Guidant Corp.’s heart defibrillators have been linked to 13 medical device injuries ending in death. On Wednesday, a federal judge approved an agreement which calls for Guidant, now part of Boston Scientific, to pay $296 million. On top of what may be the largest criminal penalty in a medical device case, Boston Scientific will serve three years’ probation.
“I believe this serves not only the interests of the community and the interests of justice, but respect for the law and corporate responsibility,” said U.S. District Judge Donovan Frank.
Previously, Judge Frank rejected the $296 million agreement after doctors and patients connected with the faulty implantable defibrillators complained that the fine was an insufficient penalty for Boston Scientific. However, once the period of probation was added, the judge agreed.
As part of its probation, Boston Scientific will have to report to the U.S. Probation Office on a quarterly basis and allow regular records inspections. Boston Scientific also was called upon to continue raising awareness about heart disease through charitable programming.
The cause of the unprecedented fine was not the failure of the device. It was due to the company’s failure to disclose important safety information about three defibrillator devices that had serious problems. Guidant was in violation of the Food, Drug and Cosmetic Act because it concealed information from the FDA about dangerous short-circuiting of the implantable defibrillators. The company was aware of the devices’ problem as far back as 2002. The company tried to fix the problem with the devices but did not report it to the FDA.
After years of making less-than-aggressive attempts to deal with the problems of the devices, Guidant finally publically detailed the device problems in 2005, which later led to an FDA recall.
In 2007, Boston Scientific settled more than 8,000 lawsuits, agreeing to pay $240 million in connection with claims that Guidant hid the defects associated with the defibrillators.