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Gatekeeping of Expert Witnesses Needs a Bair Hug

December 20th, 2017

For every Rule 702 (“Daubert”) success story, there are multiple gatekeeping failures. See David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013).1 Exemplars of inadequate expert witness gatekeeping in state or federal court abound, and overwhelm the bar. The only solace one might find is that the abuse-of-discretion appellate standard of review keeps the bad decisions from precedentially outlawing the good ones.

Judge Joan Ericksen recently provided another Berenstain Bears’ example of how not to keep the expert witness gate, in litigation claims that the Bair Hugger forced air warming devices (“Bair Huggers”) cause infections. In re Bair Hugger Forced Air Warming, MDL No. 15-2666, 2017 WL 6397721 (D. Minn. Dec. 13, 2017). Although Her Honor properly cited and quoted Rule 702 (2000), a new standard is announced in a bold heading:

“Under Federal Rule of Evidence 702, the Court need only exclude expert testimony that is so fundamentally unsupported that it can offer no assistance to the jury.”

Id. at *1. This new standard thus permits largely unsupported opinion that can offer bad assistance to the jury. As Judge Ericksen demonstrates, this new standard, which has no warrant in the statutory text of Rule 702 or its advisory committee notes, allows expert witnesses to rely upon studies that have serious internal and external validity flaws.

Jonathan Samet, a specialist in pulmonary medicine, not infectious disease or statistics, is one of the plaintiffs’ principal expert witnesses. Samet relies in large measure upon an observational study2, which purports to find an increased odds ratio for use of the Bair Hugger among infection cases in one particular hospital. The defense epidemiologist, Jonathan B. Borak, criticized the McGovern observational study on several grounds, including that the study was highly confounded by the presence of other known infection risks. Id. at *6. Judge Ericksen characterized Borak’s opinion as an assertion that the McGovern study was an “insufficient basis” for the plaintiffs’ claims. A fair reading of even Judge Ericksen’s précis of Borak’s proffered testimony requires the conclusion that Borak’s opinion was that the McGovern study was invalid because of data collection errors and confounding. Id.

Judge Ericksen’s judicial assessment, taken from the disagreement between Samet and Borak, is that there are issues with the McGovern study, which go to “weight of the evidence.” This finding obscures, however, that there were strong challenges to the internal and external validity of the study. Drawing causal inferences from an invalid observational study is a methodological issue, not a weight-of-the-evidence problem for the jury to resolve. This MDL opinion never addresses the Rule 703 issue, whether an epidemiologic expert would reasonably rely upon such a confounded study.

The defense proffered the opinion of Theodore R. Holford, who criticized Dr. Samet for drawing causal inferences from the McGovern observational study. Holford, a professor of biostatistics at Yale University’s School of Public Health, analyzed the raw data behind the McGovern study. Id. at *8. The plaintiffs challenged Holford’s opinions on the ground that he relied on data in “non-final” form, from a temporally expanded dataset. Even more intriguingly, given that the plaintiffs did not present a statistician expert witness, plaintiffs argued that Holford’s opinions should be excluded because

(1) he insufficiently justified his use of a statistical test, and

(2) he “emphasizes statistical significance more than he would in his professional work.”

Id.

The MDL court dismissed the plaintiffs’ challenge on the mistaken conclusion that the alleged “contradictions between Holford’s practice and his testimony impugn his credibility at most.” If there were truly such a deviation from the statistical standard of care, the issue is methodological, not a credibility issue of whether Holford was telling the truth. And as for the alleged over-emphasis on statistical significance, the MDL court again falls back to the glib conclusions that the allegation goes to the weight, not the admissibility of expert witness opinion testimony, and that plaintiffs can elicit testimony from Dr Samet as to how and why Professor Holford over-emphasized statistical significance. Id. Inquiring minds, at the bar, and in the academy, are left with no information about what the real issues are in the case.

Generally, both sides’ challenges to expert witnesses were denied.3 The real losers, however, were the scientific and medical communities, bench, bar, and general public. The MDL court glibly and incorrectly treated methodological issues as “credibility” issues, confused sufficiency with validity, and banished methodological failures to consideration by the trier of fact for “weight.” Confounding was mistreated as simply a debating point between the parties’ expert witnesses. The reader of Judge Ericksen’s opinion never learns what statistical test was used by Professor Holford, what justification was needed but allegedly absent for the test, why the justification was contested, and what other test was alleged by plaintiffs to have been a “better” statistical test. As for the emphasis given statistical significance, the reader is left in the dark about exactly what that emphasis was, and how it led to Holford’s conclusions and opinions, and what the proper emphasis should have been.

Eventually appellate review of the Bair Hugger MDL decision must turn on whether the district court abused its discretion. Although appellate courts give trial judges discretion to resolve Rule 702 issues, the appellate courts cannot reach reasoned decisions when the inferior courts fail to give even a cursory description of what the issues were, and how and why they were resolved as they were.

2 P. D. McGovern, M. Albrecht, K. G. Belani, C. Nachtsheim, P. F. Partington, I. Carluke, and M. R. Reed, “Forced-Air Warming and Ultra-Clean Ventilation Do Not Mix: An Investigation of Theatre Ventilation, Patient Warming and Joint Replacement Infection in Orthopaedics,” 93 J. Bone Joint 1537 (2011). The article as published contains no disclosures of potential or actual conflicts of interest. A persistent rumor has it that the investigators were funded by a commercial rival to the manufacturer of the Bair Hugger at issue in Judge Ericksen’s MDL. See generally, Melissa D. Kellam, Loraine S. Dieckmann, and Paul N. Austin, “Forced-Air Warming Devices and the Risk of Surgical Site Infections,” 98 Ass’n periOperative Registered Nurses (AORN) J. 354 (2013).

3 A challenge to plaintiffs’ expert witness Yadin David was sustained to the extent he sought to offer opinions about the defendant’s state of mind. Id. at *5.

Posted in Causation, Conflicts of Interest, Data Sharing, Rule 702, Rule 703, Scientific Evidence, Underlying Data | Comments Off on Gatekeeping of Expert Witnesses Needs a Bair Hug

Stuck in Silicone

December 12th, 2017

There was a time when silicone chemistry, biocompatibility, toxicity, and litigation weighed upon my mind. What started with a flurry of scientific interest, led to a media free for all, then FDA Commissioner David Kessler’s moratorium on silicone breast implants, and then to a feeding frenzy for the lawsuit industry. Ultimately, the federal court system found its way to engage four non-party expert witnesses, who cut through the thousands of irrelevant documents that plaintiffs’ counsel used to obfuscate the lack of causation evidence. The court-appointed experts in MDL 926 were unanimous in their rejection of the plaintiffs’ claims.1 Not long after, the Institute of Medicine (now the National Academy of Medicine) issued its voluminous review of the scientific evidence, again with the conclusion that the evidence, when viewed scientifically and critically, showed a lack of association between silicone and autoimmune disease.2

Along the way to this definitive end of the lawsuit industry’s assault on the medical device industry, the parties assembled in the courtroom of the Hon. Jack B. Weinstein, for Rule 702 hearings on the opinions proffered by the plaintiffs’ expert witnesses. Judge Weinstein, along with the late Judge Harold Baer, of the Southern District of New York, and Justice Lobis, of the New York Supreme Court, held hearings that lasted two weeks, and entertained virtually unlimited argument. In characteristic style, Judge Weinstein did not grant the defendants’ Rule 702 motions; rather he cut right to the heart of the matter, and granted summary judgment in favor of the defense on plaintiffs’ claims of systemic diseases.3

Over a dozen years later, in reflecting upon a long judicial career that involved many so-called mass torts, Judge Weinstein described the plaintiffs’ expert witnesses more plainly as “charlatans” and the silicone litigation as largely based upon fraud.4

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

Last week, I received an email from Arthur E. Brawer, who represented himself to be an Associate Clinical Professor of Medicine.5 Dr. Brawer kindly forwarded some of his publications on the subject of silicone toxicity.6 Along with the holiday gift, Dr Brawer also gave me a piece of his mind:

“I recommend you rethink your prior opinions on the intersection of science and the law as it relates to this issue, as you clearly have no idea what you are talking about regarding the matter of silicone gel-filled breast implants. Perhaps refresher courses in biochemistry and biophysics at a major university might wake you up.”

Wow, that woke me up! Who was this Dr Brawer? His name seemed vaguely familiar. I thought he might have been a lawsuit industry expert witness I encountered in the silicone litigation, but none of his articles had a disclosure of having been a retained expert witness. Perhaps that was a mere oversight on his part. Still, I went to my archives, where I found the same Dr Brawer engaged in testifying for plaintiffs all around the country. In one early testimonial adventure, Brawer described how he came up with his list of signs and symptoms to use to define “silicone toxicity”:

Q. Doctor, if a patient presented to you with green hair and claimed that her green hair was attributable to her silicone breast implants, unless you could find another explanation for that green hair, you’d put that on your list of signs and symptoms; right?

A. The answer is yes.

Notes of Testimony of Arthur E. Brawer, at 465:7-12, in Merlin v. 3M Co., No. CV-N-95-696-HDM (D. Nev.Dec. 11, 1995) (Transcript of Rule 702 hearing)

A year later, Brawer’s opinions were unceremoniously excluded in a case set for trial in Dallas, Texas.7 Surely this outcome, along with Judge Weinstein’s rulings, the findings of the court-appointed witnesses in MDL 926, and the conclusions of the Institute of Medicine would have discouraged this Brawer fellow from testifying ever again?

Apparently not. Brawer, like the Black Knight in Monty Python and the Holy Grail, still lives and breathes, but only to be cut again and again. A quick Westlaw search turned up another, recent Brawer testimonial misadventure in Laux v. Mentor Worldwide, LLC, case no. 2:16-cv-01026, 2017 WL 5235619 (C.D. Calif., Nov. 8, 2017).8 Plaintiff Anita Laux claimed that she developed debilitating “biotoxin” disease from her saline-filled silicone breast implants. In support, she proffered the opinions of three would-be expert witnesses, a plastic surgeon (Dr Susan Kolb), a chemist (Pierre Blais), and a rheumatologist (Arthur Brawer).

Plaintiffs’ theory of biotoxin disease causation started with Blais’ claim to have found mold debris in the plaintiff’s explanted implants. The court found Blais unqualified, however, to offer an opinion on microbiology or product defects, and his opinions in the case, unreliable. Id. at *4-6. Dr Kolb, the author of The Naked Truth about Breast Implants, attempted to build upon Blais’ opinions, a rather weak foundation, to construct a “differential diagnosis.” In reasoning that Ms. Laux’s medical complaints arose from a mold infection, Kolb asserted that she had ruled out all other sources of exposure to mold. Unfortunately, Kolb either forgot or chose to hide correspondence with Ms. Laux, in which the plaintiff directly provided Kolb with information about prior environmental mold exposure on multiple occasions. Id. at *3. The trial court severely deprecated Kolb’s rather selective and false use of facts used to make the attribution of Ms. Laux’s claimed medical problems.

Dr Brawer, the author of Holistic Harmony: A Guide To Choosing A Competent Alternative Medicine Provider (1999), and my recent email correspondent, also succumbed to Judge Wright’s gatekeeping in Laux. The court found that Brawer had given a toxicology opinion with no supporting data. His report was thus both procedurally deficient under Federal Rule of Civil Procedure 26, and substantively deficient under Federal Rule of Evidence 702. Finding Brawer’s report “so lacking of scientific principles and methods,” and thus unhelpful and unreliable, the trial court excluded his report and precluded his testimony at trial. Id. at *7.

Thankfully, the ghost of litigations past, communicating now by email, can be safely disregarded. And I do not have to dig my silicone polymer chemistry and biochemistry textbooks out of storage.

1 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The experts appointed by the late Judge Pointer all committed extensive time and expertise to evaluating the plaintiffs’ claims and the entire evidence. After delivering their reports, the court-appointed experts all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

2 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

3 See In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996) (granting summary judgment because of insufficiency of plaintiffs’ evidence, but specifically declining to rule on defendants’ Rule 702 and Rule 703 motions).

5 At the Drexel University School of Medicine, in Philadelphia, as well as the Director of Rheumatology at Monmouth Medical Center, in Long Branch, New Jersey.

6 Included among the holiday gift package was Arthur E. Brawer, “Is Silicone Breast Implant Toxicity an Extreme Form of a More Generalized Toxicity Adversely Affecting the Population as a Whole?,”1 Internat’l Ann. Med. (2017); Arthur E. Brawer, “Mechanisms of Breast Implant Toxicity: Will the Real Ringmaster Please Stand Up,”1 Internat’l Ann. Med. (2017); Arthur E. Brawer, “Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity,” 26 Lupus 1060 (2017); Arthur E. Brawer, “Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity,” 51 Medical Hypotheses 27 (1998).

7 Bailey v. Dow Corning Corp., c.a. 94-1199-A (Dallas Cty. Texas Dist. Ct., Sept. 15, 1996).

8 I later found that another blog had reviewed the Laux decision. Stephen McConnell, “C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case,” Drug & Device Law (Nov. 16, 2017).

Posted in Causation, Conflicts of Interest, Expert Witness Hall of Shame, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Stuck in Silicone

Disappearing Conflicts of Interest

October 29th, 2017

As the story of who funded the opposition research into Trumski and the Russian micturaters unfolds, both sides of the political spectrum seem obsessed with who funded the research. Funny thing that both sides had coins in the fountain. Funding is, in any event, an invalid proxy for good and sufficient reason. The public should be focused on the truth or falsity of the factual claims. The same goes in science, although more and more, science is evaluated by “conflicts of interest” (COIs) rather than by the strength of evidence and validity of inferences.

No one screams louder today about COIs than the lawsuit industry and its scientist fellow travelers. Although I believe we should rid ourselves of this obsession with COIs, to the extent we must put up with it, the obsession should at least be symmetrical, complete, and non-hypocritical.

In an in-press publication, Morris Greenberg has published an historical account of the role that the U.K. Medical Research Council had in studying asbestos health effects.1 Greenberg often weighs in on occupational disease issues in synch with the litigation industry, and so no one will be entirely surprised that Greenberg suspects undue industry influence (not the lawsuit industry, but an industry that actually makes things). Greenberg may be right in his historical narrative and analysis, but my point today is different. What was interesting about Greenberg’s paper was the disclosure at its conclusion, by the “American Journal of Industrial Medicine editor of record”:

“Steven B. Markowitz declares that he has no conflict of interest in the review and publication decision regarding this article.”

Markowitz’s declaration is remarkable in the era when the litigation industry and its scientific allies perpetually have their knickers knotted over perceived COIs. Well known to the asbestos bar, Markowitz has testified with some regularity for plaintiffs’ lawyers and their clients. Markowitz is also an editor in chief of the “red” journal,” the American Journal of Industrial Medicine. Many of the associate editors are regular testifiers for the lawsuit industry, such as Arthur L. Frank and Richard A. Lemen.

Even more curious is that Steven Markowitz, along with fellow plaintiffs’ expert witness, Jacqueline M. Moline, recently published a case report about mesothelioma occuring in an unusual exposure situation, in the red journal. This paper appeared online in February 2017, and carried a disclosure that “[t]he authors have served as expert witnesses in cases involving asbestos tort litigation.2” A bit misleading given how both appear virtually exclusively for claimants, but still a disclosure, whereas Markowitz, qua editor of Greenberg’s article, claimed to have none.

Markowitz, as an alumnus of the Mount Sinai School of Medicine, is, of course, a member of the secret handshake society of the litigation industry, the Collegium Ramazzini. At the Collegium, Markowitz proudly presents his labor union consultancies, but these union ties are not disclosed in Markowitz’s asbestos publications.

Previously, I blogged about Markowitz’s failure to make an appropriate COI disclosure in connection with an earlier asbestos paper.3 See “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013). At the time, there appeared to be no disclosure of litigation work, but I was encouraged to see, upon checking today, that Markowitz’s disclosure for his 2013 paper now reveals that he has received fees for expert testimony, from “various law firms.” A bit thin to leave out plaintiffs’ law firms, considering that the paper at issue is used regularly by Markowitz and other plaintiffs’ expert witnesses to advance their positions in asbestos cases. A more complete disclosure might read something like: “Markowitz has been paid to consult and testify in asbestos personal injury by plaintiffs’ legal counsel, and to consult for labor unions. In his testimony and consultations, he relies upon this paper and other evidence to support his opinions. This study has grown out of research that was originally funded by the asbestos workers’ union.”

Or we could just evaluate the study on its merits, or lack thereof.

1 Morris Greenberg, “Experimental asbestos studies in the UK: 1912-1950,” 60 Am. J. Indus. Med. XXX (2017) (doi: 10.1002/ajim.22762).

2 Steven B. Markowitz & Jacqueline M. Moline, “Malignant Mesothelioma Due to Asbestos Exposure in Dental Tape,” 60 Am. J. Indus. Med. 437 (2017).

Posted in Asbestos, Conflicts of Interest, Expert Witnesses | Comments Off on Disappearing Conflicts of Interest

Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

July 9th, 2017

Litigation-related research has been the punching bag of self-appointed public health advocates for some time. Remarkably, and perhaps not surprising to readers of this blog, many of the most strident critics have deep ties to the lawsuit industry, and have served the plaintiffs’ bar loyally and zealously for many years.1,2,3,4 And many of these critics have ignored or feigned ignorance of the litigation provenance of much research that they hold dear, such as Irving Selikoff’s asbestos research undertaken for the asbestos workers’ union and its legal advocates. These critics’ campaign is an exquisite study in hypocrisy.

For some time, I have argued that the standards for conflict-of-interest disclosures should be applied symmetrically and comprehensively to include positional conflicts, public health and environmental advocacy, as well as litigation consulting or testifying for any party. Conflicts should be disclosed, but they should not become a facile excuse or false justification for dismissing research, regardless of the party that sponsored it.5 Scientific studies should be interpreted scientifically – that is carefully, thoroughly, and rigorously – regardless whether they are conducted and published by industry-sponsored, union-sponsored, or Lord help us, even lawyer-sponsored scientists.

Several years ago, a defense lawyer, Samuel Tarry, published a case series of industry-sponsored research or analysis, which grew out of litigation, but made substantial contributions to the scientific understanding of claimed health risks. See Samuel L. Tarry, Jr., “Can Litigation-Generated Science Promote Public Health?” 33 Am. J. Trial Advocacy 315 (2009). Tarry’s paper is a helpful corrective to the biased (and often conflicted) criticisms of industry-sponsored research and analysis by the lawsuit industry and its scientific allies and consultants. It an ocean of uninformative papers about “Daubert,” Tarry’s paper stands out and should be required reading for all lawyers who practice in the area of “health effects litigation.”

Tarry presented a brief summary of the litigation context for three publications that deserve to remembered and used as exemplars of important, sound, scientific publications that helped changed the course of litigations, as well as the scientific community’s appreciation of prior misleading contentions and publications. His three case studies grew out of the silicone-gel breast implant litigation, the latex allergy litigation, and the never-ending asbestos litigation.

1. Silicone

There are some glib characterizations of the silicone gel breast implant litigation as having had no evidentiary basis. A more careful assessment would allow that there was some evidence, much of it fraudulent and irrelevant. See, e.g., Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud). The lawsuit industry worked primarily through so-called support groups, which in turn funded friendly, advocate physicians, who in turn testified for plaintiffs and their lawyers in personal injury cases.

When the defendants, such as Dow Corning, reacted by sponsoring serious epidemiologic analyses of the issue whether exposure to silicone gel was associated with specific autoimmune or connective tissue diseases, the plaintiffs’ bar mounted a conflict-of-interest witch hunt over industry funding.6 Ultimately, the source of funding became obviously irrelevant; the concordance between industry-funded and all high quality research on the litigation claims was undeniable. Obvious that is to court-appointed expert witnesses7, and to a blue-ribbon panel of experts in the Institute of Medicine8.

2. Latex Hypersensitivity

Tarry’s second example comes from the latex hypersensitivity litigation. Whatever evidentiary basis may have existed for isolated cases of latex allergy, the plaintiffs’ bar had taken and expanded into a full-scale mass tort. A defense expert witness, Dr. David Garabrant, a physician and an epidemiologist, published a meta-analysis and systematic review of the extant scientific evidence. David H. Garabrant & Sarah Schweitzer, “Epidemiology of latex sensitization and allergies in health care workers,” 110 J. Allergy & Clin. Immunol. S82 (2002). Garabrant’s formal, systematic review documented his litigation opinions that the risk of latex hypersensitivity was much lower than claimed and not the widespread hazard asserted by plaintiffs and their retained expert witnesses. Although Garabrant’s review did not totally end the litigation and public health debate about latex, it went a long way toward ending both.

3. Fraudulent Asbestos-Induced Radiography

I still recall, sitting at my desk, my secretary coming into my office to tell me excitedly that a recent crop of silicosis claimants had had previous asbestosis claims. When I asked how she knew, she showed me the computer print out for closed files for another client. Some of the names were so distinctive that the probability that there were two men with the same name was minuscule. When we obtained the closed files from storage, sure enough, the social security numbers matched, as did all other pertinent data, except that what had been called asbestosis previously was now called silicosis.

My secretary’s astute observation was mirrored in the judicial proceedings of Judge Janis Graham Jack, who presided over MDL 1553. Judge Jack, however, discovered something even more egregious: in some cases, a single physician interpreted a single chest radiograph as showing either asbestosis or silicosis, but not both. The two, alternative diagnoses were recorded in two, separate reports, for two different litigation cases against different defendants. This fraudulent practice, as well as others, are documented in Judge Jack’s extraordinary, thorough opinion. See In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005)9.

The revelations of fraud in Judge Jack’s opinion were not entirely surprising. As everyone involved in asbestos litigation has always known, there is a disturbing degree of subjectivity in the interpretation of chest radiographs for pneumoconiosis. The federal government has long been aware of this problem, and through the Centers for Disease Control and the National Institute of Occupational Safety and Health, has tried to subdue extreme subjectivity by creating a pneumoconiosis classification schemed for chest radiographs known as the “B-reader” system. Unfortunately, B-reader certification meant only that physicians could achieve inter-observer and intra-observer reproducibility of interpretations on the examination, but they were free to peddle extreme interpretations for litigation. Indeed, the B-reader certification system exacerbated the problem by creating a credential that was marketed to advance the credibility of some of the most biased, over-reading physicians in asbestos, silica, and coal pneumoconiosis litigation.

Tarry’s third example is a study conducted under the leadership of the late Joseph Gitlin, at Johns Hopkins Medical School. With funding from defendants and insurers, Dr. Joseph Gitlin conducted a concordance study of films that had been read by predatory radiologists and physicians as showing pneumoconiosis. The readers in his study found a very low level of positive films (less than 5%), despite their having been interpreted as showing pneumoconiosis by the litigation physicians. See Joseph N. Gitlin, Leroy L. Cook, Otha W. Linton, and Elizabeth Garrett-Mayer, “Comparison of ‘B’ Readers’ Interpretations of Chest Radiographs for Asbestos Related Changes,” 11 Acad. Radiol. 843 (2004); Marjorie Centofanti, “With thousands of asbestos workers demanding compensation for lung disease, a radiology researcher here finds that most cases lack merit,” Hopkins Medicine (2006). As with the Sokol hoax, the practitioners of post-modern medicine cried “foul,” and decried industry sponsorship, but the disparity between courtroom and hospital medicine was sufficient proof for most disinterested observers that there was a need to fix the litigation process.

Meretricious Mensuration10 – Manganese Litigation Example

Tarry’s examples are important reminders that corporate sponsorship, whether from the plaintiffs’ lawsuit industry or from manufacturing industry, does not necessarily render research tainted or unreliable. Although lawyers often confront exaggerated or false claims, and witness important, helpful correctives in the form of litigation-sponsored studies, the demands of legal practice and “the next case” typically prevent lawyers from documenting the scientific depredations and their rebuttals. Sadly, unlike litigations such as those involving Bendectin and silicone, the chronicles of fraud and exaggeration are mostly closed books in closed files in closed offices. These examples need the light of day and a fresh breeze to disseminate them widely in both the scientific and legal communities, so that all may have a healthy appreciation for the value of appropriately conducted studies generated in litigation contexts.

As I have intimated elsewhere, the welding fume litigation is a great example of specious claiming, which ultimately was unhorsed by publications inspired or funded by the defense. In the typical welding fume case, plaintiff claimed that exposure to manganese in welding fume caused Parkinson’s disease or manganism. Although manganism sounds as though it must be a disease that can be caused only by manganese, in the hands of plaintiffs’ expert witnesses, manganism became whatever ailment plaintiffs claimed to have suffered. Circularity and perfect definitional precision were achieved by semantic fiat.

The Sanchez-Ramos Meta-Analysis

Manganese Madness was largely the creation of the Litigation Industry, under the dubious leadership of Dickie Scruggs & Company. Although the plaintiffs enjoyed a strong tail wind in the courtroom of an empathetic judge, they had difficulties in persuading juries and ultimately decamped from MDL 1535, in favor of more lucrative targets. In their last hurrah, however, plaintiffs retained a neurologist, Juan Sanchez-Ramos, who proffered a biased, invalid synthesis, which he billed as a meta-analysis11.

Sanchez-Ramos’s meta-analysis, such as it was, provoked professional disapproval and criticism from the defense expert witness, Dr. James Mortimer. Because the work product of Sanchez-Ramos was first disclosed in deposition, and not in his Rule 26 report, Dr. Mortimer undertook belatedly a proper meta-analysis.12 Even though Dr. Mortimer’s meta-analysis was done in response to the Sanchez-Ramos’s improper, tardy disclosure, the MDL judge ruled that Mortimer’s meta-analysis was too late. The effect, however, of Mortimer’s meta-analysis was clear in showing that welding had no positive association with Parkinson’s disease outcomes. The MDL 1535 resolved quickly thereafter, and with only slight encouragement, Dr. Mortimer published a further refined meta-analysis with two other leading neuro-epidemiologists. See James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012). See also “Manganese Meta-Analysis Further Undermines Reference Manual’s Toxicology Chapter” (Oct. 15, 2012).

1 See, e.g., David Michaels & Celeste Monforton, “Manufacturing Uncertainty Contested Science and the Protection ofthe Public’s Health and Environment,” 95 Am. J. Pub. Health S39, S40 (2005); David Michaels & Celeste Monforton, “How Litigation Shapes the Scientific Literature: Asbestos and Disease Among Automobile Mechanics,” 15 J. L. & Policy 1137, 1165 (2007). Michaels had served as a plaintiffs’ paid expert witness in chemical exposure litigation, and Monforton had been employed by labor unions before these papers were published, without disclosure of conflicts.

2 Leslie Boden & David Ozonoff, “Litigation-Generated Science: Why Should We Care?” 116 Envt’l Health Persp. 121, 121 (2008) (arguing that systematic distortion of the scientific record will result from litigation-sponsored papers even with disclosure of conflicts of interest). Ozonoff had served as a hired plaintiffs’ expert witnesses on multiple occasion before the publication of this article, which was unadorned by disclosure.

3 Lennart Hardell, Martin J. Walker, Bo Walhjalt, Lee S. Friedman, and Elihu D. Richter, “Secret Ties to Industry and Conflicting Interest in Cancer Research,” 50 Am. J. Indus. Med. 227, 233 (2007) (criticizing “powerful industrial interests” for “undermining independent research on hazard and risk,” in a “red” journal that is controlled by allies of the lawsuit industry). Hardell was an expert witness for plaintiffs in mobile phone litigation in which plaintiffs claimed that non-ionizing radiation caused brain cancer. In federal litigation, Hardell was excluded as an expert witness when his proffered opinions were found to be scientifically unreliable. Newman v. Motorola, Inc., 218 F. Supp. 2d. 769, 777 (D. Md. 2002), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003).

4 See David Egilman & Susanna Bohme, “IJOEH and the Critique of Bias,” 14 Internat’l J. Occup. & Envt’l Health 147, 148 (2008) (urging a Marxist critique that industry-sponsored research is necessarily motivated by profit considerations, and biased in favor of industry funders). Although Egilman usually gives a disclosure of his litigation activities, he typically characterizes those activities as having been for both plaintiffs and defendants, even though his testimonial work for defendants is minuscule.

5 Kenneth J. Rothman, “Conflict of Interest: The New McCarthyism in Science,” 269 J. Am. Med. Ass’n 2782 (1993).

6 See Charles H. Hennekens, I-Min Lee, Nancy R. Cook, Patricia R. Hebert, Elizabeth W. Karlson, Fran LaMotte; JoAnn E. Manson, and Julie E. Buring, “Self-reported Breast Implants and Connective- Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study, 275 J. Am. Med. Ass’n 616-19 (1998) (analyzing established cohort for claimed associations, with funding from the National Institutes of Health and Dow Corning Corporation).

7 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The court-appointed expert witnesses dedicated a great deal of their professional time to their task of evaluating the plaintiffs’ claims and the evidence. At the end of the process, they all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

8 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

9 See also Lester Brickman, “On the Applicability of the Silica MDL Proceeding to Asbestos Litigation, 12 Conn. Insur. L. J. 289 (2006); Lester Brickman, “Disparities Between Asbestosis and Silicosis Claims Generated By Litigation Screenings and Clinical Studies,” 29 Cardozo L. Rev. 513 (2007).

10 This apt phraseology is due to the late Keith Morgan, whose wit, wisdom, and scientific acumen are greatly missed. See W. Keith C. Morgan, “Meretricious Mensuration,” 6 J. Eval. Clin. Practice 1 (2000).

11 See Deposition of Dr. Juan Sanchez-Ramos, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008514 (N.D. Ohio May 17, 2011).

12 See Deposition of Dr. James Mortimer, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008054 (N.D. Ohio June 29, 2011).

Posted in Asbestos, Causation, Conflicts of Interest, Meta-analysis, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

Succès de scandale – With Thanks to Rosner & Markowitz

March 26th, 2017

“for there is only one thing in the world worse than being talked about, and that is not being talked about.”

Oscar Wilde, The Picture of Dorian Gray (1890)

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

Some years ago, I co-chaired a Mealey’s conference on silicosis litigation. When plaintiffs’ counsel participate in such events, they are usually trolling for business, and jockeying for position on litigation steering committees. Ethical defense counsel are looking to put themselves out of business. My goal at the conference was to show that there was no there, there, so don’t go there. Mostly, the history of the litigation has proven me correct. In the early years of the 21st century, there were well over 10,000 cases pending. Now, there are just a hand full of pending cases. Very little money has been given to plaintiffs’ counsel; almost no sand companies have gone bankrupt.

At that Mealey’s conference, I presented a paper, which I later allowed Mealey’s to publish in its Silica Reporter. The paper became something of a “succès de scandale,” at least in getting under the skin of the Marxist historians, David Rosner and Gerald Markowitz, whom I took to task. In at least four of their publications, they have attempted unsuccessfully to rebut my arguments, and to criticize me for making them.1 At a meeting of the Committee on Science, Technology and the Law, of the National Academies of Science, I found myself presenting alongside Markowitz, on access to underlying study data. Markowitz played the victim of legal counsel’s subpoenas to his publisher for peer review comments in vinyl chloride, which grew out of his participation in the vinyl chloride litigation as an expert witness.2

I was on the panel for having served a subpoena upon Dr. Brad Racette for the underlying data of a study of parkinsonism in welders, with support in the form of the financial largesse of felon Richard Scruggs. Rosner was at this meeting only as a spectator, but he did not miss the opportunity, at a break, to get in my face, with the obvious intent of bullying me, with warnings that I would regret having ever written about them.

Back in 2007, the lawsuit-industry funded SKAPP conducted a conference, at which Rosner presented. I was not present, but a friend wrote me later, “Boy, does Rosner not like you. You steal a puppy from him or something?” When I presented at the Fourth International Conference on the History of Occupational and Environmental Health, in 2010, Rosner repeated his Middlebury behavior. As soon as I finished my talk, he rushed for the microphone and filibustered the entire question and answer period.3 I would chalk this up to fascisti of the left, except the very nice socialist historian who chaired my panel apologized profusely afterwards.

In a revised edition of one of their historical potboilers, Rosner and Markowitz repeated their calumny:

“It was not just the lead and chemical industries that saw our book and the evidence we presented as a threat. Nathan Schachtman, an attorney with the Philadelphia-based firm McCarter & English, and who defended companies sued for ‘exposures to allegedly toxic substances, including asbestos, benzene, cobalt isocyanates, silica and solvents’, also published an attack on us in Mealey’s Litigation Report: Silica, titled, ‘On Deadly Dust and Histrionic Historians’. In his attack on our earlier book, Deadly Dust, a history of the devastating lung disease silicosis, he accused us of writing a ‘jeremiad’ that ‘resonates to the passions and prejudices of the last century’. He took us to task for our ‘prejudice’ that ‘silicosis results from the valuation of profits over people’ and admonished us to point out the higher rates of silicosis in Communist countries. ‘They [the authors] fairly consistently excuse or justify the actions of labor… . They excoriate the motives and actions of industry’. But Schachtman’s true agenda emerged in the middle of his third paragraph. ‘We could safely leave the fate of Rosner’s and Markowitz’s historical scholarship to their community of academicians and historians if not for one discomforting fact,’ he wrote. ‘The views of Rosner and Markowitz have become part of the passion play that we call silicosis litigation.’16

Schachtman seemed to be saying that as long as academics speak only to one another and had no influence beyond academia, they can be tolerated. But once they begin to affect that wider world, they need to be put back in their place. All this despite the fact that, at the time of Schachtman’s piece, more than a decade after the publication of Deadly Dust in 1991, each of us had appeared on the stand in only one case.”4

Rosner and Markowitz get virtually everything wrong, but one factoid may have been true. As of 1991, Rosner and Markowitz had perhaps only “appeared on the stand in only one case,” but by the time I wrote the article in 2005, the Marxist duo had been listed as expert witnesses in hundreds, if not thousands, of cases. The language quoted above appeared in an “Epilogue” to a 2013 publication, by which time Rosner and Markowitz each had testified over a dozen times, as professional historian “arguers.” Only Markowitz testified in vinyl chloride cases, from what I can make out, but the two of them testified in many silica, asbestos, and lead cases by the time they published their Epilogue.

One obvious point is that Rosner and Markowitz are both rather disingenuous in portraying themselves as innocent academics without connections to the lawsuit industry. In their world, they seek victim status to hide their long-standing partisanship in litigation issues. The real point, however, is that Rosner and Markowitz have never rebutted my arguments that silicosis was worse for workers in East Germany, the Soviet Union, Maoist China, under communist rule than it was in the post-1935 era in the United States. Unlike the rising incidence of asbestosis, the incidence of silicosis in the United States has steadily and significantly declined after World War II. Indeed, the Centers for Disease Control has held up the control of silicosis as one of the ten great public achievements in 20th century United States.5 See “Ramazzini Serves Courtroom Silica Science Al Dente” (July 25, 2015) (showing CDC data on declining silicosis incidence in the United States, against the rising trend in asbestosis incidence).

1 To date I have found four articles that dwell on the issue. See D. Rosner & G. Markowitz, “The Trials and Tribulations of Two Historians:  Adjudicating Responsibility for Pollution and Personal Harm, 53 Medical History 271, 280-81 (2009); D. Rosner & G. Markowitz, “L’histoire au prétoire.  Deux historiens dans les procès des maladies professionnelles et environnementales,” 56 Revue D’Histoire Moderne & Contemporaine 227, 238-39 (2009); David Rosner, “Trials and Tribulations:  What Happens When Historians Enter the Courtroom,” 72 Law & Contemporary Problems 137, 152 (2009); David Rosner & Gerald Markowitz, “The Historians of Industry” Academe (Nov. 2010).

2 Markowitz was excluded in at least one case in which he was disclosed as a testifying expert witness. Quester v. B.F. Goodrich Co., Case No. 03-509539, Court of Common Pleas for Cuyahoga Cty., Ohio, Order Sur Motion to Exclude Dr. Gerald Markowitz (Sweeney, J.).

3 Nathan Schachtman & John Ulizio, “Courting Clio:  Historians and Their Testimony in Products Liability Action,” in: Brian Dolan & Paul Blanc, eds., At Work in the World: Proceedings of the Fourth International Conference on the History of Occupational and Environmental Health, Perspectives in Medical Humanities, University of California Medical Humanities Consortium, University of California Press (2012); Schachtman, “On Deadly Dust & Histrionic Historians 041904,”; “How Testifying Historians Are Like Lawn-Mowing Dogs” (May 15, 2010); A Walk on the Wild Side (July 16, 2010); Counter Narratives for Hire (Dec. 13, 2010); Historians Noir (Nov. 18, 2014).

4 Gerald Markowitz and David Rosner, Deceit and Denial: The Deadly Politics of Industrial Pollution at 313-14 (U. Calif. rev. ed. 2013). Footnote 16 was a reference to Nathan A. Schachtman, “On Deadly Dust and Histrionic Historians: Preliminary Thoughts on History and Historians as Expert Witnesses,” 2 Mealey’s Silica Litigation Report Silica 1, 2 (November 2003). Their language quoted above was largely self-plagiarized from Gerald Markowitz and David Rosner, “The Historians of Industry” (Nov. – Dec. 2010). 

5 CDC, “Ten Great Public Health Achievements — United States, 1900-1999,” 48 Morbidity & Mortality Weekly Report 241 (April 02, 1999).

Posted in Conflicts of Interest, Historian Testimony, Silica | Comments Off on Succès de scandale – With Thanks to Rosner & Markowitz

Mercola’s Middlebury Moment – Conflicts of Interest As Distraction from the Merits

March 11th, 2017

Joseph Mercola is an osteopathic physician, who is possession of alternative facts about alternative medicine, which no doubt come from alternative science in an alternative universe. He is a conspiracy theorist who sees government, the media, and the scientific community as engaged in a vast conspiracy to stand in the way of his alternative truths.1

In his alternative world, vaccines kill, timerosal and milk2 cause autism, fluoridation3 and cell phones cause cancer. On his path to alternative health and wellbeing, Mercola has made millions selling and promoting dubious “health foods”; he has also found himself on the alternative side of the law, particularly with the FDA4 and the FTC5.

Mercola is an entrepreneurial physician, who hawks untested “natural health” products, while bashing licensed, tested pharmaceuticals. Mercola may not be the most honest broker of scientific information6, and so it seems inappropriate when he lobbies for the silencing of scientific discussion and debate.

In a web post this week, Mercola claimed that the newspaper USA Today,had been ridiculed for a column by an “industry front group.”7 This was a bit of fake news from Mercola; the event he referenced actually involved an attempt by environmental activist groups8 to silence speech that they disagreed with. The speaker to be silenced was the American Council on Science and Health (ACSH). No ridicule was involved; only accusations of undisclosed funding from self-styled public interest groups, which themselves do not disclose their funding sources in their letter.9

The President of the ACSH, Hank Campbell, responded with a rebuttal to this Middlebury Maneuver10, which is worth reading.11 Campbell eloquently makes three points. First, the accusers have serious conflicts of interest, both financial and positional, themselves. Second, the crucial issue in a scientific debate is the evidence, its quality, and its ability to warrant valid inferences. The “Lobby” wants to silence speech, but has nothing to offer on the merits of any scientific issue, except politically correct, subjective opinion. Third, the Lobby ignores that the ACSH has taken stands on health issues against many the pecuniary interests of corporations; indeed it has taken one of the strongest anti-smoking stances of any advocacy group. Campbell’s rebuttal is a powerful reminder that scientific disagreements cannot be won by bullying opponents into silence.

2 Joseph Mercola, “Milk linked to autism, schizophrenia,” Optimal Wellness Center Website (Mar .21, 1999; archived Jan. 2, 2008).

3 See, e.g., A. Mesh, “Dr Joseph Mercola gives $15,000 to anti-flouride campaign,” Williamette Week (May 6, 2013); Joseph Mercola, “Is fluoride as safe as you are told,” Optimal Wellness Center Website (Feb 2, 6, and 9, 2002); Mercola, the Sun, Tanning Beds, and Melanoma (Skeptic’s Dictionary Newsletter)

4 Susan J. Walker, Director, Division of Dietary Supplement Programs, “Warning letter to Joseph Mercola, D.O.,” (Feb 16, 2005) (Ref. No. CL-04-HFS-810-134 ); Scott J. MacIntire, District Director, “Warning letter to Joseph Mercola, D.O.,” (Sept. 21, 2006); Steven Silverman, Director, Office of Compliance, Center for Devices and Radiological Health, “Warning letter to Dr. Joseph Mercola,” (Mar. 22, 2011); see also Trine Tsouderos, “FDA warns doctor: Stop touting camera as disease screening tool,” Chicago Tribune (April 26, 2011); Stephen Barrett, “Dr. Joseph Mercola Ordered to Stop Illegal Claims,” Quackwatch (Jan. 9, 2017).

6 See Kate Knibbs, “The Most Honest Man in Medicine?” The Ringer (Jan. 5, 2017); Brian Smith, “Dr Mercola: Visionary or quack?” Chicago Magazine (Feb. 12, 2012).

7 Joseph Mercola, “USA Today Ridiculed for Column by Industry Front Group,” (Mar. 07, 2017).

8 Alaska Community Action on Toxics; Beyond Toxics; Breast Cancer Action; Breast Cancer Fund; Californians for Pesticide Reform; Center for Biological Diversity; Center for Food Safety; Citizens’ Environmental Coalition; Clean and Healthy New York Community Science Institute; Empire State Consumer Project; Farmworker Association of Florida; Friends of the Earth – US; Greenpeace; HavenBMedia; Healthy Building Network; Health Care Without Harm; Learning Disabilities Association of Maine; Made Safe Organic Consumers Association; Pesticide Action Network North America; Real Food Media; The 5 Gyres Institute; US Right to Know; Vermont Public Interest Research Group; Women’s Voices for the Earth; Ann Blake, PhD, Environmental & Public Health Consulting; Josh Freeman, MD (Emeritus Chair of Family Medicine, University of Kansas School of Medicine); Matthew Anderson, MD (Associate Professor, Dept. of Family and Social Medicine, Montefiore Medical Center); Martin Donohoe, MD, FACP (Adjunct Faculty, School of Community Health, Portland State University; Board of Advisors, Oregon Physicians for Social Responsibility).

10 Addison County Independent, “Middlebury College professor injured by protesters as she escorted controversial speaker” (Mar. 6, 2017); Editorial Board, “Smothering Speech at Middlebury,” N.Y. Times (Mar. 7, 2017); Katharine Q. Seelye, “Protesters Disrupt Speech by ‘Bell Curve’ Author at Vermont College,” N.Y. Times (Mar. 3, 2017).

Posted in Conflicts of Interest, Scientific Evidence | Comments Off on Mercola’s Middlebury Moment – Conflicts of Interest As Distraction from the Merits

Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

January 11th, 2017

Science necessarily involves a willingness to follow evidence to whatever conclusions are warranted, if conclusions properly can be had. When it comes to vaccination conspiracies, Democrats have it in their political DNA to distrust pharmaceutical companies that research, develop, and manufacture vaccines. The current Republican party, which has been commandeered by theocrats and populists, see vaccination as federal government aggrandizement, and resist vaccination policy as contrary to God’s will. Science is often the loser in the cross-fire.

And so we now have the public spectacle of watching the left and the right join in similar scientific apostasies. Consider how both McCain and Obama both suggested that vaccines and autism were related in the 2008 election. (Although both candidates were to some extent slippery in their suggestions, which might have been appropriate given how little they knew about the controversies.) And consider Michelle Bachmann was converted to a similar view about the HPV vaccine on the basis of a woman’s anecdote about her child. And then on the far left, you have the uplifting story of Robert F. Kennedy Jr, and his brief on how thimerosal supposedly causes autism.

So it should be no surprise that Donald Trump, a Birther, a Mirther, a mid-night Twitterer, should embrace the anti-vaccination movement. Trump has made it clear that he rejects evidence-based policy, and so no one should expect him to embrace a scientific policy that is driven by high-quality scientific evidence. According to Kennedy, Trump wants Kennedy to head up a “commission on vaccine safety and scientific integrity.” Michael D. Shear, Maggie Haberman & Pam Belluckjan, “Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety,” N.Y. Times (Jan. 10, 2017); Domenico Montanaro, “Despite The Facts, Trump Once Again Embraces Vaccine Skeptics,” National Public Radio (Jan. 10, 2017).

Who needs the National Academy of Medicine when you can put a yutzball lawyer in charge of a “commission”?

Some of the media refer to Robert F. Kennedy Jr. as a vaccine skeptic, but their terminology is grossly inaccurate and misleading. Kennedy is a vaccine denier; he has engaged in a vitriolic campaign against the safety and efficacy of vaccines. He has aligned himself with the most extreme deniers of science, medicine, and public safety, including the likes of Andrew Wakefield and Jenny McCarthy. Kennedy has not merely engaged hyperbolic rhetoric against vaccines, he has used his radio show on the lawsuit industry’s Ring of Fire, to advance his campaign against public health as well as to shill for the lawsuit industry on other issues. See “RFK, Jr.: Science Shows That Autism — Mercury Link Exists – PT. ½,” Ring of Fire (Mar 8, 2011).

Kennedy should not be characterized as a skeptic, when he is a shrill ideologue, for whom science has no method that he is bound to respect. Back in July 2005, Kennedy published an article, “Deadly Immunity,” in both Rolling Stone and on Slate’s website. The article was a hateful screed against Big Pharma and government health agencies for an alleged conspiracy to hide the autism risks of thimerosal preservatives in vaccines. Several years later, on January 16, 2011, Salon retracted the article. See “https://en.wikipedia.org/wiki/Deadly_Immunity” entry in Wikipedia. See also Phil Plait, “Robert F. Kennedy Jr.: Anti-Vaxxer,” Slate (June 5 2013) (describing Kennedy as a full-blown anti-vaccination conspiracy theorist); Rahul K. Parikh, M.D., “Inside the vaccine-and-autism scare: A pediatrician traces the rise of the anti-vaccine movement that falsely linked thimerosal with autism and turned parents away from the most lifesaving medicine in history,” Salon (Sept. 22, 2008); Keith Kloor, “Is Robert F. Kennedy Jr. Anti-Science?” Discover Magazine (June 1, 2013); Steven Novella, “RFK Jr.s Autism Conspiracy Theory,” (Jun 20 2007).

Back in 2008, President Obama apparently considered Robert Kennedy for a cabinet-level position, but on sober reflection, thought better of it. See Steven Novella, “Politics and Science – The RFK Jr. Test,” (Nov. 07 2008). The Wall Street Journal, joined by many others, are now urging Trump to think harder and better about the issue, perhaps with some evidence as well. See Alex Berezow & Hank Campbell, “Ignore Anti-Vaccine Hysteria, Mr. Trump: Robert F. Kennedy Jr.’s conspiracy theories have no place in the White House,” Wall Street J. (Jan. 10, 2017).

Posted in Causation, Cognitive Biases, Conflicts of Interest, Evidence, Public Nuisances, Scientific Evidence, Scientific Misconduct | Comments Off on Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

Toward Better Definitions & Assessments of Conflicts of Interest in Science

October 13th, 2016

In capitalist and in communist societies, industry has a responsibility to conduct research on health and safety concerns. For corporate research to be credible, it should be methodologically sound, transparent, and available. So should non-corporate research.

In the United States and in Europe, much important research is done only by private corporate sponsors. Of course, private funding of research raises questions about potential conflicts of interest (COIs), but political frenzy over such COIs is a serious diversion often motivated by a desire to live in a faith-based world in which industry and chemicals are demonized far beyond what even precautionary principles would support. Susan Sarandon’s superstitions about the herbicide Round Up come to mind.

Although members of the Lobby, the Litigation Industry, and the environmental groups of the less rational kind frequently find their knickers in a knot over corporate scientific COIs, the fact is that publicly funded and self-styled “public interest” research is often afflicted by non-financial COIs that are more mind numbing than the anticipation of money.[1] Some groups, such as the Society of Toxicology, have implemented more complete definitions of COI to include advocacy and positional conflicts.[2]

Joseph Huggard recently posted an interesting piece at Innovative Science Solutions’ blog, on the need to “Follow the Science Not the Money,” to remind us of the first principle, that research should be evaluated primarily on its merits, and not on its perceived or imagined COIs. Huggard likens the current situation of proliferating ad hominem attacks to less talented footballer who approaches the game thinking “If you can’t play the ball, play the man.” (Or if you are Donald Trump, then play the ref.)

Huggard cites an interesting meta-observational study in which researchers attempted to obtain research protocols from epidemiologic studies on phthalate exposure. Not surprisingly, researchers who published studies that purported to find adverse associations involving phthalates were three times less likely to share their study protocols.[3] A request for study protocols is hardly an intrusive or difficult request to meet. Of course, there are “reasons,” such as researchers’ desire to privilege their methods when so-called positive studies will serve as stepping stones to funding for future studies, but future studies should be conditioned on making past protocols available, and the failure to share protocols generally is pretty dubious scientific behavior.

As grim as the situation has been in the United States, Huggard suggests that an upcoming Luxembourg Chamber of Commerce conference this week, on October 10th, will seek to redress the imbalance in European COI rhetoric by calling attention to the importance of non-financial conflicts and biases.[4] Let’s hope so, but the more likely outcome is that the Chamber of Commerce’s sponsorship will disqualify any conference recommendations among the “political scientists,” those who practice science to achieve political aims.

[1] Simon N. Young, “Bias in the research literature and conflict of interest: an issue for publishers, editors, reviewers and authors, and it is not just about the money,” 34 J. Psychiatry & Neurosci. 412 (2009) (positional conflicts, based upon prior beliefs, can create much more intractable bias than financial rewards). See also “Conflict Over Conflicts of Interest” (July 12, 2015); “Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 24, 2013); “Conflicted Public Interest Groups” (Nov 3, 2013).

[2] See, e.g., Society of Toxicology, Conflict of Interest, Bias and Advocacy: Definitions and Statements.

[3] Gerard M.H. Swaen, Miriam J.E. Urlings, and Maurice P. Zeegers, “Outcome reporting bias in observational epidemiology studies on phthalates,” 26 Ann. Epidemiol. 597E4 (2016)

[4] “Managing Bias and Conflict of Interest: Ensuring that Policy-Makers and Regulators Access the Best Quality Scientific Advice,” at the Chambre de Commerce Luxembourg, at 7, rue Alcide de Gasperi, Luxembourg (Kirchberg).

Posted in Conflicts of Interest | Comments Off on Toward Better Definitions & Assessments of Conflicts of Interest in Science

The LoGiudice Inquisitiorial Subpoena & Its Antecedents in N.Y. Law

July 14th, 2016

The plaintiffs’ bar’s inquisition into funding has been a recurring theme in the asbestos and other litigations.[1] It is thus interesting to compare the friendly reception Justice Moulton gave plaintiffs’ subpoena in LoGiudice[2] with the New York courts’ relatively recent hostility toward a defendant’s subpoena to Mt. Sinai School of Medicine.

A few years ago, Justice Sherry Heitler quashed a defendant’s attempt to subpoena information from the archives of a deceased, former faculty member of the Mount Sinai School of Medicine (“Mt. Sinai”), in Reyniak v. Barnstead Internat’l, No. 102688-08, 2010 NY Slip Op 50689, 2010 WL 1568424 (N.Y. Sup. Ct. Apr. 6, 2010). In a cursory opinion, Justice Heitler cited institutional expense, chilling of research, and scholars’ fears that their unpublished notes, ideas, and observations would become public as a result of litigation. Heitler relied upon and followed an earlier New York state court’s decision that adopted a rather lopsided “balancing” analysis, which permitted the New York courts to ignore the legitimate needs of defendants for access to underlying data.[3]

Remarkably, Justice Heitler failed to cite a federal appellate court’s subsequent decision, which upheld the tobacco companies’ subpoena to Mount Sinai.[4] Her opinion also ignored the important context of the asbestos litigation, in which Selikoff, long since deceased, played a crucial role in fomenting and perpetuating litigation, with tendentious publications and pronouncements. Some might say, “manufacturing certainty.” Perpetuating the Litigation Industry’s Selikoff mythology, Justice Heitler described Selikoff as a ground breaking asbestos researcher, but she either ignored, or was ignorant of, his testimonial adventures, his attempts to influence litigation with ex parte meetings with presiding judges, and his other questionable litigation-related conduct.

Selikoff’s participation in litigation was not always above board.  His supposedly ground-breaking work was funded by the insulator’s union, which also sought him out as a testifying expert witness. Among his many testimonial adventures,[5] Selikoff testified as early as 1966 that asbestos causes colorectal cancer, and that it caused a specific claimant’s colorectal cancer. See “Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966) (thanking Selikoff for his having given testimony to support an insulator’s claim that asbestos caused his colorectal cancer). To be sure, Selikoff made his litigation claims in the scientific literature as well, but without any acknowledgement of his involving in litigation involving this very issue, and his funding by the asbestos union.[6]

Given the dubious provenance of many of Selikoff’s opinions,[7] the disparate treatment of the subpoenas in LoGuidice and Reyniak is irreconcilable. The inflated prestige of Selikoff and Mount Sinai blinded the New York state trial courts to Selikoff’s role in litigation and his biased assessments in science. The judicial hypocrisy may well be the consequence of how the academic community has promoted Selikoff’s reputation, while working assiduously to undermine the reputations of anyone who has been connected with the defense of occupational disease claims. Consider, for instance, how Labor (Marxist) historians have railed against the role that Dr. Anthony Lanza played in personal injury litigation following the Gauley Bridge tunnel construction.  See Jock McCulloch and Geoffrey Tweedale, “Anthony J. Lanza, Silicosis and the Gauley Bridge ‘Nine’,” 27 Social History of Medicine 86 (2013). While these historians deplore Lanza, however, they laud Selikoff. See “British Labor Historians Belaboring American Labor History – Gauley Bridge” (Oct. 14, 2013). Politics and occupational disease litigation are like that.

[1] See In re All Litigation filed by Maune, Raichle, Hartley, French & Mudd LLC v. 3M Co., No. 5-15-0235, Ill. App., 5th Dist.; 2016 Ill. App. Unpub. LEXIS 1392 (June 30, 2016); “Engineers for Automakers Must Unredact Agendas in Madison County Asbestos Litigation,” Madison County Record (July 2016); Lynn A. Lenhart, “Meeting Agendas Between Non-Party Consultant and Counsel for Asbestos Friction Clients Not Privileged” (July 5, 2016).  See also Weitz & Luxenberg P.C. v. Georgia-Pacific LLC, 2013 WL 2435565, 2013 NY Slip Op 04127 (June 6, 2013), aff’d, 2013 WL 2435565 (N.Y. App. Div., 1st Dep’t June 6, 2013); “A Cautionary Tale on How Not to Sponsor a Scientific Study for Litigation” (June 21, 2013).

[2] LoGiudice v. American Talc Co., No. 190253/2014, 2016 N.Y. Misc. LEXIS 2360, (N.Y. Sup., N.Y. Cty., June 20, 2016).

[3] See In re R.J. Reynolds Tobacco Co., 136 Misc 2d 282, 285, 518 N.Y.S.2d 729 (Sup. Ct., N.Y. Cty. 1987); see also In re New York County Data Entry Worker Prod. Liab.Litig., No. 14003/92, 1994 WL 87529 (N.Y. Sup. Ct. N.Y. Cty. Jan 31, 1994) (denying discovery because “special circumstances,” vaguely defined were absent).

[4] Mount Sinai School of Medicine v. The American Tobacco Co., 866 F.2d 552 (2d Cir. 1889).

[5] “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

[6] See, e.g., Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for his causal conclusion between asbestos and all gastrointestinal cancers).movie Her trailer

[7] See generally “Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas” (Oct. 4, 2014); “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014).

Posted in Asbestos, Cognitive Biases, Conflicts of Interest, Expert Witness Discovery | Comments Off on The LoGiudice Inquisitiorial Subpoena & Its Antecedents in N.Y. Law

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

July 13th, 2016

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

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

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

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

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

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

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

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

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

Posted in Conflicts of Interest, Underlying Data | Comments Off on LoGuidice v. American Talc Co. — Subpoenas to Investigate Funding

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