BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMMITTEE

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341 OCTOBER TERM, 2000
Syllabus
BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMMITTEE
certiorari to the united states court of appeals for
the third circuit
No. 98–1768. Argued December 4, 2000—Decided February 21, 2001
Respondent represents plaintiffs claiming injuries caused by the use of
orthopedic bone screws in the pedicles of their spines. Petitioner as-
sisted the screws’ manufacturer in securing approval for the devices
from the Food and Drug Administration (FDA or Administration), which
has regulatory authority under the Federal Food, Drug, and Cosmetic
Act (FDCA), as amended by the Medical Devices Amendments of 1976
(MDA). While the screws are in a class that normally must go through
a time-consuming process to receive premarket approval (PMA), they
were approved under an exception, known as the § 510(k) process, for
predicate devices—devices that were already on the market when the
MDA was enacted—and for devices that are “substantially equivalent”
to predicate devices. The § 510(k) application filed by petitioner and
the manufacturer sought clearance to market the screws for use in arm
and leg bones, not the spine. Claiming that the FDA would not have
approved the screws had petitioner not made fraudulent representations
regarding their intended use, plaintiffs sought damages under state tort
law. The District Court dismissed these fraud-on-the-FDA claims on,
inter alia, the ground that they were pre-empted by the MDA. The
Third Circuit reversed.
Held: The plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and
are therefore impliedly pre-empted by, the FDCA, as amended by the
MDA. Pp. 347–353.
(a) The relationship between a federal agency and the entity it regu-
lates is inherently federal because it originates from, is governed by,
and terminates according to federal law. Because petitioner’s FDA
dealings were prompted by the MDA and the very subject matter of
petitioner’s statements were dictated by that statute—and in contrast
to situations implicating “federalism concerns and the historic primacy
of state regulation of [health and safety matters],” Medtronic, Inc. v.
Lohr, 518 U. S. 470, 485—no presumption against pre-emption obtains
in this case. The conflict here stems from the fact that the federal
statutory scheme amply empowers the FDA to punish and deter fraud
against the Administration, and the Administration uses this authority
to achieve a delicate balance of statutory objectives that can be skewed
by allowing state-law fraud-on-the-FDA claims. While the § 510(k)

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342 BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMM.
Syllabus
process lacks the PMA review’s rigor, the former does set forth a com-
prehensive scheme for determining substantial equivalence with a pred-
icate device. Other provisions give the FDA enforcement options that
allow it to make a measured response to suspected fraud upon the Ad-
ministration. This flexibility is a critical component of the framework
under which the FDA pursues its difficult (and often competing) objec-
tives of regulating medical device marketing and distribution without
intruding upon decisions committed by the FDCA to health care profes-
sionals. Pp. 347–350.
(b) State-law fraud-on-the-FDA claims inevitably conflict with the
FDA’s responsibility to police fraud consistently with the Administra-
tion’s judgment and objectives. Complying with the FDA’s detailed
regulatory regime in the shadow of 50 States’ tort regimes will dramati-
cally increase the burdens facing potential applicants, who might be de-
terred from seeking approval of devices with potentially beneficial off-
label uses—an accepted medical practice in which a device is used for
some other purpose than that for which the FDA approved it—for fear
of being exposed to unpredictable civil liability. Conversely, applicants’
fear that their disclosures to the FDA will later be judged insufficient
in state court might lead them to submit information that the Adminis-
tration neither needs nor wants, thus delaying the comparatively speedy
§ 510(k) process, and, in turn, impeding competition and delaying the
prescription of appropriate off-label uses. Respondent’s reliance on
Silkwood v. Kerr-McGee Corp., 464 U. S. 238, is misplaced. Silkwood
was based on traditional state tort law principles, not on a fraud-on-the-
agency theory, and, unlike Silkwood, there is clear evidence here that
Congress intended that the MDA be enforced exclusively by the Federal
Government. In addition, the MDA’s express pre-emption provision
does not bar the ordinary working of conflict pre-emption principles.
Geier v. American Honda Motor Co., 529 U. S. 861, 869. And although
Medtronic can be read to allow certain state-law causes of actions
that parallel federal safety requirements, it does not stand for the
proposition that any FDCA violation will support a state-law claim.
Pp. 350–353.
159 F. 3d 817, reversed.
Rehnquist, C. J., delivered the opinion of the Court, in which O’Con-
nor, Scalia, Kennedy, Souter, Ginsburg, and Breyer, JJ., joined.
Stevens, J., filed an opinion concurring in the judgment, in which
Thomas, J., joined, post, p. 353.
Kenneth S. Geller argued the cause for petitioner. With
him on the briefs were Alan E. Untereiner and Sharon
Swingle.

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343 Cite as: 531 U. S. 341 (2001)
Opinion of the Court
Irving L. Gornstein argued the cause for the United
States as amicus curiae urging reversal. With him on the
brief were Solicitor General Waxman, Assistant Attorney
General Ogden, Deputy Solicitor General Kneedler, Doug-
las N. Letter, Peter J. Smith, Margaret Jane Porter, and
Patricia J. Kaeding.
Michael D. Fishbein argued the cause for respondent.
With him on the brief were Arnold Levin, Sandra L. Dug-
gan, and John J. Cummings III.*
Chief Justice Rehnquist delivered the opinion of the
Court.
Respondent represents plaintiffs who claim injuries re-
sulting from the use of orthopedic bone screws in the pedi-
cles of their spines. Petitioner is a consulting company that
assisted the screws’ manufacturer, AcroMed Corporation, in
navigating the federal regulatory process for these devices.
Plaintiffs say petitioner made fraudulent representations to
the Food and Drug Administration (FDA or Administration)
in the course of obtaining approval to market the screws.
Plaintiffs further claim that such representations were at
least a “but for” cause of injuries that plaintiffs sustained
from the implantation of these devices: Had the representa-
tions not been made, the FDA would not have approved the
devices, and plaintiffs would not have been injured. Plain-
tiffs sought damages from petitioner under state tort law.
*Briefs of amici curiae urging reversal were filed for the Medical De-
vice Manufacturers Association by Daniel G. Jarcho, Donald R. Stone,
and Larry R. Pilot; for Medtronic Sofamor Danek, Inc., by James M. Beck
and Stephen S. Phillips; for Pharmaceutical Research and Manufacturers
of America by Bert W. Rein, Daniel E. Troy, and Jennifer A. Shah; for
the Product Liability Advisory Council, Inc., by Malcolm E. Wheeler; and
for the Washington Legal Foundation by Daniel J. Popeo and Richard
A. Samp.
Briefs of amici curiae urging affirmance were filed for the Association
of Trial Lawyers of America by Jeffrey Robert White and Frederick M.
Baron; and for Public Citizen by Allison M. Zieve, Brian Wolfman, and
Alan Morrison.

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344 BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMM.
Opinion of the Court
We hold that such claims are pre-empted by the Federal
Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as
amended by the Medical Device Amendments of 1976 (MDA),
90 Stat. 539, 21 U. S. C. § 301 (1994 ed. and Supp. V).
I
Regulation of medical devices is governed by the two Acts
just named. The MDA separates devices into three catego-
ries: Class I devices are those that present no unreasonable
risk of illness or injury and therefore require only general
manufacturing controls; Class II devices are those possessing
a greater potential dangerousness and thus warranting more
stringent controls; Class III devices “presen[t] a potential
unreasonable risk of illness or injury” and therefore incur
the FDA’s strictest regulation. § 360c(a)(1)(C)(ii)(II). It is
not disputed that the bone screws manufactured by AcroMed
are Class III devices.
Class III devices must complete a thorough review process
with the FDA before they may be marketed. This pre-
market approval (PMA) process requires the applicant to
demonstrate a “reasonable assurance” that the device is both
“safe . . . [and] effective under the conditions of use pre-
scribed, recommended, or suggested in the proposed labeling
thereof.” §§ 360e(d)(2)(A), (B). Among other information,
an application must include all known reports pertaining to
the device’s safety and efficacy, see § 360e(c)(1)(A); “a full
statement of the components, ingredients, and properties
and of the principle or principles of operation of such device,”
§ 360e(c)(1)(B); “a full description of the methods used in,
and the facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of,
such device,” § 360e(c)(1)(C); samples of the device (when
practicable), see § 360e(c)(1)(E); and “specimens of the label-
ing proposed to be used for such device,” § 360e(c)(1)(F).
The PMA process is ordinarily quite time consuming because

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345 Cite as: 531 U. S. 341 (2001)
Opinion of the Court
the FDA’s review requires an “average of 1,200 hours [for]
each submission.” Medtronic, Inc. v. Lohr, 518 U. S. 470,
477 (1996) (citing Hearings before the Subcommittee on
Health and the Environment of the House Committee on En-
ergy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100–34),
p. 384 (1987); Kahan, Premarket Approval Versus Premarket
Notification: Different Routes to the Same Market, 39 Food
Drug Cosm. L. J. 510, 512–514 (1984)).
An exception to the PMA requirement exists for devices
that were already on the market prior to the MDA’s enact-
ment in 1976. See 21 U. S. C. § 360e(b)(1)(A). The MDA
allows these “predicate” devices to remain available until the
FDA initiates and completes the PMA process. In order
to avoid the potentially monopolistic consequences of this
predicate-device exception, the MDA allows other manufac-
turers to distribute (also pending completion of the predicate
device’s PMA review) devices that are shown to be “substan-
tially equivalent” to a predicate device. § 360e(b)(1)(B).
Demonstrating that a device qualifies for this exception
is known as the “§ 510(k) process,” which refers to the sec-
tion of the original MDA containing this provision. Section
510(k) submissions must include the following: “Proposed
labels, labeling, and advertisements sufficient to describe the
device, its intended use, and the directions for its use,”
21 CFR § 807.87(e) (2000); “[a] statement indicating the de-
vice is similar to and/or different from other products of
comparable type in commercial distribution, accompanied by
data to support the statement,” § 807.87(f); “[a] statement
that the submitter believes, to the best of his or her knowl-
edge, that all data and information submitted in the pre-
market notification are truthful and accurate and that no
material fact has been omitted,” § 807.87(k); and “[a]ny addi-
tional information regarding the device requested by the
[FDA] Commissioner that is necessary for the Commissioner
to make a finding as to whether or not the device is substan-

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346 BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMM.
Opinion of the Court
tially equivalent to a device in commercial distribution,”
§ 807.87(l).
In 1984, AcroMed sought § 510(k) approval for its bone
screw device, indicating it for use in spinal surgery. See
In re Orthopedic Bone Screw Products Liability Litigation,
159 F. 3d 817, 820 (CA3 1998). The FDA denied approval
on the grounds that the Class III device lacked substantial
equivalence to a predicate device. See ibid. In September
1985, with the assistance of petitioner, AcroMed filed another
§ 510(k) application. “The application provided additional
information about the . . . device and again indicated its in-
tended use in spinal surgery. The FDA again rejected the
application, determining that the device was not substan-
tially equivalent to a predicate device and that it posed po-
tential risks not exhibited by other spinal-fixation systems.”
Ibid. In December 1985, AcroMed and petitioner filed a
third § 510(k) application.
“AcroMed and [petitioner] split the . . . device into its
component parts, renamed them ‘nested bone plates’ and
‘[cancellous] bone screws’ and filed a separate § 510(k)
application for each component. In both applications,
a new intended use was specified: rather than seeking
clearance for spinal applications, they sought clearance
to market the plates and screws for use in the long bones
of the arms and legs. AcroMed and Buckman claimed
that the two components were substantially equivalent
to predicate devices used in long bone surgery. The
FDA approved the devices for this purpose in February
1986.” Ibid.
Pursuant to its designation by the Judicial Panel on Multi-
district Litigation as the transferee court for In re: Ortho-
pedic Bone Screw Liability Litigation, MDL No. 1014, the
District Court for the Eastern District of Pennsylvania has
been the recipient of some 2,300 civil actions related to these
medical devices. Many of these actions include state-law

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347 Cite as: 531 U. S. 341 (2001)
Opinion of the Court
causes of action claiming that petitioner and AcroMed 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 and were subsequently
used to the plaintiffs’ detriment. The District Court dis-
missed these “fraud-on-the-FDA” claims, first on the ground
that they were expressly pre-empted by the MDA, and then,
after our decision in Medtronic, on the ground that these
claims amounted to an improper assertion of a private right
of action under the MDA.1 See 159 F. 3d, at 821.
A divided panel of the United States Court of Appeals for
the Third Circuit reversed, concluding that plaintiffs’ fraud
claims were neither expressly nor impliedly pre-empted.
We granted certiorari, 530 U. S. 1273 (2000), to resolve a split
among the Courts of Appeals on this question, see Kemp v.
Medtronic, Inc., 231 F. 3d 216, 233–236 (CA6 2000) (identify-
ing split and holding such claims expressly pre-empted), and
we now reverse.
II
Policing fraud against federal agencies is hardly “a field
which the States have traditionally occupied,” Rice v. Santa
Fe Elevator Corp., 331 U. S. 218, 230 (1947), such as to war-
rant a presumption against finding federal pre-emption of a
state-law cause of action. To the contrary, the relationship
between a federal agency and the entity it regulates is inher-
ently federal in character because the relationship originates
from, is governed by, and terminates according to federal
law. Cf. Boyle v. United Technologies Corp., 487 U. S. 500,
504–505 (1988) (allowing pre-emption of state law by federal
common law where the interests at stake are “uniquely fed-
eral” in nature). Here, petitioner’s dealings with the FDA
were prompted by the MDA, and the very subject matter
1 The District Court also determined that the plaintiffs’ fraud claims
failed for lack of proximate cause, see In re Orthopedic Bone Screw Prod-
ucts Liability Litigation, 159 F. 3d 817, 821 (CA3 1998), but that question
is not presently before us.

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348 BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMM.
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of petitioner’s statements were dictated by that statute’s
provisions. Accordingly—and in contrast to situations im-
plicating “federalism concerns and the historic primacy of
state regulation of matters of health and safety,” Medtronic,
518 U. S., at 485—no presumption against pre-emption ob-
tains in this case.
Given this analytical framework, we hold that the plain-
tiffs’ state-law fraud-on-the-FDA claims conflict with, and
are therefore impliedly pre-empted by, federal law.2 The
conflict stems from the fact that the federal statutory scheme
amply empowers the FDA to punish and deter fraud against
the Administration, and that this authority is used by the
Administration to achieve a somewhat delicate balance of
statutory objectives. The balance sought by the Adminis-
tration can be skewed by allowing fraud-on-the-FDA claims
under state tort law.
As described in greater detail above, the § 510(k) process
sets forth a comprehensive scheme for determining whether
an applicant has demonstrated that a product is substantially
equivalent to a predicate device. Among other information,
the applicant must submit to the FDA “[p]roposed labels,
labeling, and advertisements sufficient to describe the de-
vice, its intended use, and the directions for its use,” 21 CFR
§ 807.87(e) (2000), and a statement attesting to and explaining
the similarities to and/or differences from similar devices
(along with supporting data), see § 807.87(f). The FDA is
also empowered to require additional necessary information.
See § 807.87(l). Admittedly, the § 510(k) process lacks the
PMA review’s rigor: The former requires only a showing
of substantial equivalence to a predicate device, while the
latter involves a time-consuming inquiry into the risks and
efficacy of each device. Nevertheless, to achieve its limited
purpose, the § 510(k) process imposes upon applicants a vari-
ety of requirements that are designed to enable the FDA to
2 In light of this conclusion, we express no view on whether these claims
are subject to express pre-emption under 21 U. S. C. § 360k.

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make its statutorily required judgment as to whether the
device qualifies under this exception.
Accompanying these disclosure requirements are various
provisions aimed at detecting, deterring, and punishing false
statements made during this and related approval processes.
The FDA is empowered to investigate suspected fraud, see
21 U. S. C. § 372; 21 CFR § 5.35 (2000), and citizens may re-
port wrongdoing and petition the agency to take action,
§ 10.30. In addition to the general criminal proscription on
making false statements to the Federal Government, 18
U. S. C. § 1001 (1994 ed., Supp. V),3 the FDA may respond
to fraud by seeking injunctive relief, 21 U. S. C. § 332, and
civil penalties, 21 U. S. C. § 333(f)(1)(A); seizing the device,
§ 334(a)(2)(D); and pursuing criminal prosecutions, § 333(a).
The FDA 4 thus has at its disposal a variety of enforcement
options that allow it to make a measured response to sus-
pected fraud upon the Administration.
This flexibility is a critical component of the statutory and
regulatory framework under which the FDA pursues diffi-
cult (and often competing) objectives. For example, with
respect to Class III devices, the FDA simultaneously main-
tains the exhaustive PMA and the more limited § 510(k)
processes in order to ensure both that medical devices are
3 Title 18 U. S. C. § 1001(a) (1994 ed., Supp. V) provides: “[W]hoever, in
any matter within the jurisdiction of the executive, legislative, or judicial
branch of the Government of the United States, knowingly and willfully
falsifies, conceals or covers up by any trick, scheme, or device a material
fact; [or] makes any materially false, fictitious or fraudulent statement
or representation; or makes or uses any false writing or document know-
ing the same to contain any materially false, fictitious or fraudulent state-
ment or entry; shall be fined under this title or imprisoned not more than
5 years, or both.”
4 The FDCA leaves no doubt that it is the Federal Government rather
than private litigants who are authorized to file suit for noncompliance
with the medical device provisions: “[A]ll such proceedings for the enforce-
ment, or to restrain violations, of this chapter shall be by and in the name
of the United States.” 21 U. S. C. § 337(a).

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350 BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMM.
Opinion of the Court
reasonably safe and effective and that, if the device qualifies
under the § 510(k) exception, it is on the market within a
relatively short period of time. Similarly, “off-label” usage
of medical devices (use of a device for some other purpose
than that for which it has been approved by the FDA) is
an accepted and necessary corollary of the FDA’s mission to
regulate in this area without directly interfering with the
practice of medicine. See, e. g., Beck & Azari, FDA, Off-
Label Use, and Informed Consent: Debunking Myths and
Misconceptions, 53 Food & Drug L. J. 71, 76–77 (1998) (noting
that courts, several States, and the “FDA itself recogniz[e]
the value and propriety of off-label use”). Indeed, a recent
amendment to the FDCA expressly states in part that
“[n]othing in this chapter shall be construed to limit or inter-
fere with the authority of a health care practitioner to pre-
scribe or administer any legally marketed device to a patient
for any condition or disease within a legitimate health care
practitioner-patient relationship.” 21 U. S. C. § 396 (1994
ed., Supp. V). Thus, the FDA is charged with the difficult
task of regulating the marketing and distribution of medical
devices without intruding upon decisions statutorily com-
mitted to the discretion of health care professionals.
State-law fraud-on-the-FDA claims inevitably conflict with
the FDA’s responsibility to police fraud consistently with the
Administration’s judgment and objectives. As a practical
matter, complying with the FDA’s detailed regulatory re-
gime in the shadow of 50 States’ tort regimes will dramati-
cally increase the burdens facing potential applicants—bur-
dens not contemplated by Congress in enacting the FDCA
and the MDA. Would-be applicants may be discouraged
from seeking § 510(k) approval of devices with potentially
beneficial off-label uses for fear that such use might expose
the manufacturer or its associates (such as petitioner) to un-
predictable civil liability. In effect, then, fraud-on-the-FDA
claims could cause the Administration’s reporting require-
ments to deter off-label use despite the fact that the FDCA

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expressly disclaims any intent to directly regulate the prac-
tice of medicine, see 21 U. S. C. § 396 (1994 ed., Supp. V), and
even though off-label use is generally accepted.5
Conversely, fraud-on-the-FDA claims would also cause ap-
plicants to fear that their disclosures to the FDA, although
deemed appropriate by the Administration, will later be
judged insufficient in state court. Applicants would then
have an incentive to submit a deluge of information that the
Administration neither wants nor needs, resulting in addi-
tional burdens on the FDA’s evaluation of an application.
As a result, the comparatively speedy § 510(k) process could
encounter delays, which would, in turn, impede competition
among predicate devices and delay health care professionals’
ability to prescribe appropriate off-label uses.6
Respondent relies heavily on Silkwood v. Kerr-McGee
Corp., 464 U. S. 238 (1984), which it reads to “creat[e] a vir-
tually irrefutable presumption against implied preemption
of private damage remedies predicated on an alleged conflict
with a federal remedial scheme.” Brief for Respondent 34.
5 See Green & Schultz, Tort Law Deference to FDA Regulation of Medi-
cal Devices, 88 Geo. L. J. 2119, 2133 (2000) (“Physicians may prescribe
drugs and devices for off-label uses”); Smith, Physician Modification of
Legally Marketed Medical Devices: Regulatory Implications Under the
Federal Food, Drug, and Cosmetic Act, 55 Food & Drug L. J. 245, 251–252
(2000) (discussing off-label use in terms of the “practice of medicine doc-
trine[, which] stands firmly for the proposition that regulatory efforts are
directed primarily at device marketing by manufacturers, not device use
by physicians”); Beck & Azari, FDA, Off-Label Use, and Informed Con-
sent: Debunking Myths and Misconceptions, 53 Food & Drug L. J. 71, 72
(1998) (“Off-label use is widespread in the medical community and often is
essential to giving patients optimal medical care, both of which medical
ethics, FDA, and most courts recognize”).
6 In light of the likely impact that the fraud-on-the-FDA claims would
have on the administration of the Administration’s duties, we must reject
respondent’s contention that these claims “will . . . affect only the litigants
and will not have the kind of direct impact on the United States, which
preemption is designed to protect from undue incursion.” Brief for Re-
spondent 30 (citing Miree v. DeKalb County, 433 U. S. 25 (1977)).

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Silkwood is different from the present case, however, in
several respects. Silkwood’s claim was not based on any
sort of fraud-on-the-agency theory, but on traditional state
tort law principles of the duty of care owed by the producer
of plutonium fuel pins to an employee working in its plant.
See 464 U. S., at 241. Moreover, our decision there turned
on specific statutory evidence that Congress “disclaimed any
interest in promoting the development and utilization of
atomic energy by means that fail to provide adequate reme-
dies for those who are injured by exposure to hazardous
nuclear materials.” Id., at 257. In the present case, by
contrast, we have clear evidence that Congress intended that
the MDA be enforced exclusively by the Federal Govern-
ment. 21 U. S. C. § 337(a).
Respondent also suggests that we should be reluctant to
find a pre-emptive conflict here because Congress included
an express pre-emption provision in the MDA. See Brief
for Respondent 37. To the extent respondent posits that
anything other than our ordinary pre-emption principles
apply under these circumstances, that contention must fail
in light of our conclusion last Term in Geier v. American
Honda Motor Co., 529 U. S. 861 (2000), that neither an ex-
press pre-emption provision nor a saving clause “bar[s] the
ordinary working of conflict pre-emption principles.” Id.,
at 869.
We must also reject respondent’s attempt to characterize
both the claims at issue in Medtronic (common-law negli-
gence action against the manufacturer of an allegedly defec-
tive pacemaker lead) and the fraud claims here as “claims
arising from violations of FDCA requirements.” Brief for
Respondent 38. Notwithstanding the fact that Medtronic
did not squarely address the question of implied pre-emption,
it is clear that the Medtronic claims arose from the manu-
facturer’s alleged failure to use reasonable care in the pro-
duction of the product, not solely from the violation of FDCA
requirements. See 518 U. S., at 481. In the present case,

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353 Cite as: 531 U. S. 341 (2001)
Stevens, J., concurring in judgment
however, the fraud claims exist solely by virtue of the FDCA
disclosure requirements. Thus, although Medtronic can be
read to allow certain state-law causes of actions that parallel
federal safety requirements, it does not and cannot stand for
the proposition that any violation of the FDCA will support
a state-law claim.
In sum, were plaintiffs to maintain their fraud-on-the-
agency claims here, they would not be relying on traditional
state tort law which had predated the federal enactments
in questions. On the contrary, the existence of these federal
enactments is a critical element in their case. For the rea-
sons stated above, we think this sort of litigation would
exert an extraneous pull on the scheme established by Con-
gress, and it is therefore pre-empted by that scheme.
The judgment of the Court of Appeals is reversed.
It is so ordered.
Justice Stevens, with whom Justice Thomas joins,
concurring in the judgment.
As the Court points out, an essential link in the chain of
causation that respondent must prove in order to prevail is
that, but for petitioner’s fraud, the allegedly defective ortho-
pedic bone screws would not have reached the market. The
fact that the Food and Drug Administration (FDA) has done
nothing to remove the devices from the market, even though
it is aware of the basis for the fraud allegations, convinces
me that this essential element of the claim cannot be proved.
I therefore agree that the case should not proceed.1
1 Though my analysis focuses on the failure of the plaintiffs to establish
a necessary element of their claim, that failure is grounded not in the
minutiae of state law but in the details of the federal regulatory system
for medical devices. Therefore, while this case does not fit neatly into
our pre-existing pre-emption jurisprudence, it is accurate, in a sense, to
say that federal law “pre-empts” this state-law fraud-on-the-FDA claim
because the FDA has not acknowledged such a fraud and taken steps to
remove the device from the market.

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354 BUCKMAN CO. v. PLAINTIFFS’ LEGAL COMM.
Stevens, J., concurring in judgment
This would be a different case if, prior to the instant liti-
gation, the FDA had determined that petitioner had com-
mitted fraud during the § 510(k) process and had then taken
the necessary steps to remove the harm-causing product
from the market. Under those circumstances, respondent’s
state-law fraud claim would not depend upon speculation as
to the FDA’s behavior in a counterfactual situation but
would be grounded in the agency’s explicit actions. In such
a case, a plaintiff would be able to establish causation with-
out second-guessing the FDA’s decisionmaking or overbur-
dening its personnel, thereby alleviating the Government’s
central concerns regarding fraud-on-the-agency claims.
If the FDA determines both that fraud has occurred and
that such fraud requires the removal of a product from the
market, state damages remedies would not encroach upon,
but rather would supplement and facilitate, the federal en-
forcement scheme. Cf. Medtronic, Inc. v. Lohr, 518 U. S.
470, 495 (1996) (holding that the presence of a state-law dam-
ages remedy for violations of FDA requirements does not
impose an additional requirement upon medical device manu-
facturers but “merely provides another reason for manufac-
turers to comply with . . . federal law”); id., at 513 (O’Con-
nor, J., concurring in part and dissenting in part) (same).2
2 Though the United States in this case appears to take the position that
fraud-on-the-FDA claims conflict with the federal enforcement scheme
even when the FDA has publicly concluded that it was defrauded and
taken all the necessary steps to remove a device from the market, see
Brief for United States as Amicus Curiae 24, 30, that has not always been
its position. As recently as 1994, the United States took the position that
state-law tort suits alleging fraud in FDA applications for medical devices
do not conflict with federal law where the FDA has “subsequently con-
cluded” that the device in question never met the appropriate federal
requirements and “initiated enforcement actions” against those respon-
sible for fraudulently obtaining its approval. Brief for United States
as Amicus Curiae in Talbott v. C. R. Bard, Inc., No. 94–1951 (CA1), re-
printed in App. to Pet. for Cert. in Talbott v. C. R. Bard., Inc., O. T. 1995,
No. 95–1321, p. 84a.

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355 Cite as: 531 U. S. 341 (2001)
Stevens, J., concurring in judgment
Under the pre-emption analysis the Court offers today,
however, parties injured by fraudulent representations to
federal agencies would have no remedy even if recognizing
such a remedy would have no adverse consequences upon the
operation or integrity of the regulatory process. I do not
believe the reasons advanced in the Court’s opinion support
the conclusion that Congress intended such a harsh result.
Cf. Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 251 (1984)
(declining to infer that a federal statutory scheme that af-
fords no alternative means of seeking redress pre-empted
traditional state-law remedies). For that reason, although
I concur in the Court’s disposition of this case, I do not join
its opinion.