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

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).

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”).

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.

Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

May 13th, 2020

Explaining the denial of a Rule 702 motion in terms of the availability of cross-examination is just one among several dodges that judges use to avoid fully engaging with Rule 702’s requirements.[1] Another dodge involves shifting the burden of proof on admissibility from the proponent of the challenged expert witness to the challenger. This dodgewould appear to violate well-established law.

The Supreme Court, in deciding Daubert, made clear that the question whether an expert witness’s opinion was admissible was governed under the procedure set out in Federal Rule of Evidence 104(a).[2] The significance of placing the Rule 702 issues under the procedures set out in Rule 104(a) is that the trial judge must make the admissibility determination, and that he or she is not bound by the rules of evidence. The exclusion of the admissibility determination from the other rules of evidence means that trial judges can look at challenged expert witnesses’ relied-upon materials, and other facts, data, and opinions, regardless of these materials’ admissibility. The Supreme Court also made clear that the admissibility of an expert witness’s opinion testimony should be shown “by a preponderance of proof.”[3] Every court that has directly addressed the burden of proof issue in a Rule 702 challenge to expert witness testimony has clearly assigned that burden to the proponent of the testimony.[4]

Trial courts intent upon evading gatekeeping responsibility, however, have created a presumption of admissibility. When called upon to explain why they have denied Rule 702 challenges, these courts advert to the presumption as an explanation and justification for the denial.[5] Some courts even manage to discuss the burden of proof upon the proponent, and a presumption of admissibility, in almost the same breath.[6]

In his policy brief for amending Rule 702, Lee Mickus traces the presumption innovation to Borawick v. Shay, a 1995 Second Circuit decision that involved a challenge to hypnotically refreshed (or created) memory.[7] In Borawick, the Court of Appeals held that the plaintiff’s challenge turned upon whether Borawick’s testimony was competent or admissible, and that it did not involve the “the admissibility of data derived from scientific techniques or expert opinions.”[8] Nevertheless, in dicta, the court observed that “by loosening the strictures on scientific evidence set by Frye, Daubert reinforces the idea that there should be a presumption of admissibility of evidence.”[9]

Presumptions come in different forms and operate differently, and this casual reference to a presumption in dictum could mean any number of things. A presumption of admissibility could mean simply that unless there is a challenge to an expert witness’s opinion, the opinion is admissible.[10] The presumption could be a bursting-bubble (Thayer) presumption, which disappears once the opponent of the evidence credibly raises questions about the evidence’s admissibility. The presumption might be something that does not disappear, but once the admissibility is challenged, the presumption continues to provide some evidence for the proponent. And in the most extreme forms, the (Morgan) presumption might be nothing less than a judicially artful way of saying that the burden of proof is shifted to the opponent of the evidence to show inadmissibility.[11]

Although Borawick suggested that there should be a presumption, it did not exactly hold that one existed. A presumption in favor of the admissibility of evidence raises many questions about the nature, definition, and operation of the presumption. It throws open the question what evidence is needed to rebut the presumption. For instance, may a party whose expert witness is challenged not defend the witness’s compliance with Rule 702, stand on the presumption, and still prevail?

There is no mention of a presumption in Rule 702 itself, or in any Supreme Court decision on Rule 702, or in the advisory committee notes. Inventing a presumption, especially a poorly described one, turns the judicial discretion to grant or deny a Rule 702 challenge into an arbitrary decision.

Most importantly, given the ambiguity of “presumption,” a judicial opinion that denies a Rule 702 challenge by invoking a legal fiction fails to answer the question whether the proponent of the expert witness has carried the burden of showing that all the subparts of Rule 702 were satisfied by a preponderance of the evidence. While judges may prefer not to endorse or disavow the methodology of an otherwise “qualified” expert witness, their office requires them to do so, and not hide behind fictional presumptions.


[1]  “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020).

[2]  Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592 n.10 (1993).

[3]  Id., citing Bourjaily v. United States, 483 U. S. 171, 175-176 (1987).

[4]  Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir. 2010) (quoting Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir. 2006)); Beylin v. Wyeth, 738 F. Supp. 2d 887 (E.D. Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.); Pride v. BIC Corp., 218 F.3d 566, 578 (6th Cir. 2000); Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 742 (S.D. Ohio 2007).

[5]  See, e.g., Cates v. Trustees of Columbia Univ. in City of New York, No. 16CIV6524GBDSDA, 2020 WL 1528124, at *6 (S.D.N.Y. Mar. 30, 2020) (discussing presumptive admissibility); Price v. General Motors, LLC, No. CIV-17-156-R, 2018 WL 8333415, at *1 (W.D. Okla. Oct. 3, 2018) (“[T]here is a presumption under the Rules that expert testimony is admissible.”)(internetal citation omitted); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“The Second Circuit has made clear that Daubert contemplates liberal admissibility standards, and reinforces the idea that there should be a presumption of admissibility of evidence.”); Advanced Fiber Technologies (AFT) Trust v. J & L Fiber Services, Inc., No. 1:07-CV-1191, 2015 WL 1472015, at *20 (N.D.N.Y. Mar. 31, 2015) (“In assuming this [gatekeeper] role, the Court applies a presumption of admissibility.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *2 (S.D.N.Y. Jan. 22, 2015) (“[T]he court should apply ‘a presumption of admissibility’ of evidence” in carrying out the gatekeeper function.); Martinez v. Porta, 598 F. Supp. 2d 807, 812 (N.D. Tex. 2009) (“Expert testimony is presumed admissible”).

[6]  S.E.C. v. Yorkville Advisors, LLC, 305 F. Supp. 3d 486, 503-04 (S.D.N.Y. 2018) (“The party seeking to introduce the expert testimony bears the burden of establishing by a preponderance of the evidence that the proffered testimony is admissible. There is a presumption that expert testimony is admissible … .”) (internal citations omitted).

[7]  Borawick v. Shay, 68 F.3d 597, 610 (2d Cir. 1995), cert. denied, 517 U.S. 1229 (1996).

[8]  Id.

[9]  Id. (referring to Frye v. United States, 293 F. 1013 (D.C.Cir.1923)).

[10]  In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007) (Weinstein, J.) (“Since Rule 702 embodies a liberal standard of admissibility for expert opinions, the assumption the court starts with is that a well-qualified expert’s testimony is admissible.”).

[11]  See, e.g., Orion Drilling Co., LLC v. EQT Prod. Co., No. CV 16-1516, 2019 WL 4273861, at *34 (W.D. Pa. Sept. 10, 2019) (after declaring that “[e]xclusion is disfavored” under Rule 702, the court flipped the burden of production and declared the opinion testimony admissible, stating “Orion has not established that incorporation of the data renders Ray’s opinion unreliable.”).