St. Jude/Abbott Laboratories Defibrillator Lawsuits
Implantable Cardioverter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Devices (CRT-Ds) are medical devices that are implanted in patients who suffer from cardiac dysrhythmias (irregular heartbeats). These devices are implanted into the chest of the patient and are connected to the patient’s heart. The device monitors the patient’s heartbeat and if an irregular rhythm is detected by the device, it will administer a shock to the heart so that the heart begins to beat on a regular rhythm.
ICDs and CRT-Ds are powered by lithium batteries which are supposed to last for about five years after implantation. When the battery gets close to depletion, it sends a notification to the patient either by beeping or vibrating. This process is called an Elective Replacement Indicator (ERI). When an ERI is received, the patient has approximately three months left of battery life left on the device, and the patient will have to see a doctor during that three month period to have the battery replaced.
St. Jude Devices Recalled Due to Defective Batteries
In October 2016, St. Jude elected to recall more than 250,000 of its ICD and CRT-D devices due to premature battery depletion. The FDA classified this as a Class I recall (the most serious type of recall) because the problem is so serious that it can lead to serious injury or death. The recalled products include certain of St. Jude’s Fortify, Unify and Assura devices manufactured between 2010 and 2015. These devices were recalled because the batteries were depleting suddenly and prematurely. Often, patients would receive an ERI alert, but instead of having three months of power left, the device would stop functioning in as little as 24 hours putting the patient at extreme risk for a deadly cardiac event. Further, following the recall, the FDA conducted an inspection of St. Jude’s manufacturing facility in Sylmar, CA and made some very concerning findings which prompted the FDA to issue a warning letter. The warning letter laid out some disturbing findings – that despite the recall, several of the recalled devices were shipped to hospitals after the recall date; that St. Jude did not properly disclose to its own management the full scope of the battery problems; that St. Jude, despite possessing sufficient evidence as to the cause of the battery depletion issues, classified the failures as “unconfirmed” and did not include “unconfirmed” cases in presentations to the advisory board in 2014.
How Do I Know if my Device is on the Recall List?
When patients are implanted with ICDs and CRT-Ds they are given a card that shows the serial number and lot number of the product that was implanted in them. Patients can input the serial and lot numbers of their product on St. Jude’s recall website and determine if their device was recalled. If you do not know the serial and lot numbers for your device, our attorneys can help you gather that information to find out if your device is part of the recall. If you were implanted with one of these recalled ICDs or CRT-Ds, call our experienced attorneys for a free consultation to discuss your rights.