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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).

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