Drug and Medical Device Product Liability DeskbookLaw Journal Press, 2004 - 1904 strani 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. Book ʢ looseleaf, one volume, 1,158 pages; published in 2004, updated as needed; no additional charge for updates during your subscription. Looseleaf print subscribers receive supplements. The online edition is updated automatically. ISBN: 978-1-58852-121-7. |
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2 | 2-1 |
2 Guaranteed Issue In the Small Group Market 1616 | 2-2 |
3 Insurers May Use Certain Underwriting | 2-3 |
Requirements to Deny Coverage 1616 | 2-16 |
The Learned Intermediary Rule | 2-22 |
04 | 2-46 |
Adequacy of Warnings | 2-48 |
2 Establishing the Adequacy of a Warning | 2-48 |
6 Rules Regarding a Health Insurers Exit | 4-6 |
From a Market 1617 | 4-16 |
Federal Preemption as a Defense to Drug | 5-1 |
8 Special Rules Regarding Association | 5-8 |
Coverage 1618 | 5-16 |
CHAPTER 6 | 5-52 |
Enhancing Chances for Success | 5-52 |
9 Study of Conditions in the Large Group | 6-9 |
Establishing Causation in a Warning Case | 2-48 |
3 The Presumption That an Inadequate | 2-48 |
4 Other Causation Issues in Warning Cases | 2-48 |
07 | 2-48 |
08 | 3 |
Express Saving Clauses 5 024 | 5 |
09 | 9 |
11 | 9 |
13 | 2-1 |
CHAPTER 3 | 2-13 |
4 Implied Conflict Preemption in the FDCA | 3-4 |
Suspension of New Business Activity in a Service Area 1617 | 3-16 |
c Role of Feasible Safer Alternative | 3-31 |
Products Liability | 3-39 |
05 | 3-46 |
3 06 | 3-46 |
07 | 3-46 |
08 | 3-46 |
3 09 | 3-46 |
10 | 3-46 |
1 The Learned Intermediary Rule as | 4-1 |
Market 1618 | 6-16 |
4 Discontinuation of Health CoverageExit | 7-4 |
CHAPTER 8 | 9 |
from the Market 1622 | 8-16 |
e Dispensing Without Valid Renewal | 8-21 |
4 Negligence 8 0517 | 8-17 |
c Preemption Disfavored in | 9-5 |
iii | 9-9 |
Laws 1622 | 9-16 |
CHAPTER 10 | 9-38 |
3 State Law Standards for the Admissibility | 10-17 |
CHAPTER 11 | 11-1 |
11-21 | |
of COBRA Continuation 1624 | liv |
3 Newborns and Adopted Children Are Qualified Beneficiaries 1624 | 8-29 |
4 Coverage Under Another Group | 14-4 |
Health Plan 1625 | 3 |
8 Implications 1626 | 4 |
The Class Action Fairness Act CAFA 7 071 | 7 |