Ever since Buckman Co. v. Plaintiffs' Legal
Committee, 531 U.S. 341 (2001), held that state-law claims
alleging fraud on the FDA are preempted, plaintiffs have been
attempting to find some other way of bringing claims that attribute
FDA actions to a defendant's false pretenses. Since preemption
is based on the Supremacy Clause, and the constitutional
relationship between the federal and state legal systems, the
doctrine doesn't apply where recovery is sought under a federal
statute. Since the False Claims Act ("FCA") is a federal
statute, sporadic attempts have been made to bring private
fraud-on-the FDA-claims under that statute. Bexis, who invented
what became the Buckman
fraud-on-the-FDA/implied-preemption defense in the Bone
Screw litigation, even worked on an amicus brief in
one such case, United States ex rel. Gilligan v. Medtronic,
Inc., 403 F.3d 386 (6th Cir. 2005), that was ultimately
decided (favorably to the defense) on other grounds.
