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SCIENCE AND THE LAW

SCIENCE AND THE LAW. Captiva , FL 11/13/10. Science and the Law Breast Implant Chronology. 1980s: String of jury verdicts for plaintiff December 1991: Mariann Hopkins $7.3 million verdict April 1992: FDA bans silicone gel-filled breast implants

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SCIENCE AND THE LAW

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  1. SCIENCE AND THE LAW Captiva, FL 11/13/10

  2. Science and the LawBreast Implant Chronology • 1980s: String of jury verdicts for plaintiff • December 1991: Mariann Hopkins $7.3 million verdict • April 1992: FDA bans silicone gel-filled breast implants • June 1992: FDA Commissioner explains decision in NEJM and I comment • April 1994: $4.25 billion class action settlement • June 1994: First scientific evidence published in NEJM and I comment

  3. Science and the LawEvidence of Possible Risk Factors • Randomized controlled clinical trials (RCTs): Similar subjects assigned to exposure by random draw • Observational epidemiologic studies: Second choice when impossible to do RCTs • Case/control studies • Cohort studies

  4. Science and the LawComparison of risks

  5. Science and the LawConfounding

  6. Science and the LawTwo cultures SCIENCE • Collaborative • Slow and tentative • Evidence leads to opinion • Data • Publication essential • Group effort LAW • Adversarial • Fast and decisive • Opinion leads to evidence • Credentials • Publication not essential • Individualistic

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