US implantable defibrillator maker Guidant has been sentenced to pay more than $296m (£189m) in criminal fines for withholding information from the US Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices.
The company, a wholly owned subsidiary of Boston Scientific, was convicted and sentenced this week in St Paul, Minnesota, before US District Court Judge Donovan Frank. The company pleaded guilty to the charges last April.
Implantable cardioverter defibrillators are lifesaving devices used to detect and treat abnormal heart rhythms that can result in sudden cardiac death. The devices, once surgically implanted, continually monitor the electrical activity in a patient’s heart for deadly arrhythmias and deliver an electrical shock to the heart in an effort to return the heartbeat to normal rhythm. If they fail to operate properly when needed, a person can die within minutes.
Guidant made decisions at various junctures to conceal information from the FDA and medical professionals regarding the device failures. In June 2005, the company finally went public about the problem with information it had known for 10 months, and then only after three deaths had occurred.
The US Justice Department’s sentencing memorandum filed with the court explained how Guidant decided to continue to implant hundreds of defective devices, even after the company had decided to stop shipping them from the factory due to the seriousness of the health risk they represented.