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Adverse Liver Events and Causal Claims Against Black Cohosh

April 6th, 2015

Liver toxicity in pharmaceutical products liability cases is one of the more difficult categories of cases for judicial gatekeeping because of the possibility of idiosyncratic liver toxicity. Sometimes a plaintiff will exploit this difficulty and try to recover for an acute liver reaction.

Susan Grant began to take a black cohosh herbal remedy in 2002, and within a year, developed autoimmune hepatitis, which required her to undergo a liver transplant. She and her husband sued the seller of black cohosh for substantial damages. Grant v. Pharmavite, LLC, 452 F. Supp 2d 903 (D. Neb. 2006). Granted enlisted two expert witnesses, Michael Corbett, Ph.D, a toxicologist, and her treating gastroenterologist, Michael Sorrell, M.D. The defense relying upon liver expert, Phillip Guzelian, M.D., challenged the admissibility of plaintiffs’ expert witnesses’ opinions under the federal rules.

Struggling with the law, Senior Judge Strom observed that Nebraska law requires expert witness opinion testimony on causation. Id. at 906. Of course, in this diversity action, federal law controlled on the scope and the requirements of expert witness opinion testimony.

And in a similarly offbeat way, Judge Strom suggested that plaintiffs’ expert witnesses need not have opinion supported by evidence:

“While it is not necessary that an opinion be backed by scientific research, it is necessary that an expert’s testimony, which contradicts all of the research, at minimum address and distinguish the contradictory research in order to support the expressed opinion.”

Id. at 907 (emphasis added). Senior Judge Strom thus suggests had there been no published research at all, then Dr. Corbett could just make up an opinion, not backed by scientific research. This is, of course, seriously wrong, but fortunately it amounts only to obiter detritus, because Judge Strom believed that given the available studies, the testifying expert witnesses had to do more than simply criticize the studies that disagreed with their subjective opinion.

Michael Corbett, Ph.D, a consultant in “chemical toxicology,” from Omaha, Nebraska, criticized existent studies, which generally failed to identify liver toxicity, but he failed to conduct his own studies. Id. at 907. And Corbett also failed to explain why he rejected the great weight of medical publications that found that black cohosh was not hepatotoxic. Id. Michael Sorrell, M.D., started out as Ms. Grant’s treating gastroenterologist, but became a litigation expert witness. He was generally unaware of the randomized clinical trials of black cohosh, or any study that, or group of scientists who, supported his opinion. Id. at 909.

To Dr. Sorrell’s credit, he did attempt to write up a case report, which was published after the termination of the case. Unfortunately for Dr. Sorrell and his colleagues, Ms. Grant and her lawyers were less than forthcoming about her medical history, which included medications and lifestyle variables that were apparently not shared with Dr. Sorrell. Id. at 909.

You know that the quality of gatekeeping due process is strained when judges fail to cite key studies sufficiently to permit their readers to find the scientific evidence. Between Google Scholar and PubMed, however, you can find Dr. Sorrell’s case report, which was published in 2005, before Judge Strom issued his Rule 702 opinion. Josh Levitsky, Tyron A. Alli, James Wisecarver, and Michael F. Sorrell, “Fulminant liver failure associated with the use of black cohosh,” 50 Digestive Dis. Sci. 538 (2005). If nothing else, Judge Strom provoked an erratum from Dr. Sorrell and colleagues:

“After the article was published, it was brought to the authors’ attention through legal documentation and testimony that the patient admitted to consuming alcohol and had been taking other medications at the time of her initial presentation of liver failure. From these records, she reported drinking no more than six glasses of wine per week. In addition, up until presentation, she was taking valacyclovir 500 mg daily for herpes prophylaxis for 2 years, an occasional pseudoephedrine tablet, calcium carbonate 500 mg three times daily, iron sulfate 325 mg daily and ibuprofen up to three times weekly. She had been taking erythromycin tablets but discontinued those 3 months prior to presentation.

The authors regret the omission of this information from the original case report. While this new information is important to include as a correction to the history, it does not change the authors’ clinical opinion … .”

The erratum omits that Ms. Grant was taking Advil (ibuprofen) at the time of her transplantation, and that she had been taking erythromycin for 2.5 years, stopping just a few months before her acute liver illness. The Valtrex use shows that Ms. Grant had a chronic herpes infection. In the past, plaintiff took such excessive doses of ibuprofen that she developed anemia. Grant v. Pharmavite, LLC, 452 F. Supp 2d at 909 n.1. Hardly an uncomplicated case report to interpret for causality and an interesting case history of confirmation bias. Remarkably, the journal charges $39.95 to download the erratum, as much as the case report itself!

And how has the plaintiff’s claim fared in the face of the evolving scientific record since Judge Strom’s opinion?

Not well.

See, e.g., Peter W Whiting, Andrew Clouston and Paul Kerlin, “Black cohosh and other herbal remedies associated with acute hepatitis,” 177 Med. J. Australia 432 (2002); Cohen SM, O’Connor AM, Hart J, et al. Autoimmune hepatitis associated with the use of black cohosh: a case study. 11 Menopause 575 (2004); Christopher R. Lynch, Milan E. Folkers, and William R. Hutson, “Fulminant hepatic failure associated with the use of black cohosh: A case report,” 12 Liver Transplantation 989 (2006); Elizabeth C-Y Chow, Marcus Teo, John A Ring and John W Chen, “Liver failure associated with the use of black cohosh for menopausal symptoms,” 188 Med. J. Australia 420 (2008); Gail B. Mahady, Tieraona Low Dog, Marilyn L. Barrett, Mary L. Chavez, Paula Gardiner, Richard Ko, Robin J. Marles, Linda S. Pellicore, Gabriel I. Giancaspro, and Dandapantula N. Sarma, “United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity,” 15 Menopause 628 (2008) (toxicity only possible on available evidence); D. Joy, J. Joy, and P. Duane, “Black cohosh: a cause of abnormal postmenopausal liver function tests,” 11 Climacteric 84 (2008); Lily Dara, Jennifer Hewett, and Joseph Kartaik Lim, “Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements,” 14 World J. Gastroenterol. 6999 (2008); F. Borrelli & E. Ernst, “Black cohosh (Cimicifuga racemosa): a systematic review of adverse events,” Am. J. Obstet. & Gyn. 455 (2008); Rolf Teschke & A. Schwarzenboeck, “Suspected hepatotoxicity by Cimicifugae racemosae rhizoma (black cohosh, root): critical analysis and structured causality assessment,” 16 Phytomedicine 72 (2009); Stacie E. Geller, Lee P. Shulman, Richard B. van Breemen, Suzanne Banuvar, Ying Zhou, Geena Epstein, Samad Hedayat, Dejan Nikolic, Elizabeth C. Krause, Colleen E. Piersen, Judy L. Bolton, Guido F. Pauli, and Norman R. Farnsworth, “Safety and Efficacy of Black Cohosh and Red Clover for the Management of Vasomotor Symptoms: A Randomized Controlled Trial,” 16 Menopause 1156 (2009) (89 women randomized to four groups; no hepatic events in trial not powered to detect them); Rolf Teschke, “Black cohosh and suspected hepatotoxicity: inconsistencies, confounding variables, and prospective use of a diagnostic causality algorithm. A critical review,” 17 Menopause 426 (2010) (“The presented data do not support the concept of hepatotoxicity in a primarily suspected causal relationship to the use of BC and failure to provide a signal of safety concern, but further efforts have to be undertaken to dismiss or to substantiate the existence of BC hepatotoxicity as a special disease entity. The future strategy should be focused on prospective causality evaluations in patients diagnosed with suspected BC hepatotoxicity, using a structured, quantitative, and hepatotoxicity-specific causality assessment method.”); Fabio Firenzuoli, Luigi Gori, and Paolo Roberti di Sarsina, “Black Cohosh Hepatic Safety: Follow-Up of 107 Patients Consuming a Special Cimicifuga racemosa rhizome Herbal Extract and Review of Literature,” 2011 Evidence-Based Complementary & Alternative Med. 1 (2011); Rolf Teschke, Wolfgang Schmidt-Taenzer and Albrecht Wolff, “Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: is the liver-unspecific Naranjo scale precise enough to ascertain causality?” 20 Pharmacoepidemiol. & Drug Safety 567 (2011) (causation unlikely or excluded); Rolf Teschke, Alexander Schwarzenboeck, Wolfgang Schmidt-Taenzer, Albrecht Wolff, and Karl-Heinz Hennermann, “Herb induced liver injury presumably caused by black cohosh: A survey of initially purported cases and herbal quality specifications,” 11 Ann. Hepatology 249 (2011).

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Johnson of Accutane – Keeping the Gate in the Garden State

March 28th, 2015

Nelson Johnson is the author of Boardwalk Empire: The Birth, High Times, and Corruption of Atlantic City (2010), a rattling good yarn, which formed the basis for a thinly fictionalized story of Atlantic City under the control of mob boss (and Republican politician) Enoch “Nucky” Johnson. HBO transformed Johnson’s book into a multi-season series, with Steve Buscemi playing Nucky Johnson (Thompson in the series). Robert Strauss, “Judge Nelson Johnson: Atlantic City’s Godfather — A Q&A with Judge Nelson Johnson,” New Jersey Monthly (Aug. 16, 2010).

Nelson Johnson is also known as the Honorable Nelson Johnson, a trial court judge in Atlantic County, New Jersey, where he inherited some of the mass tort docket of Judge Carol Higbee. Judge Higbee has since ascended to the Appellate Division of the New Jersey Superior Court. One of the litigations Judge Johnson presides over is the mosh pit of isotretinoin (Accutane) cases, involving claims that the acne medication causes irritable bowel syndrome (IBS) and Crohn’s disease (CD). Judge Johnson is not only an accomplished writer of historical fiction, but he is also an astute evaluator of the facts and data, and the accompanying lawyers’ rhetoric, thrown about in pharmaceutical products liability litigation.

Perhaps more than his predecessor ever displayed, Judge Johnson recently demonstrated his aptitude for facts and data in serving as a gatekeeper of scientific evidence, as required by the New Jersey Supreme Court, in Kemp v. The State of New Jersey, 174 NJ 412 (2002). Faced with a complex evidentiary display on the validity and reliability of the scientific evidence, Judge Johnson entertained extensive briefings, testimony, and oral argument. When the dust settled, the 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 settling the dust, Judge Johnson dispatched several bogus and misleading “lines of evidence,” which have become standard ploys to clog New Jersey and other courthouses.

Case Reports

As so often is the case when there is no serious scientific evidence of harm in pharmaceutical cases, plaintiffs in the Accutane litigation relied heavily upon case and adverse event reports. Id. at *11. Judge Johnson was duly unimpressed, and noted that:

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

Id. at *16.

Bootstrapped, Manufactured Evidence

With respect to case reports that are submitted to the FDA’s Adverse Event Reporting System (FAERS), Judge Johnson acknowledged the “serious limitations” of the hearsay anecdotes that make up such reports. Despite the value of AERs in generating signals for future investigation, Judge Johnson, citing FDA’s own description of the reporting system, concluded that the system’s anecdotal data are “not evidentiary in a court of law.” Id. at 14 (quoting FDA’s description of FAERS).

Judge Johnson took notice of another fact; namely, the industry litigation creates evidence that it then uses to claim causal connections in the courtroom. Plaintiffs’ lawyers in pharmaceutical cases routinely file Medwatch adverse event reports, which thus inflate the “signal,” they claim supports the signal of harm from medication use. This evidentiary bootstrapping machine was hard at work in the isotretinoin litigation. See Derrick J. Stobaugh, Parakkal Deepak, and Eli D. Ehrenpreis, “Alleged Isotretinoin-Associated Inflammatory Bowel Disease: Disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System,” 69 J. Am. Acad. Dermatol. 398 (2013) (“Attorney-initiated reports inflate the pharmacovigilance signal of isotretinoin-associated IBD in the FAERS.”). Judge Johnson gave a wry hat tip to plaintiffs’ counsel’s industry, by acknowledging that the litigation industry itself had inflated this signal-generating process:

“The legal profession is a bulwark of our society, yet the courts should never underestimate the resourcefulness of some attorneys.”

In re Accutane, 2015 WL 753674, at *15.

Bias and Confounding

The epidemiologic studies referenced by the parties had identified a fairly wide range of “risk factors” for irritable bowel syndrome, including many prevalent factors in Westernized countries 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 known to be risk factors for IBD: aspirin, nonsteroidal anti-inflammatory medications (NSAIDs), oral contraceptives, and antibiotics.

In reviewing the plaintiffs’ expert witnesses’ methodology, Judge Johnson found that they had been inordinately, and inappropriately selective in the studies chosen for reliance. The challenged witnesses had discounted and discarded most of the available studies in favor of two studies that were small, biased, and not population based. Indeed, one of the studies evidenced substantial selection bias by using referrals to obtain study participants, a process deprecated by the trial court as “cherry picking the subjects.” Id. at *18. “The scientific literature does not support reliance upon such insignificant studies to arrive at conclusions.” Id.

Animal Studies

Both sides in the isotretinoin cases seemed to concede the relative unimportance of animal studies. The trial court discussed the limitations on animal studies, especially the absence of a compelling animal model of human irritable bowel syndrome. Id. at *18.

Cherry Picking and Other Crafty Stratagems

With respect to the complete scientific evidentiary display, plaintiffs asserted that their expert witnesses had considered everything, but then failed to account for most of the evidence. Judge Johnson found this approach deceptive and further evidence of a cherry-picking, pathological methodology:

‘‘Finally, coursing through Plaintiffs’ presentation is a refrain that is a ruse. Repeatedly, counsel for the Plaintiffs and their witnesses spoke of ‛lines of evidence”, emphasizing that their experts examined ‛the same lines of evidence’ as did the experts for the Defense. Counsels’ sophistry is belied by the fact that the examination of the ‘lines of evidence’ by Plaintiffs’ experts was highly selective, looking no further than they wanted to—cherry picking the evidence—in order to find support for their conclusion-driven testimony in support of a hypothesis made of disparate pieces, all at the bottom of the medical evidence hierarchy.’’

Id. at *21.

New Jersey Rule of Evidence 703

The New Jersey rules of evidence, like the Federal Rules, imposes a reasonableness limit on what sorts of otherwise inadmissible evidence an expert witness may rely upon. See “RULE OF EVIDENCE 703 — Problem Child of Article VII” (Sept. 9, 2011). Although Judge Johnson did not invoke Rule 703 specifically, he was clearly troubled by plaintiffs’ expert witnesses’ reliance upon an unadjusted odds ratio from an abstract, which did not address substantial confounding from a known causal risk factor – antibiotics use. Judge Johnson concluded that the reliance upon the higher, unadjusted risk figure, contrary to the authors’ own methods and conclusions, and without a cogent explanation for so doing was “pure advocacy” on the part of the witnesses. In re Accutane, 2015 WL 753674, at *17; see also id. at *5 (citing Landrigan v. Celotex Corp., 127 N.J. 404, 417 (1992), for the proposition that “when an expert relies on such data as epidemiological studies, the trial court should review the studies, as well as other information proffered by the parties, to determine if they are of a kind on which such experts ordinarily rely.”).

Discordance Between Courtroom and Professional Opinions

One of plaintiffs’ expert witnesses, Dr. Arthur Kornbluth actually had studied putative association between isotretinoin and CD before he became intensively involved in litigation as an expert witness. In re Accutane, 2015 WL 753674, at *7. Having an expert witness who is a real world expert can be a plus, but not when that expert witness maintains a double standard for assessing causal connections. Back in 2009, Kornbluth published an article, “Ulcerative Colitis Practice Guidelines in Adults” in The American Journal of Gastroenterology. Id. at *10. This positive achievement became a large demerit when cross-examination at the Kemp hearing revealed that Kornbluth had considered but rejected the urgings of a colleague, Dr. David Sachar, to comment on isotretinoin as a cause of irritable bowel syndrome. In front of Judge Johnson, Dr. Kornbluth felt no such scruples. Id. at *11. Dr. Kornbluth’s stature in the field of gastroenterology, along with his silence on the issue in his own field, created a striking contrast with his stridency about causation in the courtroom. The contrast raised the trial court’s level of scrutiny and skepticism about his causal opinions in the New Jersey litigation. Id. (citing and quoting Soldo v. Sandoz Pharms. Corp, 244 F. Supp. 2d 434, 528 (W.D. Pa. 2003) (“Expert opinions generated as the result of litigation have less credibility than opinions generated as the result of academic research or other forms of ‘pure’ research.”) (“The expert’s motivation for his/her study and research is important. … We may not ignore the fact that a scientist’s normal work place is the lab or field, not the courtroom or the lawyer’s office.”).

Meta-Analysis

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 performed on isotretinoin and irritable bowel outcomes. In re Accutane, 2015 WL 753674, at *8. Dr. Goodman explained that:

“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.”

Id. Dr. Goodman further explained that plaintiffs’ expert witnesses’ failure to perform a meta-analysis was telling meta-analysis “can get us closer to the truth.” Id.

Some Nitpicking

Specific Causation

After such a commanding judicial performance by Judge Johnson, nitpicking on specific causation might strike some as ungrateful. For some reason, however, Judge Johnson cited several cases on the appropriateness of expert witnesses’ reliance upon epidemiologic studies for assessing specific causation or for causal apportionment between two or more causes. In re Accutane, 2015 WL 753674, at *5 (citing Landrigan v. Celotex Corp., 127 N.J. 404 (1992), Caterinicchio v. Pittsburgh Corning, 127 N.J. 428 (1992), and Dafler v. Raymark Inc., 259 N.J. Super. 17, 36 (App. Div. 1992), aff’d. o.b. 132 N.J. 96 (1993)). Fair enough, but specific causation was not at issue in the Accutane Kemp hearing, and the Landrigan and Caterinicchio cases are irrelevant to general causation.

In both Landrigan and Caterincchio, the defendants moved for directed verdicts by arguing that, assuming arguendo that asbestos causes colon cancer, the plaintiffs’ expert witnesses had not presented a sufficient opinion to support that Landrigan’s and Caterinnichio’s colon cancers were caused by asbestos. See “Landrigan v. The Celotex Corporation, Revisited” (June 4, 2013). General causation was thus never at issue, and the holdings never addressed the admissibility of the expert witnesses’ causation opinions. Only sufficiency of the opinions that equated increased risks, less than 2.0, to specific causation was at issue in the directed verdicts, and the appeals taken from the judgments entered on those verdicts.

Judge Johnson, in discussing previous case law suggests that the New Jersey Supreme Court reversed and remanded the Landrigan case for trial, holding that “epidemiologists could help juries determine causation in toxic tort cases and rejected the proposition that epidemiological studies must show a relative risk factor of 2.0 before gaining acceptance by a court.” In re Accutane, 2015 WL 753674, at *5, citing Landrigan, 127 N.J. at 419. A close and fair reading of Landrigan, however, shows that it was about a directed verdict, 127 N.J. at 412, and not a challenge to the use of epidemiologic studies generally, or to their use to show general causation.

Necessity of Precise Biological Mechanism

In the Accutane hearings, the plaintiffs’ counsel and their expert witnesses failed to provide a precise biological mechanism of the cause of IBD. Judge Johnson implied that any study that asserted that Accutane caused IBD ‘‘would, of necessity, require an explication of a precise biological mechanism of the cause of IBD and no one has yet to venture more than alternate and speculative hypotheses on that question.’’ In re Accutane, 2015 WL 753674, at *8. Conclusions of causality, however, do not always come accompanied by understood biological mechanisms, and Judge Johnson demonstrated that the methods and evidence relied upon by plaintiffs’ expert witnesses could not, in any event, allow them to draw causal conclusions.

Interpreting Results Contrary to Publication Authors’ Interpretations

There is good authority, no less than the United States Supreme Court in Joiner, that there is something suspect in expert witnesses’ interpreting a published study’s results in contrary to the authors’ publication. Judge Johnson found that the plaintiffs’ expert witnesses in the Accutane litigation had inferred that two studies showed increased risk when the authors of those studies had concluded that their studies did not appear to show an increased risk. Id. at *17. There will be times, however, when a published study may have incorrectly interpreted its own data, when “real” expert witnesses can, and should, interpret the data appropriately. Accutane was not such a case. In In re Accutane, Judge Johnson carefully documented and explained how the plaintiffs’ expert witnesses’ supposed reinterpretation was little more than attempted obfuscation. His Honor concluded that the witnesses’ distortion of, and ‘‘reliance upon these two studies is fatal and reveals the lengths to which legal counsel and their experts are willing to contort the facts and torture the logic associated with Plaintiffs’ hypothesis.’’ Id. at *18.

[1] “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).

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The Joiner Finale

March 23rd, 2015

“This is the end
Beautiful friend
This is the end
My only friend, the end”

Jim Morrison, “The End” (c. 1966)

* * * * * * * * * *

The General Electric Co. v. Joiner, 522 U.S. 136 (1997), case was based upon polychlorinated biphenyl exposures (PCB), only in part. The PCB part did not hold up well legally in the Supreme Court; nor was the PCB lung cancer claim vindicated by later scientific evidence. See “How Have Important Rule 702 Holdings Held Up With Time?” (Mar. 20, 2015).

The Supreme Court in Joiner reversed and remanded the case to the 11th Circuit, which then remanded the case back to the district court to address claims that Mr. Joiner had been exposed to furans and dioxins, and that these other chemicals had caused, or contributed to, his lung cancer, as well. Joiner v. General Electric Co., 134 F.3d 1457 (11th Cir. 1998) (per curiam). Thus the dioxins were left in the case even after the Supreme Court ruled.

After the Supreme Court’s decision, Anthony Roisman argued that the Court had addressed an artificial question when asked about PCBs alone because the case was really about an alleged mixture of exposures, and he held out hope that the Joiners would do better on remand. Anthony Z. Roisman, “The Implications of G.E. v. Joiner for Admissibility of Expert Testimony,” 1 Res Communes 65 (1999).

Many Daubert observers (including me) are unaware of the legal fate of the Joiners’ claims on remand. In the only reference I could find, the commentator simply noted that the case resolved before trial.[1] I am indebted to Michael Risinger, and Joseph Cecil, for pointing me to documents from PACER, which shed some light upon the Joiner “endgame.”

In February 1998, Judge Orinda Evans, who had been the original trial judge, and who had sustained defendants’ Rule 702 challenges and granted their motions for summary judgments, received and reopened the case upon remand from the 11th Circuit. In March, Judge Evans directed the parties to submit a new pre-trial order by April 17, 1998. At a status conference in April 1998, Judge Evans permitted the plaintiffs additional discovery, to be completed by June 17, 1998. Five days before the expiration of their additional discovery period, the plaintiffs moved for additional time; defendants opposed the request. In July, Judge Evans granted the requested extension, and gave defendants until November 1, 1998, to file for summary judgment.

Meanwhile, in June 1998, new counsel entered their appearances for plaintiffs – William Sims Stone, Kevin R. Dean, Thomas Craig Earnest, and Stanley L. Merritt. The docket does not reflect much of anything about the new discovery other than a request for a protective order for an unpublished study. But by October 6, 1998, the new counsel, Earnest, Dean, and Stone (but not Merritt) withdrew as attorneys for the Joiners, and by the end of October 1998, Judge Evans entered an order to dismiss the case, without prejudice.

A few months later, in February 1999, the parties filed a stipulation, approved by the Clerk, dismissing the action with prejudice, and with each party to bear its own coasts. Given the flight of plaintiffs’ counsel, the dismissals without and then with prejudice, a settlement seems never to have been involved in the resolution of the Joiner case. In the end, the Joiners’ case fizzled perhaps to avoid being Frye’d.

And what has happened since to the science of dioxins and lung cancer?

Not much.

In 2006, the National Research Council published a monograph on dioxin, which took the controversial approach of focusing on all cancer mortality rather than specific cancers that had been suggested as likely outcomes of interest. See David L. Eaton (Chairperson), Health Risks from Dioxin and Related Compounds – Evaluation of the EPA Reassessment (2006). The validity of this approach, and the committee’s conclusions, were challenged vigorously in subsequent publications. Paolo Boffetta, Kenneth A. Mundt, Hans-Olov Adami, Philip Cole, and Jack S. Mandel, “TCDD and cancer: A critical review of epidemiologic studies,” 41 Critical Rev. Toxicol. 622 (2011) (“In conclusion, recent epidemiologicalevidence falls far short of conclusively demonstrating a causal link between TCDD exposure and cancer risk in humans.”

In 2013, the Industrial Injuries Advisory Council (IIAC), an independent scientific advisory body in the United Kingdom, published a review of lung cancer and dioxin. The Council found the epidemiologic studies mixed, and declined to endorse the compensability of lung cancer for dioxin-exposed industrial workers. Industrial Injuries Advisory Council – Information Note on Lung cancer and Dioxin (December 2013). See also Mann v. CSX Transp., Inc., 2009 WL 3766056, 2009 U.S. Dist. LEXIS 106433 (N.D. Ohio 2009) (Polster, J.) (dioxin exposure case) (“Plaintiffs’ medical expert, Dr. James Kornberg, has opined that numerous organizations have classified dioxins as a known human carcinogen. However, it is not appropriate for one set of experts to bring the conclusions of another set of experts into the courtroom and then testify merely that they ‘agree’ with that conclusion.”), citing Thorndike v. DaimlerChrysler Corp., 266 F. Supp. 2d 172 (D. Me. 2003) (court excluded expert who was “parroting” other experts’ conclusions).

[1] Morris S. Zedeck, Expert Witness in the Legal System: A Scientist’s Search for Justice 49 (2010) (noting that, after remand from the Supreme Court, Joiner v. General Electric resolved before trial)

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How Have Important Rule 702 Holdings Held Up With Time?

March 20th, 2015

The Daubert case arose from claims of teratogenicity of Bendectin. The history of the evolving scientific record has not been kind to those claims. See “Bendectin, Diclegis & The Philosophy of Science” (Oct. 26, 2013); Gideon Koren, “The Return to the USA of the Doxylamine-Pyridoxine Delayed Release Combination (Diclegis®) for Morning Sickness — A New Morning for American Women,” 20 J. Popul. Ther. Clin. Pharmacol. e161 (2013). Twenty years later, the decisions in the Daubert appeals look sound, even if the reasoning was at times shaky. How have other notable Rule 702 exclusions stood up to evolving scientific records?

A recent publication of an epidemiologic study on lung cancer among workers exposed to polychlorinated biphenyls (PCBs) raised an interested question about a gap in so-called Daubert scholarship. Clearly, there are some cases, like General Electric v. Joiner[1], in which plaintiffs lack sufficient, valid evidence to make out their causal claims. But are there cases of Type II injustices, for which, in the fullness of time, the insufficiency or invalidity of the available evidentiary display is “cured” by subsequently published studies?

In Joiner, Chief Justice Rehnquist noted that the district court had carefully analyzed the four epidemiologic studies claimed by plaintiff to support the association between PCB exposure and lung cancer. The first such study[2] involved workers at an Italian capacitor plant who had been exposed to PCBs.

The Chief Justice reported that the authors of the Italian capacitor study had noted that lung cancer deaths among former employees were more numerous than expected (without reporting whether there was any assessment of random error), but that they concluded that “there were apparently no grounds for associating lung cancer deaths (although increased above expectations) and exposure in the plant.”[3] The court frowned at the hired expert witnesses’ willingness to draw a causal inference when the authors of the Bertazzi study would not. As others have noted, this disapproval was beside the point of the Rule 702 inquiry. It might well be the case that Bertazzi and his co-authors could not or did not conduct a causal analysis, but that does not mean that the study’s evidence could not be part of a larger effort to synthesize the available evidence. In any event, the Bertazzi study was small and uninformative. Although all cancer mortality was increased (14 observed vs. 5.5 expected, based upon national rates; SMR = 253; 95% CI 144-415), the study was too small to be meaningful for lung cancer outcomes.

The second cited study[4], from an unpublished report, followed workers at a Monsanto PCB production facility. The authors of the Monsanto study reported that the lung cancer mortality rate among exposed workers “somewhat” higher than expected, but that the “increase, however, was not statistically significant and the authors of the study did not suggest a link between the increase in lung cancer deaths and the exposure to PCBs.” Again, the Court’s emphasis on what the authors stated is unfortunate. What is important is obscured because the Court never reproduced the data from this unpublished study.

The third study[5] cited by plaintiff’s hired expert witnesses was of “no help,” in that the study followed workers exposed to mineral oil, without any known exposure to PCBs. Although the workers exposed to this particular mineral oil had a statistically significantly elevated lung cancer mortality, the study made no reference to PCBs.

The fourth study[6] cited by plaintiffs’ expert witnesses followed a Japanese PCB-exposed group, which had a “statistically significant increase in lung cancer deaths.” The Court, however, was properly concerned that the cohort was exposed to numerous other potential carcinogens, including toxic rice oil by ingestion.

The paucity of this evidence led the Court to observe:

“Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered. … That is what the District Court did here, and we hold that it did not abuse its discretion in so doing.”

Joiner, 522 U.S. at 146 (1997).

Interestingly omitted from the Supreme Court’s discussion was why the plaintiffs’ expert witnesses failed to rely upon all the available epidemiology. The excluded witnesses relied upon an unpublished Monsanto study, but apparently ignored an unpublished investigation by NIOSH researchers, who found that there were “no excess deaths from cancers of the … the lung,” among PCB-exposed workers at a Westinghouse Electric manufacturing facility[7]. Actually, NIOSH reported a statistically non-significant decrease in lung cancer rate, with fairly a narrow confidence interval.

Two Swedish studies[8] were perhaps too small to add much to the mix of evidence, but lung cancer rates were not apparently increased in a North American study[9].

Joiner thus represents not only an analytical gap case, but also a cherry picking case, as well. The Supreme Court was eminently correct to affirm the shoddy evidence proffered in the Joiner case.

But has the District Judge’s exclusion of Joiner’s expert witnesses (Dr. Arnold Schecter and Dr. (Rabbi) Daniel Teitelbaum) stood up to the evolving scientific record?

A couple of weeks ago, researchers published a large, updated cohort study, funded by General Electric, on the mortality experience of workers in a plant that manufactured capacitors with PCBs[10]. Although the Lobby and the Occupational Medicine Zealots will whine about the funding source, the study is a much stronger study than anything relied upon by Mr. Joiner’s expert witnesses, and its results are consistent with the NIOSH study available to, but ignored by, Joiner’s expert witnesses. And the results are not uniformly good for General Electric, but on the end point of lung cancer for men, the standardized mortality ratio was 81 (95% C.I., 68 – 96), nominally statistically significantly below the expected SMR of 100.

[1] General Electric v. Joiner, 522 U.S. 136 (1997).

[2] Bertazzi, Riboldi, Pesatori, Radice, & Zocchetti, “Cancer Mortality of Capacitor Manufacturing Workers, 11 Am. J. Indus. Med. 165 (1987).

[3] Id. at 172.

[4] J. Zack & D. Munsch, Mortality of PCB Workers at the Monsanto Plant in Sauget, Illinois (Dec. 14, 1979) (unpublished report), 3 Rec., Doc. No. 11.

[5] Ronneberg, Andersen, Skyberg, “Mortality and Incidence of Cancer Among Oil-Exposed Workers in a Norwegian Cable Manufacturing Company,” 45 Br. J. Indus. Med. 595 (1988).

[6] Kuratsune, Nakamura, Ikeda, & Hirohata, “Analysis of Deaths Seen Among Patients with Yusho – A Preliminary Report,” 16 Chemosphere 2085 (1987).

[7] Thomas Sinks, Alexander B. Smith, Robert Rinsky, M. Kathy Watkins, and Ruth Shults, Health Hazard Evaluation Report, HETA 89-116-209 (Jan. 1991) (reporting lung cancer SMR = 0.7 (95%CI, 0.4 – 1.2). This unpublished study was published by the time the Joiner case was litigated. Thomas Sinks, G. Steele, Alexander B. Smith, and Ruth Shults, “Mortality among workers exposed to polychlorinated biphenyls,” 136 Am. J. Epidemiol. 389 (1992). A follow-up on this unpublished study confirmed the paucity of lung cancer in the cohort. See Avima M. Ruder, Misty J. Hein, Nancy Nilsen, Martha A. Waters, Patricia Laber, Karen Davis-King, Mary M. Prince, and Elizabeth Whelan, “Mortality among Workers Exposed to Polychlorinated Biphenyls (PCBs) in an Electrical Capacitor Manufacturing Plant in Indiana: An Update,” 114 Environmental Health Perspect. 18 (2006).

[8] P. Gustavsson, C. Hogstedt, and C. Rappe, “Short-term mortality and cancer incidence in capacitor manufacturing workers exposed to polychlorinated biphenyls (PCBs),” 10 Am. J. Indus. Med. 341 (1986); P. Gustavsson & C. Hogstedt, “A cohort study of Swedish capacitor manufacturing workers exposed to polychlorinated biphenyls (PCBs),” 32 Am. J. Indus. Med. 234 (1997) (cancer incidence for entire cohort, SIR = 86, 95%; CI 51-137).

[9] David P. Brown, “Mortality of workers exposed to polychlorinated biphenyls–an update,” 42 Arch. Envt’l Health 333 (1987)

[10] See Renate D. Kimbrough, Constantine A. Krouskas, Wenjing Xu, and Peter G. Shields, “Mortality among capacitor workers exposed to polychlorinated biphenyls (PCBs), a long-term update,” 88 Internat’l Arch. Occup. & Envt’l Health 85 (2015).

Posted in Causation, Rule 702 | Comments Off on How Have Important Rule 702 Holdings Held Up With Time?

Don’t Double Dip Data

March 9th, 2015

Meta-analyses have become commonplace in epidemiology and in other sciences. When well conducted and transparently reported, meta-analyses can be extremely helpful. In several litigations, meta-analyses determined the outcome of the medical causation issues. In the silicone gel breast implant litigation, after defense expert witnesses proffered meta-analyses[1], court-appointed expert witnesses adopted the approach and featured meta-analyses in their reports to the MDL court[2].

In the welding fume litigation, plaintiffs’ expert witness offered a crude, non-quantified, “vote counting” exercise to argue that welding causes Parkinson’s disease[3]. In rebuttal, one of the defense expert witnesses offered a quantitative meta-analysis, which provided strong evidence against plaintiffs’ claim.[4] Although the welding fume MDL court excluded the defense expert’s meta-analysis from the pre-trial Rule 702 hearing as untimely, plaintiffs’ counsel soon thereafter initiated settlement discussions of the entire set of MDL cases. Subsequently, the defense expert witness, with his professional colleagues, published an expanded version of the meta-analysis.[5]

And last month, a meta-analysis proffered by a defense expert witness helped dispatch a long-festering litigation in New Jersey’s multi-county isotretinoin (Accutane) litigation. In re Accutane Litig., No. 271(MCL), 2015 WL 753674 (N.J. Super., Law Div., Atlantic Cty., Feb. 20, 2015) (excluding plaintiffs’ expert witness David Madigan).

Of course, when a meta-analysis is done improperly, the resulting analysis may be worse than none at all. Some methodological flaws involve arcane statistical concepts and procedures, and may be easily missed. Other flaws are flagrant and call for a gatekeeping bucket brigade.

When a merchant puts his hand the scale at the check-out counter, we call that fraud. When George Costanza double dipped his chip twice in the chip dip, he was properly called out for his boorish and unsanitary practice. When a statistician or epidemiologist produces a meta-analysis that double counts crucial data to inflate a summary estimate of association, or to create spurious precision in the estimate, we don’t need to crack open Modern Epidemiology or the Reference Manual on Scientific Evidence to know that something fishy has taken place.

In litigation involving claims that selective serotonin reuptake inhibitors cause birth defects, plaintiffs’ expert witness, a perinatal epidemiologist, relied upon two published meta-analyses[6]. In an examination before trial, this epidemiologist was confronted with the double counting (and other data entry errors) in the relied-upon meta-analyses, and she readily agreed that the meta-analyses were improperly done and that she had to abandon her reliance upon them.[7] The result of the expert witness’s deposition epiphany, however, was that she no longer had the illusory benefit of an aggregation of data, with an outcome supporting her opinion. The further consequence was that her opinion succumbed to a Rule 702 challenge. 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.).

Double counting of studies, or subgroups within studies, is a flaw that most careful readers can identify in a meta-analysis, without advance training. According to statistician Stephen Senn, double counting of evidence is a serious problem in published meta-analytical studies. Stephen J. Senn, “Overstating the evidence – double counting in meta-analysis and related problems,” 9, at *1 BMC Medical Research Methodology 10 (2009). Senn observes that he had little difficulty in finding examples of meta-analyses gone wrong, including meta-analyses with double counting of studies or data, in some of the leading clinical medical journals. Id. Senn urges analysts to “[b]e vigilant about double counting,” id. at *4, and recommends that journals should withdraw meta-analyses promptly when mistakes are found,” id. at *1.

Similar advice abounds in books and journals[8]. Professor Sander Greenland addresses the issue in his chapter on meta-analysis in Modern Epidemiology:

“Conducting a Sound and Credible Meta-Analysis

Like any scientific study, an ideal meta-analysis would follow an explicit protocol that is fully replicable by others. This ideal can be hard to attain, but meeting certain conditions can enhance soundness (validity) and credibility (believability). Among these conditions we include the following:

A clearly defined set of research questions to address.
An explicit and detailed working protocol.
A replicable literature-search strategy.
Explicit study inclusion and exclusion criteria, with a rationale for each.
Nonoverlap of included studies (use of separate subjects in different included studies), or use of statistical methods that account for overlap. * * * * *”

Sander Greenland & Keith O’Rourke, “Meta-Analysis – Chapter 33,” in Kenneth J. Rothman, Sander Greenland, Timothy L. Lash, Modern Epidemiology 652, 655 (3d ed. 2008) (emphasis added).

Just remember George Costanza; don’t double dip that chip, and don’t double dip in the data.

[1] See, e.g., Otto Wong, “A Critical Assessment of the Relationship between Silicone Breast Implants and Connective Tissue Diseases,” 23 Regulatory Toxicol. & Pharmacol. 74 (1996).

[2] See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998)”; Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000).

[3] Deposition of Dr. Juan Sanchez-Ramos, Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008514 (N.D. Ohio May 17, 2011).

[4] Deposition of Dr. James Mortimer, Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008054 (N.D. Ohio June 29, 2011).

[5] James Mortimer, Amy Borenstein & Laurene Nelson, Associations of Welding and Manganese Exposure with Parkinson’s Disease: Review and Meta-Analysis, 79 Neurology 1174 (2012).

[6] Shekoufeh Nikfar, Roja Rahimi, Narjes Hendoiee, and Mohammad Abdollahi, “Increasing the risk of spontaneous abortion and major malformations in newborns following use of serotonin reuptake inhibitors during pregnancy: A systematic review and updated meta-analysis,” 20 DARU J. Pharm. Sci. 75 (2012); Roja Rahimi, Shekoufeh Nikfara, Mohammad Abdollahic, “Pregnancy outcomes following exposure to serotonin reuptake inhibitors: a meta-analysis of clinical trials,” 22 Reproductive Toxicol. 571 (2006).

[7] “Q So the question was: Have you read it carefully and do you understand everything that was done in the Nikfar meta-analysis?

A Yes, I think so.

* * *

Q And Nikfar stated that she included studies, correct, in the cardiac malformation meta-analysis?

A That’s what she says.

* * *

Q So if you look at the STATA output, the demonstrative, the — the forest plot, the second study is Kornum 2010. Do you see that?

A Am I —

Q You’re looking at figure four, the cardiac malformations.

A Okay.

Q And Kornum 2010, —

A Yes.

Q — that’s a study you relied upon.

A Mm-hmm.

Q Is that right?

A Yes.

Q And it’s on this forest plot, along with its odds ratio and confidence interval, correct?

A Yeah.

Q And if you look at the last study on the forest plot, it’s the same study, Kornum 2010, same odds ratio and same confidence interval, true?

A You’re right.

Q And to paraphrase My Cousin Vinny, no self-respecting epidemiologist would do a meta-analysis by including the same study twice, correct?

A Well, that was an error. Yeah, you’re right.

***

Q Instead of putting 2 out of 98, they extracted the data and put 9 out of 28.

A Yeah. You’re right.

Q So there’s a numerical transposition that generated a 25-fold increased risk; is that right?

A You’re correct.

Q And, again, to quote My Cousin Vinny, this is no way to do a meta-analysis, is it?

A You’re right.”

Testimony of Anick Bérard, Kuykendall v. Forest Labs, at 223:14-17; 238:17-20; 239:11-240:10; 245:5-12 (Cole County, Missouri; Nov. 15, 2013). According to a Google Scholar search, the Rahimi 2005 meta-analysis had been cited 90 times; the Nikfar 2012 meta-analysis, 11 times, as recently as this month. See, e.g., Etienne Weisskopf, Celine J. Fischer, Myriam Bickle Graz, Mathilde Morisod Harari, Jean-Francois Tolsa, Olivier Claris, Yvan Vial, Chin B. Eap, Chantal Csajka & Alice Panchaud, “Risk-benefit balance assessment of SSRI antidepressant use during pregnancy and lactation based on best available evidence,” 14 Expert Op. Drug Safety 413 (2015); Kimberly A. Yonkers, Katherine A. Blackwell & Ariadna Forray, “Antidepressant Use in Pregnant and Postpartum Women,” 10 Ann. Rev. Clin. Psychol. 369 (2014); Abbie D. Leino & Vicki L. Ellingrod, “SSRIs in pregnancy: What should you tell your depressed patient?” 12 Current Psychiatry 41 (2013).

[8] Julian Higgins & Sally Green, eds., Cochrane Handbook for Systematic Reviews of Interventions 152 (2008) (“7.2.2 Identifying multiple reports from the same study. Duplicate publication can introduce substantial biases if studies are inadvertently included more than once in a meta-analysis (Tramèr 1997). Duplicate publication can take various forms, ranging from identical manuscripts to reports describing different numbers of participants and different outcomes (von Elm 2004). It can be difficult to detect duplicate publication, and some ‘detectivework’ by the reviewauthors may be required.”); see also id. at 298 (Table 10.1.a “Definitions of some types of reporting biases”); id. at 304-05 (10.2.2.1 Duplicate (multiple) publication bias … “The inclusion of duplicated data may therefore lead to overestimation of intervention effects.”); Julian P.T. Higgins, Peter W. Lane, Betsy Anagnostelis, Judith Anzures-Cabrera, Nigel F. Baker, Joseph C. Cappelleri, Scott Haughie, Sally Hollis, Steff C. Lewis, Patrick Moneuse & Anne Whitehead, “A tool to assess the quality of a meta-analysis,” 4 Research Synthesis Methods 351, 363 (2013) (“A common error is to double-count individuals in a meta-analysis.”); Alessandro Liberati, Douglas G. Altman, Jennifer Tetzlaff, Cynthia Mulrow, Peter C. Gøtzsche, John P.A. Ioannidis, Mike Clarke, Devereaux, Jos Kleijnen, and David Moher, “The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration,” 151 Ann. Intern. Med. W-65, W-75 (2009) (“Some studies are published more than once. Duplicate publications may be difficult to ascertain, and their inclusion may introduce bias. We advise authors to describe any steps they used to avoid double counting and piece together data from multiple reports of the same study (e.g., juxtaposing author names, treatment comparisons, sample sizes, or outcomes).”) (internal citations omitted); Erik von Elm, Greta Poglia; Bernhard Walder, and Martin R. Tramèr, “Different patterns of duplicate publication: an analysis of articles used in systematic reviews,” 291 J. Am. Med. Ass’n 974 (2004); John Andy Wood, “Methodology for Dealing With Duplicate Study Effects in a Meta-Analysis,” 11 Organizational Research Methods 79, 79 (2008) (“Dependent studies, duplicate study effects, nonindependent studies, and even covert duplicate publications are all terms that have been used to describe a threat to the validity of the meta-analytic process.”) (internal citations omitted); Martin R. Tramèr, D. John M. Reynolds, R. Andrew Moore, Henry J. McQuay, “Impact of covert duplicate publication on metaanalysis: a case study,” 315 Brit. Med. J. 635 (1997); Beverley J Shea, Jeremy M Grimshaw, George A. Wells, Maarten Boers, Neil Andersson, Candyce Hamel, Ashley C. Porter, Peter Tugwell, David Moher, and Lex M. Bouter, “Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews,” 7(10) BMC Medical Research Methodology 2007 (systematic reviews must inquire whether there was “duplicate study selection and data extraction”).

Posted in Meta-analysis, Peer Review, Rule 702, statistical evidence | Comments Off on Don’t Double Dip Data

Sander Greenland on “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics”

February 8th, 2015

Sander Greenland is one of the few academics, who has served as an expert witness, who has written post-mortems of his involvement in various litigations[1]. Although settling scores with opposing expert witnesses can be a risky business[2], the practice can provide important insights for judges and lawyers who want to avoid the errors of the past. Greenland correctly senses that many errors seem endlessly recycled, and that courts could benefit from disinterested commentary on cases. And so, there should be a resounding affirmation from federal and state courts to the proclaimed “need for critical appraisal of expert witnesses in epidemiology and statistics,” as well as in many other disciplines.

A recent exchange[3] with Professor Greenland led me to revisit his Wake Forest Law Review article. His article raises some interesting points, some mistaken, but some valuable and thoughtful considerations about how to improve the state of statistical expert witness testimony. For better and worse[4], lawyers who litigate health effects issues should read it.

Other Misunderstandings

Greenland posits criticisms of defense expert witnesses[5], who he believes have misinterpreted or misstated the appropriate inferences to be drawn from null studies. In one instance, Greenland revisits one of his own cases, without any clear acknowledgment that his views were largely rejected.[6] The State of California had declared, pursuant to Proposition 65 ( the Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code sections 25249.5, et seq.), that the State “knew” that di(2-ethylhexyl)phthalate, or “DEHP” caused cancer. Baxter Healthcare challenged the classification, and according to Greenland, the defense experts erroneously interpreted inclusive studies with evidence supporting a conclusion that DEHP does not cause cancer.

Greenland argues that the Baxter expert’s reference[7] to an IARC working group’s classification of DEHP as “not classifiable as to its carcinogenicity to humans” did not support the expert’s conclusion that DEHP does not cause cancer in human. If Baxter’s expert invoked the IARC working group’s classification for complete exoneration of DEHP, then Greenland’s point is fair enough. In his single-minded attack on Baxter’s expert’s testimony, however, Greenland missed a more important point, which is that the IARC’s determination that DEHP is not classifiable as to carcinogenicity is directly contradictory of California’s epistemic claim to “know” that DEHP causes cancer. And Greenland conveniently omits any discussion that the IARC working group had reclassified DEHP from “possibly carcinogenic” to “not classifiable,” in the light of its conclusion that mechanistic evidence of carcinogenesis in rodents did not pertain to humans.[8] Greenland maintains that Baxter’s experts misrepresented the IARC working group’s conclusion[9], but that conclusion, at the very least, demonstrates that California was on very shaky ground when it declared that it “knew” that DEHP was a carcinogen. California’s semantic gamesmanship over its epistemic claims is at the root of the problem, not a misstep by defense experts in describing inconclusive evidence as exonerative.

Greenland goes on to complain that in litigation over health claims:

“A verdict of ‛uncertain’ is not allowed, yet it is the scientific verdict most often warranted. Elimination of this verdict from an expert’s options leads to the rather perverse practice (illustrated in the DEHP testimony cited above) of applying criminal law standards to risk assessments, as if chemicals were citizens to be presumed innocent until proven guilty.”

39 Wake Forest Law Rev. at 303. Despite Greenland’s alignment with California in the Denton case, the fact of the matter is that a verdict of “uncertain” was allowed, and he was free to criticize California for making a grossly exaggerated epistemic claim on inconclusive evidence.

Perhaps recognizing that he may be readily be seen as an advocate for coming to the defense of California on the DEHP issue, Greenland protests that:

“I am not suggesting that judgments for plaintiffs or actions against chemicals should be taken when evidence is inconclusive.”

39 Wake Forest Law Rev. at 305. And yet, his involvement in the Denton case (as well as other cases, such as silicone gel breast implant cases, thimerosal cases, etc.) suggest that he is willing to lend aid and support to judgments for plaintiffs when the evidence is inconclusive.

Important Advice and Recommendations

These foregoing points are rather severe limitations to Greenland’s article, but lawyers and judges should also look to what is good and helpful here. Greenland is correct to call out expert witnesses, regardless of party of affiliation, who opine that inconclusive studies are “proof” of the null hypothesis. Although some of Greenland’s arguments against the use of significance probability may be overstated, his corrections to the misstatements and misunderstandings of significance probability should command greater attention in the legal community. In one strained passage, however, Greenland uses a disjunction to juxtapose null hypothesis testing with proof beyond a reasonable doubt[10]. Greenland of course understands the difference, but the context would lead some untutored readers to think he has equated the two probabilistic assessments. Writing in a law review for lawyers and judges might have led him to be more careful. Given the prevalence of plaintiffs’ counsel’s confusing the 95% confidence coefficient with a burden of proof akin to beyond a reasonable doubt, great care in this area is, indeed, required.

Despite his appearing for plaintiffs’ counsel in health effects litigation, some of Greenland’s suggestions are balanced and perhaps more truth-promoting than many plaintiffs’ counsel would abide. His article provides an important argument in favor of raising the legal criteria for witnesses who purport to have expertise to address and interpret epidemiologic and experimental evidence[11]. And beyond raising qualification requirements above mere “reasonable pretense at expertise,” Professor Greenland offers some thoughtful, helpful recommendations for improving expert witness testimony in the courts:

“Begin publishing projects in which controversial testimony (a matter of public record) is submitted, and as space allows, published on a regular basis in scientific or law journals, perhaps with commentary. An online version could provide extended excerpts, with additional context.
Give courts the resources and encouragement to hire neutral experts to peer-review expert testimony.
Encourage universities and established scholarly societies (such as AAAS, ASA, APHA, and SER) to conduct workshops on basic epidemiologic and statistical inference for judges and other legal professionals.”

39 Wake Forest Law Rev. at 308.

Each of these three suggestions is valuable and constructive, and worthy of an independent paper. The recommendation of neutral expert witnesses and scholarly tutorials for judges is hardly new. Many defense counsel and judges have argued for them in litigation and in commentary. The first recommendation, of publishing “controversial testimony” is part of the purpose of this blog. There would be great utility to making expert witness testimony, and analysis thereof, more available for didactic purposes. Perhaps the more egregious testimonial adventures should be republished in professional journals, as Greenland suggests. Greenland qualifies his recommendation with “as space allows,” but space is hardly the limiting consideration in the digital age.

Causation

Professor Greenland correctly points out that causal concepts and conclusions are often essentially contested[12], but his argument might well be incorrectly taken for “anything goes.” More helpfully, Greenland argues that various academic ideals should infuse expert witness testimony. He suggests that greater scholarship, with acknowledgment of all viewpoints, and all evidence, is needed in expert witnessing. 39 Wake Forest Law Rev. at 293.

Greenland’s argument provides an important corrective to the rhetoric of Oreskes, Cranor, Michaels, Egilman, and others on “manufacturing doubt”:

“Never force a choice among competing theories; always maintain the option of concluding that more research is needed before a defensible choice can be made.”

Id. Despite his position in the Denton case, and others, Greenland and all expert witnesses are free to maintain that more research is needed before a causal claim can be supported. Greenland also maintains that expert witnesses should “look past” the conclusions drawn by authors, and base their opinions on the “actual data” on which the statistical analyses are based, and from which conclusions have been drawn. Courts have generally rejected this view, but if courts were to insist upon real expertise in epidemiology and statistics, then the testifying expert witnesses should not be constrained by the hearsay opinions in the discussion sections of published studies – sections which by nature are incomplete and tendentious. See “Follow the Data, Not the Discussion” (May 2, 2010).

Greenland urges expert witnesses and legal counsel to be forthcoming about their assumptions, their uncertainty about conclusions:

“Acknowledgment of controversy and uncertainty is a hallmark of good science as well as good policy, but clashes with the very time limited tasks faced by attorneys and courts”

39 Wake Forest Law Rev. at 293-4. This recommendation would be helpful in assuring courts that the data may simply not support conclusions sufficiently certain to be submitted to lay judges and jurors. Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319, 320 (7th Cir. 1996) (“But the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”) (internal citations omitted).

Threats to Validity

One of the serious mistakes counsel often make in health effects litigation is to invite courts to believe that statistical significance is sufficient for causal inferences. Greenland emphasizes that validity considerations often are much stronger, and more important considerations than the play of random error[13]:

“For very imperfect data (e.g., epidemiologic data), the limited conclusions offered by statistics must be further tempered by validity considerations.”

* * * * * *

“Examples of validity problems include non-random distribution of the exposure in question, non-random selection or cooperation of subjects, and errors in assessment of exposure or disease.”

39 Wake Forest Law Rev. at 302 – 03. Greenland’s abbreviated list of threats to validity should remind courts that they cannot sniff a p-value below five percent and then safely kick the can to the jury. The literature on evaluating bias and confounding is huge, but Greenland was a co-author on an important recent paper, which needs to be added to the required reading lists of judges charged with gatekeeping expert witness opinion testimony about health effects. See Timothy L. Lash, et al., “Good practices for quantitative bias analysis,” 43 Internat’l J. Epidem. 1969 (2014).

[1] For an influential example of this sparse genre, see James T. Rosenbaum, “Lessons from litigation over silicone breast implants: A call for activism by scientists,” 276 Science 1524 (1997) (describing the exaggerations, distortions, and misrepresentations of plaintiffs’ expert witnesses in silicone gel breast implant litigation, from perspective of a highly accomplished scientist physician, who served as a defense expert witness, in proceedings before Judge Robert Jones, in Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996). In one attempt to “correct the record” in the aftermath of a case, Greenland excoriated a defense expert witness, Professor Robert Makuch, for stating that Bayesian methods are rarely used in medicine or in the regulation of medicines. Sander Greenland, “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics,” 39 Wake Forest Law Rev. 291, 306 (2004). Greenland heaped adjectives upon his adversary, “ludicrous claim,” “disturbing, “misleading expert testimony,” and “demonstrably quite false.” See “The Infrequency of Bayesian Analyses in Non-Forensic Court Decisions” (Feb. 16, 2014) (debunking Prof. Greenland’s claims).

[2] One almost comical example of trying too hard to settle a score occurs in a footnote, where Greenland cites a breast implant case as having been reversed in part by another case in the same appellate court. See 39 Wake Forest Law Rev. at 309 n.68, citing Allison v. McGhan Med. Corp., 184 F.3d 1300, 1310 (11th Cir. 1999), aff’d in part & rev’d in part, United States v. Baxter Int’l, Inc., 345 F.3d 866 (11th Cir. 2003). The subsequent case was not by any stretch of the imagination a reversal of the earlier Allison case; the egregious citation is a legal fantasy. Furthermore, Allison had no connection with the procedures for court-appointed expert witnesses or technical advisors. Perhaps the most charitable interpretation of this footnote is that it was injected by the law review editors or supervisors.

[3] See “Significance Levels are Made a Whipping Boy on Climate Change Evidence: Is .05 Too Strict? (Schachtman on Oreskes)” (Jan. 4, 2015).

[4] In addition to the unfair attack on Professor Makuch, see supra, n.1, there is much that some will find “disturbing,” “misleading,” and even “ludicrous,” (some of Greenland’s favorite pejorative adjectives) in the article. Greenland repeats in brief his arguments against the legal system’s use of probabilities of causation[4], which I have addressed elsewhere.

[5] One of Baxter’s expert witnesses appeared to be the late Professor Patricia Buffler.

[6] See 39 Wake Forest Law Rev. at 294-95, citing Baxter Healthcare Corp. v. Denton, No. 99CS00868, 2002 WL 31600035, at *1 (Cal. App. Dep’t Super. Ct. Oct. 3, 2002) (unpublished); Baxter Healthcare Corp. v. Denton, 120 Cal. App. 4th 333 (2004)

[7] Although Greenland cites to a transcript, the citation is to a judicial opinion, and the actual transcript of testimony is not available at the citation give.

[8] See Denton, supra.

[9] 39 Wake Forest L. Rev. at 297.

[10] 39 Wake Forest L. Rev. at 305 (“If it is necessary to prove causation ‛beyond a reasonable doubt’–or be ‛compelled to give up the null’ – then action can be forestalled forever by focusing on any aspect of available evidence that fails to conform neatly with the causal (alternative) hypothesis. And in medical and social science there is almost always such evidence available, not only because of the ‛play of chance’ (the focus of ordinary statistical theory), but also because of the numerous validity problems in human research.”

[11] See Peter Green, “Letter from the President to the Lord Chancellor regarding the use of statistical evidence in court cases” (Jan. 23, 2002) (writing on behalf of The Royal Statistical Society; “Although many scientists have some familiarity with statistical methods, statistics remains a specialised area. The Society urges you to take steps to ensure that statistical evidence is presented only by appropriately qualified statistical experts, as would be the case for any other form of expert evidence.”).

[12] 39 Wake Forest Law Rev. at 291 (“In reality, there is no universally accepted method for inferring presence or absence of causation from human observational data, nor is there any universally accepted method for inferring probabilities of causation (as courts often desire); there is not even a universally accepted definition of cause or effect.”).

[13] 39 Wake Forest Law Rev. at 302-03 (“If one is more concerned with explaining associations scientifically, rather than with mechanical statistical analysis, evidence about validity can be more important than statistical results.”).

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on Sander Greenland on “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics”

Sander Greenland on “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics”

February 8th, 2015

Other Misunderstandings

Greenland goes on to complain that in litigation over health claims:

“A verdict of ‛uncertain’ is not allowed, yet it is the scientific verdict most often warranted. Elimination of this verdict from an expert’s options leads to the rather perverse practice (illustrated in the DEHP testimony cited above) of applying criminal law standards to risk assessments, as if chemicals were citizens to be presumed innocent until proven guilty.”

Perhaps recognizing that he may be readily be seen as an advocate for coming to the defense of California on the DEHP issue, Greenland protests that:

“I am not suggesting that judgments for plaintiffs or actions against chemicals should be taken when evidence is inconclusive.”

Important Advice and Recommendations

“Begin publishing projects in which controversial testimony (a matter of public record) is submitted, and as space allows, published on a regular basis in scientific or law journals, perhaps with commentary. An online version could provide extended excerpts, with additional context.
Give courts the resources and encouragement to hire neutral experts to peer-review expert testimony.
Encourage universities and established scholarly societies (such as AAAS, ASA, APHA, and SER) to conduct workshops on basic epidemiologic and statistical inference for judges and other legal professionals.”

39 Wake Forest Law Rev. at 308.

Causation

Greenland’s argument provides an important corrective to the rhetoric of Oreskes, Cranor, Michaels, Egilman, and others on “manufacturing doubt”:

“Never force a choice among competing theories; always maintain the option of concluding that more research is needed before a defensible choice can be made.”

Greenland urges expert witnesses and legal counsel to be forthcoming about their assumptions, their uncertainty about conclusions:

“Acknowledgment of controversy and uncertainty is a hallmark of good science as well as good policy, but clashes with the very time limited tasks faced by attorneys and courts”

Threats to Validity

“For very imperfect data (e.g., epidemiologic data), the limited conclusions offered by statistics must be further tempered by validity considerations.”

* * * * * *

“Examples of validity problems include non-random distribution of the exposure in question, non-random selection or cooperation of subjects, and errors in assessment of exposure or disease.”

[3] See “Significance Levels are Made a Whipping Boy on Climate Change Evidence: Is .05 Too Strict? (Schachtman on Oreskes)” (Jan. 4, 2015).

[5] One of Baxter’s expert witnesses appeared to be the late Professor Patricia Buffler.

[7] Although Greenland cites to a transcript, the citation is to a judicial opinion, and the actual transcript of testimony is not available at the citation give.

[8] See Denton, supra.

[9] 39 Wake Forest L. Rev. at 297.

Fixodent Study Causes Lockjaw in Plaintiffs’ Counsel

February 4th, 2015

Litigation Drives Science

Back in 2011, the Fixodent MDL Court sustained Rule 702 challenges to plaintiffs’ expert witnesses. “Hypotheses are verified by testing, not by submitting them to lay juries for a vote.” In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345, 1367 (S.D.Fla.2011), aff’d, Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir. 2014). The Court found that the plaintiffs had raised a superficially plausible hypothesis, but that they had not verified the hypothesis by appropriate testing[1].

Like dentures to Fixodent, the plaintiffs stuck to their claims, and set out to create the missing evidence. Plaintiffs’ counsel contracted with Dr. Salim Shah and his companies Sarfez Pharmaceuticals, Inc. and Sarfez USA, Inc. (“Sarfez”) to conduct human research in India, to support their claims that zinc in denture cream causes neurological damage[2]. In re Denture Cream Prods. Liab. Litig., Misc. Action 13-384 (RBW), 2013 U.S. Dist. LEXIS 93456, *2 (D.D.C. July 3, 2013). When the defense learned of this study, and the plaintiffs’ counsel’s payments of over $300,000, to support the study, they sought discovery of raw data, study protocol, statistical analyses, and other materials from plaintiffs’ counsel. Plaintiffs’ counsel protested that they did not have all the materials, and directed defense counsel to Sarfez. Although other courts have made counsel produce similar materials from the scientists and independent contractors they engaged, in this case, defense counsel followed the trail of documents to contractor, Sarfez, with subpoenas in hand. Id. at *3-4.

The defense served a Rule 45 subpoena on Sarfez, which produced some, but not all responsive documents. Proctor & Gamble pressed for the missing materials, including study protocols, analytical reports, and raw data. Id. at *12-13. Judge Reggie Walton upheld the subpoena, which sought underlying data and non-privileged correspondence, to be within the scope of Rules 26(b) and 45, and not unduly burdensome. Id. at *9-10, *20. Sarfez attempted to argue that the requested materials, listed as email attachments, might not exist, but Judge Walton branded the suggestion “disingenuous.” Attachments to emails should be produced along with the emails. Id. at *12 (citing and collecting cases). Although Judge Walton did not grant a request for forensic recovery of hard-drive data or for sanctions, His Honor warned Sarfez that it might be required to bear the cost of forensic data recovery if it did not comply the court’s order. Id. at *15, *22.

Plaintiffs Put Their Study Into Play

The study at issue in the subpoena was designed by Frederick K. Askari, M.D., Ph.D., an associate professor of hepatology, in the University of Michigan Health System. In re Denture Cream Prods. Liab. Litig., No. 09–2051–MD, 2015 WL 392021, at *7 (S.D. Fla. Jan. 28, 2015). At the instruction of plaintiffs’ counsel, Dr. Askari sought to study the short-term effects of Fixodent on copper absorption in humans. Working in India, Askari conducted the study on 24 participants, who were given a controlled diet for 36 days. Of the 24 participants, 12, randomly selected, received 12 grams of Fixodent per day (containing 204 mg. of zinc). Another six participants, randomly selected, were given zinc acetate, three times per day (150 mg of zinc), and the remaining six participants received placebo, three times per day.

A study protocol was approved by an independent group[3], id. at *9, and the study was supposed to be conducted with a double blind. Id. at *7. Not surprisingly, those participants who received doses of Fixodent or zinc acetate had higher urinary levels of zinc (pee < 0.05). The important issue, however, was whether the dietary zinc levels affect copper excretion in a way that would support plaintiffs’ claims that copper levels were lowered sufficiently by Fixodent to cause a syndromic neurological disorder. The MDL Court ultimately concluded that plaintiffs’ expert witnesses’ opinions on general causation claims were not sufficiently supported to satisfy the requirements of Rule 702, and upheld defense challenges to those expert witnesses. In doing so, the MDL Court had much of interest to say about case reports, weight of the evidence, and other important issues. This post, however, concentrates on the deviations of one study, commissioned by plaintiffs’ counsel, from the scientific standard of care. The Askari “research” makes for a fascinating case study of how not to conduct a study in a litigation caldron.

Non-Standard Deviations

The First Deviation – Changing the Ascertainment Period After the Data Are Collected

The protocol apparently identified a primary endpoint to be:

“the mean increase in [copper 65] excretion in fecal matter above the baseline (mg/day) averaged over the study period … to test the hypothesis that the release of [zinc] either from Fixodent or Zinc Acetate impairs [copper 65] absorption as measured in feces.”

The study outcome, on the primary end point, was clear. The plaintiffs’ testifying statistician, Hongkun Wang, stated in her deposition that the fecal copper (whether isotope Cu63 or Cu65) was not different across the three groups (Fixodent, zinc acetate, and placebo). Id. at *9[4]. Even Dr. Askari himself admitted that the total fecal copper levels were not increased in the Fixodent group compared with the placebo control group. Id. at *9.[5]

Apparently after obtaining the data, and finding no difference in the pre-specified end point of average fecal copper levels between Fixodent and placebo groups, Askari turned to a new end point, measured in a different way, not described in the protocol as the primary end point.

The Second Deviation – Changing Primary End Point After the Data Are Collected

In the early (days 3, 4, and 5) and late (days 31, 32, and 33) part of the Study, participants received a dose of purified copper 65[6] to help detect the “blockade of copper.” Id. at 8*. The participants’ fecal copper 65 levels were compared to their naturally occurring copper 63 levels. According to Dr. Askari:

“if copper is being blocked in the Fixodent and zinc acetate test subjects from exposure to the zinc in the test product (Fixodent) and positive control (zinc acetate), the ratio of their fecal output of copper 65 as compared to their fecal output of copper 63 would increase relative to the control subjects, who were not dosed with zinc. In short, a higher ratio of copper 65 to copper 63 reflects blocking of copper.”

Id.

Askari analyzed the ratio of two copper isotopes (Cu65 /Cu63), in the limited period of observation to study days 31 to 33. Id. at *9. Askari thus changed the outcome to be measured, the timing of the measurement, and manner of measurement (average over entire period versus amount on days 31 to 33). On this post hoc, non-prespecified end point, Askari claimed to have found “significant” differences.

The MDL Court expressed its skepticism and concern over the difference between the protocol’s specified end point, and one that came into the study only after the data were obtained and analyzed. The plaintiffs claimed that it was their (and Askari’s) intention from the initial stages of designing the Fixodent Blockade Study to use the Cu65/Cu63 ratio as the primary end point. According to the plaintiffs, the isotope ratio was simply better articulated and “clarified” as the primary end point in the final report than it was in the protocol. The Court was not amused or assuaged by the plaintiffs’ assurances. The study sponsor, Dr. Salim Shah could not point to a draft protocol that indicated the isotope ratio as the end point; nor could Dr. Shah identify a request for this analysis by Wang until after the study was concluded. Id. at *9.[7]

Ultimately, the Court declared that whether the protocol was changed post hoc after the primary end point provided disappointing analysis, or the isotope ratio was carelessly omitted from the protocol, the design or conduct of the study was “incompatible with reliable scientific methodology.”

The Third Deviation – Changing the Standard of “Significance” After the Data Are Collected and P-Values Are Computed

The protocol for the Blockade study called for a pre-determined Type I error rate (p-value) of no more than 5 percent.[8] Id. at *10. The difference in the isotope ratio showed an attained level of significance probability of 5.7 percent, and thus even the post hoc end point missed the prespecified level of significance. The final protocol changed the value of “significance” to 10 percent, to permit the plaintiffs to declare a “statistically significant” result. Dr. Wang admitted in deposition that she doubled the acceptable level of Type I error only after she obtained the data and calculated the p-value of 0.057. Id. at *10.[9]

The Court found that this deliberate moving of the statistical goal post reflected a “lack of objectivity and reliability,” which smacked of contrivance[10].

The Court found that the study’s deviations from the protocol demonstrated a lack of objectivity. The inadequacy of the Study’s statistical analysis plan supported the Court’s conclusion that Dr. Askari’s supposed finding of a “statistically significant” difference in fecal copper isotope ratio between Fixodent and placebo group participants was “not based on sufficiently reliable and objective scientific methodology” and thus could not support plaintiffs’ expert witnesses’ general causation claims.

The Fourth Deviation – Failing to Take Steps to Preserve the Blind

The protocol called for a double-blinded study, with neither the participants nor the clinical investigators knowing which participant was in which group. Rather than delivering the three different groups capsules that looked similar, the group each received starkly different looking capsules. Id. at *11. The capsules for one set were apparently so large that the investigators worried whether the participants would comply with the dosing regimen.

The Fifth Deviation – Failing to Take Steps to Keep Biological Samples From Becoming Contaminated

Documents and emails from Dr. Shah acknowledged that there had been “difficulties in storing samples at appropriate temperature.” Id. at *11. Fecal samples were “exposed to unfrozen and undesirable temperature conditions.” Dr. Shah called for remedial steps from the Study manager, but there was no documentation that such steps were taken to correct the problem. Id.

The Consequences of Discrediting the Study

Dr. Askari opined that the Study, along with other evidence, shows that Fixodent can cause copper deficiency myeloneuropathy (“CDM”). The plaintiffs, of course, argued that the Defendants’ criticisms of the Fixodent

Study’s methodology went merely to the “weight rather than admissibility.” Id. at *9. Askari’s study was but one leg of the stool, but the defense’s thorough discrediting of the study was an important step in collapsing the support for the plaintiffs’ claims. As the MDL Court explained:

“The Court cannot turn a blind eye to the myriad, serious methodological flaws in the Fixodent Blockade Study and conclude they go to weight rather than admissibility. While some of these flaws, on their own, may not be serious enough to justify exclusion of the Fixodent Blockade Study; taken together, the Court finds Fixodent Blockade Study is not “good science,” and is not admissible. Daubert, 509 U.S. at 593 (internal quotation marks and citation omitted).”

Id. at *11.

A study, such as the Fixodent Blockade Study, is not itself admissible, but the deconstruction of the study upon which plaintiffs’ expert witnesses relied, led directly to the Court’s decision to exclude those witnesses. The Court omitted any reference to Federal Rule of Evidence 703, which addresses the requirements of facts and data, otherwise inadmissible, which may be relied upon by expert witnesses in reaching their opinions.

[1] See “Philadelphia Plaintiff’s Claims Against Fixodent Prove Toothless” (May 2, 2012); Jacoby v. Rite Aid Corp., 2012 Phila. Ct. Com. Pl. LEXIS 208 (2012), aff’d, 93 A.3d 503 (Pa. Super. 2013); “Pennsylvania Superior Court Takes The Bite Out of Fixodent Claims” (Dec. 12, 2013).

[2] See “Using the Rule 45 Subpoena to Obtain Research Data” (July 24, 2013)

[3] The group was identified as the Ethica Norma Ethical Committee.

[4] citing Wang Dep. at 56:7–25, Aug. 13, 2013), and Wang Analysis of Fixodent Blockade Study [ECF No. 2197–56] (noting “no clear treatment effect on Cu63 or Cu65”).

[5] Askari Dep. at 69:21–24, June 20, 2013.

[6] Copper 65 is not a typical tracer; it is not radioactive. Naturally occurring copper consists almost exclusively of two stable (non-radioactive) isotope, Cu65 about 31 percent, Cu63 about 69 percent. See, e.g., Manuel Olivares, Bo Lönnerdal, Steve A Abrams, Fernando Pizarro, and Ricardo Uauy, “Age and copper intake do not affect copper absorption, measured with the use of 65Cu as a tracer, in young infants,” 76 Am. J. Clin. Nutr. 641 (2002); T.D. Lyon, et al., “Use of a stable copper isotope (65Cu) in the differential diagnosis of Wilson’s disease,” 88 Clin. Sci. 727 (1995).

[7] Shah Dep. at 87:12–25; 476:2–536:12, 138:6–142:12, June 5, 2013).

[8] The reported decision leaves unclear how the analysis would proceed, whether by ANOVA for the three groups, or t-tests, and whether there was multiple testing.

[9] Wang Dep. at 151:13–152:7; 153:15–18.

[10] 2015 WL 392021, at *10, citing Perry v. United States, 755 F.2d 888, 892 (11th Cir. 1985) (“A scientist who has a formed opinion as to the answer he is going to find before he even begins his research may be less objective than he needs to be in order to produce reliable scientific results.”); Rink v. Cheminova, Inc., 400 F.3d 1286, 1293 n. 7 (11th Cir.2005) (“In evaluating the reliability of an expert’s method … a district court may properly consider whether the expert’s methodology has been contrived to reach a particular result.” (alteration added)).

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Zoloft MDL Relieves Matrixx Depression

January 30th, 2015

When the Supreme Court delivered its decision in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), a colleague, David Venderbush from Alston & Bird LLP, and I wrote a Washington Legal Foundation Legal Backgrounder, in which we predicted that plaintiffs’ counsel would distort the holding, and inflate the dicta of the opinion. Schachtman & Venderbush, “Matrixx Unbounded: High Court’s Ruling Needlessly Complicates Scientific Evidence Principles,” 26 (14) Legal Backgrounder (June 17, 2011)[1]. Our prediction was sadly all-too accurate. Not only was the context of the Matrixx distorted, but several district courts appeared to adopt the dicta on statistical significance as though it represented the holding of the case[2].

The Matrixx decision, along with the few district court opinions that had embraced its dicta[3], was urged as the basis for denying a defense challenge to the proffered testimony of Dr. Anick Bérard, a Canadian perinatal epidemiologist, in the Zoloft MDL. The trial court, however, correctly discerned several methodological shortcomings and failures, including Dr. 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.).

Plaintiffs (through their Plaintiffs’ Steering Committee (PSC) in the Zoloft MDL) were undaunted and moved for reconsideration, asserting that the MDL trial court had failed to give appropriate weight to the Supreme Court’s decision in Matrixx, and a Third Circuit decision in DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941 (3d Cir. 1990). The MDL trial judge, however, deftly rebuffed the plaintiffs’ use of Matrixx, and their attempt to banish consideration of random error in the interpretation of epidemiologic studies. In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342; 12-md-2342, 2015 WL 314149 (E.D. Pa. Jan. 23, 2015) (Rufe, J.) (denying PSC’s motion for reconsideration).

In rejecting the motion for reconsideration, the Zoloft MDL trial judge noted that the PSC had previously cited Matrixx, and that the Court had addressed the case in its earlier ruling. 2015 WL 314149, at *2-3. The MDL Court then proceeded to expand upon its earlier ruling, and to explain how Matrixx was largely irrelevant to the Rule 702 context of Pfizer’s challenge to Dr. Bérard. There were, to be sure, some studies with nominal statistically significant results, for some birth defects, among children of mothers who took Zoloft in their first trimester of pregnancy. As Judge Rufe explained, statistical significance, or the lack thereof, was only one item in a fairly long list of methodological deficiencies in Dr. Bérard’s causation opinions:

“The [original] opinion set forth a detailed and multi-faceted rationale for finding Dr. Bérard’s testimony unreliable, including her inattention to the principles of replication and statistical significance, her use of certain principles and methods without demonstrating either that they are recognized by her scientific community or that they should otherwise be considered scientifically valid, the unreliability of conclusions drawn without adequate hypothesis testing, the unreliability of opinions supported by a ‛cherry-picked’ sub-set of research selected because it was supportive of her opinions (without adequately addressing non-supportive findings), and Dr. Bérard’s failure to reconcile her currently expressed opinions with her prior opinions and her published, peer-reviewed research. Taking into account all these factors, as well as others discussed in the Opinion, the Court found that Dr. Bérard departed from well-established epidemiological principles and methods, and that her opinion on human causation must be excluded.”

Id. at *1.

In citing the multiple deficiencies of the proffered expert witness, the Zoloft MDL Court thus put its decision well within the scope of the Third Circuit’s recent precedent of affirming the exclusion of Dr. Bennet Omalu, in Pritchard v. Dow Agro Sciences, 430 F. App’x 102, 104 (3d Cir.2011). The Zoloft MDL Court further defended its ruling by pointing out that it had not created a legal standard requiring statistical significance, but rather had made a factual finding that epidemiologist, such as the challenged witness, Dr. Anick Bérard, would use some measure of statistical significance in reaching conclusions in her discipline of epidemiology. 2015 WL 314149, at *2[4].

On the plaintiffs’ motion for reconsideration, the Zoloft Court revisited the Matrixx case, properly distinguishing the case as a securities fraud case about materiality of non-disclosed information, not about causation. 2015 WL 314149, at *4. Although the MDL Court could and should have identified the Matrixx language as clearly obiter dicta, it did confidently distinguish the Supreme Court holding about pleading materiality from its own task of gatekeeping expert witness testimony on causation in a products liability case:

“Because the facts and procedural posture of the Zoloft MDL are so dissimilar from those presented in Matrixx, this Court reviewed but did not rely upon Matrixx in reaching its decision regarding Dr. Bérard. However, even accepting the PSC’s interpretation of Matrixx, the Court’s Opinion is consistent with that ruling, as the Court reviewed Dr. Bérard’s methodology as a whole, and did not apply a bright-line rule requiring statistically significant findings.”

Id. at *4.

In mounting their challenge to the MDL Court’s earlier ruling, the Zoloft plaintiffs asserted that the Court had failed to credit Dr. Bérard’s reliance upon what Dr. Bérard called the “Rothman approach.” This approach, attribution to Professor Kenneth Rothman had received some attention in the Bendectin litigation in the Third Circuit, where plaintiffs sought to be excused from their failure to show statistically significant associations when claiming causation between maternal use of Bendectin and infant birth defects. DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941 (3d Cir. 1990). The Zoloft MDL Court pointed out that the Circuit, in DeLuca, had never affirmatively endorsed Professor Rothman’s “approach,” but had reversed and remanded the Bendectin case to the district court for a hearing under Rule 702:

“by directing such an overall evaluation, however, we do not mean to reject at this point Merrell Dow’s contention that a showing of a .05 level of statistical significance should be a threshold requirement for any statistical analysis concluding that Bendectin is a teratogen regardless of the presence of other indicial of reliability. That contention will need to be addressed on remand. The root issue it poses is what risk of what type of error the judicial system is willing to tolerate. This is not an easy issue to resolve and one possible resolution is a conclusion that the system should not tolerate any expert opinion rooted in statistical analysis where the results of the underlying studies are not significant at a .05 level.”

2015 WL 314149, at *4 (quoting from DeLuca, 911 F.2d at 955). After remand, the district court excluded the DeLuca plaintiffs’ expert witnesses, and granted summary judgment, based upon the dubious methods employed by plaintiffs’ expert witnesses in cherry picking data, recalculating risk ratios in published studies, and ignoring bias and confounding in studies. The Third Circuit affirmed the judgment for Merrell Dow. DeLuca v. Merrell Dow Pharma., Inc., 791 F. Supp. 1042 (3d Cir. 1992), aff’d, 6 F.3d 778 (3d Cir. 1993).

In the Zoloft MDL, the plaintiffs not only offered an erroneous interpretation of the Third Circuit’s precedents in DeLuca, they also failed to show that the “Rothman” approach had become generally accepted in over two decades since DeLuca. 2015 WL 314149, at *4. Indeed, the hearing record was quite muddled about what the “Rothman” approach involved, other than glib, vague suggestions that the approach would have countenanced Dr. Bérard’s selective, over-reaching analysis of the extant epidemiologic studies. The plaintiffs did not call Rothman as an expert witness; nor did they offer any of Rothman’s publications as exhibits at the Zoloft hearing. Although Professor Rothman has criticized the overemphasis upon p-values and significance testing, he has never suggested that researchers and scientists should ignore random error in interpreting research data. Nevertheless, plaintiffs attempted to invoke some vague notion of a Rothman approach that would ignore confidence intervals, attained significance probability, multiplicity, bias, and confounding. Ultimately, the MDL Court would have none of it. The Court held that the Rothman Approach (whatever that is), as applied by Dr. Bérard, did not satisfy Rule 702.

The testimony at the Rule 702 hearing on the so-called “Rothman approach” had been sketchy at best. Dr. Bérard protested, perhaps too much, when asked about her having ignored p-values:

“I’m not the only one saying that. It’s really the evolution of the thinking of the importance of statistical significance. One of my professors and also a friend of mine at Harvard, Ken Rothman, actually wrote on it – wrote on the topic. And in his book at the end he says obviously what I just said, validity should not be confused with precision, but the third bullet point, it’s saying that the lack of statistical significance does not invalidate results because sometimes you are in the context of rare events, few cases, few exposed cases, small sample size, exactly – you know even if you start with hundreds of thousands of pregnancies because you are looking at rare events and if you want to stratify by exposure category, well your stratum becomes smaller and smaller and your precision decreases. I’m not the only one saying that. Ken Rothman says it as well, so I’m not different from the others. And if you look at many of the studies published nowadays, they also discuss that as well.”

Notes of Testimony of Dr. Anick Bérard, at 76:21- 77:14 (April 9, 2014). See also Notes of Testimony of Dr. Anick Bérard, at 211 (April 11, 2014) (discussing non-statistically significant findings as a “trend,” and asserting that the lack of a significant finding does not mean that there is “no effect”). Bérard’s invocation of Rothman here is accurate but unhelpful. Rothman and Bérard are not alone in insisting that confidence intervals provide a measure of precision of an estimate, and that we should be careful not to interpret the lack of significance to mean no effect. But the lack of significance cannot be used to interpret data to show an effect.

At the Rule 702 hearing, the PSC tried to bolster Dr. Bérard’s supposed reliance upon the “Rothman approach” in cross-examining Pfizer’s expert witness, Dr. Stephen Kimmel:

“Q. You know who Dr. Rothman is, the epidemiologist?
A. Yes.
Q. You actually took a course from Dr. Rothman, didn’t you?
A. I did when I was a student way back.
Q. He is a well-known epidemiologist, isn’t he?
A. Yes, he is.
Q. He has published this book, Modern Epidemiology. Do you have a copy of this?
A. I do.
Q. Do you – Have you ever read it?
A. I read his earlier edition. I have not read the most recent edition.
Q. There’s two other authors, Sander Greenland and Tim Lash. Do you know either one of them?
A. I know Sander. I don’t know Tim.
Q. Dr. Rothman has some – he has written about confidence intervals and statistical significance for some time, hasn’t he?
A. He has.
Q. Do you agree with him that statistical significance is a not matter of validity. It’s a matter of precision?
A. It’s a matter of – well, confidence intervals are matters of precision. P-values are not.
Q. Okay. I want to put up a table and see if you are in agreement with Dr. Rothman. This is the third edition of Modern Epidemiology. And he has – and ignore my brother’s handwriting. But there is an hypothesized rate ratio under 10-3. It says: p-value function from which one can find all confidence limits for a hypothetical study with a rate ratio estimate of 3.1 Do you see that there?
A. Yes. I don’t see the top of the figure, not that it matters.
Q. I want to make sure. The way I understand this, he is giving us a hypothesis that we have a relative risk of 3.1 and it [presumably a 95% confidence interval] crosses 1, meaning it’s not statistically significant. Is that fair?
A. Well, if you are using a value of .05, yes. And again, if this is a single test and there’s a lot of things that go behind it. But, yes, so this is a total hypothetical.
Q. Yes.
A. I’ sorry. He’s saying here is a hypothetical based on math. And so here is – this is what we would propose.
Q. Yes, I want to highlight what he says about this figure and get your thoughts on it. He says:
The message of figure 10-3 is that the example data are more compatible with a moderate to strong association than with no association, assuming the statistical model used to construct the function is correct.
A. Yes.
Q. Would you agree with that statement?
A. Assuming the statistical model is correct. And the problem is, this is a hypothetical.
Q. Sure. So let’s just assume. So what this means to sort of put some meat on the bone, this means that although we cross 1 and therefore are statistically
significant [sic, non-significant], he says the more likely truth here is that there is a moderate to strong effect rather than no effect?
A. Well, you know he has hypothesized this. This is not used in common methods practice in pharmacoepi. Dr. Rothman has lots of ideas but it’s not part of our standard scientific method.

Notes of Testimony of Dr. Stephen Kimmel, at 126:2 to 128:20.

Nothing very concrete about the “Rothman approach” is put before the MDL Court, either through Dr. Bérard or Dr. Kimmel. There are, however, other instructive aspects to the plaintiff’s counsel’s examination. First, the referenced portion of the text, Modern Epidemiology, is a discussion of p-value functions, not of p-values or of confidence intervals per se. Modern Epidemiology at 158-59 (3d ed. 2008). Dr. Bérard never discussed p-value functions in her report or in her testimony, and Dr. Kimmel testified, without contradiction, that such p-value functions are “not used in common methods practice.” Second, the plaintiff’s counsel never marked and offered the Rothman text as an exhibit for the MDL Court to consider. Third, the cross-examiner first asked about the implication for a hypothetical association, and then, when he wanted to “put some meat on the bone” changed the word used in Rothman’s text, “association,” to “effect.” The word “effect” does not appear in Rothman’s text at the referenced discussion about p-value functions. Fortunately, the MDL Court was not poisoned by the “meat on the bone.”

The Pit and the Pendulum

Another document glibly referenced but not provided to the MDL Court was the publication of Sir Austin Bradford Hill’s presidential address to the Royal Society of Medicine on causation. The MDL Court acknowledged that the PSC had argued that the emphasis upon statistical significance was contrary to Hill’s work and teaching. 2015 WL 314149, at *5. In the Court’s words:

“the PSC argues that the Court’s finding regarding the importance of statistical significance in the field of epidemiology is inconsistent with the work of Bradford Hill. The PSC points to a 1965 address by Sir Austin Bradford Hill, which it has not previously presented to the Court, except in opening statements of the Daubert hearings.²⁰ The PSC failed to put forth evidence establishing that Bradford Hill’s statement that ‛I wonder whether the pendulum has not swung too far [in requiring statistical significance before drawing conclusions]’ has, in the decades since that 1965 address, altered the importance of statistical significance to scientists in the field of epidemiology.”

Id. This failure, identified by the Court, is hardly surprising. The snippet of a quotation from Hill would not sustain the plaintiffs’ sweeping generalization. The quoted language in context may help to explain why Hill’s paper was not provided:

“I wonder whether the pendulum has not swung too far – not only with the attentive pupils but even with the statisticians themselves. To decline to draw conclusions without standard errors can surely be just as silly? Fortunately I believe we have not yet gone so far as our friends in the USA where, I am told, some editors of journals will return an article because tests of significance have not been applied. Yet there are innumerable situations in which they are totally unnecessary – because the difference is grotesquely obvious, because it is negligible, or because, whether it be formally significant or not, it is too small to be of any practical importance. What is worse the glitter of the t table diverts attention from the inadequacies of the fare. Only a tithe, and an unknown tithe, of the factory personnel volunteer for some procedure or interview, 20% of patients treated in some particular way are lost to sight, 30% of a randomly-drawn sample are never contracted. The sample may, indeed, be akin to that of the man who, according to Swift, ‘had a mind to sell his house and carried a piece of brick in his pocket, which he showed as a pattern to encourage purchasers.’ The writer, the editor and the reader are unmoved. The magic formulae are there.”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 299 (1965).

In the Zoloft cases, no expert witness was prepared to state that the disparity was “grotesquely obvious,” or “negligible.” And Bradford Hill’s larger point was that bias and confounding often dwarf considerations of random error, and that there are many instances in which significance testing is unavailing or unhelpful. And in some studies, with large “effect sizes,” statistical significance testing may be beside the point.

Hill’s presidential address to the Royal Society of Medicine commemorated his successes in epidemiology, and we need only turn to Hill’s own work to see how prevalent was his use of measurements of significance probability. See, e.g., Richard Doll & Austin Bradford Hill, “Smoking and Carcinoma of the Lung: Preliminary Report,” Brit. Med. J. 740 (Sept. 30, 1950); Medical Research Council, “Streptomycin Treatment of Pulmonary Tuberculosis,” Brit. Med. J. 769 (Oct. 30, 1948).

Considering the misdirection on Rothman and on Hill, the Zoloft MDL Court did an admirable job in unraveling the Matrixx trap set by counsel. The Court insisted upon parsing the Bradford Hill factors[5], over Pfizer’s objection, despite the plaintiffs’ failure to show “an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance,” which Bradford Hill insisted was the prerequisite for the exploration of the nine factors he set out in his classic paper. Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Given the outcome, the Court’s questionable indulgence of plaintiffs’ position was ultimately harmless.

[1] See also “The Matrixx – A Comedy of Errors,” and “Matrixx Unloaded,” (Mar. 29, 2011), “The Matrixx Oversold,” and “De-Zincing the Matrixx.”

[2] See “Siracusano Dicta Infects Daubert Decisions” (Sept. 22, 2012).

[3] See, e.g., In re Chantix (Varenicline) Prods. Liab. Litig., 2012 U.S. Dist. LEXIS 130144, at *22 (N.D. Ala. 2012); Cheek v. Wyeth Pharm. Inc., 2012 U.S. Dist. LEXIS 123485 (E.D. Pa. Aug. 30, 2012); In re Celexa & Lexapro Prods. Liab. Litig., ___ F.3d ___, 2013 WL 791780 (E.D. Mo. 2013).

[4] The Court’s reasoning on this point begged the question whether an ordinary clinician, ignorant of the standards, requirements, and niceties of statistical reasoning and inference, would be allowed to testify, unconstrained by any principled epidemiologic reasoning about random or systematic error. It is hard to imagine that Rule 702 would countenance such an end-run around the requirements of sound science.

[5] Adhering to Bradford Hill’s own admonition might have saved the Court the confusion of describing statistical significance as a measure of strength of association. 2015 WL 314149, at *2.

Posted in Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Zoloft MDL Relieves Matrixx Depression

More Antic Proposals for Expert Witness Testimony – Including My Own Antic Proposals

December 30th, 2014

The late Professor Margaret Berger epitomized a person you could like and even admire, while finding many of her ideas erroneous, incoherent, and even dangerous. Berger was frequently on the losing side of expert witness admissibility issues, and she fell under the influence of the plaintiffs’ bar, holding conferences with their walking-around money, laundered through SKAPP, The Project on Scientific Knowledge and Public Policy.[1] In appellate cases, Berger often lent the credibility of her scholarship to support plaintiffs’ efforts to strip away admissibility criteria for expert witness causation opinion.[2] Still, she was always polite and respectful in debate. When Judge Weinstein appointed her to chair a committee to search for appropriate court-appointed expert witnesses in the silicone gel breast implant litigation, Professor Berger proved a careful, impartial listener to all the parties involved.

In 2009, before the publication of the Third Edition of the Reference Manual on Scientific Evidence, Professor Berger gave a presentation for an American Law Institute continuing legal education program, in which she aired her antipathy toward gatekeeping.[3] With her sights set primarily on defense expert witnesses, Berger opined that a monetary relationship between an expert witness and the defendant could be grounds for a Rule 702 exclusion. While the jingle of coin doth soothe the hurt that conscience must feel (for some expert witnesses), the focus of the Rule 702 inquiry is properly on relevance, reliability, and validity. Judge Shira Scheindlin, who sat on the same panel as Professor Berger, diplomatically pointed out that employee expert witnesses are offered all the time, and any bias is a subject for cross-examination, not disqualification. Remarkably, neither Professor Berger nor Judge Scheindlin acknowledged that conflicts of interest, actual or potential, are not relevant to the Daubert or Rule 702 factors that guide admissibility. If Berger’s radical position of identifying conflict of interest with unreliability were correct, we might dismiss her views without any consideration[4], given her conflicts of interest from her association with SKAPP, and her several amicus briefs filed on behalf of plaintiffs, seeking to avoid the exacting requirements of expert witness evidence gatekeeping.

In her ALI-CLE lecture, Professor Berger waxed enthusiastically about what was then a recent federal trial court decision in Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009). Berger asserted that the case was unpublished and that the case, like many other “Daubert” cases was hidden from view. Berger thought that Allen’s obscurity was unfortunate because the decision was “fabulous” and was based upon astute opinions of “outstanding” experts[5]. Berger was wrong on every point, from the chemical involved, to the unavailability of the opinion, to the quality of the expert witnesses (who were not ALS experts, but frequent, willing testifiers), and to the carefulness of the exposure and causation opinions offered.[6] See James L. Bernat & Richard Beresford, Ethical and Legal Issues in Neurology 59-60 (Amsterdam 2013) (discussing Allen and characterizing the court’s decision to admit plaintiffs’ expert witnesses’ opinions as based upon plausibility without more).

Implicit in Berger’s errors, however, may be the beginnings of some concrete suggestions for improving the gatekeeping process. After all, Berger thought that no one would likely find and read the Allen decision. She may have thus believed that she had some freedom from scrutiny when she praised the decision and the expert witnesses involved. Just as there is a groundswell of support for greater disclosure of underlying data to accompany scientific publications, there should be support for wide dissemination of the underlying materials behind Rule 702 opinions. Most judges cannot or will not write sufficiently comprehensive opinions describing and supporting their decisions to admit or exclude expert witness opinion to permit vigorous public scrutiny. Some judges fail to cite to the underlying studies or data that are the bases of the challenged opinions. As a result, the “Daubert” scholarship suffers because it frequently lacks access to the actual reports, testimony, studies, and data themselves. Often the methodological flaws discussed in judicial opinions are just the tip of the iceberg, with flaws running all the way to the bottom.

And while I am on “antic proposals” of my own, courts should consider requiring all parties to file proposed findings of fact and conclusions of law, with record cites, to support their litigation positions. Lawyers on both sides of the “v.” have proven themselves cavalier and careless in their descriptions and characterizations of scientific evidence, inference, and analysis. Proposed findings would permit reviewing courts, scientists, and scholars to identify errors for the benefit of appellate courts and later trial courts.

[1] SKAPP claimed to have aimed at promoting transparent decision making, but deceived the public with its disclosure of having been supported by the “Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation.” Somehow SKAPP forgot to disclose that this court order simply created a common-benefit fund for plaintiffs’ lawyers to pursue their litigation goals. How money from the silicone gel breast implant MDL was diverted for advocated anti-Daubert policies is a mystery that no amount of transparent decision making has to date uncovered. Fortunately, for the commonweal, SKAPP appears to have been dissolved. The SKAPP website lists those who guided and supported SKAPP’s attempts to subvert expert witness validity requirements; not surprisingly, the SKAPP supporters were mostly plaintiffs’ expert witnesses:

Eula Bingham, PhD
Les Boden, PhD
Richard Clapp, DSc, MPH
Polly Hoppin, ScD
Sheldon Krimsky, PhD
David Michaels, PhD, MPH
David Ozonoff, MD, MPH
Anthony Robbins, MD, MPA

[2] See, e.g., Parker v. Mobil Oil Corp., N.Y. Ct. App., Brief Amicus Curiae of Profs. Margaret A. Berger, Edward J. Imwinkelried, Sheila Jasanoff, and Stephen A. Saltzburg (July 28, 2006) (represented by Anthony Z. Roisman, of the National Legal Scholars Law Firm).

[3] Berger, “Evidence, Procedure, and Trial Update: How You Can Win (Or Lose) Your Case (Expert Witnesses, Sanctions, Spoliation, Daubert, and More)” (Mar. 27, 2009).

Berger, “Evidence, Procedure, and Trial Update: How You Can Win (Or Lose) Your Case (Expert Witnesses, Sanctions, Spoliation, Daubert, and More)” (Mar. 27, 2009).

[4] We can see this position carried to its natural, probable, and extreme endpoint in Elizabeth Laposata, Richard Barnes, and Stanton Glantz, “Tobacco Industry Influence on the American Law Institute’s Restatements of Torts and Implications for Its Conflict of Interest Policies,” 98 Iowa Law Rev. 1 (2012), where the sanctimonious authors, all anti-tobacco advocates criticize the American Law Institute for permitting the participation of lawyers who represent tobacco industry. The authors fail to recognize that ALI members include lawyers representing plaintiffs in tobacco litigation, and that it is possible, contrary to their ideological worldview, to discuss and debate an issue without reference to ad hominem “conflicts” issues. The authors might be surprised by the degree to which the plaintiffs’ bar has lobbied (successfully) for many provisions in various Restatements.

[5] Including Richard Clapp, who served as an advisor to SKAPP, which lavished money on Professor Berger’s conferences.

[6] See “Bad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing” (Nov. 30, 2012); “Gatekeeping in Allen v. Martin Surfacing — Postscript” (April 11, 2013).

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