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this pageFDA Knew About Guidant Defibrillator Problems
WASHINGTON, DC — September 23, 2005 — In February of this year, the Food and Drug Administration (FDA) received a report about short–circuiting in heart defibrillators made by Guidant Corporation, but did not issue an alert about this serious defect until June, according to a recent New York Times story (September 12, 2005). The defibrillators were short–circuiting at the rate of about one a month, the report said.
A college student, Mr. Joshua Oukrop, died in March when his Guidant defibrillator malfunctioned. Dr. Robert Hauser of Minneapolis, the physician who treated Mr. Oukrop, said that he was outraged that the FDA had been aware of the defibrillator defect, but had not informed physicians until months later. He concluded that if the agency had disclosed the problem, Mr. Oukrop’s defibrillator would have been replaced and his life may have been saved.
How a Heart Defibrillator Works
A defibrillator is a surgically implanted device that provides a shock to the heart to restore it to normal rhythm. Its purpose is to prevent cardiac arrest, a condition in which the heart stops or is unable to pump blood. The defibrillator in question was the PRIZM 2 DR, which was recalled in June (FDA News, June 17, 2005). The FDA recalled two other Guidant defibrillators that month for similar reasons—the CONTAK RENEWAL, Model H135 and the CONTAK RENEWAL 2, Model H155
All three defibrillators were part of a “Class 1” recall, the most urgent recall category. If a Class 1 device does not function properly, it can cause severe health problems or death. Five other Guidant defibrillators were recalled for less urgent problems. See Guidant Defibrillators for details.
According to the New York Times, Guidant knew for at least three years that its defibrillator models were defective (New York Times, June 25, 2005). A securities fraud lawsuit filed in federal court in Indianapolis, IL, also charges that Guidant covered up problems with its heart defibrillators in order to inflate stock prices.
Defibrillator Defects Are Increasing
In what is perhaps an attempt to stem criticism about its handling of Guidant recalls and reports, the FDA recently released its own study about defibrillators and pacemakers (FDA News, September 16, 2005). A pacemaker is an implanted device that helps the heart beat regularly and at a sustained pace. It is smaller than a defibrillator, and often used to correct slow heartbeats.
The FDA study, which was presented at a joint conference of the Heart Rhythm Society and the FDA, found that:
- Out of about 2.25 million pacemakers and 416,000 heart defibrillators implanted in the United States from 1990–2002, 17,323 devices (8834 pacemakers and 8489 heart defibrillators) had to be removed because of malfunctions.
- The rate at which heart defibrillators must be replaced due to malfunction is much higher (20.7 per 1,000 implants) than the rate of pacemaker replacements (4.6 per 1,000 implants).
- The heart defibrillator replacement rate due to malfunctions increased during the last half of the study, especially in the last three years.
- Pacemaker or defibrillator malfunctions were responsible for 61 deaths during the twelve–year period covered by the study. .
“In hindsight, the agency [FDA] perhaps could have connected the dots sooner,” admitted Bram Zuckerman, director of the FDA’s cardiovascular device division and a co–author of the study (USA Today, September 18, 2005). He talked about changes that could be made to ensure the safety of defibrillators and pacemakers.
The FDA has promised to improve its review of annual reports from companies making heart devices, and to provide better information about these devices to the medical community. It will form a special working group within its heart device division that it hopes will speed up communication. The agency is also considering these proposals: designing a new electronic system to monitor adverse events from heart devices, performing more inspections of firms that manufacture heart devices, and developing guidelines to make sure companies provide detailed information about heart device failures.
Despite these FDA announcements, Rep. Edward Markey (D–MA) and others are not yet convinced that the FDA is doing all it can to alert and protect the public from unsafe medical devices (Press Release, September 14, 2005). He had these comments about the FDA’s failure to promptly disclose the Guidant defibrillator defects: “The public deserves to know whether this is a case of FDA incompetence and lack of diligence, or whether the FDA made a decision to protect the company’s confidentiality over the public health. Either way, we have a serious problem on our hands.”
Brayton Purcell is concerned about defective Guidant defibrillators and other unsafe medical devices. Please feel free to contact us if you have been injured by a medical device and would like legal information. We have been handling medically–related consumer cases for over 20 years, and have represented hundreds of clients against medical device manufacturers.