Ancure Endograft Device Claims are Preempted, Court Affirms

SAN JOSE, Calif. - Claims brought against the manufacturers of a recalled endograft device are preempted by the Medical Device Amendments because they called for requirements that are "different from or in addition to" those imposed by the Food and Drug Administration, a California appellate court has affirmed. Norks v. Endovascular Technologies Inc., No. H033941 (Calif. App., 6th Dist.).

On Nov. 19, the California Court of Appeal, 6th District, ruled that the investigational device exemption process through which the device was approved is similar to the rigorous premarket approval process referred to in Riegel v. Medtronic Inc. (552 U.S. 312).