Medtronic's Infuse Bone Graft has been associated with some of the most extensive medical device liability cases of the past few years. The Medtronic Infuse Bone Graft is a medical device that is used to replace damaged spinal disks and simulate bone growth. Unfortunately, this device appears to have been inadequately tested before it was released on the market and many patients experienced adverse outcomes, including bone loss at the surgical site, nerve damage and other complications.
Some patients have complained that they developed cauda equina syndrome after receiving Infuse Bone Grafts. This condition is characterized by a large, space-occupying lesion within the spine that causes dangerous compression in the spinal canal. Individuals who suffer from cauda equina syndrome are often treated with emergency surgery because untreated forms of the disorder are associated with urinary retention, lower extremity pain, numbness, weakness and, in some cases, paralysis.
The exact link between the Infuse Bone Graft and cauda equina syndrome is unknown and many cases against Medtronic remain in their early stages.
In early 2012, Medtronic agreed to pay $85 million to settle a shareholder lawsuit accusing the company of making misleading statements regarding this medical device. Shareholders were upset because they alleged that the company failed to disclose that almost 85 percent of the sales depended on unapproved off-label uses. Shareholders also alleged that the company bribed doctors to prescribe this medical device for unapproved uses. The company did not admit to any wrongdoing in its settlement.
Source: Reuters, "UPDATE 1-Medtronic to pay $85 mln to settle Infuse lawsuit," March 30, 2012