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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.

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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).

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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).

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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).

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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).

Posted in Expert Witnesses, statistical evidence, Uncategorized | Comments Off on Discovery of Retained, Testifying Statistician Expert Witnesses (Part 2)

Discovery of Retained, Testifying Statistician Expert Witnesses (Part 1)

June 30th, 2015

At times, the judiciary’s resistance to delving into the factual underpinnings of expert witness opinions is extraordinary. In one case, the Second Circuit affirmed a judgment for a plaintiff in a breach of contract action, based in large part upon expert witness testimony that presented the results of a computer simulation. Perma Research & Development v. Singer Co.[1] Although the trial court had promised to permit inquiry into the plaintiff’s computer expert witness’s source of data, programmed mathematical formulae, and computer programs, when the defendant asked the plaintiff’s expert witness to disclose his underlying data and algorithms, the district judge sustained the witness’s refusal on grounds that the requested materials were his “private work product” and “proprietary information.”[2] Despite the trial court’s failure to articulate any legally recognized basis for permitting the expert witness to stonewall in this fashion, a panel of the Circuit, in an opinion by superannuated Justice Tom Clark, affirmed, on an argument that the defendant “had not shown that it did not have an adequate basis on which to cross-examine plaintiff’s experts.” Judge Van Graafeiland dissented, indelicately pointing out that the majority had charged the defendant with failing to show that it had been deprived of a fair opportunity to cross-examine plaintiff’s expert witnesses while depriving the defendant of access to the secret underlying evidence and materials that were needed to demonstrate what could have been done on cross-examination[3]. The dissent traced the trial court’s error to its misconception that a computer is just a giant calculator, and pointed out that the majority contravened Circuit precedent[4] and evolving standards[5] for handling underlying data that was analyzed or otherwise incorporated into computer models and simulations.

Although the approach of Perma Research has largely been ignored, has fallen into disrepute, and has been superseded by statutory amendments[6], its retrograde approach continues to find occasional expression in reported decisions. The refinement of Federal Rule of Evidence 702 to require sound support for expert witnesses’ opinions has opened the flow of discovery of underlying facts and data considered by expert witnesses before generating their reports. The most recent edition of the Federal Judicial Center’s Manual for Complex Litigation treats both computer-generated evidence and expert witnesses’ underlying data as both subject to pre-trial discovery as necessary to provide for full and fair litigation of the issues in the case[7].

The discovery of expert witnesses who have conducted statistical analyses poses difficult problems for lawyers. Unlike other some expert witnesses, who passively review data and arrive at an opinion that synthesizes published research, statisticians actually create evidence with new arrangements and analyses of data in the case. In this respect, statisticians are like material scientists who may test and record experimental observations on a product or its constituents. Inquiring minds will want to know whether the statistical analyses in the witness’s report were the results of pre-planned analysis protocols, or whether they were the second, third, or fifteenth alternative analysis. Earlier statistical analyses conducted but not produced may reveal what the expert witness believed would have been the preferred analysis if only the data had cooperated more fully. Statistical analyses conducted by expert witnesses provide plenty of opportunity for data-dredging, which can then be covered up by disclosing only selected analyses in the expert witness’s report.

The output of statisticians’ statistical analyses will take the form of a measure of “point estimates” of “effect size,” a significance or posterior probability, a set of regression coefficients, a summary estimate of association, or a similar measure that did not exist before the statistician used the underlying data to produce the analytical outcome, which is then the subject of further inference and opinion. Frequentist analyses must identify the probability model and other assumptions employed. Bayesian analyses must also identify prior probabilities used as the starting point used with further evidence to arrive at posterior probabilities. The science, creativity, and judgment involved in statistical methods challenge courts and counsel to discover, understand, reproduce, present, and cross-examine statistician expert witness testimony. And occasionally, there is duplicity and deviousness to uncover as well.

The discovery obligations with respect to statistician expert witnesses vary considerably among state and federal courts. The 1993 amendments to the Federal Rules of Civil Procedure created an automatic right to conduct depositions of expert witnesses[8]. Previously, parties in federal court had to show the inadequacy of other methods of discovery. Rule 26(a)(2)(B)(ii) requires the automatic production of “the facts or data considered by the [expert] witness in forming” his or her opinions. The literal wording of this provision would appear to restrict automatic, mandatory disclosure to those facts and data that are specifically considered in forming the opinions contained in the prescribed report. Several courts, however, have interpreted the term “considered” to include any information that expert witnesses review or generate, “regardless of whether the experts actually rely on those materials as a basis for their opinions.[9]”

Among the changes introduced by the 2010 amendments to the Federal Rules of Civil Procedure was a narrowing of the disclosure requirement of “facts and data” considered by expert witnesses in arriving at their opinions to exclude some attorney work product, as well as protecting drafts of expert witness reports from discovery. The implications of the Federal Rules for statistician expert witnesses are not entirely clear, but these changes should not be used as an excuse to deprive litigants of access to the data and materials underlying statisticians’ analyses. Since the 2010 amendments, courts have enforced discovery requests for testifying expert witnesses’ notes because they were not draft reports or specific communications between counsel and expert witnesses[10].

The Requirements Associated With Producing A Report

Rule 26 is the key rule that governs disclosure and discovery of expert witnesses and their opinions. Under the current version of Rule 26(a)(2)(B), the scope of required disclosure in the expert report has been narrowed in some respects. Rule 26(a)(2)(B) now requires service of expert witness reports that contain, among other things:

(i) a complete statement of all opinions the witness will express and the basis and reasons for them;

(ii) the facts or data considered by the witness in forming them;

(iii) any exhibits that will be used to summarize or support them.

The Rule’s use of “them” seems clearly to refer back to “opinions,” which creates a problem with respect to materials considered generally with respect to the case or the issues, but not for the specific opinions advanced in the report.

The previous language of the rule required that the expert report disclose “the data or other information considered by the witness.[11]” The use of “other information” in the older version of the rule, rather than the new “data” was generally interpreted to authorize discovery of all oral and written communications between counsel and expert witnesses. The trimming of Rule 26(a)(2)(B)(ii) was thus designed to place these attorney-expert witness communications off limits from disclosure or discovery.

The federal rules specify that the required report “is intended to set forth the substance of the direct examination[12].” Several court have thus interpreted the current rule in a way that does not result in automatic production of all statistical analyses performed, but only those data and analyses the witness has decided to present at trial. The report requirement, as it now stands, is thus not necessarily designed to help adverse counsel fully challenge and cross-examine the expert witness on analyses attempted, discarded, or abandoned. If a statistician expert witness conducted multiple statistical testing before arriving at a “preferred” analysis, that expert witness, and instructing counsel, will obviously be all too happy to eliminate the unhelpful analyses from the direct examination, and from the purview of disclosure.

Some of the caselaw in this area makes clear that it is up to the requesting party to discover what it wants beyond the materials that must automatically be disclosed in, or with, the report. A party will not be heard to complain, or attack its adversary, about failure to produce materials never requested.[13] Citing Rule 26(a) and its subsections, which deal with the report, and not discovery beyond the report, several cases take a narrow view of disclosure as embodied in the report requirement.[14] In one case, McCoy v. Whirlpool Corp, the trial court did, however, permit the plaintiff to conduct a supplemental deposition of the defense expert witness to question him about his calculations[15].

A narrow view of automatic disclosure in some cases appears to protect statistician and other expert witnesses from being required to produce calculations, statistical analyses, and data outputs even for opinions that are identified in their reports, and intended to be the subject of direct examination at trial[16]. The trial court’s handling of the issues in Cook v. Rockwell International Corporation is illustrative of this questionable approach. The issue of the inadequacy of expert witnesses’ reports, for failing to disclose notes, calculations, and preliminary analyses, arose in the context of a Rule 702 motion to the admissibility of the witnesses’ opinion testimony. The trial court rejected “[a]ny suggestion that an opposing expert must be able to verify the correctness of an expert’s work before it can be admitted… ”[17]; any such suggestion “misstates the standard for admission of expert evidence under [Fed. R. Evid.] 702.[18]” The Cook court further rejected any “suggestion in Rule 26(a)(2) that an expert report is incomplete unless it contains sufficient information and detail for an opposing expert to replicate and verify in all respects both the method and results described in the report.[19]” Similarly, the court rejected the defense’s complaints that one of plaintiffs’ expert witness’s expert report and disclosures violated Rule 26(a)(2), by failing to provide “detailed working notes, intermediate results and computer records,” to allow a rebuttal expert witness to test the methodology and replicate the results[20]. The court observed that

“Defendants’ argument also confuses the expert reporting requirements of Rule 26(a)(2) with the considerations for assessing the admissibility of an expert’s opinions under Rule 702 of the Federal Rules of Evidence. Whether an expert’s method or theory can or has been tested is one of the factors that can be relevant to determining whether an expert’s testimony is reliable enough to be admissible. See Fed. R. Evid. 702 2000 advisory committee’s note; Daubert, 509 U.S. at 593, 113 S.Ct. 2786. It is not a factor for assessing compliance with Rule 26(a)(2)’s expert disclosure requirements.[21]”

The Rule 702 motion to exclude an expert witness comes too late in the pre-trial process for complaints about failure to disclose underlying data and analyses. The Cook case never explicitly addressed Rule 26(b), or other discovery procedures, as a basis for the defense request for underlying documents, data, and materials. In any event, the limited scope accorded to Rule 26 disclosure mechanisms by Cook emphasizes the importance of deploying ancillary discovery tools early in the pre-trial process.

The Format Of Documents and Data Files To Be Produced

The dispute in Helmert v. Butterball, LLC, is typical of what may be expected in a case involving statistician expert witness testimony. The parties exchanged reports of their statistical expert witnesses, as well as the data output files. The parties chose, however, to produce the data files in ways that were singularly unhelpful to the other side. One party produced data files in the “portable document format” (pdf) rather than in the native format of the statistical software package used (STATA). The other party produced data in a spreadsheet without any information about how the data were processed. The parties then filed cross-motions to compel the data in its “electronic, native format.” In addition, plaintiffs pressed for all the underlying data, formulae, and calculations. The court denied both motions on the theory that both sides had received copies of the data considered, and neither was denied facts or data considered by the expert witnesses in reaching their opinions[22]. The court refused plaintiffs’ request for formulae and calculations as well. The court’s discussion of its rationale for denying the cross-motions is framed entirely in terms of what parties may expect and be entitled in the form of a report, without any mention of additional discovery mechanisms to obtain the sought-after materials. The court noted that the parties would have the opportunity to explore calculations at deposition.

The decision in Helmert seems typical of judicial indifference to, and misunderstanding of, the need for datasets, especially with large datasets, in the form uploaded to, and used in, statistical software programs. What is missing from the Helmert opinion is a recognition that an effective deposition would require production of the requested materials in advance of the oral examination, so that the examining counsel can confer and consult with a statistical expert for help in formulating and structuring the deposition questions. There are at least two remedial considerations for future discovery motions of the sort seen in Helmert. First, the moving party should support its application with an affidavit of a statistical expert to explain the specific need for identification of the actual formulae used, programming used within specific software programs to run analyses, and interim and final outputs. Second, a strong analogy with document discovery of parties, in which courts routinely order “native format” versions of PowerPoint, Excel, and Word documents produced in response to document requests. Rule 34 of the Federal Rules of Civil Procedure requires that “[a] party must produce documents as they are kept in the usual course of business[23]” and that, “[i]f a request does not specify a form for producing electronically stored information, a party must produce it in a form or forms in which it is ordinarily maintained or in a reasonably usable form or forms.[24]” The Advisory Committee notes to Rule 34[25] make clear that:

“[T]he option to produce in a reasonably usable form does not mean that a responding party is free to convert electronically stored information from the form in which it is ordinarily maintained to a different form that makes it more difficult or burdensome for the requesting party to use the information efficiently in the litigation. If the responding party ordinarily maintains the information it is producing in a way that makes it searchable by electronic means, the information should not be produced in a form that removes or significantly degrades this feature.”

Under the Federal Rules, a requesting party’s obligation to specify a particular format for document production is superseded by the responding party’s obligation to refrain from manipulating or converting “any of its electronically stored information to a different format that would make it more difficult or burdensome for [the requesting party] to use.[26]” In Helmert, the STATA files should have been delivered as STATA native format files, and the requesting party should have requested, and received, all STATA input and output files, which would have permitted the requestor to replicate all analyses conducted.

Some of the decided cases on expert witness reports are troubling because they do not explicitly state whether they are addressing the adequacy of automatic disclosure and reports, or a response to propounded discovery. For example, in Etherton v. Owners Ins. Co.[27], the plaintiff sought to preclude a defense accident reconstruction expert witness on grounds that the witness failed to produce several pages of calculations[28]. The defense argued that the “[w]hile [the witness’s] notes regarding these calculations were not included in his expert report, the report does specifically identify the methods he employed in his analysis, and the static data used in his calculations”; and by asserting that “Rule 26 does not require the disclosure of draft expert reports, and it certainly does not require disclosure of calculations, as Plaintiff contends.[29]” The court in Etherton agreed that “Fed. R. Civ. P. 26(a)(2)(B) does not require the production of every scrap of paper with potential relevance to an expert’s opinion.[30]” The court laid the discovery default here upon the plaintiff, as the requesting party: “Although Plaintiff should have known that Mr. Ogden’s engineering analysis would likely involve calculations, Plaintiff never requested that documentation of those calculations be produced at any time prior to the date of [Ogden’s] deposition.[31]”

The Etherton court’s assessment that the defense expert witness’s calculations were “working notes,” which Rule 26(a)(2) does not require to be included in or produced with a report, seems a complete answer, except for the court’s musings about the new provisions of Rule 26(b)(4)(B), which protect draft reports. Because of the court’s emphasis that the plaintiff never requested the documentation of the relevant calculations, the court’s musings about what was discoverable were clearly dicta. The calculations, which would reveal data and inferential processes considered, appear to be core materials, subject to and important for discovery[32].

[This post is a substantial revision and update to an earlier post, “Discovery of Statistician Expert Witnesses” (July 19, 2012).]

[1] 542 F.2d 111 (2d Cir. 1976), cert. denied, 429 U.S. 987 (1976)

[2] Id. at 124.

[3] Id. at 126 & n.17.

[4] United States v. Dioguardi, 428 F.2d 1033, 1038 (2d Cir.), cert. denied, 400 U.S. 825 (1970) (holding that prosecution’s failure to produce computer program was error but harmless on the particular facts of the case).

[5] See, e.g., Roberts, “A Practitioner’s Primer on Computer-Generated Evidence,” 41 U. Chi. L. Rev. 254, 255-56 (1974); Freed, “Computer Records and the Law — Retrospect and Prospect,” 15 Jurimetrics J. 207, 208 (1975); ABA Sub-Committee on Data Processing, “Principles of Introduction of Machine Prepared Studies” (1964).

[6] Aldous, Note, “Disclosure of Expert Computer Simulations,” 8 Computer L.J. 51 (1987); Betsy S. Fiedler, “Are Your Eyes Deceiving You?: The Evidentiary Crisis Regarding the Admissibility of Computer Generated Evidence,” 48 N.Y.L. Sch. L. Rev. 295, 295–96 (2004); Fred Galves, “Where the Not-So-Wild Things Are: Computers in the Courtroom, the Federal Rules of Evidence, and the Need for Institutional Reform and More Judicial Acceptance,” 13 Harv. J.L. & Tech. 161 (2000); Leslie C. O’Toole, “Admitting that We’re Litigating in the Digital Age: A Practical Overview of Issues of Admissibility in the Technological Courtroom,” Fed. Def. Corp. Csl. Quart. 3 (2008); Carole E. Powell, “Computer Generated Visual Evidence: Does Daubert Make a Difference?” 12 Georgia State Univ. L. Rev. 577 (1995).

[7] Federal Judicial Center, Manual for Complex Litigation § 11.447, at 82 (4th ed. 2004) (“The judge should therefore consider the accuracy and reliability of computerized evidence, including any necessary discovery during pretrial proceedings, so that challenges to the evidence are not made for the first time at trial.”); id. at § 11.482, at 99 (“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.”)

[8] Fed. R. Civ. P. 26(b)(4)(A) (1993).

[9] United States v. Dish Network, L.L.C., No. 09-3073, 2013 WL 5575864, at *2, *5 (C.D. Ill. Oct. 9, 2013) (noting that the 2010 amendments did not affect the change the meaning of the term “considered,” as including “anything received, reviewed, read, or authored by the expert, before or in connection with the forming of his opinion, if the subject matter relates to the facts or opinions expressed.”); S.E.C. v. Reyes, 2007 WL 963422, at *1 (N.D. Cal. Mar. 30, 2007). See also South Yuba River Citizens’ League v. National Marine Fisheries Service, 257 F.R.D. 607, 610 (E.D. Cal. 2009) (majority rule requires production of materials considered even when work product); Trigon Insur. Co. v. United States, 204 F.R.D. 277, 282 (E.D. Va. 2001).

[10] Dongguk Univ. v. Yale Univ., No. 3:08–CV–00441 (TLM), 2011 WL 1935865 (D. Conn. May 19, 2011) (ordering production of a testifying expert witness’s notes, reasoning that they were neither draft reports nor communications between the party’s attorney and the expert witness, and they were not the mental impressions, conclusions, opinions, or legal theories of the party’s attorney); In re Application of the Republic of Ecuador, 280 F.R.D. 506, 513 (N.D. Cal. 2012) (holding that Rule 26(b) does not protect an expert witness’s own work product other than draft reports). But see Internat’l Aloe Science Council, Inc. v. Fruit of the Earth, Inc., No. 11-2255, 2012 WL 1900536, at *2 (D. Md. May 23, 2012) (holding that expert witness’s notes created to help counsel prepare for deposition of adversary’s expert witness were protected as attorney work product and protected from disclosure under Rule 26(b)(4)(C) because they did not contain opinions that the expert would provide at trial)).

[11] Fed. R. Civ. P. 26(a)(2)(B)(ii) (1993) (emphasis added).

[12] Notes of Advisory Committee on Rules for Rule 26(a)(2)(B). See, e.g., Lituanian Commerce Corp., Ltd. v. Sara Lee Hosiery, 177 F.R.D. 245, 253 (D.N.J. 1997) (expert witness’s written report should state completely all opinions to be given at trial, the data, facts, and information considered in arriving at those opinions, as well as any exhibits to be used), vacated on other grounds, 179 F.R.D. 450 (D.N.J. 1998).

[13] See, e.g., Gillepsie v. Sears, Roebuck & Co., 386 F.3d 21, 35 (1st Cir. 2004) (holding that trial court erred in allowing cross-examination and final argument on expert witness’s supposed failure to produce all working notes and videotaped recordings while conducting tests, when objecting party never made such document requests).

[14] See, e.g., McCoy v. Whirlpool Corp., 214 F.R.D. 646, 652 (D. Kan. 2003) (Rule 26(a)(2) “does not require that a report recite each minute fact or piece of scientific information that might be elicited on direct examination to establish the admissibility of the expert opinion … Nor does it require the expert to anticipate every criticism and articulate every nano-detail that might be involved in defending the opinion[.]”).

[15] Id. (without distinguishing between the provisions of Rule 26(a) concerning reports and Rule 26(b) concerning depositions); see also Scott v. City of New York, 591 F.Supp. 2d 554, 559 (S.D.N.Y. 2008) (“failure to record the panoply of descriptive figures displayed automatically by his statistics program does not constitute best practices for preparation of an expert report,’’ but holding that the report contained ‘‘the data or other information’’ he considered in forming his opinion, as required by Rule 26); McDonald v. Sun Oil Co., 423 F.Supp. 2d 1114, 1122 (D. Or. 2006) (holding that Rule 26(a)(2)(B) does not require the production of an expert witness’s working notes; a party may not be sanctioned for spoliation based upon expert witness’s failure to retain notes, absent a showing of relevancy and bad faith), rev’d on other grounds, 548 F.3d 774 (9th Cir. 2008).

[16] In re Xerox Corp Securities Litig., 746 F. Supp. 2d 402, 414-15 (D. Conn. 2010) (“The court concludes that it was not necessary for the [expert witness’s] initial regression analysis to be contained in the [expert] report” that was disclosed pursuant to Rule 26(a)(2)), aff’d on other grds. sub. nom., Dalberth v. Xerox Corp., 766 F. 3d 172 (2d Cir. 2014). See also Cook v. Rockwell Int’l Corp., 580 F.Supp. 2d 1071, 1122 (D. Colo. 2006), rev’d and remanded on other grounds, 618 F.3d 1127 (10th Cir. 2010), cert. denied, ___ U.S. ___ , No. 10-1377, 2012 WL 2368857 (June 25, 2012), on remand, 13 F.Supp.3d 1153 (D. Colo. 2014), vacated 2015 WL 3853593, No. 14–1112 (10th Cir. June 23, 2015); Flebotte v. Dow Jones & Co., No. Civ. A. 97–30117–FHF, 2000 WL 35539238, at *7 (D. Mass. Dec. 6, 2000) (“Therefore, neither the plain language of the rule nor its purpose compels disclosure of every calculation or test conducted by the expert during formation of the report.”).

[17] Cook, 580 F. Supp. 2d at 1121–22.

[18] Id.

[19] Id. & n. 55 (Rule 26(a)(2) does not “require that an expert report contain all the information that a scientific journal might require an author of a published paper to retain.”).

[20] Id. at 1121-22.

[21] Id.

[22] Helmert v. Butterball, LLC, No. 4:08-CV-00342, 2011 WL 3157180, at *2 (E.D. Ark. July 27, 2011).

[23] Fed. R. Civ. P. 34(b)(2)(E)(i).

[24] Fed. R. Civ. P. 34(b)(2)(E)(ii).

[25] Fed. R. Civ. P. 34, Advisory Comm. Notes (2006 Amendments).

[26] Crissen v. Gupta, 2013 U.S. Dist. LEXIS 159534, at *22 (S.D. Ind. Nov. 7, 2013), citing Craig & Landreth, Inc. v. Mazda Motor of America, Inc., 2009 U.S. Dist. LEXIS 66069, at *3 (S.D. Ind. July 27, 2009). See also Saliga v. Chemtura Corp., 2013 U.S. Dist. LEXIS 167019, *3-7 (D. Conn. Nov. 25, 2013).

[27] No. 10-cv-00892-MSKKLM, 2011 WL 684592 (D. Colo. Feb. 18, 2011)

[28] Id. at *1.

[29] Id.

[30] Id. at *2.

[31] Id.

[32] See Barnes v. Dist. of Columbia, 289 F.R.D. 1, 19–24 (D.D.C. 2012) (ordering production of underlying data and information because, “[i]n order for the [requesting party] to understand fully the . . . [r]eports, they need to have all the underlying data and information on how” the reports were prepared).

Posted in Expert Witnesses, Scientific Evidence, statistical evidence | Comments Off on Discovery of Retained, Testifying Statistician Expert Witnesses (Part 1)

Forensic Science Conference Papers Published by Royal Society

June 27th, 2015

In February of this year, the Royal Society sponsored a two day conference, on “The paradigm shift for UK forensic science,” at The Royal Society, London. The meeting was organized by Professors Sue Black and Niamh Nic Daeid, of Dundee University, to discuss developments in the scientific reliability of the forensic sciences. The meeting program reflected a broad coverage of topics by scientists, judges, lawyers, on science in the courtroom.

The presentations are now available as papers open access in the Philosophical Transactions of the Royal Society B: Biological Sciences:

Sue Black, Niamh Nic Daeid, Introduction: Time to think differently: catalysing a paradigm shift in forensic science

The Rt Hon. the Lord Thomas of Cwmgiedd, The legal framework for more robust forensic science evidence

Éadaoin O’Brien, Niamh Nic Daeid, Sue Black, Science in the court: pitfalls, challenges and solutions

Paul Roberts, Paradigms of forensic science and legal process: a critical diagnosis

Stephan A. Bolliger, Michael J. Thali, Bridging the gap: from biometrics to forensics

Anil K. Jain, Arun Ross, Fingerprint identification: advances since the 2009 National Research Council report

Christophe Champod, The future of forensic DNA analysis

John M. Butler, The end of the (forensic science) world as we know it? The example of trace evidence

Claude Roux, Benjamin Talbot-Wright, James Robertson, Frank Crispino, Olivier Ribaux, Advances in the use of odour as forensic evidence through optimizing and standardizing instruments and canines

Kenneth G. Furton, Norma Iris Caraballo, Michelle M. Cerreta, Howard K. Holness, New psychoactive substances: catalysing a shift in forensic science practice?

Justice Tettey, Conor Crean, The logical foundations of forensic science: towards reliable knowledge

Ian Evett, The interface between forensic science and technology: how technology could cause a paradigm shift in the role of forensic institutes in the criminal justice system

Ate Kloosterman, Anna Mapes, Zeno Geradts, Erwin van Eijk, Carola Koper, Jorrit van den Berg, Saskia Verheij, Marcel van der Steen, Arian van Asten, Integrating research into operational practice

Alastair Ross, Cognitive neuroscience in forensic science: understanding and utilizing the human element

Itiel E. Dror, Review article: Cognitive neuroscience in forensic science: understanding and utilizing the human element

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Earthquake-Induced Data Loss – We’re All Shook Up

June 26th, 2015

Adam Marcus and Ivan Oransky are medical journalists who publish the Retraction Watch blog. Their blog’s coverage of error, fraud, plagiarism, and other publishing disasters is often first-rate, and a valuable curative for the belief that peer review publication, as it is now practiced, ensures trustworthiness.

Yesterday, Retraction Watch posted an article on earthquake-induced data loss. Shannon Palus, “Lost your data? Blame an earthquake” (June 25, 2015). A commenter on PubPeer raised concerns about a key figure in a paper[1]. The authors acknowledged a problem, which they traced to their loss of data in an earthquake. The journal retracted the paper.

This is not the first instance of earthquake-induced loss of data.

When John O’Quinn and his colleagues in the litigation industry created the pseudo-science of silicone-induced autoimmunity, they recruited Nir Kossovsky, a pathologist at UCLA Medical Center. Although Kossovsky looked a bit like Pee-Wee Herman, he was a graduate of the University of Chicago Pritzker School of Medicine, and the U.S. Naval War College, and a consultant to the FDA. In his dress whites, Kossovsky helped O’Quinn sell his silicone immunogenicity theories to juries and judges around the country. For a while, the theories sold well.

In testifying and dodging discovery for the underlying data in his silicone studies, Kossovsky was as slick as silicone itself. Ultimately, when defense counsel subpoenaed the underlying data from Kossovsky’s silicone study, Kossovsky shrugged and replied that the Northridge Earthquake destroyed his data. Apparently coffee cups and other containers of questionable fluids spilled on his silicone data in the quake, and Kossovsky’s emergency response was to obtain garbage cans and throw out the data. For the gory details, see Gary Taubes, “Silicone in the System: Has Nir Kossovsky really shown anything about the dangers of breast implants?” Discover Magazine (Dec. 1995).

As Mr. Taubes points out, Kossovsky’s paper was rejected by several journals before being published in the Journal of Applied Biomaterials, of which Kossovsky was a member of the editorial board. The lack of data did not, however, keep Kossovsky from continuing to testify, and from trying to commercialize, along with his wife, Beth Brandegee, and his father, Ram Kossowsky[2], an ELISA-based silicone “antibody” biomarker diagnostic test, Detecsil. Although Rule 702 had been energized by the Daubert decision in 1993, many judges were still not willing to take a hard look at Kossovsky’s study, his test, or to demand the supposedly supporting data. The Food and Drug Administration, however, eventually caught up with Kossovsky, and the Detecsil marketing ceased. Lillian J. Gill, FDA Acting Director, Office of Compliance, Letter to Beth S. Brandegee, President, Structured Biologicals (SBI) Laboratories: Detecsil Silicone Sensitivity Test (July 15, 1994); see Taubes, Discover Magazine.

After defense counsel learned of the FDA’s enforcement action against Kossovsky and his company, the litigation industry lost interest in Kossovsky, and his name dropped off trial witness lists. His name also dropped off the rolls of tenured UCLA faculty, and he apparently left medicine altogether to become a business consultant. Dr. Kossovsky became “an authority on business process risk and reputational value.” Kossovsky is now the CEO and Director of Steel City Re, which specializes in strategies for maintaining and enhancing reputational value. Ironic; eh?

A review of PubMed’s entries for Nir Kossovsky shows that his run in silicone started in 1983, and ended in 1996. He testified for plaintiffs in Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir.1994) (tried in 1991), and in the infamous case of Johnson v. Bristol-Myers Squibb, CN 91-21770, Tx Dist. Ct., 125th Jud. Dist., Harris Cty., 1992.

A bibliography of Kossovsky silicone oeuvre is listed, below.

[1] Federico S. Rodríguez, Katterine A. Salazar, Nery A. Jara, María A García-Robles, Fernando Pérez, Luciano E. Ferrada, Fernando Martínez, and Francisco J. Nualart, “Superoxide-dependent uptake of vitamin C in human glioma cells,” 127 J. Neurochemistry 793 (2013).

[2] Father and son apparently did not agree on how to spell their last name.

Nir Kossovsky, D. Conway, Ram Kossowsky & D. Petrovich, “Novel anti-silicone surface-associated antigen antibodies (anti-SSAA(x)) may help differentiate symptomatic patients with silicone breast implants from patients with classical rheumatological disease,” 210 Curr. Topics Microbiol. Immunol. 327 (1996)

Nir Kossovsky, et al., “Preservation of surface-dependent properties of viral antigens following immobilization on particulate ceramic delivery vehicles,” 29 J. Biomed. Mater. Res. 561 (1995)

E.A. Mena, Nir Kossovsky, C. Chu, and C. Hu, “Inflammatory intermediates produced by tissues encasing silicone breast prostheses,” 8 J. Invest. Surg. 31 (1995)

Nir Kossovsky, “Can the silicone controversy be resolved with rational certainty?” 7 J. Biomater. Sci. Polymer Ed. 97 (1995)

Nir Kossovsky & C.J. Freiman, “Physicochemical and immunological basis of silicone pathophysiology,” 7 J. Biomater. Sci. Polym. Ed. 101 (1995)

Nir Kossovsky, et al., “Self-reported signs and symptoms in breast implant patients with novel antibodies to silicone surface associated antigens [anti-SSAA(x)],” 6 J. Appl. Biomater. 153 (1995), and “Erratum,” 6 J. Appl. Biomater. 305 (1995)

Nir Kossovsky & J. Stassi, “A pathophysiological examination of the biophysics and bioreactivity of silicone breast implants,” 24s1 Seminars Arthritis & Rheum. 18 (1994)

Nir Kossovsky & C.J. Freiman, “Silicone breast implant pathology. Clinical data and immunologic consequences,” 118 Arch. Pathol. Lab. Med. 686 (1994)

Nir Kossovsky & C.J. Freiman, “Immunology of silicone breast implants,” 8 J. Biomaterials Appl. 237 (1994)

Nir Kossovsky & N. Papasian, “Mammary implants,” 3 J. Appl. Biomater. 239 (1992)

Nir Kossovsky, P. Cole, D.A. Zackson, “Giant cell myocarditis associated with silicone: An unusual case of biomaterials pathology discovered at autopsy using X-ray energy spectroscopic techniques,” 93 Am. J. Clin. Pathol. 148 (1990)

Nir Kossovsky & R.B. Snow RB, “Clinical-pathological analysis of failed central nervous system fluid shunts,” 23 J. Biomed. Mater. Res. 73 (1989)

R.B. Snow & Nir Kossovsky, “Hypersensitivity reaction associated with sterile ventriculoperitoneal shunt malfunction,” 31 Surg. Neurol. 209 (1989)

Nir Kossovsky & Ram Kossowsky, “Medical devices and biomaterials pathology: Primary data for health care technology assessment,” 4 Internat’l J. Technol. Assess. Health Care 319 (1988)

Nir Kossovsky, John P. Heggers, and M.C. Robson, “Experimental demonstration of the immunogenicity of silicone-protein complexes,” 21 J. Biomed. Mater. Res. 1125 (1987)

Nir Kossovsky, John P. Heggers, R.W. Parsons, and M.C. Robson, “Acceleration of capsule formation around silicone implants by infection in a guinea pig model,” 73 Plastic & Reconstr. Surg. 91 (1984)

John Heggers, Nir Kossovsky, et al., “Biocompatibility of silicone implants,” 11 Ann. Plastic Surg. 38 (1983)

Nir Kossovsky, John P. Heggers, et al., “Analysis of the surface morphology of recovered silicone mammary prostheses,” 71 Plast. Reconstr. Surg. 795 (1983)

Posted in Expert Witness Hall of Shame, Expert Witnesses, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Earthquake-Induced Data Loss – We’re All Shook Up

The One Percent Non-solution – Infante Fuels His Own Exclusion in Gasoline Leukemia Case

June 25th, 2015

Most epidemiologic studies are not admissible. Such studies involve many layers of hearsay evidence, measurements of exposures, diagnoses, records, and the like, which cannot be “cross-examined.” Our legal system allows expert witnesses to rely upon such studies, although clearly inadmissible, when “experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject.” Federal Rule of Evidence 703. One of the problems that judges face in carrying out their gatekeeping duties is to evaluate whether challenged expert witnesses have reasonably relied upon particular studies and data. Judges, unlike juries, have an obligation to explain their decisions, and many expert witness gatekeeping decisions by judges fall short by failing to provide citations to the contested studies at issue in the challenge. Sometimes the parties may be able to discern what is being referenced, but the judicial decision has a public function that goes beyond speaking to the litigants before the court. Without full citations to the studies that underlie an expert witness’s opinion, the communities of judges, lawyers, scientists, and others cannot evaluate the judge’s gatekeeping. Imagine a judicial opinion that vaguely referred to a decision by another judge, but failed to provide a citation? We would think such an opinion to be a miserable failure of the judge’s obligation to explain and justify the resolution of the matter, as well as a case of poor legal scholarship. The same considerations should apply to the scientific studies relied upon by an expert witness, whose opinion is being discussed in a judicial opinion.

Judge Sarah Vance’s opinion in Burst v. Shell Oil Co., C. A. No. 14–109, 2015 WL 3755953 (E.D. La. June 16, 2015) [cited as Burst], is a good example of judicial opinion writing, in the context of deciding an evidentiary challenge to an expert witness’s opinion, which satisfies the requirements of judicial opinion writing, as well as basic scholarship. The key studies relied upon by the challenged expert witness are identified, and cited, in a way that permits both litigants and non-litigants to review Her Honor’s opinion, and evaluate both the challenged expert witness’s opinion, and the trial judge’s gatekeeping performance. Citations to the underlying studies creates the delicious possibility that the trial judge might actually have read the papers to decide the admissibility question. On the merits, Judge Vance’s opinion in Burst also serves as a good example of judicial scrutiny that cuts through an expert witness’s hand waving and misdirection in the face of inadequate, inconsistent, and insufficient evidence for a causal conclusion.

Burst is yet another case in which plaintiff claimed that exposure to gasoline caused acute myeloid leukemia (AML), one of several different types of leukemia[1]. The claim is fraught with uncertainty and speculation in the form of extrapolations between substances, from high to low exposures, and between diseases.

Everyone has a background exposure to benzene from both natural and anthropogenic sources. Smoking results in approximately a ten-fold elevation of benzene exposure. Agency for Toxic Substances and Disease Registry (ATSDR) Public Health Statement – Benzene CAS#: 71-43-2 (August 2007). Gasoline contains small amounts of benzene, on the order of 1 percent or less. U.S. Environmental Protection Agency (EPA), Summary and Analysis of the 2011 Gasoline Benzene Pre-Compliance Report (2012).

Although gasoline has always contained benzene, the quantitative difference in levels of benzene exposure involved in working with concentrated benzene and with gasoline has led virtually all scientists and regulatory agencies to treat the two exposures differently. Benzene exposure is a known cause of AML; gasoline exposure, even in occupational contexts, is not taken to be a known cause of AML. Dose matters.

Although the reviews of the International Agency for Research on Cancer (IARC) are sometimes partisan, incomplete, and biased towards finding carcinogenicity, the IARC categorizes benzene as a known human carcinogen, in large part because of its known ability to cause AML, but regards the evidence for gasoline as inadequate for making causal conclusions. IARC, Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 45, Occupational Exposures in Petroleum Refining; Crude Oil and Major Petroleum Fuels (1989) (“There is inadequate evidence for the carcinogenicity in humans of gasoline.”) (emphasis in original)[2].

To transmogrify a gasoline case into a benzene case, plaintiff called upon Peter F. Infante, a fellow of the white-hat conspiracy, Collegium Ramazzini, and an adjunct professor at George Washington University School of Public Health and Health Services. Previously, Dr. Infante was Director of OHSA’s Office of Standards Review (OSHA). More recently, Infante is known as the president and registered agent of Peter F. Infante Consulting, LLC, in Falls Church, Virginia, and a go-to expert witness for plaintiffs in toxic tort litigation[3].

In the Burst case, Infante started out in trouble, by claiming that he had he “followed the methodology of the International Agency for Research on Cancer (IARC) and of the Occupational Safety and Health Administration (OSHA) in evaluating epidemiological studies, case reports and toxicological studies of benzene exposure and its effect on the hematopoietic system.” Burst at *4. Relying upon the IARC’s methodology might satisfy some uncritical courts, but here the IARC itself sharply distinguished its characterizations of benzene and gasoline in separate reviews. Infante’s opinion ignored this divide, although it ultimately had to connect gasoline exposure to the claimed injury[4].

Judge Vance found that Infante’s proffered opinions ransacked the catalogue of expert witness errors. Infante:

relied upon studies of benzene exposure and diseases other than the outcome of interest, AML. Burst at *4, *10, *13.

relied upon studies of benzene exposure rather than gasoline exposure. Burst at *9.

relied upon studies that assessed outcomes in groups with multiple exposures, which studies were hopelessly confounded. Burst at *7.

failed to acknowledge the inconsistency of outcomes in the studies of the relevant exposure, gasoline. Burst at *9.

relied upon studies that lacked adequate exposure measurements and characterizations, which lack was among the reasons that the ATSDR declined to label gasoline a carcinogen. Burst at *12.

relied upon studies that did not report statistically significant associations between gasoline exposure and AML. Burst at *10, *12

cherry picked studies and failed to explain contrary results. Burst at *10.

cherry picked data from within studies that did not otherwise support his conclusion. Burst at *10.

interpreted studies at odds with how the authors of published papers interpreted their own studies. Burst at *10.

failed to reconcile conflicting studies. Burst at *10.

manipulated data without sufficient explanation or justification. Burst at *14.

failed to conduct an appropriate analysis of the entire dataset, along the lines of Sir Austin Bradford Hill’s nine factors. Burst at *10.

The manipulation charge is worth further discussion because it reflects upon the trial court’s acumen and the challenged witness’s deviousness. Infante combined the data from two exposure subgroups from one study[5] to claim that the study actually had a statistically significant association. The trial court found that Dr. Infante failed to explain or justify the recalculation. Burst at *14. At the pre-trial hearing, Dr. Infante offered that he performed the re-calculation on a “sticky note,” but failed to provide his calculations. The court might also have been concerned about the misuse of claiming statistical significance in a post-hoc, non-prespecified analysis that would have clearly raised a multiple comparisons issue. Infante also combined two separate datasets from an unpublished study (the Spivey study for Union Oil), which the court found problematic for his failure to explain and justify the aggregation of data. Id. This recalculation raises the issue whether the two separate datasets could be appropriately combined.

For another study[6], Infante adjusted the results based upon his assessment that the study was biased by a “healthy worker effect[7].” Burst at *15. Infante failed to provide any explanation of how he adjusted for the healthy worker effect, thus giving the court no basis for evaluating the reliability of his methodology. Perhaps more telling, the authors of this study acknowledged the hypothetical potential for healthy worker bias, but chose not to adjust for it because their primary analyses were conducted internally within the working study population, which fully accounted for the potential bias[8].

The court emphasized that it did not question whether combining datasets or adjusting for bias was accepted or proper methodology; rather it focused its critical scrutiny on Infante’s refusal or failure to explain and justify his post-hoc “manipulations of published data.” Burst at *15. Without a showing that AML is more common among non-working, disabled men, the health worker adjustment could well be questioned.

In the final analysis, Infante’s sloppy narrative review could not stand in the face of obviously inconsistent epidemiologic data. Burst at *16. The trial court found that Dr. Infante’s methodology of claiming reliance upon multiple studies, which did not reliably (validly) support his claims or “fit” his conclusions, failed to satisfy the requirements of Federal Rule of Evidence 702. The analytical gap between the data and the opinion were too great. Id. at *8. Infante’s opinion fell into the abyss[9].

[1] See, e.g., Castellow v. Chevron USA, 97 F. Supp. 2d 780, 796 (S.D.Tex.2000) (“Plaintiffs here have not shown that the relevant scientific or medical literature supports the conclusion that workers exposed to benzene, as a component of gasoline, face a statistically significant risk of an increase in the rate of AML.”); Henricksen v. Conoco Phillips Co., 605 F.Supp.2d 1142, 1175 (E.D.Wa. 2009) (“None of the studies relied upon have concluded that gasoline has the same toxic effect as benzene, and none have concluded that the benzene component of gasoline is capable of causing AML.”); Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 450 (N.Y.2006) (“[N]o significant association has been found between gasoline exposure and AML. Plaintiff’s experts were unable to identify a single epidemiologic study finding an increased risk of AML as a result of exposure to gasoline.”).

[2] See also ATSDR Toxicological Profile for Gasoline (1995) (concluding “there is no conclusive evidence to support or refute the carcinogenic potential of gasoline in humans or animals based on the carcinogenicity of one of its components, benzene”); ATSDR, Public Health Statement for Automotive Gasoline (June 1995) (“[However, there is no evidence that exposure to gasoline causes cancer in humans. There is not enough information available to determine if gasoline causes birth defects or affects reproduction.”).

[3] See, e.g., Harris v. CSX Transp., Inc., 753 SE 2d 275, 232 W. Va. 617 (2013); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142 (E.D. Wash. 2009); Roney v. GENCORP, Civil Action No. 3: 05-0788 (S.D.W. Va. Sept. 18, 2009); Chambers v. Exxon Corp., 81 F. Supp. 2d 661 (M.D. La. 2000).

[4] Judge Vance did acknowledge that benzene studies were relevant to Infante’s causation opinion, but emphasized that such studies could not suffice to show that all gasoline exposures could cause AML. Burst at *10 (citing Dickson v. Nat’l Maint. & Repair of Ky., Inc., No. 5:08–CV–00008, 2011 WL 12538613, at *6 (W.D. Ky. April 28, 2011) (“Benzene may be considered a causative agent despite only being a component of the alleged harm.”).

[5] L. Rushton & H. Romaniuk, “A Case-Control Study to Investigate the

Risk of Leukaemia Associated with Exposure to Benzene in Petroleum Marketing and Distribution Workers in the United Kingdom,” 54 Occup. & Envt’l Med. 152 (1997).

[6] Otto Wong, et al., “Health Effects of Gasoline Exposure. II. Mortality Patterns of Distribution Workers in the United States,” 101 Envt’l Health Persp. 6 (1993).

[7] Burst at *15, citing and quoting from John Last, A Dictionary of Epidemiology (3d ed.1995) (“Workers usually exhibit lower overall death rates than the general population because the severely ill and chronically disabled are ordinarily excluded from employment.”).

[8] Wong, supra.

[9] In a separate opinion, Judge Vance excluded a physician, Dr. Robert Harrison, who similarly opined that gasoline causes AML, and Mr. Burst’s AML, without the benefit of sound science to support his opinion. Burst v. Shell Oil Co., C. A. No. 14–109, 2015 WL 2015 WL 3620111 (E.D. La. June 9, 2015).

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Diclegis and Vacuous Philosophy of Science

June 24th, 2015

Just when you thought that nothing more could be written intelligently about the Bendectin litigation, you find out you are right. Years ago, Michael Green and Joseph Sanders each wrote thoughtful, full-length books[1] about the litigation assault on the morning-sickness (nausea and vomiting of pregnancy) medication, which was voluntarily withdrawn by its manufacturer from the United States market. Dozens, if not hundreds, of law review articles discuss the scientific issues, the legal tactics, and the judicial decisions in the U.S. Bendectin litigation, including the Daubert case in Supreme Court and in the Ninth Circuit. But perhaps fresh eyes might find something new and fresh to say.

Boaz Miller teaches social epistemology and philosophy of science, and he recently weighed in on the role that scientific consensus played in resolving the Bendectin litigation. Miller, “Scientific Consensus and Expert Testimony in Courts: Lessons from the Bendectin Litigation,” Foundations of Science (2014) (Oct. 17, 2014) (in press) [cited as Miller]. Miller astutely points out that scientific consensus may or may not be epistemic, that is, based upon robust, valid, sufficient scientific evidence of causality. Scientists are people, and sometimes they come to conclusions based upon invalid evidence, or because of cognitive biases, or social pressures, and the like. Sometimes scientists get the right result for the wrong reasons. From this position he argues that adverting to scientific consensus is fraught with danger of being misled, and that the Bendectin ligitation specifically is an example of courts led astray by a “non-epistemic” scientific consensus. Miller at 1.

Miller is correct that the scientific consensus on Bendectin’s safety, which emerged after the initiation of litigation, played a role in resolving the litigation, id. at 8, but he badly misunderstands how the consensus actually operated to bring closure to the birth defects litigation. Remarkably, he pays no attention to the consolidated trial of over 800 cases before the Hon. Carl B. Rubin, in the Southern District of Ohio. This trial resulted in a defense verdict in March 1985, and judgment that withstood appellate review. Assoc. Press, “U.S. Jury Clears a Nausea Drug in Birth Defects,” N.Y. Times (Mar. 13, 1985). The subsequent litigation turned into guerilla warfare based upon relatively few remaining individual cases in state and federal courts. In one of the state court cases, the trial court appointed neutral expert witnesses, who opined that plaintiffs had failed to make out their causal claims of teratogenicity in human beings. DePyper v. Navarro, No. 83–303467-NM, 1995 WL 788828 (Mich. Cir. Ct. Nov. 27, 1995).

To be sure, plaintiffs’ expert witnesses and plaintiffs’ counsel continued in their campaign to manufacture “reasonable medical certainty” of Bendectin’s teratogenicity, well after a scientific consensus emerged. Boaz Miller makes the stunning claim that this consensus was not a “knowledge-based” consensus because:

(1) the research was controlled by parties to the dispute (Miller at 10);

(2) the consensus ignored or diminished the “value” of in vitro toxicology (Miller at 13);

(3) the consensus relied upon most heavily upon the epidemiologic evidence (Miller at 14);

(4) the animal toxicology research was “prematurely” abandoned when the U.S. withdrew its product from the market (Miller at 15); and

(5) the withdrawal ended the “threat” to public health, and the concerns about teratogenicity (Miller at 15).

Miller’s asserted reasons are demonstrably incorrect. Although Merrell Richardson funded some studies early on, by the time the scientific consensus emerged, many studies funded by neutral sources, and conducted by researchers of respected integrity, were widely available. The consensus did not diminish the value of in vivo toxicology; rather scientists evaluated the available evidence through their understanding of epidemiology’s superiority in assessing actual risks in human populations. Animal studies were not prematurely abandoned; more accurately, the animal studies gave way to more revealing, valid studies in humans about human outcomes. The sponsor’s withdrawal of Bendectin in the United States was not the cause of any abandonment of research. The drug remained available outside the United States, in countries with less rapacious tort systems, and researchers would have, in any event, continued animal studies if there were something left open by previous research. A casual browse through PubMed’s collection of articles on thalidomide shows that animal research continued well after that medication had been universally withdrawn for use in pregnant women. Given that thalidomide was unquestionably a human teratogen, there was a continued interest in understanding its teratogenicity. No such continued interest existed for Bendectin after the avalanche of exculpatory human data.

What sort of inquiry permitted Miller to reach his conclusions? His article cites no studies, no whole-animal toxicology, no in vitro research, no epidemiologic studies, no systematic reviews, no regulatory agency reviews, and no meta-analysis. All exist in abundance. The full extent of his engagement with the actual scientific data and issues is a reference to an editorial and two letters to the editor[2]! From the exchange of views in one set of letters in 1985, Miller infers that there was “clear dissent within the community of toxicologists.” Miller at 13. The letters in question, however, were written in a journal of teratology, which was not limited to toxicology, and the interlocutors were well aware of the hierarchy of evidence that placed human observational studies at the top of the evidential pyramid.

Miller argues that it was possible that the consensus was not knowledge-based because it might have reflected the dominance of epidemiology over the discipline of toxicology. Again, he ignores the known dubious validity of inferring human teratogenicity from high dose whole animal or in vitro toxicology. By the time the scientific consensus emerged with respect to Bendectin’s safety, this validity point was widely appreciated by all but the most hardened rat killers, and plaintiffs’ counsel. In less litigious countries, the drug never left the market. No regulatory agency ever called for its withdrawal.

Miller might have tested whether the scientific community’s consensus on Bendectin, circa 1992 (when Daubert was being briefed in the Supreme Court) was robust by looking to how well it stood up to further testing. He did not, but he could easily have found the following. The U.S. sponsor of Diclegis, Duchesnay USA, sought and obtained the indication for its medication in pregnancy. Under U.S. law, Duchesnay’s new drug application had to establish safety and efficacy for this indication. In 2013, the U.S. FDA approved Bendectin, under the tradename, Diclegis [3], as a combination of doxylamine succinate and pyridoxine hydrochloride for sale in the United States. Under the FDA’s pregnancy labeling system, Diclegis is a category A, with a specific indication for use in pregnancy. The FDA’s review of the actual data is largely available for all to see. See, e.g., Center for Drug Evaluation and Research, Other Reviews (Aug. 2012); Summary Review (April 2013); Pharmacology Review (March 2013); Medical Review (March 2013); Statistical Review (March 2013); Cross Discipline Team Leader Review (April 2013). Given the current scientific record, the consensus that emerged in the early 1990s looks strong. Indeed, the consensus was epistemically strong when reached two decades ago.

Miller is certainly correct that reliance upon consensus entails epistemic risks. Sometimes the consensus has not looked very hard or critically at all the evidence. Political, financial, and cognitive biases can be prevalent. Miller fails to show that any such biases were prevalent in the early 1990s, or that they infected judicial assessments of the plaintiffs’ causal claims in Bendectin litigation. Miller is also wrong to suggest that courts did not look beyond the consensus to the actual evidential base for plaintiffs’ claims. Through the lens of expert witness testimony, both party and court-appointed expert witnesses, courts and juries had a better view of the causation issues than Miller appreciates. Miller’s philosophy of science might be improved by his rolling up his sleeves and actually looking at the data[4].

[1] See Joseph Sanders, Bendectin on Trial: A Study of Mass Tort Litigation (1998); Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (1996).

[2] Robert Brent, “Editorial comment on comments on ‘Teratogen Update: Bendectin’,” 31 Teratology 429 (1985); Kenneth S. Brown, John M. Desesso, John Hassell, Norman W. Klein, Jon M. Rowland, A. J. Steffek, Betsy D. Carlton, Cas. Grabowski, William Slikker Jr. and David Walsh, “Comments on ‘Teratogen Update: Bendectin’,” 31Teratology 431 (1985); Lewis B. Holmes, “Response to comments on ‘Teratogen Update: Bendectin’,” 31 Teratology 432 (1985).

[3] See FDA News Release, “FDA approves Diclegis for pregnant women experiencing nausea and vomiting,” (April 8, 2013). The return of this drug to the United States market was held up as a triumph of science over the will of the industry litigation. See Gideon Koren, “The Return to the USA of the Doxylamine-Pyridoxine Delayed Release Combination (Diclegis®) for Morning Sickness — A New Morning for American Women,” 20 J. Popul. Ther. Clin. Pharmacol. e161 (2013).

[4] See “Bendectin, Diclegis & The Philosophy of Science” (Oct 26, 2013).

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