Tuesday, April 27, 2010

Should businessmen who covered up defect in defibrillator face criminal charges?

Two doctors urge U.S. court to reject Guidant plea
Apr 21, 2010

Two cardiologists who cared for a 21-year-old college student who died when his implantable defibrillator made by Guidant failed to deliver a life-saving shock are urging a federal judge to reject a plea agreement with the company.

Guidant LLC, which was acquired by Boston Scientific Corp in 2006, agreed to pay $296 million -- the largest criminal penalty against a medical device company -- for withholding information from the U.S. Food and Drug Administration regarding catastrophic failures in some of the devices.

Judge Donovan Frank of the U.S. District Court of Minnesota is reviewing the settlement agreement and will likely accept or reject it by the end of the month.

In a letter to the court, Drs. Robert Hauser and Barry Maron, wrote: "We are extremely dismayed by the U.S. Attorney General's decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act...

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