St. Jude Medical Implantable Defibrillators
More than 400,000 implantable defibrillator devices produced by St. Jude Medical have been recalled by the company, after two patients have died from the devices due to battery short-circuiting or failure. In October 2016, the U.S. Food & Drug Administration (FDA) initiated a recall of St. Jude Medical Cardiac Resynchronization Therapy Defibrillators (CRT-D), also known as pacemakers, and Implantable Cardioverter Defibrillators (ICD). The company recalled the devices in a recall designated Class 1, which is the most serious level of recall that involves products that may cause serious injuries or death. In October 2017, an update to the recall was issued by the FDA, citing premature batter depletion due to deposits of lithium.
St. Jude Medical ICD and CRT-D devices are used to stabilize pacing for heart rhythms that are slow and send electrical shocks or pacing to stop heart rhythms that are dangerously fast. Patients with bradycardia, tachycardia, premature ventricular contractions or with needs to treat heart failure or irregular heartbeats may have been implanted with the devices. The devices were sold in the United States between 2011 and October 2016. A federal class action lawsuit filed in September 2017 alleges the company knew that more than 250,000 products that were sold may have contained faulty batteries.
If you or a loved one has been implanted with a defibrillator by St. Jude Medical between those years, and has experienced serious complications or death, you may be entitled to compensation. Pittman, Dutton & Hellums represents clients throughout the United States and can help you obtain the justice you deserve. Read on for more information regarding these products and lawsuits.
- The first patient death from St. Jude Medical defibrillators happened in 2014; the second patient death occurred in 2016.
- In December 2014, physicians at Duke University published documented cases of premature batter failure in the defibrillators. In February 2016, doctors at University of Illinois reinforced confirmation of failure with their own cases.
- In May 2015, St. Jude Medical corrected the problem but continued to ship potentially defective devices, claiming the battery design change was to make a well-performing device better.
- After the recall was announced in October 2016, the FDA found at least 10 affected devices were shipped, and seven defective devices were implanted in patients.
- In April 2017, the FDA sent a letter to the company that acquired St. Jude Medical in 2017, Abbott, stating that St. Jude Medical had downplayed battery depletion problems and had failed to notify its medical advisory board and management team of a patient death caused by the failures.
- St. Jude Medical recalled 39 models of defibrillators, including the Quadra Assura, Unify, Fortify, Fortify Assura, Unify Assura and Unify Quadra product lines.
- The faulty defibrillators haven’t just affected American patients. In May 2017, a Canadian woman filed an $800 million lawsuit against St. Jude Medical because of near-fainting spells caused by the device. While the device has been recalled in the United States, it was only subject to a warning in Canada.
In what should be life-saving devices, the St. Jude Medical defibrillators were supposed to alert patients when the batteries were expected to run out in three months. The premature battery depletion was found to cause batteries to fail in as little as 24 hours after the alert. The depletion was caused by lithium clusters, which created abnormal electrical connections that rapidly drained battery power and/or created electrical shorting.
Without ample time to replace a depleted defibrillator, patients may experience cardiac arrest or a life-threatening episode with no chance of remedy. In addition to patient death, the faulty devices caused at least 10 cases of people fainting and 37 cases of dizziness.
Have You or Someone You Know Used a St. Jude Medical Defibrillator?
While St. Jude Medical has not recommend replacing a defibrillator if the device is not experiencing battery depletion, it is vital that any patient implanted with a St. Jude Medical defibrillator contact their physician to get information on how to stay safe. If a device gives an alert about a battery, it’s imperative to contact a doctor right away. Also, experiencing any symptoms such as dizziness or fainting warrants medical attention.
If you or a loved one has experienced any problems associated with the device, please contact Pittman, Dutton & Hellums. The current federal lawsuit alleges that St. Jude Medical, now part of Abbott, failed to warn physicians and patients about known defects, was negligent in production and dissemination of products, and more. You or a loved one who has been implanted with the device and experienced complications may be entitled to compensation. Contact us at (866) 722-0250 or online here for a free consultation.
Get a Free Case Evaluation
Fill out the form below to contact our firm. One of our experienced attorneys is prepared to speak with you. Consultations are free and confidential.