TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Archives »

Science Day Should Be Every Day in Our Courtrooms — Part II

March 24th, 2017

This post and the previous one are an expansion upon a post that I wrote with Dr. David Schwartz, of Innovative Science Solutions, LLC. Dr. Schwartz is a talented scientist with whom I had the privilege and pleasure to work at McCarter & English, before he left to become an independent scientific consultant. Dr. Schwartz is one of the founding partners of his firm, which focuses on helping lawyers with the scientific issues in complex health effects litigation. Our earlier post can be found on the Courtroom View Network’s website. “Guest Analysis: Key Takeaways from Recent Talc Powder ‘Science Day’ Hearing in California,” Courtroom View Network (Mar 24, 2017).

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

Talc Science Goes Bicoastal

This year, two trial judges have entertained Science Days in talc cases, on both coasts of the United States. In the federal talc litigation, MDL 2738,1 Judge Freda L. Wolfson conducted a Science Day on January 26, 2017. In the coordinated California state court talc cases, Judge Maren E. Nelson, of the Superior Court of California, Los Angeles County, conducted a Science Day, on March 7, 2017.2

Federal Talc MDL 2738

In the federal cases, Johnson & Johnson, one of the defendants, initiated the Science Day, in November 2016, when it asked Judge Wolfson to set aside a day in “which the parties and their experts can outline their positions/arguments regarding the medical and science issues at play.”3 In Case Management Order No. 1 (Jan. 23, 2017), Judge Wolfson apparently agreed, and the parties had their talc Science Day on January 26, 2017.4 The Science Day took up over five hours of presentations to Judge Freda L. Wolfson, and Judge Lois H. Goodman.5

California Coordinated Docket

In the California cases,6 plaintiffs’ counsel filed a formal motion, in early December 2016, to request a Science Day tutorial. The plaintiffs’ motion requested that each side be permitted two hours to present their views of the scientific evidence in support of their litigation positions on causation and liability in talc ovarian cancer cases. The plaintiffs argued that a Science Day would be “significant benefit to the Court and the parties.”7 Judge Nelson granted the request, and held Science Day on March 7, 2017.

Courtroom View Network (CVN)

The proceedings in California were recorded videographically, and are available through Courtroom View Network (CVN). Johnson & Johnson opposed televising the Science Day proceedings, on the procedural ground that CVN had not filed and served the appropriate motion. Johnson & Johnson also argued a substantive ground that the proceedings were not a formal trial, and that televising “would not confer any benefit on the public, the parties, or the Court, let alone one that outweighs the significant concerns posed by such a broadcast.”8

Whatever the merits of J & J’s procedural ground, its substantive grounds seem dubious. The importance of the Science Day proceedings transcends the pecuniary interests of the parties to the litigation. First, the presentations provide the empirical bases for other courts and lawyer to evaluate the procedures employed. Second, lawyers and judges generally, outside the talc litigation, can learn a great deal from the strengths, weaknesses, and mistakes made by the participants in the televised proceedings. Many of the scientific issues that pervade the talc litigation recur frequently in other mass tort litigations in the United States and abroad. Finally, and perhaps most important, the talc litigation involves litigation claims of huge import to the public generally. For better or worse, litigation has become an adjunct to regulation in the United States. If the plaintiffs’ claims are true, then there has been a serious failure of national and international regulatory agencies and scientific organizations in evaluating the evidentiary record. If the defendants’ claims are true, then the plaintiffs’ lawyers have misunderstood and distorted the basic process of synthesizing evidence and arriving at conclusions of causation. More important, it behooves the public to understand why one side is wrong.

Evaluation of the California Talc Litigation Science Day

Plaintiffs’ Presentations

The presentation by the plaintiff lawyers was eerily reminiscent of the scientific case made by plaintiffs in the silicone breast implant ligation. Their arguments ranged from highlighting anecdotal evidence to emphasizing the implicit sinister nature of talc migration from the vaginal opening to the ovaries. Plaintiff counsel focused heavily on the alleged role of talc in the inflammatory process and strong (unsubstantiated) implications that anything that enhances inflammation must necessarily cause cancer.

As one would expect, plaintiff counsel placed strong emphasis on the published epidemiological studies linking talc exposure to ovarian cancer. It is important to highlight that the majority of the studies showing an association between talc and ovarian cancer came from case-control studies by design (as opposed to a cohort design). Plaintiff counsel offered very little distinction between these two study designs and, instead tried to make the case that the sheer volume of studies made their argument..

Finally, it should be noted that at many times throughout the plaintiff presentations, the presenter veered off into non-scientific, ad hominem attacks against the industry and/or activities that they tried to paint as venal or unseemly. Defense counsel made objections throughout that seemed to be based upon first amendment protections for the defendants’ ability to speak to agencies about the scientific evidence. For example, the last presenter for the plaintiffs described alleged industry “lobbying” efforts at NTP. Defense counsel objected on first amendment grounds, and the judge semi-sustained the objection on the basis that it had little or nothing to do with the science. The plaintiffs’ emphasis on “lobbying” contained no examples of misrepresentations of scientific data. See “Talc Litigation in Missouri – Show Me the Law and the Evidence” (Feb. 24, 2017).

Defendants’ Presentations

In general, the defense presentations were more structured, coherent, substantial, and rigorously scientific. For example, unlike the plaintiffs’ graphics, many of the defense slides could stand on their own in a scientific or medical society presentation. The defense lawyers attempted to provide a solid foundation for the judge on the different types of ovarian cancer as well as the myriad uncertainties that exist in terms of the known causes of the condition. Many of the slides contained direct quotes from notable scientists and regulators on topics that were directly relevant to answering critical questions in the litigation.

Epidemiology and Specific Causation

Nevertheless, the defense presentations were not without their problems. Consider the following quote from an article by Graham Colditz, used in one of the defense powerpoint slides:9

“The fundamental object of epidemiology is to estimate the population average risk of the disease. Risk is a population measure, not an individual disease measure.”

Colditz has served as an expert witness on epidemiology for plaintiffs in talc and other litigations, and the defense no doubt believed that they could make their point in a rhetorically powerful way by quoting him. The problem starts with the quote’s failure to make the defense’s point. Risk is a measure or relative proportions in the sample, to be used to estimate the population measure. To say that it is a group measure, however, does not mean that there are no reasonable inferences from the group measure to the individual member of the sample or population.

The defense seems to want to argue that even there were an increased risk not explained by chance, bias, or confounding, that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer.

A fuller quotation might even have helped the defense because Colditz seems intent on undermining not just the use of group measures of risk as an individual variable, but also the use of the measure to support an inference about individuals:

“The fundamental object of epidemiology is to estimate the population average risk of disease. Risk is a population measure, not an individual measure. Epidemiology does not estimate individual levels of risk, nor does it perfectly predict individual likelihood of disease. As noted by Rose, epidemiology does not describe why an individual case of cancer arises in the population but rather the population burden of cancer.14 In his article in this issue of the Journal, Begg ignores this principle and uses the term “risk” as an individual-level variable.15”

The fuller quotation points to a disagreement in which another epidemiologist was willing to use risk to describe individual attribute, but more to the point is that Colditz’s assertion is that risk is a group measure.

Colditz, at least in this article, does not claim that the group measure of risk was irrelevant to prospective individual predictions or retrospective individual attributions. Interestingly, Graham Colditz has elsewhere asserted that an increased risk of disease cannot be translated into the “but-for” standard of causation10:

“Knowledge that a factor is associated with increased risk of disease does not translate into the premise that a case of disease will be prevented if a specific individual eliminates exposure to that risk factor. Disease pathogenesis at the individual level is extremely complex.”

Defense may have wanted to highlight this assertion even recognizing that it is controversial, and quite dependent upon the magnitude of the measured risk.

In attempting to make their point with a quote from plaintiffs’ own expert (Dr. Graham Colditz), the defense oversimplified a much more complex issue. While increased or relative risk is indeed a measure or incidence rates used to estimate rates in the broader population, this aspect of relative risk as a measure does not mean that there are no reasonable inferences that can be made from the group measure to the individual member of the sample or population. The defense seems to want to make the seemingly unreasonable point that even if an increased risk were appropriately demonstrated by the epidemiology, that that measure of risk does not tell us anything about what caused an individual claimant’s ovarian cancer. This point might be correct when the magnitude of the increased risk is small (as is alleged in the talc ovarian cancer litigation), but the sweeping generality of the defense’s assertion is jarring.

Back in the 1960s and 1970s, tobacco companies attempted to rebut inferences of individual causation, despite scientific consensus on general causation, and relative risks of 20 to 30, and more for lung cancer in smoking versus non-smoking groups. The tobacco companies’ claim of the irrelevancy of epidemiology to inferring specific causation was not particularly credible when the population attributable risk was 95 percent and greater.

Even at lower relative risks, measures of risks in epidemiologic studies and clinical trials are used to predict individual responses to treatments, to life style interventions, and to life style and other risk factors. Of course, there is always potential heterogeneity in the sample and in the population, which should be acknowledged, but when the studies are multivariate, with inclusion of the known causes and potential risk factors, then scientists and physicians routinely use these measures of risks and benefits in groups to make predictions about individuals.

Consider a man, seriously overweight, who goes to see his internist. His physician tells him,

“look in populations of overweight men, just like yourself, more men die of heart attack and stroke, and they die of these diseases at an early age, and suffer more morbidity and disability from them, then in groups of men who are not overweight, but don’t worry, that has NOTHING to do with you. We don’t know your risk, so go right on eating candy bars for breakfast, and studiously avoiding exercise.”

Of course, no sane, competent physician would advise the obese patient in this manner. Now, I understand rhetorically why the defense might want to capitalize on Colditz’ statement, but the end result appears to mislead the intended audience. The rejection of probabilistic inferences is still occasionally sanctioned by courts11, but more typically, such inferences are permitted when not conjectural.

Defense’s Misleading Claim that Case-Control Studies are Smaller than Cohort Studies

In its Science Day presentation, the defense asserted that a disadvantage of case-control studies is, among other things, their “small size.” In the same vein, the defense claimed that an advantage of cohort studies is their “large size.” The defense provided no supporting citations for its contention about the relative size of the two kinds of analytical epidemiologic studies.12

In his oral comments, the defense presenter notes the size disparity between the case-control and the cohort studies as a reason to distrust the results of the case-control studies on talc exposure and ovarian cancer. The presenter leans in and says that the cohort studies are huge, some with hundreds of thousands of women.

Now there are important qualitative differences between case-control and cohort studies, with respect to recall bias and the validity of control groups. To be sure, and fair, the defense made these points accurately. The defense’s invidious comparison of size of the two types of studies ignores that case-control studies are statistically much more efficient.

As the defense presented the matter, case-control studies are placed lower on the “hierarchy of evidence” than cohort studies. For this point, the defense did present a supporting citation13, and their claim is generally correct, but epidemiologists recognize that a well-conducted case-control study may well trump a cohort study. Case-control studies are often ranked below cohort studies because of greater potential for systematic bias, the inherent difficulty in selecting appropriate controls, and because the measure of risk in the form of an odds ratio is at best an estimate of the relative risk. The sizes of the “cases” group in a case-control study and the cohort in a cohort study are not a valid comparison.

A case-control study may be based upon hundreds of cases of ovarian cancer, a size that would require a huge cohort study. Furthermore, the size of the cohort study can be highly misleading because recruitment and inception into the cohort often takes place at a young age, when the rate of ovarian cancer is very low. The efficiency of the case-control study design is reflected in the narrow confidence intervals seen in many of the published papers. Some of these confidence intervals are as narrow as those generated by analysis of data from “larger” cohort studies.14 The size is ultimately related to the precision of the various studies’ point estimates of measured risk, not to the accuracy of their measurements. The statistical efficiency of the ovarian cancer talc case-control studies becomes an important when rare disease subtypes are considered, or when the interaction between genotype, exposure, and cancer outcomes needs to be considered.

Synthesis of Evidence for Judgments of Causation

Finally, it seems that neither the defense nor the plaintiffs adequately incorporated into their presentations the important concept of causal inference (or how evidence from disparate sources is synthesized into a judgment of causation, or into a rejection of such a claim). Specifically, counsel never explicitly set forth the importance of the Bradford Hill factors, or the techniques of proper and rigorous systematic review methodologies. The defense did touch upon many of the key considerations of the Bradford Hill factors as they applied to the relevant data, but there was no discussion of how these factors are considered after the identification of an association that is not likely the result of bias and that is beyond the play of chance. With respect to meta-analysis, both sides provided no guidance or insight into the problems that arise in conducting, reporting, and interpreting quantitative syntheses of a body of epidemiologic studies.

The Trial Court’s Role

Most trial judges, sadly, come to cases such as the talc ovarian cancer cases without any training in statistics, epidemiology, toxicology, or an adequate understanding of the role that clinical medicine plays (or does not play) in assessing important questions of causation. Judge Nelsen seemed to listen carefully, but asked few questions to suggest that Her Honor understood the discrepancy in statements made in the parties’ presentation.

Perhaps a starting point for Science Day should be an Order that sets out the procedures for the Day, as well as a statement: “The Court has read and studied the relevant chapters in the Reference Manual on Scientific Evidence (3d ed. 2011), and all materials submitted by the parties. The parties should not recreate a tutorial that covers material in the Reference Manual, unless they wish to contest its contents. Specific references to the Manual, in connection with the parties’ presentation would be very helpful to the Court.”

1  In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Prods. Liab. Litig., No. 16-2738 (D.N.J.)

2 Johnson & Johnson Talcum Powder Cases, No. JCCP4872 (Calif. Super. Ct., Los Angeles Cty.).

3  “Johnson & Johnson Files Status Report in MDL Docket, Requests ‘Science Day’ to Address Causation in Talc Cases,” HarrisMartin’s Talcum Powder Litigation Report (Nov. 16, 2016).

4  “Parties in Federal Talcum Powder MDL Hold ‘Science Day’,” HarrisMartin’s Talcum Powder Litig. Report (Jan. 26, 2017).

5  Id.

6  Johnson & Johnson Talcum Powder Cases, No. JCCP4872 (Calif. Super. Ct., Los Angeles Cty.).

7  “Plaintiffs Ask Court to Hold ‘Science Day’ in California Coordinated Talcum Powder Docket,” HarrisMartin’s Talcum Powder Litig. Report (Dec. 7, 2016).

8  See “Calif. Court Oversees ‘Science Day’ in Talcum Powder Docket One Day After J&J Opposes Broadcast of Hearing,” HarrisMartin’s Talcum Powder Litig. Report (Mar. 8, 2017).

9 “Defense Slide 129. “Epidemiology Estimates Risk in the Population, Not in Individuals,” quoting from Graham Colditz, “Cancer Culture: Epidemics, Human Behavior, and the Dubious Search for New Risk Factors,” 91 Am. J. Pub. Health 357, 357 (2001).

10 Graham A. Colditz, “From epidemiology to cancer prevention: implications for the 21st Century,” 18 Cancer Causes Control 117, 118 (2007).

11 See, e.g., Smith v. Ortho Pharmaceutical Corp., 770 F. Supp. 1561, 1573 (N.D. Ga. 1991) (“However, in an individual case, epidemiology cannot conclusively prove causation; at best, it can only establish a certain probability that a randomly selected case of disease was one that would not have occurred absent exposure, or the ‘relative risk’ of the exposed population. Epidemiology, therefore, involves evidence on causation derived from group-based information, rather than specific conclusions regarding causation in an individual case.”).

12  See Defense Slide 134, “Disadvantages of Case-Control Studies,” which sets out in bullet points, “Recall Bias, Confounding, Small Size.” And in Defense Slide 135, “Epidemiologic Studies on Talc and Ovarian Cancer: Three Types Large Prospective Cohort Studies,” the defense touts advantages of cohort studies to include “No Recall Bias” and “Large Size.” The slides contained no supporting citation for the contention about size.

13 See Defense Slide 136, “Epidemiology Studies on Talc and Ovarian Cancer: Three Types,” where the defense places case-control studies lower on the “hierarchy of evidence” than cohort studies, citing Trisha Greenhalgh, “How to Read a Paper,” 315 Brit. Med. J. 241 (1997).

14 See Wera Berge, Kenneth Mundt, Hung Luu & Paolo Boffetta, “Genital use of talc and risk of ovarian cancer: a meta-analysis,” European J. Cancer Prevention (2017), in press, DOI: 10.1097/CEJ.0000000000000340.

APPENDIX

American Bar Association’s “Civil Trial Practice Standards” (August 2007).

7. Use of Tutorials to Assist the Court

a. Pretrial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court. Tutorials are intended to provide the court with background information to assist the court in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

b. Selection of Type of Tutorial.

i. In any case in which the court believes one or more tutorials might be useful in assisting it in understanding the complex technology or other complex subject matter, the court should invite the parties to express their views on the desirability of one or more tutorials.

ii. Once the court decides to permit or require one or more tutorials, it should invite the parties to suggest the subject matter and format of each tutorial.

iii. If the parties cannot agree on the subject matter and format, the court should invite each party to submit a description of any tutorial it proposes and to explain how that tutorial will assist the court and why it is preferable to the tutorial proposed by another party. The court may approve one or more tutorials proposed by the parties, or the court may fashion its own tutorial after providing the parties with an opportunity to comment on the court’s proposed subject matter and format.

c. Procedures for Presentation. A court may consider the following procedures for the presentation of tutorials:

i. An in-court or recorded presentation by an expert jointly selected by the parties.

ii. An in-court or recorded presentation by one or more experts on behalf of each party.

iii. An in-court or recorded presentation by counsel for each party.

iv. A combined in-court or recorded presentation by counsel and one or more experts on behalf of each party.

v. An in-court or recorded presentation by an expert appointed by the court, which may include cross-examination by counsel for each party.

vi. Recorded presentations that have been prepared for generic use in particular kinds of cases by reliable sources such as the Federal Judicial Center.

d. Trial Use of Tutorials. In cases involving complex technology or other complex subject matter which may be especially difficult for non-specialists to comprehend, the court may permit or require the use of tutorials to educate the court or jury during one or more stages of the trial. Trial tutorials are intended to provide the court or jury with background information to assist in understanding the technology or other complex subject matter involved in the case. Tutorials may, but need not, seek to explain the contentions or arguments made by each party with respect to the technology or complex subject matter.

e. Selection of Type of Tutorial. The court should use the process set forth in 7.b. above.

f. Procedures for Presentation.

i. In a bench trial, the court may consider using any of the procedures set forth in 7.b. above.

ii. In a jury trial, the court should consider the use of tutorials in connection with interim statements and arguments as provided in

Standard 9.

iii. In both bench and jury trials, the court should provide parties with a full opportunity to present admissible evidence in support of their cases that may differ from or quarrel with information presented in a tutorial and to argue that the information presented in a tutorial should be rejected by the court or jury.

Posted in Rule 702, Scientific Evidence | Comments Off on Science Day Should Be Every Day in Our Courtrooms — Part II

Science Day Should Be Every Day in Our Courtrooms — Part I

March 24th, 2017

The following post and its sequel are an expansion upon a post that I wrote with Dr. David Schwartz, of Innovative Science Solutions, LLC. Dr. Schwartz is a talented scientist with whom I had the privilege and pleasure to work at McCarter & English, before he left to become an independent scientific consultant. Dr. Schwartz is one of the founding partners of his firm, which focuses on helping lawyers with the scientific issues in complex health effects litigation. Our earlier post can be found on the Courtroom View Network’s website. “Guest Analysis: Key Takeaways from Recent Talc Powder ‘Science Day’ Hearing in California,” Courtroom View Network (Mar 24, 2017).

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

Every February 28th, India celebrates National Science Day in honor the Indian physicist Sir Chandrashekhara Venkata Raman, who discovered the Raman effect. The United States has no equivalent celebration, but “Science Days” have become a commonplace in complex state and federal Litigations, around the country.

Background

The major impetus for science tutorials seems to have come from the United States Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The holding of Daubert, now incorporated into, and extended by Federal Rule of Evidence 702, requires trial judges to act as gatekeepers of the relevance and reliability of expert witness opinion testimony in their courtrooms. One of the first tests of the judiciary’s performance to perform this role came in the silicone gel breast implant litigation. The federal silicone cases were consolidated before Judge Pointer Sam C. Pointer, Jr., in MDL 926. Judge Pointer believed that trial judges in the transferor courts should conduct whatever review of expert witness opinion was needed to satisfy the then recent Daubert decision.

Some of the first federal silicone lawsuits remanded from the MDL went to Judge Robert Jones in Portland Oregon. These cases involved complex issues of immunology, clinical rheumatology, epidemiology, toxicology, surgery, and polymer and analytical chemistry. At the outset of his case management of the remanded cases, plaintiffs’ counsel requested that Judge Jones schedule an all-day tutorial for counsel to present on these scientific issues. The parties’ tutorials, along with an avalanche of defense Daubert motions, persuaded Judge Jones to take the unusual step of appointing technical advisors to assist him in assessing the scientific evidence, inferences and claims in the silicone litigation. See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1415 (D. Ore. 1996).1 Judge Jones’s technical advisors attended court throughout the Daubert hearings conducted in Portland, and they delivered advisory reports to Judge Jones to assist him in his gatekeeping function. Judge Jones ultimately granted the defense motions to exclude the plaintiffs’ expert witnesses’ claims of silicone causation of connective tissue diseases.

In large measure because of Judge Jones’s case management and exclusion of expert witness testimony, the silicone MDL court appointed a panel of neutral expert witnesses, in the fields of epidemiology, rheumatology, immunology, and toxicology.2

One of the first requests received from the Science Panel in MDL 926 was for what turned out to be a series of Science Days in which the parties’ expert witnesses would present to them, and explain their interpretation of the vast array of evidence, from different disciplines. Each presenting party expert witness was allowed 15 to 20 minutes to present. The lawyers were not entirely reduced to potted plants; they had a chance to conduct a short cross-examination. Given that the primary audience was a panel of four distinguished scientists, there was an emphasis for most of the lawyers, for the plaintiffs and the defendants, to ask pertinent, substantive questions.

The Science Panel was not entirely satisfied with the party expert witnesses, and requested a second Science Day, at which the Panel could call its own slate of scientists to address the scientific claims made in the litigation. The proceedings took place at the National Academies of Science, in Washington, D.C.

These proceedings, along with extensive submissions of articles and briefings from the parties led to the Report of National Science Panel, on November 30, 1998.

Every Day is Science Day, Somewhere

Since the breast implant litigation, many MDL and other courts have faced complex causation claims in litigation involving pharmaceutical products, medical devices, consumer products and a host of chemical exposures. Appointment of independent, neutral expert witnesses remains unusual, but trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them. For some reason, the parties, the judges, and the legal media often reference Science Days in scare quotes, signaling that perhaps other Science takes place in these proceedings. Whether the scare quotes are warranted remains to be determined.

“Science Days” have become a tradition in mass tort litigation.3 In the last few years, there is a Science Day somewhere, in some courtroom, going on, perhaps not daily, but with sufficient frequency that the phenomenon should receive more critical attention. Federal judges with multi-district litigation, or state judges with multi-county cases, set aside time to permit the parties a chance to educate them about the scientific and technical aspects of the litigations before them. Judges know that Daubert and Rule 702, or their state analogues, require them to act as gatekeepers. Furthermore, myriad motions in the discovery and trial phases of a case will require judges to make nuanced but accurate decisions about scope and content of discovery, and admissibility of documents and testimony,

Science Day – Have It Your Way

John Milton: We negotiating?

Kevin Lomax: Always.4

The Devil’s Advocate (1997).

There are no federal or state rules that set out procedures for science tutorials for judges or their appointed expert. The form and substance of Science Days depend upon a three-say negotiation among the plaintiffs, defendants, and the trial judge. Although the parties are often left to work out a plan for science day, most courts tend to weigh in by imposing time limits, and they may even rule in or rule out live witness testimony.

In 2007, the American Bar Association set out Civil Trial Practice Standards,5 which included an entire section on the use of tutorials to assist the court. [The relevant standards for tutorials is set out at the end of Part II of this post, as an appendix.]

1 See Laural L. Hooper, Joe S. Cecil, and Thomas E. Willging, “Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation,” at 9 (Federal Judicial Center 2001).

2 MDL 926 Order 31 (May 31, 1996) (order to show cause why a national Science Panel should not be appointed under Federal Rule of Evidence 706); MDL 926 Order No. 31C (Aug. 23, 1996) (appointing Drs. Barbara S. Hulka, Peter Tugwell, and Betty A. Diamond); Order No. 31D (Sept. 17, 1996) (appointing Dr. Nancy I. Kerkvliet).

3 See, e.g., Barbara J. Rothstein & Catherine R. Borden, Managing Multidistrict Litigation in Products Liability Cases: A Pocket Guide for Transferee Judges at 39 & n. 54 (Fed. Jud. Ctr. 2011); Sean Wajert, “‘Science Day’ In Mass Torts,” Mass Tort Defense (Oct. 20, 2008); Lisa M. Martin, “Using Science Day to Your Advantage,” 2(4) Pro Te: Solutio 9 (2009).

4 From the screenplay of the movie, directed by Taylor Hackford, written by Jonathan Lemkin and Tony Gilroy, and based on a novel by Andrew Neiderman.

5 American Bar Association’s “Civil Trial Practice Standards” (August 2007 & 2011 Update).

Posted in Rule 702, Scientific Evidence, Trial Procedure | Comments Off on Science Day Should Be Every Day in Our Courtrooms — Part I

Washington Legal Foundation’s Paper on Statistical Significance in Rule 702 Proceedings

March 13th, 2017

The Washington Legal Foundation has released a Working Paper, No. 201, by Kirby Griffis, entitled “The Role of Statistical Significance in Daubert / Rule 702 Hearings,” in its Critical Legal Issues Working Paper Series, (Mar. 2017) [cited below as Griffis]. I am a fan of many of the Foundation’s Working Papers (having written one some years ago), but this one gives me pause.

Griffis’s paper manages to avoid many of the common errors of lawyers writing about this topic, but adds little to the statistics chapter in the Reference Manual on Scientific Evidence (3d ed. 2011), and he propagates some new, unfortunate misunderstandings. On the positive side, Griffis studiously avoids the transposition fallacy in defining significance probability, and he notes that multiplicity from subgroups and multiple comparisons often undermines claims of statistical significance. Griffis gets both points right. These are woefully common errors, and they deserve the emphasis Griffis gives to them in this working paper.

On the negative side, however, Griffis falls into error on several points. Griffis helpfully narrates the Supreme Court’s evolution in Daubert and then in Joiner, but he fails to address the serious mischief and devolution introduced by the Court’s opinion in Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 131 S.Ct. 1309 (2011). See Schachtman, “The Matrixx – A Comedy of Errors” (April 6, 2011)”; David Kaye, “Trapped in the Matrixx: The U.S. Supreme Court and the Need for Statistical Significance,” BNA Product Safety & Liability Reporter 1007 (Sept. 12, 2011). With respect to statistical practice, this Working Paper is at times wide of the mark.

Non-Significance

Although avoiding the transposition fallacy, Griffis falls into another mistake in interpreting tests of significance; he states that a non-significant result tells us that an hypothesis is “perfectly consistent with mere chance”! Griffis at 9. This is, of course, wrong, or at least seriously misleading. A failure to reject the null hypothesis does not prove the null such that we can say that the “null results” in one study were perfectly consistent with chance. The test may have lacked power to detect an “effect size” of interest. Furthermore, tests of significance cannot rule out systematic bias or confounding, and that limitation alone ensures that Griffis’s interpretation is mistaken. A null result may have resulted from bias or confounding that obscured a measurable association.

Griffis states that p-values are expressed as percentages “usually 95% or 99%, corresponding to 0.05 or 0.01,” but this states things backwards. The p-value that is pre-specified to be “significant” is a probability or percentage that is low; it is the coefficient of confidence used to construct a confidence interval that is the complement of the significance probability. Griffis at 10. An alpha, or pre-specified statistical significance level, of 5% thus corresponds to a coefficient of confidence of 95% (or 1.0 – 0.05).

The Mid-p Controversy

In discussing the emerging case law, Griffis rightly points to cases that chastise Dr. Nicholas Jewell for the many liberties he has taken in various litigations as an expert witness for the lawsuit industry. One instance cited by Griffis is the Lipitor diabetes litigation, where the MDL court suggested that Jewell switched improperly from a Fisher’s exact test to a mid-test. Griffis at 18-19. Griffis seems to agree, but as I have explained elsewhere, Fisher’s exact test generates a one-tailed measure of significance probability, and the analyst is left to one of several ways of calculating a two-tailed test. See “Lipitor Diabetes MDL’s Inexact Analysis of Fisher’s Exact Test” (April 21, 2016). The mid-p is one legitimate approach for asymmetric distributions, and is more favorable to the defense than passing off the one-tailed measure as the result of the test. The mere fact that a statistical software package does not automatically specify the mid-p for a Fisher’s exact analysis does not make invoking this measure into p-hacking or other misconduct. Doubling the attained significance probability of a particular Fisher’s exact test result is generally considered less accurate than a mid-p calculation, even though some software packages using doubling attained significance probability as a default. As much as we might dislike bailing Jewell out of Daubert limbo, on this one, limited point, he deserved a better hearing.

Mis-Definitions

On recounting the Bendectin litigation, Griffis refers to the epidemiologic studies of birth defects and Bendectin as “experiments,” Griffis at 7, and then describes such studies as comparing “populations,” when he clearly meant “samples.” Griffis at 8.

Griffis conflates personal bias with bias as a scientific concept of systematic error in research, a confusion usually perpetuated by plaintiffs’ counsel. See Griffis at 9 (“Coins are not the only things that can be biased: scientists can be, too, as can their experimental subjects, their hypotheses, and their manipulations of the data.”) Of course, the term has multiple connotations, but too often an accusation of personal bias, such as conflict of interest, is used to avoid engaging with the merits of a study.

Relative Risks

Griffis correctly describes the measure known as “relative risk” as a determination of the “the strength of a particular association.” Griffis at 10. The discussion then lapses into using a given relative risk as a measure of the likelihood that an individual with the exposure studied develop the disease. Sometimes this general-to-specific inference is warranted, but without further analysis, it is impossible to tell whether Griffis lapsed from general to specific, deliberately or inadvertently, in describing the interpretation of relative risk.

Conclusion

Griffis is right in his chief contention that the proper planning, conduct and interpretation statistical tests is hugely important to judicial gatekeeping of some expert witness opinion testimony under Federal Rule of Evidence 702 (and under Rule 703, too). Judicial and lawyer aptitude in this area is low, and needs to be bolstered.

Posted in Rule 702, statistical evidence | Comments Off on Washington Legal Foundation’s Paper on Statistical Significance in Rule 702 Proceedings

New York Rejects the Asbestos Substantial Factor Ruse (Juni Case)

March 2nd, 2017

I recall encountering Dr. Joseph Sokolowski in one of my first asbestos personal injury cases, 32 years ago. Dr. Sokolowki was a pulmonary specialist in Cherry Hill, New Jersey, and he showed up for plaintiffs in cases in south Jersey as well as in Philadelphia. Plaintiffs’ counsel sought him out for his calm and unflappable demeanor, stentorious voice, and propensity for over-interpreting chest radiographs. (Dr. Sokolowski failed the NIOSH B-Reader examination.)

At the end of his direct examination, the plaintiff’s lawyer asked Dr. Sokolowski the derigueur “substantial factor” question, which in 1985 had already become a customary feature of such testimonies. And Dr. Sokolowski delivered his well-rehearsed answer: “Each and every exposure to asbestos was a substantial factor in causing the plaintiff’s disease.”

My cross-examination picked at the cliché. Some asbestos inhaled was then exhaled. Yes. Some asbestos inhaled was brought up and swallowed. Yes. Asbestos that was inhaled and retained near the hilum did not participate in causing disease at the periphery of the lung. Yes. And so on, and so forth. I finished with my rhetorical question, always a dangerous move, “So you have no way to say that each and every exposure to asbestos actually participated in causing the plaintiff’s disease?” Dr. Sokolowski was imperceptibly thrown off his game, but he confessed error by claiming the necessity to cover up the gap in the evidence. “Well, we have no way to distinguish among the exposures so we have to say all were involved.”

Huh? What did he say? Move to strike the witness’s testimony as irrational, and incoherent. How can a litigant affirmatively support a claim by asserting his ignorance of the necessary foundational facts? The trial judge overruled my motion with alacrity, and the parties continued with the passion play called asbestos litigation. The judge was perhaps simply eager to get on with his docket of thousands of asbestos cases, but at least Dr. Sokolowski and I recognized that the “substantial factor” testimony was empty rhetoric, with no scientific or medical basis.

Sadly, the “substantial factor” falsehood was already well ensconced in 1985, in Pennsylvania law, as well as the law of most other states. Now, 32 years later, with ever increasingly more peripheral defendants, each involving less significant, if any, asbestos exposure, the “substantial factor” ruse is beginning to unravel.1

Juni v. A.O. Smith Water Products Co.

Arthur Juni was a truck and car car mechanic, who worked on the clutches, brakes, and manifold gaskets of Ford trucks. Juni claimed to have sustained asbestos exposure in this work, as well as in other aspects of his work career. In 2012, Juni was diagnosed with mesothelioma; he died in 2014. Juni v. A.O. Smith Water Products Co., at *1,No. 190315/12 2458 2457, 2017 N.Y. Slip Op. 01523 (N.Y. App. Div. 1st Dep’t, Feb. 28, 2017).

Juni sued multiple defendants in New York Supreme Court, for New York County. Most of the defendants settled, but Ford Corporation tried the case against the plaintiff’s widow. Both sides called multiple expert witnesses, whose testimony disputed whether the chrysotile asbestos in Ford’s brakes and clutches could cause mesothelioma. The jury returned a verdict in favor of the plaintiff, but the trial court granted judgment nothwithstanding the verdict, on the ground that the evidence failed to support the causation verdict. Id. At *1; see Juni v. A. 0. Smith Water Prod., 48 Misc. 3d 460, 11 N.Y.S.3d 415 (N.Y. Sup. Ct. 2015).

Earlier this week, the first department of the New York Appellate Division affirmed the judgment for Ford. 2017 N.Y. Slip Op. 01523. The Appellate Division refused to approve plaintiffs’ theory of cumulative exposure to show causation. The plaintiffs’ expert witnesses, Drs. Jacqueline Moline and Stephen Markowitz, both asserted that even a single asbestos exposure was a “substantial contributing” cause. The New York appellate court, like the trial court before, saw through the ruse, and declared that both expert witnesses had failed to support their assertions.

The “Asbestos Exception” Rejected

Although New York has never enacted a codified set of evidence rules, and has never expressly adopted the rule of Daubert v. Merrill Richardson, the New York Court of Appeals has held that there are limits to the admissibility of expert witness opinion testimony. Parker v. Mobil Oil Corp., 7 N.Y.3d 434 (2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 NY3d 762 (2014); Sean Reeps. v BMW of North Am., LLC, 26 N.Y.3d 801 (2016). In Juni, the Appellate Division, First Department, firmly rejected any suggestion that plaintiffs’ expert witnesses in asbestos cases are privileged against challenge over admissibility or sufficiency because the challenges occur in an asbestos case. The plaintiff’s special pleading that asbestos causation of mesothelioma is too difficult was invalidated by the success of other plaintiffs, in other cases, in showing that a specific occupational exposure was sufficient to cause mesothelioma.

The Appellate Division also rejected the plaintiff’s claim, echoed in the dissenting opinion of one lone judge, that there exists a “consensus from the medical and scientific communities that even low doses of asbestos exposure, above that in the ambient environment, are sufficient to cause mesothelioma.” The Court held that this supposed consensus is not material to the claims of a particular plaintiff against a particular defendant, especially when the particular exposure circumstance is not associated with mesothelioma in most of the relevant studies. In Juni, the defense had presented many studies that failed to show any association between occupational brake work and mesothelioma. The court might also have added that a characterization of low exposure is extremely amiguous, depending upon the implicit comparison that is being made with other exposures. It is impossible to fit a particular plaintiff’s exposure into the scale of low, medium, and high without some further context.

Single Exposure Sufficiency Rejected

The evidence that chrysotile itself causes mesothelioma remains weak, but the outcome of Juni turned not on the broad general causation question, but on the question whether even suggestive evidence of chrysotile causation had been established for the exposure circumstances of an automobile mechanic, such as Mr. Juni. Plaintiffs’ expert witnesses maintained that Juni’s cumulative asbestos exposures caused his mesothelioma, but they had no meaningful quantification or even reasonable estimate of his exposure.

Citing the Court of Appeals decision in Reeps, the Appellate Division held that plaintiff’s expert witnesses’ causation opinions must be supported by reasonable quantification of the plaintiff’s exposure, or some some scientific method, such as mathematical modeling based upon actual work history, or by comparison of plaintiff’s claimed exposure with the exposure of workers in reported studies that establish a relevant risk from those workers’ exposure. In the Juni case, however, there were no exposure measurements or scientific models, and the comparison with workers doing similar tasks failed to show a causal relationship between the asbestos exposure in those tasks and mesothelioma.

Expert Witness Admissibility and Sufficiency Requires Evaluation of Both Direct and Cross-examination Testimony and Relied Upon Studies

The Juni decision teaches another important lesson for challenging expert witness testimony in New York: glib generalizations delivered on direct examination must be considered in the light of admissions and concessions made on cross-examination, and the entire record. In Juni, the plaintiffs’ expert witnesses, Jacqueline Moline and Stephen Markowitz, asserted that asbestos in Ford’s friction products was a cause of plaintiff’s mesothelioma. Cross-examination, however, revealed that these assertions were lacking in factual support.

Cumulative Exposure

On cross-examination, the plaintiffs’ expert witnesses’ statements about exposure levels proved meaningless. Moline attempted to equate visible dust with sufficient asbestos exposure to cause disease, but she conceded on cross-examination that studies had shown that 99% of brake lining debris was not asbestos. Most of the dust observed from brake drums is composed of resins used to manufacture brake linings and pads. The heat and pressure of the brake drum causes much of the remaining chrysotile to transform into a non-fibrous mineral, fosterite.

Similarly, Markowitz had to acknowledge that chrysotile has a “serpentine” structure, with individual fibers curling in a way that makes deeper penetration into the lungs more difficult. Furthermore, chrysotile, a hydrated magnesium silicate, melts in the lungs, not in the hands. The human lung can clear particulates, and so there is no certainty that remaining chrysotile fibers from brake lining exposures ever reach the periphery of the lung, where they could interact with the pleura, the tissue in which mesothelioma arises.

Increased Risk, “Linking,” and Association Are Not Causation – Exculpatory Epidemiologic Studies

When pressed, plaintiffs’ expert witnesses lapsed into characterizing the epidemiologic studies of brake and automobile mechanics as showing increased risk or association, not causation. Causation, not association, however, was the issue. Witnesses’ invocation of weasel words, such as “increased risk,” “linkage,” and “association” are insufficient in themselves to show the requisite causation in long-latency toxic exposure cases. For automobile mechanics, even the claimed association was weak at best, with plaintiffs’ expert witnesses having to acknowledge that 21 of 22 epidemiologic studies failed to show an association between automobile mechanics’ asbestos exposure and risk of mesothelioma.

The Juni case was readily distinguishable from other cases in which the Markowitz was able to identify epidemiologic studies that showed that visible dust from a specific product contained sufficient respirable asbestos to cause mesothelioma. Id. (citing Caruolo v John Crane, Inc., 226 F.3d 46 (2d Cir. 2000). As the Appellate Division put the matter, there was no “no valid line of reasoning or permissible inference which could have led the jury to reach its result.” Asbestos plaintiffs must satisfy the standards set out in the New York Court of Appeals decisions, Parker v. Mobil Oil Corp., 7 NY3d 434 2006), and Cornell v. 360 W. 51st St. Realty, LLC, 22 N.Y.3d 762 (2014), for exposure evidence and causal inferences, as well.

New York now joins other discerning courts in rejecting regulatory rationales of “no safe exposure,” and default “linear no threshold” exposure-response models as substitutes for inferring specific causation.2 A foolish consistency may be the hobgoblin of little minds, but in jurisprudence, consistency is often the bedrock for the rule of law.

1 The ruse of passing off “no known safe exposure” as evidence that even the lowest exposure was unsafe has been going on for a long time, but not all judges are snookered by this rhetorical sleight of hand. See, e.g., Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (“the failure of science to isolate a safe level of exposure does not prove specific causation”).

2 See, e.g. Bostic v. Georgia-Pacific Corp., 439 S.W.3d 332, 358 (Tex. 2014) (failing to identify safe levels of exposure does not suffice to show specific causation); Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1165-66 (E.D. Wash. 2009) (rejecting a “no threshold” model of exposure-response as unfalsifiable and unvalidated, and immaterial to the causation claims); Pluck v. BP Oil Pipeline Co., 640 F.3d 671, 679 (6th Cir. 2011) (rejecting claim that plaintiff’s exposure to benzene “above background level,” but below EPA’s maximum permissible contaminant level, caused her cancer); Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 10006, 1015 (E.D. Wash. 2010) (rejecting Dr. David Egilman’s proffered testimony on specific causation based upon his assertion that there was no known safe level of diacetyl exposure).

Posted in Asbestos, Causation, Expert Witnesses, Frye, Rule 702, Scientific Evidence | Comments Off on New York Rejects the Asbestos Substantial Factor Ruse (Juni Case)

Social Media, Rhetoric, and Science – Antivaxxers

February 24th, 2017

In a recent news conference, Donald Trump (née Drumpf) proclaimed that that he had won the presidency by the largest electoral college margin since Ronald Reagan. When an earnest (but obviously “dishonest”) reporter challenged him and pointed out that William Jefferson Clinton and Barack Obama had larger majorities in the electoral college, Trump, the fabulist-in-chief, did not lose a beat. Like the old Grinch, Trump was “so smart and so slick, he thought up a lie, and he thought it up quick!”

From his whopper, Trump retreated to the assertion that he was talking only about Republican presidents. But the earnest young reporter was relentless and pressed the challenge. And when pressed, Trump lamely offered1:

“I was given that information. I don’t know. I was just given it. We had a very, very big margin.”

Oh my. As John Adams, observed, before he became President:2

“Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence.”

For a President who regularly embraces alternative facts, who has such a tenuous relationship with reality, and who says whatever was last whispered in his ear, we would expect science to be challenging. Some observers might note that Trump’s behavior mirrors how some lawyers treat scientific evidence and issues in litigation. Rhetoric has its place in science, but scientific disputes cannot be advanced simply because someone gave you “some information.” And yet, people try all the time.

If you search out the The World Mercury Project, you will be treated to a video of Robert F. Kennedy, Jr., who had made a career for the lawsuit industry of pursuing dubious scientific claims.3

The video, also available on YouTube, is vintage Kennedy, self-aggrandizing, and holding forth with accusations against pharmaceutical companies and vaccine manufacturers of “child abuse,” and “even worse.” The epistemic arrogance continues with assertions that Kennedy knows how to fight them, the greedy, murderous bullies.

The Trump presidency, with its alternative facts and its bullying, has emboldened conspiracy theorists of all stripes.

Last week, Robert F. Kennedy, Jr., along with Robert De Niro, convened a news conference on Wednesday at the National Press Club to announce their latest stunt, a $100,000 cash reward to the first person who comes forward with a “peer-reviewed scientific study demonstrating that the mercury in vaccines is safe.” National Press Club Conference (Feb. 15, 2017) [Expurgated Version].

A stunt, of course, because no one study would “demonstrate” safety, although the mass of epidemiologic evidence does. Furthermore, even in face of the overwhelming evidence that thimerosal in vaccines is not associated with autism, we could always hypothesize that there is one child who has some unique susceptibility.

The anti-vaxxers are quick to jump on the individual susceptibility argument. At their (fake) news conference, Kennedy and De Nira exhumed Bernadine Healy, who died in 2011, for a replay of a 2008 interview, in which Healy speculated that the then available science had not ruled out the existence of susceptible subgroups of children, who might be at risk from some one or multiple vaccines. Healy is best known as the first woman physician to serve as Director of the National Institutes of Health, from 1991 to 1993. For her acknowledgement that there might be vulnerable subgroups, and that this issue of idiosyncratic reaction should be studied, Healy was named 2008 “Person of the Year” by the anti-vaccine group, the Age of Autism.

Not surprisingly, anti-vaxxers Kennedy and De Niro, and their followers, missed the obvious. Healy’s suggestion that there might be a vulnerable subgroup of children is not evidence that thimerosal or any vaccine or vaccine regimen is unsafe.

Also not surprisingly, President Trump, with his affection for alternative facts and speculative conspiracy theories, is in the same epistemic muddle as Kennedy and De Niro. While still a candidate, Trump met with Andrew Wakefield and other dubious characters from the anti-vaxxer movement. With his propensity to repeat whatever was last said to him, Trump tweets about “doctor-inflicted autism,” and other claims.

And to make matters worse, toady American Republican party cannot seem to distance themselves from whatever nonsense Alt-President Trump dishes out. Pratik Chougule, an executive editor at The American Conservative recently wrote a disturbingly uncritical essay in support of Trump’s twittering approach to scientific policy. Pratik Chougule, “Why the Kennedy-De Niro Vaccine Challenge Matters – A presidential commission led by Robert Kennedy Jr. could raise uncomfortable questions about the incentives driving vaccination recommendations,” The American Conservative (Feb. 15, 2017) (noting that Trump has said that he “‘couldn’t care less’ about the ‘shills’ of conventional medical wisdom, the pharmaceutical companies, and their ‘fudged up reports’. In typical fashion, he declares that ‘the doctors lied’ and that he is ‘being proven right about massive vaccinations’.”)

Sad. Fake news. Fake science. Where is Daubert when you need it?

Posted in Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Social Media, Rhetoric, and Science – Antivaxxers

Talc Litigation in Missouri – Show Me the Law and the Evidence

February 22nd, 2017

In New Jersey, where the courts are particularly plaintiff friendly but not beyond the persuasive force of evidence, lawsuit industry claims that talc causes ovarian cancer have not fared well. Last year, Judge Johnson, of Atlantic County, New Jersey, held that the plaintiffs’ causal claims failed to meet even the minimal New Jersey legal threshold of scientific validity.1 Meanwhile, in Missouri, juries have been returning large verdicts for plaintiffs on their claims that their use of talc products caused their ovarian cancers.2

What gives? Why is the outcome of similar litigation so different in New Jersey from that in Missouri? One might mistakenly think that courts in Missouri would be skeptical of scientifically dubious claims. After all, Missouri is the “Show Me” state; right? Many people understand the state’s nickname to mean that Missourians are not gullible.3

The reality of the origins of the Missouri nickname may well be different. The most cited account reports that a congressman from Missouri, Willard Duncan Vandiver, used the phrase in an 1899 speech:

“I come from a state that raises corn and cotton and cockleburs and Democrats, and frothy eloquence neither convinces nor satisfies me. I am from Missouri. You have got to show me.”

Basically, according to Vandiver, Missourians are “show me” simple folks because they do not read or understand eloquent language. Vandiver might have thought that scientific language was beyond his neighbors’ ken as well. Of course, things have changed since 1899. Missouri is no longer a state populated by Democrats. In the 2016 general election, Donald Drumpf received 56.8% of the Missouri votes cast. Hilary Clinton received 38.1%.4  Inquiring minds will want to know whether “Show Me” connotes incredulity or illiteracy.

One relevant difference between Missouri and many other states, and all the federal courts, is that some courts in Missouri engage in a particularly edentulous form of judicial gatekeeping of expert witness opinion testimony. The talc claims that resulted in large verdicts in Missouri never got off the dime (or got a dime) in New Jersey because plaintiffs’ expert witnesses’ opinions were excluded from courtrooms in the Garden State.

The resulting trials in Missouri have showcased some curious, doubtful rhetoric from legal counsel for the lawsuit industry. In his closing argument in Giannecchini v. Johnson & Johnson, the plaintiff’s lawyer accused Johnson & Johnson of having “rigged” regulatory agencies to ignore the dangers of talc.5 The argument was apparently effective and it has been repeated in another Missouri trial, in Swann v. Johnson & Johnson6, now underway. The plaintiffs’ opening “statement” in Swann was marked by overwrought, hyperbolic rhetoric.7

And the first trial days in Swann were dedicated by plaintiff’s counsel to showing, not that talc actually causes ovarian cancer, but to showing that the defendants engaged in lobbying with respect to the carcinogenic classification of talc by regulatory agencies.8 According to the coverage in legal news media, the first testimony offered was offered to show that after the National Toxicology Program (NTP) nominated talc for inclusion in its list of potential carcinogens, industry trade groups, such as the Cosmetic, Toiletry and Fragrance Association, “shut down serious regulator concerns through intensive lobbying efforts.”9

This is a remarkable digression from the truth finding function of an American jury trial for several reasons. First, the “shutting down” of regulator concern was not, in the media reports, associated with any fraudulent misrepresentations of the scientific record. By casting the lobbying in an unflattering light, the plaintiff was able to undermine the truth value of agencies’ refusal to characterize talc as an ovarian carcinogen. The media coverage did not suggest that the lobbying involved the presentation of sham evidence or arguments that might have misled agencies about the correctness of their position.

Second, if the industry lobbying had badly misled the National Toxicology Program, or other government body, then there would no doubt be a conclusive case for causation today. The fact of the matter, however, is that there is no conclusive case for the claim that talc causes ovarian cancer. Late last year, the “Sister Study,” which explored whether there was any association between perineal talc use and ovarian cancer, was published in Epidemiology.10 The Sister Study (2003–2009) followed a cohort of 50,884 women whose sisters had been diagnosed with breast cancer. Talc use was ascertained at baseline, before diagnosis of subsequent disease and before any chance for selective recall. The cohort was followed for a median of 6.6 years, in which time there were 154 cases of ovarian cancer, available for analysis using Cox’s proportional hazards model. Perineal talc use at baseline was not associated with later ovarian cancer. The authors reported a hazard ratio of 0.73, less than expected, with a 95% confidence interval of 0.44, 1.2. Such a powerful study, showing the absence of any large or even modest association, would hardly be feasible if the science were so clear in the year 2000 that no reasonable scientist would have advocated against the NTP’s proposed classification.

Third, the lawsuit industry’s focus on lobbying activities in the Giannecchini and the Swann cases raises serious issues of infringing upon the defendants’ first amendment rights. The defendants’ advocacy for non-sham, non-fraudulent scientific positions is protected by the federal constitution, under what has come to be known as the Noerr-Pennington doctrine.

The Noerr-Pennington Doctrine of Immunity

One of the first agenda items for the first United States Congress was the drafting of a “Bill of Rights” to be submitted to the individual States for ratification. The First amendment (originally the third until the first two were dropped) sets forth a basic “right of the people to peaceably assemble, and to petition the government for a redress of grievances.”11 In the context of lobbying legislatures and regulatory agencies, the Supreme Court has long regarded lobbying and advocacy for and against legislation and regulation as core political speech that is protected by the right to petition the government.12

Part of this constitutional guarantee is a freedom to associate with others to lobby for redress.13 The constitutional protection is not lost by an economic or self-interested motivation in the lobbying or advocacy.14  This constitutional protection of advocacy positions results in an immunity from civil liability for speech, association, and conduct undertaken to advance advocacy positions before legislatures, agencies, and courts.15 This immunity, over half a century old, has come to be known as the Noerr-Pennington doctrine.

Although the original Noerr-Pennington doctrine cases specifically addressed claims of antitrust liability, later cases have held that the immunity applies with equal force in tort cases. State courts, regardless of their state constitutions, are of course obliged to grant and protect the federal Noerr-Pennington immunity.16

The unconstitutional infringement of defendants’ first amendment rights is hardly an innovation in Giannecchini and Swann cases. For decades, the lawsuit industry, which jealously guards its own first amendment rights, has overzealously pressed conspiracy and tort claims against manufacturing industry for trying to influence legislation and regulation. In Senart v. Mobay Chem. Corp., 597 F. Supp. 502 (D. Minn. 1984), plaintiffs alleged that they were harmed by exposure to toluene diisocyanate (TDI), a feedstock chemical used in making polyurethane foam. The plaintiffs sued TDI manufacturers, on conspiracy claims that the manufacturers had jointly influenced the Occupational and Safety Health Administration (OSHA) to reject a recommendation from the National Institute for Occupational Safety and Health (NIOSH) for lower permissible exposure standards for TDI. Senart, 597 F. Supp. at 504. The plaintiffs’ conspiracy complaint was based upon allegations that the manufacturing defendants “knew of a body of scientific evidence which suggested that workers could suffer harm at exposure levels below the prevailing … standard,” and and that they “conspired to ‘obfuscate and confuse’ scientific findings which supported a more stringent standard.” Id. Plaintiffs also alleged that the TDI manufacturers knew that a more stringent TDI exposure standard would harm their businesses. Id.

The trial court dismissed the conspiracy count in Senart. “[E]ven accepting plaintiffs’ allegations as true, defendants concerted action sought only permissible ends and acted through permissible means.” Id. at 505-6 (footnote omitted). The defendants work in concert through their trade association to persuade OSHA to reject the NIOSH proposal was clearly protected by the first amendment. Id. at 506 (internal citations omitted).

Following Senart, federal courts in later products cases have applied he Noerr-Pennington doctrine to bar tort claims. In a 1996 class action, a district court held that the immunity barred a class action filed by relatives of gunshot victims against gun manufacturers. Hamilton v. ACCU-TEK 935 F. Supp. 1307 (E.D.N.Y. 1996). The court, in Hamilton, found the plaintiffs’ negligence and product liability claims untenable:

“Defendants’ efforts to affect federal firearm policies through lobbying activities are prime examples of the types of activity the First Amendment, through its rights of free speech and petition, sought to protect… . A core principle of the Noerr-Pennington doctrine is that lobbying alone cannot form the basis of liability… .”

Id. at 1321. The court in Hamilton dismissed the product liability claims. See also Tuosto v. Philip Morris USA Inc., No. 05 Civ. 9384 (PKL), 2007 WL 2398507, at *5 (S.D.N.Y. Aug. 21, 2007) (noting that the immunity “applied to bar liability in state common law tort claims, including negligence and products liability claims, for statements made in the course of petitioning the government”).

The lawsuit industry is one of the largest rent-seeking groups in the United States. Our courts need to apply constitutional standards in a symmetrical fashion, with an understanding that what is spoken in the halls of legislatures and agencies is protected at least as much as speech in the courtroom, and that the constitutional rights of manufacturing industry should not be subordinated to the rights of the lawsuit industry. Maybe lawyers need to figure out how to “show” the constitution in pictograms, without all the 18th century eloquence.

1 Carl v. Johnson & Johnson, No. ATL-L-6546-14, 2016 WL 4580145 (N.J. Super. Ct. Law Div., Atl. Cty., Sept. 2, 2016).See “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016).

2 “Talc Litigation – Stop the Madness” (Nov. 10, 2016) (describing large verdict for plaintiff in Giannecchini v. Johnson & Johnson); see also Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” Law360 (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

3 See “The Show-Me State,” last visited Feb. 21, 2017.

4 See “State of Missouri – 2016 General Election – November 8, 2016,” last visited Feb. 21, 2017. I leave it to the reader to assess whether the state nickname describes incredulity or illiteracy.

5 Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” Law360 (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

6 Swann v. Johnson & Johnson, case number 1422-CC09326-01, in the 22nd Judicial Circuit of Missouri.

7 Cara Salvatore, “J&J Hid Talc Risk For ‘Love Of Money’, Jury Hears,” Law360 (Feb. 9, 2017).

8 Cara Salvatore, “Talc Lobbyists Stymied Carcinogen Classification, Jury Hears,” Law360 (Feb. 10, 2017).

9 Id.

10 Nicole L. Gonzalez, Katie M. O’Brien, Aimee A. D’Aloisio, Dale P. Sandler, and Clarice R. Weinberg, “Douching, Talc Use, and Risk of Ovarian Cancer,” 27 Epidemiology 797 (2016).

11 U.S. Const. amend. I.

12 California Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508, 510 (1972) (disallowing a cause of action “predicated upon mere attempts to influence the Legislative branch for the passage of laws or the Executive branch for their enforcement.”); United Mine Workers of Am. v. Ill. State Bar Ass’n, 389 U.S. 217, 222 (1967) (characterizing the right to petition as “among the most precious of the liberties safeguarded by the Bill of Rights”). United Mine Workers of Am. v. Pennington, 381 U.S. 657, 669-70 (1965); Doe v. McMillan, 566 F.2d 713, 718 (D.C.Cir. 1977), cert. denied, 435 U.S. 969 (1978) (holding that the first amendment constitutional right to petition the legislature “extends to administrative agencies and the courts”).

13 N.A.A.C.P. v. Button, 371 U.S. 415, 430 (1963) (protecting the right “to engage in association for the advancement of beliefs and ideas”); N.A.A.C.P. v. Alabama ex rel. Patterson, 357 U.S. 449, 460 (1958) (“[e]ffective advocacy of both public and private points of view, particularly controversial ones, is undeniably enhanced by group association … .”). The right of association to further lobbying activities has been described as having a “preferred place” along with other first amendment freedoms, such that the Court will not tolerate “dubious intrusions.” Thomas v. Collins, 323 U.S. 516, 530 (1945).

14 Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748, 762 (1976); Sawyer v. Sandstrom, 615 F.2d 311, 316 (5th Cir. 1980) (“The right to freely associate is not limited to those associations which are ‘political in the customary sense’, but includes those which ‘pertain to the social, legal, and economic benefit of the members’.”) (citing Griswold v. Connecticut, 381 U.S. 479, 483 (1965)); International Union v. National Right to Work Legal Defense & Education Foundation, Inc., 590 F.2d 1139, 1148 (D.C. Cir. 1978) (“Even economically motivated expression or association is not disqualified from protection under the first amendment.”); Greminger v. Seaborne, 584 F.2d 275, 278 (8th Cir. 1978) (observing that the constitutionally protected “[f]reedom of association includes membership in unions or other organizations concerned with ‘business and economic causes’.”); Senart v. Mobay Chem. Corp., 597 F. Supp. 502, 506 (D.Minn. 1984) (“Selfish motivations do not lessen one’s right to present views to the government.”).

15 Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961); United Mine Workers v. Pennington, 381 U.S. 657 (1965).

16 Fraser v. Bovino, 317 N.J. Super 23, 37 (App. Div. 1998) (recognizing “the fundamental values that undergird a citizen’s right to communicate on issues of public import”); Village Supermarket, Inc. v. Mayfair, 269 N.J. Super. 224, 229-32 (Law Div. 1995) (refusing to interpret New Jersey tort law to permit claims based on lobbying activity protected by the First Amendment); ARTS4ALL Ltd. v. Hancock, 810 N.Y.S.2d 15, 16 (App. Div. 2006) (denying employee’s motion for summary judgment on claim for breach of no-disparagement clause in severance agreement, holding that employer’s statements to government officials were protected by Noerr-Pennington doctrine); Concourse Nursing Home v. Engelstein, 692 N.Y.S. 2d 888, 891 (Sup. Ct. 1999) (holding law firm was immune from business tort claims for successful lobbying efforts); I.G. Second Generation Partners v. Reade, 793 N.Y.S.2d 379, 381 (App. Div. 2005) (holding that Noerr–Pennington immunity barred claim for tortious interference); Diaz v. Southwest Wheel, 736 S.W.2d 770, 771 (Tx. Ct. App. 1987) (holding that Noerr-Pennington immunity barred conspiracy claims against tire manufacturer, which as a member of a trade association, opposed the recall on defective tire rims and restrictions on multi-piece wheels).

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Talc Litigation in Missouri – Show Me the Law and the Evidence

Kiker v. Smithkline Beecham & the Pathology of Judicial Gatekeeping

January 4th, 2017

“There is no expedient to which a man will not go to avoid the labor of thinking.”                                                                                    Sir Joshua Reynolds

Medical students study pathology not only to understand the nature, course, and causation of disease, but also to understand better normal tissue and cellular function and structure. Similarly, lawyers can improve their understanding of judicial decision making, not only from studying well-reasoned judicial opinions, but from also studying pathological opinions, with clear, demonstrable errors that help illustrate both the pathogenesis of intellectual and judicial error, as well as the normal, proper function of judging.

At the end of each year, bloggers and pundits traditionally call attention to the best and the worst decisions, usually from a partisan perspective. One federal judicial decision on Rule 702, however, stands out for special treatment as a veritable Berenstain Bears’ manual on how not to adjudicate so-called Daubert motions. Kiker v. Smithkline Beecham Corp., 2:14-cv-02164-EAS-TPK, (S.D. Ohio, Dec. 15, 2016) (Sairgus, C.J.) [cited below as Kiker slip op.] The Kiker opinion is as worthy of dissection as a judicial opinion for lawyers, as is the dissection of a cadaver by medical students in their first-year course on clinical anatomy.

The Kiker plaintiffs claimed that maternal use of paroxetine (tradename Paxil) caused her child to develop a ventricular septal defect. The defendant, GlaxoSmithKline LLC (GSK), invoking Federal Rule of Evidence 702, moved to exclude opinion testimony of several of plaintiffs’ expert witnesses, including Laura M. Plunkett, Ph.D., Ra-id Abdulla, M.D. Kiker slip op. at 1. The gravaman of the plaintiffs’ case is that GSK did adequately warn physicians of the risk to offspring of women who took paroxetine in pregnancy until September 2005. At that time, GSK revised its labeling for Paxil to warn of the “increased risk for cardiovascular malformations.” Kiker slip op. at 3.

The plaintiffs threw in the kitchen sink with their allegations, which included specific averments that GSK should have informed the medical community about “significant” adverse event reporting and the meaning of claimed deaths among rat pups in high-dose maternal toxicity testing. Not content with a failure to warn case, plaintiffs ratcheted their allegations into a fraudulent misrepresentation case, as well. Kiker slip op. at 3-4. Laura Plunkett and Ra-id Abdulla were the principal expert witnesses relied upon by plaintiffs for their hyperbolic claims.

The Standard

Chief Judge Sargus started his description of the governing law by insisting that the standard for expert witness gatekeeping was “flexible”; that is, he would follow the “Gumby Rule,” which allows the trial judge maximal flexibility and stretch to admit dubious expert witness opinions. Chief Judge Sargus employed the usual reductionist criteria for assessing “reliability.” Citing Kumho Tire, he explained that the court’s role was to ascertain whether

“an expert . . . employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, (1999). He also acknowledged that Daubert had provided some indicia of reliability in factors such as

“testing, peer review, publication, error rates, the existence and maintenance of standards controlling the technique’s operation, and general acceptance in the relevant scientific community.”

Kiker slip op. at 7, quoting from United States v. Langan, 263 F.3d 613, 621 (6th Cir. 2001) (citing Daubert v. Merrell Dow Pharm, Inc., 509 US. 579, 593-94 (1993)).

Chief Judge Sargus was then quick to point out that the cited Daubert factors do not make up a definitive, dispositive test or checklist, which presumably gave him license to ignore these factors and their absence, all together. Nowhere later in his opinion on the contested reliability of plaintiffs’ expert witnesses’s causation opinions is there any discussion of the actual testing, its validity, its pre-publication and post-publication peer review, error rates, standards for assessing causation, or general acceptance of the claimed methodologies. And of course, the discretion permitted district judges in performing their gatekeeping function is not the discretion to abandon the gatekeeping function and to ignore relevant methodological criteria. See Kumho Tire, 526 U.S. 137, 158-59 (Scalia, J., concurring).

Semantic Legerdemain Substitutes for Demonstration of General Causation

Chief Judge Sargus acknowledged that there is a “specific methodology” used by scientists to assess a body of evidence for causation of birth defects, but then proceeded to ignore that methodology without bothering to describe or apply it. Kiker slip op. at 10. What gave the trial judge his argument for ignoring the “specific methodology” used by scientists, the Daubert factors, and indeed any and all factors for assessing the validity of a scientific claim and conclusion, was the language used by the Food and Drug Administration (FDA) and GSK, the NDA-holder, in various communications. Rather than engage in an intellectually challenging exploration and evaluation of the actual scientific evidence and analysis that underlay the plaintiffs’ expert witnesses’ causation opinions, Chief Judge Sargus pointed to the language used by the FDA in its original Public Health Advisory about the issue of congenital cardiac malformations in children of mothers who ingested paroxetine in their first trimester of pregnancy:

“[t]he FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine’s prescribing information. FDA is awaiting the final results of recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.”

Kiker slip op. at 10, quoting from FDA Public Health Advisory (Dec. 8, 2005), available at <http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm051731.htm> (emphasis added).

Chief Judge Sargus apparently was oblivious to the difference between “X causes Y” and “X may increase the risk of Y.” As the trial judge, he also fixed on the FDA’s decision to change the pregnancy category labeling for paroxetine from Category C to Category D, with the latter category’s reflecting “positive evidence of human risk.” Kiker slip op. at 11. Again, the existence of evidence for risk is not, and never has been, the existence of evidence that would support a reasonable, reliable conclusion that paroxetine causes cardiac birth defects. Nothing can explain or justify this incredible reliance and misinterpretation of language, and Chief Judge Sargus makes no attempt to defend his linguistic contortions.

Chief Judge Sargus ends with an implied assertion that he, as trial judge, need not spend any time on assessing the quantity or quality of evidence for a conclusion of causality because GSK has admitted that paroxetine causes cardiac birth defects. The GSK Dear Healthcare Provider Letter, the FDA Safety Alert, along with the (preliminary) results of a single epidemiologic study

“combine in this instance to constitute an admission that Paxil can cause injury, and is sufficient to create an issue of fact regarding causation.”

Kiker slip op. at at 15.

Whence comes this incredible reliance upon the language of a package insert?  Chief Judge Sargus points to Judge James Gwin’s decision in In re Meridia, and proceeds to provide two pages, single-spaced, of block quotation from the Meridia decision. Kiker slip op. at 13-15, quoting from In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 800-01 (N.D. Ohio 2004).

Interspersed in the two pages of quotation from Meridia were citations to Ferebee and Wells, two of the most discredited, disreputable federal court decisions on biomedical causation, both of which were effectively overruled sub silentio by the Supreme Court in Daubert. Chief Judge Sargus argues that the Meridia decision held that “product inserts to both physicians and patients” constituted “admissions of Meridia’s potential to cause substantial increases in blood pressure in some patients. Meridia, 328 F. Supp. 2d at 810. Affirming the district court’s decision in Meridia, the Sixth Circuit specifically upheld the district court’s determination that the FDA warning label at issue in that case “constitutes an admission that Meridia can cause injury.” Meridia Prods. Liab. Litig. v. Abbott Labs, 447 F.3d 861, 866 (6th Cir. 2006).

This analytical shortcut has serious problems. First, as a first year law student might observe, the Meridia decision resulted in the exclusion of plaintiffs’ key expert witness and the grant of summary judgment to the defendant on adequacy of its warning, all of which the Sixth Circuit affirmed. Given that there was no liability, the comments about causation would seem to be dictum, not holding. Second, with respect to the issue of warnings as admissions, the Circuit agreed that the district court had construed the defendant’s package insert warning that the medication ‘‘substantially increases’’ blood pressure as an admission, but that such unequivocal language was quite different from warning language that states medication use ‘‘is associated with’’ an adverse event. 447 F.3d at 866. The FDA’s Public Health Advisory, the change to Category D, and GSK’s own sponsored study did not, individually or collectively, state a finding of anything more than an association, and that there “may be an increased risk.”

Of course, Chief Judge Sargus’s glib exercise eliminated all the difficult thought of evaluating actual scientific evidence. The indolent approach used in Kiker committed another blatant error. The approach not only relied incorrectly upon some language of the FDA and medication license holder, but it ignored all the contrary evidence, context, and analysis that kept the FDA from reaching a conclusion of causality in 2005, and most scientists to this very day. Furthermore, the Kiker approach conveniently ignored that over a decade of additional evidence, much of it exonerating paroxetine. Chief Judge Sargus has misidentified the weakest, incomplete, out-of-date, cherry-picked evidentiary display with reliable evidence that purports to support a causal conclusion.

Non-Specific Confusion on Specific Causation

Having announced that the court will not grant a hearing, or even an on-the-paper review of the actual evidence for plaintiffs’ causal claims, Chief Judge Sargus proceeded to make even shorter work of the issue of specific causation. The only support for specific causation in the case was in the proffered testimony of Dr. Ra-id Abdulla, a serial testifying expert witness in anti-depressant birth defects cases. Abdulla purported to conduct a differential diagnosis to discern the cause of the infant plaintiff’s birth defect, a ventricular septal defect. Kiker slip op. at 16.

The diagnosis of the infant Kiker’s birth defect, however, was never in doubt; rather it was the etiology of the septal defect, which was at issue. Abdulla claimed to have ruled out all other potential alternative causes. Kiker slip op. at 18. Even if Abdulla’s claim could be accepted for known causes of septal defects, he would still be faced with a situation in which there are baseline or background cases of septal defects, which occur in children with no known or even suspected risk factor. The court failed to explain how Abdulla ruled out such unknown, prevalent causes of septal defects in the Kiker plaintiff. To be sure, the court appeared to have fallen for the “treating physician” ruse, which suggests that treating a condition provides some magical insight into the cause of that condition. Kiker slip op. at 19-20.

No explanation was cited by the court for how Abdulla worked his magical clinical inference of specific causation. Sadly, there is no such magic, except in the form of the magic thinking evidenced here by Abdulla, and acquiesced in by Chief Judge Sargus. No biomarker of causal originst distinguishes the Kiker plaintiff’s septal defect from one caused by any other cause, whether or not established by current medical science. Moreover, Abdulla’s magical thinking cannot be swept under the Kumho Tire rug of appropriate level of rigor in the field. The Kiker court cited no evidence that pediatric cardiologists routinely and reliably make the specific causal attribution that Dr. Abdulla made in this case, as a paid, testifying expert witness. The court incredulously accepted Abdulla’s hand waving about the epistemic warrant of experience, education, training that has nothing to do with discerning individual causes.

GSK asked for oral argument, which may have been Chief Judge Sargus’s last clear chance to avoid these errors. Declaring that the record was fully developed, Judge Sargus denied the request for a hearing. Kiker slip op. at 1, 4. We are left with a profoundly flawed misunderstanding of scientific evidence and causal inference.

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Kiker v. Smithkline Beecham & the Pathology of Judicial Gatekeeping

Statistical Analysis Requires an Expert Witness with Statistical Expertise

November 13th, 2016

Christina K. Connearne sued her employer, Main Line Hospitals, for age discrimination. Main Line charged Connearne with fabricating medical records, but Connearne replied that the charge was merely a pretext. Connearney v. Main Line Hospitals, Inc., Civ. Action No. 15-02730, 2016 WL 6569292 (E.D. Pa. Nov. 4, 2016) [cited as Connearney]. Connearne’s legal counsel engaged Christopher Wright, an expert witness on “human resources,” for a variety of opinions, most of which were not relevant to the action. Alas, for Ms. Connearne, the few relevant opinions proffered by Wright were unreliable. On a Rule 702 motion, Judge Pappert excluded Wright from testifying at trial.

Although not a statistician, Wright sought to offer his statistical analysis in support of the age discrimination claim. Connearney at *4. According to Judge Pappert’s opinion, Wright had taken just two classes in statistics, but perhaps His Honor meant two courses. (Wright Dep., at 10:3–4.) If the latter, then Wright had more statistical training than most physicians who are often permitted to give bogus statistical opinions in health effects litigation. In 2015, the Medical College Admission Test apparently started to include some very basic questions on statistical concepts. Some medical schools now require an undergraduate course in statistics. See Harvard Medical School Requirements for Admission (2016). Most medical schools, however, still do not require statistical training for their entering students. See Veritas Prep, “How to Select Undergraduate Premed Coursework” (Dec. 5, 2011); “Georgetown College Course Requirements for Medical School” (2016).

Regardless of formal training, or lack thereof, Christopher Wright demonstrated a profound ignorance of, and disregard for, statistical concepts. (Wright Dep., at 10:15–12:10; 28:6–14.) Wright was shown to be the wrong expert witness for the job by his inability to define statistical significance. When asked what he understood to be a “statistically significant sample,” Wright gave a meaningless, incoherent answer:

“I think it depends on the environment that you’re analyzing. If you look at things like political polls, you and I wouldn’t necessarily say that serving [sic] 1 percent of a population is a statistically significant sample, yet it is the methodology that’s used in the political polls. In the HR field, you tend to not limit yourself to statistical sampling because you then would miss outliers. So, most HR statistical work tends to be let’s look at the entire population of whatever it is we’re looking at and go from there.”

Connearney at *5 (Wright Dep., at 10:15–11:7). When questioned again, more specifically on the meaning of statistical significance, Wright demonstrated his complete ignorance of the subject:

“Q: And do you recall the testimony it’s generally around 85 to 90 employees at any given time, the ER [emergency room]?

A: I don’t recall that specific number, no.

Q: And four employees out of 85 or 90 is about what, 5 or 6 percent?

A: I’m agreeing with your math, yes.

Q: Is that a statistically significant sample?

A: In the HR [human resources] field it sure is, yes.

Q: Based on what?

A: Well, if one employee had been hit, physically struck, by their boss, that’s less than 5 percent. That’s statistically significant.”

Connearney at *5 n.5 (Wright Dep., at 28:6–14)

In support of his opinion about “disparate treatment,” Wright’s report contained nothing than a naked comparison of two raw percentages and a causal conclusion, without any statistical analysis. Even for this simplistic comparison of rates, Wright failed to explain how he obtained the percentages in a way that permitted the parties and the trial court to understand his computation and his comparisons. Without a statistical analysis, the trial court concluded that Wright had failed to show that the disparity in termination rates among younger and older employees was not likely consistent with random chance. See also Moultrie v. Martin, 690 F. 2d 1078 (4th Cir. 1982) (rejecting writ of habeas corpus when petitioner failed to support claim of grand jury race discrimination with anything other than the numbers of white and black grand jurors).

Although Wright gave the wrong definition of statistical significance, the trial court relied upon judges of the Third Circuit who also did not get the definition quite right. The trial court cited a 2010 case in the Circuit, which conflated substantive and statistical significance and then gave a questionable definition of statistical significance:

“The Supreme Court has not provided any definitive guidance about when statistical evidence is sufficiently substantial, but a leading treatise notes that ‘[t]he most widely used means of showing that an observed disparity in outcomes is sufficiently substantial to satisfy the plaintiff’s burden of proving adverse impact is to show that the disparity is sufficiently large that it is highly unlikely to have occurred at random.’ This is typically done by the use of tests of statistical significance, which determine the probability of the observed disparity obtaining by chance.”

See Connearney at *6 & n.7, citing and quoting from Stagi v. National RR Passenger Corp., 391 Fed. Appx. 133, 137 (3d Cir. 2010) (emphasis added) (internal citation omitted). Ultimately, however, this was all harmless error on the way to the right result.

Posted in Rule 702, statistical evidence | Comments Off on Statistical Analysis Requires an Expert Witness with Statistical Expertise

Talc Litigation – Stop the Madness

November 10th, 2016

Back in September, Judge Johnson, of New Jersey, wrapped up a talc ovarian cancer case in Kemp, and politely excused the case from any further obligations to show up in court. Carl v. Johnson & Johnson, No. ATL-L-6546-14, 2016 WL 4580145 (N.J. Super. Ct. Law Div., Atl. Cty., Sept. 2, 2016) [cited as Carl]. See “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016).

In Giannecchini v. Johnson & Johnson, a Missouri jury returned a substantial verdict for plaintiff. The jury, by a 9 to 3 vote, awarded $575,000 for claimed economic loss, and $2 million for non-economic compensatory damages. The jury also found defendant Johnson & Johnson in need of punishment to the tune of $65,000,000, and Imerys Talc America Inc. for $2.5 million. Plaintiffs, having sought $285 million, were no doubt disappointed. The Giannecchini verdict was the third large verdict in the Missouri talc litigation. See Myron Levin, “Johnson & Johnson Hammered Again in Talc-Ovarian Cancer Verdict of $70 Million,” (Oct. 27, 2016); Brandon Lowrey, “J & J, Talc Co. Hit With $70M Baby Powder Cancer Verdict,” Law360 (Oct. 2016).

In his closing argument, Giannecchini’s lawyer, R. Allen Smith, reportedly accused Johnson & Johnson of having “rigged” regulatory agencies to ignore the dangers of talc, and of having “falsified” medical records to hide the problem. Smith implored the jury to “make them stop”; make them “stop this madness.”

Make them stop the madness, indeed. The November 2016 issue of Epidemiology features a publication of the “Sister Study,” which explored whether there was any association between perineal talc use and ovarian cancer. The authors acknowledged, as had Judge Johnson in the Carl case, that some prior case-control studies had found an increased risk of ovarian cancer, but that prospective cohort studies have not confirmed an association. Nicole L. Gonzalez, Katie M. O’Brien, Aimee A. D’Aloisio, Dale P. Sandler, and Clarice R. Weinberg, “Douching, Talc Use, and Risk of Ovarian Cancer,” 27 Epidemiology 797 (2016).

The Sister Study (2003–2009) followed a cohort of 50,884 women whose sisters had been diagnosed with breast cancer. Talc use was ascertained at baseline, before diagnosis of subsequent disease and before any chance for selective recall. The cohort was followed for a median of 6.6 years, in which time there were 154 cases of ovarian cancer during the follow up, available for analysis using Cox’s proportional hazards model. Perineal talc use at baseline was not associated with later ovarian cancer. The authors reported a hazard ratio of 0.73, less than expected, with a 95% confidence interval of 0.44, 1.2.

So, yes, make them stop this madness; close the gate.

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Talc Litigation – Stop the Madness

 Another Haack Article on Daubert

October 14th, 2016

In yet another law review article on Daubert, Susan Haack has managed mostly to repeat her past mistakes, while adding a few new ones to her exegesis of the law of expert witnesses. See Susan Haack, “Mind the Analytical Gap! Tracing a Fault Line in Daubert,” 654 Wayne L. Rev. 653 (2016) [cited as Gap].  Like some other commentators on the law of evidence, Haack purports to discuss this area of law without ever citing or quoting the current version of the relevant statute, Federal Rule of Evidence 703. She pours over Daubert and Joiner, as she has done before, with mostly the same errors of interpretation. In discussing Joiner, Haack misses the importance of the Supreme Court’s reversal of the 11th Circuit’s asymmetric standard of Rule 702 trial court decisions. Gap at 677. And Haack’s analysis of this area of law omits any mention of Rule 703, and its role in Rule 702 determinations. Although you can safely skip yet another Haack article, you should expect to see this one, along with her others, cited in briefs, right up there with David Michael’s Manufacturing Doubt.

A Matter of Degree

“It may be said that the difference is only one of degree. Most differences are, when nicely analyzed.”[1]

Quoting Holmes, Haack appears to complain that the courts’ admissibility decisions on expert witnesses’s opinions are dichotomous and categorical, whereas the component parts of the decisions, involving relevance and reliability, are qualitative and gradational. True, true, and immaterial.

How do you boil a live frog so it does not jump out of the water?  You slowly turn up the heat on the frog by degrees.  The frog is lulled into complacency, but at the end of the process, the frog is quite, categorically, and sincerely dead. By a matter of degrees, you can boil a frog alive in water, with a categorically ascertainable outcome.

Humans use categorical assignments in all walks of life.  We rely upon our conceptual abilities to differentiate sinners and saints, criminals and paragons, scholars and skells. And we do this even though IQ, and virtues, come in degrees. In legal contexts, the finder of fact (whether judge or jury) must resolve disputed facts and render a verdict, which will usually be dichotomous, not gradational.

Haack finds “the elision of admissibility into sufficiency disturbing,” Gap at 654, but that is life, reason, and the law. She suggests that the difference in the nature of relevancy and reliability on the one hand, and admissibility on the other, creates a conceptual “mismatch.” Gap at 669. The suggestion is rubbish, a Briticism that Haack is fond of using herself.  Clinical pathologists may diagnose cancer by counting the number of mitotic spindles in cells removed from an organ on biopsy.  The number may be characterized by as a percentage of cells in mitosis, a gradational that can run from zero to 100 percent, but the conclusion that comes out of the pathologist’s review is a categorical diagnosis.  The pathologist must decide whether the biopsy result is benign or malignant. And so it is with many human activities and ways of understanding the world.

The Problems with Daubert (in Haack’s View)

Atomism versus Holism

Haack repeats a litany of complaints about Daubert, but she generally misses the boat.  Daubert was decisional law, in 1993, which interpreted a statute, Federal Rule of Evidence 702.  The current version of Rule 702, which was not available to, or binding on, the Court in Daubert, focuses on both validity and sufficiency concerns:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

Subsection (b) renders most of Haack’s article a legal ignoratio elenchi.

Relative Risks Greater Than Two

Modern chronic disease epidemiology has fostered an awareness that there is a legitimate category of disease causation that involves identifying causes that are neither necessary nor sufficient to produce their effects. Today it is a commonplace that an established cause of lung cancer is cigarette smoking, and yet, not all smokers develop lung cancer, and not all lung cancer patients were smokers.  Epidemiology can identify lung cancer causes such as smoking because it looks at stochastic processes that are modified from base rates, or population rates. This model of causation is not expected to produce uniform and consistent categorical outcomes in all exposed individuals, such as lung cancer in all smokers.

A necessary implication of categorizing an exposure or lifestyle variable as a “cause,” in this way is that the evidence that helps establish causation cannot answer whether a given individual case of the outcome of interest was caused by the exposure of interest, even when that exposure is a known cause.  We can certainly say that the exposure in the person was a risk for developing the disease later, but we often have no way to make the individual attribution.  In some cases, more the exception than the rule, there may be an identified mechanism that allows the detection of a “fingerprint” of causation. For the most part, however, risk and cause are two completely different things.

The magnitude of risk, expressed as a risk ratio, can be used to calculate a population attributable risk, which can in turn, with some caveats, be interpreted as approximating a probability of causation.  When the attributable risk is 95%, as it would be for people with light smoking habits and lung cancer, treating the existence of the prior risk as evidence of specific causation seems perfectly reasonable.  Treating a 25% attributable risk as evidence to support a conclusion of specific causation, without more, is simply wrong.  A simple probabilistic urn model would tell us that we would most likely be incorrect if we attributed a random case to the risk based upon such a low attributable risk.  Although we can fuss over whether the urn model is correct, the typical case in litigation allows no other model to be asserted, and it would be the plaintiffs’ burden of proof to establish the alternative model in any event.

As she has done many times before, Haack criticizes Judge Kozinski’s opinion in Daubert,[2] on remand, where he entered judgment for the defendant because further proceedings were futile given the small relative risks claimed by plaintiffs’ expert witnesses.  Those relative risks, advanced by Shanna Swan and Alan Done, lacked reliability; they were the product of a for-litigation juking of the stats that were the original target of the defendant and the medical community in the Supreme Court briefing.  Judge Kozinski simplified the case, using a common legal strategem of assuming arguendo that general causation was established.  With this assumption favorable to plaintiffs made, but never proven or accepted, Judge Kozinski could then shine his analytical light on the fatal weakness of the specific causation opinions.  When all the hand waving was put to rest, all that propped up the plaintiff’s specific causation claim was the existence of a claimed relative risk, which was less than two. Haack is unhappy with the analytical clarity achieved by Kozinski, and implicitly urges a conflation of general and specific causation so that “all the evidence” can be counted.  The evidence of general causation, however, does not advance plaintiff’s specific causation case when the nature of causation is the (assumed) existence of a non-necessary and non-sufficient risk. Haack quotes Dean McCormick as having observed that “[a] brick is not a wall,” and accuses Judge Kozinski of an atomistic fallacy of ruling out a wall simply because the party had only bricks.  Gap at 673, quoting from Charles McCormick, Handbook of the Law of Evidence at 317 (1954).

There is a fallacy opposite to the atomistic fallacy, however, namely the holistic “too much of nothing fallacy” so nicely put by Poincaré:

“Science is built up with facts, as a house is with stones. But a collection of facts is no more a science than a heap of stones is a house.”[3]

Poincaré’s metaphor is more powerful than Haack’s call for holistic evidence because it acknowledges that interlocking pieces of evidence may cohere as a building, or they may be no more than a pile of rubble.  Poorly constructed walls may soon revert to the pile of stones from which they came.

Haack proceeds to criticize Judge Kozinski for his “extraordinary argument” that

“(a) equates degrees of proof with statistical probabilities;

(b) assesses each expert’s testimony individually; and

(c) raises the standard of admissibility under the relevance prong to the standard of proof.”

Gap at 672.

Haack misses the point that a low relative risk, with no other valid evidence of specific causation, translates into a low probability of specific causation, even if general causation were apodictically certain. Aggregating the testimony, say between  animal toxicologists and epidemiologists, simply does not advance the epistemic ball on specific causation because all the evidence collectively does not help identify the cause of Jason Daubert’s birth defects on the very model of causation that plaintiffs’ expert witnesses advanced.

All this would be bad enough, but Haack then goes on to commit a serious category mistake in confusing the probabilistic inference (for specific causation) of an urn model with the prosecutor’s fallacy of interpreting a random match probability as the evidence of innocence. (Or the complement of the random match probability as the evidence of guilt.) Judge Kozinski was not working with random match probabilities, and he did not commit the prosecutor’s fallacy.

Take Some Sertraline and Call Me in the Morning

As depressing as Haack’s article is, she manages to make matters even gloomier by attempting a discussion of Judge Rufe’s recent decision in the sertraline birth defects litigation. Haack’s discussion of this decision illustrates and typifies her analyses of other cases, including various decisions on causation opinion testimony on phenylpropanolamine, silicone, bendectin, t-PA, and other occupational, environmental, and therapeutic exposures. Maybe 100 mg sertraline is in order.

Haack criticizes what she perceives to be the conflation of admissibility and sufficiency issues in how the sertraline MDL court addressed the defendants’ motion to exclude the proffered testimony of Dr. Anick Bérard. Gap at 683. The conflation is imaginary, however, and the direct result of Haack’s refusal to look at the specific, multiple methodological flaws in plaintiffs’ expert witness Anick Bérard’s methodologic approach taken to reach a causal conclusion. These flaws are not gradational, and they are detailed in the MDL court’s opinion[4] excluding Anick Bérard. Haack, however, fails to look at the details. Instead Haack focuses on what she suggests is the sertraline MDL court’s conclusion that epidemiology was necessary:

“Judge Rufe argues that reliable testimony about human causation should generally be supported by epidemiological studies, and that ‘when epidemiological studies are equivocal or inconsistent with a causation opinion, experts asserting causation opinions must thoroughly analyze the strengths and weaknesses of the epidemiological research and explain why [it] does not contradict or undermine their opinion’. * * *

Judge Rufe acknowledges the difference between admissibility and sufficiency but, when it comes to the part of their testimony he [sic] deems inadmissible, his [sic] argument seems to be that, in light of the defendant’s epidemiological evidence, the plaintiffs’ expert testimony is insufficient.”

Gap at 682.

This précis is a remarkable distortion of the material facts of the case. There was no plaintiffs’ epidemiology evidence and defendants’ epidemiologic evidence.  Rather there was epidemiologic evidence, and Bérard ignored, misreported, or misrepresented a good deal of the total evidentiary display. Bérard embraced studies when she could use their risk ratios to support her opinions, but criticized or ignored the same studies when their risk ratios pointed in the direction of no association or even of a protective association. To add to this methodological duplicity, Anick Bérard published many statements, in peer-reviewed journals, that sertraline was not shown to cause birth defects, but then changed her opinion solely for litigation. The court’s observation that there was a need for consistent epidemiologic evidence flowed not only from the conception of causation (non-necessary, not sufficient), but from Berard’s and her fellow plaintiffs’ expert witnesses’ concessions that epidemiology was needed.  Haack’s glib approach to criticizing judicial opinions fails to do justice to the difficulties of the task; nor does she advance any meaningful criteria to separate successful from unsuccessful efforts.

In attempting to make her case for the gradational nature of relevance and reliability, Haack acknowledges that the details of the evidence relied upon can render the evidence, and presumably the conclusion based thereon, more or less reliable.  Thus, we are told that epidemiologic studies based upon self-reported diagnoses are highly unreliable because such diagnoses are often wrong. Gap at 667-68. Similarly, we are told that in consider a claim that a plaintiff suffered an adverse effect from a medication, that epidemiologic evidence showing a risk ratio of three would not be reliable if it had inadequate or inappropriate controls,[5] was not double blinded, and lacked randomization. Gap at 668-69. Even if the boundaries between reliable and unreliable are not always as clear as we might like, Haack fails to show that the gatekeeping process lacks a suitable epistemic, scientific foundation.

Curiously, Haack calls out Carl Cranor, plaintiffs’ expert witness in the Milward case, for advancing a confusing, vacuous “weight of the evidence” rationale for the methodology employed by the other plaintiffs’ causation expert witnesses in Milward.[6] Haack argues that Cranor’s invocation of “inference to the best explanation” and “weight of the evidence” fails to answer the important questions at issue in the case, namely how to weight the inference to causation as strong, weak, or absent. Gap at 688 & n. 223, 224. And yet, when Haack discusses court decisions that detailed voluminous records of evidence about how causal inferences should be made and supported, she flies over the details to give us confused, empty conclusions that the trial courts conflated admissibility with sufficiency.

[1] Rideout v. Knox, 19 N.E. 390, 392 (Mass. 1892).

[2] Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1320 (9th Cir. 1995).

[3] Jules Henri Poincaré, La Science et l’Hypothèse (1905) (chapter 9, Les Hypothèses en Physique)( “[O]n fait la science avec des faits comme une maison avec des pierres; mais une accumulation de faits n’est pas plus une science qu’un tas de pierres n’est une maison.”).

[4] In re Zoloft Prods. Liab. Litig., 26 F. Supp. 3d 466 (E.D. Pa. 2014).

[5] Actually Haack’s suggestion is that a study with a relative risk of three would not be very reliable if it had no controls, but that suggestion is incoherent.  A risk ratio could not have been calculated at all if there had been no controls.

[6] Milward v. Acuity Specialty Prods., 639 F.3d 11, 17-18 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).

Posted in Causation, Expert Witnesses, Rule 702, Rule 703 | Comments Off on  Another Haack Article on Daubert

« Older Entries
Newer Entries »