Download or read book State by state Survey of the Law Regarding Potential Liability for Off Label Use of Drugs and Medical Devices written by and published by . This book was released on 1999 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Should FDA Drug and Medical Device Regulation Bar State Liability Claims written by United States. Congress. House. Committee on Oversight and Government Reform and published by . This book was released on 2010 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug and Medical Device Product Liability Deskbook written by James Beck and published by Law Journal Press. This book was released on 2004 with total page 982 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Download or read book State by state Survey of the Effect of Compliance Or Noncompliance with Federal Regulatory Standards in Pharmaceutical Products Liability Litigation written by and published by Section of Litigation American Bar Association. This book was released on 1995-01-01 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book State by state Survey of the Statutes of Limitation and Repose Applicable to Pharmaceutical and Medical Device Litigation written by Barry F. McNeil and published by American Bar Association. This book was released on 1997-01-01 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug and Device Product Liability Litigation Strategy written by Mark Herrmann and published by Oxford University Press. This book was released on 2011-12-21 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Law of Off label Uses of Medicines written by Andrea Parziale and published by Taylor & Francis. This book was released on 2022-08-12 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book The Oxford Handbook of U S Health Law written by I. Glenn Cohen and published by Oxford University Press. This book was released on 2017 with total page 1233 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law, with contributions from the most eminent scholars in the field. The Handbook paints with broad thematic strokes the major features of American healthcare law and policy, its recent reforms including the Affordable Care Act, its relationship to medical ethics and constitutional principles, how it compares to the experience of other countries, and the legal framework for the patient experience. This Handbook provides valuable content, accessible to readers new to the subject, as well as to those who write, teach, practice, or make policy in health law.
Download or read book Legal and Forensic Medicine written by Roy G. Beran and published by Springer. This book was released on 2013-09-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.
Download or read book Litigation News written by and published by . This book was released on 1996 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Innovation in Medical Technology written by Margaret L. Eaton and published by JHU Press. This book was released on 2007-02-28 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.
Download or read book AHLA Pharmaceutical and Medical Device Compliance Manual Non Members written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.Coverage includes:In-depth coverage of the federal and state enforcement agenciesFederal Anti-Kickback Statute and False Claims Act detailsDistinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label useDiscussion of the Foreign Corrupt Practices Act and its extra-territorial reachCoverage and reimbursement of prescription drugs and medical devicesPrescription drug price regulationsThe Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.EDITORSKathleen M. Boozang, J.D., LL.M., Professor of Law, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJSimone Handler-Hutchinson, J.D., Executive Director, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJCONTRIBUTING AUTHORSBret A. Campbell, Esquire; Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ
Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Download or read book Index to Legal Periodicals Books written by and published by . This book was released on 2003 with total page 2072 pages. Available in PDF, EPUB and Kindle. Book excerpt:
