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.
References
Cases
Abney v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006)
BeRousse v. Janssen Research & Development, LLC, 2017 WL 4255075 (S.D. Ill. Sept. 26, 2017)
Bristol-Myers Squibb Co. v. Superior Court of California, 137 S. Ct. 1773 (2017)
Brown v. Philadelphia College of Osteopathic Medicine, 760 A.2d 863 (Pa. Super. Ct. 2000)
Cacchillo v. Insmed Inc., 833 F. Supp. 2d 218 (N.D.N.Y. 2011)
Cacchillo v. Insmed Inc., 2013 WL 622220 (N.D.N.Y. Feb. 19, 2013)
Connelly v. Iolab Corp., 1995 WL 250794 (Mo. Ct. App. May 2, 1995)
CTI Clinical Trial Services, Inc. v. Gilead Sciences, Inc., 2013 WL 1641348 (S.D. Ohio Apr. 16, 2013)
Darke v. Estate of Isner, 20 Mass. L. Rptr. 419, 2005 WL 3729113 (Mass. Super. Ct. Nov. 22, 2005)
Dubose v. Bristol-Myers Squibb Co., 2017 WL 2775034 (N.D. Cal. June 27, 2017)
Dyson v. Bayer Corp., 2018 WL 534375 (E.D. Mo. Jan. 24, 2018)
Eli Lilly and Co. v. Zenith Goldline Pharmaceuticals, Inc., 471 F.3d 1369 (Fed. Cir. 2006)
Friter v. Iolab Corp., 607 A.2d 1111 (Pa. Super. Ct. 1992)
Gaston v. Hunter, 588 P.2d 326 (Ariz. Ct. App. 1978)
Heinrich v. Sweet, 308 F.3d 48 (1st Cir. 2002)
In re: Immune Response Securities Litigation, 375 F. Supp. 2d 983 (S.D. Cal. 2005)
In re: Incyte Shareholder Litigation, 2014 WL 707207 (D. Del. Feb. 21, 2014)
In re: Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 892 F.3d 624 (4th Cir. 2018)
In re: Xarelto Cases, 2018 WL 809633 (Cal. Super. Ct. Feb. 6, 2018)
Kernke v. The Menninger Clinic, Inc., 173 F. Supp. 2d 1117 (D. Kan. 2001)
Kershaw v. Reichert, 445 N.W.2d 16 (N.D. 1989)
Kus v. Sherman Hospital, 644 N.E.2d 1214 (Ill. App. Ct. 1995)
Liu v. Janssen Research & Development, 2018 WL 272219 (Cal. Ct. App. Jan. 3, 2018)
Looney v. Moore, 886 F.3d 1058 (11th Cir. 2018)
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)
Milton v. Robinson, 27 A.3d 480 (Conn. App. Ct. 2011)
Moss v. Wyeth Inc., 872 F. Supp. 2d 162 (D. Conn. 2012)
Murthy v. Abbott Laboratories, 847 F. Supp. 2d 958 (S.D. Tex. 2012)
Perez v. Progenics Pharmaceuticals, Inc., 965 F. Supp. 2d 353 (S.D.N.Y. 2013)
Sanofi v. Glenmark Pharmaceuticals Inc., USA, 204 F. Supp. 3d 665 (D. Del. 2016)
Spedale v. Constellation Pharmaceuticals Inc., 2019 WL 3858901 (D. Ariz. Aug. 16, 2019)
Sykes v. U.S., 507 F. App’x 455 (6th Cir. 2012)
Telectronics Pacing Systems, Inc. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992)
Tracy v. Merrell Dow Pharmaceuticals, 569 N.E.2d 875 (Ohio 1991)
Wawrzynek v. Statprobe, Inc., 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007)
Wholey v. Amgen, Inc., 165 A.D.3d 458 (N.Y. App. Div. 2018)
Zeman v. Williams, 2014 WL 3058298 (D. Mass. July 7, 2014)
Statutes and Regulations
21 C.F.R. §§ 50.20, 56.101, 56.103, 312.3, 312.52 & 312.60
31 U.S.C. § 3729(a)
35 U.S.C. § 102
35 U.S.C. § 271
Secondary Sources
Agati A (2006) Clinical research trials in the courtroom. In: Clinical research law and compliance handbook. Jones & Bartlett Publishers, Sudbury
Bal S (2009) An introduction to medical malpractice in the United States. Clin Orthop Relat Res 467:339–347
Chiacchio T (2017) Avoiding drug development clinical trials from being an invalidating public use. IPWatchdog.com, November 9, 2017. https://www.ipwatchdog.com/2017/11/09/drug-development-clinical-trials-invalidating-public-use/id=89799/
ElBoghdady D (2014) SAC’s Martoma found guilty of insider trading. Washington Post, February 6, 2014
McAllister D (2007) Are clinical trial sponsors the next target for false claims act enforcement. J Clin Res Best Pract 3(10):1–10
Morreim E (2004) Litigation in clinical research: malpractice doctrines versus research realities. J Law Med Ethics 32:474–484
Morreim E (2005) Clinical trials litigation: practical realities as seen from the trenches. Account Res 12:47–67
Russo A, Johnson J (2015) Research use exemptions to patent infringement for drug discovery and development in the United States. Cold Spring Harb Perspect Med 5:1–10
Tereskerz P (2010) Data safety monitoring boards: legal and ethical considerations for research accountability. Account Res 17:30–50
Tereskerz P (2012) Clinical research and the law. Wiley-Blackwell, London
Valdes S, McGuire P (2004) Contract Research Organizations (CROs) may be the next trend in clinical trials liability. J Biolaw Bus 7:11–15
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Section Editor information
Rights and permissions
Copyright information
© 2020 Springer Nature Switzerland AG
About this entry
Cite this entry
DeBoy, J.J., Wang, A.X. (2020). Clinical Trials on Trial: Lawsuits Stemming from Clinical Research. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_164-1
Download citation
DOI: https://doi.org/10.1007/978-3-319-52677-5_164-1
Received:
Accepted:
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-52677-5
Online ISBN: 978-3-319-52677-5
eBook Packages: Springer Reference MathematicsReference Module Computer Science and Engineering