Failure-To-Warn, Negligence Claims Preempted in Medtronic Infuse Case, Calif. Federal Judge Rules

SACRAMENTO, Calif. — A California federal judge has dismissed failure-to-warn and negligence claims in a Medtronic Infuse off-label use case, finding they are preempted because they call for requirements that are “different from, or in addition to,” those required by federal law.

On Jan. 30, Senior Judge Anthony W. Ishii of the U.S. District Court for the Eastern District of California also dismissed the plaintiff’s fraud-based claims, finding they were not pled with the requisite particularity. However, the judge allowed the plaintiff to amend his complaint.

Gary Hawkins underwent three spinal surgeries during which his surgeon used Infuse in an …