Schachtman Law

TORTINI

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

Pennsylvania Workers Regain Their Right of Action in Tort against Employers for Latent Occupational Diseases

February 14th, 2014

Worker’s compensation legislation was part of great compromise in the rough-and-tumble battles between labor and management in the first few decades of the last century. In virtually every state, employers had a common law duty to provide a reasonably safe workplace. In tort litigation, however, employers enjoyed several powerful affirmative defenses: contributory negligence, the fellow-servant rule, and assumption of risk. Workers enjoyed increasingly sympathetic juries and generous damage awards. Worker’s compensation statutes made recovery for most injuries a certainty, with schedules of damages that were deeply discounted from what might be had in a jury trial. In return for well-nigh absolute liability, employers gained certainty of outcome, reduction of administrative costs, and immunity to tort liability for all but intentional harms.

After World War II, tort law began to change dramatically. Contributory negligence gave way to comparative negligence. Assumption of risk defenses were curtailed, and the fellow-servant rule was severely modified or abandoned. Labor was feeling buyers’ remorse over the workman’s compensation deal.

In 1965, the American Law Institute adopted § 402A which provided for “Special Liability of Seller of Product for Physical Harm to User or Consumer,” based upon concerns of unequal knowledge of defects and latent hazards of products sold to consumers. Liability followed for harm caused by a product irrespective of privity of contract or warranty, and even if “the seller has exercised all possible care in the preparation and sale of his product.” Restatement (Second), Torts § 402A (2)(a),(b) (1965).

Section 402A was inspired by tort cases in New Jersey and California, involving consumer products, but the Restatement was quickly, and unthinkingly, applied to sales made to large manufacturing employer-purchasers in which there was no real inequality of knowledge between seller and purchaser, or hidden or latent hazard in the product or material. (Think about how knowledgeable the United States Navy was about the hazards of asbestos insulation products it bought for ship building.) Section 402 became the vehicle for injured workers to ditch their capped damages in worker’s compensation court, and to put their cases back in front of juries, with the prospect of unlimited awards for non-economic damages.

In the workers’ compensation era, very few injured workers succeeded in making out intentional torts that would overcome their employers’ immunity to suit. Late last year, however, Pennsylvania workers regained their common law right to sue employers for negligence and other torts, for occupational diseases that manifest more than 300 weeks after last employment. Section 301(c)(2) of the Pennsylvania’s Workman’s Compensation Act, 77 P.S. § 411(2) removes these delayed manifested occupational disease claims from the scope of the Act. Since the Act’s inception, most courts have held that late manifestation (over 300 weeks) deprived the claimant of a recovery under the Act, but did not remove the employer’s immunity from suit. In an opinion issued in November 2013, Justice Todd, writing for herself and four other justices, held that the statute’s exclusion of late-manifesting occupational diseases (after 300 weeks) does not leave claimants without a remedy; the statute simply removes the latent disease cases from the purview of the Act, and returns them to the vicissitudes of common law litigation. Tooey v. AK Steel Corp., 81 A.3d 851 (2013).

The Tooey decision has profound implications for how occupational disease litigation claims will be litigated. For decades, Pennsylvania juries were treated to a faux spectacle that suggested that plaintiffs, with claimed occupational diseases, were the “victims,” of remote suppliers’ failure to warn, when in reality their diseases were largely or totally the result of employer and employee negligence. Not only will plaintiffs sue their employers, but third-party vendors will seek contribution or indemnification from negligent employers. Employers will assert comparative negligence and assumption of risk defenses, which will give the lie to the plaintiffs’ claims of inadequate warnings from the remote suppliers. Just possibly, Tooey will let the truth come out.

Posted in Learned and sophisticated intermediary, Trial Procedure | Comments Off on Pennsylvania Workers Regain Their Right of Action in Tort against Employers for Latent Occupational Diseases

The Capture of the Public Health Community by the Litigation Industry

February 10th, 2014

The American Public Health Association (APHA) is a significant organization ostensibly committed to the improvement of public health. Among its many activities, the APHA publishes a journal, the American Journal of Public Health. Here is how the APHA describes itself and its activities to advance public health:

“The American Public Health Association champions the health of all people and all communities. We strengthen the profession of public health, share the latest research and information, promote best practices and advocate for public health issues and policies grounded in research. We are the only organization that combines a 140-plus year perspective, a broad-based member community and the ability to influence federal policy to improve the public’s health.”

How could anyone be against the APHA?

A dubious development in the APHA’s history was its evolution as a tool of the litigation industry. In 2004, after several years of lobbying, agents of the litigation industry managed to push a policy statement past the Association’s leadership, to condemn the requirement of evidence-based reasoning in federal courts in the United States.

The litigation industry’s victory is memorialized in the “Final Minutes of Meetings of the APHA Governing Council, ” held in November 2004, when the industry’s attack on evidence-based science and data transparency, known as “Policy Number: 2004-11 Threats to Public Health Science,” was adopted as an APHA policy statement.

“2004-11” was published in the American Journal of Public Health and is still available on the APHA website, as Policy Number: 2004-11 Threats to Public Health Science. I have excerpted contentions and recommendations from the APHA policy, in the left column of the chart, below. My comments are on the right.

APHA Policy	Comment
“Acknowledging that within science, absolute proof and perfect information are rare;”	Notice the false dichotomy between absolute proof and perfect information and the entire remaining spectrum of scientific information. This dichotomization has been part of the litigation strategy of passing off hypotheses, preliminary conclusions, unreplicated findings, etc., as though they were acceptable bases for causal conclusions.
“Recognizing that special interests have exploited the nature of science, specifically scientific uncertainty, to delay protective legal and/or regulatory action;”	Notice the asymmetry of the accusations; the APHA apparently has no concern for “special interests” that exploit the nature of science by passing off hypotheses as conclusions, and seek to accelerate protective legal and regulatory action by manufacturing faux scientific conclusions.
“Acknowledging that some public health decisions must be made in the absence of perfect scientific information;”	“Le mieux est l’ennemi du bien.” But isn’t the good also the enemy of the shabby, dodgy, and fraudulent? Notice again the false dichotomy between “perfect” information and everything else, as though our failing to achieve the perfect opens the door to the worst. True, of course, that sometimes action is needed on incomplete records, but such action is rarely needed for compensation claims.
“Recognizing that special interests, under the guise of a call for “sound science” have sponsored and promoted changes in public policy that have weakened and continue to threaten public health protections;”	If the call for sound science cannot be sustained, then this rhetorical gambit will blowback hard on those “special interests.” Why are these putative scientists, at APHA, so afraid of sound science?
“Recognizing that special interests have challenged highly regarded public health research and researchers, and inappropriately characterized established scientific methods as ‘junk science’;”	Mon Dieu! How cheeky of those special interests. See the discussion of Dr. Barry S. Levy, below.
“Recognizing that the Daubert decision has propagated misinterpretations and misapplications of scientific principles relied upon throughout the public health sciences, such as insisting that any epidemiologic study that is relied on to support causation demonstrate a twofold increase in risk as well as a reliance on significance testing to determine which scientific findings are to be allowed as evidence;”	This contention misunderstands the basic nature of evidence law. Studies, whether they have statistically significant results, or not, are rarely admissible in evidence. What is admissible, or not, are opinions of duly qualified expert witnesses, who explain and justify the epistemic warrant for their opinions. With respect to general causation opinions, expert witnesses will often have to show that they have properly ruled out chance, bias, and confounding to arrive at a causal conclusions. Significance testing can be abused, in both directions, but the APHA ignores the need for having some quantitative approach to assess random variability. As for relative risks greater than two, the APHA is correct that general causation may often be found with small relative risks, but the attribution of causation in an individual claimant often can be made only on probabilistic inferences that will require relative risks greater than two, or even larger.
“Recognizing that special interests are engaged in a campaign to extend Daubert’s reach to those states that have not embraced prescriptive definitions of scientific reliability.”	So the APHA makes common cause with those “special interests,” which would abolish all limits on the admissibility of expert witness opinions, and all normative assessments of scientific research. This position ignores the prescriptive aspect of methodology, and the nature of epistemic warrant in a methodology.

What follows from these contentions?

“Therefore, APHA:”

“Opposes legislation or administrative policies that attempt to define the characteristics of valid public health science, or dictate prescriptive scientific methodologies; and”	Admittedly, defining good science is very difficult, but the law often works like science as defining health as the absence of disease. There are obviously some well-known pathologies of scientific method, and it hardly seems extravagant to urge courts to avoid flaws, fallacies, and fraud.
“Supports the efforts of other scientific organizations to promote the government’s ability to utilize the best available science to protect the public’s health; and”	Of course, sometimes the “best” available science is rather shabby.
“Urges friend of the court briefs that address the problem inherent in the adoption of Daubert and Daubert-like court rulings, the application of Daubert in regulatory proceedings, and when judges misinterpret scientific evidence in their implementation of the Daubert ruling.”	We do not see many APHA-types deploring jury verdicts that offend scientific sensibilities; and so the APHA’s urging here seems again rather one-sided and partisan. The fact, however, that judges’ misinterpretations of scientific evidence can be criticized publicly is one of the key differences that separates judicial gatekeeping from the black box of jury determinations.

In 2005, the APHA published, in its journal, APJH, a special supplement, “Scientific Evidence and Public Policy,” with

“academic analysis of the conflicts arising in the use of science in regulatory, civil and criminal proceedings. This special issue examines how recent developments in the legal and regulatory arenas have emboldened corporations involved in civil litigation and regulatory proceedings to accuse adversaries of practicing ‘junk science’.”

Apparently, the APHA was not, and is not, concerned with the emboldening the litigation industry and its efforts to subvert the truth-finding function of civil litigation.

David Michaels served as the guest editor for the APJH supplement. Michaels repeated many of the contentions of the 2004 Policy Statement, above, and he added some new ones of his own:

Judges are no better than juries in assessing scientific evidence.

Scientists evaluate all the evidence by applying a “weight-of-the-evidence” approach.

Uncertainty in science is normal and does not mean the underlying science flawed.

David Michaels, “Editorial: Scientific Evidence and Public Policy,” 95 (Supp. 1) Am. J. Pub. Health S5 (2005). These are all serious half truths. Many judges are quite astute when evaluating scientific evidence, but even the lowest aptitude judges must give articulated reasons for their decisions, which opens up a public process of comment, correction, and criticism. Juries vote in secret, without having to explain or justify their verdicts. Scientists, metaphorically speaking, weigh evidence, as do non-scientists, but this opaque metaphor hardly explicates the process of how scientists arrive at conclusions about causal relationships. And uncertainty is a condition of many scientific fields, but the error lies in trying to pass off tentative, uncertain, preliminary observations and findings as knowledge.

Michaels sees the development of judicial gatekeeping as favoring “the powerful,” and hurting “the weak and vulnerable.” Id. Michaels did not seem to mind if his editorial recommendations favored the litigation industry and hurt the truth. He now heads up the Occupational Health & Safety Administration.

Here is how Michaels and the APHA described the funding for the AJPH supplement:

“Support for the supplement was provided through unrestricted funding to the Project on Scientific Knowledge and Public Policy (SKAPP) from the Common Benefit Litigation Trust, a fund established by court order in the Silicone Gel Breast Implant Products Liability Litigation. SKAPP is an initiative of scholars that examines the application of scientific evidence in the legal and regulatory arenas. SKAPP is based at the George Washington University School of Public Health and Health Services; more information is available at www.DefendingScience.org.”

See APHA website <http://www.apha.org/about/news/pressreleases/2005/05arenas.htm>, last visited on February 10, 2014.

This pseudo-disclosure is perhaps the most fraudulent aspect of the entire APHA enterprise. The Common Benefit Trust was a fund that was held back from settlement monies paid by defendants in the silicone gel breast implant litigation. The Trust was nothing more than the Plaintiffs’ Steering Committee’s war chest, from which it could advance litigation goals within MDL 926 (silicone breast implant cases). Ironically, the appointment of neutral, court-appointed expert witnesses led to the triumph of “sound science,” and the collapse of the plaintiffs’ counsel house of cards. Rather than returning their litigation expense fund to the claimants, the plaintiffs’ counsel found a more worthwhile recipient — SKAPP — to advance their litigation goals, if not for MDL 926, then for the next MDL, and the next, and the next…. See SKAPP A LOT; and Conflicted Public Interest Groups.

* * * * * * *

The same year that the APHA published the SKAPP-inspired and funded challenges to Federal Rules of Evidence 702, the APHA awarded its most prestigious award, the Sedgwick Medal, to a physician whose opinions had routinely been found to be unreliable and irrelevant in various litigation industry efforts. “Barry Levy Wins APHA’s Oldest and Most Prestigious Award, the Sedgwick Medal.” (December 11, 2005).

Perhaps the APHA had Levy in mind when it complained that “special interests have challenged highly regarded public health … researchers….” Dr. Levy seems to have less favorable accolades from trial and appellate judges. For instance, one federal judge found Levy engaged in a dubious enterprise to manufacture silicosis claims in Mississippi. In re Silica Products Liability Litigation, 398 F. Supp. 2d 563, 611-16, 622 & n.100 (S.D. Texas 2005) (expressing particular disappointment with Dr. Barry Levy, who although not the worst offender of a bad lot of physicians, betrayed his “sterling credentials” in a questionable enterprise to manufacture diagnoses of silicosis for litigation).[1] Interestingly, Judge Jack’s opinion was not mentioned in the APHA press release for Dr. Levy’s award ceremony.

[1] See Schachtman, Silica Litigation: Screening, Scheming & Suing; Washington Legal Foundation Critical Legal Issues Working Paper Series No. 135 (Dec. 2005) (exploring the ethical and legal implications of the entrepreneurial litigation in which Levy and others were involved). See also Lofgren v. Motorola, Inc., 1998 WL 299925, No. CV 93-05521 (Ariz. Super. Ct., Maricopa Cty. June 1, 1998); Harman v. Lipari, N.J. L. Div. GLO-L-1375-95, Order of Nov. 3, 2000 (Tomasello, J.) (barring the use of Barry Levy in class action for medical monitoring damages); Castellow v. Chevron USA, 97 F.Supp. 2d 780, 793-95 (S.D. Tex. 2000); Knight v. Kirby Inland Marine Inc., 482 F.3d 347 (5th Cir. 2007); Watts v. Radiator Specialty Co., 990 So. 2d 143 (Miss. 2008); Aurand v. Norfolk So. Ry., 802 F.Supp.2d 950 (2011); Mallozzi v. Ecosmart Technologies, Inc., 2013 WL 2415677, No. 11-CV-2884 (SJF)(ARL) (E.D.N.Y. May 31, 2013).

Posted in Conflicts of Interest, Expert Witnesses, Rule 702 | Comments Off on The Capture of the Public Health Community by the Litigation Industry

Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff

January 4th, 2014

Dr. Selikoff had a general practice clinic in Paterson, New Jersey, in the 1950s, when his practice and his litigation support efforts were noticed by the asbestos insulation workers’ union. Wikipedia, “Irving Selikoff” (last visited Jan. 4, 2014). According to Wikipedia, “[t]he new cohort (asbestos workers) were still a small fraction of the clinic’s patient list,” but Selikoff noticed a surprising incidence of pleural mesothelioma, within a few years of opening his practice. The Wiki authors seem deliberately vague about the date of Selikoff’s, and the union’s notice. Most authors recognize the late Chris Wagner for the discovery of a high rate of mesothelioma, at least among those exposed to crocidolite asbestos. See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991). Perhaps the vagueness is due to the realization that notice to Selikoff was notice to the union and its membership.

New Jersey lawyer Jon Gelman recounts how his father, also a New Jersey lawyer, involved Dr. Selikoff, back in 1954, as an expert witness in the “original 17” UNARCO (Union Asbestos and Rubber Co.) asbestos worker claims. According to Gelman, these claims were successfully litigated with Selikoff’s services, in front of the New Jersey Division of Workers’ Compensation. Jon L Gelman, “Dr. Yasunosuke Suzuki, A Pioneer of Mesothelioma Medical Research” (Nov. 23, 2011). Gelman does not report what diseases were involved in the 17 claims, arising out of the Paterson factory that used mostly amosite asbestos from South Africa. See Herbert Seidman, Irving J. Selikoff, and Steven K. Gelb, “Mortality Experience of Amosite Asbestos Factory Workers : Dose-Response Relationships 5 to 40 Years After Onset of Short-Term Work Exposure,” 10 Am. J. Indus. Med. 479 (1986).

Over the 20 years following the UNARCO 17, Selikoff went on to have an active testimonial career, always testifying for the claimant, always testifying against the employer or the supplier.[1] In 1972, Andrew Haas, President of the asbestos workers union thanked Selikoff for his frequent expert witness testimony on behalf of union members. Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972) (cited by Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003)).

Some of the positions that Selikoff took as a partisan expert witness suggest that he was outrunning his headlights. For instance, in the mid-1960s, Selikoff testified in New York proceedings, in support of a union member, who had died of colon cancer. Although Selikoff has little or no experience as an epidemiologist, he provided the “expert witness” support for the death claim based upon the very crude data from his insulator cohort study. Here is how the union magazine heralded the compensation victory, made possible by Selikoff’s advocacy:

“The research into health hazards of insulation workers developed by the members of Local No. 12 and Local No. 32 has resulted in widening the basis of compensation claims in New York State.

Until now, the courts have been reluctant to accept many of the conditions to which insulation workers are prone, as related to employment. However, facts produced during the research investigations of Dr. 1. J. Selikoff, Dr. J. Churg, and Dr. E. Cuvler Hammond of the Environmental Sciences Laboratory of the Mt. Sinai Hospital in New York are resulting in a changing of this picture.

In the last two or three years, a number of decisions have been handed down in the courts of New York and New Jersey acknowledging that not only pneumoconiosis (asbestosis) occurring among insulation workers is compensable, but that also lung cancer and mesothelioma of the chest or mesothelioma of the abdomen should also be compensated.

A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population.

Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the Workman’s Compensation Board reviewed the matter and agreed with the Referee’s judgement and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”

“Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966).

The claimed association between colon cancer and asbestos was dubious at the time of Selikoff’s testimony, and became more so as time went on. Nonetheless, colon cancer was important issue of compensation for the union membership. Smoking was highly prevalent among the insulators, who had a high rate of lung cancer. Colorectal cancer was the leading cause of cancer mortality among non-smokers in the general population, and Selikoff’s efforts to get the insulators to stop smoking was going to shift cancer mortality, naturally, to colorectal cancer. Adding colorectal cancer to the list of “compensable diseases” became an important part of the union’s (and the litigation industry’s) compensation strategy. Selikoff dug in, publishing and republishing the data from the insulator cohort study, which was uncontrolled for smoking and other risk factors. See, e.g., Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for his causal conclusion between asbestos and all gastrointestinal cancers).

More sophisticated epidemiologists consistently rejected the Selikoff conclusion on asbestos and colon cancer, which grew out of Selikoff’s litigation activities. Richard Doll & Julian Peto, Asbestos: Effects on health of exposure to asbestos 8 (1985) (“In particular, there are no grounds for believing that gastrointestinal cancers in general are peculiarly likely to be caused by asbestos exposure.”) The litigation efforts of the unions, the litigation industry, and the army of testifying physicians organized by Dr. Selikoff, kept the asbestos-colorectal cancer issue in play in the courts, despite ever increasing data against the conclusion. Finally, four decades after the asbestos insulation union magazine’s notice about Selikoff’s success in a colon cancer case, the Institute of Medicine weighed in on the issue, to find the evidence inconsistent and insufficient to support a causal conclusion. Jonathan Samet, et al., Institute of Medicine, Asbestos: Selected Health Effects (2006).

The Selikoff acolytes, a/k/a “The Lobby,” will review this narrative as “Shooting the messenger: the vilification of Irving J. Selikoff.” Wikipedia, “Irving Selikoff” (last visited Jan. 4, 2014) (citing Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Serv. 619 (2007)).

This view is curious and incorrect for several reasons. First, it is curious that the cited authors, labor historians McCulloch and Tweedale, have themselves taken the liberty to attack important scientists for their litigation . Last year, these authors published their “vilification” of Dr. Anthony Lanza, for having participated in the defense of some litigation cases arising out of the Gauley Bridge tunnel construction. See Jock McCulloch and Geoffrey Tweedale, “Anthony J. Lanza, Silicosis and the Gauley Bridge ‘Nine’,” 26 Social History of Medicine (2013), in press. See also “British Labor Historians Belaboring American Labor History – Gauley Bridge”(Oct. 14, 2013) (pointing out errors in McCulloch and Tweedale’s account of Gauley Bridge).

Second, the Selikoff acolytes are incorrect because the historical facts of Selikoff’s involvement are important for an understanding of how some opinions, such as the notion that asbestos causes colorectal cancer, gained currency in lay and professional communities. These views may have been less attractive to the media and to judges if they had known that Selikoff was such an active worker for the litigation industry, as far back as the early 1950s.

One interesting example of how important judges misunderstood Selikoff’s activities comes from no less an astute observer than Judge Jack Weinstein, who held Selikoff up as an “independent, emiment scientist,” who eschewed the courtroom for the laboratory. See, e.g., Hon. Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995) (“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”) Weinstein was demonstrably wrong in this assessment, just as anyone who held up Lanza as never becoming involved in litigation activities would have been wrong.

Third, this information is important in understanding the evolution of the scientific community’s views about disclosing conflicts of interest. None of Selikoff’s articles disclosed funding from the unions, or his testimonial activities on behalf of the unions and their allied attorneys. For some reason, Selikoff’s heirs, who have continued to follow and to publish about the health outcomes among the asbestos insulation workers, feel that they are exempt from prevailing views about disclosure.

Dr. Steven Markowitz is the lead author on an update of the lung cancer mortality data of asbestos insulators. Steven B. Markowitz, Steven M. Levin, Albert A. Miller, and Alfred Morabia, “Asbestos, asbestosis, smoking, and lung cancer. New findings from the North American insulator cohort,” 188 Am. J. Respir. Crit. Care Med. 90 (2013). Dr. Markowitz testifies widely for plaintiffs in asbestos personal injury cases. See, e.g., Wannall v. Honeywell International Inc., 2013 WL 1966060 (D.D.C. May 14, 2013) (excluding Markowitz’ testimony as unreliable). A review of the disclosure statements for the authors of the 2013 asbestos insulator cohort study shows that Dr. Markowitz declared no consultations that could be a potential conflict of interest. See “The Mt. Sinai Catechism” (June 7, 2013); and “More Hypocrisy Over Conflicts of Interest,” (Dec. 4, 2010) (detailing failures of Selikoff acolytes, Castleman, Lemen, and Frank, in disclosing litigation activities when presenting on related issues to professional societies).

Fourth, there is a recent trend by the litigation industry to claim that failure of defense expert witnesses to make disclosures of their ties to companies constitutes fraud. Indeed, last spring, the New York Appellate Division affirmed a trial court’s decision to conduct an in camera inspection of documents underlying research studies sponsored and funded by Georgia Pacific. Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013). The Appellate Division held that the plaintiffs had made a sufficient “showing of a factual basis adequate to support a good faith belief by a reasonable person that in camera review of the materials may reveal evidence to establish the claim that the crime-fraud exception applies.” 2013 WL 2435565, at *4. See “A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013).

The claim of fraud was perhaps as tenuous as the assertion of the attorney-client privilege. For instance, some of the alleged fraudulent conduct was nothing more than an alleged failure to disclose fully the nature of the relationship between the sponsor, Georgia Pacific, and one of the authors:

“For articles lead-authored by David M. Bernstein, Ph.D., and co-authored by Holm, the only disclosure was that the research was ‘sponsored’ or ‘supported’ by a grant from GP. The articles did not disclose that Holm was specially employed by GP for the asbestos litigation or that he reported to GP’s in-house counsel.”

2013 WL 2435565, at *4. If this evidence be sufficient to show fraud, there will be many parties and expert witnesses in trouble, including the reputation of Dr. Selikoff, and his influence on asbestos litigation and regulation in this country, and abroad.

Finally, this information is important to counteract the distortions of the Selikoff acolytes. Consider for instance the current entry for Selikoff in Wikipedia. Wikipedia, “Irving Selikoff” (last visited Jan. 4, 2014):

“Part of the contrary perspective was presented by a Nathan A. Schachtman, an adjunct lecturer at the Columbia Law School. He suggested that Selikoff and his supporters may have organized ‘a lopsided medical conference, arranged for the conference to feature defendant’s expert witnesses, set out to give short shrift to opposing points of view, invited key judges to attend the conference, and paid for the judges’ travel and hotel expenses’. This quote from Schachtman came from a web site he maintained, unlike the quote from McCulloch and Tweedale, whose comments were published only after being accepted by reviewers for a refereed academic journal.“Nathan A. Schachtman”. www.law.columbia.edu. Columbia Law School. Retrieved September 16, 2013.”

While ’tis true that this humble blogger’s posts are not peer reviewed, what is interesting is that the acolytes did not, and could not, counter on the merits.

What is more, my account of “Selikoff and his supporters” did not recount that they “may have organized ‘a lopsided medical conference, arranged for the conference to feature defendant’s expert witnesses, set out to give short shrift to opposing points of view, invited key judges to attend the conference, and paid for the judges’ travel and hotel expenses’.” My account documented that Selikoff and his supporters did, in fact, do these things. Actually, they were previously documented in litigation and reported by the courts that held that one of the judges who improvidently had attended Selikoff’s Third Wave Conference had to disqualified from presiding over an asbestos class action. In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992); see Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself so as to Preserve the Appearance of Justice under 28 U.S.C.§ 455,” 38 Vill. L. Rev. 1219 (1993); W.K.C. Morgan, “Asbestos and cancer: history and public policy,” 49 Br. J. Indus. Med. 451, 451 (1992)

The point here is not to villify Selikoff but to gain historical perspective and understanding of the enthusiasms that went into creating the largest mass tort in American legal history. Selikoff was an important player in the passion play of products liability litigation, but it is time to substitute history for hagiography.

[1] Bradshaw v. Twin City Insulation Co. Ltd., Industrial Court of Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., E. D. Michigan Southern Division, Civ. Action No. 29433 (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Commonwealth Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973). Selikoff also participated as a testifying witness for the government, in United States v. Reserve Mining Co. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D.Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D.Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Minnesota v. Reserve Mining Co., 420 U.S. 1000, 95 S.Ct. 1441, 43 L.Ed.2d 758 (1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D.Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

Posted in Historian Testimony | Comments Off on Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff

The Historical Intersection of Law and Epidemiology: Miller v National Cabinet (NY Court of Appeals 1960)

January 3rd, 2014

The history of statistics, epidemiology, and products liability are intertwined in ways that call for greater attention. The 1950s and 1960s witnessed increasingly sophisticated statistical approaches to epidemiologic evidence. Starting in 1950, and continuing throughout the 1950s, Sir Richard Doll and Sir Austin Bradford Hill began their epidemiologic exploration of lung cancer among smokers. See, e.g., Richard Doll & A. Bradford Hill, “Smoking and Carcinoma of the Lung,” 2 Br. Med. J. 739 (1950); Richard Doll & A. Bradford Hill, “The mortality of doctors in relation to their smoking habits; a preliminary report,” 1 Br. Med. J. 1451 (1954). In 1955, Sir Richard Doll published his important paper that suggested an association between asbestosis and lung cancer. Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,” 12 Br. J. Indus. Med. 81 (1955). No disparity between observed and expected rates of lung cancer was observed among workers without asbestosis. Measures of p-values were used to assess the strength of the evidence against a null hypothesis of no association. As important an advance as was Doll’s paper, and as careful an investigator as he was, it is remarkable that Doll neglected to consider the potential role of smoking in producing the excess lung cancer rates among the factory workers with asbestosis.

Starting in the 1960s, Dr. Irving Selikoff began publishing his epidemiologic studies of American asbestos insulators. See, e.g., Irving J. Selikoff , Jacob Churg, and E. Cuyler Hammond, “Asbestos exposure and neoplasia,” 188 J. Am. Med. Ass’n 22 (1964). Selikoff neglected to stratify his observational data by the presence or absence of clinical asbestosis (although his later studies suggested that there was a very high prevalence of asbestosis after 20 years from first employment). In addition, these insulator studies used crude measures of smoking, which lumped the very rare non-smoking insulators in with those who “never smoked regularly.”

In 1965, Sir Austin Bradford Hill published his lecture to the Royal Society of Medicine, in which he gave a spirited defense of inferring causality from observational epidemiologic studies. Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295 (1965). Hill was justly proud of the success of observational epidemiology, at least for very large effect sizes that made residual confounding and bias unlikely.

The same years as Hill’s lecture, the American Law Institute published the Restatement (Second) of Torts, with its controversial Section 402A. Before 1965, employee-plaintiff lawsuits against remote suppliers of raw materials and products to employers were a rarity in American law. Bradford Hill’s lecture on causal assessments of “clear-cut” statistical associations came just as epidemiologic, statistical evidence was working its way into tort cases involving smoking and lung cancer. Not surprisingly, some of the first uses of epidemiologic evidence occurred in cases involving claims that tobacco caused lung cancer. See, e.g., Lartigue v. R.J. Reynolds Tobacco Co., 317 F.2d 19 (1963) (affirming defense verdict in case noted for plaintiffs’ use of epidemiologic evidence) (“The plaintiff contends that the jury’s verdict was contrary to the manifest weight of the evidence. … The jury had the benefit of chemical studies, epidemiological studies, reports of animal experiments, pathological evidence, reports of clinical observations, and the testimony of renowned doctors. The plaintiff made a convincing case, in general, for the causal connection between tobacco and cancer and, in particular, for the causal connection between Lartigue’s smoking and his cancer. The defendants made a convincing case for the lack of any causal connection.”), cert. denied, 375 U.S. 865 (1963), and cert. denied, 379 U.S. 869 (1964).

Epidemiologic and statistical evidence in tort cases has become a commonplace, even when it is distorted and abused by litigants and judges. Recent decisions involving claims that benzene caused various cancers are illustrative. See, e.g., Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009) (granting motion to exclude opinions that substantially distorted epidemiologic evidence under the vague rubric of “weight of the evidence”), rev’d, 639 F.3d 11 (1st Cir. 2011) (closing off scrutiny of expert witness’s abuse of epidemiologic evidence in one of the most controversial, reactionary decisions involving federal gatekeeping decisions of recent years), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012). See also David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013); “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (Sept. 2, 2011); “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence” (Sept. 2, 2011)

Given the problematic Milward decision, we might wonder what challenges to benzene-leukemia cases looked like just before Hill’s defense of inferring causality from observational studies began to infuse the witches’ brew of Rule 402A. What did statistical evidence look like before Hill’s paper? In court cases, typically, statistical evidence was presented crudely or not at all.

In 1960, there was little opportunity to challenge causation opinions on admissibility grounds; rather sufficiency of the evidence to support a verdict or judgment was the primary means to gain review of an adverse decision. Case reports of leukemia in workers very heavily exposed to benzene appeared in the 1920s, but it was not until the 1960s that analytical epidemiologic evidence (case-control and cohort studies) of association between leukemia and benzene were published. See generally Deborah Glass, Christopher Gray, Damien Jolley, Carl Gibbons, and Malcolm Sim, “The health watch case – control study of leukemia and benzene: the story so far,” 1076 Ann. N.Y. Acad. Sci. 80-89 (2006). Thus, when the New York Court of Appeals decided a case involving a claim of benzene-induced leukemia, in 1960, the judicial decision was driven largely by the absence of specific quantification of risk of leukemia among workers occupationally exposed to benzene.[1] Miller v. National Cabinet Co., 8 N.Y.2d 277, 281, 168 N.E.2d 811, 813, 204 N.Y.S.2d 129, 132, modified on other grounds, 8 N.Y.2d 1025, 70 N.E.2d 214, 206 N.Y.S.2d 795 (1960). The New York high court wrestled with the formalistic aspects of the expert witnesses’ testimony, including whether they expressed themselves in terms of “possibilities” or “probabilities.” Miller, 8 N.Y.2d at 284, 168 N.E.2d at 814-15, 204 N.Y.S.2d at 134.

Focusing in one of the more knowledgeable of plaintiffs’ expert witnesses, Dr. Reznikoff, the Miller court was impressed that this witness disclaimed any intent to support an inference, from statistical analyses, to the plaintiff’s decedent. Id. at 283. Furthermore, the court suggested that Reznikoff’s evidence might have been sufficient were it not for concession:

“I am sorry I can’t give you any statistics, but we don’t have them.”

Id. at 283. The court appeared also to be concerned that Reznikoff’s approach provided no mechanistic insight or understanding into why many cases of leukemia followed benzene exposure. Id.

Reznikoff’s qualifications to speak to the subject were not dispositive of the question; the court was looking for data that were not available in the 1950s, when the case was tried:

“Not every supposition of a witness concerning what might be has the force of evidence, even though he has been licensed to practice medicine. If the witness is unfamiliar with any statistical data in the medical literature or in his own practice to give an inkling either to himself or to the court or board of how high the incidence of these cases is in situations of this kind, then the doctor’s assumption that it is ‘quite high’ is without significance. The lack of any kind of statistical data, which in the absence of scientific understanding is all that there would be to go on, is the more inexplicable if the claim is well founded in view of the large number of persons who die of leukemia and of workers in industry who are exposed to benzol. If there were any observed correlation between the two, it is certain that a physician of Dr. Reznikoff’s standing would be in possession of the information.”

Id. at 283-84. The court did not excuse the claimant’s evidentiary display with the indulgent, “this was the best evidence available,” when the evidence was inadequate. Nor did the court engage in soothsaying that causality would someday be demonstrated. We might feel some frustration today, looking back, that the court missed this opportunity, but case reports, and even case reports and epidemiologic studies, have generated many false-positive associations. Clearly, more is required, and the New York Court of Appeals recognized the necessity for more.

Traumatic Cancers Distinguished

In 1960, the courts still indulged the proto-scientific opinion that traumatic injury caused cancer.[2] Some medical writers supported this opinion, but by 1960, the opinion was already falling out of favor due to an improved understanding of carcinogenesis.

There is much irony, therefore, in the Miller court drawing’s an invidious distinction between Reznikoff’s proto-epidemiologic evidence and traumatic cancer cases that were still prevalent in the 1960s. Id. at 285-86. In the traumatic cancer cases, in the 1960s, and even in the 1970s, courts sustained verdicts for cancer claimants who had shown that their cancers were diagnosed very shortly after a traumatic blow to the precise portion of the body where cancer manifested. The Miller court referred to these traumatic cancer cases as presenting the kind of causal inferences that could be understood and made by judges and juries. Today, 40 years later, we see those causal inferences as mostly rubbish, based upon incorrect, inadequate, and discarded theories of carcinogenesis.

The prospect of cancer cases sustained by epidemiologic (statistical) evidence clearly troubled the New York court:

“The courts have been confronted before with cancer cases, and this is not likely to be the last. This is not an isolated situation. Questions of causation are common to actions based on warranty, tort or workmen’s compensation proceedings. Would, for example, evidence that there are 4 to 11 times as many cases of lung cancer among cigarette smokers as among nonsmokers be sufficient to establish a cause of action for breach of warranty in the sale of cigarettes? … There appear to be no decisions upholding causation in so complex a variety of the disease as leukemia. The cancer decisions in the courts where recovery has been allowed have dealt almost entirely with trauma, and there only in instances where the trauma occurred in the spot in the body where the pre-existing cancer was and the symptoms of its aggravation were immediately apparent … . In all of those cases the immediacy of the symptoms of aggravation of the cancer by a traumatic injury suffered in the area where the cancer was located was accepted as a substitute for scientific evidence or understanding of cause and effect. Absent that, damage claims of this nature have been dismissed on the law for lack of evidence of causation.”

Id. at 285-86 (internal citations omitted). The Miller court went on to note that New York law required that the cancer must develop at the exact location of the injury. Furthermore, latency between the traumatic blow and the clinical recognition of the cancer was fatal to the claim, even in the face of opinion testimony that a plaintiff’s cancer was a “very slow growing” tumor. Today, we understand that latency between first-exposure and clinical manifestation is necessitated by the length of induction periods and the doubling time of solid tumor cancers. As a result of the Miller court’s reliance upon some dodgy notions of cancer causation, it held that Mr. Miller’s latency period disqualified the case from the immediate impact rule of traumatic cancer cases. Id. at 287-88 (distinguishing Hagy v. Allied Chemical & Dye Corp., 122 Cal. App. 2d 361, 265 P.2d 86 (1953), which involved a diagnosis of laryngeal cancer following immediately upon exposure to sulfuric acid mists).

The majority in Miller further expressed its concern that the understanding of cancer causation was marked by such uncertainty that the mere possibilities of chemical carcinogenesis should not be tolerated in this and similar cases:

“… [F]or so long as the causes of a disease — like cancer — are unknown to science, everyone contracting the disease could secure medical testimony that it is ‘possible’ that the disease is contracted from a wide variety of causes, choosing in each instance the particular possibility having the greatest promise of holding liable some responsible defendant. Any cancer expert could readily state that cancer could be caused by virus infection or by exposure to automobile exhaust fumes, sunlight, radiation, smog, smoking, hormone imbalance or according to any other theory which has been entertained by researchers or specialists as a possibility. Is a malpractice suit pending against some doctor who has given cortisone or ACTH as medicine? Then appears a medical witness who testifies that possibly cancer is caused by hormone imbalance induced thereby. Is it an action for breach of an implied warranty in the sale of cigarettes? Then the medical witness will testify that cigarettes could be a cause of lung cancer. Is it X ray or working in a garage where there have been exhaust fumes? Then the ‘possibility’ doctrine is adapted to creating questions of fact in those fields — and the same with benzol exposure and leukemia. Such a doctrine would overturn the rule that the burden is on the party asserting that a disease is based on actionable facts to prove causation. It would mean that, wherever such a cause is possible, the burden rests on the opposite party to prove that the disease resulted from something else. Consequently, for so long as the causes of the disease are unknown to medical science, the claimant or plaintiff can always recover — if the trier of the fact is favorably disposed — since no one can prove that the disease had other causes. This is a perversion of the normal rule that the disease must have resulted from the occupation and that the burden of proving causation is upon the party asserting it. The law does not intend that the less that is known about a disease the greater shall be the opportunity of recovery in court.”

Id. at 289.

The Miller decision provoked a dissent, mostly on formalistic grounds. Id. at 290. The dissenting judges asserted, without much analysis, that there was substantial evidence to support causality. Given that qualified expert witnesses showed up for the claimant seemed sufficient on this score for the dissenters. To the extent that the claimant’s expert witnesses expressed themselves in terms of possibilities, the dissenters opined that possibilities are sufficient, especially in the context of workman’s compensation cases, in which the burden of proof standards are lower than in common law civil liability cases.

The majority opinion stands as an eloquent expression of concern about the need for quantitative evidence of statistical risk in chemical exposure cancer cases. The court also presciently saw what would become a plague of litigation involving claims of cancer causation. In 1960, for benzene and leukemia, the evidence was clearly, even by the standards of the day, inadequate, and the claimant’s expert witnesses were appropriately modest about what inferences could be drawn both with respect to general and specific causation. The 1970s would witness a growing immodesty among available expert witnesses, as well as an explosive growth in the techniques and applications of analytical epidemiology to many problems, including the relationship between benzene and leukemia.

[1] A decade or two later, the scientific community recognized high levels of exposure to benzene as a cause of certain kinds of leukemia, by virtue of epidemiologic studies. See, e.g., Fusun Yaris, Mustafa Dikici, Turhan Akbulut, Ersin Yaris, Hilmi Sabuncu, “Story of benzene and leukemia: epidemiologic approach of Muzaffer Aksoy,” 46 J. Occup. Health 244 (2004); Abdul Khalade, Maritta S Jaakkola, Eero Pukkala and Jouni JK Jaakkola, “Exposure to benzene at work and the risk of leukemia: a systematic review and meta-analysis,” 9 Envt’l Health 31 (2010). See also Michael D. Green, The Paradox of Statutes of Limitations in Toxic Substances Litigation, 76 Cal. L. Rev. 965, 974 (1988).

[2] William B. Coley & Norman L. Higinbotham, “Injury as a Causative Factor in the Development of Malignant Tumors,” 98 Annals of Surgery 991 (1933); Shields Warren, “Minimal Criteria Required to Prove Causation of Traumatic or Occupational Neoplasms,” 117 Annals of Surgery 585 (April 1943); Shields Warren, “Criteria Required to Prove Causation of Occupational or Traumatic Tumors,” 10 U. Chi. L. Rev. 313, 318-20 (1943); Russell & Clark, “Medico-Legal Considerations of Trauma and Other External Influences in Relationship to Cancer,” 6 Vand. L. Rev. 868, 875 (1953); Arden R. Hedge, “Can a Single Injury Cause Cancer?” 90 California Medicine 55 (1959); Auster, “The Role of Trauma in Oncogenesis: A Juridical Consideration,” 175 J. Am. Med. Ass’n 940, 949 (1961); Comment, “Sufficiency of Proof in Traumatic Cancer Cases,” 46 Cornell L.Q. 581, 581-82 (1961); Comment, “Sufficiency of Proof in Traumatic Cancer: A Medico-Legal Quandary,” 16 Arkansas L. Rev. 243, 256 67 (1962); Dyke, “Traumatic Cancer,” 15 Clev.Mar. L. Rev 472, 484-94 (1977). See also Comment, “Judicial Attitudes Towards Legal and Scientific Proof of Cancer Causation,” 3 Columbia J. Envt’l L. 344, 354-68 (1977).

Posted in Scientific Evidence, statistical evidence | Comments Off on The Historical Intersection of Law and Epidemiology: Miller v National Cabinet (NY Court of Appeals 1960)

The Not-So-Elite Defense Bar’s Approach to Gatekeeping

January 2nd, 2014

A couple of months ago, Professor David Bernstein posted to the Volokh Conspiracy, a short piece about some of the missteps and mistakes committed by “elite defense counsel” in litigating expert witness issues. See David Bernstein, “The Elite Defense Bar and Expert Evidence” (Nov. 6, 2013). Professor Bernstein makes some interesting points about questionable positions taken by “elite defense counsel” (read: “highly paid, large firm lawyers”). For instance, according to Bernstein:

1. elite defense lawyers missed the boat early on by arguing that statistical evidence (observational epidemiology) was inadmissible or insufficient to prove general or specific causation;

2. defense counsel missed the significance of the Supreme Court’s opinion in Daubert;

3. defense counsel continued to press for Frye rule in state courts, although the Frye rule had been shown inadequate and unavailing as a rule to control medical causation opinions; and

4. defense bar has grown soft on Rule 702.

Although the charges seem at points overstated, Bernstein has presented an important indictment of the defense bar. At the very least, the charges deserve a full exploration by a wider audience. Defense lawyers who are self-critical about their practice should certainly be concerned that someone as persistently pro-702 has taken aim at them.

On the first point, many of the early scientific causation battles were fought in tobacco litigation, in which defendants and their counsel were forced to deny and contest the obvious, the causal role for tobacco in carcinogenesis, at all costs. The tobacco defense bar, however, should not be confused with the defense bar, generally. Defense lawyers in Bendectin, silicone, and asbestos cases developed arguments against specious use of epidemiologic evidence, as well as sophisticated, affirmative use of epidemiologic evidence to show lack of association. Even so, we should keep in mind that it often requires a large body of epidemiologic evidence to show “no association,” and it is not the defense’s burden to do so.

The use of statistical or probabilistic evidence for inferring specific causation has been, and remains, problematic. See, e.g., Richard Doll, “Proof of Causality: Deduction from Epidemiological Observation,” 45 Perspectives in Biology & Medicine 499, 500 (2002) (“That asbestos is a cause of lung cancer in this practical sense is incontrovertible, but we can never say that asbestos was responsible for the production of the disease in a particular patient, as there are many other etiologically significant agents to which the individual may have been exposed, and we can speak only of the extent to which the risk of the disease was increased by the extent of his or her exposure.”) Notwithstanding the controversy, defense counsel and some astute judges have understood the indeterminate nature of statistical evidence for specific causation, and have advanced a pragmatic position of resolving specific causation controversies against plaintiffs when risk ratios failed to exceed two. See, e.g., In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 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).

Early use of meta-analysis by plaintiffs’ expert witnesses elicited generalized attacks on meta-analysis by defense counsel. See, e.g., In re Paoli Railroad Yard PCB Litigation, 706 F. Supp. 358, 373 (E.D. Pa. 1988) (Kelly, R., J.) (excluding plaintiffs’ expert witness Dr. William Nicholson and his testimony based upon his unpublished meta-analysis of health outcomes among PCB-exposed workers), rev’d 916 F.2d 829, 856-57 (3d Cir. 1990), cert. denied, 499 U.S. 961 (1991). Again, it took some time for the defense to understand the potency of meta-analysis in synthesizing and presenting a summary point estimate that essentially rules out any meaningful play of chance. In the silicone gel breast implant litigation, one defense expert witness conducted and published his meta-analysis of autoimmune disease outcomes. Otto Wong, “A Critical Assessment of the Relationship between Silicone Breast Implants and Connective Tissue Diseases,” 23 Regulatory Toxicol. & Pharmacol. 74 (1996). When the MDL 926 court got around to appointing court-appointed expert witnesses, they too picked up on the approach and made meta-analyses the hallmark of their reports. See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998)”; Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000).

On the second charge, many defense lawyers missed, and continue to miss, the significance of a shift to evidence-based scientific testimony, as opposed to the authority-based worldview. When I first started trying cases, senior trial lawyers instructed me not to engage plaintiffs’ expert witnesses on substantive issues, but to limit cross-examination to “collateral attack” on bias and related issues. The problem that I saw was that when both sides limited the attack to the other side’s expert witness’s bias, the plaintiffs won because juries were often all too willing to think the worst of defense experts, and forgive plaintiffs’ experts. Nothing short of dramatically confronting the jury with the rubbish, inconsistencies, and incoherence spouted by the plaintiffs’ expert witnesses worked. I quickly learned to ignore the old timers’ advice, and most of them have now dropped off.

Bernstein gives the example of the Dow Corning lawyers’ declining the Ninth Circuit’s invitation to reframe their appeal in Hopkins v. Dow Corning, 33 F.3d 1116 (9th Cir. 1994), after the Supreme Court handed down Daubert. He may well be right about that case, but the lawyers may have been inhibited by positions that they had taken earlier in the case, before the Supreme Court breathed life into Rule 702. Still, the Hopkins decision remains a derelict on the jurisprudential sea of expert witness law. Truth be told, there are other cases that turned out badly because of overstated or poorly framed defense arguments.

As for their persistent affection for Frye, the defense lawyers referenced by Bernstein certainly lacked imagination, and maybe even a full measure of zeal. The Frye case had never proven itself to be an important defense against specious expert witness opinion testimony on medical causation issues. Daubert held out the promise that trial judges would actually have to engage with the evidence, rather than counting noses for “general acceptance,” or kicking the can, after hearing qualifications. I still recall how my colleagues and friends viewed Daubert, in 1993. Bristol Myers Squibb and other companies were inundated by silicone breast implant cases, and plaintiffs had managed to snucker a few juries into returning large verdicts against the defendants. Daubert was a lifeline, a way to focus trial judges’ attention on the plaintiffs’ expert witnesses and the fatally flawed, even fraudulent scientific studies that had found their way into the peer-reviewed journals, and into the courtroom.

What has happened to Daubert? Well, of course, it is no longer Daubert, but now a much more potent statutory rule, Federal Rule of Evidence 702, as amended in 2000, and recently “restylized.” Professor Bernstein may be on to something in calling out the hubris of big firm lawyers, who think that their prowess in litigating scientific issues comes from charging high fees. The sad truth is that the level of scientific and statistical acumen of lawyers generally, whether at the bench or at the bar, is low. There is much work for law schools to do to change this situation.

There are other forces at work in creating the phenomena described by Professor Bernstein. Many product liability cases involve multiple defendants. Defending such cases from the defense perspective is often like herding house cats. Every defense counsel thinks he or she knows the best course; no one wants to do anything that raises the profile of his client or increases the cost of defense. Furthermore, products liability defense work has become increasingly “commoditized” in the last two decades. Clients and third-party payors increasingly impose budgets that do not allow defense lawyers sufficient time to develop the necessary expertise and learning to discover, understand, and challenge plaintiffs’ scientific expert witnesses fully and effectively. There is, sadly and unfortunately, a contingent of defense lawyers who would rather see speculative claims flourish and mature into full-scale litigation, with lots of trials and appeals (and large fees), than to see specious claiming pretermitted by pre-trial judicial gatekeeping.

Another factor that may have stunted the gatekeeping process is the growth of federal (and state) multi-district litigation (MDL). By centralizing the pre-trial handling of large, multi-plaintiff tort litigation in the hands of a single judge, the MDL process has raised the stakes for the trial judge gatekeeping. The MDL judge is no longer deciding a single case, but the fate of thousands of claimants. The Rule 702 process suffers in several ways. First, many MDL judges are clearly intimidated by the life-or-death control they have over hundreds, if not thousands, of claims. These judges may well now be inclined to deny the Rule 702 challenges, in the fond hope that juries and appellate courts will take care of the problem. Second, there is no longer the incremental decision making of case-by-case exploration of the issues. There are economies of scale, to be sure, but the single MDL judge cannot learn from previous trial judges’ decisions and records. The evolutionary approach of the common-law is undermined by the efficiencies of MDL procedure. Third, the MDL process blunts one of the virtues of judicial gatekeeping in requiring the transparent statement of reasons for the grant or denial of a Rule 702 motion to exclude expert evidence. By the time the scientific, legal academic, and legal practitioner communities can weigh in on the gatekeeping process, the Rule 702 decision is a fait accompli, in the form of a single judicial decision. Compare In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.) (denying defendant’s Rule 702 motions with respect to plaintiffs’ expert witnesses’ opinions that Avandia causes heart attacks) with “FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2013) (re-evaluating evidence that Avandia does not increase risk of heart attacks). See also “Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011).

Not surprisingly, plaintiffs’ counsel have gotten better at dressing up weak and fatally flawed evidence as “inference to the best explanation,” or “weight of the evidence” evaluations that have the appearance without the reality of scientific conclusions. And as evidenced by the Third Edition of the Reference Manual on Scientific Evidence, and many recent 702 decisions in the Circuits (and Matrixx Initiatives in the Supreme Court), the federal judiciary has lost its will and its way in applying Rule 702. An activist core of federal trial and appellate courts have shown increasing hostility and outright disregard for the gatekeeping process, and a willingness to disregard the language of the statute, Supreme Court precedent, and sound scientific and statistical methodology. Rule 702 in its present form is a strong rule, but unfortunately it is neutralized in the hands of weak judges who cannot or will not explore the intricate methodological issues raised by Rule 702 and 703 motions.

The phenomenon identified by Professor Bernstein may be real, but like many natural (and unnatural) phenomena, the causes are not always easily discerned. The phenomenon and its causes are worth a deeper exploration.

Posted in Expert Witnesses, Rule 702 | Comments Off on The Not-So-Elite Defense Bar’s Approach to Gatekeeping

Gastwirth on the Wells Case

December 27th, 2013

One of the high points of 2013 for me was the Practicing Law Institute seminar on expert witness gatekeeping. I am indebted to my co-chair David Cohen, and the talented participants, Dr. David Garabrant, Joe Cecil, Mary Wells, and Mike Williams. I learned a great deal from all of them, even when we disagreed.

At the seminar, which addressed the slippage in the federal judiciary’s fidelity to Rule 702 text and principles, Joe Cecil kindly reminded me of Professor Gastwirth’s contribution on the Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262, 298 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11^th Cir.), cert. denied, 479 U.S.950 (1986). Joseph L. Gastwirth, “The need for careful evaluation of epidemiological evidence in product liablility cases: a reexamination of Wells v. Ortho and Key Pharmaceuticals,” 2 Law, Probability and Risk 151 (2003).

The Supreme Court recently reinvigorated the Wells case, and like Frankenstein’s monster, it walks again. Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011). See also “Matrixx Unloaded.” As a result of the Matrixx decision, I revisited the untoward Wells decision several times this year. See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; and here, here, here, here, and here. Joe’s reminder, however, provoked me to look one more time at Wells, through the lens of Gastwirth’s review.

Gastwirth is a well-known statistician, not a lawyer. His article undertakes some interesting sensitivity analyses of the potential role of one known confounder in the epidemiologic studies of spermicides and birth defects, cited by witnesses in Wells. Not surprisingly, Gastwirth confuses important legal concepts, when he contends that science and law have different goals because science has the luxury of waiting for additional studies to resolve indeterminate datasets. Gastwirth at 154. Gastwirth suggests that in law, causality determinations turn on fairness, but in science, they turn on the truth. Gastwirth offers no support for his assertion, and there is much law to the contrary. Federal Rule of Evidence 102, for instance, explains the “Purpose” of the Federal Rules and how they should be construed:

“These rules should be construed so as to administer every proceeding fairly, eliminate unjustifiable expense and delay, and promote the development of evidence law, to the end of ascertaining the truth and securing a just determination.”

Truth does count, at least in some courts, and it is hard to imagine a case in which the goals of truth and justice are bifurcated. Gastwirth sees law courts as unable to avoid judgment when the evidentiary display is weakly developed or not replicated, but he is wrong. Courts can, do, and should avoid permitting judgments based upon indeterminate datasets.

Gastwirth also contends that the duty to warn in tort is based upon a possibility of causation, and he opines that this is perfectly satisfactory. Gastwirth at 155. Gastwirth cites the Restatement (Third) a/Torts for his view, but the Restatement does not couch the duty to warn as predicated upon merely possible risk:

“A defendant will not be liable under an implied warranty of merchantability for failure to warn about risks that were not reasonably foreseeable at the time of sale or could not have been discovered by way of reasonable testing prior to marketing the product. A manufacturer will be held to the standard of knowledge of an expert in the appropriate field, and will remain subject to a continuing duty to warn of risks discovered following the sale of the product at issue.”

Id. (emphasis added). Gastwirth fails to explain why the epistemic standard of the Restatement should be diluted to include merely possible risks; nor does he explain why the law should impose a duty because a minority of so-called experts claim knowledge of the existence of a risk, whether potential or known.

Risks are based upon known causal relationships, viewed ex ante rather than post hoc. Gastwirth attempts to defend the Wells decision on the basis that the trial judge, Judge Shoob, could have correctly found a possible risk, but this was not then or now the standard for imposing a duty to warn. Even if possibilities were the basis for a duty to warn, the courts in Wells had to find sufficient evidence of cause in fact between the spermicidal jelly and the birth defect present in the infant plaintiff. No merely possible risk could have satisfied this burden, and Gastwirth avoids this important issue in his review. Ultimately, Gastwirth fails to come to grips with how the Wells courts artificially distinguished two causation standards – warning-harm and product-harm. Gastwirth at 184.

When courts are required to work with an epistemic standard for evaluating opinions about causal claims, they will often confront sincere beliefs supported by “putative” justifications, but which turn out to be untrue. The obvious implication is that the causal opinions were not “true” when offered, and the asserted, putative justification was no justification at all. Twenty years post-Daubert should have made our courts more sensitive to the pathology of claiming, or pathoepistemology, as I call it.

Although Gastwirth is intent to show that the district and circuit court decisions in Wells were reasonable given the record evidence at the time of their decisions, Gastwirth’s defense is tepid at best. Gastwirth concedes that the plaintiffs’ evidence in the Wells case was not very convincing, and he is quick to point out that he does not conclude that spermicides cause limb reduction defects (although he does believe that the data were sufficient for his idiosyncratic diluted duty-to-warn legal standard:

“The epidemiological evidence in the Wells case surely was not very convincing and it is understandable that scientists and legal scholars might desire stronger scientific evidence before holding a defendant liable. What seems unfortunate is the lack of discussion of the part of the record most supportive of the legal decisions from the published criticisms.²⁰¹ While it is reasonable to ask how much evidence should be required before a warning is required, is it fair to rely on studies that were published after the time of exposure to assess the producer’s duty at the time?”

Gastwirth at 184-85. The equivocation in this passage between assessing causation for a duty to warn and for product harm is typical of Gastwirth’s confusion throughout this article. As noted, Gastwirth appears to believe it is sufficient to show the plausibility of the causal relationship such that the trial court’s findings of a duty to warn, and a breach of that duty, were reasonably supported:

“It should be stressed that our examination of the studies does not conclude that exposure to spermicides causes limb reduction defects. ²⁰² Indeed, the studies published in the 1980s are sensitive to the potential effect of unmeasured known potential risk factors that were not controlled for in the analysis. Many studies observed that it is difficult to rule out small but meaningful risks given their sample size or that more studies including potential confounding variables be carried out before a scientific conclusion can be reached.²⁰³”

Gastwirth at 185 & n.202. So small increased risks were difficult to rule in or rule out, but then how can a judgment for plaintiffs be sustained unless, as I have shown elsewhere, Judge Shoob improperly placed the burden of proof upon the defendant? The studies published in the 1980s may have been sensitive to the potential effect of unmeasured and uncontrolled known potential risks, but Judge Shoob clearly was not sensitive to the problem at all.

Other problems abound. The studies involved in the Wells case not only failed to account for the few known confounders at the time, but they could not and did not sort out the residual confounding. Gastwirth concedes the point in a footnote, in which he cites a paper by Professor Gary Shaw on the role of multivitamin use in preventing birth defects. See Gastwirth at 185 & n. 202 (citing Shaw et al., “Maternal Periconceptional Use of Multivitamins and Reduced Risk for Conotruncal Heart Defects and Limb Deficiencies Among Offspring,” 59 Am. J. Med. Genetics 536 (1995) (showing that children of mothers who had taken vitamins and folic acid had a 30-35% lower risk of limb defects). Gastwirth sees the discovery of causes not previously controlled for in the spermicide/birth defect studies of the 1980s as example of the differences between scientific and legal judgments. Another way to look at such discoveries is to impose some standard of intellectual modesty upon courts in basing their findings upon speculative causal claims.

Gastwirth’s casual dismissiveness of the need for replication in a legal standard of causation is difficult to square with his acknowledgment that early studies often prove misleading about the existence of a true risk. Gastwirth, for instance, acknowledges that later publications quite commonly do not support initial hypotheses. Gastwirth at 179, 184 (citing Michael B. Bracken, “Spermicidal Contraceptives and Poor Reproductive Outcomes: The Epidemiologic Evidence Against an Association,” 151 Am. J. Obstet. & Gyncecol. 552, 555 (1985)). Gastwirth channels the anti-manufacturer Zeitgeist for his claim that “firms” may not report studies that show risk, but he ignores the pervasive, prevalent practice of academic and advocacy scientists’ not publishing negative studies in the first place, and even later in the natural history of scientific controversies.

Ultimately, however, Gastwirth’s own judgment is a self-fulfilling prophecy of how the law and science should part company over false-positive assertions of causality. Fortunately, the law has evolved in a different direction, towards convergence of scientific and legal modes of assessing causal claims. Now judges must evolve as well.

Posted in Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Gastwirth on the Wells Case

How Law Professors Think — About Expert Evidence

December 19th, 2013

In a recent law review article, two University of Virginia law professors question whether expert evidence should be subject to its own exclusionary rules. Frederick Schauer and Barbara A. Spellman, “Is Expert Evidence Really Different?” 89 Notre Dame L. Rev. 1 (2013)[Schauer & Spellman]. Professors Schauer and Spellman argue that expert evidence is not really different from other kinds of evidence, and they suggest that the exclusionary procedures introduced by Daubert and its progeny are ill conceived.

Gedankenexperiment

In order to understand the exact nature of the harms of “junk science,” the authors conduct an interesting Gedanken experiment:

“Suppose ten witnesses testify that they had never been sick a day in their lives, that they then moved in middle age to a community in close proximity to a defendant’s chemical plant, and that they were all diagnosed with the same form of cancer within a year. And suppose that this is the only evidence of causation.”

The authors conclude that this evidence is relevant under Federal Rule of Evidence 401, and sufficient to raise a triable issue of fact. From their conclusion, the authors argue further all the dangers of mass tort causation evidence are independent of junk science because a jury would be free to reach a verdict for plaintiffs based upon pure sympathy, anti-corporate animus, white-hat bias, or Robin Hood motives. The authors see, in their hypothetical, a jury reaching a judgment against the defendant

“regardless of any strong evidence of causation, and without any junk science whatsoever.”

Schauer and Spellman’s conclusions, however, are wrong. Their hypothetical evidentiary display is not even minimally logically relevant. They are correct that there is no strong evidence of causation, but whence comes the conclusion that no “junk science” would be involved in the jury’s determination? That determination would not have even the second-hand support of an expert witness opinion, but it would be jury’s first-hand, jejune interpretation of a completely indeterminate fact pattern.

These authors, after all, do not specify what kind of cancer is involved. Virtually no cancer has an induction period of less than a year. Their hypothetical does not specify what chemicals are “released,” in what route of exposure, in what level, and for what duration. Furthermore, the suggestion of logical relevance implies that the described occurrence is beyond what we would care to ascribe to chance alone, but we do not know the number of people involved, or the baseline risk of the cancer at issue. One in a million happens eight times a day, in New York City. Flipping a coin ten times, and observing 6 heads and 4 tails, would not support an inference that the best evidence we have is that the coin will always favor heads to tails in a ratio of 1.5.

Schauer and Spellman might improve their hypothetical, but they are unlikely to free themselves of the need for expertise beyond the ken of a lay jury to evaluate the clinical, epidemiologic, scientific, and statistical issues raised by their supposed disease “outbreak.” And although they have taken the expert witness as the usual purveyor of junk science out of the hypothetical by design, they have simply left the jury to draw a bogus inference. The junk is still at work, only the jury is no longer a passive recipient of the inference; they are themselves the authors of the junk-science inference.

Schauer and Spellman’s Claim That Expert Evidence Is Not Really Different

The authors make the case that there are some instances in which expert witness opinion testimony is not so different from lay opinions about intoxication or speed of a car or eyewitness identification. But Schauer and Spellman are wrong to allow themselves to be fooled about expert witness testimony in many complex mass tort cases.

Such cases commonly involve several scientific disciplines, such as toxicology, epidemiology, exposure assessment, neuropsychology, and others. The expert witness for each discipline might have a few dozen studies that are germane to the issues in the case, and each one of those studies might cite or rely upon several papers for their background, methods and inferences. Reference lists for each expert witness might run into the hundreds of articles, and in some cases, the experts might need to access underlying data and materials to understand fully the papers upon which they have relied. A careful reading of each paper might require an hour or more for the expert to understand the claims and limitations of the study. The expertise to understand the articles fully may have taken years or decades of education.

Juries do not have the time, the interest, the aptitude, the training, the experience, to read, understand, and synthesize the data and information in the studies themselves. Our trials involving complex technical issues are much like Plato’s allegory of the cave; the jury never sees the actual evidence, only shadows cast by evidence they are usually not permitted to see, and don’t care to see when they have the chance. Juries decide technical issues based upon mostly the appearance of expertise, not upon evidence.

Some years ago, I tried an asbestos case against Charles “Joey” Grant, in front of Judge Armand Della Porter and a jury in Philadelphia Court of Common Pleas. Joey represented a man who claimed that he had asbestosis from working at the Philadelphia Naval Shipyard. His chest X-ray interpretation was disputed, but he has small-airways obstruction, which his expert witness attributed to asbestosis. The defense expert thought smoking was a much more likely cause of the obstruction, but the plaintiff had denied smoking in his deposition. In order to test his assertion, the defense asked a private investigator to conduct surveillance of the plaintiff to determine whether or not he was a smoker.

The investigator, retired Alcohol Tobacco and Firearms agent Frank Buenas, tailed the plaintiff and observed and photographed him smoking. Plaintiff’s counsel, Joey Grant, seized on my not having provided Buenas an authenticated photograph of the plaintiff, and challenged the identification and every aspect of the surveillance. The direct examination lasted no more than 25 minutes; the cross-examination lasted about four hours.

Joey was a very good trial lawyer. He had just come out of the Philadelphia District Attorney’s office, after having successfully prosecuted Nicodemo “Little Nicky” Scarfo. Joey was also a good looking African American man who played well to our all female, all African American jury. The issues of the surveillance, and of whether or not he plaintiff was a smoker, were understandable and accessible to the jurors, who were riveted by Joey’s cross-examination. Ultimately, the issues were resolved for the jury in a dramatic fashion. The plaintiff, who continued to work at the Navy Yard, returned to court at the end of his shift, towards the end of the day in court. Over objection, I called him back to the stand. He had not heard the investigator’s testimony, but when I showed him Buenas’ photographs, he exclaimed “that’s my bald head!” The jurors practically lunged out of their seats when I published the photographs to the jury over Joey’s objection.

The point of the war story is to recount how the jury followed a protracted examination, and ignored their bias in favor of Joey, and their prejudice against me, the white guy representing the “asbestos companies” in this reverse-bifurcated trial. The testimony involved a predicate issue whether Buenas had followed and photographed the right man in the act of smoking. Would a jury, any jury, follow the testimony of a scientist who was being challenged on methodological details of a single study, for four hours? Would any jury remain attentive and engaged in the testimony of expert witnesses who testified on direct and cross-examination in similar detail about hundreds of studies?

Having tried cases that involve both the simple, straightforward issue such as Buenas’ investigation and surveillance, and also complex scientific issues, I believe the answer is obvious. None of the studies cited by Schauer and Spellman address the issue of complexity and how it is represented in the courtroom.

Most judges, when acting as the trier of fact, lack the interest, time, training, and competence to try complex cases. Consider the trial judge who conducted bench trial of a claim of autoimmune disease caused by silicone. The trial judge was completely unable to assess the complex immunological, toxicological, and epidemiologic evidence in the case. See Barrow v. Bristol Myers Squibb Co., No. 96 689 CIV ORL 19B, 1998 WL 812318 (M.D. Fla. Oct. 29, 1998). In another courtroom, not far away, Judge Sam Pointer had appointed four distinguished expert witnesses under Rule 706. In re Silicone Gel Breast Implant Prods. Liab. Litig. (MDL 926), 793 F. Supp. 1098 (J.P.M.L. 1992) (No. CV92-P-10000-S), Order No. 31, 31B, 31E. In November 1998, a month after the Middle District of Florida trial court decided the Barrow case, the four court-appointed expert witnesses filed their joint and individual reports that concluded that silicone in breast implants “do[es] not alter incidence or severity of autoimmune disease” and that women who have had such implants “do[] not display a silicone-induced systemic abnormality in the . . . cells of the immune system.” National Science Panel, Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction, Executive Summary at 5-6 (Nov. 17, 1998). The Panel also found that “[n]o association was evident between breast implants and any of the . . . connective tissue diseases . . . or the other autoimmune/rheumatic conditions” claimed by the thousands of women who had filed lawsuits. Id. at 6-7.

Another case, in the causal chain that produced the Daubert decision, might also have cautioned Professors Schauer and Spellman against oversimplifying the distinctions between expert and other evidence. 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 (11^th Cir.), cert. denied, 479 U.S.950 (1986). The Wells case was a bench trial, in which the trial judge honestly professed not to have understood the epidemiologic evidence, and to have decided the case on his assessment of expert witness demeanor and atmospherics. And like the Barrow case, the Wells case was clearly wrongly decided. See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1” (Nov. 12th, 2012) (footnote 1 collects a sample of citations criticizing Judge Shoob’s failure to engage with the scientific evidence).

Jury determinations, unlike the clearly erroneous determinations in Barrow and Wells, are “black boxes.” The public and the scientific community cannot really criticize jury decisions because the jury does not explain their inferences from evidence . The lack of explanation, however, does not save them from engaging in junk science. Outside the Gedanken experiment above, jurors can blame expert witnesses for their errors. In the experiment’s hypothetical, junk science is still taking place.

The Discomfort With Daubert

The authors recount many of the charges against and criticisms of the Daubert decision. Schauer & Spellman at 2. They note that some commentators assert that the Justices in Daubert embraced a “clumsy philosophy of science.” But at least Justice Blackmun engaged with the philosophy of science, and the epistemic requirements of Rule 702, and made some attempt to reconcile the truth-finding process in court with what happens in science. The attempted reconciliation was long overdue.

The authors also point out that some commentators have expressed concern that Daubert burdens mass tort and employment discriminations who “non-traditional experts and expertise.” Id. To paraphrase Tim Minchin, there is non-traditional opinion known not to be true, and non-traditional opinion not known to be true, but if non-traditional opinion is known to be true, then we call it … knowledge. Perhaps Schauer and Spellman think that our courts should be more open and inclusive, warmer and fuzzier, for clinical ecologists, naturopaths, aromatherapists, homeopaths, and other epistemiopaths. My sense is that these non-traditional experts should be relegated to live in their own world of magical thinking.

The authors give voice to “the broad worry that law should not outsource its own irreducibly legal determinations to science and scientists with different goals and consequently different standards.” But science and the law are both engaged in truth determinations. Maybe the law should worry more about having jurors and judges making their determinations with different goals and standards. Maybe the law should be more concerned with truth and scientific accuracy, and should not outsource its “irreducibly fact determinations” to the epistemiopaths.

Expert witness testimony is clearly different in many important respects from lay witness testimony and other evidence. The expert witness testimony is largely opinion. It relies upon many layers of hearsay, with many of the layers not subject to ready scrutiny and testing for veracity in a courtroom. Many layers of the “onion” represent evidence that would not be admissible under any likely evidentiary scenario in a courtroom.

And jurors are reduced to using proxies for assessing the truth of claims and defenses. Decisions in a courtroom are often made based upon witness demeanor, style, presentation, qualifications, and appearance of confidence and expertise. The authors lament the lack of empirical support for the last point, but this misses the larger point that the issue is not primarily an empirical one, and the point is not limited to jury competence. Hon. Jed S. Rakoff, “Lecture: Are federal judges competent? Dilettantes in an age of economic expertise,” 17 Fordham J. Corp. & Fin. L. 4 (2012).

The Monte Hall Problem and Cognitive Biases

The “Monty Hall problem” was originally framed by statistician Steve Selvin in publications in the American Statistician in 1975 (Selvin 1975a), (Selvin 1975b). The problem was then popularized by an exposition in Parade magazine in 1990, by Marilyn vos Savant. The problem, based upon Monty Hall’s television game show Let’s Make a Deal, and Monty’s practice of asking contestants whether they wanted to switch. A full description of the problem can be found elsewhere.

For our purposes here, the interesting point is that the correct answer was not intuitively obvious. After vos Savant published the answer, many readers wrote indignant letters, claiming she was wrong. Some of these letters were written by college and university professors of mathematics. Vos Savant’s popularization of Selvin’s puzzle illustrates that there are cognitive biases, flaws in reasoning, and paradoxes, the avoidance of which requires some measure of intelligence and specialty training in probability and statistics. See also Amos Tversky and Daniel Kahneman, “Judgment under Uncertainty: Heuristics and Biases,” 185 Science 1124 (1974).

Our system of justice suffers enough from the current regime of trial by sound-bite. It should not be further undermined by the abandonment of judicial gatekeeping and judicial review of the quality and quantity of scientific evidence in our civil and criminal trials. Opponents of gatekeeping imply that the Federal Rules of Evidence should be “liberally” construed, by which they usually mean, construed consistent to their biases and prejudices. The adjective “liberal,” both traditionally and today, however, connotes enlightened, free from superstition, bias, prejudice, and promoting accuracy in judgments that are important to institutional respect and prestige. Let’s hope that 2014 is a better year for science in the courtroom.

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Supreme Court Denies Certiorari in Harkonen v. United States

December 16th, 2013

The Supreme Court took up Dr. Harkonen’s petition for certiorari on Friday, December 13, 2013. The SCOTUS Blog made the petition its “Petition of the Day.”

Unfortunately, the blog’s attention did not carry over to the Court’s conference. The Court release its orders this morning, which included a denial of certiorari in Harkonen v. United States.

Although there was a good deal of noise about Dr. Harkonen’s intent, that issue is uniquely case specific. The real issue going forward would seem to be the reach of the government’s position, and now the Ninth Circuit’s position, that failure to disclose multiple testing or deviation from a protocol is demonstrably false or misleading. In Dr. Harkonen’s case, the causal inference was reasonably supported despite the non-protocol analysis. The use of the verb “demonstrate,” however, is often used carelessly, and the Harkonen decision may well breathe life into Rule 702 gatekeeping.

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Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims

December 12th, 2013

In the spring of 2012, Judge Sandra Mazer Moss granted summary judgment to Proctor & Gamble, after excluding, on Frye grounds, plaintiff’s expert witnesses who opined that plaintiff suffered zinc neurotoxicity from his use of Fixodent. Jacoby v. Rite Aid Corp., 2012 Phila. Ct. Com. Pl. LEXIS 208 (2012). See “Philadelphia Plaintiff’s Claims Against Fixodent Prove Toothless” (May 2, 2012). Judge Moss’s exclusion of plaintiff’s expert witnesses involved a careful analysis of the evasive, hand-waving tactics of the witnesses. Among the plaintiff’s team of expert witnesses was Dr. Martyn Smith, the chief hand waver and obscurantist in Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012).

On Monday, December 9, 2013, after a careful review, the Pennsylvania Superior Court affirmed summary judgment for Proctor & Gamble in the Jacoby case. Jacoby v. Rite Aid Corp., Pa. Super. Ct. No. 1508 EDA 2012 (Dec. 9, 2013) [Slip op.] The Superior Court panel, consisting of Judges Stevens, Lazarus, and Colville, largely adopted Judge Moss’s analysis and affirmed in a signed, but unpublished, opinion by Judge Lazarus.

Like Judge Moss before them, the Panel saw through the attempt to pass off “Weight of the Evidence” (WOE) and “Totality of the Evidence” (TOE) as scientific methodologies. The witnesses, Martyn Smith and others, failed to specify what evidence they weighed, how they weighed the evidence, and what the weights supposedly were. Another expert witness vaguely pointed to the “Naranjo scale” in support of interpreting case reports to show causal association, but this scale was similarly incompetent other than as a crude “plausibility” scale for assessing case reports.

The Superior Court’s decision in Jacoby is noteworthy on several important issues. There was no material issue as to whether zinc at some dose and duration of exposure can cause neuropathies. The Court saw, however, that the important issue was whether zinc in the form, dose, and duration ingested by plaintiff can cause the outcome he experienced, and whether his exposure to zinc in Fix-o-dent actually caused his alleged injury. The Superior Court re-affirmed Pennsylvania’s case law that makes extrapolation from different doses, different durations, and different biological circumstances, a “novel” claim that is subject to the gatekeeping by the so-called Frye standard. Slip op. at 11.

The Superior Court’s opinion astutely observed that the issue was not whether WOE and TOE are accepted scientific methodologies, but whether expert witness Martyn Smith can “evade a reasoned Frye inquiry merely by making reference to accepted methods in the abstract.” Id. at 12 (citing Betz, at 58). When pressed, Martyn Smith’s invocation of WOE amounted to little more than a distortion and abridgment of the Bradford Hill factors. The Superior Court recognized, however, that the Bradford Hill guidelines provide an evaluative process to consider whether an association, after first being shown to be clear cut and not attributable to chance, is causal or spurious. Id. at 13. As Bradford Hill postulated the question that arises before his famous nine factors come into the analysis:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965) (emphasis added).

In this case, Smith never got off the dime with his evasive tactics. He did not identify a quantified association that could be assessed for the play of random variation, or bias and confounding. Smith tried to suggest that a mere possibility of an association was sufficient to invoke the Bradford Hill guidelines, but the Superior Court rejected this attempt to invent a new-age scientific method. Slip op. at 13.

The Superior Court acknowledged that the scientific literature describes WOE as varying from nothing more than “seat-of-the-pants qualitative assessment” to “aggregating diverse modalities.” Id. at 14. In Smith’s hands, WOE was little more than a personal, subjective opinion, an ipse dixit dressed as a scientific opinion. Smith never defined his WOE approach, and the other witnesses never defined their TOE approach. The plaintiffs’ witnesses in Jacoby failed to offer an accepted methodology when they failed to identify the forms of evidence they considered, and how they went about weighing the evidence upon which they had relied. Id. at 15.

In a brief discussion, the Panel also embraced another basic evidentiary principle to dismiss a common tactic in specious claiming. The plaintiffs’ challenged defendants’ pharmokinetic study and tried to suggest that their deconstruction counted as affirmative evidence to support their own theory of biological fate and distribution. Id. at 16. The Superior Court saw through the ruse; the plaintiffs had not created affirmative evidence for their theory by arguing that the defendants’ study was flawed.

The Superior Court squarely confronted the limitations and inadequacy of relying upon descriptive, anecdotal case reports. Case reports provide a narrative and temporal history of events with respect to exposure and outcome, but they cannot fully account for confounding by known and unknown factors. Case reports represent post hoc assessments that were not planned, and therefore lack data that would permit distinguishing coincidence from causality. Id. at 17 (citing Dr. Lorene Nelson’s report). See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345 (S.D. Fla.2011).

Proctor & Gamble had the good fortunate to have obtained a good ruling in the MDL litigation in the Southern District of Florida, which no doubt helped focus the gatekeeping process in Pennsylvania state court. Unfortunately, the Superior Court Panel chose not to publish its decision. This decision is regrettable for its inconsistency with the transparency and due process expected of all courts. See Erica Weisgerber, “Unpublished Opinions: A Convenient Means to an Unconstitutional End,” 97 Georgetown L.J. 621 (2009).

Posted in Causation, Expert Witnesses, Frye, Scientific Evidence | Comments Off on Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims

The Misbegotten Judicial Resistance to the Daubert Revolution

December 8th, 2013

David Bernstein is a Professor at the George Mason University School of Law. Professor Bernstein has been writing about expert witness evidentiary issues for almost as long as I have been litigating them. I have learned much from his academic writings on expert witness issues, which include his contributions to two important multi-authored texts, The New Wigmore: Expert Evidence (2d ed. 2010), Phantom Risk: Scientific Inference and the Law (MIT Press 1993).

Bernstein’s draft article on the Daubert Counter-revolution, which some might call a surge by judicial reactionaries, has been available on the Social Science Research Network, and on his law school’s website. See “David Bernstein on the Daubert Counterrevolution” (April 19, 2013). Professor Bernstein’s article has now been published in the current issue of the Notre Dame Law Review, and is available at its website. David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013). This article might well replace the out-dated chapter by the late Professor Berger in the latest edition of the Reference Manual on Scientific Evidence.

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