Spinal surgery patients have complained of negative side effects from Medtronic’s Infuse bone graft such as difficulty breathing, speaking and swallowing and excessive bone growth. These side effects are allegedly partially the result of off-label use of the Infuse bone graft, which the patients were unaware of.

The Infuse bone graft is used to fill the spaces in the spine where bone is needed. It contains a certain protein (rhBMP-2) that encourages bone growth. It was promoted as an better alternative in bone grafting surgical methods.

However, Medtronic allegedly promoted their Infuse bone graft for purposes not specifically approved for by the U.S. Food and Drug Administration (FDA) and encouraged doctors to use the Infuse bone graft in the cervical spine.

Medtronic Infuse bone graft side effects alleged by Infuse patients include chronic pain, nerve damage, male sterility and other uro-genital injuries as well as death, in addition to the previously mentioned Infuse side effects. These side effects could be from off-label use (typically unknown to the patient) as well as for approved Infuse bone graft uses.

Medtronic Infuse Bone Graft Problems and Legal Issues

The FDA approved the Medtronic Infuse bone graft in 2002 for limited use in the lower back and for certain oral and dental procedures. It was initially marketed as an alternative way to replace damaged spinal disks.

It is alleged that Medtronic encouraged off-label use in the cervical spine and that this sales technique was extremely profitable, resulting in billions of dollars for Medtronic.

In addition, Medtronic is accused of paying some doctors to write positive reports. According to the The Wall Street Journal, one surgeon was paid $800,000 for faking an Infuse bone graft study and encouraging the FDA to not worry about off-label use or side effects.

In 2012, a study led by the Senate Finance Committee found that Medtronic paid over $200 million to authors who were consulting on the efficacy and safety of the Infuse bone graft.

The FDA has received numerous complaints concerning Infuse bone graft side effects and Infuse complications. Indeed, several Infuse bone graft lawsuits were filed due to complications both from the Infuse bone graft and from off-label uses.

Two whistleblower Infuse bone graft lawsuits have been settled in addition to a multi-million dollar settlement with the U.S. Department of Justice.

Following the Department of Justice investigation, another Infuse lawsuit was filed by shareholders who experienced a severe drop in stock prices. They were given $85 million in settlements.

In addition to these legal proceedings, hundreds of Infuse bone graft lawsuits have been filed and many of these lawsuits have been grouped together in multidistrict litigation.