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Medtronic Announces Settlement of Heart Lead Litigation

Today, Medtronic issued the following press release:

“Medtronic Settles US Lawsuits on Sprint Fidelis Family of Defibrillation Leads

MINNEAPOLIS – October 14, 2010 – Medtronic, Inc. (NYSE:MDT) today announced that it has entered into an agreement to settle existing U.S. lawsuits relating to its Sprint Fidelis® family of defibrillation leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949) that were the subject of a field action announced on October 15, 2007.

Under the terms of the agreement, Medtronic has agreed, subject to certain conditions, to settle U.S. lawsuits and claims pending as of October 15, 2010 for a total payment of $268 million. The payment includes an amount for attorneys’ fees and administrative expenses. The parties will file joint requests to terminate the Multi-District Litigation (MDL) and Minnesota state court proceedings related to the Sprint Fidelis leads and to dismiss the plaintiffs’ appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals.

The parties will also request dismissal of other Fidelis-related cases throughout the country. Medtronic can cancel the agreement if certain conditions are not met, and the agreement can be terminated by either party if the MDL proceedings are not terminated.

The cases in the settlement are those arising in the United States from the October 15, 2007 Sprint Fidelis field action, including cases currently filed either in the MDL or in state courts. All settling plaintiffs must satisfy any insurance claims and subrogation interests of Medicare or Medicaid from their settlement payments. No additional sums for these cases will be paid by Medtronic for third-party claims or attorneys’ fees.

The settlement is a compromise of disputed claims, and the parties have not admitted any liability or the validity of any defense in the litigation. Medtronic expects to record the Sprint Fidelis lead litigation settlements as a special charge in its second fiscal quarter ending October 29, 2010.”

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29 Responses to “Medtronic Announces Settlement of Heart Lead Litigation”

  1. TYRONE LUNDY says:

    THIS SETTLEMENT SHOULD HAVE BEEN MORE. THERE ARE MANY PEOPLE OUT THERE WITH THESE RECALLED LEADS. SECOND THESE COMPANIES HAVE TO HELD ACCOUNTIBLS FOR THERE PRODUCTS. THAT IS WHY THE THE MEDICAL DEVISE ACT BILL MUST BE PASTED.

  2. My son is a walking time bomb knowing the lead is faulty and the faulty part is the part that goes into the heart — the doctor says too dangerous to remove it — he is on meds for his nerves and so are his two daughters.

  3. Bob Puckett says:

    With the situation being what it is with preemption, this is the best that can be expected. Better take what you can, its better than to not get anything. I have suffered thru 6 shocks, lead replacement and a blood clot in my left arm caused by the lead replacement surgery. Had to take coumadin for 7 months and felt horrible for 5 to 6 months after the replacement.
    You people that are thinking about not taking settlement need to remember, NO LAWYER WILL TAKE A CASE AFTER SETTLEMENT IS FINALIZED. PREEMPTION TAKES CARE OF THAT.

  4. Wendy says:

    My husband Mark Turnidge heard a beeping sound and we discovered it was from his chest. He called the on call doctor and when talking with the surgeons at his Cardiovascular clinic, he was told to come in that night to be monitored and the next day for surgery at 3PM. Luckily I led to my instinct when he called me early on the day of his surgery (Jan 6, 2009) to say he was bumped to 8AM. I hussled to get there to see him off and stay. He went back to surgery, joking “I’ll see you in recovery or in heaven”.

    After several attempts to remove it they used the laser and supposedly it finally moved (b/4 he went back we talked to the surgeon about how long this would take and the answer was 1 maybe 2 hours, unless it’s fibrous. I asked if that meant it’s embedded in scar tissue. Answer I was given is, “he’s young and 33 and I do these all the time and in fact just did one on an 80 year old but it could add a few hours.

    That laser ripped through the vena cava causing him to bleed out and since he was first in a cath lab and had to be rushed to Open Heart surgery, a nurse came to get family and the epinepherin (ephedrin?) was causing the heart to beat even faster. Somehow his body made it for over 20 min w/o oxygen to his brain and when I saw him in his room, he looked terrible. So much bloating, broken capillaries and we all almost dropped to our knees. I stood at the head of the bed combing his hair through my hands, knowing he was gone and was 100% dependent on life support. For a few hours he only initiated a few breaths and by morning that was gone. After neurological tests the next day and the 3rd day one more, the conclusion was he had no brain stem function and it was just a matter of time. I had alot of my support system there and many more friends (45 or so) and I asked the nurse for permission to allow them there while we removed the tube. He remarkably died to the song, “Come to Jesus” and hadn’t moved by himself at all but when the song said “So fly to Jesus, fly to Jesus, fly to Jesus, and live”. When it was fly the very first time, his arms raised off the bed, both of them and as the song ended, his heart rate went to _______ (zero). He was my highschool sweetheart and we had a relationship unlike anyother is what people around me told me. They said we were meant to be and it was evident in how we looked at each other, talked and more. We have 1 son together and he has 1 more who’s a teen. We obv. had a little break up for a few years. I never forgot him nor he me and we got back together at the best time, a little and a lot more wise. All in all we were only apart 6 years. 91-94 and then 2000-2008. There’s never going to be enough justice for his life being taken. The defib. never once gave him a shock for an irregular heart beat. It was put in exactly 1 month after our son was born and he died from it 3 months short of 4 years. sorry so long.

  5. joe gautier says:

    I know how your son feels, I live with this everyday. Still have the faulty lead in me. I try to carry on with life, I have been shocked six times. Got to have it replaced but need my job, things are tight.

  6. Sheila says:

    My husband has just been in hospital for a week because of this faulty lead, he had it shock him 9 times in about 3 hours, it was terrifying to see him in such agony. They replaced the lead with the older stronger lead, he is lucky he didn’t have another heart attack as a result of the shocks.

  7. betty mcgraw says:

    I am 76 have a 2005 defribulator 6949 on recall. it has shocked me so bad,,after year of begging turn it off, take it out..mayo clinic said remove it at once…they turned it off.. they will not remove it..its on my right side

    on my lleft side i have a pacemaker put in 2002 it causing me much difficulyt no body will help me.. my cardio wants it out..pacemaker doctors wont listen to me they want it to die in my body or me to die first..I need help dont know how to get a lawyer ..will some body help me please betty

  8. On Nov 16th my fedilis lead cracked the device shocked me 8 times in a row and 9 times total that day. I am scared and angry at the same time.
    At this point the ICD portion of the device has been shut off with all its alarms and the doctors are confident it will not happen again,but I dont trust my doctors Medtronics or the device at all come Monday Morning I will be seeking legal council.
    Signed
    Pissed!

  9. Kathy Watson says:

    I had been shocked about 20 times. My device went off while I was pumping gas. All I could see was sparks coming from my chest. It would also happen while I was driving. Now I’m paranoid to be on the highway while traveling long distance. My faulty wire is still in my heart and an additional wire was inserted. I’ve had four procedures since ’06 and it really makes it hard to enjoy life.

  10. TYRONE LUNDY says:

    To congress I demand that you pass the medical devise safty act bill 540 hr 1346. It was the dems that came up with this bill. It is the republicans that are blocking this bill. This is a disgrace. Stop protecting corporate american and protect the consumer. Put pressure on your congress man.

  11. TYRONE LUNDY says:

    I demand that Congress pass Bill HR 540 1346. The medical safety device act. This is a disgrace that this bill has not been passed.

  12. Todd Havely says:

    I was having lunch and the thing just went off! It shocked me about 10 times in less than an hour before it could be turned off. I had it removed and another one implanted. It affected my heart in a very bad way. I will have to live with the problems for the rest of my life, but it is better than the alternative!

  13. James Clarkson says:

    I had a defibrillator put in my chest February 2007. I cannot explain what the last four years have been like except misery. After having the defibrillator installed in my chest due to sudden death syndrome, I later had to have open heart surgery along with a triple bypass. The doctor who did my open heart surgery at the Ohio State University Ross Heart Hospital said he woul have removed the leads but it was too dangerous to do so! I have been in the hospital 20-plus times for infection and shortness of breath and other problems since my open heart surgery. I just got out of the hospital November 13, 2010. What a life. I may get some money for all this but I am too sick to do much, I cannot drive anymore, what is a person to do? The rich get richer and the poor get poorer. I wish you all the best, but it seems like we are all in the same sinking boat. James Clarkson

  14. Robert Toulouse says:

    Hello, fellow defib. patient.My first difibulator was installed Jan.05 and a third lead and new difib. replaced Feb.2010.Two bad leads remain.My difib. has fired twice prior to 2010.Not sure if i’m more likly to have problems or i’m just an average case?I worry about dying like anyone else however i find driving something i no longer enjoy .Is it legal to drive in this situation? Thxs. BOB

  15. Jerry D. Ray says:

    Hi, I’m Jerry Ray. I know how it feels to be shocked by the 6949 Lead. I received mine in September of 2007, a month before the recall come out. Mine shocked 24/7 all the time. It has caused me nerve damage in my left arm. Caused me to have a stroke. I was in intensive care for a week. It took me changing doctors to get it worked out. The whole implant dropped down in my rib cage. Now along with my regular meds of 10 a day, I have to take nerve meds for my nerves.

    That lead and implant has left me scared and I have lost hope in a product that was intended to help people. Something needs be done about this. Laws need rewritten. Especially for cases of this nature. It has affected my whole family. My wife to whom I have been married for 27 years this past December 1st, has really been great standing by me through all of this. For it has left me impotent. Due to the constant shocking, I also have muscle spasms as a result of the shocking of the lead. Take care you all. May God Bless you an your families. For God will prevail in this matter. I know it is hard. But Keep The Faith. Love you all, do have a great week and days. Jerry Ray.

  16. TYRONE LUNDY says:

    Hey Jerry, I feel for you. I have contacted my congressman and requested that they pass HR 1346, the Medical Safety Act. Which has been held up by the Republicans.

  17. Karen W. Brown says:

    My father received a Medtronic Intrinsic defibrillator on April 25, 2006. The unit shocked him many times while he was just sitting. It was determined that the lead wire was broken but that he was too weak to operate. My father grew worse and evently died on June 13, 2009. He received no compensation neither did his family. He gave all his information to me while he was living I contacted a lawyer but never heard from them. My father is gone but who do I contact now.

  18. Jon Waddell says:

    I was shocked 14 times in the middle of the night, and went to the hospital. It scared the crap of my wife and myself. It even scared the cop that came to the door after we called 911. The medtronic rep came to the hospital and turned it off. My new Dr. said it never should have been installed as it never fired after 4 years except when faulty wires caused it to. Now, what in hell are we supposed to do when the only atty. involved is not taking new clients?? This sucks

  19. Monika Barkley says:

    My ICD was implanted August 07. As everyone I received the recall letter in October. My sister researched and found out Medtronics was not only aware of the possibility of the lead failure but had notified doctors and hospitals of the possibility. I found out in December of 08 that the recalled lead was one of two that paces my heart 100% of the time. My heart will not beat on its own. I am two hours away from DUMC where the ICD was implanted and was told if it fractured it would be touch and go if I even made it to the hospital in time to have the lead replaced. I spiraled downward from that point on with severe depression knowing I was walking around with a time bomb in my chest. My lead failed March 26, 2010. I was notified by my Dr that Carelink notified them of the failure potential. They disconnected the failed lead. I went into total heart block and went code blue waking up after being zapped to a doctor cutting into my neck, without anesthesia, shoving a temporary pacemaker in my neck on the right side shoving it to my heart. The most excrutiating pain I have EVER EVER EVER had (and THAT was after my first heart surgery for aortic valve replacement, stage four CHF and an aortic aneurysm) I’ve been hospitalized for severe depression and even after the lead corrected I remain on anti anxiety medication.

    That said, I have to respond to Tyrone Lundy. I too contacted my congressman Walter B Jones Jr Third District in North Carolina to support HR 1346. He is one of two congressman that initially sponsored the bill and has been trying to bring it to the floor of the democratically controlled house and senate (if you want to go there) (that was before November 2010) but the bill cannot be presented as a stand alone bill. He is a Republican. This is not a political issue. We ALL need to contact and continue to contact our elected officials to get this bill passed. It’s easier to file suit against hot coffee burns and denture cleaner then filing suit for a medically implanted device of ANY kind that fails and is recalled.

  20. Cynthia White_avant says:

    I live each and everyday with the terror, is this the day I’ll be shocked. No one can imagine what it is like to live this way unless you are living with one of those Bombs in your heart. And to add insult to injury my Doctor is relunctant to remove it because of the danger it posses to me to go under the knife again. So For now I have to live with it, until my life is in danger. Hopfully I survive what ever happens.

  21. Richard says:

    The fact that there are so many people affected by the Leads, and the supreme court decides to protect the corporation is disgusting and just one more of the many things wrong with our country. However, there will be many appeals to this rulling.

  22. reginald says:

    To Barkley, where did your sister find the research on the failure leads as to the doctors and that the hospital knew of the leads being faulty? Thanks, have a blessed day.

  23. david lotz says:

    My heart goes out to you all, my fellow medtronic victims. After my replacement surgery later this month I intend to take action via an ammended complaint and use two very basic legal tenents: the ‘warranty of merchantability’ clause in the uniform commercial code (common law) and the ‘ex-post facto’ clause in the US constitution. If there exists an attorney with a spine in our country, i hope to find her or him, and i welcome anyone else injured or not to join me in this endevour. and i also want our supreme court to explain why, contrary to common practices and common decency the $268million settlement offer specifically provides for attorney compensation from medtronic as well as the ‘normal’ contingency portion they get from our ‘contracts’ with them.

  24. Linda Pierce says:

    I read that the defibrillator wouldn’t shock a second person, and I can tell you that it will. My husband kissed me on the cheek at the same time his unit shocked him. I would describe it as like getting hit in the face with a 2×4. I’ll never forget it. We live with his condition so I can associate with everyone. We still have hope that he can be helped. All any of us can do is hope.

  25. Jim Noble says:

    Hello All,

    I’m Jim Noble and share common experience with most of you. I was just released from the hospital 2/13/2011 following a procedure of new lead insertion for correction of the failed Fidellis 6949 ICD lead. Initial plan was to remove the fractured lead and replace with new, but surgeons deemed it too risky so the old was clipped, capped and a new lead implanted. Ironically, my Medtronic ICD started failing after implant period of 40 months due to a defective internal component. The unit had never discharged. Kind of mixed emotions isn’t it?

  26. eliel says:

    Hi my ICD 6949 lead wire broke on 2/15/2011 I was zapped 13 times in less than an hour.I went to the emergency room in a CT hospital and they didn’t have the magnet that disables the device.I will like to thank Medtronic for giving me the opportunity to play russian roullet with my live on a daily bases.It’s been a living hell depressed since I received letter.I’m still in the hospital waiting to get the lead replaced this is not the vacation i hoped for.

  27. david garcia says:

    I TOO WAS SHOCKED 27+TIMES AFTER ARRIVING HOME FROM HAVING ICD IMPLANTED, HAD BEEN HOME 6 HOUR. EVERY DAY I LIVE IN FEAR THAT THIS WILL HAPPEN AGAIN EVEN THO THE LEAD WAS REPLACED IT IS SCARY. I HAVE TO WEAR EYE PATCH ON RT EYE AS I SEE DOUBLE NOW I HAVE HARDLY ANY MEMORY OF THE PAST AND HAVE SHORT TERM MEMORY LOSS AND BAD HEADAches. my voice is hardly loud enough to be neARD SO I HOPE EVERYONE BETTER DAYS AND PRAY IT NEVER HAPPENS AGAIN. god bless YOU ALL

  28. Bill says:

    My device shocked me 14 times in about 30 hours. Second time it went off, it shocked me 9 times in 10 minutes. I know the feeling of walking on eggs. I did not know about a class action lawsuit (I was never notified by anyone), now I am told it is too late to file. I did have my leads replaced. Can only hope these ones work the way they should. Can’t describe how it feels to be shocked — not fun.

  29. Mike M. says:

    My brother had the defective leads. He was routinely getting shocked. His doctors said it was too risky to replace them. Eventually they shut off his pacemaker/defib, he died 3 days later. He was 53 yrs.old.

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