St. Jude Medical to pay $27M settlement for allegedly selling defective heart devices
BALTIMORE, Md. (FOX 5 DC) - St. Jude Medical, Inc. has agreed to pay a $27 million settlement after allegations that they sold defective defibrillators for nearly two years, resulting in several injuries and deaths.
The lawsuit alleges that between November 2014 and October 2016, they sold the defective heart devices to health care facilities that were implanted into patients insured by federal healthcare programs such as Medicare and Medicaid.
Government officials announced the settlement agreement Thursday.
"The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall," said Acting United States Attorney Jonathan F. Lenzner.
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The government alleges that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of their implantable defibrillators, which are used in patients at risk of cardiac arrest due to an irregular heartbeat.
The devices are surgically implanted into patients’ chests, and when the devices detect an irregular heartbeat, they send an electrical pulse to the heart to shock it back to its normal rhythm.
The government alleged that, by 2013, St. Jude knew that lithium clusters formed on the batteries of the devices, causing some of the batteries to short and suffer a premature power drain.
The lawsuit also alleges that in late 2014, St. Jude submitted a request to the FDA to approve a change to prevent lithium clusters from draining the battery, and told the FDA, "no serious injury, permanent harm or deaths have been reported associated with this" issue. However, the government says St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty devices.
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St. Jude continued to distribute devices that had been manufactured without the new design.
In August 2016, St. Jude contacted the FDA and said the number of events involving the defibrillators had increased to 729, including two deaths and 29 events associated with loss of pacing.
The civil settlement resolves the lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the government's recovery.
The claims resolved by this settlement are allegations only, and there has been no determination of liability.