Court Rejects Preemption for Biomet ReCap Hip Device Implanted Outside of Clinical Investigation

SOUTH BEND, Ind. — A federal judge has denied Biomet’s motion to dismiss a ReCap hip resurfacing case on preemption grounds, ruling that the Investigative Device Exemption to the Medical Device Amendments to the Food, Drug and Cosmetic Act does not apply where the device was implanted outside of the clinical trial setting, as is alleged here.

Judge Robert L. Miller Jr. of the U.S. District Court for the Northern District of Indiana also ruled Aug. 21 that no federal preemption applies to state law claims asserting injuries from component parts of such devices.

Plaintiff Leslie Caccia sued Biomet for …