The U.S. Department of Justice charged Guidant Corp. on Thursday with concealing critical information from federal regulators on "catastrophic" failures in several models of its heart defibrillators.
The rare filing of criminal charges culminates a four-year federal investigation that had its roots in the suspicions of two Minneapolis doctors. As the case unfolded, it rocked not only Guidant but also the rest of the medical device industry concentrated in Minnesota.
At least seven deaths have been attributed to the three models of Guidant defibrillators that were the focus of the case. Arden Hills-based Guidant's response to the short-circuiting of the implantable, stopwatch-sized devices revealed glaring weaknesses in how manufacturers of medical devices disclose defects to doctors, patients and the federal Food and Drug Administration.
The medical device industry has since become quicker to warn regulators and the public of problems with products.
Guidant is now part of Boston Scientific Corp., which said in November that it would pay $296 million on behalf of Guidant to settle the charges. The company is expected to enter a formal guilty plea in U.S. District Court in St. Paul in the coming weeks.
"The government charges that Guidant committed serious crimes by undermining the FDA's role to guard the American public against potentially dangerous medical devices," said Assistant Attorney General Tony West, who heads the Justice Department's Civil Division. "Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law."
Asked whether any individuals could still face charges related to the Guidant case, Assistant U.S. Attorney Robert Lewis said he couldn't comment.
"We are pleased to resolve this matter," Boston Scientific spokesman Paul Donovan said in a statement. "We continue to believe that Guidant and its employees acted in good faith and with the intention of complying with applicable laws and regulations."