Boston Scientific’s Guidant unit will pay a record criminal penalty for withholding safety information about its d<"http://www.yourlawyer.com/topics/overview/guidant_defibrillators">efective implantable heart defibrillators from federal regulators. The defibrillators at the center of the U.S. Justice Departmentâ€™s criminal prosecution of Guidant Corp. were linked to the deaths of 13 people.
According to the Minneapolis Star Tribune, a previous $296 million settlement between the Department of Justice and the company was rejected by U.S. District Judge Donovan Frank last April, after some doctors and patients who received implantable defibrillators complained that the company should have faced more sanctions than a fine.
Judge Frank has now approved a new settlement that leaves the $296 million fine in tact, but also called for Boston Scientific to serve three years’ probation. The $296 million penalty is believed to be the largest criminal penalty ever imposed in a medical device case.
The Department of Justice investigation that resulted in the proposed settlement centered on three Guidant devices that had the potential to short-circuit â€” the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155) models of implantable defibrillators. According to the charges filed in federal court, Guidant violated the Food, Drug and Cosmetic Act by concealing information from the U.S. Food & Drug Administration (FDA) about catastrophic short-circuiting failures in the three models. The company discovered problems with one of the products in 2002 and became aware of problems with two others in 2004, the department said.
Three safety alerts were issued about these defibrillators in June 2005. The FDA later determined these were Class I recalls, which are the most serious type of device recall because there is a reasonable change the devices could cause serious health problems or death.
Under the terms of the new settlement, Boston Scientific is required to submit quarterly reports to the U.S. Probation Office regarding safety and compliance issues, as well as submit to regular, unannounced inspections of its records.
“I believe this serves not only the interests of the community and the interests of justice, but respect for the law and corporate responsibility,” Frank said, according to the Star Tribune.
Boston Scientific acquired Guidant in 2006. In 2007, the device maker agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm.