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Susan Haack on Judging Expert Testimony

December 19th, 2020

Susan Haack has written frequently about expert witness testimony in the United States legal system. At times, Haack’s observations are interesting and astute, perhaps more so because she has no training in the law or legal scholarship. She trained in philosophy, and her works no doubt are taken seriously because of her academic seniority; she is the Distinguished Professor in the Humanities, Cooper Senior Scholar in Arts and Sciences, Professor of Philosophy and Professor of Law at the University of Miami.

On occasion, Haack has used her background and experience from teaching about epistemology to good effect in elucidating how epistemiologic issues are handled in the law. For instance, her exploration of the vice of credulity, as voiced by W.K. Clifford,[1] is a useful counterweight to the shrill agnotologists, Robert Proctor, Naomi Oreskes, and David Michaels.

Professor Haack has also been a source of confused, fuzzy, and errant advice when it comes to the issue Rule 702 gatekeeping. Haack’s most recent article on “Judging Expert Testimony” is an example of some unfocused thinking about one of the most important aspect of modern litigation practice, admissibility challenges to expert witness opinion testimony.[2]

Uncontroversially, Haack finds the case law on expert witness gatekeeping lacking in “effective practical guidance,” and she seeks to offer courts, and presumably litigants, “operational help.” Haack sets out to explain “why the legal formulae” are not of practical use. Haack notes that terms such as “reliable” and “sufficient” are qualitative, and vague,[3] much like “obscene” and other adjectives that gave the courts such a difficult time. Rules with vague terms such as these give judges very little guidance. As a philosopher, Haack might have noted that the various judicial formulations of gatekeeping standards are couched as conclusions, devoid of explanatory force.[4] And she might have pointed out that the judicial tendency to confuse reliability with validity has muddled many court opinions and lawyers’ briefs.

Focusing specifically on the field of epidemiology, Haack attempts to help courts by offering questions that judges and lawyers should be asking. She tells us that the Reference Manual for Scientific Evidence is of little practical help, which is a bit unfair.[5] The Manual in its present form has problems, but ultimately the performance of gatekeepers can be improved only if the gatekeepers develop some aptitude and knowledge in the subject matter of the expert witnesses who undergoing Rule 702 challenges. Haack seems unduly reluctant to acknowledge that gatekeeping will require subject matter expertise. The chapter on statistics in the current edition of the Manual, by David Kaye and the late David Freeman, is a rich resource for judges and lawyers in evaluating statistical evidence, including statistical analyses that appear in epidemiologic studies.

Why do judges struggle with epidemiologic testimony? Haack unwittingly shows the way by suggestion that “[e]pidemiological testimony will be to the effect that a correlation, an increased relative risk, has, or hasn’t, been found, between exposure to some substance (the alleged toxin at issue in the case) and some disease or disorder (the alleged disease or disorder the plaintiff claims to have suffered)… .”[6] Some philosophical parsing of the difference between “correlation” and “increased risk” as two very different things might have been in order. Haack suggests an incorrect identity between correlation and increased risk that has confused courts as well as some epidemiologists.

Haack suggests asking various questions that are fairly obvious such as the soundness of the data, measurements, study design, and data interpretation. Haack gives the example of failing to ascertain exposure to an alleged teratogen  during first trimester of pregnancy as a failure of study design that could obscure a real association. Curiously she claims that some of Merrell Dow’s studies of Bendectin did such a thing, not by citing to any publications but to the second-hand accounts of a trial judge.[7] Beyond the objectionable lack of scholarship, the example comes from a medication exposure that has been as exculpated as much as possible from the dubious litigation claims made of its teratogenicity. The misleading example begs the question why choose a Bendectin case, from a litigation that was punctuated by fraud and perjury from plaintiffs’ expert witnesses, and a medication that has been shown to be safe and effective in pregnancy?[8]

Haack balks when it comes to statistical significance, which she tells us is merely based upon a convention, and set “high” to avoid false alarms.[9] Haack’s dismissive attitude cannot be squared with the absolute need to address random error and to assess whether the research claim has been meaningfully tested.[10] Haack would reduce the assessment of random error to the uncertainties of eyeballing sample size. She tells us that:

“But of course, the larger the sample is, then, other things being equal, the better the study. Andrew Wakefield’s dreadful work supposedly finding a correlation between MMR vaccination, bowel disorders, and autism—based on a sample of only 12 children — is a paradigm example of a bad study.”[11]

Sample size was the least of Wakefield’s problems, but more to the point, in some study designs for some hypotheses, a sample of 12 may be quite adequate to the task, and capable of generating robust and even statistically significant findings.

Inevitably, Haack alights upon personal bias or conflicts of interest, as a subject of inquiry.[12] Of course, this is one of the few areas that judges and lawyers understand all too well, and do not need encouragement to pursue. Haack dives in, regardless, to advise asking:

“Do those who paid for or conducted a study have an interest in reaching a given conclusion (were they, for example, scientists working for manufacturers hoping to establish that their medication is effective and safe, or were they scientists working, like Wakefield, with attorneys for one party or another)?”[13]

Speaking of bias, we can detect some in how Haack frames the inquiry. Do scientists work for manufacturers (Boo!) or were they “like Wakefield” working for attorneys for a party? Haack cannot seem to bring herself to say that Wakefield, and many other expert witnesses, worked for plaintiffs and plaintiffs’ counsel, a.k.a., the lawsuit industry. Perhaps Haack included such expert witnesses as working for those who manufacture lawsuits. Similarly, in her discussion of journal quality, she notes that some journals carry advertisements from manufacturers, or receive financial support from them. There is a distinct lack of symmetry discernible in the lack of Haack’s curiosity about journals that are run by scientists or physicians who belong to advocacy groups, or who regularly testify for plaintiffs’ counsel.

There are many other quirky opinions here, but I will conclude with the obvious point that in the epidemiologic literature, there is a huge gulf between reporting on associations and drawing causal conclusions. Haack asks her readers to remember “that epidemiological studies can only show correlations, not causation.”[14] This suggestion ignores Haack’s article discussion of certain clinical trial results, which do “show” causal relationships. And epidemiologic studies can show strong, robust, consistent associations, with exposure-response gradients, not likely consistent with random variation, and these findings collectively can show causation in appropriate cases.

My recommendation is to ignore Haack’s suggestions and to pay closer attention to the subject matter of the expert witness who is under challenge. If the subject matter is epidemiology, open a few good textbooks on the subject. On the legal side, a good treatise such as The New Wigmore will provide much more illumination and guidance for judges and lawyers than vague, general suggestions.[15]

[1] William Kingdon Clifford, “The Ethics of Belief,” in L. Stephen & F. Pollock, eds., The Ethics of Belief 70-96 (1877) (“In order that we may have the to accept [someone’s] testimony as ground for believing what he says, we must have reasonable grounds for trusting his veracity, that he is really trying to speak the truth so far as he knows it; his knowledge, that he has had opportunities of knowing the truth about this matter; and his judgement, that he has made proper use of those opportunities in coming to the conclusion which he affirms.”), quoted in Susan Haack, “Judging Expert Testimony: From Verbal Formalism to Practical Advice,” 1 Quaestio facti. Internat’l J. Evidential Legal Reasoning 13, 13 (2020).

[2]  Susan Haack, “Judging Expert Testimony: From Verbal Formalism to Practical Advice,” 1 Quaestio facti. Internat’l J. Evidential Legal Reasoning 13, 13 (2020) [cited as Haack].

[3]  Haack at 21.

[4]  See, e.g., “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions”; “Judicial Dodgers – Reassigning the Burden of Proof on Rule 702”; “Judicial Dodgers – Weight not Admissibility”; “Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent.”

[5]  Haack at 21.

[6]  Haack at 22.

[7]  Haack at 24, citing Blum v. Merrell Dow Pharms., Inc., 33 Phila. Cty. Rep. 193, 214-17 (1996).

[8]  See, e.g., “Bendectin, Diclegis & The Philosophy of Science” (Oct. 23, 2013).

[9]  Haack at 23.

[10]  See generally Deborah Mayo, Statistical Inference as Severe Testing: How to Get Beyond the Statistics Wars (2018).

[11]  Haack at 23-24 (emphasis added).

[12]  Haack at 24.

[13]  Haack at 24.

[14]  Haack at 25.

[15]  David H. Kaye, David E. Bernstein & Jennifer L. Mnookin, The New Wigmore: A Treatise on Evidence: Expert Evidence (2nd ed. 2011). A new edition is due out presently.

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Susan Haack on Judging Expert Testimony

The Knowledge Remedy Proposal

November 14th, 2020

Alexandra D. Lahav is the Ellen Ash Peters Professor of Law at the University of Connecticut School of Law. This year’s symposium issue of the Texas Law Review has published Professor Lahav’s article, “The Knowledge Remedy,” which calls for the imposition of a duty to conduct studies by defendants, to provide evidence relevant to plaintiffs’ product liability claims. Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020) [cited as Lahav].

Professor Lahav’s advocated reform is based upon the premises that (1) the requisite studies needed for causal assessment “are too costly for plaintiffs to fund,” (2) are not done by manufacturers, or (3) are not done in good faith, and (4) are not conducted or adequately funded by government. Lahav believes that plaintiffs are injured by exposure to chemicals but they cannot establish causation in court because the defendant “hid its head in the sand,” or worse, “engaged in misconduct to prevent or hide research into its products.”[1] Lahav thus argues that when defendants have been found to have engaged in misconduct, courts should order them to fund studies into risks posed by their products.

Lahav’s claims are either empty or non-factual. The suggestion that plaintiffs are injured by products but cannot “prove” causation begs the question how she knows that these people were injured by the products at issue. In law professors’ language, Lahav has committed the fallacy of petitio principia.

Lahav’s poor-mouthing on behalf of claimants is factually unsupported in this article. Lahav tells us that:

“studies are too expensive for individuals or even groups to fund.”

This is assertion is never backed up with any data or evidence about the expense involved. Case-control studies for rare outcomes suffer from potential threats to their validity, but they can be assembled relatively quickly and inexpensively. Perhaps a more dramatic refutation of Lahav’s assertions come from the cohort studies done in administrative databases, such as the national healthcare databases of Denmark or Sweden, or the Veterans’ Administration database in the United States. These studies involve querying existing databases for the exposures and outcomes of interest, with appropriate controls; such studies are frequently of as high quality and validity as can be had in observational analytical epidemiology.

There are, of course, examples of corporate defendants’ misconduct in sponsoring or conducting studies. There is also evidence of misconduct in plaintiffs’ sponsorship of studies,[2] and outright fraud.[3] And certainly there is evidence of misconduct or misdirection in governmentally funded and sponsored research, sometimes done in cahoots with plaintiffs’ counsel.[4]

Perhaps more important for the intended audience of the Texas Law Review, Lahav’s assertion is demonstrably false. Plaintiffs, plaintiffs’ counsel, and plaintiffs’ advocacy groups have funded studies, often surreptitiously, in many litigations, including those involving claims of harm from Bair Hugger, asbestos, silicone gel breast implants, welding fume, Zofran, isotretinoin, and others. Lahav’s repetition of the claim does not make it true.[5] Plaintiffs and their proxies, including scientific advocates, can and do conduct studies, very much with a view toward supporting litigation claims. Mass tort litigation is a big business, often run by lawyer oligarchs of the plaintiffs’ bar. Ignorantia facti is not an excuse for someone who argues for a radical re-ordering of an already fragile litigation system.

Lahav also complains that studies take so long that the statute of limitations will run on the injury claims before the scientific studies can be completed. There is a germ of truth in this complaint, but the issue could be resolved with minor procedural modifications. Plaintiffs could be allowed a procedure to propound a simple interrogatory to manufacturing firms to ask whether they believe that causality exists between their product and a specific kind of harm, or whether a claimant should reasonably know that such causality exists to warrant pursuing a legal claim. If the manufacturers answer in the negative, then the firms would not be able to assert a limitations defense for any injury that arose on or before the date of its answer. Perhaps the court could allow the matter to stay on its docket and require that the defendant answer the question annually. Plaintiffs and their proxies would be able to sponsor studies necessary to support their claims, and putative defendants would be on notice that such studies are underway.

Without any serious consideration of the extant regulations, Lahav even extends her claims of inadequate testing and lax regulation to pharmaceutical products, which are subject to extensive requirements of showing safety and efficacy, both before and after approval for marketing. Lahav’s advocacy ignores that an individual epidemiologic study rarely “demonstrates” causation, and many such studies are required before the scientific community can accept the causal hypothesis as “disproven.” Lahav’s knowledge remedy is mostly an ignorance ruse.

[1]  Lahav at 1361.

[2]  For a recent, egregious example, see In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) (uncovering dark data and dark money behind April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019)). See also In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657);  “April Fool – Zambelli-Weiner Must Disclose” (April 2, 2020); “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[3]  See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”) (emphasis added).

[4]  See, e.g., Robert M. Park, Paul A. Schulte, Joseph D. Bowman, James T. Walker, Stephen C. Bondy, Michael G. Yost, Jennifer A. Touchstone, and Mustafa Dosemeci, “Potential Occupational Risks for Neurodegenerative Diseases,” 48 Am. J. Ind. Med. 63, 65 (2005).

[5]  Lahav at 1369-70.

Posted in Cognitive Biases, Rule 702, Scientific Misconduct, Underlying Data | Comments Off on The Knowledge Remedy Proposal

Hacking at the “A” Cell

November 10th, 2020

At the heart of epidemiologic studies and clinical trials is the contingency table. The term, contingency table, was introduced by Karl Pearson in the early 20th century as a way to explore the independence, vel non, in a multivariate model. The simplest version of the table is the “2 by 2” table that is at the heart of case-control and other studies:

  Cases (with outcome of interest) Controls (without outcome of interest)  
Exposure of Interest Present                A                  B A + B

Marginal total of all exposed
Exposure of Interest Absent                C                  D C + D

Marginal total of all non-exposed
  A + C

Marginal total of cases

 B + D

Marginal total of controls

 A + B + C + D

Total observed in study

 

A measure of association between the exposure of interest and the outcome of interest can be shown in the odds ratio (OR), which can be assessed for random error on the assumption of no association.

OR = (A/C)/(B/D) = A*D/B*C

The measurement of the OR turns on faithfully applying the same method of counting cases regardless of exposure status. When investigators expand the “A” cell by loosening their criteria for exposure, we say that they have engaged in “hacking the A cell.”

Something akin to hacking the A cell occurred in the large epidemiologic study, known as  “Yale Hemorrhagic Stroke Project (HSP),” which was the center piece of the plaintiffs’ case in In re Phenylpropanolamine Products Liability Litigation. Although the HSP was sponsored by manufacturers, it was conducted independently without any manufacturer oversight beyond the protocol. The FDA reviewed the HSP results, and ultimately the HSP was published in the New England Journal of Medicine.[1]

The HSP was challenged in a Rule 702 hearing in the Multi-District Litigation (MDL). The MDL judge, Judge Rothstein, conducted hearings and entertained extensive briefings on the reliability of plaintiffs’ expert witnesses’ opinions, which were based largely upon the HSP. The hearings, however, could not go beyond doubts raised by the published paper, and Judge Rothstein permitted plaintiffs’ expert witnesses’ proffered testimony based upon the study, finding that:

“The prestigious NEJM published the HSP results, further substantiating that the research bears the indicia of good science.”[2]

The HSP study was subjected to much greater analysis in litigation.  After the MDL concluded its abridged gatekeeping process, the defense successfully sought the underlying data to the HSP. These data unraveled the HSP paper by showing that the study investigators had deviated from the protocol in a way to increase the number of exposed cases (A cell), with the obvious result of increasing the OR reported by the study.

Both sides of the PPA litigation accused the other side of “hacking at the A cell,” but juries seemed to understand that the hacking had started before the paper was published. A notable string of defense verdicts ensued. After one of the early defense verdicts, plaintiffs’ counsel challenged the defendant’s reliance upon underlying data that went behind the peer-reviewed publication.  The trial court rejected the request for a new trial, and spoke to the significance of challenging the superficial significance of peer review of the key study relied upon by plaintiffs in the PPA litigation:

“I mean, you could almost say that there was some unethical activity with that Yale Study.  It’s real close.  I mean, I — I am very, very concerned at the integrity of those researchers. Yale gets — Yale gets a big black eye on this.”[3]

Today we can see the equivalent of “A” cell hacking in a rather sleazy attempt by the Banana Republicans to steal a presidential election they lost. Cry-baby conservatives are seeking recounts where they lost, but not where they won. They are challenging individual ballots on the basis of outcome. They are raising speculative questions about the electoral processes of entire states, even where the states in question have handed them notable wins down ballot.

[1]  Walter N. Kernan, Catherine M. Viscoli, Lawrence M. Brass, Joseph P. Broderick, Thomas Brott, Edward Feldmann, Lewis B. Morgenstern,  Janet Lee Wilterdink, and Ralph I. Horwitz, “Phenylpropanolamine and the Risk of Hemorrhagic Stroke,” 343 New Engl. J. Med. 1826 (2000). See “Misplaced Reliance On Peer Review to Separate Valid Science From Nonsense” (Aug. 14, 2011).

[2]  In re Phenylpropanolamine Prod. Liab. Litig., 289 F. 2d 1230, 1239 (2003) (citing Daubert II for the proposition that peer review shows the research meets the minimal criteria for good science).  There were many layers of peer review for the HSP study, all of which proved ultimately ineffectual compared with the closer scrutiny that the HSP received in litigation where underlying data were produced.

[3]  O’Neill v. Novartis AG, California Superior Court, Los Angeles Cty., Transcript of Oral Argument on Post-Trial Motions, at 46 -47 (March 18, 2004) (Hon. Anthony J. Mohr).

Posted in Rule 702, Systemic Bias, Underlying Data | Comments Off on Hacking at the “A” Cell

Is Your Daubert Motion Racist?

July 17th, 2020

In this week’s New York Magazine, Jonathan Chait points out there is now a vibrant anti-racism consulting industry that exists to help white (or White?) people to recognize the extent to which their race has enabled their success, in the face of systematic inequalities that burden people of color. Chait acknowledges that some of what this industry does is salutary and timely, but he also notes that there are disturbing elements in this industry’s messaging, which is nothing short of an attack on individualism as racist myth that ignores that individuals are subsumed completely into their respective racial group. Chait argues that many of the West’s most cherished values – individualism, due process, free speech and inquiry, and the rule of law – are imperiled by so-called “radical progressivism” and “identity politics.”[1]

It is hard to fathom how anti-racism can collapse all identity into racial categories, even if some inarticulate progressives say so. Chait’s claim, however, seems to be supported by the Smithsonian National Museum of African American History & Culture, and its webpages on “Talking about Race,” which provides an extended analysis of “whiteness,” “white privilege,” and the like.

On May 31, 2020, the Museum’s website published a graphic that presented its view of the “Aspects & Assumptions of Whiteness and White Culture in the United States,” which made many startling claims about what is “white,” and by implication, what is “non-white.” [The chart is set out below.] I will leave it to the sociologists, psychologists, and anthropologists to parse the discussion of “white-dominant culture,” and white “racial identity,” provided in the Museum’s webpages. In my view, the characterizations of “whiteness” were overtly racist and insulting to all races and ethnicities. As Chait points out, with an abundance of irony, Donald Trump would seem to be the epitome of non-white, by his disavowal of the Museum’s identification of white culture’s insistence that “hard work is the key to success.”

The aspect of the graphic summary of whiteness, which I found most curious, most racist, and most insulting to people of all colors and ethnicities, is the chart’s assertion that white culture places “Emphasis on the Scientific Method,” with its valuation of “[o]bjective, rational linear thinking; “[c]ause and effect relationships”; and “[q]uantitative emphasis.” The implication is that non-whites do not emphasize or care about the scientific method. So scientific method, with its concern over validity of inference, and ruling out random and systematic errors, is just white privilege, and a microaggression against non-white people.

Really? Can the Smithsonian National Museum of African American History & Culture really mean that scientific punctilio is just another manifestation of racism and cultural imperialism. Chait seems to think so, quoting Glenn Singleton, president of Courageous Conversation, a racial-sensitivity training firm, who asserts that valuing “written communication over other forms” is “a hallmark of whiteness,” as is “scientific, linear thinking. Cause and effect.”

The Museum has apparently removed the graphic from its website, in response to a blitz of criticism from right-wing media and pundits.[2]  According to the Washington Post, the graphic has its origins in a 1978 book on White Awareness.[3] In response to the criticism, museum director Spencer Crew apologized and removed the graphic, agreeing that “it did not contribute to the discussion as planned.”[4]

The removal of the graphic is not really the point. Many people will now simply be bitter that they cannot publicly display their racist tropes. More important yet, many people will continue to believe that causal, rational, linear thinking is white, exclusionary, and even racist. Something to remember when you make your next Rule 702 motion.

   

[1]  Jonathan Chait, “Is the Anti-Racism Training Industry Just Peddling White Supremacy?” New York Magazine (July 16, 2020).

[2]  Laura Gesualdi-Gilmore “‘DEEPLY INSULTING’ African American museum accused of ‘racism’ over whiteness chart linking hard work and nuclear family to white culture,” The Sun (Jul 16 2020); “DC museum criticized for saying ‘delayed gratification’ and ‘decision-making’ are aspects of ‘whiteness’,” Fox News (July 16, 2020) (noting that the National Museum of African American History and Culture received a tremendous outcry after equating the nuclear family and self-reliance to whiteness); Sam Dorman, “African-American museum removes controversial chart linking ‘whiteness’ to self-reliance, decision-making The chart didn’t contribute to the ‘productive conversation’ they wanted to see,” Fox News (July 16, 2020); Mairead McArdle, “African American History Museum Publishes Graphic Linking ‘Rational Linear Thinking,’ ‘Nuclear Family’ to White Culture,” Nat’l Rev. (July 15, 2020).

[3]  Judy H. Katz, White Awareness: Handbook for Anti-Racism Training (1978).

[4]  Peggy McGlone, “African American Museum site removes ‘whiteness’ chart after criticism from Trump Jr. and conservative media,” Wash. Post (July 17, 2020).

Posted in Causation, Cognitive Biases, Rule 702, Scientific Evidence | Comments Off on Is Your Daubert Motion Racist?

Ingham v. Johnson & Johnson – A Case of Meretricious Mensuration?

July 3rd, 2020

There are a few incontrovertible facts underlying the Ingham fiasco. First, only God can make asbestos; it is not a man-made substance. Second, “asbestos” is not a mineralogical or geological term. The word asbestos developed in an industrial context to designate one of six different minerals that occurred in a fibrous habit, and which had commercial application. Five of the six asbestos minerals are double-chain silicates in the amphibole family: actinolite, anthophyllite, crocidolite, grunerite (known by its non-mineralogical name, amosite, from Amosa, “asbestos mines of South Africa), and tremolite. The sixth asbestos mineral is a serpentine family silicate: chrysotile.

Many other minerals occur in fibrous habit, but not all fibrous minerals are asbestos. Of the minerals designated as asbestos, some refer to minerals that occur in fibrous and non-fibrous habits: actinolite, anthophyllite, grunerite, and tremolite. An analytical report that found one of these minerals could not automatically be interpreted as having “asbestos.” The fibrous nature of the mineral would have to be ascertained as well as its chemical an structural nature.

The asbestos mineral crocidolite is known as riebeckite when non-fibrous; and chrysotile is the fibrous form that comes from a group of serpentine minerals, including non-fibrous lizardite and antigorite.[1]

The term “asbestiform” is often used to distinguish the fibrous habit of those asbestos minerals that can occur in fibrous or non-fibrous form. The term, however, is also used to refer to any inorganic fiber, natural or synthetic that resembles the long, thin habit of the asbestos minerals.[2]

What is a fiber?

The asbestos minerals were commercially useful in large part because of their fibrous habit, which allowed them to be woven into cloth or used as heat-resistant binders in insulation materials. Fibers were very long, thin structures with aspect ratios in the hundreds or thousands. Some of the fibers can fracture into long, thin fibrils. Some of the asbestos minerals can appear in their non-fibrous habit as small cleavage fragments, which may have aspect ratios ranging from 1 to 10. The EPA’s counting protocols count fragments with aspect ratios of 3 or greater as “fibers,” but that does not mean that there is strong evidence that amphibole cleavage fragments with aspect ratios of 3 cause cancer.

According to Johnson & Johnson’s principal brief, the plaintiffs’ expert witness William Longo counted any amphibole particle long and thin enough to satisfy a particular regulatory definition of “fiber” set out by the Environmental Protection Agency (EPA).[3]

Unfortunately, in its opening brief, J&J never explained clearly what separates the asbestiform from the non-asbestiform in the counting process. The appeal presents other potential problems. From a review of the appellants’ briefs, it seems unclear whether J&J disputed Longo’s adherence to the EPA definition of asbestiform. In any event, J&J appears not to have challenged the claim that any “asbestiform” fiber as defined by regulatory agencies can cause cancer. Moreover, plaintiffs’ expert witness, Dr. Jacqueline Moline, opined that cleavage fragments, or non-asbestiform amphiboles cause cancer.[4] This opinion seems highly dubious,[5] but there was NO appellate point in the defendants’ appellate brief to allege error in admitting Moline’s testimony. In addition, the appellate court’s opinion stated plaintiffs’ position that each and every exposure was a substantial causal factor without any suggestion that there was a challenge to the admissibility of this opinion.

What was the estimated exposure?

The plaintiffs’ expert witnesses appeared to be wildly inconsistent in their quantitative estimations of asbestos exposure from the ordinary use of J&J’s talcum powder. According to J&J’s appellate brief:

“Dr. Longo testified that plaintiffs’ use of the Powders would have exposed them to levels of asbestos at least ‘10 to 20 times above’ the amount in every day air that you breathe’. Tr. 1071. He put these exposure levels in the ‘same category’ as occupational levels. Tr. 1073.”[6]

There are many estimates of the ambient asbestos levels in “every day air,” but one estimate on the high side was given by the National Research Council, in 1984, as 0.0004 fibers/cm3.[7] Using Longo’s upper estimate of 20 times the “every day” level yields exposures of 0.008 f/cm3, a level that is well below the current permissible exposure level set by the U.S. Occupational Safety and Health Administration. Historically, workers in occupational cohorts experienced asbestos exposures at or even above 50 f/cm3.[8]

David Egilman also gave inflated exposure estimates that he equated with “occupational exposure” to the plaintiffs. Egilman opined, based upon Longo’s simulation study, a NIOSH study that counted all fibers, and a published study of another talc product, that the amount of asbestos dust released during personal use of J&J’s product was as high as 2.2 f/cm3, during the application process. These estimates were not time-weighted averages, and the estimates, such as they are, would be many orders of magnitude lower if they were analyzed as part of an eight-hour work day. Nonetheless, Egilman concluded that the plaintiffs’ exposures to J&J’s talc products more than doubled their ovarian cancer risk over baseline.[9]

In my previous post on Ingham, I noted how scientifically ignorant and irresponsible Egilman’s testimony was with respect to equating talc and anthopyllite.[10]  The Missouri Court of Appeals presented Egilman’s opinion as though it were well supported, and gave perfunctory consideration to J&J’s complaint about this testimony:

“Plaintiffs concede that Dr. Egilman’s intensity values for diapering came from a test that counted all types of fibers released by a sample of the Powders, including fibers that are not asbestos (principally talc fibers). RB124.  Suggesting that any of those fibers was asbestos would be speculative; assuming all of them were, as Dr. Egilman did, is absurd. Plaintiffs respond with the radical (and scientifically false) assertion that talc fibers are ‘chemically identical’ to anthophyllite asbestos fibers and therefore equivalent. Id. But plaintiffs never argued at trial, much less proved, that talc is identical to asbestos. Indeed, their own expert, Dr. Longo, distinguished between anthophyllite fibers and talc. See Tr.1062.”[11]

We should all sympathize with a litigant that has been abused by absurd opinion testimony. The Court of Appeals took a more insouciant approach:

“Defendants maintain Dr. Egilman’s measurements ‘lacked a reasonable factual basis’ for several reasons. However, their arguments are insufficient to render Dr. Egilman’s testimony inadmissible. ‘[Q]uestions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissbility and should be left for the jury’s consideration.’  Primrose Operating Co. v. Nat’l Am. Ins. Co., 382 F.3d 546, 562 (5th Cir. 2004) (alterations in original) (internal quotations omitted). The problems Defendants cite with Dr. Egilman’s testimony go to the weight of his testimony, not its admissibility.”[12]

Curiously, the Missouri Court of Appeals cited a federal court decision that applied an incorrect standard for evaluating the admissibility of expert witness opinion testimony.[13] It is inconceivable that the validity of the expert witness’s bases, and his inferences therefrom, are beyond the judicial gatekeeper’s scrutiny. If Egilman consulted a mercator projection map, from which he concluded the world was flat, would the Court of Appeals from the “Show Me” state shrug and say show it to the jury?

Perhaps even more remarkable than Longo’s and Egilman’s meretricious mensuration was Egilman’s opinion that personal use of talc more than doubled the plaintiffs’ risk of ovarian cancer. In the meta-analyses of studies of occupational asbestos exposure, the summary risk estimates were well below two.[14]

[1]  See “Serpentine subgroup,” in Wikipedia.

[2]  Lester Breslow, et al., Asbestiform Fibers: Nonoccupational Health Risks at 7 (Nat’l Research Council 1984).

[3]  Appellants’ Brief at 38, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (Sept. 6, 2019) (Tr. 1171-73).

[4]  Respondents’ Brief at 37, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (Dec. 19, 2019) (Tr.5.3369).

[5]  See, e.g., John F. Gamble & Graham W. Gibbs, “An evaluation of the risks of lung cancer and mesothelioma from exposure to amphibole cleavage fragments,” 52 Regulatory Toxicol. & Pharmacol. S154 (2008).

[6]  Appellants’ Brief at 52.

[7]  Lester Breslow, et al., Asbestiform Fibers: Nonoccupational Health Risks at 3 (Nat’l Research Council 1984).

[8]  Irving John Selikoff, “Statistical Compassion,” 44 J. Clin. Epidemiol. 141S, 142S (1991).

[9]  Ingham v. Johnson & Johnson, Slip op. at 52-53, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (June 23, 2020) (Slip op.).

[10]  See “Ingham v. Johnson & Johnson – Passing Talc Off As Asbestos,” (June 26, 2020).

[11]  Appellants’ Reply Brief at 43, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (Mar. 3, 2020)

[12]  Slip op. at 53.

[13]  See “Judicial Dodgers – Weight not Admissibility” (May 28, 2020) (collecting authorities).

[14]  See M. Constanza Camargo, Leslie T. Stayner, Kurt Straif, Margarita Reina, Umaima Al-Alem, Paul A. Demers, and Philip J. Landrigan, “Occupational Exposure to Asbestos and Ovarian Cancer: A Meta-analysis,” 119 Envt’l Health Persp. 1211 (2011); Alison Reid, Nick de Klerk, and Arthur W Musk, “Does Exposure to Asbestos Cause Ovarian Cancer? A Systematic Literature Review and Meta-Analysis,” 20 Cancer Epidemiol., Biomarkers & Prevention 1287 (2011).

Posted in Asbestos, Expert Witnesses, Rule 702 | Comments Off on Ingham v. Johnson & Johnson – A Case of Meretricious Mensuration?

Ingham v. Johnson & Johnson – Passing Talc Off As Asbestos

June 26th, 2020

In talc exposure litigation of ovarian cancer claims, plaintiffs were struggling to show that cosmetic talc use caused ovarian cancer, despite missteps by the defense.[1] And then lawsuit industrialist Mark Lanier entered the fray and offered a meretriciously beguiling move: Stop trying talc cases and start trying asbestos cases.

The Ingham appellate decision this week from the Missouri Court of Appeals appears to be a superficial affirmation of the Lanier strategy.[2] The court gave defendants some relief on jurisdictional issues, but largely affirmed the admissibility of Lanier’s expert witnesses on medical causation, both general and specific.[3]

After all, asbestos is an established cause of ovarian cancer. Or is it?

In 2006, the Institute of Medicine (now the National Academy of Medicine) addressed extra-pulmonary cancers caused by asbestos, without ever mentioning ovarian carcinoma.[4] Many textbooks and reviews found themselves unable to conclude that asbestos of any type caused ovarian cancer throughout the 20th century and a decade into the 21st century. The world of opinions changed, however, in 2011, when a working group of the International Agency for Research on Cancer (IARC) met in Lyon, France, and issued its support for the general causation claim in a suspect document published in 2012.[5] The IARC has strict rules that prohibit anyone who has any connection with manufacturing industry from serving on its working groups, but the Agency allows consultants and contractors for the lawsuit industry to serve without limitation. The 2011 working group on fibers and dusts thus sported lawsuit industry acolytes such as Peter F. Infante, Jonathan Samet, and Philip J. Landrigan.

Given the composition of this working group, no one was surprised by its finding:

“The Working Group noted that a causal association between exposure to asbestos and cancer of the ovary was clearly established, based on five strongly positive cohort mortality studies of women with heavy occupational exposure to asbestos (Acheson et al., 1982; Wignall & Fox, 1982; Germani et al., 1999; Berry et al., 2000; Magnani et al., 2008). The conclusion received additional support from studies showing that women and girls with environmental, but not occupational exposure to asbestos (Ferrante et al., 2007; Reid et al., 2008, 2009) had positive, though non-significant, increases in both ovarian cancer incidence and mortality.”[6]

The herd mentality is fairly strong in the world of occupational medicine, but not everyone concurred. A group of Australian asbestos researchers (Reid, et al.) without lawsuit industry credentials published another meta-analysis in 2011, as well.[7] Although the Australian researchers reported an increased summary estimate of risk, they were careful to point out that this elevation may have resulted from disease misclassification:

“In the studies that did not examine ovarian cancer pathology, or confirmed cases of mesothelioma from a cancer or mesothelioma registry, misclassification of the cause of death in some cases is likely to have occurred, given that misclassification was reported in those studies that did reexamine cancer pathology specimens. Misclassification may result in an underestimate of peritoneal mesothelioma and an overestimate of ovarian cancer or the converse. Among women, peritoneal mesothelioma may be more likely to be classified as ovarian, colon, or stomach cancer, rather than a rare occupational cancer.”[8]

The authors noted that Irving Selikoff had first reported that a significant number of peritoneal cancers, likely mesothelial in origin, have been misclassified as ovarian cancers. Studies that relied upon death certificates only might thus be very misleading. Supporting the danger of misclassification, the Reid study reported that:

“Only the meta-analysis of those studies that reported ovarian cancer incidence (i.e., those studies that did not rely on cause of death certification to classify their cases of ovarian cancer) did not observe a significant excess risk.”[9]

Reid also reported the absence of other indicia of causation:

“No study showed a statistically significant trend  of ovarian cancer with degree of asbestos exposure. In addition, there was no evidence of a significant trend across studies as grouped exposure increased.”[10]

Other scientists and physicians have acknowledged the controversial nature of the IARC’s determination. In 2011, pathologist Samuel Hammar, who has testified regularly for the lawsuit industry, voiced concerns about the diagnostic accuracy of ovarian cancer cases in asbestos studies:

“It has been difficult to draw conclusions on the basis of epidemiologic studies of ovarian cancers because, histologically, their distinction between peritoneal mesothelioma and carcinomatous peritonei (including primary peritoneal serous papillary adenocarcinoma) is difficult. Ovarian tumors tend to grow by extension and uncommonly metastasize through the bloodstream, which is similar to tumors of mesothelial origin … .”[11]

In 2014, a working group of the Finnish Institute of Occupational Health noted that “despite the conclusions by IARC and the support from recent studies, the hypothesis that asbestos is [a] cause of ovarian cancer remains controversial.”[12] The same year, 2014, the relevant chapter in a leading textbook by Dr. Victor L. Roggli and colleagues opined that:

“the balance of the evidence available at present does not support an association between asbestos exposure and cancers of the female reproductive system.”[13]

Two years later, a text by Dr. Dorsett D. Smith cited “the lack of certainty of the pathologic diagnosis of ovarian cancer versus a peritoneal mesothelioma in epidemiologic studies” as making the epidemiology uninterpretable and any conclusions impossible.[14]

Against this backdrop of evidence, I took a look at what Johnson & Johnson had to say about the occupational asbestos epidemiology in its briefs, in section “B. Studies on asbestos and ovarian cancer.”[15] The defense acknowledged that plaintiffs’ expert witnesses Drs. Jacqueline Moline and Dean Felsher focused on the IARC conclusion, and on studies of heavy occupational exposure. J & J recited without comment or criticism what plaintiffs’ expert witnesses had testified, much of which was quite objectionable.[16]

For instance, Moline and Felsher both reprised the scientifically and judicially debunked views that there is “no known safe level of exposure,” from which they inferred the non-sequitur that “any amount above ordinary background levels – could cause ovarian cancer.”[17] From ignorance, nothing derives but conjecture.

Another example was Felsher’s testimony that asbestos can make the body of an ovarian cancer patient therapy-resistant. In response to these and other remarkable assertions, J & J countered with only the statement that their expert witness, Dr. Huh, “did not agree that all of this was true in the context of ovarian cancer.”[18]

Huh, indeed; that the defense expert witness disagree with some of what plaintiffs’ witnesses claimed hardly frames an issue for exclusion of any expert witness’s opinion. Even more disturbing, there is no appellate point that corresponds to a motion to exclude Dr Moline’s testimony.

The Egilman Challenge

There was a challenge to the testimony of another expert witness, David Egilman, a frequent testifier for Mark Lanier and other lawsuit industrialists. One of the challenges that the defendants made on appeal to the admissibility of Dr. David Egilman’s testimony was his use of a 1972 NIOSH study that apparently quantified exposure in terms of fibers per cubic centimeter, without specifying whether all fibers in the measurement were asbestos fibers, as opposed to non-asbestos fibers, including talc fibers.

The Missouri Court of Appeals rejected this specificc challenge in part because Egilman had explained that:

“whether the 1972 NIOSH study identified fibers specifically as ‘asbestos’ was inconsequential, as the only other possible fiber that could be present in a talc sample is a ‘talc fiber, which is chemically identical to anthophyllite asbestos and structurally the same’.”[19]

Talc typically crystallizes in small plates, but it can occur occasionally as fibers. Egilman, however, equated a talc fiber as chemically and structurally identical to an anthophyllite fiber.

Does Egilman’s opinion hold water?

No, Egilman has wet himself badly (assuming the Missouri appellate court quoted testimony accurately).

According to the Mineralogical Society of America’s Handbook of Mineralogy (and every other standard work on mineralogy I reviewed), anthophyllite and talc, whether in fibrous habit or not, are two different minerals, with very different chemical formulae, crystal chemistry, and structure.[20] Anthophyllite has the chemical formula: (Mg;Fe2+)2(Mg;Fe2+)5Si8O22(OH)2 and is an amphibole double chain silicate. Talc, on the other hand, is a phyllosilicate, a hydrated magnesium silicate with the chemical formula Mg3Si4O10(OH)2. Talc crystallizes in the triclinic class, although sometimes monoclinic, and crystals are platy and very soft.

If the Missouri Court of Appeals characterized Egilman’s testimony correctly on this point, then Egilman gave patently false testimony. Talc and anthophyllite are different chemically and structurally.

[1]  See “The Slemp Case, Part I – Jury Verdict for Plaintiff – 10 Initial Observations”; “The Slemp Case, Part 2 – Openings”; “ Slemp Trial Part 3 – The Defense Expert Witness – Huh”; “Slemp Trial Part 4 – Graham Colditz”; “ Slemp Trial Part 5 – Daniel W. Cramer”; “Lawsuit Magic – Turning Talcum into Wampum”; “Talc Litigation Supported by Slippery Expert Witness” (2017).

[2]  Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (June 23, 2020) (Slip op.).

[3]  Cara Salvatore, “Missouri Appeals Court Slashes $4.7B Talc Verdict Against J&J,” Law360 (June 23, 2020).

[4]  Jonathan M. Samet, et al., Asbestos: Selected Cancers Effects (I.O.M. Committee on Asbestos 2006).

[5]  International Agency for Research on Cancer, A Review of Human Carcinogens, Monograph Vol. 100, Part C: Arsenic, Metals, Fibres, and Dusts (2012).

[6]  Id. at 256. Some members followed up their controversial finding with an attempt to justify it with a meta-analysis; see M. Constanza Camargo, Leslie T. Stayner, Kurt Straif, Margarita Reina, Umaima Al-Alem, Paul A. Demers, and Philip J. Landrigan, “Occupational Exposure to Asbestos and Ovarian Cancer: A Meta-analysis,” 119 Envt’l Health Persp. 1211 (2011).

[7]  Alison Reid, Nick de Klerk, and Arthur W Musk, “Does Exposure to Asbestos Cause Ovarian Cancer? A Systematic Literature Review and Meta-Analysis,” 20 Cancer Epidemiol., Biomarkers & Prevention 1287 (2011) [Reid].

[8]  Reid at 1293, 1287.

[9]  Id. at 1293.

[10]  Id. at 1294.

[11]  Samuel Hammar, Richard A. Lemen, Douglas W. Henderson & James Leigh, “Asbestos and other cancers,” chap. 8, in Ronald F. Dodson & Samuel P. Hammar, eds., Asbestos: Risk Assessment, Epidemiology, and Health Effects 435 (2nd ed. 2011) (internal citation omitted).

[12]  Finnish Institute of Occupational Health, Asbestos, Asbestosis and Cancer – Helsinki Criteria for Diagnosis and Attribution 60 (2014) (concluding that there was an increased risk in cohorts of women with “relatively high asbestos exposures”).

[13]  Faye F. Gao and Tim D. Oury, “Other Neoplasia,” chap. 8, in Tim D. Oury, Thomas A. Sporn & Victor L. Roggli, eds., in Pathology of Asbestos-Associated Diseases 177, 188 (3d ed. 2014).

[14]  Dorsett D. Smith, The Health Effects of Asbestos: An Evidence-based Approach 208 (2016).

[15]  Brief of Appellants Johnson & Johnson and Johnson & Johnson Consumer Inc., at 29, in Ingham v. Johnson & Johnson, No. No. ED107476, Missouri Court of Appeals for the Eastern District (St. Louis) (filed Sept. 6, 2019) [J&J Brief].

[16]  Id. at 30.

[17]  See Mark A. Behrens & William L. Anderson, “The ‘Any Exposure’ Theory: An Unsound Basis for Asbestos Causation and Expert Testimony,” 37 SW. U. L. Rev. 479 (2008); William L. Anderson, Lynn Levitan & Kieran Tuckley, “The ‘Any Exposure’ Theory Round II — Court Review of Minimal Exposure Expert Testimony in Asbestos and Toxic Tort Litigation Since 2008,” 22 Kans. J. L. & Pub. Pol’y 1 (2012); William L. Anderson & Kieran Tuckley, “The Any Exposure Theory Round III: An Update on the State of the Case Law 2012 – 2016,” Defense Counsel J. 264 (July 2016); William L. Anderson & Kieran Tuckley, “How Much Is Enough? A Judicial Roadmap to Low Dose Causation Testimony in Asbestos and Tort Litigation,” 42 Am. J. Trial Advocacy 38 (2018).

[18]  Id. at 30.

[19]  Slip op. at 54.

[20]  John W. Anthony, Richard A. Bideaux, Kenneth W. Bladh, and Monte C. Nichols, Handbook of Mineralogy (Mineralogical Soc’y of America 2001).

Posted in Asbestos, Causation, Conflicts of Interest, Rule 702 | Comments Off on Ingham v. Johnson & Johnson – Passing Talc Off As Asbestos

David Madigan’s Graywashed Meta-Analysis in Taxotere MDL

June 12th, 2020

Once again, a meta-analysis is advanced as a basis for an expert witness’s causation opinion, and once again, the opinion is the subject of a Rule 702 challenge. The litigation is In re Taxotere (Docetaxel) Products Liability Litigation, a multi-district litigation (MDL) proceeding before Judge Jane Triche Milazzo, who sits on the United States District Court for the Eastern District of Louisiana.

Taxotere is the brand name for docetaxel, a chemotherapic medication used either alone or in conjunction with another chemotherapy, to treat a number of different cancers. Hair loss is a side effect of Taxotere, but in the MDL, plaintiffs claim that they have experienced permanent hair loss, which was not adequately warned about in their view. The litigation thus involved issues of exactly what “permanent” means, medical causation, adequacy of warnings in the Taxotere package insert, and warnings causation.

Defendant Sanofi challenged plaintiffs’ statistical expert witness, David Madigan, a frequent testifier for the lawsuit industry. In its Rule 702 motion, Sanofi argued that Madigan had relied upon two randomized clinical trials (TAX 316 and GEICAM 9805) that evaluated “ongoing alopecia” to reach conclusions about “permanent alopecia.” Sanofi made the point that “ongoing” is not “permanent,” and that trial participants who had ongoing alopecia may have had their hair grow back. Madigan’s reliance upon an end point different from what plaintiffs complained about made his analysis irrelevant. The MDL court rejected Sanofi’s argument, with the observation that Madigan’s analysis was not irrelevant for using the wrong end point, only less persuasive, and that Sanofi’s criticism was one that “Sanofi can highlight for the jury on cross-examination.”[1]

Did Judge Milazzo engage in judicial dodging with rejecting the relevancy argument and emphasizing the truism that Sanofi could highlight the discrepancy on cross-examination?  In the sense that the disconnect can be easily shown by highlight the different event rates for the alopecia differently defined, the Sanofi argument seems like one that a jury could easily grasp and refute. The judicial shrug, however, begs the question why the defendant should have to address a data analysis that does not support the plaintiffs’ contention about “permanence.” The federal rules are supposed to advance the finding of the truth and the fair, speedy resolution of cases.

Sanofi’s more interesting argument, from the perspective of Rule 702 case law, was its claim that Madigan had relied upon a flawed methodology in analyzing the two clinical trials:

“Sanofi emphasizes that the results of each study individually produced no statistically significant results. Sanofi argues that Dr. Madigan cannot now combine the results of the studies to achieve statistical significance. The Court rejects Sanofi’s argument and finds that Sanofi’s concern goes to the weight of Dr. Madigan’s testimony, not to its admissibility.34”[2]

There seems to be a lot going on in the Rule 702 challenge that is not revealed in the cryptic language of the MDL district court. First, the court deployed the jurisprudentially horrific, conclusory language to dismiss a challenge that “goes to the weight …, not to … admissibility.” As discussed elsewhere, this judicial locution is rarely true, fails to explain the decision, and shows a lack of engagement with the actual challenge.[3] Of course, aside from the inanity of the expression, and the failure to explain or justify the denial of the Rule 702 challenge, the MDL court may have been able to provide a perfectly adequately explanation.

Second, the footnote in the quoted language, number 34, was to the infamous Milward case,[4] with the explanatory parenthetical that the First Circuit had reversed a district court for excluding testimony of an expert witness who had sought to “draw conclusions based on combination of studies, finding that alleged flaws identified by district court go to weight of testimony not admissibility.”[5] As discussed previously, the widespread use of the “weight not admissibility” locution, even by the Court of Appeals, does not justify it. More important, however, the invocation of Milward suggests that any alleged flaws in combining study results in a meta-analysis are always matters for the jury, no matter how arcane, technical, or threatening to validity they may be.

So was Judge Milazzo engaged in judicial dodging in Her Honor’s opinion in Taxotere? Although the citation to Milward tends to inculpate, the cursory description of the challenge raises questions whether the challenge itself was valid in the first place. Fortunately, in this era of electronic dockets, finding the actual Rule 702 motion is not very difficult, and we can inspect the challenge to see whether it was dodged or given short shrift. Remarkably, the reality is much more complicated than the simple, simplistic rejection by the MDL court would suggest.

Sanofi’s brief attacks three separate analyses proffered by David Madigan, and not surprisingly, the MDL court did not address every point made by Sanofi.[6] Sanofi’s point about the inappropriateness of conducting the meta-analysis was its third in its supporting brief:

“Third, Dr. Madigan conducted a statistical analysis on the TAX316 and GEICAM9805/TAX301 clinical trials separately and combined them to do a ‘meta-analysis’. But Dr. Madigan based his analysis on unproven assumptions, rendering his methodology unreliable. Even without those assumptions, Dr. Madigan did not find statistical significance for either of the clinical trials independently, making this analysis unhelpful to the trier of fact.”[7]

This introductory statement of the issue is itself not particularly helpful because it fails to explain why combining two individual clinical trials (“RCTs”), each not having “statistically significant” results, by meta-analysis would be unhelpful. Sanofi’s brief identified other problems with Madigan’s analyses, but eventually returned to the meta-analysis issue, with the heading:

“Dr. Madigan’s analysis of the individual clinical trials did not result in statistical significance, thus is unhelpful to the jury and will unfairly prejudice Sanofi.”[8]

After a discussion of some of the case law about statistical significance, Sanofi pressed its case against Madigan. Madigan’s statistical analysis of each of two RCTs apparently did not reach statistical significance, and Sanofi complained that permitting Madigan to present these two analyses with results that were “not statistically very impressive,” would confuse and mislead the jury.[9]

“Dr. Madigan tried to avoid that result here [of having two statistically non-significant results] by conducting a ‘meta-analysis’ — a greywashed term meaning that he combined two statistically insignificant results to try to achieve statistical significance. Madigan Report at 20 ¶ 53. Courts have held that meta-analyses are admissible, but only when used to reduce the numerical instability on existing statistically significant differences, not as a means to achieve statistical significance where it does not exist. RMSE at 361–362, fn76.”

Now the claims here are quite unsettling, especially considering that they were lodged in a defense brief, in an MDL, with many cases at stake, made on behalf of an important pharmaceutical company, represented by two large, capable national or international law firms.

First, what does the defense brief signify by placing ‘meta-analysis’ in quotes. Are these scare quotes to suggest that Madigan was passing off something as a meta-analysis that failed to be one? If so, there is nothing in the remainder of the brief that explains such an interpretation. Meta-analysis has been around for decades, and reporting meta-analyses of observational or of experimental studies has been the subject of numerous consensus and standard-setting papers over the last two decades. Furthermore, the FDA has now issued a draft guidance for the use of meta-analyses in pharmacoepidemiology. Scare quotes are at best unexplained, at worst, inappropriate. If the authors had something else in mind, they did not explain the meaning of using quotes around meta-analysis.

Second, the defense lawyers referred to meta-analysis as a “greywashed” term. I am always eager to expand my vocabulary, and so I looked up the word in various dictionaries of statistical and epidemiologic terms. Nothing there. Perhaps it was not a technical term, so I checked with the venerable Oxford English Dictionary. No relevant entries.

Pushed to the wall, I checked the font of all knowledge – the internet. To be sure, I found definitions, but nothing that could explain this odd locution in a brief filed in an important motion:

gray-washing: “noun In calico-bleaching, an operation following the singeing, consisting of washing in pure water in order to wet out the cloth and render it more absorbent, and also to remove some of the weavers’ dressing.”

graywashed: “adj. adopting all the world’s cultures but not really belonging to any of them; in essence, liking a little bit of everything but not everything of a little bit.”

Those definitions do not appear pertinent.

Another website offered a definition based upon the “blogsphere”:

Graywash: “A fairly new term in the blogsphere, this means an investigation that deals with an offense strongly, but not strongly enough in the eyes of the speaker.”

Hmmm. Still not on point.

Another one from “Urban Dictionary” might capture something of what was being implied:

Graywashing: “The deliberate, malicious act of making art having characters appear much older and uglier than they are in the book, television, or video game series.”

Still, I am not sure how this is an argument that a federal judge can respond to in a motion affecting many cases.

Perhaps, you say, I am quibbling with word choices, and I am not sufficiently in tune with the way people talk in the Eastern District of Louisiana. I plead guilty to both counts. But the third, and most important point, is the defense assertion that meta-analyses are only admissible “when used to reduce the numerical instability on existing statistically significant differences, not as a means to achieve statistical significance where it does not exist.”

This assertion is truly puzzling. Meta-analyses involve so many layers of hearsay that they will virtually never be admissible. Admissibility of the meta-analyses is virtually never the issue. When an expert witness has conducted a meta-analysis, or has relied upon one, the important legal question is whether the witness may reasonably rely upon the meta-analysis (under Rule 703) for an inference that satisfies Rule 702. The meta-analysis itself does not come into evidence, and does not go out to the jury for its deliberations.

But what about the defense brief’s “only when” language that clearly implies that courts have held that expert witnesses may rely upon meta-analyses only to reduce “numerical instability on existing statistically significant differences”? This seems clearly wrong because achieving statistical significance from studies that have no “instability” for their point estimates but individually lack statistical significance is a perfectly legitimate and valid goal. Consider a situation in which, for some reason, sample size in each study is limited by the available observations, but we have 10 studies, each with a point estimate of 1.5, and each with a 95% confidence interval of (0.88, 2.5). This hypothetical situation presents no instability of point estimates, and the meta-analytical summary point estimate would shrink the confidence interval so that the lower bound would exclude 1.0, in a perfectly valid analysis. In the real world, meta-analyses are conducted on studies with point estimates of risk that vary, because of random and non-random error, but there is no reason that meta-analyses cannot reduce random error to show that the summary point estimate is statistically significant at a pre-specified alpha, even though no constituent study was statistically significant.

Sanofi’s lawyers did not cite to any case for the remarkable proposition they advanced, but they did cite the Reference Manual for Scientific Evidence (RMSE). Earlier in the brief, the defense cited to this work in its third edition (2011), and so I turned to the cited page (“RMSE at 361–362, fn76”) only to find the introduction to the chapter on survey research, with footnotes 1 through 6.

After a diligent search through the third edition, I could not find any other language remotely supportive of the assertion by Sanofi’s counsel. There are important discussions about how a poorly conducted meta-analysis, or a meta-analysis that was heavily weighted in a direction by a methodologically flawed study, could render an expert witness’s opinion inadmissible under Rule 702.[10] Indeed, the third edition has a more sustained discussion of meta-analysis under the heading “VI. What Methods Exist for Combining the Results of Multiple Studies,”[11] but nothing in that discussion comes close to supporting the remarkable assertion by defense counsel.

On a hunch, I checked the second edition of RMSE, published in the year 2000. There was indeed a footnote 76, on page 361, which discussed meta-analysis. The discussion comes in the midst of the superseded edition’s chapter on epidemiology. Nothing, however, in the text or in the cited footnote appears to support the defense’s contention about meta-analyses are appropriate only when each included clinical trial has independently reported a statistically significant result.

If this analysis is correct, the MDL court was fully justified in rejecting the defense argument that combining two statistically non-significant clinical trials to yield a statistically significant result was methodologically infirm. No cases were cited, and the Reference Manual does not support the contention. Furthermore, no statistical text or treatise on meta-analysis supports the Sanofi claim. Sanofi did not support its motion with any affidavits of experts on meta-analysis.

Now there were other arguments advanced in support of excluding David Madigan’s testimony. Indeed, there was a very strong methodological challenge to Madigan’s decision to include the two RCTs in his meta-analysis, other than those RCTs lack of statistical significance on the end point at issue. In the words of the Sanofi brief:

“Both TAX clinical trials examined two different treatment regimens, TAC (docetaxel in combination with doxorubicin and cyclophosphamide) versus FAC (5-fluorouracil in combination with doxorubicin and cyclophosphamide). Madigan Report at 18–19 ¶¶ 47–48. Dr. Madigan admitted that TAC is not Taxotere alone, Madigan Dep. 305:21–23 (Ex. B); however, he did not rule out doxorubicin or cyclophosphamide in his analysis. Madigan Dep. 284:4–12 (“Q. You can’t rule out other chemotherapies as causes of irreversible alopecia? … A. I can’t rule out — I do not know, one way or another, whether other chemotherapy agents cause irreversible alopecia.”).”[12]

Now unlike the statistical significance argument, this argument is rather straightforward and turns on the clinical heterogeneity of the two trials that seems to clearly point to the invalidity of a meta-analysis of them. Sanofi’s lawyers could have easily supported this point with statements from standard textbooks and non-testifying experts (but alas did not). Sanofi did support their challenge, however, with citations to an important litigation and Fifth Circuit precedent.[13]

This closer look at the actual challenge to David Madigan’s opinions suggests that Sanofi’s counsel may have diluted very strong arguments about heterogeneity in exposure variable, and in the outcome variable, by advancing what seems a very doubtful argument based upon the lack of statistical significance of the individual studies in the Madigan meta-analysis.

Sanofi advanced two very strong points, first about the irrelevant outcome variable definitions used by Madigan, and second about the complexity of Taxotere’s being used with other, and different, chemotherapeutic agents in each of the two trials that Madigan combined.[14] The MDL court addressed the first point in a perfunctory and ultimately unsatisfactory fashion, but did not address the second point at all.

Ultimately, the result was that Madigan was given a pass to offer extremely tenuous opinions in an MDL on causation. Given that Madigan has proffered tendentious opinions in the past, and has been characterized as “an expert on a mission,” whose opinions are “conclusion driven,”[15] the missteps in the briefing, and the MDL court’s abridgement of the gatekeeping process are regrettable. Also regrettable is that the merits or demerits of a Rule 702 challenge cannot be fairly evaluated from cursory, conclusory judicial decisions riddled with meaningless verbiage such as “the challenge goes to the weight and not the admissibility of the witness.” Access to the actual Rule 702 motion helped shed important light on the inadequacy of one point in the motion but also the complexity and fullness of the challenge that was not fully addressed in the MDL court’s decision. It is possible that a Reply or a Supplemental brief, or oral argument, may have filled in gaps, corrected errors, or modified the motion, and the above analysis missed some important aspect of what happened in the Taxotere MDL. If so, all the more reason that we need better judicial gatekeeping, especially when a decision can affect thousands of pending cases.[16]

[1]  In re Taxotere (Docetaxel) Prods. Liab. Litig., 2019 U.S. Dist. LEXIS 143642, at *13 (E.D. La. Aug. 23, 2019) [Op.]

[2]  Op. at *13-14.

[3]  “Judicial Dodgers – Weight not Admissibility” (May 28, 2020).

[4]  Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11, 17-22 (1st Cir. 2011).

[5]  Op. at *13-14 (quoting and citing Milward, 639 F.3d at 17-22).

[6]  Memorandum in Support of Sanofi Defendants’ Motion to Exclude Expert Testimony of David Madigan, Ph.D., Document 6144, in In re Taxotere (Docetaxel) Prods. Liab. Litig. (E.D. La. Feb. 8, 2019) [Brief].

[7]  Brief at 2; see also Brief at 14 (restating without initially explaining why combining two statistically non-significant RCTs by meta-analysis would be unhelpful).

[8]  Brief at 16.

[9]  Brief at 17 (quoting from Madigan Dep. 256:14–15).

[10]  Michael D. Green, Michael Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” at 581n.89, in Fed. Jud. Center, Reference Manual on Scientific Evidence (3d ed. 2011).

[11]  Id. at 606.

[12]  Brief at 14.

[13]  Brief at 14, citing Burst v. Shell Oil Co., C. A. No. 14–109, 2015 WL 3755953, at *7 (E.D. La. June 16, 2015) (Vance, J.) (quoting LeBlanc v. Chevron USA, Inc., 396 F. App’x 94, 99 (5th Cir. 2010)) (“[A] study that notes ‘that the subjects were exposed to a range of substances and then nonspecifically note[s] increases in disease incidence’ can be disregarded.”), aff’d, 650 F. App’x 170 (5th Cir. 2016). See “The One Percent Non-solution – Infante Fuels His Own Exclusion in Gasoline Leukemia Case” (June 25, 2015).

[14]  Brief at 14-16.

[15]  In re Accutane Litig., 2015 WL 753674, at *19 (N.J.L.Div., Atlantic Cty., Feb. 20, 2015), aff’d, 234 N.J. 340, 191 A.3d 560 (2018). See “Johnson of Accutane – Keeping the Gate in the Garden State” (Mar. 28, 2015); “N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses” (Aug. 8, 2018).

[16]  Cara Salvatore, “Sanofi Beats First Bellwether In Chemo Drug Hair Loss MDL,” Law360 (Sept. 27, 2019).

Posted in Meta-analysis, Rule 702, Rule 703, statistical evidence | Comments Off on David Madigan’s Graywashed Meta-Analysis in Taxotere MDL

Legal Remedies for Suspect Medical Science in Products Cases – Part Three

June 5th, 2020

 Legislative Initiatives – The Asbestos Fairness in Compensation Act

Over the years, Congress has considered various possible solutions to the problem of asbestos liability. One proposed reform bill, which bore the title “Asbestos Fairness in Compensation Act,” was specifically motivated by a concern about the quality of the expert opinions that fueled the asbestos litigation tsunami.[1] The Report by the Senate Judiciary Committee for this bill commented on its view of medical testimony in asbestos cases:

“Defendants’ rights are further compromised when courts lack the resources to monitor the medical evidence submitted by plaintiffs.  A study by neutral academics showed that forty-one (41 %) percent of audited claims of alleged asbestosis or pleural disease were found by trust physicians to have either no disease or a less severe disease than alleged by the plaintiffs’ experts (for example, pleural disease rather than asbestosis).”[2]

A key part of the bill sought to establish a process to ensure that claims would be based upon sound medical science.  As the Senate Report explained the legislative goal:

“4. Diagnostic and latency criteria

Asbestos claimants must meet diagnostic and latency criteria to be compensated by the Fund.  The diagnostic criteria should reflect the typical components of a true medical diagnosis by a claimant’s doctor, including an in-person physical examination (or pathology in the case where the injured person is deceased) and a review of the claimant’s medical, smoking and exposure history by the doctor diagnosing an asbestos-related disease.  These requirements ensure that the claimant will be given a meaningful diagnosis related to the claimant’s condition.  The diagnosis must also include consideration of other more likely causes of the condition to ensure that asbestos exposure was the cause of any claimed nonmalignant disease (as opposed to other industrial dust exposure) or a substantial contributing factor in causing a malignant disease….”[3]

A number of the bill’s specific provisions sought to limit payments to only claimants who could qualify under properly validated medical criteria. This bill, like all those before it, died on the Hill.

The Health Care Quality Improvement Act of 1986

In 1986, Congress passed the Health Care Quality Improvement Act (“HCQIA”)[4], which was prompted by concerns that fear of litigation would deter hospitals, physicians and others from carrying out peer review of unprofessional conduct and from providing candid assessments to peer review bodies.  The Act gave all participants in a qualifying “professional review action” immunity from being held liable in damages “under any law of the United States or of any State (or political subdivision thereof) with respect to the action.”[5]  One of the immunized entities is a “professional review body,” a term defined by HCQIA to mean “a health care entity and the governing body or any committee of a health care entity which conducts professional review activity, and includes any committee of the medical staff of such an entity when assisting the governing body in a professional review activity.”[6]  Moreover, another provision of the Act[7] provides immunity from damages to any person “providing information to a professional review body regarding the competence or professional conduct of a physician. . . .unless such information is false and the person providing it knew such information was false.”

The HCQIA has given rise to litigation over whether it protects professional review bodies from defamation cases involving litigation opinions. If medico-legal opinions are within the scope of the practice of medicine, then a potentially important method for curbing unscrupulous expert witnesses and false or exaggerated opinion testimony might consist of peer review actions through professional associations or state medical boards.

In Florida litigation, an intermediate appellate court held that the Florida Medical Association did not have immunity under the HCQIA for having provided procedures for pressing complaints against medical expert witnesses for unprofessional conduct.[8] The state law that might be invoked to curb meretricious testimony by licensed physicians, through professional associations or medical licensing boards, remains a hodge-podge.[9]

The American Bar Association’s Resolution Condemning Screenings and Calling For Impairment Criteria in Asbestos Litigation

Part of the impetus for federal legislative reform of asbestos litigation and its diagnostic gamesmanship came from an American Bar Association (ABA) recommendation of enacting impairment requirements for asbestos non-malignant personal injury cases.[10]  Acting upon concerns of court dockets backlogged by unimpaired and false-positive and bogus asbestosis cases, many of which arose out of mass screenings, the ABA urged that limitations rules be relaxed so as not to require the filing of unimpaired cases and that compensation be limited to cases that have demonstrable objective evidence of physical impairment due to asbestosis.  The ABA Report helped to instigate asbestos tort reform efforts in Congress, as well as several successful state legislative efforts.

State Tort Reform Acts for Reliable Diagnostic and Impairment Criteria in Asbestos and Silica Cases

While Congress floundered on litigation reform of the asbestos racket, several states enacted meaningful procedural and substantive changes to address some of the more abusive medical screening practices in asbestos and silica cases.  Texas, Georgia, Florida, and Ohio have enacted remedial legislation that requires a demonstration of objective pulmonary impairment.  In some instances, the tort reform measures specify that the diagnosing physician have a patient-physician relationship with the claimant.  This requirement was aimed at chilling the efforts of itinerant, out-of-state screening physicians, whose conduct came under scrutiny in In re Silica.[11]

Daubert, Its Progeny, and Amended Rule of Evidence 702

The Supreme Court’s opinion in Daubert was not only a watershed in the analysis of expert evidence generally but also reflected specific concerns about expert testimony in the area of product liability litigation. Daubert itself was a pharmaceutical product liability case, as were Joiner and Kumho Tire.  Medical causation is one of the key issues in every product liability case, and the pressure to produce an opinion, whether inculpatory or exculpatory, will occasionally distort a fragile epistemic foundation that will not support a conclusion with any certainty.  In In re Silica, the prospect of creating a mass tort out of whole cloth seems to have had just such a distorting influence.[12]

As noted by Judge Jack, in making the reliability inquiry, the trial judge has the responsibility “to make certain that an expert … employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”[13] Typically, this requirement of “intellectual rigor” means that physicians proffering a diagnosis for litigation purposes must employ the same standards and practices in reaching that diagnosis that they would use in their regular, non-litigation practice of medicine.

Judge Jack was not writing on a completely blank slate in finding the silicosis diagnoses to be bogus in the MDL cases. A few years earlier, the Fourth Circuit affirmed the exclusion of a physician expert witness who insisted upon a “hands-on” examination in his medical practice, but who did not bother to examine the plaintiff personally in a case involving a failed spinal fusion.[14] Standing alone, the physician expert witness’s failure to conduct a physical examination might not have required exclusion, but the deviation from his own established, non-litigation practice provided a persuasive showing that the expert witness “did not employ in the courtroom the same methods that he employs in his own practice,” which required exclusion.[15]

A similar example of gatekeeping occurred in Ingram v. Solkatronic Chemical, Inc.,[16] where the trial judge excluded the testimony of a medical expert witness who opined that plaintiff had been injured by exposure to arsine gas.  At his deposition, the expert witness “outlined his standard diagnostic protocol when called upon to evaluate a cause of a given physical ailment.”[17]  The witness’s own protocol included taking a medical history, performing a physical examination, and determining what tests were required.  This protocol starkly contrasted with the expert witness’s anemic litigation approach to diagnosis, which failed to include physical examinations or review of complete medical or occupational histories.  Finding that the expert’s procedures “depart[ed] from his own established diagnostic standards,” the court excluded his testimony.[18]

[1]  S. 852, 109th Congress, 1st Session, and Senate Judiciary Comm. Report (June 30, 2005).

[2]  Id. at 21.

[3]  Id. at 34.

[4]  42 U.S.C. §§ 11101, et seq.

[5]  42 U.S.C. § 11111(a)(1).

[6]  42 U.S.C. § 11151(11).

[7]  42 U.S.C. § 11111(a)(2)/

[8]  Fullerton v. The Florida Med. Ass’n, 938 So.2d 587 (Fla. D. Ct. App. 2006). See also Adam Liptak, “Doctor’s Testimony Leads To a Complex Legal Fight,” N.Y. Times (June 20, 2004).

[9]  See, e.g., Sandeep K. Narang & Stephan R. Paul, “Expert Witness Participation in Civil and Criminal Proceedings,” 139 Pediatrics e1 (2017); Robert A. Bitterman, “Halting inappropriate expert witness testimony – Part I: Professional associations’ efforts to police ‘experts’,” Relias Media (Jan. 1, 2007); Robert A. Bitterman, “Halting Inappropriate Expert Witness Testimony — Part II: Efforts of State Medical Boards and State Medical Societies to Police ‘Experts’,” Relias Media (Feb. 1, 2007); Robert A. Bitterman, “Halting inappropriate expert witness testimony ? Part III: Tort reform to prevent not-so-expert opinions,” Relias Media (Mar. 1, 2007).

[10]  See ABA Commission on Asbestos Litigation, Report to the House of Delegates (Report No. 302) (February 2003).

[11]  For discussion of some of the state legislative reform, see Mark A. Behrens, “What’s New in Asbestos Litigation?” 28 Rev. Litig. 501 (2009); Jeb Barnes, “Rethinking the Landscape of Tort Reform: Legislative Inertia and Court-Base Tort Reform in the Case of Asbestos,” 28 The Justice System J. 157 (2007); Jeb Barnes, Dust-Up: Asbestos Litigation and the Failure of Commonsense Policy Reform (2011).

[12]  In re Silica Prods. Liab. Litig., 398 F.Supp. 2d 563 (S.D. Tex. 2005).

[13]  Id. at 621, quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). 

[14]  Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 203 (4th Cir. 2001).

[15]  Id.

[16]  2005 WL 3544244 (N.D. Okla., Dec. 28, 2005),

[17]  Id. at *13.

[18]  Id. at *14.  See also Goebel v. Denver and Rio Grande Western Railroad Co., 346 F.3d 987, 998 (10th Cir. 2003) (upholding admissibility of opinion of medical expert witness who “followed ‘standard medical procedure in evaluating and diagnosing’ [plaintiff]”) (internal quotations omitted); Fitzgerald v. Smith & Nephew Richards, Inc., 1999 WL 1489199 (D. Md., Dec. 30, 1999), aff’d, 11 Fed. Appx. 335, 339 (4th Cir. 2001) (excluding opinion of medical expert who testified that clinical judgment requires personal contact with patient, but who failed to examine the plaintiff or review her complete medical history; finding that the expert “did not undertake his medical review and formulate his opinions with ‘intellectual rigor’”); Wooley v. Smith & Nephew Richards, Inc., 67 F. Supp. 2d 703, 709 (S.D. Tex. 1999) (excluding testimony of medical expert witness who had not examined plaintiff, and who relied on his review of medical records selected by  plaintiff’s counsel; concluding that “no expert orthopedic surgeon would attempt to make an accurate and complete diagnosis as to the probable cause of postoperative spinal injury without interviewing or examining the patient or considering the entirety of a patient’s records”).

Posted in Expert Witnesses, Rule 702 | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part Three

Legal Remedies for Suspect Medical Science in Products Cases – Part Two

June 3rd, 2020

The Federal Multi-District Silicosis Proceedings Before Judge Janis Jack

One of the most significant developments in the role of scientific and medical evidence gatekeeping under Rule 702, and the Supreme Court’s decision in Daubert,[1] was the 2005 opinion of Judge Janis Graham Jack in the multi-district silicosis litigation.[2] Judge Jack’s lengthy opinion addresses a variety of procedural issues, including subject matter jurisdiction over some of the cases, but Her Honor’s focus was “whether the doctors who diagnosed Plaintiffs with silicosis employed a sufficiently reliable methodology for their testimony to be admissible” and “whether Plaintiffs’ counsel should be sanctioned for submitting unreliable diagnoses and failing to fully comply with discovery orders.”  Judge Jack held that thousands of diagnoses of silicosis were radically flawed and could not be treated as proper science or medicine, and she imposed sanctions against plaintiffs’ lawyers in the cases over which she had subject matter jurisdiction.

In summary, Judge Jack held that to pass the minimum reliability analysis under Daubert, a diagnosis of silicosis requires:

“(1) an adequate exposure to silica dust with an appropriate latency period,

(2) radiographic evidence of silicosis, and

(3) the absence of any good reason to believe that the radiographic findings are the result of some other condition (i.e., a differential diagnosis).

* * * * *

As discussed above, these three criteria are universally accepted, as demonstrated by learned treatises and experts in the field.  It is the implementation of these criteria in these cases which ranged from questionable to abysmal.”[3]

With respect to the first criterion, evidence of “adequate exposure to silica dust with an appropriate latency period,” the court concluded that “[t]he ‘exposure histories’ (or ‘work histories’) were virtually always taken by people with no medical training, who had significant financial incentives to find someone positive for exposure to silica (or asbestos, depending on which type of suit the employing law firm was seeking to file).”[4]  The court went on to state that:

“[t]hese ‘histories’ were devoid of meaningful details, such as the duration and intensity of exposure, which are critical to determining whether someone has sufficient exposure, dosage and latency to support a reliable diagnosis.”[5]

Judge Jack, who had been a registered nurse before going to law school and becoming a lawyer, was clearly concerned that the medical “histories were taken by receptionists [at medical screening companies allied with plaintiffs’ counsel] with no medical training.”[6]  The head of one of the screening companies “testified that the doctors who worked for his screening company simply relied upon the abbreviated work histories that [the screening company] supplied them.”[7]  As a former nurse, Judge Jack was probably more than a little put off by the screening company executive’s explanation that “to ask the doctor to take a work history in our field would be like asking [the defense attorney questioning him] to wash my car.  I mean it’s . . . very beneath him.”[8]  Judge Jack rejected this approach entirely, and found that legitimate doctors would find it necessary to take the occupational history themselves:

“This type of thorough, detailed, physician-guided work/exposure history is the kind of history that experts in the field of occupational medicine insist upon when diagnosing silicosis.  It is therefore the type of history required by the Federal Rules for these diagnoses to be admissible.  Cf. Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198 (5th Cir. 1996)… .”[9]

The second required predicate for an admissible diagnosis of silicosis was an appropriate radiographic finding – a so-called “B-read,” which is simply the interpretation of a physician, who has passed a certifying proficiency examination given by the National Institute of Occupational Health, for evaluating chest films for pneumoconiosis, using a standardized scale and notations.  Judge Jack discerned, contrary to the approach taken by some of the plaintiffs’ lawyers and certain doctors, that a positive B-read was not “a talisman that would dispel any doubts about the diagnoses as a whole.”[10]  A positive B-read simply is not sufficient alone to support a silicosis diagnosis.

Judge Jack noted that a consensus report of the American College of Occupational and Environmental Medicine rejected the use of a B-read alone as sufficient to support a diagnosis of pneumoconiosis, and emphasized the views of one testifying physician that the “ILO guidelines, by their express terms, [were] ‘not supposed to be used for designation of disease or determining compensation.’ ”[11] But even apart from rejecting the concept that a positive B-read was by itself a sufficient basis for a diagnosis of silicosis, Judge Jack fundamentally criticized the manner in which the X-rays at issue were conducted.

The B-reader system was not originally established for use in litigation, but as part of a coal workers’ surveillance program to determine whether a worker should be transferred to a low-dust environment.  And under this surveillance program, the worker is not transferred until at least two B-readers agree on a positive read.  But in most of these MDL cases, a single positive B-read was deemed sufficient by plaintiffs’ hired witnesses to establish a diagnosis of silicosis.[12]

Judge Jack also stressed that the methodology followed by the B-readers did “not correspond to the ILO’s recommended methodology for applying the ILO classification system, because according to ILO guidelines:

“When classifying radiographs for epidemiological purposes it is essential that the reader does not consider any information about the individuals concerned other than the radiographs themselves.  Awareness of supplementary details specific to the individuals themselves can introduce bias into the results.”[13]

In the cases before her, Judge Jack found that it was obvious that the so-called B-reader was “acutely aware of the precise disease he is supposed to be finding on the X-rays.  In these cases, the doctors repeatedly testified that they were told to look for silicosis, and the doctors did as they were told.”[14] Business pressures had obviously corrupted the diagnostic process, and resulted in improbable consistency in finding silicosis in whomever plaintiffs’ lawyers signed up for litigation.

This corrupt consistency, and obediency to retaining plaintiffs’ counsel, which led to Judge Jack’s approval of the testimony from the hearings that advanced the notion that some degree of blinding is needed to assure the integrity of the diagnostic process. When the radiographic films come from a mass screening, the readers should be confronted with films known to be negative through multiple, independent evaluations.

The third criterion given by Judge Jack for an admissible diagnosis of silicosis, was a proper “differential diagnosis,” which consisted of a showing of “the absence of any good reason to believe that the positive radiographic findings are the result of some other condition.”[15]

One of the physicians whose diagnoses were challenged claimed that this ruling out of other explanations for a radiographic pattern was not required for diagnosing silicosis, but Judge Jack found that this self-serving opinion was contradicted by the major textbooks in the field, by the physicians who showed up to testify in the hearings, and even by the plaintiffs’ own briefs. Judge Jack adverted to the language of Daubert to note that one factor to be considered in the “reliability” of an expert witness’s opinion was its general acceptance in the relevant scientific community.[16] The self-validating views of plaintiffs’ expert witnesses simply were not generally accepted in any legitimate segment of the medical profession. And thus Judge Jack found that, in the MDL cases, the plaintiffs’ expert witnesses’ failure to exclude other alternative causes of the radiographic findings clearly was not generally accepted in the field of occupational medicine, and that their opinions did not satisfy the requirements of Rule 702.[17] A proper differential diagnosis required what was lacking across the board in the cases, namely “a thorough occupational/exposure history and medical history,” as well as a social history that included travel destinations.[18]

In addition to Judge Jack’s carefully reasoned conclusions about the diagnostic “process” used by the challenged expert witnesses, Her Honor was presented with additional evidence of the egregious infirmity of the challenged diagnoses:

– The willingness of one doctor to render opinions on 1,239 plaintiffs in the MDL when he was admittedly not a qualified B-reader, not an expert in silicosis treatment, not qualified to read X-rays or CT scans, did no physical examinations, simply took whatever histories had been given to him by the plaintiffs’ lawyers, and spent a negligible amount of time reviewing each of the plaintiffs’ files.  The doctor testified that his practice consists almost entirely of litigation consulting and that he charges $600 per hour for that work.

– Another doctor’s abandonment of about 3,700 diagnoses under the scrutiny generated by the hearings before Judge Jack.

– The fact that 1,587 claimants who had previously been listed as having asbestosis, with no reference to silica disease, had their diagnoses changed to silicosis, with no reference to asbestos disease.  These diagnoses were produced rapidly and in large groups.

– The fact that a purported epidemic of silicosis apparently began abruptly in early 2001, when plaintiffs’ lawyers turned their attention to this alternative to asbestos litigation, and the fact that many of the silicosis claimants were recycled asbestosis clients of the plaintiffs’ firms.

The specific facts before Judge Jack may seem extreme, but the same or similar abuses have been commonplace in asbestos litigation for a long time before they were outed in the silicosis MDL.  The crucial holdings of In re Silica go beyond the serious depravity of the expert witnesses involved.

Raymark v. Stempel

In 1990, one now defunct asbestos product manufacturer, Raymark Industries, Inc. (“Raymark”), deluged with dubious lawsuits, brought RICO and other claims against medical professionals, lawyers, and claimants.[19]  Raymark based its allegations on deceptions that led it to settle an asbestos personal injury class action.

In ruling upon defendants’ motions to dismiss, the district court found that defendant medical screeners had disregarded standards set by the American Thoracic Society and reported that workers had asbestos-related “injuries” even thought the radiographic interpretations had no clinical significance.  The court stated that the screening program had produced a “steady flow of faulty claims” and was a “fraud on the court.”[20]  The court thus refused to dismiss Raymark’s claims based on common law fraud and RICO violations.[21]

Owens Corning Fiberglass Bankruptcy Proceedings

The efforts to curtail frivolous asbestos claims also include the motion by Credit Suisse in the Owens Corning bankruptcy for leave to file an adversary complaint against certain physicians who reported chest radiographs as positive for asbestos-related diseases.  This motion was granted conditionally on the agreement of Credit Suisse to indemnify Owens Corning for any potential ensuing liability, but then was withdrawn when Credit Suisse declined to provide such assurance.

[1]  Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).

[2]  In re Silica Products Liab.Litig., 398 F.Supp. 2d 563 (S.D.Tex. 2005) (“In re Silica”).

[3]  In re Silica. at 622 (internal citations and footnote omitted).

[4]  In re Silica, at 622 -23.

[5]  Id.

[6]  Id.

[7]  Id.

[8]  Id.

[9]  In re Silica, at 623-34.

[10]  In re Silica, at 625 – 26.

[11]  Id. at 626 – 27 (internal quotes omitted).

[12]  Id. at 626.

[13]  Id.

[14]  Id. at 627.

[15]  Id. at 629.

[16]  Id. at 629 – 30 (citing Daubert, 509 U.S. at 593-94; Pipitone v. Biomatrix, Inc., 288 F.3d 239, 246 (5th Cir. 2002) (upholding admissibility under Rule 702 when a physician’s “elimination of various alternative causes. . . .were [sic] based on generally accepted diagnostic principles related to these conditions”).

[17]  Id. at 629 – 30.

[18]  Id. at 630 – 32 (coccidioidomycosis is endemic to some parts of the United States and resembles silicosis radiographically).

[19]  Raymark Indus., Inc. v. Stemple, 1990 WL 72588 (D. Kan., May 30, 1990).

[20]  1990 WL 72588 at *2, *8, *18, *22.

[21] See Nathan Schachtman, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Sem. Roentgenology 140 (1992) (discussing Semple in greater detail). It is unclear how Stemple was ultimately resolved.  The court’s docket does not indicate whether this case was dismissed, voluntarily, involuntarily, as a result of settlement, or otherwise.  The clerk of the court reported that this case was sealed under court order.

Posted in Asbestos, Expert Witnesses, Rule 702, Silica | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part Two

Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent

June 2nd, 2020

The Advisory Committee notes to the year 2000 amendment to Federal Rule of Evidence 702 included a comment:

“A review of the case law after Daubert shows that the rejection of expert testimony is the exception rather than the rule. Daubert did not work a ‘seachange over federal evidence law’, and ‘the trial court’s role as gatekeeper is not intended to serve as a replacement for the adversary system’.”[internal citation omitted]

In stating its review of the caselaw, perhaps the Committee was attempting to allay the anxiety of technophobic judges. But was the Committee also attempting to derive an “ought” from an “is”?  Before the Supreme Court decided Daubert in 1993, virtually every admissibility challenge to expert witness opinion testimony failed. The trial courts were slow to adapt and to adopt the reframed admissibility standard. As the Joiner case illustrated, some Circuits were even slower to permit trial judges the discretion to assess the validity vel non of expert witnesses’ opinions.

The Committee’s observation about the “exceptional” nature of exclusions was thus unexceptional as a description of the case law before and shortly after Daubert was decided. And even if the Committee were describing a normative view, it is not at all clear how that view should translate into a ruling in a given case, without a very close analysis of the opinions at issue, under the Rule 702 criteria. In baseball, most hitters are thrown out at first base, but that fact does not help an umpire one whit in calling a specific runner “safe” or “out.”  Nonetheless, courts have repeatedly offered the observation about the exceptional nature of exclusion as both an explanation and a justification of their opinions to admit testimony.[1] The Advisory Committee note has thus mutated into a mandate to err on the side of admissibility, as though deliberately committing error was a good thing for any judge to do.[2] First rule: courts shall not err, not intentionally, recklessly, or negligently.

Close Calls and Resolving Doubts

Another mutant offspring of the “exception, not the rule” mantra is that “[a]ny doubts regarding the admissibility of an expert’s testimony should be resolved in favor of admissibility.”[3] Why not resolve the doubts and rule in accordance with the law? Or, if doubts remain, then charge them against the proponent who has the burden of showing admissibility? Unlike baseball, in which a tie goes to the runner, in expert witness law, a tie goes to the challenger because the defender of the motion has failed to show a preponderance in favor of admissibility. A better mantra: “exclusion when it is the Rule.”

Some courts re-imagine the Advisory Committee’s about exceptional exclusions as a recommendation for admitting Rule 702 expert witness opinion testimony as a preferred outcome. Again, that interpretation reverses the burden of proof and makes a mockery of equal justice and scientific due process.

Yet another similar judicial mutation is the notion that courts should refuse Rule 702 motions when they are “close calls.”[4] Telling the litigants that the call was close might help assuage the loser and temper the litigation enthusiasms of the winner, but it does not answer the key question: Did the proponent carry the burden of showing admissibility? Residual doubts would seem to weigh against the proponent.

Not all is lost. In one case, decided by a trial court within the Ninth Circuit, the trial judge explicitly pointed to the proponent’s failure to identify his findings and methodology as part of the basis for exclusion, not admission, of the challenged witness’s opinion testimony.[5] Difficulty in resolving whether the Rule 702 predicates were satisfied worked against, not for, the proponent, whose burden it was to show those predicates.

In another case, Judge David G. Campbell, of the District of Arizona, who has participated in the Rules Committee’s deliberations, showed the way by clearly stating that the exclusion of opinion testimony was required when the Rule 702 conditions were not met:

“Plaintiffs have not shown by a preponderance of the evidence that [the expert witness’s] causation opinions are based on sufficient facts or data to which reliable principles and methods have been applied reliably… .”[6]

Exclusion followed because the absent showings were “conditions for admissibility,” and not “mere” credibility considerations.

Trust Me, I’m a Liberal

One of the reasons that the Daubert Court rejected incorporating the Frye standard into Rule 702 was its view that a rigid “general acceptance” standard “would be at odds with the ‘liberal thrust’ of the Federal Rules.”[7] Some courts have cited this “liberal thrust” as though it explained or justified a particular decision to admit expert witness opinion testimony.[8]

The word “liberal” does not appear in the Federal Rules of Evidence.  Instead, the Rules contain an explicit statement of how judges must construe and apply the evidentiary provisions:

“These rules shall be construed to secure fairness in administration, elimination of unjustifiable expense and delay, and promotion of growth and development of the law of evidence to the end that the truth may be ascertained and proceedings justly determined.”[9]

A “liberal” approach, construed as a “let it all in” approach would be ill-designed to secure fairness, eliminate unjustifiable expense and time of trial, or lead to just and correct outcomes.  The “liberal” approach of letting in opinion testimony and let the jury guess at questions of scientific validiy would be a most illiberal result.  The truth will not be readily ascertained if expert witnesses are permitted to pass off hypotheses and ill-founded conclusions as scientific knowledge.

Avoiding the rigidity of the Frye standard, which was so rigid that it was virtually never applied, certainly seems like a worthwhile judicial goal. But how do courts go from the Justice Blackmun’s “liberal thrust” to infer a libertine “anything goes”? And why does liberal not connote seeking of the truth, free of superstitions? Can it be liberal to permit opinions that are based upon fallacious or flawed inferences, invalid studies, or cherry-picked data sets?

In reviewing the many judicial dodges that are used to avoid engaging in meaningful Rule 702 gatekeeping, I am mindful of Reporter Daniel Capra’s caveat that the ill-advised locutions used by judges do not necessarily mean that their decisions might not be completely justifiable on a carefully worded and reasoned opinion that showed that Rule 702 and all its subparts were met. Of course, we could infer that the conditions for admissibility were met whenever an expert witness’s opinions were admitted, and ditch the whole process of having judges offer reasoned explanations. Due process, however, requires more. Judges need to specify why they denied Rule 702 challenges in terms of the statutory requirements for admissibility so that other courts and the Bar can develop a principled jurisprudence of expert witness opinion testimony.

[1]  See, e.g., In re Scrap Metal Antitrust Litig., 527 F.3d 517, 530 (6th Cir. 2008) (“‘[R]ejection of expert testimony is the exception, rather than the rule,’ and we will generally permit testimony based on allegedly erroneous facts when there is some support for those facts in the record.”) (quoting Advisory Committee Note to 2000 Amendments to Rule 702); Citizens State Bank v. Leslie, No. 6-18-CV-00237-ADA, 2020 WL 1065723, at *4 (W.D. Tex. Mar. 5, 2020) (rejecting challenge to expert witness opinion “not based on sufficient facts”; excusing failure to assess factual basis with statement that “the rejection of expert testimony is the exception rather than the rule.”); In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., No. 2:18-CV-00136, 2019 WL 6894069, at *2 (S.D. Ohio Dec. 18, 2019) (committing naturalistic fallacy; “[A] review of the case law … shows that rejection of the expert testimony is the exception rather than the rule.”): Frankenmuth Mutual Insur. Co. v. Ohio Edison Co., No. 5:17CV2013, 2018 WL 9870044, at *2 (N.D. Ohio Oct. 9, 2018) (quoting Advisory Committee Note “exception”); Wright v. Stern, 450 F. Supp. 2d 335, 359–60 (S.D.N.Y. 2006)(“Rejection of expert testimony, however, is still ‘the exception rather than the rule,’ Fed.R.Evid. 702 advisory committee’s note (2000 Amendments)[.] . . . Thus, in a close case the testimony should be allowed for the jury’s consideration.”) (internal quotation omitted).

[2]  Lombardo v. Saint Louis, No. 4:16-CV-01637-NCC, 2019 WL 414773, at *12 (E.D. Mo. Feb. 1, 2019) (“[T]he Court will err on the side of admissibility.”).

[3]  Mason v. CVS Health, 384 F. Supp. 3d 882, 891 (S.D. Ohio 2019).

[4]  Frankenmuth Mutual Insur. Co. v. Ohio Edison Co., No. 5:17CV2013, 2018 WL 9870044, at *2 (N.D. Ohio Oct. 9, 2018) (concluding “[a]lthough it is a very close call, the Court declines to exclude Churchwell’s expert opinions under Rule 702.”); In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., No. 2:18-CV-00136, 2019 WL 6894069, at *2 (S.D. Ohio Dec. 18, 2019) (suggesting doubts should be resolved in favor of admissibility).

[5]  Rovid v. Graco Children’s Prod. Inc., No. 17-CV-01506-PJH, 2018 WL 5906075, at *13 (N.D. Cal. Nov. 9, 2018), app. dism’d, No. 19-15033, 2019 WL 1522786 (9th Cir. Mar. 7, 2019).

[6]  Alsadi v. Intel Corp., No. CV-16-03738-PHX-DGC, 2019 WL 4849482, at *4 -*5 (D. Ariz. Sept. 30, 2019).

[7]  Daubert v. Merrell Dow Pharms., Inc. 509 U.S. 579, 588 (1993).

[8]  In re ResCap Liquidating Trust Litig., No. 13-CV-3451 (SRN/HB), 2020 WL 209790, at *3 (D. Minn. Jan. 14, 2020) (“Courts generally support an attempt to liberalize the rules governing the admission of expert testimony, and favor admissibility over exclusion.”)(internal quotation omitted); Collie v. Wal-Mart Stores East, L.P., No. 1:16-CV-227, 2017 WL 2264351, at *1 (M.D. Pa. May 24, 2017) (“Rule 702 embraces a ‘liberal policy of admissibility’, under which it is preferable to admit any evidence that may assist the factfinder[.]”); In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007); Billone v. Sulzer Orthopedics, Inc., No. 99-CV-6132, 2005 WL 2044554, at *3 (W.D.N.Y. Aug. 25, 2005) (“[T]he Supreme Court has emphasized the ‘liberal thrust’ of Rule 702, favoring the admissibility of expert testimony.”).

[9]  Federal Rule of Evidence Rule 102 (“Purpose and Construction”) (emphasis added).

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