Guidant Pleads Guilty to Two Misdemeanors
By Rachel Stockton
Guidant, LLC, a division of Boston Scientific Corporation, plead guilty to two misdemeanors regarding two of its defibrillator models Monday.
Specifically, in 2002, Guidant discovered a circuitry failure in its Ventak Prizm 2 DR model, one that could have prevented the device from providing lifesaving, electrical jolts to patients with electrical malfunctions in their hearts.
Although Guidant corrected the problem, they misled the U.S. FDA by stating that the error in the defibrillator would not affect the efficacy or safety of the device.
According to the New York Times, the company also discovered a problem with two of its Renewal models in 2004. These particular devices beeped if something was wrong, sending a patient to the cardiologist to get checked out. Unfortunately, the warning screen did not fully disclose the extent of the problems discovered.
The plea deal mentioned a specific case wherein a patient was sent home after leaving the office of his physician, who followed the prompts on the screen. The patient died from cardiac arrest one week later.
In response, Guidant reported the incident to the FDA as a product correction, when in fact, according to the plea deal, it should have been labeled as a product update.
Guidant was ordered by the Department of Justice to pay $296 million in fines, the highest amount to be assessed a medical device company. This total does not include restitution for victims of the malfunctioning devices.
Boston Scientific acquired Guidant back in 2006, vowing to rebuild the troubled company. In March of 2010, the company abruptly halted the sale of their defibrillator devices because of its failure to properly notify the FDA regarding the two problematic models in question (New York Times).
Heart defibrillators are used to detect electrical abnormalities in the heart; if a problem is detected, the device sends an electrical jolt to the heart in an effort to regulate it.