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Drug & Device Product Liability Litigation Strategy [Pehme köide]

5.00/5 (3 hinnangut Goodreads-ist)
(Jones Day, Cleveland office), (Aon Corporation)
  • Formaat: Paperback / softback, 544 pages, kõrgus x laius x paksus: 233x156x28 mm, kaal: 778 g
  • Ilmumisaeg: 01-Mar-2012
  • Kirjastus: Oxford University Press
  • ISBN-10: 0199734941
  • ISBN-13: 9780199734948
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Drug & Device Product Liability Litigation StrategySuurem pilt
  • Formaat: Paperback / softback, 544 pages, kõrgus x laius x paksus: 233x156x28 mm, kaal: 778 g
  • Ilmumisaeg: 01-Mar-2012
  • Kirjastus: Oxford University Press
  • ISBN-10: 0199734941
  • ISBN-13: 9780199734948
Teised raamatud teemal:
Püsilink: https://www.kriso.ee/db/9780199734948.html
Märksõnad:
"Each year, thousands of lawsuits are filed in federal and state courts seeking recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into multidistrict litigation, and class actions. The litigation occasionally becomes life-threatening for the defendant corporations, and may breed a public relations nightmare, as occurred with Vioxx, breast implants, and fen-phen. Drug & Device Product Liability Litigation Strategy, by MarkHerrmann and David B. Alden, offers assistance to lawyers who practice in this high-stakes, high-profile, and rapidly-evolving area. The book's primary focus is to provide useful practice pointers and overall strategic guidance for attorneys involved inproduct liability litigation for prescription drugs and medical devices. It will serve as an indispensable guide to handling such a case from pre-litigation through trial. The legal landscape in this important area is expected to shift as the Supreme Court's decisions in Riegel v. Medtronic, Inc. and Wyeth v. Levine are applied, and as the President and Congress address tort reform and other health care issues. Practitioners will need thoughtful, expert advice to navigate these changes"--

"Each year, thousands of lawsuits are filed in federal and state courts seeking recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into multidistrict litigation, and class actions. The litigation occasionally becomes life-threatening for the defendant corporations, and may breed a public relations nightmare, as occurred with Vioxx, breast implants, and fen-phen. Drug & Device Product Liability Litigation Strategy, by Mark Herrmann and David B. Alden, offers assistance to lawyers who practice in this high-stakes, high-profile, and rapidly-evolving area. The book's primary focus is to provide useful practice pointers and overall strategic guidance for attorneys involved in product liability litigation for prescription drugs and medical devices. It will serve as an indispensable guide to handling such a case from pre-litigation through trial. The legal landscape in this important area is expected to shift as the Supreme Court'sdecisions in Riegel v. Medtronic, Inc. and Wyeth v. Levine are applied, and as the President and Congress address tort reform and other health care issues. Practitioners will need thoughtful, expert advice to navigate these changes"--

Provided by publisher.

Each year, thousands of lawsuits are filed in federal and state courts seeking recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into multidistrict litigation, and class actions. The litigation occasionally becomes life-threatening for the defendant corporations, and may breed a public relations nightmare, as occurred with Vioxx, breast implants, and fen-phen.

Drug & Device Product Liability Litigation Strategy, by Mark Herrmann and David B. Alden, offers assistance to lawyers who practice in this high-stakes, high-profile, and rapidly-evolving area. The book's primary focus is to provide useful practice pointers and overall strategic guidance for attorneys involved in product liability litigation for prescription drugs and medical devices. It will serve as an indispensable guide to handling such a case from pre-litigation through trial. The legal landscape in this important area is expected to shift as the Supreme Court's decisions in Riegel v. Medtronic, Inc. and Wyeth v. Levine are applied, and as the President and Congress address tort reform and other health care issues. Practitioners will need thoughtful, expert advice to navigate these changes.

Arvustused

"This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field." --Steve Phillips, Special Counsel, Medtronic, Inc. "Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive in scope, addressing not only the complicated policies, theories, and defenses unique to drugs and medical devices, but also providing extremely practical advice on client counseling, discovery, case management, trial preparation, and jury selection. And its conversational tone makes it very easy to read. Keep this book handy -- you'll want to refer to it again and again." --Russell Jackson, Partner Skadden, Arps, Slate, Meagher & Flom, New York Creator and Author, "Jackson on Consumer Class Actions & Mass Torts" blog http://www.consumerclassactionsmasstorts.com "Herrmann and Alden have written a comprehensive guide to navigating the treacherous waters of drug and medical device litigation. Among the many thorny problems addressed by the authors, their advice on multidistrict proceedings and class actions is particularly helpful, both in its depth of analysis, along with their guidance on making difficult strategic decisions in 'bet the company' proceedings. With respect to preventive counseling, the authors provide savvy insight that will be particularly useful to in-house counsel and to the outside lawyers advising them. In short, I have already consulted this book several times, and I will highly recommend it to any practitioner involved in this challenging and dynamic arena." --Howard Cyr, Senior Corporate Counsel for Fortune 100 Pharmaceutical Companies "One of the reasons that I like this book is that it not only is useful for attorneys who are new to drug and device litigation, but it also has plenty of insight and handy resources for those of us who have more than a little grey in our beards...In fact, much of what is in the book is practical advice that would be useful for any litigator...The treatise addresses not only the legal theories underlying these cases, but the ever-important procedural problems of removal, consolidation, class actions, and aggregation. If you anticipate facing MDL issues, you really must read this book. Hermann and Alden have written a book that is both easy to read and chock full of information." --Russell Jackson, Consumer Class Actions & Mass Torts blog http://www.consumerclassactionsmasstorts.com "The book has many strengths. It is comprehensive, generally accessible, eloquently written, and well-researched. Perhaps its greatest accomplishment is the breadth of its usefulness to a wide range of readers with varying levels of sophistication." --Paul Karlsgodt, ClassActionBlawg

Acknowledgment xiii
1 Introduction
1(4)
2 The FDA's Regulation of Prescription Drugs and Devices
5(22)
A Initial FDA Approval
6(9)
1 Drugs
6(5)
2 Medical Devices
11(4)
B FDA Post-Approval Safety Regulation and Monitoring
15(3)
1 Oversight of Manufacturing Practices
16(1)
2 Post-Marketing Safety Surveillance
17(1)
C Post-Approval Safety-Related Drug Labeling Changes
18(2)
D Enforcement
20(7)
3 Pre-Litigation Counseling
27(12)
A Responsible Communications
27(2)
B Information Retention
29(6)
C Ensuring That Privilege and Work Product Claims Can Be Asserted
35(4)
4 Legal Issues and Theories
39(42)
A Choice of Law
40(5)
B Failure to Warn
45(1)
C Failure to Test
45(1)
D Design Defect
45(8)
E Manufacturing Defect
53(2)
F Contract-Based Express and Implied Warranty Claims
55(5)
G Fraud or Intentional Misrepresentation, Negligent Misrepresentation, Strict Liability Misrepresentation
60(2)
H Negligence Per Se
62(1)
I State Deceptive Trade Practices Statutes
63(5)
J Non-Traditional Claims
68(13)
1 Market Share Liability
68(3)
2 Innovator Manufacturer Liability for Generic Drug Usage
71(3)
3 Medical Monitoring Claims
74(7)
5 Consolidated Proceedings
81(20)
A Consolidation
81(13)
B Mass Joinder
94(7)
6 Aggregated Proceedings---Class Actions
101(58)
A The Modern Class Action: A Brief History
102(2)
B Overview of Class-Action Procedure
104(1)
C Class-Action Procedures and Requirements
105(28)
1 Non-Textual and Implicit Requirements for Class Certification
105(1)
(a) The Class Must Be Well-Defined
106(2)
(b) The Class Representative Must Be a Class Member
108(1)
(c) Substantive Law May Not Be Changed to Make Certification Easier
109(2)
2 Express Requirements for Class Certification: Rule 23(a)
111(1)
(a) Rule 23(a)(1): Numerosity
111(1)
(b) Rule 23(a)(2): Commonality
112(1)
(c) Rule 23(a)(3): Typicality
113(1)
(d) Rule 23(a)(4): Adequacy of Representation
114(5)
3 Express Requirements for Class Certification: Rule 23(b) Categories of Class Actions
119(1)
(a) Rule 23(b)(1)
119(2)
(b) Rule 23(b)(2)
121(2)
(c) Rule 23(b)(3): The Money Damages Class
123(1)
(i) Predominance
124(1)
(1) Medical Monitoring Claims
125(2)
(2) RICO and Consumer Fraud Claims
127(2)
(3) Damages as a Basis for Defeating Predominance
129(1)
(ii) Superiority
129(1)
(1) Manageability
130(1)
(d) Rule 23(c)(4) "Issues Classes"
131(2)
D Jurisdictional Issues Unique to Class Actions: Removal and the Class Action Fairness Act
133(7)
1 Removal under CAFA
133(3)
2 Exceptions to CAFA Jurisdiction
136(3)
3 The effect of Denial of Class Certification under CAFA
139(1)
4 Strategic Considerations in Evaluating Removal
140(1)
E Notice
140(2)
1 Content
140(1)
2 Dissemination
141(1)
F Opt-outs
142(1)
G Additional Strategic and Practical Considerations
143(1)
H Settling a Class Action
144(5)
1 Class Certification Requirements for Settlement Classes
144(1)
2 Court Approval
145(2)
3 CAFA Requirements for Class Action Settlements
147(2)
I Defending against Class Certification
149(8)
1 Initial Strategic and Tactical Choices
149(2)
2 Pre-certification Discovery and Other Considerations in Opposing Class Certification
151(1)
(a) Limits on the Scope of Discovery
152(2)
(b) Discovery Directed at Absent Class Members
154(2)
(c) Expert Testimony
156(1)
(d) The Class Certification Hearing
157(1)
J Challenging the Grant of Class Certification
157(2)
7 Aggregated Proceedings---Multidistrict Litigation
159(74)
A Introduction
160(1)
B The MDL Panel and Its Statutory Authority
160(3)
C MDL Panel Proceedings
163(11)
1 Introduction
163(1)
2 Invoking the Panel's Centralization Authority
164(1)
3 Responding to a Motion to Centralize
165(1)
4 Reply and Supplemental Briefs
166(1)
5 Hearing
167(1)
6 Timing of the Panel's Decisions and Transfer
168(1)
7 Scope of MDL Panel Transfer Orders
169(1)
8 Tag-Along Actions and Conditional Transfer Orders
170(1)
9 Remand
171(2)
10 Reconsideration and Review of MDL Panel Orders
173(1)
D Will the MDL Panel Centralize Your Drug or Device Cases?
174(12)
1 General Considerations
174(1)
2 Formulaic Considerations
175(4)
3 Frequently Observed Considerations
179(2)
4 Analysis of MDL Panel Drug and Device Centralization Decisions
181(5)
E Selection of a Transferee District and Judge
186(10)
1 Introduction
186(2)
2 Factors Affecting Selection of the Transferee District and Judge
188(1)
(a) General Considerations
188(2)
(b) Concentration of Actions
190(1)
(c) Location of Witnesses and Documents
191(2)
(d) Accessibility and Availability of the Transferee Court
193(1)
(e) Other Factors Affecting Transferee Court Selection
194(2)
F Whether to Invoke the MDL Panel's Authority
196(3)
G Transfer-Related Proceedings in the Transferor Court
199(2)
H Transferee Court Proceedings
201(29)
1 The Effect of Pre-Transfer Orders by Transferor Courts
202(1)
2 The Extent of "Pretrial Proceedings" in the Transferee Court
202(2)
3 Choice-of-Law
204(3)
4 Transferee Courts' Ability to Try Transferred Cases
207(2)
5 Appeals of Transferee Court Rulings
209(1)
6 Transferee Court Case Management Tools
210(1)
(a) The Transferee Court's Perspective
210(1)
(b) Transferee Court Case Management Orders
210(5)
(c) Master Complaints
215(4)
(d) Direct Filing Provisions
219(3)
(e) Bellwether Trials
222(4)
(f) State/Federal Court Coordination
226(3)
(g) Common Fund Fee Awards
229(1)
I Transferor Court Post-Remand Review of Transferee Court Rulings
230(1)
J Conclusion
231(2)
8 Fact Discovery
233(28)
A Before Formal Discovery Commences
233(3)
B Compliance with Rule 26(a)(1) and 26(f), if Applicable
236(3)
1 Rule 26(f) Conference
236(1)
2 Initial Disclosures under Rule 26(a)(1)
237(2)
C Formal Discovery
239(22)
1 Document Requests
239(1)
(a) To the Plaintiff
239(2)
(b) To the Defendant
241(1)
(c) Protective Orders and Confidential Information
242(2)
(d) Document Collection from Third Parties
244(1)
2 Interrogatories
245(2)
3 Requests for Admission
247(1)
4 Fact Depositions
247(1)
(a) Preparing for and Taking Fact Depositions
247(4)
(b) Preparing Witnesses to Be Deposed
251(5)
(c) Conduct at Depositions
256(5)
9 Expert Retention and Discovery
261(18)
A Selecting Expert Witnesses
262(7)
1 Identifying Issues Requiring Expert Witness Attention
262(1)
2 Locating Expert Witness Candidates
263(1)
3 Interviewing Expert Witness Candidates
264(3)
4 Investigating Expert Candidates
267(1)
5 Expert Retention
268(1)
B Expert Reports
269(3)
1 Case Evaluation
269(1)
2 Report Preparation
270(2)
C Expert Testimony
272(7)
1 Preparing to Depose an Opponent's Expert
272(1)
(a) Using Consulting Experts
272(1)
(b) Using the Discovery Process
273(1)
(c) Examining an Opposing Expert
273(3)
2 Preparing Your Expert for Testimony
276(3)
10 Expert Testimony, Rule 702, and Daubert
279(38)
A Frye, Rule 702, and the Supreme Court Trilogy
280(8)
1 Frye v. United States
280(2)
2 Federal Rule of Evidence 702
282(1)
3 Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)
283(2)
4 General Electric Co. v. Joiner, 522 U.S. 136 (1997)
285(1)
5 Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999)
286(1)
6 The 2000 Amendments to Federal Rule of Evidence 702
287(1)
B Rule 702 and Daubert Challenges in Prescription Drug and Device Actions
288(23)
1 Background on Statistics and Causal Relationships
289(7)
2 Recurring Issues in Establishing General Causation
296(9)
3 Recurring Issues in Establishing Specific Causation
305(4)
4 Opinions on Ethics and Corporate and Regulators' Intent
309(2)
C Procedural Issues and Federal-State Choice of Law
311(3)
D State Approaches to Expert Testimony
314(3)
11 Preemption
317(38)
A Types of Preemption
318(1)
B Medical Devices
319(16)
1 The Scope of Express Preemption under 21 U.S.C. § 360k(a)
323(1)
(a) Device Approvals Triggering Express Preemption
323(2)
(b) Claims Subject to Express Preemption
325(4)
2 The "Parallel Requirements" Exception to Express Preemption under 21 U.S.C. § 360k(a)
329(6)
C Prescription Drugs
335(8)
1 Wyeth v. Levine
335(1)
(a) Impossibility
336(2)
(b) Frustration of Purpose
338(1)
2 Prescription Drug Preemption after Levine
339(1)
(a) When the FDA Considers and Rejects Warnings
339(1)
(b) When the FDA "Occupies a Field"
340(1)
(c) When There Is No "Newly Acquired Information"
341(1)
(d) Claims Based on Failures to Contraindicate or Withdraw a Drug
342(1)
(e) Special Cases
342(1)
D Vaccines
343(3)
E Over-the-Counter Medications
346(2)
F Raw Materials and Component Parts
348(1)
G Implied Preemption under Buckman Co. v. Plaintiffs' Legal Committee
349(6)
12 The Learned Intermediary Doctrine
355(24)
A Warnings Adequacy
359(5)
B Warnings Causation
364(5)
1 The Learned Intermediary's Independent Knowledge
364(1)
2 The Heeding Presumption
365(2)
3 What if There Had Been an Adequate Warning?
367(2)
C Exceptions
369(10)
1 Vaccines Administered in Mass Immunization Programs
369(2)
2 Prescription Oral Contraceptives
371(2)
3 Drugs Promoted through Direct-to-Consumer Advertising
373(2)
4 Overpromotion: A Pseudo-Exception
375(1)
5 Exceptions under the Restatement (Third) of Torts: Products Liability
376(3)
13 Motions in Limine
379(22)
A Evaluating Rules of Evidence
380(2)
B Identifying Grounds for Exclusion
382(14)
1 Excluding Irrelevant Evidence
382(3)
2 Excluding Unfairly Prejudicial and Confusing Evidence
385(1)
3 Excluding Specific Documents or Types of Documents
386(1)
(a) FDA Letters
386(1)
(b) Reports Relating to Adverse Events and Case Reports
387(4)
(c) Evidence of Supposed Frauds on the FDA
391(1)
(d) Medical Records
391(1)
4 Subsequent Remedial Measures
392(2)
5 Excluding Evidence of Financial Status
394(1)
6 Excluding Evidence of Promotional Materials
395(1)
C Preparing the Motion
396(3)
1 Pick Your Battles
396(1)
2 Create Standard Templates
397(1)
3 Build on Earlier Work
397(1)
4 Focus on the Judge
397(2)
D Conclusion
399(2)
14 Jury Selection
401(38)
A What Makes Jury Selection in Drug and Device Litigation Different
404(2)
B Preliminary Tasks Regarding Jury Selection
406(16)
1 Know the Case and the Rules
406(13)
2 Decide Whether to Hire a Jury Consultant
419(1)
(a) What a Jury Consultant Can Do
420(1)
(b) How to Hire a Jury Consultant
421(1)
C Understanding Juror Decision-Making: How to Decide What to Ask
422(8)
1 Everyone is Biased
422(1)
2 Understand How Jurors Make Decisions
423(1)
3 Don't Rely on Your Own Biases and Stereotypes in Picking Jurors
424(2)
4 To Know What to Ask, Know What Kind of Juror You Want
426(1)
(a) Identify the Indicators and Attitudes You Want in Your Jurors
426(1)
(b) Indicators and Attitudes Identifying Leaders and Followers
427(2)
(c) Attitudes about Personal Responsibility: Delegators vs. DIYers
429(1)
D Getting the Information You Need
430(9)
1 Constructing the Supplemental Questionnaire
430(4)
2 Submitting Questions for Judge-Conducted Voir Dire
434(1)
3 Attorney-Conducted Voir Dire
435(4)
15 The Trial of a Drug or Device Case
439(20)
A Should There Be a Trial?
439(2)
B The Theories and Themes of the Case
441(1)
C Opening Statements
442(3)
D The Substantive Defense Case
445(12)
1 The Mechanics of Direct and Cross-Examination
445(1)
2 Fact Witnesses
446(1)
(a) Have A Witness Tell the Story of Your Drug
446(1)
(b) Have A Witness Address the Clinical Trials
447(2)
(c) Have A Witness Discuss Post-Marketing Surveillance
449(2)
(d) Marketing to Physicians and Other Healthcare Professionals
451(3)
3 Expert Witnesses
454(3)
4 A Note on Foreign Regulation of the Drug
457(1)
E Closing Argument
457(2)
Table of Authorities 459(16)
Table of Cases 475(40)
Index 515
Mark Herrmann is Vice President and Chief Counsel - Litigation at Aon Corporation, which is the world's leading insurance and reinsurance broker. Before joining Aon, he was a partner at Jones Day, where his practice focused on the defense of class action and mass tort litigation, including pharmaceutical and medical device cases. He clerked for Judge Dorothy W. Nelson of the United States Court of Appeals for the Ninth Circuit and graduated from The University of Michigan Law School (J.D. 1983) and Princeton University (A.B. 1979).





David B. Alden is a partner in Jones Day's Cleveland office, where his practice focuses on products liability litigation, including pharmaceutical and medical device cases; securities and accounting fraud litigation; and issues relating to the attorney-client privilege and work product protection.