Guidant LLC was formally convicted and ordered to pay more than $296 million in criminal fines and 3 years probation for withholding information about its heart defibrillators. The government said 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,” according to a Justice Department statement. The Boston Scientific Corporation – which acquired Guidant LLC after the misconduct occurred – admitted to criminal violations relating to its interactions with the U.S. Food and Drug Administration last April. The U.S. Justice Department brought the charges against Guidant for its mishandling of 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).
