When you have a serious cardiac condition, you can't afford to pass up existing medical technology that may be necessary to maintain a regular heart beat and save your life. Heart defibrillators, such as theSt. Jude Defibrillator is one such device. However, unfortunately, serious problems with the St. Jude Defibrillator have occurred with many past patients, which mark this product as dangerous and triggered a product recall.
When ordinary consumer products turn out to be defectively manufactured or inherently dangerous, that's bad enough; but when this happens with medical devices -so that the very thing designed to help you ends up hurting you, that's even worse.
Consumer Alert Now exists to inform and protect the consumer of prescription drugs and medical devices by alerting him or her of high-risk medical products and making legal help readily available to those who have been injured due to manufacturers' negligence. Below, we look at the St. Jude Defibrillator in detail to help you better understand its purpose, its problems, and how to find compensation if it caused you or your loved one harm.
Recall of St. Jude Defibrillator Devic
On 28 August 2017, the FDA issued a "Class I" recall of the various St. Jude Defibrillator devices on the market. Class I is the most serious recall level and is only used when a product creates a significant risk of severe bodily injury and/or death. The devices specifically recalled included the Fortify, Assura, and Unify incarnations of St. Jude's implantable defibrillators, those distributed between 2010 and 2016, and a total of over 400,000 individual devices.
In 2016, the FDA had already issued an earlier recall on the St. Jude Defibrillator, but in 2018 it added information concerning the potential failure of the device's BPA (battery performance alert) system. This was after St. Jude Medical the BPA management system to detect and alert patients and their physicians when there was a danger of early battery failure on a St. Jude Defibrillator implanted in a patient. Saint Jude recommended that if an alert goes off for battery failure, that the device is removed and replaced as quickly as possible.
Thus, there have been multiple problems and recalls associated with this medical device, and potential malfunctions are usually life threatening. Anyone who is using a St. Jude Defibrillator should learn all they can about these issues and act without delay to ensure their medical safety and to recover any financial losses incurred by device failures.
Problems with The St. Jude Defibrillator
Both the Implantable Cardioverter Defibrillator(ICD) & the Cardiac Resynchronization Therapy Defibrillator(CRT-D) by Saint Jude help to correct irregular heartbeat rates -be they too slow or too fast. They are implanted below the skin of the upper chest and have lead wires that reach to the heart. Most of the time, these defibrillators work fine and save lives, but sometimes they fail and put lives at risk
The main risk is that the device may short circuit or that the battery may be prematurely drained. Such events can cause immediate symptoms like chest pains, difficulty breathing, dizziness, or even going unconscious. In some cases, if heart rhythms become irregular after the device fails, cardiac arrest and/or death can ensue.
As St. Jude Defibrillators are battery-powered, and electrical devices -they can short circuit, which then causes the batteries to fail. This is not normal but is due to a poor battery design that makes it easier for short-circuiting to occur. When this occurs, it often leads to complete loss of battery power within 24 hours, and unless you get emergency medical attention within that first day after the short-circuit, you could lose your life as a result. The device is supposed to give a 3 month warning of possible battery failure so there's plenty of time to correct it -NOT JUST 24 HOURS.
FDA warnings and letters were sent to St. Jude Medical due to these issues, and a years-long series of missteps occurred. First, while a way to fix the battery problem was devised by St. Jude, evidence suggests they continued to sell the defective devices at the same time for 3 full years. Also, when devices were forced to recall by the FDA, St. Jude was slow to identify the problem as "premature battery depletion" but listed many recalled devices as "unconfirmed" instead of "defective." This is a big part of the reason why there are so many severe lawsuits over the whole St. Jude Defibrillator debacle.
St. JudeAttempts to Fix the Problem
As mentioned earlier, St. Jude Medical did make efforts to fix the battery failure problem. They made implemented a battery performance alert system and made updates to their firmware to try to correct the manufacturing process
The original battery failure seems to have been caused by lithium deposits inside the battery that can make the device suddenly short circuit. That then leads to rapidly progressing power drainage that empties the battery of all power within about 24 hours. In some cases, the battery might last several weeks after the initial failure, however.
After the FDA recall, St. Jude sent out a letter of warning to all users of the relevant defibrillators. They warned that if an alert was received by the patient of potential battery depletion, they should replace the device within a day rather than within 90 days.
The firmware update by St. Jude was FDA-approved in April of 2018, and the FDA acknowledged this would mean a significant reduction in the risk of battery failure. The new software update can be installed on devices in only 3 minutes' time at their next scheduled doctor's appointment or sooner and will help detect if rapid battery depletion is taking place in the defibrillator device.
Things to Know About Defibrillators in General
Basically, a defibrillator is a kind of pacemaker and delivers electrical shocks to the heart to restore it to a normal rhythmic pattern after detecting an irregular rhythm. You have seen this kind of thing again and again on TV where emergency cardiac patients are treated by paramedics with handheld external pacemakers to save their lives.
External Worn Defibrillators
There are also external defibrillators (pacemakers) that patients wear continually as a precaution. In this case, electrodes are put on top of the chest along with an external medical device with a miniature computer inside. These devices usually automatically detect heart rhythm problems and send out the necessary corrective electric impulses. An adhesive pad keeps the external defibrillator in place and the shocks are sent through the pad to the patient's heart.
These devices are ready to go at any time and at any place -and anyone can use them. You don't have to rely on paramedics arriving in time with their handheld pacemaker. Plus, many of these devices give instructions on a screen or via audio recordings to guide others present in helping the person experiencing the heart rhythm problems -in case the defibrillator shocks alone don't prevent all problems. For example, CPR may still be needed in some cases. Note that defibrillation plus CPR yields a 75% survival rate while CPR alone in the first few minutes gives only a 5% survival rate.
Implantable cardio-verter defibrillators (ICDs) are like external defibrillators in most ways, except they are implanted in the patient. They are not put in deep but only just underneath the skin in the chest or abdomen area. They are small devices, so their being implanted generally doesn't cause any discomfort or awkwardness.
Whether heart beats get too fast or too slow, ICDs immediately detect it and deliver just the right strength and pattern of small electric impulses, which interrupt the heart so it can then "re-set" itself and come back to a normal rhythm again. Additionally, an ICD device will store valuable data about your heart rate history that your physician can use to custom-program the device for more ideal functioning.
Heart rhythms are detected via insulated wiring that touches your heart and then connects to the defibrillator on the other end. This enables the device to "act smart" in relation to the need of the moment. Many people say they can't even feel the defibrillator in action, while others say its shock feels uncomfortable -like a forceful kick to the body. This can vary based on the situation, the patient, and the type of device.
St. Jude Medical developed the very first ICD back in 1958, and they have been a leader in the industry ever since. No one can deny that St. Jude has seen a large degree of success for their patients over the decades and has been a true innovator in this field. Yet, given the problems with battery failure caused by faulty manufacturing of the lithium batteries in its recent defibrillators, it's clear St. Jude's record is not perfect.
Surgical Post-Surgical Complications
Although we have focused on the most noteworthy problem for which St. Jude Defibrillators have become subject to lawsuits, yet, there are actually other issues that can and sometimes do occur with St. Jude or other defibrillator devices. We can class these in two broad groups: surgical and post-surgical.
Typically, there are no complications that arise during or from the surgery used to install an internal defibrillator. But in about 3% of cases, one or more problems will occur. These include:
- Damage to the heart or blood vessels, or internal bleeding.
- Pneumo-thorax, a condition where an air pocket is trapped between the lungs and the chest wall due to a hole one lung or both lungs. This is also called a "collapsed lung."
- Infection. In around 2% or less of cases, an infection of some kind develops that stems from the ICD surgery process. This means a new surgery to remove the defibrillator while antibiotics are used to cure the infection and a third surgery to reinstall a new device.
The risk of infection is somewhat lower with the second and following surgery WHEN new lead wires don't have to be installed. And even without device failure or surgical complications, most internal defibrillators need to be removed and replaced every 5 to 10 years. However, when it's a matter of corrective surgery, some studies suggest that the risk of infection is slightly higher. Most surgical complications are minor, and very, very few die due to this surgery (way less than 1%).
After surgery has been finished and you have gone through post-op healing and recovery, without any problems, there are still other issues that can arise based on malfunctions of the device. We've seen how battery failure is one major problem, but here are a few other possible ones:
- Unnecessary shocks. Sometimes, a defibrillator will send out corrective shocks when there is nothing too correct. It might be triggered by the patient doing exercises or a faster but not at all irregular or dangerous heartbeat, for example. About one in five patients receive at least some "wrong shocks." These aren't life threatening or especially harmful, but they do cause pain. It is possible to simply reprogram the device in some cases, other time, corrective surgery may be needed.
- Dislocation of the defibrillator device, which is painful, may result in bleeding and may erode the skin just above the device.
- Dislocation of or damage to the lead wires. This can make the device not work at all, not work at full effectiveness, or deliver inappropriate shocks.
- Development of tiny cracks in the wires. Such fracturing also tends to produce pulses at the wrong time, in the wrong pattern, or with too high or low levels of force.
- Device failure. The many complicated, delicate parts of an internal defibrillation device mean that it's possible (though not common) for one or more components to fail or malfunction. This could either result in wrong shocks or in the inability to deliver shocks when necessary. This problem almost always requires corrective surgery.
About St. Jude Defibrillator Lawsuits in the US
Given the failure of some of St. Jude's Defibrillators to function properly, primarily through battery life issues, it is not surprising that many lawsuits have been filed against St. Jude by those injured or by spouses and loved ones of those who've lost their lives as a result. But not only individuals but also insurance companies have filed suits because of these device failures.
A class action suit by a group of insurers is seeking nearly $10 million in damages based on the idea that St. Jude knew of the battery defects for years being they finally issued a recall and continued to sell defective devices in the meantime. This suit was filed in Chicago and concerns a quarter million defibrillators sold in the USA between 2011 and 2016 that allegedly had a battery liable to easily short-out. This suit further alleges that St. Jude purposefully withheld information about the risk of rapid battery depletion in its defibrillation products from both doctors and consumers.
Already, St. Jude had acquiesced to the demand to reimburse patients for expenses they had to pay for extra medical care due to corrective surgery and other issues stemming from battery problems in their defibrillators. But a new lawsuit was filed because it was reasoned, Why should the insurance companies have to pay many millions of dollars in claims for these issues when they largely resulted from St. Jude's negligence?
St. Jude says that only 616 out of nearly 400,000 defibrillators it sold actually had lithium batteries that shorted out. However, the statistics are part of what's being debated. And, in any case, patients were supposed to get a three month advance warning of a likely short-out, not just a mere 24 hour space of time to get the problem corrected -something that obviously isn't always practical
There are at least 2 people who died soon after their St. Jude Defibrillator lost its battery life and was unable to deliver the electric pulses when an irregular heart rhythm occurred. And there are many others who experienced serious pain and suffering and the need for corrective surgery because of these device failures. If you are among them, then you may have a right to full compensation for both financial losses and pain and suffering caused by the failed battery of your defibrillator OR another surgical or post-surgical complication IF it occurred due to some form of negligence on the part of St. Jude, a physician, or a hospital or other medical institution.
Mass Tort, Class Action, or Individual Suit?
There are a number of options if you decide you want to pursue legal action against St. Jude or another defibrillator manufacturer for battery failure or another device defection or design flaw. You could contact a tort lawyer and seek to file an individual claim for your case alone. Sometimes, if your case is particularly unique in some way, that might be the best option.
However, usually in instances of medical device lawsuits like those over the St. Jude Defibrillator, it is best to join (or spearhead) a class action or mass tort suit. This lets you be part of a bigger movement that, by the sheer force of numbers of claims being submitted for very similar injuries suffered for the same reason from the same product, often has an enhanced chance of succeeding.
But what exactly is a class action suit versus a mass tort? The two are similar but not equivalent. A class action is a lawsuit started by one or more "lead plaintiffs" who then serve to speak for and represent others with the same or very similar claims. A judge can decide who is allowed to join the class action suit, but you can get started on joining one after a case evaluation (free of charge) from any personal injury lawyer handling such a case OR who is even just knowledgeable in that practice area.
A mass tort differs in that it is not headed by a lead plaintiff but occurs when a judge decides to join together numerous smaller individual lawsuits under one big umbrella case. With a class action, you generally get compensated on a percentage basis out of the settlement; while compensation in mass tort cases tends to vary more widely from individual to individual.
How Can Consumer Alert Now Help?
Consumer Alert Now provides in-depth information that is ready at hand online for all to see. We bring you the most relevant data on high-risk medical devices like the St. Jude Defibrillators, as well as on high risk prescription drugs. We present to you how the device or drug was intended to work, what problems with it have been experienced by patients, and how to get in touch with a good lawyer who will know how to win your case.
We do NOT give out "medical advice" as such. We do not take the place of your physician or any other health provider. Noris Consumer Alert Now a law firm. We simply enable you to be an informed patient and to find the best possible legal help without undue delay or difficulty.
Although other heart rhythm defibrillation devices have sometimes caused problems, injuries, or death to consumers in the past; the issues surrounding the St. Jude line of defibrillation devices are particularly startling and serious. Therefore, we focus on this particular issue and seek to alert the public to the dangers of a potential short-out and subsequent battery drain with many St. Jude Defibrillator products.
Finding Help for A St. Jude Defibrillator Lawsuit Near Me
The St. Jude Defibrillator entered the medical market with great promise, and in most cases, it has performed well and served patients adequately. But in other cases, it has failed them, primarily due to problems with the device's battery and battery alert system. If you are a loved one have been harmed due to a St. Jude Defibrillator device failure of any kind, do not hesitate to contact consumer Alert Now today. You can call us at (800) 511-0747 anytime 24/7. We conduct a nationwide campaign to connect those harmed by high-risk medical products, including the St. Jude Defibrillator, with experienced legal representation so they can receive full compensation for all losses.