Boston Scientific Corp.'s defibrillator subsidiary Guidant received a punishment of three years probation on Wednesday in addition to the $296 million in criminal fines and forfeitures levied against the company for withholding information about faulty heart devices.
Guidant hit with nearly $300 million in penalties, monitoring
Guidant, based in Arden Hills, Minn., pleaded guilty to two misdemeanors following the deaths of several patients who had faulty defibrillators implanted in them. Prosecutors said Guidant officials concealed information from regulators and continued to ship defibrillators known to have a “catastrophic” defect that caused short-circuiting, only going public with the information in June 2005 after three deaths had occurred.
The defects were in three models of implantable defibrillators: Ventak Prizm 2 DR model 1861, and Contak Renewal models H135 and H155.
The corporation agreed to plead guilty, and have its new owners, Boston Scientific, pay the fine. But last April, U.S. District Judge Donovan Frank rejected a proposed plea agreement which contained the $296 million fine but no probation.
A statement from the Justice Department on Wednesday said the sentence handed down by Frank will allow the U.S. Probation office to conduct unannounced inspections of company records in addition to quarterly reports the devicemaker must submit.
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