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A bone graft lawsuit was filed by a man alleging that his spinal fusion surgery went awry because Medtronic Inc. failed to adequately design and inform its patients about the Infuse bone graft complications.
According to the Medtronic lawsuit, John Arvizu underwent a lumbar spinal fusion in 2007 in which the Infuse bone graft was allegedly used for an off-label, or unapproved use.
Arvizu “was diagnosed with significant boney overgrowth and a cyst at the site of the fusion … [and] has required medical treatment,” the Infuse bone graft lawsuit states.
Further, Arvizu alleges that had his doctor not been the subject of intense marketing by Medtronic Inc., an alternative may have been used. Instead, not only was the bone graft used for an unapproved use but the surgeon reportedly did not use the LT-Cage device which restricts bone growth and can play a role in reducing the possibility of Infuse bone graft complications.
Even at a hearing at the U.S. Food and Drug Administration (FDA), a doctor who “is alleged to have received hundreds of thousands of dollars in the form of kickbacks from consulting agreements promoting Infuse, dismissed the FDA Panel’s concerns, stating, ‘this specific application before the panel today is through an anterior approach,’ and accordingly, ‘seems to me to be outside the scope of what we ought to be focusing on today.'”
Studies funded by Medtronic Inc. found that some 70 percent of patients suffered ectopic growth, or Infuse bone graft complications where tissue grows outside of the area targeted by the surgeon. However, it is also often used separately from the LT-Cage because the company still sells the products separately, according to the Infuse bone graft lawsuit.
In the case of Arvizu, the same bone growth occurred and he claims that he had to undergo significant treatment in order to repair the damage caused by the spinal fusion procedure.
The Medtronic Infuse Bone Graft Lawsuit is John Arvizu, et al. v. Medtronic Inc., et al., in the U.S. District Court for the District of Arizona.
In general, Infuse bone graft lawsuits are filed individually by each plaintiff and are not class actions.
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