Guidant, a subsidiary of Boston Scientific, has been charged with concealing information regarding catastrophic failures in three models of implantable cardioverter defibrillators.
The charges were filed in a federal district court in St. Paul, MN, 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.
The Justice Department alleges 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.
The public became aware of potential problems with the devices when two Minneapolis doctors voiced concerns after one of their patients died when his defibrillator failed to revive him. This prompted a recall of the devices, as well as the federal government's investigation. When Guidant recalled 109,000 defibrillators in 2005, seven deaths were linked to the malfunction, according to the Minneapolis Star Tribune.
A formal guilty plea agreement is expected to be filed with the court at a later date. Boston Scientific announced last November that the company would pay $296 million on behalf of Guidant in connection with these charges.
- check out the DOJ's release
- read the Tribune's coverage