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Multiplicity in the Third Circuit

September 21st, 2017

In Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283 (W. D. Pa.), plaintiffs claimed that their employer’s reduction in force unlawfully targeted workers over 50 years of age. Plaintiffs lacked any evidence of employer animus against old folks, and thus attempted to make out a statistical disparate impact claim. The plaintiffs placed their chief reliance upon an expert witness, Michael A. Campion, to analyze a dataset of workers agreed to have been the subject of the R.I.F. For the last 30 years, Campion has been on the faculty in Purdue University. His academic training and graduate degrees are in industrial and organizational psychology. Campion has served an editor of Personnel Psychology, and as a past president of the Society for Industrial and Organizational Psychology. Campion’s academic website page notes that he manages a small consulting firm, Campion Consulting Services1.

The defense sought to characterize Campion as not qualified to offer his statistical analysis2. Campion did, however, have some statistical training as part of his master’s level training in psychology, and his professional publications did occasionally involve statistical analyses. To be sure, Campion’s statistical acumen paled in comparison to the defense expert witness, James Rosenberger, a fellow and a former vice president of the American Statistical Association, as well as a full professor of statistics in Pennsylvania State University. The threshold for qualification, however, is low, and the defense’s attack on Campion’s qualifications failed to attract the court’s serious attention.

On the merits, the defense subjected Campion to a strong challenge on whether he had misused data. The defense’s expert witness, Prof. Rosenberger, filed a report that questioned Campion’s data handling and statistical analyses. The defense claimed that Campion had engaged in questionable data manipulation by including, in his RIF analysis, workers who had been terminated when their plant was transferred to another company, as well as workers who retired voluntarily.

Using simple z-score tests, Campion compared the ages of terminated and non-terminated employees in four subgroups, ages 40+, 45+, 50+, and 55+. He did not conduct an analysis of the 60+ subgroup on the claim that this group had too few members for the test to have sufficient power3. Campion found a small z-score for the 40+ versus <40 age groups comparison (z =1.51), which is not close to statistical significance at the 5% level. On the defense’s legal theory, this was the crucial comparison to be made under the Age Discrimination in Employment Act (ADEA). The plaintiffs, however, maintained that they could make out a case of disparate impact by showing age discrimination at age subgroups that started above the minimum specified by the ADEA. Although age is a continuous variable, Campion decided to conduct z-scores on subgroups that were based upon five-year increments. For the 45+, 50+, and 55+ age subgroups, he found z-scores that ranged from 2.15 to 2.46, and he concluded that there was evidence of disparate impact in the higher age subgroups4. Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283, 2015 WL 4232600, at *11 (W.D. Pa. July 13, 2015) (McVerry, S.J.)

The defense, and apparently the defense expert witnesses, branded Campion’s analysis as “data snooping,” which required correction for multiple comparisons. In the defense’s view, the multiple age subgroups required a Bonferroni correction that would have diminished the critical p-value for “significance” by a factor of four. The trial court agreed with the defense contention about data snooping and multiple comparisons, and excluded Campion’s opinion of disparate impact, which had been based upon finding statistically significant disparities in the 45+, 50+, and 55+ age subgroups. 2015 WL 4232600, at *13. The trial court noted that Campion, in finding significant disparities in terminations in the subgroups, but not in the 40+ versus <40 analysis:

“[did] not apply any of the generally accepted statistical procedures (i.e., the Bonferroni procedure) to correct his results for the likelihood of a false indication of significance. This sort of subgrouping ‘analysis’ is data-snooping, plain and simple.”

Id. After excluding Campion’s opinions under Rule 702, as well as other evidence in support of plaintiffs’ disparate impact claim, the trial court granted summary judgment on the discrimination claims. Karlo v. Pittsburgh Glass Works, LLC, No. 2:10–cv–1283, 2015 WL 5156913 (W. D. Pa. Sept. 2, 2015).

On plaintiffs’ appeal, the Third Circuit took the wind out of the attack on Campion by holding that the ADEA prohibits disparate impacts based upon age, which need not necessarily be on workers’ being over 40 years old, as opposed to being at least 40 years old. Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 66-68 (3d Cir. 2017). This holding took the legal significance out of the statistical insignificance of Campion’s comparison 40+ versus <40 age-group termination rates. Campion’s subgroup analyses were back in play, but the Third Circuit still faced the question whether Campion’s conclusions, based upon unadjusted z-scores and p-values, offended Rule 702.

The Third Circuit noted that the district court had identified three grounds for excluding Campion’s statistical analyses:

(1) Dr. Campion used facts or data that were not reliable;

(2) he failed to use a statistical adjustment called the Bonferroni procedure; and

(3) his testimony lacks ‘‘fit’’ to the case because subgroup claims are not cognizable.

849 F.3d at 81. The first issue was raised by the defense’s claims of Campion’s sloppy data handling, and inclusion of voluntarily retired workers and workers who were terminated when their plant was turned over to another company. The Circuit did not address these data handling issues, which it left for the trial court on remand. Id. at 82. The third ground went out of the case with the appellate court’s resolution of the scope of the ADEA. The Circuit did, however, engage on the issue whether adjustment for multiple comparisons was required by Rule 702.

On the “data-snooping” issue, the Circuit concluded that the trial court had applied “an incorrectly rigorous standard for reliability.” Id. The Circuit acknowledged that

“[i]n theory, a researcher who searches for statistical significance in multiple attempts raises the probability of discovering it purely by chance, committing Type I error (i.e., finding a false positive).”

849 F.3d at 82. The defense expert witness contended that applying the Bonferroni adjustment, which would have reduced the critical significance probability level from 5% to 1%, would have rendered Campion’s analyses not statistically significant, and thus not probative of disparate impact. Given that plaintiffs’ cases were entirely statistical, the adjustment would have been fatal to their cases. Id. at 82.

At the trial level and on appeal, plaintiffs and Campion had objected to the data-snooping charge on ground that

(1) he had engaged in only four subgroups;

(2) virtually all subgroups were statistically significant;

(3) his methodology was “hypothesis driven” and involved logical increments in age to explore whether the strength of the evidence of age disparity in terminations continued in each, increasingly older subgroup;

(4) his method was analogous to replications with different samples; and

(5) his result was confirmed by a single, supplemental analysis.

Id. at 83. According to the plaintiffs, Campion’s approach was based upon the reality that age is a continuous, not a dichotomous variable, and he was exploring a single hypothesis. A.240-241; Brief of Appellants at 26. Campion’s explanations do mitigate somewhat the charge of “data snooping,” but they do not explain why Campion did not use a statistical analysis that treated age as a continuous variable, at the outset of his analysis. The single, supplemental analysis was never described or reported by the trial or appellate courts.

The Third Circuit concluded that the district court had applied a ‘‘merits standard of correctness,’’ which is higher than what Rule 702 requires. Specifically, the district court, having identified a potential methodological flaw, did not further evaluate whether Campion’s opinion relied upon good grounds. 849 F.3d at 83. The Circuit vacated the judgment below, and remanded the case to the district court for the opportunity to apply the correct standard.

The trial court’s acceptance that an adjustment was appropriate or required hardly seems a “merits standard.” The use of a proper adjustment for multiple comparisons is very much a methodological concern. If Campion could reach his conclusion only by way of an inappropriate methodology, then his conclusion surely would fail the requirements of Rule 702. The trial court did, however, appear to accept, without explicit evidence, that the failure to apply the Bonferroni correction made it impossible for Campion to present sound scientific argument for his conclusion that there had been disparate impact. The trial court’s opinion also suggests that the Bonferroni correction itself, as opposed to some more appropriate correction, was required.

Unfortunately, the reported opinions do not provide the reader with a clear account of what the analyses would have shown on the correct data set, without improper inclusions and exclusions, and with appropriate statistical adjustments. Presumably, the parties are left to make their cases on remand.

Based upon citations to sources that described the Bonferroni adjustment as “good statistical practice,” but one that is ‘‘not widely or consistently adopted’’ in the behavioral and social sciences, the Third Circuit observed that in some cases, failure to adjust for multiple comparisons may “simply diminish the weight of an expert’s finding.”5 The observation is problematic given that Kumho Tire suggests that an expert witness must use “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, 150, (1999). One implication is that courts are prisoners to prevalent scientific malpractice and abuse of statistical methodology. Another implication is that courts need to look more closely at the assumptions and predicates for various statistical tests and adjustments, such as the Bonferroni correction.

These worrisome implications are exacerbated by the appellate court’s insistence that the question whether a study’s result was properly calculated or interpreted “goes to the weight of the evidence, not to its admissibility.”6 Combined with citations to pre-Daubert statistics cases7, judicial comments such as these can appear to be a general disregard for the statutory requirements of Rules 702 and 703. Claims of statistical significance, in studies with multiple exposure and multiple outcomes, are frequently not adjusted for multiple comparisons, without notation, explanation, or justification. The consequence is that study results are often over-interpreted and over-sold. Methodological errors related to multiple testing or over-claiming statistical significance are commonplace in tort litigation over “health-effects” studies of birth defects, cancer, and other chronic diseases that require epidemiologic evidence8.

In Karlo, the claimed methodological error is beset by its own methodological problems. As the court noted, adjustments for multiple comparisons are not free from methodological controversy9. One noteworthy textbook10 labels the Bonferroni correction as an “awful response” to the problem of multiple comparisons. Aside from this strident criticism, there are alternative approaches to statistical adjustment for multiple comparisons. In the context of the Karlo case, the Bonferroni might well be awful because Campion’s four subgroups are hardly independent tests. Because each subgroup is nested within the next higher age subgroup, the subgroup test results will be strongly correlated in a way that defeats the mathematical assumptions of the Bonferroni correction. On remand, the trial court in Karlo must still make his Rule 702 gatekeeping decision on the methodological appropriateness of whether Campion’s properly considered the role of multiple subgroups, and multiple anaslyses run on different models.

1 Although Campion describes his consulting business as small, he seems to turn up in quite a few employment discrimination cases. See, e.g., Chen-Oster v. Goldman, Sachs & Co., 10 Civ. 6950 (AT) (JCF) (S.D.N.Y. 2015); Brand v. Comcast Corp., Case No. 11 C 8471 (N.D. Ill. July 5, 2014); Powell v. Dallas Morning News L.P., 776 F. Supp. 2d 240, 247 (N.D. Tex. 2011) (excluding Campion’s opinions), aff’d, 486 F. App’x 469 (5th Cir. 2012).

2 See Defendant’s Motion to Bar Dr. Michael Campion’s Statistical Analysis, 2013 WL 11260556.

3 There was no mention of an effect size for the lower aged subgroups, and a power calculation for the 60+ subgroup’s probability of showing a z-score greater than two. Similarly, there was no discussion or argument about why this subgroup could not have been evaluated with Fisher’s exact test. In deciding the appeal, the Third Circuit observed that “Dr. Rosenberger test[ed] a subgroup of sixty-and-older employees, which Dr. Campion did not include in his analysis because ‘[t]here are only 14 terminations, which means the statistical power to detect a significant effect is very low’. A.244–45.” Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 82 n.15 (3d Cir. 2017).

4 In the trial court’s words, the z-score converts the difference in termination rates into standard deviations. Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283, 2015 WL 4232600, at *11 n.13 (W.D. Pa. July 13, 2015). According to the trial court, Campion gave a rather dubious explanation of the meaning of the z-score: “[w]hen the number of standard deviations is less than –2 (actually–1.96), there is a 95% probability that the difference in termination rates of the subgroups is not due to chance alone” Id. (internal citation omitted).

5 See 849 F.3d 61, 83 (3d Cir. 2017) (citing and quoting from Paetzold & Willborn § 6:7, at 308 n.2) (describing the Bonferroni adjustment as ‘‘good statistical practice,’’ but ‘‘not widely or consistently adopted’’ in the behavioral and social sciences); see also E.E.O.C. v. Autozone, Inc., No. 00-2923, 2006 WL 2524093, at *4 (W.D. Tenn. Aug. 29, 2006) (‘‘[T]he Court does not have a sufficient basis to find that … the non-utilization [of the Bonferroni adjustment] makes [the expert’s] results unreliable.’’). And of course, the Third Circuit invoked the Daubert chestnut: ‘‘Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but

admissible evidence.’’ Daubert, 509 U.S. 579, 596 (1993).

6 See 849 F.3d at 83 (citing Leonard v. Stemtech Internat’l Inc., 834 F.3d 376, 391 (3d Cir. 2016).

7 See 849 F.3d 61, 83 (3d Cir. 2017), citing Bazemore v. Friday, 478 U.S. 385, 400 (1986) (‘‘Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.’’).

8 See Hans Zeisel & David Kaye, Prove It with Figures: Empirical Methods in Law and Litigation 93 & n.3 (1997) (criticizing the “notorious” case of Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986), for its erroneous endorsement of conclusions based upon “statistically significant” studies that explored dozens of congenital malformation outcomes, without statistical adjustment). The authors do, however, give an encouraging example of a English trial judge who took multiplicity seriously. Reay v. British Nuclear Fuels (Q.B. Oct. 8,1993) (published in The Independent, Nov. 22,1993). In Reay, the trial court took seriously the multiplicity of hypotheses tested in the study relied upon by plaintiffs. Id. (“the fact that a number of hypotheses were considered in the study requires an increase in the P-value of the findings with consequent reduction in the confidence that can be placed in the study result … .”), quoted in Zeisel & Kaye at 93. Zeisel and Kaye emphasize that courts should not be overly impressed with claims of statistically significant findings, and should pay close attention to how expert witnesses developed their statistical models. Id. at 94.

9 See David B. Cohen, Michael G. Aamodt, and Eric M. Dunleavy, Technical Advisory Committee Report on Best Practices in Adverse Impact Analyses (Center for Corporate Equality 2010).

10 Kenneth J. Rothman, Sander Greenland, and Timoth L. Lash, Modern Epidemiology 273 (3d ed. 2008); see also Kenneth J. Rothman, “No Adjustments Are Needed for Multiple Comparisons,” 1 Epidemiology 43, 43 (1990)

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Seventh Circuit Franks ‘Every Exposure’ Theory for Extinction

September 11th, 2017

In Krik v. Exxon Mobil Corp., no. 15-3112, 2017 WL 3768933, Slip op. (7th Cir. Aug. 31, 2017) [slip op. cited as Krik], a jury found that smoking cigarettes causes lung cancer, which is not particularly noteworthy. The plaintiff, Charles Krik, however, wanted the jury to find that asbestos exposure, either alone or with his 45 pack-year smoking history caused his lung cancer. The jury found that smoking was the sole cause. Hannah Meisel, “7th Circuit Affirms Exxon’s Trial Win In Asbestos Cancer Suit,” Law360 (Sept. 1, 2017).

Krik’s asbestos exposure was not particularly impressive, and he apparently did not have asbestosis. He claimed asbestos exposure from his four years of work aboard naval vessels, occasionally removing insulation materials, and his two weeks as an independent contractor at an Exxon Mobil refinery, where he replaced heaters supposedly insulated with asbestos. Exxon Mobil disputed whether the heaters even had asbestos in them. The naval vessels would have had asbestos insulation from many manufacturers, but Krik focused on Owens-Illinois because it is the only solvent company remaining in the plaintiffs’ asbestos-powered perpetual litigation machine.

Lung cancer in a man with minor asbestos exposure with very substantial tobacco consumption – who are you going to call? See Arthur Frank Report, 2011 WL 12192776 (2011).

Arthur Frank is a physician who counts himself among the intellectual progeny of the late Irving Selikoff. Like Selikoff, Frank is intensely interested in outcomes that help workers show that their work has caused them illness. In furthering his interests, Frank sometimes makes things up, such as the “each and every exposure” theory. Frank is also a proponent of the “big-tent” theory of causation, which attempts to keep every possible defendant in a lawsuit, bu asserting that every asbestos exposure, regardless of its intensity, duration, quantity, variety of asbestos, or fiber length, constitutes a cause of plaintiff’s lung cancer.

Defendants moved to bar Frank’s opinions under Federal Rule of Evidence 702. See Exxon Mobil’s motion, at 2013 WL 10847058. Judge Lee of the Northern District of Illinois found that Arthur Frank’s opinions, in the form of the “each and every exposure theory,” “any exposure theory,” “single fiber theory,” or “no safe level of exposure theory” was scientifically insubstantial and inadmissible under Rule 702. Krik at 2-3. Judge Lee thus ruled that Krik could not offer expert witness opinions that espoused “every exposure” is substantial.

After Judge Lees’ ruling, Krik’s case was transferred to Judge Manish Shah, for trial. Despite the earlier ruling by Judge Lee, Krik’s counsel called Dr. Frank to testify at trial, with a repackaged opinion about Krik’s “cumulative exposure” caused his lung cancer, and every constituent exposure to that cumulative exposure was causally responsible.

After a voir dire examination of Frank, Judge Shah concluded that Frank’s opinion was still untethered to any “specific quantum of exposure attributable to the defendants, but was instead based on his medical and scientific opinion that every exposure is a substantial contributing factor to the cumulative exposure that causes cancer.” Krik v. Owens‐Illinois, Inc., No. 10‐CV‐07435, 2015 WL 5050143, at *1 (N.D. Ill. Aug. 25, 2015). Frank and plaintiffs’ counsel had attempted to circumvent the earlier ruling by Judge Lee, but their ruse failed to fool Judge Shah. On appeal to the Seventh Circuit1, a panel affirmed Judge Shah’s reasoning and exclusion of Arthur Frank’s opinions. Krik at 4-5.

Arthur Frank is used to making things up, including the law. The law of causation in most jurisdictions distinguishes between substantial and insubstantial contribution, but Frank decreed: “Either it’s zero or it’s substantial; there is no such thing as not substantial.” R. 66‐3 at 23, pageID 923. Really? In Frank’s mind, even a minute, perhaps a second, of fleeting exposure, would be a substantial contributing factor to a plaintiff’s lung cancer because he has legislated insubstantial out of existence. R. 376 at 273–74, pageID 10146‐47.

Frank’s testimony presented several problems:

First, his cumulative exposure theory was no different from the previously excluded “each and every exposure” theory. Even Frank, in his deposition testimony conflated “each and every exposure” with a cumulative exposure theory.

Second, Frank’s opinion did not conform to the legal standard. In the initial ruling on Frank, Judge Lee held that plaintiff must show that asbestos was a “substantial contributing factor” to his injury2.

Third, Frank’s opinion lacked an adequate scientific foundation. Krik was tasked with showing that asbestos was a “substantial contributing factor” to his lung cancer. Krik at 7; Krik, 76 F. Supp. 3d at 747 (Lee, J.). Frank’s opinion on “every exposure” did not help him make out his case.

The trial court judges recognized, putting aside the issue of thresholds, that asbestos‐induced lung cancers are dose dependent. At the very least, any attempt to attribute a person’s lung cancer to an exposure requires a consideration of the timing and quantum of exposure. Frank, in defiance of basic common sense and basic toxicologic principles, would – if allowed by courts – treat every exposure, regardless how de minimis, as a substantial contribution to the total exposure and the total risk. Krik at 8; Krik, 76 F. Supp. 3d at 753 (Lee, J.).

The panel of the Seventh Circuit found the trial judges’ exclusion of the Frank nonsense to be well supported and well within their discretion as gatekeepers3. Krik at 14

Krik’s counsel also complained that the trial court refused to admit the so-called Helsinki document4, a 1997 statement of public policy statement of scientists who opined that “[c]umulative exposure on a probability basis should thus be considered the main criteria for the attribution of a substantial contribution by asbestos to lung cancer risk.” R. 412‐4 at 4, pageID 13657.

The problem for counsel, and for Frank, was that Frank never referred to or embraced the Helsinki statement as an “authoritative text.” If he had, he would have been roundly impeached by the statement’s pronouncement that the “likelihood that asbestos exposure has made a substantial contribution increases when the exposure increases.” Id. The Seventh Circuit held that the exclusion of this document as a stand-alone piece of evidence did not support plaintiff’s theory, and that its exclusion was not an abuse of discretion5. Krik at 15-17.

1 The appellate court noted that it reviewed de novo the question whether the trial court properly applied Rule 702. The district court’s decision to exclude or admit expert witness opinion testimony is reviewed only for “abuse of discretion.” Krik at 4 (citing C.W. ex rel. Wood v. Textron, Inc., 807 F.3d 827, 835 (7th Cir. 2015). The party proponent has the burden of showing that the challenged expert witness testimony satisfies the Rule 702 statutory requirements, by a preponderance of evidence. Id. (citing Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009).

2 Krik v. Crane Co., 76 F. Supp. 3d 747, 753 (N.D. Ill. 2014) (citing Lindstrom v. A‐C Prod. Liab., 424 F.3d 488, 493 (6th Cir. 2005) (applying maritime law); Thacker v. UNR Indus., Inc., 603 N.E.2d 449, 457 (Ill. 1992) (Illinois law).

3 The panel noted that the Sixth and Ninth Circuits had ruled similarly. McIndoe v. Huntington Ingalls Inc., 817 F.3d 1170, 1177 (9th Cir. 2016); Lindstrom v. A‐C Prod. Liab., 424 F.3d 488, 493 (6th Cir. 2005) (“The requirement, however, is that the plaintiff make a showing with respect to each defendant that the defendant’s product was a substantial factor in plaintiff’s injury … . A holding to the contrary would permit imposition of liability on the manufacturer of any product with which a worker had the briefest of encounters on a single occasion.”).

5 Accord Rockman v. Union Carbide Corp., No. CV RDB‐16‐1169, 2017 WL 3022969, at *5 (D. Md. July 17, 2017); Bell v. Foster Wheeler Energy Corp., No. CV 15‐6394, 2016 WL 5847124, at *3, n.3 (E.D. La. Oct. 6, 2016), recon. denied, No. CV 15‐6394, 2017 WL 876983 (E.D. La. Mar. 6, 2017); Watkins v. Affinia Group, 2016‐Ohio‐2830, ¶ 37, 54 N.E.3d 174, 182; In reJames Wilson Assoc., 965 F.2d 160, 173 (7th Cir.1992); United States v. Dixon, 413 F.3d 520, 524–25 (5th Cir. 2005); Yates v. Ford Motor Co., 113 F. Supp. 3d 841, 862 (E.D.N.C. 2015); Betz v. Pneumo Abex, LLC, 44 A.3d 27, 47, 55 n.35 (Pa. 2012); Bostic v. Georgia‐Pacific Corp., 439 S.W.3d 332, 356–57 (Tex. 2014).

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Graced

September 5th, 2017

“With half-damp eyes I stared to the room
Where my friends and I spent many an afternoon
Where we together weathered many a storm
Laughin’ and singin’ till the early hours of the morn”
Bob Dylan, “Bob Dylan’s Dream” (1963)

* * * * * * * * * * * *

Well, not really singing so much as analyzing, calculating, discussing, debating, and occasionally laughing, too.

A few weeks ago, two good friends, Dr David Schwartz, and Dr Judi Steinman, came to visit me in New York. I seem to have known David and Judi, forever. David went to work for McCarter & English, shortly after finishing his post-doctoral training in neuropharmacology and neurophysiology, and his doctorate from Princeton in neuroscience. At McCarter, David worked initially on the Prozac cases, but after the 1992 Pamela Jean Johnson Christmas eve verdict in the silicone gel breast implant litigation, David jumped in to help McCarter and other lawyers understand the sketchy scientific evidence that was being proffered in support of claims by the “silicone sisters.” Judi, whose doctorate was in psychobiology and neuroscience from Rutgers, joined us on the science McCarter science team, a couple of years later. Together, we had the challenge and thrill of putting an end to a rather disreputable chapter in American tort litigation history, MDL 926, a.k.a. In re Silicone Gel Breast Implant Product Liability Litigation.

Ultimately, we all moved on from the McCarter firm. David went on to start a first-rate scientific consulting firm, Innovative Science Solutions (ISS) which serves the pharmaceutical, biotechnology, and medical device industries. As a principal in ISS, David worked with me in welding fume and other litigations, and we continue to collaborate on various projects. A few years ago, we co-produced a short film, “The Daubert Will Set Your Client Free.”

Judi moved to Hawaii, where, in 2003, she started BioTechnoLegal Services LLC, which provides scientific and medico-legal advice to lawyers in complex health-effects litigation. Judi joined the faculty of the University of Hawaii’s Department of Pharmaceutical Sciences, and for some years, she was the Program Coordinator for the University’s Master of Science program in Clinical Psychopharmacology. A couple of years ago, I gave a lecture by Skype to one of Judi’s classes at the University on meta-analysis in pharmacoepidemiology.

What a treat to have David and Judi in my living room, to talk and reminisce. David had planned to conduct an interview of me, but we might as well have conducted interviews of each other, and the varied roads we have traveled. David persisted in his plan to make me the interviewed, and he has now graced me twice by posting the interview to his firm’s website. David Schwartz, “Effective Use of Scientific Principles in the Courtroom: From Silicone to Talc and Beyond,” ISS Blog (Aug. 30, 2017)

Our discussion on a warm July afternoon made me nostalgic, but also pushed me into reflecting on how I came to live in the interdisciplinary world of law and science. Science had always been a part of my life. As a young boy, I lost myself in my grandfather’s Medical Clinics of North America, and my uncle’s college and medical school textbooks. There were several physicians in my family, and one of my favorites was my great uncle Sam, who was an orthopedic surgeon. Uncle Sam delighted my cousins and me with visits to the skeleton that dangled from a hook in his office. When I got my first microscope at age 11, Uncle Sam gave me a collection of tissue slides and taught me the difference between a sarcoma and a carcinoma. This was much more fun than trading baseball cards.

Another childhood treat was visiting my cousin Nan, whose parents had given her a subscription to “Things of Science.” Every month, she received a magical blue box with stuff – scientific stuff, with suggestions for experiments and observations. Whenever I had a chance, I would press Nan to get out the most recent box, and we would we become engrossed in the latest scientific marvel. Nan’s younger sister, Elena, a few years younger, recently reminded me how jealous she was when she was excluded from our scientific play.

In high school school, I had the good fortune to attend a National Science Foundation summer program to study physics. In college, I studied biology, and worked in the laboratory of a professor who was studying tubulin mutations and nuclear migration.

Watching the scientific process unfold through experiments and analysis was a huge thrill, but also, in some ways, a disappointment. Science is a long game, with lots of dead ends and missteps. After finishing university training in biological sciences, I stayed another year to complete a second major in philosophy, and entered graduate school to study philosophy. My experience in the laboratory ultimately made me more interested in the epistemology of scientific evidence and knowledge, as well as the implementation of scientific knowledge in policy decisions. Studying philosophy gave me plenty of opportunity to understand “meta-science,” but in the late 1970s, there were few opportunities for gainful employment. The tenure-track market was saturated by recent doctorates who had swelled the university departments during the Vietnam War. The department chairman, Arthur Smullyan, would send out regular memoranda to remind us that we were not likely going to find university-level teaching jobs. I recall sitting in Patty’s restaurant, on Sicard Street, New Brunswick, where some of my fellow graduate students and I, after finishing our qualifying exams, were drowning our sorrows in cheap beer and pizza. We all bemoaned our lack of job opportunities, and in a fit of exasperation, I suggested that we might form a consulting company. Having polished our skills in argumentation, I thought that there could be a way to eke out a living, much like Monty Python’s “Argument Clinic.” To my surprise, my colleagues pointed out that there already was such a profession. Naively, I asked which one, only to be confused why I had never before thought of law as a career. I took the LSAT, and the rest is history. When I started law school, I thought that my studying biology and philosophy were dead ends in my education, which shows how wrong I can be.

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Lawsuit Magic – Turning Talcum into Wampum

August 27th, 2017

Last week, a Los Angeles jury, with little prior experience in giving away other people’s money, awarded Eva Echeverria $417,000,000 dollars, in compensatory and punitive damages.1 Pundits in the media, and from both sides of the bar, including your humble blogger, jumped in to offer their speculation about the cause of profligacy.2

In speaking to one reporter, I described the evidence against Johnson & Johnson in an earlier trial (Slemp) as showing that the company needed to engage more fully with the scientific evidence, and not reduce complex evidence to sound bites. Alas, no good deed goes unpunished; my comments were reduced to sound bites! The reporter quoted me in part as having said that the case was a tough one for the defense, but left out that I thought the case was tough because the defense will have a difficult time educating judges and juries in the scientific methods and judgment needed to reach a sound conclusion. The reporter suggested that I had opined that the evidence against J & J was “compelling,” when I had suggested the evidence was confounded and biased, and that J & J needed to take greater care in addressing study validity.3

Perhaps more interesting than my speculation is the guesswork of the plaintiffs’ counsel, who has had more experience with conjecture than I will ever enjoy. In an interview with an American Law Media reporter4, Allen Smith offered his view that three “new” pieces of evidence explain the Los Angeles hyper-verdict:

1. evidence that other companies selling consumer talcum power have begun to place ovarian cancer warnings on their packaging, within the few months;

2. evidence that two persons involved in the Cosmetic Industry Review, which has concluded that talcum powder is safe, had received payments from Johnson & Johnson for speaking engagements; and

3. evidence that Douglas Weed, a former National Cancer Institute epidemiologist, who testified for Johnson & Johnson as an expert witness in the Echeverria case, had been sanctioned in another, non-talc case in North Carolina, for lying under oath about whether he had notes to his expert report in that other case.

Smith claimed that the new evidence was “very compelling,” especially the evidence that Johnson & Johnson had presented “unbelievable and non-credible witnesses on an issue so important like this.”

Now, Smith was trial counsel. He was intimately involved in presenting the evidence, and in watching the jurors’ reactions. Nonetheless, I am skeptical that these three “bits” explain the jury’s extravagance.

The first “bit” seems completely irrelevant. The fact of another company’s having warned within months of the trial, and years after the plaintiff was diagnosed with ovarian cancer, suggests that the evidence was inflammatory without having any probative value. Feasibility of warning was not an issue. State of the art was an issue. In the Slemp trial, Graham Colditz testified that he had had his epiphany that talc causes ovarian cancer only two years ago, when he was instructed by plaintiffs’ counsel to formulate an opinion on the causal claim. That another company recently placed a warning to ward off the lawsuit industry is hardly evidence of industry or governmental standard. All that can really be said is that some companies have been bullied or scared into warnings by the Lawsuit Industry, in the hopes of avoiding litigation. Indeed, it is not at all clear how this bit of irrelevancy was admitted into evidence. All in all, this evidence of a recent warning, years after the plaintiff’s use of the defendant’s talcum powder seems quite out of bounds.

The second bit was simply more of the same inflammatory, scurrilous attacks on Johnson & Johnson. Having watched much of the Slemp trial, I can say that this was Allen Smith’s stock in trade. From media reports, he seemed to have succeeded in injecting his personal attacks on the most peripheral of issues into the Echeverria trial. Not everything in Slemp was collateral attack, but a lot was, and much of it was embarrassing to the legal system for having tolerated it.

The third bit of evidence about Dr. Weed’s having been sanctioned was news to me. A search on Westlaw and Google Scholar failed to find the sanctions order referred to by plaintiffs’ counsel. If anyone is familiar with the North Carolina case that gave rise to the alleged court sanction, please send me a copy or a citation.

1 Daniel Siegal, “J&J Hit With $417M Verdict In 1st Calif. Talc Cancer Trial,” Law360 (Aug. 21, 2017). The case was Echeverria v. Johnson & Johnson, case no. BC628228, Los Angeles Cty. Superior Court, California.

2 See Daniel Siegal, “Science No Salve For J&J In Talc Cases, $417M Verdict Shows,” Law360, Los Angeles (Aug. 22, 2017). See also Margaret Cronin Fisk & and Edvard Pettersson, “J&J Loses $417 Million Talc Verdict in First California Case,” Bloomberg News (Aug. 21, 2017).

3 Tina Bellon, “Massive California verdict expands J&J’s talc battlefield,” Reuters (Aug. 22, 2017); Tina Bellon, “Massive California verdict expands J&J’s talc battlefield,” CNBC (Aug. 22, 2017); Tina Bellon, “J&J’s talc woes expand with massive California verdict,” BNN Reuters (Aug. 22, 2017).

4 Amanda Bronstad, “New Evidence Seen as Key in LA Jury’s $417M Talc Verdict,” Law.com (Aug. 22, 2017).

Posted in Causation, Expert Witnesses, Scientific Evidence | Comments Off on Lawsuit Magic – Turning Talcum into Wampum

Trial by Twitter

August 13th, 2017

Did you read Trump’s tweet from last night?

“Time to take down the Statue of Liberty. Ugly dress, too French, heavy calves. Sad, must go.”

OK. I admit, I made that up, but it could have been true. Trumpovich has said more outrageous, stupider things, frequently and with wild abandon.

I don’t really understand this Twitter thing. What worse is that I do understand how it feeds uncritical thinking by people who prefer sound bite to argument and discourse. But we live in a democracy, and this is what people want; right? This is what the First Amendment requires?

So why not make American great again, and merge two great institutions together: the right to trial by jury with the right to express one’s self in mindless sound bites? Let us admit it: Twitter has blossomed because Americans have the attention span of crickets. And many have no more cognitive ability than crickets, to boot, but you go to trial with the jurors you have, not the jurors you want.

Here is how trial by twitter might work. A “fair and impartial,” but appropriately ignorant jury is selected for a trial that involves a scientific controversy, at least a controversy in the minds of the litigants and their hired expert witnesses. The jurors need not be inconvenienced by travel to the local court house; they need only have their smartphones available at all times. If they cannot afford a smartphone, one will be given to them. The lawyers will then start to tweet their opening statements, alternating tweets. Each side is allowed 100 tweets. In trials designated complex, each side gets 150 tweets.

Then come the witnesses. One at a time, first for plaintiff; then for defendant. Each witness is permitted to tweet his or her testimony, after first tweeting an oath to tweet the truth, and nothing but the truth, so help me. The witness is permitted two tweets, after which the opposing counsel is permitted to cross-tweet once. Opposing counsel may interpose an objection tweet, with the trial judge tweeting his or her ruling. If the objection is sustained, then the offending tweet will be deleted. The 2:1 tweets are repeated until the witness has nothing left to tweet. After each witness, legal counsel are permitted interim argument of 25 tweets each, alternating. In an effort to promote early settlements, jurors are permitted to “like” tweets from witnesses or counsel, at every stage.

Final arguments are tweeted, of course, again with alternating tweets. The tweeter with the burden of proof gets the final tweet, followed by the judge’s instructions, delivered in tweets. A jury foreperson is appointed, and deliberations proceed by twitter, marked private. Verdicts are returned by the foreperson’s tweet, with the other jurors’ tweeting their agreement, or dissents. Post-verdict motions and appeals can easily be handled by twitter, as well.

Due process preserved, and the right to trial inviolate!

Half of advertising revenues go to Legal Services to pay for legal counsel for the indigent.

 

Posted in Trial Procedure | Comments Off on Trial by Twitter

WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle

July 31st, 2017

Multidistrict Litigations (MDLs) can be “muddles” that are easy to get in, but hard to get out of. Pfizer and subsidiary Greenstone fabulously escaped a muddle through persistent lawyering and the astute gatekeeping of a district judge, in the Eastern District of Pennsylvania. That judge, the Hon. Cynthia Rufe, sustained objections to the admissibility of plaintiffs’ epidemiologic expert witness Anick Bérard. When the MDL’s plaintiffs’ steering committee (PSC) demanded, requested, and begged for a do over, Judge Rufe granted them one more chance. The PSC put their litigation industry eggs in a single basket, carried by statistician Nicholas Jewell. Unfortunately for the PSC, Judge Rufe found Jewell’s basket to be as methodologically defective as Bérard’s, and Her Honor excluded Jewell’s proffered testimony. Motions, paper, and appeals followed, but on June 2, 2017, the Third Circuit declared that the PSC and its clients had had enough opportunities to get through the gate. Their baskets of methodological deplorables were not up to snuff. In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of Jewell’s dodgy opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully) [Slip op. cited below as Zoloft].

Plaintiffs Attempt to Substitute WOE for Depressingly Bad Expert Witness Opinion

The ruse of conflating “weight of the evidence,” as used to describe the appellate standard of review for sustaining or reversing a trial court’s factual finding with a purported scientific methodology for inferring causation, was on full display by the PSC in their attack on Judge Rufe’s gatekeeping. In their appellate brief in the Court of Appeals for the Third Circuit, the PSC asserted that Jewell had used a “weight of the evidence method,” even though that phrase, “weight of the evidence” (WOE) was never used in Jewell’s litigation reports. The full context of the PSC’s argument and citations to Milward make clear a deliberate attempt to conflate WOE as an appellate judicial standard for reviewing jury fact finding and a purported scientific methodology. See Appellants’ Opening Brief at 54 (Aug. 10, 2016) [cited as PSC] (asserting that “[a]t all times, the ultimate evaluation of the weight of the evidence is a jury question”; citing Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 20 (1st Cir. 2011), cert. denied, 133 S. Ct. 63 (2012).

Having staked the ground that WOE is akin to a jury’s factual finding, and thus immune to any but the most extraordinary trial court action or appellate intervention, the PSC then pivoted to claim that Jewell’s WOE-ful method was nothing much more than an assessment of “the totality of the available scientific evidence, guided by the well-accepted Bradford-Hill criteria.” PSC at 3, 4, 7. This maneuver allowed the PSC to argue, apparently with a straight face, that WOE methodology as used by Jewell, had been generally accepted in the scientific community, as well as by the Third Circuit, in previous cases in which the court accepted the use of Bradford Hill’s considerations as a reliable method for establishing general causation. See PSC at 4 (citing Gannon v. United States, 292 F. App’x 170, 173 n.1 (3d Cir. 2008)). Jewell then simply plugged in his expertise and “40 years of experience,” and the desired conclusion of causation popped out. Id. Quod erat demonstrandum.

In pressing its point, the PSC took full advantage of loose, inaccurate language from the American Law Institute’s Restatement’s notorious comment C:

“No algorithm exists for applying the Hill guidelines to determine whether an association truly reflects a causal relationship or is spurious.”

PSC at 33-34, citing Restatement (Third) of Torts: Physical and Emotional Harm § 28 cmt. c(3) (2010). Well true, but the absence of a mathematical algorithm hardly means that causal judgments are devoid of principles and standards. The PSC was undeterred, by text or by shame, from equating an unarticulated use of WOE methodology with some vague invocation of Bradford Hill’s considerations for evaluating associations for causality. See PSC at 43 (citing cases that never mentioned WOE but only Bradford Hill’s 50-plus year old heuristic as somehow supporting the claimed identity of the two approaches)1.

Pfizer Rebuffs WOE

Pfizer filed a comprehensive brief that unraveled the PSC’s duplicity. For unknown reasons, tactical or otherwise, however, Pfizer did not challenge the specifics of PSC’s equation of WOE with an abridged, distorted application of Bradford Hill’s considerations. See generally Opposition Brief of Defendants-Appellees Pfizer Inc., Pfizer International LLC, and Greenstone LLC [cited as Pfizer]. Perhaps given page limits and limited judicial attention spans, and just how woefully bad Jewell’s opinions were, Pfizer may well have decided that a more directed approach of assuming arguendo WOE’s methodological appropriateness was a more economical, pragmatic approach. A close reading of Pfizer’s brief, however, makes clear that it never conceded the validity of WOE as a scientific methodology.

Pfizer did point to the recasting of Jewell’s aborted attempt to apply Bradford Hill considerations as an employment of WOE methodology. Pfizer at 46-47. The argument reminded me of Abraham Lincoln’s famous argument:

“How many legs does a dog have if you call his tail a leg?

Four.

Saying that a tail is a leg doesn’t make it a leg.”

Allen Thorndike Rice, Reminiscences of Abraham Lincoln by Distinguished Men of His Time at 242 (1909). Calling Jewell’s supposed method WOE or Bradford Hill or WOE/Bradford Hill did not cure the “fatal methodological flaws in his opinions.” Pfizer at 47.

Pfizer understandably and properly objected to the PSC’s attempt to cast Jewell’s “methodology” at such a high level of generality that any consideration of the many instances of methodological infidelity would be relegated to mere jury questions. Acquiescence in the PSC’s rhetorical move would constitute a complete abandonment of the inquiry whether Jewell had used a proper method. Pfizer at 15-16.

Interestingly, none of the amici curiae addressed the slippery WOE arguments advanced by the PSC. See generally Brief of Amici Curiae American Tort Reform Ass’n & Pharmaceutical Research and Manufacturers of America (Oct. 18, 2016); Brief of Washington Legal Fdtn. as Amicus Curiae (Oct. 18, 2016). There was no meaningful discussion of WOE as a supposedly scientific methodology at oral argument. See Transcript of Oral Argument in In re Zoloft Prod. Liab. Litig., No. 16-2247 (Jan. 25, 2017).

The Third Circuit Acknowledges that Some Methodological Infelicities, Flaws, and Fallacies Are Properly the Subject of Judicial Gatekeeping

Fortunately, Jewell’s methodological infidelities were easily recognized by the Circuit judges. Jewell treated multiple studies, which were nested within one another, and thus involved overlapping and included populations, as though they were independent verifications of the same hypothesis. When the population at issue (from the Danish cohort) was included in a more inclusive pan-Scandivanian study, the relied-upon association dissipated, and Jewell utterly failed to explain or account for these data. Zoloft at 5-6.

Jewell relied upon a study by Anick Bérard, even though he later had to concede that the study had serious flaws that invalidated its conclusions, and which flaws caused him to have a lack of confidence in the paper’s findings.2 In another instance, Jewell relied innocently upon a study that purported to report a statistically significant association, but the authors of this paper were later required by the journal, The New England Journal of Medicine, to correct the very calculated confidence interval upon which Jewell had relied. Despite his substantial mathematical prowess, Jewell missed the miscalculation and relied (uncritically) upon a finding as statistically significant when in fact it was not.

Jewell rejected a meta-analysis of Zoloft studies for questionable methodological quibbles, even though he had relied upon the very same meta-analysis, with the same methodology, in his litigation efforts involving Prozac and birth defects. Not to be corralled by methodological punctilio, Jewell conducted his own meta-analysis with two studies Huybrechts (2014) and Jimenez-Solem (2012), but failed to explain why he excluded other studies, the inclusion of which would have undone his claimed result. Zoloft at 9. Jewell purported to reanalyze and recalculate point estimates in two studies, Jimenez-Solem (2012) and Huybrechts (2014), without any clear protocol or consistency in his approach to other studies. Zoloft at 9. The list goes on, but in sum, Jewell’s handling of these technical issues did not inspire confidence, either in the district or in the appellate court.

WOE to the Third Circuit

The Circuit gave the PSC every conceivable break. Because Pfizer had not engaged specifically on whether WOE was a proper, or any kind of, scientific method, the Circuit treated the issue as virtually conceded:

“Pfizer does not seem to contest the reliability of the Bradford Hill criteria or weight of the evidence analysis generally; the dispute centers on whether the specific methodology implemented by Dr. Jewell is reliable. Flexible methodologies, such as the “weight of the evidence,” can be implemented in multiple ways; despite the fact that the methodology is generally reliable, each application is distinct and should be analyzed for reliability.”

Zoloft at 18. The Court acknowledged that WOE arose only in the PSC’s appellate brief, which would have made the entire dubious argument waived under general appellate jurisdictional principles, but the Court, in a footnote, indulged the assumption, “for the sake of argument,” that WOE was Jewell’s purported method from the inception. Zoloft at 18 n. 39. Without any real evidentiary support or analysis or concession from Pfizer, the Circuit accepted that WOE analyses were “generally reliable.” Zoloft at 21.

The Circuit accepted, rather uncritically, that Jewell used a combination of WOE analysis and Bradford Hill considerations. Zoloft at 17. Although Jewell had never described WOE in his litigation report, and WOE was not a feature of his hearing testimony, the Circuit impermissibly engrafted Carl Cranor’s description of WOE as involving inference to the best explanation. Zoloft at 17 & n.37, citing Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11, 17 (1st Cir. 2011) (internal quotation marks and citation omitted).

There was, however, a limit to the Circuit’s credulousness and empathy. As the Court noted, there must be some assurance that the purported Bradford Hill/WOE method is something more than a “mere conclusion-oriented selection process.” Zoloft at 20. Ultimately, the Court put its markers down for Jewell’s putative WOE methodology:

“there must be a scientific method of weighting that is used and explained.”

Zoloft at 20. Calling the method WOE did not, in the final analysis, exclude Jewell from Rule 702 gatekeeping. Try as the PSC might, there was just no mistaking Jewell’s approach as anything other than a crazy patchwork quilt of numerical wizardry in aid of subjective, result-oriented conclusion mongering.

In the Court’s words:

“we find that Dr. Jewell did not 1) reliably apply the ‘techniques’ to the body of evidence or 2) adequately explain how this analysis supports specified Bradford Hill criteria. Because ‘any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible’, this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony.”

Zoloft at 28. As heartening as the Circuit’s conclusion is, the Court’s couching its observation as a finding (“we find”) is disheartening with respect to the Third Circuit’s apparent inability to distinguish abuse-of-discretion review from de novo appellate findings. Equally distressing is the Court’s invocation of Daubert factors, which were dicta in a Supreme Court case that was superseded by an amended statute over 17 years ago, in Federal Rule of Evidence 702.

On the crucial question whether Jewell had engaged in an unreliable application of methods or techniques that superficially, at a very high level of generality, claim to be generally accepted, the Court stayed on course. The Court “found” that Jewell had applied techniques, analyses, and critiques so obviously inconsistently that no amount of judicial indulgence, assumptions arguendo, or careless glosses could save Jewell and his fatuous opinions from judicial banishment. Zoloft 28-29. Returning to the correct standard of review (abuse of discretion), but the wrong governing law (Daubert instead of Rule 702), the Court announced that:

“[b]ecause ‘any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible’, this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony.”

Zoloft at 21 n.50 (citation omitted). The Court found itself unable to say simply and directly that “the MDL trial court decided the case well within its discretion.”

The Zoloft case was not the Third Circuit’s first WOE rodeo. WOE had raised its unruly head in Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 602 (D.N.J. 2002), aff’d, 68 F. App’x 356 (3d Cir. 2003), where an expert witness, David Ozonoff, offered what purported to be a WOE opinion. The Magistrini trial court did not fuss with the assertion that WOE was generally reliable, but took issue with how Ozonoff tried to pass off his analysis as a comprehensive treatment of the totality of the evidence. In Magistrini, Judge Hochberg noted that regardless of the rubric of the methodology, the witness must show that in conducting a WOE analysis:

“all of the relevant evidence must be gathered, and the assessment or weighing of that evidence must not be arbitrary, but must itself be based on methods of science.”

Magistrini, 180 F. Supp. 2d at 602. The witness must show that the methodology is more than a “mere conclusion-oriented selection process,” and that it has a “a scientific method of weighting that is used and explained.” Id. at 607. Asserting the use of WOE was not an excuse or escape from judicial gatekeeping as specified by Rule 702.

Although the Third Circuit gave the Zoloft MDL trial court’s findings a searching review (certainly much tougher than the prescribed abuse-of-discretion review), the MDL court’s finding that Jewell “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion” were ultimately vindicated by the Court of Appeals. Zoloft at 10.

All’s well that ends well. Perhaps. It remains unfortunate, however, that a hypothetical method, WOE — which was never actually advocated by the challenged expert witnesses, which lacks serious support in the scientific community, and which was merely assumed arguendo to be valid — will be taken by careless readers to have been endorsed the Third Circuit.

1 Among the cases cited without any support for the PSC’s dubious contention were Gannon v. United States, 292 F. App’x 170, 173 n.1 (3d Cir. 2008); Bitler v. A.O. Smith Corp., 391 F.3d 1114, 1124-25 (10th Cir. 2004); In re Joint E. & S. Dist. Asbestos Litig., 52 F.3d 1124, 1128 (2d Cir. 1995); In re Avandia Mktg., Sales Practices & Prods. Liab. Litig., No. 2007-MD-1871, 2011 WL 13576, at *3 (E.D. Pa. Jan. 4, 2011) (“Bradford-Hill criteria are used to assess whether an established association between two variables actually reflects a causal relationship.”).

2 Anick Bérard, Sertraline Use During Pregnancy and the Risk of Major Malformations, 212 Am. J. Obstet. Gynecol. 795 (2015).

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle

Weight of the Evidence in Science and in Law

July 29th, 2017

“woe to that man by whom the offense cometh”

         Matthew 18:7

Weight of the evidence (WOE) has cropped up again in recent trial and appellate court proceedings involving the admissibility of scientific expert witness opinion testimony. With some consistency, the WOE approach advocated is vacuous. The proponents of WOE do not specify what type of evidence is considered, whether all evidence was considered, or how competing and conflicting evidence was weighed.

Interpreted sympathetically, WOE might be taken to mean that “scientific judgment” was exercised with respect to causal inference, without describing exactly what was done. Although sympathetic, this interpretation renders the purported methodology meaningless. WOE-ful scientists might just as well say that they used scientific method. Not surprisingly, WOE is absent from virtually all major epidemiology textbooks

Despite the vacuity of WOE, or because of it, some lawyers, who constitute the lawsuit industry, are particularly fond of WOE.1 Expert witnesses who support the lawsuit industry have defended their “right” to inflict WOE on the litigation system, tooth and nail.2

Carl Cranor, a philosophy professor and a hired expert witness in litigation for plaintiffs’ counsel, has written about WOE and attempted to defend WOE as a scientific methodology. Cranor has caricaturized criticisms of WOE, including mine, by suggesting that the International Agency for Research on Cancer’s use of WOE rebuts my suggestion that WOE is no method at all.3 Cranor’s defense fails, however, because IARC’s method, for all its deficiencies, never invokes a method mired in WOE.

Perhaps the Lawsuit Industry likes WOE as much as it likes the equally vague term, “link.” WOE frees them from the requirement of any meaningful methodology, which means that any conclusion is possible. Under WOE, any conclusion can survive gatekeeping as an opinion. WOE frees the putative expert witness from the need to consider the quality of research. WOE-ful authors such as Carl Cranor invoke WOE or seek to inflict WOE without mentioning the crucial “nuts and bolts” of scientific inference, such as concepts of

  • Internal and external validity
  • Assessment of random error
  • Assessment of known and residual confounding
  • Known and potential threats to validity in
  • Appropriate methods of systematic review
  • Appropriate synthesis across studies, such as systematic review and meta-analysis

These important concepts are lost in the miasma of WOE.

In the published scientific literature, it is a commonplace that WOE is either poorly or not defined and specified. The phrase is vague and ambiguous; its use, inconsistent.4  Even authors sympathetic to the WOE mission have reluctantly concluded that the term is most often used in a way that “does not lend itself to transparency or repeatability except in simple cases.”5

Another reason that WOE resonates so strongly with the Lawsuit Industry is that having expert witnesses proclaim WOE as their methodology permits trial counsel to claim that the proffered opinions are immune to gatekeeping because, after all, weight-of-the-evidence questions are for the jury. Lawyers learn early on about WOE factual issues in appellate review of a wide variety of evidentiary and sufficiency issues in criminal and civil cases.6 Unless against the great WOE, WOE questions are for the jury.

Even venerable judges fall for this semantic confusion. In 1995, the Second Circuit, before the major revision of Rule 702, in 2000, noted that in discharging their gatekeeping role, trial judges do not assume:

“‘the role of St. Peter at the gates of heaven, performing a searching inquiry into the depth of an expert witness’s soul’ that would ‘inexorably lead to evaluating witness credibility and weight of the evidence, the ageless role of the jury’.”

McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1045 (2d Cir.1995) (internal citations omitted).

Of course, the expert witness’s soul is not at issue, but his methodology is. More important, however, note how the appellate court adverted to “weight of the evidence” as something that the jury must evaluate, along with witness credibility. The expert witness WOE litigation strategy deliberately trades upon the confusion between WOE in the allocation between judge and jury, and valid scientific methodology in causal inference. McCullock is proof that judges can be, and are, bamboozled by the litigation strategy.

Twenty years after McCullock, federal appellate judges are still falling for the deliberate confusion between legal and scientific WOE. The Ninth Circuit recently held that the reliability test of Federal Rule of Evidence 702 is:

“‘is not the correctness of the expert’s conclusions but the soundness of his methodology’, and when an expert meets the threshold established by Rule 702, the expert may testify and the fact finder decides how much weight to give that testimony. Challenges that go to the weight of the evidence are within the province of a fact finder, not a trial court judge. A district court should not make credibility determinations that are reserved for the jury.”

City of Pomona v. SQM North America Corp., 750 F.3d 1036, 1044 (9th Cir. 2014) (internal citation omitted), cert. denied, 135 S. Ct. 870 (2014). Characterizing a methodological dispute as one that “merely” concerns the “weight of the evidence” is a strategy to remove the dispute from judicial gatekeeping altogether.

Recently, the Third Circuit displayed this confusion of WOE with methodological impropriety by mischaracterizing failure to correct for multiple testing as merely an improper calculation that ordinarily goes to the weight of the evidence, not its admissibility. Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 83 (3d Cir. 2017).

The Third Circuit, in Karlo, cited to a Supreme Court case that predated Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), and which did involve any Rule 702 challenge to the use of a flawed statistical analysis. In Bazemore v. Friday, 478 U.S. 385, 400 (1986), plaintiffs sued as a class for employment discrimination, and sought to show the discrimination through the use of a regression analysis. The defense challenged the plaintiffs’ regression on grounds that key variables were omitted. The Court rejected a sufficiency challenge to a finding of discrimination in plaintiffs’ class action, and noted:

“Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.”

The lesson of the last two decades of judicial gatekeeping is that methodological infirmity will affect both probitiveness and admissibility7. Courts cannot escape their important gatekeeping duties by shifting their responsibility to juries under the guise of WOE.

2 See Schachtman, “Desultory Thoughts on Milward v. Acuity Specialty Products,” (Oct. 2015).

3 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 146 (2d ed. 2016) (citing and selectively quoting from Schachtman, “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (May 1, 2012)).

4 See Charles Menzie, Miranda Hope Henning, Jerome Cura, Kenneth Finkelstein, Jack Gentile, James Maughan, David Mitchell, Stephen Petron, Bonnie Potocki, Susan Svirsky & Patti Tyler, “A weight-of-evidence approach for evaluating ecological risks; report of the Massachusetts Weight-of-Evidence Work Group,” 2 Human Ecological Risk Assessment 277, 279 (1996) (“although the term ‘weight of evidence’ is used frequently in ecological risk assessment, there is no consensus on its definition or how it should be applied”); Sheldon Krimsky, “The weight of scientific evidence in policy and law,” 95 Am. J. Pub. Health S129 (2005) (“However, the term [WOE] is applied quite liberally in the regulatory literature, the methodology behind it is rarely explicated.”); V. H. Dale, G.R. Biddinger, M.C. Newman, J.T. Oris, G.W. Suter II, T. Thompson, et al., “Enhancing the ecological risk assessment process,” 4 Integrated Envt’l Assess. Management 306 (2008) (“An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence.”);  Douglas L. Weed, “Weight of Evidence: A Review of Concept and Methods,” 25 Risk Analysis 1545 (2005) (noting the “lack of definition of the term weight of evidence, multiple uses of the term and a lack of consensus about its meaning, and the many different kinds of weights, both qualitative and quantitative which can be used in risk assessment”); R.G. Stahl Jr., “Issues addressed and unaddressed in EPA’s ecological risk guidelines,” 17 Risk Policy Report 35 (1998) (noting that U.S. Environmental Protection Agency’s guidelines for ecological weight-of-evidence approaches to risk assessment fail to provide guidance); Glenn W. Suter, Susan M. Cormier, “Why and how to combine evidence in environmental assessments:  Weighing evidence and building cases,” 409 Sci. Total Env’t 1406, 1406 (2011) (noting arbitrariness and subjectivity of WOE “methodology”).

5 See Igor Linkov, Drew Loney, Susan Cormier, F. Kyle Satterstrom, and Todd Bridges, “Weight-of-evidence evaluation in environmental assessment: review of qualitative and quantitative approaches,” 407 Sci. Total Env’t 5199, 5203 (2009).

6 See, e.g., People v. Collier, 146 A.D.3d 1146, 1147-48, 2017 NY Slip Op 00342 (N.Y. App. Div. 3d Dep’t, Jan. 19, 2017) (rejecting appeal based upon defendant’s claim that conviction was against “weight of the evidence”); Venson v. Altamirano, 749 F.3d 641, 656 (7th Cir. 2014) (noting “new trial is appropriate if the jury’s verdict is against the manifest weight of the evidence”).

7 David L. Faigman, Christopher Slobogin & John Monahan, “Gatekeeping Science: Using the Structure of Scientific Research to Distinguish Between Admissibility and Weight in Expert Testimony,” 110 Northwestern L. Rev. 859, 865 (2016) (“An expert economist in an employment discrimination case who admittedly fails to control for a key variable such as seniority or wage structure in a regression analysis has committed a general error that should lead to exclusion by a judge… .”).

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Weight of the Evidence in Science and in Law

Slemp Trial Part 5 – Daniel W. Cramer

July 24th, 2017

The case of talc and ovarian cancer is a difficult and close case on general causation. Although I do not believe that the plaintiffs have made their case, their causal claims do not have the usual earmarks of “junk science,” so readily visible in many other litigations, such as the Zoloft birth defects cases.

Dr. Daniel Cramer is a physician and an epidemiology. He holds the title of professor of epidemiology at the Harvard University Chan School Of Public Health, as well as a professor of obstetrics, gynecology, and reproductive biology, at the Harvard Medical School. The plaintiffs called Cramer to testify on causation issues.

Cramer could have been purely duplicative as a witness, but he was used primarily on specific causation with a big boost on general causation because of his many publications on talc and ovarian cancer (a subject generally missing from Graham Colditz’s C.V.). The planned testimony for Cramer was to try to present the causal attribution of Slemp’s tumor to talc, with the understanding that since specific implied general causation, the plaintiff would obtain corroborating testimony on general causation as well.

With respect to Slemp’s known risk factors, such as her massive obesity and heavy smoking history, Cramer attempted to quantify her ex ante risks based upon her medical chart and from using risk ratios from available epidemiologic studies. Predictably, Cramer tried to diminish these ex ante risks by a highly selective reading of Slemp’s charts, but he ably deflected cross-examination criticisms by characterizing questions as quibbles and volunteering that he was not trying to ascribe plaintiff’s ovarian cancer exclusively to talc. Similarly, Cramer attempted to present the highest ex ante risk ratio for Slemp’s talc exposure, through his characterizations of her case as involving bilateral tumors and other features. Cramer tried to diminish the risk factor of obesity by claiming that fat women use talc more and that there was “synergy” between obesity and talc use. Cramer never described the evidentiary basis for this claimed synergy, or whether it was multiplicative or something less dramatic.

Interestingly, risk ratios from groups (epidemiologic studies) were used to describe her individual risks. The defense did not actively challenge this procedure. The premise of Cramer’s approach was that if an individual patient had a previous exposure or lifestyle variable that has been causally associated with ovarian cancer, then those exposures and lifestyle variables all participating in actually causing the patient’s cancer. As noted in the summary of Graham Colditz’s testimony, this assumption by Cramer is disputed. Cramer never attempted to justify the assumption by reference to any body of scientific evidence, or text. For Mrs. Slemp, Cramer opined that talc (as well as obesity and smoking) caused her serous borderline ovarian tumors. This conclusion was driven by his assumption that if Slemp had an exposure to a known cause of ovarian cancer, then it must have played a “substantial” role in causing the cancer.

Cross-Examination

The defense vigorously challenged Cramer for having failed to discuss causation in his publications. Most of these publications were epidemiologic studies, which did not necessarily provide an opportunity for full-ranging discussions of causal conclusions. Cramer effectively parried by noting that causation is not established by a single study, and single-study reports were not an appropriate vehicle for a full review and analysis of causation. As for his reviews and opinion pieces, Cramer defended his failure to state a clear causal conclusion on grounds that he had urged warning labels for personal talc products, and that a causal conclusion was not needed to justify such a warning because even a potential risk of ovarian cancer outweighed the negligible benefit of using talc in personal hygiene.

The defense plowed on with its claim that many studies lacked statistical significance, but Cramer generally lost defense counsel in technical details. For Cramer’s estimation of Slemp’s ex ante risk ratio from talc exposure, the defense challenged Cramer’s use of a one-tailed test of significance1. Cramer offered a half-hearted defense of a one-sided test in this context, and used the questions as an opportunity to repeat how low the p-value was with respect to the general association between talc and ovarian cancer. Cramer muddied the water by claiming that this calculation was superseded by further refinement of his estimate, which took into account the bilaterality of Slemp’s tumors, which obviated his one-sided confidence interval calculation. Although the details were not entirely forthcoming, the jury would not likely have seen this exchange as anything other than a quibble. The defense’s claim that Cramer had violated the “rules of epidemiology” never got off the ground, and given that the defense never presented an epidemiologist, the claim of counsel never was grounded in actual evidence.

Counterfactual Causation

The most important cross-examination of Dr. Cramer came from both J & J’s and Imerys’ counsel on the issue of counterfactual causation. Defense counsel asked Cramer, in several different ways, whether Ms. Slemp would have avoided having ovarian cancer if she had not used talc. Cramer stridently and belligerently refused to answer the question. The trial judge showed no interest in obtaining an answer to these questions. In the last effort to obtain a response from Cramer on “but for” causation, Cramer simply refused:

“I am not going to opine on the topic because it is not the task I was charged with.”

In other words, plaintiffs’ counsel and Cramer had discussed his inability to answer the counterfactual question, and decided it was simply better not respond to the question altogether. Since Mr. Smith, plaintiffs’ counsel, did not “task” him with counterfactual causation, Cramer was not going to answer it. Cramer’s intransigence was remarkable because the counterfactual question is an important component to causal inference in epidemiologic science. See, e.g., Michael Höfler, “Causal inference based on counterfactuals,” 5 BMC Med. Research Methodology 28 (2005).

In law, as in science, the counterfactual questions put to Cramer, are essential. Conduct or a product cannot be a legal cause of harm unless that cause alone, or acting in concert with other causes, was enough to result in the injury. Although legal treatises speak of “substantial factor,” the American Law Institute (ALI) defined that phrase (outside the context of overdetermined effects) negatively to make clear that “the actor’s negligent conduct is not a substantial factor in bringing about harm to another if the harm would have been sustained even if the actor had not been negligent.” Restatement (Second) of Torts § 432 (1965).

Given the mischief generated by some courts and commentators2 with respect to “substantial factor,” the ALI abandoned the phrase altogether in its most recent Restatement of the law of torts. In the current Restatement, the ALI has emphasized that the imposition of liability require that the harm claimed is one that would not have occurred in the absence of (“but for”) the defendant’s negligent conduct. Restatement (Third) of Torts: Physical and Emotional Harm § 26 cmt. J (2010); see also June v. Union Carbide Corp., 577 F.3d 1234, 1244 (10th Cir. 2009) (no material difference between Second and Third Restatements; holding that ‘‘a defendant cannot be liable to the plaintiff unless its conduct is either (a) a but-for cause of the plaintiff’s injury or (b) a necessary component of a causal set that (probably) would have caused the injury in the absence of other causes.’’).

Dr. Cramer’s refusal to answer the key counterfactual question about talc and Ms. Slemp’s ovarian cancer points to a lawlessness, both scientific and legal, in the proceedings in St. Louis, Missouri.

1 See “FAQ: What are the differences between one-tailed and two-tailed tests?” Institute for Digital Research and Education.

2 See David A. Fischer, “Insufficient Causes,” 94 Kent. L. J. 277, 277 (2005-06) (criticizing judicial obtuseness in misinterpreting the earlier Restatement’s use of “substantial factor”).

Posted in Causation, Risk and Risk Factor | Comments Off on Slemp Trial Part 5 – Daniel W. Cramer

David Rosner’s Document Repository

July 23rd, 2017

David Rosner and Gerald Markowitz are leftist labor and social historians in Columbia University and City University of New York, respectively. Both are frequently disclosed by plaintiffs’ counsel as expert witnesses on historical issues, and both often testify at asbestos and other personal injury trials1. Markowitz has been excluded in at least one reliability challenge2.

The two historians, who appear so often together on plaintiffs’ designations that they are sometime referred to as a unified persona, Rosnowitz, have create a website, “Project Toxicdocs,” supposedly in an alpha version3.

The Toxic Docs website does not identify Rosner and Markowitz by name as authors or sponsors, but the website’s content and goals bear their indelible stamp, as well as the concordance of their institutional affiliations of Columbia and CUNY. The website promises “[b]lazingly fast” searches and access to previously confidential, classified industry documents on “industrial poisons”:

“This dataset and website contain millions of pages of previously secret documents about toxic substances. They include secret internal memoranda, emails, slides, board minutes, unpublished scientific studies, and expert witness reports — among other kinds of documents — that emerged in recent toxic tort litigation.

Over the next couple years, we’ll be constantly adding material from lawsuits involving lead, asbestos, silica, and PCBs, among other dangerous substances. Innovations in parallel and cloud computing have made conversion of these documents into machine-readable, searchable text a far faster process than would have been the case just a decade ago.”

Similar efforts have been put into place for documents collected in tobacco and other litigations4. David Egilman, another regular testifier for the Lawsuit Industry once maintained a website with a large library of documents he relied upon for his ethics and state-of-the-art opinion testimony in various litigations.

A trial run through the “dataset” for the search term “silicosis” turned up 44 documents, most of which had nothing to do with silica or silicosis, and many of which were duplicates. Remarkably, there were no documents from government or labor unions.

We are sure that these historian expert witnesses will improve their efforts to be comprehensive and balanced, with practice.

1 See, e.g., Garcia v. Lone Star Indus., Case No. D-149, 527, 1997 WL 34904089 (Dist. Ct. Tex., Jefferson Cty., 1997) (identifying Rosner and Markowitz as testifying expert witnesses for plaintiff); City of Milwaukee v NL Industries, Inc., Circuit Ct., Milwaukee Cty., Wisc., 2007 WL 4676349 (Jan. 16, 2007) (referencing litigation report of Rosner and Markowitz); Gibson v. American Cyanamid Co., 719 F. Supp. 2d 1031, 1048 (E.D. Wis. 2010) (noting Rosner and Markowitz’s declaration for plaintiffs); Rhode Island v. Lead Industries Ass’n, C.A. No. PC 99-5226, Rhode Island Superior Court, Providence (Feb. 26, 2007) (discussing Rosner and Markowitz’s testimony on post-verdict motions); Altria Group, Inc. v. Good, No. 07-562, U.S. Sup. Ct., Amicus Brief of Allan M. Brandt, Robert N. Proctor, David M. Burns, Jonathan M. Samet, and David Rosner (June 18, 2008) (all amici except Rosner disclosed their litigation activities); Burton v. American Cyanamid Co., 775 F. Supp. 2d 1093 (E.D. Wis. 2011) (noting Rosner and Markowitz’s testimony in lead pigment case); California v. Atlantic Richfield Co., Santa Clara Super. Ct., Calif., No. 1-00-CV-788657, 2013 WL 4425657 (July 15, 2013) (noting Rosner’s testimony); Ostenrieder v. Rohm & Haas Co., Phila. Ct. C.P. Case No. 150602485, Motion in Limine to Exclude Testimony of Gerald Markowitz and David Rosner (filed by Rohm & Haas Co., subsidiary of Dow Chemical Co., June 18, 2015); Dumas v. ABB Group, Inc., civ. action no. 13-229-SLR-SRF (D. Del. Sept. 30, 2015) (referencing Rosner’s report for plaintiffs); Assenzio v. A.O. Smith Water Prods. Co., docket nos. 190008/12, 190026/12, 190200/12, 190183/12, 190184/12, NY Sup. Ct., NY Cty. (Feb. 5, 2015) (noting that Rosner testified for plaintiffs); Noll v American Biltrite, Inc., 188 Wash. App. 572, 355 P.3d 279 (Wash. Ct. App. June 29, 2015), aff’d, 355 P.3d 279 (Wash. 2015) (deposition of Gerald Markowitz given on behalf of plaintiff); Schwartz v. Honeywell Internat’l, Inc., 66 N.E.3d 118 (Ohio Ct. App. 2016) (same), app. granted, 148 Ohio St. 3d 1442, 72 N.E.3d 656 (2017); Clair v. Monsanto Co., 412 S.W.3d 295 (Mo. App. 2013) (noting Rosner as plaintiff’s expert witness); New v. Borg-Warner Corp., No. 13-cv-00675, 2015 WL 5166946 (W.D. Mo., Sept. 3, 2015) (identifying Rosner and Markowitz as plaintiff’s expert witnesses); Begin v. Air & Liquid Corp., Case No. 3:15-cv-830-SMY-DGW (S.D. Ill. May 10, 2016) (striking designation of plaintiff’s expert witness David Rosner as untimely in asbestos case); Rost v. Ford Motor Co., 151 A.3d 1032 (Pa. 2016) (noting Rosner and Markowitz as amici authors; no disclosure of litigation income); Dominick v. A.O. Smith Water Products, CA2014-000232, NY Sup. Ct., Oneida Cty., Notes of Testimony of David Rosner, Mar. 18, 2017 (Press Release from Plaintiffs’ law firm).

2 Quester v. B.F. Goodrich Co., Cuyahoga Cty., Ohio, C.P. Case No. 30-509539 (Jan. 12, 2008) (excluding Markowitz’s testimony as impermissible attempt to introduce expert witness opinion on defendants’ intent and motive).

3 Presumably an alpha version is one that has not made it to beta.

Posted in Historian Testimony, State of the Art | Comments Off on David Rosner’s Document Repository

Slemp Trial Part 4 – Graham Colditz

July 22nd, 2017

The Witness

Somehow, in opposition to two epidemiologists presented by the plaintiff in Slemp, the defense managed to call none. The first of the plaintiffs’ two epidemiology expert witnesses was Graham A. Colditz, a physician with doctoral level training in epidemiology. For many years, Colditz was a professor at the Harvard School of Public Health. Colditz left Harvard to become the Niess-Gain Professor at Washington University St. Louis School of Medicine, where he is also the Associate Director for Prevention and Control at the Alvin J. Siteman Cancer Center.

Colditz is a senior epidemiologist, with many book and article publications to his credit. Although he has not published a causal analysis of ovarian cancer and talc, Colditz was an investigator on the well-known Nurses’ Health Study. One of Colditz’s publications on the Nurses’ cohort featured an analysis of talc use and ovarian cancer outcomes.

Although he is not a frequent testifying expert witness, Colditz is no stranger to the courtroom. He was a regular protagonist in the estrogen-progestin hormone replacement therapy (HRT) litigation, which principally involves claims of female breast cancer. Colditz has a charming Australian accent, with a voice tremor that makes him sound older than 63, and perhaps even more distinguished. He charges $1,500 per hour for his testimonial efforts, but is quick to point out that he has given thousands to charity. At his hourly rate, we can be sure he needs tax deductions of some kind.

In discussing his own qualifications, Colditz was low-key and modest except for what seemed like a strange claim that his HRT litigation work for plaintiffs led the FDA to require a boxed warning of breast cancer risk on the package insert for HRT medications. This claim is certainly false, and an extreme instance of post hoc ergo propter hoc. Colditz gilded the lilly by claiming that he does not get involved unless he believes that general causation exists between the exposure or medication and the disease claimed. Since he has only been a plaintiffs’ expert witness, this self-serving claim is quite circular.

The Examinations

The direct and cross-examinations of Dr. Colditz were long and tedious. Most lawyers are reluctant to have an epidemiologists testify at all, and try to limit the length of their examinations, when they must present epidemiologic testimony. Indeed, the defense in Slemp may have opted to present a clinician based upon the prejudice against epidemiologists testifying about quantitative data and analysis. In any event, Colditz’s direct examination went not hours, but days, as did the defense’s cross-examination.

The tedium of the direct examination was exacerbated by the shameless use of leading, loaded, and argumentative questions by plaintiff’s counsel, Allen Smith. A linguistic analysis might well show that Smith spoke 25 to 30 words for every one word spoken by Colditz on direct examination. Even aside from the niceties of courtroom procedure, the direct examination was lacking in aesthetic qualities. Still, it is hard to argue with a $110 million verdict, which cries out for explanation.

There were virtually no objections to Smith’s testifying in lieu of Colditz, with Colditz reduced to just “yes.” Sometimes, Colditz waxed loquacious, and answered, “yes, sir.” From judicial responses to other objections, however, it was clear that the trial court would have provided little control of the leading and argumentative questions.

Smith’s examination also took Colditz beyond the scope of his epidemiologic expertise in to ethics, social policy, and legal requirements of warnings, again without judicial management or control. We learned, over objection, from Colditz of all witnesses that the determination of causation has nothing to do with whether a warning should be given.

The Subject Matter

Colditz was clearly familiar with the subject matter, and allowed Smith to testify for him on a fairly simplistic level. The testimony was a natural outgrowth of his professional interests, and Colditz must have appeared to have been a credible expert witness, especially in a St. Louis courtroom, given that he was in a leadership role at the leading cancer center in that city.

With Smith’s lead, Colditz broached technical issues of bias evaluation, meta-analysis and pooling, which would never be addressed later by a defense expert witness at an equal level of expertise, sophistication, and credibility. Colditz offered criticisms of the Gonzalez (Sister Study) and the latency built into the observation period of that cohort, and he introduced the concept of Berkson bias in some of the case-control studies. Neither of these particular criticisms was rebutted in the defense case, again raising the question whether the defense expert witness, Dr. Huh, a clinician specializing in gynecologic oncology, was an appropriate foil for the line up of plaintiffs’ expert witness. Dr. Colditz was able to talk authoritatively (and in some cases misleadingly) about issues, which Dr. Huh could not contradict effectively, even if he were to have tried.

Colditz characterized his involvement in the talc cases as starting with his conducting a systematic review, undertaken for litigation, but still systematic. As a professor of epidemiology, Colditz should know what a systematic review is, although he never fully described the process on either direct or cross-examinations. No protocol for the systematic review was adduced into evidence. Sadly, the defense expert witness, Dr. Huh, never stated that he had done a systematic review; nor did he offer any criticisms of Dr. Colditz’s systematic review. Indeed, Huh admitted that he had not read Colditz’s testimony. In general, observing Colditz’s testimony after having watched Dr. Huh testify shouted MISMATCH.

The Issues

Statistical Significance

The beginning point of a case such as Slemp, involving a claim that talc causes ovarian cancer, and that it caused her ovarian cancer, is whether there is supporting epidemiology for the claim. As Sir Austin Bradford Hill put it over 50 years ago:

“Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965). Colditz, and plaintiff’s counsel, did not run away from the challenge; they embraced statistical significance and presented an argument for why the association was “clear-cut” (not created by bias or confounding).

In one of his lengthy, leading questions, plaintiffs’ counsel attempted to suggest that statistical significance, or a confidence interval that excluded a risk ratio of 1.0, excluded bias as well as chance. Colditz to his credit broke from the straight jacket of “yes, sirs,” and disagreed as to bias. Smith, perhaps chastised then took a chance and asked an open-ended question about what a confidence interval was. With the bit in his mouth, Colditz managed to describe the observed confidence interval incorrectly as providing the range within which the point estimate would fall 95% of the time if the same study were repeated many times! There is a distribution of 95% confidence intervals, which cover the true parameter 95% of the time, assuming a correct statistical model, random sampling, and no bias or confounding. For the observed confidence interval, the true value is either included or not. Perhaps Colditz was thinking of a prediction interval, but Smith had asked for a definition of a confidence interval, and the jury got non-sense.

Dose Response

Colditz parsed the remaining Bradford Hill factors, and opined that exposure-gradient or dose response was good to have but not necessary to support a causal conclusion. Colditz opined, with respect to whether the statistical assessment of a putative dose-response should include non-exposed women, that the non-exposed women should be excluded. This was one of the few technical issues that Dr. Huh engaged with, in the defense case, but Dr. Colditz was not confronted with any textbooks or writings that cast doubt on his preference for excluding non-users.

Plausibility

Plaintiff’s counsel spent a great deal of time, mostly reading lengthy passages of articles on this or that plausible mechanism for talc’s causing human ovarian cancer, only to have Colditz, with little or no demonstrated expertise in biological mechanism, say “yes.” Some articles discussed that talc use was a modifiable risk and that avoiding perineal talc use “may” reduce ovarian cancer risk. Smith would read (accurately) and then ask Colditz whether he agreed that avoiding talc use would reduce ovarian cancer in women. Colditz himself catches and corrects Smith, some times, but not others.

Smith read from an article that invokes a claim that asbestos (with definition as to what mineral) causes ovarian cancer. Colditz agreed. Smith testified that talc has asbestos in it, and Colditz agreed. Smith read from an article that stated vaguely that talc is chemically similar to asbestos and thus this creates plausibility for a causal connection between talc and cancer. Colditz agreed, without any suggestion that he understands whether or not talc is morphologically similar to asbestos. It seems unlikely that Colditz had any real expertise to offer here, but Smith could not resist touching all bases with Colditz; and the defense did not object or follow up on these excesses.

Smith and Colditz, well mostly Smith, testified that tubal ligation reduces the otherwise observed increased risk of ovarian cancer from talc use. Smith here entrusts Colditz with providing the common-sense explanation. There is no meaningful cross-examination on this “jury friendly” point.

Consistency

Colditz testifed that the studies, both case-control and cohort studies, were consistent in showing an increased risk of ovarian cancer in association with talc use. Indeed, the studies are mostly consistent; the issue is whether they are consistently biased or consistently showing the true population risk. The defense chose to confront Colditz with the lack of statistical significance in some studies (with elevated risk ratios) as though these studies were inconsistent with the studies that found similar risk ratios, with p-values less than 5%. This confrontation did not go well for the defense, either on cross-examination of Colditz, or on direct examination of Dr. Huh. Colditz backed up his opinion on consistency with the available meta-analyses, which find very low p-values for the summary estimate of risk ratio for talc use and ovarian cancer.

Unlike the Zoloft case1, in which consistency was generated across different end points by cherry picking, the consistency in the talc case was evidenced by a consistent elevation of risk ratios for the same end point, across studies. When subgroups of ovarian cell or tumor types were examined, statistical significance was sometimes lost, but the direction of the risk ratio above one was maintained. Meta-analyses generated summary point estimates with very low p-values.

The Gold Standard

Colditz further gilded the consistency lilly by claiming that the Terry study2, a pooled analysis of available case-control studies, was the “gold standard” in this area of observational epidemiology. Smith and Colditz presented at some length as to how the Cochrane Collaboration has labeled combined “individual patient data” (IPD) analyses as the gold standard. Colditz skimmed over the Cochrane’s endorsement of IPD analyses as having been made in the context of systematic reviews, involving primarily randomized clinical trials, for which IPD analyses allow time-to-event measurements, which can substantially modify observed risk ratios, and even reverse their direction. The case-control studies in the Terry pooled analysis did not have anything like the kind of prospectively collected individual patient data, which would warrant holding the Terry paper up as a “gold standard,” and Terry and her co-authors never made such a claim for their analysis. Colditz’s claim about the Terry study cried out for strong rebuttal, which never came.

The defense should have known that this hyperbolic testimony would be forthcoming, but they seemed not to have a rebuttal planned, other than dismissing case-controls studies generally as smaller than cohort studies. Rather than “getting into the weeds” about the merits of pooled analyses of observational studies, as opposed to clinical trials, the defense continued with its bizarre stance that the cohort studies were better because larger, while ignoring that they are smaller with respect to number of ovarian cancer cases and have less precision than the case-control studies. See “New Jersey Kemps Ovarian Cancer – Talc Cases” (Sept. 16, 2016). The defense also largely ignored Colditz’s testimony that exposure data collected in the available cohort studies was of limited value because lacking in details about frequency and intensity of use, and in some cases, collected on only one occasion.

Specific Causation

Colditz disclaimed the ability or intention to offer a specific causation opinion about Ms. Slemp’s ovarian cancer. Nonetheless, Colditz volunteered that “cancer is multifactorial,” which says very little because it says so much. In plaintiffs’ counsel’s hands, this characterization became a smokescreen to indict every possible present risk factor as playing a part in the actual causation of a particular case, such as Ms. Slemp’s case. No matter that the plaintiff was massively obese, and a smoker; every risk factor present must be, by fiat, in the “causal pie.”

But this would seem not to be Colditz’s own opinion. Graham Colditz has elsewhere asserted that an increased risk of disease cannot be translated into the “but-for” standard of causation3:

“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.”

Just because a risk factor (assuming it is real and causal) is present does not put in the causal set.

Cross-Examination

The direct examination of Graham Colditz included scurrilous attacks on J & J’s lobbying, paying FDA user fees, and other corporate conduct, based upon documents of which Colditz had not personal knowledge. Colditz was reduced to nothing more than a backboard, off which plaintiff’s counsel could make his shots. On cross, the defense carefully dissected this direct examination and obtained disavowals from Colditz that he had suggested any untoward conduct by J & J. The jury could have been spared their valuable time by a trial judge who did not allow the scurrilous, collateral attacks in the first place.

The defense also tried to diminish Dr. Colditz’s testimony as an opinion coming from a non-physician. The problem, however, was that Colditz is a physician, who understands the biological issues, even if he is not a pathologist, toxicologist, or oncologist. Colditz did not offer opinions about Slemp’s medical treatment, and there was nothing in this line of cross-examination that lessened the impact of Colditz’s general causation testimony.

Generally, the cross-examination did not hurt Dr. Colditz’s strongly stated opinion that talc causes ovarian cancer. The defense (and plaintiff’s counsel before them) spent an inordinate amount of time on why Dr. Colditz has not updated his website to state publicly that talc causes ovarian cancer. Colditz blamed the “IT” guys, a rather disingenuous excuse. His explanation on direct, and on cross, as to why he could not post his opinion on his public-service website was so convoluted, however, that there was no clear admission or inference of dereliction. Colditz was permitted to bill his opinion, never posted to his institution’s website, as a “consensus opinion,” endorsed by several researchers, based upon hearsay emails and oral conversations.

1 See In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of dodgy opinion, which involved changing subgroup end points across studies of maternal sertraline use and infant cardiac birth defects ).

2 Kathryn L. Terry, et al., “Genital powder use and risk of ovarian cancer: a pooled analysis of 8,525 cases and 9,859 controls,” 6 Cancer Prev. & Research 811 (2013).

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

Posted in Causation, Meta-analysis, Scientific Evidence | Comments Off on Slemp Trial Part 4 – Graham Colditz

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