TORTINI

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

The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest

December 28th, 2011

Conflicts of interest (COI), real or potential, have become a weapon used to silence the manufacturing industry in various scientific debates and discussions.  Other equally “interested” parties, labor unions, advocacy groups, and consultants to the other industry – the litigation industry – have used conflicts and ethical claims to silence the manufacturing industry and to engage in unfettered false scientific speech. The public, unwilling and untrained to look at evidence on the merits, is conditioned to accepting an allegation of COI as the end of the discussion on scientific issues.

Recently, journalist Shannon Brownlee criticized the FDA for its suggestion that the agency was having difficulty in finding experts who cleared the agency’s conflict-of-interest prohibitions.  Brownlee explicitly contended that she could easily find “unbiased” scientists who could advise the agency on drug and device issues.

Shannon Brownlee, “Is There an Independent Unbiased Expert in the House” (Aug. 3, 2011).

Indeed, Brownlee sent FDA Commissioner Margaret Hamburg a list of allegedly neutral experts who could advise the agency.  Brownlee gave everyone on her list a clean bill of ethical health, and has published the list on multiple occasions, both on the website Healthnewsreview.org, and a few years ago, in the British Medical Journal:  Jeanne Lenzer & Shannon Brownlee, “Is there an (unbiased) doctor in the house?” 337 Brit. Med. J. 206 (2008).

Brownlee tells us that journalists from respectable print media, including the New York Times, and the Wall Street Journal, have requested the list, apparently to contact the “unbiased” experts to help investigate news stories about drugs and medical devices.  What the gullible may not appreciate is that the list fallaciously is based upon only one exclusionary criterion:  having consulted for the pharmaceutical industry.  The list omits other important COI exclusionary criteria, such as having consulted for the litigation industry, or having taken erroneous, unwarranted, and ideologically driven positions on scientific issues.

What litigation industry?  Brownlee may have missed the fact that plaintiffs’ lawyers represent a huge financial interest in obtaining compensation for others, with 40 percent of the proceeds going to themselves.  This litigation industry thrives, even with Dickie Scruggs in prison, and Stanley Chesley in disrepute.

In today’s litigation environment, with aggregation of claims in federal multi-district cases, plaintiffs’ counsel stand to profit in the billions from scientific positions espoused by their expert witnesses.

Who are the litigation industry expert witnesses on Brownlee’s list?  Here are some obvious candidates:

Peter R. Breggin, MD, psychiatrist, clinical psychopharmacologist, independent author and scientist; Founder and Director Emeritus, International Center for the Study of Psychiatry and Psychology

Adriane Fugh-Berman, MD, Professor, Department of Physiology and Biophysics, Georgetown University Medical Center; Director, PharmedOut.org

Curt Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine

Joseph Glenmullen, MD, Clinical instructor in psychiatry, Harvard Medical School

Bruce Psaty, MD, PhD, Professor, Medicine & Epidemiology, University of Washington Cardiovascular Health Research Unit

Also on the list were well-known anti-industry zealots, who focus almost exclusively on the manufacturing industry, while ignoring or endorsing the excesses and unwarranted claims of the litigation industry:

Lisa Bero, PhD, Professor, University of California, San Francisco U.S.

Sheldon Krimsky, PhD, Tufts University & Council for Responsible Genetics

Sidney Wolfe, MD, Director, Health Research Group of Public Citizen.

Now some people may claim that the litigation industry consultants, and the anti-industry zealots, take their positions not to please their sponsors, or to pursue lucrative opportunity, but because they fervently believe the positions that they take. But then why not give the pharmaceutical industry consultants the same benefit of the doubt?  Indeed, why not move beyond COI allegations to creating lists of scientists and physicians who have demonstrated proficiency in advancing evidence-based judgments that have withstood the test of time?

This anti-industry hypocrisy manifests not only in assertions of conflicts of interest, but also in calls for industry to disclose all underlying data from industry-funded or sponsored studies, while taking a protectionist stance on all other underlying data.

Let’s hope that in 2012, industry fights back, and evidence regains its primary role in resolving scientific disputes.

A Rule of Completeness for Statistical Evidence

December 23rd, 2011

Witnesses swear to tell the “whole” truth, but lawyers are allowed to deal in half truths.  Given this qualification on lawyers’ obligation of truthfulness, the law prudently modifies the law of admissibility for writings to permit an adverse party to require that written statements are not yanked out of context.  Waiting days, if not weeks, in a trial to restore the context is an inadequate remedy for these “half truths.”  If a party introduces all or part of a writing or recorded statement, an adverse party may ” require the introduction, at that time, of any other part — or any other writing or recorded statement — that in fairness ought to be considered at the same time.”  Fed. R. Evid. 106 (Remainder of or Related Writings or Recorded Statements).  See also Fed. R. Civ. Pro. Rule 32(a)(4) (rule of completeness for depositions).

This “rule of completeness” has its roots in the common law, and in the tradition of narrative testimony.  The Advisory Committee notes to Rule 106 comments that the rule is limited to “writings and recorded statements and does not apply to conversations.”  The Rule and the notes ignore that the problematic incompleteness might be in the form of mathematical or statistical evidence.

Confidence Intervals

Consider sampling estimates of means or proportions.  The Reference Manual on Scientific Evidence (2d ed. 2000) urges that:

“[w]henever possible, an estimate should be accompanied by its standard error.”

RMSE 2d ed. at 117-18.

The new third edition dilutes this clear prescription, but still conveys the basic message:

What is the standard error? The confidence interval?

An estimate based on a sample is likely to be off the mark, at least by a small amount, because of random error. The standard error gives the likely magnitude of this random error, with smaller standard errors indicating better estimates.”

RMSE 3d ed. at 243.

The evidentiary point is that the standard error, or the confidence interval (C.I.), is an important component of the sample statistic, without which the sample estimate is virtually meaningless.  Just as a narrative statement should not be truncated, a statistical or numerical expression should not be unduly abridged.

Of course, the 95 percent confidence interval is the estimate (the risk ratio, the point estimate) plus or minus 1.96 standard errors.  By analogy to Rule 106, lawyers should insist that the confidence interval, or some similar expression of the size of the standard error, be provided at the time that the examiner asks about, or the witness gives, the sample estimate.  There are any number of consensus position papers, as well as guidelines for authors of papers, which specify that risk ratios should be accompanied by confidence intervals.  Courts should heed those recommendations, and require parties to present the complete statistical idea – estimate and random error – at one time.

One disreputable lawyer trick is to present incomplete confidence intervals.  Plaintiffs’ counsel, for instance, may inquire into the upper bound of a confidence interval, and attempt to silence witnesses when they respond with both the lower and upper bounds.  “Just answer the question, and stop volunteering information not asked.”  Indeed, some unscrupulous lawyers have been known to cut off witnesses from providing the information about both bounds of the interval, on the claim that the witness was being “unresponsive.”  Judges who are impatient with technical statistical testimony may even admonish witnesses who are trying to make sure that they present the “whole truth.”  Here again, the completeness rule should protect the integrity of the fact finding by allowing, and requiring, that the full information be presented at once, in context.

Although I have seen courts permit the partial, incomplete presentation of statistical evidence, I have yet to see a court acknowledge the harm from failing to apply Rule 106 to quantitative, statistical evidence.  One court, however, did address the inherent error of permitting a party to emphasize the extreme values within a confidence interval as “consistent” with the data sample.  Marder v. G.D. Searle & Co., 630 F.Supp. 1087 (D.Md. 1986), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987)(per curiam).

In Marder, the plaintiff claimed pelvic inflammatory disease from a IUD.  The jury was deadlocked on causation, and the trial court decided to grant the defendant’s motion for directed verdict, on grounds that the relative risk involved was less than two. Id. at 1092. (“In epidemiological terms, a two-fold increased risk is an important showing for plaintiffs to make because it is the equivalent of the required legal burden of proof—a showing of causation by the preponderance of the evidence or, in other words, a probability of greater than 50%.”)

The plaintiff sought to resist entry of judgment by arguing that although the relative risk was less than two, the court should consider the upper bound of the confidence interval, which ranged from 0.9 to 4.0.  Id.  So in other words, the plaintiff argued that she was entitled to have the jury consider and determine that the actual value was actually 4.0.

The court, fairly decisively, rejected this attempt to isolate the upper bound of the confidence interval:

“The upper range of the confidence intervals signify the outer realm of possibilities, and plaintiffs cannot reasonably rely on these numbers as evidence of the probability of a greater than two fold risk.  Their argument reaches new heights of speculation and has no scientific basis.”

The Marder court could have gone further by pointing out that the confidence interval does not provide a probability for any value within the interval.

Multiple Testing

In some situations, completeness may require more than the presentation of the size of the random error, or the width of the confidence interval.  When the sample estimate arises from a study with multiple testing, presenting the sample estimate with the confidence interval, or p-value, can be highly misleading if the p-value is used for hypothesis testing.  The fact of multiple testing will inflate the false-positive error rate.

Here is the relevant language from Kaye and Freedman’s chapter on statistics, in the Reference Manual (3d ed.):

4. How many tests have been done?

Repeated testing complicates the interpretation of significance levels. If enough comparisons are made, random error almost guarantees that some will yield ‘significant’ findings, even when there is no real effect. To illustrate the point, consider the problem of deciding whether a coin is biased. The probability that a fair coin will produce 10 heads when tossed 10 times is (1/2)10 = 1/1024. Observing 10 heads in the first 10 tosses, therefore, would be strong evidence that the coin is biased. Nonetheless, if a fair coin is tossed a few thousand times, it is likely that at least one string of ten consecutive heads will appear. Ten heads in the first ten tosses means one thing; a run of ten heads somewhere along the way to a few thousand tosses of a coin means quite another. A test—looking for a run of ten heads—can be repeated too often.

Artifacts from multiple testing are commonplace. Because research that fails to uncover significance often is not published, reviews of the literature may produce an unduly large number of studies finding statistical significance.111 Even a single researcher may examine so many different relationships that a few will achieve statistical significance by mere happenstance. Almost any large dataset—even pages from a table of random digits—will contain some unusual pattern that can be uncovered by diligent search. Having detected the pattern, the analyst can perform a statistical test for it, blandly ignoring the search effort. Statistical significance is bound to follow.

There are statistical methods for dealing with multiple looks at the data, which permit the calculation of meaningful p-values in certain cases.112 However, no general solution is available… . In these situations, courts should not be overly impressed with claims that estimates are significant. …”

RMSE 3d ed. at 256-57.

When a lawyer asks a witness whether a sample statistic is “statistically significant,” there is the danger that the answer will be interpreted or argued as a Type I error rate, or worse yet, as a posterior probability for the null hypothesis.  When the sample statistic has a p-value below 0.05, in the context of multiple testing, completeness requires the presentation of the information about the number of tests and the distorting effect of multiple testing on preserving a pre-specified Type I error rate.  Even a nominally statistically significant finding must be understood in the full context of the study.

Many texts and journals recommend that the Type I error rate not be modified in the paper, as long as readers can observe the number of multiple comparisons that took place and make the adjustment for themselves.  Most jurors and judges are not sufficiently knowledgeable to make the adjustment without expert assistance, and so the fact of multiple testing, and its implication, are additional examples of how the rule of completeness may require the presentation of appropriate qualifications and explanations at the same time as the information about “statistical significance.”

The Integrity of Facts in Judicial Decisions

December 21st, 2011

One of the usual tasks of an appellate judge’s law clerk is to read the record – the entire record.  In my clerking experience, the law clerk who had the assignment for a case in which the judge was writing an opinion was responsible for knowing every detail of the record.  The judge believed that fidelity to the factual record was an absolute.

Not so for other appellate judges.  See, e.g., Jacoby, “Judicial Opinions as “Minefields of Misinformation: Antecedents, Consequences and Remedies,” University Public Law and Legal Theory Working Papers Paper 35 (N.Y. 2006).

Some important cases turn on facts misunderstood or misrepresented by appellate courts.  A few days ago, Kyle Graham blogged about a startling discovery in the Summers v. Tice case, which is covered in every first-year torts class.  Kyle Graham, “Summers v. Tice: The Rest of the Story” (Dec. 1, 2011).

Summers v. Tice, 33 Cal.2d 80, 199 P.2d 1 (1948), is a leading California tort law case that shifted the burden of proof on causation to the two defendants.  The rationale for shifting the burden was the gross negligence of both defendants, and the plaintiff’s faultless inability to identify which of the two defendants, Simonson or Tice, was responsible for shooting the plaintiff with a shotgun in their ill-fated quail hunt.

Professor Graham did something unusual:  he actually read the record of the bench trial.  It turns out that the facts were different from, and much more interesting than, those presented by the California Supreme Court.  Simonson admitted shooting Summers, and implicated Tice.  Tice denied shooting.  The trial judge resolved credibility issue against Tice, although it seems to have been a close issue.

More important, Tice testified that his gun was loaded with No. 6 shot, whereas Simonson had used No. 7.5 shot.  Summers admitted that the pellets had been given to him after his medical treatment, but he could not find them at the time of trial.  Had he kept the pellets, Summers would have been able to distinguish between the gunfeasors.

Spoliation anyone?  Missing evidence?  Adverse inference?

Even if the trial judge was unimpressed with Tice’s denial of having discharged his shotgun, Tice’s lack of credibility could not turn into affirmative evidence that he had used number 7.5 shot, as had Simonson.  This was a contested issue, on which the plaintiff could have adduced evidence.  The plaintiff’s failure to do so was the result of his own post-accident carelessness (or worse) in not keeping important evidence.  Tice’s testimony on the size of the shot in his gun was undisputed, even if the trial court thought that he was not a credible witness.

Thus, on the real facts, the shifting of the burden of proof, on the rationale that the plaintiff was without fault for his inability to produce evidence against Summers or Tice, was quite unjustified.  The plaintiff was culpable for the failure of proof, and there was no affirmative evidence that the two potential causative agents were indistinguishable. The defendants were not in a better position than the plaintiff to identify who had been the cause of plaintiff’s wounds.

The trial court’s credibility assessment of Tice, for having denied a role in shooting, did not turn the absence of evidence into affirmative evidence that both defendants used the same size pellets in their shotguns.  What makes for a great law school professor’s hypothetical was the result of an obviously fallacious inference, and a factual fabrication, borne of sloppy judicial decision making.

We can see a similar scenario play out in the New Jersey decisions that reversed directed verdicts in asbestos colorectal cancer cases.  Landrigan v. Celotex Corp., 127 NJ. 404, 605 A2d 1079 (1992); Caterinicchio v. Pittsburgh Corning Corp., 127 NJ. 428, 605 A.2d 1092 (1992). In both cases, the trial courts directed verdicts, assuming arguenda that asbestos can cause colorectal cancer (a dubious proposition), on the ground that the low relative risk cited by plaintiffs’ expert witnesses (about 1.5) was factually insufficient to support a verdict for plaintiffs on specific causation.  Indeed, the relative risk suggested that the odds were about 2 to 1 in defendants’ favor that the plaintiffs’ colorectal cancers were not caused by asbestos.

The intermediate appellate courts affirmed the directed verdicts, but the New Jersey Supreme Court reversed and remanded both judgments on curious grounds.  According to the Court, there were other probative factors that the juries could have used to make out specific causation:

“Dr. Wagoner did not rely exclusively on epidemiological studies in addressing that issue.   In addition to relying on such studies, he, like Dr. Sokolowski, reviewed specific evidence about decedent’s medical and occupational histories.   Both witnesses also excluded certain known risk factors for colon cancer, such as excessive alcohol consumption, a high-fat diet, and a positive family history.   From statistical population studies to the conclusion of causation in an individual, however, is a broad leap, particularly for a witness whose training, unlike that of a physician, is oriented toward the study of groups and not of individuals.   Nonetheless, proof of causation in toxic-tort cases depends largely on inferences derived from statistics about groups.”

Landrigan, 127 N.J. at 422.  The NJ Supreme Court held that the plaintiffs’ failure to show a relative risk in excess of 2.0 was not fatal to their cases, when there was other evidence that the jury could consider, in addition to the relative risks.

Well, actually there was no expert witness support for the assertion.  Completely absent from the evidentiary displays in both the Landrigan and Caterinicchio cases was any evidence, apart from plaintiffs’ expert witnesses’ hand waving, that a higher relative risk existed among the subcohort of asbestos insulators who had had heavier exposure or who had concomitant pulmonary disease.  There was no evidence that those exposed workers who lacked “excessive alcohol consumption, a high-fat diet, and a positive family history” had any increase risk.  Indeed, the Selikoff study relied upon extensively by plaintiffs’ expert witnesses failed to make any adjustment for the noted risk factors, as well as for the greater prevalence of smoking histories among the insulators than among the unexposed comparator population.  The Court turned the absence of evidence into the factual predicate for its holding that defendants were not entitled to judgment.

Now that’s judicial activism.

COURTING CLIO: HISTORIANS UNDER OATH – Part 2

December 17th, 2011

Continued from Part 1:

Court-Appointed Historians

One lawyer, Jonathan Martin, trained in historical scholarship in Princeton University, has argued that historian expert witness opinion testimony is both unavoidable and refractory to the protections of judicial gatekeeping.  Martin, Historians at the Gate:  Accommodating Expert Historical Testimony in Federal Courts.” 78 N.Y.U.L. Rev. 1518 (2003).  Mr. Martin acknowledges that historians are beholding to an objective methodology, but when they are in the employ of lawyers, historians abridge or abrogate their commitment to objectivity:

Just as scientific testimony must adhere to the scientific method so too must historical testimony adhere to the historical method.  Unfortunately, historians often neglect the conventional method of their craft when offering expert testimony.  Outside the courtroom, historians generally expect one another to formulate complex, nuanced, and balanced arguments that take into account all available evidence, including any countervailing evidence.  At trial, however, the pressures of the adversary system routinely push historians toward interpretations of the past that are compressed and categorical . . .  .  As a result, historians now frequently offer unreliable evidence.

Id. at 1521.  Mr. Martin proposes to remedy the frequent, unreliable testimony from historians by the routine appointment of court-appointed expert witnesses.

In passing, Mr. Martin notes that others have urged judicial gatekeeping, under Daubert or Frye, to address unreliable historian testimony, but he rejects gatekeeping of adversarial expert witnesses as insufficient.  Id. at 1522 n.23.  Given the dearth of reported cases of such gatekeeping, this rejection seems premature.  Perhaps more important, Mr. Martin, in his rush to advocate court-appointed historians, fails to address how and why historians’ opinions are different from the opinions of experts in other fields, which are successfully subjected to cross-examination and to reliability analysis.  Historians are not alone, certainly, in succumbing to the temptation to stray from objective methodology.  Mr. Martin is correct, however, in his implicit acknowledgment that historian opinion testimony warrants increased judicial scrutiny.

One way historians differ from other fields of objective study is that historical scholarship is perfused with argument.  In biomedical and physical sciences, the presentation of research is carefully and routinely segregated into hypothesis, materials and methods, findings, and discussion.  Research findings are neatly presented without inferences to conclusions.  If conclusions can be reliably reached from the research or experiment, the investigators present their conclusions, with appropriate qualifications and caveats, in the discussion sections of their writings.  Readers understand that the discussion section is often the least important part of a published article.

Lawyering is similarly segregated into proofs and argument.  The trial lawyers’ evidence, whether real, documentary, or testimonial, is confined to a portion of the trial open for proof of facts in issue.  The trial court has the responsibility to prevent argument, argumentative questioning, and argumentative testimony in the proof-phase of the trial.  Only in closing argument, may the trial lawyers urge inferences and conclusions that assist the trier of fact to resolve the factual disputes in the case.  To be sure, trial lawyers try and sometimes succeed in advancing their argument in the proof phase of trial, either by clever juxtaposition in presenting facts, by adducing opinions in carefully defined exceptions (such as character evidence), or by successfully evading the trial court’s supervision.

Historians, in their scholarship, may acknowledge an objective method in their fact-finding, but they are under no professional constraint to separate their fact-finding and argument.  Both popular and academic historical scholarship blend fact and opinion in a manner antithetical to the sciences.  The strength and persuasiveness of historical scholarship often turns on how well the historian creates a complex narrative of fact, inference, argument, and opinion.  And the greatest art is that which conceals itself.

The pervasive role of argument is a relatively small problem compared to the dominance and legitimacy of subjective perspective in historical narrative.  Historians write from a point of view.  Openly and honestly, they narrate historical facts and events from a Marxist, labor, feminist, free-market, religious, or other point of view.  Sometimes, their point of view is covert, but it still colors the narrative.  Importantly, the point of view is often not scientific in that the scholars would likely refuse to count any empirical evidence as refuting the “truth” of their narrative.

The problems and excesses of historian opinion testimony are thus not likely to be remedied by having a court-appointed historian weigh in on the issues.  Such a court-appointed historian would present a challenge to the parties, who would need to cross examine vigorously, and to the court, which would be obligated to review and pass on the reliability of its own expert witness.  The prestige and imprimatur of court appointment would just as likely thwart as promote the truth-finding function of trial.  The argumentativeness of historical narrative would escape meaningful detection and confrontation.  Court appointments of historian witnesses might well have the effect of ending the dispute, but not in a way that advances the just resolution of the parties’ claims.

Appointment of “neutral” expert witnesses may appear to be an attractive judicial strategy to a trial court faced with party expert witnesses that are “too extreme.”  Trial judges, especially in federal Multidistrict Litigation (MDL), hear capable advocates present highly credentialed expert witnesses.  Often the opinions of the parties’ expert witnesses are diametrically opposed in ways that do not let the trial court gauge their competing claims to truth.  If trial courts find assessment of these expert witnesses’ opinions to be difficult, juries are not likely to fare better.  In perplexity, judges may try to align themselves in the middle, and comfort themselves with the belief that the trust must lie somewhere between the parties’ polar views of the world.

In the silicone gel breast implant litigation, MDL 926, Judge Sam Pointer found himself in the “middle.”  He had refused Daubert challenges to plaintiffs’ expert witnesses, and stated that the parties’ expert witnesses were too extreme.  After Judge Jack Weinstein sua sponte raised the issue of court-appointed experts in breast implant cases, plaintiffs’ counsel petitioned Judge Pointer to appoint expert witnesses in all the federal cases.  Over defendants’ objections, Judge Pointer appointed a toxicologist, a rheumatologist, an immunologist, and an epidemiologist to address the plaintiffs’ claims that silicone causes systemic autoimmune and connective tissue diseases.  After a lengthy, expensive, complex proceeding, the MDL court-appointed expert witnesses filed reports and gave testimony that rejected plaintiffs’ claims.  Much to Judge Pointer’s surprise, but not the scientific community’s, the Court’s expert witnesses opined that plaintiffs’ claims were not supported and shown by sound scientific evidence.  Subsequently, a committee of the Institute of Medicine, of the National Academy of Sciences, reached the same exculpatory conclusion.

In MDL 926, the resort to court-appointed witnesses was necessitated by that trial court’s refusal or failure to engage in meaningful gatekeeping.  Remarkably, before the MDL Court even embarked upon the expensive detour of four Rule 706 witnesses, another federal court, employing expert witness advisors, reached the same conclusion in Daubert proceedings.  Hall v. Baxter, 947 F.Supp. 1387 (D. Or. 1996).  Judge Weinstein, sitting on all federal cases in the Eastern and Southern District of New York, had already granted partial summary judgment to defendants on plaintiffs’ systemic injury claims.  In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996).  Rule 706 was used by plaintiffs’ counsel to prolong and protract the federal proceedings, in the hope that they would be saved by research that they were sponsoring through their expert witnesses.

In looking at disputes of historical scholarship, we can easily imagine that judges will see the parties’ expert witnesses as too extreme.  The time-consuming, expensive resort to court-appointed witnesses, however, will not likely advance the resolution of issues of historical scholarship.  Unlike the selection process in MDL 926, where Judge Pointer could relatively quickly find his way to well-qualified, credible, and disinterested witnesses, the selection of an historian would stumble over the disinterestedness criterion.  Historians, by the nature of their craft, are permitted, and are encouraged, to advance a point of view that is out of place in the judicial process.

Historian Witnesses on State-of-the-Art in Tort Cases

In products liability litigation over designs or warnings, a supplier or manufacturer is typically held to the knowledge and expertise of an expert in the field.  Unfortunately, the law offers little help in answering the obvious question of which expert, of all the experts in the world, sets the appropriate standard.  In litigation over the quality of medical care, the law in many states resolves this issue by providing a defense under the “Two Schools of Thought Doctrine.”  See, e.g., “Two Schools of Thought and Informed Consent Doctrine in Pennsylvania.”  98 Dickenson L. Rev. 713 (1994).  A physician does not deviate from the standard of care simply because many or most physicians reject the approach he or she took to the patient’s problem.  As long as a substantial minority of physicians would have concurred in the judgment of the defendant physician, the claim of malpractice fails.  The Two School Doctrine has obvious implications for the standard of design or warning in products cases.

What is clear in products liability cases is that the standard of expertise must be assessed at a given time, when the product or material enters the stream of commerce.  In silicosis cases, which may involve long latency periods between exposure and manifestation of claimed disease, the parties may face historical issues of what experts knew at the legally relevant time of the sale.  Intellectual historians may indeed provide helpful insights into what was actually believed by experts in the past, but such historical data about past “beliefs” can answer the state-of-the-art inquiry only in part.  Knowledge requires at least true, justified belief.  Robert Nozick, Philosophical Explanations 167-288 (Cambridge 1981).  Hunches, suspicions, and hypotheses, even when published in respected books or journals, do not rise to the level of scientific knowledge that can be charged to the manufacturer or the supplier defendants.  Historians, unless adequately trained and expert in scientific method and research, will be inadequate to the task of explaining whether a given belief was justified and true.  Historians, motivated by politics or ideology, may try to advance their causes by trumpeting some past scientific findings, but in the last analysis, scientific theories cannot be chosen the way one chooses to be a Democrat or a Republican.  Proof of “state of the art,” or who knew what when, will require substantial expertise in science and medicine.  Historians may have to emote on the sidelines of these debates.

COURTING CLIO: HISTORIANS UNDER OATH – Part 1

December 17th, 2011

The role of historians as expert witnesses is precarious.  They purport to marshal factual evidence from reliable sources, but that is exactly what lawyers are supposed to do.  Historians argue reasonable inferences from facts to opinions about causation, motivation, and intent.  Again, that is what lawyers are supposed to do in the argument phase of a trial.  Generally speaking, historians are superfluous in trials.

Last year, John Ulizio and I submitted an abstract, “Courting Clio,” to the International Commission on Occupational Health (ICOH), for its Fourth International Conference on the History of Occupational and Environmental Health June 19 – 22, 2010.  My presentation received mixed reviews, with the negative reaction coming from a peanut gallery of a testifying historian expert witness.  SeeA Walk on the Wild Side” (July 16, 2010).  The abstract, “Courting Clio:  Historians and Their Testimony in Products Liability Action,” will appear next year in Brian Dolan and Paul Blanc, eds., At Work in the World: Proceedings of the Fourth International Conference on the History of Occupational and Environmental Health, Perspectives in Medical Humanities, University of California Medical Humanities Consortium, University of California Press (2012)(in press).

For an illustrative example of the gratuitousness of much of expert historian testimony, consider the following exchange in a deposition in a case involving claims of failure to warn, and of silicosis:

Q. Would you agree that in the 1930s, you would have to be quite a knucklehead – that’s a technical term – not to know that silica under some circumstances would cause silicosis?

A. I would agree with that characterization and the use of that technical term.

Gerald Markowitz Deposition, Mendez, at p. 115 (2005)

I believe you would have to be knucklehead to think that a jury needed Professor Markowitz to address historical knowledge about the hazards of excessive silica exposure, but plaintiffs’ lawyers persist in that practice in their silica cases.

What follows is the first part of an expanded version of the abstract presented at the ICOH.

COURTING CLIO:  HISTORIANS UNDER OATH

Introduction

Every trial involves a dispute about past facts and events.  The trier of fact must resolve the factual disputes based upon the evidence marshaled at trial.  In the common law system, the parties are primarily responsible for adducing evidence that will support their claims about historical facts.  A mature law of evidence governs admissibility of evidence, and what is reserved to counsel’s argument and the trier of fact’s reasonable inference.  The body of rules and principles that make up the law of evidence has evolved toward securing fairness, eliminating undue expense and delay, and ascertaining the truth.  Fed. R. Evid. 102.  Many would question the perfection of the current law of evidence, but few would agree to turn control over evidence and inference to historians appearing in court as expert witnesses.

Trial lawyers, using admissible evidence at trial, and fair comment in summation, attempt to persuade the triers of fact of the correctness of their version of historical facts relevant to the dispute.  In courthouses throughout the common-law world, trying cases ranging from car wrecks to complex anti-trust conspiracies, lawyers research, document, and adduce evidence of historical fact.  Judges regulate the proof of relevant historical facts by a system of rules that has been refined over centuries in the crucible of judicial experience.

At first blush, historians would appear to have little or no role in the litigation process.  Historians, in marshaling evidence and inference, are largely redundant to the lawyering process.  Indeed, reported decisions involving historians are relatively uncommon.  For the most part, historians are discussed as witnesses in only a few cases, involving such issues as land boundary disputes, navigability of rivers and riparian rights, Native American tribal status, or Nazi deportations.  See, e.g., Cayuga Indian Nation v. Pataki, 165 F.Supp. 2d 266, 300 (N.D.N.Y. 2001) (testimony on state’s purchase of tribal land); Denson v. Stack, 997 F.2d 1356, 1363-68 (11th Cir. 1993) (Clark, J., dissenting) (navigability of river in mid-19th century); Naujalis v. INS, 240 F.3d 642, 645 n.7 (7th Cir. 2001) (Nazi deportation); United States v. Dailide, 227 F.3d 385, 387 (6th Cir. 2000) (historian’s testimony in deportation proceeding).  The common themes to those cases are the arcane proofs, serious authenticity issues, and foreign language of the documentary evidence.

Historian As Advocate

There is a disturbing tendency for historians, as well as other academics, to view service as an expert witness as a way to effect social change.  Some historians have honestly acknowledged that they became lawyers manqué in their role as experts.  Professor Alfred Kelly, noted historian of the Reconstruction era, who served on the NAACP’s legal team in Brown v. Board of Education, 347 U.S. 483 (1954), strained to make out the historical case that the ratifiers of the Fourteenth Amendment had intended or anticipated to desegregate public schools.  In Richard Kluger’s history of Brown, Professor Kelly is quoted as saying that he “was caught between [his] ideals as an historian and what these people in New York [NAACP] wanted and needed.”  R. Kluger, Simple Justice:  The History of Brown v. Board of Education and Black America’s Struggle for Equality, 802 (N.Y. 1975).

Historian David Rothman recently acknowledged advocacy as the basic motivation for historians to serve as expert witnesses.  In his article, “Serving Clio and Client:  The Historian as Expert Witness,” 77 Bull. Hist. Med. 25 (2003), Rothman notes and embraces the tendentious nature of historical scholarship.  “Historians,” he tell us, “are no more or less ‘objective’ in the courtroom than they are in the lecture hall or in print.”  Id. at 44.  That assessment, alone, should give trial courts serious pause before allowing historians to testify.

In arguing why historians should serve as expert witnesses, Rothman advances the unexceptional point that litigants should have access to the expertise to have their day in court.  Id.  To the extent that historical expertise is the proper subject of opinion testimony, and the opinion is reliably based, Rothman’s point is well taken.  Emboldened, however, by the prospect of turning the witness chair into the bully pulpit, Rothman waxes expansively about the attraction of forays into the courtroom.  Historians, as expert witnesses, “may wish to bring their expertise to the support of a cause.”  Id (emphasis added).  Rothman sees historian expert witnesses as “advocates and agents of change.”  Id.

Rothman’s view of the historian as an advocate is by no means unique.  The American Historical Association (AHA), chartered by the United States Congress in 1889, has proclaimed that political views may “inform their historical practice.”  AHA, Statement on Standards of Professional Conduct, 2005 Edition, available at http://www.historians.org/pubs/Free/ProfessionalStandards.cfm (last revised January 2011).

The AHA urges hopefully that historians’ political views, when “applied with integrity,” can inform their historical researches and writing.  Id.  One of the public arenas contemplated for historical practice, by the AHA, is the courtroom, where historians will serve as expert witnesses.  Id.  In its Internet website guide to job opportunities for college graduates with degrees in history, the AHA describes “historians as advocates,” and encourages young historians that they may play an important part in the legal process by serving as expert witnesses.  AHA, http://www.historians.org/pubs/Free/careers/Index.htm (last visited on Dec.17, 2011).

Rothman’s and the AHA’s conception of the historian’s role in the trial process is inconsistent with long-established law of expert witness opinion.  Expert witnesses are simply not supposed to be advocates.  In their enthusiasm for an expansive role for historians, these historians have helped to identify much that is wrong with historian witness testimony.  Venality is a relatively weak motive, and one that is easily documented, compared with the corrupting influence of the zeal of advocacy, disguised as expert opinion.

We can find no clearer statement of judicial antipathy to expert witness advocacy than the famous copyright decision by Judge Learned Hand in Nichols v. Universal Pictures Corp., 45 F.2d 119 (2d Cir. 1930).  Both sides in Nichols presented expert testimony on “dramatic writing” in an effort to prove or disprove a claim that one screenplay infringed upon another.  Deprecating the lengthy, argumentative testimony from both sides’ experts, Judge Hand wrote that “[i]t ought not be allowed at all . . . .”  Id. at 123.  Judge Hand explained with his usual magisterial authority:  “Argument is argument whether in the box or at the bar, and its proper place is the last.”  Id.

Other areas of expertise, besides historical scholarship, fail to satisfy the basic requirements of expert witness testimony.  For instance, Judge Hand’s complaints about the “literary critic” expert witness in Nichols, have been re-lodged against witnesses with expertise in ethics.  In GST v. Telecommunications, Inc., 192 F.R.D. 109 (S.D.N.Y. 2000), both parties offered expert witness on the ethics of the conduct of corporate officers.  Invoking the requirement of helpfulness embodied in Federal Rule of Evidence 702, the Court found the proffered testimony would not aid the jury.  “It is evident that the contentious advocacy of the experts – illustrated by conclusions on the credibility of explanations regarding the business judgment of the board of directors . . . in clearly expressed, biased viewpoints – do little to aid the triers of fact on the underlying transactions.”  Id. at 110.  The trial court discerned a serious danger that expert testimony on ethics would usurp the jury’s role in applying the law to the facts found in the case.  Id.  Permitting such testimony would allow expert witnesses to attempt to substitute their judgment for the jury’s.  Id.; see, e.g., Pan American World Airways, Inc. v. Aetna Casualty & Surety, 505 F.2d 989, 998 (2d Cir. 1974) (noting disapprovingly that, evidence consisted “largely of hearsay, propaganda, speculation, and conjecture”).  See also Imwinkelried, “Expert Testimony by Ethicists:  What Should Be the Norm?” 76 Temple L. Rev. 91, 114, 128 (2003) (noting that normative testimony will virtually always be inadmissible).

Of course, the substitution of an expert witness’s judgment for that of a jury is precisely what all trial lawyers hope to accomplish.  Lawyers can select and present expert witnesses based upon their opinions and conclusion, whereas the conclusions of juries are all too unpredictable.  Trial courts must be vigilant to police expert witness opinion testimony in the area of history as much as, if not more than, in the area of scientific testimony.  Rule 702’s requirement of knowledge that will assist the trier of fact is designed to prevent expert witnesses from testifying about matters within the common understanding of the jury, and about which the jurors can reason without help from an expert witness.  In the Rezulin Multidistrict Litigation (MDL), testimony that was “a narrative of the case which a juror is equally capable of constructing” was precluded.  In re Rezulin Products Liability Litig., 309 F.Supp. 2d 531, 541 (S.D.N.Y. 2004).  Judge Kaplan explained that expert witnesses were not the appropriate conduit for a narrative of events, meetings, regulations, and documents, when they were not percipient witnesses.  Such testimony was within the jury’s lay understanding, and the law prohibited the attempt to have expert witnesses “supplant the role of counsel in making argument at trial, and the role of the jury in interpreting the evidence.”  Id. at 551.


Barring Unreliable Opinion Testimony From Historians

Stripping the argument and advocacy from historian testimony would go a long way toward remedying what is unreliable and objectionable from such opinions.  Indeed, in many cases, lawyers may find themselves with little or no reason to call on historian witnesses.

If juries should be subjected to the opinion testimony of historians, serving as expert witnesses, are there any protections against unreliable historical opinions?  We are all familiar with the extravagant claims of revisionist historians, who endeavor to reinvent the past for some political purpose.  Consider, for example, the cottage industry that decimated our forests in an effort to exculpate the late Alger Hiss.  The prospect of similar opinion testimony in the forum of tort cases is no less daunting.

The American Historical Association (A.H.A.) has recently promulgated updated standards necessary for the productions of reliable history.  Statement on Standards, supra at http://www.historians.org/pubs/Free/ProfessionalStandards.cfm (last revised January 2011).  These standards raise the important question whether courts, to the extent they permit historical testimony at all, will insist upon a showing of “reliability” before allowing widely disparate historical opinions to be presented to juries.  Surely, historical opinion that is unreliable, like unreliable scientific opinion, would not be helpful to the trier of fact.  Courts, employing various evidentiary standards, routinely exclude unhelpful testimony.  Furthermore, few lawyers would contend that they have a right, constitutional or otherwise, to present unreliable or unhelpful testimony.

The AHA’s Standards may provide a starting point for judicial consideration of the reliability of proffered historical testimony.  The Association views itself as having a special obligation to address “dilemmas and concerns about the practice of history that historians have regularly brought to the A.H.A. seeking guidance and counsel.”  Id.  The AHA Standards address “forms of professional misconduct that are especially troubling to historians,” and “identify a core set of shared values that professional historians strive to honor in the course of their work.”  Id.  The AHA thus acts as have many medical and scientific societies that have put forward guidelines and consensus statements on methodologic issues.

The AHA Standards explicitly acknowledge that historical scholarship is pursued and presented in many venues and formats, including as expert witness testimony in public arenas:

Practicing history in the public realm presents important challenges, for when historians communicate with a wide public, they must represent not just a particular interpretation or body of facts, but the best practices of the discipline of history itself.  This means they must inevitably walk a tightrope in balancing their desire to present a particular point of view with their responsibility to uphold the standards and values that underpin their professional authority as historians.  This challenge can be especially complex for . . . historians working in advocacy roles.

Id.  The Standards in many respects adopt a standard of care for historians.  Practicing history with integrity is defined in terms of both duties of aspiration and prohibition.  Among those standards relevant to a reliability assessment of historian testimony is the exhortation to acknowledge “the limits and uncertainties” of one’s arguments, as well as not to omit evidence that tends to counter or undermine one’s interpretations.  Id.  Although the Standards acknowledge the legitimacy of “point of view,” they define professional integrity in terms of, among other things, “a readiness to follow sound method and analysis wherever they may lead.”  Id.

The limits suggested by the AHA can certainly help courts evaluate historians’ testimony when carrying out their gatekeeping role for these expert witnesses.  The Standards, however, should not usurp the judicial function to define and apply criteria for the reliability and helpfulness of opinion testimony.

(to be continued)

Philadelphia Mass Tort Litigation Acknowledges Its Errant Procedures

December 16th, 2011

Judge John Herron, Administrative Judge of the Trial Division of the Philadelphia Court of Common Pleas recently announced that the Philadelphia courts will suspend their use of consolidation and reverse bifurcation in mass tort actions .  The Court had previously announced that it was studying whether consolidation and reverse bifurcation procedures have adequate procedural safeguards in place “to assure fair and just disposition of actions filed.”  See Notice to the Bar – Mass Tort Program (Dec. 8, 2011).  The Court also indicated that after a period of studying these procedures, the Court may reinstate reverse bifurcation and consolidation if the Court believes that the procedures are implemented fairly.  Reverse bifurcation in pharmaceutical cases will end permanently as of January 1, 2012.

The procedural unfairness of Philadelphia’s handling of so-called mass torts has been described by Joshua D. Wright, a professor of law and economics at George Mason University School of Law, in his study, “Are Plaintiffs Drawn to Philadelphia’s Civil Courts? An Empirical Examination.”  See also Michelle J. White, “Asbestos Litigation: Procedural Innovations and Forum Shopping,” 35 J. Leg. Stud. 365  (June 2006); Michelle J. White, “Understanding the Asbestos Crisis” (2003).

These articles only scratch the surface of what goes on in Philadelphia.  SeePhiladelphia Courts – Structural Bias and Reverse Bifurcation” (Oct. 27, 2011).

The United States Constitution places limits on courts’ abilities to grant separate trials. The Seventh Amendment’s Reexamination Clause provides that:

“no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.”

U.S. CONST, amend. VII.  The Supreme Court interpreted the Reexamination Clause to prohibit a grant of a partial new trial in some circumstances:

“Where the practice permits a partial new trial, it may not properly be resorted to unless it clearly appears that the issue to be retried is so distinct and separable from the others that a trial of it alone may be had without injustice.  . . . Here the question of damages on the counterclaim is so interwoven with that of liability that the former cannot be submitted to the jury independently of the latter without confusion and uncertainty, which would amount to a denial of a fair trial.”

Gasoline Prods. Co. v. Champlin Refining Co., 283 U.S. 494, 500 (U.S. 1931). Lower courts have divided over whether the Reexamination Clause is an obstacle to trial bifurcation, with some courts holding that the procedure is prohibited when overlapping issues in the phases of the trial will be reexamined successively in multiple trials.  See W. Russell Taber III, The Reexamination Clause: Exploring Bifurcation in Mass Tort Litigation, 73 Def. Counsel J. 63 (2006).

Philadelphia-style, across-the-board reverse bifurcation certainly has the potential to offend the Reexamination Clause, as well as other constitutional guarantees.  If the bifurcated trials contain issues that are not independent, then the Reexamination Clause would seem offended.  On the other hand, if the trial issues are independent, then the so-called “conjunction paradox” suggests that bifurcation undermines the jury’s evaluation of the burden of proof.  The product rule of probability teaches us that the probability of multiple independent events occurring is the product of the probabilities of each event’s occurring.  If, for instance, the probability of a particular plaintiff’s medical causation claim is 75%, and the plaintiff’s proximate cause claim is 75%, and the plaintiff’s negligence (breach of duty) claim is 75%, the probability of all necessary elements having occurred jointly would be 42.2%.  In a bifurcated trial, plaintiff would win each separate trial easily, but in a “straight-through” trial, plaintiff should fail to carry his burden of proof.  See generally Ward Farnsworth, The Legal Analyst: A Toolkit for Thinking about the Law 273-76 (Chicago 2007).

Apparently, last month, Philadelphia Common Pleas Court Judge Sandra Mazer Moss, who now coordinates the so-called Complex Litigation Center, announced certain asbestos cases – mesothelioma cases in which defendants did not contest diagnosis or asbestos etiology – would be tried in unbifurcated (“straight through”) trials. Michael P. Tremoglie & Jon Campisi, “Reverse Bifurcation Suspended in Philly Mass Torts,” Legal Newsline (Dec. 9, 2011); and The Pennsylvania Record (Dec. 9, 2011).

This policy, like its former incarnations, draws an invidious distinction between those cases in which diagnosis or medical causation is contested and those cases in which diagnosis or medical causation is uncontested.  Previously, Judge Moss would “sever crossclaims,” and force a defendant to proceed to try only its own liability.  The result was that a loss on both medical causation and liability required the judgment defendant to bond an entire judgment, without offset for settling defendants’ shares.  The common thread appears to be pressure defendants to settle, regardless of due process or substantial fairness.

Legalline‘s coverage noted that Judge Moss limited her abandonment of reverse bifurcation in ways that perpetuate the unfairness of Philadelphia procedures:

“This is something the litigants asked for and Judge Moss agreed to. A lot of times the cases would resolve after the damages were seen.

* * * * *

“But since it will be uncontested as to the cause, it will be a ‘straight through’ trial. This way cases will move faster through the court.”

This reasoning makes no sense.  If defendants acquiesce in medical causation, say of a lung cancer claim, they obtain a fair chance to litigate their liability defenses.  If both medical causation and liability are contested, however, defendants are subject to the backwards method of having to risk an adverse medical and damages verdict before the jury hears the defendants’ liability defenses.  Given that very few lung cancer cases, and no extrapulmonary cancers, are caused by asbestos, Philadelphia’s procedures still leave a lot to be desired.

Silica Science – Junk Science is Not Limited to The Courts

December 12th, 2011

“Clowns to the left of me; Jokers to the right; here I am, stuck in the middle with you.”


David Michaels, head of OSHA, back in October, was testifying at a House congressional oversight hearing, “Workplace Safety: Ensuring a Responsible Regulatory Environment.” The Congressmen were inquiring into OSHA’s enforcement and regulatory initiatives on several fronts, including silica exposures.

This is the same David Michaels who used to be a hired expert witness for plaintiffs in toxic tort cases. SeeDavid Michaels’ Public Relations Problem,” (Dec. 2, 2011).

Not surprisingly, when the questioning turned to silica, Michaels played the cancer card:  crystalline silica is a “known” human carcinogen.

Republican congressman Larry Bucshon (R-IN), a surgeon when he is not holding forth in Congress, found the talk of cancer to be provocative.  Buchson scolded Michaels:

“I don’t like it when people use buzz words that try to get people’s attention, and cancer is one of those.”

* * * * *

“…I’m a thoracic surgeon, so I want to focus a little bit on what you said earlier as it relates to silica dust. I’m curious about your comment about silica-dust related lung cancer, because I’ve been a thoracic surgeon for 15 years and I’ve done a lot of lung cancer surgery, and I haven’t seen one patient that’s got it from silica dust.”

A fascinating exchange for several reasons.

First, we could expect Michaels to play the cancer card, just as he has in his role as plaintiffs’ expert witness.  As we will see, his cancer evidence is not far fetched, although it is also not particularly convincing.

Second, the junk science from Congressman Buchson is distressing.  As a physician, he should know better that his experience in surgery has no relevance at all to the question whether crystalline silica can cause lung cancer.

Back in 1996, a working group of the World Health Organization’s International Agency for Research on Cancer (IARC) voted to reclassify crystalline silica, the most ubiquitous mineral on the face of Planet Earth, a known human carcinogen.  Michaels recited this “evidence,” but he failed to mention that the evidence was conflicting, as were the votes of the working group. The response of the scientific community to the IARC pronouncement was highly critical.  See Patrick A. Hessel, John F. Gamble, J. Bernard L. Gee, Graham Gibbs, Francis H.Y. Green, W. Keith C. Morgan, and Brooke T. Mossman, “Silica, Silicosis, and Lung Cancer: A Response to a Recent Working Group Report,” 42 J. Occup. Envt’l Med. 704 (2000).

The vote of the working group was very close; indeed, the swing of a single vote would have changed the outcome. One of the working group members later wrote:

“Some equally expert panel of scientists presented with the same information on another occasion could of course have reached a different verdict. The evidence was conflicting and difficult to assess and such judgments are essentially subjective.”

Corbett McDonald & Nicola Cherry, “Crystalline Silica and Lung Cancer:  The Problem of Conflicting Evidence,” 8 Indoor Built Environment 121, 121 (1999).  Remarkably, this panel member explained his decision to vote for reclassification as follows:

“The basic problem was that the evidence for carcinogenicity was conflicting – generally absent in situations of high and widespread exposure and strong only in a few rather special occupations.  The advice by the IARC to consider hazard rather than risk did much to resolve the difficulty.”

Id. at 125.  I suspect that the evidence for a difference in meaning between “hazard” and “risk” is even more tenuous and conflicting than the evidence in favor of carcinogenicity.

IARC classifications, however, take on a life of their own.  They are an invitation to stop thinking, and to stop analyzing the evidence.  Federal bureaucrats and staff scientists love them for exactly this reason:  they can hide behind the authority of the WHO without having to work on reviewing the evidence, or updating their judgment when new studies come out.

It should not be surprising, therefore, that the National Institutes of Health’s National Toxicology Program (NTP), working off the WHO decision, recognized crystalline silica as a human carcinogen. Other groups followed in lock step.  Other agencies and medical groups followed.

What you will not hear from Michaels or his followers is that when the National Institute for Occupational Safety and Health conducted the largest mortality study on the issue, it found a decreased lung cancer risk among men who actually had sufficient silica exposure to develop silicosis. See Geoffrey Calvert, et al., “Occupational silica exposure and risk of various diseases:  an analysis using death certificates from 27 states of the United States,” 60 Occup. Envt’l Med. 122 (2003).  Cf. “Congressman tells OSHA chief not to use “buzz” words like cancer.” (Oct. 10, 2011).

To give the devil his due, at least Michaels had “some” evidence to support his pronouncement, even if the evidence was incomplete and contradicted by other important evidence.  Congressman Bucshon’s recitation of his experience as a surgeon was completely off the mark.  His staffers obviously failed him in their research, and Bucshon’s reliance upon his own anecdotal experience was quite inappropriate to rebut the dubious judgment of the OSHA Administrator.

Some people might describe the exchange between Bucshon and Michaels as resembling two monkeys playing chess.  I think of it as exemplifying the scientific illiteracy in all three branches of our government.

David Michaels’ Public Relations Problem

Scientific American(s) and the other 99%

December 7th, 2011

If you have an interest in the history of science, especially as it plays out in the so-called state-of-the-art defense in products liability litigation, you may find the following offer helpful.  For the remainder of the month, Scientific American, which is now published by Nature, is making its archived issues, 1845-1909, available free of charge.

There is more fascinating than to read what people were thinking, saying, and writing, at times past.  Most of what we think we know about the past is filtered by historians rather than being obtained by accessing primary sources.  The Scientific American archive is a useful corrective measure, especially in the contentious area of health-effects litigation.

Here are some of the interesting historical insights.  In 1871, 140 years ago, Scientific American ran an article on the ill-health effects of smoking.  “To smoke or not to smoke,” Scientific American 375 (Dec. 9, 1871).  Here are some highlights:

“M. Beau notices eight cases of angina pectoris caused by the use of tobacco.

Professor Lizars records several cases of cancer of the tongue and lips caused by the use of the pipe. The writer has known one such ill stance, and never wishes to see another example of such terrible suffering resulting from a worse than useless habit.”

These pronouncements might not pass muster under today’s evidence-based medicine, but they were astute observations in need of testing, in 1871.

Not all the medical observations and claims were equally prescient.  Our forebears were not immune from the idiocies and enthusiasms of medical quackery.  Cancer remedies seemed to be a particular focus of much unenlightened attention:

“Col. Ussery, of the parish of De Soto, informs the Editor of the Caddo Gazette that he fully tested a remedy for this troublesome disease, recommended to him by a Spanish woman, a native of the country. The remedy is this:  Take an egg and break it, then pour out the white, retaining the yolk in the shell, put in salt and mix with the yolk as long as it will receive it, stir them together until the salve is formed, put a portion of this on a piece of sticking plaster and apply it to the cancer about twice a day. He has made the experiment twice in his own family with complete success.”

Remedy for Cancer,” Scientific American 298 (June 12, 1847).

Or this forerunner of the clinical trial:

“The Tuscaloosa Observer says it has seen it stated, more than once, that the common cranberry was efficacious in the cure of cancer, but have never, until very recently, been an eye-witness to the fact. Mr. Middleton Belk, residing within four or five miles of this city, who was afflicted with a cancer on the nose for the last eight years, was induced to try cranberries applied as a poultice; and to his great joy and satisfaction, has experienced a perfect and radical cure. We mention this fact at the instanee of Mr. Belk, who is desirous that others suffering under the same affliction, may avail themselves of this simple, but valuable remedy.”

Cranberries a Cure for Cancer,” 3 Scientific American 408 (Sept. 9, 1848).  Another article, three years later, touted mineral naptha as a cancer cure.  “Mineral Naptha,” 6 Scientific American 243 (April 19, 1851).

The pages of Scientific American document the rise of asbestos use and the growing awareness of asbestos’ great utility to help control and prevent fire and burns.  For instance, in 1876, the magazine described the utility of asbestos in roofing materials and in pipecovering.  “The Industrial Uses of Asbestos,” Scientific American 258 (April 22, 1876).

A few years later, an article described the widespread use of asbestos in industrial applications, both in Europe and in the United States:

“For some time past Toope’s covering for steam surfaces has been in use in England, giving great satisfaction and receiving the indorsement of many prominent English engineers.  The business of manufacturing and selling it is conducted there by a limited company located in London.
In this country Mr. Charles Toope, manufacturing agent, having an office and works at 353 East 78th street, New York City, is making and introducing the covering.  The covering is readily applied, requires no previous preparation, and when in place is permanent, being incapable of injury by jarring or pounding.”

Felt and Asbestos Covering for Steam Surfaces,” Scientific American 357 (December 4, 1880). [353 East 78th is right around the corner from me.  I doubt that many of the residents of this mid-rise apartment building know that an asbestos factory once graced their property.]  See also The Prevention of Fires in Theaters,” 35 Scientific American 401 (Dec. 23,1876); Insulated Coverings for Pipes, Boilers, Etc.,” 59 Scientific American 355, 355 (Dec. 8, 1888).

Federal Rules Get a Makeover

December 2nd, 2011

Bellbottoms are out; cuffs are in.  Robert Frost is out; Philip Levine is in.

So too with the Federal Rules.

The Federal Rules of Evidence have been “restyled.” Yesterday, the new, restyled Federal Rules of Evidence went into effect.

A PDF of the new rules is available at several places on the web, including the Federal Evidence Review website, which also has also links to the legislative history and guiding principles for this restyling.   The Legal Information Institute (LII) at Cornell Law School helpfully has posted ebooks, as ePub or mobi files, of the restyled Federal Rules of Civil Procedure, Criminal Procedure, and Evidence.

The legislative history of the restyled Evidence Rules 101-1103 make clear that the changes were designed to make the rules simpler, more readable and understandable, without changing their substantive meaning.  Was this effort worth the time and money?

The rules on expert witness opinion testimony are my particular interest.

Rule 703. Bases of an Expert’s Opinion Testimony

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

(Legislative History: Pub. L. 93-595, Jan. 2, 1975; Mar. 2, 1987, eff. Oct. 1, 1987; Apr. 17, 2000, eff. Dec. 1, 2000; Apr. 26, 2011, eff. Dec. 1, 2011.)

The rule specifies what happens “[i]f experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject,” but what happens “if not“?  The common reading interpolates “only” before “if,” but Rule 703 before and after restyling misses this drafting point.

So too does Rule 702:

Rule 702. Testimony by Expert Witnesses

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

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

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

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

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

(Legislative History: Pub. L. 93-595, Jan. 2, 1975; Apr. 17, 2000, eff. Dec. 1, 2000; Apr. 26, 2011, eff. Dec. 1, 2011.)

And if not?

The enumeration of (a) through (d) in Rule 702, however, is an improvement for reading and comprehension, especially with the conjunction connecting the last member of the series.

I suppose at age 36, everyone is entitled to a makeover.

David Michaels’ Public Relations Problem

December 2nd, 2011

OSHA requires strong, credible leadership from someone who will not outrun his scientific headlights, while at the same time enforcing standards that protect workers. President Obama made a serious error in appointing David Michaels, whose scientific and enforcement bona fides are weak.

Michaels has made a career out of targeting industry for perceived ethical lapses, yet he has routinely failed to make adequate disclosures himself, and some of his disclosures are downright deceptive.  This hypocrisy might be shrugged off as part of the politicization of occupational and environmental medicine, except that Michaels is now an Undersecretary of Labor.  When his agency starts handing out legal opinion letters to his former employers in the United States litigation industry, Michaels’ hypocrisy becomes something of a public nuisance and a scandal.  SeeManufacturing Certainty” (Oct. 25, 2011).  The Department of Labor’s “Dear Mr. Wodka” letter can now be found online at OSHA’s website.

Well before David Michaels became head of OSHA, his hypocrisy over conflicts of interest was noteworthy.  SeeHypocrisy In Conflict Disclosure Rules.” In his book, Doubt is Their Product: How Industry’s War on Science Threatens Your Health (2008), Michaels provides no disclosure of his prior activities and testimonial adventures on behalf of the litigation industry.  There is, among his acknowledgments, a tip of the hat to friends and colleagues, such as Steven Wodka.  Wodka is a plaintiffs’ lawyer who retained and paid Michaels in various litigations, but you will not learn that from reading Doubt is Their Product.  Not surprisingly, this book is waved around by plaintiffs’ counsel in cross-examinations in courtrooms all across the United States.

Michaels does reveal that his organization, The Project on Scientific Knowledge and Public Policy (SKAPP), accepted funding from “the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation.”  This revelation is, however, quite misleading.  The “Trust” is a fund for plaintiffs’ counsel in the silicone gel breast implant litigation, which was diverted to help support Michaels, and others who would advocate against evidence-based limitations to expert witness opinions.

Michaels insists that SKAPP accepts only unrestricted funding, but this insistence is also misleading.  Plaintiffs’ counsel could feel safe putting “their” money into the coffers of SKAPP, which was openly committed to undermining the implementation of evidence-based standards for causation opinion testimony in federal and state courts.  If the manufacturing industry, as opposed to the litigation industry, funded a not-for-profit, headed up by one of its testifying expert witnesses, most folks would call this maneuver “money laundering.”  Dirty money is dirty money, regardless whose ox is gored.  See also David Michaels & Celeste Monforton, “Scientific Evidence and the Regulatory System: Manufacturing Uncertainty and the Demise of the Formal Regulatory System,” 18 J. Law & Policy 17 (2005) (“Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation.”).

Other anemic or absent conflict of interest disclosures abound in Michaels’ publications.

Michaels has been involved in at least four different mass tort litigations, involving alleged injuries from exposures to asbestos, ortho-toluidene, beryllium, and vinyl chloride.  He has collaborated with Wodka in three of these litigations, by serving as Wodka’s expert witness.  This litigation collaboration should raise serious questions about the “Dear Mr. Wodka letter.”

Asbestos Litigation

Michaels has written several publications about health outcomes in sheet metal workers.  The premise of these papers is that the workers were exposed to asbestos, and they might have greater than expected cancer mortality as a result.  Most of Michaels’ papers fail to reveal that he consulted and testified for asbestos claimants.  See, e.g., David Michaels & Stephen Zoloth, “Asbestos Disease in Sheet Metal Workers: Proportional Mortality Update,” 13 Am. J. Indus. Med. 731-734 (1988).

One of Michaels’ publications on asbestos exposure and health outcomes does contains a disclosure, which even reveals on which side of asbestos litigation he worked:

“This work was supported by the Sheet Metal Occupational Health Institute Trust. Drs. Welch, Michaels, and Dement have worked as consultants for law firms representing individuals with asbestos-related disease. None of the authors have a financial interest in any organization that could profit from the research presented here.”

Laura Welch, Elizabeth Haile, John Dement, and David Michaels, “Change in Prevalence of Asbestos-Related Disease Among Sheet Metal Workers 1986 to 2004,” 131 Chest 863, 863 (2007).  Note the advocacy even in the disclosure.  Law firms that represent only individuals with asbestos-related disease!  Do we infer from this that Michaels did not consult for any law firms that represented individuals who claimed asbestos-related disease, but where the truth in God’s eye would have it that their claims were erroneous?  Perhaps the Principle of Charity requires us to infer that Michaels meant to disclose that he consulted for firms that represented persons claiming asbestos-related disease.  Having read Michaels’ litigation testimony, however, I think he really meant to say that what appears in the article.

There have been many thousands of asbestos cases, most of which have been settled or dismissed.  It is thus difficult to know exactly how many asbestos cases have seen the consulting work of David Michaels.  Clearly, however, some of Michaels’ asbestos testimony was given at the request of Steve Wodka, for Wodka’s clients.  See David Michaels deposition testimony at p. 41,  in Nicastro v. Aceto Corp., New Jersey Superior Court, Law Division for Monmouth County, Docket No. L-3062-08 (Sept. 2, 2009).

Ortho-Toluidine Litigation

According to federal Magistrate Judge H. Kenneth Schroeder, Jr., Steve Wodka represents numerous plaintiffs who claim to have been harmed by exposure to ortho-toluidine.  David Michaels is a common fixture in these cases brought by Wodka.  See Pardee v. E.I. DuPont Nemours & Co., Case 1:07-cv-00268-WMS-HKS Document 29 (W.D.N.Y. March 31, 2008).  Faced with losing his expert witness to OSHA, Wodka noticed a trial deposition de bene esse of David Michaels in several cases.

Michaels was permitted to give his testimony, before moving into his OSHA position, in the following cases:

Pardee v. E.I. DuPont Nemours & Co., W.D.N.Y., Plaintiff, No. 07-CV-0268S(Sr)

Band v. E.I. DuPont Nemours & Co., W.D.N.Y., No. 07-CV-0267S(Sr)

Weist v. E.I. DuPont Nemours & Co., W.D.N.Y., No. 05-CV-0534A(Sr)

Nicastro v. Aceto Corp., New Jersey Superior Court, Law Division for Monmouth County, Docket No. L-3062-08

Polyvinyl Chloride Litigation

David Michaels served as a plaintiffs’ expert witness in at least one PVC case, Lattin v. Borden Chemical Co., New Jersey Superior Court, Law Div. Mercer Cty. Docket No. L-3850-01.  Mr. Wodka was the attorney for plaintiff.

Beryllium Litigation

One of David Michaels’ publications criticized the beryllium industry, on grounds that it advanced weak scientific data and arguments against changes in permissible exposure limits. David Michaels & Celeste Monforton, “Beryllium’s Public Relations Problem: Protecting Workers When There Is No Safe Exposure Level,” 123 Public Health Reports 79 (2008).  In this article, Michaels acknowledges that he “served as an expert witness in a civil suit involving chronic beryllium disease.”  Apparently, Michaels forgot to point out that he was paid for his services, and that the payor was the claimant, whose interests he was advancing in his paper.

Marc Kolanz for one of the companies sued over beryllium health claims noted, in rebuttal, that:

“Dr. Michaels is a paid expert witness in beryllium litigation.  Dr. Michaels’ has not published beryllium industrial hygiene or medical research; however, he has provided litigation support serving as a paid expert witness for plaintiffs in beryllium litigation. Consistent with this role, as a hired advocate for plaintiff’s counsel, he has sought to ‘manufacture certainty’ by applying a hindsight approach to criticize the good works of dedicated beryllium researchers.”

Marc Kolanz, “Beryllium History and Public Policy,” 123 Public Health Reports 423, 427 (2008).

Michaels was an expert witness for Philadelphia plaintiffs’ attorney, Ed Reeves, in the Lonnie Pierce case, in Pennsylvania.

*   *   *   *

There is nothing ignoble or disreputable in serving as an expert witness.  Indeed, real experts may well have an obligation to make their expertise available to the civil and criminal justice system.  What is unseemly is the incessant hypocrisy in accusing manufacturing industry of conflicts of interest, while hiding and misrepresenting litigation industry conflicts.  David Michaels has been in the forefront of this hypocrisy.  The “Dear Mr. Wodka” letter deserves more scrutiny under the principles that Michaels has advocated for manufacturing industry.