Friday, January 28, 2011

DoJ go after Guidant and Boston Scientific


WASHINGTON -- The Justice Department has filed suit against two makers of implantable cardioverter defibrillators -- Guidant and Boston Scientific -- to recoup federal dollars spent on defective devices that were implanted in Medicare patients.
Boston Scientific purchased Guidant in 2006, and a year ago Guidant pleaded guilty to misleading the FDA about the problems in the devices. A district court in Minnesota accepted the company's plea on Jan. 12, 2011.
The complaint involves the Ventak Prizm 2 and the Renewal 1 and 2 devices.
The Justice Department claims that, in addition to actively concealing the problems with the devices, even after Guidant fixed some of the devices, the company continued to sell defective ones that remained in the company's inventory.
"When companies like Guidant request and receive federal dollars for products they know to be defective, the United States 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," said John R. Marti, First Assistant U.S. Attorney for the District of Minnesota in a statement released to the press.
In this new complaint, the Justice Department alleges that Guidant knew as early as April 2002 that the devices were defective but did not disclose problems until May 2005. And, even then, the disclosure only came after an article in the New York Times described the defects.
The Justice Department said the government has "joined a lawsuit filed under the qui tam or whistle blower provisions of the False Claims Act by James Allen, who allegedly received one of the defective devices. Under the act's qui tam provisions, a private citizen, known as a 'relator,' can sue on behalf of the United States and share in any recovery."
This latest action comes just days after the Heart Rhythm Society informed its members that it was cooperating with federal prosecutors who are investigating physicians' prescribing practices relating to ICDs.

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