Medtronic Lawsuit Claims Infuse Was Used in an Off-Label Manner

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Arizona residents John and Josephine Arvizu filed a Medtronic lawsuit on April 15, claiming that the Infuse Surgery technique was used in an “off-label manner,” which means it wasn’t used in a manner approved by the U.S. Food and Drug Administration (FDA).

“On Oct. 17, 2007, Plaintiff John Arvizu underwent a transforaminal lumbar interbody fusion at L5-S1 in Arizona. To achieve fusion, Plaintiff’s surgeon performed an off-label procedure by utilizing a transforaminal approach, as well as by failing to use the required LT-Cage,” the Infuse lawsuit explains.

At first, everything seemed to be going well, but that soon changed.

“In or around 2008, Plaintiff was diagnosed with significant boney overgrowth and a cyst at the site of the fusion. As a result, Plaintiff has required extensive medical treatment.” Due to this, the couple have suffered financial losses from John’s inability to work and the medical bills. Pain and suffering are also plentiful. They say that they were never made aware of the Infuse risk, and that his surgery wasn’t FDA approved.

The Arvizus joined scores of other Infuse victims who have filed similar Infuse lawsuits. There are so many Infuse lawsuits that an Infuse class action lawsuit has been formed. However, the Arvizus have yet to join the Medtronic class action lawsuit, but it’s a decision they can make in the future.

“Infuse is a bio-engineered liquid bone graft product classified by the FDA as a medical device … Infuse is used in spinal fusion surgeries, and its purpose is to foster fusion between the vertebrae without implanting a patient’s own bone or cadaver bone between the vertebrae in the spine, as the latter two options require a surgeon to harvest bone from the patient’s own hip or risk the rejecting of cadaver bone,” according to the Infuse lawsuit.

In this Infuse lawsuit, the Arvizus say “Infuse is approved by the FDA and is indicated only: (1) for anterior lumbar interbody fusions; (2) some tibia fractures; and (3) some specific dental surgeries not relevant to this case. This case concerns an off-label use in a lumbar fusion procedure. Infuse is only approved by the FDA for lumbar surgery that is performed through the abdomen (anterior approach) when it is used in combination with an LT-Cage, a hollow metal cylinder that is meant to hold the active ingredient in Infuse rhBMP-2 protein.”

These specifications were designated by the FDA in order to ensure the safety of patients. The couple says that “Infuse is not approved by the FDA for use in cervical spine surgery, or for any lumbar surgery performed through the back or side of the body (transforaminal, posterior or posterolateral approaches). All cervical spine surgeries, many lumbar surgeries (where the approach is not through the abdomen), and all Infuse back surgeries that are not done with an LT-Cage are considered off-label uses.”

The couple alleges that Infuse was not only used for off-label purposes but promoted for off-label uses by Medtronic.

“Despite this lack of FDA approval and the FDA’s explicit concerns about the dangers to patients posed by off-label uses, Infuse was improperly promoted by MEDTRONIC to be used off-label for transforaminal, posterolateral, and posterior approach spine fusions, cervical spine fusions, and procedures without the LT-Cage,” according to the Medtronic lawsuit.

The Arvizus allege that because the Medtronic bone graft product was used for unapproved purposes, serious injuries were caused by the illegal use, most notably is “ectopic” bone growth.

“This uncontrolled bone growth (also known as ‘ectopic,’ ‘heterotopic,’ or ‘exuberant’ bone growth) can result in severe damage to or compression of the surrounding neurologic structures in the spine, and bone can grow onto or around the spinal cord or nerve roots. When nerves are compressed by excessive bone growth, a patient can experience, among other adverse events, intractable pain, paralysis, spasms, and a need for additional surgery,” the Infuse lawsuit explains.

The Arizona couple filed the Infuse lawsuit for fraudulent misrepresentation and fraud in inducement, failure to warn, design defect, misrepresentation, negligence, breach of warranties, breach of Arizona’s Consumer Protection Statutes, loss of consortium and negligence.

The Infuse lawsuit is John Arvizu et al v. Medtronic Inc. et al, Case No.: 2:14-cv-00792-DGC, in the U.S. District Court for the District of Arizona.

Join a Free Medtronic Infuse Class Action Lawsuit Investigation

An investigation has been launched to find spinal surgery patients who were implanted with Medtronic’s Infuse bone graft and suffered complications such as infection, bone and nerve damage, infertility, cancer, and more. See if you qualify for compensation from the proposed Medtronic class action lawsuit by obtaining a free and confidential case evaluation:

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