If I haven’t said it before, I’ll say it now. The FDA is awesome. On the occasions when the FDA tag teams with the DOJ? Watch out!
The FDA and the DOJ just popped Guidant LLC for $296 million. Their crime was withholding information about “short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155).”
“The devices, once surgically implanted, constantly monitor the electrical activity in a patient’s heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.”
Nice company.
This $296 million fine is also “the largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act”.
Maybe nailing companies with $200 million dollar fines will get them to be a touch more responsive to things like this!
If you know someone that has an implanted defibrillator, have them check with their doctor to see if it happens to be a Ventak Prizm 2 DR (Model 1861) or either of the Contak Renewal Models (H135 and H155). You just might save their lives.
