Thousands of Infuse Bone Graft lawsuits have been filed against Medtronic Inc., alleging that it promoted the Infuse Bone Graft for off-label uses resulting in numerous negative side effects for some users.

The Infuse Bone Graft contains a protein called recombiant human bone morphogentic protein (or rhBMP-2). This protein encourages bone growth without necessarily having to remove bone from another part of the body to be grafted into the lumbar spine (the lower part of the spine).

The Infuse Bone Graft is allegedly less invasive than a traditional bone graft surgery and involves less recovery time.

The U.S. Food and Drug Administration (FDA) approved the Infuse Bone Graft for anterior approach lumbar fusion in 2002. This surgery would prevent bone/spine movement in the lumbar area.

Medtronic allegedly also promoted Infuse Bone Graft for use in the cervical area of the spine as well. However, the FDA did not approve the Infuse Bone Graft for this use.

In fact, the FDA specifically warned against using the Infuse Bone Graft in the cervical spine in 2008 after numerous Infuse Bone Graft side effects were reported. The FDA stated the safety and efficacy of using the Medtronic product in the cervical spine “have not been demonstrated.” 

Infuse Bone Graft Lawsuits

The Infuse Bone Graft has been involved in legal claims since 2006 when Medtronic had to pay a $40 million settlement to the Department of Justice in addition to settling two whistleblower lawsuits.

A whistleblower lawsuit is filed on behalf of an employee or other individual who comes forth with inside information that incriminates a company. In this situation, Medtronic was accused of off-label promotion for the Infuse Bone Graft.

In 2012, the Senate Finance Committee announced that Medtronic had used misleading advertising and kickbacks in order to encourage people to use the Infuse Bone Graft. Allegedly, over $200 million was paid to authors who were writing about the efficacy and safety of the Infuse Bone Graft.

Individuals have claimed that the Infuse Bone Graft caused them to develop one or more of the following complications:

• Difficulty breathing, speaking and swallowing
• Chronic pain requiring daily medication to manage
• Excessive bone growth
• Nerve damage
• Male sterility and other uro-genital injuries
• Death

Thousands of Infuse Bone Graft lawsuits have been filed as a result of these side effects. Patients have claimed that these side effects are the result of off-label use, which Medtronic encouraged. Plaintiffs in Infuse Bone Graft lawsuits may seek damages for medical bills, lost wages, pain and suffering, loss of quality of life, and loss of consortium if applicable.

Millions of surgeries with Infuse Bone Grafts have occurred, potentially putting thousands at risk of off-label Infuse Bone Graft side effects. It has been suggested that this risk is unnecessary as the risk of developing an off-label side effect may be greater than any benefits from using the Infuse Bone Graft over the traditional method.

An Infuse Bone Graft class action lawsuit investigation has been launched to help alleged victims pursue compensation for their injuries.