Plaintiff Given 2nd Chance to Overcome Preemption in Ariz. Federal Ankle Device Case

PHOENIX — An Arizona federal judge has dismissed a lawsuit targeting Small Bones Innovations Inc.’s ankle replacement device, ruling the claims are preempted because they seek a different design and manufacturing process than that approved by the Food and Drug Administration.

In a Sept. 28 order, Judge Michael Liburdi of the U.S. District Court for the District of Arizona allowed the plaintiff to amend his complaint to cure the pleading defects.

Richard Skinner was implanted with SBI’s Scandinavian Total Ankle Replacement (STAR) in October 2013. The STAR device is a Class III medical device, subject to the FDA’s rigorous Premarket …