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Infuse Bone Grafts Contribute to Disability, Lawsuit Claims

On August 21, 2013, plaintiffs filed a Medtronic Infuse lawsuit in the Pike Circuit Court of Kentucky. However, on September 25, 2013, the case was removed to the U.S. District Court for the Eastern District of Kentucky. This personal injury/product liability lawsuit was filed on behalf of Winston Dillon, Jr. and Teresa Dillon against Medtronic, Theresa McGrann, and PMC Hospital. It alleges that Winston Dillon, Jr. suffered significant and debilitating side effects as a result of the off-label use of the Infuse bone graft. The plaintiffs demand a jury trial and compensatory damages for past and future medical expenses, lost earnings, loss of earning capacity, emotional trauma, and physical suffering. Teresa Dillon demands compensation for loss of consortium.

Plaintiff underwent lumbar fusion surgery

On September 16, 2010, Winston Dillon, Jr. underwent a lumbar fusion surgery of his L3-4 and L4-5 vertebrae. The surgeon performed a posterior bilateral transforaminal lumbar interbody fusion with a PEEK cage. The PEEK cage contained both Infuse bone graft material and local bone graft. Although the plaintiff initially experienced a favorable recovery, he later reported significant complications, despite following his surgeon’s post-operative instructions faithfully.

According to the Medtronic Infuse lawsuit, the plaintiff experienced severe pain in his lumbar region (lower spine), which extended down his lower extremities. The pain was so severe that he had to have a spinal cord stimulator implanted.

Upon the request of the surgeon, the plaintiff underwent a CT scan of the lumbar region. The surgeon noted excessive bony growths in the area, which caused his symptoms and were allegedly the result of the improper use of the Infuse bone graft. However, the surgeon did not inform the plaintiff of the results of the CT scan. The plaintiff’s disability and side effects are expected to be ongoing.

Side effects and off-label use of Infuse

The Infuse bone graft is comprised of synthetic versions of natural proteins, called bone morphogenetic proteins. Bone grafts are commonly used in surgical procedures to replace damaged or diseased bone and encourage healing. However, the Infuse bone graft has been associated with a slew of complications, such as infection, increased risk of cancer, inflammation, osteolysis, persistent pain, and spinal nerve pain.

There have also been reports of male sterility, retrograde ejaculation, and excessive or abnormal bone growth adjacent to the spinal canal.

While watching a television advertisement, the plaintiff became aware that his symptoms were associated with the off-label use of Infuse. As noted in his complaint, the FDA only approved Infuse for use in a very specific manner: it must be used only for lumbar surgery using the anterior approach, or through the abdomen, and it must be used with an LT cage (a hollow cylinder), rather than a PEEK cage. The plaintiff’s surgeon performed the operation with a posterior approach, rather than an anterior approach, and he used a PEEK cage.

According to the plaintiff’s complaint, in 2002, the FDA raised concerns about the potential risks of off-label use of the Infuse bone graft with the manufacturer. Despite the dismissal of concerns by a Medtronic consultant, the FDA panel members again emphasized their concerns about the potential harm to patients and asked Medtronic how they sought to prevent off-label use. However, according to the allegations in Dillon’s lawsuit, a Medtronic representative (Theresa McGrann) was present in his operating room, providing instructions to the surgeon regarding the off-label use of Infuse.

Lawsuit alleges surreptitious campaign

This Medtronic Infuse lawsuit accuses the defendants of launching a “surreptitious campaign to promote Infuse for off-label uses.” The complaint claims Medtronic knew of the potential risks to patients and that off-label use of Infuse was not FDA-approved. The plaintiff claims that had he been informed that Infuse would be used in an improper manner that carried significant risks, he never would have consented to that type of surgery.