New York (PRWEB) July 5, 2005
Napoli Kaiser Bern, LLP announced today that it is investigating claims and concerns raised about defective cardiac defibrillators. Among those included in the investigation are defibrillators manufactured by Guidant Corporation and Medtronic. This investigation was spurred by recent news reports and calls from hundreds of worried patients following Guidant's recall of thousands of defective defibrillators in recent weeks. Of particular concern for patients is the fact that known defects in the defibrillators were not immediately reported to doctors or patients.
Guidant's decision to issue the recall came last week, after urging by the Food and Drug Administration. On June 17, 2005 Guidant Corp. issued a worldwide recall of nearly 50,000 cardiac defibrillators. These devices are surgically implanted in patients to prevent death from cardiac arrhythmias. The recall was necessary because of defects that could lead to serious injury and death.
"It is troubling to see that companies who are in the business of creating and marketing products for health care can be so cavalier about concealing known defects that threaten the very patients who depend on them," said Marc Jay Bern, a Senior Partner at Napoli Kaiser Bern. "We intend to investigate these claims thoroughly and in doing so, we will remind these corporate decision-makers that serious consequences will result from putting the bottom-line before the value of their patients' health and quality of life."
Cardiac defibrillators are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmias, originating in the lower chambers of the heart. The defibrillators are implanted surgically in the patient's chest. Defibrillators emit an electrical jolt to restore rhythm to a chaotically beating heart. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock.
Approximately 38,000 defibrillators have been implanted in patients in the United States. The defective Guidant models are: Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs. Guidant Corp. failed to inform doctors or patients for three years that some of their defibrillators had a defect that caused the affected devices to short-circuit.
Within a week of their initial recall announcement, Guidant issued a second safety advisory about its implantable defibrillators. Guidant told doctors to stop using five of the models because they could malfunction due to a defective switch. The latest warning applies to Guidant's Contak Renewal 3 and 4 models, Renewal RF model and the Renewal 3 and 4 AVT devices, which were included in the June 17 safety advisory.
Guidant did not tell doctors for over three years about the electrical flaw in one model, the Ventak Prizm 2 DR Model 1861, that it has recalled. It also kept selling older versions of it after developing a version not prone to short-circuiting. As noted in a recent New York Times report, Guidant's failure to disclose this problem to physicians has caused some patients to feel a sense of betrayal. Earlier disclosure might have spared these patients the tough choice they now face: to have risky surgery to replace the units or take the chance that their unit will not fail at a critical moment when defibrillation is needed.
Guidant's recall follows on the heels of Medtronic's recall of two of its defibrillators because they have been linked to at least four deaths and one injury. Medtronic said that some of these defibrillators have failed to charge properly which can result in the late delivery or nondelivery of cardiac shock therapy. The charging problem involves the Medtronic Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 implanted cardioverter-defibrillators.
Medtronic said that most of these devices were implanted in 1997 and 1998. About 1,800 are thought to be still in use. Medtronic said that with the suspect defibrillators, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or nondelivery of shock therapy. A delay or nondelivery of shock therapy can be life threatening.
The surgery to replace a defibrillator, which is the size of a pager and is implanted under the skin of the upper chest near the shoulder, takes an hour, and many people go home immediately afterwards. Full recovery takes about 7 to 10 days. Like any surgical procedure, the surgery carries a risk of infection. Infection occurs in 1 percent or less of operations, several physicians said. But patients with certain conditions, such as a weakened immune system, or who take certain drugs, such as blood thinners, may face a higher than average risk of infection, serious bleeding or other problems. Defibrillators normally have to be replaced every five to six years due to battery life; the decision as to whether to replace the defective units sooner depends on the patient's age, physical condition, and the nature and severity of the cardiac problem that led to the unit being implanted in the first place.
About Napoli, Kaiser & Bern
Napoli, Kaiser & Bern, LLP is a law firm experienced in prosecuting personal injury actions on behalf of its clients. The firmÂs litigation practice is focused on mass tort, medical malpractice, products liability, and negligence actions. Their office has been instrumental in the development of new law in the area of personal injury law and consumer rights. Napoli, Kaiser & Bern has law offices in New York City, New Jersey, Philadelphia and Oklahoma. For more information visit http://www.nblawfirm.com or call 1-888-LAW-IN-NY.