St. Jude Riata Lead Lawsuit
The St. Jude Riata and Riata ST implantable cardioverter defibrillator (ICD) leads have been recalled because of design defects, which may allow the electrodes to poke through the insulation, putting patients at risk of problems with their defibrillator.
STATUS OF ST. JUDE RIATA LAWSUITS: A number of individuals throughout the United States have filed a St. Jude Riata lead lawsuit after experiencing complications where they suffered unnecessary shocks, required surgery to remove the recalled leads or had their defibrillator fail.
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OVERVIEW: The St. Jude Riata and Riata ST leads are small wires used to connect an implantable cardiac defibrillator (ICD) to the heart. The leads monitor the heart rhythms and are designed to deliver a life-saving shock if needed to restore the heart to normal rhythms.
Due to manufacturing and design problems, the St. Jude Riata leads are prone to fail within a few years, with the small wire poking through the insulation. This could cause individuals to experience unnecessary shocks or cause the ICD to fail to deliver a necessary charge when needed.
Approximately 80,000 of the leads were still in patients at the time of the recall, leaving these individuals at risk of serious and potentially life-threatening complications.
ST. JUDE RIATA LEAD PROBLEMS: A number of articles posted on this website have highlighted and outlined the problems with St. Jude Riata leads that were implanted in patients throughout the United States.
- St. Jude Riata Defibrillator Lead Recall Issued (12/19/2011). Describing how the FDA classified a November 2011 warning letter sent to physicians and the company’s 2010 decision to halt sales for Riata leads as a Class I Medical Device Recall, suggesting that continued use of the leads poses a substantial risk of serious injury or death.
- Study presented at American College of Cardiology meeting in Chicago highlighted the Serious Risk Presented by Recalled St. Jude Defibrillator Leads (3/26/2012), highlighting how the defective leads may fail in multiple ways and pose a serious risk for patients.
- St. Jude QuickSite and QuickFlex CRT Leads Also Identified As Having Problems (4/5/2012). St. Jude announced that it will halt sales for these leads used in defibrillators known as cardiac resynchronization therapy (CRT) devices, due to similar insulation problems. At least 39 confirmed reports were identified where the conductors on St. Jude QuickSite and QuickFlex CRT leads pocked through the insulation.
- A large study presented at a meeting of the Heart Rhythm Society in Boston found that St. Jude Defibrillator Lead Failures May Be Widespread (5/14/2012). Out of 712 devices identified in a seven hospital study, researchers found at least 67 had failed by the end of December 2011. When x-ray images were reviewed for 110 of the patients, researchers found that the small lead wires had pierced through the insulation in about 25% of the cases.
- St. Jude Durata Lead Found to Have Similar Problem (6/13/2012). According to an adverse event report submitted to the FDA, one of St. Jude’s newer Durata leads was also found to have the conductor poking through the insulation in at least one patient.
- Research found that St. Jude Riata Problems Often Involve Large Diameter Leads (7/17/2012), with a 24% chance the insulation on the conducts of those leads may fail, compared to a 9.3% failure rate among small diameter St. Jude Leads.
- FDA Has Recommended X-Ray Monitoring Due to the Risk of St. Jude Riata Lead Insulation Failure (8/17/2012). Individuals with a recalled lead have been advised to obtain imaging exams, as well as other steps to monitor for problems. The FDA also ordered St. Jude to include several newer leads, including the Durata and Riata ST Optim, in additional studies that were ordered to evaluate the risk of problems
- St. Jude Defibrillator Lead Problems May Impact Newer Leads As Well (8/22/2012). According to a study published in the medical journal Europace, similar insulation problems have been identified with the St. Jude Riata ST Optim and St. Jude Durata leads, which feature redesigned insulating materials, with a mix of silicone and polyurethane.
ST. JUDE RIATA LAWSUIT ALLEGATIONS: The following articles provide additional information about the allegations and claims raised in various lawsuits over St. Jude leads:
- St. Jude Class Action Lawsuit Filed Over Defibrillator Lead Problems (6/18/2012). Investors filed a class action against St. Jude Medical alleging that the manufacturer artificially inflated it’s stock value by withholding information about problems with St. Jude Riata and QuickFlex leads.
- St. Jude Riata Lead Lawsuit Filed Over Failed Defibrillator Lead Wire (7/19/2012). A Connecticut man filed a lawsuit after his lead failed just over three years after it was implanted, requiring invasive surgery to remove and replace the small wire connecting his ICD to his heart.
According to allegations raised in lawsuits over St. Jude Riata leads:
- St. Jude Riata leads feature inconsistent insulation, which can cause the insulation to wear thinner at certain parts of the lead.
- Friction and abrasion may have been increased by inconsistent application of a lubricous interface between the inner and outer insulation.
- St. Jude Riata leads may have reduced strength of the silicone insulation due to a failure to properly cure and sterilize during the manufacturing process.
- St. Jude Riata leads may not have been crimped with a controlled and uniform degree of force, which could result in an insecure crimp over the length of the lead.
Potential claims are being reviewed by St. Jude Riata recall lawyers on behalf of individuals throughout the United States. Submit information about problems experienced by yourself, a friend or family member to determine whether financial compensation may be available through a product liability lawsuit.
ThomasFebruary 5, 2018 at 9:15 am
My name is Thomas I had one and it caused me to get a in infection around my heart and defebulator and the lead , this caused pancreatic cancer I went to lots of doctors but by the time I was sent cancer care alliance and found out I was in stage 4 in a month it went to my spleen and liver and on 12-29-2011 i was told that i only had 2 weeks ,but i went back 1-26-12 and no treatment i was [Show More]My name is Thomas I had one and it caused me to get a in infection around my heart and defebulator and the lead , this caused pancreatic cancer I went to lots of doctors but by the time I was sent cancer care alliance and found out I was in stage 4 in a month it went to my spleen and liver and on 12-29-2011 i was told that i only had 2 weeks ,but i went back 1-26-12 and no treatment i was told the cancer is completely gone -but always cancer patient and chronic pancreatitis both are terminal so how much is you life worth times 2 and my case is got the judges on my side should settle soon ,need Pancras transplant then I can be healthy .
RoselynMarch 3, 2015 at 8:27 am
Kirby and William, I'm so sorry to hear all that you have been through and I thought I had the only horror story. I received my 1st pacer/defib from St. Jude in 2004 and just like you two mentioned or more like William; I began having problems almost immediately. My battery has died 3 going on 4 times since 2004. While my battery was being changed adjustments were made to replace wires. My current[Show More]Kirby and William, I'm so sorry to hear all that you have been through and I thought I had the only horror story. I received my 1st pacer/defib from St. Jude in 2004 and just like you two mentioned or more like William; I began having problems almost immediately. My battery has died 3 going on 4 times since 2004. While my battery was being changed adjustments were made to replace wires. My current dr received the recall letter in October 2012, he sent me to duke hospital in November and by December the lead had already penetrated the lower right side portion of my heart. The only solution the drs had at that time was to do an emergency triple by-pass. Instead of the surgery to remove and replace the lead taking 3 hrs, I stayed on the operating table for 12 hrs. and the drs were not sure I would make it but I thank God for leading and guiding there hands. with all the tubes placed in my body for me to breath and not choke, I have so many cuts and scars on my body tha44t I cant hardly stand to look at my own body. but there were 2 more st jude leads attached to my device along with a st Jude defib/pacer. so other problems arose in July 2014 and another surgery was required to replace the defib/pacer with another St. Jude defib/pacer, and now another surgery is due March 2015 to totally remove St. Jude devices and leads from my body. Im only 51 and this recalled devise has ruined and almost cost me my life. Now my lawyers want me to settle for $15 to $20 thousand, and says its better than nothing, the devil is a liar. After almost losing my life and scaring up my body, not to mention the pain and suffering Ive gone and still going through. Now St. Jude will not own up to there responsibility of a defective device causing all of this and they want to toss me pennies; no , something is not better than nothing. And I will have to take those pennies to pay my lawyers 40% and pay my own medical bills.. When Im finished I may take home a couple thousand dollars, no thanks law firm of Lockridge. I was hoping they would fight harder for me but maybe I should have done like Kirby and faced the judge myself because I also Have proof of wrong doing. Thanks for the ear and I will be in prayer for all of us who cant beat the system without the Lord.
William AlexanderAugust 19, 2014 at 3:11 am
Dear Kirby. Wow what a story. Yes I have the same lead. I was fortunate that my device failed after the battery got to low for it to shock me more. I was shocked 18 time's in twenty minutes. Also I received one shock before the surgery to replace my device because it had ran low on voltage. The lawsuit looks good. I have Reza at Torklaw dot com. Ranked in the 1% of best lawyers in the united state[Show More]Dear Kirby. Wow what a story. Yes I have the same lead. I was fortunate that my device failed after the battery got to low for it to shock me more. I was shocked 18 time's in twenty minutes. Also I received one shock before the surgery to replace my device because it had ran low on voltage. The lawsuit looks good. I have Reza at Torklaw dot com. Ranked in the 1% of best lawyers in the united states. My lawsuit is not a class action. It is for what I suffered. You said you have information about fraud within the company? I could use all the help I can get. My email is sweetbilly63@ yahoo.com I will bookmark this page and hope to hear from you and others. It is amazing you are alive. I couldn't have took much more. There was NO REASON for my device to shock me. The lead was removed and yes it is faulty. Lawyer put in a motion to preserve evidence.
kirbySeptember 20, 2012 at 7:44 pm
I have been blessed to be one of the unlucky/lucky recipients of the riata lead, st judes toy defibrillator, and "new" durata lead. in 2002 I had the first of this system implanted which almost immediately began to fail. In 2006 I coded and my defibrillator failed to provide therapy "shocks", which st judes contests with falsified records made up in their own lab,9yes I can prove this). Luckily I [Show More]I have been blessed to be one of the unlucky/lucky recipients of the riata lead, st judes toy defibrillator, and "new" durata lead. in 2002 I had the first of this system implanted which almost immediately began to fail. In 2006 I coded and my defibrillator failed to provide therapy "shocks", which st judes contests with falsified records made up in their own lab,9yes I can prove this). Luckily I was in a hospital elevator when I coded and was revived by hospital personnel. unluckly I sufered brain damage from lack of oxygen. In 2011 I had an ICD storm during which my ICD fired 48 times inless than 2 hours. Due to damage to my left ventricle I had a LVAD pump implanted to replace my left ventricle. less than a month later I had another ICD storm in which my ICD fired over 50 times. Yet I am still alive due to some wonderful doctors so yeh I am lucky. Three years ago I filed a suit on my own in federal court and have fought st Judes lieing lawyers since. It looks like they will win this round of motions to dismiss in January when we are scheduled for trial. I have a ton of evidence that I would gladly share with anyone in need of help with their lawsuit. I believe St Judes will eventually lose a class action suit which does nothing for those who have lost loved ones to this criminal action committed by st judes. Fines do not scare these multi-billion dollar companies. Jail time for some smart aleck CEOS would. Everyone of the 79,000 Americans who has had their life put in danger by the riata,durata,ICD units produced by st judes should file complaints with the FDA, DOJ, and civil lawsuits. Best of luck to all of you and your loved ones. Kirby Knight
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