Daniel R. Cahoy
Assistant Professor of Business Law, the
Pennsylvania State University.
Articles by this Author
Medical Product Information Incentives and the Transparency Paradox
- By Daniel R. Cahoy
- Published 10/5/2007
- Volume 82, Issue 3
Recent allegations
that essential safety and efficacy information is often suppressed by medical
product manufacturers or poorly evaluated by regulators have led to calls for
greater information transparency. The public is justifiably concerned that its
ability to conduct an informed risk-benefit assessment of drugs and medical
devices is compromised. Several changes have already been made to federal
regulatory law and medical research policy to mandate greater disclosure and
more changes are being considered. However, it is possible that these measures
may backfire by enhancing significant tort-based economic disincentives for
generating new information. In other words, greater disclosure requirements
could, paradoxically, lead to less information production. The resulting
shortfall could be extremely dangerous and have a detrimental effect on health
care for years to come. This Article addresses the crisis on the horizon and
proposes a unique solution that connects tort law disincentives to information
production incentives. It explains why an economically rational company would
be expected to respond to transparency with less information and proposes a
tort liability limitation as a solution that will encourage a
cost-internalizing company to increase information production. This Article
also considers the impact of the FDA's recent position on preemption along with
other regulatory enhancements and concludes that these are effective, but
second-best solutions.


Copyright © 2008 The Trustees of Indiana University. All rights reserved. Hosted by