CHICAGO (Reuters) - 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.
“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.
“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.”
Reporting by Debra Sherman; Editing by Richard Chang
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