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Lawsuit Against Medtronic Inc. Will Proceed, as Judge Rejects Device Maker's Preemption Arguments to Have Medtronic Infuse Case Dismissed, Parker Waichman LLP Reports
Date:8/29/2013

x?articleid=1696646" onclick="linkClick(this.href)" rel="nofollow">http://annals.org/article.aspx?articleid=1696646; http://annals.org/article.aspx?articleid=1696645)

The two independent studies, overseen by Yale University, reveal important key findings regarding Medtronic’s Infuse product—namely, that there is little, if any, difference in the effectiveness of Infuse over a traditional bone graft. Additionally, Infuse has the potential to cause harmful, if not fatal, side effects, including:

  •     Retrograde ejaculation
  •     Cancer
  •     Pain
  •     Extraneous bone growth

Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers had failed to report serious potential complications from use of Infuse bone graft products in spinal surgery.

Infuse was approved by the FDA in 2002, explicitly for use in a single type of spinal surgery that involves fusing together vertebrae in the lower spine, with the surgeon using a frontal approach. But it became widely used off-label—meaning for uses not officially approved by the FDA. On July 8, 2008, the FDA issued a safety alert to warn about the use of Infuse in the upper spine and the neck region after receiving dozens of reports of serious side effects associated with such use of the device. Among the side effects stemming from off-label use of this device, according to
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