U.S. Files Whistleblower Suit Against Boston Scientific/Guidant

The United States has filed a complaint against Boston Scientific Corp. and related Guidant companies, under the False Claims Act, for selling cardiac devices which it knew were defective. Implantable cardiocerter defibrillaors designed to send a pulse to the heart to prevent sudden death. The government says Guidance knew as early as 2002 that the devices were potentially life-threatening. In Feb 2010 Guidant pleaded guilty to misleading the FDA about the problems. Guidant was fined $296 million in that case. The suit joined by the government was filed under seal in 2008 by whistleblower James Allen, a patient who had the device implanted and had it surgically replaced after it shocked him into unconsciousness knocking him down a flight of stairs. Under the law, he could receive upto 25% of what the government receovers. Guidance was acquired by Boston Scientific in 2006.