Boston Scientific to Pay $296 Million for Defective Guidant Defibrillators
Boston Scientific Corp. will pay $296 million to settle a federal investigation accusing its Guidant medical device unit of knowingly selling heart defibrillators that had potentially deadly defects for more than three years.
Guidant, which was acquired by Boston Scientific in 2006, was accused of issuing deficient product advisories in 2005 and taking too long to notify doctors, patients, and the Food and Drug Administration about potential problems with defective defibrillators, according to The Wall Street Journal.
Boston Scientific has agreed to settlements with former Guidant defibrillator patients, who sued claiming the company knew about the potential for life-threatening defects in the heart devices, but failed to take sufficient action to protect patients. Faulty Guidant defibrillators were linked to scores of patient deaths and injuries.
In addition to the massive fine to be paid by Boston Scientific, Guidant also will plead guilty to two misdemeanor criminal counts for failing to include information about defects to reports to the FDA, the Journal reports.
Subpoena Also Received
Also, in an unrelated development, Boston Scientific said in a filing with the Securities and Exchange Commission that it has received a subpoena from the Department of Health and Human Services Office of Inspector General, according to the Journal. The subpoena seeks information on contributions from Boston Scientific’s heart-rhythm-device business to charities with ties to doctors or their families.
The company reportedly is working on a response to the government’s subpoena.
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