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Lexis Nexis Drug and Medical Device Product Liability Deskbook
By James M. Beck and Anthony Vale
Publisher: ALM
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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
The Drug and Medical Device Product Liability Deskbook includes: detailed coverage of: warning-related claims and defenses; other information-based theories; strict liability; FDA-related per se liability; preemption of common law tort claims by the Food, Drug & Cosmetic Act and FDA regulations; class actions in drug and medical device litigation; theories of liability asserted against entities other than manufacturers; practical issues involving litigation management; the use of expert witnesses; and many other important topics. The authors include practical coverage of "what a litigator needs to know about the FDA." You'll also find out how plaintiffs and defendants can enhance their chances for success before litigation even commences.
The Drug and Medical Device Product Liability Deskbook includes: detailed coverage of: warning-related claims and defenses; other information-based theories; strict liability; FDA-related per se liability; preemption of common law tort claims by the Food, Drug & Cosmetic Act and FDA regulations; class actions in drug and medical device litigation; theories of liability asserted against entities other than manufacturers; practical issues involving litigation management; the use of expert witnesses; and many other important topics. The authors include practical coverage of "what a litigator needs to know about the FDA." You'll also find out how plaintiffs and defendants can enhance their chances for success before litigation even commences.
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Table of Contents
CHAPTER 1
Introduction
CHAPTER 2
State Common Law Claims Based Upon Informational Defects
CHAPTER 3
State Common Law Claims Based Upon Non-Informational Defects
CHAPTER 4
The Federal Framework
CHAPTER 5
Federal Preemption as a Defense to Drug and Medical Device Litigation
CHAPTER 6
Before Litigation Starts: Enhancing Chances for Success
CHAPTER 7
Class Actions
CHAPTER 8
Non-Manufacturer Defendants in Drug and Medical Device Litigation
CHAPTER 9
Issues in the Management of the Litigation
CHAPTER 10
Expert Witnesses
CHAPTER 11
Trial Issues
Index
