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Passing Hypotheses Off as Causal Conclusions – Allen v. Martin Surfacing

November 11th, 2018

The November 2018 issue of the American Bar Association Journal (ABAJ) featured an exposé-style article on the hazards of our chemical environment, worthy of Mother Jones, or the International Journal of Health Nostrums, by a lawyer, Alan Bell.1 Alan Bell, according to his website, is a self-described “environmental health warrior.” Channeling Chuck McGill, Bell also describes himself as a:

“[v]ictim, survivor, advocate and avenger. This former organized crime prosecutor almost died from an environmentally linked illness. He now devotes his life to giving a voice for those too weak or sick to fight for themselves.”

Bell apparently is not so ill that he cannot also serve as “a fierce advocate” for victims of chemicals. Here is how Mr. Bell described his own “environmentally linked illness” (emphasis added):

“Over the following months, Alan developed high fevers, sore throats, swollen glands and impaired breathing. Eventually, he experienced seizures and could barely walk. His health continued to worsen until he became so ill he was forced to stop working. Despite being examined and tested by numerous world-renowned doctors, none of them could help. Finally, a doctor diagnosed him with Multiple Chemical Sensitivity, a devastating illness caused by exposure to environmental toxins. The medical profession had no treatment to offer Alan: no cure, and no hope. Doctors could only advise him to avoid all synthetic chemicals and live in complete isolation within a totally organic environment.”

Multiple chemical sensitivity (MCS)? Does anyone still remember “clinical ecology”? Despite the strident advocacy of support groups and self-proclaimed victims, MCS is not recognized as a chemically caused illness by the World Health Organization, the American Medical Association, the American Academy of Allergy and Immunology, and the American College of Physicians.2 Double-blinded, placebo-controlled clinical trials have shown that putative MCS patients respond to placebo as strongly as they react to chemicals.3

Still, Bell’s claims must be true; Bell has written a book, Poisoned, about his ordeal and that of others.4 After recounting his bizarre medical symptoms, he describes his miraculous cure in a sterile bubble in the Arizona desert. From safe within his bubble, Bell has managed to create the “Environmental Health Foundation,” which is difficult if not impossible to find on the internet, although there are some cheesy endorsements to be found on YouTube.

According to Bell’s narrative, Daniel Allen, the football coach of the College of the Holy Cross was experiencing neurological signs and symptoms that could not be explained by physicians in the Boston area, home to some of the greatest teaching hospitals in the world. Allen and his wife, Laura, reached out Bell through his Foundation. Bell describes how he put the Allens in touch with Marcia Ratner, who sits on the Scientific Advisory Board of his Environmental Health Foundation. Bell sent the Allens to see “the world renown” Marcia Ratner, who diagnosed Mr. Allen with amyotrophic lateral sclerosis (ALS). Bell’s story may strike some as odd, considering that Ratner is not a physician. Ratner could not provide a cure for Mr. Allen’s tragic disease, but she could help provide the Allens with a lawsuit.

According to Bell:

“Testimony from a sympathetic widow, combined with powerful evidence that the chemicals Dan was exposed to caused him to die long before his time, would smash their case to bits. The defense opted to seek a settlement. The case settled in 2009.”5

The ABAJ article on the Allen case is a reprise of chapter 15 of Bell’s book “Chemicals Take Down a Football Coach.” Shame on the A.B.A. for not marking the article as unpaid advertising. More shame on the A.B.A. for not fact checking the glib causal claims made in the article, some of which have been the subject of a recently published “case report” in the red journal, the American Journal of Industrial Medicine, by Dr. Ratner and some, but not all, of the other expert witnesses for Mr. Allen’s litigation team.6 Had the editors of the ABAJ compared Mr. Bell’s statements and claims about the Allen case, they would have seen that Dr. Ratner, et al., ten years after beating back the defendants’ Daubert motion in the Allen case, described their literature review and assessment of Mr. Allen’s case, as merely “hypothesis generating”:

“This literature review and clinical case report about a 45-year-old man with no family history of motor neuron disease who developed overt symptoms of a neuromuscular disorder in close temporal association with his unwitting occupational exposure to volatile organic compounds (VOCs) puts forth the hypothesis that exposure to VOCs such as toluene, which disrupt motor function and increase oxidative stress, can unmask latent ALS type neuromuscular disorder in susceptible individuals.”7

         * * * * * * *

“In conclusion, this hypothesis generating case report provides additional support for the suggestion that exposure to chemicals that share common mechanisms of action with those implicated in the pathogenesis of ALS type neuromuscular disorders can unmask latent disease in susceptible persons. Further research is needed to elucidate these relationships.”8

So in 2018, the Allen case was merely a “hypothesis generating” case report. Ten years earlier, however, in 2008, when Ratner, Abou-Donia, Oliver, Ewing, and Clapp gave solemn oaths and testified under penalty of perjury to a federal district judge, the facts of the same case warranted a claim to scientific knowledge, under Rule 702. Judges, lawyers, and legal reformers should take note of how expert witnesses will characterize facile opinions as causal conclusions when speaking as paid witnesses, and as mere hypotheses in need of evidentiary support when speaking in professional journals to scientists. You’re shocked; eh?

Sometimes when federal courts permit dubious causation opinion testimony over Rule 702 objections, the culprit is bad lawyering by the opponent of the proffered testimony. The published case report by Ratner helps demonstrate that Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009), was the result of litigation overreach by plaintiffs’ counsel and their paid expert witnesses, and a failure of organized skepticism by defense counsel and the judiciary.

Marcia H. Ratner, Ph.D.

I first encountered Dr. Ratner as an expert witness for the litigation industry in cases involving manganese-containing welding rods. Plaintiffs’ counsel, Dickie Scruggs, et al., withdrew her before the defense could conduct an examination before trial. When I came across the Daubert decision in the Allen case, I was intrigued because I had read Ratner’s dissertation9 and her welding litigation report, and saw what appeared to be fallacies10 similar to those that plagued the research of Dr. Brad Racette, who also had worked with Scruggs in conducting screenings, from which he extracted “data” for a study, which for a while became the center piece of Scruggs’ claims.11

The Allen case provoked some research on my part, and then a blog post about that case and Dr. Ratner.12 Dr. Ratner took umbrage to my blog post; and in email correspondence, she threatened to sue me for tortious interference with her prospective business opportunities. She also felt that the blog post had put her in a bad light by commenting upon her criminal conviction for unlawful gun possession.13 As a result of our correspondence, and seeing that Dr. Ratner was no stranger to the courtroom,14 I wrote a post-script to add some context and her perspective on my original post.15

One fact Dr Ratner wished me to include in the blog post-script was that plaintiffs’ counsel in the Allen case had pressured her to opine that toluene and isocyanates caused Mr. Allen’s ALS, and that she had refused. Dr. Ratner of course was making a virtue of necessity since there was, and is, a mountain of medical opinion, authoritative and well-supportive, that there is no known cause of sporadic ALS.16 Dr. Ratner was very proud, however, of having devised a work-around, by proffering an opinion that toluene caused the acceleration of Mr. Allen’s ALS. This causal claim about accelerated onset could have been tested with an observational study, but the litigation claim about earlier onset was as lacking in evidential support as the more straightforward claim of causation.

Bell’s article in the ABAJ – or rather his advertisement17 – cited an unpublished write up of the Allen case, by Ratner, “The Allen Case: Our Daubert Strategy, Victory, and Its Legal and Medical Landmark Ramifications,” in which she kvelled about how the Allen case was cited in the Reference Manual on Scientific Evidence. The Manual’s citations, however, were about the admissibility of the industrial hygienist’s proffered testimony on exposure, based in turn on Mr. Allen’s account of acute-onset symptoms.18 The Manual does not address the dubious acceleration aspect of Ratner’s causal opinion in the Allen case.

The puff piece in the ABAJ caused me to look again at Dr. Ratner’s activities. According to the Better Business Bureau reports that Dr. Marcia Ratner is a medical consultant in occupational and environmental toxicology. Since early 2016, she has been the sole proprietor of a consulting firm, Neurotoxicants.com, located in Mendon, Vermont. The firm’s website advertises that:

“The Principals and Consultants of Neurotoxicants.com provide expert consulting in neurotoxicology and the relationships between neurotoxic chemical exposures and neurodegenerative disease onset and progression.”

Only Ratner is identified as working on consulting through the firm. According to the LinkedIn entry for Neurotoxicants.com, Ratner is the also founder and director of Medical-Legal Research at Neurotoxicants.com. Ratner’s website advertises her involvement in occupational exposure litigation as an expert witness for claimants.19 Previously, Ratner was the Vice President and Director of Research at Chemical Safety Net, Inc., another consulting firm that she had founded with the late Robert G. Feldman, MD.

Conflict of Interest

The authors of the published Allen case report gave a curious conflict-of-interest disclosure at the end of their article:

“The authors have no current specific competing interests to declare. However, Drs. Ratner, Abou-Donia and Oliver, and Mr. Ewing all served as expert witnesses in this case which settled favorably for the patient over 10 years ago with an outcome that is a fully disclosed matter of public record. Drs. Ratner, Abou-Donia and Oliver and Mr. Ewing are occasionally asked to serve as expert witnesses and/or consultants in occupational and environmental chemical exposure injury cases.”20

The disclosure conveniently omitted that Dr. Ratner owns a business that she set up to provide medico-legal consulting, and that Dr. Oliver testifies with some frequency in asbestos cases. None of the authors was, or is, an expert in the neuroepidemiology of ALS. Dr. Ratner’s conflict-of-interest disclosure in the Allen case report was, however, better than her efforts in previous publications that touched on the subject matter of her commercial consulting practice.21

1 Alan Bell, “Devastated by office chemicals, an attorney helps others fight toxic torts,” Am. Bar. Ass’n J. (Nov. 2018).

2 See, e.g., American Academy of Allergy, Asthma and Immunology, “Idiopathic environmental intolerances,” 103 J. Allergy Clin. Immunol. 36 (1999).

3 See Susanne Bornschein, Constanze Hausteiner, Horst Römmelt, Dennis Nowak, Hans Förstl, and Thomas Zilker, “Double-blind placebo-controlled provocation study in patients with subjective Multiple Chemical Sensitivity and matched control subjects,” 46 Clin. Toxicol. 443 (2008); Susanne Bornschein, Hans Förstl, and Thomas Zilker, “Idiopathic environmental intolerances (formerly multiple chemical sensitivity) psychiatric perspectives,” 250 J. Intern. Med. 309 (2001).

4 Poisoned: How a Crime-Busting Prosecutor Turned His Medical Mystery into a Crusade for Environmental Victims (Skyhorse Publishing 2017).

5 Steven H. Foskett Jr., “Late Holy Cross coach’s family, insurers settle lawsuit for $681K,” Telegram & Gazette (Oct. 1, 2009). Obviously, the settlement amount represented a deep compromise over any plaintiff’s verdict.

6 Marcia H. Ratner, Joe F. Jabre, William M. Ewing, Mohamed Abou-Donia, and L. Christine Oliver, “Amyotrophic lateral sclerosis—A case report and mechanistic review of the association with toluene and other volatile organic compounds,” 61 Am. J. Ind. Med. 251 (2018).

7 Id. at 251.

8 Id. at 258 (emphasis added).

9 Marcia Hillary Ratner, Age at Onset of Parkinson’s Disease Among Subjects Occupationally Exposed to Metals and Pesticides; Doctoral Dissertation, UMI Number 3125932, Boston University (2004). Neither Ratner’s dissertation supervisor nor her three readers were epidemiologists.

11 See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, Joel S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005).

13 See “Quincy District Court News,” Patriot Ledger June 09, 2010 (reporting that Ratner pleaded guilty to criminal possession of mace and a firearm).

14 Ratner v. Village Square at Pico Condominium Owners Ass’n, Inc., No. 91-2-11 Rdcv (Teachout, J., Aug. 28, 2012).

17 Bell is a client of the Worthy Marketing Group.

18 RMSE3d at 505-06 n.5, 512-13 n. 26, 540 n.88; see also Allen v. Martin Surfacing, 2009 WL 3461145, 2008 U.S. Dist. LEXIS 111658, 263 F.R.D. 47 (D. Mass. 2008) (holding that an industrial hygienist was qualified to testify about the concentration and duration of plaintiffs’ exposure to toluene and isocyanates).

20 Id. at 259. One of the plaintiffs’ expert witnesses, Richard W. Clapp, opted out of co-author status on this publication.

21 See Marcia H. Ratner & Edward Fitzgerald, “Understanding of the role of manganese in parkinsonism and Parkinson disease,” 88 Neurology 338 (2017) (claiming no relevant conflicts of interest); Marcia H. Ratner, David H. Farb, Josef Ozer, Robert G. Feldman, and Raymon Durso, “Younger age at onset of sporadic Parkinson’s disease among subjects occupationally exposed to metals and pesticides,” 7 Interdiscip. Toxicol. 123 (2014) (failing to make any disclosure of conflicts of interest). In one short case report written with Dr. Jonathan Rutchik, another expert witness actively participated for the plaintiffs’ litigation industry in welding fume cases, Dr. Ratner let on that she “occasionally” is asked to serve as an expert witness, but she failed to disclose that she has a business enterprise set up to commercialize her expert witness work. Jonathan Rutchik & Marcia H. Ratner, “Is it Possible for Late-Onset Schizophrenia to Masquerade as Manganese Psychosis?” 60 J. Occup. & Envt’l Med. E207 (2018) (“The authors have no current specific competing interests to declare. However, Dr. Rutchik served as expert witnesses [sic] in this case. Drs. Rutchik and Ratner are occasionally asked to serve as expert witnesses and/or consultants in occupational and environmental chemical exposure injury cases.”)

Posted in Causation, Conflicts of Interest, Rule 702, Scientific Evidence, Scientific Publishing | Comments Off on Passing Hypotheses Off as Causal Conclusions – Allen v. Martin Surfacing

Carl Cranor’s Conflicted Jeremiad Against Daubert

September 23rd, 2018

Carl Cranor’s Conflicted Jeremiad Against Daubert

It seems that authors who have the most intense and refractory conflicts of interest (COI) often fail to see their own conflicts and are the most vociferous critics of others for failing to identify COIs. Consider the spectacle of having anti-tobacco activists and tobacco plaintiffs’ expert witnesses assert that the American Law Institute had an ethical problem because Institute members included some tobacco defense lawyers.1 Somehow these authors overlooked their own positional and financial conflicts, as well as the obvious fact that the Institute’s members included some tobacco plaintiffs’ lawyers as well. Still, the complaint was instructive because it typifies the abuse of ethical asymmetrical standards, as well as ethical blindspots.2

Recently, Raymond Richard Neutra, Carl F. Cranor, and David Gee published a paper on the litigation use of Sir Austin Bradford Hill’s considerations for evaluating whether an association is causal or not.3 See Raymond Richard Neutra, Carl F. Cranor, and David Gee, “The Use and Misuse of Bradford Hill in U.S. Tort Law,” 58 Jurimetrics 127 (2018) [cited here as Cranor]. Their paper provides a startling example of hypocritical and asymmetrical assertions of conflicts of interests.

Neutra is a self-styled public health advocate4 and the Chief of the Division of Environmental and Occupational Disease Control (DEODC) of the California Department of Health Services (CDHS). David Gee, not to be confused with the English artist or the Australian coin forger, is with the European Environment Agency, in Copenhagen, Denmark. He is perhaps best known for his precautionary principle advocacy and his work with trade unions.5

Carl Cranor is with the Center for Progressive Reform, and he teaches philosophy at one of the University of California campuses. Although he is neither a lawyer nor a scientist, he participates with some frequency as a consultant, and as an expert witness, in lawsuits, on behalf of claimants. Perhaps Cranor’s most notorious appearance as an expert witness resulted in the decision of Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012). Probably less generally known is that Cranor was one of the founders of an organization, the Council for Education and Research on Toxics (CERT), which recently was the complaining party in a California case in which CERT sought money damages for Starbucks’ failure to label each cup of coffee sold as known to the State of California as causing cancer.6 Having a so-called not-for-profit corporation can also be pretty handy, especially when it holds itself out as a scientific organization and files amicus briefs in support of reversing Daubert exclusions of the founding members of the corporation, as CERT did on behalf of its founding member in the Milward case.7 The conflict of interest, in such an amicus brief, however, is no longer potential or subtle, and violates the duty of candor to the court.

In this recent article on Hill’s considerations for judging causality, Cranor followed CERT’s lead from Milward. Cranor failed to disclose that he has been a party expert witness for plaintiffs, in cases in which he was advocating many of the same positions put forward in the Jurimetrics article, including the Milward case, in which he was excluded from testifying by the trial court. Cranor’s lack of candor with the readers of the Jurimetrics article is all the more remarkable in that Cranor and his co-authors give conflicts of interest outsize importance in substantive interpretations of scholarship:

“the desired reliability for evidence evaluation requires that biases that derive from the financial interests and ideological commitments of the investigators and editors that control the gateways to publication be considered in a way that Hill did not address.”

Cranor at 137 & n.59. Well, we could add that Cranor’s financial interests and ideological commitments might well be considered in evaluating the reliability of the opinions and positions advanced in this most recent work by Cranor and colleagues. If you believe that COIs disqualify a speaker from addressing important issues, then you have all the reason you need to avoid reading Cranor’s recent article.

Dubious Scholarship

The more serious problem with Cranor’s article is not his ethically strained pronouncements about financial interests, but the dubious scholarship he and his colleagues advance to thwart judicial gatekeeping of even more dubious expert witness opinion testimony. To begin with, the authors disparage the training and abilities of federal judges to assess the epistemic warrant and reliability of proffered causation opinions:

“With their enhanced duties to review scientific and technical testimony federal judges, typically not well prepared by legal education for these tasks, have struggled to assess the scientific support for—and the reliability and relevance of—expert testimony.”

Cranor at 147. Their assessment is fair but hides the authors’ cynical agenda to remove gatekeeping and leave the assessment to lay juries, who are less well prepared for the task, and whose function ensures no institutional accountability, review, or public evaluation.

Similarly, the authors note the temporal context and limitations of Bradford Hill’s 1965 paper, which date and limit the advice provided over 50 years ago in a discipline that has changed dramatically with the advancement of biological, epidemiologic, and genetic science.8 Even at the time of its original publication in 1965, Bradford Hill’s paper, which was based upon an informal lecture, was not designed or intended to be a definitive treatment of causal inference. Cranor and his colleagues make no effort to review Bradford Hill’s many other publications, both before and after his 1965 dinner speech, for evidence of his views on the factors for causal inference, including the role of statistical testing and inference.

Nonetheless, Bradford Hill’s 1965 paper has become a landmark, even if dated, because of its author’s iconic status in the world of public health, earned for his showing that tobacco smoking causes lung cancer,9 and for advancing the role of double-blind randomized clinical trials.10 Cranor and his colleagues made no serious effort to engage with the large body of Bradford Hill’s writings, including his immensely important textbook, The Principles of Medical Statistics, which started as a series of articles in The Lancet, and went through 12 editions in print.11 Hill’s reputation will no doubt survive Cranor’s bowdlerized version of Sir Austin’s views.

Epidemiology is Dispensable When It Fails to Support Causal Claims

The egregious aspect of Cranor’s article is its bill of particulars against the federal judiciary for allegedly errant gatekeeping, which for these authors translates really into any gatekeeping at all. Cranor at 144-45. Indeed, the authors provide not a single example of what was a “proper” exclusion of an expert witness, who was contending for some doubtful causal claim. Perhaps they have never seen a proper exclusion, but doesn’t that speak volumes about their agenda and their biases?

High on the authors’ list of claimed gatekeeping errors is the requirement that a causal claim be supported with epidemiologic evidence. Although some causal claims may be supported by strong evidence of a biological process with mechanistic evidence, such claims are not common in United States tort litigation.

In support of the claim that epidemiology is dispensable, Cranor suggests that:

“Some courts have recognized this, and distinguished scientific committees often do not require epidemiological studies to infer harm to humans. For example, the International Agency for Research on Cancer (IRAC) [sic], the National Toxicology Program, and California’s Proposition 65 Scientific Advisory Panel, among others, do not require epidemiological data to support findings that a substance is a probable or—in some cases—a known human carcinogen, but it is welcomed if available.”

Cranor at 149. California’s Proposition 65!??? Even IARC is hard to take seriously these days with its capture by consultants for the litigation industry, but if we were to accept IARC as an honest broker of causal inferences, what substance “known” to IARC to cause cancer in humans (Category I) was branded as a “known carcinogen” without the support of epidemiologic studies? Inquiring minds might want to know, but they will not learn the answer from Cranor and his co-authors.

When it comes to adverting to legal decisions that supposedly support the authors’ claim that epidemiology is unnecessary, their scholarship is equally wanting. The paper cites the notorious Wells case, which was so roundly condemned in scientific circles, that it probably helped ensure that a decision such as Daubert would ultimately be handed down by the Supreme Court. The authors seemingly cannot read, understand, and interpret even the most straightforward legal decisions. Here is how they cite Wells as support for their views:

“Wells v. Ortho Pharm. Corp., 788 F.2d 741, 745 (11th Cir. 1986) (reviewing a district court’s decision deciding not to require the use of epidemiological evidence and instead allowing expert testimony).”

Cranor at 149-50 n.122. The trial judge in Wells never made such a decision; indeed, the case was tried by the bench, before the Supreme Court decided Daubert. There was no gatekeeping involved at all. More important, however, and contrary to Cranor’s explanatory parenthetical, both sides presented epidemiologic evidence in support of their positions.12

Cranor and his co-authors similarly misread and misrepresent the trial court’s decision in the litigation over maternal sertraline use and infant birth defects. Twice they cite the Multi-District Litigation trial court’s decision that excluded plaintiffs’ expert witnesses:

“In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., 26 F. Supp. 3d 449, 455 (E.D. Pa. 2014) (expert may not rely on nonstatistically significant studies to which to apply the [Bradford Hill] factors).”

Cranor at 144 n.85; 158 n.179. The MDL judge, Judge Rufe, decidedly never held that an expert witness may not rely upon a statistically non-significant study in a “Bradford Hill” analysis, and the Third Circuit, which affirmed the exclusions of the plaintiffs’ expert witnesses’ testimony, was equally clear in avoiding the making of such a pronouncement.13

Who Needs Statistical Significance

Part of Cranor’s post-science agenda is to intimidate judges into believing that statistical significance is unnecessary and a wrong-headed criterion for judging the validity of relied upon research. In their article, Cranor and friends suggest that Hill agreed with their radical approach, but nothing could be further from the truth. Although these authors parse almost every word of Hill’s 1965 article, they conveniently omit Hill’s views about the necessary predicates for applying his nine considerations for causal inference:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Cranor’s radicalism leaves no room for assessing whether a putative association is “beyond what we would care to attribute to the play of chance,” and his poor scholarship ignores Hill’s insistence that this statistical analysis be carried out.14

Hill’s work certainly acknowledged the limitations of statistical method, which could not compensate for poorly designed research:

“It is a serious mistake to rely upon the statistical method to eliminate disturbing factors at the completion of the work.  No statistical method can compensate for a badly planned experiment.”

Austin Bradford Hill, Principles of Medical Statistics at 4 (4th ed. 1948). Hill was equally clear, however, that the limits on statistical methods did not imply that statistical methods are not needed to interpret a properly planned experiment or study. In the summary section of his textbook’s first chapter, Hill removed any doubt about his view of the importance, and the necessity, of statistical methods:

“The statistical method is required in the interpretation of figures which are at the mercy of numerous influences, and its object is to determine whether individual influences can be isolated and their effects measured.”

Id. at 10 (emphasis added).

In his efforts to eliminate judicial gatekeeping of expert witness testimony, Cranor has struggled with understanding of statistical inference and testing.15 In an early writing, a 1993 book, Cranor suggests that we “can think of type I and II error rates as “standards of proof,” which begs the question whether they are appropriately used to assess significance or posterior probabilities.16 Indeed, Cranor goes further, in confusing significance and posterior probabilities, when he described the usual level of alpha (5%) as the “95%” rule, and claimed that regulatory agencies require something akin to proof “beyond a reasonable doubt,” when they require two “statistically significant” studies.17

Cranor has persisted in this fallacious analysis in his writings. In a 2006 book, he erroneously equated the 95% coefficient of statistical confidence with 95% certainty of knowledge.18 Later in this same text, Cranor again asserted his nonsense that agency regulations are written when supported by “beyond a reasonable doubt.”19 Given that Cranor has consistently confused significance and posterior probability, he really should not be giving advice to anyone about statistical or scientific inference. Cranor’s persistent misunderstandings of basic statistical concepts do, however, explain his motivation for advocating the elimination of statistical significance testing, even if these misunderstandings make his enterprise intellectually unacceptable.

Cranor and company fall into a similar muddle when they offer advice on post-hoc power calculations, which advice ignores standard statistical learning for interpreting completed studies.20 Another measure of the authors’ failed scholarship is their omission of any discussion of recent efforts by many in the scientific community to lower the threshold for statistical significance, based upon the belief that the customary 5% p-value is an order of magnitude too high.21

 

Relative Risks Greater Than Two

There are other tendentious arguments and treatments in Cranor’s brief against gatekeeping, but I will stop with one last example. The inference of specific causation from study risk ratios has provoked a torrent of verbiage from Sander Greenland (who is cited copiously by Cranor). Cranor, however, does not even scratch the surface of the issue and fails to cite the work of epidemiologists, such as Duncan C. Thomas, who have defended the use of probabilities of (specific) causation. More important, however, Cranor fails to speak out against the abuse of using any relative risk greater than 1.0 to support an inference of specific causation, when the nature of the causal relationship is neither necessary nor sufficient. In this context, Kenneth Rothman has reminded us that someone can be exposed to, or have, a risk, and then develop the related outcome, without there being any specific causation:

“An elementary but essential principle to keep in mind is that a person may be exposed to an agent and then develop disease without there being any causal connection between the exposure and the disease. For this reason, we cannot consider the incidence proportion or the incidence rate among exposed people to measure a causal effect.”

Kenneth J. Rothman, Epidemiology: An Introduction at 57 (2d ed. 2012).

The danger in Cranor’s article in Jurimetrics is that some readers will not realize the extreme partisanship in its ipse dixit, and erroneous, pronouncements. Caveat lector! 

1 Elizabeth Laposata, Richard Barnes & Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa L. Rev. 1 (2012).

2 The American Law Institute responded briefly. See Roberta Cooper Ramo & Lance Liebman, “The ALI’s Response to the Center for Tobacco Control Research & Education,” 98 Iowa L. Rev. Bull. 1 (2013), and the original authors’ self-serving last word. Elizabeth Laposata, Richard Barnes & Stanton Glantz, “The ALI Needs to Implement Modern Conflict of Interest Policies,” 98 Iowa L. Rev. Bull. 17 (2013).

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

4 Raymond Richard Neutra, “Epidemiology Differs from Public Health Practice,” 7 Epidemiology 559 (1996).

7 “From Here to CERT-ainty” (June 28, 2018).

8 Kristen Fedak, Autumn Bernal, Zachary Capshaw, and Sherilyn A Gross, “Applying the Bradford Hill Criteria in the 21st Century: How Data Integration Has Changed Causal Inference in Molecular Epidemiology,” Emerging Themes in Epidemiol. 12:14 (2015); John P. A. Ioannides, “Exposure Wide Epidemiology, Revisiting Bradford Hill,” 35 Stats. Med. 1749 (2016).

9 Richard Doll & Austin Bradford Hill, “Smoking and Carcinoma of the Lung,” 2(4682) Brit. Med. J. (1950).

10 Geoffrey Marshall (chairman), “Streptomycin Treatment of Pulmonary Tuberculosis: A Medical Research Council Investigation,” 2 Brit. Med. J. 769, 769–71 (1948).

11 Vern Farewell & Anthony Johnson, “The origins of Austin Bradford Hill’s classic textbook of medical statistics,” 105 J. Royal Soc’y Med. 483 (2012). See also Hilary E. Tillett, “Bradford Hill’s Principles of Medical Statistics,” 108 Epidemiol. Infect. 559 (1992).

13 In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of biostatistician Nichols Jewell’s dodgy opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully).

14 See “Bradford Hill on Statistical Methods” (Sept. 24, 2013).

16 Carl F. Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law at 33-34 (1993) (arguing incorrectly that one can think of α, β (the chances of type I and type II errors, respectively and 1- β as measures of the “risk of error” or “standards of proof.”); see also id. at 44, 47, 55, 72-76. At least one astute reviewer called Cranor on his statistical solecisms. Michael D. Green, “Science Is to Law as the Burden of Proof is to Significance Testing: Book Review of Cranor, Regulating Toxic Substances: A Philosophy of Science and the Law,” 37 Jurimetrics J. 205 (1997) (taking Cranor to task for confusing significance and posterior (burden of proof) probabilities).

17 Id. (squaring 0.05 to arrive at “the chances of two such rare events occurring” as 0.0025, which impermissibly assumes independence between the two studies).

18 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 100 (2006) (incorrectly asserting that “[t]he practice of setting α =.05 I call the “95% rule,” for researchers want to be 95% certain that when knowledge is gained [a study shows new results] and the null hypothesis is rejected, it is correctly rejected.”).

19 Id. at 266.

21 See, e.g., John P. A. Ioannidis, “The Proposal to Lower P Value Thresholds to .005,” 319 J. Am. Med. Ass’n 1429 (2018); Daniel J. Benjamin, James O. Berger, Valen E. Johnson, et al., “Redefine statistical significance,” 2 Nature Human Behavior 6 (2018).

Posted in Causation, Conflicts of Interest, Public Nuisances, Rule 702, Scientific Evidence, statistical evidence | Comments Off on Carl Cranor’s Conflicted Jeremiad Against Daubert

From Here to CERT-ainty

June 28th, 2018

An enterprising journalist, Michael Waters, recently published an important exposé on the Council for Education and Research on Toxics (CERT). Michael Waters, “The Secretive Non-Profit Gaming California’s Health Laws: The Council for Education and Research on Toxics has won million-dollar settlements using a controversial public health law,” The Outline (June 18, 2018). Digging deep into the shadowy organization, Mr. Waters reported that:

“CERT doesn’t have a website, a social media account, or any notable public presence, despite having won million-dollar judgments by suing corporations. However, files from the California Secretary of State show that in May 30, 2001, four people co-founded the non-profit: C. Sterling Wolfe, a former environmental lawyer; Brad Lunn; Carl Cranor, a toxicology professor at University of California Riverside; and Martyn T. Smith, a toxicology professor at Berkeley.”

Id.

Mr. Water’s investigation puts important new facts on the table about the conduct of the CERT corporation. The involvement of Christopher Sterling Wolfe, a Torrance, California, plaintiffs’ lawyer, is not terribly surprising. The involvement in CERT of frequent plaintiffs’ expert witnesses, Carl F. Cranor and Martyn T. Smith, however, raises serious ethical questions. Both Cranor and Smith were expert witnesses for plaintiffs in the infamous Milward case,1 and after the trial court excluded their testimony and granted summary judgment, CERT filed an amicus brief in the Court of Appeals.2

The rules governing amicus briefs in federal appellate courts require disclosure of the amicus’s interest in the proceedings. By the time that CERT filed its amicus brief in Milward, Cranor and Smith may not have been officers of the corporation, but given CERT’s funding of Smith’s research, these “Founding Fathers” certainly had a continuing close relationship with the corporation.3 “Coffee with Cream, Sugar & a Dash of Acrylamide” (June 9, 2018). Given CERT’s name, which suggests a public interest mission, the corporation’s litigation activities on behalf of its founders, Cranor and Smith, exhibit a certain lack of candor with the court.

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

My discussions with Mr. Waters, and his insightful piece in The Outline, led to a call from Madeleine Brand, who wanted to discuss CERT’s litigation against Starbucks, under California’s Proposition 65 laws, over acrylamide content in coffee. David Roe, a self-styled environmental activist and drafter of California’s bounty hunting law, was interviewed directly after me.4

As every California now no doubt knows, acrylamide is present in many foods. The substance is created when the amino acid asparagine is heated in the presence of sugars. Of course, I expected to hear Roe defend his creation, Proposition 65, generally, and the application of Proposition 65 to the low levels of acrylamide in coffee, perhaps on contrary-to-fact precautionary principle grounds. What surprised me were Roe’s blaming the victim, Starbucks for not settling, and his strident assertions that it was a long-established fact that acrylamide causes cancer.

Contrary to Roe’s asseverations, the National Cancer Institute has evaluated the acrylamide issues quite differently. On its website, the NCI has addressed “Acrylamide and Cancer Risk,” and mostly found none. Roe had outrageously suggested that there were no human data, because of the ethics of feeding acrylamide to humans, and so regulators had to rely upon rodent studies. The NCI, however, had looked at occupational studies in which workers were exposed to acrylamide in manufacturing processes at levels much higher than any dietary intake. The NCI observed “studies of occupational exposure have not suggested increased risks of cancer.” As for rodents, the NCI noted that “toxicology studies have shown that humans and rodents not only absorb acrylamide at different rates, they metabolize it differently as well.”

The NCI’s fact sheet is a relatively short précis, but the issue of acrylamide has been addressed in many studies, collected and summarized in meta-analyses.5 Since the NCI’s summary of the animal toxicology and human epidemiology, several important research groups have reported careful human studies that consistently have found no association between dietary acrylamide and cancer risk.6

1 Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012).

2 See “The Council for Education and Research on Toxics” (July 9, 2013).

3 A Guidestar Report show that in 2007, the corporate officer were Nancy L. Quam-Wickham and Nancy Perley, in addition to Lunn and Wolfe.

4 Not to be confused with David Roe, the famous snooker player.

5 Claudio Pelucchi, Carlo La Vecchia, Bosetti C, P. Boyle & Paolo Boffetta, “Exposure to acrylamide and human cancer–a review and meta-analysis of epidemiologic studies,” 22 Ann. Oncology 1487 (2011); Claudio Pelucchi, Cristina Bosetti, Carlotta Galeone & Carlo La Vecchia, “Dietary acrylamide and cancer risk: An updated meta-analysis,” 136 Internat’l J. Cancer 2912 (2015).

6 C. Pelucchi, V. Rosato, P. M. Bracci, D. Li, R. E. Neale, E. Lucenteforte, D. Serraino, K. E. Anderson, E. Fontham, E. A. Holly, M. M. Hassan, J. Polesel, C. Bosetti, L. Strayer, J. Su, P. Boffetta, E. J. Duell & C. La Vecchia, “Dietary acrylamide and the risk of pancreatic cancer in the International Pancreatic Cancer Case–Control Consortium (PanC4),” 28 Ann. Oncology 408 (2017) (reporting that the PanC4 pooled-analysis found no association between dietary acrylamide and pancreatic cancer); Rebecca E. Graff, Eunyoung Cho, Mark A. Preston, Alejandro Sanchez, Lorelei A. Mucci & Kathryn M. Wilson, “Dietary acrylamide intake and risk of renal cell carcinoma in two large prospective cohorts,” 27 Cancer Epidemiol., Biomarkers & Prevention (2018) (in press at doi: 10.1158/1055-9965.EPI-18-0320) (failing to find an association between dietary acrylamide and renal cell carcinoma); Andy Perloy, Leo J. Schouten, Piet A. van den Brandt, Roger Godschalk, Frederik-Jan van Schooten & Janneke G. F. Hogervorst, “The Role of Genetic Variants in the Association between Dietary Acrylamide and Advanced Prostate Cancer in the Netherlands Cohort Study on Diet and Cancer,” 70 Nutrition & Cancer 620 (2018) (finding “no clear evidence was found for interaction between acrylamide intake and selected genetic variants for advanced prostate cancer”).

Posted in Causation, Conflicts of Interest, Scientific Evidence | Comments Off on From Here to CERT-ainty

Coffee with Cream, Sugar & a Dash of Acrylamide

June 9th, 2018

Causal statements are made all the time without much thought of their epistemic warrant. On a day that the stock market indices fall, would-be economic pundits point to some putative cause, such as concern about wage inflation. When the stock market rises on the following day, the explanation is that investors were buoyed by corporate tax cuts, even though those tax cuts were supposedly designed to help companies increase wages. As philosophy professor Harry Frankfurt has explained:

“Bullshit is unavoidable whenever circumstances require someone to talk without knowing what he is talking about. Thus the production of bullshit is stimulated whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”1

Of course, Frankfurt’s dictum aptly describes the situation with much of expert witness testimony in health effects litigation.

Nothing seems to stimulate speculative causal claiming as much as the potential rewards of rent-seeking litigation under Proposition 65. By popular referendum, the State of California has taken upon itself to make pronouncements about the causal effects of various foods, drugs, and exposures. The referendum became a California statute with the Safe Drinking Water and Toxic Enforcement Act of 1986. Proposition 65 and the subsequent Enforcement Act require the State of California to publish a list of chemicals it “knows” cause cancers or birth defects. California knows a lot. The list, updated annually, now includes about 800 chemicals.

When California knows that a chemical or an exposure causes cancer, the state does not necessarily know that the chemical or exposure causes cancer in human beings; nor does it necessarily know that the chemical or exposure causes cancer at the exposure level experienced by the citizens of the state. Furthermore, many exposures occur in the context of complex mixtures in which a hypothetical effect of one chemical might be offset or antagonized by another chemical in the mixture. But nonetheless, what California “knows” can hurt you if you are on the wrong side of a Prop 65 enforcement action.

What has California gotten for all its “knowledge”? Clearly, the Proposition 65 statute has created huge incentives for private citizens to sue for violations by creating private rights of action against businesses that supposedly violate the law by failing to warn about what California knows. The proof standards for “known to cause cancer” are so removed from scientific discourse that forcing monetary settlements out of California businesses has become at once a big business itself, and a twisted process that distorts the truth of health hazards and benefits. There have been occasional outcries about the abusive system created from what once was perhaps a well-intentioned reform,2 but for the most part, Prop 65 has become the abnormal normal in California.

Mostly California has gotten lawsuits and a glut of warnings with no difference in cancer or birth defect rates than those observed in states less knowledgeable on such matters.3 Some of California’s cancer rates may be a bit lower than the national rates but this outcome is largely the result of lower state rates for smoking and obesity. Some birth defect rates (neural tube defects) are actually higher in California than in the country as a whole.4

Last year, 681 Prop 65 settlements worth $25.6 million were reported to the California attorney general’s office. Attorneys’ and expert witness fees and other litigation costs made up more than 75% of the total.5 The rate of return has been steady over the years. In 2011, 74 percent of Proposition 65 awards went to attorneys’ fees and costs.6

Council for Education and Research on Toxics (CERT)

For all the hoopla over CERT’s lawsuit against Starbucks,7 there has been little coverage of the actual testimony from the trial. One journalist did report that Peter Infante, a frequent testifier for the lawsuit industry, testified on epidemiology for CERT’s lawyer, Raphael Metzger.8 Apparently, Infante described some studies as showing statistically significant correlations between coffee drinking and some kinds of cancer. Infante demurred on whether coffee caused these kinds of cancer, and admitted that one “would need a clinical trial to resolve the issue.” David Kessler, the former FDA commissioner who helped create the breast implant litigation fiasco and who now testifies frequently for the Lawsuit Industry, testified for Starbucks. Despite his substantial fear-mongering credentials, Dr Kessler emphasized that coffee is a “staple of the American diet,” and that drinking coffee has known health benefits. As everyone now knows, Starbucks failed to persuade the California trial judge that coffee, acrylamide and all, should come under the statute’s safe harbor provisions.

Almost five years ago, I first blogged about the CERT, in connection with the Milward case.9 When I first wrote back in 2013, and until the present, CERT, has not had a website, which is odd for an organization that professes to have an educational mission. In 2013, my research on CERT showed it to be a California corporation, EIN: 42-1571530, founded in 2003, with a business address at 401 E. Ocean Blvd., Ste. 800, Long Beach, California 90802-4967, and a telephone number:  1-877-TOX-TORT. CERT’s reported mission statement was furthering scientific understanding of toxins. Plaintiffs’ lawyer Ralph Metzger, a denizen of the Prop 65 world, was noted as the contact person for CERT, and indeed, the telephone number for CERT was the same as that for Metzger’s lawfirm, the Metzger Law Group.

As I started to watch the activities of CERT, I detected some curious patterns. I saw CERT file amicus briefs in legal cases, which is not the typical activity of a scientific research organization.10 Even more curious, and somewhat dubious, in two cases in which Ralphael Metzger of the Metzger Law Group represented the plaintiffs, another firm, Richard Alexander of the Alexander Law Group, represented CERT as an amicus in the same cases.11

Given the publicity created by CERT’s victory in its Proposition 65 citizen’s action against Starbucks, I recently revisited this research. See Alexander Nazaryan, “Will coffee in California come with a cancer warning?” Los Angeles Times (Feb. 18, 2018). One group, “Deniers for Hire,” which describes itself as committed to “debunk anti-science propaganda and expose the activists who produce it,” identified CERT as:

“a sham environmentalist nonprofit that sues food companies and collects settlements to fund additional lawsuits against other food companies. Founded in 2002 by toxicologist Martyn T. Smith, with backing from the shameless trial lawyers at Metzger Law Group, CERT uses junk science to target California businesses that can be sued under the state’s ill-conceived Proposition 65.”

The connection with Martyn T. Smith, was news to me, and interesting given how frequently Smith testifies for plaintiffs in cases involving even minimal benzene exposure. If correct, this website’s connecting Martyn Smith with CERT raises additional conflict-of-interest issues.

Funding of Research

Does CERT actually support research? Perhaps, after a fashion, but the money trail is as sketchy as is the ownership issue. Searching in Google Scholar turns up several publications that openly acknowledge funding from CERT. Perhaps only the young and naïve will be surprised that CERT money went to Martyn Smith, alleged founder of CERT and testifier for plaintiffs’ counsel, and to Smith’s students.12 In one instance, CERT support has been acknowledged by Martyn Smith and co-authors for the production of a meta-analysis, which can then be relied upon by Smith and other plaintiffs’ expert witnesses in benzene litigation. Although this meta-analysis credits funding from CERT, most readers of a professional journal will have little idea of the funding’s litigation provenance.13 The corresponding author of the CERT-funded meta-analysis was an official in the California state Office of Environmental Health Hazard Assessment, an office which is in a position to make decisions that help CERT in its California litigation goals.14

The funding of Martyn Smith and his students would certainly be questionable if Smith was a founder of or a participant in CERT. When Smith’s litigation opinions were challenged in one high-profile case, CERT rallied to his rescue with an amicus brief, which did not disclose any relationship between CERT and Martyn Smith, or CERT’s funding of Smith’s research. Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11 (1st Cir. 2011).

A current online listing at Guidestar gives Nancy Quam-Wickham as the “principal officer,” with the same EIN for CERT, as I saw five years ago. Quam-Wickham is a professor of history at California State University, in Long Beach. She seems an unlikely person to head up an organization given to research and education on “toxics.” The phone number for CERT is now 6101824891, but the mailing address is still Ralphael Metzger’s law office.

The Charity Navigator website does not rate CERT because its annual revenue is below $1 million. The website describes CERT as a 501(c)(3), with the same current address as Metzger’s lawfirm. According to Charity Navigator, CERT’s IRS 990 return listed assets of $21,880, and income of $137,354, for 2017.

So what are CERT’s educational activities? The sketchiness of CERT’s appearance as an “amicus” in Ralphael Metzger’s own lawsuits seems matched by the sketchiness of the organization’s professed educational mission. A deeper dive discovered that CERT has garnered some acknowledgements on the websites of other organizations. For instance, the Green Science Policy Institute, founded in 2008, for instance, acknowledges CERT for its “generous support” of the Institute’s work.

Some of CERT’s “educational” efforts have not fared particularly well. In the Chemtura Corporation bankruptcy, CERT attempted to intervene to assert a $9 billion claim to compensate “the public” for alleged injuries from the bankrupt’s allegedly toxic chemicals. In re Chemtura Corp., No. 09-11233, U.S. Bankruptcy Court (S.D.N.Y. 2010). Bankruptcy Judge Robert Gerber was not impressed with CERT’s educational efforts, and dismissed the entity as lacking the necessary standing to make a claim.15

1 Harry Frankfurt, On Bullshit 63 (2005).

2 See, e.g., Lisa L. Halko, “California’s Attorney General Acknowledges Prop 65 Abuse,” 22 no. 29 Wash. Leg. Fdtn. Legal Backgrounder (July 27, 2007); Pamela A. MacLean, “California Judge Blasts Firm in Toxic-Warnings Case,” Nat’l L.J. (April 13, 2006); Consumer Defense Group v. Rental Housing Industry Members, 40 Cal. Rptr. 3d 832 (Cal. Ct. App. 4th 2006) (“As the Attorney General pointed out in oral argument, it does not serve the public interest to have the almost the entirety of the state of California ‘swamped in a sea [of] generic warning signs’.”).

7 Council for Education and Research on Toxics v. Starbucks Corp., BC435759, California Superior Court, Los Angeles County.

8 Edvard Pettersson, “Toxic Java? California Law Carries Big Fines, Little Evidence,” Bloomberg (Oct. 25, 2017).

10 See, e.g., Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 857 N.E.2d 1114, 824 N.Y.S.2d 584 (2006).

11 In Uriarte v. Scott Sales Co., 226 Cal. App. 4th 1396, 172 Cal. Rptr. 3d 886 (2014); Ramos v. Brenntag Specialties, Inc., 63 Cal.4th 500, 203 Cal. Rptr. 3d 273, 372 P.3d 200 (2016). In both of these cases, CERT was joined by a band of scientists proclaiming neutrality and failing to disclose their significant litigation activities and income: Dr. Jerrold Abraham, Dr. Richard W. Clapp, Dr. Ronald Crystal, Dr. David A. Eastmond, Dr. Arthur L. Frank, Dr. Robert J. Harrison, Dr. Ronald Melnick, Dr. Lee Newman, Dr. Stephen M. Rappaport, Dr. David Joseph Ross and Dr. Janet Weiss. See “Sand in My Shoe – CERTainly” (June 17, 2014). Of course, California appellate courts require that amici disclose financial interests. A motion for leave to file an amicus brief must include, among other things, the names of all persons or entities that contributed financially to the brief, and acknowledgments about whether any party of party’s lawyer helped fund the preparation or filing of the brief. Cal. Rules of Court, Rule 8.200(c)(3)(A)(ii), (B), 8.882(d)(3)(A)(ii) and (B).

12 See, e.g., Jimmy Phuong, Simon Kim, Reuben Thomas & Luoping Zhang, “Predicted Toxicity of the Biofuel Candidate 2,5-Dimethylfuran in Envt’l & Biological Systems,” 53 Envt’l & Molecular Mutagenesis 478 (2012); Michele Fromowitz, Joe Shuga, AntonioYip Wlassowsky, Zhiying Ji, Matthew North, Chris D. Vulpe, Martyn T. Smith, and Luoping Zhang, “Bone Marrow Genotoxicity of 2,5-Dimethylfuran, a Green Biofuel Candidate,” 53 Envt’l & Molecular Mutagenesis 488 (2012); Reuben Thomas, Jimmy Phuong, Cliona M. McHale and Luoping Zhang, “Using Bioinformatic Approaches to Identify Pathways Targeted by Human Leukemogens,” 9 Internat’l J. Envt’l. Research & Public Health 2479 (2012).

13 Frolayne M. Carlos-Wallace, Luoping Zhang, Martyn T. Smith, Gabriella Rader & Craig Steinmaus, “Parental, In Utero, and Early-Life Exposure to Benzene and the Risk of Childhood Leukemia: A Meta-Analysis,” 183 Am. J. Epidem. 1 (2016).

14 Dr. Craig Steinmaus, Office of Environmental Health Hazard Assessment, 1515 Clay Street, 16th Floor, Oakland, CA 94612.

15 Caroline Humer, “Judge rules against big Chemtura bankruptcy claim,” Reuters (April 8, 2010); John Parry, “Chemtura hits back at $9 billion claim over toxins,” Reuters (Mar. 24, 2010).

Posted in Causation, Conflicts of Interest, Expert Witnesses, Public Nuisances | Comments Off on Coffee with Cream, Sugar & a Dash of Acrylamide

Infante-lizing the IARC

May 13th, 2018

Peter Infante, a frequently partisan, paid expert witness for the Lawsuit Industry, recently published a “commentary” in the red journal, the American Journal of Industrial Medicine, about the evils of scientists with economic interests commenting upon the cancer causation pronouncements of the International Agency for Research on Cancer (IARC). Peter F. Infante, Ronald Melnick, James Huff & Harri Vainio, “Commentary: IARC Monographs Program and public health under siege by corporate interests,” 61 Am. J. Indus. Med. 277 (2018). Infante’s rant goes beyond calling out scientists with economic interests on IARC working groups; Infante would silence all criticism of IARC pronouncements by anyone, including scientists, who has an economic interest in the outcome of a scientific debate. Infante points to manufacturing industry’s efforts to “discredit” recent IARC pronouncements on glyphosate and red meat, by which he means that there were scientists who had the temerity to question IARC’s processes and conclusions.

Apparently, Infante did not think his bias was showing or would be detected. He and his co-authors invoke militaristic metaphors to claim that the IARC’s monograph program, and indeed all of public health, is “under siege by corporate interests.” A farcical commentary at that, coming from such stalwarts of the Lawsuit Industry. Infante lists his contact information as “Peter F. Infante Consulting, LLC, Falls Church, Virginia,” and co-author Ronald Melnick can be found at “Ronald Melnick Consulting, LLC, North Logan, Utah.” A search on Peter Infante in Westlaw yields 141 hits, all on the plaintiffs’ side of health effects disputes; he is clearly no stranger to the world of litigation. Melnick is, to be sure, harder to find, but he does show up as a signatory on Raphael Metzger’s supposed amicus briefs, filed by Metzger’s litigation front organization, Council for Education and Research on Toxics.1

Of the commentary’s authors, only James Huff, of “James Huff Consulting, Durham, North Carolina,” disclosed a connection with litigation, as a consultant to plaintiffs on animal toxicology of glyphosate. Huff’s apparent transparency clouded up when it came to disclosing how much he has been compensated for his consulting activities for claimants in glyphosate litigation. In the very next breath, in unison, the authors announce unabashedly that “[a]ll authors report no conflicts of interest.” Infante at 280.

Of course, reporting “no conflicts of interest” does not mean that the authors have no conflicts of interest, financial, positional, and idealogical. Their statement simply means that they have not reported any conflicts, through inadvertence, willfulness, or blindness. The authors, and the journal, are obviously content to mislead their readership by not-so-clever dodges.

The clumsiness of the authors’ inability to appreciate their very own conflicts infects their substantive claims in this commentary. These “consultants” tell us solemnly that IARC “[m]eetings are openly transparent and members are vetted for conflicts of interest.” Infante at 277. Working group members, however, are vetted but only for manufacturing industry conflicts, not for litigation industry conflicts or for motivational conflicts, such as advancing their own research agendas. Not many scientists have a research agenda to show that chemicals do not cause cancer.

At the end of this charade, the journal provides additional disclosures [sic]. As for “Ethics and Approval Consent,” we are met with a bold “Not Applicable.” Indeed; ethics need not apply. Perhaps, the American Journal of Industrial Medicine is beyond good and evil. The journal’s “Editor of Record,” Steven B. Markowitz “declares that he has no conflict of interest in the review and publication decision regarding this article.” This is, of course, the same Markowitz who testifies frequently for the Lawsuit Industry, without typically disclosing this conflict on his own publications.

This commentary is yet another brushback pitch, which tries to chill manufacturing industry and scientists from criticizing the work of agencies, such as IARC, captured by lawsuit industry consultants. No one should be fooled other than Mother Jones.

1See, e.g., Ramos v. Brenntag Specialties, Inc., 372 P.3d 200 (Calif. 2016) (where plaintiff was represented by Metzger, and where CERT filed an amicus brief by the usual suspects, plaintiffs’ expert witnesses, including Melnick).

Posted in Conflicts of Interest, Scientific Misconduct | Comments Off on Infante-lizing the IARC

ToxicHistorians Sponsor ToxicDocs

February 1st, 2018

A special issue of the Journal of Public Health Policy waxes euphoric over a website, ToxicDocs, created by two labor historians, David Rosner and Gerald Markowitz (also known as the “Pink Panthers”). The Panthers have gotten their universities, Columbia University and the City University of New York, to host the ToxicDocs website with whole-text searchable documents of what they advertise as “secret internal memoranda, emails, slides, board minutes, unpublished scientific studies, and expert witness reports — among other kinds of documents — that emerged in recent toxic tort litigation.” According to Rosner and Markowitz, they are “constantly adding material from lawsuits involving lead, asbestos, silica, and PCBs, among other dangerous substances.” Rosner and Markowitz are well-positioned to obtain and add such materials because of their long-term consulting and testifying work for the Lawsuit Industry, which has obtained many of these documents in routine litigation discovery proceedings.

Despite the hoopla, the ToxicDocs website is nothing new or novel. Tobacco litigation has spawned several such on-line repositories: “Truth Tobacco Industry Documents Library,” Tobacco Archives,” and “Tobacco Litigation Documents.” And the Pink Panthers’ efforts to create a public library of the documents upon which they rely in litigation go back several years to earlier websites. See David Heath & Jim Morris, “Exposed: Decades of denial on poisons. Internal documents reveal industry ‘pattern of behavior’ on toxic chemicals,” Center for Public Integrity (Dec. 4, 2014).

The present effort, however, is marked by shameless self promotion and support from other ancillary members of the Lawsuit Industry. The Special Issue of Journal of Public Health Policy is introduced by Journal editor Anthony Robbins,1 who was a mover and shaker in the SKAPP enterprise and its efforts to subvert judicial assessments of proffered opinions for validity and methodological propriety. In addition, Robbins, along with the Pink Panthers as guest editors, have recruited additional “high fives” and self-congratulatory cheerleading from other members of, and expert witnesses for, the Lawsuit Industry, as well as zealots of the type who can be counted upon to advocate for weak science and harsh treatment for manufacturing industry.2

Rosner and Markowitz, joined by Merlin Chowkwanyun, add to the happening with their own spin on ToxicDocs.3 As historians, it is understandable that they are out of touch with current technologies, even those decades old. They wax on about the wonders of optical character recognition and whole text search, as though it were quantum computing.

The Pink Panthers liken their “trove” of documents to “Big Data,” but there is nothing quantitative about their collection, and their mistaken analogy ignores their own “Big Bias,” which vitiates much of their collection. These historians have been trash picking in the dustbin of history, and quite selectively at that. You will not likely find documents here that reveal the efforts of manufacturing industry to improve the workplace and the safety and health of their workers.

Rosner and Markowitz disparage their critics as hired guns for industry, but it is hard for them to avoid the label of hired guns for the Lawsuit Industry, an industry with which they have worked in close association for several decades, and from which they have reaped thousands of dollars in fees for consulting and testifying. Ironically, neither David Rosner nor Gerald Markowitz disclose their conflicts of interest, or their income from the Lawsuit Industry. David Wegman, in his contribution to the love fest, notes that ToxicDocs may lead to more accurate reporting of conflicts of interest. And yet, Wegman does not report his testimonial adventures for the Lawsuit Industry; nor does Robert Proctor; nor do Rosner and Markowitz.

It is a safe bet that ToxicDocs does not contain any emails, memoranda, letters, and the like about the many frauds and frivolities of the Lawsuit Industry, such as the silica litigation, where fraud has been rampant.4 I looked for but did not find the infamous Baron & Budd asbestos memorandum, or any of the documentary evidence from fraud cases arising from false claiming in the asbestos, silicone, welding, Fen-Phen, and other litigations.5

The hawking of ToxicDocs in the pages of the Journal of Public Health Policy is only the beginning. You will find many people and organizations promoting ToxicDocs on Facebook, Twitter, and LinkedIn. Proving there is no limit to the mercenary nature of the enterprise, you can even buy branded T-shirts and stationery online. Ah America, where even Marxists have the enterpreurial spirit!

1 Anthony Robbins & Phyllis Freeman, “ToxicDocs (www.ToxicDocs.org) goes live: A giant step toward leveling the playing field for efforts to combat toxic exposures,” 39 J. Public Health Pol’y 1 (2018). See “More Antic Proposals for Expert Witness Testimony – Including My Own Antic Proposals” (Dec. 30 2014).

2 Robert N. Proctor, “God is watching: history in the age of near-infinite digital archives,” 39 J. Public Health Pol’y 24 (2018); Stéphane Horel, “Browsing a corporation’s mind,” 39 J. Public Health Pol’y 12 (2018); Christer Hogstedt & David H. Wegman, “ToxicDocs and the fight against biased public health science worldwide,” 39 J. Public Health Pol’y 15 (2018); Joch McCulloch, “Archival sources on asbestos and silicosis in Southern Africa and Australia,” 39 J. Public Health Pol’y 18 (2018); Sheldon Whitehouse, “ToxicDocs: using the US legal system to confront industries’ systematic counterattacks against public health,” 39 J. Public Health Pol’y 22 (2018); Elena N. Naumova, “The value of not being lost in our digital world,” 39 J. Public Health Pol’y 27 (2018); Nicholas Freudenberg, “ToxicDocs: a new resource for assessing the impact of corporate practices on health,” 39 J. Public Health Pol’y 30 (2018). These articles are free, open-access, but in this case, you may get what you have paid for.

3 David Rosner, Gerald Markowitz, and Merlin Chowkwanyun, “ToxicDocs (www.ToxicDocs.org): from history buried in stacks of paper to open, searchable archives online,” 39 J. Public Health Pol’y 4 (2018).

4 See, e.g., In re Silica Products Liab. Litig., MDL No. 1553, 398 F.Supp. 2d 563 (S.D.Tex. 2005).

5 See Lester Brickman, “Fraud and Abuse in Mesothelioma Litigation,” 88 Tulane L. Rev. 1071 (2014); Peggy Ableman, “The Garlock Decision Should be Required Reading for All Trial Court Judges in Asbestos Cases,” 37 Am. J. Trial Advocacy 479, 488 (2014).

Posted in Conflicts of Interest, Historian Testimony | Comments Off on ToxicHistorians Sponsor ToxicDocs

The Amicus Curious Brief

January 4th, 2018

Friends – Are They Boxers or Briefers*

Amicus briefs help appellate courts by bringing important views to bear on the facts and the law in disputes. Amicus briefs ameliorate the problem of the common law system, in which litigation takes place between specific parties, with many interested parties looking on, without the ability to participate in the discussion or shape the outcome.

There are dangers, however, of hidden advocacy in the amicus brief. Even the most unsophisticated court is not likely to be misled by the interests and potential conflicts of interest of groups such as the American Association for Justice or the Defense Research Institute. If the description of the group is not as fully forthcoming as one might like, a quick trip to its website will quickly clarify the group’s mission on Earth. No one is fooled, and the amicus briefs can be judged on their merits.

What happens when the amici are identified only by their individual names and institutional affiliations? A court might be misled into thinking that the signatories are merely disinterested academics, who believe that important information or argument is missing from the appellate discussion.

The Pennsylvania Supreme Court has offered itself up as an example of a court snookered by “58 physicians and scientists.”1 Rost v. Ford Motor Co., 151 A.3d 1032, 1052 (Pa. 2016). Without paying any attention to the provenance of the amicus brief or the authors’ deep ties with the lawsuit industry, the court cited the brief’s description of:

“the fundamental notion that each exposure to asbestos contributes to the total dose and increases the person’s probability of developing mesothelioma or other cancers as an ‘irrefutable scientific fact’. According to these physicians and scientists, cumulative exposure is merely an extension of the ancient concept of dose-response, which is the ‘oldest maxim in the field’.”

Id. (citing amicus brief at 2).

Well, irrefutable in the minds of the 58 amici curious perhaps, who failed to tell the court that not every exposure contributes materially to cumulative exposure such that it must be considered a “substantial contributing factor.” These would-be friends also failed to tell the court that the human body has defense mechanisms to carcinogenic exposures, which gives rise to a limit on, and qualification of, the concept of dose-response in the form of biological thresholds, below which exposures do not translate into causative doses. Even if these putative “friends” believed there was no evidence for a threshold, they certainly presented no evidence against one. Nonetheless, a confused and misguided Pennsylvania Supreme Court affirmed the judgment below in favor of the plaintiffs.

The 58 amici also misled the Pennsylvania Supreme Court on several other issues. By their failure to disclose important information about themselves, and holding themselves out (falsely but successfully) as “disinterested” physicians and scientists, these so-called friends misled the court by failing to disclose the following facts:

1. Some of them were personal friends, colleagues, and fellow-party expert witnesses of the expert witness (Arthur Frank), whose opinion was challenged in the lower courts;

2. Some of the amici had no reasonable claim to expertise on the issues addressed in the brief;

3. Some of the amici have earned substantial fees in other asbestos cases, involving the same issues raised in the Rost case;

4. Some of the amici have been excluded from testifying in similar cases, to the detriment of their financial balance sheets;

5. Some of the amici are zealous advocates, who not only have testified for plaintiffs, but have participated in highly politicized advocacy groups such as the Collegium Ramazzini.

Two of the amici are historians (Rosner and Markowitz), who have never conducted scientific research on asbestos-related disease. Their work as labor historians added no support to the scientific concepts that were put over the Pennsylvania Supreme Court. Both of these historians have testified in multiple asbestos cases, and one of them (Markowitz) has been excluded in a state court case, under a Daubert-like standard. They have never been qualified to give expert witness testimony on medical causation issues. Margaret Keith, an adjunct assistant professor of sociology, appears never to have written about medical causation between asbestos and cancer, but she at least is married to another amicus, James Brophy, who has.

Barry Castleman,2 David F. Goldsmith, John M. Dement, Richard A. Lemen, and David Ozonoff have all testified in asbestos or other alleged dust-induced disease cases, with Castleman having the distinction of having made virtually his entire livelihood in connection with plaintiffs-side asbestos litigation testifying and consulting. Castleman, Goldsmith, and Ozonoff have all been excluded from, or severely limited in, testifying for plaintiffs in chemical exposure cases.

(Rabbi) Daniel Thau Teitelbaum has the distinction of having been excluded in case that went to the United States Supreme Court (Joiner), but Shira Kramer,3 Richard Clapp, and Peter F. Infante probably make up for the lack of distinction with the number of testimonial adventures and misadventures. L. Christine Oliver and Colin L. Soskolne have also testified for the lawsuit industry, in the United States, and for Soskolne, in Canada, as well.

Lennart Hardell has testified in cellular telephone brain cancer cases,4 for plaintiffs of course, which qualified as an expert for the IARC on electromagnetic frequency and carcinogenesis.5

Celeste Monforton has earned credentials serving with fellow skapper David Michaels in the notorious Project on Scientific Knowledge and Public Policy (SKAPP) organization.6 Laura S. Welch, like Monforton, another George Washington lecturer, has served the lawsuit industry in asbestos personal injury and other cases.

Exhibit A to the Amicus brief lists the institutional affiliations of each amicus. Although some of the amici described themselves as “consultants,” only one amicus (Massimiliano Bugiani) listed his consultancy as specifically litigation related, with an identification of the party that engaged him: “Consultant of the Plaintiff in the Turin and Milan Courts.” Despite Bugiani’s honorable example, none of the other amici followed suit.

* * * * * * * *

Although many judges and lawyers agree that amicus briefs often bring important factual expertise to appellate courts, there are clearly some abuses. I, for one, am proud to have been associated with a few amicus briefs in various courts. One law professor, Allison Orr Larsen, in a trenchant law review article, has identified some problems and has suggested some reforms.7 Regardless of what readers think of Larsen’s proposed reforms, briefs should not be submitted by testifying and consulting expert witnesses for one side in a particular category of litigation, without disclosing fully and accurately their involvement in the underlying cases, and their financial enrichment from perpetuating the litigation in question.

* Thanks to Ramses Delafontaine for having alerted me to other aspects of the lack of transparency in connection with amicus briefs filed by professional historian organizations.

1 Brief of Muge Akpinar-Elci, Xaver Bauer, Carlos Bedrossian, Eula Bingham, Yv Bonnier-Viger, James Brophy, Massimiliano Buggiani, Barry Castleman, Richard Clapp, Dario Consonni, Emilie Counil, Mohamed Aquiel Dalvie, John M. Dement, Tony Fletcher, Bice Fubini, Thomas H. Gassert, David F. Goldsmith, Michael Gochfeld, Lennart Hadell [sic, Hardell], James Huff, Peter F. Infante, Moham F. Jeebhay, T. K. Joshi, Margaret Keith, John R. Keyserlingk, Kapil Khatter, Shira Kramer, Philip J. Landrigan, Bruce Lanphear, Richard A. Lemen, Charles Levenstein, Abby Lippman, Gerald Markowitz, Dario Mirabelli, Sigurd Mikkelsen, Celeste Monforton, Rama C. Nair, L. Christine Oliver, David Ozonoff, Domyung Paek, Smita Pakhale, Rolf Petersen, Beth Rosenberg, Kenneth Rosenman, David Rosner, Craig Slatin, Michael Silverstein, Colin L. Soskolne, Leslie Thomas Stayner, Ken Takahashi, Daniel Thau Teitelbaum, Benedetto Terracini, Annie Thebaud-Mony, Fernand Turcotte, Andrew Watterson, David H. Wegman, Laura S. Welch, Hans-Joachim Woitowitz as Amici Curiae in Support of Appellee, 2015 WL 3385332, filed in Rost v. Ford Motor Co., 151 A.3d 1032 (Pa. 2016).

2 See “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011).

4 Newman v. Motorola, Inc., 218 F. Supp. 2d 769 (D. Md. 2002) (excluding Hardell’s proposed testimony), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003) (affirming exclusion of Hardell).

6 See, e.g., “SKAPP A LOT” (April 30, 2010); “Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013).

7 See Allison Orr Larsen, “The Trouble with Amicus Facts,” 100 Virginia L. Rev. 1757 (2014). See also Caitlin E. Borgmann, “Appellate Review of Social Facts in Constitutional Rights Cases,” 101 Calif. L. Rev. 1185, 1216 (2013) (“Amicus briefs, in particular, are often submitted by advocates and may be replete with dubious factual assertions that would never be admitted at trial.”).

Posted in Asbestos, Causation, Conflicts of Interest, Expert Witnesses | Comments Off on The Amicus Curious Brief

Some High-Value Targets for Sander Greenland in 2018

December 27th, 2017

A couple of years ago, Sander Greenland and I had an interesting exchange on Deborah Mayo’s website. I tweaked Sander for his practice of calling out defense expert witnesses for statistical errors, while ignoring whoopers made by plaintiffs’ expert witnesses. See “Significance Levels Made a Whipping Boy on Climate-Change Evidence: Is p < 0.05 Too Strict?” Error Statistics (Jan. 6, 2015).1 Sander acknowledged that he received a biased sample of expert reports through his service as a plaintiffs’ expert witness, but protested that defense counsel avoided him like the plague. In an effort to be helpful, I directed Sander to an example of bad statistical analysis that had been proffered by Dr Bennett Omalu, in a Dursban case, Pritchard v. Dow Agro Sciences, 705 F. Supp. 2d 471 (W.D. Pa. 2010), aff’d, 430 F. App’x 102, 104 (3d Cir. 2011).2

Sander was unimpressed with my example of Dr. Omalu; he found the example “a bit disappointing though because [Omalu] was merely a county medical examiner, and his junk analysis was duly struck. The expert I quoted in my citations was a full professor of biostatistics at a major public university, a Fellow of the American Statistical Association, a holder of large NIH grants, and his analysis (more subtle in its transgressions) was admitted” (emphasis added). Sander expressed an interest in finding “examples involving similarly well-credentialed, professionally accomplished plaintiff experts whose testimony was likewise admitted… .”

Although it was heartening to read Sander’s concurrence in the assessment of Omalu’s analysis as “junk,” Sander’s rejection of Dr. Omalu as merely a low-value target was disappointing, given that Omalu also has a master’s degree in public health, from the University of Pittsburgh, where he claims he studied with Professor Lew Kuller. Omalu has also gained some fame and notoriety for his claim to have identified the problem of chronic traumatic encephalopathy (CTE) among professional football players. After all, even Sander Greenland has not been the subject of a feature-length movie (Concussion), as has Omalu.

I lost track of our exchange in 2015, until recently I was reminded of it when reading an expert report by Professor Martin Wells. Unlike Omalu, Wells meets all the Greenland criteria for high-value targets. He is not only a full, chaired professor but also the statistics department chairman at an ivy-league school, Cornell University. Wells is a fellow of both the American Statistical Association and the Royal Statistical Society, but most important, Wells is a frequent plaintiffs’ expert witness, who is well known to Sander Greenland. Both Wells and Greenland served, side by side, as plaintiffs’ expert witnesses in the pain pump litigation.

So here is the passage in the Wells’ report that is worthy of Greenland’s attention:

“If a 95% confidence interval is specified, the range encompasses the results we would expect 95% of the time if samples for new studies were repeatedly drawn from the same population.”

In re Testosterone Replacement Therapy Prods. Liab. Litig., Declaration of Martin T. Wells, Ph.D., at 2-3 (N.D. Ill., Oct. 30, 2016). Unlike the Dursban litigation involving Bennett Omalu, where the “junk analysis” was excluded, in the litigation against AbbVie for its manufacture and selling of prescription testosterone supplementation, Wells’ opinions were not excluded or limited. In re Testosterone Replacement Therapy Prods. Liab. Litig., No. 14 C 1748, MDL No. 2545, 2017 WL 1833173 (N.D. Ill. May 8, 2017) (denying Rule 702 motions).

Now this statement by Wells surely offends the guidance provided by Greenland and colleagues.3 And it was exactly the sort of misrepresentation that led to a confabulation of the American Statistical Association, and that Association’s consensus statement on statistical significance.4

And here is another example, which occurs not in a distorting litigation forum, but on the pages of an occupational health journal, where the editor in chief, Anthony L. Kiorpes, ranted about the need for better statistical editing and writing in his own journal. See Anthony L Kiorpes, “Lies, damned lies, and statistics,” 33 Toxicol. & Indus. Health 885 (2017). Kiorpes decried he misuse of statistics:

“I am not implying that it is the intent of the scientists who publish in these pages to mislead readers by their use of statistics, but I submit that the misuse of statistics, whether intentional or otherwise, creates confusion and error.”

Id. at 885. Kiorpes then proceeded to hold himself up as Exhibit A to his screed:

“Remember that p values are estimates of the probability that the null hypothesis (no difference) is true.”

Id. Uggh; we seem to be back sliding after the American Statistical Association’s consensus statement.

“Almost all scientists have stated (or have been tempted to state) something like ‘the mean of Group A was greater than that of Group B, but the difference was not statistically significant’. With very few exceptions (which I will mention below), this statement is nonsense.”

* * * * *

“What the statistics are indicating when the p-value is greater than 0.05 is that there is ‘no difference’ between group A and group B.”

Id. at 886.

Let’s hope that this gets Sander Greenland away from his biased sampling of expert witnesses, off the backs of defense expert witnesses, and on to some of the real culprits out there, in the new year.

1 See also “Sander Greenland on ‘The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics’” (Feb. 8, 2015).

2 See also “Pritchard v. Dow Agro – Gatekeeping Exemplified” (Aug. 25, 2014); “Omalu and Science — A Bad Weld” (Oct. 22, 2016); Brian v. Association of Independent Oil Distributors, No. 2011-3413, Westmoreland Cty. Ct. Common Pleas, Order of July 18, 2016 (excluding Dr. Omalu’s testimony on welding and solvents and Parkinson’s disease).

3 See, e.g., Sander Greenland, Stephen J. Senn, Kenneth J. Rothman, John B. Carlin, Charles Poole, Steven N. Goodman, and Douglas G. Altman, “Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations,” 31 Eur. J. Epidem. 337 (2016).

4 Ronald L. Wasserstein & Nicole A. Lazar, “American Statistical Association Statement on statistical significance and p values,” 70 Am. Statistician 129 (2016)

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Rule 702, statistical evidence | Comments Off on Some High-Value Targets for Sander Greenland in 2018

Gatekeeping of Expert Witnesses Needs a Bair Hug

December 20th, 2017

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

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

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

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

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

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

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

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

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

Id.

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

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

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

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

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

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

Stuck in Silicone

December 12th, 2017

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

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

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

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

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

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

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

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

A. The answer is yes.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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