Medtronic Inc. was hit with an Infuse bone graft lawsuit alleging that the medical device was used for an “off label” purpose, resulting in a serious injury.

The Medtronic Infuse Bone Graft System consists of two components with three parts. The parts include a tapered metallic spinal fusion cage, recombinant human bone morphogenetic protein and a scaffold for the protein and resulting bone growth.

The U.S. Food and Drug Administration (FDA) approved Infuse for use as a full system, with all parts used, in frontal approach lumbar spine surgery. Any other use is considered “off-label.”

This allegedly common off-label practice and resulting issues is why plaintiff Carman Kanaeholo is suing Medtronic.

According to the Medtronic Infuse lawsuit, on or around 2003, Kanaeholo underwent an anterior cervical discectomy and fusion using the Infuse Bone Graft in the procedure.

His surgeon allegedly not only used a non-FDA approved cage, but also performed an off-label fusion surgery, implanting it in the cervical spine. Medtronic representatives told his surgeon this usage was safe, and he relied on their honesty, according to the Infuse bone graft lawsuit.

Prior to this surgery, neither Kanaeholo nor his physician was warned of the off-label risks, the Infuse bone graft lawsuit alleges. Kanaeholo says that Medtronic “did not adequately inform his implanting surgeons of the true incidence of ectopic or uncontrolled or unusual bone growth resulting from the use of Infuse in off-label procedures, or of other risks or dangers or complications associated with the off-label use of Infuse in the spine.”

After the procedure, Kanaeholo suffered progressively worsening pain. Due to the off-label use of Infuse in his surgery, as stated in his Infuse lawsuit, Kanaeholo suffered from a laundry list of issues, including “autonomic neuropathy, small fiber neuropathy, peripheral neuropathy, muscle atrophy and nerve damage. extreme inflammatory reactions, chronic radiculitis, retrograde ejaculation, sterility, osteolysis (bone resorption), displacement or migration of the spacer cage, pseudoarthrosis, difficulty swallowing, difficulty breathing, and difficulty gripping and holding items, chronic pain and worse overall outcomes.”

If he and his surgeon had known of the risks, they could and would have selected a different path, he said in his Infuse lawsuit

Kanaeholo is suing Medtronic for fraudulent misrepresentation and fraud in the inducement, failure to warn, design defect, misrepresentation, negligence, negligence per se, breach of express warranty, and loss of consortium.

The Medtronic Infuse Bone Graft Lawsuit is Carman Kanaeholo v. Medtronic, et al., Case No: 1:14-cv-00369-SOM-KSC, in the U.S. District Court for the Central District of California.

Misbranding for Sales

It’s estimated that as many as 90 percent of the Infuse bone grafts implanted in spinal surgery patients are for uses not listed on the label. Developed, designed and manufactured by Medtronic, the Infuse bone graft is meant to aid fusion between the vertebrae without needing to harvest the patient’s own bone. However, when used off-label, it can result in unwanted bone growth.

According to Kanaeholo’s Infuse bone graft lawsuit, Medtronic “violated the FDCA [federal Food, Drug and Cosmetic Act of 1938] statutes and accompanying regulations by promoting Infuse for off-label uses, and by failing to account for adverse events and update its labeling, directions for use, and advertising to account for the adverse events resulting from these off-label uses.”

Many studies are used to support this assertion. Dr. Rongwei Fu, an Oregon Health and Science University researcher, stated, “[w]e found a lot of reporting bias in [Medtronic’s] published papers that tends to overstate the benefits and played down the risks.”

Further, Dr. Fu said “it was difficult to identify ‘clear indications’ for using the product, as Infuse offered no additional benefits beyond the normal benefits of the spine surgery.”

Off-label Dangers

The initial approved labeling for Infuse indicated in bold, underlined formatting, “these components must be used as a system. The Infuse Bone Graft component must not be used without the LT-Cage Lumbar Tapered Fusion Device Component.” But Medtronic ignores this warning and since Infuse’s approval in 2002 sells Infuse separately.

It wasn’t until articles published in Spine in 2006 that surgeons came to learn that, “rhBMP-2 may stimulate bone growth in areas in which bone is not desired … .” A different Spine piece, published in November 2006, entailed the risk of swelling from off-label use of Infuse in cervical spine fusions compared to traditional fusion surgeries.

Coinciding with these articles and studies detailing the risks of off-label use, Medtronic’s corrupt campaign of off-label marketing was exposed, telling the public Medtronic paid outside “Key Opinion Leader” physicians thousands to millions of dollars in exchange for publishing studies and medical journal articles downplaying the risks while promoting off-label use of the Infuse Bone Graft System.