Medical Devices

Heart Devices - Defibrillators

Since January 2005, Indianapolis-based Guidant Corp. and the nation's two other primary heart device makers — Fridley, Minn.-based Medtronic Inc. and St. Jude Medical Inc. of Little Canada, Minn. — have issued recalls or safety warnings affecting hundreds of thousands of pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).  The risks have ranged from remote serious adverse health consequences to death.

Guidant ( Indianapolis , Indiana ) devices have been at the top of the list with recalls affecting more than 80,000 ICDs and CRT-Ds, as well as potentially faulty, older pacemaker models.  It was a Guidant Ventak Prizm 2 DR ICD that short circuited in March of 2005, resulting in the death of Joshua Oukrop, a 21-year-old Minnesota college student.  Joshua was in Moab , Utah , on a spring-break bicycling trip when he fell to the ground and died of cardiac arrest.

All the electrical malfunctions involving the particular model occurred in units produced during a two-year period before mid-2002 when Guidant fixed the defect.  However, Guidant waited for three years – until learning that The New York Times was preparing an article about the device – to inform doctors and patients of the flaw. 

Dr. Robert G. Hauser and Dr. Barry Maron, Joshua's physicians, say that had they known earlier, they would have replaced the unit in their patient because he was high risk for sudden death.

Implanted defibrillators are among the fastest-growing group of medical devices with 2005 sales expected to range from 250,000 to 300,000.  However, as greater numbers of these increasingly more complex devices are implanted, they are malfunctioning at rising rates. 

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If you or a loved one have been injured as a result of these medical devices, call us at 800-748-7115 or email Attorney Joe Saunders at joe@saunderslaywers.com