Guidant Defibrillators Were Subject to Short–Circuiting
Guidant Ignored Consultant’s Advice to Release Data on Defibrillator Defects
CORPUS CHRISTI, TX — March 17, 2006 — A consultant hired by the heart device manufacturer, Guidant, advised the company to inform doctors about serious defects in its defibrillators last May, according to documents released in a Texas case (NY Times, March 9, 2006). When the company neglected to do so, the only two doctors who had been told about the problem went public with the information, which Guidant had known for three years. The defibrillators were recalled in June, and Guidant finally released detailed data about product failures in November.
A defibrillator is a surgically implanted device that provides a shock to the heart, restoring natural heart rhythm. Its purpose is to prevent cardiac arrest. The flawed devices were the PRIZM 2 DR 1861, CONTAK RENEWAL H135 and CONTAK RENEWAL H155. These models can short–circuit, leading to serious injury or death.
Guidant’s consultant, Dr. Richard Fogoros, wrote that by withholding information about the defibrillators from doctors, Guidant violated its basic ethical duty and “sacred obligation.” “Neither the doctor nor the patient consider themselves to have signed up to have Guidant dictate any treatment plans,” he wrote, according to the Times. Guidant had claimed that it did not release data because removing defective devices from patients poses risks and the percentage of defibrillators with defects was low. Normal procedure is to remove a defibrillator every five years and replace it with a new one.
The Death of Joshua Oukrop
Dr. Barry Maron was one of the doctors who told the New York Times about Guidant product defects last May. His 21–year–old patient, a college student named Joshua Oukrop, had died of cardiac arrest in March, 2005, when his Guidant PRIZM 2 DR defibrillator failed. Shortly after Mr. Oukrop’s death, Dr. Maron spoke with Guidant executives and was told about the short–circuiting defect.
“Joshua Oukrop’s death was not due to an unforeseen ‘random’ defibrillator failure, as suggested by Guidant to physicians ... but in fact was a systematic, repetitive and to some extent predictable defect ... and no one else knew,” Dr. Maron said at a recent Senate Judiciary Committee hearing (Testimony of Barry Maron, M.D., March 10, 2006). “In effect, Guidant had by themselves taken over the medical management of thousands of high–risk defibrillator patients.”
“It [Guidant’s failure to disclose information] is not a statistical issue,” he also commented. “It is not about percentages and likely probabilities. Patients are not numbers ... they are individuals with the reasonable expectation that industry ... in this case defibrillator manufacturers ... will communicate openly and accurately with their physician ... and in their best interest.”
More Problems with Guidant Defibrillators
About 42,000 Guidant defibrillators could have the short–circuiting defect, and 20,600 of these were implanted. Other defibrillator models have a switch that can stick in the “off” position, making them unable to treat abnormally fast heart rhythms. These defibrillators were also recalled. See Guidant Defibrillators Can Leave You Heartbroken for more details and a list of models.
This month, Guidant issued a warning about battery problems in its CONTAK RENEWAL 3 RF and RENEWAL 4 RF implantable defibrillators. So far, the company says that it has received 39 reports of low battery voltage.
Medical Devices and Your Legal Rights
Brayton Purcell is currently evaluating claims about defective defibrillators. Please feel free to contact us if you or a loved one has been injured and would like information about your legal options.
