabulous fictions in the courtroom, then we would all be better off if we could disabuse them of their notions. In his article, Jackler notes that his professional organization, the American Academy of Otolaryngology – Head and Neck Surgery (AAO–HNS) has, since 2003, had a policy that states:

“Physician expert witnesses should not adopt a position as an advocate or partisan in the legal proceedings”; and that

“the physician expert witness should be aware that transcripts of their deposition and courtroom testimony are public records, subject to independent peer review.”

Jackler at 7 (citing American Academy of Otolaryngology–Head and Neck Surgery official policy on expert witnesses (revised October, 2012)). So the tobacco defense expert witnesses should certainly have been prepared for the post-trial “peer review” that Jackler provides. What is curious about Jackler’s article, and his obvious sense of outrage, is that he does state whether he has filed an ethics complaint with the American Academy or with any other reviewing organization.

Philip Morris Claims that Jackler Has Undisclosed Conflicts of Interests

The Philip Morris spokes person also noted “[Dr. Jackler had] failed to disclose that he has previously worked with counsel for plaintiffs in the Engle cases.” Cutler.  Jackler responded to the BNA, stating “[c]ategorically, I have never testified in tobacco litigation. Specifically, I have never worked for lawyers on either side in any capacity in Engle cases.” What about other cases, outside Florida? Jackler’s in-press article states that it was “[s]upported by Stanford Research into the Impact of Tobacco Advertising, Stanford University School of Medicine, Stanford, CA. The authors have no other funding, financial relationships, or conflicts of interest to disclose.”

One Defense Expert Witness Responds

One defense expert witness, otolaryngologist Dr. Michael Bertino, responded to Cutler in an interview. Dr. Bertino noted that Jackler was out of touch with the risk factor epidemiology of laryngeal cancer, and that strong evidence had emerged that tobacco is not the only strong risk for this cancer. Many older studies, for instance, did not look at the role of human papilloma virus (HPV), which has been identified as a prevalent cause of oral and esophageal cancers. Cutler (citing oral interview with Dr. Bertino). Jackler’s article acknowledges that HPV has been identified in substantial percentages of oral pharyngeal cancers, but disputes that the virus is a substantial independent cause of these cancers. I will leave to others to determine whether Jackler’s review of the HPV studies is fair and balanced, and to what extent it “falsifies” Dr. Bertino’s testimony.


[1] Robert K. Jackler & H. Samji, “The price paid: Manipulation of otolaryngologists by the tobacco industry to obfuscate the emerging truth that smoking causes cancer,” 122 The Laryngoscope 75 (2011).

“Secret Histories” in Litigation

July 14th, 2015

A recent, special issue of The Public Historian, published by the University of California Press on behalf of the National Council on Public History, focuses on the role and nature of historian expert witnesses in judicial proceedings[1]. The collection raises interesting methodological questions about the historian’s craft and the interrelation between historical research and the law. The various contributions, listed at the end of this post, cover some of the diverse activities and subject-matter expertise that historians bring to the litigation process, in the United States, in Canada, and elsewhere.

My interest was drawn, not to the articles on native peoples or land rights, but to the one article on health-effect claims. See Keith A. Zahniser, “Why Litigation-Driven History Matters: Lessons Learned from the Secret History of TCE,” 37 The Public Historian 46 (2015). The author, Keith Zahniser, is a member of Historical Research Associates, Inc., which provides litigation support services, ranging from research to expert witness testimony. In his contribution to this collection of articles, Zahniser argues that litigation-driven historical research can live up to the professional standards of historians. Using an example of the history of trichloroethylene (TCE) use and its health hazards, he laments that relevant historical scholarship often remains secret and inaccessible, unpublished, and unimproved by peer review. Id. at 47-48.

Zahniser attributes the secretive nature of litigation-driven history to:

(1) confidentiality agreements;

(2) assertion of “work product” protections for documents uncovered by historical research; and

(3) assertion of “attorney-client privilege” for consulting expert historians’ opinions and identification of documents.

Id. at 49-50. Confidentiality agreements certainly could silence an expert witness during the course of the litigation, and forever after, perhaps. The assertion of work product or attorney-client privilege to avoid production of historical documents found by consulting or testifying historians is, however, more questionable. Unless the documents involved client communications made for the purpose of obtaining legal counsel, the attorney-client privilege would not apply. Opinions developed by a consulting expert witness might well be off limits to discovery in most common law jurisdictions, but historical documents, even if obtained with a consultant’s expertise and knowledge of archival sources, would not fall under the protection of the so-called work-product doctrine.

But what of Zahniser’s claim that the history of TCE has remained a “secret”? A briefest of internet searches suggests otherwise. Another consulting historian, Steve Swisdak of History Associates, presented on the history of TCE at an American Bar Association conference in 2013[2]. A scientist at GeoInsight, Inc., has published on the history of TCE, both in a journal and in a toxicology text[3]. The medicinal use of TCE is readily ascertained through publications listed in PubMed and other publication databases[4]. And a publisher of scientific bibliographies has published a timeline of TCE history[5].

Notwithstanding the complaint about “secret history,” Zahniser has not published on TCE; nor has he, or the company with which he is affiliated, made key historical documents available on their website, or any of the myriad websites that host documents for wider viewing. Finally, many historians’ reports or declarations are available through legal archives of case materials, such as WestlawNext or Lexis Advance. Zahniser’s reports on TCE do not appear to be available.

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Randolph Bergstrom, “Expert History and the Tribulations of Trials,” 37 The Public Historian 8 (2015)

Michael M. Brescia, “Bridging Troubled Waters: Historians, Natural Resource Litigation, and the Expert Witness Phenomenon,” 37 The Public Historian 11 (2015)

Jay C. Martin, “The Advocate’s Devil: The Maritime Public Historian as Expert,” 37 The Public Historian 25 (2015)

Emily Greenwald and Ian Smith, “Bury My Documents in Lenexa, Kansas: Expert Witness Work and the American Indian Records Repository,” 37 The Public Historian 39 (2015)

Keith A. Zahniser, “Why Litigation-Driven History Matters: Lessons Learned from the Secret History of TCE,” 37 The Public Historian 46 (2015)

Susan E. Gray, “Indigenous Space and the Landscape of Settlement: A Historian as Expert Witness,” 37 The Public Historian 54 (2015)

Jennifer A. Stevens, “From Archive to Evidence: Historians and Natural Resource Litigation,” 37 The Public Historian 68 (2015)

Gwynneth C. D. Jones, “Documentary Evidence and the Construction of Narratives in Legal and Historical,” 37 The Public Historian 88 (2015)

Bidtah N. Becker, “The Lawyer’s Guidebook for the Expert Witness in Natural Resources Litigation,” 37 The Public Historian 95 (2015)


[1] Thanks to Ramses Delafontaine for calling my attention to this issue of the Public Historian. Ramses’ new book provides an in-depth analysis of the role of historians as expert witnesses, in the context of tobacco litigation, as well as others. See Ramses Delafontaine, Historians as Expert Judicial Witnesses in Tobacco Litigation: A Controversial Legal Practice (2015).

[2] Steve Swisdak, “A Historical Survey of the Use and Regulation of TCE” (Oct. 11, 2013).

[3] Richard E. Doherty, “History of TCE,” in Kathleen M. Gilbert & Sarah J. Blossom, Trichloroethylene: Toxicity and Health Risks Molecular and Integrative Toxicology, at 1-14 ( 2014); Richard E. Doherty, “A History of the Production and Use of Carbon Tetrachloride, Tetrachloroethylene, Trichloroethylene and 1,1,1-Trichloroethane in the United States: Part 1 — Historical Background; Carbon Tetrachloride and Tetrachloroethylene,” 1 Envt’l Forensics 69 (2000); Richard E. Doherty, “A History of the Production and Use of Carbon Tetrachloride, Tetrachloroethylene, Trichloroethylene and 1,1,1-Trichloroethane in the United States: Part 2–Trichloroethylene and 1,1,1-Trichloroethane,”1 Envt’l Forensics 83 (2000).

[4] See, e.g., Gordon Ostlere, “The History of Trichloroethylene,” 8 Anaesthesia 21 (1953); Cecil Striker, “Clinical experiences with the use of trichlorethylene in the production of over 300 analgesias and anesthesias,” 14 Curr. Res. Anesth. 68 (1935).

[5] Icon Group Internat’l, Trichloroethylene: Webster’s Timeline History, 1949 – 2007 (2010).

Conflict Over Conflicts of Interest

July 12th, 2015

“Let him who is without sin among you be the first to throw a stone … .”       John 8:7

In the recent issue of Carcinogenesis, Jonathan Samet attempts to defend the monograph and carcinogen identification process of the International Agency for Research on Cancer (IARC). Jonathan M. Samet, “The IARC monographs: critics and controversy,” 36 Carcinogenesis 707 (2015) [cited below as Samet]. The defense is largely redundant of a publication earlier this year, in which a gaggle (124) of scientists rallied around the IARC and its carcinogenicity assessments. Neil Pearce, et al., “IARC Monographs: 40 Years of Evaluating Carcinogenic Hazards to Humans,” 123 Envt’l Health Persp. 507 (2015) [cited below as Pearce].

Professor Samet’s editorial is remarkable in several respects. First, the editorial covers the same points and arguments as the opinion piece in the Environmental Health Perspectives. Samet was one of the gaggle of 124, and so his more recent editorial in Carcinogenesis is a redundant, duplicate publication.

Samet identifies recent criticisms of IARC as falling into four categories:

“(i) reliance on epidemiological evidence that may be limited;

(ii) limitations of the IARC process and reluctance to participate in it;

(iii) issues related to specific evaluations and

(iv) issues related to the composition of the Working Groups.”

Samet at 707. Samet’s defense consists largely in following the public health meme of attributing any dissent or disagreement to industry’s conflicts of interest. In his view, IARC used to have a problem with “not maintaining sufficient distance from industrial stakeholders and the associated potential for conflict of interest[1],” but the “industry” problem has now been remedied[2]. And so Samet reasons that any continued criticisms must be the result of the industrial critics’ conflicts of interest[3]. To be sure, industry conflicts of interest are given strict scrutiny. As we shall see, litigation and compensation industry credentials are welcomed at the IARC.

Samet’s defense, which is really an attack on the bona fides of the critics, has become a commonplace in the public health community, and has degraded debate into charges and counter-charges as to who has the greater conflict of interest. This defense ignores both the specific and the general criticisms of the IARC decision process.

As Professor Cornelia Baines has noted, the IARC “process,” carries the risk of group think and of ignoring substantive disagreement. “When experts in the field are chosen, some will come armed with their zealously-promoted and ferociously-defended versions of the ‘truth’, making predictable what they will recommend at the end of the review process.” Cornelia J. Baines, “Transparency at the International Agency for Research on Cancer (IARC),” 361 Lancet 781 (2003). This danger looms especially large when members of IARC working groups have already committed to the conclusion ultimately reached, or have written and published key studies the status of which will be enhanced or undermined by the outcome of the working group’s decision. Samet and the gaggle give no consideration to this potent source of conflicts of interest.

And Geoffrey Kabat, a senior epidemiologist at Albert Einstein School of Medicine, who was one of the gaggle’s “targets,” noted that the gaggle

“confine[] themselves to generalities and fail to come to grips with any specific criticisms on their merits. The EHP defense of IARC has all the subtlety of using an elephant gun to kill a gnat.”

Geoffrey Kabat, “How Many Scientists Does It Take To Squelch A Critic? Hint: 124,” Forbes (Mar. 10, 2015) (documenting how errant and mean-spirited the gaggle’s criticisms were).

Samet argues that the likelihood that other groups, such as the Environmental Protection Agency and the National Toxicology Program, walk in lockstep with IARC, suggests how “robust” the IARC system is. Using the IARC evaluation of formaldehyde as an example, Samet points to the “confirmation” of IARC’s judgments by EPA and NTP. Samet at 707. But this example and many others merely show that the IARC and the regulatory world are robust for group think. And yet the robust agreement is not always based upon robust evidence[4].

Like the gaggle’s editorial, Samet suggests that criticisms are good except that criticisms of the IARC, and especially his IARC working group, are “unfair and unconstructive.” Pearce at 514. Samet graciously acknowledges that “[w]ith regard to particular monographs, inevitably if evidence is lacking or mixed and at equipoise, any classification can be reasonably questioned.” Samet at 707. Like the gaggle, however, he never engages with Dr. Kabat’s procedural and substantive criticisms of Samet’s working group on electromagnetic radiation exposures.

There is, of course, a serious danger of placing so much emphasis on conflicts of interest as a proxy for truth and validity. One could be hoisted with his own conflict-of-interest petard. Samet, for instance, in his Carcinogenesis editorial declares no conflict of interest, and yet he was the Chairman of the IARC working group on radiofrequency electromagnetic radiation exposure[5] that was the subject of Dr. Kabat’s and others’ scathing criticisms.

Carcinogenesis has the following policy on conflicts:

“Carcinogenesis policy requires that each author reveal any financial interests or connections , direct or indirect, or other situations that might raise the question of bias in the work reported or the conclusions, implications, or opinions stated – including pertinent commercial or other sources of funding for the individual author(s) or for the associated department(s) or organization(s), personal relationships, or direct academic competition.”

Carcinogenesis CONFLICT OF INTEREST FORM <accessed July 10, 2015>.

In addition to Samet’s personal role in the criticized IARC determination, several of the gaggle have been regular testifiers for litigation-compensation industry[6]. There are no disclosures of litigation conflicts of interest in the gaggle’s editorial. Pearce.

Samet himself has been at the center of other conflict-of-interest controversies. In 2011, two tobacco companies sued the United States Food and Drug Administration (FDA) to challenge how the agency staffed its Tobacco Products Scientific Advisory Committee (“TPSAC”), which was charged with investigating the public health implications of using menthol in cigarettes.   The companies alleged that the FDA failed to comply with the Federal Advisory Committee Act (“FACA”). The TPSAC, formed after the enactment of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) reported that menthol in cigarettes adversely affected public health, and that menthol should be removed to promote public health.

The basis of the suit was that three members of the TPSAC had served, or continued to serve, as paid expert witnesses for plaintiffs in litigation against tobacco companies. The companies claim was that the these TPSAC members, including Dr. Samet, created a partial, interested, imbalanced committee that was unfairly predisposed to view menthol in cigarettes as harmful. In 2012, a federal district court refused the FDA’s motion to dismiss[7], and last year, the court granted the tobacco companies substantially the relief they sought[8].

The FDA appealed Judge Leon’s ruling, but in March 2015, the agency announced that four members of the TPSAC were removed, including Dr. Samet. Ironically, the American Thoracic Society (ATS) submitted an amicus brief, despite having an obvious conflict of interest. Dr. Samet is a member of the ATS’s Tobacco Action Committee, through which he organizes and coordinates the ATS’s anti-tobacco activities. The ATS and Dr. Samet’s anti-tobacco activism may be laudable, but that activism, along with Dr. Samet’s engagement as a litigation expert witness for plaintiffs against tobacco companies, surely constitute a conflict of interest, if anything is.


[1] Editorial, “Transparency at IARC,” 361 Lancet 189 (2003).

[2] citing Herbert Needleman & James Huff, “The International Agency for Research on Cancer and obligate transparency,” 6 Lancet Oncol. 920 (2005)

[3] citing those who would be manufacturers of faux certainty, Naomi Oreskes & Erik Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (N.Y. 2010); David Michaels, Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health (N.Y. 2008).

[4] See, e.g., C. Bosetti, Joseph K. McLaughlin, Robert E. Tarone, E. Pira & Carlo La Vecchia, “Formaldehyde and cancer risk: a quantitative review of cohort studies through 2006,” 19 Ann. Oncol. 29 (2008).

[5] IARC Press Release N° 208, “IARC Classifies Radiofrequency Electromagnetic Fields as Possibly Carcinogenic to Humans” (31 May 2011).

[6] Including Martyn T. Smith, whose testimony has been the subject of several judicial exclusions for lack of validity.

[7] Lorillard, Inc. v. United States Food and Drug Admin., Civ. No. 11-440 (RJL), 2012 WL 3542228 (Aug. 1, 2012).

[8] Lorillard, Inc. v. United States Food and Drug Admin., 56 F. Supp. 3d 37 (D.D.C. 2014) (Leon, J.). Judge Leon’s decision is discussed in “Conflict of Interest Regulations Apply Symmetrically” (July 25, 2015). The case is currently on appeal to the Court of Appeals for the District of Columbia Circuit.

Unguarded Historian’s Inquiry into Nazi Science of Silica and Lung Cancer

July 10th, 2015

Robert N. Proctor is Professor of the History of Science, in Stanford University. In the litigation world, he is known mostly for his advocacy on behalf of tobacco plaintiffs. He has testified in dozens of cases over the years, always on behalf of claimants. See Ramses Delafontaine, “Making History in Court: A Survey of Historians as Expert Witnesses in Tobacco Litigation in the US – Robert N. Proctor,” The Judge and the Historian (last visited July 6, 2015).

Proctor’s book, The Nazi War on Cancer (Princeton 1999), which won the American Public Health Association’s 1999 Viseltear Award, is an extended exploration of the Nazi ideology of health. The value of the book is not merely in its discussion of the scientific record on various issues, such as

tobacco and asbestos, in the Nazi empire; rather Proctor’s historical narrative provides a valuable insight into how science can become the plaything of political ideologies. The Nazi War illustrates that the political pressures do not always come from corporations. Some of the most intense and unremitting pressures come from popular movements such as those made up of consumerists and environmentalists.

Although Proctor’s focus is on tobacco, and to a lesser extent, asbestos, he does have some intriguing things to say about silica, silicosis, and lung cancer. According to Proctor:

“Cancer was an occasional concern of the German industrial hygienists who worried about silicosis. A 1934 dissertation explored the coincidence of silicosis and lung cancer, the primary question being whether the quartz dust inhaled by Ruhr Valley coal miners could cause malignancies. Though the results of this particular study were negative (silicosis did not seem to predispose to lung cancer), the prescience of the interest is notable.132

Nazi War at 107 & n. 132 (citing Kurt Kollmeier, Silikose und Lungenkrebs (Bonn: Medical Dissertation, 1934), and noting that Ludwig Teleky, “Der berufliche Lugenkrebs,” 3 Actio Unio Internationalis Contra Cancrum 253 (1938) “failed to find a link.”). Lack of resolution was not a common occurrence in Nazi politics or science, but Proctor notes that:

“The question of whether silica exposure could cause cancer was never resolved in the Nazi era — and remains confused even today, more than a half century later.”

Nazi Science at 107. And despite the political ideology of OSHA’s administrator and white-hat public health zealots, the question whether silica can cause lung cancer is still not resolved.

Crayons Help Divert California from Real Risks – Tales from the Fearmonger’s Shop

July 8th, 2015

Living in a state, California, beset by the actuality of drought and the real, imminent threat of earthquake, must be scary. And still, Californians seem to relish increasing the appearance of risks everywhere. The state has astonishing epistemic insights, knowing risks not known to anyone else, through its Proposition 65. And then there are legislative fiats that posit risks, again unknown outside California. David Lazarus, “Berkeley’s warning about cellphone radiation may go too far,” Los Angeles Times (June 26, 2015). And now there are killer crayons from China. Victoria Colliver, “Asbestos fibers found in some crayons, toys from China,” SFGate (July 8, 2015).

Ms. Colliver is largely the uncritical conduit for an advocacy group, which speaks through her, without any scientific filter:

“Environmental health advocates said there is no safe level of exposure to asbestos, a group of naturally occurring minerals with microscopic fibers. The fibers can accumulate in the lungs and have been linked to cancer and other health problems.”

Id. At best, some scientists, mostly of the zealot brand, say that there is no known safe level of exposure to asbestos, but this is quite different from saying there is known to be no safe level. Honest scientists will acknowledge a dispute about whether low-level exposures are innocuous, but uncertainty about safety at low doses does not translate into certainty about unsafety at low doses. And the suggestion that fibers can accumulate in the lungs may be true for occupational and paraoccupational exposures, but human beings have defense mechanisms that block entry by, and rid the lungs of, asbestos fibers. At the cellular and subcellular level, humans have robust defenses to low-levels of carcinogens in the form of DNA repair mechanisms. Of course, as wild and unpredictable as little children can be, they rarely inhale crayons. If they do, asbestos won’t be their problem. (To be fair, one of the products tested was a powder, which could be aerosolized, but there is no quantitative assessment of the extent of asbestos in this powder product.)

Ms. Colliver’s source is a report put out by Environmental Working Group Action Fund, the website for which does not acknowledge any scientific oversight or membership. Colliver’s “hot quotes” are from Richard Lemen, who is a regular testifier for the asbestos litigation industry.

What you will not see in Colliver’s “science” coverage is that there is no mineral asbestos; rather it is a commercial term for six different fibrous naturally occurring minerals. Five of the asbestos minerals are amphiboles – crocidolite (blue), amosite (brown), tremolite, anthophyllite, and actinolite. The remaining mineral fiber is chrysotile. There are, to be sure, many other fibrous minerals, but none with any suggested carcinogenicity, other than the non-asbestos zeolite mineral erionite. The most serious health effect of some kinds of asbestos is mesothelioma, a malignancy of the serosal tissues around the lung, heart, and gut. Crocidolite and amosite are by far the major causes of mesothelioma.

Although Colliver does not link to the EWG’s report, it is easy enough to find the report on the group’s website. See Bill Walker and Sonya Lunder, “Tests Find Asbestos in Kids’ Crayons, Crime Scene Kits” (2015). Most of the products tested had no detectable asbestos fiber of any kind. The EWG report provides no quantification of the findings so it is hard to assess the extent of the asbestos present. The report does provide the identity of the fibrous asbestos minerals present: tremolite, anthophyllite, actinolite, which suggests that the fibers were present in low levels in the talcs used as binding agents or mold release for the crayons. The EWG report fails to provide quantitative information on the distribution of morphology of the so-called fibers. The biologically dangerous fibers have a high-aspect ratio. Importantly, crocidolite and amosite, which collectively are the major causes of mesothelioma, were not found.

Assuming the report is correct, the hazard to children is remote and incredibly speculative. Fibers in the crayons would not be readily aerosolized, and the fibers could not represent even a theoretical hazard unless they were inhaled. The only disease for which low exposures is even a theoretical concern is mesothelioma. Back in 2000, a similar scare erupted in the media. At that time the Consumer Product Safety Commission tested the crayons, and concluded that the risk of a child’s inhaling asbestos fiber was “extremely low.” No airborne fibers could be detected after a simulation of a child’s “vigorously coloring” with a crayon. U.S. Consumer Product Safety Commission, CPSC Staff Report on Asbestos Fibers in Children’s Crayons (2000). The business of defining what counts as an asbestos fiber, as opposed to a non-carcinogenic particle, is complicated and sometimes controversial. See Bruce W. Case, Jerrold L. Abraham, G. Meeker , Fred D. Pooley & K. E. Pinkerton, “Applying definitions of “asbestos” to environmental and “low-dose” exposure levels and health effects, particularly malignant mesothelioma,” 14 J. Toxicol. Envt’l Health B Crit. Rev. 3 (2011) (noting lack of consensus about the specific definitions for asbestos fibers).

As for low-exposure alleged risks, the evidence varies by disease outcome. For lung cancer, there is actually rather strong evidence of a threshold. And lack of conclusive evidence of a threshold below which mesothelioma will not occur is hardly evidence that mesothelioma could result from any theoretical exposure postulated from children’s use of the crayons. The business of attributing a case of mesothelioma to a low-level previous exposure is, of course, very different from predicting that a very low level exposure will have a public health effect in a large population. Asbestos minerals occur naturally, and rural and urban residents, even those without occupational exposure, have a level of asbestos that can be found in their lung tissue. There is, however, a business of attributing mesotheliomas to low-level exposures, that has become a big business indeed, in courtrooms all around the United States. The business is run by expert witnesses who regularly conflate “no known safe level” with “known no safe level,” just as Ms. Colliver did in her article. What a coincidence! See Mark A. Behrens & William L. Anderson, “The ‘any exposure’ theory: an unsound basis ·for asbestos causation and expert testimony,” 37 Southwestern Univ. L. Rev. 479 (2008); Nicholas P. Vari and Michael J. Ross, “State Courts Move to Dismiss Every Exposure Liability Theory in Asbestos Lawsuits,” 29 Legal Backgrounder (Feb. 28, 2014).

Silicone Data Slippery and Hard to Find (Part 2)

July 5th, 2015

What Does a Scientist “Gain,” When His Signal Is Only Noise

When the silicone litigation erupted in the early 1990s, Leoncio Garrido was a research professor at Harvard. In 1995, he was promoted from Assistant to Associate Professor of Radiology, and the Associate Director of NMR Core, at the Harvard Medical School. Along with Bettina Pfleiderer, Garrido published a series of articles on the use of silicon 29 nuclear magnetic resonance (NMR) spectroscopy, in which he claimed to detect and quantify silicon that migrated from the silicone in gel implants to the blood, livers, and brains of implanted women[1].

Plaintiffs touted Garrido’s work on NMR silicone as their “Harvard” study, to offset the prestige that the Harvard Nurses epidemiologic study[2] had in diminishing the plaintiffs’ claims that silicone caused autoimmune disease. Even though Garrido’s work was soundly criticized in the scientific literature[3], Garrido’s apparent independence of the litigation industry, his Harvard affiliation, and the difficulty in understanding the technical details of NMR spectroscopic work, combined to enhance the credibility of the plaintiffs’ claims.

Professor Peter Macdonald, who had consulted with defense counsel, was quite skeptical of Garrido’s work on silicone. In sum, Macdonald’s analysis showed that Garrido’s conclusions were not supported by the NMR spectra presented in Garrido’s papers. The spectra shown had signal-to-noise ratios too low to allow a determination of putative silicon biodegradation products (let alone to quantify such products), in either in vivo or ex vivo analyses. The existence of Garrido’s papers in peer-reviewed journals, however, allowed credulous scientists and members of the media to press unsupported theories about degradation of silicone into supposedly bioreactive silica.

A Milli-Mole Spills the Beans on the Silicone NMR Data

As the silicone litigation plodded on, a confidential informant dropped the dime on Garrido. The informant was a Harvard graduate student, who was quite concerned about the repercussions of pointing the finger at the senior scientist in charge of his laboratory work. Fortunately, and honorably, this young scientist more concerned yet that Garrido was manipulating the NMR spectra to create his experimental results. Over the course of 1997, the informant, who was dubbed “Mini-Mole,” reported serious questions about the validity of the silicon NMR spectra reported by Garrido and colleagues, who had created the appearance of a signal by turning up the gain to enhance the signal/noise ratio. Milli-mole also confirmed Macdonald’s suspicions that Garrido had created noise artifacts (either intentionally or carelessly) that could be misrepresented to be silicon-containing materials with silicon 29 NMR spectra.

In late winter 1997, “Mini-Mole” reported that Harvard had empanelled an internal review board to investigate Garrido’s work on silicon detection in blood of women with silicone gel breast implants. The board involved an associate dean of the medical school, along with an independent reviewer, knowledgeable about NMR. Mini-Mole was relieved that he would not be put into the position of becoming a whistle blower, and he believed that once the board understood the issues, Garrido’s deviation from the scientific standard of care would become clear. Apparently, concern at Harvard was reaching a crescendo, as Garrido was about to present yet another abstract, on brain silicon levels, at an upcoming meeting of the International Society of Magnetic Resonance in Medicine, in Vancouver, BC. Milli-Mole reported that one of the co-authors strongly disagreed with Garrido’s interpretation of the data, but was anxious about withdrawing from the publication.

Science Means Never Having to Say You’re Sorry

By 1997, Judge Pointer had appointed a panel of neutral expert witnesses, but the process had become mired in procedural diversions. Bristol-Myers Squibb sought and obtained a commission in state court (New Jersey) cases for a Massachusetts’ subpoena for Garrido’s underlying data late in1997. Before BMS or the other defendants could act on this subpoena, however, Garrido published a rather weak, non-apologetic corrigendum to one of his papers[4].

Although Garrido’s “Erratum” concealed more than it disclosed, the publication of the erratum triggered an avalanche of critical scrutiny. One of the members of the editorial board of Magnetic Resonance in Medicine undertook a critical review of Garrido’s papers, as a result of the erratum and its fallout. This scientist concluded that:

“From my viewpoint as an analytical spectroscopist, the result of this exercise was disturbing and disappointing. In my judgement as a referee, none of the Garrido group’s papers (1–6) should have been published in their current form.”

William E. Hull, “A Critical Review of MR Studies Concerning Silicone Breast Implants,” 42 Magnetic Resonance in Medicine 984, 984 (1999).

Another scientist, Professor Christopher T.G. Knight, of the University of Illinois at Urbana-Champaign, commented in a letter in response to the Garrido erratum:

“A series of papers has appeared in this Journal from research groups at Harvard Medical School and Massachusetts General Hospital. These papers describe magnetic resonance studies that purport to show significant concentrations of silicone and chemically related species in the blood and internal organs of silicone breast implant recipients. One paper in particular details 29Si NMR spectroscopic results of experiments conducted on the blood of volunteers with and without implants. In the spectrum of the implant recipients’ blood there appear to be several broad signals, whereas no signals are apparent in the spectrum of the blood of a volunteer with no implant. On these grounds, the authors claim that silicone and its degradation products occur in significant quantities in the blood of some implant recipients. Although this conclusion has been challenged, it has been widely quoted.

******

The erratum, in my opinion, deserves considerably more visibility, because it in effect greatly reduces the strength of the authors’ original claims. Indeed, it appears to be tantamount to a retraction of these.”

Christopher T.G. Knight, “Migration and Chemical Modification of Silicone in Women With Breast Prostheses,” 42 Magnetic Resonance in Med. 42:979 (1999) (internal citations omitted). Professor Knight went on to critique the original Garrido work, and the unsigned, unattributed erratum as failing to show a difference between the spectra developed from blood of women with and without silicone implants. Garrido’s erratum suggested that his “error” was simply showing a spectrum with the wrong scale, but Professor Knight showed rather conclusively that other manipulations had taken place to alter the spectrum. Id.

In a brief response[5], Garrido and co-authors acknowledged that their silicon quantification was invalid, but still maintained that they had qualitatively determined the presence of silicon entities. Despite Garrido’s response, the scientific community soon became incredulous about his silicone NMR work.

Garrido’s fall-back claim that he had detected unquantified levels of silicon using Si29 NMR was definitively refuted, in short order[6]. Ultimately, Peter Macdonald’s critique of Garrido was vindicated, and Garrido’s work became yet another weight that helped sink the plaintiffs’ case. Garrido last published on silicone in 1999, and left Harvard soon thereafter, to become the Director of the Instituto de Ciencia y Tecnología de Polímeros, in Madrid, Spain. He is now a scientific investigator at the Institute’s Physical Chemistry of Polymers Department. The Institute’s website lists Garrido as Dr. Leoncio Garrido Fernández. Garrido’s silicone publications were never retracted, and Harvard never publicly explained Garrido’s departure.


[1] See, e.g., Bettina Pfleiderer & Leoncio Garrido, “Migration and accumulation of silicone in the liver of women with silicone gel-filled breast implants,” 33 Magnetic Resonance in Med. 8 (1995); Leoncio Garrido, Bettina Pfleiderer, B.G. Jenkins, Carol A. Hulka, D.B. Kopans, “Migration and chemical modification of silicone in women with breast prostheses,” 31 Magnetic Resonance in Med. 328 (1994). Dr. Carol Hulka is the daughter of Dr. Barbara Hulka, who later served as a neutral expert witness, appointed by Judge Pointer in MDL 926.

[2] Jorge Sanchez-Guerrero, Graham A. Colditz, Elizabeth W. Karlson, David J. Hunter, Frank E. Speizer, Matthew H. Liang, “Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms,” 332 New Engl. J. Med . 1666 (1995).

[3] See R.B. Taylor, J.J. Kennan, “29Si NMR and blood silicon levels in silicone gel breast implant recipients,” 36 Magnetic Resonance in Med. 498 (1996); Peter Macdonald, N. Plavac, W. Peters, Stanley Lugowski, D. Smith, “Failure of 29Si NMR to detect increased blood silicon levels in silicone gel breast implant recipients,” 67 Analytical Chem. 3799 (1995).

[4] Leoncio Garrido, Bettina Pfleiderer, G. Jenkins, Carol A. Hulka, Daniel B. Kopans, “Erratum,” 40 Magnetic Resonance in Med. 689 (1998).

[5] Leoncio Garrido, Bettina Pfleiderer, G. Jenkins, Carol A. Hulka, Daniel B. Kopans, “Response,” 40 Magnetic Resonance in Med. 995 (1998).

[6] See Darlene J. Semchyschyn & Peter M. Macdonald, “Limits of Detection of Polydimethylsiloxane in 29Si NMR Spectroscopy,” 43 Magnetic Resonance in Med. 607 (2000) (Garrido’s erratum acknowledges that his group’s spectra contain no quantifiable silicon resonances, but their 29Si spectra fail to show evidence of silicone or breakdown products); Christopher T. G. Knight & Stephen D. Kinrade, “Silicon-29 Nuclear Magnetic Resonance Spectroscopy Detection Limits,” 71 Anal. Chem. 265 (1999).

Silicone Data Slippery and Hard to Find (Part 1)

July 4th, 2015

In the silicone gel breast implant litigation, plaintiffs’ counsel loved to wave around early Dow Corning experiments with silicone as an insecticide. As the roach crawls, it turned out that silicone was much better at attracting and dispatching dubious expert witnesses and their testimony. On this point, it is hard to dispute the judgment of Judge Jack Weinstein[1].

The silicone wars saw a bioethics expert appear as an expert witness to testify about a silicone study in which his co-authors refuse to share their data with him, embarrassing to say the least. “Where Are They Now? Marc Lappé and the Missing Data” (May 19, 2013). And another litigation expert witness lost his cachet when the Northridge earthquake at his data. “Earthquake-Induced Data Loss – We’re All Shook Up” (June 26, 2015). But other expert witnesses were up to the challenge for the most creative and clever excuses for not producing their underlying data.

Rhapsody in Goo – My Data Are Traveling; Come Back Later

Testifying expert witness, Dr. Eric Gershwin was the author of several research papers that claimed or suggested immunogenicity of silicone[2]. His results were criticized and seemed to elude replication, but he enjoyed a strong reputation as an NIH-funded researcher. Although several of his co-authors were from Specialty Labs, Inc. (Santa Monica, CA)[3], defense requests for his Gershwin’s underlying data were routinely met with the glib response that the data were in Israel, where some of his other co-authors resided.

Gershwin testified in several trials, and the plaintiffs’ counsel placed great emphasis on his publications and on his testimony given before Judge Jones’ technical advisors in August 1996, before Judge Pointer’s panel of Rule 706 experts, in July 1997, and before the Institute of Medicine (IOM) in 1998.

Ultimately, this peer review of Gershwin’s work and claims was withering. The immunologist on Judge Jones’ panel (Dr. Stenzel-Poore) found Gershwin’s claims “not well substantiated.” Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387 (D. Ore. 1996). The immunologist on Judge Pointer’s panel, Dr. Betty A. Diamond was unshakeable in her criticisms of Gershwin’s work and his conclusions. Testimony of Dr. Betty A. Diamond, in MDL 926 (April 23, 1999). And the IOM found Gershwin’s work inadequate and insufficient to justify the extravagent claims that plaintiffs were making for immunogenicity and for causation of autoimmune disease. Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

Unlike Kossovsky, who left medical practice and his university position, Gershwin has continued to teach, research, and write after the collapse of the silicone litigation industry. And he has continued to testify, albeit in other kinds of tort cases.

In 2011, in testimony in a botox case, Dr. Gershwin attempted to distance himself from his prior silicone testimony. Gershwin testified that he was “an expert for silicone implants in the late 90s.” Testimony of M.E. Gershwin, at at 18:17-25, in Ray v. Allergan, Inc., Civ. No. 3:10CV00136 (E.D. Va. Jan. 17, 2011). An expert witness for implants; how curious? Here is how Gershwin described the fate of his strident testimony in the silicone litigation:

“Q. And has a court ever limited or excluded your opinions?

A. So a long time ago, probably more than ten years ago or so, twice. I had many cases involving silicone implants. The court restricted some but not all of my testimony. Although, my understanding is that, when the FDA finally did reapprove the use of silicone implants, the papers I published and evidence I gave was actually part of the basis by which they developed their regulations. And there’s not been a single example in the literature of anyone that’s ever refuted or questioned any of my work. But I think that’s all, as far as I know.

* * * *
Q. Okay. So it’s not — you made it sound like it was some published work that you had. Was it your opinions that you expressed in the cases that you believe the FDA adopted as part of their guidelines, or do you —

A. So I’ll tell you, I haven’t visited this subject in a long time, and I certainly took quite a beating from a number of people over — I was very proud in the past that I did it. Women’s rights groups all over the United States applauded what I did. I haven’t looked at these documents in over ten years, so beyond that, you’d have to do your own research.”

Id. at 20:19 – 21:25. Actually, several courts excluded Gershwin, as well as other expert witnesses who relied upon his published papers. Proud to be beaten.

Some of Gershwin’s coauthors have stayed the course on silicone. Yehuda Shoenfeld continues to publish on sick-building syndrome and so-called silicone “adjuvant disease,” which Shoenfeld immodestly refers to as “Shoenfeld’s syndrome.[4]” Gershwin and Shoenfeld parted company in the late 1990s on silicone, although they continue to publish together on other topics[5].


[1] Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud).

[2] E. Bar-Meir, S.S. Teuber, H.C. Lin, I. Alosacie, G. Goddard, J. Terybery, N. Barka, B. Shen, J.B. Peter, M. Blank, M.E. Gershwin, Y. Shoenfeld, “Multiple Autoantibodies in Patients with Silicone Breast Implants,” 8 J. Autoimmunity 267 (1995); Merrill J. Rowley, Andrew D. Cook, Suzanne S. Teuber, M. Eric Gershwin, “Antibodies to Collagen: Comparative Epitope Mapping in Women with Silicon Breast Implants, Systemic Lupus Erythematosus and Rheumatoid Arthritis,” 6 J. Autoimmunity 775 (1994); Suzanne S. Teuber, Merrill J. Rowley, Steven H. Yoshida, Aftab A. Ansari, M.Eric Gershwin, “Anti-collagen Autoantibodies are Found in Women with Silicone Breast Implants,” 6 J. Autoimmunity 367 (1993).

[3] J. Teryberyd, J.B. Peter, H.C. Lin, and B. Shen.

[4] A partial sampler of Shoenfeld’s continued output on silicone:

Goren, G. Segal, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants: Who is at risk?” 34 Clin. Rheumatol. (2015) [in press]

Nesher, A. Soriano, G. Shlomai, Y. Iadgarov, T.R. Shulimzon, E. Borella, D. Dicker, Y. Shoenfeld, “Severe ASIA syndrome associated with lymph node, thoracic, and pulmonary silicone infiltration following breast implant rupture: experience with four cases,” 24 Lupus 463 (2015)

Dagan, M. Kogan, Y. Shoenfeld, G. Segal, “When uncommon and common coalesce: adult onset Still’s disease associated with breast augmentation as part of autoimmune syndrome induced by adjuvants (ASIA),” 34 Clin Rheumatol. 2015 [in press]

Soriano, D. Butnaru, Y. Shoenfeld, “Long-term inflammatory conditions following silicone exposure: the expanding spectrum of the autoimmune/ inflammatory syndrome induced by adjuvants (ASIA),” 32 Clin. Experim. Rheumatol. 151 (2014)

Perricone, S. Colafrancesco, R. Mazor, A. Soriano, N. Agmon-Levin, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) 2013: Unveiling the pathogenic, clinical and diagnostic aspects,” 47 J. Autoimmun. 1 (2013)

Vera-Lastra, G. Medina, P. Cruz-Dominguez Mdel, L.J. Jara, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum,” 9 Expert Rev Clin Immunol. 361 (2013)

Lidar, N. Agmon-Levin, P. Langevitz, Y. Shoenfeld, “Silicone and scleroderma revisited,” 21 Lupus 121 (2012)

S.D. Hajdu, N. Agmon-Levin, Y. Shoenfeld, “Silicone and autoimmunity,” 41 Eur. J. Clin. Invest. 203 (2011)

Levy, P. Rotman-Pikielny, M. Ehrenfeld, Y. Shoenfeld, “Silicone breastimplantation-induced scleroderma: description of four patients and a critical review of the literature,” 18 Lupus 1226 (2009)

A.L. Nancy & Y. Shoenfeld, “Chronic fatigue syndrome with autoantibodies – the result of an augmented adjuvant effect of hepatitis-B vaccine and silicone implant,” 8 Autoimmunity Rev. 52 (2008)

Molina & Y. Shoenfeld, “Infection, vaccines and other environmental triggers of autoimmunity,” 38 Autoimmunity 235 (2005)

R.A. Asherson, Y. Shoenfeld, P. Jacobs, C. Bosman, “An unusually complicated case of primary Sjögren’s syndrome: development of transient ‘lupus-type’ autoantibodies following silicone implant rejection,” 31 J. Rheumatol. 196 (2004), and Erratum in 31 J. Rheumatol. 405 (2004)

Bar-Meir, M. Eherenfeld, Y. Shoenfeld, “Silicone gel breast implants and connective tissue disease–a comprehensive review,” 36 Autoimmunity 193 (2003)

Zandman-Goddard, M. Blank, M. Ehrenfeld, B. Gilburd, J. Peter, Y. Shoenfeld, “A comparison of autoantibody production in asymptomatic and symptomatic women with silicone breast implants,” 26 J. Rheumatol. 73 (1999)

[5] See, e.g., N. Agmon-Levin, R. Kopilov, C. Selmi, U. Nussinovitch, M. Sánchez-Castañón, M. López-Hoyos, H. Amital, S. Kivity, M.E. Gershwin, Y. Shoenfeld, “Vitamin D in primary biliary cirrhosis, a plausible marker of advanced disease,” 61 Immunol. Research 141 (2015).

Discovery of Retained, Testifying Statistician Expert Witnesses (Part 2)

July 1st, 2015

Discovery Beyond the Report and the Deposition

The lesson of the cases interpreting Rule 26 is that counsel cannot count exclusively upon the report and automatic disclosure requirements to obtain the materials necessary or helpful for cross-examination of statisticians who have created their own analyses. Sometimes just asking nicely suffices[1]. Other avenues of discovery are available, however, for reluctant disclosers. In particular, Rule 26(b) authorizes discovery substantially broader than what is required for inclusion in an expert witness’s report.

Occasionally, counsel cite caselaw that has been superseded by the steady expansion of Rule 26[2]. The 1993 amendments made clear, however, that Rule 26 sets out mandatory minimum requirements that do not define or exhaust the available discovery tools to obtain information from expert witnesses[3]. Some courts continue to insist that a party make a showing of necessity to go beyond the minimal requirements of Rule 26[4], although the better reasoned cases take a more expansive view of the proper scope of expert witness discovery[5].

Although the federal rules may not require the expert witness report to include, or to attach, all “working notes or recordings,” or calculations, alternative analyses, and data output files, these materials may be the subject of proper document requests to the adverse party or perhaps subpoenas to the expert witness.  The Advisory Committee Notes explain that the various techniques of discovery kick in by virtue of Rule 26(b), where automatic disclosure and report requirements of Rule 26(a) leave off:

“Rules 26(b)(4)(B) and (C) do not impede discovery about the opinions to be offered by the expert or the development, foundation, or basis of those opinions. For example, the expert’s testing of material involved in litigation, and notes of any such testing, would not be exempted from discovery by this rule. Similarly, inquiry about communications the expert had with anyone other than the party’s counsel about the opinions expressed is unaffected by the rule. Counsel are also free to question expert witnesses about alternative analyses, testing methods, or approaches to the issues on which they are testifying, whether or not the expert considered them in forming the opinions expressed. These discovery changes therefore do not affect the gatekeeping functions called for by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and related cases.[6]

The court in Ladd Furniture v. Ernst & Young explained the structure of Rule 26 with respect to underlying documents, calculations, and data[7].  In particular, the requirements of the Rule 26(a) report do not create a limitation on Rule 26(b) discovery:

“As a basis for withholding the above information, Ladd argues that Ernst & Young is not entitled to discover any expert witness information which is not specifically mentioned in Rule 26(a)(2)(B). However, as explained below, Ladd’s position on this point is not supported by the text of Rule 26 or by the Advisory Committee’s commentary to Rule 26(a). In the text, Rule 26(a)(2)(B) provides for the mandatory disclosure of certain expert witness information, even without a request from the opposing party. However, there is no indication on the face of the rule to suggest that a party is absolutely prohibited from seeking any additional information about an opponent’s expert witnesses. In fact, Rule 26(b)(1) describes the scope of allowable discovery as follows: ‛Parties may obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action… .’ Fed. R. Civ. P. 26(b)(1).[8]

Expert witness discovery for materials that go beyond what is required in an adequate Rule 26(a) report can have serious consequences for the expert witness who fails to produce the requested materials. Opinion exclusion is an appropriate remedy against an expert witness who failed to keep data samples and statistical packages because the adversary party “could not attempt to validate [the expert witness’s] methods even if [the witness] could specifically say what he considered.[9]

No doubt expert witnesses and parties will attempt to resist the call for working notes and underlying materials on the theory that the requested documents and materials are “draft reports,” which are now protected by the revisions to Rule 26.  For the most part, these evasions have been rejected[10].  In one case, for instance, in which an expert witness’s assistants compiled and summarized information from individual case files, the court rejected the characterization of the information as part of a “draft report,” and ordered their production.[11]

Choice of Discovery Method Beyond Rule 26 Automatic Disclosure

In addition to the mandatory expert report and disclosure of data and facts, and the optional deposition by oral examination, parties have other avenues to pursue discovery of information, facts, and data, from expert witnesses. Under Rule 33(a)(2), parties may propound contention interrogatories that address expert witnesses’ opinions and conclusions. As for methods of discovery beyond what is discussed specifically in Rule 26, courts are confronted with a threshold question whether Rule 34 requests to produce, Rule 30(b)(2) depositions by oral examination, or Rule 45 subpoenas are the appropriate discovery method for obtaining documents from a retained, testifying expert witness. In the view of some courts, the resolution to this threshold question turns on whether expert witnesses are within the control of parties such that parties must respond to discovery for information, documents, and things within the custody, possession, and control of their expert witnesses.

Subpoenas Are Improper

Some federal district courts view Rule 45 subpoenas as inappropriate discovery tools for parties[12] and persons under the control of parties. In Alper v. United States[13], the district court refused to enforce plaintiff’s Rule 45 subpoena that sought documents from defendant’s expert witness. Although acknowledging that Rule 45’s language was unclear, the Alper court insisted that since a party proffers an expert witness, that witness should be considered under the party’s control[14]. And because the expert witness was “within defendant’s control,” the court noted that Rule 34 rather than Rule 45 governed the requested discovery[15]. Alper seems to be a minority view, but its approach is attractive in streamlining discovery, eliminating subpoena service issues for expert witnesses who may live outside the district, and forcing the sponsoring party to respond and to obtain compliance with its retained expert witness.

Subpoenas Are Proper

The “control” rationale of the Alper case is questionable. Rule 45 contains no statement of limitation to non-parties[16]. Parties “proffer” fact witnesses, but their proffers do not restrict the availability of Rule 45 subpoenas. More important, expert witnesses are not truly under the control of the retaining parties. Expert witnesses have independent duties to the court, and under their own professional standards, to give their own independent opinions[17].

Many courts allow discovery of expert witness documents and information by Rule 45 subpoena on either the theory that Rule 45 subpoenas are available for both parties and non-parties or the theory that expert witnesses are sufficiently independent of the sponsoring party that they are non-parties who are clearly subject to Rule 45. If expert witnesses are not parties, and Rule 26’s confidentiality provisions do not constrain the available discovery tools for expert witnesses, then expert witness subpoenas would appear to a proper discovery tool to discover documents in the witnesses’ possession, control, and custody[18]. When used as a discovery tool in this way, subpoenas used are subject to discovery deadlines[19].

Particular Concerns for Discovery of Statistician Expert Witnesses

Statistician expert witnesses require additional care and discovery investigation in complex products liability cases[20].  The caselaw sometimes takes a crabbed approach that refuses to provide parties access to their adversaries’ statistical analyses, calculations, data input  and output files, and graphical files.

Statistician expert testimony will usually involve complex statistical evidence, models, assumptions, and calculations. These materials will in turn create a difficulty in discerning the statistician’s choices from available statistical tests, and whether the statistician exploited the opportunity for multiple tests to be conducted serially with varying assumptions until a propitious result was obtained. Given these typical circumstances, statistical expert witness testimony will almost always require full disclosure to allow the adversary a fair opportunity to cross-examine at trial, or to challenge the validity of the proffered analyses under Rules 702 and 703[21].

Statisticians create and use a variety of materials that are clearly relevant to the their opinion:

  • programs and programming code run to generate all specified analyses on specified data,
  • statistical packages,
  • all data available,
  • all data “cleaning” or data selection processes,
  • selection of variables from those available,
  • data frames that show what data were included (and excluded) in the analyses,
  • data input files,
  • all specified tests run on all data,
  • all data and analysis output files that show all analyses generated,
  • all statistical test diagnostics and tests of underlying assumptions, and
  • graphical output files.

The statistician may have made any number of decisions or judgments in selecting which statistical test results to incorporate into his or her final report.  The report will in all likelihood not include important materials that would allow another statistician to fully understand, test, replicate, and criticize the more conclusory analysis and statements in the report.  In addition, lurking in the witnesses files, or in the electronic “trash bin” may be alternative analyses that were run and discarded, and not included in the final report.  Why and how those alternative analyses were run but discarded, may raise important credibility or validity questions, as well as provide insight into the statistician’s analytical process, all important considerations in preparing for cross-examination and rebuttal.  The lesson of Rule 26, and the caselaw interpreting its provisions, is that lawyers must make specific request for the materials described above.  Only with these materials firmly in hand, can a deposition fully explore the results obtained, the methods used, the assumptions made, the assumptions violated, the alternative methods rejected, the data used, the data available, data not used, the data-dredging and manipulation potential, analytical problems, and the potential failure to reconcile inconsistent results. Waiting for trial, or even for the deposition, may well be too late[22].

The warrant for examining the integrity of data relied upon by expert witnesses appears to be securely embedded in the Federal Rules of Civil Procedure, and in the Federal Rules of Evidence. Evidence Rule 703 has particular relevance to statistical or epidemiologic testimony. Lawyers facing studies of dubious quality may need to press for discovery of underlying data and materials. In the Viagra vision loss multi-district litigation (MDL), the defendant sought and obtained discovery of underlying data from plaintiffs’ expert witness’s epidemiologic study of vision loss among patients using Viagra and similar medications[23]. Although the Viagra MDL court had struggled with inferential statistics in its first approach to defendant’s Rule 702 motion, the court understood the challenge based upon lack of data integrity, and reconsidered and granted defendant’s motion to exclude the challenged expert witness[24].

The lawyering implications for discovery of statistician expert witnesses are important. Statistical evidence requires counsel’s special scrutiny to ensure compliance with the disclosure requirements of Federal Rule of Civil Procedure 26. Given the restrictive reading of Rule 26 by some courts, counsel will need to anticipate the use of other discovery tools. Lawyers should request by Rule 34 or Rule 45, all computer runs, programming routines, and outputs, and they should zealously pursue witnesses’ failure to maintain and produce data. Given the uncertainty in some districts whether expert witnesses are subject to subpoenas, counsel may consider propounding both Rule 34 requests and serving Rule 45 subpoenas.

Lawyers in data-intensive cases should give early consideration to appropriate discovery plans that contemplate data production in advance of depositions, to allow full exploration of analyses at deposition[25]. Lawyers should also be alert to the potential need to show particularized need for the requested data and analyses. In instructing expert witnesses on their preparation of their reports, lawyers should consider directing their expert witnesses to express whether they need further access to the adversary’s expert witnesses’ underlying data and materials to fully evaluate the proffered opinions. Discovery of statisticians and their data and their analyses requires careful planning, as well as patient efforts to educate the court about the need for full exploration of all data and all analyses conducted, whether or not incorporated into the Rule 26 report.


[1] Randall v. Rolls-Royce Corp., 2010 U.S. Dist. LEXIS 23421, *4-5 (S.D. Ind. March 12, 2010) (“Dr. Harnett who began his evaluation of the analysis contained in the report … soon concluded that he needed the underlying studies and statistical programs created or used by Dr. Drogin. In response to the Defendants’ request for such materials, Plaintiffs produced four discs containing more than 1,000 separate electronic files”).

[2] Marsh v. Jackson, 141 F.R.D. 431, 432–33 (W.D. Va. 1992) (holding that Rule 45 could not be used to obtain an opposing expert’s files because Rule 26(b)(4) limits expert discovery to depositions and interrogatories as a policy matter)

[3] See Advisory Comm. Notes for 1993 Amendments, to Fed. R. Civ. P. 26(a) (“The enumeration in Rule 26(a) of items to be disclosed does not prevent a court from requiring by order or local rule that the parties disclose additional information without a discovery request. Nor are parties precluded from using traditional discovery methods to obtain further information regarding these matters, … .”); United States v. Bazaarvoice, Inc., C 13-00133 WHO (LB), 2013 WL 3784240 (N.D. Cal. July 18, 2013) (“Rule 26(a)(2)(B) . . . does not preclude parties from obtaining further information through ordinary discovery tools”) (internal citations omitted).

[4] Morriss v. BNSF Ry. Co., No. 8:13CV24, 2014 WL 128393, at *4–6, 2014 U.S. Dist. LEXIS 3757, at *17 (D.Neb. Jan. 13, 2014) (holding that “absent some threshold showing of “compelling reason,” the broad discovery provisions of Rules 34 and 45 cannot be used to undermine the specific expert witness discovery rules in Rule 26(a)(2)”).

[5] Modjeska v. United Parcel Service Inc., No. 12–C–1020, 2014 WL 2807531 (E.D. Wis. June 19, 2014) (holding that Rule 26(a)(2)(B) governs only disclosure in expert witness reports and does not limit or preclude further discovery using ordinary discovery such as requests to produce); Expeditors Int’l of Wash., Inc. v. Vastera, Inc., No. 04 C 0321, 2004 WL 406999, at *3 (N.D. Ill. Feb.26, 2004). See also Wright & Miller, 9A Federal Practice & Procedure Civ. § 2452 (3d ed. 2013).

[6] Adv. Comm. Note for Rule 26(b)(4)(B)(2010).  See, e.g., Ladd Furniture v. Ernst & Young, 1998 U.S. Dist. LEXIS 17345, at *34-37 (M.D.N.C. Aug. 27, 1998).

[7] Id.

[8] Id. at *36-37.

[9] Innis Arden Golf Club v. Pitney Bowes, Inc., 629 F. Supp. 2d 175, 190 (D. Conn. 2009) (excluding expert opinion because his samples and data packages no longer existed and thus “[d]efendants could not attempt to validate [his] methods even if he could specifically say what he considered”). See also Jung v. Neschis, No. 01–Civ. 6993(RMB)(THK), 2007 WL 5256966, at *8–15 (S.D.N.Y. Oct. 23, 2007) (finding that a party’s failure to produce tape recordings that its medical expert witness relied upon for his opinion was ‘‘disturbing’’; precluding expert witness’s testimony).

[10] See, e.g., Dongguk Univ. v. Yale Univ., No. 3:08-CV-00441, 2011 WL 1935865, at *1 (D. Conn. May 19, 2011) (holding that “an expert’s handwritten notes are not protected from disclosure because they are neither drafts of an expert report nor communications between the party’s attorney and the expert witness”).

[11] D.G. ex rel. G. v. Henry, No. 08-CV-74-GKF-FHM, 2011 WL 1344200, at *1 (N.D. Okla. Apr. 8, 2011) (ordering production of the assistants’ notes because the expert witness had relied upon them in forming his opinion, which brought them within the scope of “facts or data” under the rule).

[12] Mortgage Info. Servs, Inc. v. Kitchens, 210 F.R.D. 562, 564-68 (W.D.N.C. 2002) (holding that nothing in Rule 45 precludes its use on a party); See also Mezu v. Morgan State Univ., 269 F.R.D. 565, 581 (D. Md. 2010) (“courts are divided as to whether Rule 45 subpoenas should be served on parties”); Peyton v. Burdick, 2008 U.S. Dist. LEXIS 106910 (E.D. Cal. 2008) (discussing the split among courts on the issue).

[13] 190 F.R.D. 281 (D. Mass. 2000).

[14] Id. at 283.

[15] Id. See Ambrose v. Southworth Products Corp., No. CIV.A. 95–0048–H, 1997 WL 470359, 1 (W.D. Va. June 24, 1997) (holding a “naked” subpoena duces tecum directed to a non-party expert retained by a party is not within the ambit of a Rule 45 document production subpoena, and not permitted by Fed. R. Civ. Pro. 26(b)(4)); see also Hartford Fire Ins. v. Pure Air on the Lake Ltd., 154 F.R.D. 202, 208 (N.D. Ind. 1993) (holding a party cannot use Rule 45 to circumvent Rule 26(b)(4) as a method to obtain an expert witness’s files); Marsh v. Jackson, 141 F.R.D. 431, 432 (W.D. Va. 1992) (noting that subpoena for production of documents directed to non-party expert retained by a party is not within ambit of Fed. Rule 45(c)(3)(8)(ii)).

[16] See James Wm. Moore, 9 Moore’s Federal Practice § 45.03[1] (noting that “[s]ubpoenas under Rule 45 may be issued to parties or non-parties”).

[17] See Glendale Fed. Bank, FSB v.United States, 39 Fed. Cl. 422, 424 (Fed. Cl. 1997) (“The expert witness, testifying under oath, is expected to give his own honest, independent opinion… He is not the sponsoring party’s agent at any time merely because he is retained as its expert witness”). See also National Justice Compania Naviera S.A. v. Prudential Assurance Co. Ltd., (“The Ikarian Reefer”), [1993] 2 Lloyd’s Rep. 68 at 81-82 (Q.B.D.), rev’d on other grounds [1995] 1 Lloyd’s Rep. 455 at 496 (C.A.) (embracing the enumeration of duties, including a duty to “provide independent assistance to the Court by way of objective unbiased opinion in relation to matters within his expertise,” and a duty to eschew “the role of an advocate”).

[18] Western Res., Inc. v. Union Pac. RR, No. 00-2043-CM, 2002 WL 1822428, at *3 (D. Kan. July 23, 2002) (ordering expert witness to produce prior testimony under Rule 45); All W. Supply Co. v. Hill’s Pet Prods. Div., Colgate-Palmolive Co., 152 F.R.D. 634, 639 (D. Kan. 1993) (“With regard to nonparties such as plaintiff’s expert witness, a request for documents may be made by subpoena duces tecum pursuant to Rule 45”); Smith v. Transducer Technology, Inc., No. Civ. 1995/28, 2000 WL 1717332, 2 (D.V.I. Nov. 16, 2000) (holding that Rule 30(b)(5) deposition notice, served upon opposing party, is not an appropriate discovery tool to compel expert witness to produce documents from at his deposition) (noting that a “Rule 45 subpoena duces tecum in conjunction with a properly noticed deposition may do so (subject however to any Rule 26 limitations)”); Thomas v. Marina Assocs., 202 F.R.D. 433, 434 (E.D. Pa. 2001) (denying motion to quash subpoenas issued to party’s expert witness); Quaile v. Carol Cable Co., Civ. A. No. 90-7415, 1992 WL 277981, at *2 (E.D. Pa. Oct. 5, 1992) (granting motion to compel discovery concerning expert witness’s opinions pursuant to a Rule 45 subpoena); Lawrence E. Jaffe Pension Plan v. Household Int’l, Inc., No. 02 C 5893, 2008 WL 687220, at *2 (N.D. Ill Mar. 10, 2008) (“It is clear . . . that a subpoena duces tecum . . . is an appropriate discovery mechanism against . . . a party’s expert witness”) (internal citation omitted); Expeditors Internat’l of Wash., Inc. v. Vastera, Inc., No. 04 C 0321, 2004 WL 406999, at *2-3 (N.D. Ill. Feb. 26, 2004) (holding Rule 45, not Rule 34, governs discovery from retained experts) (“Subpoena duces tecum is . . . an appropriate discovery mechanism against nonparties such as a party’s expert witness”); Reit v. Post Prop., Inc., No. 09 Civ. 5455(RMB)(KNF), 2010 WL 4537044, at *9 (S.D.N.Y. Nov. 4, 2010) (“Subpoena duces tecum … is an appropriate discovery mechanism against a nonparty expert”).

[19] See, e.g., Williamson v. Horizon Lines LLC , 248 F.R.D. 79, 83 (D. Me. 2008) (“[C]ontrary to Horizon Lines’ contention, there is a relationship between Rule 26 and Rule 45 and parties should not be allowed to employ a subpoena after a discovery deadline to obtain materials from third parties that could have been produced before discovery.”).

[20] Bartley v. Isuzu Motors Ltd., 151 F.R.D. 659, 660-61 (D. Colo. 1993) (ordering party to create and preserve “the input and output data for each variable in the program, for each iteration, or each simulation,” as well as a record of all simulations performed, even those that do not conform to the plaintiff’s claims and theories in the case).

[21] See City of Cleveland v. Cleveland Elec. Illuminating Co., 538 F. Supp. 1257 (N.D. Ohio 1980) (“Certainly, where, as here, the expert reports are predicated upon complex data, calculations and computer simulations which are neither discernible nor deducible from the written reports themselves, disclosure thereof is essential to the facilitation of effective and efficient examination of these experts at trial.”); Shu-Tao Lin v. McDonnell-Douglas, Corp., 574 F. Supp. 1407, 1412-13 (S.D.N.Y. 1983) (granting new trial, and holding that expert witness’s failure to disclosure the “nature of [the plaintiff’s testifying expert’s] computer program or the underlying data, the inputs and outputs employed in the program” deprived adversary of an “adequate basis on which to cross-examine plaintiff’s experts”), rev’d on other grounds, 742 F.2d 45 (2d Cir. 1984).

[22] Manual for Complex Litigation at 99, § 11.482 (4th ed. 2004) (“Early and full disclosure of expert evidence can help define and narrow issues. Although experts often seem hopelessly at odds, revealing the assumptions and underlying data on which they have relied in reaching their opinions often makes the bases for their differences clearer and enables substantial simplification of the issues. In addition, disclosure can facilitate rulings well in advance of trial on objections to the qualifications of an expert, the relevance and reliability of opinions to be offered, and the reasonableness of reliance on particular data.207”). See also ABA Section of Antitrust Law, Econometrics: Legal, Practical, and Technical Issues at 75-76 (2005) (advising of the necessity to obtain all data, all analyses, and all supporting materials, in advance of deposition to ensure efficient and effective discovery procedures).

[23] In re Viagra Prods. Liab. Litig., 572 F. Supp. 2d 1071, 1090 (D. Minn. 2008).

[24] In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 936, 945 (D. Minn. 2009).

[25] See Fed. R. Civ. Pro. 16(b); 26(f).

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.