On July 1, 2005, the Food and Drug Administration (“FDA”) issued its highest level warning regarding health risks associated with Guidant Implantable Defibrillators. In addition to this warning, which applied to three recalled models, an additional alert was issued as to numerous other models manufactured by the company. The reason for this high level warning was that failure of a defibrillator, whose purpose is to shock an irregularly beating heart back to proper rhythm, can result in death.
On June 17, 2005, approximately two weeks before the FDA health alert, Guidant recalled nearly 50,000 of it’s cardiac defibrillators because of defects which lead to serious injury and death among patients who had the implanted devices. The company acknowledged that the devices had failed on at least 45 different occasions. Approximately one week later, Guidant extended the recall and issued a second safety advisory wherein doctors were directed to stop using additional models of it’s cardiac defibrillator because of malfunctions caused by defective wiring. According to the manufacturer this defect could cause the device to short circuit and fail to operate. The two warnings related to the following defective Guidant Implantable Cardiac Devices (“ICDS”):
Prizm 2 DR
Contak Renewal 2
Ventak Prizm AVT
Renewal 3 AVT
Renewal 4 AVT ICDS
Finally, on July 18, 2005, Guidant Corp. announced that nearly 28,000 of its pacemakers were potentially dangerous and may need to be replaced. The company admitted that it was aware of 69 failures among these pacemakers, all manufactured between 1997 and 2000. The problem with these devices involve a degraded sealing component that can allow excessive moisture to enter the devices.
Clearly, there has been a recent flurry of activity regarding Guidant Corp. defibrillators. Yet the public should not be deceived into believing that these announcements reflect newly discovered information by the company. GUIDANT FAILED TO INFORM DOCTORS OR PATIENTS FOR NEARLY THREE YEARS THAT CERTAIN ICDS IT MANUFACTURED HAD A DEFECT WHICH COULD NECESSITATE THOUSANDS OF PATIENTS TO UNDERGO INVASIVE SURGICAL PROCEDURES TO REMOVE AND REPLACE THE UNITS.
Oshman & Mirisola, LLP is handling legal claims against Guidant involving its manufacture and sale of defective Implantable Cardiac Devices. If you have been affected by one of these units, please call us or complete the accompanying questionairre for a free case evaluation.