St. Jude / Abbott Cardiac Defibrillator Cybersecurity Lawsuits

National Cardiac Device Attorneys for Recalled St. Jude/Abbott Cardiac Device Lawsuits

Certain implantable cardiac devices could be at risk for cyber-attacks, leaving patients vulnerable to serious injury. The attorneys at Parker Waichman LLP are managing cases on behalf of injured patients and working to pursue justice for victims and families.

If you have a potential cardiac device cybersecurity case, contact our firm today to speak with an experienced medical device lawyer. You have legal rights, and we can help you protect them.

Cybersecurity Issues in Cardiac Devices

Recent news has brought to light frightening security vulnerabilities in certain cardiac devices, including implantable cardioverter defibrillators and pacemakers. These devices use wireless communication to store and transmit data to patients and doctors to optimize cardiac therapy. Both doctors and patients can view data from the devices to see whether anything needs to be adjusted or whether the patient needs a medical appointment. Wireless data can alert doctors to important information about their patients’ hearts so they can interfere before patients suffer injuries.

Because of inadequate security, unauthorized users and hackers can potentially gain access to certain devices or the data coming from the devices through the wireless communication the devices use. This leaves patients at risk for harm. If hackers gain access to the devices, they can potentially cause the following problems:

1. Change or interfere with wireless data from the devices. This can impede patient therapy because doctors will not have all the information they need.

2. Access and exploit patient information. Hacking has the potential to release sensitive information about a patient stored on the cardiac device systems and compromise patient privacy.

3. Disrupt therapy with the subject cardiac device. Hackers who gain access to the devices themselves can potentially disrupt therapy by causing premature battery depletion, administering inappropriate electronic pulses to patients, or ceasing necessary pulsing to patients.

Patients receive these devices to regulate their heart rhythm and prevent them from going into cardiac arrest. Pacemaker and defibrillator devices provide life-saving therapy, and any compromise to the devices or device systems places patients at great risk for harm.

Patients injured because of security breaches have legal rights that entitle them to just compensation. Medical device manufacturers have a legal duty to make sure their products are safe for patient use, and this duty is ongoing. When manufacturers learn of new risks associated with their products, they have an obligation to warn patients and members of the medical community. When they fail to take appropriate action to protect patients, product liability attorneys will step in to hold them accountable and seek justice on behalf of injured victims.

If you have experienced any irregularities with your cardiac device or suffered any injuries that you suspect are related to the device’s security, contact Parker Waichman LLP as soon as possible. Our lawyers will evaluate your case to determine whether you are eligible to file a lawsuit against the device manufacturer.

St. Jude/Abbott Cardiac Device Recall Lawsuits

A prominent example of cybersecurity issues in cardiac devices lies with manufacturer St. Jude Medical Inc. St. Jude is now owned by health care company Abbott and has been involved in several recalls by the U.S. Food and Drug Administration concerning cyber threats to its cardiac devices.

In January 2017, the company issued communication alerting patients and health care facilities to cybersecurity issues with its cardiac device software systems. These systems, which the company refers to by the brand name Merlin, allow data from the device to be wirelessly transmitted and uploaded for patients and physicians. The company issued a security update in January 2017 that would supposedly fix any threats of hacking within the systems.

In August 2017, the FDA issued a Class I Recall (the most severe type of recall) for St. Jude/Abbott’s pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The recall was regarding cybersecurity vulnerabilities and the potential for unauthorized users to gain access to the devices and drain the batteries or interfere with pacing. Patients with affected devices were to make appointments with their physicians to install firmware updates with enhanced security. The firmware update had to be installed in-office and directly onto the device, during which time the patients’ devices were placed in backup mode.

In April 2018, the FDA issued another Class I Recall on St. Jude/Abbott cardiac devices, this time for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall again addressed cybersecurity vulnerabilities and again directed patients to make appointments to have a firmware update installed.

In some cases, the updates failed, patients’ devices returned to the older, vulnerable firmware, or patients’ devices failed completely. Some patients also experienced discomfort during backup mode and were not able to get their devices out of backup mode. Not only do cyber threats present risks to patients, the fixes to those security issues can be dangerous.

These patients deserve answers, and so do you. If you believe your cardiac device has been compromised, contact Parker Waichman LLP today. Our attorneys provide free consultations and can speak with you over the phone or meet with you at one of our office locations.

Knowing Whether You Have an Affected Device

The news about device recalls, and security issues can be overwhelming, and it is likely difficult to sort out whether your device has been affected. If you have a St. Jude/Abbott device that is radio-frequency enabled, you were affected by the January 2017 updates to the Merlin systems. These updates were performed automatically, however, and you did not have to go into a physician’s office.

The following pacemakers and CRT-Ps were involved in the August 2017 FDA recall:

• Accent SR RF
• Accent MRI
• Assurity
• Assurity MRI
• Accent DR RF
• Anthem RF
• Allure RF
• Allure Quadra RF
• Quadra Allure MP RF

The following ICD and CRT-Ds were involved in the most recent FDA recall in April 2018:

• Fortify
• Fortify Assura
• Quadra Assura
• Quadra Assura MP
• Unify
• Unify Assura
• Unify Quadra
• Promote Quadra
• Ellipse

You might not know what brand of pacemaker you have or who manufactured it. This is one way a medical device lawyer can help you. Your attorney can order medical records that indicate which product you have and the name of the manufacturer. Upon receipt and analysis of your records, your lawyer will be able to tell you whether your device was part of any recalls and whether it is the subject of pending litigation.

When to Contact a Cardiac Defibrillator Cybersecurity Lawsuit Lawyer

It is important to remember that in all medical device cases, statutes of limitations will apply. These act as filing deadlines that can completely bar your legal rights if you fail to file your claims in court within the appropriate period of time. Every state has its own statute of limitations for medical device cases, and the amount of time you have to file can change depending on several factors. The nature of your case and the damages you will claim can factor into your filing deadline.

Because the statute of limitations is so critical and numerous circumstances can influence your own statute of limitations, it is important to seek legal representation as soon as you understand you might have a potential case. You do not have to be sure about your case before calling a lawyer — that is something you and your attorney will work through together. What is important is that you hire a lawyer as soon as possible to assess your case and determine whether you still have time to file a claim in court. You want to be sure you are working with someone who is qualified to manage your case and who will dedicate adequate time and resources to your claims.

Frequently Asked Questions

Clients who contact us about potential cardiac device cases usually have a few questions for our attorneys. Our St. Jude / Abbott cardiac defibrillator cybersecurity lawsuit attorneys have compiled some of the questions we frequently hear, along with our answers, which you can read below.

What are cybersecurity issues facing cardiac devices?

Recent reports indicate that certain cardiac devices might have cybersecurity vulnerabilities that can allow hackers to interfere with the devices’ wireless communications and potentially gain access to the devices themselves.

What kind of risk does this present to patients?

Any disruption to data transmission or therapy with the devices places patients at risk for cardiac injuries. Patients might experience symptoms associated with irregular heartbeats, such as chest pain or shortness of breath, or they might go into cardiac arrest. Cardiac arrest can result in severe injury and death.

Has the FDA recalled any cardiac devices because of security issues?

Yes, the FDA has issued two recalls that apply to St. Jude / Abbott cardiac devices. One was in August 2017, and this applied to pacemaker devices, including:

• Accent SR RF
• Accent MRI
• Assurity
• Assurity MRI
• Accent DR RF
• Anthem RF
• Allure RF
• Allure Quadra RF
• Quadra Allure MP RF

The second was in April 2018 and applies to defibrillator devices, including:

• Fortify
• Fortify Assura
• Quadra Assura
• Quadra Assura MP
• Unify
• Unify Assura
• Unify Quadra
• Promote Quadra
• Ellipse

How do I know if I have a recalled device?

To understand whether you have a recalled product, you can visit the FDA’s website and search for your device by entering in prompted information. We encourage you to also contact our offices if you have experienced an injury because of your cardiac device and believe your device might have been the subject of a recall.

Can I report information about my device to the FDA?

Yes, if you are having any issues with your cardiac device, you can report those to the FDA by using the agency’s Adverse Event Reporting System. The Adverse Event Reporting System allows you to input information about your device and experiences online that the FDA will later review. You should also communicate with your physician if you are experiencing issues with your cardiac device and should hire a qualified attorney if you have been injured because of your device.

Do I have a legal claim?

The most reliable way to ascertain whether you have a legal claim for damages related to your cardiac device is to allow our lawyers to perform an investigation of your claims. By gathering some pivotal information about your case, we will be able to determine your legal options and decide together how we should move forward. Contact our offices today to learn more about how we can help you understand whether you are eligible to file a claim against your device manufacturer.

Contact Parker Waichman LLP About Your Case

Parker Waichman LLP is currently investigating claims related to cybersecurity breaches with cardiac devices, such as pacemakers and defibrillators. If you have experienced an injury or issue with your device that you suspect related to a cyberattack, contact our St. Jude / Abbott pacemaker and defibrillator lawsuit attorneys today. You can receive your free consultation today by calling 1-800-YOURLAWYER (1-800-968-7529) or by filling out our online form.