Claims Based on Off-Label Promotion Not Preempted, Minn. App. Ct. Rules

MINNEAPOLIS — State law claims based on Medtronic’s alleged failure to warn the FDA of adverse effects in connection with the off-label use of its Infuse Bone Grafting Device are not preempted because they impose requirements that are parallel to federal device-specific requirements, the Minnesota Court of Appeals has held.

In an April 20 ruling, the court further held that the plaintiffs’ express warranty claims are not preempted because they are parallel to federal requirements regarding false or misleading off-label promotion.

Infuse, a Class III device, consists of a collagen carrier sponge soaked with liquid protein rhBMP-2 and a …