Publisher's Synopsis
FDA-regulated products, including drugs, medical devices, and vaccines, now represent about one-fifth of the U.S. economy and have become the focus of increasing litigation. The Drug and Medical Device Product Liability desk book provides an in-depth guide to legal issues related to these products, covering various aspects of litigation. It includes detailed discussions on warning-related claims and defenses, information-based theories, strict liability, and FDA-related per se liability. Additionally, it explores how the Food, Drug, and Cosmetic Act (FDCA) and FDA regulations can preempt common law tort claims. The guide also addresses important topics such as class actions in drug and medical device litigation, liability theories against parties other than manufacturers, and key litigation management strategies. The use of expert witnesses is another crucial area covered in the book, offering practical insights for litigators. Furthermore, it provides valuable information on what litigators need to understand about the FDA and outlines strategies plaintiffs and defendants can use to strengthen their cases before litigation even begins. This comprehensive resource is a must-have for those navigating the complexities of FDA-related legal challenges in the pharmaceutical and medical device industries.
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