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

Fiber Follies

August 25th, 2026

As with any potential toxic exposure, the dose and duration of exposure of asbestos matter. And these factors matter varyingly in connection to specific outcomes of interest. By 1930, virtually everyone understood that all the asbestos minerals caused asbestosis. While no one thought that just any exposure could cause asbestosis, everyone agreed that some asbestos exposures, of sufficient intensity and duration, and with some minimal latency from first exposure to manifestation, caused asbestosis.

The first serious attempt to quantify the nature and extent of asbestos exposure that caused asbestosis came in 1938, with a report from the United States government. Directed by the United States Surgeon General, the report was the first to quantify asbestos exposure in relation to the diagnosis of asbestosis. Its authors studied a cohort of over 500 North Carolina asbestos textile workers, and reported “the only cases of asbestosis, three in number, found below 5 million particles per cubic foot were diagnosed as doubtful; well-established cases occurred at higher concentrations. It appears from these data that if asbestos dust concentrations in the air breathed are kept below this limit new cases of asbestosis would not appear.”[1] From their analysis of the data, the federal government authors concluded provisionally that “5 million particles per cubic foot [5 mppcf] may be regarded tentatively as the threshold value for asbestos-dust exposure….”[2]

Eight years after this Public Health Service publication, the American Conference of Governmental Industrial Hygienists (ACGIH), in 1946, set its threshold limit value (TLV) at 5 mppcf.[3] In the period between the 1938 Public Health Service report and the 1946 ACGIH adoption of a TLV of 5 mppcf, the United States was engaged as both an employer and a contractor for products made with asbestos. The government cited and relied upon the 5 mppcf standard as protective of workers throughout the wartime manufacturing effort, as well as afterwards, into the 1960s. Whether the 5 mppcf standard protected workers from asbestosis proved to be an academic question because the government itself often failed to control asbestos exposures to that level among its own employees, most notably in government owned and contracted shipyards.[4]

By the early 1960s, the increasing prevalence of asbestosis among insulators and other end-users of asbestos-containing products became clear evidence that either the 5 mppcf TLV was being exceeded or that it was inadequately protective or both. In 1968, the ACGIH urged a change in the metric for measuring occupational exposure and the acceptable TLV to 12 fibers per cubic centimeter (f/cc). Two years later, the ACGIH further refined its TLV to a recommended TLV of 5 f/cc, counting fibers longer than 5 micrometers (µm), with a recommended excursion ceiling of 10 f/cc not to exceed 15 minutes.

Some states had adopted the ACGIH TLV as a regulatory standard, although some of the states failed to enforce the standard, and other states had no standard at all. The regulatory landscape shifted seismically for private, non-governmental employers when President Nixon signed the Williams-Steiger Act (The Occupational Safety and Health Act of 1970) into law on December 29, 1970. The following year, the newly created Occupational Health & Safety Administration (OSHA) established a permissible exposure level (PEL) for asbestos of 12 f/cc, time-weighted average over 8 hours.

The TLV and the initial OSHA PEL were set for “asbestos,” although there is no one mineral fiber that is asbestos. When the principal outcome of interest was asbestosis, the unitary standard made some sense. By the time that OSHA came upon the regulatory scene, the scientific evidence was rapidly converging upon a conclusion that not all asbestos minerals had the same carcinogenic potency or properties. The principal outcome of concern was shifting to a very specific cancer, mesothelioma, which the pathologist Christopher Wagner identified, in 1960, as almost uniquely associated with crocidolite (“blue asbestos”), one of the six asbestos minerals.[5] Indeed, by 1983, Dr. Harriet Hardy would reflect on the evolution of knowledge of the causes of mesothelioma to note that:

“A fatal malignancy [mesothelioma] associated with inhalation of a single form (crocidolite) of asbestos invaded the chest wall (pleura) and/or the abdominal wall.”[6]

By 2000, the differential mesothelioma potency of the six different asbestos minerals (amphiboles: crocidolite, amosite, tremolite, anthophyllite, and actinolite, and serpentine: chrysotile) was clear beyond cavil. Crocidolite was orders of magnitude more pathogenic than chrysotile with respect to mesothelioma, with a ratio of upwards of 500:1, with the 1 itself in doubt, and amosite somewhere in between.[7]

In more enlightened countries, such as the United Kingdom, manufacturing industry voluntarily abandoned importing crocidolite in 1970, while continuing to use chrysotile asbestos. In the United States, however, the regulatory agencies, OSHA and EPA, engaged in fiber-type egalitarianism. The federal agencies persisted, in the face of very strong contradictory evidence, in promulgating standards and rules that applied equally to all asbestos fiber types. Over the years, OSHA reduced the asbestos PEL to 0.2 f/cc, in 1983, and then to 0.1 f/cc, in 1994, where it remains today. The standard grossly overprotects against chrysotile, and grossly underprotects against crocidolite.

The rationales for the fiber-type egalitarianism was always thin to non-existent. On one theory, federal regulations do not distinguish among the six different mineral fibers because they are all capable of causing asbestosis and mesothelioma. This rationale simply confuses hazard with risk, and it ignores the shifting basis for lowering the PEL based upon perceived cancer risk, not for asbestosis risk.

Early in OSHA’s existence, the technical equipment to distinguish among mineralogical fiber types was relatively expensive and not widely distributed. One potential argument for a single standard for all fiber types was the supposed difficult of distinguishing among fiber types in the field. This rationale evaporated with the advance of technology and the spread of the necessary equipment into many work-a-day industrial hygiene laboratories.

Another rationale sometimes asserted by extreme advocacy groups such as the Collegium Ramazzini is the precautionary principle. This principle is not, however, a rational basis; it simply assumes what is to be proven in the face of contradictory evidence. The net result is that precautionary reasoning kept the much more dangerous fiber, crocidolite, in use for an intolerably long period, while subjecting chrysotile to unreasonable regulation.

Another early rationale was that many occupational epidemiologic studies involved exposures to mixtures of asbestos fiber types. This rationale was evaporated by the publication of many studies of workplaces that used a single type of asbestos fiber, which allowed reasonable, evidence-based estimates of relative pathogenicity of fiber types.

Perhaps the real reason for the embrace of fiber type egalitarianism by advocacy scientists and the lawsuit industry was that the companies that mined and sold commercial amphibole fibers (amosite and crocidolite) were mostly in South Africa, a country that refused to honor and domesticate the judgments of American courts. Advocates for the lawsuit industry needed to ensure that the chrysotile mining and milling companies could not escape liability in cases involving “mixed” fiber type exposures, by raising the differential pathogenicity. Some manufacturing companies that used commercial amphiboles such as crocidolite and amosite joined in the attack because they were concerned that companies that used only chrysotile would escape liability, leaving them to pay the entirety of verdicts. The lawsuit industry and segments of manufacturing industry worked in cahoots to subvert the evidentiary base for distinguishing among fiber types.

Fiber type egalitarianism led the Environmental Protection Agency to attempt a ban on asbestos, regardless of fiber type, in 1989. The EPA rulemaking was unceremoniously vacated in 1991, by the United States Court of Appeals, for lacking substantial evidentiary support.[8]

Advocates at the EPA, with support from NGO zealots, including the Collegium Ramazzini, have been urging a complete ban, irrespective of mineral fiber type, ever since. Asbestos found its way to the EPA’s short list of priority substances for review under amendments to the Toxic Substances Control Act. In 2019, a friendlier Circuit for the advocates declared that the Act required the EPA to address legacy uses as well.[9]

After 2019, the EPA rulemaking proceeded with a predictable disregard for the vast differences in mineral fiber types and their respective pathogenicities. In the first part of the ongoing rulemaking, the EPA invaded the jurisdictional turf of OSHA to ban the very few remaining industrial uses of chrysotile. Predictably, the EPA’s rulemaking cited epidemiology of mixed fiber type usage. This part of EPA’s rulemaking has been challenged in court. The case was argued, on June 1, 2026, on an appeal before the Fifth Circuit, in Texas Chemistry Council v. EPA (No. 24-60193).

The EPA is currently considering accepting comments on part two of its rulemaking to evaluate risks involved with legacy uses of asbestos minerals. Professor Robert Nolan and I (more the former than the latter) have filed comments in the form of a report on the “Necessary Considerations for a Science-Based Risk Evaluation of Asbestos Fiber Types in the EPA’s Planned Rulemaking.” On behalf of the International Environmental Research Foundation, we urged the agency to abandon its willful disregard of mineralogical and pathogenic differences between and among the different asbestos minerals, in order to promulgate a sane, scientific, legally defensible risk evaluation of legacy asbestos use, by fiber type.[10] The comment period has been extended to September 23, 2026.

[1] Waldemar C. Dreeseen, J. M. Dallavalle, Thomas I. Edwards, J.W. Miller & R.R. Sayers, A Study of Asbestosis in the Asbestos Textile Industry, Public Health Bulletin No. 241, at ix (1938).

[2] Id. at 91.

[3] American Conference of Governmental Industrial Hygienists, Documentation of threshold limit values – asbestos (1946).

[4] Kara Franke & Dennis Paustenbach, Government and Navy knowledge regarding health hazards of asbestos: A state of the science evaluation (1900 to 1970), 23(S3) INHALATION TOXICOL. 1, 4 (2011).

[5] Christopher Wagner, C.A. Sleggs & Paul Marchand, Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province, 17 BR. J. INDUS. MED. 260 (1960); J. Christopher Wagner, The discovery of the association between blue asbestos and mesotheliomas and the aftermath, 48 BR. J. INDUS. MED. 399 (1991).

[6] Harriet Hardy, CHALLENGING MAN-MADE DISEASE: THE MEMOIRS OF HARRIET L. HARDY, M.D. 95 (1983).

[7] John T. Hodgson & Andrew A. Darnton, The quantitative risks of mesothelioma and lung cancer in relation to asbestos exposure, 14 ANN. OCCUP. HYGIENE 565 (2000); David H. Garabrant & Susan T. Pastula, A comparison of asbestos fiber potency and elongate mineral particle (EMP) potency for mesothelioma in humans,” 361 TOXICOL. & APPLIED PHARMACOL. 127 (2018) (“relative potency of chrysotile:amosite:crocidolite was 1:83:376”). See also D. Wayne Berman & Kenny S. Crump, Update of Potency Factors for Asbestos-Related Lung Cancer and Mesothelioma, 38(S1) CRIT. REV. TOXICOL. 1 (2008).

[8] Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).

[9] Safer Chemicals, Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019).

[10] Robert P. Nolan & Nathan A. Schachtman, on behalf of the International Environmental Research Foundation, Necessary Considerations for a Science-Based Risk Evaluation of Asbestos Fiber Types in the EPA’s Planned Rulemaking; Submission in response to the EPA’s Request for Additional Information to Protect Americans from Legacy Uses and Associated Disposal of Asbestos (Aug. 22, 2026).

Posted in Asbestos, Regulation | No Comments »

Selikoff’s Role in Establishing OSHA

February 1st, 2026

In May 1970, Selikoff testified in support of the Occupational Safety and Health Act of 1970, on which the Senate was then deliberating. By many accounts, Selikoff’s testimony helped overcome significant resistance to “federalizing” the workplace,[1] by establishing national standards for worker safety and health. Activists in the labor movement credit Selikoff’s testimony as a substantial factor in the creation of OSHA.[2]

Rhetorically, Selikoff’s presentation was brilliant. He showed up with two high-ranking officers of the Asbestos Workers Union,[3] Albert Hutchinson and Andrew Haas, and with Ivan Sabourin, Chief Legal Counsel for Johns Manville Corporation. The civil litigation against Johns Manville had not yet erupted, but the storm clouds were amassing. Tort litigation standards were undergoing a radical transformation, with the help of the American Law Institute’s Restatement Second of Torts.[4] In the late 1960s, sensationalist journalistic exposés of the asbestos mining and manufacturing industry received national attention,[5] and Johns Manville’s reputation was seriously damaged. Sabourin, no doubt, had a sense that he had to join with Selikoff to promote federal remedial legislation, and Selikoff exploited the opportunity to the hilt.

In his testimony, Selikoff made a compelling case for remedial occupational safety legislation, with muscular federal oversight and enforcement. Selikoff’s strongest argument was that national occupational safety standards, with federal enforcement, were in industry’s own best interests. Although some states had regulatory oversight of workplace safety, many states did not. Some states with strong regulation had weak enforcement. Manufacturers were inclined to build factories where they would have lower rather than higher compliance costs. Among manufacturers, competition undermined even safety-minded enterprises because caring companies could compete successfully only by shedding the costs and burden of worker protection.

Not only were conscientious employers often at a competitive disadvantage, they were often hurt directly by uncaring employers in their industry. Employees move around. Workers may be over-exposed to a hazardous substance, which has a long latency, at one employer, and then end up working for a more caring employer, when they manifest with an occupational disease. Worker’s compensation laws require the current, conscientious employer to foot the bill for the bad-acting former employer. Smaller employers might lack the knowledge to address the relevant health hazards at all.[6]

Selikoff saw these and other coordination problems as inuring to the detriment of workers because no one industry will invest in changes unless such remedial changes are introduced and enforced across all employers.[7] In Selikoff’s dramatic phrasing, “those who advocate weak occupational health legislation do industry no service at all and certainly do labor a great deal of harm.”[8]

On the positive side of the ledger, the control or elimination of hazardous exposures in the workplace would have a meaningful benefit to workers. Selikoff pointed to Great Britain and Germany, where reduced exposure limits for asbestos exposure in the workplace resulted in falling rates of asbestosis and lung cancer.[9] The difficult question Selikoff’s testimony raises is whether the benefits of national standards for worker safety and health justify his testimonial exaggerations and misrepresentations.

Misleading Statistics and Fake History

On science and history, Selikoff was on shakier ground much shakier grounds than his political arguments. In 1962, Selikoff began to assemble mortality data on a cohort of 632 insulators, New York and New Jersey asbestos workers union members, who had been on the union rolls in 1943. He first published their mortality data in 1964,[10] and at the Senate hearing, Selikoff presented an updated account through April 1967. In 1970, there still not many large, well-conducted epidemiologic studies available, and Selikoff’s small cohort of insulators had the most dramatic, and exaggerated mortality statistics. Valid or not, the Selikoff data were a powerful argument for pushing forward with a federal agency that would oversee hazardous workplace operations.

According to Selikoff’s testimony, of the 632 union workers, 405 had died. Among these 405 deaths, 32 insulators died of asbestosis. From litigation of some of these cases, however, it is clear that some of the “asbestosis” deaths were due to chronic emphysema caused by cigarette smoking, in the presence of concomitant asbestosis. In any event, Selikoff took the liberty of extrapolating from his small insulator cohort, and rounded up asbestosis mortality from 8 to 10 percent. Clearly, many of these 32 insulators had been exposed above the New York and New Jersey permissible exposure limits.

Selikoff testified that there had been 20 deaths due to mesothelioma, when only one in 10,000 deaths had been expected from this rare disease. Somehow the 5 percent of cohort deaths (20/405) became “one out of seven deaths,” or over 14 percent, at another point in Selikoff’s testimony, only to have Selikoff retreat back down to 10 percent (one of every 10 deaths), a few minutes later.

Selikoff’s handling of lung cancer mortality was equally confused and confusing. Of the 405 deaths, Selikoff reported that 66 deaths had been due to lung cancer. This 16 percent was then rounded up to one of five deaths (or 20 percent), moments later. In his Senate testimony, Selikoff did not report what the smoking prevalence had been among the 632 union insulators, and how it compared with his control group. Smoking accounts for 90 percent or so of lung cancer deaths in the United States. Selikoff’s cohort’s 16 percent lung cancer mortality is actually a bit less than 17 percent, what other general population studies have shown for smokers’ lung cancer rates.[11]

Selikoff also gave a confusing and inaccurate account of the history of the knowledge of asbestos cancer risks. At one point in his testimony, Selikoff recounted a 1935 case report by Kenneth Lynch. [12]According to Selikoff, Lynch had encountered at autopsy a man who had both lung cancer and asbestosis. Lynch regarded the clinical coincidence of the two diseases as remarkable, and wondered in a published case report whether the two diseases were causally related.[13]

As Selikoff held forth to the Senate subcommittee, his account of the Lynch case report became more exaggerated.[14] What at first was a 1935 report that asked a question became an assertion that “in 1935, Kenneth Lynch reported the association of asbestos work and lung cancer and warned that they were causally related.”[15]

The problem with Selikoff’s testimony was that Lynch had done no such thing. Lynch’s case report of a man who worked for 21 years in an asbestos factory raised the question of causality, but nowhere in the 1935 publication does Lynch issue a “warning” that asbestosis and lung cancer were causally related. Lynch never reported whether or not the 57 year-old white man had been a smoker. In trying to downplaying the unexplored smoking history, Selikoff embellishes upon the case report by asserting that not “many people smoked cigarettes … in 1910-1915.”[16]

This claim about smoking prevalence is also false, and part of Selikoff’s pattern of misrepresentations about smoking that were consistently designed to minimize the role of tobacco and maximize the role of asbestos in causing lung cancer. World War I had a tremendous influence on both soldiers and the general population, with smoking prevalence among men rising dramatically after 1915. With the mass production of cigarettes, more than half of adult males in the United States smoked by 1920.[17] In September 1967, almost three years before testifying at the Senate hearings on the Occupational Health and Safety Act, Selikoff addressed a meeting of the asbestos workers international, and told them that he had

“yet to see a lung cancer in an asbestos worker who didn’t smoke cigarettes. … “[C]ancer of the lung could be wiped out in your trade if you people wouldn’t smoke cigarettes… .”[18]

Selikoff strategically omitted this detail from his Senate testimony.

On scientific and historical issues, Selikoff testified recklessly and with impunity to an audience of credulous Senators. Not only had Lynch not warned of a causal relationship in 1935, his case report was not capable of supporting such a causal inference. Case reports and series were certainly a commonplace in the medical literature, but by the early 1950s, the scientific community witnessed a dramatic shift in appreciating the need for controlled epidemiologic investigations to establish associations and causal associations.[19] Lynch’s 1935 case report had little scientific credibility after the success of lung cancer epidemiology in the 1950s.

Selikoff castigated the Public Health Service for not having researched the lung cancer issue through the 1950s. The lack of research, however, did not keep union physicians from claiming that asbestos caused lung cancer from at least the early 1950s.[20]

The Myth of the Innocent Asbestos Worker

Selikoff pressed his case for the need for national legislation by adverting to the supposed ignorance of the asbestos workers of the hazards of their trade, and how no one had told them of Lynch’s “warning.” The asbestos workers “assumed that someone was looking after any health hazards there might be.” Although no one delights in blaming the victim, Selikoff’s narrative was false.[21]

By the time Selikoff testified before the Senate subcommittee, he had been working with the asbestos workers’ union for at least eight years. In 1957, before Selikoff’s collaboration began, the asbestos insulators’ union’s periodical, distributed to its members, noted that

“[t]he problem of hazardous materials was again discussed with the importance of using preventative measures to eliminate inhalation. It is suggested that, when working under dusty conditions, respirators should be used at all times and gloves whenever conditions warrant.”[22]

Later that same year, President Sickles, at the International Convention of the Asbestos Heat, Frost and Insulators Union, reported to his union’s delegates that he

“[b]eing well aware of the health hazards in the Asbestos industry, requested authority for the General Executive Board to make a study of the health hazards … that will enable the Board to adopt any policies that will tend to protect the health of our International membership.”[23]

In 1961, before the asbestos workers formally engaged Selikoff to conduct any epidemiologic study, the union ran a full page warning in its monthly magazine. The warning featured a picture of the grim reaper urging insulators to “Wear Your Respirator.”[24] Notwithstanding widespread warnings from union leaders, Selikoff and his staff, and manufacturers’ product label warnings, Selikoff acknowledged, in 1967, that more than nine out of 10 insulators failed to wear respirators on dusty jobs.[25]

Valorization of Johns Manville Corporation

Up until Sabourin’s appearance at Selikoff’s side in the Senate hearings, Johns Manville had ducked adverse verdicts in civil litigation.[26] Sabourin was eager to please, and Selikoff was happy to show up with industry support. For sitting through Selikoff’s hyperbolic testimony, distorted statistics, and fanciful history, and for helping finance Selikoff research, Sabourin was rewarded with some sops from Selikoff. After being skewered by Paul Brodeur and others, executives at Johns Manville were no doubt pleased to have Selikoff testify that “it is idle and probably incorrect to blame the industry.”[27]

Selikoff claimed that

“it has been inspiring to me as a medical scientist to see the responsibility with which at least one large company, Johns Manville, has approached this problem. They have had the advantage of the leadership of a rather remarkable man, Mr. Clinton Burnett. They have cooperated fully. They have held nothing back because they are determined to make asbestos safe to use and to work with.”[28]

Selikoff’s allies at the tort bar would soon descend upon Johns Manville with a vengeance, with no benefit of clergy or Selikoff’s blessings.

[1] Occupational Safety and Health Act of 1970, S. 2193 and S. 2788, Before the Subcomm. on Labor & Public Welfare, 91st Cong. at 1072 (May 5, 1970) (testimony of Irving Selikoff) [cited below as Selikoff OSHA testimony].

[2] Anonymous, Irving J. Selikoff, MD, 1915-1992: A Centennial Celebration, ICAHN ARCH. (Oct. 22, 2015), at https://archives.icahn.mssm.edu/irving-j-selikoff-md-1915-1992-a-centennial-celebration/; Sheldon W. Samuels, Knut Ringen, William N. Rom, Arthur Frank, Selikoff was a brave pioneer examining workers throughout the country, Ethical thinking in occupational and environmental medicine: Commentaries from the Selikoff Fund for Occupational and Environmental Cancer Research, 65 AM. J. INDUS. MED. 286 (2022); Judson MacLaury, The Job Safety Law of 1970: Its Passage Was Perilous, 104 MONTHLY LAB. REV. 18 (Mar. 1981) (Buried in the battle of witnesses for and against the Nixon proposal were some thought-provoking comments by Irving Selikoff. He described the suffering of construction workers who succumbed to asbestosis from applying asbestos insulation to buildings. Refusing to blame any one group, he asked rhetorically, “Who killed Cock Robin?” Selikoff’s answer was: “No one …. His has been an impersonal, technological death …. We have all failed.”).

[3] International Association of Heat and Frost Insulators and Asbestos Workers. Albert Hutchinson was president of the International; Andrew Haas was treasurer.

[4] Restatement (Second) of Torts § 402A (Am. Law Inst. 1965).

[5] Paul Brodeur, The Magic Mineral, NEW YORKER (Oct. 5, 1968), at https://www.newyorker.com/magazine/1968/10/12/the-magic-mineral.

[6] Selikoff OSHA testimony at 1077.

[7] Selikoff OSHA testimony at 1077.

[8][8] Selikoff OSHA testimony at 1078-79.

[9] Selikoff OSHA testimony at 1076.

[10] Irving J. Selikoff, Jacob Churg & E. Cuyler Hammond, Asbestos Exposure and Neoplasia, 188 J. AM. MED. ASS’N 22 (1964).

[11] Paul J. Villeneuve & Yang Mao, Lifetime probability of developing lung cancer, by smoking status, Canada, 85 CAN. J. PUB. HEALTH 358 (1994).

[12] Selikoff at 1074.

[13] Kenneth M. Lynch & W. Atmar Smith, Pulmonary Asbestosis III: Carcinoma of Lung in Asbesto-Silicosis, 24 AM. J. CANCER 56 (1935).

[14] Selikoff at 1080.

[15] Selikoff OSHA testimony at 1080.

[16] Selikoff OSHA testimony at 1074.

[17] Jeffrey E. Harris, Cigarette smoking among successive birth cohorts of men and women in the United States during 1900-80, 71. J. NAT’L CANCER INSTIT. 473 (1983).

[18] Irving J. Selikoff, Address to the delegates of the twenty-first convention of the International Association of Heat and Frost Insulators and Asbestos Workers at 9 (Chicago, Illinois, Sept. 1967), https://search.worldcat.org/fr/title/dr-irving-j-selikoffs-address-to-the-delegates-of-the-twenty-first-convention-of-the-international-association-of-heat-and-frost-insulators-and-asbestos-workers-chicago-illinois-september-1967/oclc/12288308.

[19] See Colin Talley, et al., Lung Cancer, Chronic Disease Epidemiology, and Medicine, 1948 – 1964, 59 J. HIST. MED. & ALLIED SCI. 329 (2004).

[20] Herbert K. Abrams, Cancer in Industry, Illinois ST. FED. LABOR WEEKLY NEWS LTR 1 (1955); Herbert K. Abrams, Cancer in Industry, 69 THE PAINTER & DECORATOR 15 (Mar. 1955). Abrams was the medical director of the Building Service Employees Union.

[21] Selikoff OSHA testimony at 1080.

[22] Asbestos Worker (July 1957).

[23] The Asbestos Worker at 1 (Oct, 1957) (reporting on the Asbestos Workers’ 19th General Convention).

[24] 15 The Asbestos Worker at 29 (Nov. 1961). The warning was developed under the guidance of C. V. Krieger of Local No. 28, Safety Superintendent at the Long Beach Naval Shipyard.

[25] Irving J. Selikoff, Address to the delegates of the twenty-first convention of the International Association of Heat and Frost Insulators and Asbestos Workers at 8, 9-10, 24 (Chicago, Illinois, Sept. 1967), at https://search.worldcat.org/fr/title/dr-irving-j-selikoffs-address-to-the-delegates-of-the-twenty-first-convention-of-the-international-association-of-heat-and-frost-insulators-and-asbestos-workers-chicago-illinois-september-1967/oclc/12288308

[26] Johns Mansville won a jury trial in 1969, but it would go on to lose in a case brought by insulator Clarence Borel, in 1971.

[27] Selikoff OSHA testimony at 1076.

[28] Selikoff OSHA testimony at 1078.

Posted in Asbestos, Expert Witness Hall of Shame | 1 Comment »

The FDA Expert Panel on Talc – More Malarky

June 18th, 2025

On May 20, 2025, as announced, FDA Commissioner Martin Makary held his panel discussion on talc in food and medications.[1] The discussion lasted just under two hours, and is available on YouTube for your viewing and perhaps your amusement. Makary opened and closed the event with what could have been the plaintiffs’ opening and closing statements from one of the many talc trials that have clouded courtrooms across the land. He asked rhetorically: “Why don’t we talk about at our oncology meetings the 1993 National Toxicology Program results that found clear evidence of carcinogenic activity of talc in animal studies?’” Perhaps because the talc findings were questionable at best, and the asbestos findings with respect to gastrointestinal cancers were exculpatory for talc.

Makary’s introductory remarks were followed by the panelists’ introducing themselves by their training and involvement with talc issues. Other than Makary, the participants were FDA Deputy Commissioner Sara Brenner, George Tidmarsh, John Joseph Godleski, Sandra McDonald, Daniel Cramer, Joellen Schildkraut, Malcolm Sim, Steven Pfeiffer, Nicolas Wentzensen, and Nicole C. Kleinstreuer. Godleski and Cramer have served as plaintiffs’ expert witnesses in ovarian cancer litigation, which was not particularly germane to the panel discussion. In their initial discussions of qualifications and background, neither Godleski nor Cramer disclosed his potential conflicts of interest, or the amount of fees earned. Sandra McDonald described her experience in assisting Godleski, but she did not declare whether she earned any money for consulting services to the lawsuit industry. Later in the panel discussion, when George Tidmarsh stated that no one should be vilified for past practices in using talc, Daniel Cramer jumped in to vilify Johnson & Johnson with the suggestion that somehow that company had surreptitiously arranged for the National Cancer Institute to remove a statement about how talc “may be associated with talc use” from its website just before he was about to testify in his first talc trial for plaintiffs.

None of the panelists had served as a defense expert witness. Steven Pfeiffer works for a pharmaceutical company, but not one that had any experience with the safety or efficacy of talc as an ingredient in medications.

None of the panelists had participated in any toxicologic or epidemiologic study of talc on cancers or diseases of the digestive organs. None of the panelists made it his or her business to become familiar with the extensive studies of the asbestos and talc on gastrointestinal cancers. The lack of experience, or specific citations to any study, did not stop Daniel Cramer from suggesting that talc was responsible for inflammatory bowel disease, autoimmune diseases, and gastrointestinal cancers. Like Cramer, epidemiologist Joellen Schildkraut, focused on ovarian cancer, and made the false assertion that the relationship between talc and gastrointestinal cancers is understudied. Schildkraut held back from asserting that talc causes ovarian cancer, but she heartily endorsed banning talc on the precautionary principle. All the panelists concurred with the suggestion that talc be eliminated from food and drugs, without waiting for “the epidemiologists to catch up.”

Two issues were grossly misrepresented by the panelists. None of them, however, was well informed enough for the misrepresentations to have been overt lies. The first whopper was that National Toxicology Program (NTP) testing had shown carcinogenicity of talc in its inhalational studies for the lung and other organs. The second whopper was that rice on talc was used prevalently in the United States, and that it was responsible for digestive organ cancers. Nicole C. Kleinstreuer, who has worked at the NTP, and accurately described its activities gave a description of its animal talc studies, perhaps a bit slanted, but not too inaccurate. When George Tidmarsh later misrepresented NTP talc findings, however, Kleinsteuer was silent.

NTP Ingestion Studies

Makary did not identify the NTP studies to which he referred, but Kleinsteuer described a talc inhalation study that has only one referent. The NTP conducted long-term rodent inhalation and ingestion assays for both talc and different kinds of asbestos, in the 1980s and 1990s. For talc, the NTP published, in 1993, only one long-term inhalational study in rats and mice.[2] In mice, exposed to talc by inhalation for up to two years, there was no evidence of any “neoplastic” effects. The results in rats were more difficult to interpret. In male rats, exposed for over two years, there was weak evidence of neoplastic effects based upon an increased incidence of benign or malignant adrenal gland pheochromocytomas. In female rats, the NTP reported “clear evidence” of excess alveolar/bronchiolar (lung) adenomas and carcinomas and benign or malignant adrenal gland pheochromocytomas of the adrenal gland. The meaning of these rodent studies obviously varies depending upon whether you are a rat or a mouse of a certain breed; the meaning for humans is even murkier, even for humans that are rodent-like. The multiple comparisons across exposure levels for dozens if not hundreds of outcomes, and the lumping of benign and malignant effects together, certainly makes the NTP statistical analyses suspect. This report was marked by significant controversy, and some scientists refused to endorse its finding because adrenal gland pheochromocytomas were not treatment-related; the maximum-tolerated dose was exceeded for female rats at the higher exposure level, thus violating the study’s protocol; and talc is thus not expected to cause tumors in rats (and mice) exposed at levels that do not cause “marked chronic lung toxicity.”[3]

One of the lawsuit industry’s, and Makary’s, theories about the harmfulness of ingested talc is based upon the supposition that talc has asbestos contaminants. This theory is as vague as is the term asbestos, which has no mineralogical meaning; instead, the term asbestos was historically used to refer to six different minerals: actinolite, anthophyllite, amosite (cummingtonite-grunerite), chrysotile, crocidolite, and tremolite. All of these minerals, except for chrysotile, are amphibole minerals. Some of the amphibole minerals occur in both fibrous and non-fibrous form, and the ill health effects of the amphibole fibers are generally attributed to their resistance to biological degradation and their high aspect ratio. Things get a bit crazy because the federal government, for purposes of standardizing aerosol measurements, set the aspect ratio for counting “fibers,” at 3:1. The pathogenicity of “federal fibers,” which are not really fibers, is highly disputed.

The NTP never conducted long-term talc ingestion studies; it did something much better. The NTP tested dietary high-dose, long-term ingestion of various asbestos types in multiple species. The NTP did not leave the exposure issue vague with “asbestos” as the dietary source. Instead, the NTP was more precise when testing whether ingesting “asbestos” was harmful to rodents. The NTP ran separate ingestion experiments on chrysotile, amosite, and crocidolite, with the different form of asbestos making up one percent of the animals’ lifetime diet. Overall, these experiments were “null”; that is, they provided no support for the carcinogenicity of ingested asbestos of the types tested.

The NTP conducted lifetime ingestion studies in male and female rats with a diet of one percent crocidolite asbestos, the most toxic and carcinogenic form of asbestos in human beings. The NTP experiments showed that under these conditions, long-term ingestion of crocidolite asbestos was neither overtly toxic nor carcinogenic in male or in female rats.[4] After crocidolite, amosite asbestos, fibrous cummingtonite-grunerite, named for “asbestos mines of South Africa, is the most toxic and carcinogenic of the asbestos fibers. The NTP showed that feeding male and female rats amosite asbestos for one percent of their diet, for their lifetimes, was not overtly toxic, did not affect their survival, and was not carcinogenic.[5] The NTP repeated its life-time one percent amosite diet in Syrian Golden hamsters, again without toxic or carcinogenic response in either the male or female hamsters.[6]

Looking at the least toxic and carcinogenic asbestos mineral, chrysotile, the NTP’s conducted long-term one percent feed studies of both “short range” and “long range” (chrysotile fiber length) in Syrian Golden hamsters. Again the results were “null”; that is, there was no treatment-related toxicity or carcinogenicity.[7] There were no increases in adrenal cortical adenomas (benign growths) when compared with concurrent controls, but there was an increase of these benign tumors when compared with pooled control groups from other experiments. Ultimately, the NTP concluded that the biological importance of these benign adrenal growths in the absence of cancers or tumors of the gastrointestinal tract (which was the target organ) was questionable, at best.

Because of prior research suggesting that carcinogencity was a function of fiber rigidity and length, the NTP tested ingested chrysotile in rats, at two different fiber lengths. For its experiments, the NTP defined “short-range chrysotile (SR)” as short fibers with a median length of 0.66 microns, and a range of 0.088 to 51.1 microns. “Intermediate-range (IR) chrysotile fibers had a median length of 0.82 microns, with a range from 0.104 to 783.4 microns. The NTP did not use long-range chrysotile fibers, which are generally greater than 5 microns in length. Male and female F344/N rats ingested an NTP one percent diet of chrysotile, in the two lengths of chrysotile, SR and IR, for a lifetime. There were no neoplastic or non-neoplastic diseases, overt toxicity, or decrease in survival associated with SR chrysotile ingestion, in either the male or the female rats.[8] In the female rats, there was no effect on fertility or litter, overt toxicity, or carcinogenicity from IR chrysotile ingestion. The male rats also did not show any adverse clinical signs, but they experienced a statistically insignificant increase in benign colonic polyps, which the NTP stretched to characterize as “some” (but not clear) evidence of carcinogenicity.

Rice is Nice, With or Without Talc

The FDA panelists’ inaccurate claims about talc on rice also cry out for rebuttal, which no panelist seemed able or willing to give. Given that the panel was convened with only four days notice, and without public comment, it operated in a fact-free zone, and operated mostly as a propaganda exercise. The history of the ingested asbestos and talc controversy goes back over half a century. Some background is needed to understand exactly how outlandish the rice-on-talc claim is.

The causal association between asbestosis and lung cancer was well established by the early 1960s,[9] as was the causal association between crocidolite asbestos exposure and mesothelioma.[10] Some sources carelessly credit Irving Selikoff with these discoveries, but he was not so much of a discoverer, as he was a zealous spokesman for the safety of asbestos-exposed workers. Selikoff worked hand-in-hand with various labor unions to publicize and politicize asbestos risks that had been shown by other workers. Credit for the lung cancer connection properly goes to earlier work done by Sir Richard Doll and others, and the crocidolite-mesothelioma connection was shown by J. Christopher Wagner, in 1960. Where Selikoff deserves credit is in tireless efforts to expand the scope of asbestos-related diseases beyond lung cancer and mesothelioma, with or without sufficient evidence, and thus to expand the compensability of other diseases of ordinary life in asbestos workers.

In his efforts to extend the scope of compensation, Selikoff did not limit himself to risks that had been scientifically established; he sought to expand the list of asbestos-related diseases. He advanced the unsubstantiated notions that all six kinds of asbestos minerals carried the same risks, that asbestos caused virtually every kind of cancer in humans, that any asbestos in the environment required extreme remedial action, and that asbestos was responsible for a very high percentage of all human cancers.

No doubt Selikoff wanted credit for scientific discoveries, but he also wanted science that would support compensation. Selikoff understood that if the asbestos workers stopped smoking, their risks of lung cancer would fall, and their cancer morbidity and mortality would be more influenced by gastrointestinal cancers, given that colorectal cancer was the leading cause of cancer-related death in non-smoking men, in the 1960s.

By 1950, Selikoff had already become an advocate, who testified and wrote reports as a claimants’ expert witness in many asbestos cases. In the early 1950s, New Jersey lawyer Carl Gelman retained Selikoff to examine 17 workers from the Paterson plant of Union Asbestos and Rubber Company (UNARCO). Gelman filed workers’ compensation claims on behalf of these UNARCO workers, and Selikoff supported Gelman’s claims with reports and testimony. In the early 1950s, Anton Szczesniak, one of the UNARCO claimants, with Selikoff’s support as an expert witness, sought compensation for “intestinal cancer.” In 1965, Selikoff testified to support an asbestos insulator’s claim that asbestos exposure caused his colorectal cancer.[11] In 1974, Selikoff wrote a review article on asbestos exposure and gastrointestinal cancers, without any disclosure of his pro-plaintiff testimonial adventures.[12] Serious epidemiologists such as Sir Richard Doll and Sir Richard Peto pushed back on Selikoff’s exaggerated projections of asbestos-related mortality,[13] and his assertion that asbestos caused digestive system cancers.[14] Forty years after Selikoff testified for the claimant in an asbestos colorectal cancer case, the Institute of Medicine published a systematic review of the evidence available to Selikoff and later evidence, which showed that the evidence was insufficient “to infer a causal relationship between asbestos exposure and pharyngeal, stomach, and colorectal cancers.”[15]

Selikoff’s rent-seeking and fear-mongering spawned many asbestos scares. Some scientists accepted Selikoff’s dogma that a single asbestos fiber, of any variety, could cause any human cancer. The Mt. Sinai jihad against “asbestos” extended to any exposures involving asbestos, or even other minerals that contained “elongated mineral particles,” that nominally met the crude definition of asbestos. This jihad led to a prolonged litigation against the Reserve Mining Company, which had permits to dump taconite tailings in Lake Superior, since the late 1940s. Using Selikoff’s claim that “asbestiform” mineral particles had entered the water supply, the U.S. Environmental Protection Agency was able to obtain an injunction against the mining company.[16]

Regulatory overreach, Selikoff’s exaggerated testimony, and the trial judge’s partiality and bias marred the litigation.[17] After decades of research on asbestos in drinking water, there remains no substantial evidence that supports a conclusion that ingested asbestos in drinking water causes gastrointestinal or any other cancer.[18]

Selikoff was the head of an anti-asbestos lobby that promoted the fiction that asbestos was responsible for all manners of human ailments, regardless of dose or route of administration.[19] One of the panics he helped initiate involved the claim that talc-dusted rice was responsible for the high rate of stomach cancer among Japanese in Japan.

Reuben Merliss published an article in Science, in 1971, in which he attempted to attribute the high rate of stomach cancer in Japan to the Japanese custom of dusting rice with talc. Merliss relied upon overall population rates and trends to draw an ecologic inference that the Japanese rice (with talc and any asbestos contaminants) was responsible for the Japanese higher incidence of stomach cancer.[20]

The Merliss hypothesis, inspired by Selikoff, was sunk by a much more careful analysis (which got less media coverage). Two epidemiologists analyzed data about use of talc-coated rice in Japan and Hawaii, and found no support for the claim that talc-coated rice increased the risk of developing stomach cancer.[21]

Their more careful dietary assessment found high rates of stomach cancer among Japanese in Japan who did not consume talc-coated rice, while Japanese in Hawaii, who consumed considerable quantities of talc-coated rice had intermediate rates of stomach cancer (lower than in Japan). Filipinos in Hawai had very low rates of gastric cancer, even though they consumed the greatest amounts of talc-coated rice of any of the observed groups. The secular incidence trend of stomach cancer decreased more substantially among the talc-exposed Japanese living in Hawaii than among the non-exposed Japanese living in Japan.

Although the asbestos perpetual motion litigation machine continues to churn, the lawsuit industry has been hampered by the bankruptcy of virtually every company that made an asbestos-containing product, and the reduction of asbestos use and exposures over the last 50 years. The lawsuit industry’s shift to demonize and monetize talc as the next mineral target was predictable. What was not predictable was that we would have a Secretary of Health & Human Services whose sole experience in medicine has been in suing pharmaceutical and other manufacturing industries, perpetuating medieval beliefs in the miasma theory of disease causation,[22] and spreading conspiracies, misinformation, and disinformation. FDA Commissioner Makary has shown himself to be a willing accomplice in advancing the Secretary’s agenda. In his closing remarks, Makary made unsupported assertions, then retreated to the dodge that he was just asking questions. Makary strongly suggested that the recent increase in colorectal cancer among young people has been caused by the use of talc in food and medications. He failed to reference any evidence for his suggestion, which is, in any event, hard to square with the history of use of talc in medications for centuries, and the steady overall decline in the incidence of colorectal cancer in men and women.[23]

The Center for Truth in Science has sponsored rigorous systematic reviews of the evidence on cosmetic talc use and female reproductive cancers,[24] and respiratory cancers.[25] The systematic review of talc on reproductive organ cancers integrated evidence across toxicologic and epidemiologic studies, and found suggestive evidence of no association between the use of perineal talc and ovarian and endometrial cancers. The systematic review of talc use and respiratory cancers similarly integrated the available toxicologic and epistemiologic evidence, and rejected a causal association. The review reached a conclusion of suggestive evidence in the opposite direction – of no association between inhaled talc and mesothelioma or lung cancer.

The FDA talc panel was fool’s gold, and not the promised “gold standard” science. Rather than engaging with the systematic reviews sponsored by the Center, or for that matter with any systematic reviews, Commissioner Makary and his panel wallowed in anecdotes, stories, and isolated study results, without trying to identify and synthesize all the available evidence.

[1] FDA Expert Panel on Talc, “Independent Expert Panel to Evaluate Safety and Necessity of Talc in Food, Drug, and Cosmetic Products,” FDA (May 20, 2025).

[2] NTP Technical Report on the Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807-96-6) in F344/N Rats and B6C3F Mice (Sept. 1993).

[3] Jay I. Goodman, “An Analysis of the National Toxicology Program’s (NTP) Technical Report (NTP TR 421) on the Toxicology and Carcinogenesis Studies of Talc,” 21 Regulatory Toxicol. & Pharmacology 244 (1995). See also Robyn L. Prueitt, Nicholas L. Drury, Ross A. Shore, Denali N. Boon & Julie E. Goodman, “Talc and human cancer: a systematic review of the experimental animal and mechanistic evidence,” 54 Critical Reviews in Toxicology 359 (2024).

[4] NTP TR-280 Toxicology and Carcinogenesis Studies of Crocidolite Asbestos (CASRN 12001-28-4) In F344/N Rats (Feed Studies) (1988).

[5] NTP TR-279 Toxicology and Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in F344/N Rats (Feed Studies) (1990).

[6] NTP TR-249 Lifetime Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in Syrian Golden Hamsters (Feed Studies) (1983).

[7] NTP TR-246 Lifetime Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in Syrian Golden Hamsters (Feed Studies) (1990).

[8] NTP – TR-295 Toxicology and Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in F344/N Rats (Feed Studies) (1985).

[9] See Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,” 12 Br. J. Indus. Med. 81 (1955).

[10] See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).

[11] See “Health Hazard Progress Notes,”16 The Asbestos Worker 13 (May 1966) (“A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. Unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population. Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the Workman’s Compensation Board reviewed the matter and agreed with the Referee’s judgment and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”).

[12] Irving J. Selikoff, “Epidemiology of Gastrointestinal Cancer,” 9 Envt’l Health Persp. 299 (1974).

[13] Richard Doll & Richard Peto, “The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today,” 66 J. Nat’l Cancer Instit. 1191 (1981).

[14] Richard Doll and Julian Peto, Asbestos: Effects on Health of Exposure to Asbestos 8 (1985).

[15] Jonathan M. Samet, et al., Asbestos: Selected Cancers – Institute of Medicine (2006).

[16] See Wendy Wriston Adamson, Saving Lake Superior: A Story of environmental action (1974); Frank D. Schaumburg, Judgment Reserved: A Landmark Environmental Case (1976); Robert V. Bartlett, The Reserve Mining Controversy: Science, Technology, and Environmental Quality (1980); Thomas F. Bastow, This Vast Pollution: United States of America v. Reserve Mining Company (1986); Michael E. Berndt & William C. Brice, “The origins of public concern with taconite and human health: Reserve Mining and the asbestos case,” 52 Regulatory Toxicol. & Pharmacol. S31 (2008).

[17] Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976) (removing Judge Lord from case).

[18] See World Health Organization, Asbestos in Drinking Water (4th ed. 2021) (“no causal association between asbestos exposure via drinking-water and cancer development has been reported for any asbestos fibre type”); Jennifer Go, Nawal Farhat, Karen Leingartner, Elvin Iscan Insel, Franco Momoli, Richard Carrier & Daniel Krewski, “Review of epidemiological and toxicological studies on health effects from ingestion of asbestos in drinking water,” 54 Critical Reviews in Toxicology 856 (2024) (“Based on high-quality animal studies, an increased risk for cancer or non-cancer endpoints was not supported, aligning with findings from human studies. Overall, the currently available body of evidence is insufficient to establish a clear link between asbestos contamination in drinking water and adverse health effects.”); Kenneth D. MacRae, “Asbestos in drinking water and cancer,” 22 J. Royal Coll. Physicians 7 (1988).

[19] Francis Douglas Kelly Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997) (“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”).

[20] Rueben R. Merliss, “Talc-Treated Rice and Japanese Stomach Cancer,” 173 Science 1141 (1971). The claim persists in the underworld of medical speculation. See E. Whitin Kiritani, “Asbestos and Stomach Cancer in Japan – A Connection?” 33 Medical Hypotheses 159 (1990).

[21] Grant N. Stemmermann & Lawrence N. Kolonel, “Talc-coated rice as a risk factor for stomach cancer,” 31 Am. J. Clin. Nutrition 2017 (1978).

[22] Paul Offit, “Understanding RFK Jr.,” Beyond the Noise (Feb. 11, 2025).

[23] American Cancer Society, “Key Statistics for Colorectal Cancer” (last revised April 28, 2025).

[24] Heather N. Lynch, Daniel J. Lauer, Olivia Messina Leleck, Rachel D. Freid, Justin Collins, Kathleen Chen, William J. Thompson, A. Michael Ierardi, Ania Urban, Paolo Boffetta & Kenneth A. Mundt, “Systematic review of the association between talc and female reproductive tract cancers,” 5 Front. Toxicol. 1157761 (2023).

[25] Heather N. Lynch, Daniel J. Lauer, William J. Thompson, Olivia Leleck, Rachel D. Freid, Justin Collins, Kathleen Chen, A. Michael Ierardi, Ania M. Urban, Michael A. Cappello, Paolo Boffetta & Kenneth A. Mundt, “Systematic review of the scientific evidence of the pulmonary carcinogenicity of talc,” 10 Front. Public Health 989111 (2022).

Posted in Asbestos, Causation, Conflicts of Interest, Evidence, Expert Witnesses, Regulation, Toxicological Evidence | No Comments »

FDA Malarky on Ingested Talc

June 6th, 2025

A couple of weeks ago, the Wall Street Journal ran an editorial that complained that FDA Commissioner Makary had touted dodgy evidence about the potential harms of talcum powder in food and medications,[1] and called an improper public meeting to discuss his concerns. The editorial noted the procedural irregularity of convening a meeting to review evidence of the supposed harms of talc in food and drugs, without proper notice and public comment.[2] The panel met just four days after the FDA’s press release.[3]

The FDA’s announcement of the irregular meeting cited last year’s IARC classification of talc in its group 2A, “probably carcinogenic” to humans, and an article in a new journal, the Journal of the Academy of Public Health, on the editorial board of which, Martin Makary sits.

The irregularity of this FDA meeting becomes even more obvious upon closer inspection. Much could be said about the irregularity of IARC classifications. The IARC defines “probably” in its 2A “probably carcinogenic” classification in a distinctly unscientific way when it reveals, in its Preamble, that its use of probably has no quantitative meaning. In attaching a 2A label to talc, the IARC rejected a conclusion that there was sufficient evidence of human carcinogenicity for talc; indeed, it found the human epidemiology on point to be “limited,” in other words, insufficient. Furthermore, the IARC’s limited conclusion was based upon a claimed association between perineal talc exposure and ovarian cancer.[4]

The irregularities abound. The FDA announced that it was convening an “independent panel of scientific experts” to explore the issue of talc in food and in drugs. And yet, one of the panelists, Daniel Cramer, has served as an expert witness for the talc lawsuit industry on multiple occasions, against Johnson & Johnson.[5] How irregular that no defense expert witness was invited to participate in the panel.

The irregularity of Daniel Cramer’s participation may be Trumped by the irregularity of the entire enterprise. Commissioner Makary works for Secretary Robert F. Kennedy, Jr., who has spent much of his adult life advancing litigations for the lawsuit industry. Kennedy’s son, Conor, is a lawyer at Wisner Baum, a lawsuit industry firm that has cases against Johnson & Johnson. The day of the FDA meeting, but before the panel convened, Commissioner Makary barged into another Advisory Committee meeting, convened to discuss the licensing of an unrelated anti-cancer therapeutic, and ranted about how talc was causing cancer.

Earlier this week, Commissioner Makary replied to the Wall Street Journal editorial, but failed to make his case on the science.[6] He cited IARC, but failed to disclose the meaning of the IARC classification, and to what it applied. Makary cited a 2019 Taiwanese study (Chang) that he described as having reported an association between the oral intake of talc and gastrointestinal cancer.[7] What was most irregular for a scientist who has responsibility for the FDA, however, was Makary’s failure to describe the Chang study accurately.

Chang set out to study stomach cancer, not all of gastrointestinal cancers, by looking at stomach cancer incidence in users a talc, used as a Chinese herbal, in high, medium, and low levels. The study was a typical insurance claims database study, which is interesting but which can yield only limited information. Chang and colleagues had no information about lifestyle variables such as smoking, diet, or obesity. The authors note that in Taiwan, talc is used as an antipyretic and diuretic agent, but they fail to discuss why study participants would have used an herbal remedy with such an indication for any significant length of time. To their credit, the authors excluded patients with peptic ulcer disease or Helicobacter pylori infection prior to the inclusion date. Gastritis and infection with h. pylori are potent causes of stomach cancer. Unfortunately, the information on participants’ infection status, for exclusion, was made before 1997, and so the authors had no information whether the participants who had stomach cancer actually had h. pylori infections at or near the time that they were diagnosed with stomach cancer. Helicobacter pylori infections have an attributable risk for stomach cancer of about 75%.[8] Similarly, the authors lacked information on other risk factors, such as high salt intake, pernicious anemia, EBV infection, alcohol, family predisposition, and socioeconomic status.

Using the low-exposure group as their control, the Chang study reported an adjusted stomach cancer hazard ratio of 1.58 (95% CI, 0.79 – 3.17; p = 0.19), for participants with high exposure, and an adjusted hazard ratio of 2.30 (95% CI, 1.48 – 3.57; p < 0.001) among persons with medium exposure. The authors claimed these data showed an association, but they acknowledged that the lack of a dose-response relationship made the association less likely to be causal. The association, such as it was, however, came unraveled after they excluded participants whose herbal talc use was less than five years. The exclusion, which is biologically important given that latency and induction periods for carcinogenesis are likely longer than five years, vitiated the statistically significant correlation between talc ingestion and the incidence of stomach cancer. The authors’ conclusion was thus pretty tame: “[d]espite the absence of dose-response effect, there might be a link between stomach cancer and talc.” And then again, there might not be.

Makary was not content to argue from weak and equivocal evidence. He offered a sop to the lawsuit industry and his boss, Robert F. Kennedy, Jr., by asking rhetorically whether the plaintiffs’ bar might be correct on talc. According to Makary, “They [lawsuit industry firm] were [correct] with OxyContin, Vioxx and Makena. Perhaps they will be with talc.” Well, even the blind squirrel sometimes finds a nut. OxyContin litigation turned on a marketing issue, and Makena (hydroxyprogesterone caproate), a progestin injection was withdrawn because of lack of efficacy. Even Vioxx, which had an unlabeled potential harm for a limited subgroup of users, spawn a litigation in which the lawsuit industry tried to make every user, even those who may have licked a pill for one day, a winner in the lawsuit lottery.

[1] Editorial Board, “The FDA Takes a Trial-Lawyer Turn,” Wall St. J. (May 21, 2025).

[2] FDA News Release, “FDA to Host Inaugural, Independent, Scientific Expert Panel Open to Public,” FDA (May 16, 2025).

[3] FDA Expert Panel on Talc, “Independent Expert Panel to Evaluate Safety and Necessity of Talc in Food, Drug, and Cosmetic Products,” FDA (May 20, 2025). The participants were FDA Commissioner Martin A. Makary, FDA Deputy Commissioner Sara Brenner, and a group of scientists, George Tidmarsh, John Joseph Godleski, Sandra McDonald, Daniel Cramer, Joellen Schildkraut, Malcolm Sim, Steven Pfeiffer, Nicolas Wentzensen, and Nicole C. Kleinstreuer.

[4] IARC Press Release no. 352, “IARC Monographs evaluate the carcinogenicity of talc and acrylonitrile” (July 5, 2024).

[5] See Berg v. Johnson & Johnson Consumer Co., 983 F.Supp.2d 1151, 1154 (D.S.D. 2013); Carl v. Johnson & Johnson, 464 N.J. Super. 446, 237 A.3d 308, 310 (N.J. App. Div. 2020).

[6] Makary, “The FDA Presents Its Case for Targeting Talc,” Wall St. J. (June 2, 2025).

[7] Che-Jui Chang, Yao-Hsu Yang, Pau-Chung Chen, Hsin-Yi Peng, Yi-Chia, Sheng-Rong Song & Hsiao-Yu Yang, “Stomach Cancer and Exposure to Talc Powder without Asbestos via Chinese Herbal Medicine: A Population-Based Cohort Study,” 16 Internat’l J. Envt’l Res. Public Health 717 (2019).

[8] Raghav Sundar, Izuma Nakayama, Sheraz R Markar, Kohei Shitara, Hanneke W M van Laarhoven, Yelena Y. Janjigian & Elizabeth C. Smyth, “Gastric cancer,” 405 Lancet 2087, 2089 (2025).

Posted in Asbestos, Regulation, Scientific Evidence, Talc | No Comments »

Genetic Causes of Mesothelioma – Part One

February 17th, 2025

In serving as a peer reviewer of legal publications, I have encountered authors who assert in manuscripts that all human mesotheliomas are caused by asbestos. This assertion was false back in the 1980s when I was trying mesothelioma cases, but today the assertion is demonstrably false. The lawsuit industry and its expert witnesses have propagated the assertion relentlessly for the last four decades, and their over-zealous advocacy has distorted the discussion of causal claims in legal venues. When I have encountered these statements in manuscripts, I have suggested more accurate and felicitous descriptions, which only sometimes were adopted.

Scientists have long suspected that there were genetic determinants, and indeed causes, of human mesothelioma. Establishing this suspicion as fact has proven difficult in part because of the difficulty in conducting full genome sequencing of large numbers of mesothelioma patients. For some time, scientists have been publishing studies, however, which have undermined the dogma of the lawsuit industry. Last month, an important study was peer-reviewed and published in Science Reports, a journal in the Nature family, which further chipped away at the dogma, by showing the importance of certain BAP1 mutations in the rate of spontaneous malignant mesothelioma, in in-bred mice without asbestos exposure. The article is open access, and should be on the reading list of practicing lawyers and commentators who concern themselves with asbestos, and the issue of supposed pathognomonic diseases in the courts.[1] The medico-legal implications of the publication are obvious. Mesothelioma can result from highly penetrant genetic mutations in the absence of any asbestos exposure. I have reproduced the authors’ abstract below, but interested readers should obtain and study the entire study.

“Cancers of the mesothelium, such as malignant mesothelioma (MM), historically have been attributed solely to exposure to asbestos. Recent large scale genetic and genomic functional studies now show that approximately 20% of all human mesotheliomas are causally linked to highly penetrant inherited (germline) pathogenic mutations in numerous cancer related genes. The rarity of these mutations in humans makes it difficult to perform statistically conclusive genetic studies to understand their biological effects. This has created a disconnect between functional and epidemiological studies. However, since the molecular pathogenesis of MM in mice accurately recapitulates that of human disease, this disconnect between functional and epidemiological studies can be overcome by using inbred mouse strains that harbor mutation(s) in genes involved in the disease. Most mouse studies have focused on the effect of asbestos exposure, leaving the effects of genetic mutations in the absence of exposure understudied. Here, using existing peer-reviewed studies, we investigate the rate of spontaneous MM among mice with and without germline genetic mutations, in the absence of asbestos exposure. We leveraged these published data to generate a historical control dataset (HCD) to allow us to improve statistical power and account for genetic heterogeneity between studies. Our Bayesian analyses indicate that the odds of spontaneous MM among germline BAP1 mutant mice is substantially larger than that of wildtype mice. These results support the existing biological study findings that mesotheliomas can arise in the presence of pathogenic germline mutations, independently of asbestos exposure.”

[1] Dahlia M. Nielsen, Mei Hsu, Michael Zapata III, Giovanni Ciavarra & Leonel van Zyl, “Bayesian analysis of the rate of spontaneous malignant mesothelioma among BAP1 mutant mice in the absence of asbestos exposure,” 15 Sci. Reports 169 (2025).

Posted in Asbestos, Causation | No Comments »

Fraudulent Asbestos Diagnoses Redux

August 27th, 2024

An Associated Press journalist reported on an appeal from an interesting judgment, which few other journalists have followed.[1] Last week, Matthew Brown filed a report on an appeal before the Ninth Circuit challenging a judgment against a health clinic that had diagnosed supposed asbestos-related diseases among residents of Libby, Montana. The BNSF Railway (Burlington Northern Santa Fe Corporation) challenged the validity of more than 2,000 of the clinic’s diagnoses, in a qui tam action. A federal court jury in Missoula found that the Railway had carried its burden of proving that 337 of the cases were indeed false claims. The clinic’s fraud had made its patients wrongly entitled to various federally funded benefit programs. The Railway’s tenuous connection to the underlying claims was that its railroad serviced the vermiculite mine outside of town, and its trains passed through town.

According to Brown, Plaintiff BNSF claimed that the clinic had made its diagnoses of asbestos-related disease solely upon chest radiographs. The clinic apparently defended by confession and avoidance. Yes, it had made diagnoses solely upon radiographs, but its physicians claimed that they had done so in good faith, based upon guidance of federal officials. This defense seems rather dodgy given that asbestosis does not manifest as a unique radiographic pattern.

The False Claims Act case resulted in a verdict of $5.8 million in penalties and damages, with one quarter of that amount going to BNSF as the relator. The federal government had declined to prosecute the case under the Act. After judgment was entered on the verdict, CART filed for bankruptcy, but its petition was dismissed at the request of the federal government. Lawyers for the government argued that the U.S. Department of Health and Human Services was the principal funder of the clinic, as well as its primary creditor. The costs of the bankruptcy would simply fall on taxpayers, who along with the Libby-area residents, were the victims of CART’s fraud. The defendant clinic has appealed on grounds of erroneous jury instructions, according to its appellate lawyer, Tim Bechtold.

The AP story has a sub-headline claiming “[i]ndependent, fact-based, nonpartisan reporting.” Well, maybe not.

1. For some reason, Brown was coy about identifying the fraudfeasor medical clinic. The defendant in the case was the Center for Asbestos-Related Disease, Inc. (CART). Similarly, he did not identify any of the medical personnel who submitted false claims. CART had a physical presence in Libby, Montana, where W.R. Grace mined vermiculite for many years. The group has apparently filed for bankruptcy, but its website is still active. CART’s website’s landing page describes the Center as providing “advocacy, screening, care, and resources.” Notably, “advocacy” was listed first, which might not be exactly what physicians should prioritize.

2. Mr. Brown states that “[e]xposure to even a minuscule amount of asbestos can cause lung problems, according to scientists.” As Peter Woit put it, this characterization is not even wrong. Asbestos is a commercial term for six different minerals, but only in their fibrous habit. The potency for causing some diseases in humans varies by orders of magnitude among the mineral varieties. Since only god can make asbestos, and because the different varieties of asbestos are omnipresent in the natural environment, and because humans have natural defenses to inhaled minerals at levels even above “minuscule amounts,” Brown’s quote is nothing more than lawsuit industry propaganda. His statement about minuscule exposures is noteworthy for not having any identified source, although Brown used the exact phrase in an earlier article on the jury verdict.[2]

3. Mr. Brown does not provide the caption of the case he is describing, which seems like poor journalistic practice. For readers interested in the never-ending sage of fraudulent asbestos claims, the case was BNSF Railway v. Center for Asbestos Related Disease, Inc., No. CV 19-40-M-DLC (D. Mont. July 18, 2023). Some other proceedings of the case in district court are also available online. The oral argument is quite revealing in showcasing the parties’ stipulation that asbestosis cannot be diagnosed by B-readers and their interpretation of chest radiographs. The shoddy evidentiary foundations of many of the claims supported by CART are reminiscent of the fraud in In re Silica Products Liability Litigation, 398 F. Supp. 2d 563 (S.D. Tex. 2005).

4. Although Mr. Brown was reporting on the upcoming oral argument in the Ninth Circuit, he did not link to the video of that argument, which is available at the Circuit’s website. The Ninth Circuit’s docket number is 23-35507, and the case was heard on August 21, last week, by a panel of Judges Christen, Nguyen, and Hurwitz.

5. Mr. Brown provided no discussion or analysis whether CART’s defense was coherent or valid. The interested audience members can listen to the Ninth Circuit oral argument, and judge for themselves. I for one found the documented diagnostic practices “shocking and outrageous,” as Judge Clark Brown (of Boston Legal fame) used to say. By virtue of a federal statute, Libby area residents who have been diagnosed with an asbestos-related disease are eligible for various services, including Medicare, housekeeping, travel to medical appointments and disability benefits, at taxpayer expense.

[1] Matthew Brown, “Montana asbestos clinic seeks to reverse $6M in fines, penalties over false claims,” Assoc. Press News (Aug 21, 2024).

[2] Matthew Brown, “Montana health clinic must pay nearly $6 million over false asbestos claims, judge rules,” P.B.S. Newshour (July 23, 2023).

Posted in Asbestos, Medical monitoring, Public Nuisances | No Comments »

David Egilman, Rest in Peace – Part 1

April 26th, 2024

After close to a 40 year career as a testifying expert witness, David Egilman died earlier this month.[1] He was a work horse of the lawsuit industry. Although he made plenty of money as a retained witness, Egilman was motivated by his political agenda. As he noted in a 2004 lecture at the Center for Science in the Public Interest: “my bias is ideological.”[2]

By the mid-1980s, Egilman was actively engaged in medico-legal testimonial adventures. In 1986, he was sued for negligence and fraud in connection with medical reports he wrote to support worker compensation claims filed against the Dayton-Walther Corporation. Thanks to the excellent lawyering of Frank Woodside and others, the case was ultimately dismissed on grounds that the alleged fraud was not legally cognizable as pleaded.[3]

Not long after Egilman dodged the Ohio fraud case, he testified for a claimant in a disability case against the Norfolk & Western Railroad. The administrative tribunals found the claim “was not fully credible or supported by substantial evidence in the record.”[4] By 1990, testifying in the Virgin Islands, Egilman had appeared upon the asbestos scene. [5] And then, Egilman seemed to be everywhere.

With the decision in Daubert, Egilman became gun shy, and he would not appear in courtrooms in which he faced a substantial risk of being excluded. Egilman submitted reports in the cases before Judge Jones, in the District of Oregon, but after the court appointed technical advisors, Egilman decided to stay on the east coast. Egilman also sat out the hearings before Judges Weinstein and Baer, and Justice Lobis, in Brooklyn, in October 1996.

Up to the fall of 1996, Egilman had never showed up in any my cases. As I was preparing for the hearing before Judge Weinstein, I received a letter by telecopy and post, from David Egilman. The circumstances surrounding this letter were nothing less than bizarre. Earlier in the winter of 1996, George Gore (Al’s cousin) tried a silicone breast implant case for Bristol Myers Squibb in Oregon state court. I was there for the trial, mostly to monitor the proceedings, and help with witness preparation. Tragically, George’s father died during the trial, and for want of a better candidate, I substituted for him while he had to be away. When George returned (after a detour to be invested as President of the IADC), he wanted his case back. After some tussling, we agreed to share the remaining witnesses, but George was adamant that he wanted to present the closing argument.

With the jury out, the defense prospects did not look promising, and George vamoosed again. The case had been bifurcated, and there was a punitive damages phase still to go. Once again, I re-entered the fray and tried the second phase of the case. In its deliberations on the second phase, the jury deadlocked, and the parties were left to fight what the Oregon requirement of a unified jury meant.

And then, in late September 1996, a faxed letter came across my desk, from none other than David Egilman. I had a breast implant case, set for trial in Middlesex County, New Jersey, and Egilman was one of the main causation expert witnesses for the plaintiff, represented by the Wilentz firm. Perhaps the only way to tell what happened is simply to share with you what Egilman wanted from me, and then to share with you my response to the Wilentz firm. Very shortly after I wrote my letter, Chris Placitella, the Wilentz trial lawyer, withdrew Egilman from the case, and I never got another opportunity to take his deposition or to cross-examine him.

And my response directed to the firm that represented the plaintiff:

[1] Clay Risen, “David Egilman, Doctor Who Took On Drug Companies, Dies at 71,” N.Y. Times (Apr. 15, 2024).

[2] David Egilman and Susanna Rankin Bohme, “The suppression of science: How corporate interests hide the truth & how to stop them” CSPI Conference (July 2004).

[3] Dayton-Walther Corp. v. Kelly, 42 Ohio App. 3d 184 (1987).

[4] Freels v. U.S. RR Retirement Bd., 879 F.2d 335 (1989).

[5] Dunn v. Owens-Corning Fiberglas, 774 F. Supp. 929 (D.V.I. 1991).

Posted in Asbestos, Cognitive Biases, Expert Witness Hall of Shame, Public Nuisances | 7 Comments »

The Maestro and Mesothelioma – Wikipedia & False Claims

January 21st, 2024

The Maestro is a biographical film of the late Leonard Bernstein. The film, starring Bradley Cooper as Bernstein, had a limited release before streaming on Netflix. As a work of biography, the film is peculiar in its focus on Bernstein’s sexuality and filandering, while paying virtually no attention to his radical chic politics, or his engagement with teaching music appreciation.

In any event, the film sent me to Wikipedia to fact check some details of Bernstein’s life, and I was surprised to see that Wikipedia described Bernstein’s cause of death as involving mesothelioma:

“Bernstein announced his retirement from conducting on October 9, 1990.[174] He died five days later at the age of 72, in his New York apartment at The Dakota, of a heart attack brought on by mesothelioma.[175][2]”

Bernstein certainly did not have occupational exposure to amphibole asbestos, but he did smoke cigarettes, several packs a day, for decades. Mesothelioma seemed unlikely, unless perhaps he smoked Kent cigarettes in the 1950s, when they had crocidolite filters. As you can see from the above quote, the Wikipedia article cites two sources, a newspaper account and a book. Footnote number 2 is an obituary was written by Donal Henahan, and printed in the New York Times.[1] The Times reported that:

“Leonard Bernstein, one of the most prodigally talented and successful musicians in American history, died yesterday evening at his apartment at the Dakota on the Upper West Side of Manhattan. He was 72 years old.

* * * * * * *

Mr. Bernstein’s spokeswoman, Margaret Carson, said he died of a heart attack caused by progressive lung failure.”

There is no mention of mesothelioma in the Times article, and the citation provided does not support the assertion that mesothelioma was involved in the cause of Bernstein’s death. The obituary cited was published the day following Bernstein’s death the night before, which suggests that there was no information from an autopsy, which would have been important in ascertaining any tissue pathology for an accurate and complete cause of death. In 1990, the diagnosis of malignant mesothelioma was often uncertain, even with extensive tissue available post-mortem.

The other citation provided by the Wikipedia article was even less impressive. Footnote 175 pointed to a book of short articles on musicians, with an entry for Bernstein.[2] The book tells us that

“Bernstein is most remembered, perhaps, for his flamboyant conducting style. *** Leonard Bernstein died at his home from cardiac arrest brought on by mesothelioma.”

The blurb on Bernstein provides no support for the statement that cardiac arrest was brought on by mesothelioma, and the narrative struck me as odd in leaving out the progressive lung failure caused by non-malignant smoking-induced lung disease.

I set out to find what else may have been written about the causes of Bernstein’s death. I was surprised to find other references to mesothelioma, but all without any support. One online article seemed promising, but offered a glib conclusion without any source:

“Leonard Bernstein, a towering figure in American music, met his end on October 14, 1990, just five days after retiring from his illustrious career as a conductor. Found in his New York apartment, the cause of his death was a heart attack induced by mesothelioma, a consequence of a lifetime of smoking.”[3]

The lack of any foot- or end-notes disqualifies this source, and others, for establishing a diagnosis of mesothelioma. Other internet articles, inspired by the Cooper production of Maestro, made very similar statements, all without citing any source.[4] Some of the internet articles likely plagiarized others, but I was unable to find who first gave rise to the conclusion that Bernstein died of complications of “mesothelioma” caused by smoking.

Whence came the Wikipedia’s pronouncement that Bernstein died of, or with, mesothelioma? Two “mainstream” print newspapers provided some real information and insight. An article in the Washington Post elaborated on Bernstein’s final illness and the cause of his death:

“Leonard Bernstein, 72, a giant in the American musical community who was simultaneously one of this nation’s most respected and versatile composers and preeminent conductors, died yesterday at his Manhattan apartment. He died in the presence of his physician, who said the cause of death was sudden cardiac arrest caused by progressive lung failure.

On the advice of the doctor, Kevin M. Cahill, Bernstein had announced through a spokeswoman Tuesday that he would retire from conducting. Cahill said progressive emphysema complicated by a pleural tumor and a series of lung infections had left Bernstein too weak to continue working.”[5]

Ah a pleural tumor, but no report or representation that it was malignant mesothelioma.

The Los Angeles Times, with the benefit of an extra three hours to prepare its obituary for a west coast audience, provided similar, detailed information about Bernstein’s death:

“Bernstein, known and beloved by the world as ‘Lenny’, died at 6:15 p.m. in the presence of his son, Alexander, and physician, Kevin M. Cahill, who said the cause of death was complications of progressive lung failure. On Cahill’s advice, the conductor had announced Tuesday that he would retire. Cahill said progressive emphysema complicated by a pleural tumor and a series of lung infections had left Bernstein too weak to continue working.”[6]

Now a pleural tumor can be benign or malignant. And if the tumor were malignant, it may or may not be a primary tumor of the pleura. Metastatic lesions of the pleura, or in the lung parenchyma adjacent to the pleura are common enough that the physician’s statement about tumor of the pleura cannot be transformed into a conclusion about mesothelioma.[7]

Feeling good about having sorted a confusion, I thought I could add to the font of all knowledge, Wikipedia, by editing its unsupported statement about mesothelioma to “pleural tumor.” I made the edit, but within a few days, someone had changed the text back to mesothelioma, without adding any support. The strength of any statement is, of course, based entirely upon its support and the strength of its inferences. Wikipedia certainly can be a reasonable starting place to look for information, but it has no ability to support a claim, whether historical, scientific, or medical. Perhaps I should have added the citation to the Washington Post obituary when I made my edit. Still, it was clear that nothing in article’s footnotes supported the text, and someone felt justified in returning the mention of mesothelioma based upon two completely unsupportive sources. Not only is the Bernstein article in Wikipedia suspect, but there is actually an entry in Wikipedia for “Deaths from Mesothelioma,” which lists Bernstein as well. The article has but one sentence: “This is a list of individuals who have died as a result of mesothelioma, which is usually caused by exposure to asbestos.” And then follows a list of 67 persons, of varying degree of noteworthiness, who supposedly died of mesothelioma. I wonder how many of the entries are false.

[1] Donal Henahan, “Leonard Bernstein, 72, Music’s Monarch, Dies,” New York Times (October 15, 1990).

[2] Scott Stanton, The Tombstone Tourist: Musicians at 29 (2003).

[3] Soumyadeep Ganguly, “Leonard Bernstein’s cause of death explored: How does Bradley Cooper Maestro end? Movie ending explored,” SK POP (modified Dec 25, 2023).

[4] See, e.g., Gargi Chatterjee, “How did Leonard Bernstein die?” pinkvilla (Dec 23, 2023).

[5] Bart Barnes, “Conductor Leonard Bernstein Dies at 72,” Wash. Post (Oct. 15, 1990) (emphasis added).

[6] Myrna Oliver, “Leonard Bernstein Dies; Conductor, Composer. Renaissance man of his art was 72. The longtime leader of the N.Y. Philharmonic carved a niche in history with ‘West Side Story’,” Los Angeles Times (Oct. 15, 1990) (emphasis added).

[7] See, e.g., Julie Desimpel, Filip M. Vanhoenacker, Laurens Carp, and Annemiek Snoeckx, “Tumor and tumorlike conditions of the pleura and juxtapleural region: review of imaging findings,” 12 Insights Imaging 97 (2021).

Posted in Asbestos, Peer Review | 154 Comments »

Collegium Ramazzini & Its Fellows – The Lobby

November 19th, 2023

Back in 1997, Francis Douglas Kelly Liddell, a real scientist in the area of asbestos and disease, had had enough of the insinuations, slanders, and bad science from the minions of Irving John Selikoff.[1] Liddell broke with the norms of science and called out his detractors for what they were doing:

“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”[2]

What Liddell did not realize is that the Lobby had become institutionalized in the form of an organization, the Collegium Ramazzini, started by Selikoff under false pretenses.[3] Although the Collegium operates with some degree of secrecy, the open and sketchy conduct of its members suggest that we could use the terms “the Lobby” and “the Collegium Ramazzini,” interchangeably.

Ramazzini founder Irving Selikoff had an unfortunate track record for perverting the course of justice. Selikoff conspired with Ron Motley and others to bend judges with active asbestos litigation dockets by inviting them to a one-sided conference on asbestos science, and to pay for their travel and lodging. Presenters included key expert witnesses for plaintiffs; defense expert witnesses were conspicuously not invited to the conference. In his invitation to this ex parte soirée, Selikoff failed to mention that the funding came from plaintiffs’ counsel. Selikoff’s shenanigans led to the humiliation and disqualification of James M. Kelly,[4] the federal judge in charge of the asbestos school property damage litigation,

Neither Selikoff nor the co-conspirator counsel for plaintiffs ever apologized for their ruse. The disqualification did lead to a belated disclosure and mea culpa from the late Judge Jack Weinstein. Because of a trial in progress, Judge Weinstein did not attend the plaintiffs’ dog-and-pony show, Selikoff’s so-called “Third Wave” conference, but Judge Weinstein and a New York state trial judge, Justice Helen Freedman, attended an ex parte private luncheon meeting with Dr. Selikoff. Here is how Judge Weinstein described the event:

“But what I did may have been even worse [than Judge Kelly’s conduct that led to his disqualification]. A state judge and I were attempting to settle large numbers of asbestos cases. We had a private meeting with Dr. Irwin [sic] J. Selikoff at his hospital office to discuss the nature of his research. He had never testified and would never testify. Nevertheless, I now think that it was a mistake not to have informed all counsel in advance and, perhaps, to have had a court reporter present and to have put that meeting on the record.”[5]

Judge Weinstein’s false statement that Selikoff “had never testified”[6] not only reflects an incredible and uncharacteristic naiveté by a distinguished evidence law scholar, but the false statement was in a journal, Judicature, which was, and is, widely circulated to state and federal judges. The source of the lie appears to have been Selikoff himself in the ethically dodgy ex parte meeting with judges actively presiding over asbestos personal injury cases.

The point apparently weighed on Judge Weinstein’s conscience. He repeated his mea culpa almost verbatim, along with the false statement about Selikoff’s having never testified, in a law review article in 1994, and then incorporated the misrepresentation into a full-length book.[7] I have no doubt that Judge Weinstein did not intend to mislead anyone; like many others, he had been duped by Selikoff’s deception.

There is no evidence that Selikoff was acting as an authorized agent for the Collegium Ramazzini in conspiring to influence trial judges, or in lying to Judge Weinstein and Justice Freedman, but Selikoff was the founder of the Collegium, and his conduct seems to have set a norm for the organization. Furthermore, the Third-Wave Conference was sponsored by the Collegium. Two years later, the Collegium created an award in Selikoff’s name, in 1993, not long after the Third Wave misconduct.[8] Perhaps the award was the Collegium’s ratification of Selikoff’s misdeeds. Two of the recipients, Stephen M. Levin, and Yasunosuke Suzuki, were “regulars,” as expert witnesses for plaintiffs in asbestos litigation. The Selikoff Award is funded by the Irving J. Selikoff Endowment of the Collegium Ramazzini. The Collegium can fairly be said to be the continuation of Selikoff’s work in the form of advocacy organization.

Selikoff’s Third-Wave Conference and his lies to two key judges would not be the last of efforts to pervert the course of justice. With the Selikoff imprimatur and template in hand, Fellows of the Collegium have carried on, by carrying on. Collegium Fellows Carl F. Cranor and Thomas Smith Martyn Thomas served as partisan paid expert witnesses in the notorious Milward case.[9]

After the trial court excluded the proffered opinions of Cranor and Smith, plaintiff appealed, with the help of an amicus brief filed by The Council for Education and Research on Toxics (CERT). The plaintiffs’ counsel, Cranor and Smith, CERT, and counsel for CERT all failed to disclose that CERT was founded by the two witnesses, Cranor and Smith, whose exclusion was at the heart of the appeal.[10] Among the 27 signatories to the CERT amicus brief, a majority (15) were fellows of the Collegium Ramazzini. Others may have been members but not fellows. Many of the signatories, whether or not members or fellows of the Collegium, were frequent testifiers for plaintiffs’ counsel.

None raised any ethical qualms about the obvious conflict of interest on how scrupulous gatekeeping might hurt their testimonial income, or their (witting or unwitting) participation in CERT’s conspiracy to pervert the course of justice.[11]

The CERT amici signatories are listed below. The bold names are identified as Collegium fellows at its current website. Others may have been members but not fellows. The asterisks indicate those who have testified in tort litigation; please accept my apologies if I missed anyone.

Nicholas A. Ashford,
Nachman Brautbar,*
David C. Christiani,*
Richard W. Clapp,*
James Dahlgren,*
Devra Lee Davis,
Malin Roy Dollinger,*
Brian G. Durie,
David A. Eastmond,
Arthur L. Frank,*
Frank H. Gardner,
Peter L. Greenberg,
Robert J. Harrison,
Peter F. Infante,*
Philip J. Landrigan,
Barry S. Levy,*
Melissa A. McDiarmid,
Myron Mehlman,
Ronald L. Melnick,*
Mark Nicas,*
David Ozonoff,*
Stephen M. Rappaport,
David Rosner,*
Allan H. Smith,*
Daniel Thau Teitelbaum,*
Janet Weiss,* and
Luoping Zhang

This D & C (deception and charade) was repeated on other occasions when Collegium fellows and members signed amicus briefs without any disclosures of conflicts of interest. In Rost v. Ford Motor Co.,[12] for instance, an amicus brief was filed by by “58 physicians and scientists,” many of whom were Collegium fellows.[13]

Ramazzini Fellows David Michaels and Celeste Monforton were both involved in the notorious Project on Scientific Knowledge and Public Policy (SKAPP) organization, which consistently misrepresented its funding from plaintiffs’ lawyers as having come from a “court fund.”[14]

Despite Selikoff’s palaver about how the Collegium would seek consensus and open discussions, it has become an echo-chamber for the rent-seeking mass-tort lawsuit industry, for the hyperbolic critics of any industry position, and for the credulous shills for any pro-labor position. In its statement about membership, the Collegium warns that

“Persons who have any type of links which may compromise the authenticity of their commitment to the mission of the Collegium Ramazzini do not qualify for Fellowship. Likewise, persons who have any conflict of interest that may negatively affect his or her impartiality as a researcher should not be nominated for Fellowship.”

This exclusionary criterion ensures lack of viewpoint diversity, and makes the Collegium an effective proxy for the law industry in the United States.

Among the Collegium’s current and past fellows, we can find many familiar names from the annals of tort litigation, all expert witnesses for plaintiffs, and virtually always only for plaintiffs. After over 40 years at the bar, I do not recognize a single name of anyone who has ever testified on behalf of a defendant in a tort case.

Henry A. Anderson

Barry I. Castleman

Martin Cherniack

David Christiani

Arthur Frank

Lennart Hardell

David G. Hoel

Stephen M. Levin

Ronald L. Melnick

David Michaels

Celeste Monforton

Albert Miller

Brautbar Nachman

Christopher Portier

Steven B. Markowitz

Christine Oliver

Colin L, Soskolne

Yasunosuke Suzuki

Daniel Thau Teitelbaum

Laura Welch

[1] “The Lobby – Cut on the Bias” (July 6, 2020).

[2] F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997).

[3] See “The Dodgy Origins of the Collegium Ramazzini” (Nov. 15, 2023).

[4] In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992). See Cathleen M. Devlin, “Disqualification of Federal Judges – Third Circuit Orders District Judge James McGirr Kelly to Disqualify Himself So As To Preserve ‘The Appearance of Justice’ Under 28 U.S.C. § 455 – In re School Asbestos Litigation (1992),” 38 Villanova L. Rev. 1219 (1993); Bruce A. Green, “May Judges Attend Privately Funded Educational Programs? Should Judicial Education Be Privatized?: Questions of Judicial Ethics and Policy,” 29 Fordham Urb. L.J. 941, 996-98 (2002).

[5] Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994) (emphasis added).

[6] “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

[7] See Jack B. Weinstein, “Limits on Judges’ Learning, Speaking and Acting – Part I- Tentative First Thoughts: How May Judges Learn?” 36 Ariz. L. Rev. 539, 560 (1994) (“He [Selikoff] had never testified and would never testify.”); Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995) (“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”).

[8] See also “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011).

[9] Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp.2d 137, 140 (D.Mass.2009), rev’d, 639 F. 3d 11 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).

[10] See “The Council for Education and Research on Toxics” (July 9, 2013).

[11] “Carl Cranor’s Inference to the Best Explanation” (Dec. 12, 2021).

[12] Rost v. Ford Motor Co., 151 A.3d 1032, 1052 (Pa. 2016).

[13] “The Amicus Curious Brief” (Jan. 4, 2018).

[14] See, e.g., “SKAPP A LOT” (April 30, 2010); “Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013).

Posted in Asbestos, Conflicts of Interest, Scientific Misconduct | 5 Comments »

The Dodgy Origins of the Collegium Ramazzini

November 15th, 2023

Or How Irving Selikoff and His Lobby (the Collegium Ramazzini) Fooled the Monsanto Corporation

Anyone who litigates occupational or environmental disease cases has heard of the Collegium Ramazzini. The group is named after a 17th century Italian physician, Bernardino Ramazzini, who is sometimes referred to as the father of occupational medicine.[1] His children have been an unruly lot. In Ramazzini’s honor, the Collegium was founded just over 40 years old, to acclaim and promises of neutrality and consensus.

Back in May 1983, a United Press International reporter chronicled the high aspirations and the bipartisan origins of the Collegium.[2] The UPI reporter noted that the group was founded by the late Irving Selikoff, who is also well known in litigation circles. Selikoff held himself out as an authority on occupational and environmental medicine, but his actual training in medicine was dodgy. His training in epidemiology and statistics was non-existent.

Selikoff was, however, masterful at marketing and prosyletizing. Selikoff would become known for misrepresenting his training, and creating a mythology that he did not participate in litigation, that crocidolite was not used in products in the United State, and that asbestos would become a major cause of cancer in the United States, among other things.[3] It is thus no surprise that Selikoff successfully masked the intentions of the Ramazzini group, and was thus able to capture the support of two key legislators, Senators Charles Mathias (Rep., Maryland) and Frank Lautenberg (Dem., New Jersey), along with officials from both organized labor and industry.

Selikoff was able to snooker the Senators and officials with empty talk of a new organization that would work to obtain scientific consensus on occupational and environmental issues. It did not take long after its founding in 1983 for the Collegium to become a conclave of advocates and zealots.

The formation of the Collegium may have been one of Selikoff’s greatest deceptions. According to the UPI news report, Selikoff represented that the Collegium would not lobby or seek to initiate legislation, but rather would interpret scientific findings in accessible language, show the policy implications of these findings, and make recommendations. This representation was falsified fairly quickly, but certainly by 1999, when the Collegium called for legislation banning the use of asbestos. Selikoff had promised that the Collegium

“will advise on the adequacy of a standard, but will not lobby to have a standard set. Our function is not to condemn, but rather to be a conscience among scientists in occupational and environmental health.”

The Adventures of Pinocchio (1883); artwork by Enrico Mazzanti

Senator Mathias proclaimed the group to be “dedicated to the improvement of the human condition.” Perhaps no one was more snookered than the Monsanto Corporation, which helped fund the Collegium back in 1983. Monte Throdahl, a Monsanto senior vice president, reportedly expressed his hopes that the group would emphasize the considered judgments of disinterested scientists and not the advocacy and rent seeking of “reporters or public interests groups” on occupational medical issues. Forty years in, those hopes are long since gone. Recent Collegium meetings have been sponsored and funded by the National Institute for Environmental Sciences, Centers for Disease Control, National Cancer Institute, and Environmental Protection Agency. The time has come to cut off funding.

[1] Giuliano Franco & Francesca Franco, “Bernardino Ramazzini: The Father of Occupational Medicine,” 91 Am. J. Public Health 1382 (2001).

[2] Drew Von Bergen, “A group of international scientists, backed by two senators,” United Press International (May 10, 1983).

[3] “Selikoff Timeline & Asbestos Litigation History” (Feb. 26, 2023); “The Lobby – Cut on the Bias” (July 6, 2020); “The Legacy of Irving Selikoff & Wicked Wikipedia” (Mar. 1, 2015). See also “Hagiography of Selikoff” (Sept. 26, 2015); “Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas” (Oct. 4, 2014); “Irving Selikoff – Media Plodder to Media Zealot” (Sept. 9, 2014).; “Historians Should Verify Not Vilify or Abilify – The Difficult Case of Irving Selikoff” (Jan. 4, 2014); “Selikoff and the Mystery of the Disappearing Amphiboles” (Dec. 10, 2010); “Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010).

Posted in Asbestos, Conflicts of Interest, Public Nuisances, Scientific Misconduct, Scientific Publishing | 9 Comments »