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Medtronic Investigation Concludes as Another Medtronic Lawsuit is Filed

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Minneapolis, MN: A federal lawsuit into the marketing of the Medtronic Infuse bone graft has reportedly ended with no charges being filed against Medtronic. The investigation looked into allegations that Medtronic illegally marketed its bone graft device. Meanwhile, another Medtronic lawsuit, alleging Medtronic Inc. downplayed the risks associated with the Infuse, has been filed.

Medtronic Investigation Concludes as Another Medtronic Lawsuit is FiledThe federal investigation began in October 2008, with officials subpoenaing documents from the medical device maker regarding its Infuse bone graft. The investigation focused on whether Medtronic Inc. marketed the Infuse bone graft for off-label purposes. Although it is not illegal for doctors to use medications or devices off-label, it is illegal for companies to market them for such uses.

Allegations had been made that Medtronic paid doctors illegal kickbacks and fake royalties to encourage the doctors to use the Infuse in unapproved ways. The Infuse is approved for spine fusion surgeries in the lower back, but it has been used off-label in neck surgeries. According to the Star Tribune (5/16/12), four whistleblowers allege Medtronic gave doctors expensive gifts for using the Infuse off-label.

In 2008, the US Food and Drug Administration (FDA) issued a warning against using the Infuse in unapproved ways. At the time, the FDA warned that the Infuse could stimulate excess bone growth, which could result in difficulty breathing, swallowing or speaking; compression of the airway; respiratory damage; nerve damage; or death. Complications associated with the Medtronic Infuse bone graft often occurred within two weeks of surgery and sometimes required feeding tubes, tracheotomies or additional surgery.

The Department of Justice reportedly closed its investigation with no findings of wrongdoing on the part of Medtronic.

In March 2012 Medtronic announced it would pay $85 million to settle a securities class action lawsuit related to its handling of Infuse. The lawsuit had alleged that Medtronic made false and misleading statements about its bone graft. As part of the settlement, Medtronic did not admit to wrongdoing.

Meanwhile, a lawsuit has been filed against Medtronic and Norton Hospital, alleging the off-label use of Medtronic Infuse resulted in the patient becoming permanently disabled. According to the Courier-Journal (5/10/12), Crystal Stevens underwent spinal surgery in which the Medtronic Infuse was used. The type of surgery Stevens had, however, was not the type the Infuse was approved for and she suffered overgrowth—where the new bone grows outside a cage placed in the vertebrae.

That overgrowth allegedly resulted in compression of Stevens' spinal nerves, causing permanent disability. Stevens alleges Medtronic downplayed the risks of serious side effects associated with Infuse, specifically when the Infuse is used off-label. Medtronic has not commented on the lawsuit.

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READER COMMENTS

Posted by
Everett J Cook
on
I had neck fusion in 2008, now I have unbearable pain bone growing in my neck, very little use of both arms and hands shouting pain with no warning and no sex life for the last (3) three years, this is a life I would not wish on anybody. Is there a sucessful surgery or not to correct this and what are we suppose to do.

Posted by
Laura
on
I had a spinal fusion L1 L2 area I had a cage with BMP my fusion goes to my SI joint, I got a drop foot and nerve damage, I have been disabled ever since. I developed 2 cysts one in my index finger and one in my knee. I have had difficulty breathing and difficulty swallowing my food or vitamins. I feel like my neck is swollen and my upper chest feels tight and feels like it is swollen. I gone to my General I have terrible back pain. I changed doctors and he removed all the hardware but couldn't get the cage out but said he cleaned around the nerve as best as he could. Right after surgery I was worse. I seen another doctor who put the hardware back in me and used BMP soaked sponges to fuse my back. I then became unable to hold my urine and I lost my ability to have a orgasm, so I had no sex life with my husband. Luckily he loves me and this is very hard on him also to see me, an athletic person who use to have a full time Hairdressing job be disabled and stuggling everyday. My medical bills have been enormous and thats with Blue cross Blueshield and now I have Medicare also to help but my perscriptions are so exspensive monthly. I do alot of praying just to keep my sanity. My little Maltese dog gets me out walking every day twice a day , I do the best I can to exercise. But it is hard to face what I am going through but I can Thank God I am still alive and where there is life there is hope.

Posted by
Arlene Bullock
on
yes i have had 2 different surgeries on in 6-22-05 which i had back surgery in the lumbar i had type of inplant was tsrh spinal system inplant manufacturer was medtronic sofamor danek since then to present i've had nothing but content pain 24/7 then on 11-13-2009 i had to go in for neck surgery, cervical again implant manufacturer was medtronic, i somehow move my head upwards or certain ways i give myself electrical charge in my body from my neck down both arms down to both hands. its like a electric charge from a open socket. some times they go dumb for a few seconds. i put my head up to kiss my husband and i get a shock charge down both my arms and hands.

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