Medtronic Inc, one of the world’s largest medical technology companies, has recently been targeted in various lawsuits related to its Infuse Bone Graft, a medical device designed to stimulate bone growth.
Whistleblower Infuse Bone Graft Lawsuits
In two whistleblower lawsuits initiated by former Medtronic employees, Medtronic has been accused of paying kickbacks to induce surgeons to use the Infuse Bone Graft. These lawsuits allege that Medtronic used sham consulting agreements, sham royalty agreements, and lavish vacations to persuade doctors to use the Infuse Bone Graft. Although Medtronic admitted no wrongdoing, the company agreed to pay $40 million to the government to settle these lawsuits in 2006.
Personal Injury Infuse Bone Graft Lawsuits
At least three personal injury lawsuits have also been filed against Medtronic on behalf of patients injured or killed by complications with the Medtronic Infuse Bone Graft. According to these off-label whistleblower lawsuits, Medtronic actively promoted and marketed the Infuse Bone Graft off-label for use in the cervical spine (neck). The lawsuits also allege that Medtronic failed to adequately warn patients and doctors about the risk of life-threatening complications with the Infuse Bone Graft. When used during cervical fusion surgery, the Infuse Bone Graft has been associated with a high rate of serious complications involving compression of the airway and nerves which could lead to respiratory arrest or death.
Securities Class Action Infuse Bone Graft Lawsuits
In December 2008, Medtronic was also named as the defendant in a securities class action lawsuit. The class action alleges that from November 19, 2007 through November 17, 2008, Medtronic, its Chief Executive Officer and Chief Financial Officer made repeated false statements to the investing public concerning the Infuse Bone Graft, representing to investors that it was a valuable and reliable source of revenues for the company. Specifically, the class action accuses Medtronic of failing to disclose to shareholders the extent to which revenues from sales of the Infuse Bone Graft were dependent on “off-label” uses; failing to disclose that a significant and increasing number of patients subjected to such off-label uses of the Infuse Bone Graft were suffering severe medical complications; and hiding the fact that the extensive off-label usage of the Infuse Bone Graft was the result of an unlawful campaign by Medtronic to market and encourage off-label use of the product.
This is by no means the first time Medtronic has come under fire for troubles with its medical devices. Last year, the FDA issued a warning letter to Medtronic, saying it had failed to properly report adverse events related to devices in its neuromodulation business. Additionally, Medtronic has been the target of extensive litigation over its Sprint Fidelis defibrillator leads, which were recalled in 2007.
Patients who have sustained an injury due to the off-label use of the Medtronic Infuse Bone Graft may be entitled to compensation for their injuries and should contact a Medtronic bone infuse lawyer immediately.