Boston Scientific Guidant Defibrillator. Boston Scientific’s proposed plea agreement with the federal government over faulty Guidant defibrillators may be in jeopardy. Lawyers for people implanted with the potentially defective implantable defibrillators are seeking a portion of the $296 million settlement.
Plaintiffs lawyers convinced a federal judge yesterday to delay approval of a deal that would have resolved federal criminal charges against the company. Yesterday’s hearing in U.S. District Court in St. Paul, Minnesota before Judge Donovan Frank was expected to be routine, and end with the judge approving the $296 million settlement. Instead, Judge Frank said he’ll decide on the fate of the device maker’s guilty plea in the next three weeks.
settlement centered on three Guidant devices
According to the Minneapolis Star Tribune, the government investigation that resulted in the proposed settlement centered on three Guidant devices that had the potential to short-circuit — the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155) models of implantable defibrillators. According to the charges filed in federal court, Guidant violated the Food, Drug and Cosmetic Act.
Boston Scientific agreed in November to plead to the charges and pay $296 million to resolve the Guidant charges with the U.S. Department of Justice. Boston Scientific acquired Guidant in 2006 for $28.4 billion.