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
State Common Law Claims Based Upon Informational Defects
State Common Law Claims Based Upon Non-Informational Defects
The Federal Framework
Federal Preemption as a Defense to Drug and Medical Device Litigation
Before Litigation Starts: Enhancing Chances for Success
Non-Manufacturer Defendants in Drug and Medical Device Litigation
Issues in the Management of the Litigation