U.S. prosecutors indicate St. Jude Medical knowingly sold defective heart implants to the public, and the manufacturer has agreed to pay a $27 million settlement to resolve allegations brought by the government under the False Claims Act.
The Department of Justice issued a press release on July 8, announcing the St. Jude settlement agreement, which will resolve claims that the company lied to the FDA in 2014 about the safety of certain models of its Fortify Assura, Quadra and Unity implantable defibrillators. According to the charges, St. Jude claimed battery failures which were occurring in the devices presented no risk of harm to patients, despite knowing of cases of injury and death linked to those issues.
The devices in question are implanted in patients and monitor their heart rhythms. When an irregular heartbeat is detected, they give the heart electric shocks meant to put it back on the proper rhythm.
In 2014, St. Jude submitted a request to the FDA, seeking to make changes to the lithium ion batteries, which had a problem with “lithium clusters” developing which could cause the batteries to fail prematurely. According to the Justice Department, St. Jude told the FDA there were no serious injuries or deaths reported in connection to the problems.
The Justice Department says that was a lie. In fact, St. Jude was aware of at least two serious injuries and one death associated with the problem before it made the request to the FDA, according to the allegations.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration (FDA), and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Acting U.S. Attorney Jonathan F. Lenzner for the District of Maryland said in the press release. “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. The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so strengthen patient safety.”
A number of injury and wrongful death lawsuits followed the resulting St. Jude Implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) recall announced by the FDA in October 2016. That recall came after at least two deaths and dozens of adverse event reports had been linked to the St. Jude battery problem.
Months after the recall, the FDA sent a warning letter to St. Jude and its new parent company, Abbott Laboratories, warning that some devices were still shipped out after the recall, with at least seven patients implanted with defibrillators then known to be defective.
St. Jude, which was bought by Abbott Laboratories in January 2017, after the alleged events occurred, has a history of problems with its implantable heart devices. In April 2018, the company had to issue a firmware update to address additional battery issues, which the FDA declared a recall. Many of the same devices were affected.
The government’s lawsuit was brought as the result of a claim filed under the whistleblower provisions of the False Claims Act by a patient who received one of the recalled implants. The plaintiff, Debbie Burke, will receive a portion of the settlement funds.
As part of the settlement agreement (PDF), St. Jude has agreed to pay $27 million to resolve the claims but did not admit guilt. Burke will receive nearly $64,500 of that under the qui tam provisions of the False Claims Act.