ST. JUDE DEFIBRILLATOR: BATTERY DEFECT LEADS TO MASSIVE RECALL
As a digital society, we take a lot for granted in the technology that we use every day. We expect the local power company to provide us with heat and light without interruption; we expect our cars, our computers and our cell phones to work flawlessly — until the day they don’t.
But certain system failures are a lot more serious than others. In some cases, the premature failure of a power source can be literally a matter of life and death. Hundreds of thousands of people who rely on medical devices implanted in their chests to help regulate their heartbeat are facing difficult choices because of a recall of those devices, after reports surfaced that the batteries were not working properly.
The devices at issue are implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices manufactured by St. Jude Medical. More sophisticated than simple pacemakers, the devices are designed to monitor cardiac patients who have arrhythmia, or irregular heartbeats; they provide pacing for slow heart rhythms or administer an electric shock if the rhythm becomes dangerously fast, jolting the heart back to a normal pace. ICDs and CRT devices are powered by lithium batteries that have a life expectancy of five or six years. But in the case of the defective devices, the batteries have been known to experience unexpected and rapid depletion.
In 2016 St. Jude issued a recall of certain models due to reports of battery failure. The failures were attributed to lithium “clusters” forming within the battery and causing a short circuit. The Food and Drug Administration characterized the action as a Class I recall, meaning the problem had the potential of causing serious injury or death. The recall encompasses nearly 400,000 ICD and CRT devices worldwide in the company’s Fortify, Unify, and Assura model lines, manufactured between 2010 and 2015.
In some cases, the battery failure comes with little warning. The devices are equipped with an alarm mechanism, known as an elective replacement indicator, that beeps or vibrates to let the patient know that the battery is running low. In properly functioning defibrillator implants, that signal typically means that there’s three months of battery life left, and the patient should schedule surgery to have the battery replaced. But lithium clustering can cause the battery to fail in as little as 24 hours after the alert, leaving the patient vulnerable for a possibly deadly cardiac event.
The company maintains that the issue has been detected in only a small percentage of its products — a total of 1400 reported short circuits out of 398,740 units sold, as of November 30, 2017 — and that the recall is precautionary rather than an indication of widespread battery failure. But some attorneys and patient safety advocates believe the potential risk of failure is much greater, and St. Jude Medical’s approach to the recall has raised other concerns.
Last April, after an FDA inspection of St. Jude’s manufacturing facility in Sylmar, California, the agency issued a warning letter advising the company and the public of several alleged violations of federal regulations and proper procedure in the efforts to correct the problem. Among other issues, the FDA took the company to task for being selective in the data it had used over the years to determine if a recall was necessary, which disregarded “unconfirmed” reports of shorts and thereby underestimated the degree of risk.
“Your firm failed to identify lithium clusters as a hazardous situation and a potential cause of premature battery depletion,” the letter notes, despite evidence of cluster problems dating back to 2011. And, as more adverse reports surfaced, the FDA found, those reports were downplayed in presentations to the company’s management review and medical advisory boards, delaying the recall and other corrective action; those presentations didn’t even mention a 2014 patient death following a battery failure. (There are now two deaths that have been linked to the faulty batteries.)
The FDA also learned that the company had continued to ship some of the faulty ICDs after the recall was issued, and several of the devices were implanted in patients subsequent to the recall date.
Not all of the batteries in the recalled devices will develop lithium clustering, but each individual battery has the potential to fail early. Patients can determine if their ICD or CRT device is among those being recalled by checking the plastic card that was provided after the implant surgery; the information on the card includes the serial and model numbers of your device and the date of implant. That information can then be entered into a search tool on St. Jude Medical’s website to determine if your device is among those being recalled.
Patients whose devices are subject to recall should immediately contact their medical providers and discuss treatment options; individual circumstances will largely determine what sort of replacement device and surgical procedures will be required. St. Jude Medical, which was acquired by Abbott last year for $25 billion, also has developed a remote monitoring system, known as Merlin@home, that can help track the performance of its devices and transfer data (including information on battery life) over a landline to a secure website for your physician to review.
While the development of ICDs and CRT devices have been a boon to arrhythmia patients, faulty technology has also provided a range of challenges for regulators and patients alike. Some patient advocates have criticized the FDA for not intervening sooner after reports of the lithium clustering problem surfaced; St. Jude Medical corrected the problem in its manufacturing process in 2015 but didn’t issue a recall of the older units until months later. Previous recalls of defibrillators include several models manufactured by Guidant that were susceptible to short-circuiting, which ultimately led to criminal charges against the company and hundreds of millions of dollars in fines; and a 2011 recall by St. Jude of a defibrillator that malfunctioned because of faulty lead wires that connect the device to the heart.
If you have suffered injuries as the result of a medical device or dangerous drug, the product liability lawyers at FDAzar may be able to help. If you do not know the serial and model numbers for your device, our attorneys can help you gather that information to find out if your device is part of the current recall. Contact our attorneys for a free consultation to discuss your rights.