A federal judge Monday delayed a decision on whether to accept a $296 million plea agreement between the Justice Department and Guidant, a unit of Boston Scientific, that had been charged with concealing information involving some of its top-selling heart devices.
Guidant was charged in late February with concealing information regarding catastrophic failures in three models of implantable cardioverter defibrillators. The charges were filed in the St. Paul, MN, federal court following a four-year investigation into Guidant's handling of failures of the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155) ICDs. It pleaded guilty Monday to criminal violations of the Federal Food, Drug and Cosmetic Act, the Justice Department announced. However, U.S. District Court Judge Donovan Frank decided to hold off on approving the agreement after lawyers representing victims implanted with the potentially faulty devices demanded part of the settlement, the Minneapolis Star Tribune reports.
Frank said he wouldn't make a final decision on the matter right away, adding he would decide whether to accept the plea agreement within three weeks. Brooks Cutter, an attorney for the plaintiffs, argued that the plea agreement should be rejected because it lacks an express provision for restitution to patients who received the defibrillators. He also maintained that the proposed agreement is faulty because it circumscribes the number of crime victims who could see some recovery of their financial losses related to the crime and asked Frank to impose a term of probation for Guidant--a provision that's not part of the proposed plea agreement, the Pioneer Press reports.
The Justice Department had alleged that beginning in 2002, Guidant became aware that the Ventak Prizm 2 DR was prone to electrical arcing, rendering the device inoperative. Guidant altered the design of the Prizm in November 2002 and falsely told the FDA that the design changes did not affect the device's safety or effectiveness. As it turned out, the device changes were made to correct this flaw, according to documents filed by the DOJ. Similar problems were discovered in the Renewal ICDs in early 2004.
Under the terms of the proposed plea agreement, Guidant pleaded guilty to withholding information from the FDA regarding catastrophic failures in some of its devices. Specifically, Guidant admitted to making a materially false statement in a required submission to the FDA with regard to the Ventak Prizm 2DR device; and failing to notify the agency of a "correction" to the Contak Renewal devices.
- see Justice's release
- read the Star Tribune's coverage
- check out the Pioneer Press' report