Burke is a patient who received one of St. Jude Medical’s heart devices that were subject to recall.
Under the civil settlement, the company agreed to pay $27 million to the government plus accrued interest at the rate of 0.875% from January 25, 2021, to the date of payment. Of the amount, $13.5 million in restitution. Abbot serves as guarantor.
In addition, the company will pay $64,467.91 to Burke in satisfaction of any claims she may have for fees and costs under 31 U.S.C. § 3730(d).
In a statement, Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said, “To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents. We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk.”
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