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Clinical Trials on Trial: Lawsuits Stemming from Clinical Research

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Principles and Practice of Clinical Trials

Abstract

Clinical trials and the law routinely intersect, and as a result, litigation occasionally arises out of clinical trial activities. Such litigation includes not only personal injury suits – claims by individuals who allege they suffered injury during a clinical trial – but also breach-of-contract lawsuits, intellectual property matters, and even criminal prosecutions. This chapter provides an overview of the types of litigation that might arise out of clinical trials. The chapter focuses on personal injury litigation and, in particular, the related duties that courts have held apply to participants in clinical trials, including sponsors, investigators, and institutional review boards. Notwithstanding this focus, the chapter also provides an overview of lawsuits grounded in other areas of the law. The ultimate goal is to provide researchers with a basic understanding of litigation-related issues, in the hopes that such knowledge might aid them in avoiding pitfalls that increase litigation risk.

The authors represent pharmaceutical and medical device companies in various litigation matters. Any opinions expressed are those of the authors and do not necessarily reflect the views of their firm. This book chapter is for general information purposes and is not intended to be, nor should it be taken as, legal advice.

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Correspondence to John J. DeBoy J.D., M.B.A. .

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DeBoy, J.J., Wang, A.X. (2022). Clinical Trials on Trial: Lawsuits Stemming from Clinical Research. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52636-2_164

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