Claims in Multi-Plaintiff Medtronic Infuse Bone Graft Action Preempted, Ohio Federal Judge Rules

CINCINNATI — An Ohio federal judge has dismissed a multi-plaintiff action alleging injury from the alleged off-label use of Medtronic’s Infuse bone grafting device, ruling that the plaintiffs’ claims are expressly preempted because they challenge FDA-approved warnings and design specifications.

On Sept. 22, Judge Timothy Black of the U.S. District Court for the Southern District of Ohio further held that the claims based on Medtronic’s alleged failure to provide the FDA with adverse-event reports and promotion of the off-label use of Infuse are impliedly preempted because they exist only by virtue of the federal regulatory scheme.

Plaintiffs in this action …