Guidant Pleads Guilty Over Failure to Disclose Defibrillator Problems

Guidant LLC, a subsidiary of Boston Scientific, has plead guilty to federal charges that it attempted to cover up problems with defective defibrillator implants.  

The guilty plea was entered last month before U.S. District Court Judge Donovan W. Frank, according to a press release issued Monday by the Department of Justice (DOJ). Under the terms of the deal, the medical device manufacturer will pay more than $296 million in criminal fines to resolve charges that it violated the Federal Food, Drug and Cosmetic Act by failing to report defects in some of its implantable defibrillators to FDA, and then trying to make changes to the implants without alerting the federal agency that there was a problem.

DOJ investigators filed charges against Guidant on February 25 in federal court in St. Paul, Minnesota, after a four-year investigation into several models of the company’s implantable cardioverter defibrillators (ICDs). The charges allege that Guidant hid information from the FDA regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs which in some cases resulted in death.

ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. The DOJ charges allege that Guidant was aware as early as 2002 that the Ventak Prizm 2 DR had the potential to suffer an electric arc, which could short-circuit the device, making it unable to provide life-saving heart rhythm corrections when the patient needed it.

The DOJ accused the company of changing the design to fix the problem, and then lying to the FDA about the design changes to cover up the fact that there was a problem. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law. Even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

“Guidant’s guilty plea today is about accountability,” said DOJ Assistant Attorney General Tony West. “This successful prosecution serves as an important wake up call to all those who seek to withhold vital information about public health and safety. We will continue our efforts to prosecute those who jeopardize public health by evading their reporting obligations to the FDA.”

DOJ officials say that the $296 million penalty is the largest ever imposed on a medical device manufacturer for violating the Federal Food, Drug and Cosmetic Act. In 2007, Guidant settled thousands of defibrillator recall lawsuits for $195 million.