Settlement Over Guidant Heart Defibrillators Accepted by Federal Judge
A federal judge has agreed to accept a guilty plea that includes a $296 million settlement payment by Guidant over claims that it tried to cover up problems with defective heart defibrillators, but only after a three-year probation sentence was placed on the medical device manufacturer.
U.S. District Judge Donovan Frank originally rejected the proposed Guidant settlement last April, saying that it was too lenient a punishment for the company, whose defective defibrillator implants have been linked to at least six deaths.
At that time, Judge Frank said the settlement did not serve “the interests of justice.” He only agreed to the settlement last week after the agreement was renegotiated to include a three-year probation period in November.
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Justice Department (DOJ) investigators filed charges against Guidant on February 25, 2010, in federal court in St. Paul, Minnesota, after a four-year investigation into several models of the company’s implantable cardioverter defibrillators (ICDs). The charges allege that Guidant hid information from the FDA regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs.
ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. The DOJ charges claim that Guidant was aware as early as 2002 that the Ventak Prizm 2 DR had the potential to suffer an electric arc, which could short-circuit the device, making it unable to provide life-saving heart rhythm corrections when the patient needed it.
The DOJ accuses the company of changing the design to fix the problem, and then lying to the FDA about the design changes to cover up the fact that there was a problem. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.
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