The Civil Division of the US Department of Justice (DOJ) has filed a civil False Claims Act complaint against Boston Scientific, Guidant and other entities.
The complaint involves Guidant’s conduct leading to the 2005 recalls of Prizm 2 and Renewal implantable cardioverter defibrillators (ICDs).
The Guidant conduct at issue took place from 2002 to 2005, well before Boston Scientific acquired Guidant in 2006.
The Criminal Division of DOJ initiated an investigation, which resulted in a plea agreement between Guidant and the Criminal Division of the DOJ in November 2009.
After reaching the plea agreement, Guidant was notified that the investigation was to find whether it should make an additional payment of a civil penalty under the False Claims Act.
Guidant is disappointed that the Federal Government, after reaching a criminal resolution, has chosen to seek additional money in a civil lawsuit.