The federal investigation began in October 2008, with officials subpoenaing documents from the medical device maker regarding its Infuse bone graft. The investigation focused on whether Medtronic Inc. marketed the Infuse bone graft for off-label purposes. Although it is not illegal for doctors to use medications or devices off-label, it is illegal for companies to market them for such uses.
Allegations had been made that Medtronic paid doctors illegal kickbacks and fake royalties to encourage the doctors to use the Infuse in unapproved ways. The Infuse is approved for spine fusion surgeries in the lower back, but it has been used off-label in neck surgeries. According to the Star Tribune (5/16/12), four whistleblowers allege Medtronic gave doctors expensive gifts for using the Infuse off-label.
In 2008, the US Food and Drug Administration (FDA) issued a warning against using the Infuse in unapproved ways. At the time, the FDA warned that the Infuse could stimulate excess bone growth, which could result in difficulty breathing, swallowing or speaking; compression of the airway; respiratory damage; nerve damage; or death. Complications associated with the Medtronic Infuse bone graft often occurred within two weeks of surgery and sometimes required feeding tubes, tracheotomies or additional surgery.
The Department of Justice reportedly closed its investigation with no findings of wrongdoing on the part of Medtronic.
In March 2012 Medtronic announced it would pay $85 million to settle a securities class action lawsuit related to its handling of Infuse. The lawsuit had alleged that Medtronic made false and misleading statements about its bone graft. As part of the settlement, Medtronic did not admit to wrongdoing.
READ MORE MEDTRONIC INFUSE BONE GRAFT LEGAL NEWS
That overgrowth allegedly resulted in compression of Stevens' spinal nerves, causing permanent disability. Stevens alleges Medtronic downplayed the risks of serious side effects associated with Infuse, specifically when the Infuse is used off-label. Medtronic has not commented on the lawsuit.