Read the handout "1994: Bjork-Shiley Heart Valve Defect" and then discuss the issues raised below. Short Answers with minimal discussion will earn little credit. It is expected that a thorough discussion of the issues presented should take about 4-5 double spaced pages. Also, note that English usage (grammar, syntax, and spelling) will weigh as heavily in the grading as the content of your discussion. Equal weight will be given to each of the questions.

• Discuss which NSPE ethics codes were violated in the events leading to the Bowling-Pfizer settlement.

• When the Safe Medical Device Act passed in 1990, the FDA was given the power to recall medical devices. The number of Bjork-Shiley convexo-concave valves subject to strut failure was estimated to be fewer than 2000 per 89,000, or less than 2%. Discuss whether this device should have been recalled from a:

o Utilitarian ethical perspective: greatest good for the greatest number
o Rights and duties ethical perspective: individual is an "end in themselves".
o Where was the greatest ethical failure on Shiley's part?

• During the discussions of tort reform by the Congress in early 2005, the Bowling v. Pfizer settlement was mentioned as an example of an excessive judgment. The legislation resulting from these discussions, the Class Action Fairness Act of 2005 limits attorney fees and moves jurisdiction from local to federal'district courts. Discuss whether the Bowling v. Pfizer settlement was excessive.