A federal judge rejected a plea deal by Boston Scientific Corp.'s Guidant unit to pay $296 million for failing to properly disclose changes made to some implantable heart devices, saying it didn't adequately address the company's criminal conduct.
Judge rejects $296 million plea deal for Guidant
Judge Donovan Frank's ruling Tuesday faulted the deal for not putting Guidant or Boston Scientific on probation.
The plea deal filed earlier this month called for what federal prosecutors said was the largest criminal penalty assessed against a medical device company. As part of that deal, Guidant pleaded to two misdemeanor counts: submitting a false and misleading report to the Food and Drug Administration about one defibrillator model, and failing to notify regulators about a safety correction to another line of devices.
Two doctors who cared for a man who died after his Guidant device malfunctioned were among those who urged the judge to reject the plea, arguing that it was wrong for Guidant to escape by paying a fine.
Some patients had complained that the deal didn't require restitution. But Frank concluded that no patients were directly harmed by the two specific acts to which Guidant pleaded guilty. Prosecutors had noted that patients had other ways to pursue compensation. Many have already sued and reached settlements.
Frank said the government and Guidant can submit a modified plea agreement. He said Guidant is also free to withdraw its guilty plea, but that he could then "dispose of this case even less favorably than the Plea Agreement contemplated."
A spokeswoman for the U.S. attorney's office in Minnesota said prosecutors were reviewing the decision.
Boston Scientific said it plans to work with authorities to modify the plea agreement so it is acceptable to the court.
Charles Zimmerman, an attorney for victims, said he was delighted with the judge's decision, calling it a "good day for justice and public health."
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