• Judge listens to doctors (and others), spikes Guidant deal Wednesday, April 28, 2010

    Been a little hectic today so I’m slow coming around to this one, but the judge in Minnesota did what the doctors ordered and rejected a plea deal with a medical equipment maker because the U.S. Justice Department-negotiated penalty wasn’t stiff enough.

    The issue centers on defibrillators made by the former Guidant Corporation, now part of Boston Scientific, which allegedly malfunctioned and caused at least six deaths. Guidant agreed to plead guilty to two criminal misdemeanors over related report filings, and to pay a record (for a medical firm) $296 million fine. The plea did not address revelations that Guidant executives sold the devices even after they knew they had problems.

    Two doctors — Robert G. Hauser and Barry J. Maron — urged U.S. District Court Judge Donovan W. Frank to reject the deal because none of the individuals who were responsible would be punished.

    Frank declined to weigh in on the issue of whether individuals should be charged — that’s the federal prosecutors’ call — but did say the company should be put on probation. As the New York Times reported:

    Judge Frank said that prosecutors should have sought probation for Guidant and its parent, Boston Scientific. Probation would have required the companies to take certain steps, like helping to rebuild public confidence in the safety of heart devices, in addition to paying a fine.The judge also outlined other provisions that might be suitable in a new plea deal, including charitable activities by Guidant to improve heart device safety and improve medical care among minority patients.

    The Times says the U.S. Attorney’s office is mulling a next step. If they were truly concerned about enforcement, accountability and holding corporations responsible for their actions, they’d be preparing a fresh case for a grand jury.

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