TORTINI

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

Fixodent Study Causes Lockjaw in Plaintiffs’ Counsel

February 4th, 2015

Litigation Drives Science

Back in 2011, the Fixodent MDL Court sustained Rule 702 challenges to plaintiffs’ expert witnesses. “Hypotheses are verified by testing, not by submitting them to lay juries for a vote.” In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345, 1367 (S.D.Fla.2011), aff’d, Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir. 2014). The Court found that the plaintiffs had raised a superficially plausible hypothesis, but that they had not verified the hypothesis by appropriate testing[1].

Like dentures to Fixodent, the plaintiffs stuck to their claims, and set out to create the missing evidence. 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[2]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 the defense learned of this 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 scientists and independent contractors they engaged, in this case, defense counsel followed the trail of documents to contractor, Sarfez, with subpoenas in hand.  Id. at *3-4.

The defense served a Rule 45 subpoena on Sarfez, which produced some, but not all responsive documents. Proctor & Gamble pressed for the missing materials, including study protocols, analytical reports, and raw data.  Id. at *12-13.  Judge Reggie Walton 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 argue that the requested materials, listed as 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 court’s order.  Id. at *15, *22.

Plaintiffs Put Their Study Into Play

The study at issue in the subpoena was designed by Frederick K. Askari, M.D., Ph.D., an associate professor of hepatology, in the University of Michigan Health System. In re Denture Cream Prods. Liab. Litig., No. 09–2051–MD, 2015 WL 392021, at *7 (S.D. Fla. Jan. 28, 2015). At the instruction of plaintiffs’ counsel, Dr. Askari sought to study the short-term effects of Fixodent on copper absorption in humans. Working in India, Askari conducted the study on 24 participants, who were given a controlled diet for 36 days. Of the 24 participants, 12, randomly selected, received 12 grams of Fixodent per day (containing 204 mg. of zinc). Another six participants, randomly selected, were given zinc acetate, three times per day (150 mg of zinc), and the remaining six participants received placebo, three times per day.

A study protocol was approved by an independent group[3], id. at *9, and the study was supposed to be conducted with a double blind. Id. at *7. Not surprisingly, those participants who received doses of Fixodent or zinc acetate had higher urinary levels of zinc (pee < 0.05). The important issue, however, was whether the dietary zinc levels affect copper excretion in a way that would support plaintiffs’ claims that copper levels were lowered sufficiently by Fixodent to cause a syndromic neurological disorder. The MDL Court ultimately concluded that plaintiffs’ expert witnesses’ opinions on general causation claims were not sufficiently supported to satisfy the requirements of Rule 702, and upheld defense challenges to those expert witnesses. In doing so, the MDL Court had much of interest to say about case reports, weight of the evidence, and other important issues. This post, however, concentrates on the deviations of one study, commissioned by plaintiffs’ counsel, from the scientific standard of care. The Askari “research” makes for a fascinating case study of how not to conduct a study in a litigation caldron.

Non-Standard Deviations

The First Deviation – Changing the Ascertainment Period After the Data Are Collected

The protocol apparently identified a primary endpoint to be:

“the mean increase in [copper 65] excretion in fecal matter above the baseline (mg/day) averaged over the study period … to test the hypothesis that the release of [zinc] either from Fixodent or Zinc Acetate impairs [copper 65] absorption as measured in feces.”

The study outcome, on the primary end point, was clear. The plaintiffs’ testifying statistician, Hongkun Wang, stated in her deposition that the fecal copper (whether isotope Cu63 or Cu65) was not different across the three groups (Fixodent, zinc acetate, and placebo). Id. at *9[4]. Even Dr. Askari himself admitted that the total fecal copper levels were not increased in the Fixodent group compared with the placebo control group. Id. at *9.[5]

Apparently after obtaining the data, and finding no difference in the pre-specified end point of average fecal copper levels between Fixodent and placebo groups, Askari turned to a new end point, measured in a different way, not described in the protocol as the primary end point.

The Second Deviation – Changing Primary End Point After the Data Are Collected

In the early (days 3, 4, and 5) and late (days 31, 32, and 33) part of the Study, participants received a dose of purified copper 65[6] to help detect the “blockade of copper.” Id. at 8*. The participants’ fecal copper 65 levels were compared to their naturally occurring copper 63 levels. According to Dr. Askari:

“if copper is being blocked in the Fixodent and zinc acetate test subjects from exposure to the zinc in the test product (Fixodent) and positive control (zinc acetate), the ratio of their fecal output of copper 65 as compared to their fecal output of copper 63 would increase relative to the control subjects, who were not dosed with zinc. In short, a higher ratio of copper 65 to copper 63 reflects blocking of copper.”

Id.

Askari analyzed the ratio of two copper isotopes (Cu65 /Cu63), in the limited period of observation to study days 31 to 33. Id. at *9. Askari thus changed the outcome to be measured, the timing of the measurement, and manner of measurement (average over entire period versus amount on days 31 to 33). On this post hoc, non-prespecified end point, Askari claimed to have found “significant” differences.

The MDL Court expressed its skepticism and concern over the difference between the protocol’s specified end point, and one that came into the study only after the data were obtained and analyzed. The plaintiffs claimed that it was their (and Askari’s) intention from the initial stages of designing the Fixodent Blockade Study to use the Cu65/Cu63 ratio as the primary end point. According to the plaintiffs, the isotope ratio was simply better articulated and “clarified” as the primary end point in the final report than it was in the protocol. The Court was not amused or assuaged by the plaintiffs’ assurances. The study sponsor, Dr. Salim Shah could not point to a draft protocol that indicated the isotope ratio as the end point; nor could Dr. Shah identify a request for this analysis by Wang until after the study was concluded. Id. at *9.[7]

Ultimately, the Court declared that whether the protocol was changed post hoc after the primary end point provided disappointing analysis, or the isotope ratio was carelessly omitted from the protocol, the design or conduct of the study was “incompatible with reliable scientific methodology.”

The Third Deviation – Changing the Standard of “Significance” After the Data Are Collected and P-Values Are Computed

The protocol for the Blockade study called for a pre-determined Type I error rate (p-value) of no more than 5 percent.[8] Id. at *10. The difference in the isotope ratio showed an attained level of significance probability of 5.7 percent, and thus even the post hoc end point missed the prespecified level of significance. The final protocol changed the value of “significance” to 10 percent, to permit the plaintiffs to declare a “statistically significant” result. Dr. Wang admitted in deposition that she doubled the acceptable level of Type I error only after she obtained the data and calculated the p-value of 0.057. Id. at *10.[9]

The Court found that this deliberate moving of the statistical goal post reflected a “lack of objectivity and reliability,” which smacked of contrivance[10].

The Court found that the study’s deviations from the protocol demonstrated a lack of objectivity. The inadequacy of the Study’s statistical analysis plan supported the Court’s conclusion that Dr. Askari’s supposed finding of a “statistically significant” difference in fecal copper isotope ratio between Fixodent and placebo group participants was “not based on sufficiently reliable and objective scientific methodology” and thus could not support plaintiffs’ expert witnesses’ general causation claims.

The Fourth Deviation – Failing to Take Steps to Preserve the Blind

The protocol called for a double-blinded study, with neither the participants nor the clinical investigators knowing which participant was in which group. Rather than delivering the three different groups capsules that looked similar, the group each received starkly different looking capsules. Id. at *11. The capsules for one set were apparently so large that the investigators worried whether the participants would comply with the dosing regimen.

The Fifth Deviation – Failing to Take Steps to Keep Biological Samples From Becoming Contaminated

Documents and emails from Dr. Shah acknowledged that there had been “difficulties in storing samples at appropriate temperature.” Id. at *11. Fecal samples were “exposed to unfrozen and undesirable temperature conditions.” Dr. Shah called for remedial steps from the Study manager, but there was no documentation that such steps were taken to correct the problem. Id.

The Consequences of Discrediting the Study

Dr. Askari opined that the Study, along with other evidence, shows that Fixodent can cause copper deficiency myeloneuropathy (“CDM”). The plaintiffs, of course, argued that the Defendants’ criticisms of the Fixodent

Study’s methodology went merely to the “weight rather than admissibility.” Id. at *9. Askari’s study was but one leg of the stool, but the defense’s thorough discrediting of the study was an important step in collapsing the support for the plaintiffs’ claims. As the MDL Court explained:

“The Court cannot turn a blind eye to the myriad, serious methodological flaws in the Fixodent Blockade Study and conclude they go to weight rather than admissibility. While some of these flaws, on their own, may not be serious enough to justify exclusion of the Fixodent Blockade Study; taken together, the Court finds Fixodent Blockade Study is not “good science,” and is not admissible. Daubert, 509 U.S. at 593 (internal quotation marks and citation omitted).”

Id. at *11.

A study, such as the Fixodent Blockade Study, is not itself admissible, but the deconstruction of the study upon which plaintiffs’ expert witnesses relied, led directly to the Court’s decision to exclude those witnesses. The Court omitted any reference to Federal Rule of Evidence 703, which addresses the requirements of facts and data, otherwise inadmissible, which may be relied upon by expert witnesses in reaching their opinions.


 

[1] SeePhiladelphia Plaintiff’s Claims Against Fixodent Prove Toothless” (May 2, 2012); Jacoby v. Rite Aid Corp., 2012 Phila. Ct. Com. Pl. LEXIS 208 (2012), aff’d, 93 A.3d 503 (Pa. Super. 2013); “Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims” (Dec. 12, 2013).

[2] SeeUsing the Rule 45 Subpoena to Obtain Research Data” (July 24, 2013)

[3] The group was identified as the Ethica Norma Ethical Committee.

[4] citing Wang Dep. at 56:7–25, Aug. 13, 2013), and Wang Analysis of Fixodent Blockade Study [ECF No. 2197–56] (noting “no clear treatment effect on Cu63 or Cu65”).

[5] Askari Dep. at 69:21–24, June 20, 2013.

[6] Copper 65 is not a typical tracer; it is not radioactive. Naturally occurring copper consists almost exclusively of two stable (non-radioactive) isotope, Cu65 about 31 percent, Cu63 about 69 percent. See, e.g., Manuel Olivares, Bo Lönnerdal, Steve A Abrams, Fernando Pizarro, and Ricardo Uauy, “Age and copper intake do not affect copper absorption, measured with the use of 65Cu as a tracer, in young infants,” 76 Am. J. Clin. Nutr. 641 (2002); T.D. Lyon, et al., “Use of a stable copper isotope (65Cu) in the differential diagnosis of Wilson’s disease,” 88 Clin. Sci. 727 (1995).

[7] Shah Dep. at 87:12–25; 476:2–536:12, 138:6–142:12, June 5, 2013).

[8] The reported decision leaves unclear how the analysis would proceed, whether by ANOVA for the three groups, or t-tests, and whether there was multiple testing.

[9] Wang Dep. at 151:13–152:7; 153:15–18.

[10] 2015 WL 392021, at *10, citing Perry v. United States, 755 F.2d 888, 892 (11th Cir. 1985) (“A scientist who has a formed opinion as to the answer he is going to find before he even begins his research may be less objective than he needs to be in order to produce reliable scientific results.”); Rink v. Cheminova, Inc., 400 F.3d 1286, 1293 n. 7 (11th Cir.2005) (“In evaluating the reliability of an expert’s method … a district court may properly consider whether the expert’s methodology has been contrived to reach a particular result.” (alteration added)).

 

Zoloft MDL Relieves Matrixx Depression

January 30th, 2015

When the Supreme Court delivered its decision in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), a colleague, David Venderbush from Alston & Bird LLP, and I wrote a Washington Legal Foundation Legal Backgrounder, in which we predicted that plaintiffs’ counsel would distort the holding, and inflate the dicta of the opinion. Schachtman & Venderbush, “Matrixx Unbounded: High Court’s Ruling Needlessly Complicates Scientific Evidence Principles,” 26 (14) Legal Backgrounder (June 17, 2011)[1]. Our prediction was sadly all-too accurate. Not only was the context of the Matrixx distorted, but several district courts appeared to adopt the dicta on statistical significance as though it represented the holding of the case[2].

The Matrixx decision, along with the few district court opinions that had embraced its dicta[3], was urged as the basis for denying a defense challenge to the proffered testimony of Dr. Anick Bérard, a Canadian perinatal epidemiologist, in the Zoloft MDL. The trial court, however, correctly discerned several methodological shortcomings and failures, including Dr. Bérard’s reliance upon claims of statistical significance from studies that conducted dozens and hundreds of multiple comparisons. See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342; 12-md-2342, 2014 U.S. Dist. LEXIS 87592; 2014 WL 2921648 (E.D. Pa. June 27, 2014) (Rufe, J.).

Plaintiffs (through their Plaintiffs’ Steering Committee (PSC) in the Zoloft MDL) were undaunted and moved for reconsideration, asserting that the MDL trial court had failed to give appropriate weight to the Supreme Court’s decision in Matrixx, and a Third Circuit decision in DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941 (3d Cir. 1990). The MDL trial judge, however, deftly rebuffed the plaintiffs’ use of Matrixx, and their attempt to banish consideration of random error in the interpretation of epidemiologic studies. In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342; 12-md-2342, 2015 WL 314149 (E.D. Pa. Jan. 23, 2015) (Rufe, J.) (denying PSC’s motion for reconsideration).

In rejecting the motion for reconsideration, the Zoloft MDL trial judge noted that the PSC had previously cited Matrixx, and that the Court had addressed the case in its earlier ruling. 2015 WL 314149, at *2-3. The MDL Court then proceeded to expand upon its earlier ruling, and to explain how Matrixx was largely irrelevant to the Rule 702 context of Pfizer’s challenge to Dr. Bérard. There were, to be sure, some studies with nominal statistically significant results, for some birth defects, among children of mothers who took Zoloft in their first trimester of pregnancy. As Judge Rufe explained, statistical significance, or the lack thereof, was only one item in a fairly long list of methodological deficiencies in Dr. Bérard’s causation opinions:

“The [original] opinion set forth a detailed and multi-faceted rationale for finding Dr. Bérard’s testimony unreliable, including her inattention to the principles of replication and statistical significance, her use of certain principles and methods without demonstrating either that they are recognized by her scientific community or that they should otherwise be considered scientifically valid, the unreliability of conclusions drawn without adequate hypothesis testing, the unreliability of opinions supported by a ‛cherry-picked’ sub-set of research selected because it was supportive of her opinions (without adequately addressing non-supportive findings), and Dr. Bérard’s failure to reconcile her currently expressed opinions with her prior opinions and her published, peer-reviewed research. Taking into account all these factors, as well as others discussed in the Opinion, the Court found that Dr. Bérard departed from well-established epidemiological principles and methods, and that her opinion on human causation must be excluded.”

Id. at *1.

In citing the multiple deficiencies of the proffered expert witness, the Zoloft MDL Court thus put its decision well within the scope of the Third Circuit’s recent precedent of affirming the exclusion of Dr. Bennet Omalu, in Pritchard v. Dow Agro Sciences, 430 F. App’x 102, 104 (3d Cir.2011). The Zoloft MDL Court further defended its ruling by pointing out that it had not created a legal standard requiring statistical significance, but rather had made a factual finding that epidemiologist, such as the challenged witness, Dr. Anick Bérard, would use some measure of statistical significance in reaching conclusions in her discipline of epidemiology. 2015 WL 314149, at *2[4].

On the plaintiffs’ motion for reconsideration, the Zoloft Court revisited the Matrixx case, properly distinguishing the case as a securities fraud case about materiality of non-disclosed information, not about causation. 2015 WL 314149, at *4. Although the MDL Court could and should have identified the Matrixx language as clearly obiter dicta, it did confidently distinguish the Supreme Court holding about pleading materiality from its own task of gatekeeping expert witness testimony on causation in a products liability case:

“Because the facts and procedural posture of the Zoloft MDL are so dissimilar from those presented in Matrixx, this Court reviewed but did not rely upon Matrixx in reaching its decision regarding Dr. Bérard. However, even accepting the PSC’s interpretation of Matrixx, the Court’s Opinion is consistent with that ruling, as the Court reviewed Dr. Bérard’s methodology as a whole, and did not apply a bright-line rule requiring statistically significant findings.”

Id. at *4.

In mounting their challenge to the MDL Court’s earlier ruling, the Zoloft plaintiffs asserted that the Court had failed to credit Dr. Bérard’s reliance upon what Dr. Bérard called the “Rothman approach.” This approach, attribution to Professor Kenneth Rothman had received some attention in the Bendectin litigation in the Third Circuit, where plaintiffs sought to be excused from their failure to show statistically significant associations when claiming causation between maternal use of Bendectin and infant birth defects. DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941 (3d Cir. 1990). The Zoloft MDL Court pointed out that the Circuit, in DeLuca, had never affirmatively endorsed Professor Rothman’s “approach,” but had reversed and remanded the Bendectin case to the district court for a hearing under Rule 702:

“by directing such an overall evaluation, however, we do not mean to reject at this point Merrell Dow’s contention that a showing of a .05 level of statistical significance should be a threshold requirement for any statistical analysis concluding that Bendectin is a teratogen regardless of the presence of other indicial of reliability. That contention will need to be addressed on remand. The root issue it poses is what risk of what type of error the judicial system is willing to tolerate. This is not an easy issue to resolve and one possible resolution is a conclusion that the system should not tolerate any expert opinion rooted in statistical analysis where the results of the underlying studies are not significant at a .05 level.”

2015 WL 314149, at *4 (quoting from DeLuca, 911 F.2d at 955). After remand, the district court excluded the DeLuca plaintiffs’ expert witnesses, and granted summary judgment, based upon the dubious methods employed by plaintiffs’ expert witnesses in cherry picking data, recalculating risk ratios in published studies, and ignoring bias and confounding in studies. The Third Circuit affirmed the judgment for Merrell Dow. DeLuca v. Merrell Dow Pharma., Inc., 791 F. Supp. 1042 (3d Cir. 1992), aff’d, 6 F.3d 778 (3d Cir. 1993).

In the Zoloft MDL, the plaintiffs not only offered an erroneous interpretation of the Third Circuit’s precedents in DeLuca, they also failed to show that the “Rothman” approach had become generally accepted in over two decades since DeLuca. 2015 WL 314149, at *4. Indeed, the hearing record was quite muddled about what the “Rothman” approach involved, other than glib, vague suggestions that the approach would have countenanced Dr. Bérard’s selective, over-reaching analysis of the extant epidemiologic studies. The plaintiffs did not call Rothman as an expert witness; nor did they offer any of Rothman’s publications as exhibits at the Zoloft hearing. Although Professor Rothman has criticized the overemphasis upon p-values and significance testing, he has never suggested that researchers and scientists should ignore random error in interpreting research data. Nevertheless, plaintiffs attempted to invoke some vague notion of a Rothman approach that would ignore confidence intervals, attained significance probability, multiplicity, bias, and confounding. Ultimately, the MDL Court would have none of it. The Court held that the Rothman Approach (whatever that is), as applied by Dr. Bérard, did not satisfy Rule 702.

The testimony at the Rule 702 hearing on the so-called “Rothman approach” had been sketchy at best. Dr. Bérard protested, perhaps too much, when asked about her having ignored p-values:

“I’m not the only one saying that. It’s really the evolution of the thinking of the importance of statistical significance. One of my professors and also a friend of mine at Harvard, Ken Rothman, actually wrote on it – wrote on the topic. And in his book at the end he says obviously what I just said, validity should not be confused with precision, but the third bullet point, it’s saying that the lack of statistical significance does not invalidate results because sometimes you are in the context of rare events, few cases, few exposed cases, small sample size, exactly – you know even if you start with hundreds of thousands of pregnancies because you are looking at rare events and if you want to stratify by exposure category, well your stratum becomes smaller and smaller and your precision decreases. I’m not the only one saying that. Ken Rothman says it as well, so I’m not different from the others. And if you look at many of the studies published nowadays, they also discuss that as well.”

Notes of Testimony of Dr. Anick Bérard, at 76:21- 77:14 (April 9, 2014). See also Notes of Testimony of Dr. Anick Bérard, at 211 (April 11, 2014) (discussing non-statistically significant findings as a “trend,” and asserting that the lack of a significant finding does not mean that there is “no effect”). Bérard’s invocation of Rothman here is accurate but unhelpful. Rothman and Bérard are not alone in insisting that confidence intervals provide a measure of precision of an estimate, and that we should be careful not to interpret the lack of significance to mean no effect. But the lack of significance cannot be used to interpret data to show an effect.

At the Rule 702 hearing, the PSC tried to bolster Dr. Bérard’s supposed reliance upon the “Rothman approach” in cross-examining Pfizer’s expert witness, Dr. Stephen Kimmel:

“Q. You know who Dr. Rothman is, the epidemiologist?
A. Yes.
Q. You actually took a course from Dr. Rothman, didn’t you?
A. I did when I was a student way back.
Q. He is a well-known epidemiologist, isn’t he?
A. Yes, he is.
Q. He has published this book, Modern Epidemiology. Do you have a copy of this?
A. I do.
Q. Do you – Have you ever read it?
A. I read his earlier edition. I have not read the most recent edition.
Q. There’s two other authors, Sander Greenland and Tim Lash. Do you know either one of them?
A. I know Sander. I don’t know Tim.
Q. Dr. Rothman has some – he has written about confidence intervals and statistical significance for some time, hasn’t he?
A. He has.
Q. Do you agree with him that statistical significance is a not matter of validity. It’s a matter of precision?
A. It’s a matter of – well, confidence intervals are matters of precision. P-values are not.
Q. Okay. I want to put up a table and see if you are in agreement with Dr. Rothman. This is the third edition of Modern Epidemiology. And he has – and ignore my brother’s handwriting. But there is an hypothesized rate ratio under 10-3. It says: p-value function from which one can find all confidence limits for a hypothetical study with a rate ratio estimate of 3.1 Do you see that there?
A. Yes. I don’t see the top of the figure, not that it matters.
Q. I want to make sure. The way I understand this, he is giving us a hypothesis that we have a relative risk of 3.1 and it [presumably a 95% confidence interval] crosses 1, meaning it’s not statistically significant. Is that fair?
A. Well, if you are using a value of .05, yes. And again, if this is a single test and there’s a lot of things that go behind it. But, yes, so this is a total hypothetical.
Q. Yes.
A. I’ sorry. He’s saying here is a hypothetical based on math. And so here is – this is what we would propose.
Q. Yes, I want to highlight what he says about this figure and get your thoughts on it. He says:
The message of figure 10-3 is that the example data are more compatible with a moderate to strong association than with no association, assuming the statistical model used to construct the function is correct.
A. Yes.
Q. Would you agree with that statement?
A. Assuming the statistical model is correct. And the problem is, this is a hypothetical.
Q. Sure. So let’s just assume. So what this means to sort of put some meat on the bone, this means that although we cross 1 and therefore are statistically
significant [sic, non-significant], he says the more likely truth here is that there is a moderate to strong effect rather than no effect?
A. Well, you know he has hypothesized this. This is not used in common methods practice in pharmacoepi. Dr. Rothman has lots of ideas but it’s not part of our standard scientific method.

Notes of Testimony of Dr. Stephen Kimmel, at 126:2 to 128:20.

Nothing very concrete about the “Rothman approach” is put before the MDL Court, either through Dr. Bérard or Dr. Kimmel. There are, however, other instructive aspects to the plaintiff’s counsel’s examination. First, the referenced portion of the text, Modern Epidemiology, is a discussion of p-value functions, not of p-values or of confidence intervals per se. Modern Epidemiology at 158-59 (3d ed. 2008). Dr. Bérard never discussed p-value functions in her report or in her testimony, and Dr. Kimmel testified, without contradiction, that such p-value functions are “not used in common methods practice.” Second, the plaintiff’s counsel never marked and offered the Rothman text as an exhibit for the MDL Court to consider. Third, the cross-examiner first asked about the implication for a hypothetical association, and then, when he wanted to “put some meat on the bone” changed the word used in Rothman’s text, “association,” to “effect.” The word “effect” does not appear in Rothman’s text at the referenced discussion about p-value functions. Fortunately, the MDL Court was not poisoned by the “meat on the bone.”

The Pit and the Pendulum

Another document glibly referenced but not provided to the MDL Court was the publication of Sir Austin Bradford Hill’s presidential address to the Royal Society of Medicine on causation. The MDL Court acknowledged that the PSC had argued that the emphasis upon statistical significance was contrary to Hill’s work and teaching. 2015 WL 314149, at *5. In the Court’s words:

“the PSC argues that the Court’s finding regarding the importance of statistical significance in the field of epidemiology is inconsistent with the work of Bradford Hill. The PSC points to a 1965 address by Sir Austin Bradford Hill, which it has not previously presented to the Court, except in opening statements of the Daubert hearings.20 The PSC failed to put forth evidence establishing that Bradford Hill’s statement that ‛I wonder whether the pendulum has not swung too far [in requiring statistical significance before drawing conclusions]’ has, in the decades since that 1965 address, altered the importance of statistical significance to scientists in the field of epidemiology.”

Id. This failure, identified by the Court, is hardly surprising. The snippet of a quotation from Hill would not sustain the plaintiffs’ sweeping generalization. The quoted language in context may help to explain why Hill’s paper was not provided:

“I wonder whether the pendulum has not swung too far – not only with the attentive pupils but even with the statisticians themselves. To decline to draw conclusions without standard errors can surely be just as silly? Fortunately I believe we have not yet gone so far as our friends in the USA where, I am told, some editors of journals will return an article because tests of significance have not been applied. Yet there are innumerable situations in which they are totally unnecessary – because the difference is grotesquely obvious, because it is negligible, or because, whether it be formally significant or not, it is too small to be of any practical importance. What is worse the glitter of the t table diverts attention from the inadequacies of the fare. Only a tithe, and an unknown tithe, of the factory personnel volunteer for some procedure or interview, 20% of patients treated in some particular way are lost to sight, 30% of a randomly-drawn sample are never contracted. The sample may, indeed, be akin to that of the man who, according to Swift, ‘had a mind to sell his house and carried a piece of brick in his pocket, which he showed as a pattern to encourage purchasers.’ The writer, the editor and the reader are unmoved. The magic formulae are there.”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 299 (1965).

In the Zoloft cases, no expert witness was prepared to state that the disparity was “grotesquely obvious,” or “negligible.” And Bradford Hill’s larger point was that bias and confounding often dwarf considerations of random error, and that there are many instances in which significance testing is unavailing or unhelpful. And in some studies, with large “effect sizes,” statistical significance testing may be beside the point.

Hill’s presidential address to the Royal Society of Medicine commemorated his successes in epidemiology, and we need only turn to Hill’s own work to see how prevalent was his use of measurements of significance probability. See, e.g., Richard Doll & Austin Bradford Hill, “Smoking and Carcinoma of the Lung: Preliminary Report,” Brit. Med. J. 740 (Sept. 30, 1950); Medical Research Council, “Streptomycin Treatment of Pulmonary Tuberculosis,” Brit. Med. J. 769 (Oct. 30, 1948).

Considering the misdirection on Rothman and on Hill, the Zoloft MDL Court did an admirable job in unraveling the Matrixx trap set by counsel. The Court insisted upon parsing the Bradford Hill factors[5], over Pfizer’s objection, despite the plaintiffs’ failure to show “an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance,” which Bradford Hill insisted was the prerequisite for the exploration of the nine factors he set out in his classic paper. Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Given the outcome, the Court’s questionable indulgence of plaintiffs’ position was ultimately harmless.


[1] See alsoThe Matrixx – A Comedy of Errors,” and “Matrixx Unloaded,” (Mar. 29, 2011), “The Matrixx Oversold,” and “De-Zincing the Matrixx.”

[2] SeeSiracusano Dicta Infects Daubert Decisions” (Sept. 22, 2012).

[3] See, e.g., In re Chantix (Varenicline) Prods. Liab. Litig., 2012 U.S. Dist. LEXIS 130144, at *22 (N.D. Ala. 2012); Cheek v. Wyeth Pharm. Inc., 2012 U.S. Dist. LEXIS 123485 (E.D. Pa. Aug. 30, 2012); In re Celexa & Lexapro Prods. Liab. Litig.,  ___ F.3d ___, 2013 WL 791780 (E.D. Mo. 2013).

[4] The Court’s reasoning on this point begged the question whether an ordinary clinician, ignorant of the standards, requirements, and niceties of statistical reasoning and inference, would be allowed to testify, unconstrained by any principled epidemiologic reasoning about random or systematic error. It is hard to imagine that Rule 702 would countenance such an end-run around the requirements of sound science.

[5] Adhering to Bradford Hill’s own admonition might have saved the Court the confusion of describing statistical significance as a measure of strength of association. 2015 WL 314149, at *2.

The Lie Detector and Wonder Woman – Quirks and Quacks of Legal History

January 27th, 2015

From 1923, until the United States Supreme Court decided the Daubert case in 1993, Frye was cited as “controlling authority” on questions of the admissibility of scientific opinion testimony and test results. The decision is infuriatingly cryptic and unhelpful as to background or context of the specific case, as well as how it might be applied to future controversies. Of the 669 words, these are typically cited as the guiding “rule” with respect to expert witness opinion testimony:

“Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while the courts will go a long way in admitting expert testimony deduced from a well recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.”

Frye v. United States, 293 F. 1013, 1014 (D.C. Cir. 1923).

As most scholars of evidence realize, the back story of the Frye case is rich and bizarre. The expert witness involved, William Marston, was a lawyer and scientist, who had made advances in a systolic blood pressure cuff to be used as a “lie detector.” Marston was also an advocate of free love and, with his wife and his mistress, the inventor of Wonder Woman and her lasso of truth.

Jill Lepore, a professor of history in Harvard University, has written an historical account of Marston and his colleagues. Jill Lepore, The Secret History of Wonder Woman (N.Y. 2014). More recently, Lepore has written an important law review on the historical and legal record of the Frye case, which is concealed in the terse 669 words of the Court of Appeals’ opinion. Jill Lepore, “On Evidence: Proving Frye as a Matter of Law, Science, and History,” 124 Yale L.J. 1092 (2015).

Lepore’s history is an important gloss on the Frye case, but her paper points to a larger, more prevalent, chronic problem in the law, which especially afflicts judicial decisions of scientific or technical issues. As an historian, Lepore is troubled, as we all should be, by the censoring, selecting, suppressing, and distorting of facts that go into judicial decisions. From cases and their holdings, lawyers are taught to infer rules that guide their conduct at the bar, and their clients’ conduct and expectations, but everyone requires fair access to the evidence to determine what facts are material to decision.

As Professor Lepore puts it:

“Marston is missing from Frye because the law of evidence, case law, the case method, and the conventions of legal scholarship — together, and relentlessly — hide facts.”

Id. at 1097. Generalizing from Marston and the Frye case, Lepore notes that:

“Case law is like that, too, except that it doesn’t only fail to notice details; it conceals them.”

Id. at 1099.

Lepore documents that Marston’s psychological research was rife with cherry picking and data dredging. Id. at 1113-14. Despite his degree magna cum laude in philosophy from Harvard College, his L.L.B from Harvard Law School (with no particular distinction), and his Ph.D. from Harvard University, Marston was not a rigorous scientist. In exploring the historical and legal record, not recounted in the Frye decision, Lepore’s history provides a wonderful early example, of what has become a familiar phenomenon of modern litigation: an expert witness who seeks to achieve acceptance for a dubious opinion or device in the courtroom rather than in the court of scientific opinion. Id. at 1122. The trial judge in Frye’s murder case, Justice McCoy, was an astute judge, and quite modest in his ability to evaluate the validity of Marston’s opinions, but he had more than sufficient perspicacity to discern that Marston’s investigation was “wildly unscientific,” with no control groups. Id. at 1135. The trial record of defense counsel’s proffer, and Justice McCoy’s rulings and comments from the bench, reproduced in Lepore’s article, anticipate and predict much of the scholarship surrounding both Frye and Daubert cases.

Lepore complains that the important historical record, including Marston’s correspondence with Professor Wigmore, the criminal fraud charges against Marston, and the correspondence of Frye’s lawyers, lies “filed, undigitized” in various archives. Id. at 1150. Although Professor Lepore tirelessly cites to internet URL sources when available, she could have easily made the primary historical materials available for all, using readily available internet technology. Lepore’s main thesis should encourage lawyers and law scholars to look beyond appellate decisions as the data for legal analysis.

More Antic Proposals for Expert Witness Testimony – Including My Own Antic Proposals

December 30th, 2014

The late Professor Margaret Berger epitomized a person you could like and even admire, while finding many of her ideas erroneous, incoherent, and even dangerous. Berger was frequently on the losing side of expert witness admissibility issues, and she fell under the influence of the plaintiffs’ bar, holding conferences with their walking-around money, laundered through SKAPP, The Project on Scientific Knowledge and Public Policy.[1] In appellate cases, Berger often lent the credibility of her scholarship to support plaintiffs’ efforts to strip away admissibility criteria for expert witness causation opinion.[2] Still, she was always polite and respectful in debate. When Judge Weinstein appointed her to chair a committee to search for appropriate court-appointed expert witnesses in the silicone gel breast implant litigation, Professor Berger proved a careful, impartial listener to all the parties involved.

In 2009, before the publication of the Third Edition of the Reference Manual on Scientific Evidence, Professor Berger gave a presentation for an American Law Institute continuing legal education program, in which she aired her antipathy toward gatekeeping.[3] With her sights set primarily on defense expert witnesses, Berger opined that a monetary relationship between an expert witness and the defendant could be grounds for a Rule 702 exclusion. While the jingle of coin doth soothe the hurt that conscience must feel (for some expert witnesses), the focus of the Rule 702 inquiry is properly on relevance, reliability, and validity. Judge Shira Scheindlin, who sat on the same panel as Professor Berger, diplomatically pointed out that employee expert witnesses are offered all the time, and any bias is a subject for cross-examination, not disqualification. Remarkably, neither Professor Berger nor Judge Scheindlin acknowledged that conflicts of interest, actual or potential, are not relevant to the Daubert or Rule 702 factors that guide admissibility. If Berger’s radical position of identifying conflict of interest with unreliability were correct, we might dismiss her views without any consideration[4], given her conflicts of interest from her association with SKAPP, and her several amicus briefs filed on behalf of plaintiffs, seeking to avoid the exacting requirements of expert witness evidence gatekeeping.

In her ALI-CLE lecture, Professor Berger waxed enthusiastically about what was then a recent federal trial court decision in Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009). Berger asserted that the case was unpublished and that the case, like many other “Daubert” cases was hidden from view. Berger thought that Allen’s obscurity was unfortunate because the decision was “fabulous” and was based upon astute opinions of “outstanding” experts[5]. Berger was wrong on every point, from the chemical involved, to the unavailability of the opinion, to the quality of the expert witnesses (who were not ALS experts, but frequent, willing testifiers), and to the carefulness of the exposure and causation opinions offered.[6] See James L. Bernat & Richard Beresford, Ethical and Legal Issues in Neurology 59-60 (Amsterdam 2013) (discussing Allen and characterizing the court’s decision to admit plaintiffs’ expert witnesses’ opinions as based upon plausibility without more).

Implicit in Berger’s errors, however, may be the beginnings of some concrete suggestions for improving the gatekeeping process. After all, Berger thought that no one would likely find and read the Allen decision.  She may have thus believed that she had some freedom from scrutiny when she praised the decision and the expert witnesses involved. Just as there is a groundswell of support for greater disclosure of underlying data to accompany scientific publications, there should be support for wide dissemination of the underlying materials behind Rule 702 opinions. Most judges cannot or will not write sufficiently comprehensive opinions describing and supporting their decisions to admit or exclude expert witness opinion to permit vigorous public scrutiny. Some judges fail to cite to the underlying studies or data that are the bases of the challenged opinions. As a result, the “Daubert” scholarship suffers because it frequently lacks access to the actual reports, testimony, studies, and data themselves. Often the methodological flaws discussed in judicial opinions are just the tip of the iceberg, with flaws running all the way to the bottom.

And while I am on “antic proposals” of my own, courts should consider requiring all parties to file proposed findings of fact and conclusions of law, with record cites, to support their litigation positions. Lawyers on both sides of the “v.” have proven themselves cavalier and careless in their descriptions and characterizations of scientific evidence, inference, and analysis. Proposed findings would permit reviewing courts, scientists, and scholars to identify errors for the benefit of appellate courts and later trial courts.


 

[1] SKAPP claimed to have aimed at promoting transparent decision making, but deceived the public with its disclosure of having been supported by the “Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation.” Somehow SKAPP forgot to disclose that this court order simply created a common-benefit fund for plaintiffs’ lawyers to pursue their litigation goals. How money from the silicone gel breast implant MDL was diverted for advocated anti-Daubert policies is a mystery that no amount of transparent decision making has to date uncovered. Fortunately, for the commonweal, SKAPP appears to have been dissolved. The SKAPP website lists those who guided and supported SKAPP’s attempts to subvert expert witness validity requirements; not surprisingly, the SKAPP supporters were mostly plaintiffs’ expert witnesses:

Eula Bingham, PhD
Les Boden, PhD
Richard Clapp, DSc, MPH
Polly Hoppin, ScD
Sheldon Krimsky, PhD
David Michaels, PhD, MPH
David Ozonoff, MD, MPH
Anthony Robbins, MD, MPA

[2] See, e.g., Parker v. Mobil Oil Corp., N.Y. Ct. App., Brief Amicus Curiae of Profs. Margaret A. Berger, Edward J. Imwinkelried, Sheila Jasanoff, and Stephen A. Saltzburg (July 28, 2006) (represented by Anthony Z. Roisman, of the National Legal Scholars Law Firm).

[3] Berger, “Evidence, Procedure, and Trial Update: How You Can Win (Or Lose) Your Case (Expert Witnesses, Sanctions, Spoliation, Daubert, and More)” (Mar. 27, 2009).

Berger, “Evidence, Procedure, and Trial Update: How You Can Win (Or Lose) Your Case (Expert Witnesses, Sanctions, Spoliation, Daubert, and More)” (Mar. 27, 2009).

[4] We can see this position carried to its natural, probable, and extreme endpoint in Elizabeth Laposata, Richard Barnes, and Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa Law Rev. 1 (2012), where the sanctimonious authors, all anti-tobacco advocates criticize the American Law Institute for permitting the participation of lawyers who represent tobacco industry. The authors fail to recognize that ALI members include lawyers representing plaintiffs in tobacco litigation, and that it is possible, contrary to their ideological worldview, to discuss and debate an issue without reference to ad hominem “conflicts” issues. The authors might be surprised by the degree to which the plaintiffs’ bar has lobbied (successfully) for many provisions in various Restatements.

[5] Including Richard Clapp, who served as an advisor to SKAPP, which lavished money on Professor Berger’s conferences.

[6] SeeBad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing” (Nov. 30, 2012); “Gatekeeping in Allen v. Martin Surfacing — Postscript” (April 11, 2013).

New Standard for Scientific Evidence – The Mob

December 27th, 2014

A few years ago, a law student published a Note that argued for the dismantling of judicial gatekeeping.  Note, “Admitting Doubt: A New Standards for Scientific Evidence,” 123 Harvard Law Review 2021 (2010).  The anonymous Harvard law student asserted that juries are at least as good, if not better, at handling technical questions than are “gatekeeping” federal trial judges. The empirical evidence for such a suggestion is slim, and ignores the geographic variability in jury pools.

To be sure, some jurors have much greater scientific and mathematical aptitude than some judges, but the law student’s run at Rule 702 ignores some important institutional differences between judges and juries, including that judicial errors are subject to scrutiny and review, and public comment based upon written judicial opinions. Most judges have 20 years of schooling and 10 years of job experience, which should account for some superiority.

Misplaced Sovereignty

Another student this year has published a much more sophisticated version of the Harvard student’s Note, an antic proposal with a similar policy agenda that would overthrow the regime of judicial scrutiny and gatekeeping of expert witness opinion testimony. Krista M. Pikus, “We the People: Juries, Not Judges, Should be the Gatekeepers of Expert Evidence,” 90 Notre Dame L. Rev. 453 (2014). This more recent publication, while conceding that judges may be no better than juries at evaluating scientific evidence, asserts that jury involvement is required by a political commitment to popular sovereignty. Ms. Pikus begins with the simplistic notion that:

“[o]ur system of government is based on the idea that the people are sovereign.”

Id. at 470. Since juries are made up of people, jury determinations are required to implement popular sovereignty.

This notion of sovereignty is really quite foreign to our Constitution and our system of government. “We, the People” generally do not make laws or apply them, with the exception of grand and petit jury factual determinations. The vast legislative and decision making processes are entrusted to Congress, the Executive, and the ever-expanding system of administrative agencies. The Constitution was indeed motivated to prevent governmental tyranny, but mob rule was not an acceptable alternative. For the founders, juries were a bulwark of liberty, and a shield against an overbearing Crown. Jurors were white men who owned property.

Pikus argues that judges somehow lack the political authority to serve as fact finders because they are not elected, but in some states judges are elected, and in other states and in the federal system, judges are appointed and confirmed by elected officials. Juries are, of course, not elected, and with many jurisdictions permitting juries of six persons or fewer, juries are hardly representative of the “popular sovereign.” The systematic exclusion of intelligent and well-educated jurors by plaintiffs’ counsel, along with the aversion to jury service by self-employed and busy citizens, helps ensure that juries fail to represent a fair cross-section of the population. Curiously, Pikus asserts that the “right to a trial by one’s peers is an integral part of our legal system,” but the peerage concept is nowhere in the Constitution. If it were, defendants in complicated tort cases might well have a right to juries composed of scientists or engineers.

The Right to Trial by Jury

There is, of course, a federal constitutional right to trial by jury, guaranteed by the Seventh Amendment:

“In Suits at common law … the right of trial by jury shall be preserved, and no fact tried by a jury shall be otherwise reexamined in any Court of the United States, than according to the rules of the common law.”

A strict textualist might hold that federal courts could dispense with juries in cases brought under statutory tort legislation, such as the New Jersey Products Liability Act, or for claims or defenses that were not available at the time the Seventh Amendment was enacted. Even the textualist might hold that the change in complexity of fact-finding endeavors, over two centuries, might mean that both the language and the spirit of the Seventh Amendment point away from maintaining the jury in cases of sufficient complexity.

Judges versus Juries

The fact is that judges and juries can, and do, act tyrannically, in deciding factual issues, including scientific and technical issues. Ms. Pikus would push the entire responsibility for ensuring accuracy in scientific fact finding to the least reviewable entity, the petit jury. Juries can ignore facts, decide emotively or irrationally, without fear of personal scrutiny or criticism. Pikus worries that judges “insert their policy opinions into their decisions,” which they have been known to do, but she fails to explain why we should tolerate the same from unelected, unreviewable juries. Id. at 472.

Inconsistently, Pikus acknowledges that “many can agree that some cases might be better suited for a judge instead of a jury,” such as “patent, bankruptcy, or tax” cases that “typically require additional expertise.” Id. at 471 & n. 185. To this list, we could add family law, probate, and equity matters, but the real question is what is it about a tax case that makes it more intractable to a jury than a products case. State power is much more likely to be abused or at issue in a tax case than in a modern products liability case, with a greater need for a “bulwark of liberty”. And the products liability case is much more likely to require scientific and technical expertise than a tax case.

The law of evidence, in federal and in most state courts, permits expert witnesses to present conclusory opinions, without having to account for the methodological correctness of their relied-upon studies, data, and analyses. Jurors, who are poorly paid, and pulled away from their occupations and professions, do not have the aptitude, patience, time, or interest to explore the full range of inferences and analyses performed by expert witnesses. Without some form of gatekeeping, trial outcomes are reduced to juror assessment of weak, inaccurate proxies for scientific determinations.

Pikus claims that juries, and only juries, should assess the reliability of an expert witness’s testimony. Id. at 455. As incompetent as some judges may be in adjudicating scientific issues, their errors are on display for all to see, whereas the jury’s determinations are opaque and devoid of public explanation. Judges can be singled out for technical competency, with appropriate case assignments, and they can be required to participate in professional legal education, including training in statistics, epidemiology, toxicology, genetics, and other subjects. It is difficult to imagine a world in which the jurors are sent home with the Reference Manual on Scientific Evidence, before being allowed to sit on a case. Nor is it feasible to have lay jurors serve on an extended trial that includes a close assessment of the expert witnesses’ opinions, as well as all the facts and data underlying those opinions.

Pikus criticizes the so-called “Daubert” regime as a manifestation of judicial activism, but she ignores that Daubert has been subsumed into an Act of Congress, in the form of a revised and expanded Federal Rules of Evidence.

In the end, this Note, like so much of the anti-Daubert law review literature is a complaint against removing popular, political, and emotive fact finding from technical and scientific issues in litigation. To the critics, science has no criteria of validity which the law is bound to respect. And yet, as John Adams argued before the Revolution:

“Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence[1].”

Due process requires more than the enemies of Daubert would allow.


[1] John Adams, “Argument in Defense of the Soldiers in the Boston Massacre Trials” (Dec. 1770)

When is a Treating Physician Not a Treating Physician?

December 25th, 2014

When the so-called treating physician is handpicked by an attorney to advance his client’s lawsuit. See Daniel E. Cummins, “Did Your Attorney Refer You to that Doctor?” (Dec. 17, 2014).

Treating physicians are a powerful weapon in health-effects litigation because they can deliver what appears to opinions untainted by “litigation bias.” Jurors and judges, challenged by difficult medical causation issues, find the caring attitude of treating physicians as a powerful proxy for the truth, which alleviates the need to think critically and carefully about epidemiology, statistics, toxicology, and the like. Of course, some treating physicians are biased by their care and treatment of the patient, especially when their treatment did not go so well. Physicians who were not able to cure or ameliorate their patients’ conditions may welcome the opportunity to advocate for their patients to give them, or their survivors, to make up for their failure to help through the healing arts. Patient-advocacy bias, however, is more difficult to appreciate than hired-expert witness bias.

Plaintiffs’ counsel often base their litigation strategy upon using treating physicians on causation or damages issues to take advantage of jurors’ and judges’ perceptions of treating physicians as motivated by beneficence rather than lucre[1]. Of course, there are dangers in these tactics. For one thing, the treating physicians, as in Tamraz v. Lincoln Elec. Co., may not really be up to the task of delivering a causation opinion, and the plaintiffs’ counsel’s cynical tactic will make a weaker case weaker still in the eyes of the jury. And then the treating physician may not subscribe fully to the plaintiffs’ lawyer’s litigation goals and theories[2]. SeePolitics of Expert Witnesses – The Treating Physician” (June 7, 2012).

Plaintiffs’ counsel may attempt to avoid the weaknesses of their treating physician strategy by selecting a carefully screened physician, ready to endorse plaintiffs’ litigation theories, and then to refer the claimant to this physician under cover of an asserted attorney-client privilege. A recent trial court in Pennsylvania, however, dealt a serious blow to this covert strategy by holding that the lawyer’s directing of his client’s medical care is not within the scope of the attorney-client relationship, and thus not a privileged communication. English v. Stepchin, No. CP-23-CV-786-2014, 101 Del. 424 (C.P. Del. Cty. Nov. 12, 2014 Kenney, P.J.). In English, plaintiff’s counsel asserted the privilege and objected to defense counsel’s deposition question whether plaintiff’s counsel had referred plaintiff to her treating physician.

On motion to compel discovery, Delaware County President Judge Chad F. Kenney overruled the objection, and held that “whether counsel referred Plaintiff to her treating physicians does not constitute legal assistance so as to justify properly invoking the attorney-client privilege.” As Judge Kenney explained:

“Clearly, whether counsel referred Plaintiff to her treating physicians is not a communication involved in either rendering a legal opinion or securing legal services. Furthermore, we conclude that the communication of such information does not constitute assistance in a legal matter so as to properly invoke the attorney-client privilege.

* * *

The disclosure of such information is not of a nature as would discourage trust or candid communication between a lawyer and a client and we are of the opinion that it does not outweigh the interest in the accessibility of material evidence to further the truth determining process.”

Id. at 425. The assertion of the attorney-client privilege was thus rejected, and the plaintiff was required to provide details as to how she came to go to her so-called treating physician.

The English decision represents a symmetrical paring of the attorney-client privilege to match the limitations imposed by other recent decisions on defense counsel. See, e.g., In re Vioxx Prods. Liab. Litig., 501 F. Supp. 2d 789, 800, 802 (E.D.La. 2007)(“We could not see the legal significance of these comments…” by in-house counsel on “scientific reports, articles accepted for publication in noted journals, and research proposals”); Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013).


[1] See, e.g., Simmons v. Novartis Pharm. Corp., 2012 WL 2016246, *2, *7 (6th Cir. 2012) (affirming exclusion of retained expert witness, as well as a treating physician who relied solely upon a limited selection of medical studies given to him by plaintiffs’ counsel); Tamraz v. BOC Group Inc., No. 1:04-CV-18948, 2008 WL 2796726 (N.D.Ohio July 18, 2008)(denying Rule 702 challenge to treating physician’s causation opinion), rev’d sub nom. Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (6th Cir. 2010) (carefully reviewing record of trial testimony of plaintiffs’ treating physician; reversing judgment for plaintiff based in substantial part upon treating physician’s speculative causal assessment created by plaintiffs’ counsel), cert. denied, 131 S. Ct. 2454 (2011).  See generally Robert Ambrogi, “A ‘Masterly’ Opinion on Expert Testimony,” Bullseye: October 2010; David Walk, “A masterly Daubert opinion” (Sept. 15, 2010);  Ellen Melville, “Comment, Gating the Gatekeeper: Tamraz v. Lincoln Electric Co. and the Expansion of Daubert Reviewing Authority,” 53 B.C. L. Rev. 195 (2012) (student review that mistakenly equates current Rule 702 law with the Supreme Court’s 1993 Daubert decision, while ignoring subsequent precedent and revision of Rule 702).

[2] In the welding fume litigation, inspired by the money and tactics of ex-convict Richard Scruggs, plaintiffs’ counsel adopted a dual strategy of co-opting a local treating physician, and alternatively, having their ready, willing, and able retained expert witness, Dr. Paul Nausieda, claim that he had created a physician-patient relationship with the claimant.

 

More Case Report Mischief in the Gadolinium Litigation

November 28th, 2014

The Decker case is one curious decision, by the MDL trial court, and the Sixth Circuit. Decker v. GE Healthcare Inc., ___ F.3d ___, 2014 FED App. 0258P, 2014 U.S. App. LEXIS 20049 (6th Cir. Oct. 20, 2014). First, the Circuit went out of its way to emphasize that the trial court had discretion, not only in evaluating the evidence on a Rule 702 challenge, but also in devising the criteria of validity[1]. Second, the courts ignored the role and the weight being assigned to Federal Rule of Evidence 703, in winnowing the materials upon which the defense expert witnesses could rely. Third, the Circuit approved what appeared to be extremely asymmetric gatekeeping of plaintiffs’ and defendant’s expert witnesses. The asymmetrical standards probably were the basis for emphasizing the breadth of the trial court’s discretion to devise the criteria for assessing scientific validity[2].

In barring GEHC’s expert witnesses from testifying about gadolinium-naive nephrogenic systemic fibrosis (NSF) cases, Judge Dan Polster, the MDL judge, appeared to invoke a double standard. Plaintiffs could adduce any case report or adverse event report (AER) on the theory that the reports were relevant to “notice” of a “safety signal” between gadolinium-based contrast agents in MRI and NSF. Defendants’ expert witnesses, however, were held to the most exacting standards of clinical identity with the plaintiff’s particular presentation of NSP, biopsy-proven presence of Gd in affected tissue, and documentation of lack of GBCA-exposure, before case reports would be permitted as reliance materials to support the existence of gadolinium-naïve NSF.

A fourth issue with the Decker opinion is the latitude it permitted the district court to allow testimony from plaintiffs’ pharmacovigilance expert witness, Cheryl Blume, Ph.D., over objections, to testify about the “signal” created by the NSF AERs available to GEHC. Decker at *11. At the same trial, the MDL judge prohibited GEHC’s expert witness, Dr. Anthony Gaspari, to testify that the AERs described by Blume did not support a clinical diagnosis of NSF.

On a motion for reconsideration, Judge Polster reaffirmed his ruling on grounds that

(1) the AERs were too incomplete to rule in or rule out a diagnosis of NSF, although they were sufficient to create a “signal”;

(2) whether the AERs were actual cases of NSF was not relevant to their being safety signals;

(3) Dr. Gaspari was not an expert in pharmacovigilance, which studied “signals” as opposed to causation; and

(4) Dr. Gaspari’s conclusion that the AERs were not NSF was made without reviewing all the information available to GEHC at the time of the AERs.

Decker at *12.

The fallacy of this stingy approach to Dr. Gaspari’s testimony lies in the courts’ stubborn refusal to recognize that if an AER was not, as a matter of medical science, a case of NSF, then it could not be a “signal” of a possible causal relationship between GBCA and NSF. Pharmacovigilance does not end with ascertaining signals; yet the courts privileged Blume’s opinions on signals even though she could not proceed to the next step and evaluate diagnostic accuracy and causality. This twisted logic makes a mockery of pharmacovigilance. It also led to the exclusion of Dr. Gaspari’s testimony on a key aspect of plaintiffs’ liability evidence.

The erroneous approach pioneered by Judge Polster was compounded by the district court’s refusal to give a jury instruction that AERs were only relevant to notice, and not to causation. Judge Polster offered his reasoning that “the instruction singles out one type of evidence, and adds, rather than minimizes, confusion.” Judge Polster cited the lack of any expert witness testimony that suggested that AERs showed causation and “besides, it doesn’t matter because those patients are not, are not the plaintiffs.” Decker at *17.

The lack of dispute about the meaning of AERs would have seemed all the more reason to control jury speculation about their import, and to give a binding instruction on AERs and their limited significance. As for the AER patients’ not being the plaintiffs, well, the case report patients were not the plaintiffs, either. This last reason is not even wrong[3]. The Circuit, in affirming, turned a blind eye to the district court’s exercise of discretion in a way that systematically increased the importance of Blume’s testimony on signals, while systematically hobbling the defendant’s expert witnesses.


[1]THE STANDARD OF APPELLATE REVIEW FOR RULE 702 DECISIONS” (Nov. 12, 2014).

[2]Gadolinium, Nephrogenic Systemic Fibrosis, and Case Reports” (Nov. 24, 2014).

[3] “Das ist nicht nur nicht richtig, es ist nicht einmal falsch!” The quote is attributed to Wolfgang Pauli in R. E. Peierls, “Wolfgang Ernst Pauli, 1900-1958,” 5 Biographical Memoirs Fellows Royal Soc’y 175, 186 (1960).

 

Expert Witness Mining – Antic Proposals for Reform

November 4th, 2014

Law Reviews and Altered States of Reality

In 2008, Justice Breyer observed wryly that “there is evidence that law review articles have left terra firma to soar into outer space”; and Judge Posner has criticized law review articles for the “silly titles, the many opaque passages, the antic proposals, the rude polemics, [and] the myriad pretentious citations.” In 2010, Justice Scalia, who was a law-review-producing law professor for the University of Virginia for several years, responded to a lawyer’s oral argument, in McDonald v. City of Chicago, by suggesting that the argument had no support in Supreme Court precedent, but the unsupported argument would make the lawyer the “the darling of the professoriate.” At the June 2011 Fourth Circuit Judicial Conference, Chief Justice Roberts opined that law reviews are generally not “particularly helpful for practitioners and judges.”  In his words:

“Pick up a copy of any law review that you see and the first article is likely to be, you know, the influence of Immanuel Kant on evidentiary approaches in 18th-century Bulgaria, or something, which I’m sure was of great interest to the academic that wrote it, but isn’t of much help to the bar.”

See Debra Cassens Weiss, “Law Prof Responds After Chief Justice Roberts Disses Legal ScholarshipAm. Bar Ass’n J. (July 07, 2011). Lawyers would think the Justices view law review scholarship as a useless but generally harmless activity. Sometimes, however, law review articles can actually be harmful.

Selection Effects in the Retention and Presentation of Expert Witnesses

The complaints about law review scholarship are obviously based upon extremes and travesties. Interestingly, Judge Posner himself has been no slacker when it comes to producing law review articles with “antic proposals.” See, e.g., Richard A. Posner, “An Economic Approach to the Law of Evidence,” 51 Stan. L. Rev. 1477, 1541–42 (1999). In the tradition of non-traditional, rationalist proposals that ignore experience and make up something completely untested, Judge Richard Posner has advocated rule changes that would require lawyers

“to disclose the name of all the experts whom they approached as possible witnesses before settling on the one testifying. This would alert the jury to the problem of ‘witness shopping’.”

Posner, 51 Stan. L. Rev. at 1541. The point of Judge Posner’s radical reform is to alert triers of fact to whether the expert witness testifying is the first, or the umpteenth expert witness interviewed before a suitable opinion had been “procured,” so that the fact finder can draw the“ reasonable inference” that the case must be weaker than presented if the party went through so many expert witnesses before coming up with one who would testify in the case. If one party disclosed but one expert witness, the one that actually testified, and the other party disclosed X such witnesses (where X >1), then the fact finder could find in favor of the first party upon the basis of the so-called reasonable inference.

Posner’s proposal is at best a proxy for accuracy and validity in expert witness opinion testimony, and one for which Posner presents no evidence to support his hoped-for improvement in juridical accuracy. Not only does Judge Posner present no evidence that his proposed reform and suggested inference would be in the least bit reasonable and probative of the truth, he fails to address the obvious incentives that would be created by his proposal. Fearing the prejudicial inference from having consulted with “too many” expert witnesses, lawyers, operating under the Posner Rule, would have strong incentives to go to the expert witness “one-stop-shopping” mall, where they know they can obtain expert witnesses guaranteed to align themselves with the needed litigation positions and claims. The Posner Rule would also give a strong advantage to lawyers more skilled in vetting and selecting expert witnesses, to the detriment of less experienced lawyers. Of course, lawyers who are willing to go shopping at the meretricious mall or to employ a “cleaner” who brokers the selection without footprints might escape the bite of the Posner adverse inference.

Posner’s proposed rule ignores what is at the heart of identifying and selecting expert witnesses to testify. Obviously lawyers must identify potential witnesses with suitable expertise to address the issues raised by the litigation. Database searches, such as PubMed and Google Scholar searches for bio-medical experts, can go a long way towards identifying candidates, but interviews are important as well. Posner would chill lawyers’ effective representation by placing an adverse inference upon their diligence in any contact with the person other than the “one” who will be anointed to be the party’s designated testifier.

Meetings and interviews with prospective expert witnesses to ascertain whether the witness candidate has sufficient time and interest in fulfill the litigation assignment. Expertise in the area is hardly a guarantee that the candidate will be interested in answering the specific questions that are contested in the litigation. The lawyers must also ascertain whether the witness candidate has the stamina, patience, and aptitude for the litigation context. Not all real experts do, and the consequences of engaging an expert who does not have the qualities to make a good expert witness can be disastrous. Witness candidates must also be screened for their communication skills, their appearance, and even basic hygiene. The most brilliant expert who mumbles, or who is unkempt, is useless in litigation.

Lawyers must evaluate witness candidates for conflicts of interest, many of which are unknowable until there is a face-to-face meeting. Does the witness candidate have a significant other or child who works for the litigation industry (plaintiffs’ bar) or for the defendant industry under assault in the litigation at hand? Either way, the candidate may be compromised. Was the candidate mentored by an expert witness on the other side? Is the candidate on an editorial board with the adversary’s witnesses? Is the candidate close personal friends of the adversaries or their witnesses, such that he will be less than enthusiastic in showing the infirmities of the other side’s positions? Any of these questions could lead to answers that practically disqualify a witness candidate from consideration. Proceeding without such vetting could be catastrophic for the client and counsel. Burdening the vetting process with the threat of an adverse inference is deeply unfair to diligent counsel trying to represent and serve their clients.

And there are yet additional considerations that require exploration with any witness candidate. Expert witnesses are not equally able to deal with adverse authority in the form of a noted scientist who has taken a stand on the litigation issue, or a superficially appearing authoritative author who has published an adverse opinion. As well trained as they might be, some real experts are “sheep,” who are most comfortable following the herd, and not independent thinkers. Not all experts are willing or able to read studies as critically as needed for the litigation situation, which can sometimes be more demanding than the scientific arena. Lawyers charged with retaining expert witnesses must assess their clients’ positions and determine how well their expert witnesses will perform under all the circumstances of the case.

Professor Christopher Robertson proposes an even more radical reform of the law of expert witness by removing the selection and control of expert witnesses from parties and their counsel, completely. Robertson would somehow create a pool of expert witnesses on the issues in each case, and assign them to parties in a double-blinded randomized fashion. Christopher Tarver Robertson, “Blind Expertise,” 85 N.Y. Univ. L. Rev. 174, 211 (2010). Aside from depriving litigants of autonomy and control over their cases, this approach has even greater potential for generating false results. How do the expert witness come to be retained for this process? Any two expert witnesses may very well come to an incorrect analysis precisely because they do not have the benefit of each other’s report to develop the full range of data to be considered. What if the expert assigned to plaintiff concludes that there is no case, but the expert assigned to the defendant concludes that the plaintiff’s case is meritorious? Normally, plaintiffs’ expert witnesses must file their reports in advance of the defense witnesses, who then have the opportunity to rebut but also the benefit of all the data included. Simultaneous reports risk major omissions of data to be considered on both sides. The adversarial cauldron works to ensure completeness in what data and studies are considered.

Now comes Jonah Gelbach to attempt a probabilistic, theoretical defense of reforms in the Posner-Robertson mold. Jonah B. Gelbach, “Expert Mining and Required Disclosure,” 81 U. Chicago L. Rev. 131 (2014). Professor Gelbach is a well-trained economist, and a recently minted lawyer (Yale 2013), who is now an Associate Professor at the University of Pennsylvania Law School. Gelbach’s experience with the practice of law is limited to working as a law-school intern at David Rosen & Associates, in New Haven, Connecticut, before joining the Penn faculty. His proposals may need to be taken with a 100 grains of aspirin.

Although Gelbach disagrees with particulars of the Posner-Robertson proposals, Gelbach joins with them to opine that “[t]o the extent that additional fully disclosed expert testimony increases the fact finder’s information, we can expect a beneficial increase in accuracy.” Gelbach at 133. Gelbach’s dictum, however, is an ipse dixit, and he offers only a limited hypothetical case in which full disclosure of data should be required to solve the problem. And even in his hypothetical case, the disclosure of the identities of the testers is unnecessary to correct the error that Gelbach predicts. Gelbach’s call for the disclosure of consulting expert witnesses introduces only a collateral issue that has nothing to do with the accuracy of the scientific reasoning.

Gelbach analogizes “witness shopping” to data dredging and multiple testing, with a known inflation in the rate of false positive outcomes. If a party directs multiple to conduct single outcome measurements or tests, then that party can recreate the results of multiple testing without having to disclosure the number of independent tests. Gelbach’s argument is at its strongest for a simplistic model of a simple measurement, with errors normally distributed, with accuracy of the measurement tied to the outcome of the case. Gelbach at 136. Gelbach analogizes expert witness mining with data mining, and goes so far as to provide a calculation of false positive rates from multiple testing.

The sort of multiple testing Gelbach condemns is even more obvious when something other than random error is involved. Consider the need of litigants to have chest radiograph interpreted for the presence or absence of a pneumoconiosis in occupational dust disease litigation. Not only is there an intra-observer variability, there are potential or known subjective biases in radiograph interpretations. Gelbach need not worry about multiple testing because the need for economic efficiency already encourages many lawyers to employ radiologists who are must biased in favor of their clients’ positions. The bigger problem would be to encourage lawyers to obtain an honest second opinion, which might make them less strident about their litigation positions when discussing possible settlement.

Gelbach appears to believe that mandatory disclosure of the number of expert witnesses hired as well as the contents of the written and oral reports issued by the party’s nontestifying expert witnesses is needed to abate the potential harm from “expert mining.” By introducing the probabilistic modeling of Type I and Type II errors, however, Gelbach elevates proofiness over clear thinking about the issue. The simple solution to Gelbach’s soil measurement hypothetical is to require disclosure of all testing data, regardless whether conducted by expert witnesses designated as testifying or as consulting. All are agents of the party for purposes of creating data in the form of the hypothesized soil measurement. Indeed, Gelbach’s hypothetical envisions a technical laboratory that conducts such measurements, and the lab might not even be associated with a person designated to serve as an expert witness on the litigation issues.

Gelbach’s soil-measurement case is thus, for the most part, a straw-person case. In the vast majority of cases, multiple expert witness interviews leading up to selection and retention is, however, not at all like multiple testing, either in its ability to generate deliberate false positive or false negative opinions. The evidence remains what it is, and the parameter unchanged, whatever the qualitative judgments of the witness candidates. In most litigation contexts, the data upon which the expert witnesses will rely comes from published studies, and not from a single measurement under either side’s control and ability to resample many times through the agency of multiple expert witnesses. The Rules need to help the triers of fact discern the truth, not irrelevant proxies for the truth. If the triers of fact are incompetent to adjudge the actual evidence, then we may need to find triers who are competent.

The extension of the soil hypothetical to all of expert witness opinion testimony is unwarranted. Accuracy and validity of expert opinion is not “independent and identically distributed.” Truth and accuracy in scientific judgment as applied to litigation scientific questions are not random variables with known distributions.

A party may have to comb through dozens of potential expert witnesses before arriving at an expert witness with an appropriate, accurate answer to the litigation issue. When confronted with a pamphlet entitled “100 Authors against Einstein,” Albert Einstein quipped “if I were wrong, one would have been enough.”  See Remigio Russo, 18 Mathematical Problems in Elasticity 125 (1996) (quoting Einstein). Legal counsel should not have their clients’ cause compromised because they had the misfortune of consulting the “100 Authors” before arriving at Einstein’s door. The Posner-Robertson-Gelbach proposals all suffer the same flaw: they defer unduly to conformism and ignore the truth, validity, and accuracy of procured opinions.

Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the number of speakers. The number of expert witness candidates who were interviewed or who offered preliminary opinions is irrelevant to the task assigned to the finder of fact in a case involving scientific evidence. The final, proffered opinion of the testifying expert witness is only as good as the evidence and analysis upon which it rests, which under the current rules, should be fully disclosed.

Can Expert Bias and Prejudice Disqualify a Witness From Testifying?

October 11th, 2014

The Center for Science in the Public Interest (CSPI) bills itself as a consumer advocate committed to research and education in sound science. The CSPI considers itself to be “one of the nation’s top consumer advocates,” which works to “ensure that science is used to promote the public welfare.”

You may wonder whether and why “science” turns out to promote the public welfare envisioned by the CSPI? According to the CSPI, you should just accept that it does. So sure is the CSPI that industry corrupts science that it features a web-based, open database of scientists with ties to industry. There is no database of scientists’ ties to the litigation industry (plaintiffs’ lawyers), to organized labor, or advocacy groups. No doubt, implicit in its choice, is the claim that all science done by scientists with “ties” to the plaintiffs’ bar, to labor, or to advocacy groups, is “in the public interest.”

The arrogance of the implicit claim is made even more clear by how the CSPI addresses supposed corruption and conflicts of interest in science. The CSPI features an Integrity in Science Project to ferret out corruption in science, but the Project concerns itself only with industry-sponsored and funded science. The Project is candid about its one-sided jihad against industry-based science:

“Although many have cheered partnerships between industry and the research community, it is also acknowledged that they entail conflicts of interest that may compromise the judgment of trusted professionals, the credibility of research institutions and scientific journals, the safety and transparency of human subjects research, the norms of free inquiry, and the legitimacy of science-based policy.

For example:

  • There is strong evidence that researchers’ financial ties to chemical, pharmaceutical, or tobacco manufacturers directly influence their published positions in supporting the benefit or downplaying the harm of the manufacturers’ product.
  • A growing body of evidence indicates that pharmaceutical industry gifts and inducements bias clinicians’ judgments and influence doctors’ prescribing practices.
  • There are well-known cases of industry seeking to discredit or prevent the publication of research results that are critical of its products.
  • Studies of life-science faculty indicate that researchers with industry funding are more likely to withhold research results in order to secure commercial advantage.
  • Increasingly, the same academic institutions that are responsible for oversight of scientific integrity and human subjects protection are entering financial relationships with the industries whose product-evaluations they oversee.

In response to the commercialization of science and the growing problem of conflicts of interest, the Integrity in Science Project seeks to:

  • raise awareness about the role that corporate funding and other corporate interests play in scientific research, oversight, and publication;

  • investigate and publicize conflicts of interest and other potentially destructive influences of industry-sponsored science;

  • advocate for full disclosure of funding sources by individuals, governmental and non-governmental organizations that conduct, regulate, or provide oversight of scientific investigation or promote specific scientific findings;

  • encourage policy-makers at all levels of government to seek balance on expert advisory committees and to provide public, web-based access to conflict-of-interest information collected in the course of committee formation;

  • encourage journalists to routinely ask scientists and others about their possible conflicts of interests and to provide this information to the public.”

The CSPI inquiry then is entirely one-sided, with no apparent or manifest interest in exploring and revealing conflicts created by scientists’ affiliations with advocacy groups, labor, or the litigation industry. The concern about conflicts of interests is, in my view, simply an attempt to disqualify industry-sponsored scientific studies from inclusion in policy discussions. To be sure, there are notorious examples of industry-sponsored, compromised studies. But there are similarly notorious examples of union and plaintiff-lawyer sponsored studies gone awry. Why then is there no concern at the CSPI about researchers’ ties with advocacy groups, labor unions, and most important, and the litigation industry? The obvious answer is that the CSPI is engaging in advocacy for certain conclusions. The CSPI wants to put its hand on one side of the balance, and do its best to ensure that scientific debates and discussions come out a certain way, a way that favors conclusions it desires. The CSPI wants to disqualify dissenters from the conversation. The so-called “Integrity” project thus appears to be a pretense, exactly the opposite of what it purports to be.

In 2004, the CSPI’s Integrity in Science Project sponsored a conference on, among other topics, Corporate and Government Suppression of Research. Actually, there was barely any discussion of governmental suppression; the speakers spoke almost entirely on corporate conduct.

One speaker on the panel presented about corporate conflicts of interest in the starkest Marxist terms. Corporations must cheat and lie because they are capable only of acting to maximize profits, and they will inevitably see safety as a dispensable cost. The speaker, who is a frequent testifier in mass tort litigation, held forth that the problem with corporations is not that there are some rotten apples, but that the entire barrel is rotten. Suppression of scientific research, according to this speaker is not an anomaly, but totally determined by the nature of the firm. Ethical companies cannot compete, and they go out of business; ergo, any company in business is unethical.

Of course, the same uncharitable determinist views can be applied to expert witnesses, to plaintiffs’ counsel, to labor unions, and to advocacy groups. Remarkably, this speaker acknowledged that is ideology is a much larger bias than money, and then confessed that

My bias is ideological.”

This speaker testifies frequently for the litigation industry, and his zeal is so uncabined that he has been held in contempt and fined as part of his litigation activities. When one federal court judge excluded his testimony, he attacked the bona fides of the judge and sought to appeal his exclusion personally. And yet the Integrity project featured him as a speaker!

The CSPI and its cadre of anti-industry scientists brings me to the question du jour: Can an expert witness be too biased or prejudiced in a matter to serve as an expert witness? We exclude judges and jurors who have potential conflicts of interest. Surely there are fact or expert witnesses, who are so untrustworthy that they should not be allowed to testify. Consider whether an expert witnesses who, having demonstrated that they will violate court orders or other laws, want the court to qualify them as “expert witnesses” to give their opinions in a pending case. The trial court does not necessarily endorse the opinions proffered, but should the court give its imprimatur to the witnesses’ standing as having opinions that could be considered, relied upon to the exclusion of competing opinions, and form the basis for verdicts for the parties offering these suspect witnesses?

Just asking.

Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas

October 4th, 2014

Since 1663, the Royal Society has sported the motto:  “Nullius in verba,” on no one’s authority. The motto is a recognition that science, and indeed, all of knowledge turns on data properly collected, analyzed, and interpreted, and not on the prestige or authority of the speaker. In England today, there could be no better example of the disconnect between authority and knowledge than the pronouncements of Crown Prince Charles on science and medicine[1].

Although science should be about the data and methodology, the growing complexity and inaccessibility of modern science has fostered greater reliance upon reputation of researchers as a proxy for the correctness of factual statements. In some quarters, scientists are held up as shamans who are lionized and revered, at least when the scientists are advancing research and conclusions that are politically approved. When the scientists conduct research that threatens politically correct beliefs, then the scientists must be attacked, diminished, and discredited. Because the scientific claims at issue involve evidence and hard thought, the attackers and defenders seem to prefer proceed with ad hominem attacks on the personal standing and credibility of scientists whose work they embrace or distain.

The sad truth is that the persistence of interpreting science by personal charm, credibility, and political correctness of scientists’ personality remains as a legacy of our authority-based approach to knowledge. As a result, we have the spectacle of public intellectuals who complain about the demonization of scientists, while in the next breath, demonize scientists whose work threatens their political and personal preferences[2].

It would be lovely if we could ignore attacks on the personal credibility of researchers, but the sociology of knowledge and science requires us to acknowledge that reputation, prestige, and authority remain as determinants of belief. The more political and personal preferences are involved, and the greater the complexity of the underlying scientific analysis, the more we should expect people, historians, judges, and juries, to ignore the Royal Society’s Nullius in verba,” and to rely upon the largely irrelevant factors of reputation.

We would thus be on a fool’s errand not to pay attention to the social construction of reputation, both in terms of how reputations are created and how they are diminished. I have focused on Irving Selikoff, because he is such a difficult case. For virtually every advance in the scientific understanding of asbestos health effects, Selikoff did not have priority. Sir Richard Doll was ahead of Selikoff by a decade in reporting the epidemiologic association between asbestosis and lung cancer.[3] Christopher Wagner was ahead of Selikoff by several years in describing the association between amphibole asbestos and mesothelioma[4]. And the United States Navy was ahead of Selikoff in terms of detailing the difficulty in controlling confined-space asbestos lagging operations onboard ships, and the consequent asbestosis hazards[5].

Much of Selikoff’s asbestos work that was original was wrong. His advocacy of a connection between asbestos and extrapulmonary cancers, his claim that all asbestos varieties were equivalent in potency for causing mesothelioma, and his risk assessments of total attributable asbestos risks are just some examples of where Selikoff outran his scientific headlights. Still, the United States public owes Selikoff a debt of gratitude for having popularized and disseminated information about asbestos hazards at a crucial time in our history. Although Doll and Wagner had priority with respect to lung cancer and mesothelioma, they both wrote in foreign journals about exposures that were typical in the U.K. and South Africa. And while the Navy’s understanding of its own catastrophic neglect of safety in its shipyards came before Selikoff’s publications, the Navy’s coyness kept its information from being widely disseminated. Selikoff, in his 1964 publication[6], in an American journal, the Journal of the American Medical Association, thus incorporated a good amount of prior learning and showed that asbestos was a problem among asbestos insulators in the United States. At the time, insulators were often thought of as having relatively low-level asbestos exposure. Furthermore, Selikoff used his findings of asbestos-related disease among the union insulators to advance a political goal, the federalization of workplace safety and health regulation. That goal ultimately came to have bipartisan support in the United States, largely as a result of Selikoff’s advocacy.

Selikoff’s legitimate achievements should not be diminished, and historians McCulloch and Tweedale are correct to bemoan the ad hominem attacks on Selikoff, based upon ethnicity and personal characteristics. They are wrong, however, to claim that Selikoff’s training, scientific acumen, advocacy, and false positive claims are somehow off limits. Selikoff’s substantial contributions to public health by publicizing the dangers of high exposure, long-term exposure to exposure do not privilege every position he took.  Selikoff is a difficult case because he was wrong on many issues, and his reputation, authority and prestige ultimately became much greater than the evidence would ultimately support.

The labor historians and anti-asbestos zeolots are right to bristle and emote when historians and others challenge the reputation of Irving Selikoff. Like Rachel Carson and Wilhelm Heuper, Selikoff is one of the icons of the environmental and occupational safety movement. Environmentalists, labor leaders, and left-leaning politicians, have invested heavily in Selikoff’s reputation and authority to support legislation and regulations. Given Selikoff’s reputation and prestige in the field of asbestos health effects, and his role in helping pass the Williams-Steiger Act of 1969, we might wonder why no one has written a full-length biography. There are some hagiographic articles to be sure, but a full-length biography would raise questions not politely answerable.

Selikoff the Testifier

Selikoff may have been a media plodder in the mid-1950s, but his experience as a testifying witness made him particularly effective in advancing his advocacy on behalf of the asbestos and other unions in the 1960s and forward. See “Medical Horizons,” Broadcasting * Telecasting at 14 (Nov. 21, 1955) (describing Selikoff as a plodding presenter). Those who would lionize Selikoff, and privilege his claims from evidence-based scrutiny, are embarrassed by his frequent testifying. They are, however, wrong to distort Selikoff’s record of participating in the litigation process. He had an obligation to do so, to some extent. Many physicians gladly would avoid the courtroom confrontations that Dr. Selikoff undertook. Despite these feelings, physicians have an ethical obligation, by virtue of their special training and experience, to assist in the administration of justice[7]. Indeed, the Board of Trustees of the American Medical Association has recommended that the presentation of expert testimony should be considered part of the practice of medicine and thus subject to peer review[8]. Ultimately, the courtroom testimony should be judged for the validity of its conclusions just as any other scientific opinion would be.

Of course, frequent testifying can be undertaken for venal or political purposes, and the reputation makers behind Selikoff have been keen to protect him from charges of being a “frequent testifier.” Much of protection probably took place because Selikoff’s testifying took place in the past before electronic files of transcripts could circulate rapidly, and even minor cases were posted to internet databases. Thus, Judge Jack Weinstein, writing after the death of Dr. Selikoff, could incorrectly describe him as an “independent” scientist, who should not be coerced to testify when he preferred to publish his “results only in scientific journals.” Jack B. Weinstein, Individual Justice in Mass Tort Litigation:  The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995).

Judge Weinstein was clearly wrong in his assessment that Selikoff preferred scholarly journals to the courtroom, but his assessment reflects the influence of the reputation that Selikoff and his followers worked so hard to create. Of course, Judge Weinstein was also wrong to suggest that Selikoff was “independent.” He had deep ties to unions, the plaintiffs’ bar, a cadre of plaintiffs’ expert witnesses, and to positions to which all these groups subscribed. The greatest art is that which conceals itself[9].

Selikoff’s participation in litigation proceedings has thus become a debating point between those who would acclaim and those who would detract from Selikoff’s reputation. Oxford University historian Peter Bartrip, for one, noted that Selikoff had testified frequently. Peter W.J. Bartrip, Beyond the Factory Gates: Asbestos and Health in Twentieth Century America 77 & n.4 (2006); Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003). Bartrip’s history has in turn been attacked by the Lobby of anti-asbestos zealots. Marxist historians Jock McCulloch and Geoffrey Tweedale, and others, have attacked Bartrip for serving as an apologist for industry, and have suggested, in their publications, that Selikoff testified infrequently:=

“[Selikoff] gave testimony in two of the early landmark legal cases, but thereafter avoided the drama of the courtroom and the role of the expert witness, not only because it would have been a drain on his time and made his confidential trade union medical files open to legal scrutiny, but also because he felt that antagonizing industry would not help his broader agenda.”

Jock McCulloch & Geoffrey Tweedale, Defending the Indefensible : The Global Asbestos Industry and its Fight for Survival: The Global Asbestos Industry and its Fight for Survival 95 & n.36 (2008).

Two and only two; or two and then some? What was McCulloch and Tweedale’s source? They cite a personal communication from one of Selikoff’s protégés and acolytes, Dr. Stephen Levin, who testified frequently on behalf of asbestos claimants in litigation, and who no doubt shared the authors’ desire to protect and enhance Dr. Selikoff’s reputation. Perhaps more interesting is Levin’s revelation that Selikoff wished to hide his “confidential” union files from scrutiny. SeeThe Selikoff – Castleman Conspiracy (Mar. 13, 2011) (describing memorandum, dated November 5, 1979, from plaintiffs’ expert witness Barry Castleman to Selikoff urging resistance to lawful discovery attempts to obtain information about asbestos workers union).

Well, who is right? Did Selikoff testify frequently or not? On this point, McCulloch and Tweedale appear to be demonstrably wrong. I have previously pointed out some of Selikoff’s testimonial adventures[10]. See Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

There are other instances, however, of Selikoff’s medico-legal activities. According to Jon Gelman, a worker’s compensation lawyer in New Jersey, his father, also a New Jersey lawyer, employed Dr. Selikoff, in the early 1950s, as an expert witness in the “original 17” UNARCO (Union Asbestos and Rubber Co.) asbestos worker claims.  Gelman reports that these claims were successfully litigated with Selikoff’s examinations and services, in front of the New Jersey Division of Workers’ Compensation.  Jon L. Gelman, “Dr. Yasunosuke Suzuki, A Pioneer of Mesothelioma Medical Research” (Nov. 23, 2011); Jon L. Gelman, History of Asbestos and the Law (Jan. 02, 2001). See also Michael Nevins, Meanderings in New Jersey’s Medical History 146-47 (2011). Unfortunately, the reports and transcripts of the UNARCO 17 cases are not available.

For about two decades after the UNARCO 17,  Selikoff went on to have an active testimonial career, always testifying for the claimant, and against the employer or the supplier. In 1972, Andrew Haas, President of the asbestos workers union thanked Selikoff for his “frequent” expert witness testimony on behalf of union members. Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972)[11].

In addition to the cases cited in the footnotes, Selikoff testified or was involved as an expert witness in other cases. See, e.g., Babcock & Wilcox, Inc. v. Steiner, 258 Md. 468, 471, 265 A.2d 871 (1970) (affirming workman compensation award for asbestosis); Culp Industrial Insulation v. Commonwealth of Pennsylvania Workmen’s Compensation Appeal Board, 57 Pa. Commonwealth Ct. 599, 601-602 (1981). One of the earliest reported decisions in which Selikoff testified as a party expert witness was in a federal court admiralty case, in which a seaman sued the ship owner for injuries allegedly sustained as a result of a slip and fall accident. No pulmonary injury was involved. Barros v. United States, 147 F.Supp. 340, 343-44 (E.D.N.Y. 1957) (noting that Dr. Selikoff testified for seaman suing for maintenance and cure as a result of a slip and fall; finding for respondent against libelant).

Perhaps the most egregious testimonial adventure was Selikoff’s serving as an expert witness, in 1966, for a union worker who claimed that his colon cancer had been caused by asbestos. What was remarkable about this testimony was not that it was for the worker; Selikoff’s testimony seemed always to be for the claimant. What stands out is how weak and unreliable any scientific claim for colon cancer would have been in 1966 (and after for that matter). Despite the insufficiency of the evidence, and the dubious validity of the early study relied upon, Selikoff’s participation helped obtain a favorable outcome, which led to the asbestos union’s praise for his efforts:

“The research into health hazards of insulation workers developed by the members of Local No. 12 and Local No. 32 has resulted in widening the basis of compensation claims in New York State.

Until now, the courts have been reluctant to accept many of the conditions to which insulation workers are prone, as related to employment. However, facts produced during the research investigations of Dr. 1. J. Selikoff, Dr. J. Churg, and Dr. E. Cuvler Hammond of the Environmental Sciences Laboratory of the Mt. Sinai Hospital in New York are resulting in a changing of this picture.

A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population.

Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the reviewed the matter and agreed with the Referee’s judgement and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”

“Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966). See Viskovich v. Robert A. Keasbey Co., 36 A.D.2d 665 (3d Dep’t 1971)(affirming decision of the Compensation Board in awarding an asbestos insulator benefits for colon cancer; Selikoff’s case or perhaps a subsequent claim). Historians will search long, hard, and unsuccessfully for any disclosure of Selikoff’s consultancies or his testimonies on the issue of asbestos and colorectal cancer in any of his publications on the issue, or any other asbestos issue.

Even after Selikoff stopped participating directly in the litigation process, he continued his interest in the outcome of litigation. This interest was both intellectual and practical. For instance, at the fall meeting of the Medical History Society of New Jersey, Selikoff gave a presentation on “Nellie Keershaws [sic] and Frederick Legrand,” two of the bellwether asbestos litigants, in the U.K., and the U.S., respectively. Irving J. Selikoff, “Nellie Keershaws and Frederick Legrand,” at Fall Meeting, UMDNJ-New Jersey Medical School, Newark, N.J. (Saturday, Oct. 8, 1988). See 9(1) MHSNJ Newsletter (Jan. 1989).

Nellie Kershaw was diagnosed with asbestosis in the early 1920s, but her employer, Turner Brothers Asbestos, refused to pay her compensation for disability and her ultimate death. The investigation into her death gave rise to the first set of Asbestos Industry Regulations, in the United Kingdom, in 1931. Frederick LeGrande was one of the first plaintiffs in a civil action against Johns-Manville, for asbestos-related disease. Frederick LeGrande v. Johns-Manville Prods. Corp., No. 741-57 (D.N.J. filed in 1957, by William L. Brach, attorney for plaintiff).

As McCulloch and Tweedale note, Selikoff became too politically vulnerable to continue his direct participation in litigation, but he did not cease his involvement altogether. After asbestos litigation went viral in the late 1970s, Selikoff encouraged his juniors at Mt. Sinai Hospital to testify on behalf of union members and other asbestos claimants. The roster of physicians who trained at Mt. Sinai, in Selikoff’s department, read like a “Who’s Who” of asbestos plaintiffs’ expert witnesses[12]. Indeed, Selikoff trained a generation of testifying expert witnesses for the plaintiffs’ bar.

Another measure of Selikoff’s influence in the litigation arena was his attempt to influence the litigation process by conducting an ex parte seminar for key judges, with responsibility for important cases or large dockets. Plaintiffs’ lawyers, with the collaboration of Selikoff’s protégés as their “expert witnesses,” persuaded school districts and property owners that they should sue for the costs of asbestos removal and abatement. Selikoff and his acolytes then called a meeting, “The Third Wave conference,” to reflect their concern about the alleged danger of asbestos in place. Philip J. Landrigan & H. Kazemi, eds. “The Third Wave of Asbestos Disease: Exposure to Asbestos in Place – Public Health Control,” 643 Ann. N.Y. Acad. Sci. (1991). Under cover of support from the Collegium Ramazzini, and with the active support and participation of organized labor and plaintiffs’ asbestos bar, Selikoff invited judges to what was clearly a lopsided medical conference, dominated by his acolytes and plaintiffs’ expert witnesses in the very cases in which the invited judges presided. The corrupt affair led to the disqualification of Judge James McGirr Kelly, who attended the conference. In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992); see Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself so as to Preserve the Appearance of Justice under 28 U.S.C.§ 455,” 38 Vill. L. Rev. 1219 (1993); W.K.C. Morgan, “Asbestos and cancer: history and public policy,” 49 Br. J. Indus. Med. 451, 451 (1992); see alsoHistorians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014).

Perhaps even more interesting than the public corruption is the scientific corruption that took place at the Third Wave Conference. McCulloch and Tweedale report that one scientist who attended, Dr. Bruce Case, was so upset about the nonsense spouted at the Conference that he wrote an angry letter to one of the leaders in occupational pulmonary medicine, Dr. J. Bernard L. Gee., to report that the conference was “a stage-managed piece of Broadway theater[13].” The controversy led to Julian Peto’s review of the Third Wave Conference papers, and writing to the President of Mt. Sinai Hospital Center to register his observation that many of the conference papers were scientifically “dubious” and systematically biased in favor of exaggerating the risks of asbestos in place[14].

McCulloch and Tweedale attempt to defend this (indefensible) incident in the history of asbestos litigation by claiming that Selikoff and his “team” of acolytes had not been invited to an earlier conference at Harvard, on the issue of asbestos property damage. Health Effects Institute, Asbestos in Public and Commercial Buildings: A Literature Review and Synthesis of Current Knowledge (1991); Jacqueline Karn Corn, Environmental Public Health Policy for Asbestos in Schools: Unintended Consequences at 115-16 (1999). Their complaint does not ring true, however. The so-called Harvard conference had the participation of a large group of independent experts[15] as well as some scientists from the inner sanctum of Mt. Sinai[16]. The world of science ultimately has not been kind to the Selikoff view of asbestos in place[17].

Historical perspective is much needed in considering Selikoff and his contributions, both good and bad. Even after his death, Selikoff remains an important player in the passion play of the American asbestos litigation and regulation[18], and any biographer who steps up to the task will have to confront all aspects of Selikoff’s long career, both scientific advances and missteps.


[1] See Steven Novella, “Prince Charles Alternative Medicine Charity ClosesScience-Based Medicine (May 16, 2012); Laura Donnelly, “Prince Charles makes plea on alternative medicine: Prince of Wales calls for alternative medicine to be treated fairly and for regulation to govern its use,” The Telegraph (Jan. 19, 2014).

[2] Compare Jock McCulloch & Geoffrey Tweedale, Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 619 (2007) (complaining that some historians have “demonized” Dr. Irving Selikoff as “a media zealot”); Jock McCulloch & Geoffrey Tweedale, “Science is not sufficient: Irving J. Selikoff and the asbestos tragedy,” 17 New Solutions 292 (2007); Jock McCulloch and Geoffrey Tweedale, Defending The Indefensible: The Global Asbestos Industry and its Fight for Survival (2008), with Geoffrey Tweedale, “Hero or Villain?—Sir Richard Doll and Occupational Cancer” 13 Internat’l J. Occup. Envt’l Health 233 (2007) (demonizing Sir Richard Doll for his affiliations and consultancies in the field of occupational cancer).

[3] Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,”  12 Br. J. Indus. Med. 81 (1955).

[4] See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).

[5] Capt. H.M. Robbins & William T. Marr, “Asbestosis,” 19 Safety Review 10 (1962) (noting that asbestos dust counts of 200 million particles per cubic foot were not uncommon during insulation ripouts onboard naval vessels, and the existence of asbestosis cases among workers).

[6] Irving J. Selikoff, Jacob Churg & E. Cuyler Hammond, “Asbestos Exposure and Neoplasia,” 188 J. Am. Med. Ass’n 22 (1964)

[7] American Medical Association Council on Ethical and Judicial Affairs Current Opinion 9.07 on Medical Testimony (1989); Council of Medical Specialty Societies, Statement on Qualifications and Guidelines for the Physician Expert Witness, (Approved March 20,1989); American College of Physicians, Guidelines for the Physician Expert Witness. Ann Intern Med 113:789, 1990; Ethics Committee, American College of Chest Physicians Guidelines for an Expert Witness. Chest 98:1006 (1990).

[8] AMA Board of Trustees, Proceedings: House of Delegates 149-154 (June 18-22,1989). See generally Nathan Schachtman & Cynthia Rhodes, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Seminars in Roentgenology 140 (1992).

[9] Quintilian, IV Institutio Oratoria 1.57 (“But to avoid all display of art in itself requires consummate art.”)

[10] Bradshaw v. Twin City Insulation Co. Ltd., Industrial Court of Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., E. D. Michigan Southern Division, Civ. Action No. 29433 (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Commonwealth Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973).

Selikoff also participated as a testifying witness for the government, in the Reserve Mining case. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D. Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D. Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D. Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D. Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

[11] See Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003) (citing Haas).

[12] Ruth Lilis, Albert Miller, Yasunosuke Suzuki, William Nicholson, Arthur Frank, Henry Anderson, Stephen Levin, Steven Markowitz, Jacqueline Moline, Susan Daum, et al.

[13] Jock McCulloch & Geoffrey Tweedale, Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 626 & n.33 (2007).

[14] Jock McCulloch & Geoffrey Tweedale, Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 626 & n34 (2007) (citing letter from Prof. Julian Peto to Dr. Thomas Chalmers, Mount Sinai Medical Center, June 28, 1990, from the Selikoff Archive, at Mount Sinai Hospital, NY).

[15] Arthur C. Upton, Jonathan Samet, Margaret R. Becklake, John M.G. Davis, David G. Hoel (of the National Institute of Environmental Health Sciences) Morton Lippmann, Gordon Gamsu, and Julian Peto

[16] William J. Nicholson and Arthur Langer, although Dr. Langer had by this time left Mt. Sinai.

[17] See, e.g., Philip H. Abelson, “The Asbestos Removal Fiasco,” 247 Science 1017 (1990).

[18] See Department of Labor, Occupational Safety and Health Administration, Final Rule re Docket No. H-033-dl Occupational Exposure to Asbestos, Tremolite, Anthophyllite and Actinolite, 29 C.F.R. Parts 1910 and 1926, 57 Fed. Reg 24310 (June 8, 1992) (rejecting Selikoff’s and the Lobby’s attempt to have cleavage fragments regulated as though they were fibers).