Drug and Medical Device Product Liability Deskbook

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James M. Beck, Anthony Vale

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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.

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  • Availability: Available
  • Brand: Law Journal Press
  • Product Type: Books
  • Edition: 0
  • Page Count: 1158
  • ISBN: 978-1-58852-121-7
  • Pub#/SKU#: 674
  • Volume(s): 1

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  • James M. Beck

James M. Beck is counsel in the life sciences health industries group of Reed Smith LLP in Philadelphia. He has overseen the development of legal defenses, master briefs, and dispositive motions in numerous mass torts, including Seroquel, a Merck analgesic product, diet drugs, Baycol, and orthopedic bone screws. Orthopedic Bone Screw ended with summary judgments in more than 170 cases, and prevailing in every appeal. Mr. Beck is a member of the Product Liability Advisory Committee (PLAC) and has sat on PLAC’s case selection committee since 1997. He has written over 60 amicus curiae briefs on product liability issues for PLAC. In 2011, Mr. Beck was awarded the PLAC’s John P. Raleigh Award, the highest honor given by the organization to one of its members. This award recognizes Mr. Beck’s overall contributions to the law of product liability, making him the eighth recipient of the Raleigh award in the almost 30-year history of the PLAC. Mr. Beck has also prepared amicus briefs for the American Bar Association, the American Civil Liberties Union, the American Medical Association and several of its state affiliates, the Anti-Defamation League, the Business Roundtable, the Pennsylvania Defense Research Institute, the United States Chamber of Commerce, and the Washington Legal Foundation. Mr. Beck has been chair of the Publications Subcommittee of the Mass Torts Litigation Committee of the Litigation Section of the American Bar Association since 2002. He has been named Outstanding Subcommittee Chair three times, in 2003-04, 2006-07, and 2008-09. A graduate of Princeton University (B.A., cum laude, 1978) and the University of Pennsylvania Law School (J.D., 1982), Mr. Beck is admitted to practice in federal and state courts in Pennsylvania, in the Supreme Court of the United States, and has been admitted in various federal and state courts pro hac vice.

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  • Anthony Vale

Anthony Vale is a partner in the Litigation Department of Pepper Hamilton LLP in Philadelphia. He has wide experience in mass tort litigation involving drugs, devices and chemicals. He has written and lectured widely on these topics at ABA, IADC, ACI, and DRI meetings.

Mr. Vale was chair of the Class Action and Multiparty Litigation Committee of the International Association of Defense Counsel, chair of the Toxic Tort and Environmental Law Committee of ABA/TIPS, and a member of the CLE board of the American Bar Association’s Tort and Insurance Practice Section (ABA/TIPS). He has also served as president of the British American Chamber of Commerce of Greater Philadelphia.

Mr. Vale received his LL.B. in 1972 from the University of Exeter in England and attended University of Pennsylvania Law School. He is admitted to practice in Pennsylvania and before the United States Supreme Court, the Third, Fifth and Eleventh Circuit Courts of Appeal, and several federal district courts.


State Common Law Claims Based Upon
Informational Defects
§ 2.01 Introduction
§ 2.02 The Duty to Warn and Unavoidably Unsafe Product Doctrine
[1] Unavoidably Unsafe Products and Design Defects
[2] Prescription Medical Devices and Biologics as Unavoidably Unsafe Products
[3] Case-by-Case Versus Categorical Application of the Unavoidably Unsafe Product Doctrine
§ 2.03 The Learned Intermediary Rule
[1] The Learned Intermediary Rule as the Distinctive Attribute of Litigation Involving Prescription Medical Products
[2] Who Is the Learned Intermediary?
[3] Exceptions to the Learned Intermediary Rule
§ 2.04 Adequacy of Warnings
[1] Criteria for an Adequate Warning
[2] Establishing the Adequacy of a Warning as a Matter of Law
§ 2.05 Establishing Causation in a Warning Case
[1] When an Inadequate Warning is Non- Causal
[2] Issues of Fact Concerning Warning Causation
[3] The Presumption That an Inadequate Warning Is Causal
[4] Other Causation Issues in Warning Cases
[5] Miscellaneous Causation Issues in Warning Claims
§ 2.06 Overpromotion and Negligent Marketing Claims
§ 2.07 Implied Warranty Claims
§ 2.08 Express Warranty Claims
§ 2.09 Illegal Promotion and Marketing Claims
§ 2.10 Duty to Warn Claims Involving Direct Patient Warnings
§ 2.11 Warning Claims Brought by Prescribing Physicians
§ 2.12 Public Policy Considerations Underlying the Unavoidable Unsafe Product Doctrine and the Learned Intermediary Rule
§ 2.13 Fraud/Intentional Misrepresentation
§ 2.14 Negligent Misrepresentation
§ 2.15 State Consumer Protection Acts
§ 2.16 Federal RICO Claims

State Common Law Claims Based Upon Non-Informational Defects

§ 3.01 Introduction—Design Defect Claims
§ 3.02 Claims Sounding in Strict Liability
[1] Strict Liability—Pleading and Merger of Other Causes of Action
[2] Elements of Strict Liability Claims Brought Under the Restatement (Second) of Torts § 402A
[3] Requirement of an Unreasonably Dangerous Product
[4] The Unavoidably Unsafe Product Doctrine
[5] Requirements of Injury and Proximate Cause
§ 3.03 Design Defect Claims Under the Restatement (Third) of Torts: Products Liability
§ 3.04 Design Defect Claims Sounding in Negligence
§ 3.05 Manufacturing Defects
[1] Introduction
[2] The Restatement Formulation of Manufacturing Defect
[3] Plaintiff’s Prima Facie Manufacturing Defect Case
[4] Rebutting Plaintiff’s Prima Facie Case of Manufacturing Defect
§ 3.06 Medical Monitoring
§ 3.07 Independent Duty to Test
§ 3.08 Market Share Liability
§ 3.09 Cognizable Injury
§ 3.10 Miscellaneous Claims
[1] Duty to Recall
[2] Restitution/Unjust Enrichment
[3] Lanham Act
[4] Redhibition
[5] Failure to Train
[6] Intentional/Negligent Infliction of Emotional Distress
[7] Miscellaneous Federal Claims
[8] Miscellaneous State Law Claims

The Federal Framework

§ 4.01 What Litigators Need to Know About the FDA
[1] Introduction
[2] FDA Approval Processes for Prescription Medical Products
[3] Post-Approval FDA Regulation
[4] Off-Label Use
§ 4.02 The Food, Drug and Cosmetic Act as a Source of Substantive Tort Law
[1] No Private Food, Drug and Cosmetic Act Right of Action
[2] Negligence Per Se and Related Doctrines
[3] Defenses to FDCA-Based Negligence Per Se Claims
§ 4.03 Impact of Medicare Secondary Payer Legislation

Federal Preemption as a Defense to Drug and Medical Device Litigation

§ 5.01 Express Preemption
[1] General Considerations Concerning Express Preemption
[2] Application of Express Preemption to Common Law Tort Claims
[3] Express Preemption and Medical Devices
[4] Express Preemption and Prescription Drugs
[5] Express Preemption and Vaccines
[6] Express Preemption and Monograph Drugs
[7] Express Preemption and FDA Decisions Not to Regulate
[8] Express Preemption and Informed Consent
[9] Express Preemption and Discovery
§ 5.02 Implied Preemption
[1] Field Preemption
[2] Conflict Preemption
[3] Implied Preemption in Product Liability Litigation
[4] Implied Conflict Preemption in the FDCA Context
§ 5.03 Complete Preemption and Federal Question Jurisdiction

Before Litigation Starts: Enhancing Chances for Success

§ 6.01 Introduction
§ 6.02 From the Plaintiff’s Perspective
[1] Factual and Legal Investigation
[2] The Internet
§ 6.03 From the Defendant’s Perspective
[1] Prophylactic Planning
[2] Adverse Event Reporting
[3] Duty to Update Labeling
[4] Duty to Warn Regarding Off-Label Use
[5] Recalls
[6] Clinical Studies
[7] “Expanded Access”

Class Actions

§ 7.01 Overview
§ 7.02 Nature of the Certification Determination
§ 7.03 Class Actions in Personal Injury Cases
[1] Tolling of the Statute of Limitations
[2] Settlement
§ 7.04 Class Actions for Economic Loss
[1] Causes of Action
[2] Grounds for Dismissal of a Claim
§ 7.05 The Elements of a Definable and Ascertainable Class Under Rule 23(a)
[1] Numerosity
[2] Commonality
[3] Typicality
[4] Adequacy of Representation
§ 7.06 Criteria for Determining Whether a Mandatory Class Action Can Be Maintained Under Rule 23(b)(1) or Rule 23(b)(2)
[1] Overview
[2] Constitutional Issues
[3] Classes Based on Declaratory or Injunctive Relief Under Rule 23(b)(1)(A)
[4] The “Limited Fund” Class Under Rule 23(b)(1) (B)
[5] Medical Monitoring Classes Under Rule 23(b) (2)
§ 7.07 Rule 23(b)(3) and Requirements of Predominance and Superiority
[1] Predominance
[2] Superiority
[3] Manageability
§ 7.08 The Potential for Certification on a Particular Issue
§ 7.09 Federal Jurisdiction Over Class Actions—The Class Action Fairness Act (CAFA)
[1] Overview
[2] Existing Federal Question and Diversity Jurisdiction Unchanged
[3] Grounds for Diversity Jurisdiction
[4] Changes in Rules When Removing Class Actions
[5] Appellate Review of Remand Orders
§ 7.10 Settlements of Class Actions
[1] Overview
[2] Judicial Scrutiny of Class Action Settlements Under CAFA
[3] Enhanced Judicial Scrutiny of Class Action Settlements Generally
[4] Required Notice of Class Settlement
§ 7.11 Canadian Pharmaceutical and Medical Device Class Actions
[1] Overview
[2] Certification Criteria
[3] Settlement Considerations—Opt-In vs. Opt-Out Classes

Non-Manufacturer Defendants in Drug and
Medical Device Litigation
§ 8.01 Introduction
§ 8.02 Commercial Distributors
[1] General Rule of Strict Liability
[2] Restatement (Third) Position
[3] Statutory Exceptions to Strict Liability
§ 8.03 Pharmacists
[1] Majority Rule Rejecting Product Liability Claims Against Pharmacists for Prescribed Drugs
[2] Minority Rule Allowing Product Liability Claims Against Pharmacists
[3] Exceptional Circumstances Justifying Imposition of Liability on Pharmacists
§ 8.04 Bulk and Component Part Sellers
[1] General Rule
[2] Federal Law Considerations
[3] Common Law Considerations
§ 8.05 Hospitals
[1] Strict Liability
[2] Public Policy Based Rationales for Limiting Hospital Product Liability
[3] Informed Consent
[4] Negligence
[5] Miscellaneous
§ 8.06 Physicians and Similar Health Care Providers
[1] Strict Liability/Breach of Implied Warranty
[2] Informed Consent
§ 8.07 Participants in Clinical Trials
[1] Monitoring
[2] Conflicts of Interest
[3] Product Liability
§ 8.08 Promoters and Co-Promoters
[1] Wrongful Marketing or Promotion
[2] First Amendment Defense
[3] Co-Promoters
§ 8.09 Original Patent Holders and Inventors
§ 8.10 The Food and Drug Administration
§ 8.11 Parents, Subsidiaries, and Successors
§ 8.12 Manufacturer Sales Representatives and Other Personnel
§ 8.13 Publishers
§ 8.14 Reprocessors

Issues in the Management of the Litigation

§ 9.01 Overview
§ 9.02 Procedural Aggregation
[1] Initiation of Claims
[2] Joinder of Plaintiffs
§ 9.03 Collateral Estoppel
§ 9.04 Removal from State Court to Federal Court
[1] Introduction
[2] General Principles of Removal
[3] Removal in Diversity Cases
[4] Removal in Federal Question Cases
[5] Federal Officer Removal
§ 9.05 Multidistrict Litigation
[1] The Commencement of Multidistrict Litigation
[2] Requirement that Actions to Be Transferred Have Common Questions of Fact
[3] Remand of Actions at Suggestion of Transferee Court
[4] Discovery Issues in Multidistrict and Multi- Plaintiff Proceedings
§ 9.06 Discovery of the FDA
§ 9.07 Relations Between State and Federal Courts
[1] Introduction
[2] The All Writs Act and the Anti-Injunction Act
[3] Injunctions in Aid of Jurisdiction
[4] Injunctions to Protect a Federal Court Judgment

Expert Witnesses

§ 10.01 Introduction
§ 10.02 Types of Experts
§ 10.03 Discovery and Evaluation of Experts
[1] Introduction
[2] Protecting Experts from Unnecessary Disclosure
[3] Expert Witness Evaluation Tools
§ 10.04 Admissibility of Expert Testimony
[1] Introduction
[2] Daubert Experience in Drug and Medical Device Litigation
[3] State Law Standards for the Admissibility of Expert Testimony
§ 10.05 Challenges to Qualifications
§ 10.06 Expert Testimony on Regulatory Issues

Trial Issues

§ 11.01 Common Evidentiary Issues at Trial
[1] Admissibility of FDA-Related Evidence
[2] Non-FDA Evidentiary Exclusion Issues
[3] FDA Experts
§ 11.02 Bifurcation and Consolidation
[1] Bifurcation
[2] Consolidation
§ 11.03 Punitive Damages
[1] How the States View Punitives
[2] Constitutional Standards Governing Punitive Damages After State Farm
[3] Checklist for Punitive Damages Cases