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Drug and Medical Device Product Liability Deskbook [Loose-leaf]

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  • Formatas: Loose-leaf, 700 pages, aukštis x plotis: 138x105 mm
  • Išleidimo metai: 28-May-2025
  • Leidėjas: Law Journal Press
  • ISBN-10: 1588521214
  • ISBN-13: 9781588521217
Kitos knygos pagal šią temą:
Drug and Medical Device Product Liability DeskbookDidesnis paveikslėlis
  • Formatas: Loose-leaf, 700 pages, aukštis x plotis: 138x105 mm
  • Išleidimo metai: 28-May-2025
  • Leidėjas: Law Journal Press
  • ISBN-10: 1588521214
  • ISBN-13: 9781588521217
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9781588521217.html
Raktažodžiai:
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 #00674; 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.


This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.

Introduction
State Common Law Claims Based Upon Informational Defects
Introduction
2
The Duty to Warn and the Unavoidably Unsafe Product Doctrine
1(1)
Unavoidably Unsafe Products and Design Defects
7(1)
Prescription Medical Devices and Biologics as Unavoidably Unsafe Products
8(4)
Case-by-Case Versus Categorical Application of the Unavoidably Unsafe Product Doctrine
12
The Learned Intermediary Rule
1(1)
The Learned Intermediary Rule as the Distinctive Attribute of Litigation Involving Prescription Medical Products
1(25)
Who Is the Learned Intermediary?
26(5)
Exceptions to the Learned Intermediary Rule
31(1)
Over-the-Counter Drugs
32(1)
Mass Immunization Exception
33(4)
FDA-Mandated Patient Warning Exception
37(1)
Personal Choice Product Exception
38(4)
Direct-to-Consumer Marketing Exception
42(2)
FDA Recall Exception
44(1)
Miscellaneous Unrecognized Exceptions
44
Adequacy of Warnings
1(1)
Criteria for an Adequate Warning
1(22)
Establishing the Adequacy of a Warning as a Matter of Law
23
Establishing Causation in a Warning Case
1(1)
When an Inadequate Warning is Non-Causal
1(10)
Issues of Fact Concerning Warning Causation
11(4)
The Presumption That an Inadequate Warning is Causal
15(4)
Other Causation Issues in Warning Cases
19
Overpromotion and Negligent Marketing Claims
1(1)
Implied Warranty Claims
1(1)
Express Warranty Claims
1(1)
Illegal Promotion and Marketing Claims
1(1)
Duty to Warn Claims Involving Direct Patient Warnings
1(1)
Warning Claims Brought by Prescribing Physicians
1(1)
Public Policy Considerations Underlying the Unavoidable Unsafe Product Doctrine and the Learned Intermediary Rule
1(1)
State Common Law Claims Based Upon Non-Informational Defects
Introduction---Design Defect Claims
2
Claims Sounding in Strict Liability
1(1)
Strict Liability---Pleading and Merger of Other Causes of Action
2(2)
Elements of Strict Liability Claims Brought Under the Restatement (Second) of Torts § 402A
4(2)
Requirement of an Unreasonably Dangerous Product
6(2)
Consumer Expectations Test
8(2)
Risk-Utility Test
10(3)
Hybridization of Consumer Expectations and Risk-Utility Tests
13(2)
The Role of the Feasible Safer Alternative Design
15(5)
Injury Alone Is Not Sufficient to Establish an Unreasonably Dangerous Product
20(3)
The Unavoidably Unsafe Product Doctrine
23(1)
Relationship of the Unavoidably Unsafe Product Doctrine to Design Defect Claims
23(3)
Role of the Risk-Utility Test Under the Unavoidably Unsafe Product Doctrine
26(2)
Role of Feasible Safer Alternative Design Under the Unavoidably Unsafe Product Doctrine
28(2)
Requirements of Injury and Proximate Cause
30
Design Defect Claims Under the Restatement (Third) of Torts: Products Liability
1(1)
Design Defect Claims Sounding in Negligence
1(1)
Manufacturing Defects
1(1)
Introduction
1(1)
The Restatement Formulation of Manufacturing Defect
2(1)
Plaintiff's Prima Facie Manufacturing Defect Case
3(2)
Rebutting Plaintiff's Prima Facie Case of Manufacturing Defect
5
Medical Monitoring
1(1)
Independent Duty to Test
1(1)
Miscellaneous Claims
1(1)
State Consumer Protection Acts
1(2)
Restitution/Unjust Enrichment
3(1)
Lanham Act
3(1)
Redhibition
4
The Federal Framework
What Litigators Need to Know About the FDA
2
Introduction
2(1)
FDA Approval Processes for Prescription Medical Products
2(2)
Prescription Drugs
4(6)
Medical Devices
10(5)
Biologics
15(1)
Post-Approval FDA Regulation
15(8)
Off-Label Use
23
The Food, Drug and Cosmetic Act as a Source of Substantive Tort Law
1(2)
No Private Food, Drug and Cosmetic Act Right of Action
1(7)
Negligence Per Se and Related Doctrines
8(1)
General Negligence Per Se Principles Applicable to Prescription Medical Product Liability Litigation
8(5)
The Viability of Negligence Per Se Claims Based Upon Allegations of FDCA Violations
13(1)
Arguments in Favor of Allowing FDCA-Based Negligence Per Se
14(3)
Arguments in Favor of Rejecting FDCA-Based Negligence Per Se
17(7)
Defenses to FDCA-Based Negligence Per Se Claims
24(1)
Defense on the Merits/No Violation
24(1)
Non-Statutory Violations
25(3)
Imposition of Novel Duties
28(2)
Allegations Concerning the FDA Approval Process
30(3)
Violations of Vague or Generic Enactments
33(3)
Causation Issues in FDCA-Based Negligence Per Se
36
Federal Preemption as a Defense to Drug and Medical Device Litigation
Express Preemption
3
General Considerations Concerning Express Preemption
3(1)
Application of Express Preemption to Common Law Tort Claims
4(2)
The Statutory Preemption Clause in the Medical Device Amendments of 1976
6(1)
``Requirements'' Imposed by FDA Regulation of Medical Devices
7(1)
Device Classifications
7(1)
FDA Clearance of Substantially Equivalent Devices
8(1)
FDA Pre-Market Approval of New Devices
8(1)
Limited FDA Approval of Investigational Devices
9(1)
The First Wave of Express Preemption in Medical Device Litigation: 1992-1996
9(2)
Preemption of Claims Against Devices Exempted from Premarket Approval
11(3)
Violations of FDA Regulations and Negligence Per Se
14(2)
Preemption Disfavored in the Ninth Circuit
16(1)
Medtronic v. Lohr---A Riddle Wrapped in a Mystery Inside an Enigma
17(2)
Substantial Equivalence vs. Premarket Approval
19(1)
Violation, or ``Identity of Requirements,'' Claims
20(1)
Device Specificity of Federal Regulations
21(1)
Are Common Law Duties ``Requirements'' Under Section 360k(a)?
22(2)
Adding ``Conflict'' Considerations to Express Preemption
24(1)
Picking Up the Pieces After Medtronic v. Lohr---What Is Left of Express Preemption?
25(1)
Express Preemption and Substantially Equivalent Devices
25(1)
Express Preemption and the Pre-Market Approved Device
25(1)
View that Express PMA Preemption Is Extensive
26(4)
View that PMA Preemption Is Minimal
30(2)
The Minority View Rejecting Express Preemption Altogether
32(1)
Express Preemption and the Investigational Device
32(1)
View that IDE Preemption Is Extensive
33(2)
View that There Is No IDE Preemption
35(2)
The Special Case of Express Preemption in Tampon Litigation
37(2)
Express Preemption and Over-the-Counter Drugs
39(1)
Express Preemption and FDCA-Based Negligence Per Se Claims
39(1)
Express Preemption and FDA Decisions Not To Regulate
40(1)
Express Preemption and Informed Consent
41
Implied Preemption
1(1)
Field Preemption
1(1)
Conflict Preemption
1(1)
Conflict Preemption by Reason of Impossibility
1(1)
Conflict Preemption by Reason of Obstruction
2(1)
Implied Preemption in Product Liability Litigation
2(1)
Effect on Implied Preemption of an Express Preemption Clause
2(1)
Effect on Implied Preemption of Express Saving Clauses
3(1)
Implied Conflict Preemption in the FDCA Context
4(1)
Fraud on the FDA
4(3)
Private FDCA Violation Claims
7(1)
Prospects for Implied Preemption
8
Before Litigation Starts: Enhancing Chances for Success
Introduction
2
From the Plaintiff's Perspective
1(1)
Factual and Legal Investigation
1(1)
The Internet
1(1)
Government Web Sites
1(2)
Nongovernment Web Sites
3
From the Defendant's Perspective
1(1)
Prophylactic Planning
1(1)
SOPs
1(1)
Document Management
2(1)
Regulatory and Good Clinical Practice Issues
3(1)
Review of Internal and External Documents
3(1)
Freedom of Information Act
3(1)
Marketing Issues
4(1)
Adverse Event Reporting
4(2)
Duty to Update Labeling
6(1)
Section 10 of the Restatement (Third) of Torts
7(1)
Other Causes of Action
7(1)
Duty to Warn Regarding Off-Label Use
8(1)
Recalls
9(1)
Consequences
9(1)
Planning for and Executing Recalls
10(2)
Terminations of Clinical Studies
12
Class Actions
Overview
2
Nature of the Certification Determination
1(1)
The Elements of a Definable and Ascertainable Class Under Rule 23(a)
1(1)
Numerosity
2(1)
Commonality
3(1)
Typicality
3(4)
Adequacy of Representation
7
Criteria for Determining Whether a Mandatory Class Action Can Be Maintained Under Rule 23(b)(1) or Rule 23(b)(2)
1(1)
Overview
1(1)
Constitutional Issues
1(1)
Classes Based on Declaratory or Injunctive Relief Under Rule 23(b)(1)(A)
2(1)
The ``Limited Fund'' Class Under Rule 23(b)(1)(B)
3(5)
Medical Monitoring Classes Under Rule 23(b)(2)
8(1)
Medical Monitoring as Final Injunctive Relief
8(2)
Money Damages Cannot Predominate in Rule 23(b)(2) Class
10(2)
The Proposed Class Must Be Cohesive
12
Rule 23(b)(3) and Requirements of Predominance and Superiority
1(1)
Predominance
1(1)
Problems Inherent in Proposed Nationwide Classes
1(2)
Other Individual Issues
3(4)
Superiority
7(4)
Manageability
11
The Potential for Certification on a Particular Issue
1(1)
Non-Manufacturer Defendants in Drug and Medical Device Litigation
Introduction
1(1)
Commercial Distributors
1(1)
General Rule of Strict Liability
1(1)
Restatement (Third) Position
2(1)
Statutory Exceptions to Strict Liability
3
Pharmacists
1(1)
Majority Rule Rejecting Product Liability Claims Against Pharmacists for Prescribed Drugs
1(11)
Minority Rule Allowing Product Liability Claims Against Pharmacists
12(2)
Exceptional Circumstances Justifying Imposition of Liability on Pharmacists
14(1)
Obvious Inadequacies on Face of Prescription/Failure to Label Properly
15(1)
Voluntary Assumption of Duty to Warn
15(2)
Specific Knowledge of the Characteristics of a Patient/Customer
17(1)
Failure to Warn of Adverse Interaction of Two Prescribed Drugs
17(1)
Dispensing Without Valid Renewal Prescription
18
Bulk and Component Part Sellers
1(1)
General Rule
1(2)
Federal Law Considerations
3(2)
Common Law Considerations
5
Hospitals
1(1)
Strict Liability
1(1)
Restatement Position and the Sale-Service Distinction
1(5)
Implied Warranty
6(3)
Public Policy Based Rationales for Limiting Hospital Product Liability
9(2)
Informed Consent
11(1)
No Separate Duty
11(5)
Assumption of Duty
16(1)
Negligence
16
Physicians and Similar Health Care Providers
1(1)
Strict Liability/Breach of Implied Warranty
1(3)
Informed Consent
4(1)
FDA Regulatory Status
4(2)
Conflict Of Interest
6
Contract Research Organizations
1(1)
Monitoring
1(2)
Conflicts of Interest
3(1)
Product Liability
3
Promoters
1(1)
Wrongful Promotion
1(4)
First Amendment Defense
5
Brand Name Manufacturers in Generic Drug Litigation
1(1)
The Food and Drug Administration
1(1)
Issues in the Management of the Litigation
Overview
2
Aggregation
1(1)
Collateral Estoppel
1(1)
Removal from State Court to Federal Court
1(1)
Introduction
1(1)
General Principles of Removal
1(2)
Removal in Diversity Cases
3(7)
Removal in Federal Question Cases
10(2)
Federal Officer Removal
12
Multidistrict Litigation
1(1)
The Commencement of Multidistrict Litigation
1(4)
Requirement that Actions to be Transferred Have Common Questions of Fact
5(1)
All Actions Before the Panel Must Have One or More Questions of Fact in Common
5(1)
The Questions of Fact in Common Must Lend Themselves to Resolution Through Centralization
6(1)
Commonality Cannot Be Insufficiently Complex
7(1)
Transfer Must Be for the Convenience of the Parties and Witnesses
8(3)
Transfer Must Promote the Just and Efficient Conduct of Pretrial Proceedings
11(2)
Remand of Actions at Suggestion of Transferee Court
13(1)
Discovery Issues in Multidistrict and Multi-Plaintiff Proceedings
14(1)
Introduction---The Beginning of a Multidistrict Litigation
14(2)
Discovery of Defendants
16(1)
Document Preservation and Production
16(2)
Other Discovery Issues
18(1)
Cost Allocation
18(1)
Attorney-Client Privilege
19(1)
Withholding Documents
20(1)
Special Master
21(1)
Discovery of Plaintiffs
21(1)
Protecting Trade Secrets and Other Confidential Information
22(4)
Drafting a Confidentiality Order
26(1)
Information to Be Protected and Procedures for Designation
27(1)
``Attorneys' Eyes Only''
28(1)
Access to Materials Designated as Confidential
28(2)
Use of Protected Material in Litigation and Filing Under Seal
30(1)
Challenges to Designation as Confidential
31(1)
Inadvertent Production of Privileged Materials
31(1)
Issues Relating to the Termination of Litigation
32(1)
Breach of a Confidentiality Order
32
Discovery of the FDA
1(1)
Expert Witnesses
Introduction
2
Types of Experts
1(1)
Discovery and Evaluation of Experts
1(1)
Introduction
1(1)
Federal Rules Relating to Discovery of Experts
2(2)
State Rules Relating to Discovery of Experts
4(3)
Discovery of Draft Expert Reports
7(1)
Discovery of Counsel's Communications with the Expert
8(2)
Protecting Experts from Unnecessary Disclosure
10(1)
Communications between Counsel and Experts
10(1)
Communications among Experts
10(1)
Withdrawal of the Testifying Expert
11(1)
Protective Orders
12(1)
Expert Witness Evaluation Tools
13(1)
Expert Interrogatories
13(1)
Expert Depositions and Prior Testimony
13(1)
Journals and Publications
14(1)
Expert Databases
14(1)
Actions by the Office of Research Integrity and the Office for Human Research Protections
14(2)
Other Experts
16(1)
Documents Produced in the Litigation
16(1)
The Industry Client
16
Admissibility of Expert Testimony
1(1)
Introduction
1(2)
Daubert Experience in Drug and Medical Device Litigation
3(1)
Expert Opinions Based on Epidemiological Studies and Other Human Studies
3(3)
Expert Opinions Based on Case Reports and Adverse Event Reports
6(2)
Expert Opinions Based on Animal Studies
8(2)
Expert Opinions Based on Similar Drugs
10(1)
Differential Diagnosis as a Methodology for Proving Causation
11(3)
Expert Opinions Based on Regulatory Actions
14(1)
State Law Standards for the Admissibility of Expert Testimony
15
Challenges to Qualifications
1(1)
Expert Testimony on Regulatory Issues
1(1)
Trial Issues
Common Evidentiary Issues at Trial
2
Admissibility of FDA-Related Evidence
2(1)
Manufacturer-Specific Regulatory History Documents
2(3)
FDA Reports
5(1)
Adverse Drug and Medical Device Reports
6(1)
Evidence of Misstatements to the FDA
7(1)
Non-FDA Evidentiary Exclusion Issues
8(1)
Subsequent Remedial Measures
8(3)
Similar Incidents
11(2)
Financial Relationship with Physicians
13(1)
Notes of Telephone Calls by Sales Representatives
14(1)
Corporate Motive and Intent
14(1)
FDA Experts
14
Bifurcation
1(1)
How the Courts View Bifurcation
1(1)
Types of Bifurcation
2(1)
General Causation
2(1)
Liability
3(1)
Damages
4(1)
Arguments For and Against Bifurcation
4(1)
Arguments For
4(1)
Judicial Economy
4(1)
Prejudice
5(1)
Arguments Against
6(1)
Sterile Environment
6(1)
Constitutional Limitations
6(2)
Punitives
8
Punitive Damages
1(1)
How the States View Punitives
1(4)
Constitutional Standards Governing Punitive Damages After State Farm
5(1)
Reprehensibility
5(1)
Evidence of Out of State Conduct Now Highly Suspect
5(1)
Evidence of Dissimilar Conduct is Barred
6(1)
The Range of Acceptable Punitive to Compensatory Ratios
7(1)
The ``Comparable Civil Penalties'' Assessment is Narrowed
7(1)
Conclusions
8(1)
Checklist for Punitive Damages Cases
8(1)
Motions in Limine
8(1)
Bifurcation/Trifurcation
9(1)
Jury Selection
9(1)
Successful Trial Themes
10(1)
Humanize
11(1)
Appear Reasonable
12(1)
Educate
12(1)
Jury Instructions
12(1)
Post-Trial Motions
13
Index 1