David Egilman’s Methodology for Divining Causation

If the Method Yields An Erroneous Conclusion, then the Method is Wrong

David Stephen Egilman wanted very much to testify in a diacetyl case.  One judge, however, did not think that this was such a good idea, and excluded Dr. Egilman’s testimony. Newkirk v. Conagra Foods, Inc.  727  F.Supp. 2d 1006 (E.D. Wash. 2010).

Egilman was so distraught by being excluded that he sought to file a personal appeal to the United States Court of Appeal. See “Declaration of David Egilman, M.D., M.P.H., in Support of Opposition to Motion for Order to Show Cause Why Appeal Should Not Be Dismissed for Lack of Standing.”  (Attached: Egilman Motion Appeal Diacetyl Exclusion 2011 and Egilman Declaration Newkirk Diacetyl Appeal 2011.)

Egilman improvidently, if not scurrulously, attacked the district judge for having excluded Egilman’s proffered testimony.  If Egilman’s attack on the trial judge were not sufficiently odd, Egilman also claimed a right to intervene in the appeal by advancing the claim that the Rule 702 exclusion hurt his livelihood.  Here is how Egilman put the matter:

“The Daubert ruling eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me). Based on my experience, it is virtually certain that some lawyers will choose not to attempt to retain me as a result of this ruling. Some lawyers will be dissuaded from retaining my services because the ruling is replete with unsubstantiated pejorative attacks on my qualifications as a scientist and expert. The judge’s rejection of my opinion is primarily an ad hominem attack and not based on an actual analysis of what I said – in an effort to deflect the ad hominem nature of the attack the judge creates ‘straw man’ arguments and then knocks the straw men down, without ever addressing the substance of my positions.”

Egilman Declaration at ¶ 11.

The Ninth Circuit, unmoved by the prospect of an impoverished Dr. Egilman, denied his personal appeal, and affirmed the district court’s exclusion. Newkirk v. Conagra Foods, Inc., 438 Fed. Appx. 607 (9th Cir. 2011).

In his appellate papers, Egilman did not stop at simply citing his pecuniary interest.  With no sense of false shame or modesty, Egilman recited what a wonderful expert witness he has been.  Egilman suggested that courts have been duly impressed by his views on the scientific assessment of causation:

“My views on the scientific standards for the determination of cause-effect relationships (medical epistemology) have been cited by the Massachusetts Supreme Court (Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1 (1998)):

‘Although there was conflicting testimony at the Oregon hearing as to the necessity of epidemiological data to establish causation of a disease, the judge appears to have accepted the testimony of an expert epidemiologist that, in the absence of epidemiology, it is “sound science…. to rely on case reports, clinical studies, in vivo tests and animal tests.” The judge may also have relied on the affidavit of the plaintiff’s epidemiological expert, Dr. David S. Egilman, who identified several examples in which disease causation has been established based on animal and clinical case studies alone to demonstrate that “doctors utilize epidemiological data as one tool among many”.’”

Egilman Declaration at p.5-6.

We may excuse Dr. Egilman, a non-lawyer, for incorrectly referring to a non-existent court.  Massachusetts does not have a “Supreme Court,” but the quoted language did indeed come from the Supreme Judicial Court of Massachusetts, in Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1, 12, 696 N.E.2d 909, 917 (1998).

The Massachusetts court’s suggestion that there was conflicting testimony at the “Oregon hearing,” about the need for epidemiologic evidence is itself rather bizarre.  The Oregon hearing was the Rule 702 hearing before Judge Jones, of the District of Oregon.  Judge Jones appointed four technical advisors to assist him in ruling on the defendants’ motions to exclude plaintiffs’ causation opinions.  One of the appointed advisors was an epidemiologist.  More important, the plaintiffs’ counsel presented the testimony of an epidemiologist, Dr. David Goldsmith.  The Massachusetts court did not, and indeed, could not cite the Oregon District Court’s opinion, or the underlying record, for any suggestion that epidemiologic testimony was not needed to show a causal relationship between silicone breast implants and the development of autoimmune disease.  See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996). Judge Jones made his views very clear:  epidemiology was needed, but lacking, in the plaintiffs’ case.  The argument that epidemiology was unnecessary came from Dr. Egilman’s report, and the plaintiffs’ counsel’s briefs.

There is more, however, to the disingenuousness of Dr. Egilman’s citation to the Vassallo case.  The Newkirk court, in receiving his curious affidavit, would not likely know that Vassallo was a silicone gel breast implant case, and one may suspect that Dr. Egilman wanted to keep the Ninth Circuit uninformed of his role in the silicone litigation.  If Dr. Egilman submitted an affidavit in connection with the so-called Oregon hearings, which took place during the summer of 1996, it was not a particularly important piece of evidence.  Egilman is not mentioned by name in the Hall decision, even though the district court clearly rejected the plaintiffs’ witnesses and affiants, in their efforts to make a case for silicone as a cause of autoimmune disease.

A few months after the Oregon hearings, Judge Weinstein, in the fall of 1996, along with other federal and state judges, held a “Daubert” hearing on the admissibility of expert witness opinion testimony in breast implant cases, pending in New York state and federal courts.  Plaintiffs’ counsel suggested that Egilman might testify, but ultimately he was a no show.  After the New York hearings, Judge Weinstein granted, sua sponte, partial summary judgment against all plaintiffs’ claims of systemic immune-system injury.  In re Breast Implant Cases, 942 F. Supp. 958 (E.&S.D.N.Y. 1996).

At the New York hearings, plaintiffs’ counsel again attempted to make an epidemiologic case, and once again called Dr. David Goldsmith.  Marshaling the evidentiary display that Egilman would have presented had he shown up in New York, Dr. Goldsmith’s testimony did not go well. At one point, Judge Weinstein interrupted and offered his interim assessment of Dr. Goldsmith and the plaintiffs causation case:

THE COURT: Why are you presenting this witness, for epidemiological purposes?

MR. GORDON: That’s correct.

THE COURT: And I can tell you for epidemiological purposes, based on the only testimony I have seen, he doesn’t meet my standard of anybody who can be helpful to a jury, not because he isn’t a great epidemiologist, I’m sure he is, but because the data he is relying on admittedly is almost useless. I’m not going to go forward with a trial on this kind of haphazard abstract without any basic definition or explication.

Transcript at p.159:7-18, from Nyitray v. Baxter Healthcare Corp., CV 93-159 (E.D.N.Y. Oct. 9, 1996)(pre-trial hearing before Judge Jack Weinstein, Justice Lobis, and Magistrate Cheryl Pollak).  In his semi-autobiographical writings, Judge Jack B. Weinstein elaborated upon his published breast-implant decision, with a bit more detail about how he viewed the plaintiffs’ expert witnesses.  Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans”; “[t]he breast implant litigation was largely based on a litigation fraud. … Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”)

When Judge Weinstein began to create a process for the selection of Rule 706 court-appointed expert witnesses, plaintiffs’ counsel rushed to have Judge Pointer take control over the process.  Because Judge Pointer believed that there must be some germ of validity in the plaintiffs’ case, the plaintiffs were hoping that his courtroom, the center of MDL 926, would be a more favorable forum than Judge Weinstein’s withering skepticism.  Ultimately, Judge Pointer, through a select nominating committee, appointed appointed expert witnesses, in the fields of toxicology, immunology, rheumology, and epidemiology.  MDL 926 Order No. 31 (Appointment of Rule 706 Expert Witnesses).

Each of the four witnesses prepared, presented, and defended his or her own report, but all the reports soundly rejected plaintiffs’ causation theories.  Laural L. Hooper, Joe S. Cecil, and Thomas E. Willging, Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation (Fed. Jud. Ctr. 2001).

In the United Kingdom, the British Minister of Health ordered an independent review of the breast implant controversy, which led to the formation of the Independent Review Group (IRG) to evaluate the causal claims that were being made by claimants and advocates. The IRG concluded that there was no demonstrable risk of connective tissue disease from silicone breast implants. Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8, 22-23 (July 1998).

In 1999, The Institute of Medicine delivered its assessment of the safety of silicone breast implants.  Again, the plaintiffs’ theories were rejected.  Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999).

Still, Egilman persisted.  As late as 2000, Egilman was posting his breast-implant litigation report at his Brown University website.  His conclusion, however awkwardly worded, was clear enough:

“Although a prospective, large epidemiological study investigating atypical symptoms and disease would clearly contribute to underestimating of the strength of association between silicone breast implants and disease, the available epidemiologic evidence is suggestive of a causal association for silicone breast implants and atypical connective tissue diseases and scleroderma.”

David S. Egilman, “Breast Implants and Disease” (2000) (“For purposes of this report SBI induced disease is considered an iatrogenic environmental disease.”) (<> lasted visited on Mar. 28, 2000).

Sometime after 2000, Egilman developed a sensitivity to being associated with the plaintiffs’ side of the silicone litigation.  In 2009, Dr. Laurence Hirsch, published an article critical of Egilman’s disclosures of conflicts of interest, in some of his published articles.  Hirsch struck a sensitive nerve in mentioning Egilman’s involvement in the breast implant litigation:

“Egilman reports having testified for plaintiffs in legal cases involving asbestosis, occupational lung disease, beryllium poisoning, silicone breast implants and connective tissue disease (characterized as the epitome of junk science91), selective serotonin reuptake inhibitor and suicide risk, atypical antipsychotics and metabolic changes, and selective COX-2 inhibitors and cardiovascular disease, an amazing breadth of medical expertise.”

Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811, 815 (2009).

Egilman apparently besieged Dr. Hirsch and the Mayo Clinic Proceedings with his protests, and it seems that he was able to induce the author or the journal into a “correction”:

“Dr Egilman has not testified in court in breast implant and connective tissue disease, or in antidepressant or antipsychotic drug cases.”

Laurence J. Hirsch, “Corrections,” 85 Mayo Clin. Proc. 99 (2010).  But this correction is itself incorrect because Dr. Egilman testified over the course of three days, in court, in the same Vassallo v. Baxter Healthcare case he holds up as having embraced his causal “principles.”  The Vassallo case involved allegations that silicone had caused systemic autoimmune disease, an allegation that was ultimately shown to be meritless by the MDL court’s neutral expert witnesses, as well as the Institute of Medicine.

Perhaps this history helps explain Dr. Egilman’s coyness in what he told the Newkirk appellate court about his involvement in the Vassallo case.  More likely is that Dr. Egilman understands, all too well, the logical implications of his being wrong in the breast implant litigation.  If his vaunted method leads to an erroneous conclusion, then the method must be wrong.  It is a simple matter of modus tollens.





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