Biotech Torts Winter 2002 Professor Richards. What is Biotechnology? Drugs Medical Devices Genetically Modified Organisms Technologically Enhanced Humans.

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Presentation transcript:

Biotech Torts Winter 2002 Professor Richards

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

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

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

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

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

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

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

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

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

Class Actions Fen-Phen Breast Implants Norplant

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