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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.

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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 (11th 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 (11th 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).

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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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Rockefeller and McCarthy — The Rush from Responsibility

December 4th, 2013

William Rockefeller was the engineer who operated the Metro-North Railroad train at 83 mph around the Spuyten Dyvel curve, in the Bronx.  The general speed limit is 70 mph, and the speed limit going into the curve is 30 mph.  The train derailed, killing four passengers and injuring many more, some very seriously.  Rockefeller told investigators that he had become “dazed,” whatever that means in the absence of some “dazing” event.  Matt Flegenheimer & William K. Rashbaum, “Train Engineer Was Dazed Before Crash, Lawyer Says” (Dec. 3, 2013 ). George Orwell would have appreciated the slippery and soul-less use of the passive voice.  Who did the dazing?

Jeffrey P. Chartier, Rockefeller’s lawyer, described his client as suffering from “highway hypnosis.”  Chartier, testifying for his client, claimed that Rockefeller had lost concentration only momentarily, and that he was “extremely remorseful.” Metro-North trains are pretty substantial trains, not the sort that can accelerate momentarily from 30 to 82 mph.

Rockefeller is a member of the Association of Commuter Rail Employees, and so, of course, his union representative, Anthony Bottalico, had to weigh in on the issue. Bottalico casually mentioned that Rockefeller had described himself as having nodded off before the derailment.  When pressed, Bottaclico realized his error in acknowledging responsibility, and he quickly changed up:

“People use the word ‘zoned out,’ ‘nod,’ ‘fell asleep,’ … I’m not a sleep expert.”

Bottalico’s indiscretion, in speaking to the media about a pending investigation (and trying to spin the facts to exculpate the union engineer) led the safety board to remove the union as a party to the investigation.

The search for responsibility is part of our human condition.  Legal categories often drive the search.  In occupational exposure cases, employers have tort immunity by virtue of workman’s compensation immunity.  The Depression-era bargain between labor and management on workplace injuries pushes our legal system, and the litigation industry, to place responsibility on remote vendors of products and raw materials to the workplace, despite their lack of control over the dissemination of information on the job.  In most so-called sophisticated intermediary cases, the accident or injury would not have occurred at all had the employer and the employees done their respective jobs with respect to providing a safe workplace.

In the Spuyten Duyvil crash, Rockefeller’s lawyer and rail safety pundits suggest that automatic systems might have prevented the derailment.  The hard fact remains, however, that Rockefeller was the most important link in the causal chain.  He was the “least expensive” means to avoid the disaster because it was his job and his responsibility to do so.  Had Rockefeller simply done his job, four people killed in the crash would be alive today.  And many more would not be crippled and in pain.

In today’s New York Times, Joe Nocera muses about how Long Island Congresswoman Carolyn McCarthy, was diagnosed with lung cancer. McCarthy, who is 69 years old, was a life-long cigarette smoker, yet in her court filings she refers to her lung cancer as her asbestos disease. Joe Nocera, “The Asbestos Scam” N.Y. Times (Dec. 3, 2013). We live in a free country (well, sort of free) and people should be free to deceive themselves and indulge their superstitions.  But surely we can draw the line at deceiving others with such nonsense.  McCarthy was never an asbestos insulator or an asbestos-exposed tradesperson.  McCarthy’s lawyer, supposedly told The New York Post that “it has been conclusively proven that cigarette smoking and asbestos exposure act synergistically to cause lung cancer.”

Nocera points out that in fact it has not.  Even Selikoff himself, who did so much to perpetuate a theory of multiplicative, synergistic reactivity, wrote that his insulator cohort synergistic risk estimates could not be extrapolated to other exposures (such as the evanescent household exposures alleged by Congresswoman McCarthy):

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

Selikoff, et al., “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. at 487 (1979). Despite Selikoff’s atypical care, his colleagues who carried the Mt. Sinai banner into courtrooms all around this country, glibly ignored his qualification.  See also “Irving Selikoff and the Right to Peaceful Dissembling.”  Of course, when Selikoff’s heirs updated his insulator study, they did not find evidence of interaction even for insulators who lacked sufficiently heavy exposure to cause asbestosis.  Steve Markowitz, Stephen Levin, Albert Miller, and Alfredo Morabia, “Asbestos, Asbestosis, Smoking and Lung Cancer: New Findings from the North American Insulator Cohort,” Am. J. Respir. & Critical Care Med. (2013). See “The Mt. Sinai Catechism” (June 7, 2013).  I doubt that these qualifications will find their way into the reporting of The New York Post.

Ultimately, Irving Selikoff and his heirs helped create a litigation industry that has placed responsibility for asbestos disease on vendors, not employers, and completely out of proportion to any realistic appraisal of traditional tort law. Rockefeller and McCarthy, and Selikoff (and the litigation industry he helped to start) all illustrate the misallocation of responsibility for avoidable human suffering.  Denialism is where you find it.

Posted in Learned and sophisticated intermediary, Scientific Evidence | Comments Off on Rockefeller and McCarthy — The Rush from Responsibility

Pharmacovigilantism – Avandia Litigation

November 27th, 2013

Six and one-half years ago, I gave a presentation on the then newly emerging controversy over Avandia (rosiglitazone).  Plaintiffs’ counsel Vance Andrus chaired the program, Mealey’s™ Avandia Litigation Conference, in Chicago on July 13, 2007.  Vance was a gracious host despite my skepticism about the potential for plaintiffs to cash in on their use of Avandia.

Despite Vance’s best efforts, the program was one of those lopsided affairs, and I was the only presenter who came prepared to address the scientific evidence from a skeptical perspective.  The remaining presenters were mostly cheerleaders for their declaration of war against GlaxoSmithKline over claims of heart attack and stroke from the use of Avandia.

This week, a Food and Drug Administration announcement sent me back to my presentation slides, which were provocatively titled “Pharmacovigilantism and Avandia.” Dr. Steven Nissen had published a meta-analysis in the New England Journal of Medicine in May 2007, and it had all the appearances of a contrived effort to embarrass GSK. See Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” 356 New Engl. J. Med. 2457 (2007).  A few weeks later, Dr. George Diamond published a thorough debunking of the Nissen meta-analysis, by showing that the statistically significant result in Nissen’s meta-analysis could be achieved only by choosing an inappropriate meta-analytic method.  Any other choice resulted in a result that lacked statistical significance for the rate of heart attack among patients taking Avandia.

Litigation, of course, followed and the Rule 702 hearings and decision resulted in a serious abridgement of the scientific process.  The federal MDL trial judge denied GSK’s motions to exclude plaintiffs’ causation witnesses in an opinion that has become a model for Rule 702 avoidance.  In re Avandia Marketing, Sales Practices and Product Liability Litigation, 2011 WL 13576, *12 (E.D. Pa. 2011) (Rufe, J.).  See “Learning to Embrace Flawed Evidence – The Avandia MDL’s Daubert Opinion” (Jan. 10, 2011)

This week, without much fanfare, the FDA announced that maybe the evidence supporting the claims that Avandia causes heart attacks is not so strong, after all.  See “FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines” (Nov. 25, 2011).  The Avandia MDL stands out as an expensive, negligent rush to judgment; a case more of phamacovigilantism than of pharmacovigilance.

Posted in Causation, Meta-analysis, Rule 702 | Comments Off on Pharmacovigilantism – Avandia Litigation

Avoiding Nonsense About Science — Ask For The Evidence

November 25th, 2013

Sense about Science is a British charitable organization that is devoted to helping people understand scientific and medical claims. Sense about Science acknowledges that:

“Sharing scientific reasoning involves giving people the tools to question pseudoscience and misleading claims, to help cut through the noise around scientific or medical issues.”

To further its laudable goals, Sense about Science has launched an “Ask for Evidence Campaign”:

“We hear daily claims about what is good for our health, bad for the environment, how to improve education, cut crime, treat disease or improve agriculture. Some are based on reliable evidence and scientific rigour. Many are not.  How can we make companies, politicians, commentators and official bodies accountable for the claims they make? If they want us to vote for them, believe them or buy their products, then we should Ask for Evidence.”

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

Mr. Nicholas Kristof grew up on a cherry farm, and went on to a successful academic and writing career. For over a decade,  Kristof has written “columns” for The New York Times, a public platform that has helped him win two Pulitzer Prizes.  Sometimes, Kristof’s early experience in cherry picking has helped him with discussions of scientific issues, which seem more like “Nonsense about Science.”  Consider yesterday’s New York Times, in which, Kristof combines cherry picking with scare mongering.  See “Danger Lurks in That Mickey Mouse Couch”:

“RESEARCHERS this summer purchased 42 children’s chairs, sofas and other furniture from major retailers and tested them for toxic flame retardants that have been linked to cancer, birth defects, diminished I.Q.’s and other problems.”

Besides the vague and conclusory language of “links,” Kristof does not cite a scintilla of evidence; instead he cites opinion from an environmentalist organization, Center for Environmental Health (CEH).  What is the CEH?  From its website, the CEH appears to be a group led by actors, community activists, politicians, self-styled “philanthropists,” advocates for “environmental justice.”  No serious scientists appear on the CEH’s board of directors, or on its staff, which is populated mostly by lawyers and activists.

Does the CEH, without the benefit of real scientific talent, marshal serious scientific evidence?  You should judge for yourself by reading the webpage that Kristof cites.  See CEH, “Playing on Poisons: Children’s Furniture Found with Harmful Flame Retardant Chemicals” (November 20, 2013).  If diligent readers of Kristof’s column were to read his “source,” they would find only hand waving and opinionated pronouncements without any reference to supporting scientific studies. Perhaps there is something to the accusations made by Kristof and his band of “environmental justice” advocates, but nothing in the column or its sources would shed any light on the matter. 

Mr. Kristof prefers to deal in vague, if not meaningless terms, such as “links” between chemical exposures and myriad dire outcomes.  He patronizes readers by giving them no understanding of the quantity or quality of the evidence that supports his innuendo.  Kristof repeats his bad, unscientific brand of journalism on his blog. See Nicholas Kristof, “Are You Sitting Down? On a Couch?” (Nov. 23, 2013).

Citing regulatory approval of the fire retardants at issue, the American Chemistry Council has taken Mr. Kristof to task.  See “New York Times columnist and new docudrama mislead public on importance of flame retardants, strong fire safety standards” (Nov. 23, 2013).  The Council’s webpage points to other sites that provide some additional evidence of regulatory approvals and efficacy testing of fireproofing chemicals, but it does not list the chemicals involved, and it does not address the biological causal claims made by Kristof and the CEH.  Nor does the American Chemistry Council mention that the litigation industry (a/k/a plaintiffs’ bar) has waged war against the use of companies for using natural, flammable fabrics and materials.

The Sense about Science organization focuses upon scientific nonsense mostly in the United Kingdom.  Kristof’s brand of hit-and-run journalism illustrates that we very much need a similar organization in the United States.  The discussion and debate over health issues should not take place by the trading of assertions and adjectives, without reference to the actual evidence at hand.  Interestingly, in the same issue of the New York Times, which carried Kristof’s column, two reporters, Walt Bodganich and Glenn Silber, covered a flawed forensics investigation in Florida.  Bodganich & Silber, “Two Gunshots on a Summer Night,” New York Times, A1 (Nov. 24, 2013).  In almost four full pages of coverage, these Times reporters analyze the circumstantial and forensic evidence in great detail to expose a flawed police investigation.  Although the death involved, and the police incompetence suggested by these journalists, is a tragedy, the inability of a newspaper to cover a story that alleges many thousands of deaths, with any attention to the actual evidence, is a much greater tragedy.

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The aversion to reading and understanding the actual scientific evidence finds ample expression in the legal arena. In the recent case of Jackson v. Pollion, the Seventh Circuit chided the lawyers, and trial judges, for their failure to examine and understand the scientific evidence at issue in the merits of the case. Jackson v. Pollion, No. No. 12-2682 (7th Cir. Oct. 28, 2013) (Posner, J.).  Judge Posner argued the noteworthiness of the lapse by the advocates and the judges:

“This lapse is worth noting because it is indicative of a widespread, and increasingly troublesome, discomfort among lawyers and judges confronted by a scientific or other technological issue.”

Slip op. at 2.

And in more Kierkegaardian terms, Judge Posner admonishes the legal profession:

“The legal profession must get over its fear and loathing of science.”

Slip op. at 8.

Indeed!  Judge Posner’s admonition is undermined by the current Federal Rule of Evidence, which diminish the value of underlying data and evidence in expert witness opinion.  Rule 702 makes opinion admissible, and Rule 703 acknowledges that much of the bases for expert witness opinion will itself be inadmissible.  The structure of the Federal Rules of Evidence, however, undermines the importance of underlying evidence by not requiring that expert witnesses disclose the facts and data upon which they rely.

The evidence law of some states is to the contrary.  Consider Hansen v. Wyeth Inc., 77 Pa. D. & C.4th 501, 2005 WL 3068256 (Phila. Cty. Ct. Com.Pl. 2005) (Bernstein, J.).  The Hansen case focused on the testimony that was given by Dr. Harris Busch in a fenfluramine products liability case in Philadelphia.  Some may recall Busch as a veteran plaintiffs’ expert witness from the silicone gel breast implant litigation.  See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans” and the litigation as largely based upon fraud). 

In Hansen, Busch testified that Wyeth had been negligent, but on post-trial motions, Judge Bernstein found that:

“The doctor’s opinion, however, was presented in conclusory form and was ‘generically’ predicated on voluminous materials.”

Hansen, 77 Pa. D. & C.4th at 501.

Applying Pennsylvania’s version of Rule 705, which incorporated the state’s traditional common-law approach, Judge Bernstein held that Dr. Busch’s failure to give a detailed accounting of the evidentiary basis for his opinion rendered his opinion inadmissible.  Pennsylvania Rule 705 provides:

“Disclosure of facts or data underlying expert opinion.

The expert may testify in terms of opinion or inference and give reasons therefore; however the expert must testify as to the facts or data on which the opinion or inference is based.”

Hansen, 77 Pa. D. & C.4th at 504 (citing and quoting Rule 705).  The Pennsylvania version of Rule 705 differs significantly from the Federal Rule of Evidence 705 by requiring actual disclosure of the evidence upon which an expert witness opines.  In Pennsylvania state court, it is not sufficient for juries or judges to evaluate expert witness testimony upon looks, demeanor, apparent bias, and the like:

“While most rules of evidence concern the admission of facts, Rule 705 concerns itself not with admission but disclosure. Absent a clear disclosure of the factual basis of opinion testimony, an expert’s opinion does not so much assist the jury with their determination of the facts as replace the jury’s essential factfinding  role. Without a clear disclosure, the jury has no basis for determining whether the facts as understood or assumed by the expert are compatible with the facts as the jury finds them to be. Thus, Rule 705 was adopted to preserve the exclusive  factfinding function of the jury.”

Id. at 507 (internal citations omitted).  Pennsylvania Rule of Evidence 705 requires specificity by the testifying expert witness in identifying the actual basis for his or her opinion:

“The Rule 705 requirement of presenting the ‘facts and data’ which form the basis of the opinion may not be satisfied by a mere formalistic recitation of the material reviewed or considered. That pro forma routine absolutely obscures what Rule 705 intends to clarify and is tantamount to the clearly impermissible tactic of offering an opinion based on ‘all the evidence’.”

Id. at 511 -12 (internal citations omitted).

The omission of the Pennsylvania rule from federal practice and many other states’ practices illustrates our legal system’s failure to insist upon showing the factfinder the actual evidence.  We have a long way to go, in journalism, politics, and law, to become an evidence-based society.

Posted in Expert Witnesses, Underlying Data | Comments Off on Avoiding Nonsense About Science — Ask For The Evidence

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The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.