Drug And Medical Device Product Liability Deskbook

Thousands of lawsuits continue to be filed in federal and state courts each year to seek recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into federal multidistrict litigation, multi-plaintiff cases, and class actions. As drug and device litigation remains as active as ever, companies that develop new drugs and devices continue to face significant and often costly product liability litigation in the United States. This new and revised edition of Drug & Device Product Liability Litigation Strategy provides detailed background, discussion, and strategic guidance to those practicing in this field. The book offers lawyers a detailed analysis of the full range of issues involved in drug and device litigation, including pre-litigation counselling, document preservation and discovery, consolidation and mass joinder, multidistrict litigation, class action litigation, admissibility of expert testimony, dispositive and pre-trial motion practice, jury selection, and trial. This second edition not only contains thorough revisions to reflect recent changes in the legal landscape following key court decisions and statutory developments in areas such as preemption, admissibility of expert testimony, the learned intermediary doctrine, and innovator liability, but also contains new analyses of issues such as personal jurisdiction, pre-litigation counselling, and the amended Federal Rules of Civil Procedure. It is an indispensable guide to lawyers handling cases in this high-stake, high-profile, and rapidly evolving area.

3 Volumes; Looseleaf; updated with supplements & revisions.

This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.

This study examined the economic effects of product liability on firms producing drugs and medical devices. The study found that the liability system enhances the economic contributions of the industries in some ways.

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.

From the initial client interview through every step in building the case, this book provides hundreds of valuable ideas and tactics from the perspective of both plaintiffs' and defendants' counsel.

Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.