Boston Scientific Corp. and its subsidiary, Guidant, will pay $30 million to settle allegations that Guidant knowingly sold defective heart devices that were implanted in Medicare patients between 2002 and 2005.
In a civil action filed by the United States Department of Justice on January 27, 2011, the DOJ alleged that Guidant knowingly sold defective implantable defibrillators. These devices are surgically implanted into patients’ chests to detect irregular heartbeat, then send an electrical pulse to the heart to jolt its rhythm back to normal and prevent sudden cardiac death.
Guidant knew the devices were defective as early as 2002 and fixed the problem, but continued to sell the remaining stock of old, defective versions despite the risks to human life. The DOJ alleged that Guidant hid the defect from patients, doctors and the FDA until 2005, when a front-page article in The New York Times prompted Guidant to recall the devices. In 2010 Guidant pleaded guilty to criminal charges of misleading the FDA by hiding the problems with the defibrillators.
The specific devices were the Ventak Prizm 2 and the Renewal 1 and 2. If you or a loved one had one of these devices implanted and suffered any injury as a result of getting a defective version, contact Lopez McHugh for a free legal consultation.