Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants

Hulka, Barbara S.; Kerkvliet, Nancy L.; Tugwell, Peter

doi:10.1056/nejm200003163421111

Cited by 23 publications

(7 citation statements)

References 7 publications

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“…Scientists focus on the application of the scientific method, whereas the legal approach is primarily adversarial. These issues and how they were addressed is the subject of a separate publication (54). The panel members support the spirit of the intent of the process but have identified a number of substantive aspects that need to be changed to ensure that the focus on the science is preserved, if such panels are to succeed in meeting their objectives.…”

Section: Discussionmentioning

confidence: 99%

Do silicone breast implants cause rheumatologic disorders?: A systematic review for a Court-Appointed National Science Panel

Tugwell

Wells

Peterson

et al. 2001

Arthritis & Rheumatism

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103

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Objective To assist in evaluating expert testimony and scientific evidence presented in law suits brought against silicone breast implant manufacturers, a US District Court Order established a National Science Panel to assess whether existing studies provide scientific evidence of an association between silicone breast implants and systemic classic/accepted connective disease, atypical connective disease, and certain signs and symptoms identified by plaintiffs in the law suits. Local disorders potentially associated with these implants were not addressed in this review. Therefore, we performed a systematic review of published studies on the association between silicone breast implants and systemic connective tissue disorders. Methods Data from relevant studies (human cohort, case–control, or cross‐sectional studies with ≥10 participants and appropriate controls) were identified through literature searches of Medline, Current Contents, HealthStar, Biological Abstracts, EMBase, Toxline, and Dissertation Abstracts. Two independent reviewers, using standard collection forms, extracted data from the included studies. Adjusted relative risks (RRs) in cohort studies and odds ratios (ORs) in case–control and cross‐sectional studies were reported if provided; otherwise, unadjusted RRs and ORs were calculated. Results Twenty‐four studies meeting inclusion criteria were identified. No association was evident between breast implants and any established or atypical connective tissue disorder. There was discordance among studies in reports of arthralgias, lymphadenopathy, myalgias, sicca symptoms, skin changes, and stiffness. Conclusion The panel found no evidence to support expert testimony suggesting an association between silicone breast implants and connective diseases. Discordance for symptoms may reflect differences in symptoms included in various categories, the small number of cases, and the effect of having single subjects with >1 symptom represented in analyses of each symptom reported. The process presented here is an early example of the use of independent scientific panels to help courts clarify scientific evidence in legal proceedings.

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Section: Discussionmentioning

confidence: 99%

Do silicone breast implants cause rheumatologic disorders?: A systematic review for a Court-Appointed National Science Panel

Tugwell

Wells

Peterson

et al. 2001

Arthritis & Rheumatism

Self Cite

103

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“…The section of the report on meta-analyses of breast implants and connective-tissue diseases was published by Janowsky et al [16] in the NEJM and was discussed earlier in our review. [19] OFFICIAL HEALTH ORGANIZATIONS…”

Section: Legal Issues Of Silicone Brest Implantsmentioning

confidence: 99%

Silicone Gel Breast Implants and Connective Tissue Disease—A Comprehensive Review

Bar-Meir

Eherenfeld

Shoenfeld³

2003

Autoimmunity

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Silicone breast implants have been in use for breast reconstruction and breast augmentation for a long time. In the late 80's anecdotal reports describing a possible association between silicone-gel filled breast implants, and autoimmune diseases was accumulating. Due to the growing concern about the safety of silicone-gel implants, the Food and Drug administration (FDA) restricted their use to participants in controlled clinical trials, including women having reconstructive surgery. However, in recent years, large meta-analyses were unable to establish an association between silicone-gel breast implants and autoimmune disease. We review the current literature, emphasizing the most important epidemiologic studies.

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“…He then went on to recommend that courts consider appointing independent experts to assist in their gatekeeping roles (General Electric Co. v. Robert K. Joiner 1997, p. 521). Subsequently, several professional associations attempted to identify people within their disciplines who volunteered for these roles and attempted to establish procedures to implement this type of system (Haack 2001;Hulka, Kerkvliet, and Tugwell 2000). Williams and Baird (2001) note that this approach is also suggested in the second edition of the Reference Manual on Scientific Evidence (the National Conference of Lawyers and Scientists has established the Court Appointed Scientific Experts demonstration project to identify experts to assist trial judges; see www.aaas.org/spp/case/case.htm).…”

Section: Philosophy Of Science and The Supreme Courtmentioning

confidence: 99%

The Impact of the Daubert Decision on Survey Research Used in Litigation

Ford

2005

Journal of Public Policy & Marketing

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The opinions issued by the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals Inc., General Electric Co. v. Robert K. Joiner, Kumho Tire Co. Ltd. v. Carmichael, and Weisgram v. Marley changed the ground rules for whether a survey is admissible as evidence into a trial. This article provides a history of the criteria used to determine the admissibility of expert reports before Daubert and summarizes Daubert and the three other relevant opinions. It provides examples of how the Daubert criteria are being applied in cases involving survey research and provides recommendations for conducting surveys that are likely to survive a Daubert challenge.

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Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants

Cited by 23 publications

References 7 publications

Do silicone breast implants cause rheumatologic disorders?: A systematic review for a Court-Appointed National Science Panel

Do silicone breast implants cause rheumatologic disorders?: A systematic review for a Court-Appointed National Science Panel

Silicone Gel Breast Implants and Connective Tissue Disease—A Comprehensive Review

The Impact of the Daubert Decision on Survey Research Used in Litigation

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