Medtronic decided to settle in a lawsuit involving 950 patients who suffered complications after receiving off-label Medtronic Infuse Bone Graft procedures. The Medtronic Infuse Bone Graft is intended for the stimulation of bone growth in damaged spinal disks and not approved for any other uses. However, it has been used in off-label surgical procedures for cervical spine damage.
Patients who received such cervical spine treatment for cervical spine damage with the Medtronic Infuse Bone Graft experienced complications within two weeks of the procedure. Complications ranged from the swelling of airway passages to death, including difficulty breathing and swallowing, respiratory depression, nerve damage, and some cases of male sterility.
Medtronic claims no liability in this $22 million settlement, and continues to back Infuse Bone Graft. There are currently 1,200 more filed and 3,800 other unfiled claims toward Medtronic, who is estimated to settle with an additional $140 million.
Read more about the Medtronic Infuse Bone Graft’s approved uses, off-label uses, and history here.
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Sources:
- http://www.lawyersandsettlements.com/articles/medtronic-infuse-bone-graft/medtronic-lawsuit-bone-graft-16-19774.html#.U3PIQ_ldV4l
- http://www.lawyersandsettlements.com/lawsuit/medtronic-infuse-bone-graft.html#.U3OeDPldV4k