Defibrillators are probably the most well-known life-saving device. Most of us have seen scenes from popular movies or TV shows in which EMTs or other medical professionals rub the paddles together and yell “CLEAR!” before attempting to revive the ailing patient.
Over the years, the defibrillator’s technology has been improved and compacted to such a degree that they are now available as implantable devices, designed to be a permanent aid to those with heart conditions.
When working properly, the battery-powered devices sense a problematic heartbeat and send a small shock to correct it. Simple enough; there’s just one problem– when it doesn’t work correctly, the once life-saving product can lose its effectiveness, and patients are left to deal with the consequences.
What are Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)?
ICDs are miniature defibrillators that are implanted into a patient’s chest. The device is connected to the heart via wires, and when its computer detects an irregular heartbeat, it sends a small electric shock to restore the regular rhythm.
CRT-Ds are similar– they act as pacemakers, and send electrical signals when the heart is beating too slowly.
Both devices are recommended for patients who have congenital heart conditions or who are at risk for arrhythmia (abnormal heartbeat) based on a previous condition, such as:
- Cardiac Arrest
- Previous heart attack
- Previous heart surgery
- Long QT syndrome
By permanently implanting the devices, patients have around-the-clock protection from potentially life-threatening complications.
St. Jude Medical (not affiliated with the children’s hospital) was a Minnesota-based company that was one of the largest manufacturers of ICDs and CRT-Ds– they were eventually bought by Abbott Laboratories in 2017. Their defibrillators were powered by lithium batteries and were marketed as lasting 5-10 years before needing replacement.
This claim, however, was proven to be incorrect– and the results have been deadly.
Why are Earlier St. Jude Models Defective?
Like most battery-powered devices, St. Jude defibrillators were supposed to emit a warning signal when the battery was running low, giving the patient at least three months’ notice before fully depleting. By the early 2010s, it was discovered that batteries were shorting out within days or weeks of the distress signal. Without a working battery, the devices are unable to function, putting patients at risk.
In 2014, the first death attributed to premature battery failure was reported. In December of that year, Duke University researchers reported that the cause of the “premature battery depletion” was the formation of lithium clusters inside the battery, which created more electrical connections and rapidly drained the battery.
St. Jude announced that they had corrected the problem in May of 2015 by making design changes. However, it was discovered that the company continued to sell their older, defective models even after this announcement.
By 2016 a second death from defective batteries was announced. A University of Illinois study chronicled four additional cases and called for action. Finally, after pressure from the FDA, St. Jude recalled nearly 400,000 devices in October of that year. The FDA classified it as a Class 1 recall, which is the most serious type; that means that use of the device “may cause serious injury or death.”
St. Jude Medical was eventually sold to Abbott Laboratories a few months later.
What Does This Mean for Patients?
All of that being said, it’s important to sort out exactly what all of this means. Essentially, recipients of St. Jude ICDs and CRT-Ds were repeatedly lied to about the reliability of these products, even after the issue was said to be fixed. The lack of action on behalf of the manufacturer and their refusal to stop selling potentially defective devices is criminal.
Patients who currently rely on a St. Jude ICD or CRT-D should consult the FDA’s full product recall list to see if their model was previously recalled.
Am I Eligible for a Lawsuit?
If you or someone you know has had a St. Jude Medical ICD or CRT-D implanted and have since experienced complications relating to premature battery failure, you may be entitled to compensation.
Potential plaintiffs should amass the following materials in order to bring forth a claim:
- Proof of ICD or CRT-D implant surgery
- Proof of product used (make/model)
- Proof of complications related to battery failure (further heart complications, removal surgery, etc.)
Once you have compiled all the necessary information, be sure to contact the experienced team of attorneys at Van Law Firm. Our personal injury and product liability lawyers are well-versed in medical cases, and we will fight to get you the compensation you deserve, including medical reimbursement, lost wages, and pain and suffering.
Don’t wait– call (702) 529-1011 today for your free, confidential consultation.