TORTINI

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

The Seventh Circuit Regresses on Rule 702

October 29th, 2013

Earlier this month, a panel of the Seventh Circuit of the United States Court of Appeal decided a relatively straight forward case by reversing the trial court’s exclusion of a forensic accountant’s damages calculation.  Manpower, Inc. v. Insurance Company of the State of Pennsylvania, No. 12‐2688 (7th Cir. Oct. 16, 2013).  In reversing, the appellate court disregarded a congressional statute, Supreme Court precedent, and Circuit decisional law.

The case involved a dispute over insurance coverage dispute and an economic assessment of Manpower, Inc.’s economic losses that followed a building collapse.  The trial court excluded Manpower’s accounting expert witness, Sullivan, who projected a growth rate (7.76%) for the plaintiff by comparing total revenues for a five month period in 2006 to the same five months in the previous year.  Id. at 8.  The historical performance, however, included a negative annual growth rate of 4.79% , over the years 2003 to 2009.  Over the five months immediately preceding Sullivan’s chosen period in 2006, the growth rate was merely 3.8%, less than half his projected growth rate.  Id.  Sullivan tried to justify his rather his extreme selectivity in data reliance by adverting to information that he obtained from the company about its having initiated new policies and installed new managers by the end of 2005.  Id.

The trial court held that Sullivan, who was not an expert on business management, had uncritically accepted the claimant’s proffered explanation for a very short-term swing in profitability and revenue.  Id. at 9.  While suggesting that Sullivan’s opinion was not “bulletproof,” the panel of the Seventh Circuit reversed.  The panel, which should have been reviewing the district court for potential “abuse of discretion,” appears to have made its own independent determination that Sullivan opinion was “sufficiently reliable to present to a jury.” Id. at 17.  In reversing, the panel explained that “the district court exercised its gatekeeping role under Daubert with too much vigor.” Id.

The panel attempted to justify its reversal by suggesting that a district court “usurps the role of the jury, and therefore abuses its discretion, if it unduly scrutinizes the quality of the expert’s data and conclusions rather than the reliability of the methodology the expert employed.” Id. at 18.  The panel’s reversal illustrates several methodological and legal confusions that make this case noteworthy beyond its mundane subject matter.

Of course, the most striking error in the panel’s approach is citing to a Supreme Court case, Daubert, which has been effectively superseded by a Congressional statute, Federal Rule of Evidence 702, in 2000:

“A witness who is qualified as an expert … may testify in the form of an opinion or otherwise if:

(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.”

Pub. L. 93–595, § 1, Jan. 2, 1975, 88 Stat. 1937; Apr. 17, 2000 (eff. Dec. 1, 2000); Apr. 26, 2011, eff. Dec. 1, 2011.)  Ironically, the Supreme Court’s Daubert case itself, had the Manpower panel paid attention to it, reversed the Ninth Circuit for applying a standard, the so-called Frye test, which predated the adoption of the Federal Rules of Evidence in 1975.  Rather than following the holding of the Daubert case, the panel got mired down in its dicta about a distinction between methodology and conclusion.  The Supreme Court itself abandoned his distinction a few years later in General Electric Co. v. Joiner, when it noted that

“conclusions and methodology are not entirely distinct from one another.”

522 U.S. 136, 146 (1997).

The panel of the Seventh Circuit concluded, without much real analysis, that the district court had excluded Sullivan’s opinions on a basis that implicated his conclusion and data selection, not his methodology.  Id. at 19-20.  The problem, of course, is that how one selects data of past performance to project future performance is part and parcel of the methodology of making the economic projection.  The supposed distinction advanced by the panel is illusory, and contrary to post-Daubert decisions, and the Congressional revision of the statute, which requires attention to whether “the testimony is based on sufficient facts or data; the testimony is the product of reliable principles and methods; and, the expert has reliably applied the principles and methods to the facts of the case.” Rule 702.

To make matters worse, the appellate court in Manpower proceeded to attempt to justify its reversal on grounds of “[t]he latitude we afford to statisticians employing regression analysis, a proven statistical methodology used in a wide variety of contexts.” Id. at 21. Here the appellate court suggests that if expert witnesses use a statistical test or analysis, such as regression analysis, it does not matter how badly they apply the test, or how worthless their included data are.  Id. at 22.  According to the Manpower panel:

“the Supreme Court and this Circuit have confirmed on a number of occasions that the selection of the variables to include in a regression analysis is normally a question that goes to the probative weight of the analysis rather than to its admissibility. See, e.g.,Bazemore v. Friday, 478 U.S. 385, 400 (1986) (reversing lower court’s exclusion of regression analysis based on its view that the analysis did not include proper selection of variables); Cullen v. Indiana Univ. Bd. of Trustees, 338 F.3d 693, 701‐02 & n.4 (7th Cir. 2003) (citing Bazemore in rejecting challenge to expert based on omission of variables in regression analysis); In re High Fructose Corn Syrup Antitrust Litigation, 295 F.3d 651, 660‐61 (7th Cir. 2002) (detailing arguments of counsel about omission of variables and other flaws in application of the parties’ respective regression analyses and declining to exclude analyses on that basis); Adams v. Ameritech Servs., Inc., 231 F.3d 414, 423 (7th Cir. 2000) (citing Bazemore in affirming use of statistical analysis based solely on correlations—in other words, on a statistical comparison that employed no regression analysis of any independent variables at all). These precedents teach that arguments about how the selection of data inputs affect the merits of the conclusions produced by an accepted methodology should normally be left to the jury.”

Id. at 22.

Again, the Seventh Circuit’s approach in Manpower is misguided. Bazemore involved a multivariate regression analysis in the context of a discrimination case.  Neither the Supreme Court nor the Fourth Circuit considered the regression at issue in Bazemore as evidence; rather the analysis was focused upon whether, within the framework of discrimination law, the plaintiffs’ regression satisfied their burden of establishing a prima facie case that shifted the burden to the defendant. No admissibility challenge was made to the regression in Bazemore under Rule 702.  Of course, the Bazemore litigation predates the Supreme Court’s decision in Daubert by several years.  Furthermore, even the Bazemore decision acknowledged that there may be

“some regressions so incomplete as to be inadmissible as irrelevant… .”

478 U.S. 385, 400 n.10 (1986).

The need for quantitative analysis of race and other suspect class discrimination under the equal protection clause no doubt led the Supreme Court, and subsequent lower courts to avoid looking too closely at regression analyses.  Some courts, such as the Manpower panel view Bazemore as excluding regression analysis from gatekeeping of statistical evidence, which magically survives Daubert. The better reasoned cases, however, even within the Seventh Circuit fully apply the principles of Rule 702 to statistical inference and analyses. See, e.g., ATA Airlines, Inc. v. Fed. Express Corp., 665 F.3d 882, 888–89 (2011) (Posner, J.) (reversing on grounds that plaintiff’s regression analysis should never have been admitted), cert. denied, 2012 WL 189940 (Oct. 7, 2012); Zenith Elecs. Corp. v. WH-TV Broad. Corp., 395 F.3d 416 (7th Cir.) (affirming exclusion of expert witness opinion whose extrapolations were mere “ipse dixit”), cert. denied, 125 S. Ct. 2978 (2005); Sheehan v. Daily Racing Form, Inc. 104 F.3d 940 (7th Cir. 1997) (Posner, J.) (discussing specification error).  See also Munoz v. Orr, 200 F.3d 291 (5th Cir. 2000).  For a more enlightened and educated view of regression and the scope and application of Rule 702, from another Seventh Circuit panel, Judge Posner’s decision in ATA Airlines, supra, is an essential starting place. SeeJudge Posner’s Digression on Regression” (April 6, 2012).

There is yet one more flaw in the Manpower decision and its rejection of the relevancy of data quality for judicial gatekeeping.  Federal Rule of Evidence 703 specifically addresses the bases of an expert witness’s opinion testimony.  The Rule, in relevant part, provides that:

“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.”

Here the district court had acted prudently in excluding an expert witness who accepted the assertions of new management that it had, within a very short time span, turned a company from a money loser into a money earner.  As any observer of the market knows, there are too many short-term “fixes,” such as cutting personnel, selling depreciated property, and the like, to accredit any such short-term data as “reasonably relied upon.”  See In re Agent Orange Product Liability Lit., 611 F. Supp. 1223, 1246 (E.D.N.Y. 1985) (excluding opinions under Rule 703 of proffered expert witnesses who relied upon checklists of symptoms prepared by the litigants; “no reputable physician relies on hearsay checklists by litigants to reach a conclusion with respect to the cause of their affliction”), aff’d on other grounds, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).

Manpower represents yet another example of Court of Appeals abrogating gatekeeping by reversing a district judge who attempted to apply the Rules and the relevant Supreme Court precedent.  The panel in Manpower ignored Congressional statutory enactments and precedents of its own Circuit, and it relied upon cases superseded and overruled by later Supreme Court cases.  That’s regression for you.

Bendectin, Diclegis & The Philosophy of Science

October 26th, 2013

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

The sponsor of the drug, Duchesnay USA, wisely did not use the medication’s former name, Bendectin, which was the victim of a litigation industry jihad in the late 1970s through the mid-1990s. The plaintiffs’ lawyers’ war against Bendectin and its United States manufacturer is chronicled in two book-length accounts, and hundreds of articles. See Joseph Sanders, Bendectin on Trial: A Study of Mass Tort Litigation (Ann Arbor 1998); Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (Philadelphia 1996).

As recently approved by the FDA, Declegis is categorized as “Pregnancy Category A,” which means that it is medication indicated for use in pregnant women. Most drugs are not tested in pregnant women in randomized clinical trials for obvious ethical and practical reasons. Perhaps one of the good things that came out of the Bendectin litigation wars was that Bendectin became one of the most intensely studied medications available for pregnant women. Another good thing was the achievement of evidence-based standards for expert witness opinion testimony in federal court. See David Bernstein, “Bendectin is Back” (April 9, 2013).

According to FDA regulations, Category A is defined:

(1) Pregnancy category A. If adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters), the labeling must state: ‘Pregnancy Category A. Studies in pregnant women have not shown that (name of drug) increases the risk of fetal abnormalities if administered during the first (second, third, or all) trimester(s) of pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, (name of drug) should be used during pregnancy only if clearly needed.’ The labeling must also contain a description of the human studies. If animal reproduction studies are also available and they fail to demonstrate a risk to the fetus, the labeling must also state: ‘Reproduction studies have been performed in (kinds of animal(s)) at doses up to (x) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to (name of drug).’ The labeling must also contain a description of available data on the effect of the drug on the later growth, development, and functional maturation of the child.

21 CFR § 201.57 (c)(9)(i)(A)(1) (April 2012).

A Litmus Test for Philosophy of Science?

The inability to discriminate between valid and invalid science should be a disqualifying characteristic in a putative philosopher of science, or a putative expert, for that matter. Professor Susan Haack, whose writings provide both insight and confusion on the role of science in the law, revealed her robust biases and prejudices in commenting upon the Bendectin litigation. These revelations should raise red flags about her objectivity in commenting on the legal process. See Susan Haack, “Irreconcilable Differences? The Troubled Marriage of Science and Law,” 72 Law & Contemporary Problems 1 (2009).

Haack’s paper on the marital discord was based upon her presentation at the Fourth Coronado Conference, organized by SKAPP (The Project on Scientific Knowledge and Public Policy), an ideological group dedicated to opening the courthouse doors to every quackacademic theory, and shadily funded by the litigation industry of plaintiffs’ lawyers from their left-over spoils from the silicone breast implant litigation. See SKAPP A LOT (April 30, 2010); “Haacking at the Truth – Part Two” (Oct. 31, 2010).

Haack provided examples of “marginal” science and witnesses that are disturb her for biases and prejudices that she perceives in these witnesses. Haack focuses upon Dr. Robert Brent, a toxicologist, who appears to her as Merrell Dow’s expert witness “always ready to testify that Bendectin does not cause birth defects.” Id. At 17. Haack presented no evidence or basis to suggest that Brent was wrong, and indeed, Brent published widely on his views of the subject. Wide publication does not necessarily mean Brent was right, but at least he was willing to subject himself to professional peer review, and post-publication, professional challenges. Still, Haack is distressed that Dr Robert Brent opines with “unwarranted certainty” that Bendectin does not cause birth defects, but she offers no suggestion or support that his certainty was or is misplaced.

In stark contrast, Haack expressed no discomfort with Bendectin plaintiffs’ expert witness, Dr Done, or with the facile ease with which he opined with scientific certainty that Bendectin causes birth defects. Here there really is a great deal of empirical evidence, and along with the FDA’s recent approval of Diclegis for use in pregnant women, the evidence has vindicated Dr. Brent’s views on the safety and efficacy of Bendectin/Diclegis. Dr. Done’s subjective appreciation of “flaws” in some clinical studies does not turn criticism into affirmative evidence in favor of the opinion that he so zealously, and overzealously, advocated in many Bendectin cases, for his own substantial pecuniary benefit. What is remarkable about Haack’s article is that she singles out Dr. Brent in the context of a discussion of “marginal” and “willing” testifying scientists, but she omits any mention of the plaintiffs’ cadre of ready, willing, and somewhat disreputable testifiers. Perhaps even more remarkable is that Haack overlooks that Dr. Done was essentially fired from his university for his entrepreneurial testimonial activities of dubious scientific worth, and that he may well have lied about his credentials. See Michael Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation 280 – 82 (Philadelphia 1996) (citing decisional law in which Done’s lack of veracity was judicially noted).

Of course, what is most remarkable about Haack’s infatuation with Dr. Alan Done and his mosaic theory is that the theory was the concoction of plaintiffs’ lawyer, Barry Nace, and that the theory leads to such a palpably incorrect result. Barry Nace was one of the lead plaintiffs’ counsel in the Bendectin litigation. Nace was also formerly President of the litigation industry’s principal lobbying organization, the American Trial Lawyers Association (now the AAJ). After the second Ninth Circuit Daubert decision, Nace declined to pursue one of his Bendectin cases, and his client sued him. Nace’s attorney moved for summary judgment in August 1998, on grounds that included the assertion that “courts soundly and uniformly reject the notion that Bendectin causes birth defects.” See David Bernstein, “A Day Late and a Dollar Short on Bendectin(June 28, 2005).

This is the same Barry Nace lauded by Michael Green for having devised the notorious matrix theory of scientific evidence (a.k.a. the tsumish theory). Michael D. Green, “Pessimism About Milward,” 3 Wake Forest J. Law & Policy41, 62-63 (2013). Professor Haack sees Nace’s matix theory as the practical application of some of her theories. Susan Haack, “Irreconcilable Differences? The Troubled Marriage of Science and Law,” 72 Law & Contemporary Problems 1, 17 (2009); Susan Haack, “Proving Causation: The Holism of Warrant and the Atomism of Daubertm” 4 J. Health & Biomedical Law 273, 274-78 (2008). Haack’s embrace of the dubious Bendectin causal claims as supported by her matrix theory of causal inference raises the issue why we should credit a theory in the face of such a compelling counter example? As Professor Ronald Allen put the matter, before Bendectin was reintroduced into the United States market this year:

Given the weight of evidence in favor of Bendectin’s safety, it seems peculiar to argue for mosaic evidence from a case in which it would have plainly been misleading.”

Ronald J. Allen and Esfand Nafisi, “Daubert and its Discontents,” 76 Brooklyn L. Rev. 132, 148 (2010). Peculiar indeed. Professor Allen’s point is important for its wide-ranging implications. Methodologies that yield false-positive results are unreliable. Perhaps a methodology can be saved if we could quantify that a given methodology rarely yields such false results, but the matrix theory of Barry Nace and his expert witnesses seems so vague and insubstantial that no one, in all likelihood, could frame a test for the generalized approach. Expert witnesses perhaps should be judged by their track record over time, as well. See David Kaye, “The Experts in Daubert.”[1]

 


[1] Dr. Alan Done (pediatrician, pharmacology, toxicology); Dr. Jay Glasser (biostatistician, epidemiologist); Dr. Adrian Gross (veterinarian); Dr. Stuart Newman (developmental biologist); Dr. Wayne Snodgrass (Assoc. Professor of Pediatrics, Pharmacology, and Toxicology); Dr. Shanna Swan (epidemiologist); Dr. Johannes Thiersch (pathologist and pharmacologist); Dr. John Palmer (Professor of pharmacology).

 

Litigation-Driven Access to Underlying Data and Materials

October 23rd, 2013

On Monday, October 21, 2013, the Center for Public Integrity published an editorial criticizing Georgia-Pacific Corporation for its “secretive research program.” SeeFacing lawsuits over deadly asbestos, paper giant launched secretive research program.”  

Georgia-Pacific (GP) commissioned several studies to help advance its defenses in asbestos litigation. Given that plaintiffs, plaintiffs’ counsel, proxies for the plaintiffs, and self-appointed public health zealots have commissioned and conducted research designed to advance interests of the litigation industry (a/k/a the plaintiffs’ bar) and to undermine GP’s defenses, GP’s actions seem perfectly appropriate.  GP’s attempt to claim an attorney-client and work-product privilege in the communications with investigators, however, raises serious concerns by casting a shadow over industry sponsorship generally.

In response to publication of GP’s sponsored research, plaintiffs’ counsel Jerry Kristal sought discovery of some of the studies and GP’s role in instigating, planning, conducting, and interpreting the studies.  Again, these discovery requests seem perfectly reasonable, but GP reacted by asserting that its lawyers had been involved in the communication loop between GP and the scientists who conducted and published the research, and therefore, the requested evidence was protected by the attorney-client privilege.  As I have argued previously, GP’s position was a serious mistake, and it has opened itself up to a good deal of justified criticism for “secretive research.” See, e.g., Noah S. Seixas, “Protecting Our Science,” 57 Ann. Occup. Hyg. 963 (2013) (emphasizing that there was no evidence that GP’s research was in fact fraudulent, and that the papers published in the Annals of Occupational Hygiene had appropriate disclosures).  See alsoA Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013); “Using the Rule 45 Subpoena to Obtain Research Data” (July 24, 2013).

One measure of the lapse in judgment by GP in questionably asserting an attorney-client privilege is the ammunition that it gives to idealogues and zealots such as the Center for Public Integrity (CPI).  The CPI editorial quotes Harvard University Professor Sheila Jasanoff, as noting that:

“There’s something extremely smelly about claiming attorney-client privilege for something that is being claimed at the same time as good science. … Legal confidentiality protections should not be placed around good science.”

Professor Jasonoff is absolutely correct, but interestingly, her olfactory sense has been remarkably inconsistent.  Back in October 2007, Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss, and debate, litigation and compelled access to underlying research data.  Dr. Racette moaned and groaned about how disruptive subpoenas were into the operation of his research.  Some members of the Committee seemed sympathetic until I reminded them 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. 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). Most members of the Committee expressed their reassurance that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data, but at the time, Professor Jasanoff maintained her opposition to the approach. 

Jasanoff’s selective sniffing reflects the hypocrisy and asymmetry that pervades current discussions of conflicts of interest (COI) and access to data.  COI accusations are directed at industry, but not at the litigation industry, staffed by the plaintiffs’ bar and advanced by eco-zealots.  Access to data is a rallying cry against pharmaceutical industry clinical trials, and industry-sponsored studies, but when stakeholders want access to non-industry study data, suddenly privacy interests and researchers’ privileges become paramount, and researchers “feel harrassed.”  It really is time to choose:  either we stop our insistence upon seeing the data themselves, or we formulate rules that apply across the board, independent of study sponsorship.

We are becoming, by fits and starts, a data-driven and evidence-based world.  The time has come and gone to rely upon authors’ own interpretation of the data, and to realize that there is a public trust, interest, and need for data sharing.  GP’s capital mistake was the same made by Dr. Racette, when he asserted various privileges to argue against disclosure of his underlying data.  (Had GP paid attention to prior disputes, it would have learned that the attorney-client privilege has been uniformly rejected, as it was in Racette’s case.)  Jasanoff’s capital mistake is to attribute stench to GP for asserting a privilege, but excusing it when done by scientists funded or supported by the “litigation industry.”

The CPI reported that a GP spokesman refused to answer questions, but referred a reporter to GP’s court filings, where GP maintained that it “properly commissioned studies to explore scientific issues that repeatedly arise in joint compound litigation, disclosed its role in the studies themselves, and submitted them to the technical rigors of scientific peer review by qualified scientists who were neither affiliated with nor selected by Georgia-Pacific.”

Sounds good, but then why try to assert an attorney-client privilege and an attorney-work product confidentiality?  Plaintiffs’ counsel, having relied upon some rather poorly conducted studies would likely known that peer review is not a very good filter for sound science, and they would press for access to the inner workings of the studies and the possible influence that the sponsor had on any aspect of the studies.  Furthermore, faced with the prospect of GP’s succeeding in its claim of privilege, the plaintiffs were surely warranted in trying to explore exceptions to the privilege, such as the crime-fraud exception, weak though the evidence may be to support such an exception.

Now Look Who Is Manufacturing Doubt!

In the GP case, the New York Appellate Division did not hold that GP had engaged in a fraudulent scheme, only that plaintiffs’ allegations were serious enough to support an order that the trial judge review, in camera, the supposedly privileged materials.  The CPI, however, has used the decision to support its overwrought generalization of charges against all industry-sponsored studies. 

The CPI has used the commonplace smear tactic of analogizing every company’s defensive strategies against litigation, even against unwarranted claims, as a manifestation of the same tactics used by Big Tobacco.  Unfortunately, GP advanced the attorney-client privilege theory, which had been asserted previously, and unsuccessfully, by tobacco companies.  This legal misstep, however, does not justify CPI’s smear campaign against the scientists who conducted the studies at issue.  There is nothing stated or suggested in CPI’s editorial that raises any meaningful question about the validity of the research sponsored by GP.

COI and Access to Data – Two-Way Street

GP’s misguided assertion of the attorney-client privilege opened itself and industry generally to the CPI charges of using “well-paid experts to minimize the hazards of toxic chemicals and fend off liability, regulation, or both.” Indeed, the CPI’s editorial is little more than a sustained ad hominem attack on industry’s efforts to protect itself from liability and regulation, without any acknowledgement that often the attempts to impose liability or regulation are based upon dubious science or imprudent policy. Some liability claims are corrupt, and must be defended, including many frivolous and fraudulent claims in the asbestos litigation.

While the CPI rails against industry experts, it is suspiciously silent about so-called public interest groups or claimants, using well-paid experts, or worse, over-zealous experts, to obtain litigation or regulation results. To be sure, there are many instances of plaintiffs’ expert witnesses failing to disclose their potential conflicts, as well as failing to disclose their funding or support from plaintiffs’ counsel, plaintiffs, or plaintiffs’ proxies. Mr. Kristal’s strategy of claiming fraud in failing to disclose potential conflicts of interest will lead to a regime that will be uncomfortable for many scientists and physicians who fail to make appropriate disclosures.  See, e.g., “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013); “The Mt. Sinai Catechism” (June 7, 2013).

The CPI’s complaint that GP hired experts who were aligned with their cause is curious given the history of the plaintiffs’ counsel to hire expert witnesses who were aligned with their clients’ labor unions and the like.  Irving Selikoff, who was engaged by the insulators’ union to conduct a study of their cancer mortality, had testified in worker compensation proceedings and in some of the early civil actions involving claims of asbestos-related injuries.  The CPI quotes plaintiffs’ lawyer Alan Golanski as alleging that GP had tried to “seed” the medical literature with “methodologically skewed, litigation-driven research.” Of course, this is exactly what plaintiffs’ expert witnesses have done over the last half century.

It really is time to stop.  COI disclosures cannot be a full, satisfactory answer because the most potent conflicts arise out of intellectual and political commitments, not money.  Increasing transparency and access to study protocols, data, analyses may perhaps help. 

Expiation of Guilt by Expert Witnessing – The Strange Case of Gerrit Schepers

October 19th, 2013

Expert witnesses come in all sizes, colors, shapes, races, ethnicities, and personalities.  More interestingly, expert witnesses have various motives for becoming involved in the litigation process.  Most expert witnesses, I believe, become involved because they find the issues interesting, and intellectually challenging.  After looking at the claims and defenses put forward by the parties, these expert witnesses believe that one side or the other has the better warrant, or perhaps the only warrant, for its contentions.

Some witnesses sign up to “change the world.”  They are advocates, and they see the courtroom as an extension of the laboratory or the university.  They may want acceptance for their theories or beliefs, and they hope that favorable jury verdicts and judgments based upon those verdicts will elevate their theories in the world of science or policy.

Other expert witnesses are motivated by “white-hat bias.”  They see a verdict for the side for which they testify as promoting retributive, distributive, or social justice.  They may be deontological or utilitarian or Aristotelian in their assessments of the issues, but they are motivated by considerations that often transcend the facts of the particular case.

Of course, there are expert witnesses who see litigants and litigation as an ATM to aid their personal fisc.

I have known only one expert witness who was motivated by guilt.

                                                                               * * * * * *

Robert B. Anderson kindly alerted me to an interesting historical wiki on Saranac Lake, New York, with some interesting entries for some of the protagonists of the asbestos litigation:  Leroy Upson Gardner, Arthur Vorwald, Gerrit Schepers, and others. 

Dr. Edward Livingston Trudeau founded the Saranac Laboratory for the Study of Tuberculosis, in 1884, as a center for research and treatment of tuberculosis.  The Laboratory, later became known as the Trudeau Institute, was also one of the leading pneumoconiosis research facilities in the 20th century.  Many companies engaged the Laboratory to test their products, or the materials within their products; and Saranac Lake was the natural venue for various symposia and research meetings on industrial dust diseases.

As its director from 1927, until his death in 1946, Dr. Gardner helped put the Saranac Laboratory on the intellectual world map.  His directorship coincided with the period in which the pneumoconioses were becoming important topics in industrial medicine, and in labor-industry battles.  After Dr. Gardner’s death, Dr. Vorwald became the Director of Laboratories at Saranac. He held the position from 1947, until 1954, when he left to organize a new medical school department, of Industrial Medicine and Hygiene, in Wayne State University, in Michigan.

In 1954, the Laboratories fell into the hands of Dr. Schepers, who oversaw its passing into irrelevancy as research moved into the major universities.  Schepers left Saranac in 1958.

Dr. Schepers used his supposed personal knowledge of dealings with various companies to create a livelihood in later life, when he testified extensively for plaintiffs’ counsel in asbestos personal injury litigation.  As the litigation matured, so did Dr. Schepers, who became deaf and daft, and fantasized and testified to conversations with people, long dead, who could not contradict him.  Schepers thus used his longevity to good advantage.

After Dr. Schepers adopted the catechism of Mt. Sinai, his publications, from the early 1980s until his death, became particularly unreliable, and these typically are the only ones cited now by plaintiffs’ counsel and plaintiffs’ expert witnesses.  Fortunately, Dr. Schepers memorialized his contemporaneous observations, which frequently contradicted him when he was confronted by well-prepared defense counsel, in court or deposition examination.  Under the Federal Rules of Evidence, and most state evidentiary law, Schepers’ prior statements are admissible as they bear on his credibility and the truth of his later, scurrilous writings:

“When a hearsay statement … has been admitted in evidence, the declarant’s credibility may be attacked, and then supported, by any evidence that would be admissible for those purposes if the declarant had testified as a witness. The court may admit evidence of the declarant’s inconsistent statement or conduct, regardless of when it occurred or whether the declarant had an opportunity to explain or deny it. If the party against whom the statement was admitted calls the declarant as a witness, the party may examine the declarant on the statement as if on cross-examination.”

Federal Rule of Evidence 806See, e.g., “Gerrit W. H. Schepers, MD, RIP” (2011).

The Saranac Wiki also notes that Schepers was “an experienced anthropologist and neurologist.”  Most scientists, however, have been probably all too happy to forget Dr. Schepers’ work in this area.  See, e.g., G.W.H. Schepers, “The Corpus Callosum and Related Structures in the South African Negro Brain,” 24 Am. J. Physical Anthropology 161 (1938).

The Wiki points to a hagiographic obituary that quotes an anonymous friend who called Schepers “the Old War Horse, the record holder for longevity in the struggle against corporate crime.” Laurie Kazan-Allen and Barry Castleman,  “The Passing of a Great Man” (Sept. 13, 2011).   Schepers lived to 97, but his struggle was with his own past, not with alleged corporate crime.

Labor historian Jock McCulloch wrote about Schepers’ role in documenting silicosis disability among South African miners, but even Schepers’ good deeds came with a dubious shadow.  McCulloch describes a South African investigator who described “Dr Schepers as a man whose outstanding intellect was compromised by an ‘inexcusable scientific dishonesty’.”  Jock McCulloch, “Hiding a Pandemic: Dr G.W.H. Schepers and the Politics of Silicosis in South Africa,” 35 J. Southern African Studies 835, 838 (2009) (citing to South African National Archives, Pretoria, F 33\671, Supplementary Confidential Report of the Departmental Committee of Enquiry into the Relation between Silicosis and Pulmonary Disability. Departmental Committee to Inquire into the Definition of Silicosis & Chest Diseases (Oosthuizen) Departmental Committee at 23 (1954)).

Contrary to the fantasy “state of the art” that made Schepers so much in demand for plaintiffs’ lawyers, and endeared so to Kazan, Castleman, and McCulloch, Schepers’ publications tell a different story. Schepers’ very first publication on asbestos and cancer came in 1963, after the work by Dr. Christopher Wagner and others, from South Africa. At that time, he wrote about pulmonary cancers:

“Neoplasia occurs in two forms:  alveolar and bronchiole carcinoma, and pleural mesothelioma.  The latter is particularly common in crocidolite workers, and has been mainly reported from South Africa.”

G. Schepers, ““Lung Disease Caused by Inorganic and Organic Dust” 44 Chest 133, 136 (1963).  This statement came after his South Africa and Saranac experiences, but before senescence set in. Schepers also noted that “neoplasia has not yet resulted” from asbestos in experimental models.  Id. at 136.

American College of Chest Physicians (1964)     

In 1964, Schepers helped prepare a position paper on asbestosis for the American College of Chest Physicians.  This report noted that the enhanced prevalence of pulmonary neoplasia did not appear to apply for the chrysotile industry in North America:

“In the medical literature, there are more articles favoring a positive relationship between cancer of the lung and asbestosis than denying it. While it has been reported that there may be an enhanced prevalence of pulmonary neoplasia in some asbestos industries (e.g. crocidolite or amosite), or in some locations (e.g. South Africa, England), this does not appear to apply for the chrysotile industry in North America. This comment applies both with respect to intrapulmonary new growths and to pleural mesothelioma.”

Peter A. Theodos, John W. G. Hannon, Paul Cartier, Ross K. Childerhose, David T. Dubow, G. W. H. Schepers, Reginald H. Smart, and Roy E. Whitehead, “Asbestosis:  Report of the Section on Nature and Prevalence Committee on Occupational Diseases of the Chest,” 45 Chest 107, 109b (1964).  This report also put pleural plaques into proper historical and physiological perspective:

“In many individuals and perhaps even the majority of cases, these pleural plaques do not present any histologic lesions of asbestosis and contain no asbestos fibers. *** These plaques, though apparent on X‑ray, are not associated with any disability.”

Id. at 109a.

New York Academy of Science Conference on Asbestos (1964)

Also in 1964, Schepers was a significant presence at Dr. Selikoff’s 1964 conference of the New York Academy of Science, where he commented upon others’ presentations.  Here Schepers continued to express his doubts about the carcinogenicity of North American chrysotile:

“Finally, there is the question of whether inhalation of chrysotile is associated with neoplasia.  On critically reviewing the work histories of eleven cases of lung cancer in chrysotile workers, I find that all of these had at one time or another also been exposed to other forms of asbestos, mainly amosite or crocidolite.  Their predominant exposure was to chrysotile, but since there is strong evidence incriminating amosite as a carcinogen, the fact that these men also had been exposed to amosite is disruptive of a theory of carcinogenicity per se.”

Schepers, “Discussion,” in Biological Effects of Asbestos 132 Ann. N. Y. Acad. Sci. 589, 596 (1965). Schepers paved the way on manufacturing uncertainty when he suggested at the 1964 conference, an alternative hypothesis to crocidolite as a cause of mesothelioma; he suggested that some of the mesotheliomas in South Africa might have been caused by a native grass known as Klitsgras.

Talc Symposium (1973)

In May 1973, Schepers participated in a written presentation at a symposium on talc, sponsored by the United States Department of Interior.  At the time, Schepers was an employee of the United States government, the Chief of the Medical Service, Veterans Administration, in Lebanon, Pennsylvania:

“There are marked differences between the capacities of the individual classes of silicate minerals to provoke responses in human and animal tissues. There also are major misconceptions as to what these substances can do when inhaled by man or other mammals. Two of the most extreme of these are

(1) that all siliceous minerals are equally pathogenic and

(2) that there is even the least semblance between the effects of the asbestiform and the non-asbestiform silicates.”

Gerrit W. H. Schepers, “The Biological Action of Talc and Other Silicate Minerals,” at 54, in Aurel Goodwin, Proceedings of the symposium on talc: U.S. Bureau of Mines; Information Circular 8639 (1974).  This view was directly opposed to the Mt. Sinai gospel about to be delivered in another government proceeding. See U.S. Environmental Protection Agency v. Reserve Mining Co., 514 F.2d 492 (8th Cir. 1975) (en banc).  Schepers, however, had not yet gotten the memo, or perhaps his loyalty was still to his employer, the United States government.  Schepers was not, however, under the influence of any company or corporate interest, when he wrote:

“Is chrysotile a carcinogen? This is a very perplexing question. A crescendo of popular opinion has sought to incriminate chrysotile. This author remains unconvinced.  The main premise for carcinogenicity stems from epidemiological observation of employees of the insulation and shipbuilding industries. In both these industries there has been in the past considerable exposure of pipe laggers to asbestos dust. Only in recent decades, however, have these insulation bats been composed predominantly of chrysotile. In former years crocidolite and amosite were important components.

                                                                               ***

Finally, it should be pointed out that the role of cigarette smoking has not been satisfactorily discounted in the referenced epidemiological studies of lung cancer among insulation workers. In some groups reported an excess prevalence of lung cancer was not demonstrable when cigarette smoking was taken into consideration. Epidemiological surveys of chrysotile workers in Quebec showed no excess of lung cancer. A review of pleural mesothiliomatosis in Canada also failed to focus attention on Quebec or any other center where chrysotile industries are concentrated.”

Gerrit W. H. Schepers, “The Biological Action of Talc and Other Silicate Minerals,” at 70.  Unlike Dr. Selikoff, Schepers was not a crocidolite denier.

OSHA Proceedings 1976

In 1970, the Williams-Steiger Act created a new federal agency, the Occupational Safety and Health Administration, and one of its first missions was to address an asbestos problem that emerged in the 1960s.  The new agency held extensive hearings and engaged in factfinding, which was dominated by Dr. Selikoff and other proxies for the labor unions.

In 1976, Schepers was not yet under the influence of the Mt. Sinai crowd; indeed, he was an employee of the United States.  Here are the contemporaneous views of Dr. Schepers, as he attempted to influence the OSHA investigation of the asbestos fiber controversy.  In a letter dated July 19, 1976, Schepers wrote Grover Wrenn, Chief, Division of Health Standards Development, OSHA:

“This is a follow-up on our recent meeting with the Assistant Secretary of Labor at which we discussed the question of asbestosis and berylliosis and the relationship of exposure of various industrial substances to lung cancer.

I promised to help you place items in the record which you appeared not have available.”

                                                        ***

“As you can see my researches cast considerable doubt on the proposition that American fibrous minerals are carcinogenic.  I am not one of those that deny the carcinogenicity of everything.  To the contrary, I believe that I have helped prove that some environmental pollutants are carcinogenic.  For this reason you may perhaps accept the credibility of my findings when I state that I could detect no evidence of carcinogenicity for either chrysotile, talc or fiberglass.”

Asbestos Litigation – The Gathering Storm (1978)

By the late 1970s, asbestos litigation was swamping American courtrooms.  The United States Navy in particular was threatened by the potential expense of compensating its large civilian shipyard workforce.  Schepers sought out the role of testifying witness, in a letter dated March 10, 1978, Dr Schepers wrote to Captain Hoeffler, of the Navy’s Bureau of Medicine and Surgery, in Washington D.C.  Schepers shamelessly took credit for discovering the connection between mesothelioma and amphibole asbestos, in 1949. Of course, if this self-aggrandizing claim were true, Schepers would have been involved in a much more devastating cover-up than any American company.  Here is the substance of Schepers’ 1978 solicitation letter:

“Here is a CV and some reprints which will possibly be helpful.  Since I have been involved with so many things, my expertise with respect to asbestosis is somewhat hidden among the rest.  For emphasis therefore let me summarize that my clinical and research involvement with asbestosis and thus also lung cancer spans some thirty years.  I commenced this work in South Africa, where as a …. Medical director for the pneumoconiosis Bureau we researched the working conditions and health of all employees of that countries [sic] extensive crocidolite and amosite mines and industries.  The fact that mesothelioma can be associated with asbestos dust was first discovered by me during 1949 at the Penge Egnep mines in the Eastern Transvaal.  It is also important to know that only one out of three persons who develop mesothelioma ever was exposed to asbestos dust.  The Institute for Pneumoconiosis Research which I started there has abundant evidence about this.

In the USA I next studied the asbestos problem for the Quebec Government and the Johns Mansville Company and also for various asbestos producing companies.  This embraced research on human subjects, lung tissue and experimental animals.  The net result of my fifteen years of work in this field has been to convince me that chrysotile, which is the North American type of asbestos, is relatively innocuous as compared to the African and Russian varieties.  I have never seen a case of lung cancer develop on any person exposed to chrysotile only.  However I have seen plenty of lung cancers in asbestos workers.

This is because most asbestos workers are exposed to carcinogenic materials other than asbestos and all the cases with lung cancer also were chronic lung self-mutilators through cigarette smoking.  In a rather major set of experiments of mine, I exposed animals to the most potent known carcinogenic (beryllium sulphate) and then exposed them to asbestos (chrysotile) dust.  These animals had fewer cancers than those exposed to the beryllium sulphate.  So chrysotile is not even a significant co-carcinogen.  I reversed the order of the exposure – namely asbestos (chrysotile) first and the the BeSO4.  The result was the same.  The animals exposed only to chrysotile never developed any lung cancers.

I probably have the largest collection of asbestosis case materials, having been a consultant to hundreds of physicians.  I have a very detailed knowledge of what various types of asbestos can and cannot do to the lungs.  If my command of this subject can be of use to the Navy in the current law suit, please feel to use my services as consultant as you deem fit.”

Schepers Reinvented

As we can see from his 1978 correspondence, Dr. Schepers was not shy about touting his expertise, or his opinions about the innocuousness of chrysotile asbestos.  Castleman’s revisionist history has some support only from Scheper’s own later attempts to reinvent his past.  See, e.g., Gerrit W.H. Schepers, “Chronology of Asbestos Cancer Discoveries: Experimental Studies of the Saranac Laboratory,” 27 Am. J. Indus. Med. 593-606 (1995). The contemporaneous history of Schepers’ views is, however, completely at odds with words written only after decades of consulting with, and testifying for, plaintiffs’ counsel in asbestos litigation.

Like many other defense lawyers, I confronted Dr. Schepers in cases in which he testified both on state-of-the-art issues and on the causation of mesothelioma.  Towards the end of his testifying career, he likened his courtroom performances to that of “performing seal for lawyers in the courtroom.”  Testimony of Gerrit W. Schepers, in Hill v. Carey Canada, New Jersey Superior Court, Law Division for Camden County, Docket No. L-051429-84, 48-50 (July 24, 1990) (before Judge Supnick and a jury). 

The interviews he gave for the media were even more of a performance. In one interview that Schepers gave about a year or so before his death, he cut even more grandiose poses of a whistleblower and crusader.  See Lorraine Mallinder, “Deadly Secret: A 1940s whistle-blower uncovers hidden evidence linking asbestos to cancer,” 91 Canada’s History 33 (April 2011). 

Why did Schepers commit himself in retirement to the plaintiffs’ bar and their relentless prosecution of asbestos cases?  Marxist historians and writers such as McCulloch and Castleman, who see every societal ill as the result of corporate influence will not likely discern Schepers’ true motivations.  By the time I encountered Schepers he was no longer a needy former civil servant.  He was trying to rewrite history because he was personally responsible for the continued use of South African crocidolite in the United States, for decades after he claimed to have discovered its causal relation to mesothelioma.  He was a man tormented by guilt, and his ritualistic participation in trials of mesothelioma claims was expiation for his role in the tragedy.

It is sad that the asbestos litigation is still with us. Dean Wellington’s pipedream of turning the asbestos litigation feeding frenzy into an administrative routine is long gone.  The bankruptcies of dozens of companies, with the losses of jobs and income for many thousands of American workers is a great tragedy; but so is the loss of historical perspective.