1. Biotech Torts Winter 2002 Professor Richards

2. What is Biotechnology? Drugs Medical Devices Genetically Modified Organisms Technologically Enhanced Humans Replicants

3. Focus of this Course Drugs Medical Devices Learn Basic Ligation Theory Learn the Core Precedent Cases and Statutes Understand the Policy Issues

4. Legal Issues Negligence Informed Consent Products Liability Federal Preemption of State Tort Claims

5. Course Materials Cases Study Guides FDA Materials Law Reviews and other Articles

6. Course Expectations Show up to class Be prepared Poor Class Preparation Can Count Against You Closed Book in Class Final

7. Negligence Negligence in Design and Manufacture of the Devices Negligent Warnings Negligent Use of the Devices Medical Malpractice

8. Informed Consent Risk Benefit Calculus Unpreventably dangerous products Everything is a balancing act Role of the Physician Role of the Manufacturer Consent Issues in Medical Research

9. Products Liability Restatement 2nd Comment K Restatement 3 rd State Law Doctrines Who is a seller?

10. Federal Preemption Supremacy Clause Federal Law Trumps State Law Implicit Preemption Explicit Preemption Cigarette Labeling Act Medical Device Amendments of 1976 21 U.S.C. § 379r (a) – Drug Labeling

11. Class Actions Fen-Phen Breast Implants Norplant