Overview of the St. Jude Defibrillator
When a person’s heart stops beating, blood stops flowing to the brain and other vital organs, and death can result within minutes. A small medical device, placed in the chest or abdomen, is used to treat arrhythmias (irregular heartbeats), and is known as an implantable defibrillator. The defibrillator controls these life-threatening arrhythmias through the use of electrical pulses or shocks, thus preventing the patient’s death.
The defibrillator has wires with electrodes on the ends which connect to the heart chambers. If the device detects an irregular ventricle rhythm, it will use a low-energy electrical pulse to restore a normal rhythm to the heart. If these low-energy pulses fail to restore the heart’s normal rhythm, the device switches to higher-energy pulses for defibrillation. In some cases, the high-energy pulses—which last only a fraction of a second—can be painful to the patient.
Problems with the St. Jude Defibrillator
Unfortunately, it appears one manufacturer of implantable defibrillators, St. Jude Medical, is dealing with some serious issues related to their device. The U.S. Food and Drug Administration recently sent a warning letter to St. Jude Medical accusing the company of avoiding a proper investigation regarding the potential battery problems in their implantable defibrillator.
According to the FDA, St. Jude Medical downplayed the actual risks associated with the device battery, even after a death in 2014, and another in 2016 was tied to the St. Jude defibrillator. St. Jude Medical, a small Canadian-based company, sold to Chicago-based Abbot Laboratories earlier this year, for $25 billion. St. Jude Medical also failed to tell its own management—as well as a medical advisory board—that the battery issues had resulted in the death of two patients.
Two cases of battery problems were reported to St. Jude Medical by Duke University physicians in 2014, and again in 2015. These physicians concluded the lithium in the batteries was forming clusters, causing the device to malfunction and short-circuit. While St. Jude fixed the battery problem in their new defibrillators, they did not recall the older devices, nor did they alert physicians or patients about the potential problems, therefore doctors continued to implant the old devices in patients.
Patients who are experiencing symptoms associated with a battery which is short-circuiting, include:
- Chest pain;
- Shortness of breath;
- Loss of consciousness, and
The St. Jude Defibrillator Recall
A recall notification was issued by St. Jude Medical in October 2016, following a significant number of patient hospitalizations, in addition to the two deaths. This notice claimed that the St. Jude defibrillator could short-circuit and go dead due to a problem with the lithium battery chemistry. Patients were given no expected battery-indicator warning before the defibrillator died, therefore they continued to believe the device was working. Older versions of the Assura, Unify and Fortify defibrillator devices are the devices which have exhibited problems, according to St. Jude.
The FDA claims St. Jude “systematically underestimated the true risk to patients by basing their evaluations only on confirmed cases of battery failures…” while disregarding any cases in which a battery short may have been involved. Devices containing a flawed battery continued to be shipped out until October 2016, with 10 devices shipped out after the issue of the recall, and seven more implanted in patients following the announcement of the recall.
The FDA estimates that nearly 400,000 devices, sold worldwide, were affected by the recall, and 841 were returned to the company after the battery died unexpectedly. Angela Stark, FDA spokesperson, said that at least 200,000 people in the U.S. have been implanted with a defibrillator device included in the recall.
Litigation for the St. Jude Defibrillator
Litigation concerning the St. Jude defibrillator is currently underway, as patients are being given no warning that the battery in their device could fail with no warning. As of this time, no settlements involving a St. Jude defibrillator have occurred, however attorneys are still in the early stages of assisting those harmed by the device. An MDL could be established, and, if so, a few bellwether cases will be tried before a jury to allow both sides to determine how to proceed. Bellwether trials also give the manufacturer a good idea of whether they should offer a settlement to patients who were harmed by the defibrillator device.
How an Attorney from Martinson & Beason Can Help
If you have been injured by a St. Jude defibrillator, it could be beneficial to contact an experienced attorney from the law firm of Martinson & Beason. Our attorneys will work hard on your behalf to ensure you receive an equitable settlement which could include medical expenses, pain and suffering, loss of wages, other economic losses, and, punitive damages, when warranted.
Lawsuits regarding dangerous drugs and medical devices can be very complex, however the attorneys at Martinson & Beason, P.C., believe each and every client deserves the best legal representation available. We understand how difficult it can be to suffer an injury due to a dangerous medical device, then see your finances rapidly go downhill as you attempt to pay medical expenses associated with the injury. If you have a St. Jude defibrillator which has been recalled, and you have experienced problems with your defibrillator, call Martinson & Beason, P.C., today.