Medtronic Sprint Fidelis Lawsuits in Minnesota State Court Dismissed

A Minnesota judge has dismissed all state court lawsuits against Medtronic over its recalled Sprint Fidelis defibrillator leads. The decision follows a similar dismissal of the federal Sprint Fidelis litigation in January, based on the argument that the medical device manufacturer is immune from liability for injuries caused by their defective defibrillator leads since the FDA approved the devices.

In an order issued October 20, 2009, Minnesota District Court Judge Denise D. Reilly granted a motion by Medtronic to dismiss 600 Sprint Fidelis lawsuits. Reilly ruled that the plaintiffs’ claims are preempted under federal law, pursuant to a 2008 U.S. Surpeme Court decision in Riegel vs. Medtronic.

The lawsuits stem from an October 2007 Medtronic Sprint Fidelis recall that was issued after the defibrillator leads were found to be prone to fracture or break, which could result in unnecessary shocks or cause the defibrillator not to work if it is needed to deliver a life-saving jolt. More than 260,000 people had the defective leads implanted in their bodies at the time of the recall, and more than 100 Sprint Fidelis lead deaths have been reportedly linked to the problems.

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Thousands of federal and state Medtronic Sprint Fidelis lawsuits have been filed on behalf of individuals throughout the country who had their leads fracture and by individuals who are now required to obtain additional medical monitoring.

On January 5, 2009, U.S. District Judge Richard H. Kyle dismissed the consolidated federal litigation, which was centralized in a multidistrict litigation (MDL) in the District of Minnesota. Judge Kyle cited the 2008 Supreme Court Riegel decision in finding that the product liability lawsuits were pre-empted, suggesting that the plaintiffs’ remedy lies with the legislator.

Attorneys representing plaintiffs in both the state and federal litigation indicate that they are appealing the dismissals.

Congress is considering new legislation which would, if passed, nullify the Supreme Court decision in Riegel by clarifying that the federal law regarding the FDA approval process does not make medical device manufacturers immune from liability for defective products.

Support for the Medical Device Safety Act of 2009 was buoyed this summer by a report from the Government Accountability Office (GAO), which determined that the FDA is not capable of ensuring medical device safety. The report cited deficiencies in the agency’s postmarket surveillance, and determined that FDA has been unable to keep up with regular inspections of medical device production facilities.

It is unclear, however, whether Congress will move on the proposed legislation in the near future. It is also uncertain whether any such legislation would be retroactively applied to cases still pending on appeal, such as the Sprint Fidelis lawsuits.

7 Comments

  • C RAugust 12, 2010 at 6:03 am

    I was considering a Medtronics SCS (spinal cord stimulator) unit until I had a discussion with their reps. today, and my searches this evening that brought me here. Releasing ANY company from ANY product liability is a mess left over from the Bush administration. As a direct result, there are companies making absolute garbage to implant into patients with no adherence to quality control or even b[Show More]I was considering a Medtronics SCS (spinal cord stimulator) unit until I had a discussion with their reps. today, and my searches this evening that brought me here. Releasing ANY company from ANY product liability is a mess left over from the Bush administration. As a direct result, there are companies making absolute garbage to implant into patients with no adherence to quality control or even basic safety standards whatsoever. The reps. I talked to knew nothing about the devices, other than what was in the manual. The same happened when I contacted another SCS manufacturer. The very people I am supposed to call if I have a problem are the very people who know NOTHING about electronics and EMF fields, RFi, what these devices do under pressure or in a decompression situation, such as what would happen if a plane's cabin depressurized in flight. I was told the devices were not tested for these incidents. Both companies also have warnings about skydiving, but no information about what might happen if you were to be in an auto accident, which is a far larger change in speeds. Neither trace data on problems with their devices, and why should they if they aren't required to even do a basic quality control check! They can't be sued, so why not put out the cheapest quality crap available, and if a few thousand people die along the way, who cares? I've used eCigarettes from China and Taiwan that have FAR more scrutiny than any SCS implant device would ever have with these laws on the books. I also find it interesting that in other countries eCigarettes are used as quit smoking and medical devices, but not here in the US, so those wanting to manufacture quality devices here in the US can not, yet Medtronics (& other SCS makers) can manufacture garbage that has not even gone through a descent peer review, have hundreds of thousands injured and/or dead as a result and with no recourse, even though it appears they are VERY aware that the products they are manufacturing that are being implanted in people's bodies are pure trash that wouldn't be allowed on the market in a child's toy. Until these devices have much further study, I absolutely will not allow anyone to put one of these devices in me in the US. Perhaps in another country that takes patient safety FAR more seriously. This law needs to be repealed so that reasonable studies are done to ensure patient safety. There seem to be few, if any, being done at this time, at least in the US. After seeing the sheer numbers of complaints filed against Medtronic, I will never allow any of their devices to be implanted in me. They need to be shut down.

  • TimJuly 5, 2010 at 11:53 pm

    My mother had a Medtronics device fail in Feb 2007 and when she went into surgery the hospital replaced the one that was later described as "defective and under recall" with yet another one of Medtronics defective and under recall devices. It too later failed after shocking the crap out of her several times over. The leads were replaced this time by another hospital in the area and this year they [Show More]My mother had a Medtronics device fail in Feb 2007 and when she went into surgery the hospital replaced the one that was later described as "defective and under recall" with yet another one of Medtronics defective and under recall devices. It too later failed after shocking the crap out of her several times over. The leads were replaced this time by another hospital in the area and this year they failed and now my mom is dead. Her suit is one filed in regard to Medtronics/Sprint Fedelis and I am afraid that the corrupt, evil, hipocrits in our white house are in the pockets of Medtronics being puppetiered away from our rights.

  • SusanApril 27, 2010 at 4:19 pm

    Hi Amanda I had my medtronic spinal cord stimulator implanted 2008. Battery died and NO help from any of the Reps. After restart (still dont know why it died)went to have it reprogramed. They could not do it, xrayed and now say leads moved and need to re-op to move oh and by the way change the battery since they there lol. I also dont know what to do. I live in NY and will keep looking for ad[Show More]Hi Amanda I had my medtronic spinal cord stimulator implanted 2008. Battery died and NO help from any of the Reps. After restart (still dont know why it died)went to have it reprogramed. They could not do it, xrayed and now say leads moved and need to re-op to move oh and by the way change the battery since they there lol. I also dont know what to do. I live in NY and will keep looking for advice. Keep in touch with me if you learn any more...Susan

  • AmandaMarch 16, 2010 at 7:41 pm

    Is there any help for me???? I live with chronic pain everyday and I have had a spinal cord stemulator in my back since 2007. First surgery was 07 and then in 2009 it stopped working and started shocking me at the base where the battery was placed. They had to take it out, still not knowing the cause of why, and now i have a new one. Well, it is not working either, it was placed too high with the [Show More]Is there any help for me???? I live with chronic pain everyday and I have had a spinal cord stemulator in my back since 2007. First surgery was 07 and then in 2009 it stopped working and started shocking me at the base where the battery was placed. They had to take it out, still not knowing the cause of why, and now i have a new one. Well, it is not working either, it was placed too high with the hopes it would work! NICE! Real nice! Well, now doctor's do not want to see me and say they can not do anything for me!!!!!!!??????

  • DottieMarch 11, 2010 at 4:23 pm

    I sit here this morning reading stories of how Medtronics, and the drs. whom use their products, basically are getting away with less than a slap on their hands. Myself I have been dealing with problems stemming from a spinal cord stimulator implant being impanted into my abdomen back in Feb. 2002, then again, in Sept. 2002, due to it moving from its original location of about 6" from my belly but[Show More]I sit here this morning reading stories of how Medtronics, and the drs. whom use their products, basically are getting away with less than a slap on their hands. Myself I have been dealing with problems stemming from a spinal cord stimulator implant being impanted into my abdomen back in Feb. 2002, then again, in Sept. 2002, due to it moving from its original location of about 6" from my belly button, all the way to my right hip bone, and then removed in Nov. 2003, totally, due to constant problem after problem, by yet another doctor, whom then told me my body was rejecting the implants where they were located at, and he suggested trying to replace the implant, with yet another implant, this time it was placed into my backside. Which by the way my body also rejected that implant too. Then I come to realize in March of 2005 that due to those implants that were "sewn" into my deep tissues using dacron pouches (that are only supposed to be used in conjunction with the Medtronic's heart pacemakers), not in ones abdomen area. Then the doctor sends me for heat therapy to top it all off, while I had the implant and the dacron adhered itself to my intestines, as the doctor implanted the device way too deeply into my subcutaneous tissues. Which had produced a huge mass, that was removed in April 2005, to only grow back even larger within 4 months time, to then have that mass removed as well. I have totally watched a total cover up from both the hospital where the surgeries were performed at, and Medtronics, in order to cover their own butts. The hell with how ill they have made me, and the torture they have put me through, and in which I am still going through currently, where I have a seroma in the area where the stimulator implant was originally implanted into my abdomen. Which the seroma builds up to about the size of a baseball, then it bursts, monthly, and I will rectally bleed for 3-4 days, only to repeat itself every single month. In fact just this past week I now have new complications stemming from where this implant was located at, I woke up to find that I had what looked to be a large scar bubble, that was the size of a quarter, it was filled with fluids, that obviously came out from the scar, trying to get out of my abdomen some how, which did not surprise me, as I know already of the many crazy, and sometimes very unbearable things that this implants being put into my abdomen, has produced to date thus far. So I will have these complications from this implant forever, thanks to the greed of the doctor and Medtronics. To them its okay that they have made me this ill. And it not only affects me and my life, but my poor husband, and children have had to also live this nightmare with me now for 8 years to date. I feel that obviously Medtronic's is not "sufficiently teaching" the doctors how to properly do these implants, and they could care less. After all its not their lives that are screwed up for the rest of their life. Like they have done to me, and my family. I wish I could find an attorney with the guts to stand behind someone like myself to get me justice for once, and for all. I am sick of these larger medical companies getting away with the crap they're getting away with. And I feel like they need to be stopped from ruining other family's lives, too. I will do whatever it takes to see to it that these companies are shown to be what they really are, and that is money hungry,heartless sob's, in my opinion.I wish that this would even go as far as to be heard by the supreme courts, due to my situation. As to date, I have yet to find another case, that is quite as detailed, and horrific as mine is, although I have seen more than I would like to say, that have had their share of medical problem's stemming from their spinal cord stimulator implants as well. If your an attorney with the balls to go after these people, send me an email, and lets talk.I even have a world known famous toxicologist whom has looked at my case files, and said he would support my efforts if I was capable of obtaining legal representation. I welcome the call, and the challenge..Thanks for this opportunity to express my concerns. Dottie

  • kennethOctober 28, 2009 at 11:13 pm

    Always relevant to point out thar not all fda cases subject to dismissal as noted in both Reigel, and prior opinion of sct. in Lohr.

  • RBWILSSENSOctober 26, 2009 at 7:37 pm

    MEDTRONICS SENDS MILLONS TO THE LEGISATORS SO IN TURN THEY DO NOT A THING FOR THESE POOR PEOPLE WHO HAVE BEEN DAMAGED I DO NOT KNOW HOW THESE LEGISATOR SLEEP AT NIGHT 1600 PRODUCTS COVERED BY THIS LAW WHAT A BUNGE OF CROOKS VOTED THESE GUYS OUT

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