Pacemaker and Defibrillator Failures: When Devices Misfire

Warning: Pacemaker and Defibrillator Failures Can Be Deadly

If your pacemaker or defibrillator has malfunctioned, you may face life-threatening consequences. Act quickly to preserve evidence and protect your rights. In some cases, a device failure can lead to sudden cardiac death, which is fatal within one hour of the onset of symptoms. According to the American Heart Association, sudden cardiac death accounts for over 325,000 deaths in the United States each year.

What to Do When Your Pacemaker or Defibrillator Fails

1. Contact an experienced medical device lawyer as soon as possible. They can help you understand your rights and options. Section 360k of the Federal Food, Drug, and Cosmetic Act prohibits manufacturers from introducing misbranded or adulterated devices into commerce. Additionally, Section 3720 of the FD&C Act imposes reporting requirements on device manufacturers for certain types of adverse events.
2. Preserve all medical records, device packaging, and communication with your healthcare provider. Do not throw anything away. This evidence can be critical in proving your case and holding the responsible parties accountable. Keep any packaging or manuals that came with your device, as they may contain important information about its history and potential issues.
3. Follow your doctor's instructions and keep detailed records of your recovery process. This documentation can be used to support your claim for compensation and to demonstrate the extent of your injuries. Include information about your doctor's appointments, procedures, and any changes in your condition or treatment plan.
4. Do not sign any releases or make recorded statements to insurance companies without consulting a lawyer first. Anything you say can be used against you in court, so it's best to have legal representation when dealing with insurance companies. Refuse to provide any statements or sign any documents until you have had a chance to speak with a qualified attorney.

How the Law Protects Patients with Defective Devices

The law requires medical device manufacturers and providers to adhere to a standard of care. If a pacemaker or defibrillator malfunctions and causes injury, the victim may have grounds for a negligence lawsuit. In addition, the device manufacturer can be held liable under strict product liability rules. Under strict product liability, the injured party does not need to prove negligence, only that the device was defective and caused their injuries.

To prove negligence, the injured party must show that:

1. The device manufacturer or provider owed the patient a duty of care.
2. The device failed to meet reasonable safety standards.
3. The malfunction directly caused the patient's injuries.
4. The patient suffered actual damages, such as medical bills, lost wages, and pain and suffering.

Patients have a limited time to file a claim, so it's crucial to act quickly and preserve evidence. Most states have a statute of limitation of 1-3 years from the date of injury. In some cases, the discovery rule may apply, extending the time limit if the injury was not discovered until later. Additionally, Section 5440(c) of the FD&C Act provides a two-year statute of limitations for some claims involving medical devices.

Frequently Asked Questions

Q: How do I know if my device failed?
If you experience symptoms like fainting, dizziness, chest pain, or rapid heartbeat, especially after a defibrillator shock or pacemaker spike, your device may have malfunctioned. Consult your doctor immediately. If you have access to your device's data, review it for any irregularities or anomalies that could indicate a failure. In some cases, a device may show signs of corrosion or other physical damage, suggesting a potential failure.

Q: How much will it cost to hire a lawyer?
Most medical device lawyers work on a contingency fee basis. This means they receive a percentage of your settlement or judgment, typically 25-40%, but no upfront costs or hourly fees. This payment structure allows you to access quality legal representation without risking your financial stability. However, it's essential to understand the terms of your agreement with your attorney and to ask about any additional fees or expenses that may arise during the course of your case.

Q: What evidence do I need to preserve?
Keep all medical records, device packaging, and communication with your healthcare provider. If possible, retrieve your device and save its packaging and manuals. Additionally, document any symptoms you experience, the date and time they occur, and how they impact your daily life. Photographs or videos of your symptoms or device can also be helpful in proving your case.

Q: How long will my case take to settle or go to trial?
Complex medical device cases can take 2-4 years from filing to resolution. Hiring an experienced lawyer increases your chances of a favorable outcome. However, the length of your case will depend on various factors, such as the complexity of the issues, the availability of evidence, and the willingness of the parties to settle. It's essential to be patient and to trust in the process, as some cases can take longer than expected to resolve.

Q: Do I qualify for compensation?
If your device malfunctioned and caused injury, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. A editorial review can help you determine your eligibility. Factors that may impact your eligibility include the severity of your injuries, the extent to which your life has been disrupted, and the availability of insurance coverage. It's crucial to gather as much information as possible about your case and to consult with a qualified attorney to determine your best course of action.

Take Action Now

If you or a family member is dealing with an injury you suspect was caused by negligence, request a free, confidential case review through this site. A quick review can tell you where you stand and what your options are. Don't wait until it's too late to protect your rights and secure the compensation you deserve. Remember, time is of the essence in these types of cases, so don't delay in seeking legal advice.