As forecast in a previously announced agreement, the U.S. Justice Department filed misdemeanor criminal charges against Boston Scientific Corp. alleging the company’s Guidant unit concealed information from the U.S. Food and Drug Administration about failures in three models of implantable defibrillators.
Feds file misdemeanor charges against Boston Scientific
The agreement with prosecutors disclosed last November called for the company to pay $296 million and plead guilty to filing a false report to the FDA and failing to a report a device correction, both before Guidant was acquired by Boston Scientific in 2006.
“Guidant and its employees acted in good faith and believed they complied with applicable laws and regulations,” Boston Scientific President and CEO Ray Elliott said in a news release at the time.
The government alleges Guidant attempted to hide corrections it was making in response to serious flaws that were discovered in the devices. The plea is expected to be filed in U.S. District Court in St. Paul, Minn., at a later date.
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