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THE COUNCIL FOR EDUCATION AND RESEARCH ON TOXICS

July 9th, 2013

When the Milward case hit the U.S. Court of Appeals for the First Circuit, it attracted the attentions of an amicus, the Council for Education and Research on Toxics (CERT). I had never heard of CERT before, and the amicus brief filed by CERT was rather sketchy on the nature of the organization.

A bit of research on CERT revealed the following. It is a non-profit California corporation, EIN: 42-1571530, founded in 2003. CERT has a business address at:

401 E Ocean Blvd., Ste. 800, Long Beach, California 90802-4967

And a telephone number: 1-877-TOX-TORT

CERT’s mission statement? Furthering scientific understanding of toxins.

Plaintiffs’ lawyer Ralph Metzger is noted as the contact person for CERT.

Given its phone number and its contact person, one might think that its mission statement was “furthering legal positions on toxins.”

But wait; it gets better. Ralphael Metzger, at the same Long Beach, California, address is the attorney for CERT on its amicus brief in Milward!

The potential conflicts grow deeper and wider. Metzger has represented CERT, which shares at least his offices, if not his alter ego, in lawsuits including CERT v. Brad Berry Co., Ltd., No. BC461182 (Cal. Super. Ct., Los Angeles County, Cent. Dist., filed May 9, 2011), and CERT v. Starbucks Corp., BC435759 (L.A. Super. Ct., filed April 13, 2010).

CERT has sued McDonald’s and Burger King over its claim that their french fries contained high levels of acrylamide, a chemical “known” to the State of California to cause cancer. CERT has sued Chemtura on claims that the company’s chemical fire-preventive products, known as PBDEs, cause injuries to wildlife and humans.

Although not definitive, it seems that CERT’s mission is not exactly scientific, and the description of its interests in its Milward brief just a tad misleading.

In addition to the CERT, the other amici joining the brief include:

Nicholas A. Ashford,
Nachman Brautbar,
David C. Christiani,
Richard W. Clapp,
James Dahlgren,
Devra Lee Davis,
Malin Roy Dollinger,
Brian G. Durie,
David A. Eastmond,
Arthur L. Frank,
Frank H. Gardner,
Peter L. Greenberg,
Robert J. Harrison,
Peter F. Infante,
Philip J. Landrigan,
Barry S. Levy,
Melissa A. McDiarmid,
Myron Mehlman,
Ronald L. Melnick,
Mark Nicas,
David Ozonoff,
Stephen M. Rappaport,
David Rosner,
Allan H. Smith,
Daniel Thau Teitelbaum,
Janet Weiss, and
Luoping Zhang

An interesting bunch; eh? Page two of the amicus brief tells us that:

“None of the amici has any financial or other similar interest in the outcome of this lawsuit. Amici appear on their own behalf to inform this Court of the substantial medical knowledge and understanding of leukemia arising from exposure to benzene.”

That’s probably true for the Milward case itself, but more interesting for what the disclosure does not say. Many of the amici have testified frequently in toxic tort cases, and several have been excluded by the straightforward application of Rule 702 or its state counterparts. Some have lost income as a result of judicial gatekeeping, and most have seen their advocacy science curtailed by such gatekeeping.

Appendix I to the brief provides further information on the amici, but there is no mention of their testimonial adventures, their financial stake in expert witnessing, or their political or positional commitments.

I suppose from CERT you get CERT-i-tude, a certain kind of attitude.

Posted in Conflicts of Interest, Rule 702 | Comments Off on THE COUNCIL FOR EDUCATION AND RESEARCH ON TOXICS

Trevor Ogden’s Challenge to the Lobby’s Hypocrisy

July 6th, 2013

Trevor Ogden, the editor of the Annals of Occupational Hygiene, addressed sharing of underlying research data in an editorial, a few years ago. See Trevor Ogen, “Data Sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth,” 53 Ann. Occup. Hyg. 651 (2009). Ogden was responding to attacks on industry-sponsored research and demands that the exposure data from such studies be made available as a condition of publication in the Annals.

Ogden reported that he was sympathetic, to an extent, with the attack on industry bona-fides, but that editorial board discussions raised several issues with data sharing:

“(1) The researcher puts a lot of effort into getting good exposure data and may have plans for their further use; also access to the unpublished data can be an asset in getting further grants.

(2) It takes time and effort to prepare data for publication, and in the short term the people who do this to make their data available are not the ones who benefit by their availability.

(3) There may be problems with confidentiality and liability for the workplaces where the measurements were obtained.

(4) The data may be misused; in particular, they may be reinterpreted by those with a commercial interest in undermining the conclusions drawn by the original researchers.”

Id. at 652.

Had Ogden stopped there, he might have been spared the unceremonious attacks by members of “The Lobby,” but he went further to point out that some of the accusers (David Michaels; McCullogh & Tweedale) were guilty of their own rhetorical excesses.

While acknowledging that industry has taken errant positions or distorted research data on occasions, Ogden thought it was important to note that:

“industry is not always wrong, and campaigners can overlook this because it is easier to identify the paymaster than judge the science.”

* * * *

“It is a mistake if we think that because the industry helped pay for the study and has exploited the findings in its propaganda, the results must necessarily be wrong—life, including science, is not this simple.”

Id. at 653 -54.

Ogden offered, as a scientist would, further alternative explanations for why industry-sponsored scientific research appears to yield results favorable to the sponsor:

“It seems that an industry-sponsored study is much more likely to find results favourable to industry, but this may partly or wholly be because non-industry researchers find it harder to publish negative or inconclusive results. Scientific studies must be judged primarily on the quality of the evidence, not on who pays for them.”

Id. at 654. Ogden might well have opened his mind to the possibility that some government agency and academic scientists may well be biased in favor of finding outcomes that support greater agency regulation and control of occupational and environmental exposures. In any event, Ogden interpreted the situation to require skepticism of all positions, both pro- and anti-industry:

“This is not a very encouraging picture. It looks as if we cannot trust industry, and its critics are not very reliable either.”

Ogden would thus not let any side off the hook when it came to disclosures of potential conflicts of interest:

“Declarations of interest in publications are essential, especially if the authors are likely to be involved in legal testimony. Failure to offer this must be treated very seriously.”

Id. at 655.

Even Ogden’s more modest alternative explanation and his balanced comments provoked shouts of outrage from “the Lobby.” See “The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013). Ogden, however, gave them ample space in which to voice their disagreements. See Celester Monforton, Colin Soskolne, John Last, Joseph Ladou, Daniel Teitelbaum , Kathleen Ruff, “Comment on: Ogden T (2009) ‘data sharing, federal rule of evidence 702, and the lions in the undergrowth’,” 54 Ann. Occup. Hyg. 365 (2010); Barry I. Castleman, Fernand Turcotte, Morris Greenberg, “Comment on: Ogden T (2009) ‘Data sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth’,” 54 Ann. Occup. Hyg. 360 (2010).

The remarkable thing about the Lobby’s letters to the editor is that they scolded industry for conflicts of interests, but failed to reveal their own. Celeste Monforton, for instance, declared her academic affiliations, but overlooked her connection with an anti-Daubert advocacy organization that is funded by left-over common-benefit trust fund money from the silicone gel breast implant litigation. See SKAPP A LOT (April 30, 2010). Monforton and all her co-authors did, however, report their membership in the Rideau Institute on International Affairs, a Canadian “non-profit” organization, established in 2007. They failed, however, to disclose that the Rideau Institute engages in lobbying and advocacy efforts for trade unions and “non-profits.” See Rideau Institute website (“The Rideau Institute is an independent research, advocacy, and consulting group based in Ottawa. It provides research, analysis and commentary on public policy issues to decision makers, opinion leaders and the public.”). Several of Monforton’s co-authors have testified, some frequently, for the litigation industry (plaintiffs) in occupational and environmental exposure cases. Daniel Thau Teitelbaum, for instance, was an early testifier in the silicone breast implant litigation, and was the subject of analysis in General Electric Co. v. Joiner, 522 U.S. 136 (1997).

Barry Castleman’s letter is even more offensive to its own stated principles of extirpating conflicted science. Castleman has been part of the litigation industry’s expert witness army in asbestos cases for over three decades.

Ogden’s statement of the problem was insightful, even if not definitive. His suggestion that “hostile” analysts should be kept from access to underlying data ignores the intense need for this access in areas of science that inform litigation and regulation. As George A. Olah pointed out in his Nobel Prize address, scientists need adversaries to keep them creative, focused, and accurate. Ogden’s call for disclosure of interests, “especially if the authors are likely to be involved in legal testimony,” ignores that litigants on both sides need access to scientific expertise on the issues that drive litigation and regulatory battles. More distressingly, however, Ogden’s journal let his interlocutors slide on their obligation to disclose their deep financial and positional conflicts of interests.

Posted in Conflicts of Interest, Scientific Evidence, Scientific Misconduct | Comments Off on Trevor Ogden’s Challenge to the Lobby’s Hypocrisy

The Mt. Sinai Catechism

June 7th, 2013

There are mythologies in science as there in religion. Back in the day, Dr. Irving Selikoff invented a catchy catechism about synergistic interaction between asbestos and smoking in producing lung cancer. Selikoff’s study of insulators advanced lung cancer point estimates for asbestos alone, for smoking alone, and for asbestos and smoking together: 5-10-50, which became incorporated in innumerable textbooks, articles, expert witness reports, and court opinions.

E. Cuyler Hammond, Irving J. Selikoff, and Herbert Seidman, “Asbestos Exposure, Cigarette Smoking and Death Rates,” 330 Ann. N.Y. Acad. Sci. 473, 487 (1979). Selikoff tells us that each insulator, starting in 1961, answered “a detailed questionnaire,” and later, repeat questionnaires on their smoking histories. Id. at 475.

“Of the 8220 men who answered the questionnaire, 891 (11%) said that they had never smoked regularly; 488 (6%) had a history of pipe or cigar smoking but never smoked cigarettes regularly and; 6841 (83%) were either current or ex-cigarette smokers. Some of the cigarette smokers also smoked pipes or cigars or had done so in the past.”

Id. at 481.

The 5 supposedly represented the relative risk of asbestos exposure alone in insulators who did not smoke; the 10 supposedly represented the relative risk of smoking alone in the non-insulator general population of smokers; and the 50 represented the relative risk of insulators who had smoked. Selikoff claimed that his data supported a multiplicative model of synergistic interaction between smoking and asbestos exposure.

Like other mythologies, there was a good bit of exaggeration and fabrication in Selikoff’s story. First, the non-smoking relative risk was based upon the observed risk ratio among insulators who “never smoked regularly.” Smoking data were collected by survey, and the actual questionnaires and definition have never been published or provided by Selikoff and his colleagues. Even taken at face value, “never smoked regularly” is not the same as non-smoker. Adding that the insulators union was widely engaged in personal injury litigation, and that the membership had a strong motive to downplay their smoking histories, this exposure information becomes suspect.

The non-asbestos smoking lung cancer point estimate (10) was equally dubious. The ten-fold risk statistic represented an average smoking lung cancer risk in the first Cancer Prevention Survey (CPS-1). The insulators who smoked were rarely average smokers, and the CPS-1 point estimate was superseded within a couple of years by the new, revised CPS-II overall smoking lung cancer point estimate that was greater than twenty. The CPS-II results were published in the 1980s and early 1990s, but Selikoff and his protégés contained to testify to the 5-10-50. See, e.g., Shopland, “Smoking-Attributable Cancer Mortality in 1991: Is Lung Cancer Now the Leading Cause of Death Among Smokers in the United States?” 83 J. Nat’l Cancer Inst. 1142 (1991).

These problems and others led astute authors to note their dissent from the simplistic multiplicative model. F. Douglas K. Liddell, “The Interaction of Asbestos and Smoking in Lung Cancer,” 45 Ann. Occup. Hyg. 341 (2001) (“Both cigarette smoke and inhaled asbestos fibres can cause lung cancer, but the assessment of how these agents act in combination is a matter of great difficulty.”)

Despite the serious problems with the multiplicative model, Selikoff’s wanton republication of the 5-10-50 data, and the popularity of these data with testifying expert witnesses and regulating agencies, cemented their use in litigation. Consider, for instance, how the orthodoxy infiltrated the ostensibly neutral Reference Manual on Scientific Evidence, which proclaimed the multiplicative synergy of smoking and asbestos in its second edition:

“Occupational asbestos exposure in nonsmokers increases the risk of lung cancer by a factor of about five, from about 11 per 100,000, for nonsmoking industrial workers not exposed to asbestos to about 58 per 100,000 for nonsmoking asbestos workers; a significant smoking history increases the rate of lung cancer by a factor of at least ten. See U.S. Surgeon Gen., U.S. Dep’t of Health & Human Servs., The Health Consequences of Smoking: Cancer and Chronic Lung Disease in the Workplace 216 (1985); see also Rodolfo Saracci, “The Interactions of Tobacco Smoking and Other Agents in Cancer Etiology,” 9 Epidemiologic Revs. 175, 176–80 (1987). Because the effects of smoking and asbestos are multiplicative for lung cancer, the population of smoking asbestos workers has a lung cancer incidence of 5 times 10, or 50 times the background rates, rather than the 15-fold increase predicted by adding the separate risks. See U.S. Surgeon Gen., U.S. Dep’t of Health & Human Servs., supra, at 216–17.”

Mary Sue Henifin, Howard M. Kipen, and Susan R. Poulter, “Reference Guide on Medical Testimony,” in Federal Judicial Center, Reference Manual on Scientific Evidence 439, 476 & n. 136 (2d ed. 2000). Dr. Kipen was a protégé of Dr. Selikoff. The reference to the multiplicative mantra was eliminated from the Third Edition of the Reference Manual.

Back in April of this year, some other Selikoff protégés were busy trying to rehabilitate the 5-10-50 mantra, with a new study. Science Daily earnestly reported news of the new study as though it were ground breaking. See “Asbestos Exposure, Asbestosis, and Smoking Combined Greatly Increase Lung Cancer Risk” (Apr. 12, 2013) (reporting on the in-press version of Steve Markowitz, Stephen Levin, Albert Miller, and Alfredo Morabia, “Asbestos, Asbestosis, Smoking and Lung Cancer: New Findings from the North American Insulator Cohort,” Am. J. Respir. & Critical Care Med. (2013)). Interestingly, only Stephen Levin, who died over a year ago, is listed as affiliated with the Mt. Sinai School of Medicine. Although some of the other authors had previous affiliations with Mt. Sinai, they are now listed at the Center for the Biology of Natural Systems, Queens College – CUNY.

Science Daily quotes lead author Markowitz as saying that “[t]he interactions between asbestos exposure, asbestosis and smoking, and their influence on lung cancer risk are incompletely understood.” It seems unlikely that this new article will shed much light on the problem. The authors claim to apply and extend Selikoff’s approach from previous publications. This new publication thus incorporates the serious problems that had afflicted Selikoff’s papers, especially his use of CPS-I to provide a point estimate for smoking alone (the alleged 10 in the 5-10-50 theory). Here is the abstract of the paper:

“Rationale

Asbestos, smoking, and asbestosis increase lung cancer risk in incompletely elucidated ways. Smoking cessation among asbestos-exposed cohorts has been little studied.

Objectives

To measure the contributions of asbestos exposure, asbestosis, smoking and their interactions to lung cancer risk in an asbestos-exposed cohort, and to describe their reduction in lung cancer risk when they stop smoking.

Methods

We examined lung cancer mortality obtained through the National Death Index for 1981-2008 for 2,377 male North American insulators for whom chest x-ray, spirometric, occupational and smoking data were collected in 1981- 1983 and for 54,243 non-asbestos exposed blue collar male workers from Cancer Prevention Study II for whom occupational and smoking data were collected in 1982.

Measurements and Main Results

Lung cancer caused 339 (19%) insulator deaths. Lung cancer mortality was increased by asbestos exposure among non-smokers [rate ratio = 3.6 (95% CI: 1.7-7.6)], by asbestosis among non-smokers [rate ratio = 7.40 (95% CI, 4.0-13.7], and by smoking without asbestos exposure [rate ratio = 10.3 (95% CI, 8.8-12.2)]. The joint effect of smoking and asbestos alone was additive [rate ratio = 14.4 (95% CI, 10.7-19.4)] and with asbestosis, supra-additive [rate ratio = 36.8 (95% CI, 30.1-46.0)]. Insulator lung cancer mortality halved within 10 years of smoking cessation and converged with that of never-smokers 30 years following smoking cessation.

Conclusions

Asbestos increases lung cancer mortality among non-smokers. Asbestosis further increases the lung cancer risk and, considered jointly with smoking, has a supra-additive effect. Insulators benefit greatly by quitting smoking.”

The big news that Steven Markowitz did not trumpet in the press releases was that in the absence of asbestosis, there was no multiplicative interaction. The asbestos-alone (point estimate) is still suspect. The paper characterizes this point estimate as applying to non-smokers without asbestosis, but given this group’s history of equivocating between “never smoked regularly” and “non-smoker,” and the difficulty in obtaining accurate smoking histories from men enmeshed in litigation over respiratory claims, the asbestos-alone point estimate remains doubtful. Curiously, the smoking histories were collected in 1981-83, but there is no mention of any attempt to verify the histories against smoking histories provided by the study participants in earlier versions of Selikoff’s studies on the insulators.

Similarly, the smoking-alone point estimate is incredible. The authors purport to draw the smoking-alone risk ratio from CPS-II; yet the risk ratio presented (10.3) is less than half that reported in multiple publications of the CPS-II study. Markowitz and colleagues cite to two papers for the 10.3 point estimate; neither appears to support this number. Steven Stellman & Lawrence, “Smoking habits and tar levels in a new American Cancer Society prospective study of 1.2 million men and women,” 76 J. Nat’l Cancer Inst. 1057 (1986); Michael Thun, Eugenia Calle, Carmen Rodriguez, and Phyllis Wingo, “Epidemiological research at the American Cancer Society. 9 Cancer Epidemiol. Biomarkers & Prevention 861 (2000). I would welcome contradiction from anyone who can find the point estimate in the cited papers.

Consider one of the most recent publications, which drew upon CPS-II data, in the New England Journal of Medicine. For men who were current smokers, compared with men who never smoked, the relative risk of lung cancer mortality was 24.97. Michael Thun, Brian Carter, Diane Feskanich, Neal D. Freedman, Ross Prentice, Alan D. Lopez, Patricia Hartge, and Susan M. Gapstur, “50-Year Trends in Smoking-Related Mortality in the United States,” 368 New Engl. J. Med. 351 (2013).

The Markowitz, Levin, Miller paper is still “in press.” There is still time for the editors to take a closer look. There is also time for the editors to insist upon a disclosure of the authors’ conflicts of interest. See, e.g., Wannall v. Honeywell Internat’l, Inc., Civ. Action No. 10-351 (BAH), 2013 U.S. Dist. LEXIS 68523 (D.D.C. May 14, 2013) (discussing Markowitz’s participation as an expert witness).

Posted in Causation, Conflicts of Interest, Expert Witnesses, Scientific Evidence | Comments Off on The Mt. Sinai Catechism

Wake Forest Publishes the Litigation Industry’s Views on Milward

April 20th, 2013

This week, The Wake Forest Journal of Law & Policy published six articles from its 2012 Spring Symposium, on “Toxic Tort Litigation After Milward v. Acuity Products.” The Symposium was a joint production of The Center for Progressive Reform and the Wake Forest University School of Law. The articles are now available online:

Steve C. Gold, “A Fitting Vision of Science for the Courtroom” PDF

Michael D. Green, “Pessimism About Milward” PDF

Thomas O. McGarity & Sidney A. Shapiro, “Regulator Science in Rulemaking and Tort: Unifying the Weight of the Evidence Approach,” PDF

Carl F. Cranor, “Milward v. Acuity Specialty Products: Advances in General Causation Testimony in Toxic Tort Litigation,” PDF

Joseph Sanders , “Milward v. Acuity Specialty Products Group: Constructing and Deconstructing Sciences and Law in Judicial Opinion,” PDF

Steve Baughman Jensen, “Sometimes Doubt Doesn’t Sell: A Plaintiffs’ Lawyer’s Perspective on Milward v. Acuity Products” PDF

As I noted previously, this symposium was a decidedly lopsided affair, as one might expect from its sponsorship by The Center for Progressive Reform (CPR), which speaks for the litigation industry in the United States. See “Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses” (Feb. 16th, 2013).

Consistent with its sponsorship, the articles are largely cheerleading for the Milward decision. The Milward plaintiffs’ partisan expert, Carl Cranor, has a paper here, as does a plaintiffs’ lawyer prominent in ATLA/AAJ. The defense expert witnesses from Milward were not represented at the symposium in the symposium proceedings; nor were there any papers from defense counsel presented or published. Of the six published papers, only Professor Sanders adopts a somewhat neutral stance towards Milward and the First Circuit’s embrace of Weight of the Evidence in analyzing Rule 702 issues. Cf. Elizabeth Laposata, Richard Barnes, & Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa L. Rev. 1 (2012) (arguing that tobacco lawyers influenced the American Law Institute’s Restatement process).

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The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research

February 19th, 2013

“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”

This statement was not the ranting of an industrialist whose company was bankrupted by asbestos personal injury cases; nor was it the complaint of an industry scientist, dismayed at a body of research that showed his industry’s product to be harmful. The statement was made by one of the most independent, thoughtful scientists who has worked on asbestos health effects, the late Doug Liddell, of the Department of Epidemiology and Biostatistics, in McGill University. F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997).

Although Professor Liddell died in 2003, the “Lobby” lives and thrives. Witness the article published earlier this month, in The Lancet. David Holmes, “IARC in the dock over ties with asbestos industry,” 381 Lancet 359 (2013). A Scientist at the International Agency for Research on Cancer (IARC), Valerie McCormack, accepted an invitation to present data at a scientific conference in Kiev, Russia, on chrysotile asbestos risk assessment and management. McCormack’s decision set off a firestorm of protest from various sources, claiming that the Russian scientists were in “cahoots” with the Russian asbestos industry.

The Lancet article presents a muddled account of the issues, but a persistent reader may make out several supposed concerns of the “Lobbyists.” First, the Lobbyists objected on grounds that an earlier version of the paper to be delivered by McCormack, “Estimating the asbestos-related lung cancer burden from mesothelioma mortality,” was too favorable to chrysotile in relation to commercial amphibole asbestos. (The Lancet fails to mention that McCormack’s paper has since been published, with co-authorship by some distinguished scientists. See Valerie McCormack, Julian Peto, G. Byrnes, K. Straif, and P. Boffetta, “Estimating the asbestos-related lung cancer burden from mesothelioma mortality,” 106 Brit. J. Cancer 575 (2012).)

Second, the Lobbyists objected to IARC’s decision to collaborate on a study of Russian miners and millers, with Evgeny Kovalevkiy. The study, entitled “Historical cohort study of cancer mortality following exposure to chrysotile asbestos at the Uralasbest plant in Asbest, Russian Federation” is supported by the Russian Scientific Research Institute of Occupational Health (SRIOH), which supports the continued mining and exporting of chrysotile asbestos. Especially vexing to the Lobbyists, Kovalevskiy has personally advocated public policy that encourages the continued use of chrysotile. In the words of three American political scientists who sent a letter of protest to the IARC:

“Kovalevskiy is a leading promoter of use of chrysotile asbestos. He testified before the Supreme Court of Brazil in August 2012, as witness on behalf of the Brazilian Chrysotile Institute. He testified that there is no evidence whatsoever to justify banning the use of chrysotile asbestos; that he opposes placing chrysotile asbestos on the Rotterdam Convention’s List of Hazardous Substances; that, in the past, harm to health was caused by the use of amphibole asbestos and excessive, prolonged exposure levels to chrysotile asbestos, but that, today, chrysotile asbestos is causing no harm to health in Russia. We consider that it is unacceptable that a scientist, who is a promoter of chrysotile asbestos use, should be a lead scientist on an IARC research project regarding chrysotile asbestos.”

“IARC in the dock” at 360 (quoting letter signed by Richard Lemen, Arthur Frank, and Barry Castleman). The Lancet article conveniently omits any reference to the remunerative and unremunerative work by these gentlemen for the American anti-asbestos litigation industry.

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Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses

February 16th, 2013

The criticisms of corporate free speech are motivated, at bottom, over hostility to the views that would likely flow from corporate speech. In this age, it is a marvel that there is such hostility to free expression of ideas. We should be much more focused on validity and factual accuracy of arguments than on sponsorship. Sometimes, even the most biased sources manage to stumble upon the truth.

Still, sponsorship remains a major debating point for those who cannot or will not take the time to evaluate the merits of an issue. The Center for Progressive Reform (CPR) is, like many American corporations, a nonprofit organization, but it aspires to be a “research and educational organization.” The CPR’s principal aims deal with protecting health and safety against occupational and environmental harms. These are laudable goals even if the CPR is predictably a voice of entrenched interest groups, such as the litigation industry, also known as the plaintiffs’ tort bar.

One of the CPR’s key activities is “[d]efending clean science from political or corporate interference.” The CPR raises interesting questions about what is “clean,” and what is “dirty” science, and whether it is willing to defend science from all political and corporate interference, or only that interference with which it disagrees.

The American litigation industry is represented by a highly politicized “corporation,” the American Association for Justice (AAJ), previously known by the more revealing name, Association of Trial Lawyers of America (ATLA®). The AAJ describes itself as a corporation, or a “collective,” that supports plaintiff trial lawyers as their “collective voice … on Capitol Hill and in courthouses across the nation … .” The Robert A. Habush Foundation is endowed by the AAJ, and serves as an educational mission. Through the Habush Foundation, the AAJ funds educational programs, “think tanks,” and writing projects designed to influence judges, law professors, lawyers, and the public, on issues of importance to the AAJ: “the civil justice system and individual rights” for bigger, better, and more profitable litigation outcomes.

Of the two organizations, the CPR, and the AAJ/ATLA, the CPR has the more disinterested stance, in theory. The AAJ may be a “not-for-profit,” but it represents the interests of one of the most powerful, and wealthiest, interest groups in American society — the plaintiffs’ bar.

Last May, the CPR sponsored a symposium in Washington D.C. on one of the most controversial, and reactionary decisions involving federal gatekeeping of expert witness testimony, Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012). The CPR’s interest in the Milward decision is clear. One of CPR’s member “scholars,” Carl Cranor, was a partisan expert witness in Milward. The trial court had excluded Cranor’s testimony; a panel of the First Circuit of the Court of Appeals reversed and ordered that Cranor and the plaintiffs’ other expert witnesses be heard at trial. See Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence (Sept. 2, 2011); WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name (May 2, 2012). The Milward decision embraced a vacuous methodology sometimes called “weight of the evidence” (WOE) or “inference to the best explanation,” which had been previously rejected by other Circuits, as well as by the United States Supreme Court, in General Electric Co. v. Joiner, 522 U.S. 136 (1997).

The agenda for the symposium, “Toxic Tort Litigation after Milward v. Acuity Specialty Products,” reflects the CPR’s role, in conjunction with the Wake Forest Journal of Law and Public Policy, in sponsoring the event. The connection between the CPR and Wake Forest Law School may not be obvious. CPR board member, Sid Shapiro, is a law professor at Wake Forest. Shapiro and CPR member Thomas McGarity presented at the symposium. So did Professor Steve Gold, who has been an enthusiastic cheerleader for the Milward decision. Law professors Michael Green and Joseph Sanders also presented. There was only one practicing lawyer involved in the symposium, Texas plaintiffs’ lawyer, Steve Jensen, of Allen Stewart, P.C. Mr. Jensen is a past chair of the AAJ’s Section on Toxic, Environmental, and Pharmaceutical Torts.

No defense counsel participated.

The proceedings of the Milward symposium will be published in an upcoming issue (volume 3, no. 1) of the Wake Forest Journal of Law and Public Policy. This issue is scheduled to include papers from the presenters, along with one additional author, Carl Cranor.

The website of the Wake Forest Journal of Law & Policy describes the symposium:

In Milward v. Acuity Products, 639 F.3d 11 (1st Cir. 2011), the First Circuit became the first court – either federal or state – to allow a “weight of the evidence” methodology for assessing causation in a toxic tort case. The plaintiff had alleged that exposure to defendant’s benzene-containing products caused his rare leukemia (Acute Promyelocytic Leukemia (“APL”)). His expert witness, a leading toxicologist and expert on benzene, surveyed five lines of scientific evidence from the peer-reviewed literature, and concluded the available evidence, taken as a whole, supported the inference that benzene exposure can cause APL. The lower court, following a common post-Daubert approach, excluded the testimony “because no one line of evidence supported a reliable inference of causation, [and] an inference of causation based on the totality of the evidence was unreliable.” The First Circuit rejected this “atomistic” approach, noting that the district court did not have the authority to exclude evidence because reasonable experts may disagree about what it means.

This symposium will explore the implications of Milward for toxic tort litigation in the federal and state courts, including whether it correctly applies Daubert v. Merrell Dow Pharmaceuticals, Inc., 509, U.S. 579 (1993). * * * Speakers are invited to comment on any aspect on Milward that they find interesting and important, including the following issues:

What role does the weight of the evidence methodology play in scientific risk assessment, and what are the implications of this role for tort litigation?

Should well-founded testimony based on a weight of the evidence methodology be admissible in toxic tort litigation? Does the Restatement of Torts (Third) § 28 cmt. c concerning the role of scientific judgment in adjudicating general causation support the admissibility of such testimony?

Does the reliance of regulatory agencies, such as EPA, on a weight of the evidence methodology for purposes of regulating toxic chemicals support the result in Milward? Or are there differences in the legal and policy judgments being made by regulators and judges that distinguish regulatory agencies from courts?

What are the legal and policy implications of Milward for the future of toxic tort litigation?

The Journal also notes the sponsorship of the CPR, and, in a cryptic paragraph, reports that

“CPR thanks the Robert L. Habush Foundation for its support of the symposium.”

Most casual readers will not likely recognize the Habush foundation for what it is: an arm of AAJ/ATLA. I suppose it was too painful for Wake Forest or the CPR to acknowledge openly that the litigation industry itself supported this symposium. Some may find irony in the CPR’s past criticism of Citizens United v. Federal Election Commission, 558 U.S. 310 (2010), when its current status as a conduit for litigation industry money to support scholarship in that industry’s interests. See Daniel Farber, “Of the Corporations, By the Corporations, For the Corporations? The Meaning of the Citizens United Decision” (Jan. 21, 2010).

Professor Steve Gold’s paper, “When Certainty Dissolves into Probability: A Legal Vision of Toxic Causation for the Post-Genomic Era,” has been posted at the Social Science Research Network. Steve Jensen’s contribution to the symposium has been published as well, in the AAJ’s trade journal. Steve Baughman Jensen, “Reframing the Daubert Issue in Toxic Tort Cases,” Trial (Feb. 2013).

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Egilman Instigates Kerfuffle at McGill University

January 15th, 2013

Last February, the Canadian Broadcast Corporation unleashed a one-sided, twenty minute investigative journalistic film on the Quebec asbestos industry. All allegations from the plaintiffs’ litigation world were accepted as true, and the asbestos mining industry was cast as a manufacturer of doubt and deception. See “Fatal Deception” (Feb 2, 2012).

The narrator raises the suggestion that the Canadian federal government is relying upon “junk science” to justify support for continuing exports of chrysotile and for reopening the Quebec mines. This CBC production features Dr. David Egilman, holding forth on his views on the relationship between McGill University, Professor Corbett Macdonald, and the Quebec asbestos industry. Mostly, Egilman is permitted to define the issues and provide the “answers,” although the CBC film does give some air time to Professor Bruce Case, who points out that Egilman is not a scientist, but rather a social critic. When Professor Case was asked on air how he would respond to Egilman in response to his allegations, Case responded, “I wouldn’t give Dr. Egilman the time of day…because he’s not an honorable person.”

For over a decade, Egilman has been pressing his allegations that asbestos research conducted by McGill University investigators was tainted. In September 2012, McGill University’s Research Integrity Officer, Abraham Fuks, reported that the Egilman allegations were baseless and unsupported. Consultation Report to Dean David Eidelman (Sept. 23, 2012). See Egilman’s Allegations Against McDonald and His Epidemiologic Research Are Baseless (Oct. 20, 2012). Egilman responded to Professor Fuks’ report by labeling it “a shameful cover-up.” Eric Andrew-Gee, “Asbestos debate rages on at the Faculty Club: American researcher attacks McGill’s asbestos investigation,” The McGill Daily (Jan. 10, 2013).

The Egilman show apparently kicked off the new year at the McGill University Faculty Club, earlier this month, with a shouting match. According to the University’s newspaper, Egilman called MacDonald’s research on the Quebec chrysotile miners and millers “garbage,” and he called upon McGill University to retract the paper.

Egilman’s argument took the high road and the low road: He understandably objected to McGill’s and MacDonald’s refusal to share mineralogical data about tremolite content of asbestos from the Thetford Mines. Of course, the sad state of epidemiology today is that there is no mechanism for requiring data sharing, and the authors of pro-plaintiff studies have consistently refused to share data, and have fought subpoenas tooth and nail.

But then there was the low road. According to the McGill Daily, Egilman lapsed into name calling. During his presentation, Egilman referred to McGill’s Professor Fuks as Inspector Fox and included a cartoon in his slideshow of a henhouse guarded by a grinning fox. “Fuks, by the way, is German for Fox,” Egilman said.

One of the McGill professors chided Egilman for his ad hominem attack on Professor Fuks, and pointed out that Egilman could have made his points without personal attacks. Egilman responded “I could have, but it’s funny.” Id.

Egilman called upon his audience to evaluate his claims against those of Professors Case and Fuks. “One of us is an asshole,” he announced. Id. Indeed. Just perform the iterative disjunctive syllogism; it’s a matter of elimination. For a more scholarly analysis of assholes, see Aaron James, Assholes: A Theory (2012).

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Tunnel Vision on Conflicts of Interest

January 13th, 2013

Judge Alsup’s order requiring disclosure of money paid to bloggers and journalists is only a recent manifestation of a misguided attempt to control conflicts of interest among non-parties. See Can a Court Engage in Abusive Discovery? (Jan. 10, 2013). Judge Alsup’s curious orders can be traced to encouragement in the Federal Judicial Center’s “pocket guide” to managing an MDL for products liability cases. Barbara Rothstein & Catherine Borden, Managing Multidistrict Litigation in Products Liability Cases: A Pocket Guide for Transferee Judges (2011). Link or download This FJC publication suggested that an MDL court should unleash discovery against authors of published works for evidence of bias, citing an MDL trial court that ordered parties to produce lists of payments to authors of articles relied upon by expert witnesses. Id. at 35 n.48 (citing In re Welding Fume Prods. Liab. Litig., 534 F. Supp. 2d 761 (N.D. Ohio 2008).

The United States Supreme Court has also encouraged hostility to party-funded research and writing. In Exxon Shipping Co. v. Baker, 554 U.S. 471, 501 (2008), the Court struck down a large punitive damage award. Justice Souter, writing for a divided court, noted in footnote 17:

“The Court is aware of a body of literature running parallel to anecdotal reports, examining the predictability of punitive awards by conducting numerous ‘mock juries’, where different ‘jurors’ are confronted with the same hypothetical case. See, e.g., C. Sunstein, R. Hastie, J. Payne, D. Schkade, W. Viscusi, Punitive Damages: How Juries Decide (2002); Schkade, Sunstein, & Kahneman, Deliberating About Dollars: The Severity Shift, 100 Colum. L.Rev. 1139 (2000); Hastie, Schkade, & Payne, Juror Judgments in Civil Cases: Effects of Plaintiff’s Requests and Plaintiff’s Identity on Punitive Damage Awards, 23 Law & Hum. Behav. 445 (1999); Sunstein, Kahneman, & Schkade, Assessing Punitive Damages (with Notes on Cognition and Valuation in Law), 107 Yale L.J. 2071 (1998). Because this research was funded in part by Exxon, we decline to rely on it.”

Id. at n.17; see also Conflicts of Interest, Footnote 17, and Scientific McCarthyism. The glib dismissal of behavioral research on a relevant topic by the Supreme Court was remarkable. Professor Sunstein, is a professor at University of Chicago, and formerly served the Administrator of the White House Office of Information and Regulatory Affairs, in President Obama’s administration. Professor Kahneman, a Nobel Laureate, is Professor Emeritus in Princeton University. Professor W. Kip Viscusi has been one of the most prolific writers about and investigators of punitive damages. Justice Souter’s footnote might be interpreted to impugn the integrity of their research by virtue of their corporate sponsorship. More important, Justice Souter’s opinion fails to explain why the Court would not look beyond funding to the merits of the funded research. Courts consider arguments of the parties’ counsel, although of course, the parties compensate their counsel for marshalling facts, and formulating and presenting arguments. Perhaps Justice Souter would have been justified in announcing that he and his judicial colleagues had looked at Sunstein’s research more closely than other cited research. The wholesale dismissal of relevant evidence based upon funding is irrational.

A new article posted on the Social Science Research Network explores the misdirection and distortion created by the single-minded focus on financial conflicts of interest. Richard S. Saver, “Is It Really All About The Money? Reconsidering Non-Financial Interests In Medical Research,” Journal of Law, Medicine & Ethics (forthcoming 2013).

Richard Saver is a professor of law at the University of North Carolina School of Law, and also holds appointments in the UNC’s School of Medicine. Saver describes how conflicts of interest (COIs) have largely and incorrectly been reduced to financial conflicts. For instance, in 2011, the National Institutes of Health (NIH) addressed only financial issues when it promulgated rules for managing conflicts of interest in the field of medical research. Department of Health and Human Services, “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors,” 76 Fed. Reg. 53256 (Aug. 25, 2011). Several commentators advocated regulation of non-financial COI, but the agency refused to include such COIs within its rules. Id. at 53258. The Institute of Medicine (IOM), in its monograph on COI in medicine, similarly gave almost exclusive priority to financial ties. Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice (Washington, D.C.: The National Academies Press, 2009).

Saver argues that the focus on economic COI is dangerous because it instills complacency about non-financial interests, and provides a false sense of assurance that the most serious biases are disclosed or eliminated. Saver’s review of retractions, frauds, and ethical lapses in biomedical research suggests that non-financial interests, such as friendships and alliances, institutional hierarchies, intellectual biases and commitments, beneficence, “white-hat” advocacy, as well as the drive for professional achievement, recognition, and rewards, all have the potential to complicate, distort, and sometimes undermine scientific research in myriad ways. The failure to recognize serious non-economic COIs and biases, and the reluctance to treat them differently from financial COIs endangers the validity of science. Not only are these non-financial threats ignored, but financial interests receive undue attention, resulting in the erosion of public trust in scientific research that is sound.

Professor Saver’s caveats about COI moralism apply beyond biomedical research. The Exxon Shipping case, the MDL Pocket Guide, and Judge Alsup’s opinion on disclosure of payments to journalists and bloggers signal that courts are well on their way towards selectively and arbitrarily screening out evidence and arguments based upon sponsorship. What is needed is a whole-hearted commitment to consider and analyze all the available data. Time to shed the blinders.

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Can a Court Engage in Abusive Discovery?

January 11th, 2013

ABA’s Litigation News reported that the federal district judge in lawsuit between Oracle and Google sua sponte ordered the parties to identify all journalists, bloggers, or other writers paid to comment on any of the issues in the case. Jannis E. Goodnow, “Surprise Order Forces Parties to Identify Bloggers on Payroll,” Litigation News (Jan. 3, 2013).

Judge William Alsup cited his “concern” that the parties or their counsel “may have retained or paid print or Internet authors, journalists, commentators or bloggers who have and/or may publish comments on the issues.” Oracle America, Inc. v. Google Inc., No. C 10-03561 WHA, Order re Disclosure of Financial Relationships with Commentators on Issues in This Case (N.D. Calif. Aug. 7, 2012). And in a follow-up order, Judge Alsup expanded the scope of the order to include disclosure of those authors even if their payment was not specifically for commenting on the case before him. Order to Supplement (Aug. 20, 2012).

Judge Alsup offered a strange rationale for his disclosure order:

“Just as a treatise on the law may influence the courts, public commentary that purports to be independent may have an influence on the courts and/or their staff if only in subtle ways. If a treatise author or blogger is paid by a litigant, should not that relationship be known?”

Well; not really. A treatise author’s opinion is only as good as the facts and inferences that are employed in reaching a conclusion. The judge’s job is, of course, to assess the reasoning for himself.

Judge Alsup’s rhetorical question reveals a fundamental misunderstanding of the judicial function. The arguments in a case come from counsel who have are being paid. The financial biases are complex. Generally, the court might expect each side to benefit in some way financially from obtaining a ruling in line with the arguments it has advanced. Sometimes, defense counsel may benefit from perpetuating a litigation, but their reputational interests alone certainly will motivate them to prevail. Plaintiffs’ counsel hope to make money in pursuing a case. Typically, legal counsel can be trusted to address the issues comprehensively. Money will be involved.

Of course, journalists, bloggers, law professors, or pundits may put forward an argument not advanced by the parties. A trial or an appellate judge might see such an argument, but why would funding make a difference to the merits of the argument? Judges are, after all, supposed to be good at evaluating arguments without favor or prejudice. And if a judge were to encounter an argument, presented by a non-party but not by the parties, which argument was persuasive, the judge would have the option of requesting the parties’ briefing on the matter.

Disclosure of party funding of writers might legitimately be needed when there was a matter of a poll or survey evidence influenced by the funded writers. Such evidence apparently was not involved in the Oracle case; indeed, Judge Alsup’s request was based upon a purely fictitious concern. After the parties made their disclosures, Judge Alsup announced that he would not take any action because none of the journalistic commentary or blogging had influenced any of his decisions.

So this intrusive exercise in court-ordered disclosure really served no purpose at all. If a party were to propound discovery requests that did not advance the litigation, we would not hesitate to call the discovery abusive.

Unfortunately, no one is paying me to blog on the issues I find interesting.

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The Dubious Origins of the Linear No Threshold Model of Carcinogenesis

January 10th, 2013

Most regulation of chemical exposures for causing cancer outcomes is based upon a linear no-threshold exposure-response (LNT) model. This model informs risk assessments and policy judgments in the United States, Europe, and throughout the world. If the LNT model were offered to support only precautionary principle judgments, then we might excuse the pretensions of LNT advocates. The authors of LNT models, environmentalists, and a cadre of anti-industry scientists (“The Lobby”) are not willing, however, to be understood to be offering mere prudential guidance. They claim that they are offering scientific conclusions, worthy of being taken seriously, as knowledge.

Passing off prudence, aesthetics, and hostility to industrialization as science is a deception that takes place virtually every day in the front pages of the lay media, in scientific journals, as well as in the Federal Register. Implicit in the stridency of the Lobby is a desire to impose an often impossible burden upon industry to prove that there is no increased risk at miniscule exposures, and to challenge negative results with claims of inadequate power.

Professor Calabrese, in the current issue of the University of Chicago Law Review, has traced a source of the deception behind LNT to a series of events tied to the United States nuclear weapons program during World War II. Edward J. Calabrese, “US Risk Assessment Policy: A History of Deception — A Response to Arden Rowell, Allocating Pollution,” 79 U. Chi. L. Rev. 985 (2012). In 1927, Hermann J. Muller, a radiation geneticist, discovered that X-ray radiation caused mutation of fruit fly germ cells. The importance of health outcomes from radiation exposure led to Muller’s service as an advisor to the Manhattan Project during World War II. In 1946, Muller received the Nobel Prize in medicine, for his work in genetics.

Professor Calabrese points out that Muller so thoroughly dismissed threshold models of radiation mutagenicity in his Nobel address, that the LNT became accepted dogma in the regulatory and scientific agencies of the United States government, and later, around the world. Edward J. Calabrese, “Muller’s Nobel Prize Lecture: when ideology prevailed over science,” 126 Toxicol. Sci. 1 (2012). What Professor Calabrese adds to the historical narrative is that Muller was aware of high quality research that undermined the LNT, when he announced in his Nobel lecture that there was no evidence for thresholds. In the 1950’s, Muller continued to use his influence to advance the LNT model of radiation-induced carcinogenesis with the National Academies of Science Biological Effects of Atomic Radiation (“BEAR I”) Committee.

Professor Calabrese has provided an important cautionary tale about how scientific beliefs take hold and are propagated. Muller’s influence and the rise of the LNT model is a recurring tale of the role of power, persuasion, and prestige in claiming scientific truths. It is not just about money. Conflicts of interest involving professional honors, institutional recognition, friendships, intellectual commitments, and investigative “zeal,” which are often much greater threats to the integrity of science and medical research than receipt of payments. See Richard S. Saver, “Is It Really All about the Money? Reconsidering Non-Financial Interests in Medical Research,” 40 J. Law, Med. & Ethics (2012).

If Professor Calabresse is right in his historical analysis, Muller achieved his goal of protecting his discovery from challenge by a selective presentation of the relevant data at a crucial moment in the formation of scientific thinking about mutagenesis. The rise and fall of the LNT model carries with it an important lesson to judicial gatekeepers. Unlike the audience of Muller’s Nobel speech, lawyers and judges can, and must, insist upon a declaration of all materials considered so that they can determine whether an expert witness has proffered an opinion based upon a thorough, complete review of the relevant data.

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