Chapter 13
2003: Guidant Ancure
Endograft System
The New York Times Abstract:
Division of Guidant Corp, one of country’s largest makers of medical devices,
pleads guilty to 10 felonies, admitting it lied to government and hid thousands of
serious health problems, including 12 deaths, caused by one of its products; case
against division, Endovascular Technologies, results in $92.4 million in criminal
and civil penalties, largest ever imposed against maker of medical devices for fail-
ing to report problems to government; company developed stent-grafts that could
be used to treat abdominal aortic aneurysms without major surgery; problem was
with device used to insert stent-graft; equipment could become lodged, poten-
tially requiring emergency surgery to remove it; in some cases, it was broken into
pieces before being removed; Guidant hid results that its product failed to work
properly about one of every three times it was used; as part of plea, Endovascular
Technologies agrees to cooperate in investigations against executives who might
have been involved in wrongdoing; company also faces lawsuits from individuals.
(Eichenwald, 2003)
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