The securities lawsuit alleges that Medtronic artificially inflated its stock price through an 'off-label' promotional scheme involving a morphogenetic protein used in its Infuse bone graft device.
Medtronic's Infuse Bone Graft is controversial due to the compound's association with life-threatening complications including swelling of the airways, which can cause difficulty breathing, speaking and swallowing. On July 1, 2008, the FDA issued a warning concerning off-label use of the Medtronic Infuse Bone Graft. Specifically, the FDA warned that there were risks associated with the use of the bone graft on the cervical spine.
READ MORE Infuse LEGAL NEWS
The suit alleges that "Medtronic and its stable of highly paid doctor-consultants recklessly downplayed the safety risks of Infuse – especially in off-label procedures – and that Medtronic’s improper off-label marketing and revenue growth were directly tied to a troubling and financially dangerous rise in safety concerns linked to Infuse, including 'potentially serious, and even deadly, adverse events, particularly in the cervical spine."