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Judge rejects plea deal on Guidant heart device

New York Times, April 28, 2010
A federal judge in Minnesota has rejected a plea agreement between the federal government and the Guidant Corporation, saying that the deal did not hold the company sufficiently accountable for an episode in which it sold potentially flawed heart defibrillators. The deal called on Guidant to plead guilty to two misdemeanors and pay a $296 million fine, described as the largest by a medical device company. The case results from disclosures in 2005 that Guidant did not alert doctors and patients that some of its defibrillators had a defect that might cause them to fail when needed to interrupt an erratic and possibly fatal heart rhythm. At least six patients who got the devices died.