St. Jude Medical To Pay $27M For Selling Allegedly Defective Heart Devices
BALTIMORE (WJZ) -- St. Jude Medical will pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities that implanted them in patients insured by federal health care programs, according to a statement from the Maryland District of the U.S. Attorney's Office.
Abbott Laboratories acquired St. Jude in January 2017. St. Jude did not disclose serious adverse health events in connection with the premature depletion of the battery in some models of its Fortify, Fortify Assura, Quadra, and Unify devices, according to the Justice Department.
These devices 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.
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, according to the statement.
In late 2014, St. Jude submitted a request to the Food and Drug Administration 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, according to the statement. But St. Jude was aware of one death and two reported serious injuries, the statement alleges.
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 (PBD) had increased to 729, including two deaths and 29 events associated with loss of pacing.
On October 10, 2016, St. Jude issued a medical advisory regarding the PBD caused by lithium cluster shorts, which the FDA classified as a Class I recall. A Class I recall is where there is a reasonable probability that "violative" products "will cause serious adverse health consequences, including death." 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.
The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the government's recovery. The civil lawsuit was filed in the District of Maryland and is captioned United States ex rel. Burke v. St. Jude Medical, Inc., No. 16-cv-3611 (D. Md.).
According to the statement, the claims resolved by this settlement are allegations only, and there has been no determination of liability.
