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product_liability guidantGuidant Heart Defibrillators
Johnson & Johnson announced it had plans to acquire Guidant Corp. in a $25.4 billion deal in December 2004, in part to gain access to its heart defibrillator line. There could be renegotiation in the future, however, in light of the recent Guidant heart defibrillator recall announcement made June 17, 2005.
Announced on a Friday, the Guidant heart defibrillator recall affects about 50,000 of the devices. The defects among the various Guidant heart defibrillators have led to at least 45 reported malfunctions, including the deaths of two patients with the affected devices. After disclosing the Guidant heart defibrillator problems, J&J said it would continue to work towards a third quarter 2005 close of the acquisition, though acknowledging the reported events “are serious matters.”
By the following Monday, the company’s announcement regarding its Guidant heart defibrillator caused its shares to drop three percent. The U.S. Food and Drug Administration put a “recall” label on the devices – meaning Guidant must notify doctors and patients of potential problems. Though just one analyst downgraded Guidant shares, the FDA has yet to categorize the recall – which could range from the severe Class I to the least severe Class III. Should the FDA feel the Guidant heart defibrillator announcement requires a Class I status, the company’s potential costs because of the safety defects could significantly increase.
Currently, the FDA is expected to categorize the Guidant heart defibrillator recall as a Class II. The announcement affects 17,000 Guidant heart defibrillators categorized as the Ventak Prizm 2 DR models built before April 16, 2002. Of the affected Ventak Prizm 2 DR Guidant heart defibrillators, 13,900 of them are in the U.S. and contain a wiring flaw that can disable the device. There are so far 28 failures reported on the devices, one resulting in a death.
The Contak Renewal Guidant heart defibrillators built before August 26, 2004 also have a wiring problem that has affected a reported 15 devices, one resulting in a death. There are currently 11,900 of these Guidant heart defibrillators still in service, 6,700 in the U.S. All of the company’s implanted Ventak Prizm AVT, Vitality AVT and Renewal AVT devices have a memory error that can affect therapy. There are two reported incidents where the Guidant heart defibrillators failed to work properly.
There are 21,000 of these model implanted worldwide, according to the company, including 18,000 in the U.S. (view a list of the recalled Guidant devices and their model numbers.) Though the company said it expects to use a noninvasive software fix for the devices that would be administered on a patient’s next office visit, FDA spokeswoman Julie Zawisza said the devices do not fall under the agency’s recall notice.
Request more detailed Guidant recall information and submit your potential case for a free and confidential consultation by contacting the experienced product liability lawyers of Miller and Associates
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