Drug and device product liability litigation strategy / Mark Herrmann, David B. Alden.

Format:

Book

Author/Creator:

Herrmann, Mark.

Contributor:

Alden, David B.

Language:

English

Subjects (All):

Products liability--Medical instruments and apparatus--United States--Trial practice.

Products liability.

Products liability--Drugs--United States--Trial practice.

Physical Description:

1 online resource (539 p.)

Place of Publication:

Oxford, [England] ; New York, [New York] : Oxford University Press, 2012.

Language Note:

English

Summary:

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 and Device Product Liability Litigation Strategy, by Mark Herrmann and David B. Alden, offers assistance to lawyers who practice in this high-stakes,

Contents:

Cover; Contents; Acknowledgment; 1. Introduction; 2. The FDA's Regulation of Prescription Drugs and Devices; A. Initial FDA Approval; 1. Drugs; 2. Medical Devices; B. FDA Post-Approval Safety 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; A. Responsible Communications; B. Information Retention; C. Ensuring That Privilege and Work Product Claims Can Be Asserted; 4. Legal Issues and Theories; A. Choice of Law; B. Failure to Warn

C. Failure to TestD. Design Defect; E. Manufacturing Defect; F. Contract-Based Express and Implied Warranty Claims; G. Fraud or Intentional Misrepresentation, Negligent Misrepresentation, Strict Liability 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 Claims; 5. Consolidated Proceedings; A. Consolidation; B. Mass Joinder; 6. Aggregated Proceedings-Class Actions; A. The Modern Class Action: A Brief History

B. Overview of Class-Action ProcedureC. Class-Action Procedures and Requirements; 1. Non-Textual and Implicit Requirements for Class Certification; 2. Express Requirements for Class Certification: Rule 23(a); 3. Express Requirements for Class Certification: Rule 23(b) Categories of Class Actions; 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-outsG. 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. Defending against Class Certification; 1. Initial Strategic and Tactical Choices; 2. Pre-certification Discovery and Other Considerations in Opposing Class Certification; J. Challenging the Grant of Class Certification; 7. Aggregated Proceedings-Multidistrict Litigation; A. Introduction; B. The MDL Panel and Its Statutory Authority; C. MDL Panel Proceedings

1. Introduction2. Invoking the Panel's Centralization Authority; 3. Responding to a Motion to Centralize; 4. Reply and Supplemental Briefs; 5. Hearing; 6. Timing of the Panel's Decisions and Transfer; 7. Scope of MDL Panel Transfer Orders; 8. Tag-Along Actions and Conditional Transfer Orders; 9. Remand; 10. 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

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

0-19-975024-6