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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

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).

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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.

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Vaccine Court Inoculated Against Pathological Science

October 25th, 2015

Richard I. Kelley, M.D., Ph.D., is the Director of the Division of Metabolism, Kennedy Krieger Institute, and a member of the Department of Pediatrics, in Johns Hopkins University. The National Library of Medicine’s Pubmed database shows that Dr. Kelley has written dozens of articles on mitochondrial disease, but none that concludes that thimerosal or the measles, mumps and rubella vaccine plays a causal role in causing autism by inducing or aggravating mitochondrial disease. In one article, Kelley opines:

“Large, population-based studies will be needed to identify a possible relationship of vaccination with autistic regression in persons with mitochondrial cytopathies.”

Jacqueline R. Weissman, Richard I. Kelley, Margaret L. Bauman, Bruce H. Cohen, Katherine F. Murray, Rebecca L. Mitchell, Rebecca L. Kern, and Marvin R. Natowicz, “Mitochondrial Disease in Autism Spectrum Disorder Patients: A Cohort Analysis,” 3 PLoS One e3815 (Nov. 26, 2008). Those large scale population-based studies to support the speculation of Kelley and his colleagues have not materialized since 2008, and meta-analyses and systematic reviews have dampened the enthusiasm for Kelley’s hypothesis.[1]

Special Master Denise K. Vowell, in the Federal Court of Claims, has now further dampened the enthusiasm for Dr. Kelley’s mitochondrial theories, in a 115 page opinion, written in support of rejecting Kelley’s testimony and theories that the MMR vaccine caused a child’s autism. Madariaga v. Sec’y Dep’t H.H.S., No. 02-1237V (Ct. Fed. Claims Sept. 26, 2015) Slip op. [cited as Madariaga].

Special Master Vowell fulsomely recounts the history of vaccine litigation, in which the plaintiffs have presented theories that the combination of thimerosal-containing vaccines and the MMR vaccine cause autism, or just the thimerosal-containing vaccines cause autism. Madariaga at 3. Both theories were tested in the crucible of litigation and cross-examination in a series of test cases. The first theory resulted in verdicts against the claimants, which were affirmed on appeal.[2] Similarly, the trials on the thimerosal-only claims uniformly resulted in decisions from the Special Masters against the claims.[3] The three Special Masters, hearing the cases, found that the vaccine-causation claims were not close cases, and were based upon unreliable evidence.[4] Madariaga at 4.[5]

In Madariaga, Special Master Vowell noted that Doctor Kelley had conceded the “absence of an association between the MMR vaccine and autism in large epidemiological studies.” Madariaga at 61. Kelley attempted to evade the force of his lack of evidence by retreating into a claim that “autistic regressions caused by the live attenuated MMR vaccine are rare events,” and an assertion that there are many inflammatory factors that can induce autistic regression. Madariaga at 61.

Special Master described the whole of Kelley’s testimony as “meandering, confusing, and completely unpersuasive elaboration of his unique insights and methods.” Madariaga at 66. Although it is clear from the Special Master’s opinion that Kelley was unbridled in his over-interpretation of studies, and perhaps undisciplined in his interpretation of test results, the lengthy opinion provides only a high-altitude view of Kelley’s errors. There are tantalizing comments and notes in the Special Master’s decision, such as one that reports that one study may have been over-interpreted by Kelley because he ignored the authors’ comment that their findings could be consistent with chance because of their multiple comparisons, and another that paper that failed to show statistical significance. Madariaga at 90 & n.160.

The unreliability of Kelley’s testimony appeared to be more than hand waving in the absence of evidence. He compared the child’s results on a four-hour fasting test, when the child had not fasted for four hours. When pressed about this maneuver, Kelley claimed that he had made calculations to bring the child’s results “back to some standard.” Madariaga at 66 & n.115.

Although the Special Master’s opinion itself was ultimately persuasive, the tome left me eager to know more about Dr. Kelley’s epistemic screw ups, and less about vaccine court procedure.

[1] See Vittorio Demicheli, Alessandro Rivetti, Maria Grazia Debalini, and Carlo Di Pietrantonj, “Vaccines for measles, mumps and rubella in children,” Cochrane Database Syst. Rev., Issue 2. Art. No. CD004407, DOI:10.1002/14651858.CD004407.pub3 (2012) (“Exposure to the MMR vaccine was unlikely to be associated with autism … .”); Luke E. Taylor, Amy L. Swerdfeger, and Guy D. Eslick, “Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies,” 32 Vaccine 3623 (2014) (“Findings of this meta-analysis suggest that vaccinations are not associated with the development of autism or autism spectrum disorder. Furthermore, the components of the vaccines (thimerosal or mercury) or multiple vaccines (MMR) are not associated with the development of autism or autism spectrum disorder.”).

[2] Cedillo v. Sec’y, HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y, HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y, HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).

[3] Dwyer v. Sec’y, HHS, 2010 WL 892250; King v. Sec’y, HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. Sec’y, HHS, 2010 WL 892248.

[4] See, e.g., King, 2010 WL 892296, at *90 (emphasis in original); Snyder, 2009 WL 332044, at *198.

[5] The Federal Rule of Evidence technically do not control the vaccine court proceedings, but the Special Masters are bound by the requirement of Daubert v. Merrell Dow Pharm., 509 U.S. 579, 590 (1993), to find that expert witness opinion testimony is reliable before they consider it. Knudsen v. Sec’y, HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994). Madariaga at 7.

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On Amending Rule 702 of the Federal Rules of Evidence

October 17th, 2015

No serious observer or scholar of the law of evidence can deny that the lower federal courts have applied Daubert and its progeny, and the revised Federal Rule of Evidence 702, inconstantly and inconsistently, in their decisions to admit or exclude proffered expert witness opinion testimony. Opponents of trial court “gatekeeping” of expert witnesses applaud the lapses in hopes that the gates have been unhinged and that there will be “open admissions” for expert witness testimony. These opponents latch on to the suggestion that the Rules favor “liberal” admissibility with a libertine; they lose sight of the meaning of “liberal” that conveys enlightened, with an openness to progress and salutary change, and the claims of knowledge over blind faith.  Supporters of gatekeeping lament the courts’ inability or unwillingness to apply a clear statutory mandate that is designed to improve and ensure the correctness of fact finding in the federal courts. A few have decried the lawlessness of the courts’ evasions and refusals to apply Rule 702’s requirements.

Given the clear body of Supreme Court precedent, and the statutory revision to Rule 702, which was clearly designed to embrace, embody, enhance, and clarify the high Court precedent, I did not think that an amendment to Rule 702 was needed to improve the sorry state of lower court decisions. Professor David Bernstein and lawyer Eric Lasker, however, have made a powerful case for amendment as a way of awakening and galvanizing federal judges to their responsibilities under the law. David E. Bernstein & Eric G. Lasker,“Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1 (2015) [cited below as Bernstein & Lasker].

Bernstein and Lasker remind us that Rule 702 is a statute[1] that superseded inconsistent prior judicial pronouncements. The authors review many of the more egregious cases that ignore the actual text of Rule 702, while adverting to judicial gloss on the superseded rule, and even to judicial precedent and dicta pre-dating the Daubert case itself. Like the Papa Bear in the Berenstain Bear family, the authors show us how not to interpret a statute properly, through examples from federal court decisions.

The Dodgers’ Dodges

Questions about whether expert witnesses properly applied a methodology to the facts of a case are for the jury, and not the proper subject of gatekeeping.

As Bernstein and Lasker document, this thought- and Rule-avoidance dodge is particularly shocking given that the Supreme Court clearly directed close and careful analysis of the specific application of general principles to the facts of a case.[2] Shortly after the Supreme Court decided Daubert, the Third Circuit decided a highly influential decision in which it articulated the need for courts to review every step in expert witnesses’ reasoning for reliability. In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994). The Paoli case thus represents the antithesis of a judicial approach that asks only the 10,000 foot level question whether the right methodology was used; Paoli calls for a close, careful analysis of the application of a proper methodology to every step in the case. Id. (“any step that renders the analysis unreliable … renders the expert’s testimony inadmissible … whether the step completely changes a reliable methodology or merely misapplies that methodology”).

While the Paoli approach is unpopular with some judges who might prefer not to work so hard, the Advisory Committee heartily endorsed Paoli’s “any step” approach in its Note to the 2000 amendment. Bernstein & Lasker at 32. Bernstein and Lasker further point out that the Committee’s Report, Professor Dan Capra, acknowledged, shortly after the amendment went into effect, that the Paoli “any step” approach had a “profound impact” on the drafting of amended Rule 702. Bernstein & Lasker at 28.[3]

Having demonstrated the reasons, the process, and the substance of the judicial and legislative history of the revised Rule 702, Bernstein and Lasker are understandably incensed at the lawlessness of circuit and trial courts that have eschewed the statute, have ignored Supreme Court precedent, and have retreated to vague judicial pronouncements that trace back to before some or any of the important changes occurred in Rule 702.[4]

Let’s Cherry Pick and Weigh of the Evidence; Forget the Scale

Along with some courts’ insistence that trial judges may not examine the application of methods to the facts of a case, other courts, perhaps mindful of their citation practices, have endorsed “cherry picking” as a satisfactory methodology for partial expert witnesses to support their opinions. Id. at 35-36. Our law review authors also trace the influence of plaintiffs’ counsel, through their “walking around money” from the breast implant litigation, in sponsoring anti-Daubert, anti-gatekeeping conferences, at which prominent plaintiffs’ advocates and expert witnesses, such as Carl Cranor presented in favor of a vague “weight of the evidence” (WOE) approach to decision making. Id. at 39. Following these conferences, some courts have managed to embrace WOE, which is usually packaged as an abandonment of scientific standards of validity and sufficiency, in favor of selective review and subjective decisions. To do this, however, courts have had to ignore both Supreme Court precedent and the clear language of Rule 702. In Joiner, the high Court rejected WOE, over the dissent of a single justice,[5] but some of the inferior federal courts have embraced the dissent to the exclusion of the majority’s clear holding, as well as the incorporation of that holding into the revised Rule 702.[6] An interesting case of judicial disregard.

Other Dodges

The law review authors did not purport to provide an exhaustive catalogue of avoidance and evasion techniques. Here is one that is not discussed: shifting the burden of proof on admissibility to the opponent of the expert witness’s opinion:

“Testimony from an expert is presumed to be helpful unless it concerns matters within the everyday knowledge and experience of a lay juror.”

Earp v. Novartis Pharms., No. 5:11–CV–680–D, 2013 WL 4854488, at *3 (Sept. 11, 2013). See also Kopf v. Skyrm, 993 F.2d 374, 377 (4th Cir.1993); accord Koger v. Norfolk S. Ry. Co., No. 1:08–0909, 2010 WL 692842, at *1 (S.D.W.Va. Feb. 23, 2010) (unpublished).

Whence comes this presumption? Perhaps it is no more than a requirement for the opponent to object and articulate the flaws before the trial court will act. But the “presumption” sure looks like a covert shifting of the burden of proof for the requisite reliability of an expert witness’s opinion, which burden clearly falls on the proponent of the testimony.

The Proposed Amended Rule 702

There are several possible responses to the problem of the judiciary’s infidelity to basic principles, precedent, and legislative directive. Bernstein and Lasker advance amendments to the current Rule 702, as a blunt reminder that the times and the law have changed, really. Here is their proposed revision, with new language italicized, and deleted language shown to be struck:

“Rule 702. Testimony by Expert Witnesses

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

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

(b) the testimony is based on sufficient facts or data that reliably support the expert’s opinion;

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

(d) the expert has reliably applied the principles and methods to the facts of the case and reached his conclusions without resort to unsupported speculation.

Appeals of district court decisions under this Rule are considered under the abuse-of-discretion standard. Such decisions are evaluated with the same level of rigor regardless of whether the district court admitted or excluded the testimony in question. This Rule supersedes any preexisting precedent that conflicts with any or all sections of this Rule.”

Bernstein & Lasker at 44-45.

Before discussing and debating the changes, we should ask, “why change a fairly good statute just because lower courts evade its terms?” The corrupt efforts of SKAPP[7] to influence public and judicial policy, as well as the wildly one-sided Milward symposium,[8] which the authors discuss, should serve as a potent reminder that there would be many voices in the review and revision process, both from within plaintiffs’ bar, and from those sympathetic to the litigation industry’s goals and desires. Opening up the language of Rule 702 to revision could result in reactionary change, driven by the tort bar’s and allies’ lobbying. The result could be the evisceration of Rule 702, as it now stands. This danger requires a further exploration of alternatives to the proposed amendment.

Rule 702 has had the benefit of evolutionary change and development, which have made it better and also possibly burdened with vestigial language. To be sure, the rule is a difficult statute to draft, and while the authors give us a helpful start, there is many problems to be subdued before a truly workable working draft can be put be forward.

The first sentence’s new language, “the testimony satisfies each of the following requirements,” is probably already satisfied the use of “and” between the following numbered paragraphs. Given the judicial resistance to Rule 702, the additional verbiage could be helpful; it should be unnecessary. The conditionality of “if,” however, leaves the meaning of the Rule unclear when that condition is not satisfied. The Rule clearly signifies that “if” in the introductory sentence means “only if,” and the law and litigants would be better off if the Rule said what it means.

Proposed Subsection (b)

(b) the testimony is based on sufficient facts or data that reliably support the expert’s opinion;

The authors do not make much of a case for striking “sufficient.” There will be times when there are perfectly good facts and data supporting an expert witness’s opinion, in a completely reliable opinion, but the supporting facts and data do not support an epistemic claim of “knowledge,” because the support is indeterminate between the claim and many other competing hypotheses that might explain the outcome at issue. The reliably supporting facts and data may amount to little more than a scientific peppercorn, and really be too much of too little to support the claim. Deleting “sufficient” from subsection b could be a serious retrograde move, which will confuse the judiciary more than instruct it.

The revised subsection also fails to address the integrity of the facts and data, and the validity of how the data were generated. To be sure, Rule 703 could pick up some of the slack, but Rule 703 is often ignored, and even when invoked, that rule has its own drafting and interpretation problems. See “Giving Rule 703 the Cold Shoulder” (May 12, 2012); “RULE OF EVIDENCE 703 — Problem Child of Article VII” (Sept. 19, 2011). Also missing is an acknowledgment that the facts or data must often be analyzed in some way, whether by statistical tests or some other means. And finally, there is the problem in that reliable does not necessarily connote valid or accurate. Subsection (b) thus seems to cry out for additional qualification, such as:

“the testimony is based on sufficient facts or data, reliably, accurately, and validly ascertained, and analyzed, which facts or data reliably and validly support the expert’s opinion”

Proposed Subsection (c)

Bernstein and Lasker propose modifying this subsection to inject “and objectively reasonable” before “principles and methods.” The authors do not explain what objectively reasonable principles and methods encompass, and they qualification does seem self-explanatory. Perhaps they are calling for principles and methods that are “generally accepted,” and otherwise justified as warranted to produce accurate, true results? Is so, that might be a helpful addition.

Proposed Subsection (d)

Here the authors bolster the language of the subsection with a prohibition against using unsupported speculation. OK; but would supported or inspired or ingenious speculation be any better? Subsection (a) speaks of knowledge, and it should be obvious that the expert witness’s opinion has an epistemic warrant to be something more than a mere subjective opinion.

Whether Bernstein and Lasker have opened a can or a Concordat of Worms remains to be seen.

[1] The authors provide a great resource on the legislative history of attempts to revise 702, up to and including the 2000 revision. The 2000 revision began with a proposed amendment from the Advisory Committee in April 1999. The Standing Committee on Rules of Practice and Procedure approved the proposal, and forwarded the proposed amendment to the Judicial Conference, which approved the amendment without change in September 1999. The Supreme Court ordered the amendment in April 2000, and submitted the revised rule to Congress. Order Amending the Federal Rules of Evidence, 529 U.S. 1189, 1195 (2000). The revised Rule 702 became effective on December 1, 2000. See also Bernstein & Lasker at 19 n. 99 (citing Edward J. Imwinkelried, “Response, Whether the Federal Rules of Evidence Should Be Conceived as a Perpetual Index Code: Blindness Is Worse than Myopia,” 40 Wm. & Mary L. Rev. 1595, 1595-98 (1999) (noting and supporting the Supreme Court’s interpretation and application of the Federal Rules of Evidence as a statute, and subject to the judicial constraints on statutory construction). For a strident student’s pro-plaintiff view of the same legislative history, see Nancy S. Farrell, “Congressional Action to Amend Federal Rule of Evidence 702: A Mischievous Attempt to Codify Daubert v. Merrell Dow Pharmaceuticals, Inc.”, 13 J. Contemp. Health L. & Pol’y 523 (1997).

[2] General Electric Co. v. Joiner, 522 U.S. 136 (1997) (reviewing and analyzing individual studies’ internal and external validity, and rejecting plaintiffs’ argument that only the appropriateness of the methodology in the abstract was subject of gatekeeping); Kumho Tire Co. v. Carmichael, 526 U.S. 137, 156-57 (1999) (“stressing that district courts must scrutinize whether the principles and methods employed by an expert have been properly applied to the facts of the case”) (quoting what was then the proposed advisory committee’s note to Rule 702, Preliminary Draft of Proposed Amendments to the Federal Rules of Civil Procedure and Evidence: Request for Comment, 181 F.R.D. 18, 148 (1998)).

[3] citing Stephen A. Saltzburg, Edwin J. Imwinkelried, & Daniel J. Capra, “Keeping the Reformist Spirit Alive in Evidence Law,” 149 U. Pa. L. Rev. 1277, 1289-90 (2001). The authors note that other circuits have embraced the Paoli “any steps” approach. Bernstein & Lasker at 28 at n. 152 (citing Paz v. Brush Engineered Materials, Inc., 555 F.3d 383, 387-91 (5th Cir. 2009); McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1245 (11th Cir. 2005); Dodge v. Cotter Corp., 328 F.3d 1212, 1222 (10th Cir. 2003); Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 267 (2d Cir. 2002) (quoting In re Paoli, 35 F.3d at 746).

[4] See, e.g., City of Pomona v. SQM N. Am. Corp., 750 F.3d 1036, 1047 (9th Cir. 2014) (rejecting the Paoli any step approach without careful analysis of the statute, the advisory committee note, or Supreme Court decisions); Manpower, Inc. v. Ins. Co. of Pa., 732 F.3d 796, 808 (7th Cir. 2013) (“[t]he reliability of data and assumptions used in applying a methodology is tested by the adversarial process and determined by the jury; the court’s role is generally limited to assessing the reliability of the methodology – the framework – of the expert’s analysis”); Bonner v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir. 2001) (“the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination”).

[5] General Electric Co. v. Joiner, 522 U.S. 136, 146-47 (1997) (holding that district court had the “discretion to conclude that the studies upon which the experts relied were not sufficient, whether individually or in combination, to support their conclusions that Joiner’s exposure to PCB’s contributed to his cancer”). Other federal and state courts have followed Joiner. See Allen v. Pa. Eng’g Corp., 102 F.3d 194, 198 (5th Cir. 1996) (“We are also unpersuaded that the ‘weight of the evidence’ methodology these experts use is scientifically acceptable for demonstrating a medical link between Allen’s EtO exposure and brain cancer.”). For similar rejections of vague claims that weak evidence add up to more than the sum of its parts, see Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1216 n.21 (10th Cir. 2002); Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 608 (D.N.J. 2002); Caraker v. Sandoz Pharm. Corp., 188 F. Supp. 2d 1026, 1040 (S.D. Ill. 2001); Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347, 1371 (N.D. Ga. 2001), aff’d sub nom. Rider v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002); Merck & Co. v. Garza, 347 S.W.3d 256, 268 (Tex. 2011); Estate of George v. Vt. League of Cities & Towns, 993 A.2d 367, 379-80 (Vt. 2010).

[6] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 17-18 (1st Cir. 2011) (reversing the exclusion of expert witnesses who embraced WOE). Milward has garnered some limited support in a few courts, as noted by Bernstein and Lasker; see In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., Nos. 11-5304, 08-08, 2013 WL 1558690, at *4 (D.N.J. Apr. 10, 2013); Harris v. CSX Transp., Inc., 753 S.E.2d 275, 287-89, 301-02 (W. Va. 2013).

[7] “SKAPP A LOT” (April 30, 2010).

[8] “Milward Symposium Organized by Plaintiffs’ Counsel and Witnesses” (Feb. 13, 2013); [http://perma.cc/PW2V-X7TK].

Posted in Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on On Amending Rule 702 of the Federal Rules of Evidence

Clinical Trials and Epidemiologic Studies Biased by False and Misleading Data From Research Participants

October 2nd, 2015

Many legal commentators erroneously refer to epidemiologic studies as “admitted” into evidence.[1] These expressions are sloppy, and unfortunate, because they obscure the tenuousness of study validity, and the many hearsay levels that are represented by an epidemiologic study. Rule 702 permits expert witness opinion that has an epistemic basis, and Rule 703 allows expert witnesses to rely upon otherwise inadmissible facts and data, as long as real experts in the field would reasonably rely upon such facts and data. Nothing in Rule 702 or 703 make an epidemiologic study itself admissible. And the general inadmissibility of the studies themselves is a good thing, given that they will be meaningless to the trier of fact without the endorsements, qualifications, and explanations of an expert witness, and given that many studies are inaccurate, invalid, and lack data integrity to boot.

Dr. Frank Woodside was kind enough to call my attention to an interesting editorial piece in the current issue of the New England Journal of Medicine, which reinforced the importance of recognizing that epidemiologic studies and clinical trials are inadmissible in themselves. The editorial, by scientists from the National Institute of Environmental Health Studies and the National Institute on Drug Abuse, calls out the problem of study participants who lie, falsify, fail to disclose, and exaggerate important aspects of their medical histories as well as their data. See David B. Resnik & David J. McCann, “Deception by Research Participants,” 373 New Engl. J. Med. 1192 (2015). The editorial is an important caveat for those who would glibly describe epidemiologic studies and clinical trials as “admissible.”

As a reminder of the autonomy of those who participate in clinical trials and studies, we now refer to individuals in a study as “participants,” and not “subjects.” Resnik and McCann remind us, however, that notwithstanding their importance, study participants can bias a study in important ways. Citing other recent papers,[2] the editorialists note that clinical trials offer financial incentives to participants, which may lead to exaggeration of symptoms to ensure enrollment, to failure to disclose exclusionary medical conditions and information, and to withholding of embarrassing or inculpatory information. Although fabrication or falsification of medical history and data by research participants is not research misconduct by the investigators, the participants’ misconduct can seriously bias and undermine the validity and integrity of a study.

Resnik and McCann’s concerns about the accuracy and truthfulness of clinical trial participant medical data and information can mushroom exponentially in the context of observational studies that involve high-stakes claims for compensation and vindication on medical causation issues. Here are a couple of high-stakes examples.

The Brinton Study in Silicone Gel Breast Implant Litigation

In the silicone gel breast implant litigation, claimants looked forward to a study by one of their champions, Dr. Louis Brinton, of the National Cancer Institute (NCI). Brinton had obtained intramural funding to conduct a study of women who had had silicone gel breast implants and their health outcomes. To their consternation, the defendants in that litigation learned of Dr. Brinton’s close ties with plaintiffs’ counsel, plaintiffs’ support groups, and other advocates. Further investigation, including Freedom of Information Act requests to the NCI led to some disturbing and startling revelations.

In October 1996, a leading epidemiologist wrote a “concerned citizen” letter to Dr. Joseph Fraumeni, who was then the director of Epidemiology and Genetics at the NCI. The correspondent wrote to call Dr. Fraumeni’s attention to severe bias problems in Dr. Brinton’s pending study of disease and symptom outcomes among women who had had silicone breast implants. Dr. Brinton had written to an Oregon attorney (Michael Williams) to enlist him to encourage his clients to participate in Brinton’s NCI study.   Dr. Brinton had also written to a Philadelphia attorney (Steven Sheller) to seek permission to link potential study subjects to the global settlement database of information on women participating in the settlement. Perhaps most egregiously, Dr. Brinton and others had prepared a study Question & Answer sheet, from the National Institutes of Health, which ended with a ringing solicitation of “The study provides an opportunity for women who may be suffering as a result of implants to be heard. Now is your chance to make a major contribution to women’s health by supporting this essential research.” Dr. Brinton apparently had not thought of appealing to women with implants who did not have health problems.

Dr. Brinton’s methodology doomed her study from the start. Without access to the background materials, such as the principal investigator’s correspondence file, or the recruitment documents used to solicit participation of ill women in the study, the scientific community, and the silicone litigation defendants would not have had the important insights into serious bias and flaws of Brinton’s study.

The Racette-Scruggs’ Study in Welding Fume Litigation

The welding fume litigation saw its version of a study corrupted by the participation of litigants and potential litigants. Richard (Dickie) Scruggs and colleagues funded some neurological researchers to travel to Alabama and Mississippi to “screen” plaintiffs and potential plaintiffs in litigation for over claims of neurological injury and disease from welding fume exposure. The plaintiffs’ lawyers rounded up the research subjects (a.k.a. clients and potential clients), talked to them before the medical evaluations, and administered the study questionnaires. Clearly the study subjects were aware of Scruggs’ “research” hypothesis. The plaintiffs’ lawyers then invited researchers who saw the welding tradesmen, using a novel videotaping methodology, to evaluate the workers for parkinsonism.

After their sojourn, at Scruggs’ expense to Alabama and Mississippi, the researchers wrote up their results, with little or no detail of the circumstances of how they had acquired their research “participants,” or those participants’ motives to give accurate or inaccurate medical and employment history information. See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006) (a largely duplicative report of the Alabama welders study).

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette’s Alabama study on welding and parkinsonism). After the defense had the opportunity to obtain and analyze the underlying data in the Scruggs-Racette study, the welding plaintiffs largely retreated from their epidemiologic case. The Racette Alabama study faded into the background of the trials.

Both the Brinton and the Racette studies are painful reminders of the importance of assessing the motives of the study participants in observational epidemiologic studies, and the participants’ ability to undermine data integrity. If the financial motives identified by Resnik and McCann are sufficient to lead participants to give false information, or to fail to disclose correct information, we can only imagine how powerful are the motives created by the American tort litigation system among actual and potential claimants when they participate in epidemiologic studies. Resnik and McCann may be correct that fabrication or falsification of medical history and data by research participants is not research misconduct by the investigators themselves, but investigators who turn a blind eye to the knowledge, intent, and motives of their research participants may be conducting studies that are doomed from the outset.

[1] Michael D. Green, D. Michal Freedman, Leon Gordis, “Reference Guide on Epidemiology 549, 551,” in Reference Manual on Scientific Evidence (3d ed. 2011) ( “Epidemiologic studies have been well received by courts deciding cases involving toxic substances. *** Well-conducted studies are uniformly admitted.) (citing David L. Faigman et al. eds., 3 Modern Scientific Evidence: The Law and Science of Expert Testimony § 23.1, at 187 (2007–08)).

[2] Eric Devine, Megan Waters, Megan Putnam, et al., “Concealment and fabrication by experienced research subjects,” 20 Clin. Trials 935 (2013); Rebecca Dresser, “Subversive subjects: rule-breaking and deception in clinical trials,” 41 J. Law Med. Ethics 829 (2013).

Posted in Data Sharing, Rule 702, Scientific Evidence, Scientific Misconduct, Underlying Data | Comments Off on Clinical Trials and Epidemiologic Studies Biased by False and Misleading Data From Research Participants

The C-8 (Perfluorooctanoic Acid) Litigation Against DuPont, part 1

September 27th, 2015

The first plaintiff has begun her trial against E.I. Du Pont De Nemours & Company (DuPont), for alleged harm from environmental exposure to perfluorooctanoic acid or its salts (PFOA). Ms. Carla Bartlett is claiming that she developed kidney cancer as a result of drinking water allegedly contaminated with PFOA by DuPont. Nicole Hong, “Chemical-Discharge Case Against DuPont Goes to Trial: Outcome could affect thousands of claims filed by other U.S. residents,” Wall St. J. (Sept. 13, 2015). The case is pending before Chief Judge Edmund A. Sargus, Jr., in the Southern District of Ohio.

PFOA is not classified as a carcinogen in the Integrated Risk Information System (IRIS), of the U.S. Environmental Protection Agency (EPA). In 2005, the EPA Office of Pollution Prevention and Toxics submitted a “Draft Risk Assessment of the Potential Human Health Effects Associated With Exposure to Perfluorooctanoic Acid and Its Salts (PFOA),” which is available at the EPA’s website. The draft report, which is based upon some epidemiology and mostly animal toxicology studies, stated that there was “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.”

In 2013, The Health Council of the Netherlands evaluated the PFOA cancer issue, and found the data unsupportive of a causal conclusions. The Health Council of the Netherlands, “Perfluorooctanoic acid and its salts: Evaluation of the carcinogenicity and genotoxicity” (2013) (“The Committee is of the opinion that the available data on perfluorooctanoic acid and its salts are insufficient to evaluate the carcinogenic properties (category 3)”).

Last year, the World Health Organization (WHO) through its International Agency for Research on Cancer (IARC) reviewed the evidence on the alleged carcinogenicity of PFOA. The IARC, which has fostered much inflation with respect to carcinogenicity evaluations, classified as PFOA as only possibly carcinogenic. See News, “Carcinogenicity of perfluorooctanoic acid, tetrafl uoroethylene, dichloromethane, 1,2-dichloropropane, and 1,3-propane sultone,” 15 The Lancet Oncology 924 (2014).

Most independent reviews also find the animal and epidemiologic unsupportive of a causal conclusion between PFOA and any human cancer. See, e.g., Thorsten Stahl, Daniela Mattern, and Hubertus Brunn, “Toxicology of perfluorinated compounds,” 23 Environmental Sciences Europe 38 (2011).

So you might wonder how DuPont lost its Rule 702 challenges in such a case, which it surely did. In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., Civil Action 2:13-md-2433, 2015 U.S. Dist. LEXIS 98788 (S.D. Ohio July 21, 2015). That is a story for another day.

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence, Uncategorized | Comments Off on The C-8 (Perfluorooctanoic Acid) Litigation Against DuPont, part 1

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