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Defective Pacemakers and ICDs

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Recalls and Lawsuits

When the heart's electrical system is not working properly it can cause arrhythmias, or irregular heart beat rhythms. Millions of Americans experience mild or harmless arrhythmias, but certain arrhythmias can be very serious, even deadly. People who are at risk for the more dangerous arrhythmias may rely on medical devices such as pacemakers and implantable cardioverter defibrillators (ICDs) to detect and treat their life-threatening rhythms.

Quite alarmingly, in recent years there has been a steady parade of defective pacemakers and ICDs recalled involving some of the largest and well-known cardiac device manufacturers, namely Guidant Corporation (now merged with Boston Scientific) and Medtronic, Inc. Thousands of reported injuries and even some deaths have been caused by defects in Guidant pacemakers, Guidant ICDs, Medtronic pacemakers, Medtronic ICDs and Sprint Fidelis defibrillator leads — the very devices patients relied on to protect their health.

If you or your loved one had or has a potentially defective ICD or pacemaker, you may be able to receive compensation for mental, physical and financial harm. For more information, evaluate personal injury lawyers or attorneys for fatal injury who can evaluate your case.

Pacemakers

Pacemakers are small, surgically implanted devices that monitor the heart and deliver electrical impulses to maintain a safe rhythm. They are most commonly used to treat cardiac arrhythmias that involve bradycardia (a slow heart rate).

The following are some of the reasons a pacemaker may be prescribed:

  • If you are taking medications that slow the heart rate
  • If you have heart block (from aging, disease or a heart attack), a form of heart disease that affects the conduction of the electrical signals between the upper and lower chambers of the heart
  • If you lose consciousness (called syncope), possibly as a result of your heart being stimulated by body or head position (such as turning the neck)
  • If you have sinus node dysfunction (or sick sinus syndrome), meaning you have a heart abnormality that affects the normal conduction of a cardiac impulse
  • If you have had a medical procedure such as ablation to treat atrial fibrillation (when the upper chambers of the heart quiver wildly)

What Happens in an FDA Recall?

When a medical device is "recalled" by the FDA because it is in violation of FDA law, it must be removed from the marketplace but not necessarily from the person. With each recall, the FDA issues a classification based on an assessment of both the level of risk and the severity of harm caused by the potentially defective device. The class to which your medical device belongs can help your attorney determine your best legal recourse. It can also help your doctor determine the best course of action to safeguard your health.

  • A Class I recall is the most serious FDA recall, issued when the FDA determines there is a reasonable chance that serious injury or death may occur
  • A Class II recall is less dire but still serious, issued when the FDA determines there is a reasonable chance that a person may suffer temporary and/or reversible health consequences, or when there is a remote possibility of more serious injury or death
  • With a Class III recall, there is very little risk to a person's health, but because the device violates the law it must be removed from the marketplace

Hundreds of thousands of pacemakers and ICDs have been the subject of recent Class I and Class II recalls. If you have a pacemaker or ICD that has been recalled by the FDA, you may wish to speak to a lawyer about your right to pursue compensation for a defective medical device.

A pacemaker normally helps alleviate symptoms of bradycardia such as fatigue, dizziness, and syncope and allows you to resume a more active lifestyle. However, if the pacemaker is not working properly, symptoms can return, sometimes leading to more serious and even fatal consequences. If you experience any return of symptoms, seek medical attention right away.

Medtronic alone has recalled more than 60,000 pacemaker devices after it was discovered that a cleaning solvent used in the manufacturing process could disrupt the pacemaker's circuitry. This defect puts the pacemaker at risk of partial or total failure and can place the patient's health in jeopardy.

Patients who have been injured and families who have lost loved ones may have the right to sue the manufacturer, supplier or retailer for any harm they suffered from an inherently dangerous and defective medical device. A personal injury attorney can help you evaluate your legal rights and determine the best method for making your case. For example, you may be able to claim the defendant(s) are strictly liable because the product had a manufacturing defect related to the cleaning solvent. Strict product liability means there is automatically liability for any harm — in this case, it is not necessary to prove that the manufacturer acted negligently. A product liability lawyer can help you determine which laws apply to your specific situation.

Defibrillators

Defibrillators are also small, surgically implanted devices that monitor and treat irregular heart rhythms. However, defibrillators are most commonly used to deliver life-saving shocks to treat abnormally fast rhythms and prevent cardiac arrest.

The following are some of the reasons an ICD could be prescribed:

  • If you have had a heart attack
  • If you have a history of ventricular tachycardia (the heart beats too fast) or ventricular fibrillation (the ventricles quiver chaotically)
  • If you have a congenital heart defect that puts you at risk
  • If your heart does not pump enough blood

Tests for Risk of Sudden Cardiac Death

Sudden cardiac death (more commonly called a heart attack) is the leading cause of death for men and women in the United States.* ICDs can help save the lives of certain people who are at risk of sudden cardiac death. To help determine if you are a good candidate for an ICD your doctor may:

  • Record continuous cardiac activity using a small external device called a holter monitor, which is worn for 24-48 hours
  • Perform a painless test called an echocardiogram, which uses sound waves to determine the size and shape of your heart, how your heart's chambers and valves are functioning and if there appear to be blood flow problems
  • Conduct an electrophysiology study, whereby a catheter is threaded into the heart in order to see how your heart responds to electrical stimulation

* National Institutes of Health (NIH)

If the heart beats too fast, it can lead to ventricular fibrillation, which causes the lower chambers (the ventricles) of the heart to contract poorly, preventing blood from being pumped to the brain and other vital organs. While ICDs are 99 percent effective in treating life-threatening arrhythmias like ventricular fibrillation*, left untreated (if for example, an ICD fails), death can result in a matter of minutes. Of the estimated 335,000 sudden cardiac deaths that occur each year, most are believed to be caused by ventricular fibrillation.**

A staggering number of ICDs and their component parts have been recalled by some of the leading manufacturers. Some of the defects that have been discovered include:

  • Faulty seals that allow moisture to get into the device
  • Wire erosion
  • Memory problems in pacemaker's computer component
  • Faulty capacitors that can't hold their charge
  • Leads that may be prone to fracture

As a result of these defects, patients can experience unnecessary, painful shocks or may not get life-saving therapy when it is needed. Some patients choose to undergo surgery to replace the defective device. However, this surgery also has risks and has been known to cause injury and wrongful death. A product liability attorney may be able to help you recover compensation for your suffering. Contact an attorney today to explore your legal options.

Defective Cardiac Devices and Your Legal Rights

Under state product liability law, medical device manufacturers (and possibly other people or companies in the supply chain) can be liable for harm caused by defective products that are unreasonably unsafe because their design was inherently flawed, an error occurred in the manufacturing process, or the warnings or instructions for use were wrong. Negligence, breach of warranty and strict liability are some of the legal theories that might be asserted. In a successful lawsuit, you might be entitled to compensation for:

  • Monetary damages for rehabilitation and other medical expenses and lost wages
  • Non-monetary damages for loss of companionship and pain and suffering
  • Punitive damages (typically awarded to punish the manufacturer for bad behavior)
  • Wrongful death damages to compensate family members for their financial losses and emotional distress

Even if you are unable to pursue a claim under state product liability law for a defective medical device, you may still be able to sue the manufacturer. For example, if the manufacturer deceived the Food and Drug Administration (FDA) or failed to make the device in strict accordance with FDA approval, you might have a good claim to pursue. A defective medical device attorney will know the current state of the law and how it affects your case. Product liability claims can have short statutes of limitations (meaning the amount of time to file a claim), so if you believe that you may have a case it is best to speak with an attorney right away.

* Heart Rhythm Society
** American Heart Association




Did You Know?

Approximately 2.2 million Americans have a common rhythm disorder called atrial fibrillation.

Source: American Heart Association