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Author Goldberg, Richard, author.

Title Medicinal product liability and regulation / Richard Goldberg.

Published Oxford : Hart Publishing, 2013.


Location Call No. Status
Physical description xxvii, 214 pages ; 25 cm.
Bibliography Includes bibliographical references and index.
Contents Machine generated contents note: 1.Medicinal Product Liability in Context -- I.Introduction -- II.Historical Background: A Special Case? The Unique Characteristics of Medicinal Products -- III.Position Under the Product Liability Directive and the Consumer Protection Act 1987 -- IV.Vaccine Damage -- V.European Pharmaceutical Product Liability Regimes -- A.The United Kingdom -- B.Germany -- C.Sweden, Finland and Norway -- VI.Reform -- VII.Conclusion -- 2.Defective Medicinal Products in the US and UK: An Overview -- I.Introduction -- II.Defective Medicinal Products in the US -- III.Defective Medicinal Products in the UK -- A.Definition of Defect -- B.Consumer Expectations and Risk-Utility -- C.Expectations of ̀Persons Generally' -- D.Circumstances Taken into Account in Assessing Defectiveness -- E.The Defect Taxonomy -- IV.Conclusion -- 3.Design Defects and Medicinal Products -- I.Introduction -- II.Design Defects and Pharmaceutical Products: The US Experience -- A.Comment K --
Contents note continued: B.Third Restatement -- III.Design Defects and Pharmaceutical Products Under the Product Liability Directive -- A.General -- B.What is a Medicinal Product Design Defect? -- C.The Approach for Determining Whether a Medicinal Product's Design is Defective: Consumer Expectations v Risk-Benefit; Cost-Benefit; Net Benefit -- D.Relevance of Risk-Benefit to Determining Design Defectiveness: The Member States' Jurisprudence -- IV.Reform: A Net Benefit Approach to Drug Design Defects or Combined Consumer-Expectations Risk-Utility -- A.Net Benefit Approach to Drug Design Defects -- B.Combined Consumer-Expectations Risk-Utility -- V.Conclusion -- 4.Warning and Instruction Defects and Medicinal Products -- I.Introduction -- II.Warning and Instruction Defects and Pharmaceutical Products: The US Experience -- A.Main Form of Liability -- B.Use of Negligence Principles -- C.Adequacy -- D.Learned Intermediary Doctrine --
Contents note continued: III.Warning and Instruction Defects and Pharmaceutical Products Under the Product Liability Directive -- A.A Fault-based Form of Liability -- B.Impossibility of Warning: Undiscoverability or Unknowability of Risk Versus Foreseeability of Risk -- C.Unforeseeable Injuries: Is There a Role for the Article 7(e) Defence in Failure to Warn Claims? -- D.Adequacy -- E.Learned Intermediary Doctrine -- F.The Requirement of Causation -- IV.Conclusions -- 5.Causation, Risk and Epidemiological Evidence in Medicinal Product Liability Litigation: Law's Coming of Age -- I.Introduction -- II.Reconciling the Standards of Proof in Law and Science in the UK -- A.Evidence of Causation for Purposes of Science and for Purposes of Law -- B.̀Doubling of Risk' Theory -- C.Association Versus Causation -- D.Teaching the Court the Epidemiology -- E.The Statistical Chance/Personal Chance Dichotomy --
Contents note continued: F.Overcoming the Statistical Chance/Personal Chance Dichotomy: Statistical Refining Mechanisms Using Specific Risk Factors -- III.Conclusions -- 6.The Rise and Fall of the MMR Litigation: A Comparative Perspective -- I.Introduction -- II.Background: The Vaccines and Autism Controversy -- III.UK MMR Litigation -- A.Legal Aid Funding and Establishment of Group Litigation -- B.Withdrawal of Funding and Dissolution of Group Litigation -- IV.The US Omnibus Autism Proceeding Test Cases -- A.The Omnibus Autism Proceeding (OAP) -- B.The First Three Test Cases and the Petitioners' First Theory -- C.The Second Three Test Cases and the Petitioners' Second Theory -- D.Implications of the Test Cases -- V.A French Comparison: The Liberal French Approach to Hepatitis B Vaccine and Demyelinating Diseases Using Presumptions of Causation -- VI.MMR and the General Medical Council -- A.The Professional Conduct Hearing -- B.Consequences of the Professional Conduct Hearing --
Contents note continued: VII.Conclusion -- 7.Regulatory Compliance and Medicinal Product Liability -- I.Introduction -- II.Compliance with Common Practice Regulatory and Statutory Standards -- A.Compliance with Common Practice of the Pharmaceutical Industry -- B.Compliance with Statutory Requirements -- III.Defect Attributable to Mandatory Statutory or Community Requirements -- IV.Federal Preemption and Prescription Drugs -- A.Nature and Importance of the Doctrine -- B.The Preemption Taxonomy -- C.Presumption Against Preemption -- D.Emergence of an FDA Preemption Policy -- E.Rejection of the FDA Preemption Policy: Wyeth v Levine -- F.Emergence of a Two-Tier Drug Liability System: PLIVA v Mensing -- V.A Regulatory Compliance Defence for Medicinal Products -- A.Introduction -- B.Arguments in Favour of a Defence -- C.Arguments Against a Defence -- VI.Conclusion -- 8.The Development Risk Defence and Medicinal Products -- I.Nature and Scope of the Defence -- A.Introduction --
Contents note continued: B.Background and Definition -- C.Some Criticisms of the Statutory Wording -- D.Development Risk and the State of the Art Defence -- E.Optional Nature of the Defence -- F.Member States Which have Derogated from the Defence -- G.The Relevant Time at Which to Apply the Test -- II.Infringement Proceedings in the European Court of Justice: Commission v United Kingdom -- A.Initial Stages -- B.Advocate General's Opinion -- C.The Judgment of the European Court of Justice -- III.European Commission Reform Proposals -- A.Green Paper -- B.Second Commission Report and Fondazione Rosselli Study -- C.Report on Product Liability in the European Union for the European Commission (February 2003) -- D.Third and Fourth Commission Reports -- IV.Defects Which Might be Expected to be Discovered -- A.General Observations -- B.Discoverability and Economic Feasibility -- C.Discoverability of Unknown and Unknowable Defects --
Contents note continued: D.Defects Hidden from View by Limited Scientific and Technical Knowledge -- V.The Meaning and Implications of Scientific and Technical Knowledge -- A.General Observations -- B.The Constituents of Knowledge -- C.Knowledge in the Context of an Adverse Drug Reaction -- D.Knowledge and Accessibility -- E.The Example of Thalidomide -- VI.Defects Which are Known of, but Undetectable in any Particular Case -- A.Introduction -- B.Defects Which are Undetectable -- C.Comparative Jurisprudence -- D.Conclusions -- VII.Conclusion -- 9.Conclusion.
Summary This monograph seeks to determine whether medicinal products shoul be treated as a special case in the field of product liability. The author examines the role of epidemiological evidence in assessing causation in product liability cases concerning medicinal products in the light of recent developments in the UK Supreme Court, the United States, and France...
Subject Pharmacy -- Law and legislation.
Products liability -- Medical instruments and apparatus.
Products liability -- Drugs.
ISBN 9781841132518 (hbk.) : £75.00