Medical Devices: Applied Ethics and Public Policy (HONR 288L), Fall 2010
General Requirements
Distributive Studies
You may have chosen this course as part of your CORE Liberal Arts and Sciences Studies
Program, the general education portion of your degree program. CORE Distributive Studies
courses are designed to ensure that you will take a look at several different academic disciplines
and the way they create and analyze knowledge about the world. A faculty and student
committee approved this CORE Distributive Studies course because it will introduce you to ideas
and issues that are central to a major intellectual discipline and because it promises to involve
you actively in the learning process. Please take advantage of the opportunities this course offers
you.
Course Background
In this course you will learn about medical devices like artificial heart valves and artificial hearts.
We will discuss the government’s requirements for clinical testing, and the obligations that
physicians, manufacturers, FDA, and the Congress have to patients. We will use resources and
methods from the field of sociology (case studies, interviewing, and content analysis) to better
understand the impact of all of these requirements and obligations on society, and we will use
several ethical theories to analyze and evaluate public policy.
We will discuss case studies from my experience as a regulatory consultant and as the former
Director of the Division of Cardiovascular Devices at the FDA. Case studies will include
controversies concerning breast implants, allegations of scientific misconduct (the David
Baltimore case), artificial hearts, deaths due to mechanical heart valves, and others recommended
by the class. The case studies will show (a) how public policy affects patients, physicians,
researchers, and manufacturers; (b) how it is influenced; and (c) how individuals viewing the
same problem can come to different conclusions based on different ethical theories.
Ethics provides guidance on how people should interact. The relationships that exist between
physicians and patients, between medical device manufacturers and physicians, and between
medical device manufacturers and patients create the rights and obligations of each group. Ethics
helps us to define the role responsibilities that each of the individuals has in these relationships.
Sociology examines social life as it is influenced by social systems like the medical research
community, the medical industry, FDA, NIH, and the Congress. Research from in-depth
interviews, surveys, and content analysis provides important insight into what various social
groups understand about medical technology and how they are affected. This insight is important
for a proper ethical analysis of the policies of these social systems. It is also important to
understanding how to educate the public about new technologies (a requirement of professional
codes of ethics).
When we read about failures of medical devices in the news, it often appears that someone has
acted unethically – a scientist committed fraud, company management didn’t test the device
enough to assure that it was safe and effective, the public wasn’t notified of a problem in a timely
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manner, or a physician didn’t give patients adequate informed consent. The problem is often
much more complex than it first appears. There is often more than one right answer or, from
other’s perspectives, no right answer. Most of us will make important, controversial decisions in
our lives – this course will give you a process by which to make those decisions.
Required Course Materials
 Readings prepared by Glenn Rahmoeller.
 Murphy, T., Case Studies In Biomedical Research Ethics, (MIT Press, 2004 – ISBN: 0262-63286-1)
Optional Course Materials
 Levine, C., Taking Sides: Clashing Views on Controversial Bioethical Issues,
(Dushkin/McGraw-Hill, 13th edition – ISBN: 978-0-07-354566-0)
Expectations and Grading
The success of this class depends on your presence and participation in each session. Learning
will come primarily from the class discussions in which you participate. If you must miss a
class, please discuss it with me as soon as possible – all of us benefit from listening to each
other’s views, so you will be missed.
I expect you to spend an average of 3-6 hours each week preparing for this course. There are
readings assigned each week. Please come prepared to discuss the material (please note: if I
believe the class is not prepared, I reserve the right to give a quiz – in which case I will use your
quiz grade as your class grade for the day). Ten percent (10%) of your grade will be based on
how well you respond during our discussion of these issues.
You will have 10 papers due during the semester. Three of these are major papers (3-4 pages)
that will show me that you can apply what you have learned – they count for 25% of your grade.
The remaining seven papers are brief response papers (1-2 pages) relating to questions about the
readings for the day or to your research paper (outline and Power-Point). I also ask that you
include a thoughtful question about the readings that we can discuss in class. These brief
response papers count for 25% of your grade.
You must work in a group to write a research paper. You will work in teams of 3-4 students to
write a research paper on an issue that is important in some area of medicine or medical
technology. Each person in the group will be responsible for a specific section(s) of the paper –
(a) background (3-4 pages, plus list of references); (b) social implications (3-4 pages, plus list of
references); (c) ethical analysis (3-4 pages, plus list of references); and (d) introduction (1 page,
plus list of references), discussion (2-3 pages, plus list of references), conclusion (1 page). If an
additional student wants to join a team, he/she may interview an appropriate person (e.g., a
professor on campus) about the research topic and write a section of the paper (3-4 pages, plus
consent form and list of references) about the interview. The research paper will count for 15%
of your grade. Each student will receive an individual grade for his section(s) of the research
paper.
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Your group must also present this research to the class. I will give one grade for the presentation
– and all students in the group will receive that grade. Your presentation will be worth 5% of
your grade.
The remaining 20% of your grade will come from a take-home final exam. The exam will
consist of one question (see Course Packet for the question) that you must address in a 4-6 page
paper.
In summary:
 Class participation
 3 major papers
 7 brief response papers
 Research paper
 Research presentation
 Final exam paper
10%
25%
25%
15%
5%
20%
All papers should be written for a reader who is unfamiliar with the material. Assume that
person will read your papers for the purpose of understanding what you are learning from this
class. I grade all papers based on their overall quality. I take into consideration: (a)
thoroughness, (b) accuracy, (c) organization and logical flow, (d) lack of repetition, and (e)
grammar. For ease of reading and to maintain consistency, all written assignments must be
double spaced, typed in size 12 font, with 1.5 inch margins on the right and bottom of the page
(so that I have room to write my comments).
Do Your Own Work
You may discuss any of the assignments with each other. I see this as part of the learning
experience. Nevertheless, when it comes to writing the weekly responses, papers, research paper,
and final exam, you must prepare this material independently. It is acceptable to quote from
cited references, but copying from each other or copying material from other sources without
quoting and citing the source is unacceptable and will result in severe penalties.
Academic Accommodations
If you have a documented disability, you should contact Disability Support Services 0126
Shoemaker Hall. Each semester students with documented disabilities should apply to DSS for
accommodation request forms which you can provide to your professors as proof of your
eligibility for accommodations. The rules for eligibility and the types of accommodations a
student may request can be reviewed on the DSS web site at
http://www.counseling.umd.edu/DSS/receiving_serv.html.
Religious Observances
The University System of Maryland policy provides that students should not be penalized
because of observances of their religious beliefs, students shall be given an opportunity,
whenever feasible, to make up within a reasonable time any academic assignment that is missed
due to individual participation in religious observances. It is the responsibility of the student to
inform the instructor of any intended absences for religious observances in advance. Notice
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should be provided as soon as possible but no later than the end of the schedule adjustment
period. Faculty should further remind students that prior notification is especially important in
connection with final exams, since failure to reschedule a final exam before the conclusion of the
final examination period may result in loss of credits during the semester. The problem is
especially likely to arise when final exams are scheduled on Saturdays.
Academic Integrity
The University of Maryland has a nationally recognized Code of Academic Integrity,
administered by the Student Honor Council. This Code sets standards for academic integrity at
Maryland for all undergraduate and graduate students. As a student you are responsible for
upholding these standards for this course. It is very important for you to be aware of the
consequences of cheating, fabrication, facilitation, and plagiarism. For more information on the
Code of Academic Integrity or the Student Honor Council, please visit
http://www.studenthonorcouncil.umd.edu/whatis.html.
The University of Maryland is one of a small number of universities with a student-administered
Honors Code and an Honors Pledge, available on the web at
http://www.jpo.umd.edu/aca/honorpledge.html. The code prohibits students from cheating on
exams, plagiarizing papers, submitting the same paper for credit in two courses without
authorization, buying papers, submitting fraudulent documents, and forging signatures. The
University Senate encourages instructors to ask students to write the following signed statement
on each examination or assignment: "I pledge on my honor that I have not given or received any
unauthorized assistance on this examination (or assignment).”
Office Hours
I share an office on campus – room 1103 in the Chemical and Nuclear Engineering Building.
Generally, I will be in the office from 12:30-1:30 on the day that we have class. I am also
available to meet with you earlier on that day or at other times if you contact me and make an
appointment.
 phone: 301-466-6160
 e-mail: rahmoell@umd.edu
 home email: rahmoeller@verizon.net
I am looking forward to teaching this class. I want to make it an enjoyable learning experience
for everyone.
Mr. Rahmoeller
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August 30
Introduction. Introduce each other. Discuss requirements. Discuss social systems and their
impact on individuals, social science research methodology, and social science resources.
Assignment for first class:
 General Requirements. (Readings)
 Introduction. (Readings)
Discussion questions:
1. Introductions
2. Course requirements. Weekly assignments, quizzes, research paper, and final exam
paper.
3. What is sociology?
4. What is a social system?
5. What are interviews, case studies, and content analysis?
6. Where can I find sociological research databases?
September 13
Ethical Theories. Discuss virtue ethics, utilitarianism, and deontology. Discuss how to
analyze ethical problems and resolve ethical dilemmas.
Assignment for this class:
 Ethical Concepts and Theories. (Readings)
 Ethical Approach to Solving Problems. (Readings)
 Submit Paper #1.
 Select research topic in class.
Discussion questions:
1. What is ethics?
2. What is a virtue? A common virtue? A virtuous act?
3. What does it mean to be virtuous?
4. What are the basic concepts of utilitarianism?
5. What are the basic concepts of and deontology?
6. Provide an example of an ethical problem (or dilemma) for discussion.
7. How do deontology and utilitarianism differ?
8. How should we analyze ethical problems?
9. If someone’s decision is different from what you believe is the correct decision, how do
you determine if their decision is (a) different but still ethical or (b) unethical?
10. How can we resolve ethical dilemmas?
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September 20
Breast Implant Case Study. Discuss the ethical issues in this case study, the role of
government health agencies, and oversight and study design in clinical research.
Also discuss interviewing methods.
Assignment for this class:
 Table showing the development of new medical products. (Readings)
 Summary of Marcia Angell’s “Science on Trial.” (Readings)
 Oversight and Study Design (pages 13-19). (Case Studies in Biomedical Research
Ethics)
 Submit Paper #2.
 Work on research paper – collect references.
Discussion questions:
1. What roles do the FDA, NIH, CMS, and Congress play in medical research and our
access to medical care?
2. What is the relationship between the FDA, physicians, and the public?
3. Why are breast implants important to women?
4. Did the FDA treat all women the same when it banned breast implants? Explain.
5. Was FDA’s action ethical?
6. Describe the types of scientific studies that are necessary to prove whether breast
implants cause connective tissue disease in women with silicone breast implants.
7. How did the product liability suits against the breast implant manufacturers affect (a)
clinical researchers and (b) other medical device manufacturers?
8. One can imagine many types of potential device-related complications. When should a
manufacturer conduct additional testing to determine if a potential problem is real?
What criteria should the manufacturer use?
9. What criteria do you think the FDA should use in determining whether to approve a new
medical device? How safe and effective should it be?
September 27
Jarvik Artificial Heart Case Study. Discuss the ethical issues in this case study and how to
select subjects for clinical research.
Assignment for this class:
 Selection of Subjects (pages 91-96). (Case Studies in Biomedical Research Ethics)
 Rahmoeller, G., Regulation of the Artificial Heart – My Personal Experience.
(Readings)
 Select your research topic.
 Submit Paper #3.
Discussion questions:
1.
2.
3.
4.
What are the important components of ethical clinical research?
What were the FDA’s criteria for approving the artificial heart study?
What other criteria might FDA have chosen?
List an important ethical issue relevant to this study? Explain why it is important
ethically.
5. Do you believe that the FDA should have approved this study? Why?
6. Was there adequate informed consent? Explain.
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October 4
Professionalism. Discuss codes of ethics, conflicts of interest, and whistle-blowing.
Assignment for this class:
 Professionalism and Codes of Ethics, and Whistle-Blowing. (Readings)
 Find a code of ethics, review it and bring it to class, and be prepared to discuss it.
 Submit paper #4.
Discussion questions:
1. What is a professional? What special obligations does a professional have? Why?
2. What is a code of ethics? Who writes codes of ethics and why do they write them?
3. What are conflicts of interest? Why must we avoid them?
4. What is whistle-blowing? When is it acceptable? Are we ever obligated to blow the
whistle?
October 11
Ethical Obligations of Companies. Medical device case study (new device for minimally
invasive treatment of an abdominal aortic aneurysm).
Assignment for this class:
 Notes on Business Ethics. (Readings)
 Submit Paper #5 (detailed outline and list of references for your research paper; also
consent form, if you will be conducting an interview).
 Regarding class – please write (anonymously) a few sentences describing what’s going
well, what’s not going so well, and what you would change?
Discussion questions:
1. Why should ethics matter in business?
2. What are the basic ethical responsibilities of business?
3. Are business ethics different from our personal and professional ethics?
4. How should we balance our obligations to our employers with our obligations to
society?
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October 18
Bjork-Shiley Heart Valve Case Study. Discuss the obligations of manufacturers, physicians,
and the FDA in a case of a defective medical device implant.
Assignment for this class:
 Bjork-Shiley Heart Valve Case Study; Notifying Patients Of Implant Failures – Ethical
Issues; and Letter From Public Citizen’s Health Research Group. (Readings)
 Getting The Bad News About Your Artificial Heart Valve, Hastings Center Report,
March-April 1993, pages 79-85. (Readings)
 Submit paper #6.
Discussion questions:
1. What are a manufacturer’s obligations to patients, physicians, the public, and the
manufacturer’s employees and stockholders?
2. What are the FDA’s obligations to patients, Congress, physicians, and manufacturers?
3. What are the dilemmas that are created by the interests of each of the stakeholders?
4. What action would each of the stakeholders want? Why?
5. What information and data should the FDA require before requiring the removal of a
potentially dangerous device from the market?
6. When should a manufacturer notify physicians and/or patients about a device problem?
What should the notification say? Justify your answer ethically.
7. When should the FDA notify physicians and/or patients about a device problem? What
should the notification say? Justify your answer ethically.
October 25
Belmont Report. Discuss ethical guidance for clinical research, including informed consent
and the need to avoid conflicts of interest.
Assignment for this class:
 Clinical Studies For Medical Devices and The Belmont Report. (Readings)
 Informed Consent (pages 53-58) and Conflicts of Interest (pages 127-131). (Case
Studies in Biomedical Research Ethics)
 Submit Paper #7.
Discussion questions:
1.
2.
3.
4.
5.
6.
7.
8.
November 1
What is a clinical study?
What is the difference between practice, research, and experimentation?
What is beneficence?
Relevant to a clinical study, what is justice?
What is the purpose of informed consent in a clinical study?
What information should the consent material include?
How does the design of the clinical study affect the rights of the patients?
Discuss (a) assessment of risks and benefits and (b) selection of subjects relevant to
clinical studies.
Meet with each research group to discuss the group’s Power-Point presentation.
Assignment for this class:
 Submit Paper #8.
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November 8
Clinical Research. Discuss the social effects of research (including Arnold Pacey’s
triangle), use of animals in pre-clinical research, and ethical issues concerning
authorship and publication.
Assignment for this class:
 Social Effects of Research (pages 153-158), Use of Animals (pages 249-252), and
Authorship and Publication (pages 273-278). (Case Studies in Biomedical Research
Ethics)
 Submit paper #9.
Discussion questions:
1. Who should evaluate the social impact of research?
2. Should the results of one’s genetic testing be available to employers and insurance
companies?
3. What does consultation and transparency mean in relation to the social impact of
research?
4. What does speciesism mean? What is the ethical justification for treating animals with
respect?
5. Under what circumstances do you believe that animal research is ethical? Explain?
6. What are fraud, fabrication, and plagiarism?
7. What is peer review? What are its benefits?
8. When are embargoes of manuscripts ethical? Unethical?
9. What are the arguments against publishing data that have been obtained in unethical
ways? What are the arguments for publishing such data?
November 15
David Baltimore Case Study. Discuss this real life drama of a Congressional investigation
of scientific fraud in biomedical research involving a Nobel Laureate.
Assignment for this class:
 Overview. (Readings)
 Summary Of Daniel Kevles’ “The Baltimore Case” (Readings)
 Submit paper #10.
Discussion questions:
1. Select one of the primary participants (stakeholders), and prepare a list of thoughtful
questions you would like to ask that person.
2. What obligations does this stakeholder have to each of the other stakeholders?
3. What rights does this stakeholder have?
4. Discuss whether you believe this stakeholder acted ethically and justify your position.
5. What virtues did each major stakeholder exhibit and what virtues were lacking in each?
November 22
Discuss selected research paper topics.
Research papers due.
November 29
Discuss selected research paper topics.
December 6
Discuss selected research paper topics.
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