Drug and Medical Device

With each drug and medical device case, defense lawyers must take a deep dive into the intricacies of specific, frequently very narrow, areas of science and medicine. This book is meant to provide background knowledge, and act as a starting point, in several areas that defense practitioners commonly encounter. Before you meet an expert in a new field for the first time, review the relevant chapter and go into the meeting a little smarter and asking the right questions. Chapters cover navigating the strictures of reliability to challenge a differential etiology, avoiding the "causation conflation" trap in a pharmaceutical case, Bradford Hill criteria, epidemiology, immunology, genetics and molecular/cell biology, urogynecology, and bleeding and clotting.

2020-01D

Non-Member price: 225.00
Discounted member price: 125.00

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FDA Basics for the Drug and Medical Device Lawyer

FDA Basics for the Drug and Medical Device Lawyer - Print

FDA Basics for the Drug and Medical Device Lawyer should be utilized by drug and device litigators to look up specific topics and obtain a basic, straightforward explanation of the FDA’s regulation of the drug and medical device industry, including approval applications and processes, labeling, advertising and promotion, manufacturing, and post-approval commitments. This book will be a go-to reference guide when your practice ventures into new facets of this highly regulated industry. View Table of Contents

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2015-04D

Non-Member price: 210.00
Discounted member price: 135.00

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Young Lawyer Drug and Medical Device Primer 2010: CD
Defending Drug and Medical Device Litigation: A Primer for Young Lawyers. The CD is now available, containing course materials for the program presented September 29, 2010. The course materials provide basic knowledge essential to young lawyers defending drug and medical device cases, as well as a valuable refresher for more experienced defense counsel. Presentations included on the CD focus on the following issues: the FDA regulatory scheme; overview of defenses in drug and medical device litigation; failure to warn claims; medical causation and epidemioligic issues; general discovery issues; the Rule 30 (B)(6) deposition; and expert witness issues, including Daubert.

Non-Member price: 42.00
Discounted member price: 30.00

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