The Second Circuit Court of Appeals has refused to revive an Infuse bone graft lawsuit filed by a patient who suffered severe spinal injuries after receiving an Infuse bone graft.

Plaintiff Koleen O. alleges she experienced excessive bone growth after using the product; she filed an Infuse bone graft lawsuit seeking stricter safety regulations than those imposed by the FDA.

Koleen underwent spinal surgery in March 2008 to fuse two vertebrae in her neck. She chose to use the Infuse bone graft after her surgeon recommended it as a safe way to stimulate bone growth. However, it was allegedly not long after the surgery that she developed excessive bone growth, pain, and muscle spasms. Koleen also reportedly experienced difficulty swallowing and speaking.

The FDA has only approved the Infuse bone graft for certain lower-back fusions, but Medtronic allegedly advertised it as a safe medical device for cervical neck surgeries. Koleen claims that Medtronic knew that the Infuse was not safe to use in off-label surgeries, but chose not to disclose those complications to doctors or patients.

The appeals court found that the lower court correctly dismissed Koleen’s Infuse bone graft lawsuit against Medtronic. The Infuse lawsuit brought charges of negligence, fraud, false advertising, concealing information, and defective design. The panel found Koleen’s charges were meant to further her push for stricter Infuse safety labels, and that the claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The panel also ruled that Koleen’s allegations of defective manufacturing were conclusory, and should be dismissed for failing to state a claim.

Medtronic defeated a similar Infuse lawsuit earlier this year, when the Tenth Circuit refused to reexamine the case of another plaintiff who suffered serious spinal injures after using the Infuse bone graft.

Overview of Infuse Bone Graft Complications

The Infuse bone graft is a set of synthetic proteins designed to stimulate bone growth in damaged areas of the spine. It is meant to be a safer alternative to traditional spinal surgery. Infuse is made up of concentrated recombinant human morphogenetic proteins (rhBMB-2), which are synthetic proteins mixed with cow collagen. Because the product eliminates the need to harvest bone marrow from a different area in the body, as needed in traditional spinal fusion surgery, the Infuse is merely injected into the damaged area of the spine.

Because Medtronic advertised Infuse as a lower-risk and quicker-recovery alternative to traditional bone grafts, numerous spinal fusion patients have opted to use Infuse. An estimated 100,000 spinal fusion patients opt for the Infuse bone graft each year in the United States, with sales totaling $900 million in 2011 alone.

Allegedly, many patients have suffered complications after using the Infuse bone graft; as a result, Medtronic has been subject to many allegations regarding the product. Medtronic has allegedly been paying researchers to give positive reviews of Infuse in clinical studies, and has also been falsely advertising the product for off-label purposes for years.

The U.S. Senate launched an investigation into these allegations in June 2011. The investigation found that the company not only paid for positive reviews, but also allegedly concealed dangerous side effects.