"Patients with serious heart conditions who depend on these devices should not have to second-guess whether they are safe and effective," said Tony West, Assistant Attorney General for the Justice Department's Civil Division. "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."
Added John R. Marti, First Assistant U.S. Attorney for the District of Minnesota: "When companies like Guidant request and receive federal dollars for products they know to be defective, the U.S. is committed to aggressively seeking the recovery of those payments.
"That is especially true when the defective products endanger human lives. In today's environment, it is essential that Medicare and other public healthcare programs be made whole to ensure their continued vitality for future generations."
In a statement posted on its website, Boston Scientific said "The Guidant conduct at issue took place from 2002 to 2005, well before Boston Scientific acquired Guidant in 2006."
Boston Scientific's statement added "The Company is disappointed that the Federal Government, after reaching a criminal resolution with Guidant LLC, has chosen to seek additional money in a civil lawsuit. However, the Company believes that the ultimate resolution of this matter should not have a significant financial impact."