The Health Law Ethics & Policy Seminar Series
presents
Trudo Lemmens
Associate Professor, Faculty of Law, University of Toronto
Simon Stern
Assistant Professor, Faculty of Law, University of Toronto
Why Guest-Authors of Ghostwritten Publications Can Be Held Liable for Fraud
Thursday, September 15, 2011
12:30 – 2:00
Faculty of Law, University of Toronto
84 Queen’s Park, Falconer Hall, Solarium/FA2
Toronto, Ontario, M5S 2C5
Everyone is welcome to attend, no registration is required.
ABSTRACT
Ghostwriting and guest authorship of medical journal articles raise serious ethical and legal concerns, bearing on the integrity of medical research and evidence used in legal disputes. Ghostwriting involves undisclosed authorship, usually by medical communications agencies or a pharmaceutical sponsor of the published research; guest authorship involves taking authorial credit for the published work without making a substantial contribution to it. Commentators have objected to these practices because of concerns involving bias in ghostwritten clinical trial reports and review articles. We also note the effects of ghostwritten articles on questions involving the legal admissibility of scientific evidence. Efforts to curb ghostwriting practices, undertaken by medical journals, academic institutions, and professional disciplinary bodies, have thus far had little success and show little promise. These organizations have had difficulty adopting and enforcing effective sanctions, for specific reasons relating to the interests and competencies of each kind of organization.
Because of those shortcomings, a useful deterrent in curbing the practice may be achieved through the imposition of legal liability on the ‘guest authors’ who lend their names to ghostwritten articles. We explore the doctrinal grounds on which such articles might be characterized as fraudulent. A guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO). The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This doctrine has been used by the U.S. Supreme Court to impose sanctions on the authors and corporate sponsors of a ghostwritten article. We discuss the potential penalties associated with each of these varieties of fraud.
Publication:
Stern, Simon and Lemmens, Trudo, Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles (July 23, 2011). PLoS Medicine, Vol. 8, No. 8, pp. 1-5, August 2011. Available at SSRN:
http://ssrn.com/abstract=1893669 BIOGRAPHIES
Trudo Lemmens (LicJur (KULeuven); LLM, DCL (McGill)) is Associate Professor in the Faculties of Law and Medicine of the University of Toronto. He is affiliated with the University of Toronto's Joint Centre for Bioethics and the Centre for Ethics. Over the last decade, he has been a member of the School of Social Science of the Institute for Advanced Study in Princeton, a visiting fellow of the Royal Flemish Academy of Belgium for Science and the Arts, and a visiting professor at the K.U.Leuven and the University of Otago. Prof. Lemmens is a member of the Advisory Committee on Health Research of the Pan American Health Organization, and the Advisory Committee on Ethical, Legal, and Social Issues of the Canadian Longitudinal Study on Aging. He sits on the Board of the Ontario Mental Health Foundation. He has been consulted by various other international and national governmental agencies. His publications include the co-authored book Reading the Future? Legal and Ethical Challenges of Predictive Genetic Testing (Themis, 2007) and the co-edited volume Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability (University of Toronto Press, 2006) as well as numerous chapters and articles in national and international law, policy, science, medicine and bioethics journals.
Simon Stern, B.A. (Yale), Ph.D., English (UC Berkeley), J.D. (Yale), member of the Washington, D.C. Bar. While in law school Prof. Stern was Editor-in-Chief of the Yale Journal of Law & the Humanities. After law school he clerked for Ronald M. Gould on the U.S. Court of Appeals for the Ninth Circuit, practiced litigation at Shea & Gardner (now Goodwin Procter) in Washington, D.C., and then served as a Climenko Fellow and Lecturer on Law at Harvard Law School. Prof. Stern teaches in the areas of civil procedure, law and literature, legal history, and criminal law. His research focuses on the evolution of legal doctrines and methods in relation to literary and intellectual history. Current research topics include the adoption of the analytical method in the nineteenth century and its effects on modern legal reasoning and writing; the development of the "reasonable man" standard (and its precursors and analogues) since the eighteenth century; the history of the case method and the form of the case; the history of copyright law and its relation to contemporary issues in intellectual property; and relations between legal and literary views of authorial responsibility, and the forms of liability that may arise when the two coincide.
A light lunch will be served.
For other upcoming seminars, see the schedule online or contact m.casco@utoronto.ca
The Health Law Ethics and Policy Workshop series brings local, national, international scholars and policy makers as guest speakers to the Faculty of Law, University of Toronto to stimulate discussion of issues related to the intersection of law with health care and related ethical and social issues. The series is organized by the Faculty’s Health Law group and is sponsored by the CIHR Training Program in Health Law, Ethics and Policy. The training program addresses the global shortage of experts in the multidisciplinary field of health law, ethics and policy by providing key learning opportunities and competitive scholarships to outstanding Canadian and international graduate students. For more information about the seminar series and/or the training program, please visit our website at: www.healthlawtraining.ca.
