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Transparency, Confusion, and Obscurantism

October 31st, 2014

In NIEHS Transparency? We Can See Right Through You (July 10, 2014), I chastised authors Kevin C. Elliott and David B. Resnik for their confusing and confused arguments about standards of proof, the definition of risk, and conflicts of interest (COIs). See Kevin C. Elliott and David B. Resnik, “Science, Policy, and the Transparency of Values,” 122 Envt’l Health Persp. 647 (2014) [Elliott & Resnik]. In their focus on environmentalism and environmental policy, Elliott and Resnik seem intent upon substituting various presumptions, leaps of faith, and unproven extrapolations for actual evidence and valid inference, in the hope of improving the environment and reducing risk to life. But to get to their goal, Elliott and Resnik engage in various equivocations and ambiguities in their use of “risk,” and they compound the muddle by introducing a sliding scale of “standards of evidence,” for legal, regulatory, and scientific conclusions.

Dr. David H. Schwartz is a scientist, who received his doctoral degree in Neuroscience from Princeton University, and his postdoctoral training in Neuropharmacology and Neurophysiology at the Center for Molecular and Behavioral Neuroscience, in Rutgers University. Dr. Schwartz has since gone to found one of the leading scientific consulting firms, Innovative Science Solutions (ISS), which supports both regulatory and litigation claims and defenses, as may scientifically appropriate. Given his experience, Dr. Schwartz is well positioned to address the standards of scientific evidentiary conclusions across regulatory, litigation, and scientific communities.

In this month’s issue of Environmental Health Perspectives (EHP), Dr. David Schwartz adds to the criticism of Elliott and Resnik’s tendentious editorial. David H. Schwartz, “Policy and the Transparency of Values in Science,” 122 Envt’l Health Persp. A291 (2014). Schwartz points out that “[a]lthough … different venues or contexts require different standards of evidence, it is important to emphasize that the actual scientific evidence remains constant.” Id.

Dr. Schwartz points out transparency is needed in how standards and evidence are represented in scientific and legal discourse, and he takes Elliott and Resnik to task for arguing, from ignorance, that litigation burdens are different from scientific standards. At times some writers misrepresent the nature of their evidence, or its weakness, and when challenged, attempt to excuse the laxness in standards by adverting to the regulatory or litigation contexts in which they are speaking. In some regulatory contexts, the burdens of proof are deliberately reduced, or shifted to the regulated industry. In litigation, the standard or burden of proof is rarely different from the scientific enterprise itself. As the United States Supreme Court made clear, trial courts must inquire whether 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). Expert witnesses who fail to exercise the same intellectual rigor in the courtroom as in the laboratory, are eminently disposable or excludable from the legal process.

Schwartz also points out, as I had in my blog post, that “[w]hen using science to inform policy, transparency is critical. However, this transparency should include not only financial ties to industry but also ties to advocacy organizations and other strongly held points of view.”

In their Reply to Dr. Schwartz, Elliott and Resnik concede the importance of non-financial conflicts of interest, but they dig in on the supposed lower standard for scientific claims:

“we caution against equating the standards of evidence expected in tort law with those expected in more traditional scientific contexts. The tort system requires only a preponderance of evidence (> 50% likelihood) to win a case; this is much weaker evidence than scientists typically demand when presenting or publishing results, and confusion about these differing standards has led to significant legal controversies (Cranor 2006).”

Rather than citing any pertinent or persuasive legal authority, Elliott and Resnik cite an expert witness, Carl Cranor, neither a lawyer nor a scientist, who has worked steadfastly for the litigation industry (the plaintiffs’ bar) on various matters. The “caution” of Elliott and Resnik is directly contradicted by the Supreme Court’s pronouncement in Kumho Tire, and is fueled by a ignoratio elenchi that is based upon a confusion between the probability of repeated sampling with confidence intervals (usually 95%) and the posterior probability of a claim: namely, the probability of the claim given the admissible evidence. As the Reference Manual for Scientific Evidence makes clear, these are very different probabilities, which Cranor and others have consistently confused. Elliott and Resnik ought to know better.

Posted in Conflicts of Interest, Scientific Evidence | Comments Off on Transparency, Confusion, and Obscurantism

The Current Crisis – Ebola Comes to the Land of Litigation

October 29th, 2014

Lying About

President Obama has appointed a political operative, a lawyer, to be the “Ebola czar,” while the Surgeon General and Secretary of Health and Human Resources remain in hiding. Dr. Craig Spencer, who lies in a Bellevue Hospital isolation ward, lied about his travels about New York City when talking to the New York City authorities. He claimed to have been in voluntary quarantine and isolation at his Manhattan home upon returning from West Africa. Jamie Schram & Bruce Golding, “Ebola doctor ‛lied’ about NYC travels” NY Post (Oct. 29, 2014) (“The city’s first Ebola patient initially lied to authorities about his travels around the city following his return from treating disease victims in Africa, law-enforcement sources said.”) We now know he used the subways, ate at public restaurants, and generally cavorted about town.

Foolish Consistencies and Some Inconsistency, Too

President Obama has pressured Governors Christie and Cuomo to back off their stricter quarantine rules, and demonstrated that Cuomo is politically soft in the center. At the same time that the Obama’s administration has bullied critics of its voluntary quarantine protocol, they have imposed mandatory quarantine on military personnel, returning from West Africa. Secretary of War Defense has announced a mandatory quarantine. See Starr, “Hagel announces mandatory Ebola quarantine” CNN (Oct. 29, 2014). Ah, our leaders would follow Ralph Waldo Emerson, on Self-Reliance and self-quarantine: “[a] foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines. With consistency a great soul has simply nothing to do. He may as well concern himself with his shadow on the wall.”

Australia has banned travel with Ebola affected countries, which should now include the United States. Michelle Nichols and Umaru Fofana, “Australia bans travel from Ebola-hit countries; U.S. isolates troops” Reuters (Oct. 28, 2014). Of course, Australia was settled by criminals, as we all know.

Wild Nurse Hickox

Voluntary quarantine is a quaint notion. A healthcare worker takes his or her temperature twice a day, but fevers come on, when they come on. Nurse Kaci Hickox, whose “human rights” were supposedly violated by Order of Governor Christie, has been removed to Maine, whence she has announced her attention to violate Maine’s lax rule that requires voluntary quarantine. Jennifer Levitz, “Nurse in Ebola Quarantine Flap Says She Won’t Obey Maine’s Isolation Rules: Kaci Hickox Says She Will Go to Court if Restrictions Aren’t Removed by Thursday“ Wall Street Journal (Oct. 29, 2014). So much for the human rights of Maine’s good citizens, not to mention the rights of the moose, and other innocent species.

The litigation industry is, I am sure, gearing up to meet the crisis. And Nurse Hickox is now be free to litigate her voluntary quarantine in Maine.

Posted in Public Nuisances | Comments Off on The Current Crisis – Ebola Comes to the Land of Litigation

Gad-zooks – Expert Witness Dishonesty

October 18th, 2014

This is the first in what I hope will be a continuing series, tagged as the Expert Witness Hall of Shame.

*     *     *     *     *

Shayne Cox Gad is a toxicologist and a principal in the firm, Gad Consulting Services, in Cary, North Carolina. In 1977, Gad was awarded his doctorate in pharmacology and toxicology by the University of Texas (Austin). Some years later, Gad apparently awarded himself a Silver Star, and three Purple Hearts.

The Stolen Valor Act[1], effective in December 2006, made false representations of having received military decorations or awards a federal crime. Gad was charged with violating the Stolen Valor Act, and in February 2009, he pleaded guilty to dishonesty and specious claiming prohibited by the Act.

Before and after his conviction by guilty plea, Gad testified as an expert witness in litigation. He was an expert witness for plaintiff in an Oklahoma state court case, Helton v. Allergan, Inc., in which Dr. Sharla Helton complained that Botox caused her neurologic problems and pain that prevented her from working as an obstetrician/gynecologist.

Whatever the merits of the claims about Botox, Allergan might well have resisted settling a case in which plaintiff’s claim rested upon the testimony of an expert witness, convicted for dishonesty. Trial counsel for Allergan, Vaughn Crawford, cross-examined Gad, on April 27, 2010. Vaughn’s examination went immediately to prior conviction. “Allergan unmasks anti-Botox expert” (April 28, 2010; updated Aug. 21, 2013). Vaughn sprung the impeachment:

Q You are the same Shayne Cox Gad who has been adjudged guilty by the Eastern Federal District Court in North Carolina for crimes involving false statements and dishonesty, aren’t you, sir.

A Yes, sir.

Q Yes. Specifically in February of 2009, you were adjudged guilty by that Court of falsely representing that you had been awarded military decorations and medals including the Navy cross, aren’t you, sir.

A Yes, sir.

Helton v. Allergan, Inc., Notes of Testimony by Shayne Cox Gad at 48-49 (April 27, 2010).

Crawford pressed. Not only had Gad confessed to the crime, he had made various acts of contrition in his Pre-sentencing Report, in which Gad asked that he be placed on probation rather than incarcerated. One of the representations Gad made in the Report was that he would no longer testify as an expert witness in litigation. Gad’s plea was accepted and he was placed on probation as he and his lawyer requested.

As dramatic as Crawford’s impeachment of Gad must have been, the jury shrugged it off and awarded Dr. Helton 15 million dollars, which came to 18 million with pre-judgment interest. Helton v. Allergan Inc., No. CJ-2009-2171 (Okla. Dist. Ct., Oklahoma Cty.) (jury voted 10 to 2 to award actual but no punitive damages). The Oklahoma intermediate appellate court affirmed in an unpublished opinion, and the Oklahoma Supreme Court refused to grant discretionary review. Helton v. Allergan Inc., No. 2009-2171 (Okla. Civ. App. Sept. 6, 2013); “Okla. Appeals Court Backs $15M Award In Botox Injury,” Law 360 (Sept. 10, 2013). See PR Newswire, “Botox Victim Wins $18 Million: Oklahoma Supreme Court Affirms Botulism Verdict for McGinnis Lochridge Client Against Allergan, Inc.,” (May 9, 2014) (law firm press release misleadingly claiming that the Oklahoma Supreme Court had affirmed, when in fact, the Court had declined discretionary review).

Having pled guilty in federal court, Gad would have recited the facts of his crime in court before the imposition of sentencing, as required under Federal Rule of Criminal Procedure 11. Furthermore, even if Gad’s criminal defense lawyer drafted the Pre-sentencing Report, Gad was the principal responsible for his agent attorney’s representation that he, Gad, would not testify again as an expert witness.

Gad tried to resist the gist of the cross-examination by suggesting that others, not he, had made the representation. And on redirect, plaintiff’s counsel Chester elicited an apology, not to the court, or to the defendants, but to Dr. Helton, the plaintiff:

Q Would you, at least, apologize to my client for me because she hired me and I hired you.

A I do apologize for that.

Q Have you lied about anything in this case?

A No, sir.

Q You put five kids through college; is that right?

A Yes, sir.

Q You’ve had this career. Why would you do something like this?

A Well, that, of course, was discussed in a lot more detail in the documents having to do with it, but it was something that got out there 25 years ago and I thought it was put away. I did my best to expunge it from the record, and I was unsuccessful. Twenty-five years ago I was a very different person, a lot younger than I am now.

Helton v. Allergan, Inc., Notes of Testimony by Shayne Cox Gad at 141 (April 27, 2010).

The internet is, however, unforgiving and unforgetting. A curriculum vitae for Gad, labeled August 2005, states the following for military service:

“June 1970 to April 1974 (Active):

Served on riverine craft in Mekong Delta of Vietnam and as O.I.C. of Armory, Quonset Point, Rhode Island. Served on USS Intrepid (CVS-11) as special 7 weapons officer, deck division officer and as First Lieutenant. Qualified as O.D. underway on Intrepid. Made several deployments overseas – mainly to Europe and the Mediterranean. Released from active duty in the permanent grade of LT(jg). Received Silver Star, 3 Bronze Stars, 3 Purple Hearts.  * * *

Holds current (2003) top secret clearance.”

C.V. for Shayne Cox Gad, Ph.D., D.A.B.T., A.T.S. (emphasis added).

The charging document against Gad, from United States v. Gad, also refutes the notion that Gad’s false statements occurred in the distant past, but rather that they were made “[o]n or about November 2004, and continuing up to and including March 29, 2007 … .” Immunity from prosecution for perjury in another case, United States v. Caputo appeared to be part of the consideration for the plea deal in U.S. v. Gad. Thus the inclusion of a representation, in the pre-sentencing report, that “[a]dditionally, Dr. Gad has agreed to no longer testify as an expert witness in the future.”

The mischief Gad created by his dishonesty was thus not limited to the Helton case. Gad’s testimony looks even more dubious in view of the Caputo case, a criminal case in which Gad testified for a federal prosecutor. In Caputo, the prosecutor informed the defendants, executives of AbTox Inc., that Gad “had committed perjury by falsely claiming military experience and decorations.” United States v. Caputo, Case No. 10-1964, 397 Fed. Appx. 216, (7th Cir. Oct. 12, 2010) (unpublished). See also “AbTox Execs Seek New Trial Over Witness ‘Perjury’ – Law360” (Sept. 16, 2010).

The Caputo defendants had been charged with lying to the FDA and selling a misbranded medical sterilization devices. United States v. Caputo, 517 F.3d 935 (7th Cir. 2008) (affirming convictions). In rebuttal, Gad testified that defendants could not reasonably have held the beliefs they claimed to have held in good faith. Because of how the issue of good faith arose, the Circuit held that Gad’s perjurious testimony was harmless error that could not support the grant of a new trial. United States v. Caputo, Case No. 10-1964, 397 Fed. Appx. 216, (7th Cir. Oct. 12, 2010).

When the government informed the defendants that Gad had committed perjury, the Caputo defendants moved for a new trial on grounds of newly discovered evidence. The defendants went beyond Gad’s perjury disclosed by the prosecutors, and charged that Gad’s resume was a sham and that Gad had lied about other credentials as well.

According to the defendants’ motion in Caputo, Gad had misrepresented several credentials and misleadingly claimed to have had professional experience in medicine and toxicology, which experience Gad, in fact, lacked. The defendants, in Caputo, alleged other misrepresentations. Gad had testified in their case, and in the Helton case, that he had taught a course at the Duke University Medical School in the early 2000s and had lectured at the school since. Gad’s resume listed a professorship of toxicology at the College of St. Elizabeth, where he purportedly developed the school’s bachelor of science toxicology program, according to the motion. In their motion for a new trial, the AbTox executives, Caputo and Riley, provided an offer of proof that neither Duke University Medical School nor the College of St. Elizabeth had any record of Gad’s faculty status, and St. Elizabeth lacked a bachelor’s program in toxicology. Caputo and Riley also adverted to the federal prosecutors’ own earlier finding that Gad had lied about his military record during their trial.

I don’t know whether Gad testified again.  Some of Gad’s dubious views on toxicology are cited with approval by legal commentators who would dilute the scientific standard for causation[2].

“Falsus in uno, falsus in omnibus.” The essence of the crime is specious claiming.

[1] United States v. Alvarez, 132 S. Ct. 1421 (2012) (holding that the Stolen Valor Act was unconstitutional).

[2] See Shayne C. Gad, “Model Selection and Scaling,” in Shayne C. Gad & Christopher P. Chengelis eds., Animal Models in Toxicology 813 (1992), cited by Carl F. Cranor & David A. Eastmond, “Scientific Ignorance and Reliable Patterns of Evidence in Toxic Tort Causation: Is There a Need for Liability Reform? 64 Law & Contemporary Problems 5, 27 & n.120 (2001), and by Erica Beecher-Monas, Evaluating Scientific Evidence An Interdisciplinary Framework for Intellectual Due Process at 74 & n.63 (2007) (citing Gad’s book at page 826, for the argument that humans may be more sensitive to chemical effects than smaller species).

 

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Courts Can and Must Acknowledge Multiple Comparisons in Statistical Analyses

October 14th, 2014

In excluding the proffered testimony of Dr. Anick Bérard, a Canadian perinatal epidemiologist in the Université de Montréal, the Zoloft MDL trial court discussed several methodological shortcomings and failures, including Bérard’s reliance upon claims of statistical significance from studies that conducted dozens and hundreds of multiple comparisons. See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342; 12-md-2342, 2014 U.S. Dist. LEXIS 87592; 2014 WL 2921648 (E.D. Pa. June 27, 2014) (Rufe, J.). The Zoloft MDL court was not the first court to recognize the problem of over-interpreting the putative statistical significance of results that were one among many statistical tests in a single study. The court was, however, among a fairly small group of judges who have shown the needed statistical acumen in looking beyond the reported p-value or confidence interval to the actual methods used in a study[1].

A complete and fair evaluation of the evidence in situations as occurred in the Zoloft birth defects epidemiology required more than the presentation of the size of the random error, or the width of the 95 percent confidence interval.  When the sample estimate arises from a study with multiple testing, presenting the sample estimate with the confidence interval, or p-value, can be highly misleading if the p-value is used for hypothesis testing.  The fact of multiple testing will inflate the false-positive error rate. Dr. Bérard ignored the context of the studies she relied upon. What was noteworthy is that Bérard encountered a federal judge who adhered to the assigned task of evaluating methodology and its relationship with conclusions.

*   *   *   *   *   *   *

There is no unique solution to the problem of multiple comparisons. Some researchers use Bonferroni or other quantitative adjustments to p-values or confidence intervals, whereas others reject adjustments in favor of qualitative assessments of the data in the full context of the study and its methods. See, e.g., Kenneth J. Rothman, “No Adjustments Are Needed For Multiple Comparisons,” 1 Epidemiology 43 (1990) (arguing that adjustments mechanize and trivialize the problem of interpreting multiple comparisons). Two things are clear from Professor Rothman’s analysis. First for someone intent upon strict statistical significance testing, the presence of multiple comparisons means that the rejection of the null hypothesis cannot be done without further consideration of the nature and extent of both the disclosed and undisclosed statistical testing. Rothman, of course, has inveighed against strict significance testing under any circumstance, but the multiple testing would only compound the problem. Second, although failure to adjust p-values or intervals quantitatively may be acceptable, failure to acknowledge the multiple testing is poor statistical practice. The practice is, alas, too prevalent for anyone to say that ignoring multiple testing is fraudulent, and the Zoloft MDL court certainly did not condemn Dr. Bérard as a fraudfeasor[2].

In one case, a pharmaceutical company described a p-value of 0.058 as statistical significant in a “Dear Doctor” letter, no doubt to avoid a claim of under-warning physicians. Vanderwerf v. SmithKline Beecham Corp., 529 F.Supp. 2d 1294, 1301 & n.9 (D. Kan. 2008), appeal dism’d, 603 F.3d 842 (10th Cir. 2010). The trial court[3], quoting the FDA clinical review, reported that a finding of “significance” at the 0.05 level “must be discounted for the large number of comparisons made. Id. at 1303, 1308.

Previous cases have also acknowledged the multiple testing problem. In litigation claims for compensation for brain tumors for cell phone use, plaintiffs’ expert witness relied upon subgroup analysis, which added to the number of tests conducted within the epidemiologic study at issue. Newman v. Motorola, Inc., 218 F. Supp. 2d 769, 779 (D. Md. 2002), aff’d, 78 Fed. App’x 292 (4th Cir. 2003). The trial court explained:

“[Plaintiff’s expert] puts overdue emphasis on the positive findings for isolated subgroups of tumors. As Dr. Stampfer explained, it is not good scientific methodology to highlight certain elevated subgroups as significant findings without having earlier enunciated a hypothesis to look for or explain particular patterns, such as dose-response effect. In addition, when there is a high number of subgroup comparisons, at least some will show a statistical significance by chance alone.”

Id. And shortly after the Supreme Court decided Daubert, the Tenth Circuit faced the reality of data dredging in litigation, and its effect on the meaning of “significance”:

“Even if the elevated levels of lung cancer for men had been statistically significant a court might well take account of the statistical “Texas Sharpshooter” fallacy in which a person shoots bullets at the side of a barn, then, after the fact, finds a cluster of holes and draws a circle around it to show how accurate his aim was. With eight kinds of cancer for each sex there would be sixteen potential categories here around which to “draw a circle” to show a statistically significant level of cancer. With independent variables one would expect one statistically significant reading in every twenty categories at a 95% confidence level purely by random chance.”

Boughton v. Cotter Corp., 65 F.3d 823, 835 n. 20 (10th Cir. 1995). See also Novo Nordisk A/S v. Caraco Pharm. Labs., 775 F.Supp. 2d 985, 1019-20 & n.21 (2011) (describing the Bonferroni correction, and noting that expert witness biostatistician Marcello Pagano had criticized the use of post-hoc, “cherry-picked” data that were not part of the prespecified protocol analysis, and the failure to use a “correction factor,” and that another biostatistician expert witness, Howard Tzvi Thaler, had described a “strict set of well-accepted guidelines for correcting or adjusting analysis obtained from the `post hoc’ analysis”).

The notorious Wells[4] case was cited by the Supreme Court in Matrixx Initiatives[5] for the proposition that statistical significance was unnecessary. Ironically, at least one of the studies relied upon by the plaintiffs’ expert witnesses in Wells had some outcomes with p-values below five percent. The problem, addressed by defense expert witnesses and ignored by the plaintiffs’ witnesses and Judge Shoob, was that there were over 20 reported outcomes, and probably many more outcomes analyzed but not reported. Accordingly, some qualitative or quantitative adjustment was required in Wells. See Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation 93 (1997)[6].

Reference Manual on Scientific Evidence

David Kaye’s and the late David Freedman’s chapter on statistics in the third, most recent, edition of Reference Manual, offers some helpful insights into the problem of multiple testing:

“4. How many tests have been done?

Repeated testing complicates the interpretation of significance levels. If enough comparisons are made, random error almost guarantees that some will yield ‘significant’ findings, even when there is no real effect. To illustrate the point, consider the problem of deciding whether a coin is biased. The probability that a fair coin will produce 10 heads when tossed 10 times is (1/2)10 = 1/1024. Observing 10 heads in the first 10 tosses, therefore, would be strong evidence that the coin is biased. Nonetheless, if a fair coin is tossed a few thousand times, it is likely that at least one string of ten consecutive heads will appear. Ten heads in the first ten tosses means one thing; a run of ten heads somewhere along the way to a few thousand tosses of a coin means quite another. A test—looking for a run of ten heads—can be repeated too often.

Artifacts from multiple testing are commonplace. Because research that fails to uncover significance often is not published, reviews of the literature may produce an unduly large number of studies finding statistical significance.111 Even a single researcher may examine so many different relationships that a few will achieve statistical significance by mere happenstance. Almost any large dataset—even pages from a table of random digits—will contain some unusual pattern that can be uncovered by diligent search. Having detected the pattern, the analyst can perform a statistical test for it, blandly ignoring the search effort. Statistical significance is bound to follow.

There are statistical methods for dealing with multiple looks at the data, which permit the calculation of meaningful p-values in certain cases.112 However, no general solution is available… . In these situations, courts should not be overly impressed with claims that estimates are significant. …”

Reference Manual on Scientific Evidence at 256-57 (3d ed. 2011).

When a lawyer asks a witness whether a sample statistic is “statistically significant,” there is the danger that the answer will be interpreted or argued as a Type I error rate, or worse yet, as a posterior probability for the null hypothesis.  When the sample statistic has a p-value below 0.05, in the context of multiple testing, completeness requires the presentation of the information about the number of tests and the distorting effect of multiple testing on preserving a pre-specified Type I error rate.  Even a nominally statistically significant finding must be understood in the full context of the study.

Some texts and journals recommend that the Type I error rate not be modified in the paper, as long as readers can observe the number of multiple comparisons that took place and make the adjustment for themselves.  Most jurors and judges are not sufficiently knowledgeable to make the adjustment without expert assistance, and so the fact of multiple testing, and its implication, are additional examples of how the rule of completeness may require the presentation of appropriate qualifications and explanations at the same time as the information about “statistical significance.”

*     *     *     *     *

Despite the guidance provided by the Reference Manual, some courts have remained resistant to the need to consider multiple comparison issues. Statistical issues arise frequently in securities fraud cases against pharmaceutical cases, involving the need to evaluate and interpret clinical trial data for the benefit of shareholders. In a typical case, joint venturers Aeterna Zentaris Inc. and Keryx Biopharmaceuticals, Inc., were both targeted by investors for alleged Rule 10(b)(5) violations involving statements of clinical trial results, made in SEC filings, press releases, investor presentations and investor conference calls from 2009 to 2012. Abely v. Aeterna Zentaris Inc., No. 12 Civ. 4711(PKC), 2013 WL 2399869 (S.D.N.Y. May 29, 2013); In re Keryx Biopharms, Inc., Sec. Litig., 1307(KBF), 2014 WL 585658 (S.D.N.Y. Feb. 14, 2014).

The clinical trial at issue tested perifosine in conjunction with, and without, other therapies, in multiple arms, which examined efficacy for seven different types of cancer. After a preliminary phase II trial yielded promising results for metastatic colon cancer, the colon cancer arm proceeded. According to plaintiffs, the defendants repeatedly claimed that perifosine had demonstrated “statistically significant positive results.” In re Keryx at *2, 3.

The plaintiffs alleged that defendants’ statements omitted material facts, including the full extent of multiple testing in the design and conduct of the phase II trial, without adjustments supposedly “required” by regulatory guidance and generally accepted statistical principles. The plaintiffs asserted that the multiple comparisons involved in testing perifosine in so many different kinds of cancer patients, at various doses, with and against so many different types of other cancer therapies, compounded by multiple interim analyses, inflated the risk of Type I errors such that some statistical adjustment should have been applied before claiming that a statistically significant survival benefit had been found in one arm, with colorectal cancer patients. In re Keryx at *2-3, *10.

The trial court dismissed these allegation given that the trial protocol had been published, although over two years after the initial press release, which started the class period, and which failed to disclose the full extent of multiple testing and lack of statistical correction, which omitted this disclosure. In re Keryx at *4, *11. The trial court emphatically rejected the plaintiffs’ efforts to dictate methodology and interpretative strategy. The trial court was loathe to allow securities fraud claims over allegations of improper statistical methodology, which:

“would be equivalent to a determination that if a researcher leaves any of its methodology out of its public statements — how it did what it did or was planning to do — it could amount to an actionable false statement or omission. This is not what the law anticipates or requires.”

In re Keryx at *10[7]. According to the trial court, providing p-values for comparisons between therapies, without disclosing the extent of unplanned interim analyses or the number of multiple comparisons is “not falsity; it is less disclosure than plaintiffs would have liked.” Id. at *11.

“It would indeed be unjust—and could lead to unfortunate consequences beyond a single lawsuit—if the securities laws become a tool to second guess how clinical trials are designed and managed. The law prevents such a result; the Court applies that law here, and thus dismisses these actions.”

Id. at *1.

The court’s characterization of the fraud claims as a challenge to trial methodology rather than data interpretation and communication decidedly evaded the thrust of the plaintiffs’ fraud complaint. Data interpretation will often be part of the methodology outlined in a protocol. The Keryx case also confused criticism of the design and execution of a clinical trial with criticism of the communication of the trial results.

[1] Predictably, some plaintiffs’ counsel accused the MDL trial judge of acting as a statistician and second-guessing the statistical inferences drawn by the party expert witness. See, e.g., Max Kennerly, “Daubert Doesn’t Ask Judges To Become Experts On Statistics” (July 22, 2014). Federal Rule of Evidence 702 requires trial judges to evaluate the methodology used to determine whether it is valid. Kennerly would limit the trial judge to a simple determination of whether the expert witness used statistics, and whether statistics generally are appropriately used. In his words, “[t]o go with the baseball metaphors so often (and wrongly) used in the law, when it comes to Daubert, the judge isn’t an umpire calling balls and strikes, they’re [sic] more like a league official checking to make sure the players are using regulation equipment. Mere disagreements about the science itself, and about the expert’s conclusions, are to be made by the jury in the courtroom.” This position is rejected by the explicit wording of the statute, as well as the Supreme Court opinions leading up to the revision in the statute. To extend Kennerly’s overextended metaphor even further, the trial court must not only make sure that the players are using regulation equipment, but also that pitchers, expert witnesses, aren’t throwing spitballs or balking in their pitching of opinions. Judge Rufe, in the Zoloft MDL, did no more than asked of her by Rule 702 and the Reference Manual.

[2] Perhaps the prosecutor, jury, and trial and appellate judges in United States v. Harkonen would be willing to brand Dr. Bérard a fraudfeasor. U.S. v. Harkonen, 2009 WL 1578712, 2010 WL 2985257 (N.D. Cal.), aff’d, 2013 WL 782354 (9th Cir. Mar. 4, 2013), cert. denied, ___ U.S. ___ (2013).

[3] The trial court also acknowledged the Reference Manual on Scientific Evidence 127-28 (2d ed. 2000). Unfortunately, the court erred in interpreting the meaning of a 95 percent confidence interval as showing “the true relative risk value will be between the high and low ends of the confidence interval 95 percent of the time.” Vanderwerf v. SmithKlineBeecham Corp., 529 F.Supp. 2d at 1302 n.10.

[4] Wells v. Ortho Pharm. Corp., 615 F. Supp. 262 (N.D. Ga. 1985), aff ’d, and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986).

[5] Matrixx Initiatives, Inc. v. Siracusano, 131 S.Ct. 1309 (2011)

[6] Zeisel and Kaye contrast the lack of appreciation for statistical methodology in Wells with the handling of the multiple comparison issue in an English case, Reay v. British Nuclear Fuels (Q.B. Oct. 8, 1993). In Reay, children of fathers who worked in nuclear power plants and who developed leukemia, sued. Their expert witnesses relied upon a study that reported 50 or so hypotheses. Zeisel and Kaye quote the trial judge as acknowledging that the number of hypotheses considered inflates the nominal value of the p-value and reduces confidence in the study’s result. Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation 93 (1997) (discussing Reay case as published in The Independent, Nov. 22, 1993).

[7] Of course, this is exactly what happened to Dr. Scott Harkonen, who was indicted and convicted under the Wire Fraud Act, despite issuing a press release that included a notice of an investor conference call within a couple of weeks, when investors and others could inquire fully about the clinical trial results.

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Can Expert Bias and Prejudice Disqualify a Witness From Testifying?

October 11th, 2014

The Center for Science in the Public Interest (CSPI) bills itself as a consumer advocate committed to research and education in sound science. The CSPI considers itself to be “one of the nation’s top consumer advocates,” which works to “ensure that science is used to promote the public welfare.”

You may wonder whether and why “science” turns out to promote the public welfare envisioned by the CSPI? According to the CSPI, you should just accept that it does. So sure is the CSPI that industry corrupts science that it features a web-based, open database of scientists with ties to industry. There is no database of scientists’ ties to the litigation industry (plaintiffs’ lawyers), to organized labor, or advocacy groups. No doubt, implicit in its choice, is the claim that all science done by scientists with “ties” to the plaintiffs’ bar, to labor, or to advocacy groups, is “in the public interest.”

The arrogance of the implicit claim is made even more clear by how the CSPI addresses supposed corruption and conflicts of interest in science. The CSPI features an Integrity in Science Project to ferret out corruption in science, but the Project concerns itself only with industry-sponsored and funded science. The Project is candid about its one-sided jihad against industry-based science:

“Although many have cheered partnerships between industry and the research community, it is also acknowledged that they entail conflicts of interest that may compromise the judgment of trusted professionals, the credibility of research institutions and scientific journals, the safety and transparency of human subjects research, the norms of free inquiry, and the legitimacy of science-based policy.

For example:

  • There is strong evidence that researchers’ financial ties to chemical, pharmaceutical, or tobacco manufacturers directly influence their published positions in supporting the benefit or downplaying the harm of the manufacturers’ product.
  • A growing body of evidence indicates that pharmaceutical industry gifts and inducements bias clinicians’ judgments and influence doctors’ prescribing practices.
  • There are well-known cases of industry seeking to discredit or prevent the publication of research results that are critical of its products.
  • Studies of life-science faculty indicate that researchers with industry funding are more likely to withhold research results in order to secure commercial advantage.
  • Increasingly, the same academic institutions that are responsible for oversight of scientific integrity and human subjects protection are entering financial relationships with the industries whose product-evaluations they oversee.

In response to the commercialization of science and the growing problem of conflicts of interest, the Integrity in Science Project seeks to:

  • raise awareness about the role that corporate funding and other corporate interests play in scientific research, oversight, and publication;

  • investigate and publicize conflicts of interest and other potentially destructive influences of industry-sponsored science;

  • advocate for full disclosure of funding sources by individuals, governmental and non-governmental organizations that conduct, regulate, or provide oversight of scientific investigation or promote specific scientific findings;

  • encourage policy-makers at all levels of government to seek balance on expert advisory committees and to provide public, web-based access to conflict-of-interest information collected in the course of committee formation;

  • encourage journalists to routinely ask scientists and others about their possible conflicts of interests and to provide this information to the public.”

The CSPI inquiry then is entirely one-sided, with no apparent or manifest interest in exploring and revealing conflicts created by scientists’ affiliations with advocacy groups, labor, or the litigation industry. The concern about conflicts of interests is, in my view, simply an attempt to disqualify industry-sponsored scientific studies from inclusion in policy discussions. To be sure, there are notorious examples of industry-sponsored, compromised studies. But there are similarly notorious examples of union and plaintiff-lawyer sponsored studies gone awry. Why then is there no concern at the CSPI about researchers’ ties with advocacy groups, labor unions, and most important, and the litigation industry? The obvious answer is that the CSPI is engaging in advocacy for certain conclusions. The CSPI wants to put its hand on one side of the balance, and do its best to ensure that scientific debates and discussions come out a certain way, a way that favors conclusions it desires. The CSPI wants to disqualify dissenters from the conversation. The so-called “Integrity” project thus appears to be a pretense, exactly the opposite of what it purports to be.

In 2004, the CSPI’s Integrity in Science Project sponsored a conference on, among other topics, Corporate and Government Suppression of Research. Actually, there was barely any discussion of governmental suppression; the speakers spoke almost entirely on corporate conduct.

One speaker on the panel presented about corporate conflicts of interest in the starkest Marxist terms. Corporations must cheat and lie because they are capable only of acting to maximize profits, and they will inevitably see safety as a dispensable cost. The speaker, who is a frequent testifier in mass tort litigation, held forth that the problem with corporations is not that there are some rotten apples, but that the entire barrel is rotten. Suppression of scientific research, according to this speaker is not an anomaly, but totally determined by the nature of the firm. Ethical companies cannot compete, and they go out of business; ergo, any company in business is unethical.

Of course, the same uncharitable determinist views can be applied to expert witnesses, to plaintiffs’ counsel, to labor unions, and to advocacy groups. Remarkably, this speaker acknowledged that is ideology is a much larger bias than money, and then confessed that

“My bias is ideological.”

This speaker testifies frequently for the litigation industry, and his zeal is so uncabined that he has been held in contempt and fined as part of his litigation activities. When one federal court judge excluded his testimony, he attacked the bona fides of the judge and sought to appeal his exclusion personally. And yet the Integrity project featured him as a speaker!

The CSPI and its cadre of anti-industry scientists brings me to the question du jour: Can an expert witness be too biased or prejudiced in a matter to serve as an expert witness? We exclude judges and jurors who have potential conflicts of interest. Surely there are fact or expert witnesses, who are so untrustworthy that they should not be allowed to testify. Consider whether an expert witnesses who, having demonstrated that they will violate court orders or other laws, want the court to qualify them as “expert witnesses” to give their opinions in a pending case. The trial court does not necessarily endorse the opinions proffered, but should the court give its imprimatur to the witnesses’ standing as having opinions that could be considered, relied upon to the exclusion of competing opinions, and form the basis for verdicts for the parties offering these suspect witnesses?

Just asking.

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Substantial Factor Versus Sine Qua Non Causation

October 7th, 2014

In a prosecution against the eponymously named Mr. Mullet, and other Amish defendants, the Department of Justice grabbed an an Amish beard- and hair-cutting case from state authorities and cast it as a hate crime. United States v. Mullet, 868 F.Supp. 2d 618 (N.D. Ohio 2012). The criminal statute invoked by the federal prosecutors prohibits

“willfully caus[ing] bodily injury to any person . . . because of the actual or perceived . . . religion . . . of [that] person… .”

18 U.S.C. § 249(a)(2)(A). The prosecution managed to persuade the trial judge, Judge Polster, that “because of” means merely “significant motivating factor,” but the Sixth Circuit would have none of it, and reversed. United States v. Miller, 2014 U.S. App. LEXIS 16532, 2014 FED App. 0210P (6th Cir. ); see Debra Cassens Weiss, “6th Circuit reverses hate-crime convictions of Amish in beard- and hair-cutting attacks” (Aug 28, 2014).

The Court of Appeals held, in a two to one decision, that the statute required a “but for” jury instruction, reversed and remanded. Most plainly, the appellate court stated that:

“[B]ecause of” in brief means what it says: The prohibited act or motive must be an actual cause of the specified outcome.”

United States v. Miller, at *12.

The appellate court cited the common meaning of “because of” and the treatment this phrase has received in criminal[1] and civil[2] cases in the United States Supreme Court. The defendants had presented evidence of other non-religious, non-prohibited motives and thus the district court’s charge was not harmless.

The court then, rather inconsistently, pointed to the “beyond a reasonable doubt standard” and constitutional concerns over religious freedom, as requiring “but for,” despite the identical interpretive outcome in civil cases. Id. What happens when, as in Miller, there are clearly several motives involved:

“How should a jury measure whether a specific motive was significant in inspiring a defendant to act? Is a motive significant if it is one of three reasons he acted? One of ten?”

Id. at *12. The same difficulty could be raised against using the “significant” or “substantial factor” test in civil cases.

More persuasive was simply the invocation of common usage and the need to construe a statute leniently in favor of the defendant.

The dissenting judge would have brushed this all under the rug as “harmless error,” but failure to charge properly on the correct causation standard is rarely going to pass as harmless, and it did not do so here. Even the dissenter, however, acknowledged that:

“This but-for requirement is part of the common understanding of cause.”

Id. (Sargus, J., dissenting) at *46 (quoting from Burrage v. United States, 134 S. Ct. 881, 888 (2014)).

[1] Burrage v. United States, 134 S. Ct. 881, 887–89 (2014) (criminal).

[2] Univ. of Tex. Sw. Med. Ctr. v. Nassar, 133 S. Ct. 2517, 2528 (2013) (civil); Gross v. FBL Fin. Servs., Inc., 557 U.S. 167, 176–77 (2009) (civil); Safeco Ins. Co. of Am. v. Burr, 551 U.S. 47, 63–64 & n.14 (2007) (civil).

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Cancer Epidemiology 100 Years Ago

October 6th, 2014

Writing from the Department of Pathology of Columbia University, at the College of Physicians and Surgeons, Isaac Levin published a study of cancer etiology in 1910. Isaac Levin, “III. The Study of the Etiology of Cancer Based on Clinical Statistics,” 51 Ann. Surg. Jun 768 (1910). Levin looked at population and gender prevalence among cancer cases, without age correction or any statistical measure of random error. He compared population prevalence of specific or all-cause mortality without isolating exposure and outcome. Levin’s efforts were earnest, but surely they strike us as primitive. If you want to be disabused of the belief that epidemiology today is a primitive scientific enterprise, mired in methodologies and interpretative strategies of the past, Levin’s article is a welcome documentation that progress is possible and has in fact occurred.

Levin sums up what was known about occupation and cancer in 1910, which was not much:

“QUESTION 10,- OCCUPATION.–Occupation undoubtedly plays an important role in the causation of cancer. The carcinoma of the scrotum of the chimney sweeps, tumors of the bladder of the aniline workers, and X-ray cancer are well known, but it will require a great deal of research to, show how direct the influence is that these occupations exert on the causation of cancer, since only a certain number of the workers contract the disease.”

Id. at 776. No acknowledgment of dose response, or thresholds. No quantitation of risk against baselines.

Levin goes on to note that:

“[o]f extreme interest seems to be the fact, noted both in England and America, that cancer is comparatively rare among the miners. Table IV, compiled from the twelfth U. S. Census, illustrates this fact:

Table IV from Levin 1910

Table IV from Levin 1910

[Open in new window for clearer image]

Wilkesbarre and Scranton are mining towns and the death rate is lower than in Harrisburg or in the whole state of Pennsylvania. It seems also to be the opinion of the surgeons in Pennsylvania (personal communication) that cancer is rare among miners.”

Id. at 776.

There are some other quaint relics of the past here. On the questionnaire used for 4,000 cases or so, here is how Levin inquired of “Race or Nationality”

“RACE OR NATIONALITY. …………Australoid – Coolies of East India; Negroid – Negroes, Negritos of the Philippines; Mongoloid – Chinese, Japanese, American Indians, Filipinos; Melanochroic – Italians, Spaniards, Greeks, Arabs, Jews; Xanthochroic – Fair Europeans. State not only the name of the race, but also of the subdivision]”

Id. at 772. Anthropology was fairly primitive as well, in 1910.

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Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas

October 4th, 2014

Since 1663, the Royal Society has sported the motto:  “Nullius in verba,” on no one’s authority. The motto is a recognition that science, and indeed, all of knowledge turns on data properly collected, analyzed, and interpreted, and not on the prestige or authority of the speaker. In England today, there could be no better example of the disconnect between authority and knowledge than the pronouncements of Crown Prince Charles on science and medicine[1].

Although science should be about the data and methodology, the growing complexity and inaccessibility of modern science has fostered greater reliance upon reputation of researchers as a proxy for the correctness of factual statements. In some quarters, scientists are held up as shamans who are lionized and revered, at least when the scientists are advancing research and conclusions that are politically approved. When the scientists conduct research that threatens politically correct beliefs, then the scientists must be attacked, diminished, and discredited. Because the scientific claims at issue involve evidence and hard thought, the attackers and defenders seem to prefer proceed with ad hominem attacks on the personal standing and credibility of scientists whose work they embrace or distain.

The sad truth is that the persistence of interpreting science by personal charm, credibility, and political correctness of scientists’ personality remains as a legacy of our authority-based approach to knowledge. As a result, we have the spectacle of public intellectuals who complain about the demonization of scientists, while in the next breath, demonize scientists whose work threatens their political and personal preferences[2].

It would be lovely if we could ignore attacks on the personal credibility of researchers, but the sociology of knowledge and science requires us to acknowledge that reputation, prestige, and authority remain as determinants of belief. The more political and personal preferences are involved, and the greater the complexity of the underlying scientific analysis, the more we should expect people, historians, judges, and juries, to ignore the Royal Society’s Nullius in verba,” and to rely upon the largely irrelevant factors of reputation.

We would thus be on a fool’s errand not to pay attention to the social construction of reputation, both in terms of how reputations are created and how they are diminished. I have focused on Irving Selikoff, because he is such a difficult case. For virtually every advance in the scientific understanding of asbestos health effects, Selikoff did not have priority. Sir Richard Doll was ahead of Selikoff by a decade in reporting the epidemiologic association between asbestosis and lung cancer.[3] Christopher Wagner was ahead of Selikoff by several years in describing the association between amphibole asbestos and mesothelioma[4]. And the United States Navy was ahead of Selikoff in terms of detailing the difficulty in controlling confined-space asbestos lagging operations onboard ships, and the consequent asbestosis hazards[5].

Much of Selikoff’s asbestos work that was original was wrong. His advocacy of a connection between asbestos and extrapulmonary cancers, his claim that all asbestos varieties were equivalent in potency for causing mesothelioma, and his risk assessments of total attributable asbestos risks are just some examples of where Selikoff outran his scientific headlights. Still, the United States public owes Selikoff a debt of gratitude for having popularized and disseminated information about asbestos hazards at a crucial time in our history. Although Doll and Wagner had priority with respect to lung cancer and mesothelioma, they both wrote in foreign journals about exposures that were typical in the U.K. and South Africa. And while the Navy’s understanding of its own catastrophic neglect of safety in its shipyards came before Selikoff’s publications, the Navy’s coyness kept its information from being widely disseminated. Selikoff, in his 1964 publication[6], in an American journal, the Journal of the American Medical Association, thus incorporated a good amount of prior learning and showed that asbestos was a problem among asbestos insulators in the United States. At the time, insulators were often thought of as having relatively low-level asbestos exposure. Furthermore, Selikoff used his findings of asbestos-related disease among the union insulators to advance a political goal, the federalization of workplace safety and health regulation. That goal ultimately came to have bipartisan support in the United States, largely as a result of Selikoff’s advocacy.

Selikoff’s legitimate achievements should not be diminished, and historians McCulloch and Tweedale are correct to bemoan the ad hominem attacks on Selikoff, based upon ethnicity and personal characteristics. They are wrong, however, to claim that Selikoff’s training, scientific acumen, advocacy, and false positive claims are somehow off limits. Selikoff’s substantial contributions to public health by publicizing the dangers of high exposure, long-term exposure to exposure do not privilege every position he took.  Selikoff is a difficult case because he was wrong on many issues, and his reputation, authority and prestige ultimately became much greater than the evidence would ultimately support.

The labor historians and anti-asbestos zeolots are right to bristle and emote when historians and others challenge the reputation of Irving Selikoff. Like Rachel Carson and Wilhelm Heuper, Selikoff is one of the icons of the environmental and occupational safety movement. Environmentalists, labor leaders, and left-leaning politicians, have invested heavily in Selikoff’s reputation and authority to support legislation and regulations. Given Selikoff’s reputation and prestige in the field of asbestos health effects, and his role in helping pass the Williams-Steiger Act of 1969, we might wonder why no one has written a full-length biography. There are some hagiographic articles to be sure, but a full-length biography would raise questions not politely answerable.

Selikoff the Testifier

Selikoff may have been a media plodder in the mid-1950s, but his experience as a testifying witness made him particularly effective in advancing his advocacy on behalf of the asbestos and other unions in the 1960s and forward. See “Medical Horizons,” Broadcasting * Telecasting at 14 (Nov. 21, 1955) (describing Selikoff as a plodding presenter). Those who would lionize Selikoff, and privilege his claims from evidence-based scrutiny, are embarrassed by his frequent testifying. They are, however, wrong to distort Selikoff’s record of participating in the litigation process. He had an obligation to do so, to some extent. Many physicians gladly would avoid the courtroom confrontations that Dr. Selikoff undertook. Despite these feelings, physicians have an ethical obligation, by virtue of their special training and experience, to assist in the administration of justice[7]. Indeed, the Board of Trustees of the American Medical Association has recommended that the presentation of expert testimony should be considered part of the practice of medicine and thus subject to peer review[8]. Ultimately, the courtroom testimony should be judged for the validity of its conclusions just as any other scientific opinion would be.

Of course, frequent testifying can be undertaken for venal or political purposes, and the reputation makers behind Selikoff have been keen to protect him from charges of being a “frequent testifier.” Much of protection probably took place because Selikoff’s testifying took place in the past before electronic files of transcripts could circulate rapidly, and even minor cases were posted to internet databases. Thus, Judge Jack Weinstein, writing after the death of Dr. Selikoff, could incorrectly describe him as an “independent” scientist, who should not be coerced to testify when he preferred to publish his “results only in scientific journals.” Jack B. Weinstein, Individual Justice in Mass Tort Litigation:  The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995).

Judge Weinstein was clearly wrong in his assessment that Selikoff preferred scholarly journals to the courtroom, but his assessment reflects the influence of the reputation that Selikoff and his followers worked so hard to create. Of course, Judge Weinstein was also wrong to suggest that Selikoff was “independent.” He had deep ties to unions, the plaintiffs’ bar, a cadre of plaintiffs’ expert witnesses, and to positions to which all these groups subscribed. The greatest art is that which conceals itself[9].

Selikoff’s participation in litigation proceedings has thus become a debating point between those who would acclaim and those who would detract from Selikoff’s reputation. Oxford University historian Peter Bartrip, for one, noted that Selikoff had testified frequently. Peter W.J. Bartrip, Beyond the Factory Gates: Asbestos and Health in Twentieth Century America 77 & n.4 (2006); Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003). Bartrip’s history has in turn been attacked by the Lobby of anti-asbestos zealots. Marxist historians Jock McCulloch and Geoffrey Tweedale, and others, have attacked Bartrip for serving as an apologist for industry, and have suggested, in their publications, that Selikoff testified infrequently:=

“[Selikoff] gave testimony in two of the early landmark legal cases, but thereafter avoided the drama of the courtroom and the role of the expert witness, not only because it would have been a drain on his time and made his confidential trade union medical files open to legal scrutiny, but also because he felt that antagonizing industry would not help his broader agenda.”

Jock McCulloch & Geoffrey Tweedale, Defending the Indefensible : The Global Asbestos Industry and its Fight for Survival: The Global Asbestos Industry and its Fight for Survival 95 & n.36 (2008).

Two and only two; or two and then some? What was McCulloch and Tweedale’s source? They cite a personal communication from one of Selikoff’s protégés and acolytes, Dr. Stephen Levin, who testified frequently on behalf of asbestos claimants in litigation, and who no doubt shared the authors’ desire to protect and enhance Dr. Selikoff’s reputation. Perhaps more interesting is Levin’s revelation that Selikoff wished to hide his “confidential” union files from scrutiny. See “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011) (describing memorandum, dated November 5, 1979, from plaintiffs’ expert witness Barry Castleman to Selikoff urging resistance to lawful discovery attempts to obtain information about asbestos workers union).

Well, who is right? Did Selikoff testify frequently or not? On this point, McCulloch and Tweedale appear to be demonstrably wrong. I have previously pointed out some of Selikoff’s testimonial adventures[10]. See “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

There are other instances, however, of Selikoff’s medico-legal activities. According to Jon Gelman, a worker’s compensation lawyer in New Jersey, his father, also a New Jersey lawyer, employed Dr. Selikoff, in the early 1950s, as an expert witness in the “original 17” UNARCO (Union Asbestos and Rubber Co.) asbestos worker claims.  Gelman reports that these claims were successfully litigated with Selikoff’s examinations and services, in front of the New Jersey Division of Workers’ Compensation.  Jon L. Gelman, “Dr. Yasunosuke Suzuki, A Pioneer of Mesothelioma Medical Research” (Nov. 23, 2011); Jon L. Gelman, History of Asbestos and the Law (Jan. 02, 2001). See also Michael Nevins, Meanderings in New Jersey’s Medical History 146-47 (2011). Unfortunately, the reports and transcripts of the UNARCO 17 cases are not available.

For about two decades after the UNARCO 17,  Selikoff went on to have an active testimonial career, always testifying for the claimant, and against the employer or the supplier. In 1972, Andrew Haas, President of the asbestos workers union thanked Selikoff for his “frequent” expert witness testimony on behalf of union members. Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972)[11].

In addition to the cases cited in the footnotes, Selikoff testified or was involved as an expert witness in other cases. See, e.g., Babcock & Wilcox, Inc. v. Steiner, 258 Md. 468, 471, 265 A.2d 871 (1970) (affirming workman compensation award for asbestosis); Culp Industrial Insulation v. Commonwealth of Pennsylvania Workmen’s Compensation Appeal Board, 57 Pa. Commonwealth Ct. 599, 601-602 (1981). One of the earliest reported decisions in which Selikoff testified as a party expert witness was in a federal court admiralty case, in which a seaman sued the ship owner for injuries allegedly sustained as a result of a slip and fall accident. No pulmonary injury was involved. Barros v. United States, 147 F.Supp. 340, 343-44 (E.D.N.Y. 1957) (noting that Dr. Selikoff testified for seaman suing for maintenance and cure as a result of a slip and fall; finding for respondent against libelant).

Perhaps the most egregious testimonial adventure was Selikoff’s serving as an expert witness, in 1966, for a union worker who claimed that his colon cancer had been caused by asbestos. What was remarkable about this testimony was not that it was for the worker; Selikoff’s testimony seemed always to be for the claimant. What stands out is how weak and unreliable any scientific claim for colon cancer would have been in 1966 (and after for that matter). Despite the insufficiency of the evidence, and the dubious validity of the early study relied upon, Selikoff’s participation helped obtain a favorable outcome, which led to the asbestos union’s praise for his efforts:

“The research into health hazards of insulation workers developed by the members of Local No. 12 and Local No. 32 has resulted in widening the basis of compensation claims in New York State.

Until now, the courts have been reluctant to accept many of the conditions to which insulation workers are prone, as related to employment. However, facts produced during the research investigations of Dr. 1. J. Selikoff, Dr. J. Churg, and Dr. E. Cuvler Hammond of the Environmental Sciences Laboratory of the Mt. Sinai Hospital in New York are resulting in a changing of this picture.

A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population.

Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the reviewed the matter and agreed with the Referee’s judgement and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”

“Health Hazard Progress Notes: Compensation Advance Made in New York State,” 16(5) Asbestos Worker 13 (May 1966). See Viskovich v. Robert A. Keasbey Co., 36 A.D.2d 665 (3d Dep’t 1971)(affirming decision of the Compensation Board in awarding an asbestos insulator benefits for colon cancer; Selikoff’s case or perhaps a subsequent claim). Historians will search long, hard, and unsuccessfully for any disclosure of Selikoff’s consultancies or his testimonies on the issue of asbestos and colorectal cancer in any of his publications on the issue, or any other asbestos issue.

Even after Selikoff stopped participating directly in the litigation process, he continued his interest in the outcome of litigation. This interest was both intellectual and practical. For instance, at the fall meeting of the Medical History Society of New Jersey, Selikoff gave a presentation on “Nellie Keershaws [sic] and Frederick Legrand,” two of the bellwether asbestos litigants, in the U.K., and the U.S., respectively. Irving J. Selikoff, “Nellie Keershaws and Frederick Legrand,” at Fall Meeting, UMDNJ-New Jersey Medical School, Newark, N.J. (Saturday, Oct. 8, 1988). See 9(1) MHSNJ Newsletter (Jan. 1989).

Nellie Kershaw was diagnosed with asbestosis in the early 1920s, but her employer, Turner Brothers Asbestos, refused to pay her compensation for disability and her ultimate death. The investigation into her death gave rise to the first set of Asbestos Industry Regulations, in the United Kingdom, in 1931. Frederick LeGrande was one of the first plaintiffs in a civil action against Johns-Manville, for asbestos-related disease. Frederick LeGrande v. Johns-Manville Prods. Corp., No. 741-57 (D.N.J. filed in 1957, by William L. Brach, attorney for plaintiff).

As McCulloch and Tweedale note, Selikoff became too politically vulnerable to continue his direct participation in litigation, but he did not cease his involvement altogether. After asbestos litigation went viral in the late 1970s, Selikoff encouraged his juniors at Mt. Sinai Hospital to testify on behalf of union members and other asbestos claimants. The roster of physicians who trained at Mt. Sinai, in Selikoff’s department, read like a “Who’s Who” of asbestos plaintiffs’ expert witnesses[12]. Indeed, Selikoff trained a generation of testifying expert witnesses for the plaintiffs’ bar.

Another measure of Selikoff’s influence in the litigation arena was his attempt to influence the litigation process by conducting an ex parte seminar for key judges, with responsibility for important cases or large dockets. Plaintiffs’ lawyers, with the collaboration of Selikoff’s protégés as their “expert witnesses,” persuaded school districts and property owners that they should sue for the costs of asbestos removal and abatement. Selikoff and his acolytes then called a meeting, “The Third Wave conference,” to reflect their concern about the alleged danger of asbestos in place. Philip J. Landrigan & H. Kazemi, eds. “The Third Wave of Asbestos Disease: Exposure to Asbestos in Place – Public Health Control,” 643 Ann. N.Y. Acad. Sci. (1991). Under cover of support from the Collegium Ramazzini, and with the active support and participation of organized labor and plaintiffs’ asbestos bar, Selikoff invited judges to what was clearly a lopsided medical conference, dominated by his acolytes and plaintiffs’ expert witnesses in the very cases in which the invited judges presided. The corrupt affair led to the disqualification of Judge James McGirr Kelly, who attended the conference. In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992); see Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself so as to Preserve the Appearance of Justice under 28 U.S.C.§ 455,” 38 Vill. L. Rev. 1219 (1993); W.K.C. Morgan, “Asbestos and cancer: history and public policy,” 49 Br. J. Indus. Med. 451, 451 (1992); see also “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014).

Perhaps even more interesting than the public corruption is the scientific corruption that took place at the Third Wave Conference. McCulloch and Tweedale report that one scientist who attended, Dr. Bruce Case, was so upset about the nonsense spouted at the Conference that he wrote an angry letter to one of the leaders in occupational pulmonary medicine, Dr. J. Bernard L. Gee., to report that the conference was “a stage-managed piece of Broadway theater[13].” The controversy led to Julian Peto’s review of the Third Wave Conference papers, and writing to the President of Mt. Sinai Hospital Center to register his observation that many of the conference papers were scientifically “dubious” and systematically biased in favor of exaggerating the risks of asbestos in place[14].

McCulloch and Tweedale attempt to defend this (indefensible) incident in the history of asbestos litigation by claiming that Selikoff and his “team” of acolytes had not been invited to an earlier conference at Harvard, on the issue of asbestos property damage. Health Effects Institute, Asbestos in Public and Commercial Buildings: A Literature Review and Synthesis of Current Knowledge (1991); Jacqueline Karn Corn, Environmental Public Health Policy for Asbestos in Schools: Unintended Consequences at 115-16 (1999). Their complaint does not ring true, however. The so-called Harvard conference had the participation of a large group of independent experts[15] as well as some scientists from the inner sanctum of Mt. Sinai[16]. The world of science ultimately has not been kind to the Selikoff view of asbestos in place[17].

Historical perspective is much needed in considering Selikoff and his contributions, both good and bad. Even after his death, Selikoff remains an important player in the passion play of the American asbestos litigation and regulation[18], and any biographer who steps up to the task will have to confront all aspects of Selikoff’s long career, both scientific advances and missteps.

[1] See Steven Novella, “Prince Charles Alternative Medicine Charity Closes” Science-Based Medicine (May 16, 2012); Laura Donnelly, “Prince Charles makes plea on alternative medicine: Prince of Wales calls for alternative medicine to be treated fairly and for regulation to govern its use,” The Telegraph (Jan. 19, 2014).

[2] Compare Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 619 (2007) (complaining that some historians have “demonized” Dr. Irving Selikoff as “a media zealot”); Jock McCulloch & Geoffrey Tweedale, “Science is not sufficient: Irving J. Selikoff and the asbestos tragedy,” 17 New Solutions 292 (2007); Jock McCulloch and Geoffrey Tweedale, Defending The Indefensible: The Global Asbestos Industry and its Fight for Survival (2008), with Geoffrey Tweedale, “Hero or Villain?—Sir Richard Doll and Occupational Cancer” 13 Internat’l J. Occup. Envt’l Health 233 (2007) (demonizing Sir Richard Doll for his affiliations and consultancies in the field of occupational cancer).

[3] Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,”  12 Br. J. Indus. Med. 81 (1955).

[4] See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).

[5] Capt. H.M. Robbins & William T. Marr, “Asbestosis,” 19 Safety Review 10 (1962) (noting that asbestos dust counts of 200 million particles per cubic foot were not uncommon during insulation ripouts onboard naval vessels, and the existence of asbestosis cases among workers).

[6] Irving J. Selikoff, Jacob Churg & E. Cuyler Hammond, “Asbestos Exposure and Neoplasia,” 188 J. Am. Med. Ass’n 22 (1964)

[7] American Medical Association Council on Ethical and Judicial Affairs Current Opinion 9.07 on Medical Testimony (1989); Council of Medical Specialty Societies, Statement on Qualifications and Guidelines for the Physician Expert Witness, (Approved March 20,1989); American College of Physicians, Guidelines for the Physician Expert Witness. Ann Intern Med 113:789, 1990; Ethics Committee, American College of Chest Physicians Guidelines for an Expert Witness. Chest 98:1006 (1990).

[8] AMA Board of Trustees, Proceedings: House of Delegates 149-154 (June 18-22,1989). See generally Nathan Schachtman & Cynthia Rhodes, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Seminars in Roentgenology 140 (1992).

[9] Quintilian, IV Institutio Oratoria 1.57 (“But to avoid all display of art in itself requires consummate art.”)

[10] Bradshaw v. Twin City Insulation Co. Ltd., Industrial Court of Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., E. D. Michigan Southern Division, Civ. Action No. 29433 (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Commonwealth Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973).

Selikoff also participated as a testifying witness for the government, in the Reserve Mining case. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D. Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D. Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D. Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D. Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

[11] See Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003) (citing Haas).

[12] Ruth Lilis, Albert Miller, Yasunosuke Suzuki, William Nicholson, Arthur Frank, Henry Anderson, Stephen Levin, Steven Markowitz, Jacqueline Moline, Susan Daum, et al.

[13] Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 626 & n.33 (2007).

[14] Jock McCulloch & Geoffrey Tweedale, “Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619, 626 & n34 (2007) (citing letter from Prof. Julian Peto to Dr. Thomas Chalmers, Mount Sinai Medical Center, June 28, 1990, from the Selikoff Archive, at Mount Sinai Hospital, NY).

[15] Arthur C. Upton, Jonathan Samet, Margaret R. Becklake, John M.G. Davis, David G. Hoel (of the National Institute of Environmental Health Sciences) Morton Lippmann, Gordon Gamsu, and Julian Peto

[16] William J. Nicholson and Arthur Langer, although Dr. Langer had by this time left Mt. Sinai.

[17] See, e.g., Philip H. Abelson, “The Asbestos Removal Fiasco,” 247 Science 1017 (1990).

[18] See Department of Labor, Occupational Safety and Health Administration, Final Rule re Docket No. H-033-dl Occupational Exposure to Asbestos, Tremolite, Anthophyllite and Actinolite, 29 C.F.R. Parts 1910 and 1926, 57 Fed. Reg 24310 (June 8, 1992) (rejecting Selikoff’s and the Lobby’s attempt to have cleavage fragments regulated as though they were fibers).

Posted in Conflicts of Interest, Expert Witnesses, Historian Testimony | Comments Off on Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas

Contrivance Standard Applied to Gatekeepers and Expert Witnesses

October 1st, 2014

In Rink v. Cheminova, Inc., 400 F.3d 1286 (11th Cir. 2005), the Eleventh Circuit’s articulated a “contrivance standard,” which suggested that a district court “may properly consider whether the expert’s methodology has been contrived to reach a particular result.” Id. at 1293 & n.7; see also “The Contrivance Standard for Expert Witness Gatekeeping” (Sept. 28, 2014).

Although this standard has some appeal, it raises questions of motives that can complicate the Rule 702 inquiry into whether an purported opinion is “knowledge.” A less psychoanalytic inquiry into the expert witness’s motivation should generally be the first line of approach.

In the Zoloft MDL, the trial court banished Dr. Anick Bérard from federal court birth defect cases because of her unprincipled and inexplicable cherry picking of data, relied upon for her causation opinions. See In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig. MDL No. 2342; 12-md-2342, 2014 U.S. Dist. LEXIS 87592; 2014 WL 2921648 (E.D. Pa. June 27, 2014) (Rufe, J.). The “contrivance” was objectively obvious and manifest in double-counting data points, and ignoring point estimates that were contrary to the desired outcome, even from papers that provided point estimates that were selectively embraced.

In the Chantix MDL, the trial court found the defendant to have harped on methodological peccadilloes but obviously did not like the beatific music (3x). Cherry picking was going on, but it was perfectly acceptable to this MDL court:

“Why Dr. Kramer chose to include or exclude data from specific clinical trials is a matter for crossexamination, not exclusion under Daubert.”

In re Chantix (varenicline) Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1288 (2012) (MDL No. 2092) (permitting Dr. Shira Kramer to testify on causation despite her embracing a “weight of the evidence” method that turned largely on‘‘subjective interpretations’’ of various, undescribed, non-prespecified lines of evidence).

The differing approaches to cherry picking are hard to reconcile other than to note that Chantix had drawn a “black box” warning from the FDA, and the SSRIs involved in Zoloft had not been given any heightened warning from the FDA, foreign agencies, or any professional society. FDA labeling, of course, should not have been determinative of the causation question. The mind of the gatekeeper, however, is inscrutable.

 

 

Posted in Expert Witnesses, Rule 702 | Comments Off on Contrivance Standard Applied to Gatekeepers and Expert Witnesses

CHARGE: Coyness in Disclosing Conflicts

October 1st, 2014

Back in June, the Environmental Health Perspectives posted an “in-press” version of a study from the CHARGE group on autism disorders and pesticide exposures. This month, the October issue of EHP has the final version of the article. Janie F. Shelton, Estella M. Geraghty, Daniel J. Tancredi, Lora D. Delwiche, Rebecca J. Schmidt, Beate Ritz, Robin L. Hansen, and Irva Hertz-Picciotto, “Neurodevelopmental disorders and prenatal residential Proximity to Agricultural pesticides: the CHARGE Study,” 122 Envt’l Health Persp. (2014).

At the time of the in-press publication, I posted a plea that the media pay attention to principal investigator Dr. Hertz-Picciotto’s conflict of interest disclosure, and its failure to acknowledge her advocacy role on the advisory board of Autism Speaks. See “NIEHS Study – CHARGE Failure to Disclose Conflicts of Interest” (June 23, 2014). The published version does indeed, by way of an erratum, acknowledge Hertz-Picciotto’s, and other authors’, membership in Autism Speaks, and their regret in omitting this information earlier.

Unfortunately, the erratum fails to mention that Hertz-Picciotto also serves on the advisory board of the radically anti-chemical Healthy Child, Healthy World organization, located in California (12100 Wilshire Blvd. Suite 800, Los Angeles CA 90025). Healthy Child Healthy World is a California non-profit corporation that advocates to:

“Demand corporate accountability
Engage communities for collective action
Support safer chemicals and products
Influence legislative and regulatory reform.”

It looks as though more regrets and more errata are in order.

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