Manhattan law firms Weitz & Luxenberg, PC and Seeger Weiss, LLP have jointly filed a class action lawsuit on behalf of patients implanted with malfunctioning defibrillators manufactured by Guidant Corporation.
Guidant, which has been in acquisition talks with pharmaceutical giant Johnson & Johnson, has recalled the VENTAK PRIZM 2 DR (Model 1861), the CONTAK RENEWAL (Models H135 and H155) and the VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL 4 AVT ICDs after the devices failed to work properly.
According to Guidants press release of June 17, 2005, the PRIZM 2 model has had 28 reports of failure and one death in 26,000 devices built before April 2002. The CONTAK model has 15 reports of failure and one death in 16,000 devices built before August of 2004. Both models have a flaw that causes a short circuit, preventing the defibrillator from delivering a shock to a heart in fibrillation.
The VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL 4 AVT ICDs have a memory error causing two confirmed malfunctions in 21,000 implants. The memory error requires the devices to be reprogrammed.
Guidant has already come under scrutiny for failing to tell doctors and patients for three years about a flaw in the VENTAK PRIZM 2 Model 1861 that could cause a short-circuit. While Guidant informed the FDA of the malfunction in its August 2003 annual report, it has been asserted that the company made no move to alert doctors or heart patients of the malfunction until after it was told that the New York Times was preparing an article on May 23, 2005 about the faulty devices.
Patients who have been implanted with the flawed devices now face difficult medical and emotional choices, since the faulty defibrillators most likely require replacement. Defibrillator patients will be forced to undergo dangerous cardiac surgery or cope with the stress and mental anguish of not knowing if their defibrillator might malfunction at a critical moment. They must also contend with lost wages, medical bills, and rehabilitative expenses following replacement surgery.