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Health Law and Ethics
February 19, 2003

Medical Monitoring for Pharmaceutical InjuriesTort Law for the Public's Health?

Author Affiliations

Author Affiliations: Department of Health Policy and Management, Harvard School of Public Health (Drs Studdert, Mello, and Brennan) and Brigham and Women's Hospital (Dr Brennan), Boston, Mass.


Health Law and Ethics Section Editors: Lawrence O. Gostin, JD, Center for Law and the Public's Health at Georgetown University, Washington, DC, and the Johns Hopkins University, Baltimore, Md; Helene M. Cole, MD, Contributing Editor, JAMA.

JAMA. 2003;289(7):889-894. doi:10.1001/jama.289.7.889

A remarkable development in personal injury litigation in recent years involves attempts to expand legal claims beyond existing injuries to anticipated future harms. Attorneys have begun to sue on behalf of individuals exposed to defective pharmaceutical products who have no current injury, but who may be at risk for developing one after a latency period. This strategy seeks to make drug manufacturers pay for medical monitoring, a court-ordered program that provides diagnostic tests to exposed individuals to facilitate early detection of adverse health effects. Because medical monitoring does not depend on the existence of an actual injury and large populations may be exposed, some commentators have warned that it has the potential to spiral out of control. We examine medical monitoring in the context of 2 major cases involving diet drugs and an oral hypoglycemic drug. We conclude that this expansion of tort law should be applied sparingly, but that the performance of courts to date in these cases gives cause for optimism. Judges appear to be paying close attention to sophisticated epidemiological, clinical, and cost-effectiveness considerations. Medical monitoring arms the courts with a new mechanism for addressing harms proactively rather than reactively, which could yield new victories for public health.