Drug and Medical Device Product Liability Deskbook

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ALM Product :BOOK
ISBN: 9781588521217
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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.

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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