Boston Scientific's Guidant devision was ordered to pay $296 million dollars and will serve three years probation for not telling regulators about changes it made to it's internal cardiac defibrillators. One of the prosecutors in the case said, "Guidant officials made deliberate decisions to conceal information from regulators."
This is believed to be the largest criminal penalty every imposed in a medical device case.
In investigating why one of their patients died as a result of a short circuited defibrillator, two Minnesota doctors went to the media after finding out Guidant had failed to disclose the defect to regulators.
If you have been injured from a faulty medical device, contact Rheingold, Giuffra, Ruffo & Plotkin LLP for a free consultation.