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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

Belgian Waffles and Post Hoc Ergo Propter Hoc

June 22nd, 2017

In language that could well be a Sokol hoax on the vacuousness of post-modernist non-thinking, the Court of Justice of the European Union issued a press release to announce its judgment in N.W. v. Sanofi Pasteur MSD, Case C-621/15 (Luxembourg, 21 June 2017). With European hypersensitivity to public disclosure, and in recognition of the right to be forgotten, the plaintiffs are known only as the “W” family. Mr. J. W. received Sanofi’s hepatitis B vaccine between late 1998 and the middle of 1999. In the summer of 1999, Mr. W. began to experience symptoms, which led to a diagnosis of multiple sclerosis over a year later, in November 2000. J.W. and his family sued Sanofi Pasteur in 2006. J.W. died in 2012.

The Ws filed their case in Paris, where the courts found for Sanofi Pasteur. The Cour d’Appel de Paris, impressed by the lack of scientific consensus to support W’s causal claim, held that the plaintiffs had failed to demonstrate causality. The Cour d’Appel de Paris court dismissed the W’s case. The dismissal was remarkable in the context of credulous French courts that had routinely recognized such claims. See C. Rougé-Maillart, N. Guillaume, N. Jousset, and M, Penneau, “Recognition by French courts of compensation for post-vaccination multiple sclerosis: the consequences with regard to expert practice,”47 Med. Sci. Law 185 (2007) (summarizing the course of M.S. and hepatitis B vaccination litigation in France). The Ws appealed further to the French Cour de Cassation (Court of Cassation), which punted to the EU Court of Justice, to ask whether the EU directive on liability for defective products required a different result than handed down by the Cour d’Appel.

The “Court of Justice” stated that the claimants had the burden of proof, but dubiously framed the causation issue as a choice between “certain and irrefutable evidence” and evidence of a “sufficiently high degree of probability.” What gives rise to sufficiently high degree of probability? In bold type, the EU press release announces that:

“Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence.”

But what is “serious, specific, and consistent evidence”? Scouring both the press release and the full decision of the Court provides one answer:

Anecdotes. Unspecified number of case reports of multiple sclerosis occurring in patients after vaccination, without regard to an anticipated or expected incidence of the disease in the vaccinated population suffices. The Court of Justice sums up the Ws’ case as a showing that:

“The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof.”

The significant number of cases is never quantified or even described. The “sufficiently high probability” is never quantified or described. Presumably, the judges in Brussels can count, and the probability is some number greater than zero, but less than 1. The Court of Justice follows many other lay courts in falsely dichotomizing scientific disputes as involving either “certain, irrefutable” evidence or something less, and good enough for government (judicial) work. Even its representation of the Ws’ evidence as “serious, specific and consistent” and its suggestion of a “sufficiently high” probability are false, at least without spelling out the evidentiary base of the anecdotal evidence that is elevated to legally sufficient in the eyes of the Court of Justice. The Court fails to acknowledge, as a Court of Justice should, that large, high quality epidemiologic studies fail to find associations between hepatitis B vaccination and multiple sclerosis. See, e.g., Annette Langer-Gould, Lei Qian, Sara Y. Tartof, PhD; Sonu M. Brara, Steve J. Jacobsen, Brandon E. Beaber, Lina S. Sy, Chun Chao, Rulin Hechter, Hung Fu Tseng, “Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases,” 71 J. Am. Med. Ass’n Neurol. 1506 (2014); Miguel A. Hernán & Susan S. Jick, “Hepatitis B vaccination and multiple sclerosis: the jury is still out,” 15 Pharmacoepidemiology & Drug Safety 653 (2006).

The European right to be forgotten has apparently been extended to scientific evidence. There may be reasons more legitimate than racist xenophobia to exit the European Union.

Posted in Causation, Scientific Evidence | Comments Off on Belgian Waffles and Post Hoc Ergo Propter Hoc

The Slemp Case, Part 2 – Openings

June 10th, 2017

“The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations” (May 13, 2017)

The legal community is still trying to grasp the enormity of the $110M verdict against Johnson & Johnson, in the Slemp case. J & J says it will appeal, but resolution of legal issues will not necessarily clarify what happened factually in the Slemp case. Some legal commentators have attempted superficial analyses that try to correlate case outcomes with how cases are selected for trial in Missouri. In the five talc trials to date, plaintiffs have prevailed (with fulsome verdicts) in both cases in which plaintiffs’ counsel selected the case for trial. See Amy Rubenstein and Malerie Ma Roddy, “Talc Talk: 1 Of These Verdicts Is Not Like The Others,” Law360 (June 1, 2017). In the three other cases, selected by defense counsel, the defense has lost two of the three cases, again with outlandish verdicts. No statistical analysis of these correlations will suggest that the selection process is correlated with verdict outcome. If there is no general causation, then selection of plaintiff for trial should not correlate with outcome. More important, the Missouri verdicts cannot be reconciled with the ruling by Judge Johnson in the New Jersey talc cases. Carl v. Johnson & Johnson, No. ATL-L-6546-14, 2016 WL 4580145 (N.J. Super. Ct. Law Div., Atl. Cty., Sept. 2, 2016); see also “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016).

A manufacturer is legally held to the standard of having expert knowledge of the hazards of a product, and warning about those hazards that are not common knowledge. The conflicts noted above, and the exculpatory views of various professional groups and federal and international agencies should mean, in a sane system of products liability law, that a manufacturer would have no liability in the ovarian cancer – talc cases. A recent review concluded:

“While mechanistic, pathology, and animal studies do not support evidence for the carcinogenicity of talc on the ovarian epithelium 329, epidemiological studies have indicated an association with talc use and increased OC [ovarian cancer] risk.”

Brett M. Reid, Jennifer B. Permuth, Thomas A. Sellers, “Epidemiology of ovarian cancer: a review,” Cancer Biol. Med. 14 (2017). The authors went on, however, to note that the association was not consistently found among studies, and that the IARC had rejected the causal contention as having been shown. How on this evidence, can a manufacturer be held liable for not warning of a causal connection? And how could a manufacturer be found to have acted maliciously or outrageously, with substantial scientific support?

What is needed is careful, detailed evaluation of the actual evidence at trial. The International Agency for Research on Cancer (IARC), the FDA, the NTP, and virtually every other agency and professional group that has addressed the question whether talc causes ovarian cancer, have declared that there is no causal connection established. Have the plantiffs in these cases hit a treasure trove of data not seen by the scientific and regulatory community? Or have plaintiffs exploited the weaknesses of the jury system, and advanced arguments and evidence that would never move a panel of disinterested scientists?

Meaningful analyses of the talc trials are not likely to happen from hipshot commentary. Fortunately, Courtroom View Network videotaped the Slemp trial from openings to return of verdict, which has created a rich resource for lawyers, legal analysts, political scientists, scientists, and regulators to judge the efficacy and content of courtroom presentations of complex scientific evidence.

Less is More, Except When Less is Just Less

There are two common, glib pronouncements you can often hear uttered in defense counsel confabulations. The first is “Less is More.” The second is “Let’s not get into weeds.” These generalizations cannot be tested with jury research in which both sides’ presentations are often no longer than 60 minutes, or so. Actual research of trial research rarely can move beyond anecdotal observations.

In Slemp, the defense case went took up two days. The plaintiffs’ case took 12 days. The plaintiff presented multiple medical expert witnesses, including two epidemiologists who have been involved in studying talc and ovarian cancer, and publishing on the issue, for decades. The defense presented just one expert witness, Dr. Warner Huh, a gynecologic oncologist. Dr. Huh claimed to have epidemiologic expertise by virtue of his work on studies on cervical cancer screening. Dr. Huh, as we will see, never explained how, when, and where he received training in epidemiologic study design and biostatistics. This defense strategy on expert witnesses requires careful analysis. Furthermore, the plaintiffs’ counsel presented a minimally qualified regulatory expert witness to serve primarily as a document reader. The defense effectively cross-examined this witness by showing his ignorance and selectivity in document reading and presentation. J & J, however, never called a fact witness, or corporate witness, to give viva voce testimony, that rebutted the innuendo, defamations, and characterizations of the company by plaintiffs’ counsel.

The Opening “Statements”

Perhaps it is best to begin at the beginning. Voir dire is not available at Courtroom View Network, but the opening statements are on line. There is a widespread myth that Hans Zeisel’s research established that most cases are won in the openings. Zeisel debunked that reading of his work, without disagreeing that the first impressions of opening statement can be powerful. See Hans Zeisel, “A Jury Hoax: The Superpower of the Opening Statement,” 14 Litigation 17 (Summer 1988). Inquiring minds might want to know how the openings statements went for the parties involved in Slemp.

Counsel for the plaintiff and for the two defendants (J & J, Imerys) all gave strong arguments that went well beyond stating what the evidence will show. All counsel worked hard to establish ethos and pathos, but plaintiff’s counsel excelled at creating the appearance of scientific logos, even when there was none. Defense counsel, on the other hand, tried to avoid talking about epidemiology for the most part. When the defense did discuss epidemiology, they made some disturbing, unnecessary mistakes.

Plaintiffs’ Opening

The plaintiff’s opening was noteworthy for its fear mongering. There are some authors who seem to want to take credit for a so-called reptile strategy, but fear mongering has been part of the dark side of rhetoric since at least the dawn of recorded history.¹ Edmund Burke captured the sum and substance of the reptile strategy, which was so much on display in 18^th century politics:

“No passion so effectually robs the mind of all its powers of acting and reasoning as fear.”

Edmund Burke, A Philosophical Inquiry into The Origin of Our Ideas of The Sublime And Beautiful – With Several Other Additions at Sect. II. Terror (1757). Plaintiff’s counsel argued that all women, everywhere [including the women jurors and the male jurors’ female kin] are threatened by the evil corporate behemoth that sells baby powder. Women, everywhere, are developing ovarian cancer by the millions because they have used talcum powder. Only this jury can stop the carnage because regulators have ignored the situation. Regulators and the scientific establishment are venal, and J & J has bought them off. Steve Bannon would be proud.

The plaintiff’s counsel argued that J & J’s talcum powder contains not one, not two, but three carcinogens: talc, asbestos, and heavy metals. Talc, of course, is the focus of the claim and the trial, but what about the other two? Plaintiffs’ counsel did not advert to any evidence or opinion that heavy metals cause ovarian cancer; nor did he even slow down to say what heavy metals he was claiming were present. The evidence that asbestos causes ovarian cancer is perhaps marginally credible, but the causal conclusion is still doubtful. The studies that suggest an association are generally poorly done and heavily confounded. The real issue, however, with the asbestos claim, other than its effectiveness in instilling fear and knee-jerk reactions among lay jurors, is that it obscures an important issue whether the tremolite that sometimes accompanies talc in serpentine rock deposits is actually tremolite asbestos. Tremolite, as a mineral, has numerous crystallogaphic “habits,” including acicular fibers, angular particles, plates, etc.² Some time ago, the federal government adopted a convention of counting anything as a “fiber,” if it were greater than 5 μm in length, and it had an aspect ratio of at least three to one. Another agency, the U.S. EPA adopted a minimal 5:1 aspect ratio, but both federal regulatory definitions disregard both mineralogical and biological considerations for what is a “fiber” with biological effects. Pace Melanie³, a thing is not a phallic system if it is just longer than it is wide, and a tremolite cleavage fragment is not a fiber, even if it is three times longer than wide.

There were other notable rhetorical moves in Plaintiff’s opening statement. In most other litigations, Plaintiffs run away from the need to rule out random error in studies that their expert witnesses proffer as support for causal claims. See, e.g., In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, U.S. Court of Appeals, 3rd Circuit, No. 16-2247 (June 2, 2017). In doing so, Plaintiffs often distort the consensus views about statistical significance, from the American Statistical Association⁴ and other groups. In the Slemp case, however, Plaintiff’s counsel swung to an opposite extreme by over-endorsing statistical significance as the apparent end-all and be-all for assessing causality. Study validity, whether internal or external, received no serious mention; bias in the studies relied upon was not discussed in any meaningful way.

To highlight the disingenuousness of the Plaintiffs’ opening with respect to failing to consider study validity and bias, and its over-endorsement of statistical significance, the Plaintiff later in the trial flashed sound bites from a report, commissioned by J & J, on the claimed causal connection. The report was by done other than Professor Kenneth Rothman, along with others. Professor Rothman has been in the forefront of criticizing the use of statistical significance testing as a bright-line criterion for causation. Rothman, along with Jonathan Samet (hardly a defense friendly epidemiologist) and Harris Pastides, reported, in 2000, that there was a “statistically significant” association, but demurred on causation because of the problem of study bias and validity:

“A weighted average of the results from epidemiologic studies to date measuring the relation between talc and ovarian cancer risk gives an overall relative risk of 1.31, with a 95% confidence interval of 1.21-1.41. Bias and causation are competing explanations for the weak positive association observed. This weak association could be an underestimate of a stronger association if there are errors in measuring talc exposure that apply uniformly to all study subjects (non-differential misclassification). On the other hand, non-differential misclassification does not bias an association that is null to begin with, so postulating non-differential misclassification cannot shed light on whether the association results from a causal relation or not. Most of the published studies are interview-based case-control studies, subject to recall bias, which can readily give rise to associations of this magnitude. The evidence from these studies regarding recall bias is mixed. Uncontrolled confounding can also easily explain associations this weak; although no single confounding factor would seem to account for the overall effect, the combined effect of several such unidentified confounders could do so. In considering these competing explanations of bias and causation, the evidence in favor of a causal explanation is only the overall weak association of a relative risk of 1.31. The lack of a plausible biologic mechanism, on the other hand, weighs against a causal interpretation. Also weighing against a causal explanation is the dose-response pattern among talc users, which is an inverse trend for both duration of use and frequency of use. A causal relation would predict a positive trend, not an inverse trend. Based on these considerations, we suggest that the evidence to date does not indicate that talc can be ‘reasonably anticipated to be a human carcinogen’.”

Kenneth J. Rothman Harris Pastides Jonathan Samet, “Interpretation of Epidemiologic Studies on Talc and Ovarian Cancer,” (Nov. 28, 2000).

From a rhetorical perspective, one of the more interesting moves in Plaintiff’s opening was a pivot from causation to association. Without ever really discussing the standards or factors for inferring causation, Plaintiff’s counsel invoked regulatory standards and avoided addressing himself to the Missouri standard of causation. The standards for whether to warn and for determining cause in fact were conflated and confused, in what seemed liked a deliberate effort.

Defense Openings

J & J’s Opening

The defense strategies were apparent enough. The defense emphasized that Ms. Slemp had a serous borderline tumor (SBT). The emphasis appeared to be a plea of confession and avoidance. In other words, maybe there is something going on with talc and ovarian cancer, but this is an SBT, and it is different, so you do not need to worry too much about the more general claim that talc causes ovarian cancer. SBTs are a subset of epithelial ovarian tumors, often characterized as semi-malignant, with a more favorable outcome than other ovarian epithelial tumors. The defense also strived to shift the spotlight to Ms. Slemp and her strikingly poor health, preëxisting her cancer diagnosis, as well as her massive obesity and her heavy smoking, both risk factors for ovarian cancer.

On the positive side, J & J’s counsel anticipated and warned the jury that plaintiffs’ expert witnesses would be seriously challenged on their post-hoc analyses and their failing to share their causal conclusions with the scientific community. J & J’s counsel did engage on the general causation claim, but mostly to argue that most governmental agencies and professional organizations have refused to accept the causal claim. To the limited extent that J & J got into the “weeds,” it identified the Bradford Hill factors as the generally accepted decision procedure for reaching causal conclusions. So far, so good (except for the insistence upon referring to Sir Austin as Sir Bradford, as though Bradford was the man’s first name). What defense counsel did not say, astonishingly, is that Sir Austin’s nine factors require a necessary predicate that is satisfied when:

“Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance.”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). See “Woodside & Davis on the Bradford Hill Considerations” (Aug. 23, 2013). To be sure, there are any number of studies on talc and ovarian cancer that satisfy Hill’s requirement of an association not attributable to the play of chance, but what is lacking is the clear-cut association; that is, the associations that are “statistically significant” have not ruled out bias and confounding. The defense opening did introduce the concept of recall bias, which plays an important part in undermining the validity of the available case-control studies. What the defense did not say, however, is that misclassification biases in cohort studies do not always bias towards the null, and even if they did, then the latest cohort study (with a hazard ratio below 1.0) would have had a risk ratio even lower than 1.0 than what was reported.

The defense did emphasize the absence of the Bradford Hill factors for plausibility and dose response. A more sophisticated analysis would have acknowledged what Sir Austin had over 60 years ago: plausibility or explanation is not necessary to infer causation. Not all the Bradford Hill factors are equal, and the defense diluted the analysis by falsely elevating one factor, plausibility, to the status of a necessary criterion.

The defense opening also had some dubious moves. It deprecated case-control studies as inferior to cohort studies, both as a general proposition and specifically with respect to talc. Case-control studies are generally harder to do, as the Plaintiffs’ bar learned when it based an entire mass tort litigation on a single case-control study, the so-called Yale Hemorrhagic Stroke Project.⁵ The Plaintiffs won the Daubert war⁶ in that litigation, but lost their jury trials because juries ultimately saw the methodological flaws that the MDL court disregarded. The general proposition that cohort studies are always superior to case-control studies, however, is doubtful. The defense did not need to stake out this claim, especially since it was not going to call an epidemiologist to testify.

Some of the claims that the defense committed to in its opening were as stunning as they were dubious. J & J’s counsel promised that he would show that talc has been proven safe. That claim is, however, beyond what the available science can show, especially with a plethora of statistically significant associations in case-control studies. J & J need only show that the plaintiffs’ claim has not been established, but it created an unnecessary burden of proving safety. The rhetorical value of the claim is obvious, but promising to show something that cannot be delivered seems like a recipe for disaster. $110 million is a disaster.

Then there was a defense claim that epidemiology cannot show that talc causes ovarian cancer. The claim was unclear as to whether epidemiology cannot establish general or specific causation, and vague as to whether the inability resulted from the weak, equivocal evidence in the instance of talc and ovarian cancer, or some deeper inability that stems from the nature of the evidence itself. Of course, given that there is an expected base rate of ovarian cancer in the general population, epidemiology will be required, even if it may not be sufficient. But if epidemiology alone is not sufficient, then what else is required? The defense never clarified its claim.

As for specific causation, the notion that epidemiology never informs individual patient predictions or causal assessments seems far fetched. If are dealing with a case of mesothelioma and occupational crocidolite exposure, with relative risks in the thousands, the attribution based upon the existence of a very high relative risk seems eminently reasonable. The same with maternal thalidomide use and an infant’s phocomelia, even though there is a baseline risk of phocomelia. Even in the case of a heavy smoker and lung cancer, with relative risks in the range of 20 to 40, inferring specific causation seems like a sound inference, especially in the absence of evidence that the risk is segregated in some subgroup of the population that suffers the outcome.

Imerys’s Opening

Counsel for Imerys also gave an opening statement, which started on common defense themes of the need to reserve judgment until all evidence is heard, and the need to consider context for statements. Imerys echoed the dubious claims that epidemiology can never inform inferences about individual patients, that epidemiology has determined that talc is safe, that cohort studies are always better than case-control studies, and that cohort studies are better because they have many thousand of women in them as opposed to “just a handful” in case-control studies.

Imerys, however, soon wandered into territory that affirmatively undermined J & J’s defense. First, it applauded itself for having warned of “possible causation,” which tended to concede the point to plaintiffs that there is a duty to warn of possibly caused outcomes. Second, Imerys appropriately urged its bulk supplier defense, which placed the spotlight on J & J’s alleged culpability.

The Imerys lawyer may have offended the Missouri jury by referring to talc as a mineral formed millions of years ago. A large percentage of Americans believe that the Earth was created less than 6,000 years ago. And yet, we still believe that allowing ordinary citizens to decide scientific issues is a good thing!

In its opening, Imerys also misstated the law to its own detriment. In discussing its obligations to warn, Imerys asserted that as a mining company it had to follow the rules established by OSHA. Actually, not. Mining companies are under the jurisdiction of the Mining Safety and Health Administration (MSHA), and OSHA Hazards Communication regulations did not apply to mining companies for the years involved in the Slemp case. See Memorandum from Patricia K. Clark, Director of OSHA Compliance Programs, to Regional Administrators re Hazard Communication and Mining Operations (Mar. 3, 1992).

1 See also Anthony Pratkanis & Elliot Aronson, Age of Propaganda: The Everyday Use and Abuse of Persuasion at 210 (2000) (“[A]ll other things being equal, the more frightened a person is by a communication, the more likely her or she is to take positive preventive action.”); H.L. Mencken, In Defence of Women § 13 “Women and the Emotions” (1923) (“The whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, most of them imaginary.”); Conor Boyack, Feardom: How Politicians Exploit Your Emotions and What You Can Do to Stop Them (2014).

2 John W. Anthony, Richard A. Bideaux, Kenneth W. Bladh, and Monte C. Nichols, The Handbook of Mineralogy, vol. II (1995).

3 Melanie Safka, “Psychotherapy” (“A thing is a phallic symbol if it’s longer than it’s wide”).

4 Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” The American Statistician, available online (Mar. 7, 2016), in-press at DOI:10.1080/00031305.2016.1154108, <http://dx.doi.org/10.1080/>.

5 Walter N. Kernan, Catherine M. Viscoli, et al., “Phenylpropanolamine and the Risk of Hemorrhagic Stroke,” 343 New Engl. J. Med. 1826 (2000).

6 See In re Phenylpropanolamine Prod. Liab. Litig., 289 F. 2d 1230 (2003).

Posted in Asbestos, Causation, Scientific Evidence | Comments Off on The Slemp Case, Part 2 – Openings

The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations

May 13th, 2017

“While I greatly appreciate you informing me, on three separate occasions, that I am not under investigation, I nevertheless concur with the judgment of the Department of Justice that you are not able to effectively lead the Bureau.”

Letter from Donald Trump to James Comey (May 9, 2017) (emphasis added)

Just as a President’s poor diction does not define or guide good English grammar, a lay civil jury’s verdict on scientific issues does not resolve open scientific questions of causation between exogenous exposures and cancer or other chronic disease outcomes. Last week, a jury in St. Louis returned a substantial verdict for compensatory and punitive damages against Johnson & Johnson, and others, for supposedly causing Lois Slemp to develop ovarian cancer. From some of the media coverage, readers might infer that Ms. Slemp’s attorneys’ had presented a credible case of causation between perineal talc use and ovarian cancer. See, e.g., Daniel Siegal, “J&J Hit With $110M Verdict In Latest Mo. Talc Cancer Trial,” Law360 (May 4, 2017). The cause of this verdict requires close scrutiny of the scientific evidence, the jury and juries generally, the lawyering from both sides, and the judicial management of the trial.

“Hit.” Hit? When did comic-book language invade legal journalism? Why not “slammed,” “zapped,” or “kapow”?

The case, which has gained this recent notoriety is Lois Slemp v. Johnson & Johnson, case no. 1422-CC09326-01, 22nd Judicial Circuit Court of Missouri. The jury awarded Ms. Slemp $5.4 million in compensation, and $66 million against Johnson & Johnson, $39 million against Johnson & Johnson Consumer, and $50,000 against Imerys (the talc miner and supplier), in punitive damages. On the compensatory award, the jury ascribed 99 percent of fault to the two J & J companies, and 1 percent to Imerys. Id.

The truth is that the Slemp verdict, as is the case for most civil jury verdicts, does not represent a valid scientific judgment. Nonetheless, the verdict requires explanation. If talc does not cause ovarian cancer, we may well ask whether the case was poorly defended, whether the court system failed to serve as a gatekeeper, and whether the scientific case was beyond the comprehension of the lay jury.

The verdict of course also raises serious questions about our civil justice system. The law of products liability typically states that a manufacturer or seller is held to the level of an expert in knowing the harmful aspects of its products. If this knowledge is widely known about consumers, then the seller will generally have an obligation to warn about the latent harm. But what happens when there is no knowledge of a causal relationship? Or what happens when experts legitimately disagree? How can a manufacturer or seller be charged with outrageous misconduct, let alone negligence, when experts sincerely and legitimately disavow a causal relationship?

David H. Schwartz, Ph.D. of Innovative Science Solutions LLC, and I posted a preliminary, big-picture overview of the Slemp case at the Courtroom View Network’s website. See Schwartz & Schachtman, “10 Key Scientific Takeaways From Recent $110M Talc Powder Verdict,” Courtroom View Network Blog (May 12, 2017). Thanks to the generosity of Courtroom View, David and I were able to view the video of the Slemp trial, and to evaluate the legal process of presenting a complicated scientific case to a lay jury. There is much to be said about that process, what went right and what went wrong, but for now, I will simply repeat, below, what we said on CVN’s blog. I hope in subsequent posts to look more closely at specific issues, especially with respect to the presentation of statistical and epidemiologic evidence, by all parties.

* * * * *

The following is a republication (with minor formatting changes) of the original post, by David H. Schwartz and Nathan Schachtman.

Establishing a rigorous and reliable causal inference between an exposure and an adverse health outcome is one of the most difficult things to do in the health sciences. However, it is sometimes even more difficult to effectively and appropriately demonstrate that a causal relationship does not exist.

The difficulty of this task was illustrated in the most recent talcum powder trial in St. Louis, Missouri. As was widely reported, Johnson & Johnson and talc raw material producer Imerys received the third (and largest) plaintiff verdict in their four recent talc trials (3 plaintiff verdicts and one defense verdict). Having the enviable opportunity to watch the trial (in real time or on demand) on Courtroom View Network’s website provides an invaluable opportunity to review and learn from an important ongoing mass tort action.

At this trial, the defense put up a single expert witness, Dr. Huh, a clinician who defended the aggressive and wide-ranging scientific claims advanced by plaintiff’s expert witnesses in a number of scientific disciplines, including epidemiology, clinical medicine, and pathology. Dr. Huh, a skilled and experienced ObGyn and a clinical gynecological oncologist, attempted to neutralize plaintiff’s scientific allegations made by putting the clinical characteristics of the patient into context, while dismissing the many statistically significant epidemiological studies touted by plaintiffs as adequately establishing a causal inference for talcum powder and ovarian cancer.

In his cross examination, plaintiff counsel continuously barraged Dr. Huh with technical observations relating to the large body of epidemiologic studies that plaintiff expert witnesses claimed demonstrated that talc exposure caused ovarian cancer. From the perspective of a scientist who has consulted with many product manufacturers alleged to cause cancer and other chronic diseases, and a lawyer who has tried many science-based cases over the past 32 years, this most recent trial illustrates some important and emblematic issues that arise in pharmaceutical, medical device, and toxic tort cases. We provide 10 such observations below.

1. Provide overall context of Bradford Hill criteria

Unlike other legal cases where there is a paucity of epidemiologic data showing statistically significant associations between an exposure and a disease endpoint, in this case there are many epidemiologic studies – and even some meta-analyses – that invite plaintiffs to make the claim that the available scientific evidence meets the Bradford Hill criteria. Therefore, it is critical to provide the jury with a lucid understanding of why the Bradford Hill criteria are utilized and how they should appropriately be applied. Indeed, the Bradford Hill criteria were developed for a situation exactly like the talc litigation; that is, a relatively weak association is reported and scientists want to determine whether that association should validly and reliably be considered causal.

2. Build solid foundation for “correlation does not equal causation” argument

Multiple studies assert an association between talc and ovarian cancer. However, the defense position is that the studies used to make this assertion suffer from bias and confounding, making them unreliable. Relying upon multiple flawed or biased studies to demonstrate a relationship between two factors does not make the two factors causally related. For example, it does not matter how many times one shows that wearing work boots is associated with back injury, it does not make wearing work boots a cause of back injury. (The two factors are associated, but not causally so.) It is critical for the defense to make it crystal clear (as many times as he is questioned) that “correlation does not equal causation.”

3. Develop a genetic defense

Knowledge of the role of genetic data related to ovarian cancer is moving at breakneck speed. Indeed, a study was published in March identifying nine new susceptibility loci for different epithelial ovarian cancer histotypes. While these data may or may not have been relevant to the individual patient in the Slemp trial, there is no way to know unless the defense had a full genome sequence of the plaintiff’s germline. Such information could conceivably be aligned with newly published data to demonstrate that her genetic profile was consistent with the development of ovarian cancer.

4. Hone the lack of consistency argument

Not surprisingly, in his cross examination of Dr. Huh, plaintiff counsel repeatedly referred to the many case-control studies that reported statistically significant associations between talc and ovarian cancer to support the view that the Hill criterion of “consistency” was met. Dr. Huh repeatedly attempted to rebut this assertion, but failed to make a clear argument as to why these multiple studies failed to support the criterion of consistency. He did refer to the fact that the cohort studies disagreed with the case control studies, but failed to clearly articulate his interpretation of that discrepancy.

At the end of the day, it is not at all surprising that multiple confounded and biased studies all demonstrate the same association. To truly demonstrate the criterion of consistency, one must show that the same results are obtained when using different study methods. Indeed, when a different study design is utilized (cohort studies), the association vanishes. One can posit methodological flaws in the cohort studies (misclassification bias as was repeatedly stated by plaintiff counsel), but flaws can also be posited for the case control studies (recall bias and confounding). The point is that repeating the same poorly conceived study design over and over does not constitute consistency and that the criterion of consistency is therefore not met in this data set.

An example, such as the strong relationship between Vitamin A and cancer prevention might have helped. In observational studies, Vitamin A is clearly associated with a reduction of lung cancer rates based on multiple observational studies. When the claim was tested in randomized clinical trials, the claim failed miserably; indeed, Vitamin A might even increase the rate of lung malignancies in those who took supplements. Similarly, hormone replacement therapy (HRT) was once thought to decrease the risk of cardiovascular disease based on multiple observational studies. It was not until a large randomized controlled trial was conducted that the putative association between HRT and cardiovascular benefit was discredited.

5. Do not let conflict of interest arguments cloud the causal inference assessment

Alleged conflicts of interest were raised repeatedly in accusatory tones, suggesting that any research that J & J funded could not be trusted. Furthermore, suggestions were made that J & J controlled where funding was allocated through their contributions to the National Institutes of Health. These arguments must be addressed aggressively and should not be allowed to hang in the air without response.

6. Pathological evidence must be confronted by someone who studied the pathology slides

Plaintiff counsel confronted Dr. Huh with allegations by plaintiff’s pathologist about the type of cancer from which plaintiff suffered. Because Dr. Huh is not a pathologist and because he did not look at plaintiff’s pathology sides, he attempted to use his clinical impressions and medical records to counter the pathological evidence offered by the plaintiff’s expert witness in pathology. The defense seemed enamored of a “less is more” strategy, but forcing expert witnesses into testimony beyond their expertise requires fortitude and perhaps luck.

7. Put “authoritative”statements into appropriate context

Throughout his cross examination, plaintiff’s counsel confronted Dr. Huh with statements from web sites and textbooks suggesting that talc caused ovarian cancer or where talc is listed as a risk factor for ovarian cancer. Many times, such statements referred to a putative association as opposed to a causal relationship. It is critical to point out their inherent weaknesses, including the fact that they have been cherry picked and to counter with other authoritative sources where talc is not listed as a risk factor and/or the causal link has been questioned. It is also important to be ready with other risk factors that could be equally likely to be linked to ovarian cancer and to emphasize that focusing on talc is arbitrary. The plaintiff is this recent trial was morbidly obese, an undisputed risk factor for ovarian cancer.

As with the lack of consistency argument (#3, above), rebuttal of this contention would be effectively guided using specific examples. For instance, many textbooks and other authoritative sources stated that HRT had cardiovascular benefits based on multiple observational studies. The fact is that these statements were wrong.

8. Concede that cohort studies are not always better than case-control studies

The talc defense strongly asserted the view that cohort studies are necessarily better than case control studies. While this contention is generally true (all factors being equal), it is not always true and it leads to some effective cross examination (e.g., the general assertion that cohort studies may suffer, in some instances, from misclassification bias). As one of us (NAS) stated in a recent post related to the California Science Day hearings, there is no reason to make the blanket statement that cohort studies are always better than case control studies.

Rather, the general point can be made that each study type has its appropriate use and that in this case, the findings from studies using the two different methodologies do not agree with each other. Clearly, the role of differential recall is just as likely to bias a case control study as the role of misclassification is to bias a cohort study. This leaves the evidence at a draw at best.

9. Provide a multi-disciplinary defense

In a case involving so many complex disciplines, it does not seem tenable to address all of them with a single expert, even one as well qualified and experienced as Dr. Huh. Many defense lawyers firmly believe in the “less is more” strategy, but complex scientific data sets such as these necessitate a complete presentation of the exculpatory evidence. Although it is easy in hindsight to criticize trial strategy, forcing a clinical oncologist to address pathology, toxicology, and epidemiology places an unfair burden on the lone witness. Certainly, a jury may be more prone to view an expert witness, who is willing to testify outside his area of expertise, as a hired gun advocate.

10. Careful and consistent use of terminology

Because of the nuanced nature of the defense case (i.e., statistically significant associations demonstrated in observational studies may not be causal in nature), it is critical to use terms consistently and carefully. Terms such as “association,” “link,” “causal inference,” and “causation” must be carefully defined and utilized judiciously and with clear intent.

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Of course, looking at testimony in hind-sight is always 20/20. As stated at the outset of this piece defending the assertion that an exposure is not causally related to a clearly defined injury is one of the most difficult things to do in the courtroom, especially when this is attempted through a single expert witness and there are numerous studies purporting to make such a link. Nevertheless, some extremely critical lessons can be learned from this experience to guide future cases.

Posted in Causation, Expert Witnesses, Scientific Evidence | Comments Off on The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations

Talc Litigation Supported by Slippery Expert Witness

April 25th, 2017

Another day, another talc trial in Missouri. This one involves Lois Slemp, who sued Johnson & Johnson and its talc supplier, Imerys Talc America Inc., on her claim that her long-term use of talc caused her to develop borderline ovarian cancer.

To support her causal claim, Slemp’s lawyers called upon Dr. Daniel Cramer, a gynecologist and epidemiologist, from Harvard, to testify. See Daniel Siegal, “J & J’s Talc Caused Woman’s Cancer, Harvard MD Tells Jury,” Law360 (April 24, 2017) [cited as Siegel]. At first blush, counsel’s retention of Dr. Cramer seems like a brilliant choice. Cramer is a Professor of Epidemiology, at Harvard University’s T.H. Chan School Of Public Health, and a Professor of Obstetrics, Gynecology and Reproductive Biology, at Harvard Medical School. For over 30 years, Cramer has published primary studies, reviews, and commentary pieces in which he has addressed the epidemiologic and biological evidence involving talc and ovarian cancer.¹

Cramer, as both a physician and an epidemiologist, addressed both general and specific causation in the Slemp case. Notwithstanding Slemp’s risk factors of family history of cancer and obesity, Cramer asserted with “reasonable degree of medical and scientific certainty” that talc was “the major contributing cause and substantial cause in the development of her serious borderline tumor.” Siegel, supra.

Somehow this physician epidemiologist has taken a putative risk factor and converted it into the cause. This conversion would perhaps make sense if the risk factor were necessary or sufficient to cause the outcome, but the evidence involving talc and ovarian cancer does not even remotely resemble such a situation. The epidemiologic evidence is weak and inconsistent, but if causation were assumed on the basis of cherry-picked studies, the relative risk for ovarian cancer would be somewhere around 1.2. Somewhat like the magic grits in My Cousin Vinny, Dr. Cramer has found a putative risk factor that blocks out all other risk factors, including the idiopathic, baseline risks that afflict all women in the age range of Ms. Slemp.

On cross-examination, Cramer was confronted with his failure to have asserted general causation in his professional, peer-reviewed publications on talc and ovarian cancer. Defense counsel Orlando Richmond drew the jury’s attention to an invidious comparison between Cramer’s courtroom assertions and his epistemically more modest conclusions and qualifications in the scientific literature, in which he never claimed a causal relationship between talc use and ovarian cancer:

Q. “Nowhere in the published scientific literature, did you or your colleagues, ever publish, ever publish, that genital talc use causes serious borderline tumors, the disease Ms. Slemp has. Isn’t that a correct statement, sir?”

A. “We certainly made a powerful case for there being an association. We may not have used the word ‘causal,’ if I had known how important that word was, I would have used it a long time ago.”

Siegel.

Wow! A Harvard professor of medicine and epidemiology, who teaches at the Harvard School of Public Health, and who labored in the field of epidemiology for over three decades, was unaware until earlier this week, when he darkened the doorway of a Missouri courtroom, that there was an important distinction between association and causation, and this distinction was crucial to discussions and debates in science and public policy.

Now that is slipperier than the most lubricious talc dusting. Why would such an accomplished physician scientist equivocate so? Perhaps Cramer refrained from drawing a causal conclusion because uncertainty favored obtaining future grants to study the same issue. Maybe he refrained from drawing a causal conclusion because doing so would have made him subject to criticism, ridicule, and rebuttal from his professional colleagues. I cannot think of a flattering reason for Cramer’s timidity in expressing himself clearly to his professional peers over the course of 34 years of researching the issues.

Previously, I have called attention to “white hat” bias in the courtroom, which occurs when scientists enter the fray based upon their distorted perceptions of siding with the “little guy” in a misguided quest for social justice. Cramer’s participation in the litigation process illustrates another kind of bias in play in courtrooms. After 30 years of publishing on talc and ovarian cancer, Cramer has failed to obtain acceptance of a claim for causality from the scientific community, but the courtroom is a venue where he can obtain the approving judgment of a scientifically naïve jury or judge and thus gain some vindication for his work that has gone unappreciated by professional colleagues and policy makers.

1 See, e.g., Daniel W. Cramer, et al., “The Association Between Talc Use and Ovarian Cancer: A Retrospective Case-Control Study in Two U.S. States,” 27 Epidemiology 334 (2016); Daniel W. Cramer, “The epidemiology of endometrial and ovarian cancer,” 26 Hematol. Oncol. 1 (2012); M. A. Gates, Daniel W. Cramer, et al., “Talc use, variants of the GSTM1, GSTT1, and NAT2 genes, and risk of epithelial ovarian cancer,” 17 Cancer Epidemiol. Biomarkers Prevention 2436 (2008); Joshua Muscat, M. Huncharek, and Daniel W. Cramer, “Talc and anti-MUC1 antibodies,” 14 Cancer Epidemiol Biomarkers Prevention 2679 (2005); Daniel W. Cramer, et al., “Presence of talc in pelvic lymph nodes of a woman with ovarian cancer and long-term genital exposure to cosmetic talc,” 110 Obstet. & Gynecol. 498 (2007); D. M. Gertig, Daniel W. Cramer, Graham A. Colditz, et al., “Prospective study of talc use and ovarian cancer,” 92 J. Nat’l Cancer Inst. 249 (2000); Daniel W. Cramer, “Perineal talc exposure and subsequent epithelial ovarian cancer: a case-control study,” 94 Obstet. & Gynecol. 160 (1999); Daniel W. Cramer, et al., “Genital talc exposure and risk of ovarian cancer,” 81 Internat’l J. Cancer 351 (1999); Bernard L. Harlow, Daniel W. Cramer, et al., “Perineal exposure to talc and ovarian cancer risk,” 80 Obstet. & Gynecol. 19 (1992); Daniel W. Cramer, et al., “Ovarian cancer and talc: a case-control study, 50 Cancer 372 (1982).

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Science Day Should Be Every Day in Our Courtrooms — Part II

March 24th, 2017

This post and the previous one are an expansion upon a post that I wrote with Dr. David Schwartz, of Innovative Science Solutions, LLC. Dr. Schwartz is a talented scientist with whom I had the privilege and pleasure to work at McCarter & English, before he left to become an independent scientific consultant. Dr. Schwartz is one of the founding partners of his firm, which focuses on helping lawyers with the scientific issues in complex health effects litigation. Our earlier post can be found on the Courtroom View Network’s website. “Guest Analysis: Key Takeaways from Recent Talc Powder ‘Science Day’ Hearing in California,” Courtroom View Network (Mar 24, 2017).

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Talc Science Goes Bicoastal

This year, two trial judges have entertained Science Days in talc cases, on both coasts of the United States. In the federal talc litigation, MDL 2738,¹ Judge Freda L. Wolfson conducted a Science Day on January 26, 2017. In the coordinated California state court talc cases, Judge Maren E. Nelson, of the Superior Court of California, Los Angeles County, conducted a Science Day, on March 7, 2017.²

Federal Talc MDL 2738

In the federal cases, Johnson & Johnson, one of the defendants, initiated the Science Day, in November 2016, when it asked Judge Wolfson to set aside a day in “which the parties and their experts can outline their positions/arguments regarding the medical and science issues at play.”³ In Case Management Order No. 1 (Jan. 23, 2017), Judge Wolfson apparently agreed, and the parties had their talc Science Day on January 26, 2017.⁴ The Science Day took up over five hours of presentations to Judge Freda L. Wolfson, and Judge Lois H. Goodman.⁵

California Coordinated Docket

In the California cases,⁶ plaintiffs’ counsel filed a formal motion, in early December 2016, to request a Science Day tutorial. The plaintiffs’ motion requested that each side be permitted two hours to present their views of the scientific evidence in support of their litigation positions on causation and liability in talc ovarian cancer cases. The plaintiffs argued that a Science Day would be “significant benefit to the Court and the parties.”⁷ Judge Nelson granted the request, and held Science Day on March 7, 2017.

Courtroom View Network (CVN)

The proceedings in California were recorded videographically, and are available through Courtroom View Network (CVN). Johnson & Johnson opposed televising the Science Day proceedings, on the procedural ground that CVN had not filed and served the appropriate motion. Johnson & Johnson also argued a substantive ground that the proceedings were not a formal trial, and that televising “would not confer any benefit on the public, the parties, or the Court, let alone one that outweighs the significant concerns posed by such a broadcast.”⁸

Whatever the merits of J & J’s procedural ground, its substantive grounds seem dubious. The importance of the Science Day proceedings transcends the pecuniary interests of the parties to the litigation. First, the presentations provide the empirical bases for other courts and lawyer to evaluate the procedures employed. Second, lawyers and judges generally, outside the talc litigation, can learn a great deal from the strengths, weaknesses, and mistakes made by the participants in the televised proceedings. Many of the scientific issues that pervade the talc litigation recur frequently in other mass tort litigations in the United States and abroad. Finally, and perhaps most important, the talc litigation involves litigation claims of huge import to the public generally. For better or worse, litigation has become an adjunct to regulation in the United States. If the plaintiffs’ claims are true, then there has been a serious failure of national and international regulatory agencies and scientific organizations in evaluating the evidentiary record. If the defendants’ claims are true, then the plaintiffs’ lawyers have misunderstood and distorted the basic process of synthesizing evidence and arriving at conclusions of causation. More important, it behooves the public to understand why one side is wrong.

Evaluation of the California Talc Litigation Science Day

Plaintiffs’ Presentations

The presentation by the plaintiff lawyers was eerily reminiscent of the scientific case made by plaintiffs in the silicone breast implant ligation. Their arguments ranged from highlighting anecdotal evidence to emphasizing the implicit sinister nature of talc migration from the vaginal opening to the ovaries. Plaintiff counsel focused heavily on the alleged role of talc in the inflammatory process and strong (unsubstantiated) implications that anything that enhances inflammation must necessarily cause cancer.

As one would expect, plaintiff counsel placed strong emphasis on the published epidemiological studies linking talc exposure to ovarian cancer. It is important to highlight that the majority of the studies showing an association between talc and ovarian cancer came from case-control studies by design (as opposed to a cohort design). Plaintiff counsel offered very little distinction between these two study designs and, instead tried to make the case that the sheer volume of studies made their argument..

Finally, it should be noted that at many times throughout the plaintiff presentations, the presenter veered off into non-scientific, ad hominem attacks against the industry and/or activities that they tried to paint as venal or unseemly. Defense counsel made objections throughout that seemed to be based upon first amendment protections for the defendants’ ability to speak to agencies about the scientific evidence. For example, the last presenter for the plaintiffs described alleged industry “lobbying” efforts at NTP. Defense counsel objected on first amendment grounds, and the judge semi-sustained the objection on the basis that it had little or nothing to do with the science. The plaintiffs’ emphasis on “lobbying” contained no examples of misrepresentations of scientific data. See “Talc Litigation in Missouri – Show Me the Law and the Evidence” (Feb. 24, 2017).

Defendants’ Presentations

In general, the defense presentations were more structured, coherent, substantial, and rigorously scientific. For example, unlike the plaintiffs’ graphics, many of the defense slides could stand on their own in a scientific or medical society presentation. The defense lawyers attempted to provide a solid foundation for the judge on the different types of ovarian cancer as well as the myriad uncertainties that exist in terms of the known causes of the condition. Many of the slides contained direct quotes from notable scientists and regulators on topics that were directly relevant to answering critical questions in the litigation.

Epidemiology and Specific Causation

Nevertheless, the defense presentations were not without their problems. Consider the following quote from an article by Graham Colditz, used in one of the defense powerpoint slides:⁹

“The fundamental object of epidemiology is to estimate the population average risk of the disease. Risk is a population measure, not an individual disease measure.”

Colditz has served as an expert witness on epidemiology for plaintiffs in talc and other litigations, and the defense no doubt believed that they could make their point in a rhetorically powerful way by quoting him. The problem starts with the quote’s failure to make the defense’s point. Risk is a measure or relative proportions in the sample, to be used to estimate the population measure. To say that it is a group measure, however, does not mean that there are no reasonable inferences from the group measure to the individual member of the sample or population.

The defense seems to want to argue that even there were an increased risk not explained by chance, bias, or confounding, that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer.

A fuller quotation might even have helped the defense because Colditz seems intent on undermining not just the use of group measures of risk as an individual variable, but also the use of the measure to support an inference about individuals:

“The fundamental object of epidemiology is to estimate the population average risk of disease. Risk is a population measure, not an individual measure. Epidemiology does not estimate individual levels of risk, nor does it perfectly predict individual likelihood of disease. As noted by Rose, epidemiology does not describe why an individual case of cancer arises in the population but rather the population burden of cancer.¹⁴ In his article in this issue of the Journal, Begg ignores this principle and uses the term “risk” as an individual-level variable.¹⁵”

The fuller quotation points to a disagreement in which another epidemiologist was willing to use risk to describe individual attribute, but more to the point is that Colditz’s assertion is that risk is a group measure.

Colditz, at least in this article, does not claim that the group measure of risk was irrelevant to prospective individual predictions or retrospective individual attributions. Interestingly, Graham Colditz has elsewhere asserted that an increased risk of disease cannot be translated into the “but-for” standard of causation¹⁰:

“Knowledge that a factor is associated with increased risk of disease does not translate into the premise that a case of disease will be prevented if a specific individual eliminates exposure to that risk factor. Disease pathogenesis at the individual level is extremely complex.”

Defense may have wanted to highlight this assertion even recognizing that it is controversial, and quite dependent upon the magnitude of the measured risk.

In attempting to make their point with a quote from plaintiffs’ own expert (Dr. Graham Colditz), the defense oversimplified a much more complex issue. While increased or relative risk is indeed a measure or incidence rates used to estimate rates in the broader population, this aspect of relative risk as a measure does not mean that there are no reasonable inferences that can be made from the group measure to the individual member of the sample or population. The defense seems to want to make the seemingly unreasonable point that even if an increased risk were appropriately demonstrated by the epidemiology, that that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer. This point might be correct when the magnitude of the increased risk is small (as is alleged in the talc ovarian cancer litigation), but the sweeping generality of the defense’s assertion is jarring.

Back in the 1960s and 1970s, tobacco companies attempted to rebut inferences of individual causation, despite scientific consensus on general causation, and relative risks of 20 to 30, and more for lung cancer in smoking versus non-smoking groups. The tobacco companies’ claim of the irrelevancy of epidemiology to inferring specific causation was not particularly credible when the population attributable risk was 95 percent and greater.

Even at lower relative risks, measures of risks in epidemiologic studies and clinical trials are used to predict individual responses to treatments, to life style interventions, and to life style and other risk factors. Of course, there is always potential heterogeneity in the sample and in the population, which should be acknowledged, but when the studies are multivariate, with inclusion of the known causes and potential risk factors, then scientists and physicians routinely use these measures of risks and benefits in groups to make predictions about individuals.

Consider a man, seriously overweight, who goes to see his internist. His physician tells him,

“look in populations of overweight men, just like yourself, more men die of heart attack and stroke, and they die of these diseases at an early age, and suffer more morbidity and disability from them, then in groups of men who are not overweight, but don’t worry, that has NOTHING to do with you. We don’t know your risk, so go right on eating candy bars for breakfast, and studiously avoiding exercise.”

Of course, no sane, competent physician would advise the obese patient in this manner. Now, I understand rhetorically why the defense might want to capitalize on Colditz’ statement, but the end result appears to mislead the intended audience. The rejection of probabilistic inferences is still occasionally sanctioned by courts¹¹, but more typically, such inferences are permitted when not conjectural.

Defense’s Misleading Claim that Case-Control Studies are Smaller than Cohort Studies

In its Science Day presentation, the defense asserted that a disadvantage of case-control studies is, among other things, their “small size.” In the same vein, the defense claimed that an advantage of cohort studies is their “large size.” The defense provided no supporting citations for its contention about the relative size of the two kinds of analytical epidemiologic studies.¹²

In his oral comments, the defense presenter notes the size disparity between the case-control and the cohort studies as a reason to distrust the results of the case-control studies on talc exposure and ovarian cancer. The presenter leans in and says that the cohort studies are huge, some with hundreds of thousands of women.

Now there are important qualitative differences between case-control and cohort studies, with respect to recall bias and the validity of control groups. To be sure, and fair, the defense made these points accurately. The defense’s invidious comparison of size of the two types of studies ignores that case-control studies are statistically much more efficient.

As the defense presented the matter, case-control studies are placed lower on the “hierarchy of evidence” than cohort studies. For this point, the defense did present a supporting citation¹³, and their claim is generally correct, but epidemiologists recognize that a well-conducted case-control study may well trump a cohort study. Case-control studies are often ranked below cohort studies because of greater potential for systematic bias, the inherent difficulty in selecting appropriate controls, and because the measure of risk in the form of an odds ratio is at best an estimate of the relative risk. The sizes of the “cases” group in a case-control study and the cohort in a cohort study are not a valid comparison.

A case-control study may be based upon hundreds of cases of ovarian cancer, a size that would require a huge cohort study. Furthermore, the size of the cohort study can be highly misleading because recruitment and inception into the cohort often takes place at a young age, when the rate of ovarian cancer is very low. The efficiency of the case-control study design is reflected in the narrow confidence intervals seen in many of the published papers. Some of these confidence intervals are as narrow as those generated by analysis of data from “larger” cohort studies.¹⁴ The size is ultimately related to the precision of the various studies’ point estimates of measured risk, not to the accuracy of their measurements. The statistical efficiency of the ovarian cancer talc case-control studies becomes an important when rare disease subtypes are considered, or when the interaction between genotype, exposure, and cancer outcomes needs to be considered.

Synthesis of Evidence for Judgments of Causation

Finally, it seems that neither the defense nor the plaintiffs adequately incorporated into their presentations the important concept of causal inference (or how evidence from disparate sources is synthesized into a judgment of causation, or into a rejection of such a claim). Specifically, counsel never explicitly set forth the importance of the Bradford Hill factors, or the techniques of proper and rigorous systematic review methodologies. The defense did touch upon many of the key considerations of the Bradford Hill factors as they applied to the relevant data, but there was no discussion of how these factors are considered after the identification of an association that is not likely the result of bias and that is beyond the play of chance. With respect to meta-analysis, both sides provided no guidance or insight into the problems that arise in conducting, reporting, and interpreting quantitative syntheses of a body of epidemiologic studies.

The Trial Court’s Role

Most trial judges, sadly, come to cases such as the talc ovarian cancer cases without any training in statistics, epidemiology, toxicology, or an adequate understanding of the role that clinical medicine plays (or does not play) in assessing important questions of causation. Judge Nelsen seemed to listen carefully, but asked few questions to suggest that Her Honor understood the discrepancy in statements made in the parties’ presentation.

Perhaps a starting point for Science Day should be an Order that sets out the procedures for the Day, as well as a statement: “The Court has read and studied the relevant chapters in the Reference Manual on Scientific Evidence (3d ed. 2011), and all materials submitted by the parties. The parties should not recreate a tutorial that covers material in the Reference Manual, unless they wish to contest its contents. Specific references to the Manual, in connection with the parties’ presentation would be very helpful to the Court.”

1 In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Prods. Liab. Litig., No. 16-2738 (D.N.J.)

2 Johnson & Johnson Talcum Powder Cases, No. JCCP4872 (Calif. Super. Ct., Los Angeles Cty.).

3 “Johnson & Johnson Files Status Report in MDL Docket, Requests ‘Science Day’ to Address Causation in Talc Cases,” HarrisMartin’s Talcum Powder Litigation Report (Nov. 16, 2016).

4 “Parties in Federal Talcum Powder MDL Hold ‘Science Day’,” HarrisMartin’s Talcum Powder Litig. Report (Jan. 26, 2017).

5 Id.

6 Johnson & Johnson Talcum Powder Cases, No. JCCP4872 (Calif. Super. Ct., Los Angeles Cty.).

7 “Plaintiffs Ask Court to Hold ‘Science Day’ in California Coordinated Talcum Powder Docket,” HarrisMartin’s Talcum Powder Litig. Report (Dec. 7, 2016).

8 See “Calif. Court Oversees ‘Science Day’ in Talcum Powder Docket One Day After J&J Opposes Broadcast of Hearing,” HarrisMartin’s Talcum Powder Litig. Report (Mar. 8, 2017).

9 “Defense Slide 129. “Epidemiology Estimates Risk in the Population, Not in Individuals,” quoting from Graham Colditz, “Cancer Culture: Epidemics, Human Behavior, and the Dubious Search for New Risk Factors,” 91 Am. J. Pub. Health 357, 357 (2001).

10 Graham A. Colditz, “From epidemiology to cancer prevention: implications for the 21st Century,” 18 Cancer Causes Control 117, 118 (2007).

11 See, e.g., Smith v. Ortho Pharmaceutical Corp., 770 F. Supp. 1561, 1573 (N.D. Ga. 1991) (“However, in an individual case, epidemiology cannot conclusively prove causation; at best, it can only establish a certain probability that a randomly selected case of disease was one that would not have occurred absent exposure, or the ‘relative risk’ of the exposed population. Epidemiology, therefore, involves evidence on causation derived from group-based information, rather than specific conclusions regarding causation in an individual case.”).

12 See Defense Slide 134, “Disadvantages of Case-Control Studies,” which sets out in bullet points, “Recall Bias, Confounding, Small Size.” And in Defense Slide 135, “Epidemiologic Studies on Talc and Ovarian Cancer: Three Types Large Prospective Cohort Studies,” the defense touts advantages of cohort studies to include “No Recall Bias” and “Large Size.” The slides contained no supporting citation for the contention about size.

13 See Defense Slide 136, “Epidemiology Studies on Talc and Ovarian Cancer: Three Types,” where the defense places case-control studies lower on the “hierarchy of evidence” than cohort studies, citing Trisha Greenhalgh, “How to Read a Paper,” 315 Brit. Med. J. 241 (1997).

14 See Wera Berge, Kenneth Mundt, Hung Luu & Paolo Boffetta, “Genital use of talc and risk of ovarian cancer: a meta-analysis,” European J. Cancer Prevention (2017), in press, DOI: 10.1097/CEJ.0000000000000340.

APPENDIX

American Bar Association’s “Civil Trial Practice Standards” (August 2007).

7. Use of Tutorials to Assist the Court

a. Pretrial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court. Tutorials are intended to provide the court with background information to assist the court in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

b. Selection of Type of Tutorial.

i. In any case in which the court believes one or more tutorials might be useful in assisting it in understanding the complex technology or other complex subject matter, the court should invite the parties to express their views on the desirability of one or more tutorials.

ii. Once the court decides to permit or require one or more tutorials, it should invite the parties to suggest the subject matter and format of each tutorial.

iii. If the parties cannot agree on the subject matter and format, the court should invite each party to submit a description of any tutorial it proposes and to explain how that tutorial will assist the court and why it is preferable to the tutorial proposed by another party. The court may approve one or more tutorials proposed by the parties, or the court may fashion its own tutorial after providing the parties with an opportunity to comment on the court’s proposed subject matter and format.

c. Procedures for Presentation. A court may consider the following procedures for the presentation of tutorials:

i. An in-court or recorded presentation by an expert jointly selected by the parties.

ii. An in-court or recorded presentation by one or more experts on behalf of each party.

iii. An in-court or recorded presentation by counsel for each party.

iv. A combined in-court or recorded presentation by counsel and one or more experts on behalf of each party.

v. An in-court or recorded presentation by an expert appointed by the court, which may include cross-examination by counsel for each party.

vi. Recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial Center.

d. Trial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court or jury during one or more stages of the trial. Trial tutorials are intended to provide the court or jury with background information to assist in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

e. Selection of Type of Tutorial. The court should use the process set forth in 7.b. above.

f. Procedures for Presentation.

i. In a bench trial, the court may consider using any of the procedures set forth in 7.b. above.

ii. In a jury trial, the court should consider the use of tutorials in connection with interim statements and arguments as provided in

Standard 9.

iii. In both bench and jury trials, the court should provide parties with a full opportunity to present admissible evidence in support of their cases that may differ from or quarrel with information presented in a tutorial and to argue that the information presented in a tutorial should be rejected by the court or jury.

Posted in Rule 702, Scientific Evidence | Comments Off on Science Day Should Be Every Day in Our Courtrooms — Part II

Science Day Should Be Every Day in Our Courtrooms — Part I

March 24th, 2017

The following post and its sequel are an expansion upon a post that I wrote with Dr. David Schwartz, of Innovative Science Solutions, LLC. Dr. Schwartz is a talented scientist with whom I had the privilege and pleasure to work at McCarter & English, before he left to become an independent scientific consultant. Dr. Schwartz is one of the founding partners of his firm, which focuses on helping lawyers with the scientific issues in complex health effects litigation. Our earlier post can be found on the Courtroom View Network’s website. “Guest Analysis: Key Takeaways from Recent Talc Powder ‘Science Day’ Hearing in California,” Courtroom View Network (Mar 24, 2017).

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

Every February 28^th, India celebrates National Science Day in honor the Indian physicist Sir Chandrashekhara Venkata Raman, who discovered the Raman effect. The United States has no equivalent celebration, but “Science Days” have become a commonplace in complex state and federal Litigations, around the country.

Background

The major impetus for science tutorials seems to have come from the United States Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The holding of Daubert, now incorporated into, and extended by Federal Rule of Evidence 702, requires trial judges to act as gatekeepers of the relevance and reliability of expert witness opinion testimony in their courtrooms. One of the first tests of the judiciary’s performance to perform this role came in the silicone gel breast implant litigation. The federal silicone cases were consolidated before Judge Pointer Sam C. Pointer, Jr., in MDL 926. Judge Pointer believed that trial judges in the transferor courts should conduct whatever review of expert witness opinion was needed to satisfy the then recent Daubert decision.

Some of the first federal silicone lawsuits remanded from the MDL went to Judge Robert Jones in Portland Oregon. These cases involved complex issues of immunology, clinical rheumatology, epidemiology, toxicology, surgery, and polymer and analytical chemistry. At the outset of his case management of the remanded cases, plaintiffs’ counsel requested that Judge Jones schedule an all-day tutorial for counsel to present on these scientific issues. The parties’ tutorials, along with an avalanche of defense Daubert motions, persuaded Judge Jones to take the unusual step of appointing technical advisors to assist him in assessing the scientific evidence, inferences and claims in the silicone litigation. See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1415 (D. Ore. 1996).¹ Judge Jones’s technical advisors attended court throughout the Daubert hearings conducted in Portland, and they delivered advisory reports to Judge Jones to assist him in his gatekeeping function. Judge Jones ultimately granted the defense motions to exclude the plaintiffs’ expert witnesses’ claims of silicone causation of connective tissue diseases.

In large measure because of Judge Jones’s case management and exclusion of expert witness testimony, the silicone MDL court appointed a panel of neutral expert witnesses, in the fields of epidemiology, rheumatology, immunology, and toxicology.²

One of the first requests received from the Science Panel in MDL 926 was for what turned out to be a series of Science Days in which the parties’ expert witnesses would present to them, and explain their interpretation of the vast array of evidence, from different disciplines. Each presenting party expert witness was allowed 15 to 20 minutes to present. The lawyers were not entirely reduced to potted plants; they had a chance to conduct a short cross-examination. Given that the primary audience was a panel of four distinguished scientists, there was an emphasis for most of the lawyers, for the plaintiffs and the defendants, to ask pertinent, substantive questions.

The Science Panel was not entirely satisfied with the party expert witnesses, and requested a second Science Day, at which the Panel could call its own slate of scientists to address the scientific claims made in the litigation. The proceedings took place at the National Academies of Science, in Washington, D.C.

These proceedings, along with extensive submissions of articles and briefings from the parties led to the Report of National Science Panel, on November 30, 1998.

Every Day is Science Day, Somewhere

Since the breast implant litigation, many MDL and other courts have faced complex causation claims in litigation involving pharmaceutical products, medical devices, consumer products and a host of chemical exposures. Appointment of independent, neutral expert witnesses remains unusual, but trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them. For some reason, the parties, the judges, and the legal media often reference Science Days in scare quotes, signaling that perhaps other Science takes place in these proceedings. Whether the scare quotes are warranted remains to be determined.

“Science Days” have become a tradition in mass tort litigation.³ In the last few years, there is a Science Day somewhere, in some courtroom, going on, perhaps not daily, but with sufficient frequency that the phenomenon should receive more critical attention. Federal judges with multi-district litigation, or state judges with multi-county cases, set aside time to permit the parties a chance to educate them about the scientific and technical aspects of the litigations before them. Judges know that Daubert and Rule 702, or their state analogues, require them to act as gatekeepers. Furthermore, myriad motions in the discovery and trial phases of a case will require judges to make nuanced but accurate decisions about scope and content of discovery, and admissibility of documents and testimony,

Science Day – Have It Your Way

John Milton: We negotiating?

Kevin Lomax: Always.⁴

The Devil’s Advocate (1997).

There are no federal or state rules that set out procedures for science tutorials for judges or their appointed expert. The form and substance of Science Days depend upon a three-say negotiation among the plaintiffs, defendants, and the trial judge. Although the parties are often left to work out a plan for science day, most courts tend to weigh in by imposing time limits, and they may even rule in or rule out live witness testimony.

In 2007, the American Bar Association set out Civil Trial Practice Standards,⁵ which included an entire section on the use of tutorials to assist the court. [The relevant standards for tutorials is set out at the end of Part II of this post, as an appendix.]

1 See Laural L. Hooper, Joe S. Cecil, and Thomas E. Willging, “Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation,” at 9 (Federal Judicial Center 2001).

2 MDL 926 Order 31 (May 31, 1996) (order to show cause why a national Science Panel should not be appointed under Federal Rule of Evidence 706); MDL 926 Order No. 31C (Aug. 23, 1996) (appointing Drs. Barbara S. Hulka, Peter Tugwell, and Betty A. Diamond); Order No. 31D (Sept. 17, 1996) (appointing Dr. Nancy I. Kerkvliet).

3 See, e.g., Barbara J. Rothstein & Catherine R. Borden, Managing Multidistrict Litigation in Products Liability Cases: A Pocket Guide for Transferee Judges at 39 & n. 54 (Fed. Jud. Ctr. 2011); Sean Wajert, “‘Science Day’ In Mass Torts,” Mass Tort Defense (Oct. 20, 2008); Lisa M. Martin, “Using Science Day to Your Advantage,” 2(4) Pro Te: Solutio 9 (2009).

4 From the screenplay of the movie, directed by Taylor Hackford, written by Jonathan Lemkin and Tony Gilroy, and based on a novel by Andrew Neiderman.

5 American Bar Association’s “Civil Trial Practice Standards” (August 2007 & 2011 Update).

Posted in Rule 702, Scientific Evidence, Trial Procedure | Comments Off on Science Day Should Be Every Day in Our Courtrooms — Part I

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.

1 See “Mercola Interview of Sharyl Attkisson About Media Obstruction.”

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).

5 “Marketers of indoor tanning systems to pay refunds to consumers: Defendants ran ads claiming that Indoor tanning is safe, Doesn’t increase the risk of skin cancer,” FTC news release (April 14, 2016); see also “Dr. Joseph Mercola’s battle with his state licensing board”; Stephen Barrett, “Dr Joseph Mercola’s battle with his state licensing board,” Casewatch (Sept. 1, 2015)

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).

9 “Public Interest Groups to USA Today: Ditch Corporate Front Group Science Columns” (Feb. 9, 2017).

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).

11 Hank Campbell, “Anti-Science Groups Demand Media Give Them Equal Time Or Ban Scientists,” (Feb. 27, 2017).

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

New York Rejects the Asbestos Substantial Factor Ruse (Juni Case)

March 2nd, 2017

I recall encountering Dr. Joseph Sokolowski in one of my first asbestos personal injury cases, 32 years ago. Dr. Sokolowki was a pulmonary specialist in Cherry Hill, New Jersey, and he showed up for plaintiffs in cases in south Jersey as well as in Philadelphia. Plaintiffs’ counsel sought him out for his calm and unflappable demeanor, stentorious voice, and propensity for over-interpreting chest radiographs. (Dr. Sokolowski failed the NIOSH B-Reader examination.)

At the end of his direct examination, the plaintiff’s lawyer asked Dr. Sokolowski the derigueur “substantial factor” question, which in 1985 had already become a customary feature of such testimonies. And Dr. Sokolowski delivered his well-rehearsed answer: “Each and every exposure to asbestos was a substantial factor in causing the plaintiff’s disease.”

My cross-examination picked at the cliché. Some asbestos inhaled was then exhaled. Yes. Some asbestos inhaled was brought up and swallowed. Yes. Asbestos that was inhaled and retained near the hilum did not participate in causing disease at the periphery of the lung. Yes. And so on, and so forth. I finished with my rhetorical question, always a dangerous move, “So you have no way to say that each and every exposure to asbestos actually participated in causing the plaintiff’s disease?” Dr. Sokolowski was imperceptibly thrown off his game, but he confessed error by claiming the necessity to cover up the gap in the evidence. “Well, we have no way to distinguish among the exposures so we have to say all were involved.”

Huh? What did he say? Move to strike the witness’s testimony as irrational, and incoherent. How can a litigant affirmatively support a claim by asserting his ignorance of the necessary foundational facts? The trial judge overruled my motion with alacrity, and the parties continued with the passion play called asbestos litigation. The judge was perhaps simply eager to get on with his docket of thousands of asbestos cases, but at least Dr. Sokolowski and I recognized that the “substantial factor” testimony was empty rhetoric, with no scientific or medical basis.

Sadly, the “substantial factor” falsehood was already well ensconced in 1985, in Pennsylvania law, as well as the law of most other states. Now, 32 years later, with ever increasingly more peripheral defendants, each involving less significant, if any, asbestos exposure, the “substantial factor” ruse is beginning to unravel.¹

Juni v. A.O. Smith Water Products Co.

Arthur Juni was a truck and car car mechanic, who worked on the clutches, brakes, and manifold gaskets of Ford trucks. Juni claimed to have sustained asbestos exposure in this work, as well as in other aspects of his work career. In 2012, Juni was diagnosed with mesothelioma; he died in 2014. Juni v. A.O. Smith Water Products Co., at *1,No. 190315/12 2458 2457, 2017 N.Y. Slip Op. 01523 (N.Y. App. Div. 1st Dep’t, Feb. 28, 2017).

Juni sued multiple defendants in New York Supreme Court, for New York County. Most of the defendants settled, but Ford Corporation tried the case against the plaintiff’s widow. Both sides called multiple expert witnesses, whose testimony disputed whether the chrysotile asbestos in Ford’s brakes and clutches could cause mesothelioma. The jury returned a verdict in favor of the plaintiff, but the trial court granted judgment nothwithstanding the verdict, on the ground that the evidence failed to support the causation verdict. Id. At *1; see Juni v. A. 0. Smith Water Prod., 48 Misc. 3d 460, 11 N.Y.S.3d 415 (N.Y. Sup. Ct. 2015).

Earlier this week, the first department of the New York Appellate Division affirmed the judgment for Ford. 2017 N.Y. Slip Op. 01523. The Appellate Division refused to approve plaintiffs’ theory of cumulative exposure to show causation. The plaintiffs’ expert witnesses, Drs. Jacqueline Moline and Stephen Markowitz, both asserted that even a single asbestos exposure was a “substantial contributing” cause. The New York appellate court, like the trial court before, saw through the ruse, and declared that both expert witnesses had failed to support their assertions.

The “Asbestos Exception” Rejected

Although New York has never enacted a codified set of evidence rules, and has never expressly adopted the rule of Daubert v. Merrill Richardson, the New York Court of Appeals has held that there are limits to the admissibility of expert witness opinion testimony. Parker v. Mobil Oil Corp., 7 N.Y.3d 434 (2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 NY3d 762 (2014); Sean Reeps. v BMW of North Am., LLC, 26 N.Y.3d 801 (2016). In Juni, the Appellate Division, First Department, firmly rejected any suggestion that plaintiffs’ expert witnesses in asbestos cases are privileged against challenge over admissibility or sufficiency because the challenges occur in an asbestos case. The plaintiff’s special pleading that asbestos causation of mesothelioma is too difficult was invalidated by the success of other plaintiffs, in other cases, in showing that a specific occupational exposure was sufficient to cause mesothelioma.

The Appellate Division also rejected the plaintiff’s claim, echoed in the dissenting opinion of one lone judge, that there exists a “consensus from the medical and scientific communities that even low doses of asbestos exposure, above that in the ambient environment, are sufficient to cause mesothelioma.” The Court held that this supposed consensus is not material to the claims of a particular plaintiff against a particular defendant, especially when the particular exposure circumstance is not associated with mesothelioma in most of the relevant studies. In Juni, the defense had presented many studies that failed to show any association between occupational brake work and mesothelioma. The court might also have added that a characterization of low exposure is extremely amiguous, depending upon the implicit comparison that is being made with other exposures. It is impossible to fit a particular plaintiff’s exposure into the scale of low, medium, and high without some further context.

Single Exposure Sufficiency Rejected

The evidence that chrysotile itself causes mesothelioma remains weak, but the outcome of Juni turned not on the broad general causation question, but on the question whether even suggestive evidence of chrysotile causation had been established for the exposure circumstances of an automobile mechanic, such as Mr. Juni. Plaintiffs’ expert witnesses maintained that Juni’s cumulative asbestos exposures caused his mesothelioma, but they had no meaningful quantification or even reasonable estimate of his exposure.

Citing the Court of Appeals decision in Reeps, the Appellate Division held that plaintiff’s expert witnesses’ causation opinions must be supported by reasonable quantification of the plaintiff’s exposure, or some some scientific method, such as mathematical modeling based upon actual work history, or by comparison of plaintiff’s claimed exposure with the exposure of workers in reported studies that establish a relevant risk from those workers’ exposure. In the Juni case, however, there were no exposure measurements or scientific models, and the comparison with workers doing similar tasks failed to show a causal relationship between the asbestos exposure in those tasks and mesothelioma.

Expert Witness Admissibility and Sufficiency Requires Evaluation of Both Direct and Cross-examination Testimony and Relied Upon Studies

The Juni decision teaches another important lesson for challenging expert witness testimony in New York: glib generalizations delivered on direct examination must be considered in the light of admissions and concessions made on cross-examination, and the entire record. In Juni, the plaintiffs’ expert witnesses, Jacqueline Moline and Stephen Markowitz, asserted that asbestos in Ford’s friction products was a cause of plaintiff’s mesothelioma. Cross-examination, however, revealed that these assertions were lacking in factual support.

Cumulative Exposure

On cross-examination, the plaintiffs’ expert witnesses’ statements about exposure levels proved meaningless. Moline attempted to equate visible dust with sufficient asbestos exposure to cause disease, but she conceded on cross-examination that studies had shown that 99% of brake lining debris was not asbestos. Most of the dust observed from brake drums is composed of resins used to manufacture brake linings and pads. The heat and pressure of the brake drum causes much of the remaining chrysotile to transform into a non-fibrous mineral, fosterite.

Similarly, Markowitz had to acknowledge that chrysotile has a “serpentine” structure, with individual fibers curling in a way that makes deeper penetration into the lungs more difficult. Furthermore, chrysotile, a hydrated magnesium silicate, melts in the lungs, not in the hands. The human lung can clear particulates, and so there is no certainty that remaining chrysotile fibers from brake lining exposures ever reach the periphery of the lung, where they could interact with the pleura, the tissue in which mesothelioma arises.

Increased Risk, “Linking,” and Association Are Not Causation – Exculpatory Epidemiologic Studies

When pressed, plaintiffs’ expert witnesses lapsed into characterizing the epidemiologic studies of brake and automobile mechanics as showing increased risk or association, not causation. Causation, not association, however, was the issue. Witnesses’ invocation of weasel words, such as “increased risk,” “linkage,” and “association” are insufficient in themselves to show the requisite causation in long-latency toxic exposure cases. For automobile mechanics, even the claimed association was weak at best, with plaintiffs’ expert witnesses having to acknowledge that 21 of 22 epidemiologic studies failed to show an association between automobile mechanics’ asbestos exposure and risk of mesothelioma.

The Juni case was readily distinguishable from other cases in which the Markowitz was able to identify epidemiologic studies that showed that visible dust from a specific product contained sufficient respirable asbestos to cause mesothelioma. Id. (citing Caruolo v John Crane, Inc., 226 F.3d 46 (2d Cir. 2000). As the Appellate Division put the matter, there was no “no valid line of reasoning or permissible inference which could have led the jury to reach its result.” Asbestos plaintiffs must satisfy the standards set out in the New York Court of Appeals decisions, Parker v. Mobil Oil Corp., 7 NY3d 434 2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 N.Y.3d 762 (2014), for exposure evidence and causal inferences, as well.

New York now joins other discerning courts in rejecting regulatory rationales of “no safe exposure,” and default “linear no threshold” exposure-response models as substitutes for inferring specific causation.² A foolish consistency may be the hobgoblin of little minds, but in jurisprudence, consistency is often the bedrock for the rule of law.

1 The ruse of passing off “no known safe exposure” as evidence that even the lowest exposure was unsafe has been going on for a long time, but not all judges are snookered by this rhetorical sleight of hand. See, e.g., Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (“the failure of science to isolate a safe level of exposure does not prove specific causation”).

2 See, e.g. Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (failing to identify safe levels of exposure does not suffice to show specific causation); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1165-66 (E.D. Wash. 2009) (rejecting a “no threshold” model of exposure-response as unfalsifiable and unvalidated, and immaterial to the causation claims); Pluck v. BP Oil Pipeline Co., 640 F.3d 671, 679 (6th Cir. 2011) (rejecting claim that plaintiff’s exposure to benzene “above background level,” but below EPA’s maximum permissible contaminant level, caused her cancer); Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 10006, 1015 (E.D. Wash. 2010) (rejecting Dr. David Egilman’s proffered testimony on specific causation based upon his assertion that there was no known safe level of diacetyl exposure).

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Social Media, Rhetoric, and Science – Antivaxxers

February 24th, 2017

In a recent news conference, Donald Trump (née Drumpf) proclaimed that that he had won the presidency by the largest electoral college margin since Ronald Reagan. When an earnest (but obviously “dishonest”) reporter challenged him and pointed out that William Jefferson Clinton and Barack Obama had larger majorities in the electoral college, Trump, the fabulist-in-chief, did not lose a beat. Like the old Grinch, Trump was “so smart and so slick, he thought up a lie, and he thought it up quick!”

From his whopper, Trump retreated to the assertion that he was talking only about Republican presidents. But the earnest young reporter was relentless and pressed the challenge. And when pressed, Trump lamely offered¹:

“I was given that information. I don’t know. I was just given it. We had a very, very big margin.”

Oh my. As John Adams, observed, before he became President:²

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

For a President who regularly embraces alternative facts, who has such a tenuous relationship with reality, and who says whatever was last whispered in his ear, we would expect science to be challenging. Some observers might note that Trump’s behavior mirrors how some lawyers treat scientific evidence and issues in litigation. Rhetoric has its place in science, but scientific disputes cannot be advanced simply because someone gave you “some information.” And yet, people try all the time.

If you search out the The World Mercury Project, you will be treated to a video of Robert F. Kennedy, Jr., who had made a career for the lawsuit industry of pursuing dubious scientific claims.³

The video, also available on YouTube, is vintage Kennedy, self-aggrandizing, and holding forth with accusations against pharmaceutical companies and vaccine manufacturers of “child abuse,” and “even worse.” The epistemic arrogance continues with assertions that Kennedy knows how to fight them, the greedy, murderous bullies.

The Trump presidency, with its alternative facts and its bullying, has emboldened conspiracy theorists of all stripes.

Last week, Robert F. Kennedy, Jr., along with Robert De Niro, convened a news conference on Wednesday at the National Press Club to announce their latest stunt, a $100,000 cash reward to the first person who comes forward with a “peer-reviewed scientific study demonstrating that the mercury in vaccines is safe.” National Press Club Conference (Feb. 15, 2017) [Expurgated Version].

A stunt, of course, because no one study would “demonstrate” safety, although the mass of epidemiologic evidence does. Furthermore, even in face of the overwhelming evidence that thimerosal in vaccines is not associated with autism, we could always hypothesize that there is one child who has some unique susceptibility.

The anti-vaxxers are quick to jump on the individual susceptibility argument. At their (fake) news conference, Kennedy and De Nira exhumed Bernadine Healy, who died in 2011, for a replay of a 2008 interview, in which Healy speculated that the then available science had not ruled out the existence of susceptible subgroups of children, who might be at risk from some one or multiple vaccines. Healy is best known as the first woman physician to serve as Director of the National Institutes of Health, from 1991 to 1993. For her acknowledgement that there might be vulnerable subgroups, and that this issue of idiosyncratic reaction should be studied, Healy was named 2008 “Person of the Year” by the anti-vaccine group, the Age of Autism.

Not surprisingly, anti-vaxxers Kennedy and De Niro, and their followers, missed the obvious. Healy’s suggestion that there might be a vulnerable subgroup of children is not evidence that thimerosal or any vaccine or vaccine regimen is unsafe.

Also not surprisingly, President Trump, with his affection for alternative facts and speculative conspiracy theories, is in the same epistemic muddle as Kennedy and De Niro. While still a candidate, Trump met with Andrew Wakefield and other dubious characters from the anti-vaxxer movement. With his propensity to repeat whatever was last said to him, Trump tweets about “doctor-inflicted autism,” and other claims.

And to make matters worse, toady American Republican party cannot seem to distance themselves from whatever nonsense Alt-President Trump dishes out. Pratik Chougule, an executive editor at The American Conservative recently wrote a disturbingly uncritical essay in support of Trump’s twittering approach to scientific policy. Pratik Chougule, “Why the Kennedy-De Niro Vaccine Challenge Matters – A presidential commission led by Robert Kennedy Jr. could raise uncomfortable questions about the incentives driving vaccination recommendations,” The American Conservative (Feb. 15, 2017) (noting that Trump has said that he “‘couldn’t care less’ about the ‘shills’ of conventional medical wisdom, the pharmaceutical companies, and their ‘fudged up reports’. In typical fashion, he declares that ‘the doctors lied’ and that he is ‘being proven right about massive vaccinations’.”)

Sad. Fake news. Fake science. Where is Daubert when you need it?

1 German Lopez, “Trump keeps lying about his Electoral College victory: He made two false claims about his win at a news conference on Thursday,” (Feb. 16, 2017).

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

3 See Seth Mnookin, “How Robert F. Kennedy, Jr., Distorted Vaccine Science; His anti-vaccine credentials date back to 2005,” Scientific American (Jan. 11, 2017); “Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety,” (Jan. 11th, 2017).

Posted in Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Social Media, Rhetoric, and Science – Antivaxxers