• Doctors’ advice: Reject plea deal, target executives Wednesday, April 21, 2010

    If you’ll pardon the pun, this is a heartening development.

    Two cardiologists instrumental in bringing attention to apparent corporate malfeasance by the manufacturers of faulty heart defibrillators say a plea deal in which the company pays a fine should be rejected by the judge.

    The reason: No individuals are being held responsible for decisions that allegedly led to the deaths of patients.

    The case revolves around defibrillators made by the former Guidant Corporation, now part of Boston Scientific, which allegedly short-circuited, causing arrhythmia problems and at least six deaths — including one of the doctors’ patients. Guidant agreed to the civil settlement, in which it will plead guilty to two criminal misdemeanors and pay a whopping $296 million fine.

    Not good enough, say the two doctors. The New York Times reports today that Drs. Robert G. Hauser and Barry J. Maron wrote a letter to the Minnesota judge handling the case urging him to reject the agreement. From their letter:

    On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement. …

    Also at issue in this case is the safety of future generations of
    patients who receive medical devices. Manufacturers control the
    quality of their products. Manufacturers are the first to know when a
    medical device is dangerous or underperforming. Thus, it is in the
    best interest of patients, and society in general, for manufacturers to
    be liable for the safety and effectiveness of their products. To allow a
    repeat offender, like Guidant, to escape with a fine (that is entirely
    borne by the shareholders of Boston Scientific) does not hold the
    guilty parties fully accountable and inevitably undermines patient
    safety.

    Yeah, what they said.

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