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Welding Litigation – Another Positive Example of Litigation-Generated Science

July 11th, 2017

In a recent post¹, I noted Samuel Tarry’s valuable article² for its helpful, contrarian discussion of the importance of some scientific articles with litigation provenances. Public health debates can spill over to the courtroom, and developments in the courtroom can, on occasion, inform and even resolve those public health debates that gave rise to the litigation. Tarry provided an account of three such articles, and I provided a brief account of another article, a published meta-analysis, from the welding fume litigation.

The welding litigation actually accounted for several studies, but in this post, I detail the background of another published study, this one an epidemiologic study by a noted Harvard epidemiologist. Not every expert witness’s report has the making of a published paper. In theory, if the expert witness has conducted a systematic review, and reached a conclusion that is not populated among already published papers, we might well expect that the witness had achieved the “least publishable unit.” The reality is that most causal claims are not based upon what could even remotely be called a systematic review. Given the lack of credibility to the causal claim, rebuttal reports are likely to have little interest to serious scientists.

Martin Wells

In the welding fume cases, one of plaintiffs’ hired expert witnesses, Martin Wells, a statistician, proffered an analysis of Parkinson’s disease (PD) mortality among welders and welding tradesmen. Using the National Center for Health Statistics (NCHS) database, Wells aggregated data from 1993 to 1999, for PD among welders and compared this to PD mortality among non-welders. Wells claimed to find an increased risk of PD mortality among younger (under age 65 at death) welders and welding tradesmen in this dataset.

The defense sought discovery of Wells’s methods and materials, and obtained the underlying data from the NCHS. Wells had no protocol, no pre-stated commitment to which years in the dataset he would use, and no pre-stated statistical analysis plan. At a Rule 702 hearing, Wells was unable to state how many welders were included in his analysis, why he selected some years but not others, or why he had selected age 65 as the cut off. His analyses appeared to be pure data dredging.

As the defense discovered, the NCHS dataset contained mortality data for many more years than the limited range employed by Wells in his analysis. Working with an expert witness at the Harvard School of Public Health, the defense discovered that Wells had gerrymandered the years included (and excluded) in his analysis in a way that just happened to generate a marginally, nominally statistically significant association.

NCHS Welder Age Distribution

The defense was thus able to show that the data overall, and in each year, were very sparse. For most years, the value was either 0 or 1, for PD deaths under age 65. Because of the huge denominators, however, the calculated mortality odds ratios were nominally statistically significant. The value of four PD deaths in 1998 is clearly an outlier. If the value were three rather than four, the statistical significance of the calculated OR would have been lost. Alternatively, a simple sensitivity test suggests that if instead of overall n = 7, n were 6, statistical significance would have been lost. The chart below, prepared at the time with help from Dr. David Schwartz, of Innovative Science solutions, shows the actual number of “underlying cause” PD deaths that were in the dataset for each year in the NCHS dataset, and how sparse and “granular” these data were:

A couple of years later, the Wells’ litigation analysis showed up as a manuscript, with only minor changes in its analyses, and with authors listed as Martin T. Wells and Katherine W. Eisenberg, in the editorial offices of Neurology. Katherine W. Eisenberg, AB and Martin T. Wells, Ph.D., “A Mortality Odds Ratio Study of Welders and Parkinson Disease.” Wells disclosed that he had testified for plaintiffs in the welding fume litigation, but Eisenberg declared no conflicts. Having only an undergraduate degree, and attending medical school at the time of submission, Ms. Eisenberg would not seem to have had the opportunity to accumulate any conflicts of interest. Undisclosed to the editors of Neurology, however, was that Ms. Eisenberg was the daughter of Theodore (Ted) Eisenberg, a lawyer who taught at Cornell University and who represented plaintiffs in the same welding MDL as the one in which Wells testified. Inquiring minds might have wondered whether Ms. Eisenberg’s tuition, room, and board were subsidized by Ted’s earnings in the welding fume and other litigations. Ted Eisenberg and Martin Wells had collaborated on many other projects, but in the welding fume litigation, Ted worked as an attorney for MDL welding plaintiffs, and Martin Wells was compensated handsomely as an expert witness. The acknowledgment at the end of the manuscript thanked Theodore Eisenberg for his thoughtful comments and discussion, without noting that he had been a paid member of the plaintiff’s litigation team. Nor did Wells and Eisenberg tells the Neurology editors that the article had grown out of Wells’ 2005 litigation report in the welding MDL.

The disclosure lapses and oversights by Wells and the younger Eisenberg proved harmless error because Neurology rejected the Wells and Eisenberg paper for publication, and it was never submitted elsewhere. The paper used the same restricted set of years of NCHS data, 1993-1999. The defense had already shown, through its own expert witness’s rebuttal report, that the manuscript’s analysis achieved statistical significance only because it omitted years from the analysis. For instance, if the authors had analyzed 1992 through 1999, their Parkinson’s disease mortality point estimate for younger welding tradesmen would no longer have been statistically significant.

Robert Park

One reason that Wells and Eisenberg may have abandoned their gerrymandered statistical analysis of the NCHS dataset was that an ostensibly independent group³ of investigators published a paper that presented a competing analysis. Robert M. Park, Paul A. Schulte, Joseph D. Bowman, James T. Walker, Stephen C. Bondy, Michael G. Yost, Jennifer A. Touchstone, and Mustafa Dosemeci, “Potential Occupational Risks for Neurodegenerative Diseases,” 48 Am. J. Ind. Med. 63 (2005) [cited as Park (2005)]. The authors accessed the same NCHS dataset, and looked at hundreds of different occupations, including welding tradesmen, and four neurodegenerative diseases.

Park, et al., claimed that they looked at occupations that had previously shown elevated proportional mortality ratios (PMR) in a previous publication of the NIOSH. A few other occupations were included; in all their were hundreds of independent analyses, without any adjustment for multiple testing. Welding occupations⁴ were included “[b]ecause of reports of Parkinsonism in welders [Racette et al.,, 2001; Levy and Nassetta, 2003], possibly attributable to manganese exposure (from welding rods and steel alloys)… .”⁵ Racette was a consultant for the Lawsuit Industry, which had been funded his research on parkinsonism among welders. Levy was a testifying expert witness for Lawsuit, Inc. A betting person would conclude that Park had consulted with Wells and Eisenberg, and their colleagues.

These authors looked at four neurological degenerative diseases (NDDs), Alzheimer’s disease, Parkinson’s disease, motor neuron disease, and pre-senile dementia. The authors looked at NCHS death certificate occupational information from 1992 to 1998, which was remarkable because Wells had insisted that 1992 somehow was not available for inclusion in his analyses. During 1992 to 1998, in 22 states, there were 2,614,346 deaths with 33,678 from Parkinson’s diseases. (p. 65b). Then for each of the four disease outcomes, the authors conducted an analysis for deaths below age 65. For the welding tradesmen, none of the four NDDs showed any associations. Park went on to conduct subgroup analyses for each of the four NDDs for death below age 65. In these subgroup analyses for welding tradesmen, the authors purported to find only an association only with Parkinson’s disease:

“Of the four NDDs under study, only PD was associated with occupations where arc-welding of steel is performed, and only for the 20 PD deaths below age 65 (MOR=1.77, 95% CI=1.08-2.75) (Table V).”

Park (2005), at 70.

The exact nature of the subgroup was obscure, to say the least. Remarkably, Park and his colleagues had not calculated an odds ratio for welding tradesmen under age 65 at death compared with non-welding tradesmen under age 65 at death. The table’s legend attempts to explain the authors’ calculation:

“Adjusted for age, race, gender, region and SES. Model contains multiplicative terms for exposure and for exposure if age at death <65; thus MOR is estimate for deaths occurring age 65+, and MOR, age <65 is estimate of enhanced risk: age <65 versus age 65+”

In other words, Park looked to see whether welding tradesmen who died at a younger age (below age 65) were more likely to have a PD cause of death than welding tradesmen who died an older age (over age 65). The meaning of this internal comparison is totally unclear, but it cannot represent a comparison of welder’s with non-welders. Indeed, every time, Park and his colleagues calculated and reported this strange odds ratio for any occupational group in the published paper, the odds ratio was elevated. If the odds ratio means anything, it is that younger Parkinson’s patients, regardless of occupation, are more likely to die of their neurological disease than older patients. Older men, regardless of occupation, are more likely to die of cancer, cardiovascular disease, and other chronic diseases. Furthermore, this age association within (not between) an occupational groups may be nothing other than a reflection of the greater severity of early-onset Parkinson’s disease in anyone, regardless of their occupation.

Like the manuscript by Eisenberg and Wells, the Park paper was an exercise in data dredging. The Park study reported increased odds ratios for Parkinson’s disease among the following groups on the primary analysis:

biological, medical scientists [MOR 2.04 (95% CI, 1.37-2.92)]

clergy [MOR 1.79 (95% CI, 1.58-2.02)]

religious workers [MOR 1.70 (95% CI, 1.27-2.21)]

college teachers [MOR 1.61 (95% CI, 1.39-1.85)]

social workers [MOR 1.44 (95% CI, 1.14-1.80)]

As noted above, the Park paper reported all of the internal mortality odds ratios for below versus above age 65, within occupational groups were nominally statistically significantly elevated. Nonetheless, the Park authors were on a mission, and determined to make something out of nothing, at least when it came to welding and Parkinson’s disease among younger patients. The authors’ conclusion reflected stunningly poor scholarship:

“Studies in the US, Europe, and Korea implicate manganese fumes from arc-welding of steel in the development of a Parkinson’s-like disorder, probably a manifestation of manganism [Sjogren et al., 1990; Kim et al., 1999; Luccini, et al., 1999; Moon et al., 1999]. The observation here that PD mortality is elevated among workers with likely manganese exposures from welding, below age 65 (based on 20 deaths), supports the welding-Parkinsonism connection.”

Park (2005) at 73.

Stunningly bad because the cited papers by Sjogren, Luccini, Kim, and Moon did not examine Parkinson’s disease as an outcome; indeed, they did not even examine a parkinsonian movement disorder. More egregious, however, was the authors’ assertion that their analysis, which compared the odds of Parkinson’s disease mortality between welders under age 65 to that mortality for welders over age 65, supported an association between welding and “Parkinsonism.”

Every time the authors conducted this analysis internal to an occupational group, they found an elevation among under age 65 deaths compared with over age 65 deaths within the occupational group. They did not report comparisons of any age-defined subgroup of a single occupational group with similarly aged mortality in the remaining dataset.

Elan Louis

The plaintiffs’ lawyers used the Park paper as “evidence” of an association that they claimed was causal. They were aided by a cadre of expert witnesses who could cite to a paper’s conclusions, but could not understand its methods. Occasionally, one of the plaintiffs’ expert witnesses would confess ignorance about exactly what Robert Park had done in this paper. Elan Louis, one of the better qualified expert witnesses on the side of claimants, for instance, testified in the plaintiffs’ attempt to certify a national medical monitoring class action for welding tradesmen. His testimony about what to make of the Park paper was more honest than most of the plaintiffs’ expert witnesses:

Q. My question to you is, is it true that that 1.77 point estimate of risk, is not a comparison of this welder and allied tradesmen under this age 65 mortality, compared with non-welders and allied tradesmen who die under age 65?

A. I think it’s not clear that the footnote — I think that the footnote is not clearly written. When you read the footnote, you didn’t read the punctuation that there are semicolons and colons and commas in the same sentence. And it’s not a well constructed sentence. And I’ve gone through this sentence many times. And I’ve gone through this sentence with Ted Eisenberg many times. This is a topic of our discussion. One of the topics of our discussions. And it’s not clear from this sentence that that’s the appropriate interpretation. * * * However, the footnote, because it’s so poorly written, it obscures what he actually did. And then I think it opens up alternative interpretations.

Q. And if we can pursue that for a moment. If you look at other tables for other occupational titles, or exposure related variables, is it true that every time that Mr. Park reports on that MOR age under 65, that the estimate is elevated and statistically significantly so?

A. Yes. And he uses the same footnote every time. He’s obviously cut and paste that footnote every single time, down to the punctuation is exactly the same. And I would agree that if you look for example at table 4, the mortality odds ratios are elevated in that manner for Parkinson’s Disease, with reference to farming, with reference to pesticides, and with reference to farmers excluding horticultural deaths.

Deposition testimony of Elan Louis, at p. 401-04, in Steele v. A. O. Smith Corp., no. 1:03 CV-17000, MDL 1535 (Jan. 18, 2007). Other less qualified, or less honest expert witnesses on the plaintiffs’ side were content to cite Park (2005) as support for their causal opinions.

Meir Stampfer

The empathetic MDL trial judge denied the plaintiffs’ request for class certification in Steele, but individual personal injury cases continued to be litigated. Steele v. A.O. Smith Corp., 245 F.R.D. 279 (N.D. Ohio 2007) (denying class certification); In re Welding Fume Prods. Liab. Litig., No. 1:03-CV-17000, MDL 1535, 2008 WL 3166309 (N.D. Ohio Aug. 4, 2008) (striking pendent state-law class actions claims)

Although Elan Louis was honest enough to acknowledge his own confusion about the Park paper, other expert witnesses continued to rely upon it, and plaintiffs’ counsel continued to cite the paper in their briefs and to use the apparently elevated point estimate for welders in their cross-examinations of defense expert witnesses. With the NCHS data in hand (on a DVD), defense counsel returned to Meir Stampfer, who had helped them unravel the Martin Wells’ litigation analysis. The question for Professor Stampfer was whether Park’s reported point estimate for PD mortality odds ratio was truly a comparison of welders versus non-welders, or whether it was some uninformative internal comparison of younger welders versus older welders.

The one certainty available to the defense is that it had the same dataset that had been used by Martin Wells in the earlier litigation analysis, and now by Robert Park and his colleagues in their published analysis. Using the NCHS dataset, and Park’s definition of a welder or a welding tradesman, Professor Stampfer calculated PD mortality odds ratios for each definition, as well as for each definition for deaths under age 65. None of these analyses yielded statistically significant associations. Park’s curious results could not be replicated from the NCHS dataset.

For welders, the overall PD mortality odds ratio (MOR) was 0.85 (95% CI, 0.77–0.94), for years 1985 through 1999, in the NCHS dataset. If the definition of welders was expanded to including welding tradesmen, as used by Robert Park, the MOR was 0.83 (95% CI, 0.78–0.88) for all years available in the NCHS dataset.

When Stampfer conducted an age-restricted analysis, which properly compared welders or welding tradesmen with non-welding tradesmen, with death under age 65, he similarly obtained no associations for PD MOR. For the years 1985-1991, death under 65 from PD, Stampfer found MORs 0.99 (95% CI, 0.44–2.22) for just welders, and 0.83 (95% CI, 0.48–1.44) all welding tradesmen.

And for 1992-1999, the years used by Park (2005), and similar to the date range used by Martin Wells, for PD deaths at under age 65, for welders only, Stampfer found a MOR of 1.44 (95% CI, 0.79–2.62), and for all welding tradesmen, 1.20 (95% CI, 0.79–1.84)

None of Park’s slicing, dicing, and subgrouping of welding and PD results could be replicated. Although Dr. Stampfer submitted a report in Steele, there remained the problem that Park (2005) was a peer-reviewed paper, and that plaintiffs’ counsel, expert witnesses, and other published papers were citing it for its claimed results and errant discussion. The defense asked Dr. Stampfer whether the “least publishable unit” had been achieved, and Stampfer reluctantly agreed. He wrote up his analysis, and published it in 2009, with an appropriate disclosure⁶. Meir J. Stampfer, “Welding Occupations and Mortality from Parkinson’s Disease and Other Neurodegenerative Diseases Among United States Men, 1985–1999,” 6 J. Occup. & Envt’l Hygiene 267 (2009).

Professor Stampfer’s paper may not be the most important contribution to the epidemiology of Parkinson’s disease, but it corrected the distortions and misrepresentations of data in Robert Park’s paper. His paper has since been cited by well-known researchers in support of their conclusion that there is no association between welding and Parkinson’s disease⁷. Park’s paper has been criticized on PubPeer, with no rebuttal⁸.

Almost comically, Park has cited Stampfer’s study tendentiously for a claim that there is a healthy worker bias present in the available epidemiology of welding and PD, without noting, or responding to, the devastating criticism of his own Park (2005) work:

“For a mortality study of neurodegenerative disease deaths in the United States during 1985 – 1999, Stampfer [61] used the Cause of Death database of the US National Center for Health Statistics and observed adjusted mortality odds ratios for PD of 0.85 (95% CI, 0.77 – 0.94) and 0.83 (95% CI, 0.78 – 0.88) in welders, using two definitions of welding occupations [61]. This supports the presence of a significant HWE [healthy worker effect] among welders. An even stronger effect was observed in welders for motor neuron disease (amyotrophic lateral sclerosis, OR 0.71, 95% CI, 0.56 – 0.89), a chronic condition that clearly would affect welders’ ability to work.”

Robert M. Park, “Neurobehavioral Deficits and Parkinsonism in Occupations with Manganese Exposure: A Review of Methodological Issues in the Epidemiological Literature,” 4 Safety & Health at Work 123, 126 (2013). Amyotrophic lateral sclerosis has a sudden onset, usually in middle age, without any real prodomal signs or symptoms, which would keep a young man from entering welding as a trade. Just shows you can get any opinion published in a peer-reviewed journal, somewhere. Stampfer’s paper, along with Mortimer’s meta-analysis helped put the kabosh on welding fume litigation.

Addendum

A few weeks ago, the Sixth Circuit affirmed the dismissal of a class action that was attempted based upon claims of environmental manganese exposure. Abrams v. Nucor Steel Marion, Inc., Case No. 3:13 CV 137, 2015 WL 6872511 (N. D. Ohio Nov. 9, 2015) (finding testimony of neurologist Jonathan Rutchik to be nugatory, and excluding his proffered opinions), aff’d, 2017 U.S. App. LEXIS 9323 (6th Cir. May 25, 2017). Class plaintiffs employed one of the regulators, Jonathan Rutchik, from the welding fume parkinsonism litigation).

1 See “Samuel Tarry’s Protreptic for Litigation-Sponsored Publications” (July 9, 2017).

2 Samuel L. Tarry, Jr., “Can Litigation-Generated Science Promote Public Health?” 33 Am. J. Trial Advocacy 315 (2009)

3 Ostensibly, but not really. Robert M. Park was an employee of NIOSH, but he had spent most of his career working as an employee for the United Autoworkers labor union. The paper acknowledged help from Ed Baker, David Savitz, and Kyle Steenland. Baker is a colleague and associate of B.S. Levy, who was an expert witness for plaintiffs in the welding fume litigation, as well as many others. The article was published in the “red” journal, the American Journal of Industrial Medicine.

4 The welding tradesmen included in the analyses were welders and cutters, boilermakers, structural metal workers, millwrights, plumbers, pipefitters, and steamfitters. Robert M. Park, Paul A. Schulte, Joseph D. Bowman, James T. Walker, Stephen C. Bondy, Michael G. Yost, Jennifer A. Touchstone, and Mustafa Dosemeci, “Potential Occupational Risks for Neurodegenerative Diseases,” 48 Am. J. Ind. Med. 63, 65a, ¶2 (2005).

5 Id.

6 “The project was supported in part through a consulting agreement with a group of manufacturers of welding consumables who had no role in the analysis, or in preparing this report, did not see any draft of this manuscript prior to submission for publication, and had no control over any aspect of the work or its publication.” Stampfer, at 272.

7 Karin Wirdefeldt, Hans-Olov Adami, Philip Cole, Dimitrios Trichopoulos, and Jack Mandel, “Epidemiology and etiology of Parkinson’s disease: a review of the evidence,” 26 Eur. J. Epidemiol. S1 (2011).

8 The criticisms can be found at <https://pubpeer.com/publications/798F9D98B5D2E5A832136C0A4AD261>, last visited on July 10, 2017.

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Judge Bernstein’s Criticism of Rule 703 of the Federal Rules of Evidence

August 30th, 2016

Federal Rule of Evidence Rule 703 addresses the bases of expert witness opinions, and it is a mess. The drafting of this Rule is particularly sloppy. The Rule tells us, among other things, that:

“[i]f experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted.”

This sentence of the Rule has a simple grammatical and logical structure:

If A, then B;

where A contains the concept of reasonable reliance, and B tells us the consequence that the relied upon material need not be itself admissible for the opinion to be admissible.

But what happens if the expert witness has not reasonably relied upon certain facts or data; i.e., ~A? The conditional statement as given does not describe the outcome in this situation. We are not told what happens when an expert witness’s reliance in the particular field is unreasonable. ~A does not necessarily imply ~B. Perhaps the drafters meant to write:

B if and only if A.

But the drafters did not give us the above rule, and they have left judges and lawyers to make sense of their poor grammar and bad logic.

And what happens when the reliance material is independently admissible, say as a business record, government report, and first-person observation? May an expert witness rely upon admissible facts or data, even when a reasonable expert would not do so? Again, it seems that the drafters were trying to limit expert witness reliance to some rule of reason, but by tying reliance to the admissibility of the reliance material, they managed to conflate two separate notions.

And why is reliance judged by the expert witness’s particular field? Fields of study and areas of science and technology overlap. In some fields, it is common place for putative experts to rely upon materials that would not be given the time of day in other fields. Should we judge the reasonableness of homeopathic healthcare providers’ reliance by the standards of reasonableness in homeopathy, such as it is, or should we judge it by the standards of medical science? The answer to this rhetorical question seems obvious, but the drafters of Rule 703 introduced a Balkanized concept of science and technology by introducing the notion of the expert witness’s “particular field.” The standard of Rule 702 is “knowledge” and “helpfulness,” both of which concepts are not constrained by “particular fields.”

And then Rule 703 leaves us in the dark about how to handle an expert witness’s reliance upon inadmissible facts or data. According to the Rule, “the proponent of the opinion may disclose [the inadmissible facts or data] to the jury only if their probative value in helping the jury evaluate the opinion substantially outweighs their prejudicial effect. And yet, disclosing inadmissible facts or data would always be highly prejudicial because they represent facts and data that the jury is forbidden to consider in reaching its verdict. Nonetheless, trial judges routinely tell juries that an expert witness’s opinion is no better than the facts and data on which the opinion is based. If the facts and data are inadmissible, the jury must disregard them in its fact finding; and if an expert witness’s opinion is based upon facts and data that are to be disregarded, then the expert witness’s opinion must be disregarded as well. Or so common sense and respect for the trial’s truth-finding function would suggest.

The drafters of Rule 703 do not shoulder all the blame for the illogic and bad results of the rule. The judicial interpretation of Rule 703 has been sloppy, as well. The Rule’s “plain language” tells us that “[a]n expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed.” So expert witnesses should be arriving at their opinions through reliance upon facts and data, but many expert witnesses rely upon others’ opinions, and most courts seem to be fine with such reliance. And the reliance is often blind, as when medical clinicians rely upon epidemiologic opinions, which in turn are based upon data from studies that the clinicians themselves are incompetent to interpret and critique.

The problem of reliance, as contained within Rule 703, is deep and pervasive in modern civil and criminal trials. In the trial of health effect claims, expert witnesses rely upon epidemiologic and toxicologic studies that contain multiple layers of hearsay, often with little or no validation of the trustworthiness of many of those factual layers. The inferential methodologies are often obscure, even to the expert witnesses, and trial counsel are frequently untrained and ill prepared to expose the ignorance and mistakes of the expert witnesses.

Back in February 2008, I presented at an ALI-ABA conference on expert witness evidence about the problems of Rule 703.[1] I laid out a critique of Rule 703, which showed that the Rule permitted expert witnesses to rely upon “castles in the air.” A distinguished panel of law professors and judges seemed to agree; at least no one offered a defense of Rule 703.

Shortly after I presented at the ALI-ABA conference, Professor Julie E. Seaman published an insightful law review in which she framed the problems of rule 703 as constitutional issues.[2] Encouraged by Professor Seaman’s work, I wrote up my comments on Rule 703 for an ABA publication,[3] and I have updated those comments in the light of subsequent judicial opinions,[4] as well as the failure of the Third Edition of the Reference Manual of Scientific Evidence to address the problems.[5]

===================

Judge Mark I. Bernstein is a trial court judge for the Philadelphia County Court of Common Pleas. I never tried a case before Judge Bernstein, who has announced his plans to leave the Philadelphia bench after 29 years of service,[6] but I had heard from some lawyers (on both sides of the bar) that he was a “pro-plaintiff” judge. Some years ago, I sat next to him on a CLE panel on trial evidence, at which he disparaged judicial gatekeeping,[7] which seemed to support his reputation. The reality seems to be more complex. Judge Bernstein has shown that he can be a critical consumer of complex scientific evidence, and an able gatekeeper under Pennsylvania’s crazy quilt-work pattern of expert witness law. For example, in a hotly contested birth defects case involving sertraline, Judge Bernstein held a pre-trial evidentiary hearing and looked carefully at the proffered testimony of Michael D. Freeman, a chiropractor and self-styled “forensic epidemiologist, and Robert Cabrera, a teratologist. Applying a robust interpretation of Pennsylvania’s Frye rule, Judge Bernstein excluded Freeman and Cabrera’s proffered testimony, and entered summary judgment for defendant Pfizer, Inc. Porter v. Smithkline Beecham Corp., 2016 WL 614572 (Phila. Cty. Ct. Com. Pl.). See “Demonstration of Frye Gatekeeping in Pennsylvania Birth Defects Case” (Oct. 6, 2015).

And Judge Bernstein has shown that he is one of the few judges who takes seriously Rule 705’s requirement that expert witnesses produce their relied upon facts and data at trial, on cross-examination. In Hansen v. Wyeth, Inc., Dr. Harris Busch, a frequent testifier for plaintiffs, glibly opined about the defendant’s negligence. On cross-examination, he adverted to the volumes of depositions and documents he had reviewed, but when defense counsel pressed, the witness was unable to produce and show exactly what he had reviewed. After the jury returned a verdict for the plaintiff, Judge Bernstein set the verdict aside because of the expert witness’s failure to comply with Rule 705. Hansen v. Wyeth, Inc., 72 Pa. D. & C. 4th 225, 2005 WL 1114512, at *13, *19, (Phila. Ct. Common Pleas 2005) (granting new trial on post-trial motion), 77 Pa. D. & C. 4th 501, 2005 WL 3068256 (Phila. Ct. Common Pleas 2005) (opinion in support of affirmance after notice of appeal).

In a recent law review article, Judge Bernstein has issued a withering critique of Rule 703. See Hon. Mark I. Bernstein, “Jury Evaluation of Expert Testimony Under the Federal Rules,” 7 Drexel L. Rev. 239 (2015). Judge Bernstein is clearly dissatisfied with the current approach to expert witnesses in federal court, and he lays almost exclusive blame on Rule 703 and its permission to hide the crucial facts, data, and inferential processes from the jury. In his law review article, Judge Bernstein characterizes Rules 703 and 705 as empowering “the expert to hide personal credibility judgments, to quietly draw conclusions, to individually decide what is proper evidence, and worst of all, to offer opinions without even telling the jury the facts assumed.” Id. at 264. Judge Bernstein cautions that the subversion of the factual predicates for expert witnesses’ opinions under Rule 703 has significant, untoward consequences for the court system. Not only are lawyers allowed to hire professional advocates as expert witnesses, but the availability of such professional witnesses permits and encourages the filing of unnecessary litigation. Id. at 286. Hear hear.

Rule 703’s practical consequence of eliminating the hypothetical question has enabled the expert witness qua advocate, and has up-regulated the trial as a contest of opinions and opiners rather than as an adversarial procedure that is designed to get at the truth. Id. at 266-67. Without having access to real, admissible facts and data, the jury is forced to rely upon proxies for the truth: qualifications, demeanor, and courtroom poise, all of which fail the jury and the system in the end.

As a veteran trial judge, Judge Bernstein makes a persuasive case that the non-disclosure permitted under Rule 703 is not really curable under Rule 705. Id. at 288. If the cross-examination inquiry into reliance material results in the disclosure of inadmissible facts, then judges and the lawyers must deal with the charade of a judicial instruction that the identification of the inadmissible facts is somehow “not for the truth.” Judge Bernstein argues, as have many others, that this “not for the truth” business is an untenable fiction, either not understood or ignored by jurors.

Opposing counsel, of course, may ask for an elucidation of the facts and data relied upon, but when they consider the time and difficulty involved in cross-examining highly experienced, professional witnesses, opposing counsel usually choose to traverse the adverse opinion by presenting their own expert witness’s opinion rather than getting into nettlesome details and risking looking foolish in front of the jury, or even worse, allowing the highly trained adverse expert witness to run off at the mouth.

As powerful as Judge Bernstein’s critique of Rule 703 is, his analysis misses some important points. Lawyers and judges have other motives for not wanting to elicit underlying facts and data: they do not want to “get into the weeds,” and they want to avoid technical questions of valid inference and quality of data. Yet sometimes the truth is in the weeds. Their avoidance of addressing the nature of inference, as well as facts and data, often serves to make gatekeeping a sham.

And then there is the problem that arises from the lack of time, interest, and competence among judges and jurors to understand the technical details of the facts and data, and inferences therefrom, which underlie complex factual disputes in contemporary trials. Cross examination is reduced to the attempt to elicit “sound bites” and “cheap shots,” which can be used in closing argument. This approach is common on both sides of the bar, in trials before judges and juries, and even at so-called Daubert hearings. See David E. Bernstein & Eric G. Lasker,“Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1, 32 (2015) (“Rule 703 is frequently ignored in Daubert analyses”).

The Rule 702 and 703 pretrial hearing is an opportunity to address the highly technical validity questions, but even then, the process is doomed to failure unless trial judges make adequate time and adopt an attitude of real intellectual curiosity to permit a proper exploration of the evidentiary issues. Trial lawyers often discover that a full exploration is technical and tedious, and that it pisses off the trial judge. As much as judges dislike having to serve as gatekeepers of expert witness opinion testimony, they dislike even more having to assess the reasonableness of individual expert witness’s reliance upon facts and data, especially when this inquiry requires a deep exploration of the methods and materials of each relied upon study.

In favor of something like Rule 703, Bernstein’s critique ignores that there are some facts and data that will never be independently admissible. Epidemiologic studies, with their multiple layers of hearsay, come to mind.

Judge Bernstein, as a reformer, is wrong to suggest that the problem is solely in hiding the facts and data from the jury. Rules 702 and 703 march together, and there are problems with both that require serious attention. See 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); see also “On Amending Rule 702 of the Federal Rules of Evidence” (Oct. 17, 2015).

And we should remember that the problem is not solely with juries and their need to see the underlying facts and data. Judges try cases too, and can butcher scientific inference with any help from a lay jury. Then there is the problem of relied upon opinions, discussed above. And then there is the problem of unreasonable reliance of the sort that juries cannot discern even if they see the underlying, relied upon facts and data.

[1] Schachtman, “Rule 703 – The Problem Child of Article VII”; and “The Effective Presentation of Defense Expert Witnesses and Cross-examination of Plaintiffs’ Expert Witnesses”; at the ALI-ABA Course on Opinion and Expert Witness Testimony in State and Federal Courts (February 14-15, 2008).

[2] See Julie E. Seaman, “Triangulating Testimonial Hearsay: The Constitutional Boundaries of Expert Opinion Testimony,” 96 Georgetown L.J. 827 (2008).

[3] Nathan A. Schachtman, “Rule of Evidence 703—Problem Child of Article VII,” 17 Proof 3 (Spring 2009).

[4] “RULE OF EVIDENCE 703 — Problem Child of Article VII” (Sept. 19, 2011)

[5] See “Giving Rule 703 the Cold Shoulder” (May 12, 2012); “New Reference Manual on Scientific Evidence Short Shrifts Rule 703,” (Oct. 16, 2011).

[6] Max Mitchell, “Bernstein Announces Plan to Step Down as Judge,” The Legal Intelligencer (July 29, 2016).

[7] See Schachtman, “Court-Appointed Expert Witnesses,” for Mealey’s Judges & Lawyers in Complex Litigation, Class Actions, Mass Torts, MDL and the Monster Case Conference, in West Palm Beach, Florida (November 8-9, 1999). I don’t recall Judge Bernstein’s exact topic, but I remember he criticized the Pennsylvania Supreme Court’s decision in Blum v. Merrill Dow Pharmaceuticals, 534 Pa. 97, 626 A.2d 537 ( 1993), which reversed a judgment for plaintiffs, and adopted what Judge Bernstein derided as a blending of Frye and Daubert, which he called Fraubert. Judge Bernstein had presided over the Blum trial, which resulted in the verdict for plaintiffs.

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LoGuidice v. American Talc Co. — Subpoenas to Investigate Funding

July 13th, 2016

Mickey Gunter is a University Distinguished Professor of Geological Sciences, at the University of Idaho. Gunter has long been involved in the mineralogical issues surrounding asbestos contamination and content. He served as a member of an EPA review committee for World Trade Center dust screening method (2005), a member of an ATSDR expert panel on asbestos biomarkers (2006), and as a panel member and reviewer for the Institute of Medicine and National Research Council, Workshop on NIOSH research on asbestos and elongated mineral particles (2009). Gunter has been publishing on asbestos and asbestiform mineralogy for well over a decade.[1]

Gunter has testified for talc companies that have been dragged into mesothelioma litigation, based upon testing he conducted for Colgate-Palmolive [Colgate], starting in 2011. In his testimony, Gunter has acknowledged that University employees and laboratories were involved in testing Colgate-Palmolive’s Cashmere Bouquet talcum powder for asbestos content and contamination. In addition to compensating Gunter, Colgate and others have contributed to the University of Idaho, and provided support for Gunter’s student assistant, Mr. Matthew Sanchez.

In a recent New York trial court ruling, Justice Peter H. Moulton refused a motion to quash plaintiff’s subpoena served on the University of Idaho, designed to obtain evidence to show that Colgate-Palmolive Company’s gifts to the University affected research that has become relevant to their claims that Colgate’s talcum powder was contaminated with asbestos. LoGiudice v. American Talc Co., No. 190253/2014, 2016 N.Y. Misc. LEXIS 2360, (N.Y. Sup., N.Y. Cty., June 20, 2016).

The plaintiffs based their lawsuit on the conjecture that the exposure to Colgate-Palmolive’s talc must contain asbestos because the talc caused mesothelioma. Somehow idiopathic mesothelioma and occult asbestos exposure magically disappear in the plaintiffs’ worldview.

The plaintiffs’ vacuous and circular arguments supposedly thus made their claim of financial bias relevant. Plaintiff’s mesothelioma must have been caused by cosmetic talc, but Gunter’s and Sanchez’s test results found no asbestos in the talc the tested. Therefore, the test results were skewed by financial bias. There is no suggestion in Justice Moultin’s opinion to suggest that there was any error, omission, or misconduct involved in the analytical testing conducted by Professor Gunter and his assistant.

Without much real analysis, Justice Moulton found the subpoena-based inquiry into financial influence relevant and proper. Gunter had testified about asbestos contamination in Cashmere Bouquet and conducted research, published articles, and given speeches[2] on the subject. With minor modifications to the plaintiffs’ subpoena, he denied Colgate’s motion to quash, and allowed the plaintiffs proceed with their investigation. What the disinterested observer might well miss is that Gunter’s views were well formed, articulated, and published in advance of his retention by Colgate in litigation.

Professor Gunter thus represents an example of a litigant’s (Colgate’s) seeking out a highly qualified scientist, with relevant expertise, in part based upon his previously stated views. To be sure, his testing results of the particular talc were not done and available until commissioned by Colgate, but Gunter’s sound views about what would count as an asbestos fiber, based upon mineralogical, scientific criteria (rather than arbitrary legal, regulatory criteria) were well known in advance of retention.

[1] See, e.g., B. D. McNamee, Mickey E. Gunter & C. Viti, “Asbestiform talc from a talc mine near Talcville, New York, U.S.A.: composition, morphology, and genetic relationships with amphiboles,” Canadian Mineralogist (2016 in press); Bryan R. Bandli & Mickey E. Gunter, “Examination of asbestos standard reference materials, amphibole particles of differing morphology, and phase discrimination from talc ores using scanning electron microscopy and transmitted electron backscatter diffraction,” 20 Microscopy and Microanalysis 1805 (2014); B. D. McNamee & Mickey E. Gunter, “Compositional analysis and morphological relationships of amphiboles, talc, and other minerals found in the talc deposits from the Gouverneur Mining District, New York,” 61 The Microscope 147 ((2013) (part one); 62 The Microscope 3 (2014) (part two); Bryan R. Bandli & Mickey E. Gunter, “Mineral identification using electron backscatter diffraction from unpolished specimens: Applications for rapid asbestos identification,” 61 The Microscope 37 (2013); M. R. Van Baalen, Brooke T. Mossman, Mickey E. Gunter & C.A. Francis, “Environmental geology of Belvidere Mt., Vermont,” in Westerman, D.S. and Lathrop, A.S. eds., Guidebook to Field Trips in Vermont and adjacent regions of New Hampshire and New York. New England Intercollegiate Geological Conference, 101^st Annual Meeting, B11-23 (2009); Mickey E. Gunter, “Asbestos sans mineralogy,” 5 Elements 141 (2009); D. M. Levitan, J. M. Hammarstrom, Mickey E. Gunter, R. R. Seal II, I. M. Chou & N. M. Piatak, “Mineralogy of mine waste at the Vermont Asbestos Group mine, Belvidere Mountain, Vermont,” 94 American Mineralogist 1063 (2009); Mickey E. Gunter, E. Belluso & A. Mottana, “Amphiboles: Environmental and health concerns. In Amphiboles: Crystal Chemistry, Occurrences, and Health Concerns,” 67 Reviews in Mineralogy & Geochemistry 453 (2007).

[2] See, e.g., Mickey Gunter, Matthew Sanchez & Richard Van Orden, “Fibrous talc (ribbon talc/”kinky” talc),” at Talc Methods Expert Panel Meeting, United States Pharmacopeial Convention, Rockville, Maryland (June 28, 2016).

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FOIA Exemptions Gobble Up The Statute

November 27th, 2015

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

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

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

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

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

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

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

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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).

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Avoiding Nonsense About Science — Ask For The Evidence

November 25th, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Slip op. at 2.

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

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

Slip op. at 8.

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

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

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

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

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

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

“Disclosure of facts or data underlying expert opinion.

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

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

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

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

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

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

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

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Litigation-Driven Access to Underlying Data and Materials

October 23rd, 2013

On Monday, October 21, 2013, the Center for Public Integrity published an editorial criticizing Georgia-Pacific Corporation for its “secretive research program.” See “Facing lawsuits over deadly asbestos, paper giant launched secretive research program.”

Georgia-Pacific (GP) commissioned several studies to help advance its defenses in asbestos litigation. Given that plaintiffs, plaintiffs’ counsel, proxies for the plaintiffs, and self-appointed public health zealots have commissioned and conducted research designed to advance interests of the litigation industry (a/k/a the plaintiffs’ bar) and to undermine GP’s defenses, GP’s actions seem perfectly appropriate. GP’s attempt to claim an attorney-client and work-product privilege in the communications with investigators, however, raises serious concerns by casting a shadow over industry sponsorship generally.

In response to publication of GP’s sponsored research, plaintiffs’ counsel Jerry Kristal sought discovery of some of the studies and GP’s role in instigating, planning, conducting, and interpreting the studies. Again, these discovery requests seem perfectly reasonable, but GP reacted by asserting that its lawyers had been involved in the communication loop between GP and the scientists who conducted and published the research, and therefore, the requested evidence was protected by the attorney-client privilege. As I have argued previously, GP’s position was a serious mistake, and it has opened itself up to a good deal of justified criticism for “secretive research.” See, e.g., Noah S. Seixas, “Protecting Our Science,” 57 Ann. Occup. Hyg. 963 (2013) (emphasizing that there was no evidence that GP’s research was in fact fraudulent, and that the papers published in the Annals of Occupational Hygiene had appropriate disclosures). See also “A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013); “Using the Rule 45 Subpoena to Obtain Research Data” (July 24, 2013).

One measure of the lapse in judgment by GP in questionably asserting an attorney-client privilege is the ammunition that it gives to idealogues and zealots such as the Center for Public Integrity (CPI). The CPI editorial quotes Harvard University Professor Sheila Jasanoff, as noting that:

“There’s something extremely smelly about claiming attorney-client privilege for something that is being claimed at the same time as good science. … Legal confidentiality protections should not be placed around good science.”

Professor Jasonoff is absolutely correct, but interestingly, her olfactory sense has been remarkably inconsistent. Back in October 2007, Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss, and debate, litigation and compelled access to underlying research data. Dr. Racette moaned and groaned about how disruptive subpoenas were into the operation of his research. Some members of the Committee seemed sympathetic until I reminded them that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan. See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005). See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009). Most members of the Committee expressed their reassurance that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data, but at the time, Professor Jasanoff maintained her opposition to the approach.

Jasanoff’s selective sniffing reflects the hypocrisy and asymmetry that pervades current discussions of conflicts of interest (COI) and access to data. COI accusations are directed at industry, but not at the litigation industry, staffed by the plaintiffs’ bar and advanced by eco-zealots. Access to data is a rallying cry against pharmaceutical industry clinical trials, and industry-sponsored studies, but when stakeholders want access to non-industry study data, suddenly privacy interests and researchers’ privileges become paramount, and researchers “feel harrassed.” It really is time to choose: either we stop our insistence upon seeing the data themselves, or we formulate rules that apply across the board, independent of study sponsorship.

We are becoming, by fits and starts, a data-driven and evidence-based world. The time has come and gone to rely upon authors’ own interpretation of the data, and to realize that there is a public trust, interest, and need for data sharing. GP’s capital mistake was the same made by Dr. Racette, when he asserted various privileges to argue against disclosure of his underlying data. (Had GP paid attention to prior disputes, it would have learned that the attorney-client privilege has been uniformly rejected, as it was in Racette’s case.) Jasanoff’s capital mistake is to attribute stench to GP for asserting a privilege, but excusing it when done by scientists funded or supported by the “litigation industry.”

The CPI reported that a GP spokesman refused to answer questions, but referred a reporter to GP’s court filings, where GP maintained that it “properly commissioned studies to explore scientific issues that repeatedly arise in joint compound litigation, disclosed its role in the studies themselves, and submitted them to the technical rigors of scientific peer review by qualified scientists who were neither affiliated with nor selected by Georgia-Pacific.”

Sounds good, but then why try to assert an attorney-client privilege and an attorney-work product confidentiality? Plaintiffs’ counsel, having relied upon some rather poorly conducted studies would likely known that peer review is not a very good filter for sound science, and they would press for access to the inner workings of the studies and the possible influence that the sponsor had on any aspect of the studies. Furthermore, faced with the prospect of GP’s succeeding in its claim of privilege, the plaintiffs were surely warranted in trying to explore exceptions to the privilege, such as the crime-fraud exception, weak though the evidence may be to support such an exception.

Now Look Who Is Manufacturing Doubt!

In the GP case, the New York Appellate Division did not hold that GP had engaged in a fraudulent scheme, only that plaintiffs’ allegations were serious enough to support an order that the trial judge review, in camera, the supposedly privileged materials. The CPI, however, has used the decision to support its overwrought generalization of charges against all industry-sponsored studies.

The CPI has used the commonplace smear tactic of analogizing every company’s defensive strategies against litigation, even against unwarranted claims, as a manifestation of the same tactics used by Big Tobacco. Unfortunately, GP advanced the attorney-client privilege theory, which had been asserted previously, and unsuccessfully, by tobacco companies. This legal misstep, however, does not justify CPI’s smear campaign against the scientists who conducted the studies at issue. There is nothing stated or suggested in CPI’s editorial that raises any meaningful question about the validity of the research sponsored by GP.

COI and Access to Data – Two-Way Street

GP’s misguided assertion of the attorney-client privilege opened itself and industry generally to the CPI charges of using “well-paid experts to minimize the hazards of toxic chemicals and fend off liability, regulation, or both.” Indeed, the CPI’s editorial is little more than a sustained ad hominem attack on industry’s efforts to protect itself from liability and regulation, without any acknowledgement that often the attempts to impose liability or regulation are based upon dubious science or imprudent policy. Some liability claims are corrupt, and must be defended, including many frivolous and fraudulent claims in the asbestos litigation.

While the CPI rails against industry experts, it is suspiciously silent about so-called public interest groups or claimants, using well-paid experts, or worse, over-zealous experts, to obtain litigation or regulation results. To be sure, there are many instances of plaintiffs’ expert witnesses failing to disclose their potential conflicts, as well as failing to disclose their funding or support from plaintiffs’ counsel, plaintiffs, or plaintiffs’ proxies. Mr. Kristal’s strategy of claiming fraud in failing to disclose potential conflicts of interest will lead to a regime that will be uncomfortable for many scientists and physicians who fail to make appropriate disclosures. See, e.g., “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013); “The Mt. Sinai Catechism” (June 7, 2013).

The CPI’s complaint that GP hired experts who were aligned with their cause is curious given the history of the plaintiffs’ counsel to hire expert witnesses who were aligned with their clients’ labor unions and the like. Irving Selikoff, who was engaged by the insulators’ union to conduct a study of their cancer mortality, had testified in worker compensation proceedings and in some of the early civil actions involving claims of asbestos-related injuries. The CPI quotes plaintiffs’ lawyer Alan Golanski as alleging that GP had tried to “seed” the medical literature with “methodologically skewed, litigation-driven research.” Of course, this is exactly what plaintiffs’ expert witnesses have done over the last half century.

It really is time to stop. COI disclosures cannot be a full, satisfactory answer because the most potent conflicts arise out of intellectual and political commitments, not money. Increasing transparency and access to study protocols, data, analyses may perhaps help.

Posted in Data Sharing, Underlying Data | Comments Off on Litigation-Driven Access to Underlying Data and Materials

Using the Rule 45 Subpoena to Obtain Research Data

July 24th, 2013

Back in June, Mr. William Ruskin posted a blog post, “When Should Data Underlying Scientific Studies Be Discoverable?” on his firm’s Toxic Tort Litigation Blog. Earlier this week, the Defense Research Institute’s blog, dri-today republished the post, and I posted a response, “Research Data from Published Papers Generally Should Be Available,” on the DRI blog.

Mr. Ruskin’s blog post calls attention to the important problem of access to research data in litigation and other contexts. The effort to obtain Dr. Racette’s underlying data is an interesting case study in these legal discovery battles. Ruskin notes that there is the potential for “injustice” from such discovery, but he fails to acknowledge that the National Research Council has been urging scientists for decades to have a plan for data sharing as part of their protocol, and that the National Institutes of Health now requires such planning. Some journals require a commitment to data sharing as a condition to publication. The Annals of Internal Medicine, which is probably the most rigorously edited internal medicine journal, requires authors to state to what extent they will share data when their articles appear in print. Ultimately, litigants are entitled to “everyman’s” and “every woman’s” evidence, regardless whether they are scientists. If scientists complied with the best practices, guidances, and regulations on planning for data sharing, the receipt of a subpoena for underlying data would not be a particularly disruptive event in their laboratories.

In the case of Dr. Racette, it was clear that the time he needed to spend to respond to defense counsel’s subpoena was largely caused by his failure to comply with NIH guidelines on data sharing. Racette was represented by university counsel, who refused to negotiate over the subpoena, and raised frivolous objections. Ultimately, the costs of production were visited upon the defendants who paid what seemed like rather exorbitant amounts for Racette and his colleagues to redact individual identifier information. The MDL court suggested that Racette was operating independently of plaintiffs’ counsel, but the fact was that plaintiffs’ counsel recruited the study participants and brought them to the screenings, where Racette and colleagues videotaped them to make their assessments of Parkinsonism. Much more could be said but for a protective order that was put in place by the MDL court. What I can say is that after the defense obtained a good part of the underlying data, the Racette study was no longer actively used by plaintiffs’ counsel in the welding fume cases.

It is not only litigation that gives rise to needs for transparency and openness. Regulation and public policy disputes similarly create need for data access. As Mr. Ruskin acknowledges, the case of Weitz & Luxenberg v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013), is very different, but at bottom is the same secrecy and false sense of entitlement to privilege underlying data. The Appellate Division’s invocation of the crime-fraud exception seems to be hyperbolic precisely because no attorney-client privilege attached in the first place. Basic tenets of openness and transparency in science should have guided the Appellate Division.

The Georgia-Pacific effort was misguided on many levels, but we should at least rejoice that science won, and that G-P will be required to share underlying data with plaintiffs’ counsel or whoever wants access. Without reviewing the underlying data and documents, it is hard to say what the studies were designed to do, but saying that they were designed “to cast doubt,” as Mr. Ruskin does, is uncharitable to G-P. After all, G-P may well have found itself responding in court to some rather dodgy data, and thought it could sponsor stronger studies that were likely to refute the published papers. And the published papers may have been undertaken to “cast certainty,” or even a faux certainty, over issues that were not what they were portrayed to be in the papers.

Earlier this month, Judge Reggie Walton granted a motion to compel a litigant’s motion for underlying research in the denture cream litigation. Plaintiffs’ counsel contracted with Dr. Salim Shah and his companies Sarfez Pharmaceuticals, Inc. and Sarfez USA, Inc. (“Sarfez”) to conduct human research in India, to support their claims that zinc in denture cream causes neurological damage. In re Denture Cream Prods. Liab. Litig., Misc. Action 13-384 (RBW), 2013 U.S. Dist. LEXIS 93456, *2 (D.D.C. July 3, 2013). When defense counsel learned of the Sarfez study, known as the Zinc/077/12 Study, and the plaintiffs’ counsel’s payments of over $300,000, to support the study, they sought discovery of raw data, study protocol, statistical analyses, and other materials from plaintiffs’ counsel. Plaintiffs’ counsel protested that they did not have all the materials, and directed defense counsel to Sarfez. Although other courts have made counsel produce similar materials from the scientist independent contractors they engaged, in this case, defense counsel followed the trail of documents to contractor, Sarfez. Id. at *3-4.

After serving a Rule 45 subpoena on Sarfez, things got interesting. Raising no objections, and asserting no privileges, Sarfez served about 1,500 pages of responsive documents. Some of the documents were emails, but crucial attachments were missing, including protocols, analytical reports, and raw data. Id. at *12-13. When the defendant, Proctor & Gamble Company (P&G) pressed, Sarfez resisted further production. P&G filed a motion to compel, and Sarfez objected on various grounds, including lack of relevancy.

The objections did not go very far. Plaintiffs’ counsel, who probably should have been tasked with producing the subpoenaed materials in the first instance, had already declared their intent to rely upon the study that they contracted for with Sarfez. Id. at *9. Judge Walton noted that relevancy did not require that the subpoenaed materials be admissible at trial, but only that they may be relevant to the claim or defense of a party. Id. at *6. Judge Walton also upheld the subpoena, which sought underlying data and non-privileged correspondence, to be within the scope of Rules 26(b) and 45, and not unduly burdensome. Id. at *9-10, *20.

Sarfez attempted to suggest that the email attachments might not exist, but Judge Walton branded the suggestion “disingenuous.” Attachments to emails should be produced along with the emails. Id. at *12 (citing and collecting cases). Although Judge Walton did not grant a request for forensic recovery of hard-drive data or for sanctions, His Honor warned Sarfez that it might be required to bear the cost of forensic data recovery if it did not comply the district court’s order. Id. at *15, *22.

The Denture Cream case is a helpful reminder that not only industrial defendants sponsor scientific studies in litigation contexts. Plaintiffs’ counsel, and sometimes their interest proxies — labor unions, support groups, advocacy groups, zealous scientists, and regulatory agencies — sponsor and conduct studies as well. Proctor & Gamble should not have been put to the expense and trouble of a Rule 45 subpoena, but it is encouraging to see that Judge Walton cut through the evasions and disingenuous claims, and enforced the research subpoena in this case.

Posted in Rule 703, Underlying Data | Comments Off on Using the Rule 45 Subpoena to Obtain Research Data

EPA Research on Ultrafine Particulate Matter

June 26th, 2013

White Hat Bias

Hyping environmental and so-called toxic risk has gone on so long that many Americans have no sense of the truth when it comes to the causal consequences of personal, occupational, and environmental exposures. Recently, I listened to a lecture given by Judge Calibresi of the Second Circuit. In the course of talking about regulatory prohibitions and tort-law incentives, he told of his visit to the late Professor Bickel, who had then just been diagnosed with brain cancer. In his lecture, Judge Calibresi stated that he knew that Bickel’s brain cancer was caused by his smoking, and went on to muse whether banning smoking would have saved his friend’s life. Judge Calibresi’s ruminations upon the nature of regulation and tort law were profound; his cursory hipshot about what caused his friend’s terminal illness, juvenile.

Some years ago, a science journalist published an account of how dire predictions of asbestos deaths had not come to pass. Tom Reynolds, “Asbestos-Linked Cancer Rates Up Less Than Predicted,” 84 J. Nat’l Cancer Instit. 560 (1992)

Reynolds quoted one scientist as saying that:

“the government’s exaggeration of the asbestos danger reflects a 1970s’ Zeitgeist that developed partly in response to revelations of industry misdeeds. ‘It was sort of the “in” thing to exaggerate … [because] that would be good for the environmental movement’…. ‘At the time it looked like you were wearing a white hat if you made these wild estimates. But I wasn’t sure whoever did that was doing all that much good.”

Id. at 562. Reynolds’ quote captures the nature of “white-hat” bias, a form of political correctness applied to issues that really depend upon scientific method and data for their resolution. Perhaps the temptation to overstate the evidence against a toxic substance is unavoidable, but it diminishes the authority and credibility of regulators entrusted with promulgating and enforcing protective measures.

White-Hat Bias & Black-Hat Ethics

I recently came across a disturbing article in the Environmental Health Perspectives, a peer-reviewed journal, supported by the National Institute of Environmental Health Sciences, National Institutes of Health, United States Department of Health and Human Services. The article detailed a case report of an individual woman experimentally exposed to ultrafine particulate matter (PM 2.5) in a test chamber. Andrew J. Ghio, Maryann Bassett, Tracey Montilla, Eugene H. Chung, Candice B. Smith, Wayne E. Cascio, and Martha Sue Carraway, “Case Report: Supraventricular Arrhythmia after Exposure to Concentrated Ambient Air Pollution Particles,” 120 Envt’l Health Perspect. 2275 (2012) [Ghio article]. There were no controls.

The point of the case report was that a person exposed to PM 2.5, experimentally, experienced a “cardiac event,” (atrial fibrillation or AFib) which resolved after cessation of exposure. The experiment was conducted in a federal agency facility, Environmental Public Health Division, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Chapel Hill, North Carolina.

The authors stated that the experiment had the approval of the University of North Carolina School of Medicine Committee on the Protection of the Rights of Human Subjects. Given that the EPA has made extraordinary claims about the harmfulness of PM 2.5, including heart disease, lung disease, and cancers, and that there was no imaginable benefit to the subject from participating in the experiment, this experiment seemed dubious indeed. The narrative of the case report, however, reveals even more disturbing information about the potential improprieties of the human experiment.

The PM Chamber

The human guinea pig was 58 years old. Her age is significant. Although the authors claim that AFib is uncommon among those under 60, it does increase with age. The human subject in the published experiment was close to the age at which AFib is no longer uncommon, and she was unwell to begin with.

The case report notes that the human subject had previously participated in the same exposure “protocol” without “complications.” The report does not explain why this human subject was returning to the EPA center for being placed in a “chamber,” and being exposed sequentially to “filtered air and concentrated ambient particles (CAPs).” The implied suggestion is that she was a likely candidate to experience a “cardiac event” eventually from repeated exposures in the PM 2.5 chamber.

The “Subject”

The human subject was not well. Although she was asymptomatic on the day of the experimental exposure to CAPs, she had a history of osteoarthritis and hypertension. The latter condition was being treated with an angiotensin-converting enzyme inhibitor and a diuretic (10 mg. lisinopril and 12.5 mg. hydrochlorothiazide). The subject had had surgeries for hernia repair, cholecystectomy, and knee arthroplasty. She was a little over 5 feet 6 inches tall, and obese, weighing over 230 pounds, with a 45 inch waist.

In addition to her chronic hypertension, morbid obesity, and musculoskeletal disease, the subject also had a family and personal history of heart disease. Her father had died from a myocardial infarction, at the age of 57. Immediately before the experimental exposure, a Holter monitor showed evidence of increased supraventricular ectopy, with 157 ± 34 premature atrial contractions/hour.

The investigators do not tell us how the experimental exposure relates to typical urban exposures, or to EPA regulatory standards, guidelines, or recommendations. About 23 minutes after exposure to CAPs started (filter weight, 112 μg/m³; particle number, 563,912/cc), the human subject developed a “nonsustained atrial fibrillation that quickly organized into atrial flutter.” The woman remained asymptomatic, and her EKG showed that she spontaneously reverted to a normal sinus rhythm.

The investigators acknowledge that there are many risk factors for AFib, and that the subject had several of them: hypertension, obesity, and possibly family history. The woman had a history of premature atrial contractions, which may have increased her risk for AFib.

Despite this rich clinical background, the authors claim, without apparently trying very hard, that there was no “obvious” explanation for the subject’s arrhythmia while in the chamber. They argue, however, that the exposure to PM 2.5 was causal because the arrhythmia began in the chamber, and resolved when the subject was removed from exposure. The argument is rather weak considering that the subject may have been stressed by the mere fact of placement in a chamber, or being wired up to monitors. See, e.g., Luana Colloca, MD, PhD, and Damien Finniss, MSc Med., “Nocebo Effects, Patient-Clinician Communication, and Therapeutic Outcomes,” 307 J. Am. Med. Ass’n 567, 567 (2012). The authors of the PM 2.5 case report acknowledge that “coincident atrial fibrillation cannot be excluded,” but they fail to deal with the potentially transient nature of AFib.

Human experimentation requires a strong rationale in terms of helping the experimental participant. What was the rationale for this human experiment? Here is what the EPA investigators posit:

“Although epidemiologic data strongly support a relationship between exposure to air pollutants and cardiovascular disease, this methodology does not permit a description of the clinical presentation in an individual case. To our knowledge, this is the first case report of cardiovascular disease after exposure to elevated concentrations of any air pollutant.”

Ghio at 275. The authors seemed to be saying that we know that PM 2.5 causes cardiovascular disease, but we wanted to be able to describe a person in the throes of a cardiovascular event brought on by exposure. See also Andrew J. Ghio, Jon R. Sobus, Joachim D. Pleil, Michael C. Madden, “Controlled human exposures to diesel exhaust,” 142 Swiss Med. Weekly w13597 (2012).

The Whole Truth

The Ghio article mentions only the one woman who experienced the mild, transient AFib. A reader might wonder whether she was the only test subject. Why was she retested after a previously incident-free experience in the chamber? How many other people were subjected to this protocol?

What is remarkable is that the authors claim not only an “association,” but causality, in a totally uncontrolled experiment, and without ruling out chance, bias, or confounding. The article is both deficient in scientific methodological rigor, and dubious on ethical principles.

EPA – Hoisted With Its Own Petard

What I did not realize when I read this experimental case report is that the article had been a cause célèbre of the anti-regulatory right. The EPA had walked right onto an ethical landmine by first sponsoring this research, and then by relying upon it to support a regulatory report. Steven Milloy editorialized about the EPA research, followed by a FOIA investigation. In September 2012, a regulatory watchdog group filed a lawsuit to strike an EPA report, which was based in part upon the questionable research.

Milloy’s strategy was designed to impale the EPA on the horns of a dilemma:

“I accused EPA of either: (1) conducting unethical human experimentation or exaggerating the dangers of fine airborne particulate matter (PM_2.5). It must be one or the other; it can’t be neither, according to EPA’s own documents.”

Steven Milloy, “Did Obama’s EPA relaunch Tuskegee experiments?” (April 24, 2012). The EPA had branded diesel particulate, which was used in the experiments, as “carcinogenic” and “lethal,” even from short exposures. Accordingly, if the EPA were sincere, it should have never conducted the experiment documented in Environmental Health Perspectives. If the agency believed that PM 2.5 was innocuous, then it unethically exaggerated and overstated its dangers.

In course of his FOIA initiative, Milloy did obtain answers to some of the questions I had from reading the Ghio article. There were apparently about 40 human subjects, who were subjected to PM 2.5 exposure in chambers fed by diesel exhaust or other sources. The exposure levels were upwards of 20 times what the EPA labeled a “permissible” level. Of course, the EPA is positionally committed to a “linear, no-threshold” model of carcinogenesis, which makes any exposure to a substance it “knows” to cause cancer ethically improper.

The information from the FOIA requests puts the Ghio article in an extremely bad light. The human subject on whom the authors reported had run about 40 other people through their chamber without ill effect, but failed to mention these cases. The consent forms and IRB documents show that the investigators were specifically interested in “vulnerable” patients, who had diabetes, asthma, etc. The fair inference is that the investigators wanted to provoke an anecdote that would support their causal narrative, which they believed had already been established with epidemiologic evidence. This seems like a scientific hat trick: bad science, bad ethics, and bad publication practice.

The lawsuit did not fare well. Predictably, it foundered on the lack of final agency action, and the lack of standing. On January 31, 2013, Judge Anthony J. Trenga dismissed the complaint, after having previously denied a temporary restraining order. The American Tradition Institute Environmental Law Center v. U.S. EPA, Case 1:12-cv-01066-AJT-TCB (E.D. Va. 2013). While legally correct, the opinion is blandly devoid of any sense of ethical concern.

From a brief search, there does not appear to be an appeal to the Fourth Circuit in the works. Of course, there were no personal injuries alleged in the ATI lawsuit, and the human subject in the Ghio article has appeared not to have sued. Despite the lack of legal recourse, the science “right” is up in arms over EPA duplicity. In a recent publication, Milloy and a co-author, quote former EPA Administrator Lisa Jackson, at a congressional hearing:

“Particulate matter causes premature death. It’s directly causal to dying sooner than you should.”

When Representative, now Senator, Edward J. Markey asked, “How would you compare [the benefits of reducing airborne PM2.5] to the fight against cancer?” Jackson answered hyperbolically:

“If we could reduce particulate matter to healthy levels, it would have the same impact as finding a cure for cancer in our country.”

Steve Milloy & John Dale Dunn, “Environmental Protection Agency’s Air Pollution Research: Unethical and Illegal?” 17 J. Am. Phys. & Surg. 109 (2012) (quoting Jackson). The FOIA and other background materials from this EPA posturing can be found on one of Milloy’s websites.

Sadly, I found the answers raised by the Ghio article only because of the anti-regulatory activism of Milloy and the American Tradition Institute. The white-hat bias remains a potent force in regulatory agencies, and in scientific laboratories.

Posted in Causation, Scientific Misconduct, Underlying Data | Comments Off on EPA Research on Ultrafine Particulate Matter