THE BJORK-SHILEY HEART VALVE

HW4-BjorkShileyHeartValve_Spring20191.docx

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ENGR 2510 – Biomedical Engineering Principles, Spring 2019

Assignment #4

Due: Tuesday, Feb 12th (5 pm)

Instructions: This assignment should be completed individually . Read the provided article (Defects and Deceptions: The Bjork-Shiley Heart Valve), and answer the following questions. Submit electronically via Blackboard or submit a hard-copy to the instructor’s mailbox.

1. What evidence was there that the strut fractures that occurred in Bjork-Shiley’s C/C valves were not random component failures?

2. Why did Shiley, Inc. claim that their C/C valves should be marketed despite the known strut failures?

3. How did Shiley, Inc. mislead patients, surgeons, and the FDA?

4. Considering Utilitarian ethical theory, were Shiley’s actions ethical? Explain.

5. Considering Kant’s ethical theory, were Shiley’s actions ethical? Explain.

6. The Safe Medical Devices Act was enacted following the Bjork-Shiley incident. How do the provisions of the Act prevent similar incidences from occurring?