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

Regressive Methodology in Pharmaco-Epidemiology

October 24th, 2020

Medications are rigorously tested for safety and efficacy in clinical trials before approval by regulatory agencies such as the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA). The approval process, however, contemplates that more data about safety and efficacy will emerge from the use of approved medications in pharmacoepidemiologic studies conducted outside of clinical trials. Litigation of safety outcomes rarely arises from claims based upon the pivotal clinical trials that were conducted for regulatory approval and licensing. The typical courtroom scenario is that a safety outcome is called into question by pharmacoepidemiologic studies that purport to find associations or causality between the use of a specific medication and the claimed harm.

The International Society for Pharmacoepidemiology (ISPE), established in 1989, describes itself as an international professional organization intent on advancing health through pharmacoepidemiology, and related areas of pharmacovigilance. The ISPE website defines pharmacoepidemiology as

“the science that applies epidemiologic approaches to studying the use, effectiveness, value and safety of pharmaceuticals.”

The ISPE conceptualizes pharmacoepidemiology as “real-world” evidence, in contrast to randomized clinical trials:

“Randomized controlled trials (RCTs) have served and will continue to serve as the major evidentiary standard for regulatory approvals of new molecular entities and other health technology. Nonetheless, RWE derived from well-designed studies, with application of rigorous epidemiologic methods, combined with judicious interpretation, can offer robust evidence regarding safety and effectiveness. Such evidence contributes to the development, approval, and post-marketing evaluation of medicines and other health technology. It enables patient, clinician, payer, and regulatory decision-making when a traditional RCT is not feasible or not appropriate.”

ISPE Position on Real-World Evidence (Feb. 12, 2020) (emphasis in original).

The ISPE publishes an official journal, Pharmacoepidemiology and Drug Safety, and sponsors conferences and seminars, all of which are watched by lawyers pursuing and defending drug and device health safety claims. The endorsement by the ISPE of the American Statistical Association’s 2016 statement on p-values is thus of interest not only to statisticians, but to lawyers and claimants involved in drug safety litigation.

The ISPE, through its board of directors, formally endorsed the ASA 2016 p-value statement on April 1, 2017 (no fooling) in a statement that can be found at its website:

The International Society for Pharmacoepidemiology, ISPE, formally endorses the ASA statement on the misuse of p-values and accepts it as an important step forward in the pursuit of reasonable and appropriate interpretation of data.

On March 7, 2016, the American Statistical Association (ASA) issued a policy statement that warned the scientific community about the use P-values and statistical significance for interpretation of reported associations. The policy statement was accompanied by an introduction that characterized the reliance on significance testing as a vicious cycle of teaching significance testing because it was expected, and using it because that was what was taught. The statement and many accompanying commentaries illustrated that p-values were commonly misinterpreted to imply conclusions that they cannot imply. Most notably, “p-values do not measure the probability that the studied hypothesis is true, or the probability that the data were produced by random chance alone.” Also, “a p-value does not provide a good measure of evidence regarding a model or hypothesis.” Furthermore, reliance on p-values for data

interpretation has exacerbated the replication problem of scientific work, as replication of a finding is often confused with replicating the statistical significance of a finding, on the erroneous assumption that replication should lead to studies getting similar p-values.

This official statement from the ASA has ramifications for a broad range of disciplines, including pharmacoepidemiology, where use of significance testing and misinterpretation of data based on P-values is still common. ISPE has already adopted a similar stance and incorporated it into our GPP [ref] guidelines. The ASA statement, however, carries weight on this topic that other organizations cannot, and will inevitably lead to changes in journals and classrooms.

There are points of interpretation of the ASA Statement, which can be discussed and debated. What is clear, however, is that the ASA never urged the abandonment of p-values or even of statistical significance. The Statement contained six principles, some of which did nothing other than to attempt to correct prevalent misunderstandings of p-values. The third principle stated that “[s]cientific conclusions and business or policy decisions should not be based only on whether a p-value passes a specific threshold.” (emphasis added).

This principle, as stated, thus hardly advocated for the abandonment of a threshold in testing; rather it made the unexceptional point that the ultimate scientific conclusion (say about causality) required more assessment than only determining whether a p-value passed a specified threshold.

Presumably, the ISPE’s endorsement of the ASA’s 2016 Statement embraces all six of the articulated principles, including the ASA’s fourth principle:

4. Proper inference requires full reporting and transparency

P-values and related analyses should not be reported selectively. Conducting multiple analyses of the data and reporting only those with certain p-values (typically those passing a significance threshold) renders the reported p-values essentially uninterpretable. Cherry-picking promising findings, also known by such terms as data dredging, significance chasing, significance questing, selective inference, and “p-hacking,” leads to a spurious excess of statistically significant results in the published literature and should be vigorously avoided. One need not formally carry out multiple statistical tests for this problem to arise: Whenever a researcher chooses what to present based on statistical results, valid interpretation of those results is severely compromised if the reader is not informed of the choice and its basis. Researchers should disclose the number of hypotheses explored during the study, all data collection decisions, all statistical analyses conducted, and all p-values computed. Valid scientific conclusions based on p-values and related statistics cannot be drawn without at least knowing how many and which analyses were conducted, and how those analyses (including p-values) were selected for reporting.”

The ISPE’s endorsement of the ASA 2016 Statement references the ISPE’s own

Guidelines for Good Pharmacoepidemiology Practices (GPP),” which were promulgated initially in 1996, and revised as recently as June 2015. Good practices, as of 2015, provided that:

“Interpretation of statistical measures, including confidence intervals, should be tempered with appropriate judgment and acknowledgements of potential sources of error and limitations of the analysis, and should never be taken as the sole or rigid basis for concluding that there is or is not a relation between an exposure and outcome. Sensitivity analyses should be conducted to examine the effect of varying potentially critical assumptions of the analysis.”

All well and good, but this “good practices” statement might be taken as a bit anemic, given that it contains no mention of, or caution against, unqualified or unadjusted confidence intervals or p-values that come from multiple testing or comparisons. The ISPE endorsement of the ASA Statement now expands upon the ISPE’s good practices to include the avoidance of multiplicity and the disclosure of the full extent of analyses conducted in a study.

What happens in the “real world” of publishing, outside the board room?

Last month, the ISPE conducted its (virtual) 36th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. The abstracts and poster presentations from this Conference were published last week as a Special Issue of the ISPE journal. I spot checked the journal contents to see how well the presentations lived up to the ISPE’s statistical aspirations.

One poster presentation addressed statin use and skin cancer risk in a French prospective cohort.[1]  The authors described their cohort of French women, who were 40 to 65 years old, in 1990, and were followed forward. Exposure to statin medications was assessed from 2004 through 2014. The analysis included outcomes of any skin cancer, melanoma, basal-cell carcinoma (BCC), and squamous-call carcinoma (SCC), among 66,916 women. Here is how the authors describe their findings:

There was no association between ever use of statins and skin cancer risk: the HRs were 0.96 (95% CI = 0.87-1.05) for overall skin cancer, 1.18 (95% CI = 0.96-1.47) for melanoma, 0.89 (95% CI = 0.79-1.01) for BCC, and 0.90 (95% CI = 0.67-1.21) for SCC. Associations did not differ by statin molecule nor by duration or dose of use. However, women who started to use statins before age 60 were at increased risk of BCC (HR = 1.45, 95% CI = 1.07-1.96 for ever vs never use).

To be fair, this was a poster presentation, but this short description of findings makes clear that the investigators looked at least at the following subgroups:

Exposure subgroups:

  • specific statin drug
  • duration of use
  • dosage
  • age strata


Outcome subgroups:

  • melanoma
  • basal-cell carcinoma
  • squamous-cell carcinoma

The reader is not told how many specific statins, how many duration groups, dosage groups, and age strata were involved in the exposure analysis. My estimate is that the exposure subgroups were likely in excess of 100. With three disease outcome subgroups, the total subgroup analyses thus likely exceeded 300. The authors did not provide any information about the full extent of their analyses.

Here is how the authors reported their conclusion:

“These findings of increased BCC risk in statin users before age 60 deserve further investigations.”

Now, the authors did not use the phrase “statistically significant,” but it is clear that they have characterized a finding of “increased BCC risk in statin users before age 60,” and in no other subgroup, and they have done so based upon a reported nominal “HR = 1.45, 95% CI = 1.07-1.96 for ever vs never use.” It is also clear that the authors have made no allowance, adjustment, modification, or qualification, for the wild multiplicity arising from their estimated 300 or so subgroups. Instead, they made an unqualified statement about “increased BCC risk,” and they offered an opinion about the warrant for further studies.

Endorsement of good statistical practices is a welcome professional organizational activity, but it is rather meaningless unless the professional societies begin to implement the good practices in their article selection, editing, and publishing activities.

[1]  Marie Al Rahmoun, Yahya Mahamat-Saleh, Iris Cervenka, Gianluca Severi, Marie-Christine Boutron-Ruault, Marina Kvaskoff, and Agnès Fournier, “Statin use and skin cancer risk: A French prospective cohort study,” 29 Pharmacoepidemiol. & Drug Safety s645 (2020).

Two Schools of Thought for Warning Standards

September 19th, 2020

In products liability litigation over designs and warnings, a supplier or manufacturer is typically held to the knowledge and expertise of an expert in the relevant field. Experts, especially in the early days of understanding a newly identified putative risk, may disagree on the quality and quantity of evidence in support of the claimed risk. And of course they may dispute whether the claimed risk exists at all, or the criteria by which the risk should be established. Unfortunately, the law offers little help in answering the obvious question of which expert or group of experts, and which criteria, of all the experts and criteria in the world, are the appropriate reference standards. The point of adverting to experts is, no doubt, that the law knows nothing about causal claims unless there is admissible and sufficient evidence of the risk, typically from a qualified expert, serving as an expert witness, who proffers an opinion about causal claim.

The standard formulation evades the necessity of confronting the epistemic standard for knowledge of the risk by pointing to some expert’s or group of experts’ opinion. Rather than looking directly at whether the causal claim is “true, justified belief,” the law asks whether expert witnesses hold such opinions. This maneuver has several inherent risks of its own. First, it transmutes factfinding into an exercise in the sociology or sampling of expert witnesses. In the case of claims that involve long latencies between the exposure to the putative risk and the manifestation of harm, this sociological exercise becomes one of intellectual history. One of the reasons that the Frye standard was so difficult in practice was its insistence that courts ascertain whether a particular claim or a use of scientific device was “generally accepted.” The assessment of the relevant expert’s knowledge of risk has generally not gone well in litigation contexts. Second, the maneuver of looking to experts’ opinions introduces a different kind of risk; that is, the maneuver risks diluting the standard for warning, “knowledge and expertise” to subjective opinion, hunches, conjecture, and the like.

An analogue of the standard for warning of risks may be found in the law of medical malpractice. Historically, American law relied heavily upon generally held opinions as the measure of knowledge, which were incorporated into standards of reasonable professional care. The law that governs litigation over the quality of medical care in many states resolves this issue by providing a defense under the “Two Schools of Thought Doctrine.”[1] A physician does not deviate from the standard of care simply because many or even most physicians reject the approach he or she took in the care and treatment of the aggrieved patient’s problem. As long as a substantial minority of physicians would have concurred in the judgment of the defendant physician, the claim of malpractice fails.

Pennsylvania confronted the nose-counting problem in Jones v. Chidester, by passing the buck to the jury. The Pennsylvania Supreme Court held that a physician would escape liability if his medical treatment received the support of a “considerable number” of medical experts.[2] The court allocated to the jury the factual determination how many recognized and respected medical experts were needed to create a “school of thought,” but it left completely unclear how a jury would make such a determination.[3]

The law’s lassitude in relying upon professional custom and opinion, rather than whether the custom had sound evidentiary and methodological foundations, might be taken as deference to, and protection of, the medical profession. Or, less charitably, this reliance might be taken as intellectual laziness to avoid engagement with the intellectual basis for the custom or the school of thought. Indeed, the continuing validity of the “nose-counting” approach may certainly be questioned in the era of “evidence-based medicine,” which rejects custom as the basis for medical interventions in favor of the novelty of evidence itself.[4]

If the Two Schools Doctrine should be good law, it has obvious implications for the standard of design or warning in products cases, as well as for the standard of causation. How can a judge or jury impose liability upon a manufacturer for failing to warn about a risk that “a school of thought” among scientists believes is not a risk? An even more extreme disparity arises when the jury or judge comes to the belief that a manufacturer deserves to be punished for failing to warn about supposed risks when many scientists and even regulators do not believe exist.

It is a mystery.

[1]        See, e.g., MacDonald v. United States, 767 F. Supp. 1295, 1308 (M.D. Pa. 1991) (outlining the history and development of the two-schools doctrine under Pennsylvania law); Young v. United States, 574 F. Supp. 571, 581 (D. Del. 1983) (holding that medical profession’s acceptance of alternative appropriate remedies is a complete defense to claim of negligence for failing to use another remedy);  Scheuler v. Strelinger, 204 A.2d 577, 204 A.2d 577, 585  (1964).

[2]        Jones v. Chidester, 531 Pa. 31, 610 A.2d 964, 967 (1992).

[3]        See, e.g., Dailey, “The Two Schools of Thought and Informed Consent Doctrine in Pennsylvania,” 98 Dickenson L. Rev. 713 (1994); Douglas Rader Brown, “Panacea or Pandora’s Box: The ‘Two Schools of Medical Thought’ Doctrine after Jones v. Chidester, 610 A.2d 964 (Pa. 1992),” 44 J. Urban & Contemp. Law 223 (1993).

[4]           See Terence M. Davidson & Christopher P. Guzelian, “Evidence-Based Medicine (EBM): The (Only) Means for Distinguishing Knowledge of Medical Causation from Expert Opinion in the Courtroom,” 47 Trial & Insur. Prac. L. J. 741 (2012) (discussing the advent of evidence-based medicine and its implications for medical education an practice).

The Defenestration of Sir Ronald Aylmer Fisher

August 20th, 2020

Fisher has been defenestrated. Literally.

Sir Ronald Fisher was a brilliant statistician. Born in 1890, he won a scholarship to Gonville and Caius College, in Cambridge University, in 1909. Three years later, he gained first class honors in Mathematics, and he went on to have extraordinary careers in genetics and statistics. In 1929, Fisher was elected to the Royal Society, and in 1952, Queen Bessy knighted him for his many contributions to the realm, including his work on experimental design and data interpretation, and his bridging the Mendelian theory of genetics and Darwin’s theory of evolution. In 1998, Bradley Efron described Fisher as “the single most important figure in 20th century statistics.[1] And in 2010, University College, London, established the “R. A. Fisher Chair in Statistical Genetics” in honor of Fisher’s remarkable contributions to both genetics and statistics. Fisher’s college put up a stained-glass window to celebrate its accomplished graduate.

Fisher was, through his interest in genetics, also interested in eugenics through the application of genetic learning to political problems. For instance, he favored abolishing extra social support to large families, in favor of support proportional to the father’s wages. Fisher also entertained with some seriousness grand claims about the connection between rise and fall of civilizations and the loss of fertility among the upper classes.[2] While a student at Caius College, Fisher joined the Cambridge Eugenics Society, as did John Maynard Keynes. For reasons having to do with professional jealousies, Fisher’s appointment at University College London, in 1933, was as a professor of Eugenics, not Statistics.

After World War II, an agency of the United Nations, the United Nations Educational, Scientific and Cultural Organization (UNESCO) sought to forge a scientific consensus against racism, and Nazi horrors.[3] Fisher participated in the UNESCO commission, which he found to be “well-intentioned” but errant for failing to acknowledge inter-group differences “in their innate capacity for intellectual and emotional development.”[4]

Later in the UNESCO report, Fisher’s objections are described as the same as those of Herman Joseph Muller, who won the Nobel Prize for Medicine in 1946, The report provides Fisher’s objections in his own words:

“As you ask for remarks and suggestions, there is one that occurs to me, unfortunately of a somewhat fundamental nature, namely that the Statement as it stands appears to draw a distinction between the body and mind of men, which must, I think, prove untenable. It appears to me unmistakable that gene differences which influence the growth or physiological development of an organism will ordinarily pari passu influence the congenital inclinations and capacities of the mind. In fact, I should say that, to vary conclusion (2) on page 5, ‘Available scientific knowledge provides a firm basis for believing that the groups of mankind differ in their innate capacity for intellectual and emotional development,’ seeing that such groups do differ undoubtedly in a very large number of their genes.”[5]

Fisher’s comments may not be totally anodyne by today’s standards, but he had also commented that that:

“the practical international problem is that of learning to share the resources of this planet amicably with persons of materially different nature, and that this problem is being obscured by entirely well-intentioned efforts to minimize the real differences that exist.”[6]

Fisher’s comments seem to reflect his beliefs in the importance of the genetic contribution to “intelligence and emotional development,” which today retain both their plausibility and controversial status. Fisher’s participation in the UNESCO effort, and his emphasis on sharing resources peacefully, seem to speak against malignant racism, and distinguish him from the ugliness of the racism expressed by the Marxist statistician (and eugenicist) Karl Pearson.[7]

Cancel Culture Catches Up With Sir Ronald A. Fisher

Nonetheless the Woke mob has had its daggers out for Sir Ronald, for some time. Back in June of this year, graffiti covered the walls of Caius College, calling for the defenestration of Fisher.  A more sedate group circulated a petition for the removal of the Fisher window.[8] Later that month, the university removed the Fisher window, literally defenestrating him.[9]

The de-platforming of Fisher was not contained to the campus of a college in Cambridge University.  Fisher spent some of his most productive years, outside the university, at the Rothamsted Experimental Station.  Not to be found deficient in the metrics of social justice, Rothamsted Research issued a statement, on June 9, 2020, concerning its most famous resident scientist:

“Ronald Aylmer Fisher is often considered to have founded modern statistics. Starting in 1919, Fisher worked at Rothamsted Experimental Station (as it was called then) for 14 years.

Among his many interests, Fisher supported the philosophy of eugenics, which was not uncommon among intellectuals in Europe and America in the early 20th Century.

The Trustees of the Lawes Agricultural Trust, therefore, consider it appropriate to change the name of the Fisher Court accommodation block (opened in 2018 and named after the old Fisher Building that it replaced) to ‘AnoVa Court’, after the analysis of variance statistical test developed by Fisher’s team at Rothamsted, and which is widely used today. Arrangements for this change of name are currently being made.”

I suppose that soon it will verboten to mention Fisher’s Exact Test.

Daniel Cleather, a scientist and self-proclaimed anarchist, goes further and claims that the entire enterprise of statistics is racist.[10] Cleather argues that mathematical models of reality are biased against causal explanation, and that this bias supports eugenics and politically conservative goals. Cleather claims that statistical methods were developed “by white supremacists for the express purpose of demonstrating that white men are better than other people.” Cleather never delivers any evidence, however, to support his charges, but he no doubt feels strongly about it, and feels unsafe in the presence of Fisher’s work on experimental methods.

It is interesting to compare the disparate treatment that other famous scholars and scientists are receiving from the Woke. Aristotle was a great philosopher and “natural philosopher” scientist. There is a well-known philosophical society, the Aristotlean Society, obviously named for Aristotle, as is fitting. In the aftermath of the killings of George Floyd, Breonna Taylor and Ahmaud Arbery, the Aristotlean Society engaged in this bit of moral grandstanding, of which The Philosopher would have likely disapproved:

A statement from the Aristotelian Society

“The recent killings of George Floyd, Breonna Taylor and Ahmaud Arbery have underlined the systemic racism and racial injustice that continue to pervade not just US but also British society. The Aristotelian Society stands resolutely opposed to racism and discrimination in any form. In line with its founding principles, the Society is committed to ensuring that all its members can meet on an equal footing in the promotion of philosophy. In order to achieve this aim, we will continue to work to identify ways that we can improve, in consultation with others. We recognise it as part of the mission of the Society to actively promote philosophical work that engages productively with issues of race and racism.”

I am sure it occurred to the members of the Society that Aristotle had expressed a view that some people were slaves by nature.[11] Today, we certainly do not celebrate Aristotle for this view, but we have not defenestrated him for a view much more hateful than any expressed by Sir Ronald. My point is merely that the vaunted Aristotelian Society is well able to look at the entire set of accomplishments of Aristotle, and not throw him out the window for his views on slavery. Still, if you have art work depicting Aristotle, you may be wise to put it out of harms way.

If Aristotle’s transgressions were too ancient for the Woke mob, then consider those of Nathan Roscoe Pound, who was the Dean of Harvard Law School, from 1916 to 1936. Pound wrote on jurisprudential issues, and he is generally regarded as the founder of “sociological jurisprudence,” which seeks to understand law as influenced and determined by sociological conditions. Pound is celebrated especially by the plaintiffs’ bar, for his work for National Association of Claimants‘ Compensation Attorneys, which was the precursor to the Association of Trial Lawyers of America, and the current, rent-seeking, American Association for Justice. A group of “compensation lawyers” founded the Roscoe Pound –American Trial Lawyers Foundation (now the The Pound Civil Justice Institute) in 1956, to build on Pound’s work.

Pound died in 1964, but he lives on in the hearts of social justice warriors, who seem oblivious of Pound’s affinity for Hitler and Nazism.[12] Pound’s enthusiasm was not a momentary lapse, but lasted a decade according to Daniel R. Coquillette, professor of American legal history at Harvard Law School.[13] Although Pound is represented in various ways as having been a great leader throughout the Harvard Law School, Coquillette says that volume two of his history of the school will address the sordid business of Pound’s Nazi leanings. In the meanwhile, no one is spraying graffiti on Pound’s portraits, photographs, and memorabilia, which are scattered throughout the School.

I would not want my defense of Fisher to be taken as a Trumpist “what-about” rhetorical diversion. Still, the Woke criteria for defenestrations seem, at best, to be applied inconsistently. More important, the Woke seem to have no patience for examining the positive contributions made by those they denounce. In Fisher’s (and Aristotle’s) case, the balance between good and bad ideas, and the creativity and brilliance of his important contributions, should allow of people of good will to celebrate his many achievements, without moral hand waving. If the Aristotelian Society can keep its name, the Cambridge should be able to keep its stained-glass window memorial to Fisher.

[1]        Bradley Efron, “R. A. Fisher in the 21st century,” 13 Statistical Science 95, 95 (1998).

[2]        See Ronald A. Fisher, The Genetical Theory of Natural Selection 228-55 (1930) (chap. XI, “Social Selection of Fertility,” addresses the “decay of ruling classes”).

[3]        UNESCO, The Race Concept: Results of an Inquiry (1952).

[4]        Id. at 27 (noting that “Sir Ronald Fisher has one fundamental objection to the Statement, which, as he himself says, destroys the very spirit of the whole document. He believes that human groups differ profoundly “in their innate capacity for intellectual and emotional development.”)

[5]        Id. at 56.

[6]        Id. at 27.

[7]        Karl Pearson & Margaret Moul, “The Problem of Alien Immigration into Great Britain, Illustrated by an Examination of Russian and Polish Jewish Children, Part I,” 1 Ann. Human Genetics 5 (1925) (opining that Jewish immigrants “will develop into a parasitic race. […] Taken on the average, and regarding both sexes, this alien Jewish population is somewhat inferior physically and mentally to the native population.” ); “Part II,” 2 Ann. Human Genetics 111 (1927); “Part III,” 3 Ann. Human Genetics 1 (1928).

[8]        “Petition: Remove the window in honour of R. A. Fisher at Gonville & Caius, University of Cambridge.” See Genevieve Holl-Allen, “Students petition for window commemorating eugenicist to be removed from college hall; The petition surpassed 600 signatures in under a day,” The Cambridge Tab (June 2020).

[9]        Eli Cahan, “Amid protests against racism, scientists move to strip offensive names from journals, prizes, and more,” Science (July 2, 2020); Sam Kean “Ronald Fisher, a Bad Cup of Tea, and the Birth of Modern Statistics: A lesson in humility begets a scientific revolution,” Distillations (Science History Institute) (Aug. 6, 2019). Bayesians have been all-too-happy to throw shade at Fisher. See Eric-Jan Wagenmakers & Johnny van Doorn, “This Statement by Sir Ronald Fisher Will Shock You,” Bayesian Spectacles (July 2, 2020).

[10]      Daniel Cleather, “Is Statistics Racist?Medium (Mar. 9, 2020).

[11]      Aristotle, Politics, 1254b16–21.

[12]      James Q. Whitman, Hitler’s American Model: The United States and the Making of Nazi Race Law 15 & n. 39 (2017); Stephen H. Norwood, The Third Reich in the Ivory Tower 56-57 (2009); Peter Rees, “Nathan Roscoe Pound and the Nazis,”  60 Boston Coll. L. Rev. 1313 (2019); Ron Grossman, “Harvard accused of coddling Nazis,” Chicago Tribune (Nov. 30, 2004).

[13]      Garrett W. O’Brien, “The Hidden History of the Harvard Law School Library’s Treasure Room,” The Crimson (Mar. 28, 2020).

Tort Law’s Sleight of Hand – Part 6

August 11th, 2020

The dissenting justices, in an opinion by Justice Gorsuch, would have affirmed the trial court’s application of the bright-line bare metal defense, in DeVries. Citing black-letter law as restated by the American Law Institute, the dissent opined that the common law precedent and policy favored a rule that “the supplier of a product generally must warn about only those risks associated with the product itself, not those associated with the ‘products and systems into which [it later may be] integrated’.”[1]

The dissent criticized the court’s retrospective imposition of a liability rule and its ignoring common law precedent, as well as the unpredictability and cost of the court’s new rule, and the breadth and the difficulty of cabining the three-part test. As part of its criticism of the majority opinion, the dissent argued that the stated rule will lead to incoherent and incongruous results, and presented a parade of horribles that might arise within the scope of the new rule:

“The traditional common law rule [which would recognize the bare metal defense] better accords, too, with consumer expectations. A home chef who buys a butcher’s knife may expect to read warnings about the dangers of knives but not about the dangers of undercooked meat. Likewise, a purchaser of gasoline may expect to see warnings at the pump about its flammability but not about the dangers of recklessly driving a car.”[2]

How telling that all the envisioned bad legal consequences involve one-on-one consumer cases, without the presence of a sophisticated employer as intermediary, operating under a complex regulatory scheme to provide a comprehensive safety program to the end user!

The dissent continues its vision of bad consequences by contemplating the substantial costs placed upon product manufacturers whose products are meant to be used with other companies’ products:

“Consider what might follow if the Court’s standard were widely adopted in tort law. Would a company that sells smartphone cases have to warn about the risk of exposure to cell phone radiation? Would a car maker have to warn about the risks of improperly stored antifreeze? Would a manufacturer of flashlights have to warn about the risks associated with leaking batteries? Would a seller of hot dog buns have to warn about the health risks of consuming processed meat?”[3]

Again, the dissent is fixated on consumer products, used by ordinary consumers, outside of a heavily regulated workplace, and without the need for a highly technical industrial hygiene safety regimen.

When the dissent considered the issue of who was in the best position to warn, Justice Gorsuch simply argued, without evidence, that the parts supplier, not the bare metal manufacturer was in the “best position” to warn:

“The manufacturer of a product is in the best position to understand and warn users about its risks; in the language of law and economics, those who make products are generally the least-cost avoiders of their risks. By placing the duty to warn on a product’s manufacturer, we force it to internalize the full cost of any injuries caused by inadequate warnings—and in that way ensure it is fully incentivized to provide adequate warnings. By contrast, we dilute the incentive of a manufacturer to warn about the dangers of its products when we require other people to share the duty to warn and its corresponding costs.”[4]

Of course, in McAffee’s case, the asbestos insulation manufacturers had been warning for over a decade before he started his service in the Navy. As documented by the plaintiffs’ own expert witness, Barry Castleman:

“In 1964, Johns-Manville (“J-M”) was among the first companies to provide warnings with its asbestos-containing products, namely its asbestos insulation. During and after this time frame, J-M sold asbestos insulation to the United States military. In any extensive review of J-M documents, which have included visits to the J-M archives in Denver, Colorado, I have never seen any evidence that J-M removed or altered the warning labels that appeared on its asbestos insulation for sales to the United States military.”[5]

As for the argument without evidence about which party, bare metal manufacturer or asbestos-insulation manufacturer, can “best” warn, all the justices ignored the party that can truly best warn, the government. Placing liability on any supplier dilutes the incentive for the Navy to carry out its statutory duties. As Justice Gorsuch acknowledged:

“Tort law is supposed to be about aligning liability with responsibility, not mandating a social insurance policy in which everyone must pay for everyone else’s mistakes.”[6]

It really is time for remote suppliers to stop having to pay for injuries caused by their purchasers, especially when the purchasers are knowledgeable and have duties to protect their employees from the injuries claims.

As disconnected as the justices in DeVries were from the realities of military service-related and industrial injuries, there is some good news to come out of the high court. First, despite the suggestions of why there might be a duty, the  Court did not hold that there was a duty; it provided three considerations for the trial court’s determining whether a duty exists, on remand.

Second, the Court located the relevant considerations for the existence and scope of a putative duty in Section 388. Although all the justices missed the relevance of this section to the three-way industrial situation, the case law under Section 388 is voluminous, and speaks directly to the situation of a “chattel to be supplied for the use of another.” In fairness to the Court, and to the parties, the case did not go up on appeal on the basis of a “sophisticated intermediary” defense. Summary judgment had been granted below on the simple notion that a seller should not be responsible for warning of another company’s product. The manufacturer appellants did extensively discuss Navy knowledge or changing “state of the art,” in their briefs. At best, the appellants’  discussions were tangential. The shape of the initial summary judgment motion may have been shaped by an earlier decision of the asbestos MDL court, which rejected the sophisticated intermediary defense under maritime law.[7] The Supreme Court’s embrace of Section 388, and its incorporation of 388’s standards, into the three articulated conditions for the existence of a duty (and particularly into the third condition, “the manufacturer has no reason to believe that the product’s users will realize that danger.”).

Third, there is a renewed summary judgment motion now pending before the MDL court. In addition to now explicitly raising a government contractor defense,[8] the defendants have carefully marshaled the evidence of Navy knowledge to show that the third condition of DeVries must necessarily fail: the manufacturer had ample reason to believe that the product’s users will realize the relevant danger.[9]

[1]  DeVries, 139 S.Ct. at 997 (Gorsuch, J., dissenting) (quoting from Restatement (Third) of Torts: Products Liability § 5, Comment b, p. 132 (1997)).

[2]  DeVries, 139 S.Ct. at 998 (Gorsuch, J., dissenting).

[3]  DeVries, 139 S.Ct. at 999 (Gorsuch, J., dissenting).

[4]  DeVries, 139 S.Ct. at 999 (Gorsuch, J., dissenting) (citing Steven Shavell, Economic Analysis of Accident Law 17 (1987); Guido Calabresi, The Costs of Accidents 135 & n. 1 (1970); Italia Societa per Azioni di Navigazione v. Oregon Stevedoring Co., 376 U.S. 315, 324 (1964)).

[5]  Declaration of Barry L. Castleman (July 18, 2008), in Joint Appendix, vol. 2,  at 462, in Air and Liquid Systems Corp. v. DeVries, No. 17-1104 (filed July 9, 2018), available at <>

[6]  DeVries, 139 S.Ct. at 999 (Gorsuch, J., dissenting).

[7]  Mack v. General Electric Co., 896 F. Supp. 2d 333 (E.D. Pa. 2012).

[8]  Boyle v. United Technologies Corp., 487 U.S. 500 (1988).

[9]  See Memorandum of Law in support of Defendant General Electric Company’s Renewed Motion for Summary Judgment, in DeVries v. General Elec. Co., no. 5:13-cv-00474-ER, docket entry no. 396 (E.D. Pa. filed April, 1, 2020).

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