Thousands of people have been placed at risk because of defective batteries in ICD
Thousands of people have been placed at risk because of defective batteries in implantable cardioverter defibrillators (ICDs) manufactured by St. Jude Medical, Inc. The batteries in these devices can short circuit and deplete before patients have time to consult their physicians about battery replacement. Parker Waichman LLP is pursuing lawsuits against the ICD manufacturers to recover compensation for those injured and placed at risk for life-threatening injuries.
St. Jude’s ICDs Outfitted with Dangerous Batteries
An implantable cardioverter defibrillator is a small computer-like device implanted under the skin in the chest area. It is designed to monitor a patient’s heartbeat to detect irregular heartbeats, known as arrhythmias. Arrhythmias can refer to slow heartbeat or rapid heartbeat. If left undetected and untreated, arrhythmias can lead to sudden cardiac arrest and death. When an ICD detects a highly abnormal heartbeat, it will send an electric pulse or electric shock to the heart to reestablish normal rhythm and prevent the patient from entering cardiac arrest.
ICDs run on lithium batteries, which should last several years after implantation. When the batteries are nearly depleted, they will send a vibration alert to the patient to let them know it is almost time for a battery replacement. Often doctors will test the alert with patients following ICD implantation so that patients know what it feels like and knows when to make an appointment. Usually, these alerts will trigger when patients have three months’ battery power left, giving them plenty of time to make accommodations with their doctors.
However, certain ICDs manufactured by St. Jude Medical, Inc., (a subsidiary of Abbott Laboratories) were outfitted with dangerous batteries. The lithium batteries in the St. Jude Fortify, Unify, and Assura ICDs (including Quadra ICDs) have a propensity to develop lithium deposits inside the batteries. These “lithium clusters,” as they’re called, can build up inside the battery, creating short circuits that drain the battery much faster than expected. These batteries can be depleted years earlier than expected and within as little as one day from the low-battery alert sent to the patient. The alert triggers, but the battery becomes depleted faster than the patient can go to his or her doctor.
The battery malfunctions in the St. Jude ICDs place patients at severe risk of life-threatening cardiac complications. Without the use of their ICDs, patients’ irregular heartbeats will go unmitigated. Parker Waichman LLP is offering a free case review for victims of these defective products, and we are currently reviewing new cases. Contact our national law firm today to see if you might qualify to join our lawsuit against the manufacturers.
More battery-related cases: Battery Defect Lawyers
St. Jude Knew ICD Batteries Were Defective Long Before Recall
Documents from the U.S. Food and Drug Administration (FDA) show that, as early as 2011, St. Jude knew the lithium batteries in its ICDs were defective. It received notice from its battery supplier, Greatbatch Medical (recently changed to Integer Holdings, Inc.), sometime in 2011 that its batteries could prematurely deplete. From 2011 to 2014, St. Jude reviewed more than 40 cases of prematurely drained batteries showing evidence of lithium clusters, and in 2014, it requested that Greatbatch implement a new design to address the issue of lithium clusters. St. Jude had a newly designed ICD rectifying the problem sometime in 2015.
However, St. Jude did not notify the FDA about the risk of premature battery depletion in its ICDs until August 2016. It did not notify doctors or the public about the risk until October 2016, when the FDA initiated a CLASS I RECALL (the most serious category of medical device recalls) for the three St. Jude’s lines of ICDs.
Also, even though St. Jude knew about the lithium cluster and battery depletion issue in 2011, and even though it possessed a corrected ICD in 2015, St. Jude continued to sell its old, defective ICDs nearly up until the device recall in 2016.
Parker Waichman LLP is standing up for patients placed at severe risk by St. Jude’s negligence and egregious conduct. Because of this unbelievable lack of regard for patient safety, patients have suffered while St. Jude and Abbott made money. If you received a St. Jude ICD implant before October 2016 and experienced an issue with your ICD battery, contact our firm immediately for a case consultation.
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Call Parker Waichman LLP for Your St. Jude ICD Case Review
Time is limited to join our St. Jude ICD lawsuit, so contact our St. Jude Medical Implantable Cardioverter Defibrillators law firm today for a free case consultation by calling 1-800-YOURLAWYER (1-800-968-7529) or by filling out our online form.