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Judge Denies Medtronic’s Bid to Dismiss Lawsuit Alleging that the Off-Label Usage of its Infuse Bone Growth Product Caused Disability, Parker Waichman LLP Notes
Date:7/25/2013

ence 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 due to off-label use, according to the FDA, are:

  •     Swelling of neck and throat tissue, resulting in compression of the airway and/or neurological structures in the neck
  •     Difficulty swallowing, breathing or speaking
  •     Nerve damage
  •     Severe dysphagia

The FDA also noted in the 2008 safety alert that, since 2004, it had received nearly 40 reports of complications arisi
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