Medtronic Infuse Off Label Use Lawsuits

Harvey Kirk

By Harvey Kirk
Posted August 23, 2012


Since the Medtronic Infuse bone graft was approved in 2002, it has been used largely “off-label” during procedures for which it was never approved by the FDA and for which the manufacturer knew there was an increased risk of serious and potentially life-threatening complications.

Despite the known risk of problems with Medtronic Infuse off-label use, the manufacturer illegally promoted the device, increasing sales and causing thousands of individuals throughout the United States to experience complications after receiving the bone graft.

The lawyers at Saiontz & Kirk, P.A. are pursuing potential Medtronic Infuse off-label lawsuits against the manufacturer for recklessly encouraging use of the bone growth agent in ways that were never approved by the FDA or determined to be safe and effective.

Individuals have experienced a high rate of problems with off-label use of the Medtronic Infuse bone graft, including:

  • Excessive or Uncontrolled Bone Growth (often referred to as Ectopic or Exuberant Bone Growth)
  • Inflammatory Reactions
  • Back and Leg Pain
  • Radiculitis
  • Retrograde Ejaculation
  • Urinary Retention
  • Bone Resorption
  • Implant Displacement
  • Overall Worse Outcomes

Medtronic Infuse is a bone morphogenetic protein (BMP) approved in 2002 by the FDA for use during spinal surgery for a single-level anterior lumbar fusion. The device is only supposed to be used between L4 and S1, and with a combination of components that includes the LT-CAGE Lumbar Tapered Fusion Device and rhBMP-2 that is applied to an absorbable collagent sponge (ACS), which is designed to disappear over time.

Off-Label Medtronic Infuse Use could include:

  • Lumbar surgery through the back (posterior) or side (lateral)
  • Lumbar surgery at multiple levels of the spine
  • Lumbar surgery that is outside of the L4-S1 Region
  • Use for a cervical fusion surgery
  • Use with a component other than the LT-CAGE

Tens of thousands of individuals throughout the United States have received the Medtronic Infuse bone graft off-label, based on false and misleading statements made by Medtronic and “opinion leaders” paid by Medtronic to promote the off-label use. If Medtronic had not promoted Infuse illegally for off-label use, most physicians would have been without the knowledge necessary to use the device for such procedures and individuals could have avoided problems through traditional bone graft procedures.

The overwhelming majority of sales for the device have been driven by off-label use of the Medtronic Infuse, reaching as high as 85% of all sales at one point. Medtronic promoted the off-label use by paying “consulting” and royalty fees to physicians who would push the non-approved uses by authoring scientific studies and directly soliciting other surgeons. In fact, Medtronic sales representatives were often in the operating room to assist surgeons with off-label use during surgery.

As a result of the Infuse off-label promotion, Medtronic has faced at least two whistleblower lawsuits (which resulted in a settlement with the federal government), a shareholder class action lawsuit (which resulted in a settlement for failing to disclose the level of off-label sales), several regulatory actions by the FDA and a congressional investigation by the U.S. Senate Committee on Finance.


The Medtronic Infuse lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for individuals throughout the United States who experienced complications after receiving the bone graft off-label. To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

2 Comments • Add Your Comments

  • Joe says:

    I am contacting you to alert you to a case involving Medtronic and the off-label use of Deep Brain Stimulation for Essential Tremor. In short, Medtronic states that the device is approved only for ‘unilateral’ placement (not bilateral). Physicians often recommend bilateral placement even though there is clinical research indicating an increased occurrence of brain edema (T2 Instability) along the path of the leads when bilateral implantation is done (as compared to unilateral implantation). My father-in-law whose medical chart states that he initially requested unilateral implantation was subsequently ‘persuaded’ by the physician to have bilateral done. He experienced brain edema and was rendered paralyzed and bed-ridden as direct result (no stroke, no infection). I have a web-site dediciated to this issue ( and am currently awaiting a reply from the FDA as to whether or not his adverse event was falsified by Medtronic.

    Posted on February 7, 2013 at 8:55 am

  • JOHN says:


    Posted on January 6, 2014 at 6:31 pm

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