WASHINGTON, Jan 27 (Reuters) - The U.S. Justice Department said on Thursday that it sued Boston Scientific Corp and Guidant, which it acquired in 2006, for selling defective heart devices implanted in Medicare patients.
The Justice Department's lawsuit alleged that Guidant sold the devices even though it knew they were defective and hid the problems with their defibrillators from patients, doctors and the U.S. Food and Drug Administration (FDA).
The department said it alleged that Guidant knew as early as April 2002 that an implantable cardiac device it manufactured and sold contained a potentially life-threatening defect and it knew as early as November 2003 that another device contained a similar defect.
The lawsuit alleged that Guidant did not fully disclose the problem to doctors and the FDA until May 2005, after first being contacted by a reporter.
Guidant was acquired in April 2006 by Boston Scientific, a $27 billion deal that has caused the medical device maker numerous headaches. It has since struggled with product recalls, regulatory issues, lawsuits and a heavy debt load.
The Guidant unit last year pleaded guilty to two misdemeanor charges of withholding information from the FDA related to the heart devices and agreed to pay $296 million in fines in a settlement with the Justice Department.
In the latest case, the Justice Department said it joined a whistleblower lawsuit filed in federal court in Minnesota.
Boston Scientific shares were down 12 cents in after-hours trading to $7.04. They had closed up 1 cent to $7.16 in regular trading on the New York Stock Exchange.
(Reporting by James Vicini and Jeremy Pelofsky; Editing by Steve Orlofsky, Gary Hill) Keywords: BOSTONSCIENTIFIC/LAWSUIT (jim.vicini@thomsonreuters.com; 202-898-8396; Reuters Messaging: jim.vicini.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The Justice Department's lawsuit alleged that Guidant sold the devices even though it knew they were defective and hid the problems with their defibrillators from patients, doctors and the U.S. Food and Drug Administration (FDA).
The department said it alleged that Guidant knew as early as April 2002 that an implantable cardiac device it manufactured and sold contained a potentially life-threatening defect and it knew as early as November 2003 that another device contained a similar defect.
The lawsuit alleged that Guidant did not fully disclose the problem to doctors and the FDA until May 2005, after first being contacted by a reporter.
Guidant was acquired in April 2006 by Boston Scientific, a $27 billion deal that has caused the medical device maker numerous headaches. It has since struggled with product recalls, regulatory issues, lawsuits and a heavy debt load.
The Guidant unit last year pleaded guilty to two misdemeanor charges of withholding information from the FDA related to the heart devices and agreed to pay $296 million in fines in a settlement with the Justice Department.
In the latest case, the Justice Department said it joined a whistleblower lawsuit filed in federal court in Minnesota.
Boston Scientific shares were down 12 cents in after-hours trading to $7.04. They had closed up 1 cent to $7.16 in regular trading on the New York Stock Exchange.
(Reporting by James Vicini and Jeremy Pelofsky; Editing by Steve Orlofsky, Gary Hill) Keywords: BOSTONSCIENTIFIC/LAWSUIT (jim.vicini@thomsonreuters.com; 202-898-8396; Reuters Messaging: jim.vicini.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2011. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.