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product_liability guidantGuidant Recall
Thousands of cardiac patients are now wondering if they must undergo another surgery to replace a possible cardiac defibrillator defect. Guidant Corp. announced it was issuing a Guidant recall on its implanted cardiac defibrillator on June 17, 2005. Affecting around 50,000 of the devices, the Guidant recall is linked to at least 45 failures of the device and the deaths of two patients.
Although neither Guidant nor the FDA recommended the devices be removed or replaced, the Guidant recall has left patients confused about their individual risks. Some doctors are prepared to receive a high volume of phone calls and office visits from patients with the devices affected by the Guidant recall, but the company and FDA officials said patients should continue normal visits with their doctors.
In addition, Guidant said patients who recently received a defibrillation shock from their device should check with their doctors. Implanted in cardiac patients to sense and correct an irregular heartbeat, the Guidant recall was issued after the company said some of its Ventak Prizm 2 DR models built prior to April 16, 2002 that remain in use contain a wiring flaw that can disable them. The company said 17,000 of the particular model remain in use, and 13,900 of those are in the U.S. A reported 28 failures have been made in association to the particular Guidant recall model, one resulting in a death.
Guidant’s Contak Renewal devices that were built prior to August 26, 2004 also have wiring problems and are included in the Guidant recall. Fifteen reported failures have been made in association with the model, one resulting in a death. There are 11,900 of the Guidant recall models still in service, 6,700 in the U.S.
In addition to wiring flaws, all models of Guidant’s implanted Ventak Prizm AVT, Vitality AVT and Renewal AVT devices have a memory error that can affect therapy. In two incidents, the devices have failed to work properly because of the defect. Initially, the company indicated it would not cover the Guidant recall replacements of more than five years old since they are off-warranty, but the company appeared to have changed its position.
At the time of the Guidant recall announcement, the company began telling doctors it will pay to cover the entire cost of each replacement defibrillator among the models at risk of failing. There are 21,000 devices implanted worldwide with computer memory problems affected by the Guidant recall, including 18,000 in the U.S. Guidant said it expects to use a non-invasive software fix for the devices that would be administered on a patient’s next office visit. (view a list of the recalled Guidant devices and their model numbers.)
News of the Guidant recall is expected to affect the Johnson & Johnson acquisition. The health care company had plans to acquire Guidant, partially because of its defibrillator line. Though J&J said it is continuing to work on a third-quarter close of the purchase, the Guidant recall announcement could result in a renegotiation of the $25.4 billion deal that was announced in December 2004.
Costing an estimated $25,000 per unit for each replacement defibrillator, Guidant could be facing costs of as much as $225 million because of the Guidant recall.
Contact the experienced product liability lawyers of Miller & Associates to assist you with your Guidant defibrillator concerns.
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