Medtronic Inc. is facing hundreds if not thousands of lawsuits claiming that their Infuse bone graft system has been promoted for off-label uses which have led to serious medical complications.

Patients who have undergone spinal surgery (in the cervical spine) and used a Medtronic Infuse bone graft have alleged severe complications such as difficulty breathing, speaking and swallowing; chronic pain;  excessive bone growth; nerve damage and male sterility. An Infuse bone graft class action lawsuit investigation is currently underway.

The Medtronic Infuse bone graft contains a protein called rhBMP-2. It is a recombinant human bone morphogenetic protein that encourages bone growth. It is inserted into the parts of the spine where bone is needed.

Medtronic is accused in hundreds of product liability lawsuits of intentionally concealing Infuse bone graft complications and marketing the product for use outside of anterior approach lumbar fusion. The FDA approved the Infuse bone graft  system for that purpose in 2002 and has not approved it for anything else since. However, the FDA has received numerous reports of the Infuse bone graft being used for other procedures.

In 2008, the FDA saw the need to specifically state that the Infuse bone graft  has not been approved for use in cervical spine procedures. Patients who have used the bone graft in the cervical spine have experienced severe medical complications that could potentially be very expensive for patients to manage. Additionally, some spinal surgery patients died after receiving the Infuse bone graft.

Infuse Bone Graft Lawsuits

Already, Medtronic has faced several large lawsuits due to their promotion of off-label uses for the bone graft.

Two whistleblower lawsuits have been filed where an employee of Medtronic came forth with specific information. Additionally, Medtronic paid $40 million in settlements with the U.S. Department of Justice in 2006. When that Infuse bone graft investigation happened, stock prices dropped, which caused the shareholders to file a class action lawsuit. The plaintiffs won $85 million in the subsequent class action settlement.

According to these lawsuits and class action lawsuit, the Medtronic Infuse bone graft was allegedly falsely advertised. The Senate Finance Committee investigated this allegation. In 2012, they announced that Medtronic paid $200 million to study authors who promoted their product, encouraging favorable reports and increased sales.

Because of this alleged behavior, Infuse bone graft complications have affected hundreds of individuals who were not warned about the risks of using the medical device for their procedure.

An Infuse gone graft class action lawsuit investigation is currently underway. Plaintiffs are hoping to receive compensation for their medical bills associated with Infuse bone graft complications as well as pain and suffering or loss of a family member.