RESPONDENT: Plaintiffs' Legal Committee
LOCATION: Office of Attorney General
DOCKET NO.: 98-1768
DECIDED BY: Rehnquist Court (1986-2005)
LOWER COURT: United States Court of Appeals for the Third Circuit
CITATION: 531 US 341 (2001)
ARGUED: Dec 04, 2000
DECIDED: Feb 21, 2001
Irving L. Gornstein - Department of Justice, on behalf of the United States, as amicus curiae, supporting the petitioner
Kenneth Steven Geller - Argued the cause for the petitioner
Michael D. Fishbein - Argued the cause for the respondent
Facts of the case
The Federal Food, Drug, and Cosmetic Act (FDCA) and the Medical Device Amendments of 1976 (MDA) regulate medical devices. Under the MDA, Class III devices "present a potential unreasonable risk of illness or injury" and thus require the Food and Drug Administration's (FDA) strictest regulation. In 1985, after a previously failed attempt, the AcroMed Corporation sought approval for its orthopedic bone screw device, a Class III device, for use in spinal surgery with the assistance of Buckman Company, a regulatory consultant to medical device manufacturers. The FDA also denied the second application. On the third attempt, instead of trying to show the bone screw device was "substantially equivalent" to similar devices already on the market and thus as safe and effective, AcroMed and Buckman split the device into its component parts, renamed them, and altered the intended use of the parts. Thus, the FDA approved the component devices for long bone surgery. Subsequently, the Judicial Panel on Multidistrict Litigation has directed over 2,300 civil actions related to these medical devices to the Federal District Court. Many actions claim, under state tort law, that AcroMed and Buckman made fraudulent representations to the FDA as to the intended use of the bone screws and that, as a result, the devices were improperly given market clearance, which injured the plaintiffs. The District Court dismissed the fraud claims as pre-empted by the MDA. The Court of Appeals reversed.
Does the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, pre-empt civil actions related to the alleged fraudulent approval of orthopedic bone screw devices?
Media for Buckman Company v. Plaintiffs' Legal CommitteeAudio Transcription for Oral Argument - December 04, 2000 in Buckman Company v. Plaintiffs' Legal Committee
Audio Transcription for Opinion Announcement - February 21, 2001 in Buckman Company v. Plaintiffs' Legal Committee
William H. Rehnquist:
The second case, I have to announce is No. 98-1768, Buckman Co. versus the Plaintiffs' Legal Committee.
Here the respondent represents plaintiffs who claimed injuries resulting from the use of orthopedic bone’s screws in the pedicles of their spines.
Petitioner is a consulting company that assisted the screws' manufacturer in navigating the federal regulatory process for these devices.
The plaintiffs’ claim the petitioner statement to the Food and Drug Administration or FDA as to the intended use of the use of these screws fraudulently induced the FDA to give market approval and ultimately led to plaintiffs’ injuries.
The District Court concluded that these State law so-called fraud on the FDA claims were improper under the Medical Device Amendments to the Federal Food, Drug And Cosmetic Acts or the MDA, but the Court of Appeals for the Third Circuit reversed that decision, saying that there was no express or implied conflict between the plaintiffs’ claims and the MDA.
In an opinion filed with the Clerk of the Court today, we reverse.
Under the Supremacy Clause United States Constitution, State law claims have conflict with the federal statute are invalid under what is known as the implied preemption doctrine.
The plaintiffs fraud on the FDA claims create such a conflict with the regulatory regime established by the MDA.
The bones screws at issue here were introduced under a provision of the MDA, directing the FDA to approve devices that it determines, are substantially equivalent to a device that is already on the market.
Referred to as the 510(k) process, this exception to the FDA’s more time consuming in normal processes prevents unnecessary delay in the development of competition among medical device manufactures.
The 510(k) process sets forth a comprehensive scheme for deciding whether an applicant’s device qualifies.
The process also includes various provisions aimed at detecting, deterring, and punishing false statements.
The statute makes clear that it is the FDA’s responsibility not that of private litigants to issue a measured response to incidence of non-compliance. The FDA is charged with achieving a variety of difficult and often competing statutory objectives and it would inevitably forth that task if plaintiffs at each of the 50 states, were able to bootstraps state tort claims under the federal regulatory regime.
Both manufacture’s willingness to participate in the approval process and their conduct within that regime would be skewed by fears of unpredictable state litigation.
This would interfere with the FDA’s own judgment is to how best to achieve the statute’s goal.
The conflict between the MDA and plaintiffs’ fraud on the FDA claims dictates that the latter are impliedly preempted.
Justice Stevens has filed an opinion concurring in the judgment in which Justice Thomas joins.