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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.

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

Tremolitic Tergiversation or Ex-PIRG-Gation?

August 11th, 2018

My first encounter with the Public Interest Research Group (PIRG) was as an undergraduate when my college mandated that part of the student activity fee went to New Jersey PIRG. The college administration gave students no choice in the matter.

Upon investigating PIRG’s activities and rhetoric, I found the organization filled with self-aggrandizement, and puffed out with a self-satisfied arrogance. Epistemically, politically, and historically, an organization that declared all its goals to be “in the public interest” was jarring and objectionable, but it was probably just my own idiosyncratic sensitivity.

Many of my fellow students and I protested the forced support for PIRG, and ultimately the college yielded to the tide of opinion. Students were give a choice to opt out of paying the portion of their fees that went to PIRG.

Almost 50 years later, I still have a healthy skepticism of most self-proclaimed “public interest” groups, including PIRG. And so, my antennae went up upon seeing a New York Times article about a PIRG back-to-school shopping guide, with warnings about hazardous materials in crayons and magic markers. See Niraj Chokshi, “Asbestos in a Crayon, Benzene in a Marker: A School Supply Study’s Toxic Results,” N.Y. Times (Aug. 8, 2018). The hazard lurking in crayons, according to PIRG, was none other than the emperor of all toxic substances: asbestos. The Times dutifully reported that PIRG had found only “trace” tremolite, but the newspaper made no attempt to quantify the amount found; nor did the paper describe the meaninfulness of inhalational exposure from trace amount of tremolite embedded in wax. Instead, the Times reported a worrisome quote: “Tremolite is responsible for many cases of asbestos-related cancer and asbestos diseases, according to the Abramson Cancer Center at the University of Pennsylvania.”

* * * * * * * * * * *

“A thing is a phallic symbol if it is longer than it is wide.” 

Melanie, Safka (1972)

“A thing is a fiber if it is three times longer than it is wide.” 

O.S.H.A., 29 C.F.R. § 1910.1001(b) (defining fiber as having a length-to- diameter ratio of at least 3 to 1).

Ergo, all fibers are phallic symbols.

* * * * * * * * * * *

The New York Times article did link to PIRG’s report, which at least allowed readers to inspect the inculpatory evidence. U.S. PIRG, Safer School Supplies: Shopping Guide: Consumer Guide for Finding Non-Toxic School Supplies (2018). Unfortunately, the PIRG report did not answer crucial questions. There was no quantification of the tremolite asbestos, and there was no discussion of the ability of the tremolite to escape the wax matrix of the crayon, to become airborne, and to be inhaled. The report did cite the methodology used to ascertain the presence of the tremolite (EPA Method: EPA/600/R-93/116). Safer Schools at 5. In Appendix A to the report, the authors showed two microphotographs of tremolite particles, but without any measurement scale. One of the two tremolite particles looks like a cleavage fragment, not a fiber. The other photomicrograph shows something that might be a fiber, but without a scale and a report of the elemental peaks, the reader cannot tell for sure. Safer Schools at 21.

The controversy over the potential health effects of tremolite cleavage fragments has a long history. Compare Robert Reger & W. Keith C. Morgan, “On talc, tremolite, and tergiversation,” 47 Brit. J. Indus. Med. 505 (1990) with Bruce W. Case, “On talc, tremolite, and tergiversation. Ter-gi-ver-sate: 2: to use subterfuges,” 48 Brit. J. Indus. Med. 357 (1991). The regulatory definition of fiber does not distinguish between biologically significant fibers and particles with an aspect ratio greater than three. John Gamble & Graham Gibbs, “An evaluation of the risks of lung cancer and mesothelioma from exposure to amphibole cleavage fragments,” 52 Regulatory Toxicol. & Pharmacol. S154 (2008) (the weight of evidence fully supports a conclusion that non-asbestiform amphiboles do not increase the risk of lung cancer or mesothelioma); Brent L. Finley, Stacey M. Benson & Gary M. Marsh, “Cosmetic talc as a risk factor for pleural mesothelioma: a weight of evidence evaluation of the epidemiology,” 29 Inhalation Toxicol. 179 (2017).

Surely the public interest includes the facts and issues left out by PIRG’s report.

 

 

Posted in Asbestos, Scientific Evidence | Comments Off on Tremolitic Tergiversation or Ex-PIRG-Gation?

N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses

August 8th, 2018

The United States Supreme Court’s decision in Daubert is now over 25 years old. The idea of judicial gatekeeping of expert witness opinion testimony is even older in New Jersey state courts. The New Jersey Supreme Court articulated a reliability standard before the Daubert case was even argued in Washington, D.C. See Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991). Articulating a standard, however, is something very different from following a standard, and in many New Jersey trial courts, until very recently, the standard was pretty much anything goes.

One counter-example to the general rule of dog-eat-dog in New Jersey was Judge Nelson Johnson’s careful review and analysis of the proffered causation opinions in cases in which plaintiffs claimed that their use of the anti-acne medication isotretinoin (Accutane) caused Crohn’s disease. Judge Johnson, who sits in the Law Division of the New Jersey Superior Court for Atlantic County held a lengthy hearing, and reviewed the expert witnesses’ reliance materials.1 Judge Johnson found that the plaintiffs’ expert witnesses had employed undue selectivity in choosing what to rely upon. Perhaps even more concerning, Judge Johnson found that these witnesses had refused to rely upon reasonably well-conducted epidemiologic studies, while embracing unpublished, incomplete, and poorly conducted studies and anecdotal evidence. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div., Atlantic Cty. Feb. 20, 2015). In response, Judge Johnson politely but firmly closed the gate to conclusion-driven duplicitous expert witness causation opinions in over 2,000 personal injury cases. “Johnson of Accutane – Keeping the Gate in the Garden State” (Mar. 28, 2015).

Aside from resolving over 2,000 pending cases, Judge Johnson’s judgment was of intense interest to all who are involved in pharmaceutical and other products liability litigation. Judge Johnson had conducted a pretrial hearing, sometimes called a Kemp hearing in New Jersey, after the New Jersey Supreme Court’s opinion in Kemp v. The State of New Jersey, 174 N.J. 412 (2002). At the hearing and in his opinion that excluded plaintiffs’ expert witnesses’ causation opinions, Judge Johnson demonstrated a remarkable aptitude for analyzing data and inferences in the gatekeeping process.

When the courtroom din quieted, the trial court ruled that the proffered testimony of Dr., Arthur Kornbluth and Dr. David Madigan did not meet the liberal New Jersey test for admissibility. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div. Atlantic Cty. Feb. 20, 2015). And in closing the gate, Judge Johnson protected the judicial process from several bogus and misleading “lines of evidence,” which have become standard ploys to mislead juries in courthouses where the gatekeepers are asleep. Recognizing that not all evidence is on the same analytical plane, Judge Johnson gave case reports short shrift.

“[u]nsystematic clinical observations or case reports and adverse event reports are at the bottom of the evidence hierarchy.”

Id. at *16. Adverse event reports, largely driven by the very litigation in his courtroom, received little credit and were labeled as “not evidentiary in a court of law.” Id. at 14 (quoting FDA’s description of FAERS).

Judge Johnson recognized that there was a wide range of identified “risk factors” for irritable bowel syndrome, such as prior appendectomy, breast-feeding as an infant, stress, Vitamin D deficiency, tobacco or alcohol use, refined sugars, dietary animal fat, fast food. In re Accutane, 2015 WL 753674, at *9. The court also noted that there were four medications generally acknowledged to be potential risk factors for inflammatory bowel disease: aspirin, nonsteroidal anti-inflammatory medications (NSAIDs), oral contraceptives, and antibiotics. Understandably, Judge Johnson was concerned that the plaintiffs’ expert witnesses preferred studies unadjusted for potential confounding co-variables and studies that had involved “cherry picking the subjects.” Id. at *18.

Judge Johnson had found that both sides in the isotretinoin cases conceded the relative unimportance of animal studies, but the plaintiffs’ expert witnesses nonetheless invoked the animal studies in the face of the artificial absence of epidemiologic studies that had been created by their cherry-picking strategies. Id.

Plaintiffs’ expert witnesses had reprised a common claimants’ strategy; namely, they claimed that all the epidemiology studies lacked statistical power. Their arguments often ignored that statistical power calculations depend upon statistical significance, a concept to which many plaintiffs’ counsel have virulent antibodies, as well as an arbitrarily selected alternative hypothesis of association size. Furthermore, the plaintiffs’ arguments ignored the actual point estimates, most of which were favorable to the defense, and the observed confidence intervals, most of which were reasonably narrow.

The defense responded to the bogus statistical arguments by presenting an extremely capable clinical and statistical expert witness, Dr. Stephen Goodman, to present a meta-analysis of the available epidemiologic evidence.

Meta-analysis has become an important facet of pharmaceutical and other products liability litigation[1]. Fortunately for Judge Johnson, he had before him an extremely capable expert witness, Dr. Stephen Goodman, to explain meta-analysis generally, and two meta-analyses he had performed on isotretinoin and irritable bowel outcomes.

Dr. Goodman explained that the plaintiffs’ witnesses’ failure to perform a meta-analysis was telling when meta-analysis can obviate the plaintiffs’ hyperbolic statistical complaints:

“the strength of the meta-analysis is that no one feature, no one study, is determinant. You don’t throw out evidence except when you absolutely have to.”

In re Accutane, 2015 WL 753674, at *8.

Judge Johnson’s judicial handiwork received non-deferential appellate review from a three-judge panel of the Appellate Division, which reversed the exclusion of Kornbluth and Madigan. In re Accutane Litig., 451 N.J. Super. 153, 165 A.3d 832 (App. Div. 2017). The New Jersey Supreme Court granted the isotretinoin defendants’ petition for appellate review, and the issues were joined over the appropriate standard of appellate review for expert witness opinion exclusions, and the appropriateness of Judge Johnson’s exclusions of Kornbluth and Madigan. A bevy of amici curiae joined in the fray.2

Last week, the New Jersey Supreme Court issued a unanimous opinion, which reversed the Appellate Division’s holding that Judge Johnson had “mistakenly exercised” discretion. Applying its own precedents from Rubanick, Landrigan, and Kemp, and the established abuse-of-discretion standard, the Court concluded that the trial court’s ruling to exclude Kornbluth and Madigan was “unassailable.” In re Accutane Litig., ___ N.J. ___, 2018 WL 3636867 (2018), Slip op. at 79.3

The high court graciously acknowledged that defendants and amici had “good reason” to seek clarification of New Jersey law. Slip op. at 67. In abandoning abuse-of-discretion as its standard of review, the Appellate Division had relied upon a criminal case that involved the application of the Frye standard, which is applied as a matter of law. Id. at 70-71. The high court also appeared to welcome the opportunity to grant review and reverse the intermediate court reinforce “the rigor expected of the trial court” in its gatekeeping role. Id. at 67. The Supreme Court, however, did not articulate a new standard; rather it demonstrated at length that Judge Johnson had appropriately applied the legal standards that had been previously announced in New Jersey Supreme Court cases.4

In attempting to defend the Appellate Division’s decision, plaintiffs sought to characterize New Jersey law as somehow different from, and more “liberal” than, the United States Supreme Court’s decision in Daubert. The New Jersey Supreme Court acknowledged that it had never formally adopted the dicta from Daubert about factors that could be considered in gatekeeping, slip op. at 10, but the Court went on to note what disinterested observers had long understood, that the so-called Daubert factors simply flowed from a requirement of sound methodology, and that there was “little distinction” and “not much light” between the Landrigan and Rubanick principles and the Daubert case or its progeny. Id at 10, 80.

Curiously, the New Jersey Supreme Court announced that the Daubert factors should be incorporated into the New Jersey Rules 702 and 703 and their case law, but it stopped short of declaring New Jersey a “Daubert” jurisdiction. Slip op. at 82. In part, the Court’s hesitance followed from New Jersey’s bifurcation of expert witness standards for civil and criminal cases, with the Frye standard still controlling in the criminal docket. At another level, it makes no sense to describe any jurisdiction as a “Daubert” state because the relevant aspects of the Daubert decision were dicta, and the Daubert decision and its progeny were superseded by the revision of the controlling statute in 2000.5

There were other remarkable aspects of the Supreme Court’s Accutane decision. For instance, the Court put its weight behind the common-sense and accurate interpretation of Sir Austin Bradford Hill’s famous articulation of factors for causal judgment, which requires that sampling error, bias, and confounding be eliminated before assessing whether the observed association is strong, consistent, plausible, and the like. Slip op. at 20 (citing the Reference Manual at 597-99), 78.

The Supreme Court relied extensively on the National Academies’ Reference Manual on Scientific Evidence.6 That reliance is certainly preferable to judicial speculations and fabulations of scientific method. The reliance is also positive, considering that the Court did not look only at the problematic epidemiology chapter, but adverted also to the chapters on statistical evidence and on clinical medicine.

The Supreme Court recognized that the Appellate Division had essentially sanctioned an anything goes abandonment of gatekeeping, an approach that has been all-too-common in some of New Jersey’s lower courts. Contrary to the previously prevailing New Jersey zeitgeist, the Court instructed that gatekeeping must be “rigorous” to “prevent[] the jury’s exposure to unsound science through the compelling voice of an expert.” Slip op. at 68-9.

Not all evidence is equal. “[C]ase reports are at the bottom of the evidence hierarchy.” Slip op. at 73. Extrapolation from non-human animal studies is fraught with external validity problems, and such studies “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (internal quotations omitted).

Perhaps most chilling for the lawsuit industry will be the Supreme Court’s strident denunciation of expert witnesses’ selectivity in choosing lesser evidence in the face of a large body of epidemiologic evidence, id. at 77, and their unprincipled cherry picking among the extant epidemiologic publications. Like the trial court, the Supreme Court found that the plaintiffs’ expert witnesses’ inconsistent use of methodological criteria and their selective reliance upon studies (disregarding eight of the nine epidemiologic studies) that favored their task masters was the antithesis of sound methodology. Id. at 73, citing with approval, In re Lipitor, ___ F.3d ___ (4th Cir. 2018) (slip op. at 16) (“Result-driven analysis, or cherry-picking, undermines principles of the scientific method and is a quintessential example of applying methodologies (valid or otherwise) in an unreliable fashion.”).

An essential feature of the Supreme Court’s decision is that it was not willing to engage in the common reductionism that has “all epidemiologic studies are flawed,” and which thus privileges cherry picking. Not all disagreements between expert witnesses can be framed as differences in interpretation. In re Accutane will likely stand as a bulwark against flawed expert witness opinion testimony in the Garden State for a long time.

1 Judge Nelson Johnson is also the author of Boardwalk Empire: The Birth, High Times, and Corruption of Atlantic City (2010), a spell-binding historical novel about political and personal corruption.

2 In support of the defendants’ positions, amicus briefs were filed by the New Jersey Business & Industry Association, Commerce and Industry Association of New Jersey, and New Jersey Chamber of Commerce; by law professors Kenneth S. Broun, Daniel J. Capra, Joanne A. Epps, David L. Faigman, Laird Kirkpatrick, Michael M. Martin, Liesa Richter, and Stephen A. Saltzburg; by medical associations the American Medical Association, Medical Society of New Jersey, American Academy of Dermatology, Society for Investigative Dermatology, American Acne and Rosacea Society, and Dermatological Society of New Jersey, by the Defense Research Institute; by the Pharmaceutical Research and Manufacturers of America; and by New Jersey Civil Justice Institute. In support of the plaintiffs’ position and the intermediate appellate court’s determination, amicus briefs were filed by political action committee the New Jersey Association for Justice; by the Ironbound Community Corporation; and by plaintiffs’ lawyer Allan Kanner.

3 Nothing in the intervening scientific record called question upon Judge Johnson’s trial court judgment. See, e.g., I.A. Vallerand, R.T. Lewinson, M.S. Farris, C.D. Sibley, M.L. Ramien, A.G.M. Bulloch, and S.B. Patten, “Efficacy and adverse events of oral isotretinoin for acne: a systematic review,” 178 Brit. J. Dermatol. 76 (2018).

4 Slip op. at 9, 14-15, citing Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991) (“We initially took that step to allow the parties in toxic tort civil matters to present novel scientific evidence of causation if, after the trial court engages in rigorous gatekeeping when reviewing for reliability, the proponent persuades the court of the soundness of the expert’s reasoning.”).

5 The Court did acknowledge that Federal Rule of Evidence 702 had been amended in 2000, to reflect the Supreme Court’s decision in Daubert, Joiner, and Kumho Tire, but the Court did not deal with the inconsistencies between the present rule and the 1993 Daubert case. Slip op. at 64, citing Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 320-21, 320 n.8 (3d Cir. 2003).

6 See Accutane slip op. at 12-18, 24, 73-74, 77-78. With respect to meta-analysis, the Reference Manual’s epidemiology chapter is still stuck in the 1980s and the prevalent resistance to poorly conducted, often meaningless meta-analyses. See “The Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence” (Nov. 14, 2011) (The Reference Manual fails to come to grips with the prevalence and importance of meta-analysis in litigation, and fails to provide meaningful guidance to trial judges).

Posted in Evidence, Expert Witnesses, Frye, Meta-analysis, Reference Manual on Scientific Evidence, Rule 702, Scientific Evidence, statistical evidence, Statistical Power | Comments Off on N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses

Two Stanford Researchers Are Anti-Semantic

August 4th, 2018

Two Stanford University communications researchers have shown that fraudulent publications and authors’ linguistic obfuscation are correlated, p < 0.05. David M. Markowitz & Jeffrey T. Hancock, “Linguistic Obfuscation in Fraudulent Science,” 35 J. Language & Social Psych. 435 (2016); Bjorn Carey, “Stanford researchers uncover patterns in how scientists lie about their data,” Stanford Report (Nov. 16, 2015) [Carey, below]

Stanford Professor of Communication, Jeff Hancock, and graduate student David Markowitz observed that there are repeating patterns of expression in the language used by scientific fraudfeasors. They hypothesized that scientific fraudfeasors would signal their duplicity in their linguistic expressions as well. These authors created a linguistic obfuscation index based upon the prevalence of jargon, abstraction, positive emotion terms, and readability. They then compared the obfuscation index scores of 253 papers retracted for fraudulent data with 253 unretracted papers, and 63 papers retracted for reasons other than fraud. Not surprisingly, Hancock and Markowitz found differences, with fraudulent papers having higher obfuscation scores, and generally more jargon.

As Markowitz explained:

“We believe the underlying idea behind obfuscation is to muddle the truth. *** Scientists faking data know that they are committing a misconduct and do not want to get caught. Therefore, one strategy to evade this may be to obscure parts of the paper. We suggest that language can be one of many variables to differentiate between fraudulent and genuine science.”

Carey. Professor Hancock acknowledged that there remained a high error rate in their obfuscation analysis, which needed to be lowered before automatic linguistic analyses could be useful for detecting fraud. Hancock also acknowledged that such the use of such a computerized linguistic tool might undermine the trust upon which science is based. Id.

Well detecting fraud might undermine trust, but look where trust has gotten us in science.

Trust but verify.

I cannot wait until I proffer the first expert witness rebuttal report in litigation, to show that my adversary’s expert witness has crossed the obfuscation line.

Posted in Scientific Misconduct | Comments Off on Two Stanford Researchers Are Anti-Semantic

From Here to CERT-ainty

June 28th, 2018

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

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

Id.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Coffee with Cream, Sugar & a Dash of Acrylamide

June 9th, 2018

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

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

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

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

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

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

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

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

Council for Education and Research on Toxics (CERT)

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

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

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

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

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

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

Funding of Research

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

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

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

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

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

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

1 Harry Frankfurt, On Bullshit 63 (2005).

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

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

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

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

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

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

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

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

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

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

Infante-lizing the IARC

May 13th, 2018

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

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

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

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

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

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

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

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

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

P-Values: Pernicious or Perspicacious?

May 12th, 2018

Professor Kingsley R. Browne, of the Wayne State University Law School, recently published a paper that criticized the use of p-values and significance testing in discrimination litigation. Kingsley R. Browne, “Pernicious P-Values: Statistical Proof of Not Very Much,” 42 Univ. Dayton L. Rev. 113 (2017) (cited below as Browne). Browne amply documents the obvious and undeniable, that judges, lawyers, and even some ill-trained expert witnesses, are congenitally unable to describe and interpret p-values properly. Most of Browne’s examples are from the world of anti-discrimination law, but he also cites a few from health effects litigation as well. Browne also cites from many of the criticisms of p-values in the psychology and other social science literature.

Browne’s efforts to correct judicial innumeracy are welcomed, but they take a peculiar turn in this law review article. From the well-known state of affairs of widespread judicial refusal or inability to discuss statistical concepts accurately, Browne argues for what seem to be two incongruous, inconsistent responses. Rejecting the glib suggestion of former Judge Posner that evidence law is not “fussy” about evidence, Browne argues that federal evidence law requires courts to be “fussy” about evidence, and that Rule 702 requires courts to exclude expert witnesses, whose opinions fail to “employ[] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Browne at 143 (quoting from Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). Browne tells us, with apparently appropriate intellectual rigor, that “[i]f a disparity that does not provide a p-value of less than 0.05 would not be accepted as meaningful in the expert’s discipline, it is not clear that the expert should be allowed to testify – on the basis of his expertise in that discipline – that the disparity is, in fact, meaningful.” Id.

In a volte face, Browne then argues that p-values do “not tell us much,” basically because they are dependent upon sample size. Browne suggests that the quantitative disparity between expected value and observed proportion or average can be assessed without the use of p-values, and that measuring a p-value “adds virtually nothing and just muddies the water.” Id. at 152. The prevalent confusion among judges and lawyers seems sufficient in Browne’s view to justify his proposal, as well as his further suggestion that Rule 403 should be invoked to exclude p-values:

“The ease with which reported p-values cause a trier of fact to slip into the transposition fallacy and the difficulty of avoiding that lapse of logic, coupled with the relatively sparse information actually provided by the p-value, make p-values prime candidates for exclusion under Federal Rule of Evidence 403. *** If judges, not to mention the statistical experts they rely on, cannot use the information without falling into fallacious reasoning, the likelihood that the jury will misunderstand the evidence is very high. Since the p-value actually provides little useful relevant information, the high risk of misleading the jury greatly exceeds its scant probative value, so it simply should not be presented to the jury.”

Id. at 152-53.

And yet, elsewhere in the same article, Browne ridicules one court and several expert witnesses who have argued in favor of conclusions that were based upon p-values up to 50%.1 The concept of p-values cannot be so flexible as to straddle the extremes of having no probative value, and yet capable of rendering an expert witness’s opinions ludicrous. P-values quantify an estimate of random error, even if that error rate varies with sample size. To be sure, the measure of random error depends upon the specified model and assumption of a null hypothesis, but the crucial point is that the estimate (whether mean, proportion, risk ratio, risk difference, etc.) is rather meaningless without some further estimate of random variability of the estimate. Of course, random error is not the only type of error, but the existence of other potential systematic errors is hardly a reason to ignore random error.

In the science of health effects, many applications of p-values have given way to the use of confidence intervals, which arguably provide more direct assessments of both sample estimates, along with ranges of potential outcomes that are reasonably compatible with the sample estimates. Remarkably, Browne never substantively discusses confidence intervals in his article.

Under the heading of other problems with p-values and significance testing, Browne advances four additional putative problems with p-values. First, Browne asserts with little to no support that “[t]he null hypothesis is unlikely a priori.” Id. at 155. He fails to tell us why the null hypothesis of no disparity is not a reasonable starting place in the absence of objective evidence of a prior estimate. Furthermore, a null hypothesis of no difference will have legal significance in claims of health effects, or of unlawful discrimination.

Second, Browne argues that significance testing will lead to “[c]onflation of statistical and practical (or legal) significance” in the minds of judges and jurors. Id. at 156-58. This charge is difficult to sustain. The actors in legal cases can probably best appreciate practical significance and its separation from statistical significance, most readily. If a large class action showed that the expected value of a minority’s proportion was 15%, and the observed proportion was 14.8%, p < 0.05, most innumerate judges and jurors would sense that this disparity was unimportant and that no employer would fine tune its discriminatory activities so closely as to achieve such a meaningless difference.

Third, Browne reminds us that the validity and the interpretation of a p-value turns on the assumption that the statistical model is perfectly specified. Id. at 158-59. His reminder is correct, but again, this aspect of p-values (or confidence intervals) is relatively easy to explain, as well as to defend or challenge. To be sure, there may be legitimate disputes about whether an appropriate model was used (say binomial versus hypergeometric), but such disputes are hardly the most arcane issues that judges and jurors will face.

Fourth, Browne claims that “the alternative hypothesis is seldom properly specified.” Id. at 159-62. Unless analysts are focused on measuring pre-test power or type II error, however, they need not advance an alternative hypothesis. Furthermore, it is hardly a flaw with significance testing that it does not account for systematic bias or confounding.

Browne does not offer an affirmative response such as urging courts to adopt a Bayesian program. A Bayesian response to prevalent blunders in interpreting statistical significance would introduce perhaps even more arcane and hard-to-discern blunders in court proceedings. Browne also leaves courts without a meaningful approach to evaluate random error other than to engage in crude comparisons between two means or proportions. The recommendations in this law review article appear to be a giant step, backwards, into an epistemic void.

1See Browne at 146, citing In re Photochromic Lens Antitrust Litig., 2014 WL 1338605 (M.D. Fla. April 3, 2014) (reversing magistrate judge’s exclusion of an expert witness who had advanced claims based upon p-value of 0.50); id. at 147 n. 116, citing In re High-Tech Employee Antitrust Litig., 2014 WL 1351040 (N.D. Cal. 2014).

Posted in Evidence, Rule 702, statistical evidence | Comments Off on P-Values: Pernicious or Perspicacious?

Stranger to the Contract and to the World

March 10th, 2018

It Was a Dark and Stormy Night

All around the country, first year law students are staring at the prospect of their final examination in contracts, one of the required courses in the law school curriculum in the United States. So here is a practice question.

A lawyer for David Dennison drafts a memorandum of agreement between Mr Dennison and Stephanie Clifford. The memorandum calls for Ms Clifford to remain silent about a sexual liaison between Mr Dennison and her, in return for payment of $130,000, in “hush money.”

Mr Dennison never signed the putative contract, and he never provided the consideration for Ms Clifford’s silence. The lawyer for Mr Dennison, however, wired Ms Clifford the money, although he apparently was never given the money by his client, or reimbursed for the payment, later1.

Mr Dennison’s lawyer also represents the President of the United States (POTUS). POTUS may well be Mr Dennison, but he has never acknowledged that Dennison was a name he used. Mr Dennison’s lawyer has publicly acknowledged that he provided the money to Ms. Clifford, and that his client Mr Dennison or whoever Mr Dennison is, did not reimburse him2.

The putative contract calls for arbitration and penalties. A company, EC, LLC, obtained a temporary restraining order (TRO) from the designated alternative dispute resolution company. EC, LLC v Peterson, ADR Services TRO (Feb. 27, 2018)3. A week later, Stephanie Clifford sued POTUS (a.k.a. David Dennison) for declaratory relief, in California Superior Court, Los Angeles County, after the TRO was entered. Clifford v. Trump, Calif. Super. Ct., Los Angeles Cty. Complaint (Mar. 06, 2018)4.

Prepare a bench memorandum for the trial court judge who has been assigned the declaratory judgment action. Make sure you address all issues of contract formation and enforcement, affirmative defenses such as the statute of frauds5, as well as professional ethics of the lawyers involved. Address the ethical propriety of POTUS’s lawyer’s paying consideration for a hush contract out of his own pocket and then claiming the benefit of the bargain for his client, as well as the legal consequences of his public disclosure on the enforceability of the putative contract. If you come up with a negotiation strategy for the wife of POTUS to vitiate her pre-nuptial agreements with POTUS, you will receive extra credit.

Watch the upcoming issues of the New York Times for the answer to this practice question.

1 Amy Davidson Sorkin, “Does Stormy Daniels Have a Case Against Donald Trump?” New Yorker (Mar. 7, 2018).

2 Debra Cassens Weiss, “Stormy Daniels sues Trump, says confidentiality deal is void because he didn’t sign it,” Am. Bar. Ass’n J. (Mar. 7, 2018).

3 Jim Rutenberg & Peter Baker, “Trump Lawyer Obtained Restraining Order to Silence Stormy Daniels,” N.Y. Times (Mar. 7, 2018).

4 Rebecca R. Ruiz & Matt Stevens, “Stormy Daniels Sues, Saying Trump Never Signed ‘Hush Agreement’,” N.Y. Times (Mar. 6, 2018).

Posted in Uncategorized | Comments Off on Stranger to the Contract and to the World

Statistical Deontology

March 2nd, 2018

In courtrooms across America, there has been a lot of buzzing and palavering about the American Statistical Association’s Statement on Statistical Significance Testing,1 but very little discussion of the Society’s Ethical Guidelines, which were updated and promulgated in the same year, 2016. Statisticians and statistics, like lawyers and the law, receive their fair share of calumny over their professional activities, but the statistician’s principal North American professional organization is trying to do something about members’ transgressions.

The American Statistical Society (ASA) has promulgated ethical guidelines for statisticians, as has the Royal Statistical Society,2 even if these organizations lack the means and procedures to enforce their codes. The ASA’s guidelines3 are rich with implications for statistical analyses put forward in all contexts, including in litigation and regulatory rule making. As such, the guidelines are well worth studying by lawyers.

The ASA Guidelines were prepared by the Committee on Professional Ethics, and approved by the ASA’s Board in April 2016. There are lots of “thou shall” and “thou shall nots,” but I will focus on the issues that are more likely to arise in litigation. What is remarkable about the Guidelines is that if followed, they probably are more likely to eliminate unsound statistical practices in the courtroom than the ASA State on P-values.

Defining Good Statistical Practice

“Good statistical practice is fundamentally based on transparent assumptions, reproducible results, and valid interpretations.” Guidelines at 1. The Guidelines thus incorporate something akin to the Kumho Tire standard that an expert witness ‘‘employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.’’ Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).

A statistician engaged in expert witness testimony should provide “only expert testimony, written work, and oral presentations that he/she would be willing to have peer reviewed.” Guidelines at 2. “The ethical statistician uses methodology and data that are relevant and appropriate, without favoritism or prejudice, and in a manner intended to produce valid, interpretable, and reproducible results.” Id. Similarly, the statistician, if ethical, will identify and mitigate biases, and use analyses “appropriate and valid for the specific question to be addressed, so that results extend beyond the sample to a population relevant to the objectives with minimal error under reasonable assumptions.” Id. If the Guidelines were followed, a lot of spurious analyses would drop off the litigation landscape, regardless whether they used p-values or confidence intervals, or a Bayesian approach.

Integrity of Data and Methods

The ASA’s Guidelines also have a good deal to say about data integrity and statistical methods. In particular, the Guidelines call for candor about limitations in the statistical methods or the integrity of the underlying data:

“The ethical statistician is candid about any known or suspected limitations, defects, or biases in the data that may impact the integrity or reliability of the statistical analysis. Objective and valid interpretation of the results requires that the underlying analysis recognizes and acknowledges the degree of reliability and integrity of the data.”

Guidelines at 3.

The statistical analyst openly acknowledges the limits of statistical inference, the potential sources of error, as well as the statistical and substantive assumptions made in the execution and interpretation of any analysis,” including data editing and imputation. Id. The Guidelines urge analysts to address potential confounding not assessed by the study design. Id. at 3, 10. How often do we see these acknowledgments in litigation-driven analyses, or in peer-reviewed papers, for that matter?

Affirmative Actions Prescribed

In the aid of promoting data and methodological integrity, the Guidelines also urge analysts to share data when appropriate without revealing the identities of study participants. Statistical analysts should publicly correct any disseminated data and analyses in their own work, as well as working to “expose incompetent or corrupt statistical practice.” Of course, the Lawsuit Industry will call this ethical duty “attacking the messenger,” but maybe that’s a rhetorical strategy based upon an assessment of risks versus benefits to the Lawsuit Industry.

Multiplicity

The ASA Guidelines address the impropriety of substantive statistical errors, such as:

“[r]unning multiple tests on the same data set at the same stage of an analysis increases the chance of obtaining at least one invalid result. Selecting the one “significant” result from a multiplicity of parallel tests poses a grave risk of an incorrect conclusion. Failure to disclose the full extent of tests and their results in such a case would be highly misleading.”

Guidelines at 9.

There are some Lawsuit Industrialists who have taken comfort in the pronouncements of Kenneth Rothman on corrections for multiple comparisons. Rothman’s views on multiple comparisons are, however, much broader and more nuanced than the Industry’s sound bites.4 Given that Rothman opposes anything like strict statistical significance testing, it follows that he is relatively unmoved for the need for adjustments to alpha or the coefficient of confidence. Rothman, however, has never deprecated the need to consider the multiplicity of testing, and the need for researchers to be forthright in disclosing the the scope of comparisons originally planned and actually done.

2 Royal Statistical Society – Code of Conduct (2014); Steven Piantadosi, Clinical Trials: A Methodologic Perspective 609 (2d ed. 2005).

3 Shelley Hurwitz & John S. Gardenier, “Ethical Guidelines for Statistical Practice: The First 60 Years and Beyond,” 66 Am. Statistician 99 (2012) (describing the history and evolution of the Guidelines).

4 Kenneth J. Rothman, “Six Persistent Research Misconceptions,” 29 J. Gen. Intern. Med. 1060, 1063 (2014).

Posted in Data Sharing, Expert Witness Discovery, Scientific Misconduct, statistical evidence, Underlying Data | Comments Off on Statistical Deontology

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