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Bone Graft Lawsuit Attorney

Medtronic Infuse Bone Graft
Lawsuit

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Manufactured and sold by Medtronic, Inc., the Infuse Bone Graft has been approved for use in lower spine-repair surgery to promote bone growth. Recently Infuse has been linked to several cases of death or life-threatening complications when used in surgeries on the upper spine and neck or other unapproved procedures.

It is alleged that surgeons with financial ties to Medtronic promoted the use of the protein unofficially in a number of unapproved settings, and complications have included bone growths near nerves or in areas not targeted by the therapy. This has resulted in additional medical interventions and in some cases emergency surgery. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufactures like Medtronic to actively promote such "off label" uses.

Medtronic’s Infuse bone graft system consists of the LT-Cage Device, a small, hollow metal cylinder, which is filled with a genetically engineered material that stimulates bone growth, known as rhBMP-2 (recombinant human Bone Morphogenetic Protein-2). In 2002, the FDA approved the Infuse system for use in one type of spine surgery, anterior approach lumbar fusion. While Infuse was later approved for use in two types of dental surgeries, it was never approved for any other spine surgery.

FDA Issues Warning For Medtronic Infuse Bone Graft

On July 1, 2008 the FDA issued a public health warning to surgeons about reports of life-threatening complications associated with the use of the Infuse Bone Graft in surgeries on the cervical spine, around the neck.

The FDA had also received at least 38 reports of complications during the past four years associated with its use in cervical spine fusions, for which it is not approved. The complications included swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Other reports describe difficulty swallowing, breathing or speaking.

Medtronic Infuse Bone Graft Injuries

Medtronics Infuse bone graft device has been associated with serious injuries especially when used in off-label procedures. Serious injuries reported have included:

  • ectopic or uncontrolled bone growth at or near the site of the surgery
  • nerve injuries causing severe and chronic pain
  • cancer
  • male sterility, retrograde ejaculation, or other uro-genital injuries
  • chronic radiating pain in the legs or arms

Failure To Report Infuse Bone Graft Complications

In June 2011, a study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said these complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials conducted between 2000 and 2010. The Spine Journal review also examined payment data from Medtronic to the doctors who co-authored the Infuse studies, and found that the median amount the company paid to doctors was at least $12 million to $16 million per study.

Medtronic Infuse Bone Graft Time Line

July 2002: Medtronic’s InFUSE Bone Graft utilizing Recombinant Human Bone Morphogenetic Protein (rhBMP) receives FDA approval for lumbar spinal fusion procedures performed anteriorally.

July 2008:  The FDA issues a Public Health Notification warning of life-threatening complications associated with rhBMP when used in the cervical spine.  

December 2008:   The Minneapolis Firefighters’ Relief Association filed a shareholder lawsuit in Minnesota alleging Medtronic officers made false and misleading statements regarding its Medtronic InFUSE.  The lawsuit further alleges that Medtronic failed to disclose that up to 85% of its InFUSE Bone Graft sales involved “off-label” uses.

June 2011: The Spine Journal reports that Medtronic paid physician researchers $12 million to $16 million, while the physician researchers overstated InFUSE’s benefits and understated the risks claiming there were none.  

June 2011: U.S. Department of Justice begins to investigate Medtronic on allegations that it paid physicians to overstate InFUSE’s benefits and understate the risks associated with the InFUSE.

September 2011: Judge Paul Magnuson orders Medtronic to release documents regarding the safety and risks of InFUSE Bone Graft in the shareholder lawsuit.

December 2011:  Medtronic settles a lawsuit with the Department of Justice, agreeing to pay $23.5 million to resolve allegations that it paid illegal kickbacks to physicians.

March 2012: Medtronic settles the shareholder lawsuit, agreeing to pay $85 million.

Medtronic Infuse Bone Graft Lawyer Accepting Cases for Medtronic Infuse Bone Graft Lawsuit

If you or a loved one have been injured as a result of the Medtronic Infuse Bone Graft you may be entitled to compensation. Contact the Infuse Bone Graft Attorneys of Ennis & Ennis today for a free case evaluation. Our experienced Medtronic Infuse Bone Graft Lawyers can answer any questions you may have about a potential Medtronic Infuse Bone Graft Lawsuit. Call the Attorneys of Ennis & Ennis, P.A. toll free 1-800-856-6405 or fill out the form on this page for a FREE legal consultation.

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Ennis & Ennis, P.A. is currently handling cases for the Medtronic Infuse Bone Graft:

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Medtronic Infuse Bone Graft Attorney

If you or a loved one have been injured as a result of the Medtronic Infuse Bone Graft you may be entitled to compensation. Contact the Infuse Bone Graft Attorneys of Ennis & Ennis today for a free case evaluation. Our experienced Medtronic Infuse Bone Graft Lawyers can answer any questions you may have about a potential Medtronic Infuse Bone Graft Lawsuit. Call the Attorneys of Ennis & Ennis, P.A. toll free 1-800-856-6405 or fill out the form on this page for a FREE legal consultation.
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