Silicone Data Slippery and Hard to Find (Part 1)

In the silicone gel breast implant litigation, plaintiffs’ counsel loved to wave around early Dow Corning experiments with silicone as an insecticide. As the roach crawls, it turned out that silicone was much better at attracting and dispatching dubious expert witnesses and their testimony. On this point, it is hard to dispute the judgment of Judge Jack Weinstein[1].

The silicone wars saw a bioethics expert appear as an expert witness to testify about a silicone study in which his co-authors refuse to share their data with him, embarrassing to say the least. “Where Are They Now? Marc Lappé and the Missing Data” (May 19, 2013). And another litigation expert witness lost his cachet when the Northridge earthquake at his data. “Earthquake-Induced Data Loss – We’re All Shook Up” (June 26, 2015). But other expert witnesses were up to the challenge for the most creative and clever excuses for not producing their underlying data.

Rhapsody in Goo – My Data Are Traveling; Come Back Later

Testifying expert witness, Dr. Eric Gershwin was the author of several research papers that claimed or suggested immunogenicity of silicone[2]. His results were criticized and seemed to elude replication, but he enjoyed a strong reputation as an NIH-funded researcher. Although several of his co-authors were from Specialty Labs, Inc. (Santa Monica, CA)[3], defense requests for his Gershwin’s underlying data were routinely met with the glib response that the data were in Israel, where some of his other co-authors resided.

Gershwin testified in several trials, and the plaintiffs’ counsel placed great emphasis on his publications and on his testimony given before Judge Jones’ technical advisors in August 1996, before Judge Pointer’s panel of Rule 706 experts, in July 1997, and before the Institute of Medicine (IOM) in 1998.

Ultimately, this peer review of Gershwin’s work and claims was withering. The immunologist on Judge Jones’ panel (Dr. Stenzel-Poore) found Gershwin’s claims “not well substantiated.” Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387 (D. Ore. 1996). The immunologist on Judge Pointer’s panel, Dr. Betty A. Diamond was unshakeable in her criticisms of Gershwin’s work and his conclusions. Testimony of Dr. Betty A. Diamond, in MDL 926 (April 23, 1999). And the IOM found Gershwin’s work inadequate and insufficient to justify the extravagent claims that plaintiffs were making for immunogenicity and for causation of autoimmune disease. Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

Unlike Kossovsky, who left medical practice and his university position, Gershwin has continued to teach, research, and write after the collapse of the silicone litigation industry. And he has continued to testify, albeit in other kinds of tort cases.

In 2011, in testimony in a botox case, Dr. Gershwin attempted to distance himself from his prior silicone testimony. Gershwin testified that he was “an expert for silicone implants in the late 90s.” Testimony of M.E. Gershwin, at at 18:17-25, in Ray v. Allergan, Inc., Civ. No. 3:10CV00136 (E.D. Va. Jan. 17, 2011). An expert witness for implants; how curious? Here is how Gershwin described the fate of his strident testimony in the silicone litigation:

“Q. And has a court ever limited or excluded your opinions?

A. So a long time ago, probably more than ten years ago or so, twice. I had many cases involving silicone implants. The court restricted some but not all of my testimony. Although, my understanding is that, when the FDA finally did reapprove the use of silicone implants, the papers I published and evidence I gave was actually part of the basis by which they developed their regulations. And there’s not been a single example in the literature of anyone that’s ever refuted or questioned any of my work. But I think that’s all, as far as I know.

* * * *
Q. Okay. So it’s not — you made it sound like it was some published work that you had. Was it your opinions that you expressed in the cases that you believe the FDA adopted as part of their guidelines, or do you —

A. So I’ll tell you, I haven’t visited this subject in a long time, and I certainly took quite a beating from a number of people over — I was very proud in the past that I did it. Women’s rights groups all over the United States applauded what I did. I haven’t looked at these documents in over ten years, so beyond that, you’d have to do your own research.”

Id. at 20:19 – 21:25. Actually, several courts excluded Gershwin, as well as other expert witnesses who relied upon his published papers. Proud to be beaten.

Some of Gershwin’s coauthors have stayed the course on silicone. Yehuda Shoenfeld continues to publish on sick-building syndrome and so-called silicone “adjuvant disease,” which Shoenfeld immodestly refers to as “Shoenfeld’s syndrome.[4]” Gershwin and Shoenfeld parted company in the late 1990s on silicone, although they continue to publish together on other topics[5].

[1] Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud).

[2] E. Bar-Meir, S.S. Teuber, H.C. Lin, I. Alosacie, G. Goddard, J. Terybery, N. Barka, B. Shen, J.B. Peter, M. Blank, M.E. Gershwin, Y. Shoenfeld, “Multiple Autoantibodies in Patients with Silicone Breast Implants,” 8 J. Autoimmunity 267 (1995); Merrill J. Rowley, Andrew D. Cook, Suzanne S. Teuber, M. Eric Gershwin, “Antibodies to Collagen: Comparative Epitope Mapping in Women with Silicon Breast Implants, Systemic Lupus Erythematosus and Rheumatoid Arthritis,” 6 J. Autoimmunity 775 (1994); Suzanne S. Teuber, Merrill J. Rowley, Steven H. Yoshida, Aftab A. Ansari, M.Eric Gershwin, “Anti-collagen Autoantibodies are Found in Women with Silicone Breast Implants,” 6 J. Autoimmunity 367 (1993).

[3] J. Teryberyd, J.B. Peter, H.C. Lin, and B. Shen.

[4] A partial sampler of Shoenfeld’s continued output on silicone:

Goren, G. Segal, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvant (ASIA) evolution after silicone implants: Who is at risk?” 34 Clin. Rheumatol. (2015) [in press]

Nesher, A. Soriano, G. Shlomai, Y. Iadgarov, T.R. Shulimzon, E. Borella, D. Dicker, Y. Shoenfeld, “Severe ASIA syndrome associated with lymph node, thoracic, and pulmonary silicone infiltration following breast implant rupture: experience with four cases,” 24 Lupus 463 (2015)

Dagan, M. Kogan, Y. Shoenfeld, G. Segal, “When uncommon and common coalesce: adult onset Still’s disease associated with breast augmentation as part of autoimmune syndrome induced by adjuvants (ASIA),” 34 Clin Rheumatol. 2015 [in press]

Soriano, D. Butnaru, Y. Shoenfeld, “Long-term inflammatory conditions following silicone exposure: the expanding spectrum of the autoimmune/ inflammatory syndrome induced by adjuvants (ASIA),” 32 Clin. Experim. Rheumatol. 151 (2014)

Perricone, S. Colafrancesco, R. Mazor, A. Soriano, N. Agmon-Levin, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvants (ASIA) 2013: Unveiling the pathogenic, clinical and diagnostic aspects,” 47 J. Autoimmun. 1 (2013)

Vera-Lastra, G. Medina, P. Cruz-Dominguez Mdel, L.J. Jara, Y. Shoenfeld, “Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum,” 9 Expert Rev Clin Immunol. 361 (2013)

Lidar, N. Agmon-Levin, P. Langevitz, Y. Shoenfeld, “Silicone and scleroderma revisited,” 21 Lupus 121 (2012)

S.D. Hajdu, N. Agmon-Levin, Y. Shoenfeld, “Silicone and autoimmunity,” 41 Eur. J. Clin. Invest. 203 (2011)

Levy, P. Rotman-Pikielny, M. Ehrenfeld, Y. Shoenfeld, “Silicone breastimplantation-induced scleroderma: description of four patients and a critical review of the literature,” 18 Lupus 1226 (2009)

A.L. Nancy & Y. Shoenfeld, “Chronic fatigue syndrome with autoantibodies – the result of an augmented adjuvant effect of hepatitis-B vaccine and silicone implant,” 8 Autoimmunity Rev. 52 (2008)

Molina & Y. Shoenfeld, “Infection, vaccines and other environmental triggers of autoimmunity,” 38 Autoimmunity 235 (2005)

R.A. Asherson, Y. Shoenfeld, P. Jacobs, C. Bosman, “An unusually complicated case of primary Sjögren’s syndrome: development of transient ‘lupus-type’ autoantibodies following silicone implant rejection,” 31 J. Rheumatol. 196 (2004), and Erratum in 31 J. Rheumatol. 405 (2004)

Bar-Meir, M. Eherenfeld, Y. Shoenfeld, “Silicone gel breast implants and connective tissue disease–a comprehensive review,” 36 Autoimmunity 193 (2003)

Zandman-Goddard, M. Blank, M. Ehrenfeld, B. Gilburd, J. Peter, Y. Shoenfeld, “A comparison of autoantibody production in asymptomatic and symptomatic women with silicone breast implants,” 26 J. Rheumatol. 73 (1999)

[5] See, e.g., N. Agmon-Levin, R. Kopilov, C. Selmi, U. Nussinovitch, M. Sánchez-Castañón, M. López-Hoyos, H. Amital, S. Kivity, M.E. Gershwin, Y. Shoenfeld, “Vitamin D in primary biliary cirrhosis, a plausible marker of advanced disease,” 61 Immunol. Research 141 (2015).

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