Title :
Moral blindness and the Guidant recall
Abstract :
This paper discusses the moral blindness practiced by Guidant when they withheld important information from doctors and patients who use their defibrillator. It was discovered that Guidant was aware of the failure and flaws of their defibrillator which can cause severe risk to heart patients leading to death. It was only when the defibrillator´s shortcomings were to be disclosed in a newspaper that Guidant issued an advisory. Since the malfunctioning defibrillator can cause serious adverse health consequences or death, the FDA classified Guidant´s advisory as a Class I recall.
Keywords :
cardiology; defibrillators; ethical aspects; Guidant recall; death; heart patients; malfunctioning defibrillator; moral blindness; serious adverse health consequences; Biomedical imaging; Blindness; Cardiology; Circuits; Educational institutions; Electric shock; Ethics; Heart; Manufacturing; Statistics; Defibrillators, Implantable; Disclosure; Equipment Safety; Mandatory Reporting; Product Surveillance, Postmarketing; Prosthesis Failure; United States;
Journal_Title :
Engineering in Medicine and Biology Magazine, IEEE
DOI :
10.1109/MEMB.2006.1578669