Off-Label Promotion Claims in Medtronic Infuse Case Not Preempted, Ill. Federal Judge Rules

CHICAGO — Claims brought against Medtronic Inc. in connection with its alleged off-label promotion of the Infuse Bone Grafting Device are not federally preempted because plaintiffs are not seeking to impose requirements that are “different from or in addition to” federal requirements.

On June 2, Judge Virginia M. Kendall of the U.S. District Court for the Northern District of Illinois reasoned that to the extent Medtronic may have failed to market and promote its device as required by the Food and Drug Administration, it has also removed itself from whatever protection federal oversight of medical devices would have provided.

Donna …