Lessons from Litigation over Silicone Breast Implants: A Call for Activism by Scientists

Author:

Rosenbaum James T.1

Affiliation:

1. The author is at Casey Eye Institute, Oregon Health Sciences University, 3375 S.W. Terwilliger Boulevard, Portland, OR 97201, USA, and is a Senior Scholar supported by Research to Prevent Blindness. The author has provided medico-legal advice for attorneys representing Baxter Healthcare, Bristol-Myers Squibb, Dow Chemical, Minnesota Mining & Manufacturing (3M), and plaintiffs in silicone breast implant litigation. The author has testified in court proceedings on behalf of manufacturers.

Abstract

In ongoing litigation to determine whether silicone breast implants cause autoimmune disease, the question of what constitutes good science is being addressed by courts, and the answer has implications for approximately $50 billion in settlements. A federal court recently used neutral scientific advisers in excluding the admissibility of the “expert” opinion that implants cause systemic disease. The lesson from this litigation paradigm is that scientists should actively ensure that neutral, reliable scientific expertise is available to the court.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

Multidisciplinary

Reference41 articles.

1. Sanchez-Guerrero J., Schur P. H., Sergent J. S., Liang M. H., Arthritis Rheum. 37, 158 (1994).

2. M. Angell Science on Trial (Norton New York 1996).

3. Kessler D. A., N. Engl. J. Med. 326, 1713 (1992).

4. R. W. Schell and K. E. Welch Mealey’s Breast Implant Litigation Conference 471 (1996).

5. See “Petition to Ease Restrictions on Access to Silicone Breast Implants ” filed with the FDA on 19 September 1996 and assigned docket no. 96P-0337/CP 1 for the American Cancer Society and American Society for Clinical Oncology statements.

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