Medtronic attempted to have an Infuse bone graft lawsuit dismissed from court. While the motion was granted in part, they were unable to overthrow all of the plaintiff’s claims that the Medtronic Infuse Bone Graft caused severe complications and that Medtronic was responsible for these bone graft complications.

Thousands of individuals, including plaintiff Brett S. and his brother, have filed Infuse Bone Graft lawsuits against Medtronic claiming that the company promoted off-label use.

The Medtronic Infuse bone graft was approved for spinal fusion surgery in the lumbar spine. Medtronic allegedly also promoted their device for use in the cervical spine as well. However, the U.S. Food and Drug Administration (FDA) was clear in stating that the Infuse bone graft was not approved for use in the cervical spine.

Initially, both Brett and Leigh S. filed the Infuse Bone Graft lawsuit together as they had both undergone spinal fusion surgery with an Infuse bone graft. The ruling by U.S. District Judge Andrew Gordon dismissing part of the Infuse Bone Graft lawsuit separated the two plaintiffs.

Brett “would file an amended complaint … [asserting] claims against Medtronic for manufacturing defect, failure to warn, negligence, fraud, intentional misrepresentation, Nevada unfair competition, and breach of express and implied warranty,” Judge Gordon said about the Infuse bone graft lawsuit.

Medtronic claimed it would attempt to dismiss these allegations as well.

Infuse Bone Graft Complications

The Medtronic Infuse Bone Graft contains a protein called recombinant human bone morphogenetic protein-2, which stimulates bone growth. It was created as an alternative to traditional bone grafts which essentially requires bone be removed from one part of the body and be placed in another.

However, the plaintiff allegedly suffered from excessive bone growth and nerve damage after undergoing spinal fusion surgery with the Infuse Bone Graft.

“Medtronic knowingly failed to report adverse events to the FDA as required … [and] engaged in a concerted campaign to promote uses of Infuse not approved by the FDA,” said the Infuse bone graft lawsuit.

Brett’s initial claims for manufacturing defect, part of his negligence claim, unfair competition, and breach of implied warranty were dismissed with prejudice, which means he may not attempt to refile those claims. His claim of breach of express warranty was dismissed without prejudice. All other counts named in the Infuse bone graft lawsuit remain.

Brett is one of thousands of individuals who have suffered severe bone graft complications after undergoing surgery that was later discovered to be allegedly “off-label.”

Potential Medtronic Infuse Bone Graft complications may include:

• Difficulty breathing, speaking and swallowing
• Chronic pain requiring daily medication to manage
• Excessive bone growth
• Nerve damage
• Male sterility and other uro-genital injuries
• Back and leg pain
• Radiculitis (pain that spreads through the spinal nerves)
• Implant displacement
• Retrograde ejaculation (occurs when semen enters the bladder)
• Male sterility
• Cancer
• Infection
• Osteolysis (degeneration of bone tissue)
• Ectopic none formation (unwanted bone in the spinal canal)
• Death

This Infuse Bone Graft Lawsuit is Case No. 2:14-cv-00213, in the U.S. District Court for the District of Nevada.