FALL
2007 HONORS COURSES
HONR 288L Medical Devices: Applied
Ethics and Public Policy
Monday, 2:00-4:30 p.m.
Glenn A. Rahmoeller, Senior Lecturer in University Honors
Ethical theories provide a basis for making decisions,
using logic and reason to act in our long-term interest. Applied ethics
is the application of ethical theories to real life situations. In this
course we will use case studies from the professor’s experience as a
regulatory consultant and as the former Director of the Division of
Cardiovascular Devices at the FDA. We will examine how controversial
decisions were made by the FDA, manufacturers, physicians, and other
government organizations, and whether those decisions were ethical.
We will also examine other current issues from the literature and news
media. Case studies will include controversies concerning breast implants,
genetic testing, allegations of scientific misconduct (the David Baltimore
case), artificial hearts, transplants, and deaths due to mechanical
heart valves.
Ethics provides guidance on how people should act. The
relationships that exist between physicians and patients, between medical
device manufacturers and physicians, and between medical device manufacturers
and patients determine the rights and obligations of each group. Ethics
helps us to understand the obligations that each individual has in these
relationships. When we read about failures of medical devices in the
news, it often appears that someone has acted unethically–the company
management didn’t test the device enough to assure that it was safe
and effective, the public wasn’t notified of the problem is often much
more complex than it first appears. There is often more than one right
answer depending on one’s ethical perspective. Most of us will make
important, controversial decisions in our lives–this course will give
you a process by which to make those decisions.
Reading List:
M. Angell, Science on Trial: The Clash of Medical Evidence and the Law
in the Breast Implant Case
C. Levine, Taking Sides: Clashing Views on Controversial Bioethical
Issues
Readings prepared by the instructor
CORE–Behavioral and Social Science [SB]
