No Preemption for Medtronic Infuse Bone Graft Suit

The Medtronic Infuse Bone Graft System uses a liquid bone protein to encourage bone growth in spinal fusion surgery. However, its “off-label” non-FDA approved use in certain types of fusion surgery may lead to serious adverse effects.

In a recent California case, the court determined that the plaintiff’s injury claims from the Infuse System were not preempted by federal law under the US Supreme Court’s decision in  Reigel v. Medtronic, Inc (552 U.S. 312) because Medtronic promoted the Infuse product for off label uses.