Nine months after pleading guilty, Guidant LLC was formally convicted and sentenced this week in St. Paul, MN, for failing to report to the federal government life-threatening defects in the medical device maker's implantable cadrioverter defibrillators.
U.S. District Judge Donovan W. Frank ordered Guidant, a wholly-owned subsidiary of Boston Scientific Corp., to pay more than $296 million in criminal fines and forfeiture, and to submit to three-years of supervised probation.
The Justice Department brought criminal charges against Guidant for failing to notify the Food and Drug Administration about short-circuiting failures in three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant's Cardiac Rhythm Management division, which produced the defibrillators, is headquartered in Arden Hills, MN.
Guidant was charged in federal court last February, and pleaded guilty in April.
The surgically implanted defibrillators monitor electrical activity in a patient's heart for deadly arrhythmias, and deliver an electric shock to the heart to return the heartbeat to normal rhythm. If they fail, a person can die within minutes.
"FDA always works closely with companies to support compliance with standards that prevent serious safety problems from occurring," said Margaret Hamburg, MD, commissioner of Food and Drugs. "However, as today's sentence demonstrates, when companies fail to comply, we will use our enforcement tools to ensure the safety and efficacy of the medical products that Americans rely on every day."
Federal prosecutors said Guidant hid information from the FDA and medical professionals about the device failures. In June 2005, the company finally went public with information it had known for 10 months, and only after three deaths had occurred.