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Remember the old Chinese proverb, fool me once…

Medtronic faces an increasing number of product liability and personal injury lawsuit. Most recently, a Louisiana man, filed a lawsuit alleging that the company’s Infuse bone graft caused unwanted bone growth along his spinal cord, which worsened his back pain following a lumbar fusion.

The plaintiff, Martin Gavin alleges that Medtronic concealed information about the risk of complications from the Medtronic Infuse bone graft.

What is Medtronic Infuse?

Infuse, also known as bone morphogenetic protein-2, is a powerful bioengineered agent used in spinal fusion surgery. The product stimulates bone growth and eliminates the need to harvest a small amount of a patient's own bone to create a fusion between two vertebrae. As a result, it is highly popular with spine surgeons.

FDA Approved Infuse for limited use

The FDA approved Infuse in 2002 for use during anterior lumbar fusion surgeries. But as a result of slick and pressured marketing, it has been widely used off-label for a number of other types of spinal surgery, which have been found to increase the risk of severe adverse side effects.

Plaintiffs allege that they were never told that the Infuse was only approved for single-level anterior lumbar fusion, and had ever been adequately tested or approved for the type of spine surgery they underwent.

Medtronic Infuse Off Label Use

Off-label use of the Medtronic Infuse bone graft during procedures other than single-level anterior lumbar fusion have been linked to the growth of bone in those areas, leading to swelling and nerve damage.

FDA 2008 Warning

The FDA issued an alert in 2008, advising doctors not to use the Medtronic Infuse in neck or cervical spinal fusion procedures. The FDA had received numerous adverse event reports, involving potentially fatal complications that included swelling of the neck and respiratory difficulties.

U.S. Department of Justice investigation

The U.S. Department of Justice initiated an investigation focusing on the actions of Medtronic in 2008. The U.S DOJ was particularly interested in investigating whether Medtronic illegally promoted and marketed the Infuse bone graft for uses that were never approved by the FDA.

Other Medtronic Infuse Side Effects

Last year, concerns also emerged that the Medtronic Infuse bone graft may increase the risk of cancer. There have also been concerns that med treated with Medtronic Infuse may face a risk of sterility.

Medtronic Shareholder Suit

Medtronic Inc agreed to pay $85 million to settle a shareholder lawsuit accusing it of making misleading statements concerning Infuse.

The settlement resolves claims that Medtronic failed to reveal that as much as 85.2 percent of Infuse sales depended on so-called "off-label" uses, where doctors sometimes paid by Medtronic would prescribe the product for applications not approved by the U.S. Food and Drug Administration.

Shareholders said Infuse sales and Medtronic's share price fell after the company revealed that the U.S. Department of Justice was probing off-label marketing and the U.S. Senate began its own inquiry.

Scope of Medtronic Infuse Problems

According to Medtronic, Infuse has been implanted into more than 500,000 patients and it is used by more than 2,300 surgeons. Its sales amount to several hundred million dollars a year.


  1. Gravatar for Barry Shearer

    As a victim of off label use of Infuse I have attempted to learn all I can about this issue and so far my anger and disgust over the behavior of those involved in the improper marketing and use of this product continues to grow. I wish I could be surprised but I'm not. If this is what is known, what remains to be discovered about the greed and disregard for patient safety.

  2. Gravatar for Lisa Anne

    Why does these surgeons continue to put people's lives at risk. I to am a victim of the enfuse bone overgrowth. No one ever said or explained anything about the potential risks involved. My surgeon said Nothing!!!! I currently work in the medical field and if I had even been told half the truth, Hello Google it and decide from just the first google results. I may be scared for life and because of the bone overgrowth, the nerve damage is so severe. I may havevto stop working. WHY DON'T THEY STOP putting on lives at risk to make money. I bet you ask these sales reps and surgeons. Do they have Enfuse implanted in their back? Guarentee because they know the risks, none of them would take that risk.

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