Lawsuit Over Medtronic Infuse and LT-Cage Filed After Failed Spine Fusion

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By: Irvin Jackson | Published: September 24th, 2012

A Missouri woman has joined a growing number of individuals throughout the country who are pursuing a lawsuit over the Medtronic Infuse Bone Graft and LT-Cage, alleging that the spinal fusion implant failed after it was used “off-label” for a procedure that was never established as safe or effective. 

A complaint (PDF) was filed by Laura Blankenship on September 13, in the U.S. District Court for the Central District of California against Medtronic, Inc., claiming that complications from a Medtronic Infuse spine fusion have left her with persistent neck and back pain.

According to the lawsuit, Blankenship underwent surgery where her surgeon used the Medtronic Infuse Bone Graft and LT-Cage to promote the fusion of vertebrae in her spine. However, the surgeon used the product “off-label” after Medtronic allegedly promoted Infuse for applications beyond what was approved by the FDA.

Blankenship claims that the Medtronic Infuse spine fusion failed, leaving her with worse neck and back pain that was caused by excessive bone growth around the implant.

Medtronic Infuse is a bone morphogenetic protein (BMP) that is applied to an absorbable collagen sponge placed within a device known as an LT-Cage, which is then implanted to encourage bone growth and fuse the gaps between vertebrae. Since introducing the product in 2002, Medtronic has aggressively promoted Infuse bone graft surgery as an alternative to traditional spine fusions, where bone is harvested from another part of the body or from cadavers.

However, although the FDA only approved the Medtronic Infuse and LT-Cage for the limited spinal procedures involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front, the Medtronic Infuse has been widely used “off-label” for other types of spine fusion surgery, which have been linked to an increased risk of severe and painful complications caused by excessive or ectopic bone growth.

In 2008, the FDA issued an alert about the risks associated with such unapproved uses of Medtronic Infuse, after receiving a number of reports involving serious complications and deaths, often involving use in the cervical spine where the bone growth problems may impact the airway.

Medtronic has been accused of illegally promoting off-label use of Infuse by providing false and misleading statements and paying “opinion leaders” to encourage uses beyond what was approved by the FDA. As a result, some estimates such that as much as 85% of all sales for Medtronic Infuse were for such off-label uses.

Blankenship’s case joins a growing number of Medtronic Infuse and LT-Cage lawsuits filed in state and federal courts throughout the country. The complaints involve similar allegations that Medtronic negligently designed and manufactured a defective product, failing to adequately research the device or warn about the risk of complications. Many of the lawsuits also seek punitive damages against the company for its alleged reckless behavior in Infuse illegal promotions.

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There Are 22 Comments So Far • (Add Your Comments)

  1. How do I find out the type of hardware thet used when performing my operation?
    Had my c5 removed twice!

  2. I had an antieor lumbar fusion in 2009 sinse thin I have incontince sweating severe pain in both legs severe pain in my groin the name of the cage is peek.I just found, out a few months ago thers a recall on peek but tne surgeon that done the surgery moved out of state so what do I do next

  3. i had a fusion between L3-L4-L5+S1 2nd surgery,1st surgery of Nov 1999, doctor kept telling me the pain would go away for 13 months, never did!!! Had 2nd July 2002 when the doctors, recommended by 1st surgeon, took piece of my right hip to fuse all vertebre together……10 yrs later still have the severe pain in back, now going down rt leg and hip, that was never hurt until the doctor took piece. Right foot totally numb, feels like nail going right thru middle of foot, something like you feel as frostbite. So much pain going from side of foot to middle of calf in muscles. Hip hurts constancly. Have been to other orthapedic surgeons, they say that they can do surgery but it won’t help. Thing is that I never needed back surgery because chart stated “ABNORMAL AORTA FOR PERSON OF THIS AGE” see the cartiologist did bi-pass in Sept 02. Thing of all of this is that doctor put me in this pain instead of doing other tests as I had asked him about what my chart stated, as his answers to question ‘could this be my problem’ was that I was too young for aorta problems……I live in Ohio, never knew about the year we had for malpractice….this same 1st doctor just did operation on neighbor and left small opening on his spinal column, his neck filled with spinal fluid….how can we fight for OUR rights?

  4. i had a lumbar fusion n 02 the screw broke then just last wk underwent surgery 4 that. i need help n finding an attorney 2 take my case.

  5. in 2011 i had lumbar fusion of L4L5 and sence have had nothing but problems . I t really floored me to read some of these troubles that some of these people have had .cause they are all the same as im having .i have terrible pains in lower back groin and hips. the surgen passed me on to a pain management dr and they have been suscribing pain meds sence. and wanting to give me injections all the time . now drs say my right hip has to be replaced cause of avascular nacrosis ,caused by lack of blood going to the joint. i dont want a surgery .i just want part of my life back..

  6. I had a spine fusion in June of 2005. I went into surgery thinking
    A cut would be in my hip for bone graft. I woke up a week later,
    And friend, husband and son informed me half way through my
    Surgery, my surgeon, came out and told my family a screw was stripped, and that he had sent his staff down for more tools because he had used All tools he had. Although I woke up a week later, there
    Was no cut in my hip, and the surgery report states “all screws were placed perfectly the first time. How do I know if Medtronic was used
    Here. Today I am totally disabled and feeling worse every day.

  7. Lumbar fusion c4-5 doctors stated to me pain and numbness would go away after healing process. Pain worse than ever numbness causes dangerous falls. Pain medication does not help. Surgery in 1997; this is 2013##!!##!##### Can not find any help. HELP ME PLEASE!!!!!!!!!!!

  8. Had fracture l4,l5,s1. Had to insert a peek cage felt good for
    About 2 months then terrible pain down my leg again
    Dr said get cr-scan.went back to see dr, he said
    He has only seen this two other times in an old lady
    Heavy set man, and now me 47yrs old and fairly
    Fit.dr said a bone broke than was holding in the peek
    Cage, now the hardware. Is backing out, so now i had to go
    Through another surgery,dr had to remove all
    Hardware and took out the cage and didnt put the cage
    Back in had to use bigger screws,does anyone out
    There think i have a case,or does anyone know
    Of any cases over peek cages? Thanks

  9. I have had 2 neck surgeries, Im still in constant pain. I got a letter from a firm that y cages were recalled. Can someone please get back to me asap. I cant even work due to the pain. I need to know who to call to get something figured out.

  10. I had Lumbar fusion at L5S1 in 1999, my Dr. said the pain would go away with surgery. Dr. said the procedure would include, the removal of the disc and taking bone from my hip putting bone into a cage to replace the disc. Still in serve pain I went back to Dr., he sent me for a CT. Dr. said I have permanent nerve damage and he put me in the hospital with a pain med IV. I Have been in severe chronic PAIN, back locks up, burning, stabbing pain, numbness, tightness, stiffness, unable to sleep due to severe chronic pain, weakness, tingling and radiating pain, depression every sense. I found out later my spine was curved Please Help me!!!

  11. I had a fusion from L3-S1 and the pain never completely went away, It worsened 10fold in less than a year. I get constant stabs of pain, underlying buttock pain, pins and needles in legs, sometimes my right foot drags behind me, I had to leave my job, can’t do anything. No surgeon can help. Can you? I can’t live like this . The surgery was supposed to make me better, I am worse and out of options.

  12. Had a spinal fusion done in 2007. Medtronic hardware was used. I had a posterior fusion from L1 to T12. Almost 3/4th of my back. Since then I have had 5 surgeries to repair broken rods & removal of iliac screws in my hips that had became loose. I actually heard the hardware break. I ended up losing the best job I have ever had & have applied for disability. Cannot find an attorney to take my case. Medtronic is too big of a company

  13. i had spinal fusion surgery in 2008 with using bone graft from my right hip. as many stated the surgen said the pain will go away. here it is 5 yrs later and my hip is still tender to the touch, and server pain radiated in my hip if im walking, getting out of car. my back still is very very sore. I believe I was talked into having a neurotransmitter by another surgen, which I did have done, figuring something might help. well, no go. im still in constant pain. ive told every dr. about my hip especially, they all say oh its your back not your hip. I know where the pain is. the hip. im so frustrated.

  14. Does anyone know if medtroncis salesmen gave spinal surgeons samples of Medtronics Infuse RhBMP2 in 2002 and 2003? Thank you for any help.

  15. I had this cage put in my neck in 2009. According to the doctor it was supposed to be the best and do away with the pain I had in my neck and head. It did not. I was told to take more “meds”, but a working person cannot take a lot of pills and work. I had another surgery in 2010. They had to fiix the two vertebrae below the previous ones. I used another surgeon. He told me he could not remove the cage that had been put in because it would do more damage than good. Muscles had grown around the cage.
    I have had another surgery on my neck and am looking at one more. I also suffer from spinal stenosis. The doctor who did the first procedure had one lawsuit, That I know of, filed against him, but there were other friends who also had the same surgery by him and they have suffered like I have. Two of them had to go to anothersurgeon, the same one I used last times, to get relief.
    It looks like something could be done about a doctor putting these implants in, knowing they are doing more harm than good
    Is there anything we can do do to stop this malpractice for which the doctor is getting rich on causing other people so much pain?

  16. wife had Medtronic products screws, pins and infuse 3 years ago and now its failing and shes in worse pain and can hardly move. I would like anymore feed back if theres someone out there with similar
    problems.

  17. I had surgery on my back in 2004 shooting pain down my leg. My neck had surgery in 2005. I hurt all the time when I had the surgerys I had way to many nerve blocks headache . No lawyer will touch the case in Florida cause the doctor is very well known. I tried from Miami to Tallahassee and no one would help me. I finally got a well known attorney got a letter saying they will not represent me and to call for any information. Well I’ve call 4 times no response. So I’m still in pain after all these years. Just isn’t right..

  18. I’ve lost allot of my memory. But about 8 yrs ago it started with having severe pain in my neck n back. This Dr I went to started putting injections up n down my spine every two weeks for 2 yrs. I kept telling her it wasn’t helping she sent me to her boy friend for a neck surgery , fusion . Which made things even worse. The next Dr I found had the same idea he started injecting me a lot and burning the nerves in my neck so I wouldn’t feel the pain. Ha what a joke. I have more pain then ever @ 36 I feel 86 pain is off the charts. Bad sweats non stop muscle spasms my shoulders swell up n touch my ears. I’m on string pain meds. N that just takes the edge off. These so called dr.s have made my life hell. Someone please tell me what to do. Can any one help me plz..

  19. Had titanium bak cage fail during a L3-4-5 fusion. The bolt threads stripped. And a 4 hour surgery took 9 hrs and horribly failed. The striooed bolt was discarded and cadaver bones never fused. Plus the surgeon asked me to be his first person to do his bak fitanium anterior double level fusion. Why did the titanium bak bolt strip?.

  20. I had spinal fusion done at the L4-L5 with this cage 9 years ago. The Dr. also added rods and screws too..Before surgery I was having pain issues, but could have somewhat of a normal life. I helped move my mother from another state over a weekend…packing up a 3 bedroom home and moving her to live with us 3 states away! After surgery, the pain in my legs and lower back were worse!!! I wanted to cut my legs off!!! They passed me off to the pain management specialist too and that did nothing to fix the pain. I couldn’t drive, sleep.. anything for almost 1 yr. I found strong pain meds the only option of relief.. and am now disabled due to the pain and the pain meds.. I sleep a lot and can’t do housework and can’t afford to get someone in to clean. I wish I had never had this surgery done. NEVER NEVER NEVER!!!!

  21. Had my L1 T11 Fused nothing but pain? Any Suggestions about Law Suit..

  22. Hello Im a 39-yr-old female. I have five lumbar surgeries. This all following a car accident while 8-months preg. Eight months after accident had my 1st sugery which my L5/S1 nuckles of disks was shaved. In May of 2006 had same area fused. They used medtronic cages & took bone from my hip. Which by November of 06 had my 3rd surgery due to bone growing over nerves. Tons of pain. I had no relief from any of these. So in 09 had my 4Th surgery was told that the cage/spacer was the wrong size & was told I basically had a failed fusion. No pain relief just put on more pain meds that just cover the pain for about an hour two if Im lucky. Pain cont to get so bad started having bad falls again unbearable pain. 2012 went in was told my screw was outta place & had to have hardware removed. Got hardware out of left side however, doctor could not get right side hardware out said it was stuck in my back. I now to date have hip problems worse pain then ever & had MRI done its shows since hardware removal on left side the once complete fused bone has progressivly narrowed. I am unable to work can not do house work can not drive to long. Im also now dealing with mid back and neck issues that have been detected by MRI. I have been put on oxygen my doctors can not figure out why my oxygen is low have done over 40 test to find out. Any ideas that anyone may have as far as any type of lawsuit or attorney would be a huge BLESSING to myself & my children. Tho no amount of money can ever give me back what has been taken. It could give hope of some sort of a life with my soon to be grandchildren. Thanks for taking time to read my surgical story. (sorry for any misspelled words)

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