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The ASA’s Statement on Statistical Significance – Buzzing from the Huckabees

March 19th, 2016

People say crazy things. In a radio interview, Evangelical Michael Huckabee argued that the Kentucky civil clerk who refused to issue a marriage license to a same-sex couple was as justified in defying an unjust court decision as people are justified in disregarding Dred Scott v. Sanford, 60 U.S. 393 (1857), which Huckabee described as still the “law of the land.”1 Chief Justice Roger B. Taney would be proud of Huckabee’s use of faux history, precedent, and legal process to argue his cause. Definition of “huckabee”: a bogus factoid.

Consider the case of Sander Greenland, who attempted to settle a score with an adversary’s expert witness, who had opined in 2002, that Bayesian analyses were rarely used at the FDA for reviewing new drug applications. The adversary’s expert witness obviously got Greenland’s knickers in a knot because Greenland wrote an article in a law review of all places, in which he presented his attempt to “correct the record” and show how the statement of the opposing expert witness was“ludicrous” .2 To support his indictment on charges of ludicrousness, Greenland ignored the FDA’s actual behavior in reviewing new drug applications,3 and looked at the practice of the Journal of Clinical Oncology, a clinical journal published 24 issues a year, with occasional supplements. Greenland found the word “Bayesian” 50 times in over 40,000 journal pages, and declared victory. According to Greenland, “several” (unquantified) articles had used Bayesian methods to explore, post hoc, statistically nonsignificant results.”4

Given Greenland’s own evidence, the posterior odds that Greenland was correct in his charges seem to be disturbingly low, but he might have looked at the published papers that conducted more serious, careful surveys of the issue.5 This week, the Journal of the American Medical Association published yet another study by John Ioannidis and colleagues, which documented actual practice in the biomedical literature. And no surprise, Bayesian methods barely register in a systematic survey of the last 25 years of published studies. See David Chavalarias, Joshua David Wallach, Alvin Ho Ting Li, John P. A. Ioannidis, “Evolution of reporting P values in the biomedical literature, 1990-2015,” 315 J. Am. Med. Ass’n 1141 (2016). See also Demetrios N. Kyriacou, “The Enduring Evolution of the P Value,” 315 J. Am. Med. Ass’n 1113 (2016) (“Bayesian methods are not frequently used in most biomedical research analyses.”).

So what are we to make of Greenland’s animadversions in a law review article? It was a huckabee moment.

Recently, the American Statistical Association (ASA) issued a statement on the use of statistical significance and p-values. In general, the statement was quite moderate, and declined to move in the radical directions urged by some statisticians who attended the ASA’s meeting on the subject. Despite the ASA’s moderation, the ASA’s statement has been met with huckabee-like nonsense and hyperbole. One author, a pharmacologist trained at the University of Washington, with post-doctoral training at the University of California, Berkeley, and an editor of PloS Biology, was moved to write:

“However, the ASA notes, the importance of the p-value has been greatly overstated and the scientific community has become over-reliant on this one – flawed – measure.”

Lauren Richardson, “Is the p-value pointless?” (Mar. 16, 2016). And yet, no where in the ASA’s statement does the group suggest that the the p-value was a “flawed” measure. Richardson suffered a lapse and wrote a huckabee.

Not surprisingly, lawyers attempting to spin the ASA’s statement have unleashed entire hives of huckabees in an attempt to deflate the methodological points made by the ASA. Here is one example of a litigation-industry lawyer who argues that the American Statistical Association Statement shows the irrelevance of statistical significance for judicial gatekeeping of expert witnesses:

“To put it into the language of Daubert, debates over ‘p-values’ might be useful when talking about the weight of an expert’s conclusions, but they say nothing about an expert’s methodology.”

Max Kennerly, “Statistical Significance Has No Place In A Daubert Analysis” (Mar. 13, 2016) [cited as Kennerly]

But wait; the expert witness must be able to rule out chance, bias and confounding when evaluating a putative association for causality. As Austin Bradford Hill explained, even before assessing a putative association for causality, scientists need first to have observations that

“reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance.”

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

The analysis of random error is an essential step on the methodological process. Simply because a proper methodology requires consideration of non-statistical factors does not remove the statistical from the methodology. Ruling out chance as a likely explanation is a crucial first step in the methodology for reaching a causal conclusion when there is an “expected value” or base rate of for the outcome of interest in the population being sampled.

Kennerly shakes his hive of huckabees:

“The erroneous belief in an ‘importance of statistical significance’ is exactly what the American Statistical Association was trying to get rid of when they said, ‘The widespread use of “statistical significance” (generally interpreted as p ≤ 0.05)’ as a license for making a claim of a scientific finding (or implied truth) leads to considerable distortion of the scientific process.”

And yet, the ASA never urged that scientists “get rid of” statistical analyses and assessments of attained levels of significance probability. To be sure, they cautioned against overinterpreting p-values, especially in the context of multiple comparisons, non-prespecified outcomes, and the like. The ASA criticized bright-line rules, which are often used by litigation-industry expert witnesses to over-endorse the results of studies with p-values less than 5%, often in the face of multiple comparisons, cherry-picked outcomes, and poorly and incompletely described methods and results. What the ASA described as a “considerable distortion of the scientific process” was claiming scientific truth on the basis of “p < 0.05.” As Bradford Hill pointed out in 1965, a clear-cut association, beyond that which we would care to attribute to chance, is the beginning of the analysis of an association for causality, not the end of it. Kennerly ignores who is claiming “truth” in the litigation context.  Defense expert witnesses frequently are opining no more than “not proven.” The litigation industry expert witnesses must opine that there is causation, or else they are out of a job.

The ASA explained that the distortion of the scientific process comes from making a claim of a scientific conclusion of causality or its absence, when the appropriate claim is “we don’t know.” The ASA did not say, suggest, or imply that a claim of causality can be made in the absence of finding statistical significance, and as well as validation of the statistical model on which it is based, and other factors as well. The ASA certainly did not say that the scientific process will be served well by reaching conclusions of causation without statistical significance. What is clear is that statistical significance should not be an abridgment for a much more expansive process. Reviewing the annals of the International Agency for Research on Cancer (even in its currently politicized state), or the Institute of Medicine, an honest observer would be hard pressed to come up with examples of associations for outcomes that have known base rates, which associations were determined to be causal in the absence of studies that exhibited statistical significance, along with many other indicia of causality.

Some other choice huckabees from Kennerly:

“It’s time for courts to start seeing the phrase ‘statistically significant’ in a brief the same way they see words like ‘very,’ ‘clearly,’ and ‘plainly’. It’s an opinion that suggests the speaker has strong feelings about a subject. It’s not a scientific principle.”

Of course, this ignores the central limit theorems, the importance of random sampling, the pre-specification of hypotheses and level of Type I error, and the like. Stuff and nonsense.

And then in a similar vein, from Kennerly:

“The problem is that many courts have been led astray by defendants who claim that ‘statistical significance’ is a threshold that scientific evidence must pass before it can be admitted into court.”

In my experience, litigation-industry lawyers oversell statistical significance rather than defense counsel who may question reliance upon studies that lack it. Kennerly’s statement is not even wrong, however, because defense counsel knowledgeable of the rules of evidence would know that statistical studies themselves are rarely admitted into evidence. What is admitted, or not, is the opinion of expert witnesses, who offer opinions about whether associations are causal, or not causal, or inconclusive.

1 Ben Mathis-Lilley, “Huckabee Claims Black People Aren’t Technically Citizens During Critique of Unjust Laws,” The Slatest (Sept. 11 2015) (“[T]he Dred Scott decision of 1857 still remains to this day the law of the land, which says that black people aren’t fully human… .”).

2 Sander Greenland, “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics,” 39 Wake Forest Law Rev. 291, 306 (2004). See “The Infrequency of Bayesian Analyses in Non-Forensic Court Decisions” (Feb. 16, 2014).

3 To be sure, eight years after Greenland published this diatribe, the agency promulgated a guidance that set recommended practices for Bayesian analyses in medical device trials. FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (February 5, 2010); 75 Fed. Reg. 6209 (February 8, 2010); see also Laura A. Thompson, “Bayesian Methods for Making Inferences about Rare Diseases in Pediatric Populations” (2010); Greg Campbell, “Bayesian Statistics at the FDA: The Trailblazing Experience with Medical Devices” (Presentation give by Director, Division of Biostatistics Center for Devices and Radiological Health at Rutgers Biostatistics Day, April 3, 2009). Even today, Bayesian analysis remains uncommon at the U.S. FDA.

4 39 Wake Forest Law Rev. at 306-07 & n.61 (citing only one paper, Lisa Licitra et al., Primary Chemotherapy in Resectable Oral Cavity Squamous Cell Cancer: A Randomized Controlled Trial, 21 J. Clin. Oncol. 327 (2003)).

5 See, e.g., J. Martin Bland & Douglas G. Altman, “Bayesians and frequentists,” 317 Brit. Med. J. 1151, 1151 (1998) (“almost all the statistical analyses which appear in the British Medical Journal are frequentist”); David S. Moore, “Bayes for Beginners? Some Reasons to Hesitate,” 51 The Am. Statistician 254, 254 (“Bayesian methods are relatively rarely used in practice”); J.D. Emerson & Graham Colditz, “Use of statistical analysis in the New England Journal of Medicine,” in John Bailar & Frederick Mosteler, eds., Medical Uses of Statistics 45 (1992) (surveying 115 original research studies for statistical methods used; no instances of Bayesian approaches counted); Douglas Altman, “Statistics in Medical Journals: Developments in the 1980s,” 10 Statistics in Medicine 1897 (1991); B.S. Everitt, “Statistics in Psychiatry,” 2 Statistical Science 107 (1987) (finding only one use of Bayesian methods in 441 papers with statistical methodology).

Posted in Causation, Rule 702, Scientific Evidence, statistical evidence | Comments Off on The ASA’s Statement on Statistical Significance – Buzzing from the Huckabees

The American Statistical Association’s Statement on and of Significance

March 17th, 2016

In scientific circles, some commentators have so zealously criticized the use of p-values that they have left uninformed observers with the impression that random error was not an interesting or important consideration in evaluating the results of a scientific study. In legal circles, counsel for the litigation industry and their expert witnesses have argued duplicitously that statistical significance was at once both unimportant, except when statistical significance is observed, in which causation is conclusive. The recently published Statement of the American Statistical Association (“ASA”) restores some sanity to the scientific and legal discussions of statistical significance and p-values. Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” The American Statistician, available online (Mar. 7, 2016), in-press at DOI:10.1080/00031305.2016.1154108, <http://dx.doi.org/10.1080/>.

Recognizing that sound statistical practice and communication affects research and public policy decisions, the ASA has published a statement of interpretative principles for statistical significance and p-values. The ASA’s statement first, and foremost, points out that the soundness of scientific conclusions turns on more than statistical methods alone. Study design, conduct, and evaluation often involve more than a statistical test result. And the ASA goes on to note, contrary to the contrarians, that “the p-value can be a useful statistical measure,” although this measure of attained significance probability “is commonly misused and misinterpreted.” ASA at 7. No news there.

The ASA’s statement puts forth six principles, all of which have substantial implications for how statistical evidence is received and interpreted in courtrooms. All are worthy of consideration by legal actors – legislatures, regulators, courts, lawyers, and juries.

“1. P-values can indicate how incompatible the data are with a specified statistical model.”

The ASA notes that a p-value shows the “incompatibility between a particular set of data and a proposed model for the data.” Although there are some in the statistical world who rail against null hypotheses of no association, the ASA reports that “[t]he most common context” for p-values consists of a statistical model that includes a set of assumptions, including a “null hypothesis,” which often postulates the absence of association between exposure and outcome under study. The ASA statement explains:

“The smaller the p-value, the greater the statistical incompatibility of the data with the null hypothesis, if the underlying assumptions used to calculate the p-value hold. This incompatibility can be interpreted as casting doubt on or providing evidence against the null hypothesis or the underlying assumptions.”

Some lawyers want to overemphasize statistical significance when present, but to minimize the importance of statistical significance when it is absent.  They will find no support in the ASA’s statement.

“2. P-values do not measure the probability that the studied hypothesis is true, or the probability that the data were produced by random chance alone.”

Of course, there are those who would misinterpret the meaning of p-values, but the flaw lies in the interpreters, not in the statistical concept.

“3. Scientific conclusions and business or policy decisions should not be based only on whether a p-value passes a specific threshold.”

Note that the ASA did not say that statistical significance is irrelevant to scientific conclusions. Of course, statistical significance is but one factor, which does not begin to account for study validity, data integrity, or model accuracy. The ASA similarly criticizes the use of statistical significance as a “bright line” mode of inference, without consideration of the contextual considerations of “the design of a study, the quality of the measurements, the external evidence for the phenomenon under study, and the validity of assumptions that underlie the data analysis.” Criticizing the use of “statistical significance” as singularly assuring the correctness of scientific judgment does not, however, mean that “statistical significance” is irrelevant or unimportant as a consideration in a much more complex decision process.

“4. Proper inference requires full reporting and transparency”

The ASA explains that the proper inference from a p-value can be completely undermined by “multiple analyses” of study data, with selective reporting of sample statistics that have attractively low p-values, or cherry picking of suggestive study findings. The ASA points out that common practices of selective reporting compromises valid interpretation. Hence the correlative recommendation:

“Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”

ASA Statement. See also “Courts Can and Must Acknowledge Multiple Comparisons in Statistical Analyses” (Oct. 14, 2014).

“5. A p-value, or statistical significance, does not measure the size of an effect or the importance of a result.”

The ASA notes the commonplace distinction between statistical and practical significance. The independence between statistical and practice significance does not, however, make statistical significance irrelevant, especially in legal and regulatory contexts, in which parties claim that a risk, however small, is relevant. Of course, we want the claimed magnitude of association to be relevant, but we also need the measured association to be accurate and precise.

“6. By itself, a p-value does not provide a good measure of evidence regarding a model or hypothesis.”

Of course, a p-value cannot validate the model, which is assumed to generate the p-value. Contrary to the hyperbolic claims one sees in litigation, the ASA notes that “a p-value near 0.05 taken by itself offers only weak evidence against the null hypothesis.” And so the ASA counsels that “data analysis should not end with the calculation of a p-value when other approaches are appropriate and feasible.” 

What is important, however, is that the ASA never suggests that significance testing or measurement of significance probability is not an important and relevant part of the process. To be sure, the ASA notes that because of “the prevalent misuses of and misconceptions concerning p-values, some statisticians prefer to supplement or even replace p-values with other approaches.”

First of these other methods unsurprisingly is estimation with assessment of confidence intervals, although the ASA also includes Bayesian and other methods as well. There are some who express irrational exuberance about the protential of Bayesian methods to restore confidence in scientific process and conclusions. Bayesian approaches are less manipulated than frequentist ones, largely because very few people use Bayesian methods, and even fewer people really understand them.

In some ways, Bayesian statistical approaches are like Apple computers. The Mac OS is less vulnerable to viruses, compared with Windows, because its lower market share makes it less attractive to virus code writers. As Apple’s OS has gained market share, its vulnerability has increased. (My Linux computer on the other hand is truly less vulnerable to viruses because of system architecture, but also because Linux personal computers have almost no market share.) If Bayesian methods become more prevalent, my prediction is that they will be subject to as much abuse as frequent views. The ASA wisely recognized that the “reproducibility crisis” and loss of confidence in scientific research were mostly due to bias, both systematic and cognitive, in how studies are done, interpreted, and evaluated.

Posted in Rule 702, Scientific Evidence, statistical evidence | Comments Off on The American Statistical Association’s Statement on and of Significance

Birth Defects Case Exceeds NY Court of Appeal’s Odor Threshold

March 14th, 2016

The so-called “weight of the evidence” (WOE) approach by expert witnesses has largely been an argument for subjective weighting of studies and cherry picking of data to reach a favored, pre-selected conclusion. The approach is so idiosyncratic and amorphous that it really is no method at all, which is exactly why it seems to have been embraced by the litigation industry and its cadre of expert witnesses.

The WOE enjoyed some success in the First Circuit’s Milward decision, with much harrumphing from the litigation industry and its proxies, but more recently courts have mostly seen through the ruse and employed their traditional screening approaches to exclude opinions that deviate from the relevant standard of care of scientific opinion testimony.[1]

In Reeps, the plaintiff child was born with cognitive and physical defects, which his family claimed resulted from his mother’s inhalation of gasoline fumes in her allegedly defective BMW. To support their causal claims, the Reeps proffered the opinions of two expert witnesses, Linda Frazier and Shira Kramer, on both general and specific causation of the child’s conditions. The defense presented reports from Anthony Scialli and Peter Lees.

Justice York, of the Supreme Court for New York County, sustained defendants’ objections to the admissibility of Frazier and Kramer’s opinions, in a careful opinion that dissected the general and specific causation opinions that invoked WOE methods. Reeps v. BMW of North America, LLC, 2012 NY Slip Op 33030(U), N.Y.S.Ct., Index No. 100725/08 (New York Cty. Dec. 21, 2012) (York, J.), 2012 WL 6729899, aff’d on rearg., 2013 WL 2362566.

The First Department of the Appellate Division affirmed Justice York’s exclusionary ruling and then certified the appellate question to the New York Court of Appeals. 115 A.D.3d 432, 981 N.Y.S.2d 514 (2013).[2] Last month, the New York high court affirmed in a short opinion that focused on the plaintiff’s claim that Mrs. Reeps must have been exposed to a high level of gasoline (and its minor constituents, such as benzene) because she experienced symptoms such as dizziness while driving the car. Sean R. v. BMW of North America, LLC, ___ N.E.3d ___, 2016 WL 527107, 2016 N.Y. Slip Op. 01000 (2016).[3]

The car in question was a model that was recalled by BMW for a gasoline line leak, and there was thus no serious question that there had been some gasoline exposure to the plaintiff’s mother and thus to the plaintiff and thus perhaps to the plaintiff in utero. According to the Court of Appeals, the plaintiff’s expert witness Frazier concluded that the gasoline fume exposures to the car occupants exceeded 1,000 parts per million (ppm) because studies showed that symptoms of acute toxicity were reported when exposures reached or exceeded 1,000 ppm. The mother of the car’s owner claimed to suffer dizziness and nausea when riding in the car, and Frazier inferred from these self-reported, in litigation, symptoms that the plaintiff’s mother also sustained gasoline exposures in excess of 1,000 ppm. From this inference about level of exposure, Frazier then proceeded to use the “Bradford Hill criteria” to opine that unleaded gasoline vapor is capable of causing the claimed birth defects based upon “the link between exposure to the constituent chemicals and adverse birth outcomes.” And then using the wizardry of differential etiology, Frazier was able to conclude that the mother’s first-trimester exposure to gasoline fumes was the probable cause of plaintiff’s birth defects.

There was much wrong with Frazier’s opinions, as detailed in the trial court’s decision, but for reasons unknown, the Court of Appeals chose to focus on Frazier’s symptom-threshold analysis. The high court provided no explanation of how Frazier applied the Bradford Hill criteria, or her downward extrapolation from high-exposure benzene or solvent exposure birth defect studies to a gasoline-exposure case that involved only a small percentage of benzene or solvent in the high-exposure studies. There is no description from the Court of what a “link” might be, or how it is related to a cause; nor is there any discussion of how Frazier might have excluded the most likely cause of birth defects: the unknown. The Court also noted that plaintiff’s expert witness Kramer had employed a WOE-ful analysis, but it provided no discussion of what was amiss with Kramer’s opinion. A curious reader might think that the Court had overlooked and dismissed “sound science,” but Justice York’s trial court opinion fully addressed the inadequacies of these other opinions.

The Court of Appeals acknowledge that “odor thresholds” can be helpful in estimating a plaintiff’s level of exposure to a potentially toxic chemical, but it noted that there was no generally accepted exposure assessment methodology that connected the report of an odor to adverse pregnancy outcomes.

Frazier, however, had not adverted to an odor threshold, but a symptom threshold. In support, Frazier pointed to three things:

  1. A report of the American Conference of Governmental and Industrial Hygienists (ACGIH), (not otherwise identified) which synthesized the results of controlled studies, and reported a symptom threshold of “mild toxic effects” to be about 1,000 ppm;
  1. A 1991 study (not further identified) that purportedly showed a dose-response between exposures to ethanol and toluene and headaches; and
  1. A 2008 report (again not further identified) that addressed the safety of n-Butyl alcohol in cosmetic products.

Item (2) seems irrelevant at best, given that ethanol and toluene are again minor components of gasoline, and that the exposure levels in the study are not given. Item (3) again seems off the report because the Court’s description does not allude to any symptom threshold; nor is there any attempt to tie exposure levels of n-Butyl to the experienced levels of gasoline in the Reeps case.

With respect to item (1), which supposedly had reported that if exposure exceeded 1,000 ppm, then headaches and nausea can occur acutely, the Court asserted that the ACGIH report did not support an inverse inference, that if headaches and nausea had occurred, then exposures exceeded 1,000 ppm.

It is true that ) does not logically support ), but the claimed symptoms, their onset and abatement, and the lack of other known precipitating causes would seem to provide some evidence for exposures above the symptom threshold. Rather than engaging with the lack of scientific evidence on the claimed causal connection between gasoline and birth defects, however, the Court invoked the lack of general acceptance of the “symptom-threshold” methodology to dispose of the case.

In its short opinion, The Court of Appeals did not address the quality, validity, or synthesis of studies urged by plaintiff’s expert witnesses; nor did it address the irrelevancy of whether the plaintiff’s grandmother or his mother had experienced acute symptoms such as nausea to the level that might be relevant to causing embryological injury. Had it done so, the Court would have retraced the path of Justice York, in the trial court, who saw through the ruse of WOE and the blatantly false claim that the scientific evidence even came close to satisfying the Bradford Hill factors. Furthermore, the Court might have found that the defense expert witnesses were entirely consistent with the Centers for Disease Control:

“The hydrocarbons found in gasoline can cross the placenta. There is no direct evidence that maternal exposure to gasoline causes fetotoxic or teratogenic effects. Gasoline is not included in Reproductive and Developmental Toxicants, a 1991 report published by the U.S. General Accounting Office (GAO) that lists 30 chemicals of concern because of widely acknowledged reproductive and developmental consequences.”

Agency for Toxic Substances and Disease Registry, “Medical Management Guidelines for Gasoline” (Oct. 21, 2014, last updated) (“Toxic Substances Portal – Gasoline, Automotive”); Agency for Toxic Substances and Disease Registry, “Public Health Statement for Automotive Gasoline” (June 1995) (“There is not enough information available to determine if gasoline causes birth defects or affects reproduction.”); see also National Institute for Occupational Safety & Health, Occupational Exposure to Refined Petroleum Solvents: Criteria for a Recommended Standard (1977).

[1] See, e.g., In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345, 1367 (S.D. Fla. 2011), aff’d, Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir. 2014). See also “Fixodent Study Causes Lockjaw in Plaintiffs’ Counsel” (Feb. 4, 2015); “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (May 1, 2012); “I Don’t See Any Method At All”   (May 2, 2013).

[2] “New York Breathes Life Into Frye Standard – Reeps v. BMW” (March 5, 2013); “As They WOE, So No Recovery Have the Reeps” (May 22, 2013).

[3] See Sean T. Stadelman “Symptom Threshold Methodology Rejected by Court of Appeals of New York Pursuant to Frye,” (Feb. 18, 2016).

Posted in Causation, Expert Witnesses, Frye, Scientific Evidence | Comments Off on Birth Defects Case Exceeds NY Court of Appeal’s Odor Threshold

Systematic Reviews and Meta-Analyses in Litigation, Part 2

February 11th, 2016

Daubert in Knee’d

In a recent federal court case, adjudicating a plaintiff’s Rule 702 challenge to defense expert witnesses, the trial judge considered plaintiff’s claim that the challenged witness had deviated from PRISM guidelines[1] for systematic reviews, and thus presumably had deviated from the standard of care required of expert witnesses giving opinions about causal conclusions.

Batty v. Zimmer, Inc., MDL No. 2272, Master Docket No. 11 C 5468, No. 12 C 6279, 2015 WL 5050214 (N.D. Ill. Aug. 25, 2015) [cited as Batty I]. The trial judge, the Hon. Rebecca R. Pallmeyer, denied plaintiff’s motion to exclude the allegedly deviant witness, but appeared to accept the premise of the plaintiff’s argument that an expert witness’s opinion should be reached in the manner of a carefully constructed systematic review.[2] The trial court’s careful review of the challenged witness’s report and deposition testimony revealed that there had mean no meaningful departure from the standards put forward for systematic reviews. See “Systematic Reviews and Meta-Analyses in Litigation” (Feb. 5, 2016).

Two days later, the same federal judge addressed a different set of objections by the same plaintiff to two other of the defendant’s, Zimmer Inc.’s, expert witnesses, Dr. Stuart Goodman and Dr. Timothy Wright. Batty v. Zimmer, Inc., MDL No. 2272, Master Docket No. 11 C 5468, No. 12 C 6279, 2015 WL 5095727, (N.D. Ill. Aug. 27, 2015) [cited as Batty II]. Once again, plaintiff Batty argued for the necessity of adherence to systematic review principles. According to Batty, Dr. Wright’s opinion, based upon his review of the clinical literature, was scientifically and legally unreliable because he had not conducted a proper systematic review. Plaintiff alleged that Dr. Wright’s review selectively “cherry picked” favorable studies to buttress his opinion, in violation of systematic review guidelines. The trial court, which had assumed that a systematic review was the appropriate “methodology” for Dr. Vitale, in Batty I, refused to sustain the plaintiff’s challenge in Batty II, in large part because the challenged witness, Dr. Wright, had not claimed to have performed a systematic or comprehensive review, and so his failure to follow the standard methodology did not require the exclusion of his opinion at trial. Batty II at *3.

The plaintiff never argued that Dr. Wright misinterpreted any of his selected studies upon which he relied, and the trial judge thus suggested that Dr. Wright’s discussion of the studies, even if a partial, selected group of studies, would be helpful to the jury. The trial court thus left the plaintiff to her cross-examination to highlight Dr. Wright’s selectivity and lack of comprehensiveness. Apparently, in the trial judge’s view, this expert witness’s failure to address contrary studies did not render his testimony unreliable under “Daubert scrutiny.” Batty II at *3.

Of course, it is no longer the Daubert judicial decision that mandates scrutiny of expert witness opinion testimony, but Federal Rule of Evidence 702. Perhaps it was telling that when the trial court backed away from its assumption, made in Batty I, that guidelines or standards for systematic reviews should inform a Rule 702 analysis, the court cited Daubert, a judicial opinion superseded by an Act of Congress, in 2000. The trial judge’s approach, in Batty II, threatens to make gatekeeping meaningless by deferring to the expert witness’s invocation of personal, idiosyncratic, non-scientific standards. Furthermore, the Batty II approach threatens to eviscerate gatekeeping for clinical practitioners who remain blithely unaware of advances in epidemiology and evidence-based medicine. The upshot of Batty I and II combined seems to be that systematic review principles apply to clinical expert witnesses only if those witness choose to be bound by such principles. If this is indeed what the trial court intended, then it is jurisprudential nonsense.

The trial court, in Batty II, exercised a more searching approach, however, to Dr. Wright’s own implant failure analysis, which he relied upon in an attempt to rebut plaintiff’s claim of defective design. The plaintiff claimed that the load-bearing polymer surfaces of the artificial knee implant experienced undue deformation. Dr. Wright’s study found little or no deformation on the load bearing polymer surfaces of the eight retrieved artificial joints. Batty II at *4.

Dr. Wright assessed deformation qualitatively, not quantitatively, through the use of a “colormetric map of deformation” of the polymer surface. Dr. Wright, however, provided no scale to define or assess how much deformation was represented by the different colors in his study. Notwithstanding the lack of any metric, Dr. Wright concluded that his findings, based upon eight retrieved implants, “suggested” that the kind of surface failing claimed by plaintiff was a “rare event.”

The trial court had little difficulty in concluding that Dr. Wright’s evidentiary base was insufficient, as was his presentation of the study’s data and inferences. The challenged witness failed to explain how his conclusions followed from his data, and thus his proffered testimony fell into the “ipse dixit” category of inadmissible opinion testimony. General Electric v. Joiner, 522 U.S. 136, 146 (1997). In the face of the challenge to his opinions, Dr. Wright supplemented his retrieval study with additional scans of surficial implant wear patterns, but he failed again to show the similarity of previous use and failure conditions in the patients from whom these implants were retrieved and the plaintiff’s case (which supposedly involved aseptic loosening). Furthermore, Dr. Wright’s interpretation of his own retrieval study was inadequate in the trial court’s view because he had failed to rule out other modes of implant failure, in which the polyethylene surface would have been preserved. Because, even as supplemented, Dr. Wright’s study failed to support his proffered opinions, the court held that his opinions, based upon his retrieval study had to be excluded under Rule 702. The trial court did not address the Rule 703 implications for Dr. Wright’s reliance upon a study that was poorly designed and explained, and which lacked the ability to support his contention that the claimed mode of implant failure was a “rare” event. Batty II at *4 – 5.

[1] See David Moher , Alessandro Liberati, Jennifer Tetzlaff, Douglas G. Altman, & The PRISMA Group, “Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement,” 6 PLoS Med e1000097 (2009) [PRISMA].

[2] Batty v. Zimmer, Inc., MDL No. 2272, Master Docket No. 11 C 5468, No. 12 C 6279, 2015 WL 5050214 (N.D. Ill. Aug. 25, 2015).

Posted in Causation, Expert Witnesses, Rule 702, Rule 703, Scientific Evidence | Comments Off on Systematic Reviews and Meta-Analyses in Litigation, Part 2

Systematic Reviews and Meta-Analyses in Litigation

February 5th, 2016

Kathy Batty is a bellwether plaintiff in a multi-district litigation[1] (MDL) against Zimmer, Inc., in which hundreds of plaintiffs claim that Zimmer’s NexGen Flex implants are prone to have their femoral and tibial elements prematurely aseptically loosen (independent of any infection). Batty v. Zimmer, Inc., MDL No. 2272, Master Docket No. 11 C 5468, No. 12 C 6279, 2015 WL 5050214 (N.D. Ill. Aug. 25, 2015) [cited as Batty].

PRISMA Guidelines for Systematic Reviews

Zimmer proffered Dr. Michael G. Vitale, an orthopedic surgeon, with a master’s degree in public health, to testify that, in his opinion, Batty’s causal claims were unfounded. Batty at *4. Dr. Vitale prepared a Rule 26 report that presented a formal, systematic review of the pertinent literature. Batty at *3. Plaintiff Batty challenged the admissibility of Dr. Vitale’s opinion on grounds that his purportedly “formal systematic literature review,” done for litigation, was biased and unreliable, and not conducted according to generally accepted principles for such reviews. The challenged was framed, cleverly, in terms of Dr. Vitale’s failure to comply with a published set of principles outlined in “PRISMA” guidelines (Preferred Reporting Items for Systematic reviews and Meta-Analyses), which enjoy widespread general acceptance among the clinical journals. See David Moher , Alessandro Liberati, Jennifer Tetzlaff, Douglas G. Altman, & The PRISMA Group, “Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement,” 6 PLoS Med e1000097 (2009) [PRISMA]. Batty at *5. The trial judge, Hon. Rebecca R. Pallmeyer, denied plaintiff’s motion to exclude Dr. Vitale, but in doing so accepted, arguendo, the plaintiff’s implicit premise that an expert witness’s opinion should be reached in the manner of a carefully constructed systematic review.

The plaintiff’s invocation of the PRISMA guidelines presented several difficult problems for her challenge and for the court. PRISMA provides a checklist of 27 items for journal editors to assess the quality and completeness of systematic reviews that are submitted for publication. Plaintiff Batty focused on several claimed deviations from the guidelines:

  • “failing to explicitly state his study question,
  • failing to acknowledge the limitations of his review,
  • failing to present his findings graphically, and failing to reproduce his search results.”

Batty’s challenge to Dr. Vitale thus turned on whether Zimmer’s expert witness had failed to deploy “same level of intellectual rigor,” as someone in the world of clinical medicine would [should] have in conducting a similar systematic review. Batty at *6.

Zimmer deflected the challenge, in part by arguing that PRISMA’s guidelines are for the reporting of systematic reviews, and they are not necessarily criteria for valid reviews. The trial court accepted this rebuttal, Batty at *7, but missed the point that some of the guidelines call for methods that are essential for rigorous, systematic reviews, in any forum, and do not merely specify “publishability.” To be sure, PRISMA itself does not always distinguish between what is essential for journal publication, as opposed to what is needed for a sufficiently valid systematic review. The guidelines, for instance, call for graphical displays, but in litigation, charts, graphs, and other demonstratives are often not produced until the eve of trial, when case management orders call for the parties to exchange such materials. In any event, Dr. Vitale’s omission of graphical representations of his findings was consistent with his finding that the studies were too clinical heterogeneous in study design, follow-up time, and pre-specified outcomes, to permit nice, graphical summaries. Batty at *7-8.

Similarly, the PRISMA guidelines call for a careful specification of the clinical question to be answered, but in litigation, the plaintiff’s causal claims frame the issue to be addressed by the defense expert witness’s literature review. The trial court readily found that Dr. Vitale’s research question was easily discerned from the context of his report in the particular litigation. Batty at *7.

Plaintiff Batty’s challenge pointed to Dr. Vitale’s failure to acknowledge explicitly the limitations of his systematic review, an omission that virtually defines expert witness reports in litigation. Given the availability of discovery tools, such as a deposition of Dr. Vitale (at which he readily conceded the limitations of his review), and the right of confrontation and cross-examination (which are not available, alas, for published articles), the trial court found that this alleged deviation was not particularly relevant to the plaintiff’s Rule 702 challenge. Batty at *8.

Batty further charged that Dr. Vitale had not “reproduced” his own systematic review. Arguing that a systematic review’s results must be “transparent and reproducible,” Batty claimed that Zimmer’s expert witness’s failure to compile a list of studies that were originally retrieved from his literature search deprived her, and the trial court, of the ability to determine whether the search was complete and unbiased. Batty at *8. Dr. Vitale’s search protocol and inclusionary and exclusionary criteria were, however, stated, explained, and reproducible, even though Dr. Vitale did not explain the application of his criteria to each individual published paper. In the final analysis, the trial court was unmoved by Batty’s critique, especially given that her expert witnesses failed to identify any relevant studies omitted from Dr. Vitale’s review. Batty at *8.

Lumping or Commingling of Heterogeneous Studies

The plaintiff pointed to Dr. Vitale’s “commingling” of studies, heterogeneous in terms of “study length, follow-up, size, design, power, outcome, range of motion, component type” and other clinical features, as a deep flaw in the challenged expert witness’s methodology. Batty at *9. Batty’s own retained expert witness, Dr. Kocher, supported Batty’s charge by adverting to the clinical variability in studies included in Dr. Vitale’s review, and suggesting that “[h]igh levels of heterogeneity preclude combining study results and making conclusions based on combining studies.” Dr. Kocher’s argument was rather beside the point because Dr. Vitale had not impermissibly combined clinically or statistically heterogeneous outcomes.[2] Similarly, the plaintiff’s complaint that Dr. Vitale had used inconsistent criteria of knee implant survival rates was dismissed by the trial court, which easily found Dr. Vitale’s survival criteria both pre-specified and consistent across his review of studies, and relevant to the specific alleged by Ms. Batty. Batty at *9.

Cherry Picking

The trial court readily agreed with Plaintiff’s premise that an expert witness who used inconsistent inclusionary and exclusionary criteria would have to be excluded under Rule 702. Batty at *10, citing In Re Zoloft, 26 F. Supp. 3d 449, 460–61 (E.D. Pa.2014) (excluding epidemiologist Dr. Anick Bérard proffered testimony because of her biased cherry picking and selection of studies to support her studies, and her failure to account for contradictory evidence). The trial court, however, did find that Dr. Vitale’s review was corrupted by the kind of biased cherry picking that Judge Rufe found to have been committed by Dr. Anick Bérard, in the Zoloft MDL.

Duplicitous Duplication

Plaintiff’s challenge of Dr. Vitale did manage to spotlight an error in Dr. Vitale’s inclusion of two studies that were duplicate analyses of the same cohort. Apparently, Dr. Vitale had confused the studies as not being of the same cohort because the two papers reported different sample sizes. Dr. Vitale admitted that his double counting the same cohort “got by the peer-review process and it got by my filter as well.” Batty at *11, citing Vitale Dep. 284:3–12. The trial court judged Dr. Vitale’s error to have been:

“an inadvertent oversight, not an attempt to distort the data. It is also easily correctable by removing one of the studies from the Group 1 analysis so that instead of 28 out of 35 studies reporting 100% survival rates, only 27 out of 34 do so.”

Batty at *11.

The error of double counting studies in quantitative reviews and meta-analyses has become a prevalent problem in both published studies[3] and in litigation reports. Epidemiologic studies are sometimes updated and extended with additional follow up. The prohibition against double counting data is so obvious that it often is not even identified on checklists, such as PRISMA. Furthermore, double counting of studies, or subgroups within studies, is a flaw that most careful readers can identify in a meta-analysis, without advance training. According to statistician Stephen Senn, double counting of evidence is a serious problem in published meta-analytical studies.[4] Senn observes that he had little difficulty in finding examples of meta-analyses gone wrong, including meta-analyses with double counting of studies or data, in some of the leading clinical medical journals. Senn urges analysts to “[b]e vigilant about double counting,” and recommends that journals should withdraw meta-analyses promptly when mistakes are found.”[5]

An expert witness who wished to skate over the replication and consistency requirement might be tempted, as was Dr. Michael Freeman, to count the earlier and later iteration of the same basic study to count as “replication.” Proper methodology, however, prohibits double dipping data to count the later study that subsumes the early one as a “replication”:

“Generally accepted methodology considers statistically significant replication of study results in different populations because apparent associations may reflect flaws in methodology. Dr. Freeman claims the Alwan and Reefhuis studies demonstrate replication. However, the population Alwan studied is only a subset of the Reefhuis population and therefore they are effectively the same.”

Porter v. SmithKline Beecham Corp., No. 03275, 2015 WL 5970639, at *9 (Phila. Cty. Pennsylvania, Ct. C.P. October 5, 2015) (Mark I. Bernstein, J.)

Conclusions

The PRISMA and similar guidelines do not necessarily map the requisites of admissible expert witness opinion testimony, but they are a source of some important considerations for the validity of any conclusion about causality. On the other hand, by specifying the requisites of a good publication, some PRISMA guidelines are irrelevant to litigation reports and testimony of expert witnesses. Although Plaintiff Batty’s challenge overreached and failed, the premise of her challenge is noteworthy, as is the trial court’s having taken the premise seriously. Ultimately, the challenge to Dr. Vitale’s opinion failed because the specified PRISMA guidelines, supposedly violated, were either irrelevant or satisfied.

[1] Zimmer Nexgen Knee Implant Products Liability Litigation.

[2] Dr. Vitale’s review is thus easily distinguished from what has become commonplace in litigation of birth defect claims, where, for instance, some well-known statisticians [names available upon request] have conducted qualitative reviews and quantitative meta-analyses of highly disparate outcomes, such as any and all cardiovascular congenital anomalies. In one such case, a statistician expert witness hired by plaintiffs presented a meta-analysis that included study results of any nervous system defect, and central nervous system defect, and any neural tube defect, without any consideration of clinical heterogeneity or even overlap with study results.

[3] See, e.g., Shekoufeh Nikfar, Roja Rahimi, Narjes Hendoiee, and Mohammad Abdollahi, “Increasing the risk of spontaneous abortion and major malformations in newborns following use of serotonin reuptake inhibitors during pregnancy: A systematic review and updated meta-analysis,” 20 DARU J. Pharm. Sci. 75 (2012); Roja Rahimi, Shekoufeh Nikfara, Mohammad Abdollahic, “Pregnancy outcomes following exposure to serotonin reuptake inhibitors: a meta-analysis of clinical trials,” 22 Reproductive Toxicol. 571 (2006); Anick Bérard, Noha Iessa, Sonia Chaabane, Flory T. Muanda, Takoua Boukhris, and Jin-Ping Zhao, “The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: A systematic review and meta-analysis,” 81 Brit. J. Clin. Pharmacol. (2016), in press, available at doi: 10.1111/bcp.12849.

[4] Stephen J. Senn, “Overstating the evidence – double counting in meta-analysis and related problems,” 9, at *1 BMC Medical Research Methodology 10 (2009).

[5] Id. at *1, *4.

DOUBLE-DIP APPENDIX

Some papers and textbooks, in addition to Stephen Senn’s paper, cited above, which note the impermissible method of double counting data or studies in quantitative reviews.

Aaron Blair, Jeanne Burg, Jeffrey Foran, Herman, Gibb, Sander Greenland, Robert Morris, Gerhard Raabe, David Savitz, Jane Teta, Dan Wartenberg, Otto Wong, and Rae Zimmerman, “Guidelines for Application of Meta-analysis in Environmental Epidemiology,” 22 Regulatory Toxicol. & Pharmacol. 189, 190 (1995).

“II. Desirable and Undesirable Attributes of Meta-Analysis

* * *

Redundant information: When more than one study has been conducted on the same cohort, the later or updated version should be included and the earlier study excluded, provided that later versions supply adequate information for the meta-analysis. Exclusion of, or in rare cases, carefully adjusting for overlapping or duplicated studies will prevent overweighting of the results by one study. This is a critical issue where the same cohort is reexamined or updated several times. Where duplication exists, decision criteria should be developed to determine which of the studies are to be included and which excluded.”

Sander Greenland & Keith O’Rourke, “Meta-Analysis – Chapter 33,” in Kenneth J. Rothman, Sander Greenland, Timothy L. Lash, Modern Epidemiology 652, 655 (3d ed. 2008) (emphasis added)

“Conducting a Sound and Credible Meta-Analysis

Like any scientific study, an ideal meta-analysis would follow an explicit protocol that is fully replicable by others. This ideal can be hard to attain, but meeting certain conditions can enhance soundness (validity) and credibility (believability). Among these conditions we include the following:

  • A clearly defined set of research questions to address.

  • An explicit and detailed working protocol.

  • A replicable literature-search strategy.

  • Explicit study inclusion and exclusion criteria, with a rationale for each.

  • Nonoverlap of included studies (use of separate subjects in different included studies), or use of statistical methods that account for overlap.* * * * *”

Matthias Egger, George Davey Smith, and Douglas G. Altman, Systematic Reviews in Health Care: Meta-Analysis in Context 59 – 60 (2001).

“Duplicate (multiple) publication bias

***

The production of multiple publications from single studies can lead to bias in a number of ways.85 Most importantly, studies with significant results are more likely to lead to multiple publications and presentations,45 which makes it more likely that they will be located and included in a meta-analysis. The inclusion of duplicated data may therefore lead to overestimation of treatment effects, as recently demonstrated for trials of the efficacy of ondansetron to prevent postoperative nausea and vomiting86.”

Khalid Khan, Regina Kunz, Joseph Kleijnen, and Gerd Antesp, Systematic Reviews to Support Evidence-Based Medicine: How to Review and Apply Findings of Healthcare Research 35 (2d ed. 2011)

“2.3.5 Selecting studies with duplicate publication

Reviewers often encounter multiple publications of the same study. Sometimes these will be exact  duplications, but at other times they might be serial publications with the more recent papers reporting increasing numbers of participants or lengths of follow-up. Inclusion of duplicated data would inevitably bias the data synthesis in the review, particularly because studies with more positive results are more likely to be duplicated. However, the examination of multiple reports of the same study may provide useful information about its quality and other characteristics not captured by a single report. Therefore, all such reports should be examined. However, the data should only be counted once using the largest, most complete report with the longest follow-up.”

Julia H. Littell, Jacqueline Corcoran, and Vijayan Pillai, Systematic Reviews and Meta-Analysis 62-63 (2008)

“Duplicate and Multiple Reports

***

It is a bit more difficult to identify multiple reports that emanate from a single study. Sometimes these reports will have the same authors, sample sizes, program descriptions, and methodological details. However, author lines and sample sizes may vary, especially when there are reports on subsamples taken from the original study (e.g., preliminary results or special reports). Care must be taken to ensure that we know which reports are based on the same samples or on overlapping samples—in meta-analysis these should be considered multiple reports from a single study. When there are multiple reports on a single study, we put all of the citations for that study together in summary information on the study.”

Kay Dickersin, “Publication Bias: Recognizing the Problem, Understanding Its Origins and Scope, and Preventing Harm,” Chapter 2, in Hannah R. Rothstein, Alexander J. Sutton & Michael Borenstein, Publication Bias in Meta-Analysis – Prevention, Assessment and Adjustments 11, 26 (2005)

“Positive results appear to be published more often in duplicate, which can lead to overestimates of a treatment effect (Timmer et al., 2002).”

Julian P.T. Higgins & Sally Green, eds., Cochrane Handbook for Systematic Reviews of Interventions 152 (2008)

“7.2.2 Identifying multiple reports from the same study

Duplicate publication can introduce substantial biases if studies are  inadvertently included more than once in a meta-analysis (Tramer 1997). Duplicate publication can take various forms, ranging from identical manuscripts to reports describing different numbers of participants and different outcomes (von Elm 2004). It can be difficult to detect duplicate publication, and some ‘detectivework’ by the review authors may be required.”

Posted in Causation, Expert Witnesses, Meta-analysis, Rule 702 | Comments Off on Systematic Reviews and Meta-Analyses in Litigation

Lawyers as Historians

February 2nd, 2016

“It has been said that though God cannot alter the past, historians can; it is perhaps because they can be useful to Him in this respect that He tolerates their existence.”     Samuel Butler

The negligence standard does not require omniscience by the defendant; rather, in products liability law, the manufacturer is expected to know what experts in the relevant field know, at the time of making and marketing the allegedly offending product. In long-tail litigation, involving harms that occur, if at all, only after a long latency period, the inquiry thus become an historical one, sometimes reaching back decades. Combine this aspect of products liability law, with the propensity of plaintiffs to ascribe long-standing, often fantastic, secret conspiracies and cabals to manufacturers, the historical aspect of many products cases becomes essential. The law leaves much uncertainty about how litigants are supposed to deal with uncertainty among experts at the relevant point in time. Plaintiffs typically find one or a few experts who were “out there,” at the time of the marketing, with good intuitions, but poor evidentiary bases, in asserting a causal connection. Defendants may take the opposite tack, but the important point is that the standard is epistemic and the Gettier problem[1] seriously afflicts most discussions in the legal state-of-art defenses.

Scott Kozak in a recent article calls attention to the exercised writings of David Rosner and Gerald Markowitz, who attempt to privilege their for-pay, for-plaintiffs, testimonial adventures, while deprecating similar work by defense expert witnesses and defense counsel.[2] Kozak’s article is a helpful reminder of how Markowitz and Rosner misunderstand and misrepresent the role of lawyers, while aggressively marketing their Marxist historiography in service of the Litigation Industry. Although Rosnowitz’s approach has been debunked on many occasions,[3] their biases and errors remain important, especially given how frequently they have showed up as highly partisan, paid expert witnesses in litigation. As I have noted on many occasions, historians can play an important scholarly role in identifying sources, connections, and interpretations of evidence, but the work of drawing and arguing those inferences in court, belongs to lawyers, who are subject to rules of procedure, evidence, and ethics.

Of course, lawyers, using the same set of skills of factual research and analysis as historians, have made important contributions to historical scholarship. A recent article[4] in the Wall Street Journal pointed out the historical contributions made by William Henry Herndon, Abraham Lincoln’s law partner, to our understanding of the Lincoln presidency.[5] The example could be multiplied.

Recently, I set out to research some issues in my own family history, surrounding its immigration and adjustment to life in the United States. I found some interesting points of corroboration between the oral and the documentary history, but what was most remarkable was what omitted from the oral history, and rediscovered among ancient documents. The information omitted could have been by accident or by design.  The embarrassing, the scandalous, the unpleasant, the mistakes, and the inane seem destined to be forgotten or suppressed, and thus left out of the narrative. The passage of time cloaked past events in a shroud of mystery.  And then there was false memory and inaccurate recall.  The Rashomon effect is in full bloom in family histories, as are all the cognitive biases, and unwarranted exceptionalist propaganda.

From all this, you might think that family histories are as intellectually corrupt and barren as national histories. Perhaps, but there is some documentary evidence that is likely to be mostly correct. Sometimes the documents even corroborate the oral history. Every fact documented, however, raises multiple new questions. Often, we are left with the black box of our ancestors’ motivation and intent, even when we can establish some basic historical facts.

In conducting this bit of family research, I was delighted to learn that there are standards for what constitutes reasonably supportable conclusions in family histories. The elements of the “genealogical proof standard,” set out in various places,[6] are generally regarded as consisting of:

 

  • reasonably exhaustive search
  • complete and accurate citation to sources
  • analysis and correlation of collected information
  • resolution of conflicting evidence
  • soundly reasoned, coherently written conclusion

If only all historians abided by this standard! There are standards for professional conduct of historians,[7] but curiously they are not as demanding as what the genealogical community has accepted as guiding and governing genealogical research.  The Genealogy Standards is worth consulting as a set of methodological principles that historians of all stripes should be heeding, and should be excluded from courtroom when disregarded.

[1] Edmund L. Gettier, “Is Justified True Belief Knowledge?” 23 Analysis 121 (1963).

[2] Scott Kozak, “Use and Abuse of ‘Historical Experts’ in Toxic Tort Cases,” in Toxic & Hazardous Substances Litigation (March 2015), available at < >.

[3] For a sampling of Rosnowitz decontruction, see “Counter Narratives for Hire”; “Historians Noir”; “Too Many Narratives – Historians in the Dock”; “Courting Clio: Historians Under Oath – Part 2”; “Courting Clio: Historians Under Oath – Part 1”; “Courting Clio: Historians and Their Testimony in Products Liability Litigation”; “How testifying historians are like lawn-mowing dogs” (May 2010); “What Happens When Historians Have Bad Memories”; “Narratives & Historians for Hire”; “A Walk on the Wild Side” (July 16, 2010).”

[4] David S. Reynolds, “Abraham Lincoln and Friends,” Wall St. J. (Jan. 29, 2016).

[5] Douglas L. Wilson & Rodney O. Davis, eds., Herndon on Lincoln: Letters (2016).

[6] See generally Board for Certification of Genealogists, Genealogy Standards (50th Anniversary ed. 2014).

[7] See, e.g., American Historical Ass’n, Statement on Standards of Professional Conduct, 2005 Edition, available at <http://www.historians.org/pubs/Free/ProfessionalStandards.cfm> (last revised January 2011). For histories that live up to high standards, see Annette Gordon-Reed, The Hemingses of Monticello: An American Family (2009); Timothy Snyder, Black Earth: The Holocaust as History and Warning (2015). But see David Rosner & Gerald Markowitz, Deadly Dust: Silicosis and the On-Going Struggle to Protect Workers’ Health (2006).

Posted in Expert Witnesses, Historian Testimony, Rule 702 | Comments Off on Lawyers as Historians

Lipitor MDL Takes The Fat Out Of Dose Extrapolations

December 2nd, 2015

Philippus Aureolus Theophrastus Bombastus von Hohenheim thankfully went by the simple moniker Paracelsus, sort of the Cher of the 1500s. Paracelsus’ astrological research is graciously overlooked today, but his 16th century dictum, in the German vernacular has created a lasting impression on linguistic conventions and toxicology:

“Alle Ding’ sind Gift, und nichts ohn’ Gift; allein die Dosis macht, dass ein Ding kein Gift ist.”

(All things are poison and nothing is without poison, only the dose permits something not to be poisonous.)

or more simply

“Die Dosis macht das Gift.”

Paracelsus, “Die dritte Defension wegen des Schreibens der neuen Rezepte,” Septem Defensiones (1538), in 2 Werke 510 (Darmstadt 1965). Today, his notion that the “dose is the poison” is a basic principle of modern toxicology,[1] which can be found in virtually every textbook on the subject.[2]

Paracelsus’ dictum has also permeated the juridical world, and become a commonplace in legal commentary and judicial decisions. The Reference Manual on Scientific Evidence is replete with supportive statements on the general acceptance of Paracelsus’ dictum. The chapter on epidemiology notes:

“The idea that the ‘dose makes the poison’ is a central tenet of toxicology and attributed to Paracelsus, in the sixteenth century… [T]his dictum reflects only the idea that there is a safe dose below which an agent does not cause any toxic effect.”

Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” 549, 603 & n.160, in Reference Manual on Scientific Evidence (3d ed. 2011). Citing an unpublished, non-scientific advocacy piece written for a regulatory agency, the chapter does, however, claim that “[t]he question whether there is a no-effect threshold dose is a controversial one in a variety of toxic substances areas.”[3] The epidemiology chapter thus appears to confuse two logically distinct propositions: that there is no threshold dose and that there is no demonstrated threshold dose.

The Reference Manual’s chapter on toxicology also weighs in on Paracelsus:

“There are three central tenets of toxicology. First, “the dose makes the poison”; this implies that all chemical agents are intrinsically hazardous—whether they cause harm is only a question of dose. Even water, if consumed in large quantities, can be toxic.”

Bernard D. Goldstein & Mary Sue Henifin, “Reference Guide on Toxicology,” 633, 636, in Reference Manual on Scientific Evidence (3d ed. 2011) (internal citations omitted).

Recently, Judge Richard Mark Gergel had the opportunity to explore the relevance of dose-response to plaintiffs’ claims that atorvastatin causes diabetes. In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Prod. Liab. Litig., MDL No. 2:14–mn–02502–RMG, Case Mgmt. Order 49, 2015 WL 6941132 (D.S.C. Oct. 22, 2015) [Lipitor]. Plaintiffs’ expert witnesses insisted that they could disregard dose once they had concluded that there was a causal association between atorvastatin at some dose and diabetes. On Rule 702 challenges to plaintiffs’ expert witnesses, the court held that, when there is a dose-response relationship and there is an absence of association at low doses, then plaintiffs must show, through expert witness testimony, that the medication is capable of causing the alleged harm at particular doses. The court permitted the plaintiffs’ expert witnesses to submit supplemental reports to address the dose issue, and the defendants to relodge their Rule 702 challenge after discovery on the new reports. Lipitor at *6.

The Lipitor court’s holding built on the ruling by Judge Breyer’s treatment of dose in In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., 524 F. Supp. 2d 1166, 1174-75 (N.D. Cal.2007). Judge Breyer, Justice Breyer’s kid brother, denied defendants’ Rule 702 challenges to plaintiffs’ expert witnesses who opined that Bextra and Celebrex can cause heart attacks and strokes, at 400 mg./day. For plaintiffs who ingested 200 mg/day, however, Judge Breyer held that the lower dose had to be analyzed separately, and he granted the motions to exclude plaintiffs’ expert witnesses’ opinions about the alleged harms caused by the lower dose. Lipitor at *1-2. The plaintiffs’ expert witnesses reached their causation opinions about 200 mg by cherry picking from the observational studies, and disregarding the randomized trials and meta-analyses of observational studies that failed to find an association between 200 mg/day and cardiovascular risk. Id. at *2. Given the lack of support for an association at 200mg/day, the court rejected the plaintiffs’ speculative downward extrapolation asserted.

Because of dose-response gradients, and the potential for a threshold, a risk estimate based upon greater doses or exposure does not apply to a person exposed at lower doses or exposure levels. See Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” 549, 613, in Reference Manual on Scientific Evidence (3d ed. 2011) (“[A] risk estimate from a study that involved a greater exposure is not applicable to an individual exposed to a lower dose.”).

In the Lipitor case, as in the Celebrex case, multiple studies reported no statistically significant associations between the lower doses and the claimed adverse outcome. This absence, combined with a putative dose-response relationship, made plaintiffs’ downward extrapolation impermissibly speculative. See, e.g., McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1241 (11th Cir. 2005) (reversing admission of expert witness’s testimony when the witness conceded a dose-response, but failed to address the dose of the medication needed to cause the claimed harm).

Courts sometimes confuse thresholds with dose-response relationships. The concepts are logically independent. There can be a dose-response relationship with or without a threshold. And there can be an absence of a dose-response relationship with a threshold, as in cases in which the effect is binary: positive at or above some threshold level, and negative below. A causal claim can run go awry because it ignores the possible existence of a threshold, or the existence of a dose-response relationship. The latter error is commonplace in litigation and regulatory contexts, when science or legal advocates attempt to evaluate risk using data that are based upon higher exposures or doses. The late Irving Selikoff, no stranger to exaggerated claims, warned against this basic error, when he wrote that his asbestos insulator cancer data were inapposite for describing risks of other tradesmen:

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

E.. Cuyler Hammond, Irving J. Selikoff, and Herbert Seidman, “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. 473, 487 (1979).[4] Given that the dose-response between asbestos exposure and disease outcomes was an important tenant of the Selikoff’s work, it is demonstrable incorrect for expert witnesses to invoke relative risks for heavily exposed asbestos insulators and apply them to less exposed workers, as though the risks were the same and there are no thresholds.

The legal insufficiency of equating high and low dose risk assessments has been noted by many courts. In Texas Independent Ginners Ass’n v. Marshall, 630 F.2d 398 (5th Cir. 1980), the Circuit reviewed an OSHA regulation promulgated to protect cotton gin operators from the dangers of byssinosis. OSHA based its risk assessments on cotton dust exposures experienced by workers in the fabric manufacturing industry, but the group of workers to be regulated had intermittent exposures, at different levels, from that of the workers in the relied upon studies. Because of the exposure level disconnect, the Court of Appeals struck the OSHA regulation. Id. at 409. OSHA’s extrapolation from high to low doses was based upon an assumption, not evidence, and the regulation could not survive the deferential standard required for judicial review of federal agency action. Id.[5]

The fallacy of “extrapolation down” often turns on the glib assumption that an individual claimant must have experienced a “causative exposure” because he has the disease that can result at some, higher level of exposure. In reasoning backwards from untoward outcome to sufficient dose, when dose is at issue, is a petitio principii, as recognized by several astute judges:

“The fallacy of the ‘extrapolation down’ argument is plainly illustrated by common sense and common experience. Large amounts of alcohol can intoxicate, larger amounts can kill; a very small amount, however, can do neither. Large amounts of nitroglycerine or arsenic can injure, larger amounts can kill; small amounts, however, are medicinal. Great volumes of water may be harmful, greater volumes or an extended absence of water can be lethal; moderate amounts of water, however, are healthful. In short, the poison is in the dose.”

In re Toxic Substances Cases, No. A.D. 03-319.No. GD 02-018135, 05-010028, 05-004662, 04-010451, 2006 WL 2404008, at *6-7 (Alleghany Cty. Ct. C.P. Aug. 17, 2006) (Colville, J.) (“Drs. Maddox and Laman attempt to “extrapolate down,” reasoning that if high dose exposure is bad for you, then surely low dose exposure (indeed, no matter how low) must still be bad for you.”)(“simple logical error”), rev’d sub nom. Betz v. Pneumo Abex LLC, 998 A.2d 962 (Pa. Super. 2010), rev’d 615 Pa. 504, 44 A.3d 27 (2012).

Exposure Quantification

An obvious corollary of the fallacy of downward extrapolation is that claimants must have a reasonable estimate of their dose or exposure in order to place themselves on the dose-response curve, to estimate in turn what their level of risk was before they developed the claimed harm. For example, in Mateer v. U.S. Aluminum Co., 1989 U.S. Dist. LEXIS 6323 (E.D. Pa. 1989), the court, applying Pennsylvania law, dismissed plaintiffs’ claim for personal injuries in a ground-water contamination case. Although the plaintiffs had proffered sufficient evidence of contamination, their expert witnesses failed to quantify the plaintiffs’ actual exposures. Without an estimate of the claimants’ actual exposure, the challenged expert witnesses could not give reliable, reasonably based opinions and conclusions whether plaintiffs were injured from the alleged exposures. Id. at *9-11.[6]

Science and law are sympatico; dose or exposure matters, in pharmaceutical, occupational, and environmental cases.

[1] Joseph F. Borzelleca, “Paracelsus: Herald of Modern Toxicology,” 53 Toxicol. Sci. 2 (2000); David L. Eaton, “Scientific Judgment and Toxic Torts – A Primer in Toxicology for Judges and Lawyers,” 12 J.L. & Pol’y 5, 15 (2003); Ellen K. Silbergeld, “The Role of Toxicology in Causation: A Scientific Perspective,” 1 Cts. Health Sci. & L. 374, 378 (1991). Of course, the claims of endocrine disruption have challenged the generally accepted principle. See, e.g., Dan Fagin, “Toxicology: The learning curve,” Nature (24 October 2012) (misrepresenting Paracelsus’ dictum as meaning that dose responses will be predictably linear).

[2] See, e.g., Curtis D. Klaassen, “Principles of Toxicology and Treatment of Poisoning,” in Goodman and Gilman’s The Pharmacological Basis of Therapeutics 1739 (11th ed. 2008); Michael A Gallo, “History and Scope of Toxicology,” in Curtis D. Klaassen, ed., Casarett and Doull’s Toxicology: The Basic Science of Poisons 1, 4–5 (7th ed. 2008).

[3] Michael D. Green, D. Michal Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” 549, 603 & n.160, in Reference Manual on Scientific Evidence (3d ed. 2011) (Irving J. Selikoff, Disability Compensation for Asbestos-Associated Disease in the United States: Report to the U.S. Department of Labor 181–220 (1981). The chapter also cites two judicial decisions that clearly were influenced by advocacy science and regulatory assumptions. Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1536 (D.C. Cir. 1984) (commenting that low exposure effects are “one of the most sharply contested questions currently being debated in the medical community”); In re TMI Litig. Consol. Proc., 927 F. Supp. 834, 844–45 (M.D. Pa. 1996) (considering extrapolations from high radiation exposure to low exposure for inferences of causality).

[4] See also United States v. Reserve Mining Co., 380 F. Supp. 11, 52-53 (D. Minn. 1974) (questioning the appropriateness of comparing community asbestos exposures to occupational and industrial exposures). Risk assessment modesty was uncharacteristic of Irving Selikoff, who used insulator risk figures, which were biased high, to issue risk projections for total predicted asbestos-related mortality.

[5] See also In re “Agent Orange” Prod. Liab. Litig., 611 F. Supp. 1223, 1250 (E.D.N.Y. 1985), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988) (noting that the plaintiffs’ expert witnesses relied upon studies that involved heavier exposures than those experienced by plaintiffs; the failure to address the claimants’ actual exposures rendered the witnesses’ proposed testimony legally irrelevant); Gulf South Insulation v. United States Consumer Products Safety Comm’n, 701 F.2d 1137, 1148 (5th Cir. 1983) (invalidating CPSC’s regulatory ban on urea formaldehyde foam insulation, as not supported by substantial evidence, when the agency based its ban upon high-exposure level studies and failed to quantify putative risks at actual exposure levels; criticizing extrapolations from high to low doses); Graham v. Wyeth Laboratories, 906 F.2d 1399, 1415 (10th Cir.) (holding that trial court abused its discretion in failing to grant new trial upon a later-discovered finding that plaintiff’s expert misstated the level of toxicity of defendant’s DTP vaccine by an order of magnitude), cert. denied, 111 S.Ct. 511 (1990).

Two dubious decisions that fail to acknowledge the fallacy of extrapolating down from high-exposure risk data have come out of the Fourth Circuit. See City of Greenville v. W.R. Grace & Co., 827 F.2d 975 (4th Cir. 1987) (affirming judgment based upon expert testimony that identified risk at low levels of asbestos exposure based upon studies at high levels of exposure); Smith v. Wyeth-Ayerst Labs Co., 278 F. Supp. 2d 684, 695 (W.D.N.C. 2003)(suggesting that expert witnesses may extrapolate down to lower doses, and even to extrapolate to different time window of latency).

[6] See also Christophersen v. Allied-Signal Corp., 939 F.2d 1106, 1111, 1113-14 (5th Cir. 1991) (en banc) (per curiam) (trial court may exclude opinion of expert witness whose opinion is based upon incomplete or inaccurate exposure data), cert. denied, 112 S. Ct. 1280 (1992); Wills v. Amareda Hess Co., 2002 WL 140542, *10 (S.D.N.Y. Jan. 31, 2002) (noting that the plaintiff’s expert witness failed to quantify the decedent’s exposure, but was nevertheless “ready to form a conclusion first, without any basis, and then try to justify it” by claiming that the decedent’s development of cancer was itself sufficient evidence that he had had intensive exposure to the alleged carcinogen).

Posted in Causation, Expert Witnesses, Rule 702 | Comments Off on Lipitor MDL Takes The Fat Out Of Dose Extrapolations

Putting the Liability Spotlight on Employers

November 30th, 2015

In 2013, the Pennsylvania Supreme Court held that employers could be directly liable to employees for injuries that become manifest outside the time limits (300 weeks) of the Commonwealth’s workman’s compensation statute. Tooey v. AK Steel Corp., 81 A.3d 851 (Pa. 2013). The implications for so-called long latency, toxic tort claims were obvious, and the generated some commentary. See “Pennsylvania Workers Regain Their Right of Action in Tort against Employers for Latent Occupational Diseases” (Feb. 14, 2014); “The Erosion of Employer Immunity in Tort Litigation” (Jan. 20, 2015).

The Legal Intelligencer has now reported the first “cashing in” or “cashing out” on the change in Pennsylvania law. Plaintiff’s lawyer, Benjamin Shein, took an employer to trial on claims that the employer was responsible for alleged asbestos exposure that caused John F. Busbey to develop mesothelioma. Bobbie R. Bailey of Leader & Berkon, in Los Angeles, defended. The case was tried before Philadelphia Judge Lisette Shirdan-Harris and a jury. After a three week trial, on November 10, the jury returned a verdict in favor of plaintiff, against the employer defendant, in the amount of 1.7 million dollars. Busbey v. ESAB Group, Phila. Court of Common Pleas, No. 120503046. Max Mitchell, “Employer Found Liable In Asbestos Verdict: Busbey v. ESAB Group $1.7 Million Verdict,” The Legal Intelligencer (Dec. 1, 2015).

For witnesses, Shein called frequent litigation-industry testifiers, Dr. Steven Markowitz on occupational disease, and Dr. Daniel Dupont, a local pulmonary physician. Shein also called one of the pink panther historians, Gerald Markowitz. See “Narratives & Historians for Hire” (Dec. 15, 2010). The employer defendant called an industrial hygienist, Delno D. Malzahn.

According Ben Shein, the verdict represented the first trial win in Pennsylvania for an asbestos claim against an employer, since the Pennsylvania Supreme Court decided Tooey in 2013. From the Legal Intelligencer’s account, and the line-up of litigation industry witnesses, the plaintiff’s trial evidence on exposure and standard of care seems shaky, and the winner may not be discernible until the appellate review is concluded.

In Illinois, an intermediate appellate court held out the prospect of a legal change similar to Tooey. In 2014, the Illinois Court of Appeals held that workman compensation petitioners, whose claims fell outside the Illinois statute were not barred by the exclusive remedy provisions that gave employers immunity from civil suit. Folta v. Ferro Engineering, 2014 IL App (1st) 123219. See Patrick W. Stufflebeam, “Folta v. Ferro Engineering: A Shift in Illinois Workers’ Compensation Protection for Illinois Employers in Asbestos Cases,” News & Press: IDC Quarterly (Mar. 11, 2015).

The Illinois Supreme Court allowed an appeal, as well as extensive amicus briefings from the Illinois Trial Lawyers Association, the Asbestos Disease Awareness Organization, the Illinois AFL-CIO, the Illinois Self-Insurers’ Association, the Illinois Defense Trial Counsel, a joint brief from insurers,[1] and a joint brief from various manufacturing companies.[2]

Earlier this month, the Illinois Supreme Court reversed and held that even though claims fell outside the Illinois workman’s compensation statute, those claims were still barred by the Act’s exclusive remedy provisions that gave employers immunity from civil suit. Folta v. Ferro Engineering, 2015 IL 118070 (November 4, 2015).

[1] the American Insurance Association, Property Casualty Insurers Association of America, and the Travelers Indemnity Company.

[2] Caterpillar Inc., Aurora Pump Company, Innophos, Inc., Rockwell Automation, Inc., United States Steel Corporation, F.H. Leinweber Company, Inc., Driv-Lok, Inc., Ford Motor Company, and ExxonMobil Oil Corporation.

Posted in Asbestos, Historian Testimony, Learned and sophisticated intermediary, Sophisticated User | Comments Off on Putting the Liability Spotlight on Employers

Manganese Madness Redux

November 28th, 2015

Before Dickie Scruggs had to put away his hand-tailored suits and don prison garb,[1] he financed and led an effort against the welding industry with claims that manganese in welding fume caused manganism, in several thousand tradesmen. After his conviction for scheming to bribe a judge, Scrugg’s lieutenants continued the fight, but ultimately gave up, despite having a friendly federal forum.

Scruggs has served his sentence, six years, in federal prison, and he has set out to use his freedom to promote adult education. Emily Le Coz, “Dickie Scruggs: A 2nd chance; Mississippi’s famed trial lawyer-turned-felon grants his first post-prison interview,” The Clarion-Ledger (April 25, 2015). Having confessed his crime and served his time, Scruggs deserves a second chance. Judge Zouhary of the Northern District of Ohio, however, recently ruled that the manganese litigation will not get a second chance in the form of a civil nuisance claim. Abrams v. Nucor Steel Marion, Inc., Case No. 3:13 CV 137, 2015 WL 6872511 (N.D. Ohio Nov. 9, 2015) (Zouhary, J.).

In Abrams, plaintiffs sued Nucor for trespass and private nuisance because of “hazardous” and “ultra-hazardous” levels of manganese, which landed on plaintiffs’ property from defendant’s plant. Plaintiffs did not claim personal injury, but rather asserted that manganese particulate damaged their real property and diminished its value.[2]

The parties agreed that the alleged indirect trespass would require a showing of “unauthorized, intentional physical entry or intrusion of a chemical by aerial dispersion onto Plaintiffs’ land, which causes substantial physical damage to the land or substantial interference with the reasonable and foreseeable use of the land.” Abrams, 2015 WL 6872511, at *1. Plaintiffs intended to make this showing by demonstrating, with the help of their hired expert witness, Jonathan Rutchik, that the manganese deposited on their land was harmful to human health.

Dr. Rutchik, a physician who specializes in neurology and preventive/ occupational medicine, was a veteran of the Scruggs’ offensive against the welding industry. Rutchik testified for plaintiffs in a losing effort in California, and was listed in other California cases. See, e.g., Thomas v. The Lincoln Electric Co., Alameda County 13 Case No. RG-06-272122; formerly Solano County Case No. FCS-027382), notes of Jonathan Rutchik’s testimony from Jan. 20, 2009, before Hon. Robert B. Freedman and a jury.

In Abrams, as an expert expert witness, Dr. Rutchik was able to conclude, to a reasonable degree of medical certainty, “that persons who reside full time in the ‘class area’ [0.25 to 0.5 miles from Nucor’s steel plant] for a period of ten (10) years or more will suffer harm to their health caused by such chronic exposure to such elevated levels of manganese”. Abrams, 2015 WL 6872511, at *3.  Having served as a trial judge in a welding fume case, Judge Zahoury is also a veteran of Scrugg’s litigation industry’s offensive against manganese. Perhaps that background expertise helped him see through the smoke and fume of Dr. Rutchik’s opinions. In fairly short order, Judge Zahoury found that Rutchik’s opinions were conclusory, overly broad, general, and vague, not “the product of reliable principles and methodology,” and not admissible. Id. Judge Zahoury was no doubt impressed by jarring comparison of Dr. Rutchik’s opinion that Plaintiffs “will suffer harm to their health,” with the good health of the nearby residents, who had not shown any symptoms of manganese-related exposures.

Rutchik had not conducted any physical examinations to support a claim that there was prevalent illness; nor did he rely upon any testing of his extravagant, litigation-driven claims. Rutchik has thus failed to “test [his] hypothesis in a timely and reliable manner or to validate [his] hypotheses by reference to generally accepted scientific principles as applied to the facts of the case renders [his] testimony . . . inadmissible.” Id. at *4 (citations omitted). Being unsupported by the record or by efforts to test his theories empirically, Rutchik’s opinion had to be excluded under Rule 702.

Rutchik has published on manganese toxicity, but he has consistently failed to disclose his remunerated service to the litigation industry in cases such as Thomas and Abrams. See Jonathan S. Rutchik, Wei Zheng, Yueming Jiang, Xuean Mo, “How does an occupational neurologist assess welders and steelworkers for a manganese-induced movement disorder? An international team’s experiences in Guanxi, China, part I,” 54 J. Occup. Envt’l Med. 1432 (2012) (No disclosure of conflict of interest); Jonathan S. Rutchik, Wei Zheng, Yueming Jiang, Xuean Mo, “How does an occupational neurologist assess welders and steelworkers for a manganese-induced movement disorder? An international team’s experiences in Guanxi, China Part II,” 54 J. Occup. Envt’l Med. 1562 (2012) (No disclosure of conflict of interest); Jonathan S. Rutchik, “Occupational Medicine Physician’s Guide to Neuropathy in the Workplace Part 3: Case Presentation,” 51 J. Occup. Envt’l Med. 861 (2009) (No disclosure of conflict of interest); Jonathan S Rutchik, et al., “Toxic Neuropathy: Practice Essentials, Background, Pathophysiology,” Medscape Reference (April 30, 2014) (“Disclosure:  Nothing to disclose” [sic]).

[1] “Richard Scruggs,” in Wikipedia, at <https://en.wikipedia.org/wiki/Richard_Scruggs>, last visited Nov. 27, 2015.

[2] Plaintiffs attempted to expand their claims to particulate matter, including manganese on the eve of trial, but Judge Zouhary would have none of this procedural shenanigan.

Posted in Conflicts of Interest, Rule 702 | Comments Off on Manganese Madness Redux

FOIA Exemptions Gobble Up The Statute

November 27th, 2015

Last week, the Supreme Court refused to hear a case in which petitioners sought review of a First Circuit decision that upheld the “commercial information” exemption (exemption 4) to the Freedom of Information Act, 5 U.S.C. § 552 (FOIA). New Hampshire Right to Life v. Dep’t Health & Human Services, 778 F.3d 43 (1st Cir. 2015). See Lyle Denniston, “Court bypasses FOIA challenge,” SCOTUSblog (Nov. 16, 2015).

An anti-abortion group filed a FOIA request to obtain documents that Planned Parenthood had sent to the federal government’s Department of Health and Human Services, in support of federal funding, for family planning activities in New Hampshire. The requested documents described Planned Parenthood’s internal medical standards and guidelines, as well as its set fees for various services. The federal trial court upheld the agency’s refusal to disclose the Planned Parenthood documents on the basis of § 552(b)(4) (Exemption 4, for “trade secrets and commercial or financial information obtained from a per­son and privileged or confidential”), as well as internal agency documents, on the basis of § 552(b)(5) (Exemption 5). The First Circuit affirmed the non-freedom of information. 778 F.3d 43.

Justice Thomas, joined by Justice Scalia, dissented from the Court’s denial of review. New Hampshire Right to Life, No. 14–1273, SCOTUS (Nov. 16, 2015) [Thomas Dissent] Justice Thomas intimated that the First Circuit’s decision may well have offended the Supreme Court’s interpretation of FOIA as reflecting “a general philosophy of full agency disclosure unless information is exempted under clearly delineated statutory language.” Department of Defense v. FLRA, 510 U. S. 487, 494 (1994).

Justice Thomas noted that the First Circuit based its conclusion not on the ordinary meaning of the term “confidential,” but on speculation whether FOIA disclosure might harm Planned Parenthood’s position in a conjectured market. The First Circuit ordained the Planned Parenthood manual confidential because “[a]potential future competitor could take advantage of the institutional knowledge contained in the Manual” to com­pete against the organization in the future. Justice Thomas intimated that he, and concurring Justice Scalia, disapproved of this speculation upon speculation approach. Thomas Dissent at 2. The dissenters also noted that the Supreme Court has yet to interpret Exemption 4, to FOIA, and that the lower courts have embraced this exemption as a broad exclusion, in derogation of the language and spirit of FOIA.

In discovery efforts to obtain information about litigation science, funded by the National Institute of Environmental Health and Science (NIEHS), FOIA officers appear to invoke Exemption 4 routinely to deny disclosure. One case in point was the effort to obtain information about NIEHS-funded research of Dr. Brad A. Racette, on the prevalence of parkinsonism among welding tradesmen in Wisconsin Great Lakes shipyards. Racette is an academic researcher, on the faculty of Washington University St. Louis; he is not engaged in any commercial enterprise, in any imaginable use of the word “commercial.” His Wisconsin research was sponsored by the Boilermakers’ union, which had worked with the litigation industry (trial bar) to develop a litigation case against the manufacturers of welding rods. FOIA requests for scientific data, protocols, and analyses were met, by NIEHS, with over-zealous redactions with the invocation of FOIA exemptions, including assertions that data and analyses were “confidential commercial information.”

The redaction of one of Racette’s ESNAP reports, on Grant Number SR01ES13743-4, is illustrative. The multi-year grant, entitled “Epidemilogy [sic] of Parkinsonism in Welders,” was awarded to principal investigator Brad Racette in 2007. On October 29, 2009, Racette submitted a report that included data and data analysis. The NIEHS, on its own, or acting at the request of the principal investigator, redacted data, analyses, and conclusions, on grounds of “confidential commercial information.” Invoking an exemption for “commercial information” for federally funding of an epidemiologic study, conducted by university-based scientists seems an extreme distortion of the FOIA statute.

Cynics may say that Justices Thomas and Scalia dissented in the Planned Parenthood case because they were eager, to advance their theological ideology to exploit the opportunity to order disclosure that could hurt the good work that Planned Parenthood does. The dissenting justices deserve, however, to be taken at their word, and applauded for chastising their colleagues who were willing to abide the frustation of the word and spirit of the FOIA statute. Sadly, federal agencies seem to be determined to make information unfree. In the most recent evaluations, the Department of Health and Human Services received a failing grade, among the lowest grades for FOIA performance and responsiveness; only the State Department failed with a lower score. National Freedom of Information Coalition, “FOIA report card shows federal agencies missing the mark,” (Mar. 16, 2015); Center for Effective Government, “Making the Grade – Access to Information Scorecard 2015.”

Posted in Data Sharing, Underlying Data | Comments Off on FOIA Exemptions Gobble Up The Statute

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