108 Engineering Ethics: An Industrial Perspective
Palast, G. The explosive truth behind U.S. wave of corporate crime. London Observer, A5,
November 1, 1998.
Piehler, H. R., and Hughes,A. A.,The role of postmarket surveillance in the medical device risk
management system. In Engineering Systems Symposium, Cambridge, MA, March 31, 2004.
Special Masters/Trustees, First Report of the Special Masters/Trustees Covering Period
from February 28, 1992 to February 28, 1995. Bowling-Pfizer Litigation. 1995.
Special Masters/Trustees, Twenty-First Report of the Special Masters/Trustees Covering
Period from June 4, 2004 to November 4, 2004. Bowling-Pfizer Litigation. 2004.
United States Code (USC), 2005. http://www.straylight.law.cornell.edu/uscode.
United States Congress, The Bjork-Shiley Heart Valve: “Earn While You Learn. Committee
Print 101-R, Subcommittee on Oversight and Investigations, Committee on Energy and
Commerce, U.S. House of Representatives, February 1990.
1. Of the eight ethical dilemmas presented in Chapter 1, which were present
in the events leading to the Bowling-Pfizer settlement?
2. Should Dr. Bjork have publicly disclosed in 1980 his request to Shiley
for corrective action? Should he have disclosed this to FDA in 1980?
3. When the Safe Medical Device Act passed in 1990, 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%. Should this device have been recalled? Discuss.
4. When the Safe Medical Device Act passed in 1990, medical device manu-
facturers were mandated to file Medical Device Reports (MDRs) with
FDA when serious adverse device incidents occurred. An FDA review of
the MDRs from 1991 revealed that 59 deaths and 929 serious injuries were
attributed to design-related failures (FDA, 2004). No animal or clinical
trials of the Bjork-Shiley convexo-concave design were conducted before
valves of this design began to be implanted (Piehler, 2004). In fact,
Congress dubbed the Shiley methodology of implanting its valves, then
modifying its design iteratively (Delrin disc : Pyrolyte disc : 60-degree
convexo-concave : 70-degree convexo-concave : monostrut) as “Earn
While You Learn” (U.S. Congress, 1990).What types of testing should have
been conducted before the first implant?
5. During discussions of congressional tort reform 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 (USC, 2005). Do you
believe the Bowling v. Pfizer settlement was excessive? Discuss.
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