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Love that Hormesis to Pieces

October 12th, 2017

Hermann Joseph Muller was an American biologist who won the Nobel Prize in 1946, for Physiology or Medicine, for his work on fruit fly genetics. In his Nobel Prize speech, Muller opined that there was no threshold dose for radiation-induced mutagenesis. Muller’s speech became a locus of support for what later became known as the “linear no threshold” (LNT) theory of carcinogenesis.

Muller was an ardent eugenicist, although of the communist, not the Nazi, variety.1 After 1932, Muller’s political enthusiasms took him to the Soviet Union, where Muller blithely ignored murderous purges and famines, in order to pursue his scientific interests for the greater glory of the Proletarian Dicatorship.2 Muller became enamored of a People’s eugenics program. On May 5, 1936, Muller wrote to “Comrade Stalin,” “[a]s a scientist with confidence in the ultimate Bolshevik triumph throughout all possible spheres of human endeavor,” to offer the brutal dictator “a matter of vital importance arising out of my own science – biology, and, in particular, genetics.”3

Comrade Stalin was underwhelmed by Muller’s offer, and threw his lot in with Trofim Lysenko. A disheartened Muller managed to extricate himself from the Soviet fatherland, but not so much from its politics and ideology4. After returning to the United States, he remained active in noteworthy liberal and progressive political activities. Alas, he also seemed to remain a Communist fellow traveler, who found time to criticize only the Soviet embrace of Lysenkoism and its treatment of dissident geneticists (such as himself), with nary a mention of Ukrainian farmers, political dissidents, or the Soviet subjugation of eastern and central Europe.5

In retreating from his Soviet homeland, Muller did not abandon his eugenic vision for the United States. In 1966, Muller urged the immediate establishment of sperm banks for “outstanding men,” such as himself, to make deposits for use in artificial insemination6

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Back in a 1976, George E. P. Box outlined his notion that all models are wrong even though some may be useful7. The LNT model, as devised by Muller and embraced by regulatory agencies around the world, has long since lost its usefulness in describing and predicting biological phenomena. LNT is scientific in the sense that it is testable and falsifiable; LNT has been tested and falsified. Muller’s model ignores relevant biological processes of tolerance, defense, and adaptation8. 

The resilience of the LNT seems to be due to the advocacy of scientists and regulators who find the simplistic LNT model to be useful in ensuring regulation of, and compensation for, low-dose exposures. The perpetual machine litigation created with asbestos comes to mind. Other “political scientists” come to mind as well. Theory and data are often in tension, but at the end of any debate, scientists are obligated to “save the phenomena.” Fortunately, there are scientists who are challenging the dominance of the LNT model, and who are pointing out where the model just does not fit the data9.

In the United States, Muller’s theories were subjected to some real-world tests. In May 1947, Muller warned of the possible evolution of evil monsters born to Japanese survivors of Hiroshima and Nagasaki, on the basis of his assessment that the atomic bombs had produced countless mutants. Later that year, however, Austin Brues, director of the Argonne National Laboraty, published his findings of children born to Hiroshima survivors, who had no more mutations than baseline expectation10.

Notwithstanding the shaky evidentiary foundations of Muller’s views, his prestige as a Nobel laureate encouraged the adoption and promotion of the LNT model by the National Academy of Sciences’ Biological Effects of Atomic Radiation (BEAR) I Genetics Panel. Edward J. Calabrese, a prominent toxicologist in the Department of Environmental Health Sciences, School of Public Health and Health Sciences, University of Massachusetts, has taken pains, on multiple occasions, to trace the genealogy of this error. His most recent, and most succinct effort, is a worthwhile read for policy makers, judges, and lawyers who want to understand the historical dimension of the LNT model11. A fuller bibliography is set out as an appendix to this post.

 

1 Herman Joseph Muller, Out of the Night – a Biologist’s View of the Future (1935).

2 Elof Alex Carlson, Genes, Radiation, and Society: The Life and Work of H.J. Muller (1981).

3 John Glad, “Hermann J. Muller’s 1936 Letter to Stalin,” 43 The Mankind Quarterly 305 (2003).

4 See, e.g., Peter J. Kuznick, Beyond the Laboratory: Scientists as Political Activists in 1930’s America 121 (1987).

5 Hermann J. Muller, “The Crushing of Genetics in the USSR,” 4 Bull. Atomic Scientists 369 (1948). Some have attempted to protect Muller’s conduct by arguing that he testified before the House Un-American Activities Committee, where he was critical of Soviet restrictions on secondary education. See Thomas D. Clark, Indiana University: Midwestern Pioneer 310 (1977). Given Muller’s privileged position to observe first hand what had happened to Ukrainian farmers and others, this coming forward on Soviet education seems feeble indeed.

6 See “Sperm Banks Urged by Nobel Laureate,” N.Y. Times (Sept. 13, 1966).

7 See George E. P. Box, “Science and Statistics,” 71 J. Am. Stat. Ass’ 791 (1976); George E. P. Box, “Robustness in the strategy of scientific model building,” in R. L. Launer & G.N. Wilkinson, Robustness in Statistics at 201–236 (1979); George E. P. Box & Norman Draper, Empirical Model-Building and Response Surfaces at 74 (1987) (“Remember that all models are wrong; the practical question is how wrong do they have to be to not be useful.”).

8 See, e.g., Adam D. Thomas, Gareth J. S. Jenkins, Bernd Kaina, Owen G. Bodger, Karl-Heinz Tomaszowski, Paul D. Lewis, Shareen H. Doak, and George E. Johnson, “Influence of DNA Repair on Nonlinear Dose-Responses for Mutation,” 132 Toxicol. Sci. 87 (2013).

9 See, e.g., Bill Sacks & Jeffry A. Siegel, “Preserving the Anti-Scientific Linear No-Threshold Myth: Authority, Agnosticism, Transparency, and the Standard of Care,” 15 Dose-Response: An Internat’l J. 1 (2017); Charles L. Sanders, Radiobiology and Radiation Hormesis: New Evidence and its Implications for Medicine and Society (2017).

10 William Widder, “Probe Effects of Atom Bomb: Study Betrays No Evidence of Mutations,” Greensburg Daily News (Greensburg, Indiana) at 22 (Mon, Nov. 24, 1947).

11 Edward J.Calabrese, “The Mistaken Birth and Adoption of the LNT: An Abridged Version,” 15 Dose-Response: An Internat’l J. (2017).

Appendix

Edward J.Calabrese & Linda A. Baldwin, “Chemical hormesis: its historical foundations as a biological hypothesis,” 19 Human & Experimental Toxicol. 2 (2000)

Edward J. Calabrese and Linda A. Baldwin, “Hormesis: U-shaped dose responses and their centrality in toxicology,” 22 Trends Pharmacol. Sci. 285 (2001)

Edward J.Calabrese, “Hormesis: a revolution in toxicology, risk assessment and medicine: Re-framing the dose–response relationship,” 5 Eur. Mol. Bio. Org. Reports S37 (2004)

Edward J. Calabrese & Robyn Blain, “The occurrence of hormetic dose responses in the toxicological literature, the hormesis database: an overview,” 202 Toxicol. & Applied Pharmacol. 289 (2005);

Edward J. Calabrese, “Pain and U-shaped dose responses: occurrence, mechanisms and clinical Implications,” 38 Crit. Rev. Toxicol. 579 (2008)

Edward J. Calabrese, “Neuroscience and hormesis: overview and general findings,” 38 Crit. Rev. Toxicol. 249 (2008)

Edward J. Calabrese, “Linear No Threshold (LNT) – The New Homeopathy,” 31 Envt’l Toxicol. & Chem. 2723 (2012)

Edward J. Calabrese, “Muller’s Nobel Prize Lecture: When Ideology Prevailed over Science,” 126 Toxicol. Sci. 1 (2012)

Edward J. Calabrese, “How the U.S. National Academy of Sciences misled the world community on cancer risk assessment: new findings challenge historical foundations of the linear dose response, 87 Arch. Toxicol. 2063 (2013)

Edward J. Calabrese, “On the origins of the linear no-threshold (LNT) dogma by means of untruths, artful dodges and blind faith,” 142 Envt’l Research 432 (2015)

Edward J. Calabrese, “An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment,” 89 Arch. Toxicol. 647 (2015)

Edward J. Calabrese, “LNTgate: How scientific misconduct by the U.S. NAS led to governments adopting LNT for cancer risk assessment,” 148 Envt’l Research 535 148 (2016)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 1. The Russell-Muller debate,” 154 Envt’l Res. 435 (2017)

Edward J. Calabrese, “The threshold vs LNT showdown: Dose rate findings exposed flaws in the LNT model part 2. How a mistake led BEIR I to adopt LNT,” 154 Envt’l Res. 452 (2017)

Posted in Causation, Historian Testimony, Scientific Evidence | Comments Off on Love that Hormesis to Pieces

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).

Posted in Asbestos, Causation, Rule 702 | Comments Off on Seventh Circuit Franks ‘Every Exposure’ Theory for Extinction

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

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… .”).

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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”).

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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).

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Slemp Trial Part 3 – The Defense Expert Witness – Huh

July 9th, 2017

On June 19, 2017, the U.S. Supreme Court curtailed the predatory jurisdictional practices of the lawsuit industry in seeking out favorable trial courts with no meaningful connection to their claims. See Bristol-Myers Squib Co. v. Superior Court, No. 16-466, 582 U.S. ___ (June 19, 2017). The same day, the defendants in a pending talc cancer case in St. Louis filed a motion for a mistrial. Swann v. Johnson & Johnson, Case No. 1422-CC09326-01, Division 10, Circuit Court of St. Louis City, Missouri. Missouri law may protect St. Louis judges from having to get involved in gatekeeping scientific expert witness testimony, but when the Supreme Court speaks to the requirements of the federal constitution’s due process clause, even St. Louis judges must listen. Bristol-Myers held that the constitution limits the practice of suing defendants in jurisdictions unrelated to the asserted claims, and the St. Louis trial judge, Judge Rex Burlison, granted the requested mistrial in Swann. As a result, there will not be another test of plaintiffs’ claims that talc causes ovarian cancer, and the previous Slemp case will remain an important event to interpret.

The Sole Defense Expert Witness

Previous posts1 addressed some of the big picture issues as well as the opening statements in Slemp. This posts turns to the defense expert witness, Dr. Walter Huh, in an attempt to understand how and why the jury returned its egregious verdict. Juries can, of course, act out of sympathy, passion, or prejudice, but their verdicts are usually black boxes when it comes to discerning their motivations and analyses. A more interesting and fruitful exercise is to ask whether a reasonable jury could have reached the conclusion in the case. The value of this exercise is limited, however. A reasonable jury should have reasonable expertise in the subject matter, and in our civil litigation system, this premise is usually not satisfied.

Dr. Walter Huh, a gynecologic oncologist, was the only expert witness who testified for the defense. As the only defense witness, and as a clinician, Huh had a terrible burden. He had to meet and rebut testimony outside his fields of expertise, including pathology, toxicology, and most important, epidemiology. Huh was by all measures well-spoken, articulate, and well-qualified as a clinical gynecologic oncologist. Defense counsel and Huh, however, tried to make the case that Huh was qualified to speak to all issues in the case. The initial examination on qualifications was long and tedious, and seemed to overcompensate for the obvious gaps in Dr. Huh’s qualifications. In my view, the defense never presented much in the way of credible explanations about where Huh had obtained the training, experience, and expertise to weigh in on areas outside clinical medicine. Ultimately, the cross-examination is the crucial test of whether this strategy of one witness for all subjects can hold. The cross-examination of Dr. Huh, however, exposed the gaps in qualifications, and more important, Dr. Huh made substantive errors that were unnecessary and unhelpful to the defense of the case.

The defense pitched the notion that Dr. Huh somehow trumped all the expert witnesses called by plaintiff because Huh was the “only physician heard by the jury” in court. Somehow, I wonder whether the jury was so naïve. It seems like a poor strategic choice to hope that the biases of the jury in favor of the omniscience of physicians (over scientists) will carry the day.

There were, to be sure, some difficult clinical issues, on which Dr. Huh could address within his competence. Cancer causation itself is a multi-disciplinary science, but in the case of a disease, such as ovarian cancer, with a substantial base-rate in the general population and without any biomarker of a causal pathway between exposure and outcome, epidemiology will be a necessary tool. Huh was thus forced to “play” on the plaintiffs’ expert witnesses’ home court, much to his detriment.

General Causation

Don’t confuse causation with links, association, and risk factors

The defense strong point is that virtually no one, other than the plaintiffs’ expert witnesses themselves, and only in the context of litigation, has causally attributed ovarian cancer to talc exposure. There are, however, some ways that this point can be dulled in the rough and tumble of trial. Lawyers, like journalists, and even some imprecise scientists, use a variety of terms such as “risk,” “risk factor,” “increased risk,” and “link,” for something less than causation. Sometimes these terms are used deliberately to try to pass off something less than causation as causation; sometimes the speaker is confused; and sometimes the speaker is simply being imprecise. It seems incumbent upon the defense to explain the differences between and among these terms, and to stick with a consistent, appropriate terminology.

One instance in which Dr. Huh took his eye off the “causation ball,” arose when plaintiffs’ counsel showed him a study conclusion that talc use among African American women was statistically significantly associated with ovarian cancer. Huh answered, non-responsively, “I disagree with the concept that talc causes ovarian cancer.” The study, however, did not advance a causal conclusion and there was no reason to suggest to the jury that he disagreed with anything in the paper; rather it was the opportunity to repeat that association is not causation, and the article did not contradict anything he had said.

Similarly, Dr. Huh was confronted with several precautionary recommendations that women “may” benefit from avoiding talc. Remarkably, Huh simply disagreed, rather than making the obvious point that the recommendation was not stated as something that would in fact benefit women.

When witnesses answer long, involved questions, with a simple “yes,” then they may have made every implied proposition in the questions into facts in the case. In an exchange between plaintiff’s counsel and Huh, counsel asked whether a textbook listed talc as a risk factor.2 Huh struggled to disagree, which disagreement tended to impair his credibility, for disagreeing with a textbook he acknowledged using and relying upon. Disagreement, however, was not necessary; the text merely stated that “talc … may increase risk.” If “increased risk” had been defined and explained as something substantially below causation, then Huh could have answered simply “yes, but that quotation does not support a causal claim.”

At another point, plaintiffs’ counsel, realizing that none of the individual studies reached a causal conclusion, asked whether it would be improper for a single study to give such a conclusion. It was a good question, with a solid premise, but Dr. Huh missed the opportunity for explaining that the authors of all the various individual studies had not conducted systematic reviews that advanced the causal conclusion that plaintiffs would need. Certainly, the authors of individual studies were not prohibited from taking the next step to advance a causal conclusion in a separate paper with the appropriate analysis.

Bradford Hill’s Factors

Dr. Huh’s testimony provided the jury with some understanding of Sir Austin Bradford Hill’s nine factors, but Dr. Huh would have helped himself by acknowledging several important points. First, as Hill explained, the nine factors are invoked only after there is a clear-cut (valid) association beyond that which we care to attribute to chance. Second, establishing all nine factors is not necessary. Third, some of the nine factors are more important than others.

Study validity

In the epidemiology of talc and ovarian cancer, statistical power and significance are not the crucial issues; study validity is. It should have been the plaintiff’s burden to rule out bias, and confounding, as well as chance. Hours had passed in the defense examination of Dr. Huh before study validity was raised, and it was never comprehensively explained. Dr. Huh explained recall bias as a particular problem of case-control studies, which made up the bulk of evidence upon which plaintiffs’ expert witnesses relied. A more sophisticated witness on epidemiology might well have explained that the selection of controls can be a serious problem without obvious solutions in case-control studies.

On cross-examination, plaintiffs’ counsel, citing Kenneth Rothman, asked whether misclassification bias always yields a lower risk ratio. Dr. Huh resisted with “not necessarily,” but failed to dig in whether the conditions for rejecting plaintiffs’ generalization (such as polychotomous exposure classification) obtained in the relevant cohort studies. More importantly, Huh missed the opportunity to point out that the most recent, most sophisticated cohort study reported a risk ratio below 1.0, which on the plaintiffs’ theory about misclassification would have been even lower than 1.0 than reported in the published paper. Again, a qualified epidemiologist would not have failed to make these points.

Dr. Huh never read the testimony of one of the plaintiffs’ expert witnesses on epidemiology, Graham Colditz, and offered no specific rebuttal of Colditz’s opinions. With respect to the other of plaintiffs’ epidemiology expert witness, Dr. Cramer, Huh criticized him for engaging in post-hoc secondary analyses and asserted that Cramer’s meta-analysis could not be validated. Huh never attempted to validate the meta-analysis himself; nor did Huh offer his own meta-analysis or explain why a meta-analysis of seriously biased studies was unhelpful. These omissions substantially blunted Huh’s criticisms.

On the issue of study validity, Dr. Huh seem to intimate that cohort studies were necessarily better than case-control studies because of recall bias, but also because there are more women involved in the cohort studies than in the case-control studies. The latter point, although arithmetically correct, is epidemiologically bogus. There are often fewer ovarian cancer cases in the cohort study, especially if the cohort is not followed for a very long time. The true test comes in the statistical precision of the point estimate, relative risk or odds ratio, in the different type of study. The case-control studies often generate much more precise point estimates as seen from their narrower confidence intervals. Of course, the real issue is not precision here, but accuracy.  Still, Dr. Huh appeared to have endorsed the defense counsel misleading argument about study size, a consideration that will not help the defense when the contentions of the parties are heard in scientific fora.

Statistical Significance

Huh appeared at times to stake out a position that if a study does not have statistical significance, then we must accept the null hypothesis. I believe that most careful scientists would reject this position. Null studies simply fail to reject the null hypothesis.

Although there seems to be no end to fallacious reasoning by plaintiffs, there is a particular defense fallacy seen in some cases that turn on epidemiology. What if we had 10 studies that each found an elevated risk ratio of 1.5, with two-tailed 95 percent confidence intervals of 0.92 – 2.18, or so. Can the defense claim victory because no study is statistically significant? Huh seemed to suggest so, but this is clearly wrong. Of course, we might ask why no one conducted the 11th study, with sufficient power to detect a risk ratio of 1.5, at the desired level of significance. But parties go to trial with the evidence they have, not what they might want to have. On the above 10-study hypothetical, a meta-analysis might well be done (assuming the studies could be appropriately included), and the summary risk ratio for all studies would be 1.5, and highly statistically significant.

On the question of talc and ovarian cancer, there were several meta-analyses at issue, and so the role of statistical significance of individual studies was less relevant. The real issue was study validity. This issue was muddled by assertions that risk ratios such as 2.05 (95%, 0.94 – 4.47) were “chance findings.” Chance may not have been ruled out, but the defense can hardly assert that chance and chance alone produced the findings; otherwise, it will be sunk by the available meta-analyses.

Strength of Association

The risk ratios involved in most of the talc ovarian cancer studies are small, and that is obviously an important factor to consider in evaluating the studies for causal conclusions. Still, it is also obvious that sometimes real causal associations can be small in magnitude. Dr Huh could and should have conceded in direct that small associations can be causal, but explained that validity concerns about the studies that show small associations become critical. Examples would have helped, such as the body of observational epidemiology that suggested that estrogen replacement therapy in post-menopausal women provided cardiovascular benefit, only to be reversed by higher quality clinical trials. Similarly, observational studies suggested that lung cancer rates were reduced by Vitamin A intake, but again clinical trial data showed the opposite.

Consistency of Studies

Are studies that have statistically non-significant risk ratios above 1.0 inconsistent with studies that find statistically significant elevated risk ratios? At several points, Huh appears to say that such a group of studies is inconsistent, but that is not necessarily so. Huh’s assertion provoked a good bit of harmful cross-examination, in which he seemed to resist the notion that meta-analysis could help answer whether a group of studies is statistically consistent. Huh could have conceded the point readily but emphasized that a group of biased studies would give only a consistently biased estimate of association.

Authority

One of the cheapest tricks in the trial lawyers’ briefcase is the “learned treatise” exception to the rule against hearsay.”3 The lawyer sets up witnesses in deposition by obtaining their agreement that a particular author or text is “authoritative.” Then at trial, the lawyer confronts the witnesses with a snippet of text, which appears to disagree with the expert witnesses’ testimony. Under the rule, in federal and in some state courts, the jury may accept the snippet or sound bite as true, and also accept that the witnesses do not know what they are talking about when they disagree with the “authoritative” text.

The rule is problematic and should have been retired long ago. Since 1663, the Royal Society has sported the motto:  “Nullius in verba.”  Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the prestige of the speaker. And yet, we lawyers will try, and sometimes succeed, with this greasy kidstuff approach cross-examination. Indeed, when there is an opportunity to use it, we may even have an obligation to use so-called learned treatises to advance our clients’ cause.

In the Slemp trial, the plaintiff’s counsel apparently had gotten a concession from Dr. Huh that plaintiff’s expert witness on epidemiology, Dr. Daniel Cramer, was “credible and authoritative.” Plaintiff’s counsel then used Huh’s disagreement with Cramer’s testimony as well as his published papers to undermine Huh’s credibility.

This attack on Huh was a self-inflicted wound. The proper response to a request for a concession that someone or some publication is “authoritative,” is that this word really has no meaning in science. “Nullius in verba,” and all that. Sure, someone can be a respected research based upon past success, but past performance is no guarantee of future success. Look at Linus Pauling and Vitamin C. The truth of a conclusion rests on the data and the soundness of the inferences therefrom.

Collateral Attacks

The plaintiff’s lawyer in Slemp was particularly adept at another propaganda routine – attacking the witness on the stand for having cited another witness, whose credibility in turn was attacked by someone else, even if that someone else was a crackpot. Senator McCarthy (Joseph not Eugene) would have been proud of plaintiff’s lawyer’s use of the scurrilous attack on Paolo Boffetta for his views on EMF and cancer, as set out in Microwave News, a fringe publication that advances EMF-cancer claims. Now, the claim that non-ionizing radiation causes cancer has not met with much if any acceptance, and Boffetta’s criticisms of the claims are hardly unique or unsupported. Yet plaintiff’s counsel used this throw-away publication’s characterization of Boffetta as “the devil’s advocate,” to impugn Boffetta’s publications and opinions on EMF, as well as Huh’s opinions that relied upon some aspect of Boffetta’s work on talc. Not that “authority” counts, but Boffetta is the Associate Director for Population Sciences of the Tisch Cancer Institute and Chief of the Division of Cancer Prevention and Control of the Department of Oncological Sciences, at the Mt. Sinai School of Medicine in New York. He has published many epidemiologic studies, as well as a textbook on the epidemiology of cancer.4

The author from the Microwave News was never identified, but almost certainly lacks the training, experience, and expertise of Paolo Boffetta. The point, however, is that this cross-examination was extremely collateral, had nothing to do with Huh, or the issues in the Slemp case, and warranted an objection and admonition to plaintiff’s counsel for the scurrilous attack. An alert trial judge, who cared about substantial justice, might have shut down this frivolous, highly collateral attack, sua sponte. When Huh was confronted with the “devil’s advocate” characterization, he responded “OK,” seemingly affirming the premise of the question.

Specific Causation

Dr. Huh and the talc defendants took the position that epidemiology never informs assessment of individual causation. This opinion is hard to sustain. Elevated risk ratios reflect more individual cases than expected in a sample. Epidemiologic models are used to make individual predictions of risk for purposes of clinical monitoring and treatment. Population-based statistics are used to define range of normal function and to assess individuals as impaired or disabled, or not.

At one point in the cross-examination, plaintiffs’ counsel suggested the irrelevance of the size of relative risk by asking whether Dr. Huh would agree that a 20% increased risk was not small if you are someone who has gotten the disease. Huh answered “Well, if it is a real association.” This answer fails on several levels. First, it conflates “increased risk” and “real association” with causation. The point was for Huh to explain that an increased risk, if statistically significant, may be an association, but it is not necessary causal.

Second, and equally important, Huh missed the opportunity to explain that even if the 20% increased risk was real and causal, it would still mean that an individual patient’s ovarian cancer was most likely not caused by the exposure. See David H. Schwartz, “The Importance of Attributable Risk in Toxic Tort Litigation,” (July 5, 2017).

Conclusion

The defense strategy of eliciting all their scientific and medical testimony from a single witness was dangerous at best. As good a clinician as Dr. Huh appears to be, the defense strategy did not bode well for a good outcome when many of the scientific issues were outside of Dr. Huh’s expertise.

2 Jonathan S. Berek & Neville F. Hacker, Gynecologic Oncology at 231 (6th ed. 2014).

3 See “Trust-Me Rules of Evidence” (Oct. 18 2012).

4 See, e.g., Paolo Boffetta, Stefania Boccia, Carol La Vecchia, A Quick Guide to Cancer Epidemiology (2014).

Posted in Causation, Meta-analysis, statistical evidence | Comments Off on Slemp Trial Part 3 – The Defense Expert Witness – Huh

Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

July 9th, 2017

Litigation-related research has been the punching bag of self-appointed public health advocates for some time. Remarkably, and perhaps not surprising to readers of this blog, many of the most strident critics have deep ties to the lawsuit industry, and have served the plaintiffs’ bar loyally and zealously for many years.1,2,3,4 And many of these critics have ignored or feigned ignorance of the litigation provenance of much research that they hold dear, such as Irving Selikoff’s asbestos research undertaken for the asbestos workers’ union and its legal advocates. These critics’ campaign is an exquisite study in hypocrisy.

For some time, I have argued that the standards for conflict-of-interest disclosures should be applied symmetrically and comprehensively to include positional conflicts, public health and environmental advocacy, as well as litigation consulting or testifying for any party. Conflicts should be disclosed, but they should not become a facile excuse or false justification for dismissing research, regardless of the party that sponsored it.5 Scientific studies should be interpreted scientifically – that is carefully, thoroughly, and rigorously – regardless whether they are conducted and published by industry-sponsored, union-sponsored, or Lord help us, even lawyer-sponsored scientists.

Several years ago, a defense lawyer, Samuel Tarry, published a case series of industry-sponsored research or analysis, which grew out of litigation, but made substantial contributions to the scientific understanding of claimed health risks. See Samuel L. Tarry, Jr., “Can Litigation-Generated Science Promote Public Health?” 33 Am. J. Trial Advocacy 315 (2009). Tarry’s paper is a helpful corrective to the biased (and often conflicted) criticisms of industry-sponsored research and analysis by the lawsuit industry and its scientific allies and consultants. It an ocean of uninformative papers about “Daubert,” Tarry’s paper stands out and should be required reading for all lawyers who practice in the area of “health effects litigation.”

Tarry presented a brief summary of the litigation context for three publications that deserve to remembered and used as exemplars of important, sound, scientific publications that helped changed the course of litigations, as well as the scientific community’s appreciation of prior misleading contentions and publications. His three case studies grew out of the silicone-gel breast implant litigation, the latex allergy litigation, and the never-ending asbestos litigation.

1. Silicone

There are some glib characterizations of the silicone gel breast implant litigation as having had no evidentiary basis. A more careful assessment would allow that there was some evidence, much of it fraudulent and irrelevant. See, e.g., Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud). The lawsuit industry worked primarily through so-called support groups, which in turn funded friendly, advocate physicians, who in turn testified for plaintiffs and their lawyers in personal injury cases.

When the defendants, such as Dow Corning, reacted by sponsoring serious epidemiologic analyses of the issue whether exposure to silicone gel was associated with specific autoimmune or connective tissue diseases, the plaintiffs’ bar mounted a conflict-of-interest witch hunt over industry funding.6 Ultimately, the source of funding became obviously irrelevant; the concordance between industry-funded and all high quality research on the litigation claims was undeniable. Obvious that is to court-appointed expert witnesses7, and to a blue-ribbon panel of experts in the Institute of Medicine8.

2. Latex Hypersensitivity

Tarry’s second example comes from the latex hypersensitivity litigation. Whatever evidentiary basis may have existed for isolated cases of latex allergy, the plaintiffs’ bar had taken and expanded into a full-scale mass tort. A defense expert witness, Dr. David Garabrant, a physician and an epidemiologist, published a meta-analysis and systematic review of the extant scientific evidence. David H. Garabrant & Sarah Schweitzer, “Epidemiology of latex sensitization and allergies in health care workers,” 110 J. Allergy & Clin. Immunol. S82 (2002). Garabrant’s formal, systematic review documented his litigation opinions that the risk of latex hypersensitivity was much lower than claimed and not the widespread hazard asserted by plaintiffs and their retained expert witnesses. Although Garabrant’s review did not totally end the litigation and public health debate about latex, it went a long way toward ending both.

3. Fraudulent Asbestos-Induced Radiography

I still recall, sitting at my desk, my secretary coming into my office to tell me excitedly that a recent crop of silicosis claimants had had previous asbestosis claims. When I asked how she knew, she showed me the computer print out for closed files for another client. Some of the names were so distinctive that the probability that there were two men with the same name was minuscule. When we obtained the closed files from storage, sure enough, the social security numbers matched, as did all other pertinent data, except that what had been called asbestosis previously was now called silicosis.

My secretary’s astute observation was mirrored in the judicial proceedings of Judge Janis Graham Jack, who presided over MDL 1553. Judge Jack, however, discovered something even more egregious: in some cases, a single physician interpreted a single chest radiograph as showing either asbestosis or silicosis, but not both. The two, alternative diagnoses were recorded in two, separate reports, for two different litigation cases against different defendants. This fraudulent practice, as well as others, are documented in Judge Jack’s extraordinary, thorough opinion. See In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005)9.

The revelations of fraud in Judge Jack’s opinion were not entirely surprising. As everyone involved in asbestos litigation has always known, there is a disturbing degree of subjectivity in the interpretation of chest radiographs for pneumoconiosis. The federal government has long been aware of this problem, and through the Centers for Disease Control and the National Institute of Occupational Safety and Health, has tried to subdue extreme subjectivity by creating a pneumoconiosis classification schemed for chest radiographs known as the “B-reader” system. Unfortunately, B-reader certification meant only that physicians could achieve inter-observer and intra-observer reproducibility of interpretations on the examination, but they were free to peddle extreme interpretations for litigation. Indeed, the B-reader certification system exacerbated the problem by creating a credential that was marketed to advance the credibility of some of the most biased, over-reading physicians in asbestos, silica, and coal pneumoconiosis litigation.

Tarry’s third example is a study conducted under the leadership of the late Joseph Gitlin, at Johns Hopkins Medical School. With funding from defendants and insurers, Dr. Joseph Gitlin conducted a concordance study of films that had been read by predatory radiologists and physicians as showing pneumoconiosis. The readers in his study found a very low level of positive films (less than 5%), despite their having been interpreted as showing pneumoconiosis by the litigation physicians. See Joseph N. Gitlin, Leroy L. Cook, Otha W. Linton, and Elizabeth Garrett-Mayer, “Comparison of ‘B’ Readers’ Interpretations of Chest Radiographs for Asbestos Related Changes,” 11 Acad. Radiol. 843 (2004); Marjorie Centofanti, “With thousands of asbestos workers demanding compensation for lung disease, a radiology researcher here finds that most cases lack merit,” Hopkins Medicine (2006). As with the Sokol hoax, the practitioners of post-modern medicine cried “foul,” and decried industry sponsorship, but the disparity between courtroom and hospital medicine was sufficient proof for most disinterested observers that there was a need to fix the litigation process.

Meretricious Mensuration10 – Manganese Litigation Example

Tarry’s examples are important reminders that corporate sponsorship, whether from the plaintiffs’ lawsuit industry or from manufacturing industry, does not necessarily render research tainted or unreliable. Although lawyers often confront exaggerated or false claims, and witness important, helpful correctives in the form of litigation-sponsored studies, the demands of legal practice and “the next case” typically prevent lawyers from documenting the scientific depredations and their rebuttals. Sadly, unlike litigations such as those involving Bendectin and silicone, the chronicles of fraud and exaggeration are mostly closed books in closed files in closed offices. These examples need the light of day and a fresh breeze to disseminate them widely in both the scientific and legal communities, so that all may have a healthy appreciation for the value of appropriately conducted studies generated in litigation contexts.

As I have intimated elsewhere, the welding fume litigation is a great example of specious claiming, which ultimately was unhorsed by publications inspired or funded by the defense. In the typical welding fume case, plaintiff claimed that exposure to manganese in welding fume caused Parkinson’s disease or manganism. Although manganism sounds as though it must be a disease that can be caused only by manganese, in the hands of plaintiffs’ expert witnesses, manganism became whatever ailment plaintiffs claimed to have suffered. Circularity and perfect definitional precision were achieved by semantic fiat.

The Sanchez-Ramos Meta-Analysis

Manganese Madness was largely the creation of the Litigation Industry, under the dubious leadership of Dickie Scruggs & Company. Although the plaintiffs enjoyed a strong tail wind in the courtroom of an empathetic judge, they had difficulties in persuading juries and ultimately decamped from MDL 1535, in favor of more lucrative targets. In their last hurrah, however, plaintiffs retained a neurologist, Juan Sanchez-Ramos, who proffered a biased, invalid synthesis, which he billed as a meta-analysis11.

Sanchez-Ramos’s meta-analysis, such as it was, provoked professional disapproval and criticism from the defense expert witness, Dr. James Mortimer. Because the work product of Sanchez-Ramos was first disclosed in deposition, and not in his Rule 26 report, Dr. Mortimer undertook belatedly a proper meta-analysis.12 Even though Dr. Mortimer’s meta-analysis was done in response to the Sanchez-Ramos’s improper, tardy disclosure, the MDL judge ruled that Mortimer’s meta-analysis was too late. The effect, however, of Mortimer’s meta-analysis was clear in showing that welding had no positive association with Parkinson’s disease outcomes. The MDL 1535 resolved quickly thereafter, and with only slight encouragement, Dr. Mortimer published a further refined meta-analysis with two other leading neuro-epidemiologists. See James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012). See also “Manganese Meta-Analysis Further Undermines Reference Manual’s Toxicology Chapter” (Oct. 15, 2012).

1 See, e.g., David Michaels & Celeste Monforton, “Manufacturing Uncertainty Contested Science and the Protection ofthe Public’s Health and Environment,” 95 Am. J. Pub. Health S39, S40 (2005); David Michaels & Celeste Monforton, “How Litigation Shapes the Scientific Literature: Asbestos and Disease Among Automobile Mechanics,” 15 J. L. & Policy 1137, 1165 (2007). Michaels had served as a plaintiffs’ paid expert witness in chemical exposure litigation, and Monforton had been employed by labor unions before these papers were published, without disclosure of conflicts.

2 Leslie Boden & David Ozonoff, “Litigation-Generated Science: Why Should We Care?” 116 Envt’l Health Persp. 121, 121 (2008) (arguing that systematic distortion of the scientific record will result from litigation-sponsored papers even with disclosure of conflicts of interest). Ozonoff had served as a hired plaintiffs’ expert witnesses on multiple occasion before the publication of this article, which was unadorned by disclosure.

3 Lennart Hardell, Martin J. Walker, Bo Walhjalt, Lee S. Friedman, and Elihu D. Richter, “Secret Ties to Industry and Conflicting Interest in Cancer Research,” 50 Am. J. Indus. Med. 227, 233 (2007) (criticizing “powerful industrial interests” for “undermining independent research on hazard and risk,” in a “red” journal that is controlled by allies of the lawsuit industry). Hardell was an expert witness for plaintiffs in mobile phone litigation in which plaintiffs claimed that non-ionizing radiation caused brain cancer. In federal litigation, Hardell was excluded as an expert witness when his proffered opinions were found to be scientifically unreliable. Newman v. Motorola, Inc., 218 F. Supp. 2d. 769, 777 (D. Md. 2002), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003).

4 See David Egilman & Susanna Bohme, “IJOEH and the Critique of Bias,” 14 Internat’l J. Occup. & Envt’l Health 147, 148 (2008) (urging a Marxist critique that industry-sponsored research is necessarily motivated by profit considerations, and biased in favor of industry funders). Although Egilman usually gives a disclosure of his litigation activities, he typically characterizes those activities as having been for both plaintiffs and defendants, even though his testimonial work for defendants is minuscule.

5 Kenneth J. Rothman, “Conflict of Interest: The New McCarthyism in Science,” 269 J. Am. Med. Ass’n 2782 (1993).

6 See Charles H. Hennekens, I-Min Lee, Nancy R. Cook, Patricia R. Hebert, Elizabeth W. Karlson, Fran LaMotte; JoAnn E. Manson, and Julie E. Buring, “Self-reported Breast Implants and Connective- Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study, 275 J. Am. Med. Ass’n 616-19 (1998) (analyzing established cohort for claimed associations, with funding from the National Institutes of Health and Dow Corning Corporation).

7 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The court-appointed expert witnesses dedicated a great deal of their professional time to their task of evaluating the plaintiffs’ claims and the evidence. At the end of the process, they all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

8 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

9 See also Lester Brickman, “On the Applicability of the Silica MDL Proceeding to Asbestos Litigation, 12 Conn. Insur. L. J. 289 (2006); Lester Brickman, “Disparities Between Asbestosis and Silicosis Claims Generated By Litigation Screenings and Clinical Studies,” 29 Cardozo L. Rev. 513 (2007).

10 This apt phraseology is due to the late Keith Morgan, whose wit, wisdom, and scientific acumen are greatly missed. See W. Keith C. Morgan, “Meretricious Mensuration,” 6 J. Eval. Clin. Practice 1 (2000).

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

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

Posted in Asbestos, Causation, Conflicts of Interest, Meta-analysis, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

Every Time a Bell Rings

July 1st, 2017

“Every time a bell rings, an angel gets his wings.”
Zuzu Bailey

And every time a court issues a non-citable opinion, a judge breaks fundamental law. Whether it wants to or not, a common law court, in deciding a case, creates precedent, and an expectation and a right that other, similarly situated litigants will be treated similarly. Deciding a case and prohibiting its citation deprives future litigants of due process and equal protection of the law. If that makes for more citable opinions, more work for judges and litigants, so be it; that is what our constitution requires.

Back in 2015, Judge Bernstein issued a ruling in a birth defects case in which the mother had claimed to have taken sertraline during pregnancy and this medication use caused her child to be born with congenital malformations. Applying what Pennsylvania courts insist is a Frye standard, Judge Bernstein excluded the proffered expert witness testimony that attempted to draw a causal connection between the plaintiff’s birth defect and the mother’s medication use. Porter v. SmithKline Beecham Corp., No. 03275, 2015 WL 5970639 (Phila. Cty. Pennsylvania, Ct. C.P. October 5, 2015) (Mark I. Bernstein, J.) Judge Bernstein has since left the bench, but he was and is a respected commentator on Pennsylvania evidence1, even if he was generally known for his pro-plaintiff views on many legal issues. Bernstein’s opinion in Porter was a capable demonstration of how Pennsylvania’s Frye rule can be interpreted to reach essentially the same outcome that is required by Federal Rule of Evidence 702. See “Demonstration of Frye Gatekeeping in Pennsylvania Birth Defects Case” (Oct. 6, 2015); 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 statistical analyses and opinions, and the trial court’s entry of summary judgment on claims that sertraline causes birth defects).

In May of this year, the Pennsylvania Superior Court affirmed Judge Bernstein’s judgment, and essentially approved and adopted his reasoning. Porter v. SmithKline Beecham Corp., No. 3516 EDA 2015,2017 WL 1902905 (Pa. Super. May 8, 2017). What the Superior Court purport to giveth, the Superior Court taketh away. The Porter decision is franked as a “Non-Precedential Decision – See Superior Court I.O.P. 65.37.”

What is this Internal Operating Procedure that makes the Superior Court think that it can act and decide cases without creating precedent? Here is the relevant text from the Pennsylvania Code:

  1. An unpublished memorandum decision shall not be relied upon or cited by a Court or a party in any other action or proceeding, except that such a memorandum decision may be relied upon or cited
  1. when it is relevant under the doctrine of law of the case, res judicata, or collateral estoppel, and
  1. when the memorandum is relevant to a criminal action or proceeding because it recites issues raised and reasons for a decision affecting the same defendant in a prior action or proceeding.

210 Pa. Code § 65.37. Unpublished Memoranda Decisions. So, in other words, it is secret law.

No citation and no precedent rules are deeply problematic, and have attracted a great deal of scholarly attention2. And still, courts engage in this problematic practice. Prohibiting citation of Superior Court decisions in Pennsylvania is especially problematic in a state in which the highest court hears relatively few cases, and where the Justices involve themselves in internecine disputes. As other commentators have noted, prohibiting citation to prior decisions admitting or excluding expert witness testimony stunts the development of an area of evidence law, in which judges and litigants are often confused and in need of guidance. William E. Padgett, “‘Non-Precedential’ Unpublished Decisions in Daubert and Frye Cases, Often Silenced,” Nat’l L. Rev. (2017). The abuses of judge-made secret law from uncitable decisions has been abolished in the federal appeals courts for over a decade3. It is time for the state courts to follow suit.

1 See, e.g., Mark I. Bernstein, Pennsylvania Rules of Evidence (2017).

2 See Erica Weisgerber, “Unpublished Opinions: A Convenient Means to an Unconstitutional End,” 97 Georgetown L.J. 621 (2009);  Rafi Moghadam, “Judge Nullification: A Perception of Unpublished Opinions,” 62 Hastings L.J. 1397 (2011);  Norman R. Williams, “The failings of Originalism:  The Federal Courts and the Power of Precedent,” 37 U.C.. Davis L. Rev.761 (2004);  Dione C. Greene, “The Federal Courts of Appeals, Unpublished Decisions, and the ‘No-Citation Rule,” 81 Indiana L.J. 1503 (2006);  Vincent M. Cox, “Freeing Unpublished Opinions from Exile: Going Beyond the Citation Permitted by Proposed Federal Rule of Appellate Procedure 32.1,” 44 Washburn L.J. 105 (2004);  Sarah E. Ricks, “The Perils of Unpublished Non-Precedential Federal Appellate Opinions: A Case Study of The Substantive Due Process State-Created Danger Doctrine in One Circuit,” 81 Wash. L.Rev. 217 (2006);  Michael J. Woodruff, “State Supreme Court Opinion Publication in the Context of Ideology and Electoral Incentives.” New York University Department of Politics (March 2011);  Michael B. W. Sinclair, “Anastasoff versus Hart: The Constitutionality and Wisdom of Denying Precedential Authority to Circuit Court Decisions”; Thomas Healy, “Stare Decisis as a Constitutional Requirement,” 104 W. Va. L. Rev. 43 (2001); David R. Cleveland & William D. Bader, “Precedent and Justice,” 49 Duq. L. Rev. 35 (2011); Johanna S. Schiavoni, “Who’s Afraid of Precedent,” 49 UCLA L. Rev. 1859 (2002); Salem M. Katsh and Alex V. Chachkes, “Constitutionality of ‘No-Citation’ Rules,” 3 J. App. Prac. & Process 287 (2001); David R. Cleveland, “Appellate Court Rules Governing Publication, Citation, and Precedent of Opinions: An Update,” 16 J. App. Prac. & Process 257 (2015). See generally The Committee for the Rule of Law (website) (collecting scholarship and news on the issue of unpublished and supposedly non-precedential opinions). The problem even has its own Wikipedia page. See “Non-publication of legal opinions in the United States.”

3 See Fed. R. App. Proc. 32.1 (prohibiting federal courts from barring or limiting citation to unpublished federal court opinions, effective after Jan. 1, 2007).

Posted in Causation, Expert Witnesses, Frye, Rule 702 | Comments Off on Every Time a Bell Rings

Belgian Waffles and Post Hoc Ergo Propter Hoc

June 22nd, 2017

In language that could well be a Sokol hoax on the vacuousness of post-modernist non-thinking, the Court of Justice of the European Union issued a press release to announce its judgment in N.W. v. Sanofi Pasteur MSD, Case C-621/15 (Luxembourg, 21 June 2017). With European hypersensitivity to public disclosure, and in recognition of the right to be forgotten, the plaintiffs are known only as the “W” family. Mr. J. W. received Sanofi’s hepatitis B vaccine between late 1998 and the middle of 1999. In the summer of 1999, Mr. W. began to experience symptoms, which led to a diagnosis of multiple sclerosis over a year later, in November 2000. J.W. and his family sued Sanofi Pasteur in 2006. J.W. died in 2012.

The Ws filed their case in Paris, where the courts found for Sanofi Pasteur. The Cour d’Appel de Paris, impressed by the lack of scientific consensus to support W’s causal claim, held that the plaintiffs had failed to demonstrate causality. The Cour d’Appel de Paris court dismissed the W’s case. The dismissal was remarkable in the context of credulous French courts that had routinely recognized such claims. See C. Rougé-Maillart, N. Guillaume, N. Jousset, and M, Penneau, “Recognition by French courts of compensation for post-vaccination multiple sclerosis: the consequences with regard to expert practice,”47 Med. Sci. Law 185 (2007) (summarizing the course of M.S. and hepatitis B vaccination litigation in France). The Ws appealed further to the French Cour de Cassation (Court of Cassation), which punted to the EU Court of Justice, to ask whether the EU directive on liability for defective products required a different result than handed down by the Cour d’Appel.

The “Court of Justice” stated that the claimants had the burden of proof, but dubiously framed the causation issue as a choice between “certain and irrefutable evidence” and evidence of a “sufficiently high degree of probability.” What gives rise to sufficiently high degree of probability? In bold type, the EU press release announces that:

“Where there is a lack of scientific consensus, the proof of the defect of the vaccine and of a causal link between the defect and the damage suffered may be made out by serious, specific and consistent evidence.”

But what is “serious, specific, and consistent evidence”? Scouring both the press release and the full decision of the Court provides one answer:

Anecdotes. Unspecified number of case reports of multiple sclerosis occurring in patients after vaccination, without regard to an anticipated or expected incidence of the disease in the vaccinated population suffices. The Court of Justice sums up the Ws’ case as a showing that:

“The temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of the person vaccinated and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered may, where applicable, constitute sufficient evidence to make out such proof.”

The significant number of cases is never quantified or even described. The “sufficiently high probability” is never quantified or described. Presumably, the judges in Brussels can count, and the probability is some number greater than zero, but less than 1. The Court of Justice follows many other lay courts in falsely dichotomizing scientific disputes as involving either “certain, irrefutable” evidence or something less, and good enough for government (judicial) work. Even its representation of the Ws’ evidence as “serious, specific and consistent” and its suggestion of a “sufficiently high” probability are false, at least without spelling out the evidentiary base of the anecdotal evidence that is elevated to legally sufficient in the eyes of the Court of Justice. The Court fails to acknowledge, as a Court of Justice should, that large, high quality epidemiologic studies fail to find associations between hepatitis B vaccination and multiple sclerosis. See, e.g., Annette Langer-Gould, Lei Qian, Sara Y. Tartof, PhD; Sonu M. Brara, Steve J. Jacobsen, Brandon E. Beaber, Lina S. Sy, Chun Chao, Rulin Hechter, Hung Fu Tseng, “Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Diseases,” 71 J. Am. Med. Ass’n Neurol. 1506 (2014); Miguel A. Hernán & Susan S. Jick, “Hepatitis B vaccination and multiple sclerosis: the jury is still out,” 15 Pharmacoepidemiology & Drug Safety 653 (2006).

The European right to be forgotten has apparently been extended to scientific evidence. There may be reasons more legitimate than racist xenophobia to exit the European Union.

Posted in Causation, Scientific Evidence | Comments Off on Belgian Waffles and Post Hoc Ergo Propter Hoc

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