Three lawsuits filed against Medtronic, Inc. over injuries associated with its Infuse bone graft device will be remanded to the Circuit Court of the City of St. Louis for further proceedings, according to the law firms Parker Waichman LLP, Neblett Beard & Arsenault, and The Drakulich Firm, which are collaborating on the cases.
The three cases have been sent back to the 22nd Judicial Circuit (St. Louis City) Court under Judge John F. Garvey. Allegations in the cases include that Medtronic and the other defendants were involved in a fraudulent marketing and promotional scheme, promoting illegal and dangerous uses of Infuse. The individuals bringing the lawsuits claim they underwent surgeries involving “off-label” uses of Infuse – uses not approved by the Food and Drug Administration (FDA) – and this led to their injuries.
Infuse is a genetically engineered, synthetic, recombinant human bone morphogenetic protein (rhBMP-2) that received FDA approval in 2002 for specific purposes:
- To stimulate spine growth in patients suffering from lower spinal degenerative disease
- For use in one type of spinal surgery
- For use in some dental procedures
Infuse is not approved for use on the upper spine though it is widely used in these off label procedures, Parker Waichman notes. Medtronic has been embroiled in controversy over Infuse. Early reports in medical journals claimed superior results for Infuse surgery, but in 2008, the FDA warned of reports of life-threatening complications in off-label uses, such as fusions in the upper (cervical) spine.
A 2011 issue of the journal Spine devoted entirely to critiques of Medtronic-funded Infuse research said the research did not report serious complications including infections, increased cancer risk, male sterility, bone dissolution, and worsened back and leg pain, according to Reuters.