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Class Action Lawsuit Filed Against Guidant Over Defibrillators
Source: PR Newswire
Published: June 27, 2005
A class action lawsuit was filed against Guidant Corp on behalf of patients implanted with malfunctioning defibrillators made by the company. The devices were recalled after they failed to work properly.
The devices recalled include the VENTAK PRIZM 2DR (Model 1861), the CONTAK RENEWAL (Models H135 and H155) and the VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL 4 AVT ICDs.
According to Guidant's news 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.
At this time, the FDA is not recommending that individual patients who have one of the Guidant devices have it removed or replaced.
"This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient," the Agency said. "Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision."
The law firms Weitz & Luxenberg and Seeger Weiss filed the lawsuit.
Cardiac patients who been implanted with any recalled models, those who have undergone replacement surgeries, or who have suffered emotional injuries due to malfunctioning defibrillators may view the law firms' corporate websites at
http://www.weitzlux.com/ and
http://www.seegerweiss.com for more information.
Read Full Story at PR Newswire