TORTINI

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

When There Is No Risk in Risk Factor

February 20th, 2012

Some of the terminology of statistics and epidemiology is not only confusing, but it is misleading.  Consider the terms “effect size,” “random effects,” and “fixed effect,” which are all used to describe associations even if known to be non-causal.  Biostatisticians and epidemiologists know that the terms are about putative or potential effects, but the sloppy, short-hand nomenclature can be misleading.

Although “risk” has a fairly precise meaning in scientific parlance, the usage for “risk factor” is fuzzy, loose, and imprecise.  Journalists and plaintiffs’ lawyers use “risk factor,” much as they another frequently abused term in their vocabulary:  “link.”  Both “risk factor” and “link” sound as though they are “causes,” or at least as though they have something to do with causation.  The reality is usually otherwise.

The business of exactly what “risk factor” means is puzzling and disturbing.  The phrase seems to have gained currency because it is squishy and without a definite meaning.  Like the use of “link” by journalists, the use of “risk factor” protects the speaker against contradiction, but appears to imply a scientifically valid conclusion.  Plaintiffs’ counsel and witnesses love to throw this phrase around precisely because of its ambiguity.  In journal articles, authors sometimes refer to any exposure inquired about in a case-control study to be a “risk factor,” regardless of the study result.  So a risk factor can be merely an “exposure of interest,” or a possible cause, or a known cause.

The author’s meaning in using the phrase “risk factor” can often be discerned from context.  When an article reports a case-control study, which finds an association with an exposure to some chemical the article will likely report in the discussion section that the study found that chemical to be a risk factor.  The context here makes clear that the chemical was found to be associated with the outcome, and that chance was excluded as a likely explanation because the odds ratio was statistically significant.  The context is equally clear that the authors did not conclude that the chemical was a cause of the outcome because they did not rule out bias or confounding; nor did they do any appropriate analysis to reach a causal conclusion and because their single study would not have justified reaching a causal association.

Sometimes authors qualify “risk factor” with an adjective to give more specific meaning to their usage.  Some of the adjectives used in connection with the phrase include:

– putative, possible, potential, established, well-established, known, certain, causal, and causative

The use of the adjective highlights the absence of a precise meaning for “risk factor,” standing alone.  Adjectives such as “established,” or “known” imply earlier similar findings, which are corroborated by the study at hand.  Unless “causal” is used to modify “risk factor,” however, there is no reason to interpret the unqualified phrase to imply a cause.

Here is how the phrase “risk factor” is described in some noteworthy texts and treatises.

Legal Treatises

Professor David Faigman, and colleagues, with some understatement, note that the term “risk factor is loosely used”:

Risk Factor An aspect of personal behavior or life-style, an environmental exposure, or an inborn or inherited characteristic, which on the basis of epidemiologic evidence is known to be associated with health-related condition(s) considered important to prevent. The term risk factor is rather loosely used, with any of the following meanings:

1. An attribute or exposure that is associated with an increased probability of a specified outcome, such as the occurrence of a disease. Not necessarily a causal factor.

2. An attribute or exposure that increases the probability of occurrence of disease or other specified outcome.

3. A determinant that can be modified by intervention, thereby reducing the probability of occurrence of disease or other specified outcomes.”

David L. Faigman, Michael J. Saks, Joseph Sanders, and Edward Cheng, Modern Scientific Evidence:  The Law and Science of Expert Testimony 301, vol. 1 (2010)(emphasis added).

The Reference Manual on Scientific Evidence (2011) (RMSE3d) does not offer much in the way of meaningful guidance here.  The chapter on statistics in the third edition provides a somewhat circular, and unhelpful definition.  Here is the entry in that chapter’s glossary:

risk factor. See independent variable.

RMSE3d at 295.  If the glossary defined “independent variable” as a simply a quantifiable variable that was being examined for some potential relationship with the outcome, or dependent, variable, the RMSE would have avoided error.  Instead the chapter’s glossary, as well as its text, defines independent variables as “causes,” which begs the question why do a study to determine whether the “independent variable” is even a candidate for a causal factor?  Here is how the statistics chapter’s glossary defines independent variable:

“Independent variables (also called explanatory variables, predictors, or risk factors) represent the causes and potential confounders in a statistical study of causation; the dependent variable represents the effect. ***. “

RMSE3d at 288.  This is surely circular.  Studies of causation are using independent variables that represent causes?  There would be no reason to do the study if we already knew that the independent variables were causes.

The text of the RMSE chapter on statistics propagates the same confusion:

“When investigating a cause-and-effect relationship, the variable that represents the effect is called the dependent variable, because it depends on the causes.  The variables that represent the causes are called independent variables. With a study of smoking and lung cancer, the independent variable would be smoking (e.g., number of cigarettes per day), and the dependent variable would mark the presence or absence of lung cancer. Dependent variables also are called outcome variables or response variables. Synonyms for independent variables are risk factors, predictors, and explanatory variables.”

FMSE3d at 219.  In the text, the identification of causes with risk factors is explicit.  Independent variables are the causes, and a synonym for an independent variable is “risk factor.”  The chapter could have avoided this error simply by the judicious use of “putative,” or “candidate” in front of “causes.”

The chapter on epidemiology exercises more care by using “potential” to modify and qualify the risk factors that are considered in a study:

“In contrast to clinical studies in which potential risk factors can be controlled, epidemiologic investigations generally focus on individuals living in the community, for whom characteristics other than the one of interest, such as diet, exercise, exposure to other environmental agents, and genetic background, may distort a study’s results.”

FMSE3d at 556 (emphasis added).

 

Scientific Texts

Turning our attention to texts on epidemiology written for professionals rather than judges, we find that sometimes the term “risk factor” with a careful awareness of its ambiguity.

Herbert I. Weisberg is a statistician whose firm, Correlation Research Inc., specializes in the applied statistics in legal issues.  Weisberg recently published an interesting book on bias and causation, which is recommended reading for lawyers who litigate claimed health effects.  Weisberg’s book defines “risk factor” as merely an exposure of interest in a study that is looking for associations with a harmful outcome.  He insightfully notes that authors use the phrase “risk factor” and similar phrases to avoid causal language:

“We will often refer to this factor of interest as a risk factor, although the outcome event is not necessarily something undesirable.”

Herbert I. Weisberg, Bias and Causation:  Models and Judgment for Valid Comparisons 27 (2010).

“Causation is discussed elliptically if at all; statisticians typically employ circumlocutions such as ‘independent risk factor’ or ‘explanatory variable’ to avoid causal language.”

Id. at 35.

Risk factor : The risk factor is the exposure of interest in an epidemiological study and often has the connotation that the outcome event is harmful or in some way undesirable.”

Id. at 317.   This last definition is helpful in illustrating a balanced, fair definition that does not conflate risk factor with causation.

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Lemuel A. Moyé is an epidemiologist who testified in pharmaceutical litigation, mostly for plaintiffs.  His text, Statistical Reasoning in Medicine:  The Intuitive P-Value Primer, is in places a helpful source of guidance on key concepts.  Moyé puts no stock in something’s being a risk factor unless studies show a causal relationship, established through a proper analysis.  Accordingly, he uses “risk factor” to signify simply an exposure of interest:

4.2.1 Association versus Causation

An associative relationship between a risk factor and a disease is one in which the two appear in the same patient through mere coincidence. The occurrence of the risk factor does not engender the appearance of the disease.

Causal relationships on the other hand are much stronger. A relationship is causal if the presence of the risk factor in an individual generates the disease. The causative risk factor excites the production of the disease. This causal relationship is tight, containing an embedded directionality in the relationship, i.e., (1) the disease is absence in the patient, (2) the risk factor is introduced, and (3) the risk factor’s presence produces the disease.

The declaration that a relationship is causal has a deeper meaning then the mere statement that a risk factor and disease are associated. This deeper meaning and its implications for healthcare require that the demonstration of a causal relationship rise to a higher standard than just the casual observation of the risk factor and disease’s joint occurrence.

Often limited by logistics and the constraints imposed by ethical research, the epidemiologist commonly cannot carry out experiments that identify the true nature of the risk factor–disease relationship. They have therefore become experts in observational studies. Through skillful use of observational research methods and logical thought, epidemiologists assess the strength of the links between risk factors and disease.”

Lemuel A. Moyé, Statistical Reasoning in Medicine:  The Intuitive P-Value Primer 92 (2d ed. 2006)

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In A Dictionary of Epidemiology, which is put out by the International Epidemiology Association, a range of meanings is acknowledged, although the range is weighted toward causality:

“RISK FACTOR (Syn: risk indicator)

1. An aspect of personal behavior or lifestyle, an environmental exposure, or an inborn or inherited characteristic that, on the basis of scientific evidence, is known to be associated with meaningful health-related condition(s). In the twentieth century multiple cause era, a synonymous with determinant acting at the individual level.

2. An attribute or exposure that is associated with an increased probability of a specified outcome, such as the occurrence of a disease. Not necessarily a causal factor: it may be a risk marker.

3. A determinant that can be modified by intervention, thereby reducing the probability of occurrence of disease or other outcomes. It may be referred to as a modifiable risk factor, and logically must be a cause of the disease.

The term risk factor became popular after its frequent use by T. R. Dawber and others in papers from the Framingham study.346 The pursuit of risk factors has motivated the search for causes of chronic disease over the past half-century. Ambiguities in risk and in risk-related concepts, uncertainties inherent to the concept, and different legitimate meanings across cultures (even if within the same society) must be kept in mind in order to prevent medicalization of life and iatrogenesis.124–128,136,142,240

Miquel Porta, Sander Greenland, John M. Last, eds., A Dictionary of Epidemiology 218-19 (5th ed. 2008).  We might add that the uncertainties inherent in risk concepts should be kept in mind to prevent overcompensation for outcomes not shown to be caused by alleged tortogens.

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One introductory text uses “risk factor” as a term to describe the independent variable, while acknowledging that the variable does not become a risk factor until after the study shows an association between factor and the outcome of interest:

“A case-control study is one in which the investigator seeks to establish an association between the presence of a characteristic (a risk factor).”

Sylvia Wassertheil-Smoller, Biostatistics and Epidemiology: A Primer for Health and Biomedical Professionals 104 (3d ed. 2004).  See also id. at 198 (“Here, also, epidemiology plays a central role in identifying risk factors, such as smoking for lung cancer”).  Although it should be clear that much more must happen in order to show a risk factor is causally associated with an outcome, such as lung cancer, it would be helpful to spell this out.  Some texts simply characterize risk factor as associations, not necessarily causal in nature.  Another basic text provides:

“Analytical studies examine an association, i.e. the relationship between a risk factor and a disease in detail and conduct a statistical test of the corresponding hypothesis … .”

Wolfgang Ahrens & Iris Pigeot, eds., Handbook of Epidemiology 18 (2005).  See also id. at 111 (Table describing the reasoning in a case-control study:    “Increased prevalence of risk factor among diseased may indicate a causal relationship.”)(emphasis added).

These texts, both legal and scientific, indicate a wide range of usage and ambiguity for “risk factor.”  There is a tremendous potential for the unscrupulous expert witness, or the uneducated lawyer, to take advantage of this linguistic latitude.  Courts and counsel must be sensitive to the ambiguity and imprecision in usages of “risk factor,” and the mischief that may result.  The Reference Manual on Scientific Evidence needs to sharpen and update its coverage of this and other statistical and epidemiologic issues.

Interstitial Doubts About the Matrixx

February 6th, 2012

Statistics professors are excited that the United States Supreme Court issued an opinion that ostensibly addressed statistical significance.  One such example of the excitement is an article, in press, by Joseph B. Kadane, Professor in the Department of Statistics, in Carnegie Mellon University, Pittsburgh, Pennsylvania.  See Joseph B. Kadane, “Matrixx v. Siracusano: what do courts mean by ‘statistical significance’?” 11[x] Law, Probability and Risk 1 (2011).

Professor Kadane makes the sensible point that the allegations of adverse events did not admit of an analysis that would imply statistical significance or its absence.  Id. at 5.  See Schachtman, “The Matrixx – A Comedy of Errors” (April 6, 2011)”;  David Kaye, ” Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety and Liability Reporter 1007 (Sept. 12, 2011).  Unfortunately, the excitement has obscured Professor Kadane’s interpretation of the Court’s holding, and has led him astray in assessing the importance of the case.

In the opening paragraph of his paper, Professor Kadane quotes from the Supreme Court’s opinion that “the premise that statistical significance is the only reliable indication of causation … is flawed,” Matrixx Initiatives, Inc. v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309 (2011).  The quote is accurate, but Professor Kadane proceeds to claim that this quote represents the holding of the Court. Kadane, supra at 1. The Court held no such thing.

Matrixx was a security fraud class action suit, brought by investors who claimed that the company misled them when they spoke to the market about the strong growth prospects of the company’s product, Zicam cold remedy, when they had information that raised concerns that might affect the product’s economic viability and its FDA license.  The only causation required for the plaintiffs to show was an economic loss caused by management’s intentional withholding of “material” information that should have been disclosed under all the facts and circumstances.  Plaintiffs do not have to prove that the medication causes the harm alleged in personal injury actions.  Indeed, it might turn out to be indisputable that the medication does not cause the alleged harm, but earlier, suggestive studies would provoke regulatory intervention and even a regulatory decision to withdraw the product from the market.  Investors obviously could be hurt under this scenario as much as, if not more than, if the medication caused the harms alleged by personal-injury plaintiffs. 

Kadane’s assessment goes awry in suggesting that the Supreme Court issued a holding about facts that were neither proven nor necessary for it to reach its decision.  Court can, and do, comment, note, and opine about many unnecessary facts or allegations in reaching a holding, but these statements are obiter dicta, if they are not necessary to the disposition of the case. Because medical causation was not required for the Supreme Court to reach its decision, its presence or absence was not, and could not, be part of the Court’s holding. 

Kadane makes a similar erroneous statement that the lower appellate courts, which earlier had addressed “statistical significance,” properly or improperly understood, found that “statistical significance in the strict sense [was] neither necessary … nor sufficient … to require action to remove a drug from the market.”  Id. at 6.  The earlier appellate decisions addressed securities fraud, however, not regulatory action of withdrawal of a product.  Kadane’s statement mistakes what was at issue, and what was decided, in all the cases discussed.

Kadane seems at least implicitly to recognize that medical causation is not at issue when he states that “the FDA does not require proof of causation but rather reasonable evidence of an association before a warning is issued.”  Id. at 7 (internal citation omitted).  All that had to have happened for the investors to have been harmed by the Company’s misleading statements was for Matrixx Initiatives to boast about future sales, and to claim that there were no health issues that would lead to regulatory intervention, when they had information raising doubts about their claim of no health issues. See FDA Regulations, 21 U.S.C. § 355(d), (e)(requiring drug sponsor to show adequate testing, labeling, safety, and efficacy); see also 21 C.F.R. § 201.57(e) (requiring warnings in labeling “as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”); 21 C.F.R. § 803.3 (adverse event reports address events possibly related to the drug or the device); 21 C.F.R. § 803.16 (adverse event report is not an admission of causation).

Kadane’s analysis of the case goes further astray when he suggests that the facts were strong enough for the case to have survived summary judgment.  Id. at 9.  The Matrixx case was a decision on the adequacy of the pleadings, not of the adequacy of the facts proven.  Elsewhere, Kadane acknowledges the difference between a challenge to the pleadings and the legal sufficiency of the facts, id. at 7 & n.8, but Kadane asserts, without explanation, that the difference is “technical” and does not matter.”  Not true.  The motion to dismiss is made upon receipt of the plaintiffs’ complaint, but the motion for summary judgment is typically made at the close of discovery, on the eve of trial.  The allegations can be conclusory, and they need have only plausible support in other alleged facts to survive a motion to dismiss.  The case, however, must have evidence of all material facts, as well as expert witness opinion that survives judicial scrutiny for scientific validity under Rule 702, to survive a motion for summary judgment, which comes much later in the natural course of any litigated case.

Kadane appears to try to support the conflation of dismissals on the pleadings and summary judgments by offering a definition of summary judgment that is not quite accurate, and potentially misleading:  “The idea behind summary judgment is that, even if every fact alleged by the opposing party were found to be true, the case would still fail for legal reasons.” Id. at 2.  The problem is that at the summary judgment stage, as opposed to the pleading stage, the party with the burden of proof cannot rest upon his allegations, but must come forward with facts, not allegations, to support every essential element of his case.  A plaintiff in a personal injury action (not a securities fraud case), for example, may easily survive a motion to dismiss by alleging medical causal connection, but at the summary judgment stage, that plaintiff must serve a report of an appropriately qualified expert witness, who in turn has presented a supporting opinion, reliably ground in science, to survive both evidentiary challenges and a dispositive motion.

Kadane concludes that the Matrixx decision’s “fact-based consideration” is consistent with a “Bayesian decision-theoretic approach that models how to make rational decisions under uncertainty.”  Id. at 9.  I am 99.99999% certain that Justice Sotomayor would not have a clue about what Professor Kadane was saying.  Although statistical significance may have played no role in the Court’s holding, and in Kadane’s Bayesian decision-theoretic approach, I am 100% certain that the irrelevance of statistical significance to the Court’s and Prof. Kadane’s approaches is purely coincidental.

Federal Rule of Evidence 702 Requires Perscrutations — Samaan v. St. Joseph Hospital (2012)

February 4th, 2012

After the dubious decision in Milward, the First Circuit would seem an unlikely forum for perscrutations of expert witness opinion testimony.  Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied, ___ U.S.___ (2012).  SeeMilwardUnhinging the Courthouse Door to Dubious Scientific Evidence” (Sept. 2, 2011).  Late last month, however, a First Circuit panel of the United States Court of Appeals held that Rule 702 required perscrutation of expert witness opinion, and then proceeded to perscrutate perspicaciously, in Samaan v. St. Joseph Hospital, 2012 WL 34262 (1st Cir. 2012).

The plaintiff, Mr. Samaan suffered an ischemic stroke, for which he was treated by the defendant hospital and physician.  Plaintiff claimed that the defendants’ treatment deviated from the standard of care by failing to administer intravenous tissue plasminogen activator (t-PA).  Id. at *1.  The plaintiff’s only causation expert witness, Dr. Ravi Tikoo, opined that the defendants’ failure to administer t-PA caused plaintiffs’ neurological injury.  Id. at *2.   Dr. Tikoo’s opinions, as well as those of the defense expert witness, were based in large part upon data from a study done by one of the National Institutes of Health:  The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group, “Tissue Plasminogen Activator for Acute Ischemic Stroke,” 333 New Engl. J. Med. 1581 (1995).

Both the District Court and the Court of Appeals noted that the problem with Dr. Tikoo’s opinions lay not in the unreliability of the data, or in the generally accepted view that t-PA can, under certain circumstances, mitigate the sequelae of ischemic stroke; rather the problem lay in the analytical gap between those data and Dr. Tikoo’s conclusion that the failure to administer t-PA caused Mr. Samaan’s stroke-related injuries.

The district court held that Dr. Tikoo’s opinion failed to satisfy the requirements of Rule 702. Id. at *8 – *9.  Dr. Tikoo examined odds ratios from the NINDS study, and others, and concluded that a patient’s chances of improved outcome after stroke increased 50% with t-PA, and thus Mr. Samaan’s healthcare providers’ failure to provide t-PA had caused his poor post-stroke outcome.  Id. at *9.  The appellate court similarly rejected the inference from an increased odds ratio to specific causation:

“Dr. Tikoo’s first analysis depended upon odds ratios drawn from the literature. These odds ratios are, as the term implies, ratios of the odds of an adverse outcome, which reflect the relative likelihood of a particular result.FN5 * * * Dr. Tikoo opined that the plaintiff more likely than not would have recovered had he received the drug.”

Id. at *10.

The Court correctly identified the expert witness’s mistake in inferring specific causation from an odds ratio of about 1.5, without any additional information.  The Court characterized the testimonial flaw as one of “lack of fit,” but it was equally an unreliable inference from epidemiologic data to a conclusion about specific causation.

While the Court should be applauded for rejecting the incorrect inference about specific causation, we might wish that it had been more careful about important details.  The Court misinterpreted the meaning of an odds ratio to be a relative risk.  The NINDS study reported risk ratio results both as an odds ratio and as a relative risk.  The Court’s sloppiness should be avoided; the two statistics are different, especially when the outcome of interest is not particularly rare.

Still, the odds ratio is interesting and important as an approximation for the relative risk, and neither measure of risk can substitute for causation, especially when the magnitude of the risk is small, and less than two-fold.  The First Circuit recognized and focused in on this gap between risk and causal attribution in an individual’s case:

“[Dr. Tikoo’s] reasoning is structurally unsound and leaves a wide analytical gap between the results produced through the use of odds ratios and the conclusions drawn by the witness. When a person’s chances of a better outcome are 50% greater with treatment (relative to the chances of those who were not treated), that is not the same as a person having a greater than 50% chance of experiencing the better outcome with treatment. The latter meets the required standard for causation; the former does not.  To illustrate, suppose that studies have shown that 10 out of a group of 100 people who do not eat bananas will die of cancer, as compared to 15 out of a group of 100 who do eat bananas. The banana-eating group would have an odds ratio of 1.5 or a 50% greater chance of getting cancer than those who eschew bananas. But this is a far cry from showing that a person who eats bananas is more likely than not to get cancer.

Even if we were to look only at the fifteen persons in the banana-eating group who did get cancer, it would not be likely that any particular person in that cohort got it from the consumption of bananas. Correlation is not causation, and a substantial number of persons with cancer within the banana-eating group would in all probability have contracted the disease whether or not they ate bananas.FN6

We think that this example exposes the analytical gap between Dr. Tikoo’s methods and his conclusions.  Although he could present figures ranging higher than 50%, those figures were not responsive to the question of causation. Let us take the “stroke scale” figure from the NINDS study as an example. This scale measures the neurological deficits in different parts of the nervous system. Twenty percent of patients who experienced a stroke and were not treated with t-PA had a favorable outcome according to this scale, whereas that figure escalated to 31% when t-PA was administered.

Although this means that the patients treated with t-PA had over a 50% better chance of recovery than they otherwise would have had, 69% of those patients experienced the adverse outcome (stroke-related injury) anyway.FN7  The short of it is that while the odds ratio analysis shows that a t-PA patient may have a better chance of recovering than he otherwise would have had without t-PA, such an analysis does not show that a person has a better than even chance of avoiding injury if the drug is administered. The odds ratio, therefore, does not show that the failure to give t-PA was more likely than not a substantial factor in causing the plaintiff’s injuries. The unavoidable conclusion from the studies deemed authoritative by Dr. Tikoo is that only a small number of patients overall (and only a small fraction of those who would otherwise have experienced stroke-related injuries) experience improvement when t-PA is administered.”

*11 and n.6 (citing Milward).

The court in Samaan thus suggested, but did not state explicitly, that the study would have to have shown better than a 100% increase in the rate of recovery for attributability to have exceeded 50%.  The Court’s timidity is regrettable. Yes, Dr. Tikoo’s confusing the percentage increased risk with the percentage of attributability was quite knuckleheaded.  I doubt that many would want to subject themselves to Dr. Tikoo’s quality of care, at least not his statistical care.  The First Circuit, however, stopped short of stating what magnitude increase in risk would permit an inference of specifc causation for Mr. Samaan’s post-stroke sequelae.

The Circuit noted that expert witnesses may present epidemiologic statistics in a variety of forms:

“to indicate causation. Either absolute or relative calculations may suffice in particular circumstances to achieve the causation standard. See, e.g., Smith v. Bubak, 643 F.3d 1137, 1141–42 (8th Cir.2011) (rejecting relative benefit testimony and suggesting in dictum that absolute benefit “is the measure of a drug’s overall effectiveness”); Young v. Mem’l Hermann Hosp. Sys., 573 F.3d 233, 236 (5th Cir.2009) (holding that Texas law requires a doubling of the relative risk of an adverse outcome to prove causation), cert. denied, ___ U.S. ___, 130 S.Ct. 1512, 176 L.Ed.2d 111 (2010).”

 Id. at *11.

Although the citation to Texas law with its requirement of a doubling of a relative risk is welcome and encouraging, the Court seems to have gone out of its way to muddle its holding.  First, the Young case involved t-PA and a claimed deviation from the standard of care in a stroke case, and was exactly on point.  The Fifth Circuit’s reliance upon Texas substantive law left unclear to what extent the same holding would have been required by Federal Rule of Evidence 702.

Second, the First Circuit, with its banana hypothetical, appeared to confuse an odds ratio with a relative risk.  The odds ratio is different from a relative risk, and typically an odds ratio will be higher than the corresponding relative risk, unless the outcome is rare.  See Michael O. Finkelstein & Bruce Levin, Statistics for Lawyers at 37 (2d ed. 2001). In studies of medication efficacy, however, the benefit will not be particularly rare, and the rare disease assumption cannot be made.

Third, risk is not causation, regardless of magnitude.  If the magnitude of risk is used to infer specific causation, then what is the basis for the inference, and how large must the risk be?  In what way can epidemiologic statistics be used “to indicate” specific causation?  The opinion tells us that Dr. Tivoo’s reliance upon an odds ratio of 1.5 was unhelpful, but why?  The Court, which spoke so clearly and well in identifying the fallacious reasoning of Dr. Tivoo, faltered in identifying what use of risk statistics would permit an inference of specific causation in this case, where general causation was never in doubt.

The Fifth Circuit’s decision in Young, supra, invoked a greater than doubling of risk required by Texas law.  This requirement is nothing more than a logical, common-sense recognition that risk is not causation, and that small risks alone cannot support an inference of specific causation.  Requiring a relative risk greater than two makes practical sense despite the apoplectic objections of Professor Sander Greenland.  SeeRelative Risks and Individual Causal Attribution Using Risk Size” (Mar. 18, 2011).

Importantly, the First Circuit panel in Samaan did not engage in the hand-waving arguments that were advanced in Milward, and stuck to clear, transparent rational inferences.  In footnote 6, the Samaan Court cited its earlier decision in Milward, but only with double negatives, and for the relevancy of odds ratios to the question of general causation:

“This is not to say that the odds ratio may not help to prove causation in some instances.  See, e.g., Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11, 13–14, 23–25 (1st Cir.2011) (reversing exclusion of expert prepared to testify as to general rather than specific causation using in part the odds ratio).”

Id. at n.6.

The Samaan Court went on to suggest that inferring specific causation from the magnitude of risk was “theoretically possible”:

Indeed, it is theoretically possible that a particular odds ratio calculation might show a better-than-even chance of a particular outcome. Here, however, the odds ratios relied on by Dr. Tikoo have no such probative force.

Id. (emphasis added).  But why and how? The implication of the Court’s dictum is that when the risk ratio is small, less than or equal to two, the ratio cannot be taken to have supported the showing of “better than even chance.” In Milward, one of the key studies relied upon by plaintiff’s expert witness reported an increased risk of only 40%.  Although Milward presented primarily a challenge on general causation, the Samaan decision suggests that the low-dose benzene exposure plaintiffs are doomed, not by benzene, but by the perscrutation required by Rule 702.

Ethics and Daubert: The Scylla and Charybdis of Medical Monitoring

February 1st, 2012

Build a courtroom and they will come. The floodgates argument, all too quickly rejected by the judiciary, proved all too true in West Virginia. West Virginia built a courtroom that would entertain multiple claims from virtually every West Virginian. This jurisprudential hospitality offers medical monitoring that requires no predicate present injury. Bower v. Westinghouse Electric Corp., 522 S.E.2d 424 (W.Va. 1999).

Everyone is exposed to hazardous substances and to medications with potential side effects. In West Virginia, almost everyone is a potential plaintiff in a medical monitoring case.

Universal health care may be attainable, after all, funded by the manufacturers of predominately beneficial products. Almost heaven West Virginia, indeed. Type 2 diabetes mellitus, or adult-onset diabetes, is a devastating disease that results from uncontrolled blood sugars. The medical complications of diabetes are extensive and well known: blindness, gangrene, kidney failure, heart attack, stroke, liver disease, and others. The costs of this medical care are staggering, and diabetics are among the neediest patients in our health care system. Imagine if the “compensation goals” of the tort system could be subverted to provide medical monitoring to diabetic patients. If possible anywhere, it would seem West Virginia would be the most likely candidate.

Between March 1997 and March 2000, many Type 2 diabetics achieved control of their blood sugars with the help of a new oral medication, Troglitazone (Rezulin®).  Troglitazone modifies the Type 2 diabetic patient’s resistance to insulin. The drug effectively reduces blood sugar, and it avoids the need for exogenous insulin. Most life-saving drugs have side effects, and Troglitazone is no exception. Physicians, knowledgeable about Troglitazone’s efficacy and its potential for rare, idiosyncratic liver toxicity, prescribed the drug to help their patients gain control over their blood sugar levels and to avoid the serious complications of diabetes. In March 2000, the manufacturer of Troglitazone voluntarily withdrew the drug from the market. Adverse publicity over liver toxicity and the availability of two other more recent glitazones, which initially had the appearance of a safer adverse event profile, had shifted the risk-benefit balance against Troglitazone.

No one can be surprised that Rezulin plaintiffs sought class certification in West Virginia state court; nor can anyone, in view of Bower, be surprised that asymptomatic plaintiffs sought medical monitoring as a remedy, within the context of the class action. Observers unfamiliar with the weakness of the Rezulin plaintiffs’ scientific proofs might, however, be surprised at the plaintiffs’ failure, initially at the trial court level, to win class certification in West Virginia, for a medical monitoring class. In re West Virginia Rezulin Litigation, W.Va. Cir.Ct., Civil Action No. 00-C-1180H, Amended Order Denying Class Certification (Dec. 12, 2001) (Hutchison, J.), 2001 WL 1818442 (Dec 13, 2001).

The West Virginia trial court’s rejection of the proposed Rezulin medical monitoring class is remarkable for many reasons. Some commentators regard West Virginia law as the outer limits of medical monitoring jurisprudence.  In the Rezulin case, however, Judge John Hutchison delivered a thorough, analytical opinion, which demonstrated that the liberal West Virginia criteria for a medical monitoring remedy cannot be satisfied as easily as once thought. Among the notable holdings were the trial court’s insistence that:

(1) the monitoring proponents adduce epidemiologic evidence that the exposure at issue can actually cause the latent injury for which monitoring is sought;

(2) the proponents of monitoring identify highly sensitive tests, which when deployed on the exposed population that has a relatively high prevalence of the latent injury, will have a high predictive value; and

(3) the proposed monitoring will allow for early preventive care.

In determining whether the class plaintiffs had met the criteria for medical monitoring, Judge Hutchison did not face any significant evidentiary gatekeeping responsibility. The trial court did not have to ponder the contours of any reliable epidemiologic studies. The court found no epidemiologic studies to show that Rezulin can cause latent injury months or years after the drug is discontinued.

Similarly, the court did not have to delve into any evidentiary thicket of contradictory scientific proof to determine whether the proposed medical monitoring program was based upon reliable scientific and medical methods. The court found that most of the proposed tests had low sensitivity, and that there were no diagnostic tests that can determine whether any liver injury was caused by Rezulin. Given the many other causes of liver diseases among the plaintiff class members, there was no evidence of any prevalence of latent injury from Rezulin. Without an assessment of prevalence of latent injury, any proposed test would have little or no positive predictive value. The proposed program failed for lack of substantial evidentiary support.

The court was further impressed by the riskiness of the proposed monitoring program. The proposed tests, lacking sensitivity and specificity, were likely to result in many “false positives,” which in turn would lead to liver biopsies.  (Indeed, false positives would likely swamp any true positives if any there should be). Liver biopsies, however, are painful, invasive, and carry a small, but definite, risk of death. Furthermore, the court found that the proposed tests would not facilitate medical interventions that could prevent or resolve the detected problem.

This failure to obtain class certification for medical monitoring is noteworthy for more than the narrow case holdings. There is intriguing obiter dictum. The court noted that one of the plaintiffs’ expert witnesses admitted that the proposed monitoring program was an “experiment.” The court found this admission directly relevant to the plaintiffs’ failure to produce epidemiologic evidence that the substance at issue could actually cause latent injury. Apparently, the plaintiffs’ witness was advocating implementation of the monitoring program so it might yield the evidence that the class must proffer before it could obtain the monitoring remedy. The court readily dismissed this Alice in Wonderland insistence upon “[s]entence first—verdict afterwards.” The court showed little patience for the “stuff and nonsense” of trying to satisfy the criterion of epidemiologic evidence with the anticipated results that would come from the proposed monitoring program itself.

Implicit in the trial court’s rejection of evidentiary bootstrapping is a larger, ethical concern. There is something unsettling about a court-ordered medical monitoring program that is an “experiment.” Class certification decisions are complicated enough without having to endorse experimentation on human beings. Perhaps the suggestion of human experimentation chilled any residual enthusiasm for the notion that medical monitoring might otherwise be a suitable judicial remedy for achieving corrective justice in a mass tort case.

And yet there is an “experimental” aspect to many, if not most, proposed monitoring programs. Little or no clinical experience is available to support the claimed benefits of many proposed large, lifelong monitoring regimes. Indeed, such programs are not wholly benign. The potential harms of monitoring, some of which were acknowledged in Judge Hutchison’s opinion, are significant.

The imposition of potentially harmful monitoring should, indeed, trouble our courts and cause their reticence in embracing monitoring as a remedy. Courts need to confront the ethical implications that flow from the experimental nature of many medical monitoring proposals.

Proposals for monitoring differ from expert witness opinion that is typically offered in personal injury cases involving present injuries. Physician witnesses, at the request of the parties, usually examine claimants, evaluate and diagnose their conditions, and opine about prognosis and etiology. Although such witnesses use their medical experience, training, and knowledge, they generally are not acting within the context of a patient-physician relationship. Adams v. Harron, 191 F.3d 447, 1999 WL 710326 (4th Cir. 1999). In the usual personal injury case, physician witnesses are not advocating medical interventions; at most, they are endorsing or criticizing the reasonable medical necessity of medical plans of treating physicians.  In medical monitoring class actions, however, physician expert witnesses advocate medical interventions for people they have often never met and have never evaluated.

Recommendations for preventive health measures carry risks of harm, and these risks must provoke ethical scrutiny of the proposed monitoring. The offering of an opinion that a plaintiff, or a class of plaintiffs, should receive medical monitoring is the practice of medicine. As part of medical practice, the presentation of such opinions is subject to ethical constraints, which courts should observe and foster. Medico-legal opinions that recommend preventive interventions represent a significant involvement in the claimant’s actual medical care. Screening or monitoring recommendations must acknowledge and avoid the highly individualized risks of harm and the essential need for informed consent to protect individual autonomy.

Physicians who prepare medical monitoring litigation plans cannot absolve themselves of ethical and professional responsibility by disclaiming the existence of physician-patient relationships. Such physicians are not practicing mere courthouse medicine; they are engaged in medical practice, as defined by the American Medical Association, AMA Policy H-265.993, and in the sense that they are seeking to control future medical interventions for the class members.  Physicians who propose medical monitoring or screening for claimants thus operate under the ethical constraints of avoiding harm, providing benefits, and respecting individual patient autonomy. The medical community recognizes that good intentions notwithstanding, monitoring can be harmful. “[P]reventive therapies can give rise to anticipatory anxiety, side effects, the stress of false-positive results and an unhealthy preoccupation with disease.” Huston, “The Perils of Prevention,” 154 Canadian Med. Ass’n J. 1463 (1996). Other potential adverse effects of monitoring include deriving false assurances of health and being labeled as “sick.” Marshall, “Prevention. How Much Harm? How Much Benefit? 3. Physical, Psychological and Social Harm,” 155 Canadian Med. Ass’n J. 169 (1996).

Furthermore, some screening programs will detect true-positive results with little or no clinical significance.  For example, in cancer screening, some nodules detected will be benign. Other nodules may be extremely indolent malignancies, which would never become aggressive, metastatic growths. Indeed, such masses, picked up in screening, might regress before they would have been otherwise detectable. Screening programs must come to grips with the vagaries of the diseases and conditions that are the subject of the monitoring. The potential for harm, from monitoring, may be increased by the litigation setting, in which people are encouraged to become invested in illness seeking behaviors.

Given the potential for harm, physician witnesses who advocate monitoring face ethical and evidentiary burdens to establish the efficacy and benefit of the planned screening. At a minimum, class members will have to be properly advised, and will have to be given informed consent. The process of obtaining consent must accommodate the intensely personal and individualized judgments about the risks of monitoring.

Well-established criteria for evaluating public health interventions are available and employed by such agencies and groups as the United States Preventive Task Force, the Canadian Task Force on the Periodic Health Examination, the Cochrane Collaboration, and others.  The existence of generally accepted evaluative criteria has obvious implications for determining the admissibility of monitoring proposals under either Daubert or Frye standards. Expert witnesses, in this ethically sensitive area, must be held to the same intellectual rigor that would be employed to evaluate monitoring or screening programs in the field of public health. Pitfalls, fallacies, and methodological error are abundant in the field of preventive medicine. Marshall, “Prevention. How Much Harm? How Much Benefit? 2. Ten Potential Pitfalls in Determining the Clinical Significance of Benefits,” 154 Canadian Med. Ass’n J. 1837 (1996). Even well-intentioned advice, such as counseling routine mammography in women, has been the subject of heated controversy and intense methodological debate. Ernster, “Mammograms and Personal Choice,” The New York Times (Feb. 14, 2002).   Courts must acknowledge that if a proposed preventive program does not satisfy generally accepted criteria for medical interventions and does not have proven benefits that clearly outweigh the potential harms, medical monitoring becomes a court-sanctioned human experiment.

The guiding principles and corollaries for human experimental research can be found in several sources, including The Nuremberg Code, Permissible Medical Experiments, World Medical Association, “Declaration of Helsinki’s Ethical Principles for Medical Research Involving Human Subjects,” 284 J. Am. Med. Ass’n 3043 (Dec. 20, 2000), as restated on several occasions, regulations of the Food and Drug Administration, Protection of Human Subjects, 21 C.F.R. § 50.25; and the Department of Health and Human Services, 45 C.F.R. § 46.

Informed consent is the absolute requirement for any human medical experimentation. Regulations and guidelines of various federal and state agencies and medical organizations, however, place further limitations on the course of permissible experimental design.  The Declaration of Helsinki, for instance, requires that the research design be clearly set out in an experimental protocol, which has been approved by an independent ethical review committee. The proposed medical research

“must conform to generally scientific principles, [and] be based on a thorough knowledge of the scientific literature….”

Declaration of Helsinki, ¶11 (2000). Permissible Medical Experiments, supra. Daubert and Frye thus become ethical imperatives, as well as legal requirements, before any serious consideration can be given to a medical monitoring program.

In all likelihood, no court, if it really thought about the matter, would want to serve as an Institutional Review Board, and to sit in judgment of an experimental protocol. The realization that the proposed remedy is itself an experiment should suffice to quash any advocacy for the result. Indeed, an awareness of the ethical problems entailed by poorly supported medical monitoring programs must guide and propel courts to be vigilant in their gatekeeping responsibilities.  Much of the earlier case law on monitoring developed before the principles and implications of Daubert could be realized in monitoring cases, and these older judgments must be questioned in the light of these ethical and evidentiary concerns.

Judge Hutchison’s decision to deny certification for a Rezulin medical monitoring class obviated consideration of the ethical and evidentiary problems posed by monitoring remedies. The clear absence of proof to support the remedy for the Rezulin plaintiffs avoided debate over how to protect the informed consent process when the personal perception of the risks of monitoring will be perceived differently by each class member.

The paradisiacal Appalachian dream, however, did not last very long.

The Supreme Court of West Virginia did not appear to be concerned by the ethics of human experimentation or the need for showing a basis in evidence for the reliability or accuracy of screening tests.  Chief Justice Starcher, writing for a unanimous court, reversed and remanded the case to proceed as a class action.  The Supreme Court’s opinion was a mechanical recitation of class action rules, interpreted to disallow any preliminary inquiry into the merits of the suit. In re West Virginia Rezulin Litig., 585 S.E.2d 52 (W.Va. 2003).  The word “ethics” does not appear in the Supreme Court’s opinion. The Nuremberg Code was nowhere in sight.

Perhaps most medical monitoring class action battles are now behind us, given that federal courts have come to their senses and have generally disallowed class actions for this remedy.  The cases on the book, however, represent ethically dubious judgments, which call for condemnation from the medical and legal community.  Courts must take stock of the certainty that many medical monitoring schemes will produce far more false positive cases than true positive cases, and widespread fear, anxiety, and harm from unnecessary medical interventions.  See generally Christopher P. Guzelian, Bruce E. Hillner, and Philip S. Guzelian, “A Quantitative Methodology for Determining the Need for Exposure-Prompted Medical Monitoring,” 79 Indiana L. J. 57 (2004).

[An earlier version of this post was published under the same title in Industrywide Liability News (Spring 2002)]

Ethics and Statistics

January 21st, 2012

Chance magazine has started a new feature, the “Ethics and Statistics column, which is likely to be of interest to lawyers and to statisticians who work on litigation issues.  The column is edited by Andrew Gelman.  Judging from the Gelman’s first column, I think that the column may well become a valuable forum for important scientific and legal issues arising from studies used in public policy formulation, and in reaching conclusions that are the bases for scientific expert witnesses’ testimony in court.

Andrew Gelman is a professor of statistics and political science in Columbia University.  He is also the director of the University’s Applied Statistics Center.   Gelman’s inaugural column touches on some issues of great importance to legal counsel who litigate scientific issues involving scientific studies:  access to underlying data in the studies that are the bases for expert witness opinions.  See Andrew Gelman, “Open Data and Open Methods,” 24 Chance 51 (2011).

Gelman acknowledges that conflicts are not only driven by monetary gain; they can be potently raised by positions or causes espoused by the writer:

“An ethics problem arises when you are considering an action that

(a) benefits you or some cause you support,

(b) hurts or reduces benefits to others, and

(c) violates some rule.”

Id. at 51a.

Positional conflicts among scientists whose studies touch upon policy issues give rise to “the ethical imperative to share data.”  Id. at 51c.  Naming names, Professor Gelman relates an incident in which he wrote to an  EPA scientist, Carl Blackman, who had presented a study on the supposed health effects of EMF radiation.   Skeptical of how Blackman had analyzed data, Gelman wrote to Blackman to request his data to carry out additional, alternative statistical analyses.  Blackman answered that he did not think these other analyses were needed, and he declined to share his data.

This sort of refusal is all too common, and typical of the arrogance of scientists who do not want others to be able to take a hard look at how they arrived at their conclusions.  Gelman reminds us that:

“Refusing to share your data is improper… .”

* * * *

“[S]haring data is central to scientific ethics.  If you really believe your results, you should want your data out in the open. If, on the other hand, you have a sneaking suspicion that maybe there’s something there you don’t want to see, and then you keep your raw data hidden, it’s a problem.”

* * * *

“Especially for high-stakes policy questions (such as the risks of electric power lines), transparency is important, and we support initiatives for automatically making data public upon publication of results so researchers can share data without it being a burden.”

Id. at 53.

To be sure, there are some problems with sharing data, but none that is insuperable, and none that should be an excuse for withholding data.  The logistical, ethical, and practical problems of data sharing should now be anticipated long before publication and the requests for data sharing arrive.

Indeed, the National Institutes of Health requires data sharing plans to be part of a protocol for a federally funded study.  See Final NIH Statement on Sharing Research Data (Feb. 26, 2003). Unfortunately, the NIH’s implementation and enforcement of its data-sharing policy is as spotty as a Damien Hirst painting.  SeeSeeing Spots” The New Yorker (Jan. 23, 2012).

Defendants’ Petition for Certiorari in Milward – DENIED

January 9th, 2012

The Supreme Court reported this morning that the defendants petition for certiorari in U.S. Steel Corp. v. Milward, Docket No.. 11-316, was denied.

While unfortunate for the parties involved, the denial was not a surprise.  The Supreme Court does not sit to review factual errors and distortions, such as those that pervaded the First Circuit’s decision below.  Furthermore, most of the justices are at sea when it comes to scientific evidence, as shown by Justice Sotomayor’s incredible discussion of causal concepts, in Mattrix Initiatives v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309 (2011).  SeeMatrixx Unloaded.”

Indeed, there were great dangers involved in seeking this discretionary review in the Supreme Court.  As I have written, the SKAPP-a-lites have larded up the most recent edition of the Reference Manual on Scientific Evidence with language that could easily be marshaled in favor of a loosey-goosey interpretation of Rule 702.  See Reference Manual on Scientific Evidence v3.0 – Disregarding Study Validity in Favor of the ‘Whole Gamish’.”

What is needed is not Supreme Court review, but a thorough dismemberment of the philosophy behind the Circuit’s decision in Milward, and the wayward, or the Milward, trend towards anything goes in the latest edition of the Reference Manual on Scientific EvidenceSeeMilward — Unhinging the Courthouse Door to Dubious Scientific Evidence.”

It was shame and humiliation that drove the Daubert decision in the Supreme Court, and ultimately the revision of Federal Rule of Evidence 702.   When the Courts suddenly realized that the scientific community was looking at their aberrant judgments,  they changed up.  The silicone gel breast implant litigation illustrates the phenomenon of how the courts react to the medical and scientific communties’ condemnation.

The Milward decision calls for a similar collateral attack on the unprincipled use of so-called “weight of the evidence” thinking.  Some evidence, after all, is a mere feather’s weight, and not an appropriate basis for a scientific conclusion.

FW: Defendants’ Petition for Certiorari in Milward – DENIED

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Nathan A. Schachtman
11:37 AM (12 minutes ago)
to me

From: Nathan A. Schachtman [mailto:Nathan@SchachtmanLaw.com]
Sent: Monday, January 09, 2012 11:22 AM
To: ‘Nathan A. Schachtman’
Subject: Defendants’ Petition for Certiorari in Milward – DENIED

The Supreme Court reported this morning that the defendants petition for certiorari in U.S. Steel Corp. v. Milward, Docket No.. 11-316, was denied.

While unfortunate for the parties involved, the denial was not a surprise.  The Supreme Court does not sit to review factual errors and distortions, such as those that pervaded the First Circuit’s decision below.  Furthermore, most of the justices are at sea when it comes to scientific evidence, as shown by Justice Sotomayor’s incredible discussion of causal concepts, in Mattrix Initiatives v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309 (2011).  See “Matrixx Unloaded.”

http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf

http://schachtmanlaw.com/matrixx-unloaded/

Indeed, there were great dangers involved in seeking this discretionary review in the Supreme Court.  As I have written, the SKAPP-a-lites have larded up the most recent edition of the Reference Manual on Scientific Evidence with language that could easily be marshaled in favor of a loosey-goosey interpretation of Rule 702.

What is needed is not Supreme Court review, but a thorough dismemberment of the philosophy behind the Circuit’s decision in Milward, and the wayward, or the Milward, trends towards anything goes in the latest edition of the Reference Manual on Scientific Evidence.  See “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence.”

http://schachtmanlaw.com/milward-unhinging-the-courthouse-door-to-dubious-scientific-evidence/

The courts need to be made to feel ashamed of their judgments with respect to scientific matters.

It was the shame and humiliation of Bendectin litigation and others that moved the Court in Daubert, and later Joiner.

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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)

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.