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Plaintiff Cites Serious Injuries From Off-Label Infuse Bone Graft Surgery

A lawsuit involving Infuse bone graft complications was recently filed. The Medtronic spinal fusion lawsuit, brought over the Infuse device, has been transferred from the District of California Central (Case Number 2:12-CV-07884) to the U.S. District Court, Eastern District of Missouri (St. Louis) (Case Number 4:13-CV-01087) on June 10, 2013. The case is scheduled to be heard before District Judge Carol E. Jackson.

The lawsuit alleges a number of Infuse bone graft problems and that Medtronic and its co-defendants negligently manufactured, designed, marketed, distributed, and sold the Infuse bone graft product.

Serious Infuse bone graft complications alleged

According to the Medtronic spinal fusion lawsuit, the female plaintiff underwent a cervical discectomy and fusion surgery, at her C4-5, C5-6, and C6-7 vertebrae, on or about September 19, 2007 to cure her neck and back pain. The plaintiff’s surgeon who, the lawsuit alleges, was unaware of Infuse’s off-label uses, utilized the Infuse Bone Graft and LT-Cage in an off-label spinal fusion procedure.

Among other issues, the lawsuit alleges that Medtronic failed to provide appropriate warnings concerning the dangers involved with using Infuse in off-label procedures, specifically using Infuse to surgically treat spinal immobility and nerve damage. Among the Infuse bone graft complications alleged, the lawsuit claims that the surgery failed to resolve the plaintiff’s condition and that her pain has worsened since she underwent Infuse surgery.

The plaintiff now seeks compensatory, general, special, and punitive damages; interest; and costs in the personal injury, product liability lawsuit due to alleged Infuse bone graft complications.

According to the lawsuit , the plaintiff began experiencing severe, chronic, ongoing numbness and pain in her ears, head, throat, neck, shoulders, and arms. In addition to severe pain, she also suffers from vertigo, daily headaches, and decreased range of motion. Her physician deemed the Infuse surgery unsuccessful and the pain permanent and total; pain management has been recommended and degeneration is now occurring above and below the area of the fusion, the lawsuit alleges.

The complaint names the following defendants:

  • Medtronic Inc.
  • Medtronic Sofamor Danek, Inc.
  • Medtronic Sofamor Danek USA, Inc.
  • Medtronic Vertelink Inc.
  • Warsaw Orthopedic Inc.

Off label Medtronic Infuse bone graft procedures tied to injuries

Medtronic’s Infuse bone graft product has been the subject of increasing controversy and has been the focus of a Senate probe. Also, a warning was issued about the Infuse device by the U.S. Food and Drug Administration (FDA) in 2008 over reports of life-threatening injuries associated with off-label procedures. Amid accusations that the Medtronic was marketing the device for off-label uses, recent studies reveal that Infuse does not provide superior results over traditional bone graft procedures and is, in fact, tied to significant risks. Meanwhile, reports of  Infuse bone graft complications continue to rise.

Infuse, which received FDA approval in 2002, is comprised of recombinant human bone morphogenetic protein (rhBMP-2) as well as a sponge that is made from cow collagen. The sponge is soaked in rhBMP-2 and is then seated within a scaffold, which is supposed to cause the bone to grow, according to the lawsuit.The device is only approved for lower back procedures and some dental procedures; however, Infuse is typically used off-label in cervical spinal fusion procedures to reduce pain, as was done in this  case, and has been linked serious adverse reactions, as has been alleged in this case.