St. Jude Implantable Cardioverter Defibrillator
St. Jude knew for years that its St. Jude implantable cardioverter defibrillator (ICD) was faulty, yet sold it anyway.
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.
St. Jude Implantable Cardioverter Defibrillator Battery Depletion
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’s letter to physicians warned that nearly 400,000 St. Jude ICDs sold worldwide and made before May 2015 are at risk of premature battery depletion. Lithium cluster formations make the affected devices susceptible to short-circuiting. This can cause total battery failure in as little as 24 hours.
Symptoms of a short-circuited St. Jude Medical defibrillator battery may include:
- Loss of consciousness
- Chest pain
- Shortness of breath
St. Jude Implanted Defibrillators 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
St. Jude Knew Devices Were Defective Before the Recall and Downplayed Its ICD Failures
The defect with lithium batteries in St. Jude devices was first disclosed in a journal article in 2014. St. Jude and the Food and Drug Administration “should have notified doctors and patients much sooner, because it is the doctor’s and patient’s decision as to what to do, not SJM or FDA,” said Dr. Robert Hauser, a Minneapolis-based cardiologist.
Even after one person died in 2014, St. Jude continued to market its device as a safe pacemaker. In fact, the company continued to sell 250,000 defibrillators between 2014 and October 2016 in the United States. The FDA stated that St. Jude knew of the problem for years, and systematically underestimated the risk to patients. 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 its faulty device to be implanted even after the recall.
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury as a result of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other women and their families from needless distress.
We Want to Help St. Jude Implanted Cardioverter Defibrillators Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. Why did St. Jude not tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement could also provide compensation for your injuries and damages. The types of recoverable losses are:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a company is found to be highly reckless, 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.
The Michael Brady Lynch Firm is currently accepting cases in all 50 state. Please use the form on this page or call toll-free 24 hours a day at 877-513-9517.