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Article Excerpt
Since the FDA announced recalls for 11 models of implantable defibrillators made by Guidant Corp. in July 2005, nearly 400 cases have been filed against the company, and the FDA and the Department of Justice have launched investigations. Now, additional recalls and unsealed documents point to more problems.
The defibrillators, which are implanted in the patient's chest, are intended to shock an abnormal heartbeat back to a normal rhythm, but defects cause them to issue shocks when they are not needed or prevent them from working when they are needed.
Lawsuits have asserted that Guidant knew certain defibrillators were defective and fixed the problem in later versions--but continued to sell the older models still on shelves. (See Allison Torres Burtka, Implanted Defibrillators Linked to Patient Deaths and Injuries, TRIAL, Oct. 2005, at 14.) New York Attorney General Eliot Spitzer filed suit against the company in November,...
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