For conduct relating to certain of its cardiac devices, the U.S. filed a complaint on Jan. 27 against both Boston Scientific Corp. and Guidant. Under the False Claims Act, the government alleges that Guidant sold cardiac devices, the Ventak Prizm 2 and the Renewal 1 and 2, even though Guidant knew the devices were defective. Despite Guidant's fixing the defect in these lines of devices, the company continued to sell their remaining stock of defective devices anyway, the U.S. department said in a statement.
The devices at issue are implantable cardioverter defibrillators, which are designed to deliver therapy to prevent sudden cardiac death. The devices are surgically implanted into patients' chests. When they detect an irregular heartbeat, the devices send an electrical pulse to the heart to "shock" it back to normal rhythm.
The government charges that Guidant hid the problems with their defibrillators from patients, doctors and the FDA. In February 2010, Guidant pleaded guilty to misleading the FDA about the problems in the devices. Guidant was acquired by Boston Scientific in 2006.
"When a medical device manufacturer conceals problems with its products, as is alleged here, not only is taxpayer money wasted, but lives are put at risk," said Tony West, assistant Attorney General for the Justice Departments Civil Division.
The goverment further alleges that Guidant did not fully disclose the problem in the devices to doctors and the FDA until May 2005, after first being contacted by a reporter. The company subsequently recalled the devices shortly after a front-page article about the defects appeared in The New York Times.