Infuse Bone Graft Lawsuits

People who sued Medtronic claimed the company pushed doctors to use its Infuse Bone Graft for spinal fusion surgery in the neck or cervical spine. Plaintiffs claimed that Medtronic marketed the graft for off-label cervical spine fusion surgery while knowing the procedure could cause serious complications.

Infuse contains recombinant human bone morphogenetic protein-2 (rhBMP-2), a protein that helps regrow bone. It’s FDA-approved for lower back lumbar fusion surgery but not for use in the neck. It also has FDA approval for specific dental and trauma indications.

The Infuse Bone Graft system comes with the human bone morphogenetic protein and a scaffold or cage for the protein, and it must be used with both components. During an Infuse spinal procedure, doctors remove the disk space contents of the patient’s damaged disk. They then implant the bone graft and a cage around the graft to keep it stabilized as it heals. Infuse encourages new bone tissue growth at the site of implantation.

Most of this litigation is no longer active, and Drugwatch doesn’t know of any attorneys still taking cases. Drugwatch’s legal partners are no longer taking these cases, and we are only updating this page to provide information on this litigation for the general public.

These serious complications can lead to more severe health problems.

These serious complications may require emergency treatment, surgery or the insertion of feeding tubes.

According to Medtronic’s 2017 annual report, the company had resolved 6,000 Infuse lawsuits. It didn’t provide a specific settlement amount, though the report shows Medtronic set aside $300 million to cover “certain litigation charges.”

The 2017 settlement of the last batch of cases was the end of this litigation, and Drugwatch isn’t aware of any lawyers taking Infuse lawsuits as of March 2025.

The U.S. Department of Justice also investigated Medtronic. The investigation ended in a $40 million payout to settle allegations of illegal kickbacks to doctors as incentives to use Medtronic’s Infuse product in 2006. In these types of cases, kickbacks are typically financial bribes from a medical company to incentivize doctors to recommend their products to other providers and to use them on their patients. Allegedly, Medtronic paid consulting fees to doctors to publish studies that downplay the risks of Infuse.

Patients have filed thousands of lawsuits claiming Infuse Bone Graft has caused complications ranging from unwanted bone growth to death. Lawsuits named Medtronic, the hospitals where plaintiffs’ spinal surgeries were performed and/or the surgeons who performed their procedures.

Karl Sanda’s Infuse Bone Graft Story

Karl Sanda’s doctor, Mark T. Nolden, diagnosed him with cervical spondylosis and degenerative cervical stenosis in the vertebrae in his cervical spine. He recommended spinal fusion surgery to alleviate chronic pain and other neck problems. However, Sanda’s doctor didn’t tell him he would use the Infuse Bone Graft off-label during the surgery.

No one told Sanda that off-label use came with serious complications, like seroma (a pocket of fluid), chronic neck pain, throat swelling and more. He wasn’t informed these side effects could be life-threatening and lead to permanent injuries.

A few days after the surgery, Sanda developed a life-threatening seroma that required emergency surgery. While the seroma was removed, Sanda was left partially paralyzed with permanent disability and pain. He never recovered from the surgeries and still has “daily severe disabling pain and paralysis.”

Sanda filed an Infuse Bone Graft lawsuit in 2013. The resolution for his case was never publicized.

UCLA Hospital Pays $8.45M Settlement with Infuse Patients

Two patients who received Infuse bone grafts at the University of California Los Angeles later sued the teaching hospital, surgeon Jeffrey Wang and Medtronic, for alleged injuries resulting from the off-label use of the product.

The plaintiffs, Ralph Weiss and Jerome Lew alleged that Medtronic’s Infuse product was used in ways not approved by the FDA in both surgeries.

They further alleged that Wang failed to inform them of a financial relationship between the surgeon and the product manufacturer. The lawsuits claimed that Wang received hundreds of thousands of dollars in lectures, consulting work and royalties from Medtronic.

The University of California Los Angeles settled with Weiss and Lew for a combined $8.45 million, with Weiss receiving a little more than $4.25 million. Medtronic also settled with Lew for an undisclosed amount, but the judge dropped Medtronic as a defendant in Weiss’ case.

Editor Lindsay Donaldson contributed to this article.