TORTINI

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Selikoff Timeline & Asbestos Litigation History

December 20th, 2018

The critics and cheerleaders of Dr. Irving John Selikoff agree that he was a charming, charismatic, and courageous man, a compassionate physician, and a zealous advocate for worker safety and health. The consensus falls apart over the merits of Selikoff’s actual research, his credentials, and his advocacy tactics.1

Selikoff’s collaborators, protégés, and fellow travelers tend to brand any challenge or criticism as “scurrilous.”2 They attack the messenger for attacking the messenger. Certainly in his lifetime, Selikoff attracted harsh and vituperative attacks, some of which were mean-spirited and even anti-semitic.

Although I am not a Jew, I am, following Jonathan Miller, “Jew-ish, just not the whole hog.” As such, I can appreciate the ire of some of Selikoff’s defenders over the nature of these attacks. Selikoff’s legitimate achievements should not be diminished, and his defenders are correct to bemoan the ad hominem attacks on Selikoff, based upon ethnicity and personal characteristics.

Selikoff’s defenders are wrong, however, to claim that Selikoff’s training, scientific acumen, advocacy, and false positive claims are somehow off limits. Selikoff advanced his scientific and political agenda by promoting his reputation and work, and he thus put his credentials, work, and methods into issue. Selikoff’s contributions to public health in publicizing the dangers of high exposure, long-term asbestos exposure do not privilege every position he took. Selikoff is a difficult case because he was wrong on many issues, and his reputation, authority and prestige ultimately became much greater than the evidence would ultimately support.

Although Selikoff died in 1992, his legacy lives on in the perpetual litigation machine that is run by the litigation industry and Selikoff’s juniors and imitators, who serve as testifying expert witnesses. One of Selikoff’s great achievements, the federalization of worker safety and health in the Williams-Steiger Occupational Safety and Health Act of 1970,3 languishes because of inadequate resources for enforcement and frivolous efforts to address non-existent problems, such as the lowering of the crystalline silica permissible exposure limit. Activists have taken to redress the problem by advocating for nugatory “warnings” from remote suppliers, in the face of employer failures to monitor and supervise workers and the workplace, and to provide administrative, engineering, and personal protective controls.

Selikoff diverted regulatory attention from asbestos fiber type, with the result that the OSHA PELs were lowered for both chrysotile and amphibole asbestos, thus leaving the ultra-hazardous crocidolite asbestos in use. Selikoff perpetuated a good deal of mischief and misinformation to keep his myth that all fiber types are the same (and that “asbestos is asbestos is asbestos”). In doing so, he actually hurt people.

An anonymous snark on Wikipedia noted some of my blog posts about Selikoff, and offered the lame criticism that my writings were not peer reviewed.4 The snark (Tweedale?) was of course correct on this limited point, but generally in this field, peer review is worth a warm bucket of spit.And the Selikoffophiles continue to tell tall tales about Selikoff’s work and in particular about how he became involved in asbestos medicine. See, e.g., Philip Landrigan, “Stephen Levin, MD, honored with the Collegium Ramazzini’s Irving J. Selikoff Memorial Award in 2009.”So here is a timeline of Selikoff’s life and asbestos work. If anyone notes an error or inconsistency in this time line, please contact me, provide better sources, and ask for a correction. If I am wrong, I will readily note the correction and eat my words, but I am sure they will be quite digestible.5  

Jan. 15, 1915.  Irving John Selikoff was born as Irving Selecoff in the brain basket of America, Brooklyn, New York, to Abraham and Matilda (Tillie) Selecoff.6 His father, Abraham, was born on April 6, 1885, in the Kiev oblast of what is now Ukraine.7

1920.  According to the 1920 census, the Selekoff family lived at 816 179th Street, in the Bronx. Irving’s father, Abraham, was self-employed as a hat manufacturer, doing business later as United Headwear Corporation.8 The family had two children, Irving, and his older sister, Gladys.

1930. Asbestos workers’ journal published a story about the (non-malignant) risks of asbestos exposure. See The Asbestos Menace,” The Asbestos Worker 9-11 (Sept. 1930).

June 1935.  Selikoff was graduated from Columbia University, with a B.S. degree.

December 1935.  Selikoff arrived Boston from Yarmouth, on the S.S. Yarmouth, on December 24, 1935, apparently en route from Scotland.

August 1936.  Selikoff sat for the university entrance boards in Scotland.

September 1936.  Selikoff married Lydia Kapilian, in the Bronx.9

October 1936.  Selikoff entered Anderson’s College of Medicine, in Glasgow, Scotland.10

1936.  Alice Hamilton published an article on the risks and benefits of industrial asbestos use, in a key labor unionist journal. Alice Hamilton, “Industrial Poisons,” 43 The American Federationist 707-13 (1936).

April 26, 1937.  Selikoff arrived in New York, from Greenock, Scotland, on the S.S. Carinthia.

July 14, 1938.  Selikoff arrived in Quebec, from Greenock, Scotland, on the S.S. Duchess Atholl.

June 24, 1939.  Selikoff arrived in New York, from Liverpool, London, on the S.S. Mauretania. Because of the developing hostilities in Europe, Selikoff apparently did not return to Glasgow, in the fall of 1939.

November 1939.  Unable to return to Scotland, Selikoff applied to Melbourne University for coursework to finish his non-degree course of qualification for medication practice in the United Kingdom.11

Mar. 4, 1940.  Selecoff (as his name was then often spelled) arrived in Vancouver from Sydney, on the S.S. Aorangi.

April 1940.  Irving Selikoff was living with his parents, and his married sister and her family, in Rye, New York, according to the 1940 census, taken on April 10, 1940.

May 27, 1940.  Selikoff enrolled in the University of Melbourne as a non-degree student, for coursework to finish his qualification for medical license in Scotland.12

Mar. 24, 1941.  Selikoff arrived in Los Angeles, California, from Sydney, Australia, on the S.S. Mariposa. According to Bartrip, Selikoff had completed his last course at the University of Melbourne, for his “tailor-made” program, on February 27, 1941. Selikoff never gained entrance to a degree program at Melbourne.13

1941.  Selikoff joined the Mount Sinai Hospital as an assistant in Anatomy and Pathology, “immediately following his university training.”14

November 1, 1943.  Selikoff received an M.D., degree from Middlesex University,15 after two semesters in residence. This school was regarded as “substandard” and not approved by the American Medical Association. The school lost its accreditation in 1946, and closed.16 After receiving this degree, Selikoff continued his efforts to return to Scotland, to complete his “triple qualification” for medical licensure in Scotland, which would allow him to sit for the licensing examination in one of the United States.

1943 – 1944.  Selikoff served as an intern, at the Beth Israel Hospital, in Newark, New Jersey.17

1944 – 1946.  Selikoff served as a resident, at the Sea View Hospital, in New York City.18

April 23, 1945.  Selikoff was listed in the British Medical Registry, based upon his qualification by the Scottish Conjoint Board for his work at Anderson’s and his non-degree work at the University of Melbourne.19

June 2, 1945.  Selikoff arrived in Montreal, Quebec, from Liverpool, England, on the S.S. Axel Johnson.

February 1946.  Selikoff married Celia Schiffrin in Manhattan.20 It was the second marriage for both bride and groom.

1947.  After having left Mt. Sinai Hospital, in 1943, for an internship and a residency, Selikoff resumed his association with Mt. Sinai Hospital.21

1949.  Selikoff opened a medical office at 707 Broadway, Paterson, New Jersey,22 not far from a factory run by the Union Asbestos and Rubber Company (UNARCO). In the same year, the Selikoffs were living at 965 Fifth Avenue, near 78th Street, in Manhattan.23 By the early 1950s, Selikoff and his wife had moved to 505 Upper Boulevard, Ridgewood, New Jersey.

1950.  Selikoff’s medical practice in Paterson, New Jersey, afforded him the opportunity to observe “the incidence of lung disease among workers at the Union Asbestos and Rubber Company (UNARCO),”24 which operated one of its factories in Paterson.

1951.  New Jersey lawyer Carl Gelman retained Dr. Irving Selikoff to examine 17 workers from the Paterson plant of Union Asbestos and Rubber Company (UNARCO). Gelman filed workers’ compensation claims on behalf of the UNARCO workers.25

1952.  Supported by Selikoff’s report, UNARCO worker Anton Szczesniak settled his worker’s compensation case, involving “intestinal cancer,” for $2,000 in 1952.26 Selikoff published data on the carcinogenicity of amosite in 1972,27 a delay of twenty years.28

1952.  Selikoff and colleagues published the results of a clinical trial of isoniazid for tuberculosis patients.29

1952.  Selikoff was featured in Life magazine coverage of isoniazid, a chemotherapy for tuberculosis.30

1952.  Selikoff was an assistant attending physician for thoracic diseases in the department of thoracic diseases at Mt. Sinai Hospital. In this year, Selikoff delivered the monthly Physiological Chemistry Seminar lecture at Mt. Sinai Hospital on: “Antitubercular Hydrazines,” along with Drs. H. H. Fox and Richard J. Schnitzer, of Hoffman-La Roche.

1955.  Selikoff received the Albert Lasker Clinical Medical Research Award for his work on the clinical trial of isoniazid to treat tuberculosis, along with Walsh McDermott and Carl Muschenheim, of the Hoffmann-La Roche Research Laboratories, and Edward H. Robitzek, of the Squibb Institute for Medical Research.31

1954.  UNARCO closed its Paterson, New Jersey plant, and moved it to Tyler, Texas.32

1955.  Selikoff’s involvement in the isoniazid clinical trials continued to attract media attention. His first television appearance was panned, but he would later develop considerable public speaking skills.33

1955.  Sir Richard Doll published his epidemiologic study of lung cancer among British asbestos workers.34 This study was known to Selikoff, who relied upon it in his litigation reports to support the compensation claims of asbestos workers in the 1950s.35  Labor unions were aware of the causal claim. Herbert K. Abrams, union physician and the Medical Director of Local 25 Chicago, Building Service Employees International Union, concluded that asbestos causes cancer in a prominent union journal. Herbert K. Abrams, “Cancer in Industry,” American Federationist (1955). Dr. Abrams’ article was republished in many union newsletters. See also Lester Breslow, LeMar Hoaglin, Gladys Rasmussen & Herbert K. Abrams, “Occupations and Cigarette Smoking as Factors in Lung Cancer,” 44 Am. J. Pub. Health. 171, 171 (1954).

1956.  Selikoff became an associate attending physician for thoracic disease at Mt. Sinai Hospital.

1957.  Attorney William L. Brach filed perhaps the first civil action (as opposed to worker’s compensation claim), on behalf of Frederick LeGrande, against Johns-Manville, for asbestos-related disease, on July 17, 1957. Frederick LeGrande v. Johns-Manville Prods. Corp., No. 741-57 (D.N.J.).

1957. President Sickles, International Convention of the Asbestos Heat, Frost and Insulators Union, reported to his unions 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.” The Asbestos Worker at 1 (Oct, 1957) (reporting on the Asbestos Workers’ 19th General Convention).

1960.  Dr. J. Christopher Wagner published a case series of mesothelioma among persons exposed to crocidolite, in the region of South Africa where crocidolite is mined and milled. After this publication, the causal role of crocidolite became quickly accepted in the scientific and medical community.36

1960-1961.  Selikoff published two papers on the patho-physiology of asbestosis, based on data from 17 UNARCO workers,37 obtained from his medico-legal evaluations of the men.38

Irving and Celia Selikoff in 1961 Brazilian visa documents

1961. Asbestos insulators’ union discussed collaboration with scientists to discuss lung cancer and other diseases among its membership.39 Union members, intensely interested in legal redress for compensation, became aware of Selikoff’s research hypothesis in advance of Selikoff’s survey of the members’ smoking habits, which the workers had a motive to under report.

November 1961. The Asbestos insulators’ union’s magazine featured a full page warning of the grim reaper urging insulators to Wear Your Respirator.” The Asbestos Worker (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.

July 12, 1962.  Selikoff visited Asbestos Corporation of America, an intermediary broker of asbestos fibers. In a memorandum Selikoff prepared from his discussions with Wade I. Duym, the general manager of the company, and others, he detailed the widespread use of amphibole asbestos fibers in a variety of products. He noted that amosite was used primarily in the insulation trade, and that it was the asbestos “of choice” for sprayed-on products, high temperature insulating cements and pipecovering (magnesia and calcium silicates). Selikoff described crocidolite, from Africa and Bolivia, as a strong, chemically resistant, relatively inexpensive fiber that was used in asbestos cement products, and in Kent cigarette filters.

September 1962. Selikoff presented to a meeting of the Asbestos Workers, to request their help in conducting his study of insulator mortality and morbidity. Irving Selikoff, “Speech at Asbestos Workers Union Annual Meeting,” The Asbestos Worker 8 (Sept. 1962).

1962.  Asbestos insulators’ union acknowledged that its leadership has been collaborating with Dr. Irving Selikoff.40 In September 1962, Selikoff and colleagues began physical examinations of members of the New York and New Jersey locals.41`

1962.  In a publication for Naval personnel, with virtually no circulation in the general industrial community, the United States government acknowledged that shipyard and on-board exposures greatly exceeded the ACGIH’s then current TLV for asbestos.42

1963.  Selikoff established the Environmental Sciences Laboratory, later known as the Division of Environmental and Occupational Medicine, in the Mt. Sinai School of Medicine’s Department of Community Medicine.

1964.  Selikoff published his first article on cancer in a cohort of union asbestos insulators from New York and New Jersey.43 Selikoff and his co-authors failed to disclose funding from the union, or the union members’ awareness of the research hypotheses under investigation.

1964.  In October 1964, Selikoff organized and co-chaired (with Dr. Jacob Churg) a conference, “The Biological Effects of Asbestos, for the New York Academy of Sciences, in New York City. The conference featured presentations and papers from many international investigators. Several presenters, including Selikoff, documented the prevalent use of amphibole asbestos (both crocidolite and amosite) in the United States.44

1965.  Papers presented at the 1964 New York Academy of Sciences conference were published in late 1965, in a non-peer reviewed publication, volume 132, of the Annals of the New York Academy of Sciences.

1966.  Selikoff testified on behalf of insulator claiming that his asbestos exposure caused his colorectal cancer.45 Forty years later, the Institute of Medicine (now the National Academy of Medicine) comprehensively reviewed the extant evidence and announced that the evidence was “suggestive but not sufficient to infer a causal relationship between asbestos exposure and pharyngeal, stomach, and colorectal cancers.”46

1966 – 1972.  Selikoff testified frequently in civil action and in worker compensation proceedings for claimants who alleged asbestos-related injuries.47 In 1972, Andrew Haas, President of the asbestos workers’ union thanked Selikoff for his “frequent” expert witness testimony on behalf of union members.48

September 1967. In an address to the International Association of Heat and Frost Insulators and Asbestos Workers, Selikoff acknowledged the widespread use of amosite, particularly in shipyards, the absence of lung cancer among non-smoking insulation workers, and the failure of more than 9 out of 10 insulators to wear respirators on dusty jobs. See 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) (“I have 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, period.”).

September 1968.  Selikoff “warns” the United States of asbestos hazards that existed and continue to exist in the government’s shipyards.49 The warning was largely about seeking media attention by Selikoff; the government, and especially the Navy, had long known of asbestos hazards.50

May 1968.  Selikoff testified that all fibers are equally potent, to Congress in support of a bill that would become the OSH Act.

1969.  Selikoff served as president of the New York Academy of Sciences.

1972.  Selikoff was shown to consistently over-read chest radiographs for potential asbestos-related abnormalities.51

1973.  Selikoff  testified for the government in United States v. Reserve Mining Co., No. 5-72 Civil 19 (D. Minn. Sept. 21, 1973).52 On September 20, Selikoff testified about the town where Reserve Mining’s taconite mine was located: “I think we ought to have a sign at the entrance to sections of the town ‘Please Close Your Windows Before Driving Through’. I certainly would want to close mine.” When his testimony continued the following day, Selikoff acknowledged that he had been “facetious” in his previous day’s testimony.53

1974. After having given “facetious” testimony, Selikoff stopped testifying. Marxist historians Jock McCulloch and Geoffrey Tweedale suggest that Selikoff “ avoided the drama of the courtroom and the role of the expert witness” because of the drain on his time, his desire to avoid antagonizing industry, and his need to prevent discovery of trade union medical files.54

1974.  Selikoff published a review on asbestos and gastrointestinal cancer, without disclosing his funding from the asbestos insulation union or his receipt of fees for litigation work in which he maintained a causal relationship in advance of any data.55

July 1978.  The National Cancer Institute (NCI) invited Dr. Hans Weill to co-chair a conference on lung cancer surveillance. Ten days later, the NCI retracted the invitation. When Weill inquired about the reasons for the shoddy treatment, an NCI official (Margaret Sloan) told him that “representatives of organized labor” objected to his participation. Sloan’s superior at NCI stated that Selikoff had raised the question whether the conference’s recommendations would lose credibility if Weill were a co-chair. When asked about his role in this sordid affair, Selikoff equivocated, saying he had “simply” said that “[s]ince Weill was a consultant to the Asbestos Information Center, I didn’t know if this would enhance or detract from hearing all points of view.”56

Nov. 5, 1979.  Barry Castleman, career testifier for asbestos claimants, prepared a memorandum to Selikoff to urge him to resist allowing discovery of asbestos worker union members’ knowledge of the hazards of asbestos.57

1981.  Sir Richard Doll and Professor Richard Peto published a rebuttal to wildly exaggerated asbestos risk assessments based upon Selikoff’s insulator studies.58

1984.  Selikoff prepared a report on his group’s epidemiologic study of Electric Boat employees, who were engaged in the construction of submarines.59 The data did not fit the Mt. Sinai Catechism of large increased risks.60 Selikoff never published these data in a medical journal or a textbook.61

March 1986.  Selikoff’s wife, Celia, died.62

1987 – 1989.  Selikoff’s insulator cohort study data took on an outsize importance in litigation because of plaintiffs’ heavy reliance upon his studies in court cases. When litigants asked for these data, Selikoff consistently refused to share, which necessitated federal court intervention.63

1988.  Selikoff and William Nicholson prepared a manuscript report of a study of the mortality experience at a New Jersey asbestos product manufacturing plant of Johns Manville.64 Their report documented the substantial use of crocidolite in various products, and the resulting horrific mesothelioma mortality. Selikoff never published this crocidolite-exposed cohort, although he tirelessly republished his insulator cohort data repeatedly with the misrepresentation that the insulators were not exposed to crocidolite.

June 7 to June 9, 1990. Selikoff conspired with Ron Motley and others to pervert the course of justice by inviting judges with active asbestos dockets to a one-sided conference on asbestos science, and to pay for their travel and lodging. In his invitation to this ex parte soirée, Selikoff failed to mention that the funding came from plaintiffs’ counsel.65  Shortly after the Third Circuit spoke on the Mt. Sinai dress rehearsal for the plaintiffs’ asbestos property damage trial case, Judge Jack Weinstein issued a curious mea culpa. Because of a trial in progress, Judge Weinstein did not attend the “Third Wave” conference, but he and a state 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.”66

What is curious is that Judge Weinstein, usually a careful judge and scholar, was so incorrect about Dr. Selikoff’s having never testified. His account suggests that Dr. Selikoff was the source for this falsehood. 67

Oct. 2, 1990.  Selikoff wrote to Judge Jack Weinstein and Justice Helen Freedman, presumably after the “regrettable” ex parte luncheon meeting, to hold forth with his views on the health effects of occupational and para-occupational exposure to asbestos.

May 20, 1992.  Selikoff dies several months before the U.S. Court of Appeals condemns the Selikoff-Motley conspiracy.68

2013.  Follow up of the national insulator cohort fails to support multiplicative interaction between smoking and asbestos for lung cancer outcomes in the absence of asbestosis.69


1 Rachel Maines, Asbestos and Fire: Technological Tradeoffs and the Body at Risk 155 (2005) (“charming, courageous, and compassion medical professional with more charisma than credentials”).

2 Jock McCulloch & Geoffrey Tweedale, Shooting the messenger: the vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619 (2007); Scientific Prestige, Reputation, Authority & The Creation of Scientific Dogmas” (Oct. 4, 2014); David Egilman, Geoffrey Tweedale, Jock McCulloch, William Kovarik, Barry Castleman, William Longo, Stephen Levin, and Susanna Rankin Bohme, “P.W.J. Bartrip’s Attack on Irving J. Selikoff,” 46 Am. J. Indus. Med. 151, 152 (2004) [Egilman (2004)].

3 84 Stat. 1590, et seq., 29 U.S.C. § 651, et seq.

5 See Wikipedia, “Irving Selikoff” (last visited Dec. 4, 2018).

6 Kings County Birth Certificate no. 4595 (Jan. 15, 1915). His family later adopted the surname Selikoff. Irving Selikoff’s social security records list his father as Abraham Selikoff and his mother as Tillie Katz.

7 Abraham Selecoff World War II draft registration, serial no. U1750.

8 Abraham Selecoff World War II draft registration, serial no. U1750.

9 Bronx marriage certificate no. 8246 (Sept. 27, 1936); Bronx marriage license no. 8652 (Sept. 24, 1936). Irving’s parents were listed as Abraham Selikoff and Tillie Katz. His residence was at 109 W. 112th Street. Lydia was listed as the daughter of Mendel Kapilian and Bessie Weller. Irving and Lydia were divorced sometime between 1939 and 1941. The marriage certificates stated Lydia to have been 21 years old. Her Social Security records (SSN 112-052-2143), however, gave her birth date as April 22, 1917, (making her 19), and subsequent marriage names of Quint and Teichner.

10 This and other details of Selikoff’s checkered medical education come from Peter Bartrip’s exposé. Although Bartrip’s research was attacked for its allegedly gratuitous attacks on Selikoff’s research prowess, Bartrip’s account of Selikoff’s medical education in Scotland, Australia, and the United States has gone largely unrebutted, and must for the present be accepted. Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 8 (2003) [Bartrip 2003]; Peter Bartrip, “Around the World in Nine Years: A Medical Education Revisited,” 59 J. History of Med. 135 (2004). One group of plaintiffs’ expert witnesses took Bartrip to task for not disclosing that he had served as a defense expert witness, but none of the complainants disclosed their substantial testimonial adventures for the litigation industry! While making some interesting points, these critics of Bartrip did not really contest his historical work on Selikoff: “Bartrip’s critiques of Anderson’s College (AC) and Middlesex University School of Medicine (MSUM) may be accurate, but are beside the point.” David Egilman, Geoffrey Tweedale, Jock McCulloch, William Kovarik, Barry Castleman, William Longo, Stephen Levin, and Susanna Rankin Bohme, “P.W.J. Bartrip’s Attack on Irving J. Selikoff,” 46 Am. J. Indus. Med. 151, 152 (2004).

11 Bartrip 2003, at 15 & n.44-51.

12 Bartrip 2003, at 17 & n.54-55.

13 Bartrip 2003 at 18.

14 William J. Nicholson & Alvin S. Teirstein, “Remembering Irving J. Selikoff,” 61 Mt. Sinai J. Med. 500 (1994) [Nicholson & Teirstein]. This account seems doubtful.

15 See Stephen Rushmore, “Middlesex University School of Medicine,” 230 New Engl. J. Med. 217 (1944).

16 Anthony Seaton, “The Strange Case of Irving Selikoff,” 60 Occup. Med. 53 (2010); Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003).

17 Bartrip 2003 at 22.

18 Bartrip 2003 at 22.

19 Bartrip 2003 at 21.

20 New York County marriage license no. 3879 (Feb. 2, 1946). Celia had been married to Nathan Michaels in 1937. Manhattan Marriage License no. 21454 (1937).

21 Nicholson & Teirstein.

22 City Directory of Paterson, New Jersey at p. 218 (1949).

23 Manhattan Telephone Directory (1949).

24 George W. Conk, “Deadly Dust: Occupational Health and Safety as a Driving Force in Workers’ Compensation Law and the Development of Tort Doctrine,” 69 Rutgers L. Rev. 1140, 1154 & n. 136 (2017).

25 Jon L. Gelman, “History of Asbestos and the Law” (Jan. 2, 2001). Carl Gelman was a life-long Paterson resident. His legal practice specialized in workers’ compensation, and he chaired state bar association’s workers’ compensation section for several years. His practice represented claimants from 1936, until his retirement in 1986. In the mid-1970s, with Karl Asch, Gelman’s firm sued asbestos suppliers to Raybestos Manhattan on behalf of multiple employees.Gelman died on February 24, 2009. “Obituary for Carl Gelman,” The Record/Herald News (Mar. 16, 2009); “163 Who Had Jobs at Raybestos Sue,” N.Y. Times (May 7, 1975). The suit for $326 million settled for $15.5 million.

26 Barry I. Castleman, Asbestos: Medical and Legal Aspects at 142 (1984); Matt Mauney, “Unarco,” Mesothelioma Center (Nov. 2018). Of course, there were no data to support this claim in 1952. Selikoff was publically and positionally committed to his causal hypothesis as a conclusion well in advance of conducting any studies or having any supporting data.

27 Irving J. Selikoff, E. Cuyler Hammond, and Jacob Churg, “The carcinogenicity of amosite asbestos,” 25 Arch. Envt’l Health 183 (1972). This 1972 publication was the first epidemiologic study on the carcinogenicity of amosite.

28 David E. Lilienfeld, “The Silence: The Asbestos Industry and Early Occupational Cancer Research – A Case Study,” 81 Am. J. Pub. Health 791 (1991).

29 Irving J. Selikoff, Edward H. Robitzek, and George G. Ornstein, “Treatment of pulmonary tuberculosis with hydrazine derivatives of isonicotinic acid,” 150 J. Am. Med. Ass’n 973 (1952).

30 “TB Milestone,” Life (Mar. 3, 1952).

32 Irving J. Selikoff, “Asbestos in Paterson, New Jersey and Tyler, Texas – A Tale of Two Cities,” Transcript of Lecture (Houston, Texas, Oct. 11, 1979).

33 See “Medical Horizons,” Broadcasting * Telecasting at 14 (Nov. 21, 1955) (describing Selikoff as a plodding presenter). See also Irving Selikoff – Media Plodder to Media Zealot” (Sept. 9, 2014).

35 Selikoff letter to Thomas Mancuso (Mar. 30, 1989).

36 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).

37 Arthur M. Langer, “Asbestos Studies in the Environmental Sciences Laboratory Mount Sinai School of Medicine 1965 – 1985: Investigations Reflecting State-of-the-Art; Contributions to the Understanding of Asbestos Medicine” (Unpublished MS, Nov. 7, 2008).

38 Alvin S. Tierstein, A. Gottlieb, Mortimer E. Bader, Richard A. Bader & Irving Selikoff, “Pulmonary mechanics in asbestosis of the lungs,” 8 Clin. Res. 256 (1960); Mortimer E. Bader, Richard A. Bader & Irving Selikoff, “Pulmonary function in asbestosis of the lung; an alveolar-capillary block syndrome, 30 Am. J. Med. 235 (1961).

39 Asbestos Worker (May 1961) (“The subject matter of Health Hazards was discussed and President Sickles reported on the possibility of an early meeting with people connected with the Medical Association for the purpose of running various tests on certain materials used by our membership in order to determine the extent of their contribution to lung cancer, silicosis, asbestosis, tuberculosis, etc.”).

40 Asbestos Worker (May 1962) (“President Sickles advised the Board as to a meeting which had been held with Vice President Rider and a Dr. Irving Selikoff, of the Paterson Clinic in connection with our issue on Health Hazards and the Committee on Health Hazards with the approval of the Board instructed President Sickles to continue his efforts in this direction.”)

41 Asbestos Worker at 25 (Feb. 1963).

42 Capt. H.M. Robbins & William T. Marr, “Asbestosis,” 19 Safety Review 10 (1962) (noting that asbestos dust counts of 200 million particles per cubic foot were not uncommon during insulation ripouts onboard naval vessels).

43 Irving J. Selikoff, Jacob Churg, and E. Cuyler Hammond, “Asbestos Exposure and Neoplasia,” 188 J. Am. Med. Ass’n 22 (1964).

44 Irving J. Selikoff, Jacob Churg, E. Cuyler Hammond, “The Occurrence of Asbestosis among Insulation Workers in the United States,” 132 Ann. N.Y. Acad. Sci. 139, 142 (1965) (“In later specimens so obtained, crocidolite has also been found. Moreover, materials used for ship insulation, while containing the same amounts of asbestos as above, began in 1934 to have significant amounts of amosite in addition to chrysotile, because of the lighter weight of the material.”); Harrington, “Chemical Studies of Asbestos,” 132 Ann. N.Y. Acad. Sci. 31, 41 (1965) (reporting the finding of chrysotile and crocidolite asbestos in equal proportions in specimens of 85% magnesia pipe-covering sections); N.W. Hendry, “The Geology, Occurrences, and Major Uses of Asbestos 132 Annals N.Y. Acad. Sci. 12, 19 (1965) (reporting that, in 1963, the U.S. used  22,000 tons of amosite in manufactured products, and 17,000 tons of crocidolite in acid-resistent filters, packings, insulations, and certain types of lagging. United States Department of Commerce statistics show that for the years 1957 to 1962, more crocidolite was used in the United States than was amosite. In 1962, the use of blue was twice as great as that for brown. 132 Ann. N.Y. Acad. Sci. at 753, Table 17 (1965); see also id. at 762, Table 23 (1965) (South African blue fiber imports exceeded brown fiber imports, starting about 1954). See alsoSelikoff and the Mystery of the Disappearing Amphiboles (Dec. 10, 2010); James R. Millette, Steven Compton, and Christopher DePasquale, “Microscopical Analyses of Asbestos-Cement Pipe and Board,” 66 The Microscope 3 (2018) (reporting analyses of cement formulations with substantial crocidolite).

45 Asbestos Worker at 13 (May 1966).

46 Jonathan Samet, et al., eds., Institute of Medicine Review of Asbestos: Selected Cancers (2006); see also Richard Doll & Julian Peto, Asbestos: Effects on health of exposure to asbestos 8 (1985) (“In particular, there are no grounds for believing that gastrointestinal cancers in general are peculiarly likely to be caused by asbestos exposure.”).

47Selikoff and the Mystery of the Disappearing Testimony” (Dec. 3, 2010); see, e.g., Barros v. United States, 147 F.Supp. 340, 343-44 (E.D.N.Y. 1957) (noting that Dr. Selikoff testified for seaman suing for maintenance and cure as a result of a slip and fall; finding for respondent against libelant); Bradshaw v. Twin City Insulation Co. Ltd., Indus. Ct. Indiana, Claim No. O.D.1454 (Oct. 14, 1966); Bradshaw v. Johns-Manville Sales Corp., Civ. Action No. 29433, E. D. Mich. S. Div. (July 6, 1967); Bambrick v. Asten Hill Mfg. Co., Pa. Cmwlth. Ct. 664 (1972); Tomplait v. Combustion Engineering Inc.., E. D. Tex. Civ. Action No. 5402 (March 4, 1968); Babcock & Wilcox, Inc. v. Steiner, 258 Md. 468, 471, 265 A.2d 871 (1970) (affirming workman compensation award for asbestosis); Rogers v. Johns-Manville Products Corp., Cir. Ct. Mo., 16th Jud. Cir., Div. 9, Civ. Action No. 720,071 (Feb. 19, 1971); Utter v. Asten-Hill Mfg. Co., 453 Pa. 401 (1973); Karjala v Johns-Manville Products Corp., D. Minn., Civ. Action Nos. 5–71 Civ. 18, and Civ. 40 (Feb. 8, 1973); Culp Industrial Insulation v. Commonwealth of Pennsylvania Workmen’s Compensation Appeal Board, 57 Pa. Commonwealth Ct. 599, 601-602 (1981).

48 Andrew Haas, Comments from the General President, 18 Asbestos Worker (Nov. 1972); see also Peter W.J. Bartrip, “Irving John Selikoff and the Strange Case of the Missing Medical Degrees,” 58 J. History Med. 3, 27 & n.88-92 (2003) (citing Haas).

49 Thomas O’Toole, “U.S. Warned of Asbestos Peril,” Wash. Post. A4 (Dec. 4, 1968).

50 The United States Government’s Role in the Asbestos Mess” (Jan. 31, 2012). See also 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 Toxicology 1 (2011); Capt. H.M. Robbins & W.T. Marr, “Asbestosis,” Safety Review (Oct. 1962); See also Walter Olson, “Asbestos awareness pre-Selikoff,” (Oct. 19, 2007).

51 See Charles E. Rossiter, “Initial repeatability trials of the UICC/Cincinnati classification of the radiographic appearances of pneumoconioses,” 29 Brit. J. Indus. Med. 407 (1972) (among physician readers of chest radiographs, Selikoff was at the extreme of least likely to call a film normal (less than half the average of all readers), and the most likely to interpret films to show excess profusion of small irregular linear densities). See Selikoff and the Mystery of the Disappearing Asbestosis” (Dec. 6, 2010). The unions, of course, interested in maximizing compensation for their members loved Selikoff’s over-reading of chest films. Selikoff’s colleagues (Ruth Lilis?) routinely teased Selikoff about not being able to read chest radiographs. Selikoff was rumored to have taken and failed the NIOSH B-Reader examination, a rumor which needs to be resolved by a FOIA request.

52 United States v. Reserve Mining Co. See United States v. Reserve Mining Co., 56 F.R.D. 408 (D.Minn.1972); Armco Steel Corp. v. United States, 490 F.2d 688 (8th Cir. 1974); United States v. Reserve Mining Co., 380 F.Supp. 11 (D.Minn.1974); Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir. 1974); Minnesota v. Reserve Mining Co., 418 U.S. 911 (1974); Minnesota v. Reserve Mining Co., 419 U.S. 802 (1974); United States v. Reserve Mining Co., 394 F.Supp. 233 (D.Minn.1974); Reserve Mining Co. v. Environmental Protection Agency, 514 F.2d 492 (8th Cir. 1975); Minnesota v. Reserve Mining Co., 420 U.S. 1000, 95 S.Ct. 1441, 43 L.Ed.2d 758 (1975); Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976); United States v. Reserve Mining Co., 408 F.Supp. 1212 (D.Minn.1976); United States v. Reserve Mining Co., 412 F.Supp. 705 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 789 (D.Minn.1976); United States v. Reserve Mining Co., 417 F.Supp. 791 (D.Minn.1976); 543 F.2d 1210 (1976).

53 Robert V. Bartlett, The Reserve Mining Controversy: Science, Technology, and Environmental Quality 140-41 (1980) (describing Selikoff’s testimony).

54 Jock McCulloch & Geoffrey Tweedale, Defending the Indefensible : The Global Asbestos Industry and its Fight for Survival: The Global Asbestos Industry and its Fight for Survival 95 & n.36 (2008). These authors ignored more reasons Selikoff stood down from the witness chair: his self-serving insistence upon the importance of his own research detracted from the work of previous authors (e.g., Sir Richard Doll, J. Christopher Wagner, et al.) in litigation of personal injury claims of asbestos health effects. Plaintiffs’ counsel needed to push back the dates of first knowledge of asbestos health effects well before Selikoff’s first insulator study in 1964. The litigation industry needed Selikoff to continue to generate publicity, and to stop testifying. Selikoff surely must have had some concerns about how further testifying would eventually lead to questions about his credentials. Furthermore, Selikoff had an entire generation of younger, less politically visible colleagues at Mt. Sinai to fill the ranks of expert witnesses for the litigation industry (Miller, Levin, Nicholson, Lillis, Daum, Anderson, et al.).

55 Irving J. Selikoff, “Epidemiology of gastrointestinal cancer,” 9 Envt’l Health Persp. 299 (1974) (arguing for his causal conclusion between asbestos and all gastrointestinal cancers).

56 Nicholas Wade, “The Science and Politics of a Disinvitation,” 201 Science 892 (1978) (commenting that the NCI was negligent in failing to evaluate the ad hominem opinions given to it by Selikoff).

57 SeeThe Selikoff – Castleman Conspiracy” (Mar. 13, 2011); What Happens When Historians Have Bad Memories” (Mar. 15, 2014); “Castleman-Selikoff – Can Their Civil Conspiracy Survive Death? (Dec. 3, 2018). In 2014, Castleman testifies that he has no recollection of the memorandum.

58 See 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 Inst. 1191 (1981).

60 The Mt. Sinai Catechism” (June 5, 2013).

62 Celia Selikoff Social Security Records, SSN 064-12-6401. Celia was born on Sept. 12, 1908.

63 A New York state trial court initially sided with Selikoff over this subpoena battle. In re R.J. Reynolds Tobacco Co., 136 Misc.2d 282, 518 N.Y.S.2d 729 (N.Y. Sup. Ct., N.Y. Cty. 1987). The federal court subsequently required Selikoff to honor another litigant’s subpoena. In re American Tobacco Co., 866 F.2d 552 (2d Cir. 1989).

64 William J. Nicholson & Irving J. Selikoff, “Mortality experience of asbestos factory workers; effect of differing intensities of asbestos exposure”: unpublished manuscript produced in litigation (1988) (“[O]ther asbestos varieties (amosite, crocidolite, anthophyllite) were also used for some products. In general, chrysotile was used for textiles, roofing materials, asbestos cements, brake and friction products, fillers for plastics, etc.; chrysotile with or without amosite for insulation materials; chrysotile and crocidolite for a variety of asbestos cement products.”)

65 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).

66 Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994) (emphasis added). Judge Weinstein’s false statement that Selikoff “had never testified” not only reflects an incredible and uncharacteristic naiveté by His Honor; the false statement was in a journal, Judicature, which was widely circulated to state and federal judges.

67 Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994). The point apparently weighed on Judge Weinstein’s conscience. He repeated his mea culpa almost verbatim, along with the false statement about Selikoff’s never having testified, in a law review article in 1994, and then incorporated the misrepresentation into a full-length book. 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.”).

68 Social Security records for Irving John Selikoff, social sec. no. 085-16-1882. See Bruce Lambert, “Irving J. Selikoff Is Dead at 77; TB Researcher Fought Asbestos,” N.Y. Times (May 22, 1992).

69 Steve Markowitz, Stephen Levin, Albert Miller, and Alfredo Morabia, “Asbestos, Asbestosis, Smoking and Lung Cancer: New Findings from the North American Insulator Cohort,” Am. J. Respir. & Critical Care Med. (2013)).

Castleman-Selikoff – Can Their Civil Conspiracy Survive Death?

December 4th, 2018

Several, years ago, I wrote about Barry Castleman’s 1979 memorandum to Irving Selikoff, in which Castleman implored Selikoff to refuse to cooperate with lawful discovery from defense counsel in asbestos personal injury cases. The Selikoff – Castleman Conspiracy(Mar. 13, 2011). The document, titled Defense Attorneys’ Efforts to Use Background Files of Selikoff-Hammond Studies to Avert Liability,” was dated November 5, 1979. Coming from The Legacy Tobacco Documents Library at the University of California, San Francisco, created by litigation industry’s tobacco subsidiary, the document is clearly authentic. Barry Castleman, however, has testified that he cannot remember the 35+ year old memorandum, which failure of recall is not probative of anything.1  He refuses to renounce his role as a co-conspirator.

Jock McCulloch and Geoffrey Tweedale have both made careers of attacking any manufacturing and mining industry with connections to asbestos, while supporting the litigation industry that thrives on asbestos. Sadly, Jock McCulloch died of mesothelioma, earlier this year, on January 18, 2018, in Australia. McCulloch attributed his disease to his exposure to crocidolite when he researched one of his books on blue asbestos in South Africa.2 Although I found his scholarship biased and exaggerated, I admired his tenacious zeal in pressing his claims. His candor about the cause of his last illness was exemplary compared with Selikoff’s failure to acknowledge the extent to which amosite and crocidolite were used in the United States.

In 2007, Jock McCulloch and Geoffrey Tweedale wrote an article in which they attacked those who dared to say anything negative about Irving Selikoff.3 Of course, in claiming that the asbestos industry was “shooting the messenger,” these authors were, well, shooting the messenger, too. In 2008, McCulloch and Tweedale wrote a much more interesting, hagiographic article about Selikoff.4 From the legal perpective, perhaps the most interesting revelation in this article was that the authors had drawn “upon unprecedented access to the Selikoff archive at Mount Sinai Hospital in New York City.”

Several years later, defense counsel in the United States attempted to visit the Selikoff archives at Mt. Sinai Hospital. After an unseemly delay, the inquisitive counsel were met with unprecedented obstruction and denial of access:

From: [ARCHIVIST]
To: [DEFENSE COUNSEL]
Subject: Request for appointment with Archivist
Date: Wed, 3 Sep 2014 16:18:53 +0000

I realize that this must seem out of the blue, but we have recently realized that the stub email address we have – msarchives – has not been forwarding email the way it was intended to do. I apologize for not responding to you previously, and for what it is worth, here is the answer to your question.

Some Selikoff material in the Mount Sinai Archives, although I believe some of his research material is still with our Dept. of Preventive Medicine. Our collection is currently closed to researchers, as per the request of Mount Sinai’s Legal Department in 2009. Here is their statement concerning these records:

It was agreed that Dr. Selikoff’s correspondence and archives that are kept within the auspices of the MSSM library under the direction of the MSSM archivist, Barbara Niss, would be kept confidential for at least an additional 25 years to protect Dr. Selikoff’s research endeavors and the privacy of all the individuals, particularly the research subjects, who he studied and with whom he communicated. It is anticipated that twenty-five years from now, these individuals will no longer be alive and their concerns about keeping these matters private will have become moot. However, if we determine that this is not the case, we will reserve the option to continue to keep these documents confidential. We are also taking this action to preserve the academic freedom of our researchers so they can pursue their research, communicate with colleagues and comment on these important environmental/scientific issues, without concerns that they will be subpoenaed as non-party witnesses in these massive tort litigations.

Again, my apologies for the very late reply. Please let me know if you have questions.

So there you have it, 35 years after Castleman implored Selikoff not to cooperate with lawyers’ proper fact discovery, the Selikoff archive is still at its obstruction and denial.


1 See The Selikoff – Castleman Conspiracy” (Mar. 13, 2011). In 2014, Castleman testifies that he has no recollection of the memorandum. The document was also available at Scribd.

2 See Laurie Kazan-Allen, “In Memory of Jock McCulloch” (Jan. 21, 2018) (quoting an email from Jock McCulloch, dated July 21, 2017: “The injury almost certainly occurred while I was researching Asbestos Blues in South Africa, which is all of twenty years ago.”); “Remembering Jock McCulloch,” Toxic Docs Blog (Jan. 28, 2018) (quoting his partner’s tribute about the cause of his death: “His exposure to blue asbestos was probably in South Africa during the mid-1990s, when he was researching a book on the history of mining.).

3 Jock McCulloch & Geoffrey Tweedale, “Shooting the Messenger: The Vilification of Irving J. Selikoff,” 37 Internat’l J. Health Services 619 (2007).

4 Jock McCulloch and Geoffrey Tweedale, “Science is not Sufficient: Irving J. Selikoff and the Asbestos Tragedy,” 17 New Solutions 293 (2008).

“Each and Every Exposure” Is a Substantial Factor

December 3rd, 2018

“Every time a bell rings an angel gets his wings”
It’s a Wonderful Life (1946)

Every time a plaintiff shows the smallest imaginable exposure, there is a full recovery.
… The American tort system.

 

In 1984, Philadelphia County had a non-jury system for asbestos personal injury cases, with a right to “appeal” for a de novo trial with a jury. The non-jury trials were a wonderful training ground for a generation of trial lawyers, and for a generation or two of testifying expert witnesses. When I started to try asbestos cases as a young lawyer, the plaintiffs’ counsel had already taught their expert witnesses to include the “each and every exposure” talismanic language in their direct examination testimonies on the causation of the plaintiffs’ condition. The litigation industry had figured out that this expression would help avoid a compulsory non-suit on proximate causation.

Back in those wild, woolly frontier days, I encountered the slick Dr. Joseph Sokolowski (“Sok”), a pulmonary physician in private practice in New Jersey. Sok, like many other pulmonary physicians in the Delaware Valley area, had seen civilian workers referred by Philadelphia Naval Shipyard to be evaluated for asbestosis. When the plaintiff-friendly physicians diagnosed asbestosis, a few preferred firms would then pursue their claims under the Federal Employees Compensation Act (FECA). The United States government would notify the workers of their occupational disease, and urge them to pursue the government’s outside vendors of asbestos-containing materials, with a reminder that the government had a lien against any civil action recovery. The federal government thus made common cause with the niche law practices of workers’ compensation lawyers,1 and helped launch the tsunami of asbestos litigation.2

Sok was perfect for his role in the federal kick-back scheme. He could deliver the most implausible testimony, and weather brutal cross-examination without flinching. He had the face of a choir boy, and his service as an outside examiner for the Navy Yard employees gave his diagnoses the apparent imprimatur of the federal government. Although Sok had no real understanding of epidemiology, he could readily master the Selikoff litany of 5-10-50, for relative risks for lung cancer, from asbestos alone (supposedly), from smoking alone, and from asbestos and smoking combined, respectively. And he similarly mastered his lines that “each and every exposure” is substantial, when pressed on whether and how exposure to a minor vendor’s product was a substantial factor. Back in those days, before Johns-Manville (JM) Corporation went bankrupt, honest witnesses at the Navy Yard acknowledged that JM supplied the vast majority of asbestos products, but that testimony changed literally over the course of a trial day, when the plaintiffs’ bar learned of the JM bankruptcy.

It was into this topsy-turvy litigation world, I was thrown. I had the sense that there was no basis for the “each and every exposure” opinion, but my elders at the defense bar seemed to avoid the opinion studiously on cross-examination. I recall co-defendants’ counsels’ looks of horror and disapproval when I broached the topic in my first cross-examination. Sok had known to incorporate the “each and every exposure” opinion into his direct testimony, but he had no intelligible response to my question about what possible basis there was for the opinion. “Well, we have to blame each and every exposure because we have no way distinguish among exposures.” I could not let it lie there, and so I asked: “So your opinion about each and every exposure is based upon your ignorance?” My question was quickly met with an objection, and just as quickly with a rather loud and disapproving, “Sustained!” When Sok finished his testimony, I moved to strike his substantial factor opinion as having no foundation, but my motion was met with by judicial annoyance and apathy.

And so I learned that science and logic had nothing to do with asbestos litigation. Some determined defense counsel persevered, however, and in the face of over one hundred bankruptcies,3 a few courts started to take the evidence and arguments against the “every exposure” testimony, seriously. Last week, the New York Court of Appeals, New York’s highest court, agreed to state out loud that the plaintiffs’ “every exposure” theory had no clothes, no foundation, and no science. Juni v. A.O. Smith Water Products Co., No. 123, N.Y. Court of Appeals (Nov. 27, 2018).4

In a short, concise opinion, with a single dissent, the Court held that plaintiffs’ evidence (any exposure, no matter how trivial) in a mesothelioma death case was “insufficient as a matter of law to establish that respondent Ford Motor Co.’s conduct was a proximate cause of the decedent’s injuries.” The ruling affirmed the First Department’s affirmance of a trial court’s judgment notwithstanding the $11 million jury verdict against Ford.5 Arguing for the proposition that every exposure is substantial, over three dozen scientists, physicians, and historians, most of whom regularly support and testify for the litigation industry, filed a brief in support of the plaintiffs.6 The Atlantic Legal Foundation filed an amicus brief on behalf of several scientists,7 and I had the privilege of filing an amicus brief on behalf of the Coalition for Litigation Justice and nine other organizations in support of Ford’s positions.8

It has been 34 years since I first encountered the “every exposure is substantial” dogma in a Philaddelphia courtroom. Some times in litigation, it takes a long time to see the truth come out.


1 E.g., Shein and Brookman; Greitzer & Locks; both of Philadelphia.

2 Encouraging litigation against its suppliers, the federal government pulled off a coup of misdirection. First, it deflected public censure from the Navy and other governmental branches for its own carelessness in the use, installation, and removal of asbestos-containing insulations. Second, the government winnowed the ranks of older, better compensated workers. Third, and most diabolically, the government, which was self-insured for FECA claims, recovered most of their outlay when its former employees recovered judgments or settlements against the government’s outside asbestos product vendors. “The United States Government’s Role in the Asbestos Mess” (Jan. 31, 2012). See also Walter Olson, “Asbestos awareness pre-Selikoff,” Point of Law (Oct. 19, 2007); “The U.S. Navy and the asbestos calamityPoint of Law (Oct. 9, 2007).

4 The plaintiffs were represented by Alani Golanski of Weitz & Luxenberg LLP.

6 Abby Lippman, Annie Thebaud Mony, Arthur L. Frank, Barry Castleman, Bruce P. Lanphear,

Celeste Monforton, Colin L. Soskolne, Daniel Thau Teitelbaum, Dario Consonni, Dario Mirabelli, David Egilman, David F. Goldsmith, David Ozonoff, David Rosner, Fiorella Belpoggi, James Huff, John Heinzow, John M. Dement, John Coulter Maddox, Karl T. Kelsey, Kathleen Ruff, Kenneth D. Rosenman, L. Christine Oliver, Laura Welch, Leslie Thomas Stayner, Morris Greenberg, Nachman Brautbar, Philip J. Landrigan, Xaver Baur, Hans-Joachim Woitowitz, Bice Fubini, Richard Kradin, T.K. Joshi, Theresa S. Emory, Thomas H. Gassert,

Tony Fletcher, and Yv Bonnier Viger.

7 John Henderson Duffus, Ronald E. Gots, Arthur M. Langer, Robert Nolan, Gordon L. Nord, Alan John Rogers, and Emanuel Rubin.

8 Amici Curiae Brief of Coalition for Litigation Justice, Inc., Business Council of New York State, Lawsuit Reform Alliance of New York, New York Insurance Association, Inc., Northeast Retail Lumber Association, National Association of Manufacturers, Chamber of Commerce of the U.S.A., American Tort Reform Association, American Insurance Association, and NFIB Small Business Legal Center Supporting Defendant-Respondent Ford Motor Company.

The “Rothman” Amicus Brief in Daubert v. Merrill Dow Pharmaceuticals

November 17th, 2018

Then time will tell just who fell
And who’s been left behind”

                  Dylan, “Most Likely You Go Your Way” (1966)

 

When the Daubert case headed to the Supreme Court, it had 22 amicus briefs in tow. Today that number is routine for an appeal to the high court, but in 1992, it was a signal of intense interest in the case among both the scientific and legal community. To the litigation industry, the prospect of judicial gatekeeping of expert witness testimony was an anathema. To the manufacturing industry, the prospect was precious to defend against specious claiming.

With the benefit of 25 years of hindsight, a look at some of those amicus briefs reveals a good deal about the scientific and legal acumen of the “friends of the court.” Not all amicus briefs in the case were equal; not all have held up well in the face of time. The amicus brief of the American Association for the Advancement of Science and the National Academy of Science was a good example of advocacy for the full implementation of gatekeeping on scientific principles of valid inference.1 Other amici urged an anything goes approach to judicial oversight of expert witnesses.

One amicus brief often praised by Plaintiffs’ counsel was submitted by Professor Kenneth Rothman and colleagues.2 This amicus brief is still cited by parties who find support in the brief for their excuses for not having consistent, valid, strong, and statistically significance evidence to support their claims of causation. To be sure, Rothman did target statistical significance as a strict criterion of causal inference, but there is little support in the brief for the loosey-goosey style of causal claiming that is so prevalent among lawyers for the litigation industry. Unlike the brief filed by the AAAS and the National Academy of Science, Rothman’s brief abstained from the social policies implied by judicial gatekeeping or its rejection. Instead, Rothman’s brief wet out to make three narrow points:

(1) courts should not rely upon strict statistical significance testing for admissibility determinations;

(2) peer review is not an appropriate touchstone for the validity of an expert witness’s opinion; and

(3) unpublished, non-peer-reviewed “reanalysis” of studies is a routine part of the scientific process, and regularly practiced by epidemiologists and other scientists.

Rothman was encouraged to target these three issues by the lower courts’ opinions in the Daubert case, in which the courts made blanket statements about the role of absent statistical significance and peer review, and the illegitimacy of “re-analyses” of published studies.

Professor Rothman has made many admirable contributions to epidemiologic practice, but the amicus brief submitted by him and his colleagues falls into the trap of making the sort of blanket general statements that they condemned in the lower courts’ opinions. Of the brief’s three points, the first, about statistical significance is the most important for epidemiologic and legal practice. Despite reports of an odd journal here or there “abolishing” p-values, most medical journals continue to require the presentation of either p-values or confidence intervals. In the majority of medical journals, 95% confidence intervals that exclude a null hypothesis risk ratio of 1.0, or risk difference of 0, are labelled “statistically significant,” sometimes improvidently in the presence of multiple comparisons and lack of pre-specification of outcome.

For over three decades, Rothman has criticized the prevailing practice on statistical significance. Professor Rothman is also well known for his advocacy for the superiority of confidence intervals over p-values in conveying important information about what range of values are reasonably compatible with the observed data.3 His criticisms of p-values and his advocacy for estimation with intervals have pushed biomedical publishing to embrace confidence intervals as more informative than just p-values. Still, his views on statistical significance have never gained complete acceptance at most clinical journals. Biomedical scientists continue to interpret 95% confidence intervals, at least in part, as to whether they show “significance” by excluding the null hypothesis value of no risk difference or of risk ratios equal to 1.0.

The first point in Rothman’s amicus brief is styled:

THE LOWER COURTS’ FOCUS ON SIGNIFICANCE TESTING IS BASED ON THE INACCURATE ASSUMPTION THAT ‘STATISTICAL SIGNIFICANCE’ IS REQUIRED IN ORDER TO DRAW INFERENCES FROM EPIDEMIOLOGICAL INFORMATION”

The challenge by Rothman and colleagues to the “assumption” that statistical significance is necessary is what, of course, has endeared this brief to the litigation industry. A close read of the brief, however, shows that Rothman’s critique of the assumption is equivocal. Rothman et amici characterized the lower courts as having given:

blind deference to inappropriate and arcane publication standards and ‘significance testing’.”4

The brief is silent about what might be knowing deference, or appropriate publication standards. To be sure, judges have often poorly expressed their reasoning for deciding scientific evidentiary issues, and perhaps poor communication or laziness by judges was responsible for Rothman’s interest in joining the Daubert fray. Putting aside the unclear, rhetorical, and somewhat hyperbolic use of “arcane” in the quote above, the suggestion of inappropriate blind deference is itself expressed in equivocal terms in the brief. At times the authors rail at the use of statistical significance as the “sole” criterion, and at times, they seem to criticize its use at all.

At least twice in their brief, Rothman and friends declare that the lower court:

misconstrues the validity and appropriateness of significance testing as a decision making tool, apparently deeming it the sole test of epidemiological hypotheses.”5

* * * * * *

this Court should reject significance testing as the sole acceptable criterion of scientific validity in epidemiology.”6

Characterizing “statistical significance” as not the sole test or criterion of scientific inference is hardly controversial, and it implies that statistical significance is one test, criterion, or factor among others. This position is consistent with the current ASA Statement on Significance Testing.7 There is, of course, much more to evaluate in a study or a body of studies, than simply whether they individually or collectively help us to exclude chance as an explanation for their findings.

Statistical Significance Is Not Necessary At All

Elsewhere, Rothman and friends take their challenge to statistical significance testing beyond merely suggesting that such testing is only one test or criterion among others. Indeed, their brief in other places states their opinion that significance testing is not necessary at all:

Testing for significance, however, is often mistaken for a sine qua non of scientific inference.”8

And at other times, Rothman and friends go further yet and claim not only that significance is not necessary, but that it is not even appropriate or useful:

Significance testing, however, is neither necessary nor appropriate as a requirement for drawing inferences from epidemiologic data.”9

Rothman compares statistical significance testing with “scientific inference,” which is not a mechanical, mathematical procedure, but rather a “thoughtful evaluation[] of possible explanations for what is being observed.”10 Significance testing, in contrast,” is “merely a statistical tool,” used inappropriately “in the process of developing inferences.”11 Rothman suggests that the term “statistical significance” could be eliminated from scientific discussions without loss of meaning, and this linguistic legerdemain shows that the phrase is unimportant in science and in law.12 Rothman’s suggestion, however, ignores that causal assessments have always required an evaluation of the play of chance, especially for putative causes, which are neither necessary nor sufficient, and which modify underlying stochastic processes by increasing or decreasing the probability of a specified outcome. Asserting that statistical significance is misleading because it never describes the size of an association, which the Rothman brief does, is like telling us that color terms tell us nothing about the mass of a body.

The Rothman brief does make the salutary point that labeling a study outcome as not “statistically significant” carries the danger that the study’s data have no value, or that the study may be taken to reject the hypothesized association. In 1992, such an interpretation may have been more common, but today, in the face of the proliferation of meta-analyses, the risk of such interpretations of single study outcomes is remote.

Questionable History of Statistics

Rothman suggests that the development of statistical hypothesis testing occurred in the context of agricultural and quality-control experiments, which required yes-no answers for future action.13 This suggestion clearly points at Sir Ronald Fisher and Jerzy Neyman, and their foundational work on frequentist statistical theory and practice. In part, the amici correctly identified the experimental milieu in which Fisher worked, but the description of Fisher’s work is neither accurate nor fair. Fisher spent a lifetime thinking and writing about statistical tests, in much more nuanced ways than implied by the claim that such testing occurred in context of agricultural and quality-control experiments. Although Fisher worked on agricultural experiments, his writings acknowledged that when statistical tests and analyses were applied to observational studies, much more searching analyses of bias and confounding were required. Fisher’s and Berkson’s reactions to the observational studies of Hill and Doll on smoking and lung cancer are telling in this regard. These statisticians criticized the early smoking lung cancer studies, not for lack of statistical significance, but for failing to address confounding by a potential common genetic propensity to smoke and to develop lung cancer.

Questionable History of Drug Development

Twice in Rothman’s amicus brief, the authors suggest that “undue reliance” on statistical significance has resulted in overlooking “effective new treatments” because observed benefits were considered “not significant,” despite an “indication” of efficacy.14 The brief never provided any insight on what is due reliance and what is undue reliance on statistical significance. Their criticism of “undue reliance” implies that there are modes or instances of “due reliance” upon statistical significance. The amicus brief fails also to inform readers exactly what “effective new treatments” have been overlooked because the outcomes were considered “not significant.” This omission is regrettable because it leaves the reader with only abstract recommendations, without concrete examples of what such effective treatments might be. The omission was unfortunate because Rothman almost certainly could have marshalled examples. Recently, Rothman tweeted just such an example:15

“30% ↓ in cancer risk from Vit D/Ca supplements ignored by authors & editorial. Why? P = 0.06. http://bit.ly/2oanl6w http://bit.ly/2p0CRj7. The 95% confidence interval for the risk ratio was 0.42–1.02.”

Of course, this was a large, carefully reported randomized clinical trial, with a narrow confidence interval that just missed “statistical significance.” It is not an example that would have given succor to Bendectin plaintiffs, who were attempting to prove an association by identifying flaws in noisy observational studies that generally failed to show an association.

Readers of the 1992 amicus brief can only guess at what might be “indications of efficacy”; no explanation or examples are provided.16 The reality of FDA approvals of new drugs is that pre-specified 5% level of statistical significance is virtually always enforced.17 If a drug sponsor has “indication of efficacy,” it is, of course, free to follow up with an additional, larger, better-designed clinical trial. Rothman’s recent tweet about the vitamin D clinical trial does provide some context and meaning to what the amici may have meant over 25 years ago by indication of efficacy. The tweet also illustrates Rothman’s acknowledgment of the need to address random variability in a data set, whether by p-value or confidence interval, or both. Clearly, Rothman was criticizing the authors of the vitamin D trial for stopping short of claiming that they had shown (or “demonstrated”) a cancer survival benefit. There is, however, a rich literature on vitamin D and cancer outcomes, and such a claim could be made, perhaps, in the context of a meta-analysis or meta-regression of multiple clinical trials, with a synthesis of other experimental and observational data.18

Questionable History of Statistical Analyses in Epidemiology

Rothman’s amicus brief deserves credit for introducing a misinterpretation of Sir Austin Bradford Hill’s famous paper on inferring causal associations, which has become catechism in the briefs of plaintiffs in pharmaceutical and other products liability cases:

No formal tests of significance can answer those questions. Such tests can, and should, remind us of the effects that the play of chance can create, and they will instruct us in the likely magnitude of those effects. Beyond that they contribute nothing to the ‘proof’ of our hypothesis.”

Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 290 (1965) (quoted at Rothman Brief at *6).

As exegesis of Hill’s views, this quote is misleading. The language quoted above was used by Hill in the context of his nine causal viewpoints or criteria. The Rothman brief ignores Hill’s admonition to his readers, that before reaching the nine criteria, there is a serious, demanding predicate that must be shown:

Disregarding then any such problem in semantics we have this situation. Our observations reveal an association between two variables, perfectly clear-cut and beyond what we would care to attribute to the play of chance. What aspects of that association should we especially consider before deciding that the most likely interpretation of it is causation?”

Id. at 295 (emphasis added). Rothman and co-authors did not have to invoke the prestige and authority of Sir Austin, but once they did, they were obligated to quote him fully and with accurate context. Elsewhere, in his famous textbook, Hill expressed his view that common sense was insufficient to interpret data, and that the statistical method was necessary to interpret data in medical studies.19

Rothman complains that statistical significance focuses the reader on conjecture on the role of chance in the observed data rather than the information conveyed by the data themselves.20 The “incompleteness” of statistical analysis for arriving at causal conclusions, however, is not an argument against its necessity.

The Rothman brief does make the helpful point that statistical significance cannot be sufficient to support a conclusion of causation because many statistically significant associations or correlations will be non-causal. They give a trivial example of wearing dresses and breast cancer, but the point is well-taken. Associations, even when statistically significant, are not necessarily causal conclusions. Who ever suggested otherwise, other than expert witnesses for the litigation industry?

Unnecessary Fears

The motivation for Rothman’s challenge to the assumption that statistical significance is necessary is revealed at the end of the argument on Point I. The authors plainly express their concern that false negatives will shut down important research:

To give weight to the failure of epidemiological studies to meet strict ‘statistical significant’ standards — to use such studies to close the door on further inquiry — is not good science.”21

The relevance of this concern to the proceedings is a mystery. The judicial decisions in the case are not referenda on funding initiatives. Scientists were as free in 1993, after Daubert was decided, as they were in 1992, when Rothman wrote, to pursue the hypothesis that Bendectin caused birth defects. The decision had the potential to shut down tort claims, and left scientists to their tasks.

Reanalyses Are Appropriate Scientific Tools to Assess and Evaluate Data, and to Forge Causal Opinions

The Rothman brief took issue with the lower courts’ dismissal of plaintiffs’ expert witnesses’ re-analyses of data in published studies. The authors argued that reanalyses were part of the scientific method, and not “an arcane or specialized enterprise,” deserving of heightened or skeptical scrutiny.22

Remarkably, the Rothman brief, if accepted by the Supreme Court on the re-analysis point, would have led to the sort of unthinking blanket acceptance of a methodology, which the brief’s authors condemned in the context of blanket acceptance of significance testing. The brief covertly urges “blind deference” to its authors on the blanket approval of re-analyses.

Although amici have tight page limits, the brief’s authors made clear that they were offering no substantive opinions on the data involved in the published epidemiologic studies on Bendectin, or on the plaintiffs’ expert witnesses’ re-analyses. With the benefit of hindsight, we can see that the sweeping language used by the Ninth Circuit on re-analyses might have been taken to foreclose important and valid meta-analyses or similar approaches. The Rothman brief is not terribly explicit on what re-analysis techniques were part of the scientific method, but meta-analyses surely had been on the authors’ minds:

by focusing on inappropriate criteria applied to determine what conclusions, if any, can be reached from any one study, the trial court forecloses testimony about inferences that can be drawn from the combination of results reported by many such studies, even when those studies, standing alone, might not justify such inferences.”23

The plaintiffs’ statistical expert witness in Daubert had proffered a re-analysis of at least one study by substituting a different control sample, as well as a questionable meta-analyses. By failing to engage on the propriety of the specific analyses at issue in Daubert, the Rothman brief failed to offer meaningful guidance to the appellate court.

Reanalyses Are Not Invalid Just Because They Have Not Been Published

Rothman was certainly correct that the value of peer review was overstated by the defense in Bendectin litigation.24 The quality of pre-publication peer review is spotty, at best. Predatory journals deploy a pay-to-play scheme, which makes a mockery of scientific publishing. Even at respectable journals, peer review cannot effectively guard against fraud, or ensure that statistical analyses have been appropriately done.25 At best, peer review is a weak proxy for study validity, and an unreliable one at that.

The Rothman brief may have moderated the Supreme Court’s reaction to the defense’s argument that peer review is a requirement for studies, or “re-analyses,” relied upon by expert witnesses. The Court in Daubert opined, in dicta, that peer review is a non-dispositive consideration:

The fact of publication (or lack thereof) in a peer reviewed journal … will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.”26

To the extent that Rothman and colleagues might have been disappointed in this outcome, they missed some important context of the Bendectin cases. Most of the cases had been resolved by a consolidated causation issues trial, but many opt-out cases had to be tried in state and federal courts around the country.27 The expert witnesses challenged in Daubert (Drs. Swan and Done) participated in many of these opt-out cases, and in each case, they opined that Bendectin was a public health hazard. The failure of these witnesses to publish their analyses and re-analyses spoke volumes about their bona fides. Courts (and juries if the Swan and Done proffered testimony were admissible) could certainly draw negative inferences from the plaintiffs’ expert witnesses’ failure to publish their opinions and re-analyses.

The Fate of the “Rothman Approach” in the Courts

The so-called “Rothman approach” was urged by Bendectin plaintiffs in opposing summary judgment in a case pending in federal court, in New Jersey, before the Supreme Court decided Daubert. Plaintiffs resisted exclusion of their expert witnesses, who had relied upon inconsistent and statistically non-significant studies on the supposed teratogenicity of Bendectin. The trial court excluded the plaintiffs’ witnesses, and granted summary judgment.28

On appeal, the Third Circuit reversed and remanded the DeLucas’s case for a hearing under Rule 702:

by directing such an overall evaluation, however, we do not mean to reject at this point Merrell Dow’s contention that a showing of a .05 level of statistical significance should be a threshold requirement for any statistical analysis concluding that Bendectin is a teratogen regardless of the presence of other indicia of reliability. That contention will need to be addressed on remand. The root issue it poses is what risk of what type of error the judicial system is willing to tolerate. This is not an easy issue to resolve and one possible resolution is a conclusion that the system should not tolerate any expert opinion rooted in statistical analysis where the results of the underlying studies are not significant at a .05 level.”29

After remand, the district court excluded the DeLuca plaintiffs’ expert witnesses, and granted summary judgment, based upon the dubious methods employed by plaintiffs’ expert witnesses in cherry picking data, recalculating risk ratios in published studies, and ignoring bias and confounding in studies. The Third Circuit affirmed the judgment for Merrell Dow.30

In the end, the decisions in the DeLuca case never endorsed the Rothman approach, although Professor Rothman can take credit perhaps for forcing the trial court, on remand, to come to grips with the informational content of the study data, and the many threats to validity, which severely undermined the relied-upon studies and the plaintiffs’ expert witnesses’ opinions.

More recently, in litigation over alleged causation of birth defects in offspring of mothers who used Zoloft during pregnancy, plaintiffs’ counsel attempted to resurrect, through their expert witnesses, the Rothman approach. The multidistrict court saw through counsel’s assertions that the Rothman approach had been adopted in DeLuca, or that it had become generally accepted.31 After protracted litigation in the Zoloft cases, the district court excluded plaintiffs’ expert witnesses and entered summary judgment for the defense. The Third Circuit found that the district court’s handling of the statistical significance issues was fully consistent with the Circuit’s previous pronouncements on the issue of statistical significance.32


1 filed in Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. Supreme Court No. 92-102 (Jan. 19, 1993), was submitted by Richard A. Meserve and Lars Noah, of Covington & Burling, and by Bert Black, 12 Biotechnology Law Report 198 (No. 2, March-April 1993); see Daubert’s Silver Anniversary – Retrospective View of Its Friends and Enemies” (Oct. 21, 2018).

2 Brief Amici Curiae of Professors Kenneth Rothman, Noel Weiss, James Robins, Raymond Neutra and Steven Stellman, in Support of Petitioners, 1992 WL 12006438, Daubert v. Merrell Dow Pharmaceuticals, Inc., U.S. S. Ct. No. 92-102 (Dec. 2, 1992). [Rothman Brief].

3 Id. at *7.

4 Rothman Brief at *2.

5 Id. at *2-*3 (emphasis added).

6 Id. at *7 (emphasis added).

7 See Ronald L. Wasserstein & Nicole A. Lazar, “The ASA’s Statement on p-Values: Context, Process, and Purpose,” 70 The American Statistician 129 (2016)

8 Id. at *3.

9 Id. at *2.

10 Id. at *3 – *4.

11 Id. at *3.

12 Id. at *3.

13 Id. at *4 -*5.

14 Id. at*5, *6.

15 at <https://twitter.com/ken_rothman/status/855784253984051201> (April 21, 2017). The tweet pointed to: Joan Lappe, Patrice Watson, Dianne Travers-Gustafson, Robert Recker, Cedric Garland, Edward Gorham, Keith Baggerly, and Sharon L. McDonnell, “Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older WomenA Randomized Clinical Trial,” 317 J. Am. Med. Ass’n 1234 (2017).

16 In the case of United States v. Harkonen, Professors Ken Rothman and Tim Lash, and I made common cause in support of Dr. Harkonen’s petition to the United States Supreme Court. The circumstances of Dr. Harkonen’s indictment and conviction provide a concrete example of what Dr. Rothman probably was referring to as “indication of efficacy.” I supported Dr. Harkonen’s appeal because I agreed that there had been a suggestion of efficacy, even if Harkonen had overstated what his clinical trial, standing alone, had shown. (There had been a previous clinical trial, which demonstrated a robust survival benefit.) From my perspective, the facts of the case supported Dr. Harkonen’s exercise of speech in a press release, but it would hardly have justified FDA approval for the indication that Dr. Harkonen was discussing. If Harkonen had indeed committed “wire fraud,” as claimed by the federal prosecutors, then I had (and still have) a rather long list of expert witnesses who stand in need of criminal penalties and rehabilitation for their overreaching opinions in court cases.

17 Robert Temple, “How FDA Currently Makes Decisions on Clinical Studies,” 2 Clinical Trials 276, 281 (2005); Lee Kennedy-Shaffer, “When the Alpha is the Omega: P-Values, ‘Substantial Evidence’, and the 0.05 Standard at FDA,” 72 Food & Drug L.J. 595 (2017); see alsoThe 5% Solution at the FDA” (Feb. 24, 2018).

18 See, e.g., Stefan Pilz, Katharina Kienreich, Andreas Tomaschitz, Eberhard Ritz, Elisabeth Lerchbaum, Barbara Obermayer-Pietsch, Veronika Matzi, Joerg Lindenmann, Winfried Marz, Sara Gandini, and Jacqueline M. Dekker, “Vitamin D and cancer mortality: systematic review of prospective epidemiological studies,” 13 Anti-Cancer Agents in Medicinal Chem. 107 (2013).

19 Austin Bradford Hill, Principles of Medical Statistics at 2, 10 (4th ed. 1948) (“The statistical method is required in the interpretation of figures which are at the mercy of numerous influences, and its object is to determine whether individual influences can be isolated and their effects measured.”) (emphasis added).

20 Id. at *6 -*7.

21 Id. at *9.

22 Id.

23 Id. at *10.

24 Rothman Brief at *12.

25 See William Childs, “Peering Behind The Peer Review Curtain,” Law360 (Aug. 17, 2018).

26 Daubert v. Merrell Dow Pharms., 509 U.S. 579, 594 (1993).

27 SeeDiclegis and Vacuous Philosophy of Science” (June 24, 2015).

28 DeLuca v. Merrell Dow Pharms., Inc., 131 F.R.D. 71 (D.N.J. 1990).

29 DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941, 955 (3d Cir. 1990).

30 DeLuca v. Merrell Dow Pharma., Inc., 791 F. Supp. 1042 (D.N.J. 1992), aff’d, 6 F.3d 778 (3d Cir. 1993).

31 In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342; 12-md-2342, 2015 WL 314149 (E.D. Pa. Jan. 23, 2015) (Rufe, J.) (denying PSC’s motion for reconsideration), aff’d, 858 F.3d 787 (3d Cir. 2017) (affirming exclusion of plaintiffs’ expert witnesses’ dubious opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully). See generallyZoloft MDL Relieves Matrixx Depression” (Jan. 30, 2015); “WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle” (July 31, 2015).

32 See Pritchard v. Dow Agro Sciences, 430 F. App’x 102, 104 (3d Cir. 2011) (excluding Concussion hero, Dr. Bennet Omalu).

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.