Medtronic Infuse Bone Graft Side Effects no Laughing Matter
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.