par John R. Fischer
, Senior Reporter | July 14, 2021
St. Jude Medical will pay $27 million to settle false claims allegations that it knowingly sold thousands of defective heart implants.
The U.S. Justice Department has accused the company of failing to disclose serious adverse health events, including one death, related to the premature depletion of the battery in certain models of implantable defibrillators.
“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,” Acting Assistant Attorney General Brian Boynton of the Justice Department’s civil division, said in a statement.
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Abbott acquired St. Jude in January 2017
. Kate Dyer, of Abbott's public affairs, said in a statement that “this relates to a matter that took place prior to Abbott's acquisition of St. Jude Medical.”
The department said in its case that the devices were sold to providers and then implanted between November 2014 and October 2016 into patients insured by federal healthcare programs.
It claims that St. Jude Medical knew by 2013 that lithium clusters were forming on and causing the batteries of these devices to short and suffer premature power drainage. This included certain models of its Fortify, Fortify Assura, Quadra and Unify devices.
The company in late 2014 submitted a request to approve a change to prevent lithium clusters from draining the battery and told the FDA that “no serious injury, permanent harm or deaths have been reported associated with this” issue. The Justice Department says this was a lie and that St. Jude Medical knew of two reported serious injuries and one death associated with premature battery depletion (PBD) induced by the lithium clusters, but continued to distribute the devices manufactured without the new design.
The company contacted the FDA in August 2016 to inform it that the number of PBD events rose to 729, including two deaths and 29 events related to loss of pacing. It issued a media advisory in October of that year regarding PDB caused by lithium cluster shorts. This led to a Class I recall, after which St. Jude no longer sold the older devices.
The settlement includes the resolution of claims brought under the whistleblower provisions of the False Claims Act by Debbie Burke, a patient who received one of the faulty devices.
The case is titled, United States ex rel. Debbie Burke v. St. Jude Medical, Inc., No. 16-cv-3611 (D. Md.)