Drug and Device Product Liability Litigation Strategy

Drug and Device Product Liability Litigation Strategy
Author: Mark Herrmann
Publisher: Oxford University Press
Total Pages: 539
Release: 2011-12-21
Genre: Law
ISBN: 0199750246

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.

Drug and Medical Device Product Liability Deskbook

Drug and Medical Device Product Liability Deskbook
Author: James Beck
Publisher: Law Journal Press
Total Pages: 982
Release: 2004
Genre: Law
ISBN: 9781588521217

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

Drug and Device Product Liability Litigation Strategy
Author: Mark Herrmann
Publisher: Oxford University Press, USA
Total Pages: 539
Release: 2012
Genre: Law
ISBN: 0199734941

In Drug and Device Product Liability Litigation Strategy, Mark Herrmann and David B. Alden provide useful practice pointers and overall strategic guidance for attorneys in product liability litigation involving prescription drugs and medical devices.

Dietary Supplements

Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
Total Pages: 32
Release: 1998
Genre: Advertising
ISBN:

Innovation and Protection

Innovation and Protection
Author: I. Glenn Cohen
Publisher: Cambridge University Press
Total Pages: 295
Release: 2022-04-07
Genre: Law
ISBN: 1108838634

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Model Rules of Professional Conduct

Model Rules of Professional Conduct
Author: American Bar Association. House of Delegates
Publisher: American Bar Association
Total Pages: 216
Release: 2007
Genre: Law
ISBN: 9781590318737

The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Medical Devices and the Public's Health

Medical Devices and the Public's Health
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 318
Release: 2011-11-25
Genre: Medical
ISBN: 0309212421

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Tragic Failures

Tragic Failures
Author: Carl F. Cranor
Publisher: Oxford University Press
Total Pages: 265
Release: 2017
Genre: Medical
ISBN: 0190635754

A world awash in little understood chemicals tragically harms adults and children alike. Laws keep health agencies in the dark about toxicants, slow, well motivated research hampers protections, and strenuous vested opposition exacerbates the harm. How science is used in the tort law can facilitate or frustrate redress of harm. This book recommends better approaches.