St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities.  St. Jude was acquired by Abbott Laboratories in early 2017.

St. Jude failed to disclose serious health events caused by the early 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 from an irregular heartbeat.  The heart devices are implanted in a patient’s chests and are activated when the device detects an irregular heartbeat.  The devices send an electrical pulse to the heart to restore its regular rhythm.

St. Jude knew by 2013 that lithium clusters formed on the batteries of the devices, which caused some of the batteries to short and suffer a premature power drain.  The clusters can move after formation, typically due to movement of the device. In most instances, these clusters are harmless. However, if the clusters form a bridge between the cathode and the anode surfaces of the battery or other parts of the ICD or CRT-D, they can conduct electric current leading to a battery short, which can prematurely drain the battery of power (known as Premature Battery Depletion, or “PBD”). It was not possible to determine whether a lithium cluster had bridged the anode and cathode surfaces without first explanting the device.

In 2013, St. Jude engineers, along with the battery manufacturer, began developing an improvement to the battery of its devices to prevent lithium clusters from causing PBD. The fix would add an upward-facing cup around the existing downward-facing cup, forming a seal that would fully prevent clusters from bridging the battery to the ICD and CRT-D.

On August 21, 2014, St. Jude submitted a Real Time Review (“RTR”) request to the FDA in order to seek permission to make the design change to the batteries of its ICD and CRT-D devices. A Real Time Review Pre-Market Approval Supplement (“PAS”) is a process that permits manufacturers of devices to obtain expedited consideration from the FDA for minor changes to already approved devices.

In its  RTR submission to the FDA, St. Jude’s disclosed that there had been lithium clusters and PBD, but also represented that “no serious injury, permanent harm or deaths have been reported associated with this complaint.” St. Jude’s knew this statement was false and misleading.

Contrary to this representation, St. Jude knew of two reported serious injuries and one death.  Had the FDA been informed of this information, the FDA would have ordered a product recall.

St. Jude’s continued to distribute the flawed devices.  Later, in 2016, St. Jude contacted the FDA and notified the FDA of the number of adverse events, which by then had reached 729, including two deaths and 29 events where loss of pacemaker services occurred. 

On October 10, 2016, St. Jude issued a medical advisory caused by the battery shorts.  The FDA ruled that this was a Class I product recall (i.e., a reasonable probability that violative products will cause serious adverse health consequences, including death).  St’ Jude stopped selling the devices.  Thousands of defective devices remained implanted in patients.

As a result of the foregoing conduct, the United States alleges that between November 20, 2014, and October 10, 2016, St. Jude knowingly submitted or caused false or fraudulent claims for the Fortify, Unify, and Assura (including Quadra) devices to be submitted to, or caused purchases by, Medicare, TRICARE, and FEHBP.

The whistleblower, a patient who received one of the defective devices, initiated the False Claims Act suit.