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A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation

June 21st, 2013

Weitz & Luxenberg P.C. v. Georgia-Pacific

Earlier this month, the First Department of the New York Appellate Division upheld a trial court’s ruling that a former manufacturer of an asbestos-containing product, Georgia-Pacific LLC (G-P), must produce underlying data from eight published research studies, funded by the company. These studies apparently addressed health outcomes from the use of the company’s product, a joint compound, or from its chrysotile asbestos component. The trial court had also ordered an in camera review of various other documents on G-P’s privilege log. Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013)

The appellate court accepted that G-P had funded the eight studies as part of its legal defense to asbestos personal injury litigation. The studies at issue involved recreating G-P’s asbestos-containing joint compound to assess biopersistence and pathogenicity of its (past) chrysotile content. According to the Appellate Division’s opinion, G-P was closely involved in the development of the published articles. G-P’s Director of Toxicology and Chemical Management, Stewart Holm, became a contractor to provide “consulting services” to G-P’s in-house counsel. Both Holm and in-house counsel were involved in pre-publication review of the articles.

G-P claimed attorney-client and work-product privilege to resist production of documents that reflected communications with consulting experts or legal staff. The Special Master directed an in camera review of documents on G-P’s privilege log, and the production of the underlying data and materials from the studies. The motion court refused G-P’s motions to vacate the Special Master’s recommendations, and to reconsider.

The trial and appellate court rulings seem fairly straightforward except that the appellate court omitted serious consideration of the existence and scope of the privilege, and focused upon the applicability of the crime-fraud exception. This exception requires that the legal advice, sought to be protected, involves some fraudulent scheme or wrongful conduct, but the court seemed all too willing to engage in an analysis of the applicability of the exception before it considered whether the privilege applied in the first place.

The Appellate Division held that the plaintiffs had made a sufficient “showing of a factual basis adequate to support a good faith belief by a reasonable person that in camera review of the materials may reveal evidence to establish the claim that the crime-fraud exception applies.” Slip op. at 4. Here is how the appellate court described the plaintiffs’ claim that the attorney-client privilege had been lost:

“Holm co-authorized nearly all of the studies, which were intended to cast doubt on the capability of chrysotile asbestos to cause cancer. On the two articles that he did not co-author, he [*4]and GP’s counsel participated in lengthy ‘WebEx conferences’ in which they discussed the manuscripts and suggested revisions. Despite this extensive participation, none of the articles disclosed that GP’s in-house counsel had reviewed the manuscripts before they were submitted for publication. Two articles falsely stated that ‘[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript’. For articles lead-authored by David M. Bernstein, Ph.D., and co-authored by Holm, the only disclosure was that the research was ‘sponsored’ or ‘supported’ by a grant from GP. The articles did not disclose that Holm was specially employed by GP for the asbestos litigation or that he reported to GP’s in-house counsel. Furthermore, there were no grant proposals, and Dr. Bernstein was hired by GP on an hourly basis. Nor did the articles reveal that Dr. Bernstein has been disclosed as a GP expert witness in NYCAL since 2009, that he had testified as a defense expert for Union Carbide Corporation in asbestos litigation, or that he had been paid by, and spoken on behalf of, the Chrysotile Institute, the lobbying arm of the Quebec chrysotile mining industry. Although GP belatedly endeavored to address the inadequacies of certain of its disclosures, its corrections failed to acknowledge its in-house counsel’s participation and did not make clear that Dr. Bernstein’s testimony as an expert witness preceded the publication of the first GP reformulated joint compound article in 2008.”

The court was obviously concerned that G-P in-house counsel was involved in the publication process, and that this involvement was not disclosed. Slip at 4, citing United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D. D.C. 2006) (applying fraud-crime exception to tobacco industry), aff’d in relevant part, 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S.Ct. 3501 (2010).

What Appellate Division appeared to overlook is whether the attorney-client privilege applied in the first place. In her initial recommendation, Special Master Laraine Pacheco gave careful consideration to the logically prior question whether the disputed materials were “legal” such that any privilege even attached to the disputed materials in the first place. See Recommendation of Special Master at 3, citing United States Postal Serv. v. Phelps Dodge Ref. Corp., 852 F. Supp. 156, 160 (E.D.N.Y. 1994) (“Defining the scope of the privilege for in-house counsel is complicated by the fact that these attorneys frequently have multi-faceted duties that go beyond traditional tasks performed by lawyers. . . . Needless to say, the attorney-client privilege attaches only to legal, as opposed to business, services. The communication must be made to the attorney acting in her capacity as counsel. If the communication is made to the attorney in her capacity as a business adviser, for example, it ought not be privileged”); In re Grand Jury Subpoena, 599 F.2d 504, 511 (2d Cir. 1979) (“Participation of the general counsel does not automatically cloak the investigation with legal garb”). The Special Master seemed to think that there was no privilege, which stood in need of an exception.

The Special Master also noted that no privilege attaches to materials that were intended for ultimate publication:

“New York of course accepts the unremarkable proposition that if a client communicates to the lawyer with the intent that the communication is to be released to the public, that communication is not privileged.”

Recommendation at 3, citing In re New York Renu with Moistureloc Prod. Liability Litig. , 2008 U.S. Dist. LEXIS 88515, at *5, 14 (D.S.C. May 8, 2008) (applying New York law) (relying on Michael M. Martin, et al., New York Evidence Handbook 318 (2d ed. 2002)). Furthermore, there was a question whether G-P had waived its privilege claim by selectively producing some documents that it wanted to put into the record of the case. Id. The Special Master’s points appear important and persuasive, but the Appellate Division skipped over them in order to address the exception, which assumes that the privilege applies in the first place.

American Law Institute (ALI), The Law Governing Lawyers § 68 (1998). The mere participation of in-house counsel is not dispositive of the question. The privilege applies to communications made for the purpose of obtaining legal advice. In-house lawyers are often consulted for advice on non-legal issues. Courts have thus been drawn in to controversies over sorting out whether the communication was engaged in for purpose of obtaining “legal assistance.” ALI § 72. The law acknowledges that communications may have multiple purposes and motives, but the predominant function of the communication must relate to legal advice if it is to retain its privileged status. ALI § 72, comment c.

In Burton v. R.J. Reynolds Tobacco Co., both the magistrate and district judges accepted, as a general principle:

“An analysis of scientific data may be the subject of a privileged communication. To establish that such communications are protected by the attorney-client privilege there must be a connection between the scientific information which is the subject of the communication and the rendering of legal advice.”

200 F.R.D. 661, 668 (D. Kan. 2001). The court, however, proceeded to analyze the disputed claims of privilege and rejected most of them on grounds that the attorney communications were not in response to requests for legal advice. For instance, the court rejected the claim of privilege for a memorandum, written by an RJR scientist who assisted RJR patent lawyers as a scientific paralegal. The RJR scientist commented on “patentability,” but the court found that the document primarily concerned scientific research with no connection to the rendering of legal advice. Id. at 670. Even stingier was the court’s interpretation of a memorandum from RJR’s CEO to its general counsel, which discussed outside counsel’s recommendation that the company “should fund additional medical research in order to gain additional facts that [it]] can use to defend [itself] against [its] critics.” The court characterized the referenced advice as relating to public relations advice, not legal counsel. Id. at 672.

In the Vioxx MDL, Judge Fallon struggled with the issue whether many of activities of in-house counsel were truly “legal,” especially when the attorney communications were comments and edits of “scientific reports, articles accepted for publication in noted journals, and research proposals,” or word choice comments in scientific articles and study proposals. In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 800, 802 (E.D.La. 2007)(“We could not see the legal significance of these comments… .”).

Merck advanced a theory that the pharmaceutical industry was so pervasively regulated that the court should assume that its in-house lawyers were providing legal advice in making such comments and edits. Special Master Rice, a noted privilege scholar appointed to review the privilege claims, and Judge Fallon, never accepted Merck’s blanket rationale, although they did acknowledge that some service, initially appearing to be non-legal (such as “commenting upon and editing television ads and other promotional materials”) could in fact be legal advice when understood in the context of the pharmaceutical industry’s regulatory framework. Id. (citing Vodra et al., “The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges,” 61 Food & Drug L.J. 623 (2006)).

Concerned that such a blanket justification would seriously curtail discovery, the Special Master and the MDL Court insisted that Merck, in claiming a privilege, carry its burden to show that each document was, in fact, a confidential communication of legal advice. Id. The Special Master professed to be receptive to Merck’s evidence that, in the context of the highly regulated pharmaceutical industry, in-house counsel’s extensive changes and commentary to technical and scientific matters were legal services. Id. at 811-12. Judge Fallon, quoting from the Special Master Rice’s report, noted that:

“The responsive communication from the attorney is protected only to the extent that the response reveals the content of the client’s prior confidential communication.”

In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 795 (E.D.La. 2007). As a result, an attorney’s transmission to the client of information obtained from third-parties is not privileged. Id. at 796. Similarly, the derivative nature of the privilege may lead to a refusal to apply it to in-house lawyers’ line edits of a non-privileged document, which was circulated to other corporate employees outside the legal department. Id.

The Vioxx analysis shows that the presumption that in-house or outside (or out-house) counsel are writing to provide legal advice, in response to client communications can be lost. When the communications at issue are not for the purpose of providing legal advice, there may well be no protection under the attorney-client privilege. In re Vioxx Prods. Liab. Litig., 501 F.Supp. 2d 789, 797 n. 12 (E.D. La. 2007)(quoting Special Master Rice, who was quoting from his treatise at § 7.28). See also . In re Seroquel Prods. Liab. Litig., 2008 WL 1995058, at* 6- 7 (M.D. Fla. 2008) (rejecting “pervasive regulation” theory, and relying heavily upon Judge Fallon’s analysis in Vioxx).

The Appellate Division’s enthusiasm for accepting the existence of the privilege in Georgia-Pacific, and to except its application by the crime-fraud exception, is deeply troubling because the court left unclear exactly what G-P’s crime or fraud was. Perhaps G-P had failed to disclose some of the above-quoted facts in its discovery, but the anemic disclosures are all-too-common in most publications. They are hardly a crime. No provision of the penal code was cited. Although some of the suggested conduct is unseemly, it is not clearly a fraud.

The only supposed falsehood was that “[t]wo articles falsely stated that ‘[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript’.” Slip op. at 4. The recited “good faith” belief does not suggest that G-P designed or analyzed the studies. It is unclear whether G-P’s in-house counsel’s participation in a Webex conference realistically could be considered “preparing” a manuscript. The court’s vague accusations leave unclear exactly what G-P did to design the study, analyze the data, or prepare the manuscript. Such vague accusations would hardly pass the strictures of Federal Rule of Civil Procedure 9(b) (“Fraud or Mistake; Conditions of Mind. In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”)

Work Product Protection

The Appellate Division’s decision was on firmer ground with respect to rejecting G-P’s asserted work-product protection for attorney mental impressions, writings, trial preparation materials, and the like. As the court noted, there is a strong public interest in having disputes resolved on the basis of complete, accurate information. Slip op. at 6, citing In re American Tobacco Co., 880 F.2d 1520, 1529 (2d Cir 1989). Of course, in the American Tobacco case, the Second Circuit upheld a subpoena (previously quashed by New York state courts) against Dr. Selikoff’s Environmental Sciences Department, at the Mt. Sinai School of Medicine.

In the case on appeal, the court noted that G-P had admitted to commissioning the studies in anticipation of litigation, and to having its trial counsel or its expert witnesses use the studies at trial. Slip op. at 6. The appellate court also held that the plaintiffs’ substantial need for the underlying data and related materials, and the prejudice from being denied access, were obvious. The appellate court cast a broad, but not an unlimited net, for materials that would have to be produced. “[T]he data, protocols, process, conduct, discussion, and analyses underlying these studies” must be produced, but not “any internal communications that portray its attorneys’ or consultants’ notes, comments or opinions.” Slip op. at 7. The court identified the rationale for requiring production:

“A significant expenditure of time and money would be required to duplicate the studies, if they could be exactly duplicated at all, whereas scrutiny of the underlying data may provide a permissible manner in which to attack the findings that would be consistent with the intent of the CMO to minimize the cost of and streamline discovery.”

Id. Indeed, the lesson of the American Tobacco case, cited by the court, is that a party’s need and entitlement to underlying data and materials trumps even an independent researcher’s claim of “scholar’s privilege” or proprietary interest in data. Litigants are entitled to everyman’s and everywoman’s evidence, even if they are scientists. Courts may have to fashion protection to protect some of the scientists’ interests, but the wholesale denial of access to underlying data from published studies is, and should be, a relic of the past.

It is reflective of the Zeitgeist that the appellate court couched some of its rationale in corporation bashing:

“Large corporations often invest strategically in research agendas whose objective is to develop a body of scientific knowledge favorable to a particular economic interest or useful for defending against particular claims of legal liability.”

Slip op. at 6, quoting from In re Welding Fume Prods. Liability Litig., 534 F.Supp. 2d 761, 769 n.10 (N.D. Ohio 2008). Well the litigation industry, a.k.a. the plaintiffs’ bar, similarly invests in its research agenda, as evidenced in any number of litigations, including asbestos, silicone, welding cases, etc. More important, the plaintiffs’ bar has powerful interest proxies, such as support groups, labor unions, so-called public-interest groups, and captured governmental agencies, which are frequently involved in advocacy science. The need for access to underlying data, protocols, questionnaires, research materials is not limited to plaintiffs or defendants in litigation.

Eight Articles

A Pubmed search turned up exactly eight articles for <S.E. Holm and asbestos>. Two of the articles at issue did not have Holm as an author, so the following list is not identical to the eight articles at issue.

1. Exposures from chrysotile-containing joint compound: evaluation of new model relating respirable dust to fiber concentrations.

Brorby GP, Sheehan PJ, Berman DW, Bogen KT, Holm SE.

Risk Anal. 2013 Jan;33(1):161-76.

2. More on the dynamics of dust generation: the effects of mixing and sanding chrysotile, calcium carbonate, and other components on the characteristics of joint-compound dusts.

Berman DW, Brorby GP, Sheehan PJ, Bogen KT, Holm SE.

Ann Occup Hyg. 2012 Aug;56(7):852-67.

3. Chamber for testing asbestos-containing products: validation and testing of a re-created chrysotile-containing joint compound.

Sheehan PJ, Brorby GP, Berman DW, Bogen KT, Holm SE.

Ann Occup Hyg. 2011 Aug;55(7):797-809.

4. Quantification of the pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite-asbestos following short-term inhalation exposure.

Bernstein DM, Rogers RA, Sepulveda R, Donaldson K, Schuler D, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2011 Jun;23(7):372-91.

5. Potential artifacts associated with historical preparation of joint compound samples and reported airborne asbestos concentrations.

Brorby GP, Sheehan PJ, Berman DW, Bogen KT, Holm SE.

J Occup Environ Hyg. 2011 May;8(5):271-8.

6. The pathological response and fate in the lung and pleura of chrysotile in combination with fine particles compared to amosite asbestos following short-term inhalation exposure: interim results.

Bernstein DM, Rogers RA, Sepulveda R, Donaldson K, Schuler D, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2010 Sep;22(11):937-62.

7. Re-creation of historical chrysotile-containing joint compounds.

Brorby GP, Sheehan PJ, Berman DW, Greene JF, Holm SE.

Inhal Toxicol. 2008 Sep;20(11):1043-53.

8. A biopersistence study following exposure to chrysotile asbestos alone or in combination with fine particles.

Bernstein DM, Donaldson K, Decker U, Gaering S, Kunzendorf P, Chevalier J, Holm SE.

Inhal Toxicol. 2008 Sep;20(11):1009-28.

I thank William Ruskin for calling my attention to this interesting case in his blog post about the Weitz & Luxenberg v. Georgia-Pacific case.

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Irving Selikoff and the Right to Peaceful Dissembling

June 5th, 2013

Among concerned writers on corporate conflicts of interest, it is a commonplace that industrial sponsors of epidemiologic and other research selectively publish studies favorable to their positions in litigation and regulatory controversies. In my experience, most companies are fairly scrupulous about publishing the studies they funded. If there is a correlation in industry funding and outcome, it is largely the result of corporate funding being directed to areas in which weak or corrupt politically motivated, public-interested scientists have already published studies with dubious results. Common sense suggests that a fair test of the their claims will result in exonerative results.

It is also a commonplace that academic and public-spirited researchers will not have similar motives to suppress unfavorable results. Again, in my experience, the opposite is true. Consider that paragon of public-interested, political scientist, the late Dr. Irving Selikoff. During the course of discovery in the Caterinnichio case, I obtained manuscripts of two studies that Selikoff and his colleague, Bill Nicholson, prepared, but never published. One study examined the mortality, and especially the cancer mortality, of workers at a Johns-Manville asbestos product manufacturing plant in New Jersey. William J. Nicholson& Irving J. Selikoff, “Mortality experience of asbestos factory workers; effect of differing intensities of asbestos exposure”(circa 1988).

Selikoff’s failure to publish this manuscript on the Manville plantworkers is curious given his tireless and repeated republication of data from his insulator cohort. For those familiar with Selikoff’s agenda, the failure to publish this paper appears to have an obvious goal: suppress the nature and extent of Johns Manville’s use of crocidolite asbestos in its products:

“[O]ther asbestos varieties (amosite, crocidolite, anthophyllite) were also used for some products. In general, chrysotile was used for textiles, roofing materials, asbestos cements, brake and friction products, fillers for plastics, etc.; chrysotile with or without amosite for insulation materials; chrysotile and crocidolite for a variety of asbestos cement products.”

Id. The suppression of studies obviously takes place outside the world of commercial or industrial interests. See “Selikoff and the Mystery of the Disappearing Amphiboles.”

There was yet another studied never published by Selikoff, his work, again with Bill Nicholson, on the mortality of shipyard workers at the Electric Boat Company, in Groton, Connecticut. Irving Selikoff & William Nicholson, “Mortality Experience of 1,918 Employees of the Electric Boat Company, Groton, Connecticut January 1, 1967 – June 30, 1978” (Jan. 27, 1984) [cited below as Electric Boat].

Many of the asbestos cases that worked their way through the legal system in the 1980s and 1990s were filed by shipyard workers. Most of these shipyard workers were not insulators, but claimed asbestos bystander exposure from work near insulators. Invariably, the expert witnesses for these shipyard worker plaintiffs relied upon risk data from the Selikoff of asbestos insulators, even though Selikoff himself cautioned against using the insulator data for non-insulators:

“These particular figures apply to the particular groups of asbestos workers in this study. The net synergistic effect would not have been the same if their smoking habits had been different; and it probably would have been different if their lapsed time from first exposure to asbestos dust had been different or if the amount of asbestos dust they had inhaled had been different.”

Selikoff, et al., “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. at 487 (1979).

Having access to Selikoff’s shipyard worker data would have been extremely useful to the fact-finding process, because these data failed to support the cancer projections used by testifying expert witnesses. Selikoff and Nicholson pointed out that about 50% of the Electric Boat shipyard workers had X-ray abnormalities Electric Boat at 2. (This finding must be interpreted in the darkness of Selikoff’s documented propensity to overread chest X-rays for asbestos findings. Rossiter, “Initial repeatability trials of the UICC/ Cincinnati classification of the radiographic appearances of pneumoconioses.” 29 Brit. J. Indus. Med. 407 (1972) (reporting IJS’s readings as among the most extreme outliers in a panel of pulmonary and radiology physicians; showing that IJS films were read as showing abnormal profusion of small, irregular densities up to twice as often as the most reliable readers in the study.)).

Selikoff’s unpublished Electric Boat study cautioned that the mortality data reflected short duration and latency, and that the full extent of asbestos-related manifestations had not been reached. Electric Boat at 3. This assertion was not really borne out by the data. Selikoff’s paper reported the following observed and expected data for lung cancer:

Years from onset of employment	10-14	15-19	20-24	25-29	30+	TOTAL
OBSERVED	4	23.3	15	3	4	35
EXPECTED	1.3	17.7	8.1	4.7	5.1	25.9

The study is primitive even by then contemporary standards. There is no control for smoking; and no data on smoking habits. There is no data on radiation exposure. (Electric Boat built nuclear submarines.) No p-values or confidence intervals are supplied; nor are any estimates of trends included.

Despite Selikoff’s assertion that the follow-up period was not sufficiently long to capture asbestos-related malignancies, the data tell a different story. The lung cancer Obs./Exp. ratios are increased for 10-14 years, and for 15-19 years, and so these risk ratios reflect that the cohort likely had non-asbestos-related risks for lung cancer, which risks are at work before the cohort entered the lagged period in which they might have elevated asbestos-related risks. Although the numbers are smaller for the time intervals that involve more than 20 years from first employment, the observed numbers and risk ratios of lung cancers hardly suggests very much in terms of an occupational asbestos risk.

These data were obtained only because Bill Nicholson often served as an expert witness for plaintiffs in personal injury actions. When he did so in New Jersey, he was subject to fairly broad discovery obligations, and thus I was able to obtain his unpublished studies. Otherwise, the public and the scientific community learned only what Selikoff selectively disclosed in media interviews. See Samuel G. Freedman, “Worker’s suit over asbestos at Groton shipyard to open” New York Times (Jan. 19, 1982) (noting the 50% prevalence finding, but not the mortality data).

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Where Are They Now? Marc Lappé and the Missing Data

May 19th, 2013

The recrudescence of silicone “science” made me wonder where some of the major players in the silicone litigation are today. Some of the plaintiffs’ expert witnesses were characters who gave the litigation “atmosphere.”

Marc Alan Lappé was an experimental pathologist, who testified frequently for plaintiffs in toxic exposure cases. He founded an organization, The Center for Ethics & Toxics (CETOS), to serve as platform for his advocacy activities. Lappé was a new-age scientist, and an author of popular books on toxic everything: Chemical Deception: The Toxic Threat to Health and the Environment, and Against the Grain: Biotechnology and the Corporate Takeover of Your Food. When the silicone-gel breast implant litigation went viral, or immunologic, Lappé was embraced by the silicone sisters and their lawyers as one of their leading immunology guys. Lappé, a revolutionary, obliged and produced another pop science classic: Marc Lappé, The Tao Of Immunology: A Revolutionary New Understanding Of Our Body’s Defenses (1997).

Lappé jumped in to the silicone litigation early. He supported autoimmune claims, as well as the dubious claim that polyurethane-covered breast implants caused or accelerated breast cancer. Livshits v. Natural Y Surgical Specialties, Inc., 1991 WL 261770 (S.D.N.Y. Nov. 27, 1991). In depositions and in trial testimony, Lappé was combative and evasive, but when he wanted to be clear, he could be clear enough:

“It’s my opinion that silicone directly or indirectly can precipitate an activated immune state in such women that can lead to an autoimmune condition.”

Lappé Dep. 44:19-22 (Aug. 21, 1995), in Roden v. Medical Engineering Corp., No. 94-02-103, in District Court of Wise County, Texas, 271st Judicial District.

Plaintiffs also offered Lappé as an ethicist, in what was an obvious attempt to turn personal injury cases into passion plays and to raise the emotional temperature of the court rooms. Plaintiffs were able to get away with such nonsense in some state court cases, but the federal judges generally would not abide expert witnesses on ethics. See, e.g., Switzer v. McGhan Medical Corp., CV 94-P-14229-S, Transcript at 96-98, N.D. Ala. (Jan. 4, 1996) (Pointer, J.) (noting that Lappé would not be permitted to testify that the defendant’s conduct was unethical or unconscionable). Ironically, Lappé would become ensnared by an article, the publication of which was surrounded in ethical controversy.

Although Lappé had some experience in experimental immunology, he had no background in silicone. Undaunted, he set about to publish a work of science fiction. Marc Lappé, “Silicone-reactive disorder: a new autoimmune disease caused by immunostimulation and superantigens,” 41 Medical Hypotheses 348 (1993). Lappé went on to find some researchers with whom he could join forces, and in 1993, he and his co-authors published an article based upon what was ostensibly bench research on silicone immunology. Alas, Lappé did not really know the other authors, who were pitching their immunological screening test to plaintiffs’ support groups and to plaintiffs’ lawyers. Lappé signed up as a co-author without knowing the authors’ marketing plan, and without ever having seen the underlying data and statistical analyses. Given his credentials as a bioethicist, the lapse was remarkable. Lappé learned only through his involvement as an expert witness that his coauthors had been warned by the Food and Drug Administration about unlawful marketing of their “test,” and that some of his co-authors were involved in litigation against Bristol-Myers Squibb. Although the article was clearly intended to support both the marketing of the test, the litigation that would have benefited his coauthors directly, as well as Lappé’s testimonial adventures, the article contained no conflict of interest disclosures. Laurence Wolf, Marc Lappé, Robert Peterson, and Edward Ezrailson, “Human immune response to polydimethylsiloxane (silicone): screening studies in a breast implant population,” 7 Faseb J. 1265 (1993).

Lappé was an advocate, but he was not stupid. The late Chuck Walsh took some of Lappé’s early depositions in the breast implant litigation, and pressed him on whether he had seen or had access to the underlying data. Lappé Dep. Roden at 94:4 -21 (Aug. 21, 1995). Lappé also acknowledged that he had been unaware that the data presented in the published paper was truncated from the data originally obtained in the study. Id. at 108:19 – 109:7. Lappé bristled, as well he should, at these challenges to his ethical bona fides. He apparently requested the underlying data on more than one occasion, but his colleagues would not share the data with him:

Question: I want to ask you, did you ever get the basic raw data?

Answer: That was asked and answered as recently as three weeks ago. And the same answer applies today: No. I had asked for it. It was not give[n] to me. I have asked for it again. It’s not been given to me.

Lappé Dep. at 172:9-14 (Mar. 21, 1996), in Wolf v. Surgitek, Inc., No. 92-60186, 113th Judicial District, District Court of Harris County, Texas.

In early 1998, before Judge Pointer’s neutral expert witnesses delivered their reports in the multi-district proceedings, I traveled to Gualala, California, to take Lappé’s deposition in Page v. Bristol-Myers Squibb Co., No. JCCP-2754-03740, California Superior Court, County of San Diego (Jan. 19, 1998). I recall the little coastal town of Gualala well. The hotel, restaurant, and even the deposition room were infested with fruit flies, no doubt because pesticides were banned under Lappé’s influence. When I asked Lappé whether he had changed his views in any way, he gracefully backed away from his previous testimony:

“I believe that the current evidence, the weight of evidence suggests that the antibodies that are formed in women, perhaps in excess of their background levels for IGG antibody, may not have a specificity towards silicone itself as an antigen but may bind preferentially to silicone and therefore given nonspecific binding results such as those as the Emerald Labs detected in their plate bioassay. I think their evidence does not presently weigh in favor of considering silicone by itself as an antigen.”

Lappé Dep. Wolf at 100: 5-18. Later that year, 1998, Tim Pratt extracted further concessions from Lappé, in a Mississippi case. Lappé acknowledged that the MDL court’s neutral expert witnesses had done a “reasonably good job,” and that he agreed with them that there was not consistent evidence to support the claim that silicone caused autoimmune disease. Lappé Dep. at 26:1-9 (Dec. 17, 1998), in Brassell v. Medical Engineering Corp., Case No. 251-96-1074 CIV, Hinds County Circuit Court, Mississippi.

The litigation faded away, and so did Lappé. He died in 2005. Douglas Martin, “Marc Lappé, 62, Dies; Fought Against Chemical Perils,” N.Y. Times (May 21, 2005). Few other expert witnesses for silicone plaintiffs had the intellectual integrity to confess error. I hope he has found his missing data.

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Egilman Instigates Kerfuffle at McGill University

January 15th, 2013

Last February, the Canadian Broadcast Corporation unleashed a one-sided, twenty minute investigative journalistic film on the Quebec asbestos industry. All allegations from the plaintiffs’ litigation world were accepted as true, and the asbestos mining industry was cast as a manufacturer of doubt and deception. See “Fatal Deception” (Feb 2, 2012).

The narrator raises the suggestion that the Canadian federal government is relying upon “junk science” to justify support for continuing exports of chrysotile and for reopening the Quebec mines. This CBC production features Dr. David Egilman, holding forth on his views on the relationship between McGill University, Professor Corbett Macdonald, and the Quebec asbestos industry. Mostly, Egilman is permitted to define the issues and provide the “answers,” although the CBC film does give some air time to Professor Bruce Case, who points out that Egilman is not a scientist, but rather a social critic. When Professor Case was asked on air how he would respond to Egilman in response to his allegations, Case responded, “I wouldn’t give Dr. Egilman the time of day…because he’s not an honorable person.”

For over a decade, Egilman has been pressing his allegations that asbestos research conducted by McGill University investigators was tainted. In September 2012, McGill University’s Research Integrity Officer, Abraham Fuks, reported that the Egilman allegations were baseless and unsupported. Consultation Report to Dean David Eidelman (Sept. 23, 2012). See Egilman’s Allegations Against McDonald and His Epidemiologic Research Are Baseless (Oct. 20, 2012). Egilman responded to Professor Fuks’ report by labeling it “a shameful cover-up.” Eric Andrew-Gee, “Asbestos debate rages on at the Faculty Club: American researcher attacks McGill’s asbestos investigation,” The McGill Daily (Jan. 10, 2013).

The Egilman show apparently kicked off the new year at the McGill University Faculty Club, earlier this month, with a shouting match. According to the University’s newspaper, Egilman called MacDonald’s research on the Quebec chrysotile miners and millers “garbage,” and he called upon McGill University to retract the paper.

Egilman’s argument took the high road and the low road: He understandably objected to McGill’s and MacDonald’s refusal to share mineralogical data about tremolite content of asbestos from the Thetford Mines. Of course, the sad state of epidemiology today is that there is no mechanism for requiring data sharing, and the authors of pro-plaintiff studies have consistently refused to share data, and have fought subpoenas tooth and nail.

But then there was the low road. According to the McGill Daily, Egilman lapsed into name calling. During his presentation, Egilman referred to McGill’s Professor Fuks as Inspector Fox and included a cartoon in his slideshow of a henhouse guarded by a grinning fox. “Fuks, by the way, is German for Fox,” Egilman said.

One of the McGill professors chided Egilman for his ad hominem attack on Professor Fuks, and pointed out that Egilman could have made his points without personal attacks. Egilman responded “I could have, but it’s funny.” Id.

Egilman called upon his audience to evaluate his claims against those of Professors Case and Fuks. “One of us is an asshole,” he announced. Id. Indeed. Just perform the iterative disjunctive syllogism; it’s a matter of elimination. For a more scholarly analysis of assholes, see Aaron James, Assholes: A Theory (2012).

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Discovery of Statistician Expert Witnesses

July 19th, 2012

This post has been updated and superseded by “Discovery of Retained, Testifying Statistician Expert Witnesses (Part 1) (June 30, 2015).“

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Viagra, Part II — MDL Court Sees The Light – Bad Data Trump Nuances of Statistical Inference

July 8th, 2012

In the Viagra vision loss MDL, the first Daubert hearing did not end well for the defense. Judge Magnuson refused to go beyond conclusory statements by the plaintiffs’ expert witness, Gerald McGwin, and to examine the qualitative and quantitative evaluative errors invoked to support plaintiffs’ health claims. The weakness of McGwin’s evidence, however, appeared to encourage Judge Magnuson to authorize extensive discovery into McGwin’s study. In re Viagra Products Liab. Litig., 572 F. Supp. 2d 1071, 1090 (D. Minn. 2008).

The discovery into McGwin’s study had already been underway, with subpoenas to him and to his academic institution. As it turned out, defendant’s discovery into the data and documents underlying McGwin’s study won the day. Although Judge Magnuson struggled with inferential statistics, he understood the direct attack on the integrity of McGwin’s data. Over a year after denying defendant’s Rule 702 motion to exclude Gerald McGwin, the MDL court reconsidered and granted the motion. In re Viagra Products Liab. Litig., 658 F. Supp. 2d 936, 945 (D. Minn. 2009).

The basic data on prior exposures and risk factors for the McGwin study was collected by telephone surveys, from which the information was coded into an electronic dataset. In analyzing the data, McGwin used the electronic dataset and not the survey forms. Id. at 939. The transfer from survey forms to electronic dataset did not go smoothly; about 11 patients were miscoded as “exposed“ when their use of Viagra post-dated the onset of NAION. Id. at 942. Furthermore, the published article incorrectly stated personal history of heart attack as a “risk factor ”; the survey inquired about family not personal history of heart attack. Id. at 944.

The plaintiffs threw several bombs in response, but without legal effect. First, the plaintiffs claimed that the study participants had been recontacted and the database had been corrected, but they were unable to document this process or the alleged corrections. Id. at 433. Furthermore, the plaintiffs could not explain how, if their contention had been true, McGwin would have not committed serious violations of his university’s institutional review board’s regulations with respect to deviations from the original protocol. Id. at 943 n.7.

Second, the plaintiffs argued that the underlying survey forms were “inadmissible ” and thus the defense could not use them to impeach the McGwin study. Some might think this a duplicitous argument, utterly at odds with Rule 703 – rely upon a study but prevent use of underlying data and documents to explain that the study does not show what it purports to show. The MDL court spared the plaintiffs the embarrassment of ruling that the documents on which McGwin had based his study were inadmissible, and found that the forms were business records and admissible under Federal Rule of evidence 803(6). The court could have gone further to point out that McGwin’s reliance upon hearsay in the form of his study, McGwin 2006, opened the door to impeaching the hearsay relied upon with other hearsay. See Rule 806.

When defense counsel sat down with McGwin in a deposition, they found that he had not undertaken any new analyses of corrected data. Plaintiffs’ counsel directed him not to do so. Id. at 940-41. But then after the deposition was over, McGwin submitted a letter to the journal to report a corrected analysis. Pfizer’s counsel obtained the letter in response to their subpoena to McGwin’s university, the University of Alabama, Birmingham. Mirabile dictu; now the increase risk appeared limited to only to the defendant’s medication, Viagra!

The trial court was not amused. First, the new analysis was no longer peer reviewed, and the court had placed a great deal of emphasis on peer review in denying the first challenge to McGwin. Second, the new analysis was no longer that of an independent scientist, but was conducted and submitted as a letter to the editor, while McGwin was working for plaintiffs’ counsel. Third, the plaintiffs and McGwin conceded that the data were not accurate. Last, but not least, the trial court clearly was not pleased that the plaintiffs’ counsel had deliberately delayed McGwin’s further analyses until after the deposition, and then tried to submit yet another supplemental report with those further analyses. In sum:

“the Court finds good reason to vacate its original Daubert Order permitting Dr. McGwin to testify as a general causation expert based on the McGwin Study as published. Almost every indicia of reliability the Court relied on in its previous Daubert Order regarding the McGwin Study has been shown now to be unreliable. Peer review and publication mean little if a study is not based on accurate underlying data. Likewise, the known rate of error is also meaningless if it is based on inaccurate data. Even if the McGwin Study as published was conducted according to generally accepted epidemiologic research and did not result from post-litigation research, the fact that the McGwin Study appears to have been based on data that cannot now be documented or supported renders it inadmissibly unreliable. The Court concludes that under Daubert, Dr. McGwin’s opinion, to the extent that it is based on the McGwin Study as published, lacks sufficient indicia of reliability to be admitted as a general causation opinion.”

Id. at 945-46. The remaining evidence was the Margo & French study, but McGwin had previously criticized that study as lacking data that ensured that Viagra use preceded onset of NAION. In the end, McGwin was left with bupkes, and the plaintiffs were left with even less.

*******************

McGwin 2006 Was Also A Pain in the Rear End for McGwin

The Rule 702 motions and hearings on McGwin’s proposed testimony had consequences in the scientific world itself. In 2011, the British Journal of Ophthalmology retracted McGwin’s 2006 paper. “Retraction: Non-arteritic anterior ischaemic optic neuropathy and the treatment of erectile dysfunction, ” 95 Brit. J. Ophthalmol. 595 (2011).

Interestingly, the retraction was reported in the Retraction Watch blog, “Retractile dysfunction? Author says journal yanked paper linking Viagra, Cialis to vision problem after legal threats.” The blog treated the retraction as routine except for the hint of “legal pressure”:

“One of the authors of the paper, a researcher at the University of Alabama named Gerald McGwin Jr., told us that the journal retracted the article because it had become a tool in a lawsuit involving Pfizer, which makes Viagra, and, presumably, men who’d developed blindness after taking the drug:

‘The article just became too much of a pain in the rear end. It became one of those things where we couldn’t provide all the relevant documentation [to the university, which had to provide records for attorneys].’

Ultimately, however, McGwin said that the BJO pulled the plug on the paper.”

Id. The legal threat is hard to discern other than the fact that lawyers wanted to see something that peer reviewers almost never see – the documentation underlying the published paper. So now, the study that formed the basis for the original ruling against Pfizer floats aimlessly as a derelict on the sea of science. McGwin is, however, still at his craft. In a study he published in 2010, he claimed that Viagra but not Cialis use was associated with hearing impairment. Gerald McGwin, Jr, “Phosphodiesterase Type 5 Inhibitor Use and Hearing Impairment,” 136 Arch. Otolaryngol. Head & Neck Surgery 488 (2010).

Where are Senator Grassley and Congressman Waxman when you need them?

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Giving Rule 703 the Cold Shoulder

May 12th, 2012

I have written previously about the gap in Rule 702, which provides a multi-factorial test for the admissibility of an opinion from a properly qualified expert witness:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

Noticeably absent from Rule 702 is any requirement that the facts or data upon which the expert witness relies be worth a damn. From Rule 702(b), (c), and (d) alone, an expert witness, armed with sufficient unreliable, fraudulent, imaginary, or simply incorrect facts and data, using reliable principles and methods, and applying those principles and methods reliably to the facts of the case, gets to testify at trial. Arguably, the first subsection, Rule 702(a), which limits testimony to helpful “knowledge” provides an overriding condition that helps to qualify the next three. It is difficult to imagine that knowledge is based upon unreliable facts and data.

Still, the failure to require reliable data explicitly within the scope of Rule 702 is disturbing. This unhappy state of affairs, in which courts do not exercise gatekeeping over the quality of the data themselves, is apparently the law of the Tenth Circuit, of the United States Court of Appeals.

In Pritchett v. I-Flow Corporation, the plaintiff had shoulder surgery, which required the use of a “pain pump” to inject anesthetic medication into the shoulder post-operatively. The plaintiff went on to develop “chondrolysis” in his shoulder joint, a condition that involves partial or complete loss of cartilage in the shoulder joint. Pritchett v. I-Flow Corp., Civil Action No. 09-cv-02433-WJM-KLM. (D. Colo. April 17, 2012) (Mix, J., Magistrate Judge).

The opinion is a mechanical recitation of Daubert procedure and method, with little analysis of the expert witness’s opinion, until the magistrate judge describes the requirement of Rule 702 (b) for “sufficient facts and data”:

“i. Sufficient Facts and Data

The proponent of the opinion must first show that the witness gathered “sufficient facts and data” to formulate the opinion. In the Tenth Circuit, assessment of the sufficiency of the facts and data used by the witness is a quantitative, rather than a qualitative, analysis. Fed. R. Evid. 702, Advisory Committee Notes to 2000 Amendments; see also United States v. Lauder, 409 F.3d 1254, 1264 n.5 (10th Cir. 2005). That is to say, the Court does not examine whether the facts obtained by the witness are themselves reliable; whether the facts used are qualitatively reliable is a question of the weight that should be given to the opinion by the fact-finder, not the admissibility of the opinion. Lauder, 409 F.3d at 1264. Instead, “this inquiry examines only whether the witness obtained the amount of data that the methodology itself demands.” Crabbe, 556 F. Supp. 2d at 1223.”

Pritchett v. I-Flow Corp. (emphasis added). That is to say: the whole gatekeeping enterprise is really about appearances and not about trying to ensure more accurate fact finding.

If the court’s analysis of Rule 702 should be correct, it is in any event an incomplete analysis that omits the important role of Rule 703:

Rule 703. Bases of an Expert’s Opinion Testimony

An expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed. If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted. But if the facts or data would otherwise be inadmissible, the proponent of the opinion may disclose them to the jury only if their probative value in helping the jury evaluate the opinion substantially outweighs their prejudicial effect.

According to Magistrate Mix, the reliability of the facts and data do not count for gatekeeping. Chalk up another loophole to the law’s requirement of reliable scientific evidence.

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Discovery into the Origin of Historian Expert Witnesses’ Opinions

January 30th, 2012

As every trial lawyer in America knows, the Federal Rules of Civil Procedure were recently changed to protect expert witness draft reports and lawyer-expert witness communications from discovery. See Rule 26. Duty to Disclose; General Provisions Governing Discovery (amended effective December 2010).

In particular, Rule 26(b) (4)(B), and (C) provides:

(4)(B) Trial-Preparation Protection for Draft Reports or Disclosures. Rules 26(b)(3)(A) and (B) protect drafts of any report or disclosure required under Rule 26(a)(2), regardless of the form in which the draft is recorded.

(C) Trial-Preparation Protection for Communications Between a Party’s Attorney and Expert Witnesses. Rules 26(b)(3)(A) and (B) protect communications between the party’s attorney and any witness required to provide a report under Rule 26(a)(2)(B), regardless of the form of the communications, except to the extent that the communications:

(i) relate to compensation for the expert’s study or testimony;

(ii) identify facts or data that the party’s attorney provided and that the expert considered in forming the opinions to be expressed; or

(iii) identify assumptions that the party’s attorney provided and that the expert relied on in forming the opinions to be expressed.

In some ways, this amendment was a retrograde step. Although protecting drafts and communications from discovery helps ease the expense and inconvenience of working with expert witnesses, the amendment also serves to protect unscrupulous lawyers and expert witnesses who work in concert to present tendentious opinions.

In the sciences, tendentious opinions will ultimately be embarrassed by future facts, but in the field of history, the interpretative narratives are often unfalsifiable and malleable. Discovery into the creative process of historian expert witnesses’ opinions needs to be complete and thorough.

Consider the consider the case of Barry Castleman, who has testified for decades for the asbestos litigation industry, on historical issues in asbestos personal injury cases. Back in 1986, when Castleman was still “researching” his opinions, he received a letter from plaintiffs’ lawyer, Tom Hart:

Mr. Barry Castleman January 9, 1986
1722 Linden Avenue
Baltimore, Maryland 21217

RE: Kenneth Lynch

Dear Barry:

As a follow-up to our conversation on January 6, 1986, I have reviewed our files and find that we do not have a file on Kenneth Lynch. Apparently I was provided with some of these papers indirectly. I seem to recall that the attorneys from California came to South Carolina and conducted the search for Kenneth Lynch’s papers.

We have not been eager to pursue this due to our understanding that Dr. Lynch was not convinced that asbestos was a cause of cancer. Despite his earlier publications, he remained personally reluctant to state that asbestos was causally related to the formation of cancers until some time in the late 1950’s or early 1960’s. This indecision on his part would be contrary to our best interests in the asbestos litigation and, accordingly, we have discouraged other counsel from exploring this further.

Since we do not have the specific documents you need, perhaps Marcia Hughes could provide them to you from Dick Gerry’s office in San Diego.

With best regards, I am

Very truly yours,

Thomas H. Hart, III

Dr. Lynch was a well-known South Carolina pathologist, who, along with Dr. William Smith, published a case report of lung cancer in a patient with asbestosis. See Kenneth M. Lynch & William A. Smith, “Pulmonary asbestosis III: carcinoma of lung in asbestosilicosis,” 23 Am. J. Cancer 56 (1935). Plaintiffs’ counsel were eager to over interpret this case report as showing an association, which was beyond the ability of a single, uncontrolled case to do.

The new Rule can be seen to have a few holes in it. Discovery is permitted into facts or data provided by counsel, and which were considered by the expert witness. Discovery is also permitted into the identity of assumptions given by the directing counsel, and relied upon by the expert witness. The letter from Hart to Castleman above, however, illustrates that important insights may result from suggestions, implicit or explicit, not to look at certain facts.

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Lording the Data – Scientific Fraud

November 10th, 2011

Last week, the New York Times published a news story about psychologist Diederik Stapel, of the Netherlands. Tilburg University accused him of having committed research fraud in several dozen published papers, including the journal Science, the official journal of the AAAS. See Benedict Carey, “Fraud Case Seen as a Red Flag for Psychology Research: Noted Dutch Psychologist, Stapel, Accused of Research Fraud,” New York Times (Nov. 2, 2011). The Times expressed surprise over the suggestion that psychology is plagued by fraud and sloppy research. The surprise is that there are not more stories in the lay media over the poor quality of scientific research. The readers of Retraction Watch, and the Office of Research Integrity’s blog will recognize how commonplace Stapel’s fraud is.

Stapel’s fraud has wide-ranging implications for the doctoral students, whose dissertations he supervised, and for colleagues, with whom he collaborated. Stapel apologized and expressed his regret, but his conduct leaves a large body of his work, and that of others, under a cloud of suspicion.

Lording the Data

The University committee reported that Stapel had escaped detection for a long time because he was “lord of the data,” by refusing to disclose and share the data.

“Outright fraud may be rare, these experts say, but they contend that Dr. Stapel took advantage of a system that allows researchers to operate in near secrecy and massage data to find what they want to find, without much fear of being challenged.”

Benedict Carey, “Fraud Case,” New York Times (Nov. 2, 2011). Data sharing is preached but rarely practice.

In a recent publication, Dr. Wicherts and his colleagues, at the University of Amsterdam, reported that two-thirds of his sample of Dutch research psychologists refused to share their data, in contravention of the established ethical rules of the discipline. Remarkably, many of the refuseniks had explicit contractual obligations with their publishing journals to provide data. Jelte Wicherts, Marjan Bakker, Dylan Molenaar, “Willingness to Share Research Data Is Related to the Strength of the Evidence and the Quality of Reporting of Statistical Results,” PLoS ONE 6(11): e26828 (Nov. 2, 2011)

Scientific fraud seems no more common among scientists with industry ties, which are so often the subject of ad hominem conflict of interest claims. Instead, fraudfeasors such as Stapel or Hwang Woo-suk are more often simply egotistical, narcissistic, self-aggrandizing, self-promoting, or delusional. In the United States, litigation, occasionally has brought out charlatans, but it has also resulted in high-quality studies that have provided strong evidence for or against litigation claims. Compare 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 silicone litigation as “charlatans” and the litigation as largely based upon fraud) with Committee on the Safety of Silicone Breast Implants, Institute of Medicine, Safety of Silicone Breast Implants (Wash. D.C. 1999) (reviewing studies, many of which were commissioned by litigation defendants, and which collectively showed lack of association between silicone and autoimmune diseases).

The relation between litigation and research is one that has typically been approached by self-righteous voices, such as David Michaels and David Egilman, and others who have their own deep conflicts of interest. What is clear is that all litigants, as well as the public, would benefit from enforcing data sharing requirements. See “Litigation and Research” (April 15, 2007) (science should not be built upon blind trust of scientists: “Nullius in verba.”).

The Times article emphasized Wicherts’ research about lack of data sharing, and suggested that data sharing could improve the quality of scientific publications. The time may have come, however, for sterner measures of civil and criminal penalties for scientists who abuse and waste governmental funding, or who aid and abet fraudulent litigation.

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New Reference Manual on Scientific Evidence Short Shrifts Rule 703

October 16th, 2011

In “RULE OF EVIDENCE 703 — Problem Child of Article VII (Sept. 19, 2011),” I wrote about how Federal Rule of Evidence 703 is generally ignored and misunderstood in current federal practice. The Supreme Court, in deciding Daubert, shifted the focus to Rule 702, as the primary tool to deploy in admitting, as well as limiting and excluding, expert witness opinion testimony. The Court’s decision, however, did not erase the need for an additional, independent rule to control the quality of inadmissible materials upon which expert witnesses rely. Indeed, Rule 702 as amended in 2000, incorporated much of the learning of the Daubert decision, and then some, but it does not address the starting place of any scientific opinion: the data, the analyses (usually statistical) of data, and the reasonableness of relying upon those data and analyses. Instead, Rule 702 asks whether the proffered testimony is based upon:

sufficient facts or data,
the product of reliable principles and methods, and
a reliable application of principles and methods to the facts of the case

Noticeably absent from Rule 702, in its current form, is any directive to determine whether the proffered expert witness opinion is based upon facts or data of the sort upon which experts in the pertinent field would reasonably rely. Furthermore, Daubert did not address the fulsome importation and disclosure of untrustworthy hearsay opinions through Rule 703. See Problem Child (discussing the courts’ failure to appreciate the structure of peer-reviewed articles, and the need to ignore the discussion and introduction sections of such articles as often containing speculative opinions and comments). See also Luciana B. Sollaci & Mauricio G. Pereira, “The introduction, methods, results, and discussion (IMRAD) structure: a fifty-year survey,” 92 J. Med. Libr. Ass’n 364 (2004); Montori, et al., “Users’ guide to detecting misleading claims in clinical research reports,” 329 Br. Med. J. 1093, 1093 (2004) (advising readers on how to avoid being misled by published literature, and counseling readers to “Read only the Methods and Results sections; bypass the Discuss section.”) (emphasis added).

Given this background, it is disappointing but not surprising that the new Reference Manual on Scientific Evidence severely slights Rule 703. Using either a word search in the PDF version or the index at end of book tells the story: There are five references to Rule 703 in the entire RMSE! The statistics chapter has an appropriate but fleeting reference:

“Or the study might rest on data of the type not reasonably relied on by statisticians or substantive experts and hence run afoul of Federal Rule of Evidence 703. Often, however, the battle over statistical evidence concerns weight or sufficiency rather than admissibility.”

RMSE 3d at 214. At least this chapter acknowledges, however briefly, the potential problem that Rule 703 poses for expert witnesses. The chapter on survey research similarly discusses how the data collected in a survey may “run afoul” of Rule 703. RMSE 3d at 361, 363-364.

The chapter on epidemiology takes a different approach by interpreting Rule 703 as a rule of admissibility of evidence:

“An epidemiologic study that is sufficiently rigorous to justify a conclusion that it is scientifically valid should be admissible,¹⁸⁴ as it tends to make an issue in dispute more or less likely.¹⁸⁵“

Id. at 610. This view is mistaken. Sufficient rigor in an epidemiologic study is certainly needed for reliance by an expert witness, but such rigor does not make the study itself admissible; the rigor simply permits the expert witness to rely upon a study that is typically several layers of inadmissible hearsay. See “Reference Manual on Scientific Evidence v3.0 – Disregarding Study Validity in Favor of the “Whole Gamish” (Oct. 14, 2011) (discussing the argument put forward by the epidemiology chapter for considering Rule 703 as an exception to the rule against hearsay).

While the treatment of Rule 703 in the epidemiology chapter is troubling, the introductory chapter on the admissibility of expert witness opinion testimony by the late Professor Margaret Berger really sets the tone and approach for the entire volume. See Berger, “The Admissibility of Expert Testimony,” RSME 3d 11 (2011). Professor Berger never mentions Rule 703 at all! Gone and forgotten. The omission is not, however, an oversight. Rule 703, with its requirement of qualifying each study relied upon as having been “reasonably relied upon,” as measured by what experts in the appropriate discipline, is the refutation of Berger’s argument that somehow a pile of weak, flawed studies, taken together can yield a scientifically reliable conclusion. See “Whole Gamish,” (Oct. 14th, 2011).

Rule 703 is not merely an invitation to trial judges; it is a requirement to look at the discrete studies relied upon to determine whether the building blocks are sound. Only then can the methods and procedures of science begin to analyze the entire evidentiary display to yield reliable scientific opinions and conclusions.

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