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E-raamat: Drug and Device Product Liability Litigation Strategy

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(Vice President and Chief Counsel, Litigation at Aon Corporation), (Partner, Jones Day), (Partner, King and Spalding's Tort Litigation and Environmental Group)
  • Formaat: 400 pages
  • Ilmumisaeg: 18-Jan-2018
  • Kirjastus: Oxford University Press
  • Keel: eng
  • ISBN-13: 9780192525321
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Drug and Device Product Liability Litigation StrategySuurem pilt
  • Formaat: 400 pages
  • Ilmumisaeg: 18-Jan-2018
  • Kirjastus: Oxford University Press
  • Keel: eng
  • ISBN-13: 9780192525321
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Thousands of lawsuits continue to be filed in federal and state courts each year to seek recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into federal multidistrict litigation, multi-plaintiff cases, and class actions. As drug and device litigation remains as active as ever, companies that develop new drugs and devices continue to face significant and often costly product liability litigation in the United States.

This new and revised edition of Drug & Device Product Liability Litigation Strategy provides detailed background, discussion, and strategic guidance to those practicing in this field. The book offers lawyers a detailed analysis of the full range of issues involved in drug and device litigation, including pre-litigation counselling, document preservation and discovery, consolidation and mass joinder, multidistrict litigation, class action litigation, admissibility of expert testimony, dispositive and pre-trial motion practice, jury selection, and trial. This second edition not only contains thorough revisions to reflect recent changes in the legal landscape following key court decisions and statutory developments in areas such as preemption, admissibility of expert testimony, the learned intermediary doctrine, and innovator liability, but also contains new analyses of issues such as personal jurisdiction, pre-litigation counselling, and the amended Federal Rules of Civil Procedure. It is an indispensable guide to lawyers handling cases in this high-stake, high-profile, and rapidly evolving area.
Table of Cases xvii
Table of Authorities lv
1 Introduction 1(4)
2 FDA's Regulation of Prescription Drugs and Devices 5(16)
A FDA Approval/Clearance
1 Prescription drugs
a New Drug Applications
b Abbreviated New Drug Applications
2 Medical devices
a Premarket approval
b Section 510(k) clearance
B FDA Post-Approval/Clearance Regulation and Monitoring
1 Oversight of manufacturing practices
2 Post-marketing safety surveillance
C Post-Approval Safety-Related Drug Labeling Changes
D Enforcement
3 Pre-Litigation Counseling 21(12)
A Proactive Risk Assessments
B Responsible Communications
C Information Retention
D Ensuring that Privilege and Work Product Claims Can Be Asserted
1 Privilege logs
2 Inadvertent production of privileged materials
4 Legal Issues and Theories 33(30)
A Choice of Law
B Failure to Warn
C Failure to Test
D Design Defect
E Manufacturing Defect
F Express and Implied Warranty
G Fraud and Misrepresentation
H Negligence Per Se
I State Deceptive Trade Practices Statutes
J Non-Traditional Claims
1 Market share liability
2 Innovator manufacturer liability for generic drug usage
3 Medical monitoring
5 Aggregated Proceedings-Consolidation and Mass Joinder 63(23)
A Introduction
B Federal Versus State Court
C Recent Developments in Personal-Jurisdiction Jurisprudence
D Consolidation
1 Consolidation in federal court
2 Consolidation in state courts
E Mass Joinder
6 Aggregated Proceedings-Class Actions 86(52)
A The Modern Class Action: A Brief History
B Overview of Class-Action Procedure
C Class-Action Procedures and Requirements
1 Non-textual and implicit requirements for class certification
a The class must be well-defined
b The class representative must be a class member
c Substantive law may not be changed to make certification easier
2 Express requirements for class certification: Rule 23 (a)
a Rule 23(a)(1): Numerosity
b Rule 23(a)(2): Commonality
c Rule 23(a)(3): Typicality
d Rule 23(a)(4): Adequacy of representation
3 Express requirements for class certification: Rule 23 (b) categories of class actions
a Rule 23(b)(1)
b Rule 23(b)(2)
c Rule 23(b)(3): The money damages class
d Rule 23(c)(4) "issues classes"
D Jurisdictional Issues Unique to Class Actions: Removal and the Class Action Fairness Act
1 Removal under CAFA
2 Exceptions to CAFA jurisdiction
3 The effect of denial of class certification under CAFA
4 Strategic considerations in evaluating removal
E Notice
1 Content
2 Dissemination
F Opt-outs
G Additional Strategic and Practical Considerations
H Settling a Class Action
1 Class certification requirements for settlement classes
2 Court approval
3 CAFA requirements for class-action settlements
I Defeating Class Certification
1 Initial strategic and tactical choices
2 Pre-certification discovery and other considerations in opposing class certification
a Limits on the scope of discovery
b Discovery directed at absent class members
c Expert testimony
d The class certification hearing
J Challenging the Grant of Class Certification
7 Aggregated Proceedings-Multidistrict Litigation 138(57)
A Introduction
B The MDL Panel and Its Statutory Authority
C MDL Panel Proceedings
1 Introduction
2 Invoking the Panel's centralization authority
3 Responding to a motion to centralize
4 Reply and supplemental briefs
5 Hearing
6 The Panel's decision and transfer
7 Tag-along actions and Conditional Transfer Orders
8 Remand
9 Reconsideration and review of MDL Panel orders
D Will the MDL Panel Centralize Your Drug or Device Cases?
1 General considerations
2 Formulaic considerations
3 Frequently observed considerations
4 Analysis of MDL Panel drug and device centralization decisions
E Selection of a Transferee District and Judge
1 Introduction
2 Factors affecting selection of the transferee district and judge
a General considerations
b Concentration of actions
c Location of witnesses and documents
d Accessibility and availability of the transferee court
e Other factors affecting transferee court selection
F Whether to Invoke the MDL Panel's Authority
G Transfer-Related Proceedings in the Transferor Court
H Transferee Court Proceedings
1 The effect of pre-transfer orders by transferor courts
2 The extent of "pretrial proceedings" in the transferee court
3 Choice of law
4 Transferee courts' ability to try transferred cases
5 Appeals of transferee court rulings
6 Transferee court case management tools
a The transferee court's perspective
b Case management orders
c Master complaints
d Direct-filing provisions
e Bellwether trials
f State/federal court coordination
g Common fund fee awards
I Transferor Court Post-Remand Review of Transferee Court Rulings
J Conclusion
8 Fact Discovery 195(27)
A Before Formal Discovery Commences
B Compliance With Rules 26(a)(1) and 26(f)
1 Rule 26(f) conference
2 Initial disclosures under Rule 26(a)(1)
C Formal Discovery
1 Permissible scope of discovery
2 Document requests
a To the plaintiff
b To the defendant
c Protective orders and confidential information
d Document collection from third parties
3 Interrogatories
4 Requests for admission
5 Fact depositions
a Preparing for and taking fact depositions
b Preparing witnesses to be deposed
c Conduct at depositions
9 Expert Retention and Discovery 222(14)
A Selecting Expert Witnesses
1 Identifying issues requiring expert witness attention
2 Locating expert witness candidates
3 Interviewing expert witness candidates
4 Investigating expert candidates
5 Expert retention
B Expert Reports
1 Case evaluation
2 Report preparation
C Expert Testimony
1 Deposing an opponent's expert
a Using consulting experts
b Using the discovery process
c Examining an opposing expert
2 Preparing your expert for testimony
10 Expert Testimony, Rule 702, and Daubert 236(32)
A Frye, Rule 702, and the Supreme Court Trilogy
1 Frye v. United States
2 Federal Rule of Evidence
702(1)
3 Daubert v. Merrell Dow Pharmaceuticals, Inc.
4 General Electric Co. v. Joiner
5 Kumho Tire Co. v. Carmichael
6 The 2000 Amendments to Federal Rule of Evidence
702
B Rule 702 and Daubert Challenges in Prescription Drug and Device Actions
1 Background on statistics and causal relationships
2 Recurring issues in establishing general causation
3 Recurring issues in establishing specific causation
4 Opinions on ethics and corporate and regulators' intent
C Procedural Issues and Choice of Law
D State Approaches to Expert Testimony
11 Preemption 268(39)
A General Considerations
B Medical Devices
1 Express preemption of medical device claims
a Device approvals triggering express preemption
b Claims subject to express preemption
2 Implied preemption of medical device claims
3 The "parallel requirements" exception to express preemption
C Prescription Drugs
1 FDNs regulation of prescription drug labeling
2 Levine, Mensing, and Bartlett Trilogy
a Wyeth v. Levine
b PLIVA, Inc. v. Mensing
c Mutual Pharmaceutical Co. v. Bartlett
3 Prescription drug preemption after Levine, Mensing, and Bartlett
a When FDA considered and rejected the proposed warnings
b When FDA "occupies a field"
c When there is no "newly acquired information"
d Claims based on failures to contraindicate or withdraw a drug
e Authority to change drug labeling
f Special cases
D Vaccines
1 The Vaccine Act
1(1)
2 The Vaccine Act's preemption provision
E Over-the-Counter Medications
1(1)
F Raw Materials and Component Parts
1(306)
G Implied Preemption under Buckman
12 The Learned Intermediary Doctrine 307(20)
A Warnings Adequacy
B Warnings Causation
1 The learned intermediary's independent knowledge
2 The heeding presumption
3 What if there had been an adequate warning?
C Exceptions
1 Vaccines administered in mass immunization programs
2 Prescription oral contraceptives
3 Drugs promoted through direct-to-consumer advertising
4 Overpromotion: A pseudo-exception
5 Exceptions under the RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY
13 Motions in Limine 327(20)
A Evaluating Rules of Evidence
B Identifying Grounds for Exclusion
1 Balancing relevance against prejudice
2 Excluding specific documents or types of documents
a FDA letters
b FDA and foreign regulatory actions
c Evidence of supposed fraud on FDA
d Adverse event reports and case reports
e Evidence related to other injuries
f Medical records
g Marketing or promotional materials
h Defendant's post-injury conduct and knowledge
i Government investigations and plea agreements
j Expert testimony
3 Subsequent remedial measures
4 Excluding evidence of financial status
C Preparing the Motion
1 Pick your battles
2 Build on earlier work
3 Create standard templates
4 Focus on the judge
D Conclusion
14 Jury Selection 347(33)
A What Makes Jury Selection Different in Drug and Device Litigation
B Preliminary Tasks Regarding Jury Selection
1 Know the case and the rules
a Issue 1-How many jurors and alternates will be selected?
b Issue 2-Will the venire panel be an adequate size?
c Issue 3-Will questionnaires and supplemental questionnaires be used?
d Issue 4-Should you conduct juror investigations?
e Issue 5-What procedure will be used for voir dire?
f Issue 6-What jury selection system will be used?
g Issue 7-How many peremptory challenges will each side be allowed?
2 Decide whether to hire a jury consultant
1(379)
a What a jury consultant can do
b How to hire a jury consultant
C Understanding Juror Decision-Making: How to Decide What to Ask
1 Everyone is biased
2 Understand how jurors make decisions
3 Don't rely on your own biases and stereotypes in picking jurors
4 To know what to ask, know what kind of juror you want
a Identify the indicators and attitudes you want in your jurors
b Indicators and attitudes identifying leaders and followers
c Attitudes about personal responsibility: delegators vs. DIYers
D Getting the Information You Need
1 Constructing the Supplemental Questionnaire
2 Attorney-conducted voir dire
15 The Trial of a Drug or Device Case 380(21)
A The Necessity of a Trial Strategy
B Theories and Themes of the Case
C Opening Statements
D The Substantive Defense Case
1 The mechanics of direct and cross-examination
2 Fact witnesses
a Tell the story of your drug/device
b Address the clinical trials and FDA approval/clearance
c Have a witness discuss post-marketing surveillance
d Marketing to physicians and other healthcare professionals
e Subpoenaing defense employee witnesses
f Trial strategy begins at the deposition stage
3 Expert witnesses
4 A note on time
E Closing Argument
F Jury Instructions and Verdict Form
Index 401
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.



Geoffrey M. Drake is a partner in King and Spalding's Tort Litigation and Environmental Group, where he represents companies in high-exposure product liability, personal injury, toxic tort, commercial and whistleblower litigation, as well as internal and external government investigations. He is also a member of the Next Generation Advisory Board for Emory University's Institute for Complex Litigation and Mass Claims.
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