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Drug
and Medical Device Product Liability Deskbook
James M. Beck and Anthony
Vale
Looseleaf, 700 pages
2008, Law
Journal Press
This book is updated
as needed. Your purchase price includes the cost of any
updates that may be issued within three months of your order.
This book is shipped by the publisher.
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Table of Contents
FDA-regulated
products now account for an estimated one-fifth of overall economic
activity in the U.S. In recent years, there has been an explosion
of litigation in this area. This timely new 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; the use of the class action in drug and medical
device litigation; theories of liability asserted against entities
other than manufacturers; practical issues involving management
of litigation; 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 what plaintiffs
and defendants can do to enhance their chances for success before
litigation has even been commenced.
About
the authors:
James
M. Beck
is counsel in the mass torts and product liability group of Dechert
LLP in Philadelphia. In addition to handling cases at the trial
and appellate level, he is a frequent lecturer and writer on product
liability issues. His article, “FDA, Off-Label Use and Informed
Consent: Debunking Myths and Misconceptions” for the Food
and Drug Law Journal, has been cited by the U.S. Supreme Court
and by other appellate courts. He is also the editor of a 50-state
ABA survey on FDCA-related tort causes of action and the ABA Mass
Tort Subcommittee newsletter.
Mr. Beck is
responsible for the annual Pennsylvania Bar Institute statewide
CLE program on developments in Pennsylvania tort law. He is a
member of the Product Liability Advisory Committee (PLAC), the
Pennsylvania Defense Research Institute, and the American, Pennsylvania,
and Philadelphia Bar Associations. A graduate of Princeton University
(B.A., cum laude, 1978) and the University of Pennsylvania Law
School (J.D., 1982), Mr. Beck is admitted to practice in federal
and state courts in Pennsylvania, in the Supreme Court of the
United States, and has been admitted in various federal and state
courts pro hac vice.
Anthony Vale is a partner in the Litigation
Department of Pepper Hamilton LLP in Philadelphia. Mr. Vale was
an active barrister in London before coming to the United States
in 1977. He represents companies in the medical device, pharmaceutical
and chemical industries and has written and lectured widely.
Mr. Vale is
a member of the CLE board of the American Bar Association's Tort
and Insurance Practice Section (ABA/TIPS). He has served as chair
of the Class Action and Multiparty Litigation Committee of the
International Association of Defense Counsel, chair of the Toxic
Tort and Environmental Law Committee of ABA/TIPS, and president
of the British American Chamber of Commerce of Greater Philadelphia.
Mr. Vale received
his LL.B. in 1972 from the University of Exeter in England and
also attended University of Pennsylvania Law School. He is admitted
to practice in Pennsylvania and before the United States Supreme
Court, the Third, Fifth and Eleventh Circuit Courts of Appeal,
and several federal district courts.
Table of Contents
Related books:
Drug Injury:
Liability, Analysis, and Prevention
Hospital
Liability
Medical Device Accidents
and Illustrative Cases
Preparation
and Trial of Medical Malpractice Cases
Product
Liability
Product
Liability: Winning Strategies and Techniques
Table of Contents
Click here
for a Detailed Table of Contents
1. INTRODUCTION
2. STATE
COMMON LAW CLAIMS BASED UPON INFORMATIONAL DEFECTS
3. STATE COMMON
LAW CLAIMS BASED UPON NON-INFORMATIONAL DEFECTS
4. THE FEDERAL
FRAMEWORK
5. FEDERAL
PREEMPTION AS A DEFENSE TO DRUG AND MEDICAL DEVICE LITIGATION
6. BEFORE
LITIGATION STARTS: ENHANCING CHANCES FOR SUCCESS
7. CLASS
ACTIONS
8. NON-MANUFACTURER
DEFENDANTS IN DRUG AND MEDICAL DEVICE LITIGATION
9. ISSUES
IN THE MANAGEMENT OF THE LITIGATION
10. EXPERT
WITNESSES
11. TRIAL
ISSUES
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