January 28, 2011 – The Civil Division of the U.S. Department of Justice (DOJ) filed a civil False Claims Act lawsuit against Boston Scientific, Guidant LLC and other entities seeking additional payments related to faulty implantable cardioverter defibrillators (ICDs).
The complaint involves Guidant's conduct leading to the 2005 recalls of Prizm 2 and Renewal 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 into this conduct in 2005, and that investigation resulted in a plea agreement between Guidant LLC and the Criminal Division of the DOJ in November 2009.
Shortly after reaching this plea agreement with the Criminal Division of the DOJ, the company was notified that the Civil Division of the DOJ was initiating an investigation into whether Guidant should make an additional payment of a civil penalty under the False Claims Act. This DOJ civil investigation has been disclosed in periodic SEC filings since that time.
Boston Scientific issued a statement today saying the company is disappointed that the federal government, after reaching a criminal resolution with Guidant, has chosen to seek additional money in a civil lawsuit. However, the company believes the ultimate resolution of the matter should not have a significant financial impact.
For more information: www.bostonscientific.com