TORTINI

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

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.

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). SeeMisplaced 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).

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).

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]  SeeSerpentine 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]  SeeJudicial 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).