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Two doctors are asking a federal court in Minnesota to reject the plea agreement between medical device maker Guidant LLC, owned by Boston Scientific Corp, and the U.S. Attorney General, resolving charges the company withheld information about its defibrillators from the FDA. Drs. Robert Hauser and Barry Maron were the physicians treating one young patient whose defibrillator, made by Guidant, did not function as needed and allegedly caused his death. The plea agreement allows the company to plead guilty to two misdemeanor charges and agrees to a fine of $296 million, the largest criminal penalty ever levied against a medical devices company.
According to the Pioneer Press, the two doctors also blew the whistle on Guidant in 2005, taking the company to task for its failure to disclose the problems with its implantable defibrillators. The doctors went public with their concerns when the Guidant Prizm 2 implantable defibrillator implanted in their patient, Joshua Okrup, a 21-year-old college student, failed to administer the shock that would have restarted Okrup's heart.
Okrup, a student from Grand Rapids, Minn., died during a spring break mountain biking trip in Utah. The doctors said that if not for the unreported problem with the device, Okrup likely would have been saved by his defibrillator.
The Pioneer Press reports that in their letter to the court, Hauser and Maron urged the court to hold individuals accountable for failing to warn the FDA, doctors and patients about the short-circulating failures in three defibrillator models and not to let the shareholders of Boston Scientific pick up the considerable tab for their misdeeds. U.S. District Court Judge Donovan Frank is expected to rule this month on whether he will accept the Guidant plea agreement.
A civil suit against Guidant over the defibrillators is still proceeding. Plaintiffs in that suit also object to the plea agreement.