Medtronic Ordered to Produce Infuse Bone Graft Safety Data

New York, NYMedtronic Inc, has been ordered to produce documents pertaining to the safety of its Medtronic Infuse Bone Graft protein compound by a federal judge hearing a securities lawsuit filed against the company.

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.

In June, 2011, Spine Journal devoted the entire month's issue to evaluating company-sponsored studies of Infuse. They found issues with 13 studies conducted by physicians sponsored by Medtronic: all 13 studies reportedly left out or downplayed the rates of adverse events linked to the use of recombinant human bone morphogenetic protein-2. As a result of the journal's findings, and the scrutiny Medtronic is under from federal agencies over the Infuse bone morphogenetic compound, Medtronic's share price dropped, and shareholders filed a securities lawsuit.

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."