The Department of Justice has announced that St. Jude Medical will pay a $27 million settlement to resolve allegations that it knowingly sold defective heart devices.
The defective heart devices were implanted into thousands of patients who were insured through Medicare and Medicaid, according to the DOJ.
“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,” according to Acting U.S. Attorney Jonathan Lenzner.
St. Jude was accused of failing to notify the FDA of serious injuries due to premature battery depletion in certain implantable defibrillators, including Fortify, Fortify Assura, Quadra and Unify devices.
St. Jude submitted an FDA request to fix the battery problem in 2014, claiming that no serious injuries had been reported — even though the company was aware of 2 reported serious injuries and one death.
Despite these serious problems, the DOJ claims that St. Jude continued to sell the defective devices for two more years. By August 2016, St. Jude finally told the FDA that premature battery depletion had caused at least 2 deaths and 29 events with loss of pacemaking.
The FDA announced a Class I recall in October 2016 — the most serious type of recall.
St. Jude stopped selling the heart devices after they were recalled, but thousands were implanted in patients from 2014 to 2016, when the company was aware of the battery problems, according to the DOJ.