ST. PAUL, Minn., April 5 (UPI) — Guidant LLC pleaded guilty in Minnesota to not reporting problems with heart defibrillators and is to pay more than $296 million in penalties, officials said.
If the plea the Boston Scientific Corp. subsidiary entered Monday in U.S. District Court in St. Paul is accepted by Judge Donovan W. Frank, it would be the largest criminal penalty ever imposed on a device manufacturer for violating the Federal Food Drug and Cosmetic Act, U.S. Food and Drugs Administration Commissioner Margaret Hamburg said.
Guidant’s admission to criminal violations culminated a four-year investigation into Guidant’s handling of short-circuiting failures of three models of its implantable defibrillators, the U.S. Justice Department said in a release.
“Guidant’s guilty plea today is about accountability,” Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division, said. “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.”
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