FDA Issues Cybersecurity Recall of St. Jude/Abbott Defibrillators;
Parker Waichman LLP is Reviewing Claims Against Manufacturer
Due to the threat of cyberattacks, the U.S. Food and Drug Administration has initiated a corrective action for certain implantable defibrillators manufactured by St. Jude Medical Inc. (now Abbott). Parker Waichman is investigating cases on behalf of affected patients, and we are fighting for just compensation from the manufacturer.
If you have been injured due to a firmware cybersecurity issue with your St. Jude/Abbott defibrillator, contact our offices today. Our attorneys offer free case review and will work with you to help you understand your potential legal options.
Cybersecurity Issues in Certain St. Jude / Abbott Defibrillators
Certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by St. Jude have cybersecurity vulnerabilities, as confirmed by the FDA. The devices were originally manufactured by St. Jude Medical, which is now owned by the healthcare company Abbott. The ICDs and CRT-Ds are implantable electronic devices that monitor and control heart rhythm. They send mild electric pulses to maintain normal heart rhythm and can deliver strong defibrillating shocks if a patient goes into cardiac arrest.
The devices are enabled with wireless radio frequency communication that allows both patients and physicians to track and read data coming from the devices. A component system for the devices, called Merlin@home, receives wireless data from the devices and will upload the data to a software program for patients to view at home and for physicians to view in their offices. If something is awry with the device, or the device is detecting issues with a patient’s heart, patients and physicians can connect with each other to schedule an appointment for appropriate medical treatment.
Recently, Abbott learned of security vulnerabilities in both its Merlin system, and its defibrillator devices that could allow unauthorized users or hackers to interfere with patient therapy and device data. The security issues might have been known to Abbott in 2015 or earlier, but Abbott did not take action to fix the issues until 2017. Starting in 2017, the FDA became involved in the matter and had taken several steps to alert the public and implement designed fixes.
Potential Effects of Cyberattacks and Injuries to Patients
A cyberattack on ICD/CRT-D monitoring systems or the devices themselves could have severe consequences to patients. If an unauthorized user gains access to the devices’ wireless communications, this user could do the following:
- Interfere with device data – A hacker could disrupt the data coming from a patient’s device or interfere with the upload, transmission, or reading of that data. If patients and physicians do not have accurate data, they might not be aware of problems with the devices or potential medical issues with patients’ hearts. This places patient health in jeopardy, as it prevents patients from receiving timely medical care.
- Compromise patient privacy – A large amount of information about a patient can be gained from accessing his or her cardiac device. Any interception of the patient’s medical data is a serious security risk and violation of the patient’s privacy. These devices are connected across the internet and health databases, and sensitive patient information could be at risk.
- Interfere with device function – Most alarmingly, a hacker could potentially directly interfere with the function of patients’ devices. This includes depleting the battery power, ceasing pulsing activity, or delivery inappropriate pulsing and shocks to patients. If the device function is compromised, patients can experience the following symptoms and injuries:
- Rapid heartbeat or heart pounding
- Shortness of breath
- Chest pain
- Cardiac arrest
Abbott has tried to make this cybersecurity issue seem minimal, but it has the potential to severely affect patients and families. That’s why our firm is pursuing litigation against the manufacturer to secure needed compensation for injured patients.
Parker Waichman LLP Fighting for Victims’ Rights
Patients undergo invasive ICD and CRT-D implantation procedures to protect themselves from sudden cardiac arrest and death. Cyber threats to these devices can potentially lead to the very complications these patients and their doctors were trying to avoid. Our attorneys are alarmed by the information we have uncovered about this cybersecurity threat, and we are fighting to seek justice for patients in the face of what appears to be extreme negligence by the device manufacturer.
Parker Waichman LLP is a national product liability law firm with decades of experience handling medical device cases against major corporate manufacturers. We have secured more than $2 billion for our clients because we are committed to holding negligent parties responsible for placing innocent people at risk. Our clients trust us to pursue the outcomes they need during some of the most traumatic times of their lives, and we work tirelessly to deliver.
We are taking the cybersecurity issues with St. Jude/Abbott ICD and CRT-D devices very seriously. We understand the potential ramification of cyberattacks on these life-saving cardiac devices, and we are battling to help all injured patients achieve meaningful results through the justice system. If you have experienced any irregularities with your ICD or CRT-D device that you think might be related to a cyberattack, contact our offices immediately. We will quickly schedule an appointment for you with one of our skilled medical device lawyers who can analyze the facts of your potential lawsuit.
FDA Initiating Recall of St. Jude/Abbott ICD Devices
In response to the information it has received from Abbott, the FDA has released safety alerts, and communications are confirming Abbott’s ICD and CRT-D devices are at risk for cyberattacks. The FDA has, in turn, issued a corrective action or Class I Recall (the most serious type of recall) for these devices.
As part of the recall, patients with affected devices need to make appointments with their physicians to have firmware updates installed on their implants. Affected devices include (all manufactured by St. Jude/Abbott prior to April 2018):
- Fortify Assura
- Quadra Assura
- Quadra Assura MP
- Unify Assura
- Unify Quadra
- Promote Quadra
Patients with these devices, which are enabled with wireless radio frequency communication, need to see their physicians as soon as possible to receive necessary security updates. The update, which is supposed to strengthen security across all systems, will take approximately three minutes and must be completed in-office. During the update process, patients’ devices will be placed in backup mode, and high-voltage capabilities will be disabled.
Notably, some devices cannot be updated because of technology limitations. These include St. Jude/Abbott ICDs and CRT-Ds in the Current and Promote brand lines. Patients with these devices can completely disable radio frequency communications, but this is not recommended in most situations because it disallows data transmission to physicians.
Some patients are reporting complications with the update process itself, which Abbott admits might fail, and some patients do not even have the option to receive the update. We believe Abbott has placed patients at unnecessary and serious risk because of inadequate security measures, and we are working to uncover the facts and hold the manufacturer accountable.
Hiring a Medical Device Attorney for Your Defibrillator Security Case
If you have a potential claim related to your ICD or CRT-D device, you need to hire an experienced ICD or CRT-D device attorney to investigate your case and pursue compensation on your behalf. These medical device cases can be extremely complex and require significant resources to litigate. The right firm can offer you protection and peace of mind throughout the duration of your case.
When you hire a qualified attorney from Parker Waichman LLP, your case will benefit in the following ways:
- Records order and product identification – You are likely wondering as you read about the St. Jude/Abbott device recall whether you have an affected device. Even looking at the list of applicable devices, you might not know for sure whether you are included in this recall. When you hire our firm, we will order your medical records and identify the exact cardiac device you have and the injuries you have experienced because of that device.
- Analysis of applicable statutes of limitations – Statutes of limitations act as filing deadlines in all states and apply to every type of case. Our attorneys are diligent about determining statutes of limitations to make sure we have enough time to build your winning case.
- Expert witness review – A major component of successful medical device cases is expert witness testimony. As a longstanding and reputable firm, we have access to some of the best experts in the country. These qualified experts will review your case information and help us understand how we can best approach your litigation.
- Document preparation and case filing – Once we have everything else in place, our lawyers will draft all necessary documents for filing and will file your case in court. We will make sure we file in the most appropriate venue, based on our research.
The above steps move your case just to the filing point, and these actions alone require far more time and money than the average person can spare. When you work with Parker Waichman LLP, we cover all your case expenses without asking for any money up front from you. And if you do not receive a payment at the end of your case, neither will we.
Contact us today to ask for more information about how we can help you and why so many families have selected our firm for their important legal needs.
Free Case Review for St. Jude/Abbott ICD Cybersecurity Injuries – You Could Be Eligible for Compensation
Parker Waichman LLP offers a free consultation and initial reviews for medical device cases, including cases related to St. Jude/Abbot ICD and CRT-D security issues. We know you have enough stress as it is, and you do not need to worry about whether you can afford skilled legal representation. We eliminate that barrier by working for you with zero retainers and zero bills in your mailbox.
Your case could result in compensation for your medical expenses, your lost wages, your physical pain and suffering, and more. We have the skills, experience, and resources to achieve the results you deserve while minimizing the stress on your shoulders.
Because statutes of limitations are in place, you should not delay in seeking qualified review of your claims. You might have limited time to file a claim in court and pursue the damages you need. Contact our defective firmware St. Jude/Abbott cardiac implant law offices today to discuss your case with a Parker Waichman LLP attorney.
Contact Parker Waichman LLP
Parker Waichman LLP is aggressively pursuing litigation related to cybersecurity problems with St. Jude/Abbott cardiac implants. If you have endured an issue with your St. Jude ICD or CRT-D and believe it might be related to a security issue, contact our offices today. You can schedule your free consultation and case review with an attorney by calling 1-800-YOURLAWYER (1-800-968-7529) or by filling out our online form.
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation
Have you or your loved one suffered a battery alert or software issue with a St. Jude - Abbott Defibrillator?Click To Get A Free Case Review