A judge rejected the initial plea agreement in defibrillator recall case.
A long tale of intrigue involving the former Guidant Corp.'s controversial 2005 recall of heart defibrillators could end Wednesday morning in a St. Paul courtroom.
In an agreement reached with the U.S. Department of Justice last year, Guidant (now part of Boston Scientific Corp.) pleaded guilty to two federal criminal charges related to the recall, including making false statements to the Food and Drug Administration (FDA) about the devices' safety.
The company, which employs about 5,000 Minnesotans, also agreed to pay a $296 million fine. It would have been the largest criminal penalty ever levied in medical technology for violating federal laws.
But last April, U.S. District Judge Donovan Frank balked at the agreement, saying it didn't serve the best interests of justice or the public. He sent both sides back to the drawing board.
Since then, lawyers for the Justice Department have filed briefs saying $296 million in fines is "an appropriate resolution to this case." And Guidant -- at the judge's behest -- documented new programs to ensure it complies with federal laws as well as provided information on its charitable activities.
Frank will likely decide today whether to accept the agreement.
The case stems from the 2005 recalls of Guidant's Ventak Prizm and Contak Renewal defibrillators, stopwatch-sized devices that shock an errantly beating heart back into rhythm. The problem with Guidant's devices came to light when two Minneapolis doctors went public with their concerns after a young patient died due to a faulty defibrillator.
Janet Moore • 612-673-7752