Abbott's St. Jude Medical To Pay $27 Mln To Settle Allegations Over Heart Devices

(RTTNews) - St. Jude Medical Inc. agreed to pay $27 million to settle allegations that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities that, in turn, implanted the devices into patients insured by federal health care programs, the U.S. Department of Justice said in a statement.

St. Jude was acquired by Abbott Laboratories in January 2017.

The U.S. alleged that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices, which are implantable defibrillators 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 U.S. 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, in turn, suffer a premature power drain.

The U.S. alleged 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, according to the government's allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with premature battery depletion induced by lithium clusters.

St. Jude continued to distribute devices that had been manufactured without the new design.

In August 2016, St. Jude contacted the FDA and informed it that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing.

In October 2016, St. Jude issued a medical advisory regarding the PBD caused by lithium cluster shorts, which FDA classified as a Class I recall. After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 20, 2014, and October 10, 2016.