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Contra Parascandola’s Reduction of Specific Causation to Risk

August 22nd, 2014

Mark Parascandola is a photographer who splits his time between Washington DC, and Almeria, Spain.  Before his career in photography, Parascandola studied philosophy (Cambridge), and did graduate work in epidemiology (Johns Hopkins, MPH). In 1997 to 1998, he studied the National Cancer Institute’s role in determining that smoking causes some kinds of cancer.  He went on to serve as a staff epidemiologist at NCI, at its Tobacco Control Research Branch, in the Division of Cancer Control and Population Sciences (DCCPS).

Back in the 1990s, Parascandola wrote an article, which is a snapshot and embellishment of arguments given by Sander Greenland, on the use and alleged abuse of relative risks to derive a “probability of causation.” See Mark Parascandola, “What’s Wrong with the Probability of Causation?” 39 Jurimetrics J. 29 (1998)[cited here are Parascandola]. Parascandola’s article is a locus of arguments that have recurred from time to time, and worth revisiting.

Parascandola offers an interesting historical factoid, which is a useful reminder to those who suggest that the RR > 2 argument was the brainchild of lawyers:  The argument was first suggested in 1959, by Dr. Victor P. Bond, a physician with expertise in medical physics at the Brookhaven National Laboratory.  See Parascandola at 31 n. 6 (citing Victor P. Bond, The Medical Effects of Radiation (1960), reprinted in NACCA 13th Annual Convention 1959, at 126 (1960).

Unfortunately, Parascandola is a less reliable reporter when it comes to the judicial use of the relative risk greater than two (RR > 2) argument.  He argues that Judge Jack Weinstein opposed the RR > 2 argument on policy grounds, when in fact, Judge Weinstein rejected the anti-probabilistic argument that probabilistic inference could never establish specific causation, and embraced the RR > 2 argument as a logical policy compromise that would allow evidence of risk to substitute for specific causation in a limited fashion. Parascandola at 33-34 & n.20. Given Judge Weinstein’s many important contributions to tort and procedural law, and the importance of the Agent Orange litigation, it is worth describing Judge Weinstein’s views accurately. See In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 817, 836 (E.D.N.Y. 1984) (“A government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship.  A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him. … This means that at least a two-fold increase in incidence of the disease attributable to Agent Orange exposure is required to permit recovery if epidemiological studies alone are relied upon.”), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988); see also In re “Agent Orange” Prod. Liab. Litig., 611 F. Supp. 1223, 1240, 1262 (E.D.N.Y. 1985)(excluding plaintiffs’ expert witnesses), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).[1]

Parascandola’s failure to cite and describe Judge Weinstein’s views raises some question of the credibility of his analyses, and his assertion that “[he] will demonstrate that the PC formula is invalid in many situations and cannot fill the role it is given.” Parascandola at 30 (emphasis added).

Parascandola describes basic arithmetic of probability of causation (PC) in terms of a disease for which we “expect cases” and for which we have “excess cases.” The rate of observed cases in an exposed population divided by the rate of expected cases in an unexposed population provides an estimate of the population relative risk (RR). The excess cases can be obtained simply from the difference between observed cases in the exposed group and the expected cases in the unexposed group.  The attributable fraction is the ratio of excess cases to total cases.

The probability of causation “PC” = 1 – (1/RR).

Heterogeneity Yields Uncertainty Argument

The RR describes a group statistic, and an individual’s altered risk will almost certainly not be exactly equal to the group’s average risk. Parascandola notes that sometimes this level of uncertainty can be remedied by risk measurements for subgroups that better fit an individual plaintiff’s characteristics.  All true, but this is hardly an argument against RR > 2.  At best, the heterogeneity argument is an expression of inference skepticism of the sort that led Judge Weinstein to accept RR > 2 as a reasonable compromise. The presence of heterogeneity of this sort simply increases the burden upon plaintiff to provide RR statistics from studies that very tightly resemble plaintiff in terms of exposure and other characteristics.

Urning for Probablistic Certainty

Parascandola describes how the PC formula arises from a consideration of the “urn model” of disease causation.  Suppose in group of sufficient size there were expected 200 stomach cancer cases within a certain time, but 300 were observed. We can model the situation with an urn of 300 marbles, 200 of which are green, and 100 are red. Blindfolded or colorblind, we pull a single marble from the urn, and we have only a 1/3 chance of obtaining a red, “excess” marble case. Parascandola at 36-37 (borrowing from David Kaye, “The Limits of the Preponderance of the Evidence Standard: Justifiably Naked Statistical Evidence and Multiple Causation,” 7 Am. Bar Fdtn. Res. J. 487, 501 (1982)).

Parascandola argues that the urn model is not necessarily correct.  Causation cannot always be reduced to a single cause. Complex etiologic mechanisms and pathways are common.  Interactions between and among causes frequently occur.  Biological phenomena are sometimes “over-determined.” Parascandola asks us to assume that some of the non-excess cases are also “etiologic cases,” which were caused by the exposure but which would not have occurred but for the exposure.  Id. at 37. Borrowing from Greenland, Parascandola asserts that “[a]ll excess cases are etiologic cases, but not vice versa.” Id. at 38 & n.37 (quoting from Sander Greenland & James M. Robins, “Conceptual Problems in the Definition and Interpretation of Attributable Fractions,” 128 Am. J. Epidem. 1185, 1185 (1988)).

Parascandola’s argument, if accepted, proves too much to help plaintiffs who hope to establish specific causation with evidence of increased risk. His argument posits a different, more complex model of causation, for which plaintiffs usually have no evidence.  (If they did have such evidence, then they would have nothing to fear in the assumptions of the simplistic urn model; they could rebut those assumptions.) Parascandola’s argument pushes the speculation envelope by asking us to believe that some “non-excess” cases are etiologic cases, but providing no basis for identifying which ones they are.  Unless and until such evidence is forthcoming, Parascandola’s argument is simply uncontrolled multi-leveled conjecture.

Again borrowing from Sander Greenland’s speculation, Parascandola advances a variant of the argument above by suggesting that an exposure may not increase the overall number of excess cases, but that it may accelerate the onset of the harm in question. While it is true that the element of time is important, both in law and in life, the invoked speculation can be, and usually is, tested by time windows or time series analyses in observational epidemiology and clinical trials.  The urn model is “flat” with respect to the temporal dimension, but if plaintiffs want to claim acceleration, then they should adduce Kaplan-Meier curves and the like.  But again, with the modification of the time dimension, plaintiffs will still need hazard ratios or other risk ratios greater than two to make out their case, unless there is a biomarker/fingerprint of individual causation. The introduction of the temporal element is important to an understanding of risk, but Parascandola’s argument does not help transmute evidence of risk in a group to causation in an individual.

Joint Chancy Causation

In line with his other speculative arguments, Parascandola asks:  what if a given cancer in the exposed group is the product of two causes rather than due to one or another of the two causes? Parascandola at 40. This question restates the speculative argument in only slightly different terms.  We could multiply the possible causal sets by suggesting that the observed effect resulted from one or the other or both or none of the causes.  Parascandola calls this “joint chancy causation,” but he manages to show only that the inference of causation from prior chance or risk is a very chancy (or dicey) step in his argument.  Parascandola argues that we should not assume that the urn model is true, when multiple causation models are “plausible and consistent” with other causal theories.

Interestingly, this line of argument would raise the burden upon plaintiffs by requiring them to specify the applicable causal model in ways that (1) they often cannot, and (2) they now, under current law, are not required to do.

Conclusion

In the end, Parascandola realizes that he has raised, not lowered, the burden for plaintiffs.  His counter is to suggest, contrary to law and science, that “the existence of alternative hypotheses should not prevent the plaintiff’s case from proceeding.” Parascandola at 41 n.50.  Because he says so. In other words, Parascandola is telling us that irrespective of how poorly established a hypothesis is, or of how speculative an inference is, or of the existence and strength of alternative hypotheses,

“This trial must be tried.”

W.S. Gilbert, Trial by Jury (1875).

With bias of every kind, no doubt.

That is not science, law, or justice.

[1] An interesting failure or lack of peer review in a legal journal.

 

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Climategate on Appeal

August 17th, 2014

Michael Mann, a Professor of Meteorology at Penn State University, studies and writes about climate change. When the email servers of the University of East Anglia were hacked in 2009, Mann’s emails were among those used to suggest that there was a conspiracy to suppress evidence inconsistent with climate change.

Various committees investigated allegations of scientific malfeasance, which has come to be known as “climategate”; none found evidence of scientific misconduct. Some of the committees, however, did urge that the investigators engage in greater sharing of their supporting data, methods, and materials.

In February 2010, Penn State issued a report of its investigation, which found there was “no credible evidence that Dr. Mann had or has ever engaged in, or participated in, directly or indirectly, any actions with an intent to suppress or to falsify data.” A Final Investigation Report, from Penn State in June 2010, further cleared Mann.

In the United Kingdom, a Parliamentary Committee on Science and Technology published a report, in March 2010, finding that the criticisms of the Climate Research Unit (CRU) at the University of East Anglia (UEA) were not well founded. A month later, the UEA issued a Report of an International Panel, which found no evidence of deliberate scientific malpractice. Another UEA report, the Independent Climate Change Email Review report, found no reason to doubt the honesty of the scientists involved. An official UK governmental report, in September 2010, similarly cleared the climate researchers of wrongdoing.

The view from this side of the Atlantic largely exonerated the climate researchers of any scientific misconduct. An EPA report, in July 2010, dismissed the email content as merely a “candid discussion” among scientists collaborating on complex data. An independent review by the Department of Commerce’s Inspector General found no “inappropriate” manipulation of data in the emails. The National Science Foundation reported, in August 2011, that it could discern no research misconduct in the climategate emails.

Rand Simberg, an adjunct scholar with the Competitive Enterprise Institute (CEI) wrote a blog post, “The Other Scandal in Unhappy Valley” (July 13, 2012), in which he referred to Mann and his research as “wrongdoing” and “hockey-stick deceptions.” Simberg describes the hacked UEA emails as having “revealed” that Mann “had been engaging in data manipulation to keep the blade on his famous hockey-stick graph.” Similarly, Simberg states that “many of the luminaries of the ‛climate science’ community were shown to have been behaving in a most unscientific manner.”

The current on-line version of the Simberg’s blog post ends with a note[1]:

“*Two inappropriate sentences that originally appeared in this post have been removed by the editor.”

A post by Mark Steyn on the National Review online website called Mann’s hockey stick “fraudulent.” A subsequent National Review piece offered that in “common polemical usage, ‛fraudulent’ doesn’t mean honest-to-goodness criminal fraud. It means intellectually bogus and wrong.”

Legal counsel for Penn State wrote the Competitive Enterprise Institute, in August 2012, to request an apology from Simberg and the CEI, and a retraction of Simberg’s blog post. I am not sure what was in the two, subsequently removed, “inappropriate sentences” in Simberg’s piece were, or when the sentences were removed, but Dr. Mann, represented by Cozen O’Connor, went on to  sue Mark Steyn, Rand Simberg, the CEI, and National Review, for libel, in October 2012, in the Superior Court of the District of Columbia. Further publications led to an Amended Complaint in 2013.

Mann obviously does not like being called the author of fraudulent and intellectually bogus work, and he claims that the publications by Simberg and Steyn are libelous as “allegations of academic fraud.”

The D.C. Superior Court denied defendants’ motion to dismiss, setting up interlocutory appeals to the D.C. Court of Appeals, which is the highest court for the District. The appellate court allowed an interlocutory appeal, with a schedule that calls for appellants’ briefs by August 4, 2014. Dr. Mann’s brief is due by September 3, 2014, and appellants’ reply briefs by September 24, 2014.  The Court set consideration of the appeal for its November calendar.

Defendants CEI and National Review filed their opening briefs last week. This week, on August 11, 2014, the Cato Institute, Reason Foundation, Individual Rights Foundation and Goldwater Institute filed a brief in support of CEI and National Review. Other amici who filed in support of the defendants are Mark Steyn, the District of Columbia, and the Alliance Defending Freedom, and the Electronic Frontier Foundation.

I am not sure that all the epithets point to academic fraud.  Some of the adjectives, such as “bogus” do not really connote scienter or intent to deceive.  The use of the adjective “fraudulent,” however, does connote intentional falsity, designed to mislead. Deceit and intent to mislead seem to be at the heart of an accusation of fraud.

The defendants’ arguments, and their amici, on appeal predictably rely heavily upon the First Amendment to protect their speech, but surprisingly, they characterize labeling someone’s research as “fraudulent” as merely “hyperbolic” or “robust” debate and polemics.

Some of the defendants’ other arguments are even more surprising.  For instances, Cato correctly points out that “Courts are ill-suited to officiate scientific debate to determine ‛truth’ or ‛falsity’.” True, but officiate they must in criminal fraud, intellectual property, product liability, and in securities fraud cases, as well as many other kinds of litigations. Cato admonishes that the “[e]volution of scientific thought over time highlights the danger of courts[’] determining ‛truth’ in public debate.” Dangerous indeed, but a commonplace in state and federal courts throughout the land.

Is this Think Tank Thuggery or robust free speech? The use of “fraudulent” seems to be an accusation, and it would have much more “robust” to have had a careful documentation of what exactly was Professor Mann’s supposed deviation from a scientific standard of care.

[1] The words “fraud” and “fraudulent” do not appear in the current on-line version of Simberg’s post.

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Homeopathy on Trial

August 7th, 2014

As Tim Minchin put it in his poem, “Storm,” an alternative medicine is either not shown to be effective or has been shown to be ineffective; because if an alternative medicine has been shown to be effective, then we call it “medicine.”

Standard Homeopathic Company makes and sells various so-called alternative medicine remedies. Plaintiffs filed suit against Standard for misleadingly claiming efficacy, and sought class action certification.  Class actions have become increasingly difficult to maintain in federal court, but this one seems like a worthy candidate. The plaintiffs, in their Third Amended Complaint, alleged that “there is ‘little evidence’ that homeopathy is effective.” Usually, plaintiffs are perfectly happy with just a ‘little evidence’ to support claims for many dollars, but here they complained about being duped by homeopathy and its claims of dubious validity.

On August 1, 2014, District Judge Dolly Gee certified a class on behalf of purchasers of defendants’ homeopathic remedies (Calms Forte, Teething Tablets, Migraine Headache Relief, Colic Tablets, etc.) from February 2008 to the present. Allen v. Hyland’s Inc., 2:12-cv-01150, 2014 WL 3819713 (C.D. Calif. Aug. 1, 2014). The win was no doubt as sweet as the sugar pills that they had bought.

Standard Homeopathic is represented by Norton Rose Fulbright, which also represents ethical drug manufacturers.  Curiously, the defense lawyers must not have seen the substantial potential conflict of interest in representing a homeopathic manufacturer. Watching defendants’ attempts to defend the truth of their advertised claims for homeopathic remedies should make for an interesting litigation to watch.

 

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The Illinois Medical Studies Act and Access to Underlying Research Data

August 2nd, 2014

In the course of the welding fume litigation, defense counsel sought underlying data and documentation from a study published by Dr. Brad Racette and others, on their observations of Alabama welders[1]. The Alabama study, with its duplicate publication, aroused counsel’s suspicion for several reasons, not the least of which was that plaintiffs’ counsel had participated in creating the study by providing their clients as participants at screenings to be conducted by Dr. Racette and his colleagues.  According to the disclosure in the Neurology article, the study was

“[s]upported by NIH grants K23NS43351 and NS41509, the Greater St. Louis Chapter of the American Parkinson’s Disease Association, and the Welder Health Fund. The Welder Health Fund was created by Gulf States Trial Attorneys to support medical–legal screening of welders for Parkinson disease. No author has taken any money personally related to this research.”

A little research showed that the referenced NIH grants were not for this specific study, which was a creation of the litigation industry d/b/a the Welder Health Fund.

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette author of study on welding and parkinsonism).

Dr. Racette continued the controversy with a one-sided editorial in Neurology, which he wrote along with his legal counsel from the subpoena contest. Brad A. Racette, Ann Bradley, Carrie A. Wrisberg, and Joel S. Perlmutter, “The Impact of Litigation on Neurologic Research,” 67 Neurology 2124 (2006) [“Litigation Impact”]. Defense counsel wrote a response, which was limited due to the nature of the 400-word cap on letters to the editor. Nathan A. Schachtman, “The Impact of Litigation on Neurologic Research,” 69 Neurology 495 (2007).  A slightly more expansive response was published on the TortsProf blog. Schachtman, “Letter: Litigation and Research” (April 15, 2007).

The debate continued in October 2007, when Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss litigation and compelled access to underlying research data.  Dr. Racette complained about how disruptive subpoenas were into the operation of his research.  The Committee members appeared unimpressed by the alleged burdens when they realized that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan[2]. Most members of the Committee expressed the view that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data.

The fight over Dr. Racette’s data had consequences in the courtroom.  Defense expert witnesses were able to see how Dr. Racette was able to generate the appearance of large increased prevalence of “parkinsonism” (idiosyncratically defined and ascertained), which appearance was at odds with the vast data from analytical epidemiologic studies from around the world. James Mortimer, Amy Borenstein, and Laurene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012) (reporting a statistically significant decreased risk of Parkinson’s disease among welding tradesmen).  Remarkably, the plaintiffs’ counsel, who had sponsored the Alabama study, did not show the underlying Racette data and materials to their expert witnesses.  Within a short time after the subpoena was enforced, plaintiffs’ counsel mostly withdrew the epidemiologic component of their cases. Racette’s study ceased to play a major role in the plaintiffs’ claims. The debate over access to underlying data continues, both for clinical trials and for observational studies[3].

In “Litigation Impact,” Racette and colleagues offered specific remedial suggestions concerning the access of data.  One suggestion is to prohibit all data access categorically. Ironically, Racette’s suggestion run contrary to the widespread view that clinical trial data must be shared. Here is how Racette presents his suggestion:

“Stronger, more comprehensive federal legislation recognizing a research scholar privilege and ensuring that research data are uniformly protected against disclosure in all states is essential to advancing medical science.

Protections for study participants and researchers against disclosure of study data could be modeled after provisions such as those set forth in the Illinois Medical Studies Act. This Act specifically designates medical research study data and protocols as protected and prohibits the disclosure of research data obtained as part of a medical study.40,41 Enforcement includes a potential misdemeanor conviction for any person disclosing medical study data. Such legislation must strike a critical balance between the rights of industry to defend itself and the rights of researchers.”

Litigation Impact at 2128.

Is Racette correct that Illinois Medical Studies Act prevents disclosure of underlying research study data?

The claim seems dubious, but the Act is hardly a model of clarity:

Sec. 8-2101. Information obtained. All information, interviews, reports, statements, memoranda, recommendations, letters of reference or other third party confidential assessments of a health care practitioner’s professional competence, or other data of the Illinois Department of Public Health, local health departments, the Department of Human Services (as successor to the Department of Mental Health and Developmental Disabilities), the Mental Health and Developmental Disabilities Medical Review Board, Illinois State Medical Society, allied medical societies, health maintenance organizations, medical organizations under contract with health maintenance organizations or with insurance or other health care delivery entities or facilities, tissue banks, organ procurement agencies, physician-owned insurance companies and their agents, committees of ambulatory surgical treatment centers or post-surgical recovery centers or their medical staffs, or committees of licensed or accredited hospitals or their medical staffs, including Patient Care Audit Committees, Medical Care Evaluation Committees, Utilization Review Committees, Credential Committees and Executive Committees, or their designees (but not the medical records pertaining to the patient), used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services, except that in any health maintenance organization proceeding to decide upon a physician’s services or any hospital or ambulatory surgical treatment center proceeding to decide upon a physician’s staff privileges, or in any judicial review of either, the claim of confidentiality shall not be invoked to deny such physician access to or use of data upon which such a decision was based.
(Source: P.A. 92-644, eff. 1-1-03.)

Ill.Ann.Stat. ch. 735 § 5 (Code of Civil Procedure)/8–2101, et seq. (Medical Studies).

Racette’s suggestion that the Act protects the underlying data from research studies is not supported by reliable precedent.  Plaintiffs’ lawyers, including lawyers who worked with Dr. Racette in the welding litigation, have objected to discovery on the basis of the Act, but the objections were apparently not further litigated. See Videotape Deposition of Paul A. Nausieda, M.D. in Boren v. A.O. Smith Corp., Circuit Court of Illinois, Third Judicial Circuit (Dec. 22, 2004).

The Act itself has no ostensible connection to protecting the underlying data in an epidemiologic study.  Niven v. Siquiera, 109 Ill. 2d 357, 487 N.E.2d 937 (1985) (“the purpose of the Act is to encourage candid and voluntary studies and programs used to improve hospital conditions and patient care or to reduce the rates of death and disease”); Matviuw v. Johnson, 70 Ill. App.3d 481, 486, 388 N.E.2d 795, 799 (1st Dist. 1979). The Act protects peer-review or quality-control committees that supervise overall medical care with a view to improving the quality and standard of care, and reducing morbidity and mortality of patients. The privilege is designed to permit persons to speak freely to committees, and to protect their self-evaluative deliberations. Id.; Walker v. Alton Memorial Hospital Ass’n, 91 Ill. App.3d 310, 314, 414 N.E.2d 850, 853 (5th Dist. 1980). For a document to fall within the scope of the Act, it must be “generated specifically for the use of a peer-review committee.” Webb v. Mt. Sinai Hospital and Medical Center of Chicago, Inc., 807 N.E.2d 1026, 1033 (Ill. App. Ct. 2004)(internal citation omitted).

Given the language of the Act, and its interpretation in the Illinois courts, it is not surprising that attempts to assert the statutory privilege to defeat research subpoenas have failed.

In Andrews v. Eli Lilly & Co., Inc., 97 F.R.D. 494 (N.D. Ill. 1983), the district judge quashed a subpoena that sought production of records from research that was exploring the association between maternal use of diethylstilbestrol and daughters’ development of adenocarcinoma of the vagina. In granting the motion to quash, the district judge acknowledged that the Medical Studies Act protected the records from disclosure. Id. at 500. The party seeking discovery, argued that the Illinois statute was limited to hospital peer review.  The district court acknowledged that the purpose of the Act was to ensure confidentiality of the peer-review process, but that the “plain language” of the statute did not limit protected material to that used for peer review. Id. at 500 n.19. In any event, Andrews was stripped of any precedential force when it was vacated by the United States Court of Appeals.   Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1984).

In the Orthopedic Bone Screw MDL, plaintiffs sought research study documents from the Scoliosis Research Society. Invoking the Illinois Medical Studies Act, the Society moved for a protective order to prevent disclosure of the names of physicians and patients who participated in “The Pedicle Screw Cohort Study,” and the disclosure of documents from that study. In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1996 WL 34394351 (E.D. Pa. Feb. 14, 1996), app. dism’d, 94 F.3d 110 (3d Cir. 1996). The Society claimed that the Act provided an unconditional confidentiality for all data and related information underlying a “a medical study.” Id. at *2.

The MDL court denied the plaintiffs’ motion to enforce, but rejected the claim that the Act created a privilege that applied in the case. Id. at *3 (citing the predominant federal interest in determining whether a state court privilege applied, and the lack of Illinois interests in a choice of law analysis).

In another multi-district litigation, Pfizer sought peer reviewer and editorial comments from the Journal of the American Medical Association, on articles and manuscripts of studies involving its COX-2 inhibitor medications, Bextra and Celebrex.  In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., Case No. 08 C 402, 2008 U.S. Dist. LEXIS 21098; 2008 WL 4345158 (N.D. Ill. Mar. 14, 2008). The Journals asserted privileges, including a statutory privilege under the Illinois Medical Studies Act. Id. at *10-12. The federal district court ruled that the privilege appeared not to apply to manuscripts, articles, peer reviewer and editorial comments:

“The Medical Studies Act, 735 ILCS 5/8-2101, provides that [a]ll information, interviews, reports, statements, memoranda, recommendations, letters of reference or third party confidential assessments of a health care practitioner’s professional competence, or other data …  of allied medical societies . . . used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services . . . . 735 ILCS 5/8-2101. The purpose of the Act is to ‛ensure that members of the medical profession can maintain effective professional self-evaluation and to improve the quality of healthcare’.

To that end, the Act clearly protects from disclosure information gathered in the course of a peer review, but only if it is used in connection with a program or study designed to improve internal quality control or patient care, or to reduce morbidity and mortality. Putting aside the question of whether the Journals would qualify as ‛allied medical societies’, the Court is not persuaded that the specific information identified in the subpoenas fits within this definition. In her declaration, Dr. DeAngelis represented that JAMA ‛publishes scientific articles, commentaries, and news involving all fields of medicine, including medical research, significant clinical observations, diagnostic and therapeutic developments, legal and social matters of interest to  physicians, and issues of medical ethics’; JAMA’s motto, she said, is ‛to promote the science and art of medicine and the betterment of the public health’. DeAngelis Declaration, PP12-13. A lofty goal – but one that far transcends the provisions of the Medical Studies Act. The Act protects from disclosure documents only when ‛used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation’; surely not everything published in JAMA and AIM – or everything considered for publication – can fairly be described this way. And, on the limited record before it, the Court cannot say that all of the documents requested in the subpoenas can be either.”

Id. at *11-14.

Racette’s suggestion that the Illinois Medical Studies Act can provide guidance with respect to research subpoenas is wrong on the law, facts, and policy of the need for data sharing. The public, and its members, remain entitled to every man’s evidence. See Lord Hardwicke’s Speech on Lord Orford’s Bill (May 25, 1742), quoted in George Harris, The Life of Lord Chancellor Hardwicke; with Selections from His Correspondence, Diaries, Speeches, and Judgments, Vol. 2, at 8 (1847).

[1] See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006).

[2] See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005).  See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009).

[3] See, e.g., Jesse A Berlin, Sandra Morris, Frank Rockhold, Lisa Askie, Davina Ghersi, and Joanne Waldstreicher, “Bumps and bridges on the road to responsible sharing of clinical trial data,” 11 Clinical Trials 7 (2014); Rebecca Kush & Michel Goldman, “Fostering Responsible Data Sharing through Standards,” 370 New Engl. J. Med. 2163 (June 5, 2014); Jerome P. Reiter & Satkartar K. Kinney, “Sharing Confidential Data for Research Purposes: A Primer,” 22 Epidemiology 632 (2011).

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The Role of the “Science Lawyer” in Modern Litigation

July 27th, 2014

“For the rational study of the law the blackletter man may be the man of the present, but the man of the future is the man of statistics and the master of economics.”[1]

“Judges commonly are elderly men, and are more likely to hate at sight any analysis to which they are not accustomed, and which disturbs repose of mind … .”[2]

The emergence of complex scientific issues in post-World War II American litigation has challenged state and federal legal systems, both civil and criminal. Various issues, such as the validity of forensic science and biological causation, have tested the competency of lawyers, both judges and counsel. This scientific complexity also questions whether lay juries can or should be continued in their traditional role as fact finders[3].  Some commentators have suggested that complexity should be a basis for reallocating fact finding to judges.[4] Other commentators remain ideologically or constitutionally committed to the jury as fact finder.

The superiority of judges as fact finders in complex scientific cases remains to be shown. Clearly juries often perform better than individual lay judges as scientific fact finders, but their time commitment is inadequate.  Furthermore, the jury decision process is typically a binary decision without any articulation of reasoning.  The jury’s hidden reasoning process on important scientific issues violates basic tenets of transparency and due process.  Many modern cases present such difficult scientific issues that some authors have argued that we should establish scientific courts or institute procedures for blue-ribbon juries[5].  The constitutionality of having scientists, or specially qualified judges, serve as fact finders has never been clearly addressed.[6]  Other commentators have argued in favor of the existing set of judicial tools, such as appointment of testifying “neutral” expert witnesses and scientific advisors for trial judges.[7] These approaches have been generally available in federal and some state trial courts, but they have rarely been used.  Some examples of their deployment include the silicone gel breast implant litigation[8], and cases involving Parlodel[9] and Bendectin[10].

Over 20 years ago, in 1993, the United States Supreme Court handed down its Daubert decision.  In large measure, the Court’s insistence upon trial court gatekeeping of expert witnesses has obscured the discussion and debate about science courts and alternative procedures for addressing complex scientific issues in litigation.  With fear and trembling, and sometimes sickness not quite unto death, federal and state judges, and lawyers on both sides of the “v,” must now do more than attack, defend, and evaluate expert witnesses on simplistic surrogates for the truth, such as personal bias or qualifications.  Lord have mercy, judges and lawyers must now actually read and analyze the bases of expert witnesses’ opinions, assess validity of studies and conclusions, and present their challenges and evaluations in clear, non-technical language.

The notion that “law is an empty vessel” is an imperfect metaphor, but it serves to emphasize that lawyers may have to get their hands wet with vessel’s contents, now and then.  In litigating scientific issues, lawyers and judges will necessarily have to engage with substantive matters.  Lawyers without scientific training or aptitude are not likely to serve clients, whether plaintiffs or defendants, well in the post-Daubert litigation world.  Untrained lawyers will choose the wrong theory, emphasize the wrong evidence, and advance the wrong conclusions.  The stakes are higher now for all the players.  An improvident claim or defense will become a blot on a lawyer’s escutcheon.  A poor gatekeeping effort or judicial decision[11] can embarrass the entire judicial system[12].

Over a decade ago, Professor David Faigman asked whether science was different for lawyers.  Professor Faigman emphatically answered his own question in the negative, and urged lawyers and courts to evolve from their pre-scientific world view.[13] Both lawyers and judges must learn about the culture, process, and content of science.  Science is often idealized as a cooperative endeavor, when in fact, much scientific work can be quite adversarial.[14]Some judges and commentators have argued that the scientific enterprise should be immune from the rough and tumble of legal discovery because the essential collaborative nature of science is threatened by the adversarial interests at play in litigation.  In becoming better judges of science, judges (and lawyers) need to develop a sense of the history of science, with its findings, fanaticisms, feuds, and fraud. The good, bad, and the ugly are all the proper subject for study. Professor George Olah, in accepting his Nobel Prize in Chemistry, rebutted the lofty sentiments about scientific collegiality and collaboration[15]:

“Intensive, critical studies of a controversial topic always help to eliminate the possibility of any errors. One of my favorite quotation is that by George von Bekessy (Nobel Prize in Medicine, 1961).

‘[One] way of dealing with errors is to have friends who are willing to spend the time necessary to carry out a critical examination of the experimental design beforehand and the results after the experiments have been completed. An even better way is to have an enemy. An enemy is willing to devote a vast amount of time and brain power to ferreting out errors both large and small, and this without any compensation. The trouble is that really capable enemies are scarce; most of them are only ordinary. Another trouble with enemies is that they sometimes develop into friends and lose a good deal of their zeal. It was in this way the writer lost his three best enemies. Everyone, not just scientists, needs a few good enemies!’”

In other words, peer review is a shabby substitute for cross-examination and an adversarial process.[16]  That adversarial process cannot always unfold fully and fairly in front of a jury.

Chief Justice Rehnquist no doubt spoke for most judges and lawyers in expressing his discomfort with the notion that courts would have to actually look at science (rather than qualifications, demeanor, and credibility)[17]:

“I defer to no one in my confidence in federal judges; but I am at a loss to know what is meant when it is said that the scientific status of a theory depends on its ‘falsifiability’, and I suspect some of them will be, too.”

Before the Daubert decision, some commentators opined that judges and lawyers were simply too innumerate and too dull to be involved in litigating scientific issues[18]. Today, most federal judges at least would not wear their ignorance so proudly, largely because of the efforts of the Federal Judicial Center, and its many educational efforts.  Judges (and lawyers) cannot and should not be scientific or statistically illiterate[19].  If generalist judges think this is beyond their ken, then they should have the intellectual integrity to say so, and get out of the way.  If the scientific tasks are beyond the ken of judges, then they are likely beyond the abilities of ordinary jurors as well, and we should start to think seriously once again about science courts and blue-ribbon juries.

Astute and diligent gatekeeping judges and qualified juries can get the job done[20]. Certainly, some judges have seen through expert witnesses’ evasions and errors in reasoning, and lawyers’ shystering on both sides of litigation.  Evaluating scientific evidence and drawing inferences from scientific studies do require understanding of basic statistical concepts, study design, and scientific apparatus, but at the bottom, there is no esoteric “scientific method” that is not careful and skeptical reasoning about evidence in the context of all the facts.[21]  Surely, judges with university educations, “20 years of schooling,” and at least 10 years of exemplary professional practice should, in theory, be able to get the job done, even if a few judges are unqualified or ill suited by aptitude or training. To take an example from the breast implant litigation, understanding a claim about immunology may well require some depth in what the immune system is, how it works, and how it may be altered.  This understanding will require time, diligence, intellectual energy, and acumen.  Surely, ordinary lay juries often do not have the time to devote to such a case to do justice to the issues. If judges do not have the interest or the time to render the required service, they should say so.

And what about lawyers?  Twenty years into the Daubert era is time enough for law schools to implement curriculum to train lawyers to understand and to litigate scientific issues, in civil, criminal, and regulatory contexts.  Many law schools still fail to turn out graduates with basic competence to understand and advocate about scientific issues.[22]  Lawyers who want to litigate scientific issues owe their clients and themselves the commitment to understand the issues.  It has been a long time since C.P. Snow complained of the “two cultures,” science and the humanities, and the hostility he faced when he challenged colleagues about their ignorance of science.[23]  Law schools have a role in building a bridge between the two cultures of science and the humanities. Just as tax programs in law schools require basic accounting, law schools should ensure that their graduates, destined to work on scientific litigation, legislation, and regulation, have had some education in statistics, probability, and scientific method.

Becoming or remaining scientific literate is a daunting but essential task for busy lawyers who hope to serve clients well in technical litigation.  There are many resources available for the “scientific legal counselor.”  Dr. David Schwartz at Innovative Science Solutions LLC has published a resource guide, The Litigator’s Guide to Combating Junk Science, available at his firm’s website.[24] Sense About Science, a charitable trust, has worked hard to advance an evidence-based world view, and to help people, including lawyers, make sense of scientific and medical claims.  Its website offers some helpful publications,[25] one of the more interesting being its recent pamphlet, Making Sense of Uncertainty.[26]

The Sense About Science group’s annual lectures are important events, which have featured lectures by:

  • Dr Fiona Godlee, the editor of the British Medical Journal, on “It’s time to stand up for science once more,” in 2010.[27]
  • Dr Olivia Judson, scientist and science journalist, on “Why Experiment?” in 2009.[28]
  • Professor Alan Sokal, quantum physicist and famous perpetrator of the Sokal hoax[29] that helped deconstruct the post-modernist deconstructionists, on “What is Science and Why Should We Care?” in 2008.[30]
  • Sir John Krebs FRS, discoverer of the Krebs cycle, on “Science Advice, Impartiality and Policy,” in 2006.[31]

In addition to keeping abreast of scientific developments, science lawyers need to understand both how science is “made,” and how it goes bad.  The National Institutes of Health website has many resources about the grant process.  Science lawyers should understand the grant process and how to use the Freedom of Information Act to obtain information about research at all stages of development.  Contrary to the fairy-tale accounts of idealized science, the scientific research process goes astray with some frequency, so much so that there is a federal agency, the Office of Research Integrity (ORI) tasked with investigating research misconduct. News of the ORI’s investigations, and findings, is readily available through its website and its informative blog.[32] Research misconduct has resulted in an ever-increasing rate of retractions in peer-reviewed journals.  The Retraction Watch[33] blog offers a fascinating window into the inadequacies of peer review, and the attempts, some successful, some not, of the scientific community to police itself.

Before Daubert was decided, the legal system emphasized credentials and qualifications of witnesses, “authoritative texts,” and general acceptance.  Science, however, is built upon an evidence-based foundation.  Since 1663, the Royal Society has sported the motto:  “Nullius in verba”: on no person’s authority.  When confronted with a pamphlet entitled “100 Authors against Einstein,” Albert Einstein quipped “if I were wrong, one would have been enough.”[34]  Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the prestige of the speaker.  The shift from authority-based decision making to evidence-based inferences and conclusions has strained the legal system in the United States, where people are free to propagate cults and superstitions.  The notion that lawyers who spend most of their time litigating leveraged boxcar leases can appreciate the nuances, strengths, weaknesses, and flaws of scientific studies and causal inference is misguided.  Litigants, whether those who make claims or those who defend claims, deserve legal counsel who are conversant with the language of their issues.  Law schools, courts, and bar associations must rise to the occasion to meet the social need.

[1] Oliver Wendell Holmes, Jr., “The Path of the Law,” 10 Harv. L. Rev. 457, 469 (1897)

[2] Oliver Wendell Holmes, Jr., Collected Legal Papers 230 (1921).

[3] An earlier version of this post appeared as a paper in David M. Cohen & Nathan A. Schachtman, eds., Daubert Practice 2013: How to Avoid Getting Sliced by Cutting-Edge Developments in Expert Witness Challenges (PLI 2013).

[4] See Ross v. Bernhard, 396 U.S. 531, 538 n.l0 (1970) (suggesting that the right to a jury trial may be limited by considerations of complexity, and that practical abilities and limitations of juries are a factor in determining whether an issue is to be decided by the judge or the jury).  See also Note, “The Right to a Jury Trial in Complex Civil litigation,” 92 Harv. L. Rev. 898 (1979) (considering the implications of footnote 10 in Ross for complex litigation; noting that the Ross test has been applied infrequently, and in the limited contexts of antitrust or securities cases); Peter Huber, “Comment, A Comment on Toward Incentive-Based Procedure: Three Approaches for Regulating Scientific Evidence by E. Donald Elliott,” 69 Boston Univ. L. Rev. 513, 514 (1989) (arguing that judges cannot make difficult scientific judgments).  See also George K. Chamberlin, “Annotation: Complexity of Civil Action as Affecting Seventh Amendment Right to Trial by Jury,” 54 A.L.R. FED. 733, 737-44 (1981).

[5] James A. Martin, “The Proposed Science Court,” 75 Mich. L. Rev. 1058, 1058-91 (1977) (evaluating the need and feasibility of various proposals for establishing science courts); Troyen A. Brennan, “Helping Courts with Toxic Torts,” 51 U. Pitt. L. Rev. 1, 5 (1989) (arguing for administrative panels or boards to assist courts with scientific issues); Donald Elliott, “Toward Incentive-Based Procedure: Three Approaches for Regulating Scientific Evidence,” 69 Boston Univ. L. Rev. 487, 501-07 (1989) (discussing various models of ancilliary peer review for courts); Paul K. Sidorenko, “Comment, Evidentiary Dilemmas in Establishing Causation: Are Courts Capable of Adjudicating Toxic Torts?” 7 Cooley L. Rev. 441, 442 (1990) (recommending administrative panels of scientific experts in toxic tort litigation); John W. Osborne, “Judicial Technical Assessment of Novel Scientific Evidence,” 1990 U. Ill. L. Rev. 497, 540-46 (arguing for procedures with specially qualified judges); Edward V. DiLello, “Note, Fighting Fire with Firefighters: A Proposal for Expert Judges at the Trial Level,” 93 Colum. L. Rev. 473, 473 (1993) (advocating establishment of specialist judicial assistants for judges).  For a bibliography of publications on the science court concept, see Jon R. Cavicchi, “The Science Court: A Bibliography” (1994) <http://ipmall.info/risk/vol4/spring/bibliography.htm>, last visited on July 27, 2014.

[6] See Ross v. Bernhard, 396 U.S. at 538 n.l0.

[7] John W. Wesley, “Scientific Evidence and the Question of Judicial Capacity,” 25 William & Mary L. Rev. 675, 702-03 (1984).

[8] See Karen Butler Reisinger, “Expert Panels: A Comparison of Two Models,” 32 Indiana L.J. 225 (1998); Laural L. Hooper, Joe S. Cecil & Thomas E. Willging, Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation, (Federal Judicial Center 2001), available at http://www.fjc.gov/public/pdf.nsf/lookup/neuscipa.pdf/$file/neuscipa.pdf

[9] Soldo v. Sandoz Pharms. Corp., 244 F. Supp. 2d 434 (W.D. Pa. 2003); see also Joe S. Cecil, “Construing Science in the Quest for Ipse Dixit,” 33 Seton Hall L. Rev. 967 (2003).

[10] DePyper v. Navarro, No. 191949, 1998 WL 1988927 (Mich. Ct. App. Nov. 6, 1998)

[11] See, e.g., Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986).

[12] See, e.g., James L. Mills and Duane Alexander, “Teratogens and ‘Litogens’,” 15 New Engl. J. Med. 1234 (1986); Samuel R. Gross, “Expert Evidence,” 1991 Wis. L. Rev. 1113, 1121-24 (1991) (“Unfortunately, Judge Shoob’s decision is absolutely wrong. There is no scientifically credible evidence that Ortho-Gynol Contraceptive Jelly ever causes birth defects.”). See also Editorial, “Federal Judges v. Science,” N.Y. Times, December 27, 1986, at A22 (unsigned editorial);  David E. Bernstein, “Junk Science in the Courtroom,” Wall St. J. at A 15 (Mar. 24,1993) (pointing to Wells as a prominent example of how the federal judiciary had embarrassed American judicial system with its careless, non-evidence based approach to scientific evidence); Bert Black, Francisco J. Ayala & Carol Saffran-Brinks, “Science and the Law in the Wake of Daubert: A New Search for Scientific Knowledge,” 72 Texas L. Rev. 715, 733-34 (1994) (lawyers and leading scientist noting that the district judge “found that the scientific studies relied upon by the plaintiffs’ expert were inconclusive, but nonetheless held his testimony sufficient to support a plaintiffs’ verdict. *** [T]he court explicitly based its decision on the demeanor, tone, motives, biases, and interests that might have influenced each expert’s opinion. Scientific validity apparently did not matter at all.”) (internal citations omitted); Troyen A. Brennan, “Untangling Causation Issues in Law and Medicine: Hazardous Substance Litigation,” 107 Ann. Intern. Med. 741, 744-45 (1987) (describing the result in Wells as arising from the difficulties created by the Ferebee case; “[t]he Wells case can be characterized as the court embracing the hypothesis when the epidemiologic study fails to show any effect”).  Kenneth R. Foster, David E. Bernstein, and Peter W. Huber, eds., Phantom Risk: Scientific Inference and the Law 28-29, 138-39 (MIT Press 1993) (criticizing Wells decision); Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation § 6.5, at 93 (1997) (noting the multiple comparisons in studies of birth defects among women who used spermicides, based upon the many reported categories of birth malformations, and the large potential for even more unreported categories); id. at § 6.5 n.3, at 271 (characterizing Wells as “notorious,” and noting that the case became a “lightning rod for the legal system’s ability to handle expert evidence.”).

[13] David L. Faigman, “Is Science Different for Lawyers?” 297 Science 339, 340 (2002) (“some courts are still in a prescientific age”).

[14] McMillan v. Togus Reg’l Office, 294 F. Supp. 2d 305, 317 (E.D.N.Y. 2003) (“As in political controversy, ‘science is, above all, an adversary process’.”) (internal citation omitted).

[15] George A. Olah, “My Search for Carbocations and Their Role in Chemistry,” Nobel Lecture (Dec. 8, 1994), quoting George von Békésy, Experiments in Hearing 8 (N.Y. 1960).

[16] Nietzsche expressed Olah’s sentiment more succinctly.  Friedrich Nietzsche, The Twilight of the Idols Maxim 8 (1899) (“Out of life’s school of war: What does not destroy me, makes me stronger.”).

[17] Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 598 (1993) (Justice Rehnquist, C.J., concurring and dissenting).

[18] Joseph Nicol, “Symposium on Science and the Rules of Evidence,” 99 F.R.D. 188, 221 (1983) (claiming that lawyers and judges are “simply are incapable by education, and all too often by inclination, to become sufficiently familiar with scientific evidence to discharge their responsibilities toward the administration of justice.”)

[19] Robert P. Merges, “The Nature and Necessity of Law and Science,” 381 Leg. Educ. 315, 324-26 (1988) (arguing that lawyers can and should understand scientific concepts and issues)

[20] David L. Faigman, “To Have and Have Not: Assessing the Value of Social Science to the Law as Science and Policy,” 38 Emory L.J. 1005, 1014, 1030 (1989) (contending that judges can understand science and that lawyers must probe beyond conclusions into methods by which the conclusions were reached).

[21] David H. Kaye, “Proof in Law and Science,” 32 Jurimetrics J. 313, 318 (1992) (arguing that science and law share identical methods of establishing factual conclusions); Lee Loevinger, “Standards of Proof in Science and Law,” 32 Jurimetrics J. 323, 328 (1992) (“[T]he basic principles of reasoning or logic are no different in the field of law than science.”).

[22] Howell E. Jackson, “Analytical Methods for Lawyers,” 53 J. Legal Educ. 321 (2003); Steven B. Dow, “There’s Madness in the Method:  A Commentary on Law, Statistics, and the Nature of Legal Education,” 57 Okla. L. Rev. 579 (2004).

[23] C.P. Snow, The Rede Lecture 1959.

[24] Available with registration at http://www.innovativescience.net/complimentary-copy-of-our-junk-science-ebook/

[25]http://www.senseaboutscience.org/

[26] http://www.senseaboutscience.org/resources.php/127/making-sense-of-uncertainty

[27] http://www.senseaboutscience.org/pages/annual-lecture-2010.html

[28] http://www.senseaboutscience.org/pages/annual-lecture-2009.html

[29] Sokal’s famous parody of postmodern writers, the so-called “‘Sokal Hoax,” was his publication in one of the postmodernists’ own journals on how gravity was nothing more than a social construct.  Alan D. Sokal, “Transgressing the Boundaries: Towards a Transformative Hermeneutics of Quantum Gravity,” Social Text 217 (Nos. 46/47 1996) (“It has thus become increasingly apparent that physical ‘reality’, no less than social ‘reality’, is at bottom a social and linguistic construct; that scientific ‘knowledge’, far from being objective, reflects and encodes the dominant ideologies and power relations of the culture that produced it; that the truth claims of science are inherently theory-laden and self-referential; and consequently, that the discourse of the scientific community, for all its undeniable value, cannot assert a privileged epistemological status with respect to counter-hegemonic narratives emanating from dissident or marginalized communities.”)

[30] http://www.senseaboutscience.org/pages/annual-lecture-2008.html

[31] http://www.senseaboutscience.org/pages/annual-lecture-2006.htm

[32] http://ori.hhs.gov/blog/

[33] http://retractionwatch.wordpress.com/

[34] See Remigio Russo, 18 Mathematical Problems in Elasticity 125 (1996) (quoting Einstein).

Posted in Scientific Evidence | Comments Off on The Role of the “Science Lawyer” in Modern Litigation

Conflict of Interest Regulations Apply Symmetrically

July 25th, 2014

Last week, a federal judge ruled that working as a plaintiffs’ expert witness in tobacco litigation or as consultants for pharmaceutical companies with tobacco-cessation medications was a conflict of interest, which invalidated a FDA report on menthol cigarettes. Lorillard Inc. et al. v. U.S. Food and Drug Administration, 1:11-cv-00440, D.D.C. (July 21, 2014).

The report was issued in 2011 by the agency’s Tobacco Products Scientific Advisory Committee (TPSAC).  Two tobacco companies sought an injunction against the FDA’s report because of the improper memberships on the TPSAC of Drs. Jonathan Samet and Neil Benowitz. Lorillard’s General Counsel also challenged agency pronouncements under the Data Quality Act.  Letter Request for Correction of Information Disseminated to the Public and the Tobacco Products Scientific Advisory Committee (March 16, 2011) (petition lodged under the Data Quality Act (DQA), 44 U.S.C. § 3516, and the related agency regulations of the Office of Management and Budget, Health and Human Services, and FDA).

Although the TPSAC report concluded that menthol cigarettes imparted no greater risk of lung cancer than the already deadly non-menthol cigarettes, the report claimed that studies show menthol flavoring increased usage among young people and African Americans.  The TPSAC recommended a ban on menthol cigarettes in the interest of public health. The district court held that the FDA’s decision that the disputed members had no conflict of interest violated the Administrative Procedures Act, and that the violation required the agency to reconstitute the TPSAC in compliance with the applicable ethics regulations.

What is remarkable about the case is its rejection of the delusion that advocacy for plaintiffs is not a potential conflict of interest, whereas advocacy for a company is.  An amicus brief filed on behalf of several medical and public health groups, including Public Citizen, Inc., American Cancer Society, American Medical Association, American Thoracic Society, and others, supported the agency’s motion to dismiss. Amici argued that balancing scientific opinions of experts on the committee would impair the integrity of advisory committees and would be unmanageable for courts. Given the obvious adversarial bias from service as an expert witness in tobacco litigation, the district court rejected amici’s arguments. Although amici’s position is understandable as a reaction to the callousness of tobacco marketing, the brief’s indifference to the ethical implications about conflicts of interest is surprising.  One can only imagine the hue and cry if there had been committee members who had been engaged as expert witnesses for the tobacco companies.

The implications of the Lorillard decision are considerable, especially for FDA advisory committees. See Glenn Lammi, “FDA Advisory Committee Not Rife with Conflicts of Interest? — ‛Please!’ Quips Federal Judge” (July 24, 2014) (discussing Lorillard case and detailing efforts to obtain FDA compliance with the Federal Advisory Committee Act). Industry representatives are typically non-voting members, but members who have been retained by the litigation industry have served in voting positions. In other contexts, expert witnesses for plaintiffs accuse scientists who testify for a defendant of “conflicts of interest,” but conveniently ignore and fail to disclose their own. See “More Hypocrisy Over Conflicts of Interest” (Dec. 4, 2010) (Arthur Frank, Richard Lemen, and Barry Castleman); James Coyne, “Lessons in Conflict of Interest: The Construction of the Martyrdom of David Healy and The Dilemma of Bioethics,” 5 Am. J. Bioethics W3 (2005). The Lorillard case teaches that “white hat” bias is as disqualifying as “black hat” bias.

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Subgroups — Subpar Statistical Practice versus Fraud

July 24th, 2014

Several people have asked me why I do not enable comments on this blog.  Although some bloggers (e.g., Deborah Mayo’s Error Statistics site) have had great success in generating interesting and important discussions, I have seen too much spam on other websites, and I want to avoid having to police the untoward posts.  Still, I welcome comments and I try to respond to helpful criticism.  If and when I am wrong, I will gladly eat my words, which usually have been quite digestible.

Probably none of the posts here have generated more comments and criticisms than those written about the prosecution of Dr. Harkonen.  In general, critics have argued that defending Harkonen and his press release was tantamount to condoning bad statistical practice.  I have tried to show that Dr. Harkonen’s press release was much more revealing than it was portrayed in abbreviated accounts of his case, and the evidentiary support for his claim of efficacy in a subgroup was deeper and broader than acknowledged. The criticism and condemnation of Dr. Harkonen’s press release in the face of prevalent statistical practice, among leading journals and practitioners, is nothing short of hypocrisy and bad faith. If Dr. Harkonen deserves prison time for a press release, which promised a full analysis and discussion in upcoming conference calls and presentations at scientific meetings, then we can only imagine what criminal sanction awaits the scientists and journal editors who publish purportedly definitive accounts of clinical trials and epidemiologic studies, with subgroup analyses not prespecified and not labeled as post-hoc.

The prevalence of the practice does not transform Dr. Harkonen’s press release into “best practice,” but some allowance must be made for offering a causal opinion in the informal context of a press release rather than in a manuscript for submission to a journal.  And those critics, with prosecutorial temperaments, must recognize that, when the study was presented at conferences, and when manuscript was written up and submitted to the New England Journal of Medicine, the authors did reveal the ad hoc nature of the subgroup.

The Harkonen case will remain important for several reasons. There is an important distinction in the Harkonen case, ignored and violated by the government’s position, between opinion and fact.  If Harkonen is guilty of Wire Fraud, then so are virtually every cleric, minister, priest, rabbi, imam, mullah, and other religious person who makes supernatural claims and predictions.  Add in all politicians, homeopaths, vaccine deniers, and others who reject evidence for superstition, who are much more culpable than a scientist who accurately reports the actual data and p-value.

Then there is the disconnect between what expert witnesses are permitted to say and what resulted in Dr. Harkonen’s conviction. If any good could come from the government’s win, it would be the insistence upon “best practice” for gatekeeping of expert witness opinion testimony.

For better or worse, scientists often describe post-hoc subgroup findings as “demonstrated” effects. Although some scientists would disagree with this reporting, the practice is prevalent.  Some scientists would go further and contest the claim that pre-specified hypotheses are inherently more reliable than post-hoc hypotheses. See Timothy Lash & Jan Vandenbroucke, “Should Preregistration of Epidemiologic Study Protocols Become Compulsory?,” 23 Epidemiology 184 (2012).

One survey compared grant applications with later published papers and found that subgroup analyses were pre-specified in only a minority of cases; in a substantial majority (77%) of the subgroup analyses in the published papers, the analyses were not characterized as either pre-specified or post hoc. Chantal W. B. Boonacker, Arno W. Hoes, Karen van Liere-Visser, Anne G. M. Schilder, and Maroeska M. Rovers, “A Comparison of Subgroup Analyses in Grant

Applications and Publications,” 174 Am. J. Epidem. 291, 291 (2011).  Indeed, this survey’s comparison between grant applications and published papers revealed that most of the published subgroup analyses were post hoc, and that the authors of the published papers rarely reported justifications for their post-hoc subgroup. Id.

Again, for better or worse, the practice of presenting unplanned subgroup analyses, is common in the biomedical literature. Several years ago, the New England Journal of Medicine reported a survey of publication practice in its own pages, with findings similar to those of Boonacker and colleagues. Rui Wang, Stephen W. Lagakos, James H. Ware, David J. Hunter, and Jeffrey M. Drazen, “Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials,” 357 New Eng. J. Med. 2189 (2007).  In general, Wang, et al.,  were unable to determine the total number of subgroup analyses performed; and in the majority (68%) of trials discussed, Wang could not determine whether the subgroup analyses were prespecified. Id. at 2912. Although Wang proposed guidelines for identifying subgroup analyses as prespecified or post-hoc, she emphasized that the proposals were not “rules” that could be rigidly prescribed. Id. at 2194.

The Wang study is hardly unique; the Journal of the American Medical Association reported a similar set of results. An-Wen Chan, Asbjørn Hrobjartsson, Mette T. Haahr, Peter C. Gøtzsche, and Douglas G. Altman, “Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials Comparison of Protocols to Published Articles,” 291 J. Am. Med. Ass’n 2457 (2004).  Chan and colleagues set out to document and analyze “outcome reporting bias” in studies; that is, the extent to which publications fail to report accurately the pre-specified outcomes in published studies of randomized clinical trials.  The authors compared and analyzed protocols and published reports of randomized clinical trials conducted in Denmark in 1994 and 1995. Their findings document a large discrepancy between idealized notion of pre-specification of study design, outcomes, and analyses, and the actual practice revealed by later publication.

Chan identified 102 clinical trials, with 3,736 outcomes, and found that 50% of efficacy, and 65% of harm outcomes were incompletely reported. There was a statistically significant risk of statistically significant outcomes to be fully reported compared with statistically insignificant results. (pooled odds ratio for efficacy outcomes = 2.4; 95% confidence interval, 1.4 – 4.0, and pooled odds ratio for harm outcomes = 4.7; 95% confidence interval, 1.8 -12.0. Their comparison of protocols with later published articles revealed that a majority of trials (62%) had at least one primary outcome that was changed, omitted, or innovated in the published version. The authors concluded that published accounts of clinical trials were frequently incomplete, biased, and inconsistent with protocols.

This week, an international group of scientists published their analysis of agreement vel non between protocols and corresponding later publications of randomized clinical trials. Matthias Briel, DISCO study group, “Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications,” 349 Brit. Med. J. g4539 (Published 16 July 2014). Predictably, the authors found a good deal of sloppy practice, or worse.  Of the 515 journal articles identified, about half (246 or 47.8%) reported one or more subgroup analysis. Of the articles that reported subgroup analyses, 81 (32.9%) publications stated that the subgroup analyses were prespecified, but in 28 of these articles (34.6%), the corresponding protocols did not identify the subgroup analysis.

In 86 of the publications surveyed, the authors found that the articles claimed a subgroup “effect,” but only 36 of the corresponding protocols reported a planned subgroup analysis.  Briel and the DISCO study group concluded that protocols of randomized clinical trials insufficiently describe subgroup analyses. In over one-third of publications, the articles reported subgroup analyses not pre-specified in earlier protocols. The DISCO study group called for access to protocols and statistical analysis plans for all randomized clinical trials.

In view of these empirical data, the government’s claims against Dr. Harkonen stand out, at best, as vindictive, selective prosecution.

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Careless Scholarship About Silica History

July 21st, 2014

David Egilman is the Editor in Chief of the International Journal of Occupational and Environmental Health (IJOEH). A YouTube “selfie” interview provides some insight into Dr. Egilman’s motivations and editorial agenda.  Previous posts have chronicled Egilman’s testimonial adventures because of his propensity to surface in litigations of interest. See, e.g., “David Egilman’s Methodology for Divining Causation” (Sept. 6, 2012); “Egilman Petitions the Supreme Court for Review of His Own Exclusion in Newkirk v. Conagra Foods” (Dec. 13, 2012).

Dr. Egilman has used his editorial role at the IJOEH to disseminate his litigation positions.  Several of his articles are little more than his litigation reports, filed in various cases, ranging from occupational dust disease claims to pharmaceutical off-target effect claims. A recent issue of the IJOEH has yet another article of this ilk, which scatters invective across several litigations. David Egilman, Tess Bird[1], and Caroline Lee[2], “Dust diseases and the legacy of corporate manipulation of science and law, 20 Internat’l J. Occup. & Envt’l Health 115 (2014).

The article mostly concerns Egilman’s allegations that companies influenced the scientific, medical, and governmental understanding and perception of asbestos hazards.  I will defer to others to address his allegations with respect to asbestos. The article, however, in its Abstract, takes broader aim at other exposures, in particular, silica:

“Knowledge that asbestos and silica were hazardous to health became public several decades after the industry knew of the health concerns. This delay was largely influenced by the interests of Metropolitan Life Insurance Company (MetLife) and other asbestos mining and product manufacturing companies.”

Egilman at 115, Abstract (emphasis added).

In their Abstract, the authors further proclaim their purpose

“To understand the ongoing corporate influence on the science and politics of asbestos and silica exposure, including litigation defense strategies related to historical manipulation of science.”

Egilman at 115. I demur for the time being with respect to asbestos, but the authors’ claims about silica are never supported in their article. A brief review of two monographs by Frederick L. Hoffman should be sufficient to condemn the authors’ carelessness to the dustbin of occupational history. Frederick L. Hoffman, Mortality from Respiratory Diseases in the Dusty Trades; Dep’t of Labor, Bureau of Labor Statistics (1918); The Problem of Dust Phthisis in the Granite Stone Industry; Dep’t of Labor, Bureau of Labor Statistics (1922).  The bibliographies in both these monographs documents the widespread interest in, and awareness of, the occupational hazards of silica dusts, going back into the 19th century, among the media, the labor movement, and the non-industrial scientific community.

Not surprisingly, the authors’ conclusions are stated only in terms of asbestos hazards, knowledge, and company conduct:

“Conclusions: Asbestos product companies would like the public to believe that there was a legitimate debate surrounding the dangers of asbestos during the twentieth century, particularly regarding the link to cancer, which delayed adequate regulation. The asbestos–cancer link was not a legitimate contestation of science; rather the companies directly manipulated the scientific literature. There is evidence that industry manipulation of scientific literature remains a continuing problem today, resulting in inadequate regulation and compensation and perpetuating otherwise preventable worker and consumer injuries and deaths.”

The authors note that Rutherford Johnstone’s 1960 “seminal” textbook relied upon a study (Braun and Truan), which study Egilman attacks as corrupted by industry influence. Rutherford Johnstone & Seward E. Miller, Occupational Diseases and Industrial Medicine 328 (Philadelphia 1960). According to the Egilman, Rutherford Johnstone was the official American Medical Asociation’s consultant for occupational disease questions, which explains why he was providing answers to questions submitted to the Journal of the American Medical Association, on silica and asbestos issues. The authors note that Johnstone, in 1961, asserted that there was no epidemiologic evidence that asbestos causes lung cancer among American workers, which view reflects Johnstone’s reliance upon the Braun-Truan study. The authors fail, however, to note that Johnstone also opined that

“There is no epidemiological evidence that silicosis, resulting from undue exposure to free silica produces cancer of the lung.”

Rutherford T. Johnstone, “Silicosis and Cancer,” 176 J. Am. Med. Ass’n 81, 81 (1961). Neither the authors nor anyone else has ever shown that Johnstone was misled by any industry group with respect to his silica/lung cancer opinion.

Some of the Egilman’s scholarship is quite careless.  For instance, he, along with his employees, assert that

“By the mid 1940s, the international scientific community had recognized the link between asbestos and cancer.10–18”

Readers should review all the endnotes, 10 – 18, but endnote 12 is especially interesting:

“12 Macklin MT, Macklin CC. Does chronic irritation cause primary carcinoma of the human lung? Arch Path. 1940;30:924–55.”

As I have noted before, the Macklins, and especially Dr. Madge Macklin, brought a great deal of rigor and skepticism to broad claims about the causation of lung cancer. See “Silicosis, Lung Cancer, and Evidence-Based Medicine in North America” (July 4, 2014).  This citation and others do not appear to support the sweep of Egilman and his student authors’ claim.

The next mention of silica occurs in the context of an allegation that corporations (presumably not plaintiffs’ lawyers’ law firm corporations) have worked to “disguise” health concerns and influence governmental policy about several products, materials, including silica:

“During the last several decades, researchers in a wide spectrum of fields have documented the direct and purposeful efforts of corporations to disguise public health concerns and affect government policies, particularly in the tobacco, alcohol, silica, and asbestos industries, and more recently, the pharmaceutical, chemical, and ultra-processed food and drink industries.79,73”

Egilman at 121.

The authors’ citations, however, do not support any such allegation about silica. Endnote 73[3] is an article by Egilman, and others, on Vioxx; and endnote 79[4] is an article about alcohol, tobacco, and foods. In the very next sentence, the authors further claim that:

“Corporate-funded ‘objective science’ leading to the corruption of scientific literature remains a major problem.65,68,69,71,73,75,80–86”

Once again, none of the endnotes (65, 68, 69, 71, 75, and 80-86) supports the authors’ claim that anyone in the mining, milling, or marketing of crystalline silica has funded science in a way that led to the corruption of the scientific literature. Not surprisingly, the authors ignore the frauds perpetuated by litigation industry players. See, e.g., In re Silica Products Liab. Lit., 398 F. Supp. 2d 563 (S.D. Tex. 2005) (federal trial judge rebukes the litigation industry for fraudulent claiming in MDL 1553).

[1] The article acknowledges that Ms. Bird and Ms. Lee were employees of Dr. Egilman.  Ms. Bird appears now to be a student in the U.K., studying medical anthropology.  Ms. Bird, and Ms. Lee, appeared on earlier works by Egilman.  See, e.g., David S Egilman, Tess Bird, and Caroline Lee, “MetLife and its corporate allies: dust diseases and the manipulation of science,” 19 Internat’l J. Occup. & Envt’l Health 287 (2013); David Steven Egilman, Emily Laura Ardolino, Samantha Howe, and Tess Bird, “Deconstructing a state-of-the-art review of the asbestos brake industry,” 21 New Solutions 545 (2011).

[2] Ms. Lee appears to have been employed for Egilman’s litigation consulting firm, Never Again Consulting, from 2011 until August 2013, when she entered the University of Maryland law school.

[3] Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx. Br Med J. 2007;334(7585):120–3.

[4] Moodie R, Stuckler D, Montiero C, Sheron N, Neal B, Thamarangsi T, et al. Profits and pandemics: prevention of harmful effects of tobacco, alcohol, and ultra-processed food and drink industries. Lancet. 2013;381:670–79.

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Discovery of Litigation Financing – The Jackpot Justice Finance Corporation

July 16th, 2014

Over two years ago, I wrote that courts and counsel have not done enough to adapt to the litigation industry’s use of third-party financing. See “Litigation Funding” (May 8, 2012). A few days ago, Byron Stier, at the Mass Tort Litigation Blog, posted a short news item about a recent effort to modify discovery rules to take into account the litigation industry’s business model of seeking third-party litigation funding.  See “Industry Groups Seek Amendment of Rule 26 to Require Disclosure of Third Party Litigation Financing” (July 13, 2014).

Stier reported that the U.S. Chamber of Commerce Institute for Legal Reform, American Insurance Association, American Tort Reform Association, Lawyers for Civil Justice, and National Association of Manufacturers, back in April 2014, wrote a letter to the Committee on Rules of Practice and Procedure of the Administrative Office of the federal courts, to propose an amendment to Federal Rule of Civil Procedure 26(a)(1)(A). Their proposed new language is underscored, and follows 26(a)(1)(A)(i)-(iv):

“(v) for inspection and copying as under Rule 34, any agreement under which any person, other than an attorney permitted to charge a contingent fee representing a party, has a right to receive compensation that is contingent on, and sourced from, any proceeds of the civil action, by settlement, judgment or otherwise.”

This proposal is important and necessary to ensure that defendants can inquire about financial bias in jury voir dire, as well as identify bias among judges, special masters, and witnesses.  Other procedural rule reforms will be needed as well. Appellate briefs should disclose financiers that have a stake in the litigation. When courts limit counsel and parties’ communications to the media about a case, such limits should apply as well to insurers and third-party financiers of the litigation efforts. Third-party financiers provide a convenient way for the litigation industry to lobby regulators and legislators, and more expansive disclosure rules are needed to capture the activities of the litigation financiers.  Funding of litigation-related research by third-party financiers should be anticipated by journal editors with more expansive disclosure rules; journal editors should be alert to evolving financial markets that may influence research agendas and publications. Lawyers’ scrutiny of new clients for conflicts now requires inquiry into the veiled interests created by litigation financing.

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Too Many Narratives – Historians in the Dock

July 13th, 2014

Historical Associates Inc. (HAI) is a commercial vendor for historical services, including litigation services. Understandably, this firm, like the academic historians who service the litigation industry, takes a broad view of the desirability of historian expert witness testimony.  An article in one of the HAI’s newsletters stakes out lawyer strategies in trying to prove historical facts.  Lawyers can present percipient witnesses, or they

“can present the story themselves, but in the end, arguments by advocates can raise questions of bias that obscure, rather than clarify, the historical facts at issue.”

Mike Reis and Dave Wiseman, “Introducing and interpreting facts-in-evidence: the historian’s role as expert witness,” HAIpoints 1 (Summer 2010)[1]. These commercial historians recommend that advocacy bias, so clear in lawyers’ narratives, be diffused or obscured by having a professional historian present the “story.”  They tout the research skills of historians: “Historians know how to find critical historical information.” And to be sure, historians, whether academic or for-hire may offer important bibliographic services, as well as help in translating, authenticating, and contextualizing documents.  But these historians from HAI want a role on center-stage, or at least in the witness box.  They tell us that:

“Historians synthesize information into well-documented, compelling stories.”

Ah yes, compelling stories, as in “the guiltless gust of a rattling good yarn[2].” The legal system should take a pass on such stories.

*     *     *     *     *     *

A recent law review article attempts to provide a less commercial defense of expert witness testimony.  See Alvaro Hasani, “Putting history on the stand: a closer look at the legitimacy of criticisms levied against historians who testify as expert witnesses,” 34 Whittier L. Rev. 343 (2013) [Hasani].  Hasani argues that historians strive to provide objective historical “interpretation,” by selecting reliable sources, and reliably reading and interpreting these sources to create a reliable “narrative.” Hasani at 355. Hasani points to some courts that have thrown up their hands and declared Daubert reliability factors inapplicable to non-scientific historian testimony. See, e.g., United States v. Paracha, No. 03 CR. 1 197(SHS), 2006 WL 12768, at *19 (S.D.N.Y. Jan. 3, 2006) (noting that Daubert is not designed for gatekeeping of a non-scientific, historian expert witness’s methodology); Saginaw Chippewa Indian Tribe of Michigan v. Granholm, 690 F. Supp. 2d 622, 634 (E.D. Mich. 2010) (noting that “[t]here is no way to ‘test’ whether the experts’ testimony concerning the historical understanding of the treaties is correct. Nor is it possible to establish an ‘error rate’ for historical experts.”).

Not all testifying historians agree, however, that their research and findings are non-scientific.  Here is how one plaintiffs’ expert witness characterized historical thinking:

“Q. Do you believe that historical thinking is a form of scientific thinking?

A. I do. I think that history is sometimes classed with the humanities, sometimes classed with the social sciences, but I think there is a good deal of historical research and writing that is a form of social science.”

Examination Before Trial of Gerald Markowitz, in Mendez v. American Optical, District Court for Tarrant County, Texas (342d Judicial District), at 44:13-20 (July 19, 2005). Professor Susan Haack, and others, have made a persuasive case that the epistemic warrants for claims of knowledge, whether denominated scientific or non-scientific, are not different in kind. If historian testimony is not about knowledge of the past, then it clearly has no role in a trial. Furthermore, Professor Markowitz is correct that sometimes historical opinions are scientific in the sense that they can be tested. If a labor historian asserts that workers are exploited and subjected to unsafe work conditions due to the very nature of capitalism and the profit motives, then that historian’s opinion will be substantially embarrassed by the widespread occupational disease in European and Asian communist regimes.

When Deborah Lipstadt described historian David Irving as a holocaust denier[3], Irving sued Lipstadt for defamation.  In defending against the claim, Lipstadt successfully carried the burden of proving the truth of her accusation.  The trial court’s judgment, quoted by Hasani, reads like a so-called Daubert exclusion of plaintiff Irving’s putative historical writing. Irving v. Penguin Books Ltd., No. 1996-1-1113, 2000 WL 362478, at ¶¶ 1.1, 13.140 (Q.B. Apr. 11, 2000)(finding that “Irving ha[d] misstated historical evidence; adopted positions which run counter to the weight of the evidence; given credence to unreliable evidence and disregarded or dismissed credible evidence.”).

The need for gatekeeping of historian testimony should be obvious.  Historian testimony is often narrative of historical fact that is not beyond the ken of an ordinary fact finder, once the predicate facts are placed into evidence.  Such narratives of historical fact present a serious threat to the integrity of fact finding by creating the conditions for delegation and deferring fact finding responsibility to the historian witness, with an abdication of responsibility by the fact finder. See Ronald J. Allen, “The Conceptual Challenge of Expert Evidence,” 14 Discusiones Filosóficas 41, 50-53 (2013).

Some historians clearly believe that they are empowered by the witness chair to preach or advocate. Allan M. Brandt, who has served as a party expert witness to give testimony on many occasions for plaintiffs in tobacco cases, unapologetically described the liberties he has taken thus:

“It seems to me now, after the hopes and disappointments of the courtroom battle, that we have a role to play in determining the future of the tobacco pandemic. If we occasionally cross the boundary between analysis and advocacy, so be it. The stakes are high, and there is much work yet to do.”

Allan M. Brandt, The Cigarette Century: The Rise, Fall, and Deadly Persistance of the Product That Defined American 505 (2007).

Hasani never comes to grips with the delegation problem or with Brandt’s attitude, which is quite prevalent in the product liability arena. The problem is more than merely “occasional.” The overreaching by historian witnesses reflects the nature of their discipline, the lack of necessity for their testimony, and the failure of courts to exercise their gatekeeping. The problem with Brandt’s excuse making is that neither analysis nor advocacy is needed or desired. Advocacy is the responsibility of counsel, as well as the kind of analysis involved in much of historian testimony.  For instance, when historians offer testimony about the so-called “state of the art,” they are drawing inferences from published and unpublished sources about what people knew or should have known, and about their motivations.  Although their bibliographic and historical researches can be helpful to the fact finder’s effort to understand who was writing what about the issue in times past, historians have no real expertise, beyond the lay fact finder, in discerning intentions, motivations, and belief states.

Hasani concludes that the prevalence of historian expert witness testimony is growing. Hasani at 364.  He cites, however, only four cases for the proposition, three of which pre-date Daubert.  The fourth is an native American rights case. Hasani at 364 n.139. There is little or no evidence that historian expert witness testimony is becoming more prevalent, although it continues in product liability where state of the art — who knew what, when — remains an issue in strict liability and negligence. Mack v. Stryker Corp., 893 F. Supp. 2d 976 (D. Minn. 2012), aff’d, 748 F.3d 845 (8th Cir. 2014). There remains a need for judicial vigilance in policing such state-of-the-art testimony.

[1] Mike Reis is the Vice President and Director of Litigation Research at History Associates Inc. Mr. Reis was received his bachelor’s degree from Loyola College, and his master’s degree from George Washington University, both in history. David Wiseman, an erstwhile trial attorney, conducts historical research for History Associates.

[2] Attributed to Anthony Burgess.

[3] Deborah E. Lipstadt, Denying the Holocaust: The Growing Assault on Truth and Memory 8 (1993).

 

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