St. Jude Knew Its ICD Could Injure and Didn’t Care
If the FDA did not step in to recall St. Jude Medical’s implantable cardioverter defibrillator (ICD) the company would still be manufacturing and According to reports, the company knew for years its device had a serious malfunction, yet instead of correcting it, St. Jude Medical downplayed reports and even went so far as to continue distributing the devices, causing its potentially deadly pacemakers to be implanted in patients. If the FDA did not step in to recall St. Jude Medical’s implantable cardioverter defibrillator (ICD) devices, would the company still be manufacturing and distributing a faulty pacemaker that could cause serious injury, even death?
About the St. Jude Implantable Cardioverter Defibrillator
An implantable cardiac defibrillator (ICD) is a small cardiac device placed in the chest or abdomen to help maintain a normal heart rhythm. Colloquially, these are called pacemakers. The ICD provides pacing for slow heart rhythms, and an electrical shock to stop extremely fast heart rhythms. ICDs are powdered by lithium-based batteries. Following implantation, an ICD’s battery power slowly begins to deplete. When the charge level is low, it sends a notification to the patient informing them it is time to have the battery replaced.
However, those ICDs manufactured by St. Jude Medical can lose charge very quickly often without an adequate warning. This may leave patients with mere hours to undergo a replacement surgery before the device stops working entirely. Consequently, patients may be left without the needed pacing or shocks provided by the ICD to keep their hearts functioning correctly. This had the potential to lead to severe, and even fatal, complications.
St. Jude Knew Their ICD Was Dangerous for Years Before Recall
In 2014, Duke University disclosed the defect with lithium batteries in St. Jude devices and the first patient with the St. Jude ICD dies. St. Jude Medical does not disclose it. Then in 2015, researchers at the University of Illinois also concluded that St. Jude ICD batteries form clusters that caused it to short-circuit.
Instead of recalling its devices in 2015, St. Jude quietly fixed the problem in new defibrillators; however, they never recalled the older models. They also never even warned doctors or patients. Therefore, doctors continued implanting the old devices in patients, and in 2016 the second patient dies.
Abbott Laboratories Buys St. Jude Medical
In 2015, defibrillators accounted for nearly a third of St. Jude’s sales, which was around $1.6 billion. Then in January 2016, Abbott Laboratories bought St. Jude Medical for $25 billion. However, St. Jude failed to tell its own management and a medical advisory board that the battery problems had led to the death of a patient
FDA St. Jude ICD Recall
In October 2016, the FDA initiated a formal recall of the St. Jude implantable cardioverter defibrillator. This was a Class 1 Recall, which is the highest and most serious level. This level involves products that can cause severe health problems and even death.
The recall involved the following devices which were manufactured between January 2010 and May 2015 and distributed between February 2010 and October 2016. The U.S. recall affects upwards of 250,000 devices:
- Fortify VR: Model No(s). CD1231-40, CD1231-40Q
- Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
- Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
- Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
- Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
- Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
- Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
- Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
- Unify: Model No(s). CD3231-40, CD3231-40Q
- Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
- Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
- Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
- Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C
Almost 900 defibrillators experienced premature battery depletion. This included almost 50 that had visible electrical shorting due to the lithium clusters.
Still Harming Patients
An FDA spokesperson said the agency did not insist on an earlier recall because it was relying on erroneous information the company previously provided. The company only focused on a few confirmed battery failure cases. Even when an outside supplier provided evidence to the medical company that its batteries were a problem, St. Jude still denied it.
Even the FDA knew it when they issued St. Jude another warning letter on April 12, 2017, stating:
“By basing your firm’s risk evaluation on ‘confirmed’ cases and not considering the potential for ‘unconfirmed’ cases to have been shorts, your firm underestimated the occurrence of the hazardous situation.”
Most alarming is that St. Jude still shipped and allowed doctors to implant its faulty device even after the recall.
If you or someone you loved received a St. Jude ICD that the FDA recalled, contact us today. St. Jude Medical acted recklessly and punitive damages may be awarded to punish the company and deter similar conduct in the future. If a doctor implanted you with a St. Jude implantable cardioverter defibrillator, and it suddenly died, please speak to us to learn more about your rights.