Guidant Settlement In Defibrillator Fraud Suit
Just days before trial was scheduled to begin, Guidant Corporation, a subsidiary of Boston Scientific, settled a fraud suit for an undisclosed amount, according to The New York Times. The plaintiffs claimed that the company failed to warn them that their implanted defibrillators might malfunction and knowingly chose to sell off a defective inventory. Guidant has recalled thousands of implantable defibrillators since June 2005.
The settlement comes following a meeting between the U.S. Food and Drug Administration (FDA) and Guidant to discuss the removal of several models of pacemakers and implantable defibrillators from hospital inventories due to defectiveness. The defect in these devices involves a component that controls how the device holds its power supply. The defect may cause the device to lose power and malfunction, causing intermittent or permanent loss of therapy, premature battery depletion or other malfunctions. Earlier this year, Guidant issued a press release regarding its XIENCE V Everolimus Eluting Coronary Stent, a device that is not classified as an implantable defibrillator, stating that a small percentage of the inventory "was not manufactured with strict adherence to its quality standards."
For more information regarding Guidant recalls of the above devices, see the July 2005 FDA Release, as updated in October 2005. FDA encourages consumers and professionals to submit reports directly to MedWatch, the FDA's voluntary reporting program. Reports may be submitted by telephone (800-FDA-1088), facsimile (800-FDA-0178), mail (MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787) or online.
The settlement comes following a meeting between the U.S. Food and Drug Administration (FDA) and Guidant to discuss the removal of several models of pacemakers and implantable defibrillators from hospital inventories due to defectiveness. The defect in these devices involves a component that controls how the device holds its power supply. The defect may cause the device to lose power and malfunction, causing intermittent or permanent loss of therapy, premature battery depletion or other malfunctions. Earlier this year, Guidant issued a press release regarding its XIENCE V Everolimus Eluting Coronary Stent, a device that is not classified as an implantable defibrillator, stating that a small percentage of the inventory "was not manufactured with strict adherence to its quality standards."
For more information regarding Guidant recalls of the above devices, see the July 2005 FDA Release, as updated in October 2005. FDA encourages consumers and professionals to submit reports directly to MedWatch, the FDA's voluntary reporting program. Reports may be submitted by telephone (800-FDA-1088), facsimile (800-FDA-0178), mail (MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787) or online.
Post A Comment / Question