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A class action alleges that cardiac devices such as pacemakers built by St. Jude Medical Inc., which include a “remote monitoring” feature use a transmitter and network that are completely unsecure from hacking.
The complaint asserts that all pacemakers, implantable cardioverter-defibrillators (“ICDs”) and cardiac resynchronization therapy defibrillators / pacemakers (“CRTs”) made by St. Jude Medical lack security measures that threaten the basic performance of these medically necessary devices.
The class action lawsuit states that in 2008, St. Jude Medical started advertising its “remote monitoring” ICDs and pacemakers.
Using a network, or “telemetry” system, patients using these new devices could transmit their implant data to their doctors at home.
This means patients would not have to go to the doctor for routine check-ups and data tests, which used to involve office visits every three months.
As the class action notes, these frequent office visits were “time consuming, expensive and inconvenient” for patients, and St. Jude advertised that consumers with remote monitoring devices had a “2.4 times greater probability of survival.”
However, the class action cites a third-party study which found that “St. Jude’s cardiac devices with RF telemetry capabilities, the Merlin@home transmitter and the Merlin.net PCN lacked even the most basic security defenses (such as strong authentication, encrypted software and code, anti-debugging tools, anti-tampering mechanisms and the use of a wand to activate RF wireless communications) that are used by other cardiac device manufacturers.”
St. Jude’s telemetry network does not even have the safety feature of requiring a password to protect a patient’s data, according to the complaint.
The study also showed how hackers could “obtain root access” in at least three ways, which would allow these bad actors to access data and exercise some control over these devices.
Plaintiff Clinton W. Ross, Jr. states that he had a St. Jude Quadra Assura CRT defibrillator implanted in November of 2015.
Ross claims that he was told the Quadra Assura would be remotely monitored by St. Jude’s “Merlin@home” transmitter, and that it was safe and secure.
However, Ross says that his physician has recommended that he stop using the Merlin@home transmitter because of its unsecure network.
Ross states that he does not intend to use the transmitter again until the safety issues are resolved by St. Jude Medical, and now has to go in for routine office visits for monitoring.
The St. Jude Medical unsecure pacemaker class action lawsuit alleges that St. Jude expressly told doctors and patients that its remote monitoring devices were safe.
The complaint argues that St. Jude Medical has breached an express warranty to consumers, that the company fraudulently concealed the flaw in its device network, and was negligent towards its customers.
The lawsuit seeks certification of a Class of all person implanted with a “pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy pacemaker and/or defibrillator with radiofrequency (‘RF’) telemetry capability that was designed, manufactured, marketed, distributed or sold by the Defendants.”
The class action asks for restitution and damages for all Class Members.
Ross is represented by Mike Arias, Alfredo Torrijos, Elise R. Sanguinetti, and Jamie G. Goldstein of Arias Sanguinetti Stahle & Torrijos LLP.
The St. Jude Medical Unsecure Pacemaker Class Action Lawsuit is Clinton W. Ross Jr. v. St. Jude Medical Inc., et al., Case No. 2:16-cv-06465, in the U.S. District Court for the Central District of California.
UPDATE: The St. Jude Medical Unsecure Pacemaker class action lawsuit was dismissed on December 28, 2016.
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23 thoughts onSt. Jude Medical Class Action Alleges Pacemakers Unsecure
My husband had a pacemaker/defibrillator implanted in (I think) 2010. I am not sure if it was made by St Jude. For about 2-3 months he was feeling great, we went hiking and even were intimate for the first time in a long time. Suddenly though his energy level started to drop and soon he was right back where he started. When he went in for a follow up the doctor said something at the remote site had gone wrong and his pacemaker had been reset by the computer system. One of his ventricles was set very fast and the other very slow. After it was reset it was never right again because the mishap had caused another injury to his heart. On March 19, 2013 he went in for a scheduled hernia surgery and died. He was 50 years old.
I just rec’d a call from my Dr. and asked for an appt with me to discuss the St. Judes Pacemaker/defibrelator recall. what should I expect to hear from him? The appt is 4:30 EST today.
My husband had a valve replacement done on June 3 and died on Sunday.
My brother in law have this device September 2015 and after that he’s holding his chest and he said pacemaker is catching up. So we thought it’s new that’s why he’s not comfortable. And October 10, 2016 he passed away we just found him on the floor. we never received a call if the machine is working even 3 hours of his death no calls. My husband went to the hospital angry and the nurse told him no monitor on weekdays and th next day doctor called and told us the machine is recall. We are so mad. This is not a joke this is about life
first I had a pace maker, then after a second attempt to fix the electrical part of my heart they took out the pace maker and put in a ICD. I just heard about the battery problem. Sounds like they have known for years. How do I sign up for the lawsuit? Before I just get swept under the rug.
The case is still moving through the courts and has not yet reached a settlement. Claim forms are usually not made available to consumers until after a court approved settlement is reached. We recommend you sign up for a free account at TopClassActions.com and follow the case. We will update the article with any major case developments or settlement news! Setting up a free account with Top Class Actions will allow you to receive instant updates on ANY article that you ‘Follow’ on our website. A link to creating an account may be found here: https://topclassactions.com/signup/. You can then ‘Follow’ the article above, and get notified immediately when we post updates!
I hv a defective defibrillator in me, as I found out October 2016. Are you also stating the new machine St. Jude fedexed to me overnight is also defective n I shld not be using it on a daily basis as originally advided?
I had a new pacemaker put in 6 months ago am I at risk I have had dizzy spells and figured I was ok because of new pacemaker. I have three episodes of feeling dizzy and did not even think of pace maker I am concerned.i have a merlin home monitor should I run this every day was running it once a month because it was new
Please get back to me a little concerned because I have had dizzy spells and figured I was ok because of pace maker maureenmorrissey1@aol.com does running this merlin device read correctly
My husband has been using a Merlin At Home to monitor his pacemaker since 2010. Can you please let me know how we can become a member of this class action law suit?
I have a pacemaker through ST JUDES and I have to run the test from my merlin device and every so often I have to go into the doctor office when st Jude’s come to town. but with this pacemaker I feel like my heart is in distress at night I have to set up on the side of the bed to catch my breath and hold my chest I receive the pacemaker November 9,2014
I am on my 2nd. St.Jude pacer, both of which have been monitored by a Merlin. I will add that in 3/2016 I was notified by my Cardiologist that he received a remote alert from my Merlin, showing my battery level was fast dropping. 2 weeks later a new battery replacement was done. Nothing to do with security, which is very worrisome to me. Please keep me updated. Thank You
What is the criteria to join the class action suit on St Jude pace makers?
my husband has had his St Jude transmitter for quit a few years should we unplug it?