The U.S. lawsuit claims Guidant knew as early as in April, 2002 that the Prizm 2 contained a potentially life-threatening defect, and that it knew that the Renewal 1 and 2 contained a similar defect.
Yet, "even after Guidant took corrective action to fix the defects, the company continued to sell its stock of the old, defective versions of the devices" according to the DoJ statement.
"Moreover, as information about the cause and nature of the defect grew within the top ranks of the company, the U.S. contends that Guidant took steps to hide the problem from patients, doctors and the FDA."
In the court decision earlier this month, Guidant was ordered to forfeit $42 million and pay a criminal fine of $253 million and was sentenced to three years of probation, submit quarterly reports to the U.S. Probation Office, and allow regular, unannounced inspections of its records. The court also required Guidant to notify its employees and shareholders of its criminal conviction.
In a written statement, Guidant said, "The DOJ's investigation began prior to Boston Scientific's 2006 acquisition of Guidant, as did the alleged conduct and product sales. The Company no longer sells the products involved in the investigation."