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Cartoon Advocacy for Causal Claims

October 5th, 2018

I saw him today at the courthouse
On his table was a sawed-in-half man
He was practiced at the art of deception
Well I could tell by his blood-stained hands
Ah yeah! Yeah¹

Mark Lanier’s Deceptive Cartoon Advocacy

A recent book by Kurt Andersen details the extent of American fantasy, in matters religious, political, and scientific.² Andersen’s book is a good read and a broad-ranging dissection of the American psyche for cadswallop. The book has one gaping hole, however. It completely omits the penchant for fantasy in American courtrooms.

Ideally, the trial lawyers in a case balance each other and their distractions drop out of the judge or jury’s search for the truth. Sometimes, probably too frequently in so-called toxic tort cases, plaintiffs’ counsel’s penchant for fantasy is so great and persistent that it overwhelms the factfinder’s respect for the truth, and results in an unjust award. In a telling article in Forbes, Mr. Daniel Fisher has turned his sights upon plaintiffs’ lawyer Mark Lanier and his role in helping a jury deliver a $5 billion (give or take a few shekels).³

The $5 billion verdict came in the St. Louis, Missouri, courtroom of Judge Rex Burlison, who presided over a multi-plaintiff case in which the plaintiffs claimed that they had developed ovarian cancer from using Johnson & Johnson’s talcum powder. In previous trials, plaintiffs’ counsel and expert witnesses attempted to show that talc itself could cause ovarian cancer, with inconsistent jury results. Mr. Lanier took a different approach in claiming that the talcum powder was contaminated with asbestos, which caused his clients to develop ovarian cancer.

The asserted causal relationship between occupational or personal exposure to talc and ovarian cancer is tenuous at best, but there is at least a debatable issue about the claimed association between occupational asbestos use and ovarian cancer. The more thoughtful reviews of the issue, however, are cautious in noting that disease outcome misclassification (misdiagnosing mesotheliomas that would be expected in these occupational cohorts with ovarian cancer) make conclusions difficult. See, e.g., Alison Reid, Nick de Klerk and Arthur W. (Bill) Musk, “Does Exposure to Asbestos Cause Ovarian Cancer? A Systematic Literature Review and Meta-analysis,” 20 Cancer Epidemiol. Biomarkers & Prevention 1287 (2011).

Fisher reported that Lanier, after obtaining the $5 billion verdict, presented to a litigation industry meeting, held at a plush Napa Valley resort. In this presentation, Lanier described his St. Louis achievement by likening himself to a magician, and explained “how I sawed the man in half.” Of course, if Lanier had sawed the man in half, he would be a murderer, and the principle of charity requires us to believe that he is merely a purveyor of magical thinking, a deceiver, practiced in the art of deception.

Lanier’s boast about his magical skills is telling. The whole point of the magician’s act is to thrill an audience by the seemingly impossible suspension of the laws of nature. Deception, of course, is the key to success for a magician, or an illusionist of any persuasion. It is comforting to think that Lanier regards himself as an illusionist because his self-characterization suggests that he does not really believe in his own courtroom illusions.

Lanier’s magical thinking and acts have gotten him into trouble before. Fisher noted that Lanier had been branded as deceptive by the second highest court in the United States, the United States Court of Appeals, in Christopher v. DePuy Orthopaedics, Inc., Nos. 16-11051, et al., 2018 U.S. App. LEXIS 10476 (5^th Cir. April 25, 2018). In Christopher, Lanier had appeared to engineer payments to expert witnesses in a way that he thought he could tell the jury that the witnesses had no pecuniary interest in the case. Id. at *67. The Court noted that “[l]awyers cannot engage with a favorable expert, pay him ‘for his time’, then invite him to testify as a purportedly ‘non-retained’ neutral party. That is deception, plain and simple.” Id. at *67. The Court concluded that “Lanier’s deceptions furnish[ed] independent grounds for a new trial, id. at *8, because Lanier’s “deceptions [had] obviously prevented defendants from ‘fully and fairly’ defending themselves.” Id. at *69.

Cartoon Advocacy

In his presentation to the litigation industry meeting in Napa Valley, Lanier explained that “Every judge lives by certain rules, just like in sports, but every stadium is also allowed to size themselves appropriately to the game.” See Fisher at note 3. Lanier’s magic act thrives in courtrooms where anything goes. And apparently, Lanier was telling his litigation industry audience that anything goes in the St. Louis courtroom of Judge Burlison.

In some of the ovarian cancer cases, Lanier had a problem: the women had a BrCa2 deletion mutation, which put them at a very high lifetime risk of ovarian cancer, irrespective of what exogenous exposures they may have had. Lanier was undaunted by this adverse evidence, and he spun a story that these women were at the edge of a cliff, when evil Johnson & Johnson’s baby powder came along and pushed them over the cliff:

Lanier Exhibit (from Fisher’s article in Forbes)

Whatever this cartoon lacks in artistic ability, we should give the magician his due; this is a powerful rhetorical metaphor, but it is not science. If it were, there would be a study that showed that ovarian cancers occurred more often in women with BrCa 2 mutations and talcum exposure than in women with BrCa 2 mutations without talcum exposure. The cartoon also imputes an intention to harm specific plaintiffs, which is not supported by the evidence. Lanier’s argument about the “edge of the cliff” does not change the scientific or legal standard that the alleged harm be the sine qua non of the tortious exposure. In the language of the American Law Institute’s Restatement of Torts⁴:

“An actor’s tortious conduct must be a factual cause of another’s physical harm for liability to be imposed. Conduct is a factual cause of harm when the harm would not have occurred absent the conduct.”

Lanier’s cartoon also mistakes risk, if risk it should be, with cause in fact. Reverting back to basic principles, Kenneth Rothman reminds us⁵:

“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.”

Chain, Chain, Chain — Chain of Foolish Custody

Johnson & Johnson has moved for a new trial, complaining about Lanier’s illusionary antics, as well as cheesy lawyering. Apparently, Lanier used a block of cheese to illustrate his view of talc mining. In most courtrooms, argument is confined to closing statements of counsel, but in Judge Burlison’s courtroom, Lanier seems to have engaged in one, non-stop argument from the opening bell.

Whether there was asbestos in Johnson & Johnson’s baby powder was obviously a key issue in Lanier’s cases. According to Fisher’s article, Lanier was permitted, over defense objections, to present expert witness opinion testimony based upon old baby powder samples bought from collectors on eBay, for which chain of custody was lacking or incomplete. If this reporting is accurate, then Mr. Lanier is truly a magician, with the ability to make well-established law disappear.⁶

The Lanier Firm’s Website

One suggestion of how out of control Judge Burlison’s courtroom was is evidenced in Johnson & Johnson’s motion for a new trial, as reported by Fisher. Somehow, defense counsel had injected the content of Lanier’s firm’s website into the trial. According to the motion for new trial, that website had stated that talc “used in modern consumer products” was not contaminated with asbestos. In his closing argument, however, Lanier told the jury he had looked at his website, and the alleged admission was not there.

How the defense was permitted to talk about what was on Lanier’s website is a deep jurisprudential puzzle. Such a statement would be hearsay, without an authorizing exception. Perhaps the defense argued that Lanier’s website was the admission by an agent of the plaintiffs, authorized to speak for them. The attorney-client relationship does create an agent-principal relationship, but it is difficult to fathom that it extends to every statement that Mr. Lanier made outside the record of the trials before the court. If you dear reader are aware of authority to the contrary, please let me know.

Whatever tenuous basis the defense may have advanced, in this cartoon trial, to inject Mr. Lanier’s personal extrajudicial statements into evidence, Mr. Lanier went one parsec farther, according to Fisher. In his closing argument, Lanier blatantly testified that he had checked the website cited and that the suggested statement was not there.

Sounds like a cartoon and a circus trial all bound up together; something that would bring smiles to the faces of Penn Jillette, P.T. Barnum, and Donald Duck.

1 With apologies to Mick Jagger and Keith Richards, and their “You Can’t Always Get What You Want,” from which I have borrowed.

2 Kurt Andersen, Fantasyland: How America Went Haywire – A 500-Year History (2017).

3 Daniel Fisher, “A Bale Of Hay And A Block Of Cheese: How Mark Lanier Won $4.7 Billion Talcum Powder Verdict,” Forbes (Oct. 3, 2018).

4 “Factual Cause,” A.L.I. Restatement of the Law of Torts (Third): Liability for Physical & Emotional Harm § 26 (2010).

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

6 Paul C. Giannelli, “Chain of Custody,” Crim. L. Bull. 446 (1996); R. Thomas Chamberlain, “Chain of Custody: Its Importance and Requirements for Clinical Laboratory Specimens,” 20 Lab. Med. 477 (1989).

Posted in Asbestos, Causation, Scientific Evidence | Comments Off on Cartoon Advocacy for Causal Claims

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.¹¹Hill’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).

5 See “Late Lessons from Early Warnings: The Precautionary Principle 1896-2000, a Conversation with David Gee” (2009).

6 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).

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 21^st 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).

12 See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 2”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 3”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 4”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 5”; “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 6.”

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).

15 “Rhetorical Strategy in Characterizing Scientific Burdens of Proof” (Nov. 15, 2014).

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.

20 See “Failed Gatekeeping in Ambrosini v. Labarraque (1996)” (Dec. 28, 2017).

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

Ninth Circuit’s Difficulty with Process of Elimination

September 16th, 2018

Differential etiology is a high-fallutin’ term given to a simple disjunctive syllogism in which all disjuncts in the premise but one are eliminated. The syllogism would be a persuasive argument for the one remaining disjunct but only if all the other premises are effectively eliminated. Otherwise, we are left with competing disjunctive premises that remain, without any way of embracing the “one,” for which someone is contending.

Over 100 years ago, the United States Supreme Court recognized the need for eliminating all but the claimed cause in a simple FELA negligence action. In a unanimous decision, the Court declared:

“And where the testimony leaves the matter uncertain and shows that any one of half a dozen things may have brought about the injury, for some of which the employer is responsible and for some of which he is not, it is not for the jury to guess between these half a dozen causes and find that the negligence of the employer was the real cause, when there is no satisfactory foundation in the testimony for that conclusion. If the employe is unable to adduce sufficient evidence to show negligence on the part of the employer, it is only one of the many cases in which the plaintiff fails in his testimony, and no mere sympathy for the unfortunate victim of an accident justifies any departure from settled rules of proof resting upon all plaintiffs.”

Patton v. Texas & Pacific RR, 179 U.S. 658, 663-64 (1901).

Recently the United States Court of Appeals, for the Ninth Circuit, recognized the need to rule out alternative factual explanations before a court could enter judgment on a claim of copyright infringement.¹ Cobbler Nevada, LLC v Thomas Gonzales, No. 17-35041 (9th Cir., Aug. 27, 2018). The facts of Cobbler Nevada are illustrative.

Someone with access to an IP address registered to Thomas Gonzales used BitTorrent to download a copy of “The Cobbler,” an Adam Sandler movie. Cobbler Nevada LLC sued Mr. Gonzales, not for bad taste, but for infringing on its copyright to the movie. Mr. Gonzales, however, was the owner of an adult foster home, in which several other people had access to Gonzales’ IP address. Cobbler Nevada had no evidence that eliminated the possibility of downloading by other people in the home.

An amended complaint accused Mr. Gonzales of directly infringing the copyright, and alternatively, of contributing to the infringement by not policing this own internet connection.

The panel affirmed the rejection of the infringement claim because the claimant had failed to rule out downloading by someone who other Gonzales:

“The direct infringement claim fails because Gonzales’ status as the registered subscriber of an infringing IP address, standing alone, does not create a reasonable inference that he is also the infringer… .”

Id. The panel reasoned that others in the household could have accessed Gonzales’ internet connection, and that the law did not impose a duty to secure the connection from a “frugal” neighbor.

In personal injury cases, the Ninth Circuit takes a very different, and thoroughly illogical approach from its astute reasoning in Cobbler Nevada. In one Ninth Circuit case, the plaintiff claimed without much of any supporting evidence that he had sustained a drug-induced disease, when over 70 percent of cases of that disease were idiopathic. The trial court accurately diagnosed the situation as an impossible proof problem for the plaintiff because the differential etiology method could not eliminate idiopathic causes in the case before the court. Rule 702 led to the exclusion of plantiffs’ proffered opinions, and the trial court entered summary judgment for the defendants. The Ninth Circuit reversed in an ipse dixit judgment that threw logic to the wind. Wendell v. Johnson & Johnson, No. 09-cv-04124, 2014 WL 2943572, at *5 (N.D. Cal. June 30, 2014), rev’d sub nom. Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227 (9th Cir. 2017).²

The two cases, Wendell and Cobbler Nevada, cannot be reconciled. The aberrant and costive reasoning of Wendell will give rise to unflattering speculation about the Circuit’s motivation. Perhaps the next edition of the Reference Manual on Scientific Evidence should have a chapter on elementary logic, to help avoid such embarrassing situations.

1 Jason Tashea, “9th Circuit rules that sharing IP address is insufficient for copyright infringement,” Am. Bar. Ass’n J. (Sept. 4, 2018).

2 For a lively vivisection of the Ninth Circuit’s decision in Wendell, see David L. Faigman & Jennifer Mnookin, “The Curious Case of Wendell v. GlaxoSmithKline LLC,” 48 Seton Hall L. Rev. 607 (2018).

Posted in Causation, Expert Witnesses, Rule 702 | Comments Off on Ninth Circuit’s Difficulty with Process of Elimination

The Appeal of the Learned Treatise

August 16th, 2018

In many states, the so-called “learned treatise” doctrine creates a pseudo-exception to the rule against hearsay. The contents of such a treatise can be read to the jury, not for its truth, but for the jury to consider against the credibility of an expert witness who denies the truth of the treatise. Supposedly, some lawyers can understand the distinction between the treatise’s content’s being admitted for its truth as opposed to the credibility of an expert witness who denies its truth. Under the Federal Rules of Evidence, and in some states, the language of the treatise may be considered for its truth as well, but the physical treatise may not be entered into evidence. There are several serious problems with both the state and the federal versions of the doctrine.¹

Legal on-line media recently reported about an appeal in the Pennsylvania Superior Court, which heard arguments in a case that apparently turned on allegations of trial court error in refusing to allow learned treatise cross-examination of a plaintiff’s expert witness in Pledger v. Janssen Pharms., Inc., Phila. Cty. Ct. C.P., April Term 2012, No. 1997. See Matt Fair, “J&J Urges Pa. Appeals Court To Undo $2.5M Risperdal Verdict,” Law360 (Aug. 8, 2018) (reporting on defendants’ appeal in Pledger, Pa. Super. Ct. nos. 2088 EDA 2016 and 2187 EDA 2016).

In Pledger, plaintiff claimed that he developed gynecomastia after taking the defendants’ antipsychotic medication Risperdal. Defendants warned about gynecomastia, but the plaintiff claimed that the defendants had not accurately quantified the rate of gynecomastia in its package insert.

From Mr. Fair’s reporting, readers can discern only one ground for appeal, namely whether the “trial judge improperly barred it from using a scientific article to challenge an expert’s opinion that the antipsychotic drug Risperdal caused an adolescent boy to grow breasts.” Without having heard the full oral argument, or having read the briefs, the reader cannot tell whether there were other grounds. According to Mr. Fair, defense counsel contended that the trial court’s refusal to allow the learned treatise “had allowed the [plaintiff’s] expert’s opinion to go uncountered during cross-examination.” The argument, according to Mr. Fair, continued:

“Instead of being able to confront the medical causation expert with an article that absolutely contradicted and undermined his opinion, the court instead admonished counsel in front of the jury and said, ‘In Pennsylvania, we don’t try cases by books, we try them by live witnesses’.”

The cross-examination at issue, on the other hand, related to whether gynecomastia could occur naturally in pre-pubertal boys. Plaintiffs’ expert witness, Dr. Mark Solomon, a plastic surgeon, opined that gynecomastia did not occur naturally, and the defense counsel attempted to confront him with a “learned treatise,” an article from the Journal of Endocrinology, which apparently stated to the contrary. Solomon, following the usual expert witness playbook, testified that he had not read the article (and why would a surgeon have read this endocrinology journal?) Defense counsel pressed, and according to Mr. Fair, the trial judge disallowed further inquiry on cross-examination. On appeal, the defendants argued that the trial judge violated the learned treatise rule that allows “scholarly articles to be used as evidence.” The plaintiffs contended, in defense of their judgment below, that the “learned treatise rule” does not allow “scholarly articles to simply be read verbatim into the record,” and that the defense had the chance to raise the article in the direct examination of its own expert witnesses.

The Law360 reporting is curious on several fronts. The assigned error would have only been in support of a challenge to the denial of a new trial, and in a Risperdal case, the defense would likely have made a motion for judgment notwithstanding the verdict, as well as for new trial. Although the appellate briefs are not posted online, the defense’s post-trial motions in Pledger v. Janssen Pharms., Inc., Phila. Cty. Ct. C.P., April Term 2012, No. 1997, are available. See Defendants’ Motions for Post-Trial Relief Pursuant to Pa.R.C.P. 227.1 (Mar. 6, 2015).

At least at the post-trial motion stage, the defendants clearly made both motions for judgment and for a new trial, as expected.

As for the preservation of the “learned treatise” issue, the entire assignment of error is described in a single paragraph (out of 116 paragraphs) in the post-trial motion, as follows:

27. Moreover, appearing to rely on Aldridge v. Edmunds, 750 A.2d 292 (Pa. 2000), the Court prevented Janssen from cross-examining Dr. Solomon with scientific authority that would undermine his position. See, e.g., Tr. 60:9-63:2 (p.m.). Aldridge, however, addresses the use of learned treatises in the direct examination, and it cites with approval the case of Cummings v. Borough of Nazareth, 242 A.2d 460, 466 (Pa. 1968) (plurality op.), which stated that “[i]t is entirely proper in examination and cross-examination for counsel to call the witness’s attention to published works on the matter which is the subject of the witness’s testimony.” Janssen should not have been so limited in its cross examination of Dr. Solomon.

In Cummings, the issue revolved around using manuals that contained industry standards for swimming pool construction, not the appropriateness of a learned scientific treatise. Cummings v. Nazareth Borough, 430 Pa. 255, 266-67 (Pa. 1968). The defense motion did not contend that the defense counsel had laid the appropriate foundation for the learned treatise to be used. In any event, the trial judge wrote an opinion on the post-trial motions, in which he did not appear to address the learned treatise issue at all. Pledger v Janssen Pharms, Inc., Phila. Ct. C.P., Op. sur post-trial motions (Aug. 10., 2017) (Djerassi, J.).

The Pennsylvania Supreme Court has addressed the learned treatise exception to the rule against hearsay on several occasions. Perhaps the leading case described the law as:

“well-settled that an expert witness may be cross-examined on the contents of a publication upon which he or she has relied in forming an opinion, and also with respect to any other publication which the expert acknowledges to be a standard work in the field. * * * In such cases, the publication or literature is not admitted for the truth of the matter asserted, but only to challenge the credibility of the witness’ opinion and the weight to be accorded thereto. * * * Learned writings which are offered to prove the truth of the matters therein are hearsay and may not properly be admitted into evidence for consideration by the jury.”

Majdic v. Cincinnati Mach. Co., 537 A. 2d 334, 621-22 (Pa. 1988) (internal citations omitted).

The Law360 report is difficult to assess. Perhaps the reporting by Mr. Fair was non-eponymously unfair? There is no discussion of how the defense had laid its foundation. Perhaps the defense had promised “to connect up” by establishing the foundation of the treatise through a defense expert witness. If there had been a foundation established, or promised to be established, the post-trial motion would have, in the normal course of events, cited the transcript for the proffer of a foundation. And why did Mr. Fair report on the oral argument as though the learned treatise issue was the only issue before the court? Inquiring minds want to know.

Judge Djerassi’s opinion on post-trial motions was perhaps more notable for embracing some testimony on statistical significance from Dr. David Kessler, former Commissioner of the FDA, and now a frequent testifier for the lawsuit industry on regulatory matters. Judge Djerassi, in his opinion, stated:

“This statistically significant measure is shown in Table 21 and was within a chi-square rate of .02, meaning within a 98% chance of certainty. In Dr. Kessler’s opinion this is a statistically significant finding. (N.T. 1/29/15, afternoon, pp. p. 27, ln. 2 10-11, p. 28, lns. 7-12).”

Post-trial opinion at p.11.² Surely, the defense’s expert witnesses explained that the chi-square test did not yield a measure of certainty that the measured statistic was the correct value.

The trial court’s whopper was enough of a teaser to force me to track down Kessler’s testimony, which was posted to the internet by the plaintiffs’ law firm. Judge Djerassi’s erroneous interpretation of the p-value can indeed be traced to Kessler’s improvident testimony:

Q. And since 2003, what have you been doing at University of California San Francisco, sir?

A. Among other things, I am currently a professor of pediatrics, professor of epidemiology, professor of biostatistics.

Pledger Transcript, Thurs., Jan. 28, 2015, Vol. 3, Morning Session at 111:3-7.

A. What statistical significance means is it’s mathematical and scientific calculations, but when we say something is statistically significant, it’s unlikely to happen by chance. So that association is very likely to be real. If you redid this, general statistically significant says if I redid this and redid the analysis a hundred times, I would get the same result 95 of those times.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Morning Session at 80:18 – 81:2.

Q. So, sir, if we see on a study — and by the way, do the investigators of a study decided in their own criteria what is statistically significant? Do they assign what’s called a P value?

A. Exactly. So you can set it at 95, you can set it at 98, you can set it at 90. Generally, 95 significance level, for those of you who are mathematicians or scientifically inclined, it’s a P less than .05.

Q. As a general rule?

A. Yes.

Q. So if I see a number that is .0158, next to a dataset, that would mean that it occurs by chance less than two in 100. Correct?

A. Yes, that’s what the P value is saying.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Morning Session at 81:5-20

Q. … If someone — if something has a p-value of less than .02, the converse of it is that your 98 — .98, that would be 98 percent certain that the result is not by chance?

A. Yes. That’s a fair way of saying it.

Q. And if you have a p-value of .10, that means the converse of it is 90 percent, or 90 percent that it’s not by chance, correct?

A. Yes.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Afternoon Session at 7:14-22.

Q. Okay. And the last thing I’d like to ask about — sorry to keep going back and forth — is so if the jury saw a .0158, that’s of course less than .02, which means that it is 90 — almost 99 percent not by chance.

A. Yes. It’s statistically significant, as I would call it.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Afternoon Session at 8:7-13.

1 See “Further Unraveling of the Learned Treatise Exception” (Sept. 29, 2010); “Unlearning The Learned Treatise Exception” (Aug. 21, 2010); “The New Wigmore on Learned Treatises” (Sept. 12, 2011); “Trust Me” Rules of Evidence” (Oct. 18, 2012).

2 See also Djerassi opinion at p.13 n. 13 (“P<0.02 is the chi—square rate reflecting a data outcome within a 98% chance of certainty.”).

Posted in Causation, Expert Witnesses, statistical evidence | Comments Off on The Appeal of the Learned Treatise

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 (1^st 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’.”).

3 See California Cancer Facts and Figures 2017.

4 Birth Defects State Profile – California (2012).

5 Sara Randazzo, “In California, Where Cancer Warnings Abound, Coffee Is Next in Line; Judge is expected to rule whether 1986 state law, meant to warn of potential harms, applies to coffee,” Wall St. J. (Jan. 24, 2018).

6 Anastasia Killian, “Prop 65 Has its Perks for Plaintiffs’ Lawyers in Coffee Litigation,” Forbes (Oct. 10, 2012); Report of California Attorney General for 2011.

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).

9 “THE COUNCIL FOR EDUCATION AND RESEARCH ON TOXICS” (July 9, 2013).

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

Wrong Words Beget Causal Confusion

February 12th, 2018

In clinical medical and epidemiologic journals, most articles that report about associations will conclude with a discussion section in which the authors hold forth about

(1) how they have found that exposure to X “increases the risk” of Y, and

(2) how their finding makes sense because of some plausible (even if unproven) mechanism.

In an opinion piece in Significance,¹ Dalmeet Singh Chawla cites to a study that suggests the “because” language frequently confuses readers into believing that a causal claim is being made. The study abstract explains:

“Most researchers do not deliberately claim causal results in an observational study. But do we lead our readers to draw a causal conclusion unintentionally by explaining why significant correlations and relationships may exist? Here we perform a randomized study in a data analysis massive online open course to test the hypothesis that explaining an analysis will lead readers to interpret an inferential analysis as causal. We show that adding an explanation to the description of an inferential analysis leads to a 15.2% increase in readers interpreting the analysis as causal (95% CI 12.8% – 17.5%). We then replicate this finding in a second large scale massive online open course. Nearly every scientific study, regardless of the study design, includes explanation for observed effects. Our results suggest that these explanations may be misleading to the audience of these data analyses.”

Leslie Myint, Jeffrey T. Leek, and Leah R. Jager, “Explanation implies causation?” (Nov. 2017) (on line manuscript).

Invoking the principle of charity, these authors suggest that most researchers are not deliberately claiming causal results. Indeed, the language of biomedical science itself is biased in favor of causal interpretation. The term “statistical significance” suggests causality to naive readers, as does stats talk about “effect size,” and “fixed effect models,” for data sets that come no where near establishing causality.

Common epidemiologic publication practice tolerates if not encourages authors to state that their study shows (finds, demonstrates, etc.) that exposure to X “increases the risk” of Y in the studies’ samples. This language is deliberately causal, even if the study cannot support a causal conclusion alone or even with other studies. After all, a risk is the antecedent of a cause, and in the stochastic model of causation involved in much of biomedical research, causation will manifest in a change of a base rate to a higher or lower post-exposure rate. Given that mechanism is often unknown and not required, then showing an increased risk is the whole point. Eliminating chance, bias, confounding, and study design often is lost in the irrational exuberance of declaring the “increased risk.”

Tighter editorial control might have researchers qualify their findings by explaining that they found a higher rate in association with exposure, under the circumstances of the study, followed by an explanation that much more is needed to establish causation. But where is the fun and profit in that?

Journalists, lawyers, and advocacy scientists often use the word “link,” to avoid having to endorse associations that they know, or should know, have not been shown to be causal.² Using “link” as a noun or a verb clearly implies a causal chain metaphor, which probably is often deliberately implied. Perhaps publishers would defend the use of “link” by noting that it is so much shorter than “association,” and thus saves typesetting costs.

More attention is needed to word choice, even and especially when statisticians and scientists are using their technical terms and jargon.³ If, for the sake of argument, we accept the sincerity of scientists who work as expert witnesses in litigation in which causal claims are overstated, we can see that poor word choices confuse scientists as well as lay people. Or you can just read the materials and methods and the results of published study papers; skip the introduction and discussion sections, as well as the newspaper headlines.

1 Dalmeet Singh Chawla, “Mind your language,” Significance 6 (Feb. 2018).

2 See, e.g., Perri Klass, M.D., “https://www.nytimes.com/2017/12/04/well/family/does-an-adhd-link-mean-tylenol-is-unsafe-in-pregnancy.html,” N.Y. Times (Dec. 4, 2017); Nicholas Bakalar, “Body Chemistry: Lower Testosterone Linked to Higher Death Risk,” N.Y. Times (Aug. 15, 2006).

3 Fang Xuelan & Graeme Kennedy, “Expressing Causation in Written English,” 23 RELC J. 62 (1992); Bengt Altenberg, “Causal Linking in Spoken and Written English,” 38 Studia Linguistica 20 (1984).

Posted in Causation, Scientific Misconduct | Comments Off on Wrong Words Beget Causal Confusion

Ninth Circuit Quashes Harkonen’s Last Chance

January 8th, 2018

With the benefit of hindsight, even the biggest whopper can be characterized as a strategic choice for trial counsel. As are result of this sort of thinking, the convicted have a very difficult time in pressing claims of ineffective assistance of counsel. After the fact, a reviewing or an appellate court can always imagine a strategic reason for trial counsel’s decisions, even if they contributed to the client’s conviction.

In the Harkonen case, a pharmaceutical executive was indicted and tried for wire fraud and misbranding. His crime was to send out a fax with a preliminary assessment of a recently unblinded clinical trial. In his fax, Dr Harkonen described the trial’s results as “demonstrating” a survival benefit in study participants with mild and moderate disease. Survival (or mortality) was not a primary outcome of the trial, but it was a secondary outcome, and arguably the most important one of all. The subgroup of “mild and moderate” was not pre-specified, but it was highly plausible.

Clearly, Harkonen’s post hoc analysis would not be sufficient normally to persuade the FDA to approve a medication, but Harkonen did not assert or predict that the company would obtain FDA approval. He simply claimed that the trial “demonstrated” a benefit. A charitable interpretation of his statement, which was several pages long, would include the prior successful clinical trial, as important context for Harkonen’s statement.

The United States government, however, was not interested in the principle of charity, the context, or even its own pronouncements on the issue of statistical significance. Instead, the United States Attorney pushed for draconian sentences under the Wire Fraud Act, and the misbranding sections of the Food, Drug, and Cosmetics Act. A jury acquitted on the misbranding charge, but convicted on wire fraud. The government’s request for an extreme prison term and fines was rebuffed by the trial court, which imposed a term of six months of house arrest, and a small fine.¹ The conviction, however, effectively keeps Dr Harkonen from working again in the pharmaceutical industry.

In post-verdict challenges to the conviction, Harkonen’s lawyers were able to marshal support from several well-renown statisticians and epidemiologists, but the trial court was reluctant to consider these post-verdict opinions when the defense called no expert witness at trial. The trial situation, however, was complicated and confused by the government’s pre-trial position that it would not call expert witnesses on the statistical and clinical trial interpretative issues. Contrary to these representations, the government called Dr Thomas Fleming, as statistician, who testified at some length, and without objection, to strict criteria for assessing statistical significance and causation in clinical trials.

Having read Fleming’s testimony, I can say that the government got away with introducing a great deal of expert witness opinion testimony, without effective contradiction or impeachment. With the benefit of hindsight, the defense decision not to call an expert witness looks like a serious deviation from the standard of care. Fleming’s “facts” about how the FDA would evaluate the success or failure of the clinical trial were not relevant to whether Harkonen’s claim of a demonstrated benefit were true or false. More importantly, Harkonen’s claim involved an inference, which is not a fact, but an opinion. Fleming’s contrary opinion really did not turn Harkonen’s claim into a falsehood. A contrary rule would have many expert witnesses in civil and in criminal litigation behind bars on similar charges of wire or mail fraud.

After Harkonen exhausted his direct appeals,² he petitioned for a writ of coram nobis. The trial court denied the petition,³ and in a non-precedential opinion [sic], the Ninth Circuit affirmed the denial of coram nobis.⁴ United States v. Harkonen, slip op., No. 15-16844 (9th Cir., Dec. 4, 2017) [cited below as Harkonen].

The Circuit rejected Harkonen’s contention that the Supreme Court had announced a new rule with respect to statistical significance, in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27 (2011), which change in law required that his conviction be vacated. Harkonen’s lawyer, like much of the plaintiffs’ tort bar, oversold the Supreme Court’s comments about statistical significance, which were at best dicta, and not very well considered or supported dicta, at that. Still, there was an obvious tension, and duplicity, between positions that the government, through the Solicitor General’s office, had taken in Siracusano, and positions the government took in the Harkonen case.⁵ Given the government’s opportunistic double-faced arguments about statistical significance, the Ninth Circuit held that Harkonen’s proffered evidence was “compelling, especially in light of Matrixx,” but the panel concluded that his conviction was not the result of a “manifest injustice” that requires the issuance of the writ of coram nobis. Harkonen at 2 (emphasis added). Apparently, Harkonen had suffered an injustice of a less obvious and blatant variety, which did not rise to the level of manifest injustice.

The Ninth Circuit gave similarly short shrift to Harkonen’s challenge to the competency of his counsel. His trial lawyers had averred that they thought that they were doing well enough not to risk putting on an expert witness, especially given that the defense’s view of the evidence came out in the testimony of the government’s witnesses. The Circuit thus acquiesced in the view that both sides had chosen to forgo expert witness testimony, and overlooked the defense’s competency issue for not having objected to Fleming’s opinion trial testimony. Harkonen at 2-4. Remarkably, the appellate court did not look at how Fleming was allowed to testify on statistical issues, without being challenged on cross-examination.

1 See “The (Clinical) Trial by Franz Kafka”; “Further Musings on U.S. v. Harkonen”;

“Harkonen’s Appeal Updated.” See also Patti Zettler, “U.S. v. Harkonen: Should Scientists Worry About Being Prosecuted for How They Interpret Their Research Results?” Stanford Center for Law & the Biosciences (Oct. 7, 2013); William M. Briggs, “Use The Wrong P-value, Go To Jail: Not A Joke: Updated With Amicus Brief,” Statistician to the Stars (Oct. 1, 2013).

2 United States v. Harkonen, 510 F. App’x 633, 638 (9th Cir. 2013), cert. denied, 134 S. Ct. 824 (2013).

3 “District Court Denies Writ of Coram Nobis to Dr Harkonen.”

4 Dave Simpson, “9th Circuit Refuses To Rethink Ex-InterMune CEO’s Conviction,” Law360 (Dec. 5, 2017).

5 “Multiplicity versus Duplicity – The Harkonen Conviction”; “The Matrixx Motion in U.S. v. Harkonen.”

Posted in Causation, Scientific Evidence, statistical evidence | Comments Off on Ninth Circuit Quashes Harkonen’s Last Chance

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).

3 See “Lumpenepidemiology” (Dec. 14, 2012); “Open Admissions for Expert Witnesses in Chantix Litigation” (Sept. 1, 2012); “As They WOE, So No Recovery Have the Reeps” (May 22, 2013).

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).

5 See IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 102 (2013).

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

Failed Gatekeeping in Ambrosini v. Labarraque (1996)

December 28th, 2017

The Ambrosini case straddled the Supreme Court’s 1993 Daubert decision. The case began before the Supreme Court clarified the federal standard for expert witness gatekeeping, and ended in the Court of Appeals for the District of Columbia, after the high court adopted the curious notion that scientific claims should be based upon reliable evidence and valid inferences. That notion has only slowly and inconsistently trickled down to the lower courts.

Given that Ambrosini was litigated in the District of Columbia, where the docket is dominated by regulatory controversies, frequently involving dubious scientific claims, no one should be surprised that the D.C. Court of Appeals did not see that the Supreme Court had read “an exacting standard” into Federal Rule of Evidence 702. And so, we see, in Ambrosini, this Court of Appeals citing and purportedly applying its own pre-Daubert decision in Ferebee v. Chevron Chem. Co., 552 F. Supp. 1297 (D.D.C. 1982), aff’d, 736 F.2d 1529 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984).¹ In 2000, the Federal Rule of Evidence 702 was revised in a way that extinguishes the precedential value of Ambrosini and the broad dicta of Ferebee, but some courts and commentators have failed to stay abreast of the law.

Escolastica Ambrosini was using a synthetic progestin birth control, Depo-Provera, as well as an anti-nausea medication, Bendectin, when she became pregnant. The child that resulted from this pregnancy, Teresa Ambrosini, was born with malformations of her face, eyes, and ears, cleft lip and palate, and vetebral malformations. About three percent of all live births in the United States have a major malformation. Perhaps because the Divine Being has sovereign immunity, Escolastica sued the manufacturers of Bendectin and Depo-Provera, as well as the prescribing physician.

The causal claims were controversial when made, and they still are. The progestin at issue, medroxyprogesterone acetate (MPA), was embryotoxic in the cynomolgus monkey², but not in the baboon³. The evidence in humans was equivocal at best, and involved mostly genital malformations⁴; the epidemiologic evidence for the MPA causal claim to this day remains unconvincing⁵.

At the close of discovery in Ambrosini, Upjohn (the manufacturer of the progestin) moved for summary judgment, with a supporting affidavit of a physician and geneticist, Dr. Joe Leigh Simpson. In his affidavit, Simpson discussed three epidemiologic studies, as well as other published papers, in support of his opinion that the progestin at issue did not cause the types of birth defects manifested by Teresa Ambrosini.

Ambrosini had disclosed two expert witnesses, Dr. Allen S. Goldman and Dr. Brian Strom. Neither Goldman nor Strom bothered to identify the papers, studies, data, or methodology used in arriving at an opinion on causation. Not surprisingly, the district judge was unimpressed with their opposition, and granted summary judgment for the defendant. Ambrosini v. Labarraque, 966 F.2d 1462, 1466 (D.C. Cir. 1992).

The plaintiffs appealed on the remarkable ground that Goldman’s and Strom’s crypto-evidence satisfied Federal Rule of Evidence 703. Even more remarkably, the Circuit, in a strikingly unscholarly opinion by Judge Mikva, opined that disclosure of relied-upon studies was not required for expert witnesses under Rules 703 and 705. Judge Mikva seemed to forget that the opinions being challenged were not given in testimony, but in (late-filed) affidavits that had to satisfy the requirement of Federal Rule of Civil Procedure 26. Id. at 1468-69. At trial, an expert witness may express an opinion without identifying its bases, but of course the adverse party may compel disclosure of those bases. In discovery, the proffered expert witness must supply all opinions and evidence relied upon in reach the opinions. In any event, the Circuit remanded the case for a hearing and further proceedings, at which the two challenged expert witnesses, Goldman and Strom, would have to identify the bases of their opinions. Id. at 1471.

Not long after the case landed back in the district court, the Supreme Court decided Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). With an order to produce entered, plaintiffs’ counsel could no longer hide Goldman and Strom’s evidentiary bases, and their scientific inferences came under judicial scrutiny.

Upjohn moved again to exclude Goldman and Strom’s opinions. The district court upheld Upjohn’s challenges, and granted summary judgment in favor of Upjohn for the second time. The Ambrosinis appealed again, but the second case in the D.C. Circuit resulted in a split decision, with the majority holding that the exclusion of Goldman and Strom’s opinions under Rule 702 was erroneous. Ambrosini v. Labarraque, 101 F.3d 129 (D.C. Cir. 1996).

Although issued two decades ago, the majority’s opinion remains noteworthy as an example of judicial resistance to the existence and meaning of the Supreme Court’s Daubert opinion. The majority opinion uncritically cited the notorious Ferebee⁶ and other pre-Daubert decisions. The court embraced the Daubert dictum about gatekeeping being limited to methodologic consideration, and then proceeded to interpret methodology as superficially as necessary to sustain admissibility. If an expert witness claimed to have looked at epidemiologic studies, and epidemiology was an accepted methodology, then the opinion of the expert witness must satisfy the legal requirements of Daubert, or so it would seem from the opinion of the U.S. Court of Appeals for the District of Columbia.

Despite the majority’s hand waving, a careful reader will discern that there must have been substantial gaps and omissions in the explanations and evidence cited by plaintiffs’ expert witnesses. Seeing anything clearly in the Circuit’s opinion is made difficult, however, by careless and imprecise language, such as its descriptions of studies as showing, or not showing “causation,” when it could have meant only that such studies showed associations, with more or less random and systematic error.

Dr. Strom’s report addressed only general causation, and even so, he apparently did not address general causation of the specific malformations manifested by the plaintiffs’ child. Strom claimed to have relied upon the “totality of the data,” but his methodologic approach seems to have required him to dismiss studies that failed to show an association.

“Dr. Strom first set forth the reasoning he employed that led him to disagree with those studies finding no causal relationship [sic] between progestins and birth defects like Teresa’s. He explained that an epidemiologist evaluates studies based on their ‘statistical power’. Statistical power, he continued, represents the ability of a study, based on its sample size, to detect a causal relationship. Conventionally, in order to be considered meaningful, negative studies, that is, those which allege the absence of a causal relationship, must have at least an 80 to 90 percent chance of detecting a causal link if such a link exists; otherwise, the studies cannot be considered conclusive. Based on sample sizes too small to be reliable, the negative studies at issue, Dr. Strom explained, lacked sufficient statistical power to be considered conclusive.”

Id. at 136⁷.

Putting aside the problem of suggesting that an observational study detects a “causal relationship,” as opposed to an association in need of further causal evaluation, the Court’s précis of Strom’s testimony on power is troublesome, and typical of how other courts have misunderstood and misapplied the concept of statistical power. Statistical power is a probability of observing an association of a specified size at a specified level of statistical significance. The calculation of statistical power turns indeed on sample size, the level of significance probability preselected for “statistical significance, an assumed probability distribution of the sample, and, critically, an alternative hypothesis. Without a specified alternative hypothesis, the notion of statistical power is meaningless, regardless of what probability (80% or 90% or some other percentage) is sought for finding the alternative hypothesis. Furthermore, the notion that the defense must adduce studies with “sufficient statistical power to be considered conclusive” creates an unscientific standard that can never be met, while subverting the law’s requirement that the claimant establish causation.

The suggestion that the studies that failed to find an association cannot be considered conclusive because they “lacked sufficient statistical power” is troublesome because it distorts and misapplies the very notion of statistical power. No attempt was made to describe the confidence intervals surrounding the point estimates of the null studies; nor was there any discussion whether the studies could be aggregated to increase their power to rule out meaningful associations.

The Circuit court’s scientific jurisprudence was thus seriously flawed. Without a discussion of the end points observed, the relevant point estimates of risk ratios, and the confidence intervals, the reader cannot assess the strength of the claims made by Goldman and Strom, or by defense expert Simpson, in their reports. Without identifying the study endpoints, the reader cannot evaluate whether the plaintiffs’ expert witnesses relied upon relevant outcomes in formulating their opinions. The court viewed the subject matter from 30,000 feet, passing over at 600 mph, without engagement or care. A strong dissent, however, suggested serious mischaracterizations of the plaintiffs’ evidence by the majority.

The only specific causation testimony to support plaintiff’s claims came from Goldman, in what appears to have been a “differential etiology.” Goldman purported to rule out a genetic cause, even though he had not conducted a critical family history or ordered a state-of-the-art chromosomal study. Id. at 140. Of course, nothing in a differential etiology approach would allow a physician to rule out “unknown” causes, which, for birth defects, make up the most prevalent and likely causes to explain any particular case. The majority acknowledged that these were short comings, but rhetorically characterized them as substantive, not methodologic, and therefore as issues for cross-examination, not for consideration by a judicial gatekeeping. All this is magical thinking, but it continues to infect judicial approaches to specific causation. See, e.g., Green Mountain Chrysler Plymouth Dodge Jeep v. Crombie, 508 F. Supp. 2d 295, 311 (D.Vt. 2007) (citing Ambrosini for the proposition that “the possibility of uneliminated causes goes to weight rather than admissibility, provided that the expert has considered and reasonably ruled out the most obvious”). In Ambrosini, however, Dr. Goldman had not ruled out much of anything.

Circuit Judge Karen LeCraft Henderson dissented in a short, but pointed opinion that carefully marshaled the record evidence. Drs. Goldman and Strom had relied upon a study by Greenberg and Matsunaga, whose data failed to show a statistically significant association between MPA and cleft lip and palate, when the crucial issue of timing of exposure was taken into consideration. Ambrosini, 101 F.3d at 142.

Beyond the specific claims and evidence, Judge Henderson anticipated the subsequent Supreme Court decisions in Joiner, Kumho Tire, and Weisgram, and the year 2000 revision of Rule 702, in noting that the majority’s acceptance of glib claims to have used a “traditional methodology” would render Daubert nugatory. Id. at 143-45 (characterizing Strom and Goldman’s methodologies as “wispish”). Even more importantly, Judge Henderson refused to indulge the assumption that somehow the length of Goldman’s C.V. substituted for evidence that his methods satisfied the legal (or scientific) standard of reliability. Id.

The good news is that little or nothing in Ambrosini survives the 2000 amendment to Rule 702. The bad news is that not all federal judges seem to have noticed, and that some commentators continue to cite the case, as lovely.

Probably no commentator has promiscuously embraced Ambrosini as warmly as Carl Cranor, a philosopher, and occasional expert witness for the lawsuit industry, in several publications and presentations.⁸ Cranor has been particularly enthusiastic about Ambrosini’s approval of expert witness’s testimony that failed to address “the relative risk between exposed and unexposed populations of cleft lip and palate, or any other of the birth defects from which [the child] suffers,” as well as differential etiologies that exclude nothing.⁹ Somehow Cranor, as did the majority in Ambrosini, believes that testimony that fails to identify the magnitude of the point estimate of relative risk can “assist the trier of fact to understand the evidence or to determine a fact in issue.”¹⁰ Of course, without that magnitude given, the trier of fact could not evaluate the strength of the alleged association; nor could the trier assess the probability of individual causation to the plaintiff. Cranor also has written approvingly of lumping unrelated end points, which defeats the assessment of biological plausibility and coherence by the trier of fact. When the defense expert witness in Ambrosini adverted to the point estimates for relevant end points, the majority, with Cranor’s approval, rejected the null findings as “too small to be significant.”¹¹ If the null studies were, in fact, too small to be useful tests of the plaintiffs’ claims, intellectual and scientific honesty required an acknowledgement that the evidentiary display was not one from which a reasonable scientist would draw a causal conclusion.

1Ambrosini v. Labarraque, 101 F.3d 129, 138-39 (D.C. Cir. 1996) (citing and applying Ferebee), cert. dismissed sub nom. Upjohn Co. v. Ambrosini, 117 S.Ct. 1572 (1997) See also David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89Notre Dame L. Rev. 27, 31 (2013).

2 S. Prahalada, E. Carroad, M. Cukierski, and A.G. Hendrickx, “Embryotoxicity of a single dose of medroxyprogesterone acetate (MPA) and maternal serum MPA concentrations in cynomolgus monkey (Macaca fascicularis),” 32 Teratology 421 (1985).

3 S. Prahalada, E. Carroad, and A.G. Hendrick, “Embryotoxicity and maternal serum concentrations of medroxyprogesterone acetate (MPA) in baboons (Papio cynocephalus),” 32 Contraception 497 (1985).

4 See, e.g., Z. Katz, M. Lancet, J. Skornik, J. Chemke, B.M. Mogilner, and M. Klinberg, “Teratogenicity of progestogens given during the first trimester of pregnancy,” 65 Obstet Gynecol. 775 (1985); J.L. Yovich, S.R. Turner, and R. Draper, “Medroxyprogesterone acetate therapy in early pregnancy has no apparent fetal effects,” 38 Teratology 135 (1988).

5 G. Saccone, C. Schoen, J.M. Franasiak, R.T. Scott, and V. Berghella, “Supplementation with progestogens in the first trimester of pregnancy to prevent miscarriage in women with unexplained recurrent miscarriage: a systematic review and meta-analysis of randomized, controlled trials,” 107 Fertil. Steril. 430 (2017).

6 Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1535 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984).

7 Dr. Strom was also quoted as having provided a misleading definition of statistical significance: “whether there is a statistically significant finding at greater than 95 percent chance that it’s not due to random error.” Ambrosini at 101 F.3d at 136. Given the majority’s inadequate description of the record, the description of witness testimony may not be accurate, and error cannot properly be allocated.

8 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 320, 327-28 (2006); see also Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 238 (2d ed. 2016).

9 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 320 (2006).

10 Id.

11 Id. ; see also Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 238 (2d ed. 2016).

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