Medtronic has been accused of marketing the Infuse bone graft for off-label purposes. As a result, unknown Infuse bone graft side effects have been experienced by patients who have undergone spinal fusion surgery and have claimed that they were not aware their procedure was off-label in the first place.

This allegation has led to over 1,000 Infuse bone graft lawsuits that have been filed against Medtronic.

The Infuse bone graft promotes bone growth through a synthetic liquid protein called recombinant human bone morphogenetic protein (rhBMP-2). It is used in spinal fusion surgery to  prevent movement in the lumbar area of the spine, which is in a lower spine. Usually, bone marrow from different parts of the body would be used for this treatment, but the Infuse bone graft would increase recovery time and be less invasive.

The Infuse Bone Graft System was approved by the U.S. Food and Drug Administration (FDA) in 2002 for anterior approach lumbar fusion only. However, it has been suggested that Medtronic marketed the bone graft for use in the cervical spine as well, which is near the neck.

While doctors are allowed to use devices such as the Infuse bone graft for off-label uses if they see fit, it is illegal for a manufacturer to market a drug or medical device for unapproved uses.

Many individuals have claimed they experienced Infuse bone graft side effects as a result of off-label use.

Infuse Bone Graft Dangers

Infuse bone graft side effects may include:

• Difficulty breathing, speaking, and swallowing
• Chronic pain
• Excessive bone growth
• Nerve damage
• Male sterility
• Cancer
• Paralysis
• Death

Over 1 million patients have undergone spinal fusion surgery with an Infuse bone graft, many for off-label uses.

In 2008, the FDA issued a warning about potential Infuse bone graft side effects, mentioning that it had not been approved for off-label uses, after they had received several adverse reports about Infuse bone graft side effects and complications.

Internal medicine specialist Mark Helfand said in a Bloomberg News report: “We couldn’t find a clear advantage in terms of benefits, and when you take into account there could be potential risks that should be more carefully evaluated, it tips the scales toward not using it.” 

Infuse Bone Graft Lawsuits

Medtronic off-label promotion has led to several Infuse bone graft lawsuits, including two whistleblower Infuse lawsuits and a settlement with the U.S. Department of Justice.

Infuse bone graft whistleblower lawsuits were filed by employees from inside Medtronic who came forth with a complaint against the medical device manufacturer. Following the Justice Department investigation, Medtronic paid an $85 million settlement to stockholders due to a drop in prices.

Medtronic allegedly paid over $200 million to authors who were brought on as consultants looking at the Infuse Bone Graft System, with the purpose of encouraging favorable reviews.

Plaintiffs in Infuse bone graft lawsuits may be awarded damages for medical bills, lost wages, pain and suffering, loss of quality of life, and loss of consortium if applicable.

Medtronic has been accused of concealing Infuse bone graft side effects and risks from patients and medical professionals and promoting their bone graft for off-label uses. In addition to individual Infuse bone graft lawsuits, a Medtronic Infuse bone graft class action lawsuit investigation is currently underway.