Case A well-respected and influential arthroplasty (knee replacement) surgeon ha

Question

Case A well-respected and influential arthroplasty (knee replacement) surgeon has been approached by a new company to use their newly developed prosthesis in all of his female patients. While the company has not yet undergone clinical trials for their first product, the FDA has approved its design under a 510 Exemption. The company offered the doctor an expense paid week-long training course in an animal lab in California. The doctor was also offered an opportunity to purchase a 1% equity interest in the company, and once the doctor uses the device, he will be paid exist1,000 per patient fee to gather information on the post-marketing experience with the device. In this scenario, identify at least four (4) of the many ethical issues present related to the doctor's fiduciary responsibilities to the patient. Also, for each of the ethical challenges raised, identify the ethical value(s) and/or principle(s) underlying your concerns. Finally, respond to the question, "What should the good doctor do?" Then state the most compelling justification for your decision. Total possible points for this case is 10 points/10% of your final course grade. Throughout the course, we have studied the patient care experience involving certain ethical obligations for health care professionals. This fiduciary duty (derived from fiducia, Latin for trust) is based on a relationship of trust and patient confidence. As you address this case, be mindful of those obligations which include acting for the benefit and best interest of the patient. Ethical Issues 1) 2) 3) 4) Values/Principles for each issue 1) 2) 3) 4) What should the good doctor do? What is your ethical justification for your decision?

Explanation / Answer

A good doctor should ask the company to finish the clinical trial on their new prosthesis to prove the device's safety and efficacy before being tried on patients.

From the utilitarian point of ethical/moral view, the advantages of using the new device should outweigh its disadvantages. The data which would be helpful to arrive at this conclusion is not available. So, the device cannot be used on the patients.

Ethical issues Values / principles for each issue 1 The FDA has approved only design of the prosthesis under 501 exemption Since the product has not undergone clinical trials to prove its efficacy and safety, ethically it is not good to use this device 2 The company offering the doctor an expense paid week long training course Ethically doctor should not accept any kind of benefits either monetary or paid trips from drug companies 3 The doctor allowed to purchase 1% equity intrest in the company Doctors should refrain from making business partnerships with pharma companies 4 Doctor to be paid $1000 per patient to gather information on post marketing information Confidentiality between the patient data is compromised and doctor-patient relationship is compromised

Related Questions

Navigate

• Browse (All)
• Browse C
• Subjects

---

---

Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.