104 Engineering Ethics: An Industrial Perspective
observation that there were no great differences in the wear flats on frac-
tured and unfractured struts indicated that weld quality contributed to
fatigue fracture (Piehler, 2004).
U.S. GOVERNMENT
INTERVENTION
The 60-degree convexo-concave valve was approved for sale in the
United States by the Food and Drug Administration (FDA) in 1979. The
70-degree convexo-concave valve was never approved for sale in this
country. In its premarket application to FDA, Shiley claimed an inflated
performance advantage of lowered blood clotting incidence. Additionally,
Shiley failed to provide FDA with all information it possessed concerning
valve fractures, including the fact that 18 valves had fractured during proto- ...