This is a distillation, by a selection of seasoned practitioners from leading law firms, universities, and public interest organizations, of the top legal and enforcement matters that we collectively reckoned to be among the most influential of 2017 and early 2018. But there is much more here than summaries of ten cases. The authors have situated each case in its legal or regulatory context, citing and discussing other recent and not-so-recent matters that contribute to the state of play. In addition, we have chapters discussing significant litigation and enforcement settlements and significant regulatory and enforcement actions of the past year. The authors also teamed up to nominate and discuss the currently ongoing cases that were expected to yield significant decisions and results in the months following our time of press.
Food and drug law might seem a narrow topic, but to my mind, the most impressive thing about this book is its breadth. It covers food, drugs, dietary supplements, medical devices, and tobacco products, and when appropriate, our team has not hesitated to discuss cases outside of the food and drug area that are important developments in areas of law that strongly impact practice the FDA product arena. Conversely, many of the legal issues described in this book have much more general applicability. Bristol Myers Squibb v. Superior Court of California deals with jurisdictional issues important to anyone litigating a class action, for example, and Eike v. Allergan has broad applicability in consumer deception cases. Core issues in FDA law continue to be aired in the courts; two significant examples in this volume are Sandoz v. Amgen’s interpretation of the Biologics Price Competition and Innovation Act and T.H. v. Novartis’ entry in the controversy over who, if anyone, is legally responsible for failure to warn for a generic drug when the original brand maker is no longer in a position to update the labeling.
August T. Horvath, Editor
Partner and Co-Chair of the Advertising & Marketing Law Practice Group, Foley Hoag LLP