An Arizona man claims that Medtronic failed to adequately warn consumers about the risks and severity of Infuse side effects related to the off-label use of the spinal fusion device.

Plaintiff Doug Thames has filed an Infuse lawsuit against Medtronic Inc., the manufacturer of the Infuse bone graft and combination devices, claiming he sustained adverse reactions as a result of spinal fusion surgery, causing him to be permanently disabled as a direct result of Medtronic’s fraudulent misrepresentation of the Infuse bone graft device.

Thames also claims in the Infuse lawsuit that Medtronic consciously provided lucrative consulting fees (amounting to millions of dollars per year) to surgeons, including Thames’ own surgeon, to actively promote the off-label use of the Infuse bone graft, even though the defendant was aware of the dangerous risks associated with off-label use of Infuse for spinal surgery fusion.

Thames alleges Medtronic knew or should have known of the risks of the Infuse bone graft device but continued to manufacture and promote the device for off-label purposes without adequate warnings, testing, or U.S. Food and Drug Administration (FDA) approval.

What Is the Infuse Bone Graft?

The Medtronic Infuse bone graft is a medical device intended to be used during lower back lumbar (spinal) surgery or spinal fusion surgery to stimulate bone growth and replace damaged spinal disks.

It was developed as an alternative to traditional bone grafting, which involves painful bone-harvesting from other areas of the body and marketed and sold as one of the alternatives to harvesting a bone graft from the hip.

The Medtronic Infuse bone graft device itself consists of two parts — a sponge-like substance, which is soaked in a biological agent, a synthetic liquid form of bone morphogenetic protein, or BMP. The device is implanted between vertebrae, and the BMP stimulates the bones to grow. The sponge dissolves and is absorbed into the body.

Medtronic and Infuse Bone Graft Complications

When the FDA approved the device in 2002, the federal agency only approved it for use in one specific type of surgery — the lower-spine (lumbar) region. However, there is evidence that the company marketed the device “off-label” for use in upper-spinal or cervical surgeries.

The problem is that when the bone graft is used during these unapproved procedures, Infuse side effects may cause excessive bone growth in areas where it is not wanted, which may cause:

• Nerve damage
• Male sterility and other uro-genital injuries
• Death

Medtronic Infuse Lawsuits

Medtronic is facing intense pressure regarding its Infuse bone graft. The FDA has issued safety warnings and the U.S. Department of Justice (DOJ) has begun a criminal investigation.

Medtronic is also accused of engaging in illegal “off-label” promotion of the Medtronic Infuse Bone Graft System.

Thames is seeking all general, medical, economic, consequential, and punitive damages for Medtronic’s alleged concealment of the dangerous risks associated with Infuse. Thames has demanded a jury trial for this case.

The Medtronic Infuse Spinal Fusion Surgery Lawsuit is Doug Thames v. Medtronic Inc., et al, Case No. 3:14-cv-08145-DCG, in the U.S. District Court for the Central District of California.