Biotech Torts
Winter 2002
Professor Richards
What is Biotechnology?
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Drugs
Medical Devices
Genetically Modified Organisms
Technologically Enhanced Humans
Replicants
Focus of this Course
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Drugs
Medical Devices
Learn Basic Ligation Theory
Learn the Core Precedent Cases and
Statutes
Understand the Policy Issues
Legal Issues
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Negligence
Informed Consent
Products Liability
Federal Preemption of State Tort Claims
Course Materials
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Cases
Study Guides
FDA Materials
Law Reviews and other Articles
Course Expectations
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Show up to class
Be prepared
Poor Class Preparation Can Count
Against You
Closed Book in Class Final
Negligence
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Negligence in Design and Manufacture
of the Devices
Negligent Warnings
Negligent Use of the Devices
Medical Malpractice
Informed Consent
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Risk Benefit Calculus
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Unpreventably dangerous products
Everything is a balancing act
Role of the Physician
Role of the Manufacturer
Consent Issues in Medical Research
Products Liability
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Restatement 2nd
Comment K
Restatement 3rd
State Law Doctrines
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Who is a seller?
Federal Preemption
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Supremacy Clause
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Federal Law Trumps State Law
Implicit Preemption
Explicit Preemption
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Cigarette Labeling Act
Medical Device Amendments of 1976
21 U.S.C. § 379r (a) – Drug Labeling
Class Actions
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Fen-Phen
Breast Implants
Norplant