Product Description
Table of Contents
Additional Information
This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.
1. Introduction I. The Legal Context A. Basis of Liability B. Litigation Systems C. Funding and Costs D. US: The Class Action and MDL E. Europe F. Settlement Schemes 2. The Regulation of Medicines and Medical Devices I. Medicinal Products A. Historical Drug/Pharmaceutical Regulation in the UK B. European Regulation of Medicinal Products C. European Regulation of Medical Devices D. General Product Safety Regulation in Europe E. Medicinal Product Regulation in the US F. US Regulation of Medical Devices 3. Detailed Case Descriptions and Regulatory Histories I. Teratogens and Foetal Damage A. Thalidomide (alpha-phthalimido-glutarimide) B. Hormonal Pregnancy Tests - Including Primodos C. Diethylstilboestrol (DES) D. Epilim/Depakote/Depakene (sodium valproate, valproic acid, magnesium valproate, valproate semisodium or valpromide) E. Accutane/Roaccutane (isotretinoin) II. Contraceptives and Hormone Replacement Therapy A. Gravigard or Copper 7 Intrauterine Device B. Third-Generation Oral Contraceptives C. Norplant (levonorgestrel) D. Hormone Replacement Therapy III. Vaccines A. DTP Vaccine B. MMR Vaccine IV. Neuromodulators A. Benzodiazepines B. Merital (nomifensine) C. Selective Serotonin Reuptake Inhibitors D. Sabril (vigabatrin) E. Mirapexin/Sifrol/Daquiran (pramipexole) V. Non-Steroidal Anti-Inflammatories A. Opren (benoxaprofen) B. Vioxx (rofecoxib) VI. Pancreatic Function (Endocrine and Exocrine) and Obesity Treatments A. Adifax/Isomeride/Redux (dexfenfluramine) and Ponderax (fenfluramine) B. Mediator (benfluorex) C. Human Insulin D. Pancreatic Enzymes VII. Contaminated Human-Tissue-Derived Products A. Blood Products B. Human Growth Hormone VIII. Cardiovascular Pharmaceuticals A. Eraldin (practolol) B. Manoplax (flosequinan) C. Lipobay (cerivastatin) IX. Anti-Protozoan Medications A. Emaform, Entero-Form or Chinoform (clioquinol) B. Lariam (mefloquine) X. Breast and Other Cosmetic Implants A. Dow-Corning Silicone Implants B. Trilucent Breast Implants C. Poly Implant Prothese (PIP) Hydrogel Breast Implants D. Poly Implant Prothese (PIP) IMGHC Silicone Breast Implants XI. Urinary Incontinence and Pelvic Prolapse Treatments A. Micturin (terodiline) B. Urogynaecological Mesh 4. Conclusions I. Prevention is Better than a Cure II. Adverse Event Reporting III. Correlation or Causation? IV. Thresholds V. Product Withdrawals VI. Compensation or Redress? VII. Public Regulation v Private Regulation A. Compensation - Redress B. Deterrence VIII. Conclusions
Author(s) | By Sonia Macleod, Sweta Chakraborty. |
---|---|
Publisher | Bloomsbury Publishing PLC |
ISBN | 9781509916696 |
Format | Hardback |
Pages | 320 |
Published in | United Kingdom |
Published | 21 Feb 2019 |
Availability | Available |
Practice Area
-
Company, commercial & competition
- Agency law
- Aviation law
- Commercial law
- Company law
- Company, commercial & competition law
- Competition law \ Antitrust law
- Construction & engineering law
- Contract law
- E-commerce law
- Energy & natural resources law
- Franchising law
- Outsourcing law
- Partnership law
- Procurement law
- Sale of goods law
- Shipping law
-
Constitutional & administrative
- Asylum law
- Citizenship & nationality law
- Constitutional & administrative law
- Election law
- Freedom of expression law
- Freedom of information law
- Government powers
- Human rights & civil liberties law
- Immigration law
- Judicial review
- Local government law
- Military & defence law
- Parliamentary & legislative practice
- Privacy law
-
Criminal law & procedure
- Criminal justice law
- Criminal law & procedures
- Criminal procedure
- Criminal procedure: law of evidence
- Fraud
- Harassment law
- Juvenile criminal law
- Offences against property
- Offences against public health, safety, order
- Offences against the government
- Offences against the person
- Police law & police procedures
- Road traffic law, motoring offences
- Sentencing & punishment
- Terrorism law
- Employment & labour
- Environment, transport & planning
- Equity & trusts
- Family
- Financial
- IT & Communications
- Intellectual property
-
International
- Customary law
- Diplomatic law
- International
- International arbitration
- International communications & telecommunications law
- International courts & procedures
- International criminal law
- International economic & trade law
- International environmental law
- International human rights law
- International humanitarian law
- International law
- International law of territory & statehood
- International law of transport, communications & commerce
- International law reports
- International maritime law
- International organisations & institutions
- International space & aerospace law
- Investment treaties & disputes
- Jurisdiction & immunities
- Law of the sea
- Private international law & conflict of laws
- Public international law
- Responsibility of states & other entities
- Settlement of international disputes
- Tariffs
- Transnational commercial law
- Treaties & other sources of international law
-
Jurisprudence & general
- Advocacy
- Civil codes \ Civil law
- Common law
- Comparative law
- Criminology: legal aspects
- Ecclesiastical (canon) law
- Gender & the law
- Islamic law
- Jurisprudence & general issues
- Jurisprudence & philosophy of law
- Law & society
- Law as it applies to other professions
- Legal ethics & professional conduct
- Legal history
- Legal profession: general
- Legal skills & practice
- Paralegals & paralegalism
- Roman law
- Systems of law
- Law - other
- Law: study & revision guides
- Laws of Specific jurisdictions
-
Legal system
- Arbitration, mediation & alternative dispute resolution
- Civil procedure, litigation & dispute resolution
- Civil procedure: law of evidence
- Civil remedies
- Courts & procedure
- Damages & compensation
- Injunctions & other orders
- Judicial powers
- Legal system: costs & funding
- Legal system: general
- Legal system: law of contempt
- Regulation of legal profession
- Restitution
- Primary sources
- Private \ Civil law: general works
- Property
- Social
- Taxation & duties
- Torts & Delicts
- Wills & probate \ Succession
My Cart
You have no items in your shopping cart.