Brief of Buckman Co. v. Plantiffs' Legal Committee, 121 S.Ct. 1012, 148 L.Ed.2d 854 (U.S. 2001)
|||SUPREME COURT OF THE UNITED STATES
|||February 21, 2001
|||BUCKMAN COMPANY, PETITIONER
PLAINTIFFS' LEGAL COMMITTEE
|||SYLLABUS BY THE COURT
|||OCTOBER TERM, 2000
|||BUCKMAN CO. v. PLAINTIFFS' LEGAL COMM.
|||NOTE: Where it is feasible, a syllabus (headnote) will be released, as
is being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
|||SUPREME COURT OF THE UNITED STATES
|||BUCKMAN CO. v. PLAINTIFFS' LEGAL COMMITTEE
|||Certiorari To The United States Court Of Appeals For The Third Circuit
|||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 assisted
the screws' manufacturer in securing approval for the devices from the Food
and Drug Administration (FDA or Agency), 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
|||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.
|||(a) The relationship between a federal agency and the entity it regulates
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 Agency, and the Agency 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) process lacks
the PMA review's rigor, the former does set forth a comprehensive scheme
for determining substantial equivalence with a predicate device. Other provisions
give the FDA enforcement options that allow it to make a measured response
to suspected fraud upon the Agency. This flexibility is a critical component
of the framework under which the FDA pursues its difficult (and often competing)
objectives of regulating medical device marketing and distribution without
intruding upon decisions committed by the FDCA to health care professionals.
|||(b) State-law fraud-on-the-FDA claims inevitably conflict with the FDA's
responsibility to police fraud consistently with the Agency's judgment and
objectives. Complying with the FDA's detailed regulatory regime in the shadow
of 50 States' tort regimes will dramatically increase the burdens facing
potential applicants, who might be deterred 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 Agency 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&nbhyph;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. 8-11.
|||159 F. 3d 817, reversed.
|||Rehnquist, C. J., delivered the opinion of the Court, in which O'Connor,
Scalia, Kennedy, Souter, Ginsburg, and Breyer, JJ., joined. Stevens, J.,
filed an opinion concurring in the judgment, in which Thomas, J., joined.
|||Court below: 159 F.3d 817
|||Kenneth S. Geller argued the cause for petitioner. With him on the briefs
were Alan E. Untereiner and Sharon Swingle. 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, Douglas 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. Duggan,
and John J. Cummings III. Briefs of amici curiae urging reversal were filed
for the Medical Device 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.
|||The opinion of the court was delivered by: Chief Justice Rehnquist
|||On Writ Of Certiorari To The United States Court Of Appeals For The Third
|||Respondent represents plaintiffs who claim injuries resulting from the
use of orthopedic bone screws in the pedicles 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 Agency) 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 representations not been
made, the FDA would not have approved the devices, and plaintiffs would
not have been injured. Plaintiffs sought damages from petitioner under state
tort law. 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.
|||Regulation of medical devices is governed by the two Acts just named.
The MDA separates devices into three categories: 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
|||Class III devices must complete a thorough review process with the FDA
before they may be marketed. This premarket approval (PMA) process requires
the applicant to demonstrate a "reasonable assurance" that the
device is both "safe ... [and] effective under the conditions of use
prescribed, 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 labeling
proposed to be used for such device," §360e(c)(1)(F). The PMA process
is ordinarily quite time consuming because 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 Energy & 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 enactment 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 manufacturers to distribute (also pending completion of the predicate
device's PMA review) devices that are shown to be "substantially 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 section 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 device 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
knowledge, that all data and information submitted in the premarket notification
are truthful and accurate and that no material fact has been omitted,"
§807.87(k); and "[a]ny additional 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 substantially 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 use
in spinal surgery. The FDA again rejected the application, determining that
the device was not substantially equivalent to a predicate device and that
it posed potential 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 Multidistrict Litigation
as the transferee court for In re: Orthopedic 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 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 dismissed 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.*fn1 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. ___ (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) (identifying split and
holding such claims expressly pre-empted), and we now reverse.
|||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 warrant 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
inherently 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
federal" in nature). Here, petitioner's dealings with the FDA were
prompted by the MDA, and the very subject matter of petitioner's statements
were dictated by that statute's provisions. Accordingly -- and in contrast
to situations implicating "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 obtains in this case.
|||Given this analytical framework, we hold that the plaintiffs' state-law
fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted
by federal law.*fn2 The conflict stems
from the fact that the federal statutory scheme amply empowers the FDA to
punish and deter fraud against the Agency, and that this authority is used
by the Agency to achieve a somewhat delicate balance of statutory objectives.
The balance sought by the Agency 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 device,
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 variety of requirements that
are designed to enable the FDA to 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 report
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. IV),*fn3
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*fn4
thus has at its disposal a variety of enforcement options that allow it
to make a measured response to suspected fraud upon the Agency.
|||This flexibility is a critical component of the statutory and regulatory
framework under which the FDA pursues difficult (and often competing) objectives.
For example, with respect to Class III devices, the FDA simultaneously maintains
the exhaustive PMA and the more limited §510(k) processes in order to ensure
both that medical devices are 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 interfere with the authority
of a health care practitioner to prescribe 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. IV). Thus, the FDA is charged with the difficult task of regulating
the marketing and distribution of medical devices without intruding upon
decisions statutorily committed 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 Agency's judgment and objectives.
As a practical matter, complying with the FDA's detailed regulatory regime
in the shadow of 50 States' tort regimes will dramatically increase the
burdens facing potential applicants -- burdens 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 unpredictable civil liability. In effect, then,
fraud-on-the-FDA claims could cause the Agency's reporting requirements
to deter off-label use despite the fact that the FDCA expressly disclaims
any intent to directly regulate the practice of medicine, see 21 U. S. C.
§396 (1994 ed., Supp. IV), and even though off-label use is generally accepted.*fn5
|||Conversely, fraud-on-the-FDA claims would also cause applicants to fear
that their disclosures to the FDA, although deemed appropriate by the Agency,
will later be judged insufficient in state court. Applicants would then
have an incentive to submit a deluge of information that the Agency neither
wants nor needs, resulting in additional 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
|||Respondent relies heavily on Silkwood v. Kerr&nbhyph;McGee Corp.,
464 U. S. 238 (1984), which it reads to "creat[e] a virtually irrefutable
presumption against implied preemption of private damage remedies predicated
on an alleged conflict with a federal remedial scheme." Brief for Respondent
34. 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
remedies 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 Government.
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 express 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 negligence action against the manufacturer
of an allegedly defective 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 manufacturer's alleged failure to use reasonable care in the production
of the product, not solely from the violation of FDCA requirements. See
518 U. S., at 481. In the present case, 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 reasons
stated above, we think this sort of litigation would exert an extraneous
pull on the scheme established by Congress, and it is therefore pre-empted
by that scheme.
|||The judgment of the Court of Appeals is reversed.
|||It is so ordered.
|||Stevens, J., conrurring in judgment
|||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 orthopedic 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
|||This would be a different case if, prior to the instant litigation, the
FDA had determined that petitioner had committed 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
without second-guessing the FDA's decisionmaking or overburdening its personnel,
thereby alleviating the Government's central concerns regarding fraud-on-the-agency
|||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 enforcement scheme. Cf. Medtronic, Inc. v. Lohr, 518 U. S. 470,
495 (1996) (holding that the presence of a state-law damages remedy for
violations of FDA requirements does not impose an additional requirement
upon medical device manufacturers but "merely provides another reason
for manufacturers to comply with . . . federal law"); id., at 513 (O'Connor,
J., concurring in part and dissenting in part) (same).*fn8
|||Under the preemption 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 affords no alternative means of seeking redress preempted traditional
state-law remedies). For that reason, although I concur in the Court's disposition
of this case, I do not join its opinion.
|||*fn1 The District Court also determined
that the plaintiffs' fraud claims failed for lack of proximate cause, see
In re Orthopedic Bone Screw Products Liability Litigation, 159 F. 3d 817,
821 (CA3 1998), but that question is not presently before us.
|||*fn2 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.
|||*fn3 18 U. S. C. §1001(a) (1994 ed.,
Supp. IV) 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 statements or representation; or makes or
uses any false writing or document knowing the same to contain any materially
false, fictitious or fraudulent statement or entry; shall be fined under
this title or imprisoned not more than 5 years, or both."
|||*fn4 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 enforcement, or to restrain violations, of this
chapter shall be by and in the name of the United States." 21 U. S.
|||*fn5 See Green & Schultz, Tort Law
Deference to FDA Regulation of Medical 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 doctrine[, 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 Consent: 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").
|||*fn6 In light of the likely impact that
the fraud-on-the-FDA claims would have on the administration of the Agency'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 Respondent 30 (citing Miree v. DeKalb County,
433 U. S. 25 (1977)).
|||*fn7 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 preemption jurisprudence,
it is accurate, in a sense, to say that federal law "preempts"
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.
|||*fn8 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
concluded" that the device in question never met the appropriate federal
requirements and "initiated enforcement actions" against those
responsible for fraudulently obtaining its approval. Brief for United States
as Amicus Curiae in Talbott v. C. R. Bard, Inc., No. 94-1951 (CA1), reprinted
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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