Overview

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.

Full Product Details

9780199734948

Table of Contents

Reviews

This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field. --Steve Phillips, Special Counsel, Medtronic, Inc. Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive in scope, addressing not only the complicated policies, theories, and defenses unique to drugs and medical devices, but also providing extremely practical advice on client counseling, discovery, case management, trial preparation, and jury selection. And its conversational tone makes it very easy to read. Keep this book handy -- you'll want to refer to it again and again. --Russell Jackson, Partner Skadden, Arps, Slate, Meagher & Flom, New York Creator and Author, Jackson on Consumer Class Actions & Mass Torts blog http: //www.consumerclassactionsmasstorts.com Herrmann and Alden have written a comprehensive guide to navigating the treacherous waters of drug and medical device litigation. Among the many thorny problems addressed by the authors, their advice on multidistrict proceedings and class actions is particularly helpful, both in its depth of analysis, along with their guidance on making difficult strategic decisions in 'bet the company' proceedi

""This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field."" --Steve Phillips, Special Counsel, Medtronic, Inc. ""Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive in scope, addressing not only the complicated policies, theories, and defenses unique to drugs and medical devices, but also providing extremely practical advice on client counseling, discovery, case management, trial preparation, and jury selection. And its conversational tone makes it very easy to read. Keep this book handy -- you'll want to refer to it again and again."" --Russell Jackson, Partner Skadden, Arps, Slate, Meagher & Flom, New York Creator and Author, ""Jackson on Consumer Class Actions & Mass Torts"" blog http://www.consumerclassactionsmasstorts.com ""Herrmann and Alden have written a comprehensive guide to navigating the treacherous waters of drug and medical device litigation. Among the many thorny problems addressed by the authors, their advice on multidistrict proceedings and class actions is particularly helpful, both in its depth of analysis, along with their guidance on making difficult strategic decisions in 'bet the company' proceedings. With respect to preventive counseling, the authors provide savvy insight that will be particularly useful to in-house counsel and to the outside lawyers advising them. In short, I have already consulted this book several times, and I will highly recommend it to any practitioner involved in this challenging and dynamic arena."" --Howard Cyr, Senior Corporate Counsel for Fortune 100 Pharmaceutical Companies ""One of the reasons that I like this book is that it not only is useful for attorneys who are new to drug and device litigation, but it also has plenty of insight and handy resources for those of us who have more than a little grey in our beards...In fact, much of what is in the book is practical advice that would be useful for any litigator...The treatise addresses not only the legal theories underlying these cases, but the ever-important procedural problems of removal, consolidation, class actions, and aggregation. If you anticipate facing MDL issues, you really must read this book. Hermann and Alden have written a book that is both easy to read and chock full of information."" --Russell Jackson, Consumer Class Actions & Mass Torts blog http://www.consumerclassactionsmasstorts.com ""The book has many strengths. It is comprehensive, generally accessible, eloquently written, and well-researched. Perhaps its greatest accomplishment is the breadth of its usefulness to a wide range of readers with varying levels of sophistication."" --Paul Karlsgodt, ClassActionBlawg

<br> This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field. <br>--Steve Phillips, Special Counsel, Medtronic, Inc. <br><p><br> Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive in scope, addressing not only the complicated policies, theories, and defenses unique to drugs and medical devices, but also providing extremely practical advice on client counseling, discovery, case management, trial preparation, and jury selection. And its conversational tone makes it very easy to read. Keep this book handy -- you'll want to refer to it again and again. <br>--Russell Jackson, Partner <br>Skadden, Arps, Slate, Meagher & Flom, New York <br>Creator and Author, Jackson on Consumer Class Actions & Mass Torts blog <br>http: //www.consumerclassactionsmasstorts.com <br><p><br> Herrmann and Alden have written a comprehensive guide to navigating the treacherous waters of drug and medical device litigation. Among the many thorny problems addressed by the authors, their advice on multidistrict proceedings and class actions is particularly helpful, both in its depth of analysis, along with their guidance on making difficult strategic decisions in 'bet the company' proceedi

<br> This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field. <br>--Steve Phillips, Special Counsel, Medtronic, Inc. <br><p><br> Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive

This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field. --Steve Phillips, Special Counsel, Medtronic, Inc. Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive in scope, addressing not only the complicated policies, theories, and defenses unique to drugs and medical devices, but also providing extremely practical advice on client counseling, discovery, case management, trial preparation, and jury selection. And its conversational tone makes it very easy to read. Keep this book handy -- you'll want to refer to it again and again. --Russell Jackson, Partner Skadden, Arps, Slate, Meagher & Flom, New York Creator and Author, Jackson on Consumer Class Actions & Mass Torts blog http: //www.consumerclassactionsmasstorts.com Herrmann and Alden have written a comprehensive guide to navigating the treacherous waters of drug and medical device litigation. Among the many thorny problems addressed by the authors, their advice on multidistrict proceedings and class actions is particularly helpful, both in its depth of analysis, along with their guidance on making difficult strategic decisions in 'bet the company' proceedings. With respect to preventive counseling, the authors provide savvy insight that will be particularly useful to in-house counsel and to the outside lawyers advising them. In short, I have already consulted this book several times, and I will highly recommend it to any practitioner involved in this challenging and dynamic arena. --Howard Cyr, Senior Corporate Counsel for Fortune 100 Pharmaceutical Companies One of the reasons that I like this book is that it not only is useful for attorneys who are new to drug and device litigation, but it also has plenty of insight and handy resources for those of us who have more than a little grey in our beards...In fact, much of what is in the book is practical advice that would be useful for any litigator...The treatise addresses not only the legal theories underlying these cases, but the ever-important procedural problems of removal, consolidation, class actions, and aggregation. If you anticipate facing MDL issues, you really must read this book. Hermann and Alden have written a book that is both easy to read and chock full of information. --Russell Jackson, Consumer Class Actions & Mass Torts blog http: //www.consumerclassactionsmasstorts.com The book has many strengths. It is comprehensive, generally accessible, eloquently written, and well-researched. Perhaps its greatest accomplishment is the breadth of its usefulness to a wide range of readers with varying levels of sophistication. --Paul Karlsgodt, ClassActionBlawg

"""This treatise is a welcome addition to the literature discussing the defense of drug and device product liability cases. The book starts with the fundamentals (such as describing the FDA's regulatory authority and traditional causes of action), but quickly advances to a post-graduate course on the most sophisticated issues that arise in the context of multidistrict litigation, including the choice-of-law implications of filing a master complaint, and complexities caused by so-called direct filing provisions. Drug & Device Product Liability Litigation Strategy belongs on the bookshelf of every litigator who practices in this field."" --Steve Phillips, Special Counsel, Medtronic, Inc. ""Drug and Device Product Liability Litigation Strategy is a 'must read' for both novice and veteran litigators in the field of medical product liability. Seldom do such treatises succeed in giving valuable advice to both types of audiences -- but this one really does. It is comprehensive in scope, addressing not only the complicated policies, theories, and defenses unique to drugs and medical devices, but also providing extremely practical advice on client counseling, discovery, case management, trial preparation, and jury selection. And its conversational tone makes it very easy to read. Keep this book handy -- you'll want to refer to it again and again."" --Russell Jackson, Partner Skadden, Arps, Slate, Meagher & Flom, New York Creator and Author, ""Jackson on Consumer Class Actions & Mass Torts"" blog http://www.consumerclassactionsmasstorts.com ""Herrmann and Alden have written a comprehensive guide to navigating the treacherous waters of drug and medical device litigation. Among the many thorny problems addressed by the authors, their advice on multidistrict proceedings and class actions is particularly helpful, both in its depth of analysis, along with their guidance on making difficult strategic decisions in 'bet the company' proceedings. With respect to preventive counseling, the authors provide savvy insight that will be particularly useful to in-house counsel and to the outside lawyers advising them. In short, I have already consulted this book several times, and I will highly recommend it to any practitioner involved in this challenging and dynamic arena."" --Howard Cyr, Senior Corporate Counsel for Fortune 100 Pharmaceutical Companies ""One of the reasons that I like this book is that it not only is useful for attorneys who are new to drug and device litigation, but it also has plenty of insight and handy resources for those of us who have more than a little grey in our beards...In fact, much of what is in the book is practical advice that would be useful for any litigator...The treatise addresses not only the legal theories underlying these cases, but the ever-important procedural problems of removal, consolidation, class actions, and aggregation. If you anticipate facing MDL issues, you really must read this book. Hermann and Alden have written a book that is both easy to read and chock full of information."" --Russell Jackson, Consumer Class Actions & Mass Torts blog http://www.consumerclassactionsmasstorts.com ""The book has many strengths. It is comprehensive, generally accessible, eloquently written, and well-researched. Perhaps its greatest accomplishment is the breadth of its usefulness to a wide range of readers with varying levels of sophistication."" --Paul Karlsgodt, ClassActionBlawg"

Author Information

Mark Herrmann is Vice President and Chief Counsel - Litigation at Aon Corporation, which is the world's leading insurance and reinsurance broker. Before joining Aon, he was a partner at Jones Day, where his practice focused on the defense of class action and mass tort litigation, including pharmaceutical and medical device cases. Mr. Herrmann wrote The Curmudgeon's Guide To Practicing Law (2006), co-authored Statewide Coordinated Proceedings: State Court Analogues to the Federal MDL Process (2004), taught Complex Litigation on the adjunct faculty of Case Western Reserve University School of Law, and co-founded and, for several years, co-authored the Drug & Device Law Blog. He clerked for Judge Dorothy W. Nelson of the United States Court of Appeals for the Ninth Circuit and graduated from The University of Michigan Law School (J.D. 1983) and Princeton University (A.B. 1979). David B. Alden is a partner in Jones Day's Cleveland office, where his practice focuses on products liability litigation, including pharmaceutical and medical device cases; securities and accounting fraud litigation; and issues relating to the attorney-client privilege and work product protection. Mr. Alden graduated from The University of Michigan Law School (J.D. 1983) and Oberlin College (B.A. 1980).

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