Author: James Beck
Publisher: Law Journal Press
ISBN: 9781588521217
Category : Law
Languages : en
Pages : 982
Book Description
This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Drug and Medical Device Product Liability Deskbook
Author: James Beck
Publisher: Law Journal Press
ISBN: 9781588521217
Category : Law
Languages : en
Pages : 982
Book Description
This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Publisher: Law Journal Press
ISBN: 9781588521217
Category : Law
Languages : en
Pages : 982
Book Description
This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Drug and Device Product Liability Litigation Strategy
Author: Mark Herrmann
Publisher: Oxford University Press
ISBN: 0199750246
Category : Law
Languages : en
Pages : 539
Book Description
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, high-profile, and rapidly-evolving area. The book's primary focus is to provide useful practice pointers and overall strategic guidance for attorneys in product liability litigation involving prescription drugs and medical devices. It will serve as an indispensable guide to handling such a case from pre-litigation through trial. The legal landscape in this important area is expected to shift as the Supreme Court's decisions in Riegel v. Medtronic, Inc. and Wyeth v. Levine are applied, and as the President and Congress address tort reform and other health care issues. Practitioners will need thoughtful, expert advice to navigate these changes.
Publisher: Oxford University Press
ISBN: 0199750246
Category : Law
Languages : en
Pages : 539
Book Description
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, high-profile, and rapidly-evolving area. The book's primary focus is to provide useful practice pointers and overall strategic guidance for attorneys in product liability litigation involving prescription drugs and medical devices. It will serve as an indispensable guide to handling such a case from pre-litigation through trial. The legal landscape in this important area is expected to shift as the Supreme Court's decisions in Riegel v. Medtronic, Inc. and Wyeth v. Levine are applied, and as the President and Congress address tort reform and other health care issues. Practitioners will need thoughtful, expert advice to navigate these changes.
Pharmacoepidemiology
Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220
Book Description
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220
Book Description
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.
Medicinal Product Liability and Regulation
Author: Richard Goldberg
Publisher: Bloomsbury Publishing
ISBN: 1782251537
Category : Law
Languages : en
Pages : 242
Book Description
The piecemeal developments in product liability reform in Europe have their origins in the tragic association of phocomelia in children with thalidomide in 1962. In many ways these events have continued to generate pressure for reform of product liability, especially for the victims of drug-induced injury. This monograph attempts to address the major problems that typify claims for drug-induced injury, as well as highlighting the complex interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability under the product liability directive, the claimant may have considerable difficulty in establishing that the relevant product is defective and that it caused the damage. It may also be necessary to overcome the development risk defence where this is pleaded. The monograph addresses these problems on a comparative jurisprudential basis, and seeks to determine whether medicinal products should be treated as a special case in the field of product liability. It 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, Canada and France. In particular, it addresses the difficulties in reconciling the standards of proof in law and science, including the theory that causation can be proved on the balance of probabilities by reference to the doubling of risk of injury. An important case study compares and contrasts the approaches of the UK and the US to the measles, mumps, rubella Litigation. The book also examines the question as to whether compliance with regulatory standards should protect pharmaceutical manufacturers from product liability suits. It seeks to support a via media whereby the victims of drug induced injury can receive justice, while at the same time encouraging drug safety and innovation in drug development.
Publisher: Bloomsbury Publishing
ISBN: 1782251537
Category : Law
Languages : en
Pages : 242
Book Description
The piecemeal developments in product liability reform in Europe have their origins in the tragic association of phocomelia in children with thalidomide in 1962. In many ways these events have continued to generate pressure for reform of product liability, especially for the victims of drug-induced injury. This monograph attempts to address the major problems that typify claims for drug-induced injury, as well as highlighting the complex interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability under the product liability directive, the claimant may have considerable difficulty in establishing that the relevant product is defective and that it caused the damage. It may also be necessary to overcome the development risk defence where this is pleaded. The monograph addresses these problems on a comparative jurisprudential basis, and seeks to determine whether medicinal products should be treated as a special case in the field of product liability. It 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, Canada and France. In particular, it addresses the difficulties in reconciling the standards of proof in law and science, including the theory that causation can be proved on the balance of probabilities by reference to the doubling of risk of injury. An important case study compares and contrasts the approaches of the UK and the US to the measles, mumps, rubella Litigation. The book also examines the question as to whether compliance with regulatory standards should protect pharmaceutical manufacturers from product liability suits. It seeks to support a via media whereby the victims of drug induced injury can receive justice, while at the same time encouraging drug safety and innovation in drug development.
Product Liability Desk Reference
Author: MORTON F. DALLER
Publisher: Wolters Kluwer Law & Business
ISBN: 1543837344
Category :
Languages : en
Pages : 1186
Book Description
Product Liability Desk Reference: A Fifty-State Compendium, 2022 Edition
Publisher: Wolters Kluwer Law & Business
ISBN: 1543837344
Category :
Languages : en
Pages : 1186
Book Description
Product Liability Desk Reference: A Fifty-State Compendium, 2022 Edition
New Medical Devices
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038472
Category : Medical
Languages : en
Pages : 203
Book Description
In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Publisher: National Academies Press
ISBN: 0309038472
Category : Medical
Languages : en
Pages : 203
Book Description
In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Women and Health Research
Author: Anna C. Mastroianni
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 268
Book Description
Publisher:
ISBN:
Category : Human experimentation in medicine
Languages : en
Pages : 268
Book Description
Innovation and Protection
Author: I. Glenn Cohen
Publisher: Cambridge University Press
ISBN: 1108838634
Category : Law
Languages : en
Pages : 295
Book Description
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Publisher: Cambridge University Press
ISBN: 1108838634
Category : Law
Languages : en
Pages : 295
Book Description
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Product Liability Desk Reference: A Fifty-State Compendium, 2021 Edition
Author: Daller, Daller
Publisher: Wolters Kluwer
ISBN: 1543818935
Category :
Languages : en
Pages : 1154
Book Description
On the front lines of product liability disputes, successful litigation planning begins with immediate access to the product liability laws of various jurisdictions--plus an understanding of the countless differences among them. That's exactly what you get with the thoroughly up-to-date and expanded edition of Product Liability Desk Reference, 2021 Edition, edited by Morton F. Daller. Whether you represent the plaintiff or defendant, the Product Liability Desk Reference, 2021 Edition is a comprehensive resource that provides the most recent statutory and case law developments on product liability laws for each of the fifty states and the District of Columbia. With coverage that is clear and concise, you will be able to make an initial assessment of the strengths and weaknesses of your case across jurisdictions. Practitioner-oriented, and written by leading state experts, each chapter summarizes the variants and developments particular to a specific state jurisdiction, resulting in a text that will assist you in making critical choices in product liability disputes wherever they arise. You'll find detailed coverage of each state's standards regarding: Causes of action Statutes of limitation and repose Strict liability Negligence Breach of Warranty Punitive damages Wrongful death Pre- and post-judgment interest Employer immunity from suit Joint and severable liability Relevant statutes to product liability actions. Previous Edition: Product Liability Desk Reference: A Fifty State Compendium, 2020 Mid-Year Edition, ISBN 9781543818925¿ Note: Online subscriptions are for three-month periods.
Publisher: Wolters Kluwer
ISBN: 1543818935
Category :
Languages : en
Pages : 1154
Book Description
On the front lines of product liability disputes, successful litigation planning begins with immediate access to the product liability laws of various jurisdictions--plus an understanding of the countless differences among them. That's exactly what you get with the thoroughly up-to-date and expanded edition of Product Liability Desk Reference, 2021 Edition, edited by Morton F. Daller. Whether you represent the plaintiff or defendant, the Product Liability Desk Reference, 2021 Edition is a comprehensive resource that provides the most recent statutory and case law developments on product liability laws for each of the fifty states and the District of Columbia. With coverage that is clear and concise, you will be able to make an initial assessment of the strengths and weaknesses of your case across jurisdictions. Practitioner-oriented, and written by leading state experts, each chapter summarizes the variants and developments particular to a specific state jurisdiction, resulting in a text that will assist you in making critical choices in product liability disputes wherever they arise. You'll find detailed coverage of each state's standards regarding: Causes of action Statutes of limitation and repose Strict liability Negligence Breach of Warranty Punitive damages Wrongful death Pre- and post-judgment interest Employer immunity from suit Joint and severable liability Relevant statutes to product liability actions. Previous Edition: Product Liability Desk Reference: A Fifty State Compendium, 2020 Mid-Year Edition, ISBN 9781543818925¿ Note: Online subscriptions are for three-month periods.
Principles and Practice of Pharmaceutical Medicine
Author: Lionel D. Edwards
Publisher: John Wiley & Sons
ISBN: 9780470093146
Category : Medical
Languages : en
Pages : 780
Book Description
The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS
Publisher: John Wiley & Sons
ISBN: 9780470093146
Category : Medical
Languages : en
Pages : 780
Book Description
The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS