Dangerous Drugs & Medical Devices

Guidant pacemaker/defibrillator

Guidant pleads guilty to concealing defibrillator defects
January 13, 2011

Guidant Corporation pled guilty in federal court this week on charges that it had suppressed information about defects in its implantable pacemaker-defibrillators. Guidant submitted a plea agreement in federal court in St Paul Minnesota, in which it pled guilty to concealment of information. US District Judge Donovan Frank accepted the plea agreement, which included a $296 million fine, and he placed the company on probation for three years.

Guidant initiated a recall in 2005 with a letter to physicians warning about the risk of short circuits, with possible consequences including heart failure and deaths. At that time it had a case file of 69 incidences of pacemaker failure, some of which had resulted in patient deaths. The FDA classified Guidant’s action as a Class I recall, the most serious level of recall.

Department of Justice prosecutors asserted in court that Guidant had known since 2002 that a seal on some of its implantable defibrillators was at risk of leaking, which could lead to short-circuiting and failure. For more than three years Guidant suppressed this information, telling neither patients nor surgeons nor FDA officials. Assistant US attorney stated in court that, “there were decisions made deliberately to advantage the company by withholding information and misrepresenting information.”

At the time of the recall some 18,000 Guidant defibrillators were in service in the US, and another 10,000 world wide. The actions of the Justice Department and concerned medical device attorneys led to the recall and the eventual resolution of the case.

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The Guidant pacemaker/defibrillator is a device surgically implanted in the heart to regulate heart rhythm. The FDA’s warning stated, "A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death." As many as 28,000 people have had this device implanted, and may be at risk.

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