St. Jude Medical to Pay $27M to Resolve Healthcare Fraud Allegations

The Justice Department announced that St. Jude Medical agreed to pay $27 million to resolve a healthcare fraud allegation that it violated the False Claims Act and sold defective heart devices. 

The medical device manufacturer, which Abbott acquired in January 2017, allegedly sold the defective devices to healthcare facilities between November 2014 and October 2016. The facilities then implanted the devices into patients insured by federal healthcare programs.

“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Acting US Attorney Jonathan F. Lenzner, said in the announcement. 

“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,” Lenzner continued. 

The government stated that St. Jude Medical failed to disclose serious adverse health events related to premature battery depletion (PBD) in specific models of its defibrillators.

The devices, Fortify, Fortify Assura, Quandra, and Unify, are surgically implanted into a patient’s chest and sends an electrical pulse to the heart to “shock” it back to normal rhythm if an irregular heartbeat is detected. 

In 2014, St. Jude Medical submitted a request to FDA to approve a change to prevent lithium clusters from draining the battery. The center told FDA that there was no serious injury, permanent harm, or deaths reported in association with the devices.

According to the recent allegations, St. Jude Medical was aware at the time of “two reported serious injuries and one death associated with premature battery depletion” induced by lithium clusters.

In August 2016, St. Jude Medical told FDA that the number of PBD events increased to 729, including two deaths and 29 events associated with loss of pacing. Two months later, FDA recalled the devices. 

Once the devices were recalled, St. Jude Medical no longer sold the devices, but thousands of devices had already been implanted inside patients over a period of two years. 

“The FDA regulates medical devices to assure that patient health is protected. Reporting information untruthfully to the agency about the safety of medical devices jeopardizes patients’ health and safety,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office.   

“We will continue to investigate and bring to justice those who place the public health at risk,” McCormack concluded.