Off-Label Promotion Claims in Medtronic Infuse Case Not Preempted, Md. Appeals Court Rules

BALTIMORE — Federal law does not preempt claims based on false statements allegedly made by Medtronic in its off-label promotion of the Infuse Bone Graft device, a Maryland appeals court has ruled in reinstating fraud, negligent misrepresentation and consumer protection act claims against the manufacturer.

In an Oct. 6 opinion, the Maryland Court of Special appeals also reversed a lower court’s ruling that federal law preempts claims for breach of express warranties Medtronic may have made in voluntary communications with the public or members of the medical professions outside of the context of the device’s FDA-approved labeling.

In 2007, Steven …