Fraud on FDA claim survives preemption.

• Position: Food and Drug Administration

The federal preemption provisions of the Medical Device Amendments, 21 U.S.C. [sections] 360k(a), do not preclude private tortactions grounded on so-called fraud on the FDA claims, the Third Circuit held in In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817 (3d Cir. 1998), with one of the panel's judges dissenting.

The litigation involves more than 2,000 individual actions that were consolidated for pretrial proceedings pursuant to the multi-district litigation statute. The plaintiffs claim that they suffered injuries resulting from the implantation of orthopedic bone screws into the pedicles of their spines. They alleged that one of the defendants, Buckman Co., a regulatory consultant to medical device manufacturers, made fraudulent representations to the Food and Drug Administration concerning an AcroMed Corp. orthopedic bone screw device, known as the variable screw placement (VSP) spinal plate fixation system. The fraud they alleged was that AcroMed, through Buckman, "sought approval of its VSP plates and screws for use in long bones simply as a pretext in order to market the device for its true intended use in the spine."

Buckman was successful in getting the FDA to approve the VSP system as a "Section 510(k)" device--that is, one exempted from the regular approval process because it is "substantially equivalent" to an existing predicate device.

The federal preemption language of Section 360k(a) provides that "no state or political subdivision of a state may establish or continues in effect with respect to a device intended for human use any requirement--(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."

Relying on the U.S. Supreme Court's narrow reading of statutory preemption language in Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), the Third Circuit stated that it was apparent that there was no "requirement" at issue in this case because the state common law on which the plaintiffs relied did not impose any obligation on Buckman inconsistent with federal law.

The district court had conceded that Lohr undercut the defendants' reliance on preemption, but it dismissed the fraud on the FDA claims on two grounds--first, that to allow the claims would create a private right to action for violation of...