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Recently another lawsuit has been filed against Medtronic over its Infuse bone growth product, this time in Louisiana. The complaint alleges that the Medtronic’s “off-label” uses of the device were never approved by the FDA as safe and effective and caused the plaintiff to suffer injuries following a lumbar fusion.

A Louisiana man, Chris Wilcox filed his complaint in the U.S. District Court for the Eastern District of Louisiana, alleging  that Medtronic failed to warn, designed a defective product and breached warranty. Wilcox also claims that Medtronic promoted Infuse for certain lumbar fusion procedures that were never approved by the FDA.

What is BMP Infuse?

Medtronic Infuse is a bone morphogenetic protein (BMP) that is applied to a collagen sponge placed in a metal cage known as an LT-Cage. The bone protein drug, sponge and cage is then implanted to encourage bone growth and fuse the vertebrae.

Infuse is touted as an alternative to regular spinal surgery, where bone chips used in vertebral fusion process as scaffolding is obtained from the patient’s own pelvis or from a donor cadaver.

BMP Infuse Only FDA Approved for Anterior Approach

BMP Infuse was only approved by the FDA, for single-level anterior lumbar interbody fusion (ALIF). The Medtronic Infuse has been promoted “off-label” for other types of spine fusion surgery.

When used in unapproved types of surgery, BMP Infuse has been associated with an increased risk of serious and severe complications caused by excessive or ectopic bone growth. According to some experts, the off-label use of the product account for 85% to 90% of all Infuse spine fusion surgeries.

Plaintiff Allegations

According to Wilcox, he underwent posterior lumbar fusion, and Medtronic Infuse BMP was used. This was an off-label use or unapproved used, because it involved a posterior approach, and because the LT-Cage was not used.

After the Medtronic Infuse surgery, Wilcox suffered severe  back pains, and other problems. It was discovered that Wilcox was suffering from uncontrolled bone growth, known as ectopic bone overgrowth, around the Infuse implant. As a result of the problems caused by Medtronic Infuse, Wilcox has required at least four follow up surgical procedures to decompress the nerve roots.

Medtronic Infuse May Face Federal Pre-Emption

Medtronic is exposed to a large number of similar Medtronic Infuse complaints throughout the United States. Medtronic has argued that the product liability lawsuits are pre-empted by federal regulations, since Infuse went through the FDA pre-market approval process.

In 2008, in Riegel v. Medtronic, the U.S. Supreme Court ruled  that medical device makers are exempt from product liability lawsuits if a product has been approved by the FDA. As a result, many complaints filed against Medtronic have been thrown out, despite evidence that the medical devices were dangerous and defective. Wilcox and other plaintiffs argue that the off-label promotion of Medtronic Infuse leaves the company unprotected by the U.S. Supreme Court ruling.

Medtronic Infuse: No Benefit over Traditional Methods

Recently, two studies were published in the Annals of Internal Medicine demonstrating that Medtronic Infuse provides no benefits over traditional spine surgery.

These studies involved independent re-evaluations of data from all clinical trials conducted involving Medtronic Infuse.  Medtronic had influenced prior studies to hide complication rates and potential side effects.

US Senate Investigations

In 2012, the U.S. Senate Finance Committee released  investigation reports that Medtronic had manipulated previous medical studies that appeared to downplay Infuse risks and overstate its effectiveness.

Medtronic paid out $210 million to authors of company sponsored studies. Those studies failed to disclose that Infuse could increase the risk of male sterility, bone growth problems, cancer and back and leg pain.

The report’s findings reveal that “Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.”

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