The Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device (“Infuse”), developed by Medtronic, was created to assist patients with degenerative disk disease (DDD). The two-part device is implanted on the lumbar section of the spine to provide back support for the patient. Additionally, the Infuse Bone Graft portion of the product contains a recombinant human bone morphogenic protein, which is a synthetic version of a protein found naturally in the human body. This protein solution is soaked into an absorbable collagen sponge during surgery, which then serves as a terrace upon which new bone, stimulated by the protein, can grow. Medtronic asserts that Infuse provides a simpler and less painful alternative to the traditional bone graft taken from the hip.
In 2002, the FDA approved limited use of the Infuse system in the lumbar spine, specifically for DDD; for use in repairing open fractures on the tibia; for certain facial and cranial grafts; and occasionally for oral and dental procedures. No other uses were approved by the FDA. Medtronic allegedly encouraged hospitals and physicians to use the Infuse system off-label for treatments in the cervical spine. While Medtronic profited immensely from this off-label use, which contributed to an over $3 billion boost in sales, patients with the Infuse system on their cervical spine experienced a variety of serious health complications. These complications include difficulty breathing, airway compression, nerve damage, respiratory system damage, and in some cases, death. These complications occurred between two days and two weeks after surgery. In many cases, additional procedures were required to correct the problems caused by the Infuse system.
The FDA issued a warning against off-label usage of the Infuse system in 2008, after receiving at least 38 reports of complications. Later that same year, the Wall Street Journal released a report showing that at least 200 patients had experienced threatening complications. This report also indicated that surgeons may have been bribed by Medtronic to write favorable reports of the system for off-label use. In July 2011, the US Senate Finance Committee launched an official investigation against these surgeons who were believed to have been acting on behalf of Medtronic. The 16-month investigation found that Medtronic employees had been collaborating with physician authors to edit or compose inaccurate and misleading studies about the benefits and safety of the Infuse bone graft. Over a 14 year period, physician authors received over $210 million from Medtronic to write these biased reports. In September 2011, Yale launched a similar investigation of the Medtronic device. Yale investigators found that, when comparing the Infuse bone graft to a traditional bone graft, hardly any difference in effectiveness was found. Furthermore, the Yale study confirmed the US Senate Committee assertion that initial Medtronic studies regarding the safety of the Infuse product were biased and inaccurate.
Since 2008, multiple lawsuits have been filed against Medtronic for a variety of reasons concerning the Infuse program. Three former-employees sued the company for having not disclosed risk information; two of these cases were settled without Medtronic admitting wrongdoing, and one of the cases was dismissed. Certain law firms, such as Parker Waichman, encourage whistleblowers to step forward against Medtronic. Many patients who have received off-label treatment using the Infuse system have also filed suits against Medtronic. Patient complaints from plaintiffs suing Medtronic include ectopic bone growth into the spinal cord, coma, paralysis, muscle spasms, and wrongful death. Adding to the weight of the patient complaints, these risks were either undisclosed or underdisclosed to patients who received treatment using the Infuse system.
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