Three Medtronic Infuse bone graft lawsuits were voluntarily dismissed from court.

The plaintiffs, three shareholders, filed the Medtronic Infuse bone graft after multiple individuals suffered from severe bone graft complications arising from off-label use and filed Medtronic lawsuits of their own.

Medtronic Infuse Bone Graft Lawsuit Dismissals

Medtronic has been accused of marketing the Medtronic Infuse bone graft for off-label purposes. While the tool is approved for use in the lumbar spine, Medtronic allegedly also said it was safe for use in the cervical spine as well. This reportedly resulted in multiple side effects involving bone graft complications such as nerve damage, male sterility, and others.

The Medtronic Infuse bone graft lawsuits claimed that Medtronic intentionally worked around FDA regulations when promoting their device. After an 18-month investigation, a litigation committee found that the claims were invalid.

Following motions for approval and denial, the Medtronic Infuse bone graft lawsuits were voluntarily withdrawn with prejudice, meaning they may not be amended. The claims were officially dismissed on May 27 and June 4.

Medtronic Infuse bone graft lawsuits have been struggling recently. One plaintiff attempted to convince the 10th U.S. Circuit Court of Appeals to rehear her case. The plaintiff claimed that her bone graft complications were valid and that Medtronic should be held responsible for their alleged off-label promoting activities.

The Medtronic Infuse bone graft lawsuit was dismissed after a panel found that the federal Food, Drug and Cosmetic Act did not differentiate between on-label and off-label purposes.

About Medtronic Infuse Bone Graft Complications

The Medtronic Infuse contains a synthetic protein called rhBMP-2. This protein can encourage bone growth and acts as a bone in places where needed. It was approved in 2002.

In 2008, the FDA warned against Infuse use in the cervical spine. Already, Medtronic has paid millions in settlements following claims surrounding the Medtronic Infuse.

Bone graft complications may include the following side effects:

• Male sterility
• Uro-genital injuries
• Nerve damage
• Excessive bone growth
• Chronic pain
• Difficulty breathing, swallowing, and speaking
• Death

Medtronic Infuse bone graft lawsuits may help plaintiffs win compensation for medical treatment, lost wages, legal costs, as well as the pain and suffering caused by the device. Already, hundreds have filed Medtronic Infuse lawsuits or have joined a Medtronic Infuse class action lawsuit investigation that has been launched.

Medtronic may be held liable for their alleged off-label marketing behaviors. Plaintiffs have claimed that they were not aware of the off-label nature of their procedures or of the potential bone graft complications that could follow.