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this pageFDA Warns Guidant About Plant Problems; Limits Sale of Some Guidant Defibrillators and Pacemakers
WASHINGTON, DC — January 6, 2006 — A manufacturer of heart devices, Guidant Corporation, recently received a warning letter from the Food and Drug Administration (FDA) about “significant” problems at its plant in St. Paul, Minnesota. The FDA charges that violations that it found in an August inspection have not been corrected. These include inadequately packing, storing, processing, tracking and testing products as well as failing to identify defects. The agency will not allow exports or new uses of the heart devices until Guidant corrects the deficiencies.
Guidant makes implantable pacemakers and defibrillators. A defibrillator 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. A pacemaker is used to manage a heartbeat that is too slow or irregular. It contains a battery and lead that sends electrical pulses to the heart to maintain normal rhythm. The FDA letter noted that 35 of Guidant’s Insignia pacemakers failed since September 1, 2005, because they had loose material in their crystal components.
Guidant Knew About Defibrillator Risks, Company Documents Show
Guidant knew as early as 2002 that short circuits might occur in 15 out of every 10,000 of its Prizm 2 DR Model defibrillators, according to company documents produced in a lawsuit against Guidant in Texas (New York Times, December 24, 2005). About 1 in 10 of these defibrillator failures would be life threatening or fatal, the company estimated.
Another Guidant document stated that the company would not further investigate the defibrillator defects unless the failure rate reached 15 devices per year. Guidant finally notified doctors of the Prizm 2 DR defibrillator problem at the end of May, 2005, when it learned that the New York Times was preparing an article critical of the device, the newspaper reported.
The FDA recalled the Prizm 2 DR defibrillator in June, 2005. At that time, the agency also recalled two other Guidant defibrillators, the Contak Renewal and the Contak Renewal 2, which were also prone to short–circuiting. All three defibrillators were part of the most urgent category, a “Class 1” recall for drugs or devices that may cause severe damage or death. Last month, the FDA belatedly received reports of a total of three more deaths from the three defibrillators (New York Times, December 14, 2005). The fatalities had occurred shortly after the recalls.
“For Guidant, these people are numbers,” charged Dr. William Maisel, a heart doctor at Beth Israel Deaconess Medical Center in Boston and chairman of the FDA advisory committee that reviews heart devices (New York Times, December 24, 2005). “Their descriptions are full of numbers. But for me, these patients are people.”
Other Guidant Defibrillators Are Flawed
Guidant heart devices have been involved in other serious, but less urgent recalls known as “Class 2” recalls. Some newer Guidant defibrillator models have a switch that can stick in the “off” position. Another model has a programming error that may limit heart therapy unless it is readjusted. For a list of models, see Other Flawed Guidant Defibrillators.
Both the Class 1 and Class 2 recalls mean that these heart devices will no longer be sold. However, the FDA has not issued advice about whether implanted Guidant defibrillators should be removed and replaced. Doctors will consider the possibility that a defibrillator will fail as well as the risks involved with replacing it, including injury and infections.
Brayton Purcell is currently evaluating claims about defective defibrillators and pacemakers. Please feel free to contact us if you or a loved one has been injured and would like to receive legal information. We have been handling medically–related consumer cases for over 20 years, and have represented hundreds of clients against medical device manufacturers.