medtronic infuse lawsuit settlement amounts

The overwhelming majority of sales for the device have been driven by off-label use of the Medtronic Infuse, reaching as high as 85% of all sales at one point. If Medtronic had not promoted Infuse illegally for off-label use, most physicians would have been without the knowledge necessary to use the device for such procedures and individuals could have avoided problems through traditional bone graft procedures. Tens of thousands of individuals throughout the United States have received the Medtronic Infuse bone graft off-label, based on false and misleading statements made by Medtronic and “opinion leaders” paid by Medtronic to promote the off-label use. Use with a component other than the LT-CAGE.Lumbar surgery that is outside of the L4-S1 Region.Lumbar surgery at multiple levels of the spine.Lumbar surgery through the back (posterior) or side (lateral).Off-Label Medtronic Infuse Use could include: The device is only supposed to be used between L4 and S1, and with a combination of components that includes the LT-CAGE Lumbar Tapered Fusion Device and rhBMP-2 that is applied to an absorbable collagent sponge (ACS), which is designed to disappear over time. Medtronic Infuse is a bone morphogenetic protein (BMP) approved in 2002 by the FDA for use during spinal surgery for a single-level anterior lumbar fusion. Excessive or Uncontrolled Bone Growth (often referred to as Ectopic or Exuberant Bone Growth).Individuals have experienced a high rate of problems with off-label use of the Medtronic Infuse bone graft, including:

are pursuing potential Medtronic Infuse off-label lawsuits against the manufacturer for recklessly encouraging use of the bone growth agent in ways that were never approved by the FDA or determined to be safe and effective. Since the Medtronic Infuse bone graft was approved in 2002, it has been used largely “off-label” during procedures for which it was never approved by the FDA and for which the manufacturer knew there was an increased risk of serious and potentially life-threatening complications.ĭespite the known risk of problems with Medtronic Infuse off-label use, the manufacturer illegally promoted the device, increasing sales and causing thousands of individuals throughout the United States to experience complications after receiving the bone graft. Camp Lejeune Water Contamination Lawsuit.

Medtronic infuse lawsuit settlement amounts