Parker & Waichman, LLP Investigating Guidant Defibrillator Claims after Receiving Hundreds of Inquiries from Patients Nervous About the Risk of Device FailureJun 27, 2005 | PRIMEZONE
Parker & Waichman, LLP (www.yourlawyer.com) announces that it has commenced an investigation into defective defibrillators manufactured by Guidant Corporation (NYSE: GDT).
The investigation comes after the firm was contacted by hundreds of concerned patients following Guidant’s recall announcement for thousands of defective implantable cardioverter defibrillators, or ICD’s. Parker & Waichman, LLP is offering free case evaluations to all cardiac defibrillator patients as many patients do not know their exact defibrillator model. To receive a free case evaluation, please visit: http://www.yourlawyer.com/practice/overview.htm?topic=Guidant%20Defibrillators .
On June 16, 2005 Guidant announced that, in conjunction with the FDA, it was recalling 50,000 faulty cardiac defibrillators due to life threatening malfunctions in the devices. Seven Guidant ICD models were part of this recall, including the VENTAK PRIZM 2 DR, VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT, RENEWAL 4 AVT, CONTAK RENEWAL (Model H135) and the CONTAK RENEWAL 2 (Model H155).
In a company press release, Guidant said the PRIZM 2 model has had 28 reports of failure and one death in the 26,000 devices built before April 2002. The CONTAK model has 15 reports of failure and one death in the 16,000 devices built before August of 2004. Both the PRIZM 2 and CONTAK models have a flaw that causes the defibrillators to short circuit and fail to deliver a shock to the heart. The VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL 4 AVT ICDs were being recalled because of a memory error that has caused two confirmed malfunctions in 21,000 implants. This error requires the devices to be reprogrammed.
Less than one week after the major recall was issued, Guidant issued an advisory warning about five more of its defibrillator models which have a potential electrical defect (faulty switch) that could cause a malfunction. Those models are the CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF. There are some 46,000 of these devices already in use. Guidant acknowledged that the FDA may classify this advisory as a recall.
In its August 2003 annual report, Guidant first informed the FDA of problems with its defibrillators, but the company never notified patients or doctors about the defects. It has been alleged that the company only notified patients and doctors about the defects after learning that the New York Times was preparing an article on May 23, 2005 about the faulty devices. The New York Times reported that Guidant failed tell doctors and patients for three years that the VENTAK PRIZM 2 DR model contained a flaw that has caused some defibrillators to short-circuit . However, Guidant stood by its decision to continue selling the PRIZM 2 DR for months, declaring that the original device was still reliable.
“It certainly appears that Guidant became aware that their defibrillators were defective some time ago, but they chose to hide the problems from patients and doctors,” said Herb Waichman, founding partner of Parker & Waichman, a law firm committed to helping people with defibrillators explore their legal options. “This is an egregious example of a company putting profits over patient safety. How a company could continue to sell faulty heart devices while knowing that device failure can lead to loss of life is a question that our clients would like answered.”
Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide with offices in New York and New Jersey. Parker & Waichman, LLP has helped thousands of clients receive fair compensation for injuries resulting from defective medical products. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-YOURLAWYER (1-800-968-7529).
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