St. Jude Medical Defibrillator Failure?
Have you or a loved one had a St. Jude defibrillator implanted and have thereafter been injured or killed? If a defect in the defibrillator’s battery caused or contributed to your injury or your loved one’s death, you may be entitled to recover compensation for the expenses, costs, and losses you and your family have experienced.
Parker Waichman LLP understands that an award of monetary compensation cannot ever truly replace a lost loved one, a decreased life span, or weeks or months of pain and suffering. However, Parker Waichman LLP believes when you do encounter these painful difficulties that those who are responsible for causing them should be held accountable.
What is an Implantable Cardiac Defibrillator?
Simply put, a defibrillator (also known as a pacemaker or an implantable cardiac defibrillator, or ICD) is a medical device implanted in the chest of a person to help that individual maintain a regular and healthy heart rhythm. These devices run on batteries and are designed to provide the person and his or her doctor with ample opportunity to replace batteries that are losing power. If a person’s defibrillator runs out of power, it can no longer provide the life-saving benefits it is designed to provide.
FDA Recall of St. Jude Implantable Cardiac Defibrillators
The Food and Drug Administration (FDA) has recalled approximately 400,000 defibrillators manufactured by St. Jude Medical Inc. prior to May 2015. This recall was prompted by a defective battery design that could cause the battery to fail with little to no notice. If a battery failure were to occur, the patient’s life would be in danger. Unless the patient and/or his or her physician were to take immediate action, a subsequent cardiac event could be fatal.
Side Effects and Symptoms of a Defective St. Jude Defibrillator
Individuals who have had a St. Jude defibrillator implanted within them and who experience any of the following symptoms should proceed to the nearest emergency room and/or obtain immediate medical treatment:
- Lightheadedness: It may feel as if you are not thinking as clear as you normally do, or that your head feels as if it is “in the clouds”. You may notice an onset of dizziness if you stand up too quickly.
- Dizziness: Are you noticing that you are having trouble maintaining your balance when walking or standing? If so, you may need immediate medical care and should proceed to the closest emergency room.
- Loss of consciousness: Fainting spells that come upon you suddenly and without warning may be indicators that you are suffering cardiac incident. These incidents can cause serious injury or even death without prompt medical intervention.
- Shortness of breath: Finding yourself winded and short of breath with little or no reason can also be a sign of
- Chest pain: Often considered to be one of the “classic” symptoms of a heart attack, if you experience unexplained or sudden chest pain you may have little precious time to seek help.
These symptoms may appear individually or in conjunction with one another and/or other symptoms. You may also experience other symptoms not on this list. As a general rule, if you experience sudden and unexplained symptoms and you have had a St. Jude Medical defibrillator implanted, you should seek prompt medical attention.
You May Be Entitled to Reimbursement of Costs, Punitive Damages, Pain and
Recovering from a cardiac incident such as a heart attack can require surgical intervention, medications, and/or lifestyle changes. It can take some time before you are ready to return to your normal activities (if you are able to return to them at all).
As a result, you may incur expenses such as:
- Costs associated with ambulatory or emergency medical care and transport;
- Medical bills and surgical costs;
- Prescription drug costs;
- Therapy and physical rehabilitation costs;
- Lost wages due to time missed from work;
- Lost future earnings that are the result of being unable to return to one’s previous occupation;
- Counseling or mental health services, if you find that you are depressed after your incident;
- Mental pain and anguish; and/or
- Other economic and noneconomic expenses and losses.
The batteries that are allegedly defective and that led to St. Jude’s ICDs being recalled are not the original batteries designed for these devices. Instead, the allegedly defective batteries were designed and used in St. Jude devices after the devices and original power sources were approved by the FDA. St. Jude announced the new batteries as an improvement over the original power source, designed to last longer than the original. By 2014, however, it was clear that St. Jude knew these newer, “improved” batteries had problems.
Statute of Limitations
It is important that you move quickly after your St. Jude Medical defibrillator incident. Depending on your state of residence and the jurisdiction in which your incident occurs, you may have as little as one year from the date you discover (or the date you should have discovered) that you suffered some harm as the result of a St. Jude Medical Inc. device. Once this time period (often referred to as the statute of limitations) has run, you will generally be unable to file a claim for compensation for your injuries. Besides this, working with a law firm soon after your injury has been discovered can help ensure that your case continues to advance through the recovery process.
What is more, it takes quick action to determine if the battery cluster in your St. Jude ICD is truly defective. Important tangible evidence and witnesses with knowledge about St. Jude defibrillators and their defective batteries can either be lost or become much more difficult to locate and preserve with the passage of time. Once some of these documents and evidence is lost, it becomes irreplaceable. Contacting Parker Waichman LLP as soon as possible to safeguard your legal rights and maximize your opportunity for recovery by filing a St. Jude Defibrillator Lawsuit.
Do I Have Grounds for a St. Jude Defibrillator Lawsuit?
If you had a defective St. Jude defibrillator implanted and that defibrillator thereafter caused you to suffer injuries or an adverse health-related event, you may be able to recover compensation for your injuries, losses, and expenses. Some of the devices that have been included in recalls include:
- Fortify VR
- Fortify ST VR
- Fortify Assura VR
- Fortify Assura ST VR
- Fortify DR
- Fortify ST DR
- Fortify Assura DR
- Fortify Assura ST DR
- Unify Quadra
- Unify Assura
- Quadra Assura
- Quadra Assura MP
Evaluating whether you have a St. Jude Medical defibrillator claim following a heart attack or other cardiac incident begins by determining if your ICD (or pacemaker) is one that is manufactured by St. Jude Medical Inc. If it is one of the models for which a recall has been issued, additional inquiry must be made into whether your St. Jude defibrillator had a faulty battery. Lastly, if your St. Jude ICD is found to have such defect, a final inquiry must be made to determine if your medical event or injury was caused by your ICD’s battery failure or defect.
St. Jude Medical Inc. may be responsible for paying your financial losses, expenses, and costs because of legal obligations placed on manufacturers of medical devices. American legal principles require that these manufacturers design and produce devices that are reasonably safe for their intended use and that are free from unnecessary defects. When a defective device such as a St. Jude ICD is identified, the manufacturer has a further obligation to attempt to identify and correct the defect by either repairing or replacing the device. In the case of St. Jude Medical Inc. defibrillators, it is believed that even after St. Jude learned that there were problems with its batteries they nevertheless continued to sell defective batteries for years.
Process of a St. Jude Defibrillator Injury Lawsuit
A St. Jude defibrillator injury case begins with an evaluation of the facts and circumstances surrounding your injury. This is necessary in order to determine if you may have a viable claim and the nature and amount of compensation to which you may be entitled. (After all, you would not want to invest a significant amount of time and money in a lawsuit or claim that has little chance of success. During this initial stage, you (as well as your attorney) should review whether the defibrillator device you use is one of the defective models manufactured by St. Jude, how the device failed, what injuries you suffered as a direct result of the defective defibrillator, and any evidence, facts, or circumstances that would suggest your own careless or negligent decision may have contributed to some of your injuries. This would also be the stage during which you and your attorney discuss the amount and quality of evidence and witnesses available to support your claims, as this will have a direct bearing on your prospects for success.
Once a review of the facts of your claim has been completed and it has been determined that you may have a viable claim for compensation, your lawsuit begins when your initial pleading is prepared, filed with the court, and delivered to St. Judge and/or any other at-fault parties. This pleading sets forth the basic facts and legal authority that you believe entitle you to a financial recovery. The other party – St. Jude and/or another named defendant – will have an opportunity to respond to this initial pleading through an answer. Similar to your initial pleading, in its answer St. Jude and/or any other defendant will either admit, deny, or state it cannot either admit or deny your allegations. If the other party believes it has legal defenses to your allegations, the party will use its answer in order to set forth those facts and legal authorities supporting its contentions and defense(s).
By this time, it may have been a few weeks to a few months since you first began investigating your case and determining what legal rights you possess. If the case has not been settled or otherwise resolved at this point, your defibrillator injury case will enter a phase known as discovery. During the discovery phase, each party in the dispute will exchange certain information with one another so that each side has an adequate opportunity to prepare for trial. Exhibits, documents, photographs, and reports must be made available to the other side, as must the names of witnesses and names and professional background information of any expert witnesses that the party intends to use. During this phase, depositions – that is, questioning of a witness under oath – may also occur. Discovery may take anywhere from several weeks to several months or longer to complete.
A trial occurs if the case still does not settle. Both parties will have an opportunity to present evidence and witness testimony in support of their respective positions and claims. The losing party may have a right to appeal an adverse decision.
St. Jude Defibrillator Injury Claim FAQs
In the aftermath of a battery failure and other St. Jude-related defibrillator injury, you may have questions regarding your rights, your lawsuit, and what you can expect moving forward. This is completely normal. Parker Waichman LLP is committed to helping you answer the questions that are most important and pressing most important to you, including:
How are St. Jude Medical ICDs defective?
The defect in the recalled St. Jude Medical Inc. defibrillators is found in the device’s battery / power source. In a normal pacemaker, the device’s battery drains at a regular and predictable rate and gives ample warning to both the patient and the patient’s doctor before the battery needs to be replaced. In St. Jude Medical defibrillators, however, the battery may suddenly and unexpectedly drain completely. This renders the device useless for regulating the patient’s heart rhythm and providing an essential shock if the heart stops beating altogether. If the patient fails to notice signs of a cardiac incident and seek medical attention, serious injury or even death may result to the patient.
Will my case settle or go to trial?
It is impossible to accurately predict which cases and claims will settle out of court and which ones will proceed to trial. St. Jude may consider settling your case if the evidence suggesting you suffered a defibrillator-related injury event is strong and its liability for your injuries is clear. Even if a settlement offer is made, this does not necessarily mean that such offer is in your best interests. Speak with your attorney first before accepting any settlement from St. Jude to ensure that the terms of the settlement adequately provide for and protect your interests.
Does the fact that St. Jude defibrillators have been recalled help my case?
While the fact that several defibrillator models manufactured by St. Jude have bene recalled certainly helps your case, this fact does not mean you are automatically entitled to compensation. If your injuries and the losses you suffered cannot be tied or linked to the defective defibrillator (for example), you may not be entitled to compensation.
Will my case need expert witnesses? Isn’t my testimony enough?
Because defibrillators are complicated devices and because an adverse health event may have more than one plausible explanation or cause, expert witnesses are usually required in these cases in order to help the factfinder obtain clarity on whether your defibrillator was, in fact, defective and led to your health issues and injuries.
What rights do I have if I have a St. Jude ICD but never attempted to have the device replaced?
The purpose of the FDA’s recall of St. Jude pacemakers is to alert those who have had these devices implanted of the dangers they pose and what they should do to protect themselves. If you received notification that your ICD was subject to the recall but took no action, this does not necessarily relieve St. Jude of its legal obligations. However, failing to take appropriate actions following a recall may (depending on the state in which your suit is filed) impact the amount of compensation you receive for your claim – or whether you are able to recover compensation at all – will depend on a thorough evaluation of all of the facts surrounding your injury.
How Can a St. Jude Defibrillator Lawyer Help Me?
It would be wonderful for injured patients who received a recalled medical device manufactured by St. Jude’s if the mere fact they suffered some adverse health consequence was enough to guarantee them financial recovery. Unfortunately, this is not the case: absent evidence linking your health concern or incident to your St. Judge medical device, you may not be able to recover any compensation at all. One or more expert witnesses (such as medical doctors and/or engineers and others familiar with the St. Jude-brand defibrillator in question) may be necessary to testify on your behalf in order for your case to succeed Having a knowledgeable St. Jude defibrillator lawyer with you means that you will have access to a wealth of legal knowledge and resources ready to assist you in locating the tangible evidence and witness testimony you will need to “connect the dots” and show that your health concerns were the cause of the St. Jude defibrillator device. Moreover, because statutes and rules dictate what evidence may be presented and how such evidence may be presented, an attorney’s assistance will help ensure that the evidence and testimony you need in order to prevail is able to be properly admitted in court and considered by the judge or jury.
Beyond increasing your overall chances for success if your case proceeds to trial, having an attorney represent you throughout the pendency of your case enables you to focus on regaining and maintaining your health and providing for your family. Before a St. Jude defibrillator lawsuit reaches the courtroom, there are many junctures at which the legitimacy and viability of the case are challenged. Failing to respond promptly or in the correct manner can result in the dismissal of your case. However, with an experienced and knowledgeable attorney at your side, these junctures and challenges can be successfully overcome without you needing to divert your focus away from your health and/or your family’s wellbeing.
Talk with One of Our St. Jude Defibrillator Attorneys Today
Parker Waichman LLP is ready and able to promptly assist you and your family following an injury or negative event involving a St. Jude defibrillator. The injuries you can suffer from these defective devices and the costs you may incur as a result can both be severe and significant. What is more, the process that must be followed and the evidence that must be gathered can be time-consuming and confusing for those without experience in this particular area of the law.
Parker Waichman LLP wants to assist you in your quest for compensation by providing you with legal experience, knowledge, and representation so that you can focus on your physical health and recovery. Though Parker Waichman’s team of experienced St. Jude defibrillator attorneys are committed to advancing your claim as swiftly as possible, we will always take the time to address your questions and concerns and keep you informed of the status of your case. Schedule a free initial consultation to discuss your circumstances with us by calling 1-800-YOURLAWYER (1-800-968-7529).
Why Choose Parker Waichman LLP For Your St. Jude Defibrillator-related Injury
We are here to assist you in the aftermath of a St. Jude defibrillator-related injury or fatality. Our firm has years of experience in helping those who have been hurt and injured by defective medical devices like St. Jude-brand defibrillators. Our law firm has recovered over $2 billion in compensation for our clients through trial verdicts and settlements.
Contact Parker Waichman LLP right away for your free case analysis with one of our experienced and knowledgeable St. Jude Implantable Cardiac Defibrillator Pacemaker Lawsuit Lawyers today.
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