RIEGEL, individually and as administrator of ESTATE OF RIEGEL v. MEDTRONIC, INC.

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312 OCTOBER TERM, 2007
Syllabus
RIEGEL, individually and as administrator of
ESTATE OF RIEGEL v. MEDTRONIC, INC.
certiorari to the united states court of appeals for
the second circuit
No. 06–179. Argued December 4, 2007—Decided February 20, 2008
The Medical Device Amendments of 1976 (MDA) created a scheme of fed
eral safety oversight for medical devices while sweeping back state
oversight schemes. The statute provides that a State shall not “estab
lish or continue 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 [federal law] 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”
relevant federal law. 21 U. S. C. § 360k(a). The MDA calls for federal
oversight of medical devices that varies with the type of device at issue.
The most extensive oversight is reserved for Class III devices that un
dergo the premarket approval process. These devices may enter the
market only if the Food and Drug Administration (FDA) reviews their
design, labeling, and manufacturing specifications and determines that
those specifications provide a reasonable assurance of safety and effec
tiveness. Manufacturers may not make changes to such devices that
would affect safety or effectiveness unless they first seek and obtain
permission from the FDA.
Charles Riegel and his wife, petitioner Donna Riegel, brought suit
against respondent Medtronic after a Medtronic catheter ruptured in
Charles Riegel’s coronary artery during heart surgery. The catheter is
a Class III device that received FDA premarket approval. The Riegels
alleged that the device was designed, labeled, and manufactured in a
manner that violated New York common law. The District Court held
that the MDA pre-empted the Riegels’ claims of strict liability; breach
of implied warranty; and negligence in the design, testing, inspection,
distribution, labeling, marketing, and sale of the catheter, and their
claim of negligent manufacturing insofar as the claim was not premised
on the theory that Medtronic had violated federal law. The Second Cir
cuit affirmed.
Held: The MDA’s pre-emption clause bars common-law claims challenging
the safety or effectiveness of a medical device marketed in a form that
received premarket approval from the FDA. Pp. 321–330.

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Syllabus
(a) The Federal Government has established “requirement[s] appli
cable . . . to” Medtronic’s catheter within § 360k(a)(1)’s meaning. In
Medtronic, Inc. v. Lohr, 518 U. S. 470, 495, 500–501, the Court inter
preted the MDA’s pre-emption provision in a manner “substantially in
formed” by an FDA regulation, 21 CFR § 808.1(d), which says that state
requirements are pre-empted only when the FDA “has established spe
cific counterpart regulations or there are other specific requirements
applicable to a particular device” under federal law. Premarket ap
proval imposes “specific requirements applicable to a particular device.”
The FDA requires that a device that has received premarket approval
be marketed without significant deviations from the specifications in the
device’s approval application, for the reason that the FDA has deter
mined that those specifications provide a reasonable assurance of safety
and effectiveness. Pp. 321–323.
(b) Petitioner’s common-law claims are pre-empted because they are
based upon New York “requirement[s]” with respect to Medtronic’s
catheter that are “different from, or in addition to,” the federal ones,
and that relate to safety and effectiveness, § 360k(a). Pp. 323–330.
(1) Common-law negligence and strict-liability claims impose “re
quirement[s]” under the ordinary meaning of that term, see, e. g., Lohr,
supra, at 503–505, 512; Cipollone v. Liggett Group, Inc., 505 U. S. 504,
521–523, 548–549. There is nothing in the MDA that contradicts this
normal meaning. Pp. 323–325.
(2) The Court rejects petitioner’s contention that the duties under
lying her state-law tort claims are not pre-empted because general
common-law duties are not requirements maintained “with respect to
devices.” Petitioner’s suit depends upon New York’s “continu[ing] in
effect” general tort duties “with respect to” Medtronic’s catheter. Title
21 CFR § 808.1(d)(1)—which states that MDA pre-emption does not ex
tend to “[s]tate or local requirements of general applicability [whose]
purpose . . . relates either to other products in addition to devices . . .
or to unfair trade practices in which the requirements are not limited
to devices”—does not alter the Court’s interpretation. Pp. 327–330.
(c) The Court declines to address in the first instance petitioner’s ar
gument that this lawsuit raises “parallel” claims that are not pre-empted
by § 360k under Lohr, supra, at 495, 513. P. 330.
451 F. 3d 104, affirmed.
Scalia, J., delivered the opinion of the Court, in which Roberts, C. J.,
and Kennedy, Souter, Thomas, Breyer, and Alito, JJ., joined, and in
which Stevens, J., joined except for Parts III–A and III–B. Stevens,
J., filed an opinion concurring in part and concurring in the judgment, post,
p. 330. Ginsburg, J., filed a dissenting opinion, post, p. 333.

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314 RIEGEL v. MEDTRONIC, INC.
Counsel
Allison M. Zieve argued the cause for petitioner. With
her on the briefs were Brian Wolfman, Scott L. Nelson, and
Wayne P. Smith.
Theodore B. Olson argued the cause for respondent.
With him on the brief were Matthew D. McGill, Amir C.
Tayrani, Kenneth S. Geller, David M. Gossett, and Andrew
E. Tauber.
Deputy Solicitor General Kneedler argued the cause for
the United States as amicus curiae urging affirmance.
With him on the brief were Solicitor General Clement, As
sistant Attorney General Keisler, Daryl Joseffer, Douglas
N. Letter, Sharon Swingle, and Daniel Meron.*
*Briefs of amici curiae urging reversal were filed for the State of New
York et al. by Andrew M. Cuomo, Attorney General of New York, Barbara
D. Underwood, Solicitor General, Michelle Aronowitz, Deputy Solicitor
General, and Richard Dearing and Cecelia Chang, Assistant Solicitors
General, and by the Attorneys General for their respective jurisdictions
as follows: Terry Goddard of Arizona, Dustin McDaniel of Arkansas,
Richard Blumenthal of Connecticut, Joseph R. Biden III of Delaware,
Linda Singer of the District of Columbia, Bill McCollum of Florida, Mark
J. Bennett of Hawaii, Lawrence G. Wasden of Idaho, Lisa Madigan of Illi
nois, Tom Miller of Iowa, Paul J. Morrison of Kansas, Douglas F. Gansler
of Maryland, Martha Coakley of Massachusetts, Lori Swanson of Minne
sota, Jim Hood of Mississippi, Jeremiah W. (Jay) Nixon of Missouri, Mike
McGrath of Montana, Catherine Cortez Masto of Nevada, Gary K. King
of New Mexico, Wayne Stenehjem of North Dakota, Marc Dann of Ohio,
Hardy Myers of Oregon, Henry D. McMaster of South Carolina, Robert E.
Cooper, Jr., of Tennessee, Mark L. Shurtleff of Utah, William H. Sorrell
of Vermont, Rob McKenna of Washington, Darrell V. McGraw, Jr., of
West Virginia, J. B. Van Hollen of Wisconsin, and Patrick J. Crank of
Wyoming; for AARP et al. by David C. Frederick and Brendan J. Crim
mins; for the American Association for Justice et al. by Jeffrey Robert
White and Kathleen Flynn Peterson; for the Consumers Union of United
States, Inc., by Lisa Heinzerling and Mark Savage; for the Public Health
Advocacy Institute et al. by Timothy J. Dowling; and for Senator Edward
M. Kennedy et al. by William B. Schultz.
Briefs of amici curiae urging affirmance were filed for the Advanced
Medical Technology Association et al. by Carter G. Phillips, Daniel E.
Troy, Rebecca K. Wood, Eamon P. Joyce, Michael W. Davis, Paul J. Malo
ney, and William J. Carter; for the Chamber of Commerce of the United

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315 Cite as: 552 U. S. 312 (2008)
Opinion of the Court
Justice Scalia delivered the opinion of the Court.
We consider whether the pre-emption clause enacted in
the Medical Device Amendments of 1976, 21 U. S. C. § 360k,
bars common-law claims challenging the safety and effective
ness of a medical device given premarket approval by the
Food and Drug Administration (FDA).
I
A
The Federal Food, Drug, and Cosmetic Act (FDCA), 52
Stat. 1040, as amended, 21 U. S. C. § 301 et seq., has long re
quired FDA approval for the introduction of new drugs into
the market. Until the statutory enactment at issue here,
however, the introduction of new medical devices was left
largely for the States to supervise as they saw fit. See Med
tronic, Inc. v. Lohr, 518 U. S. 470, 475–476 (1996).
The regulatory landscape changed in the 1960’s and 1970’s,
as complex devices proliferated and some failed. Most nota
bly, the Dalkon Shield intrauterine device, introduced in
1970, was linked to serious infections and several deaths, not
to mention a large number of pregnancies. Thousands of
tort claims followed. R. Bacigal, The Limits of Litigation:
The Dalkon Shield Controversy 3 (1990). In the view of
many, the Dalkon Shield failure and its aftermath demon
strated the inability of the common-law tort system to man
age the risks associated with dangerous devices. See, e. g.,
S. Foote, Managing the Medical Arms Race 151–152 (1992).
Several States adopted regulatory measures, including Cali
fornia, which in 1970 enacted a law requiring premarket
approval of medical devices. 1970 Cal. Stats. ch. 1573,
States of America by Alan Untereiner, Robin S. Conrad, and Amar D.
Sarwal; for CropLife America et al. by Lawrence S. Ebner and Douglas
T. Nelson; for the Product Liability Advisory Council, Inc., by Robert N.
Weiner; and for the Washington Legal Foundation by Daniel J. Popeo and
Richard A. Samp.

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§§ 26670–26693; see also Leflar & Adler, The Preemption
Pentad: Federal Preemption of Products Liability Claims
After Medtronic, 64 Tenn. L. Rev. 691, 703, n. 66 (1997) (iden
tifying 13 state statutes governing medical devices as of
1976).
Congress stepped in with passage of the Medical Device
Amendments of 1976 (MDA), 21 U. S. C. § 360c et seq.,1 which
swept back some state obligations and imposed a regime of
detailed federal oversight. The MDA includes an express
pre-emption provision that states:
“Except as provided in subsection (b) of this section,
no State or political subdivision of a State may establish
or continue in effect with respect to a device intended
for human use any requirement—
“(1) which is different from, or in addition to, any re
quirement 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.” § 360k(a).
The exception contained in subsection (b) permits the FDA
to exempt some state and local requirements from
pre-emption.
The new regulatory regime established various levels of
oversight for medical devices, depending on the risks they
present. Class I, which includes such devices as elastic
bandages and examination gloves, is subject to the lowest
level of oversight: “general controls,” such as labeling re
quirements. § 360c(a)(1)(A); FDA, Device Advice: Device
Classes, http://www.fda.gov/cdrh/devadvice/3132.html (all In
ternet materials as visited Feb. 14, 2008, and available
in Clerk of Court’s case file). Class II, which includes such
devices as powered wheelchairs and surgical drapes, ibid.,
1 Unqualified § 360 et seq. numbers hereinafter refer to sections of 21
U. S. C.

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is subject in addition to “special controls” such as per
formance standards and postmarket surveillance measures,
§ 360c(a)(1)(B).
The devices receiving the most federal oversight are those
in Class III, which include replacement heart valves,
implanted cerebella stimulators, and pacemaker pulse gen
erators, FDA, Device Advice: Device Classes, supra. In
general, a device is assigned to Class III if it cannot be
established that a less stringent classification would provide
reasonable assurance of safety and effectiveness, and the
device is “purported or represented to be for a use in sup
porting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human
health,” or “presents a potential unreasonable risk of illness
or injury.” § 360c(a)(1)(C)(ii).
Although the MDA established a rigorous regime of pre
market approval for new Class III devices, it grandfathered
many that were already on the market. Devices sold before
the MDA’s effective date may remain on the market until the
FDA promulgates, after notice and comment, a regulation
requiring premarket approval. §§ 360c(f)(1), 360e(b)(1). A
related provision seeks to limit the competitive advantage
grandfathered devices receive. A new device need not un
dergo premarket approval if the FDA finds it is “substan
tially equivalent” to another device exempt from premarket
approval. § 360c(f)(1)(A). The agency’s review of devices
for substantial equivalence is known as the § 510(k) process,
named after the statutory provision describing the review.
Most new Class III devices enter the market through
§ 510(k). In 2005, for example, the FDA authorized the mar
keting of 3,148 devices under § 510(k) and granted premarket
approval to just 32 devices. P. Hutt, R. Merrill, & L. Gross
man, Food and Drug Law 992 (3d ed. 2007).
Premarket approval is a “rigorous” process. Lohr, supra,
at 477. A manufacturer must submit what is typically a
multivolume application. FDA, Device Advice—Premar

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ket Approval (PMA) 18, http://www.fda.gov/cdrh/devadvice/
pma/printer.html. It includes, among other things, full re
ports of all studies and investigations of the device’s safety
and effectiveness that have been published or should reason
ably be known to the applicant; a “full statement” of the de
vice’s “components, ingredients, and properties and of the
principle or principles of operation”; “a full description of the
methods used in, and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing and in
stallation of, such device”; samples or device components re
quired by the FDA; and a specimen of the proposed labeling.
§ 360e(c)(1). Before deciding whether to approve the appli
cation, the agency may refer it to a panel of outside experts,
21 CFR § 814.44(a) (2007), and may request additional data
from the manufacturer, § 360e(c)(1)(G).
The FDA spends an average of 1,200 hours reviewing each
application, Lohr, 518 U. S., at 477, and grants premarket ap
proval only if it finds there is a “reasonable assurance” of the
device’s “safety and effectiveness,” § 360e(d). The agency
must “weig[h] any probable benefit to health from the use of
the device against any probable risk of injury or illness from
such use.” § 360c(a)(2)(C). It may thus approve devices
that present great risks if they nonetheless offer great bene
fits in light of available alternatives. It approved, for exam
ple, under its Humanitarian Device Exemption procedures, a
ventricular assist device for children with failing hearts,
even though the survival rate of children using the device
was less than 50 percent. FDA, Center for Devices and Ra
diological Health, Debakey VAD Child Left Ventricular As
sist System-H030003, Summary of Safety and Probable Ben
efit 20 (2004), http://www.fda.gov/cdrh/pdf3/H030003b.pdf.
The premarket approval process includes review of the
device’s proposed labeling. The FDA evaluates safety and
effectiveness under the conditions of use set forth on the
label, § 360c(a)(2)(B), and must determine that the proposed
labeling is neither false nor misleading, § 360e(d)(1)(A).

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After completing its review, the FDA may grant or deny
premarket approval. § 360e(d). It may also condition ap
proval on adherence to performance standards, 21 CFR
§ 861.1(b)(3), restrictions upon sale or distribution, or com
pliance with other requirements, § 814.82. The agency is
also free to impose device-specific restrictions by regula
tion. § 360j(e)(1).
If the FDA is unable to approve a new device in its pro
posed form, it may send an “approvable letter” indicating
that the device could be approved if the applicant submitted
specified information or agreed to certain conditions or re
strictions. 21 CFR § 814.44(e). Alternatively, the agency
may send a “not approvable” letter, listing the grounds
that justify denial and, where practical, measures that the
applicant could undertake to make the device approvable.
§ 814.44(f).
Once a device has received premarket approval, the MDA
forbids the manufacturer to make, without FDA permission,
changes in design specifications, manufacturing processes, la
beling, or any other attribute, that would affect safety or
effectiveness. § 360e(d)(6)(A)(i). If the applicant wishes to
make such a change, it must submit, and the FDA must ap
prove, an application for supplemental premarket approval,
to be evaluated under largely the same criteria as an initial
application. § 360e(d)(6); 21 CFR § 814.39(c).
After premarket approval, the devices are subject to re
porting requirements. § 360i. These include the obligation
to inform the FDA of new clinical investigations or scientific
studies concerning the device which the applicant knows of
or reasonably should know of, 21 CFR § 814.84(b)(2), and to
report incidents in which the device may have caused or con
tributed to death or serious injury, or malfunctioned in a
manner that would likely cause or contribute to death or se
rious injury if it recurred, § 803.50(a). The FDA has the
power to withdraw premarket approval based on newly re
ported data or existing information and must withdraw ap

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proval if it determines that a device is unsafe or ineffective
under the conditions in its labeling. § 360e(e)(1); see also
§ 360h(e) (recall authority).
B
Except as otherwise indicated, the facts set forth in this
section appear in the opinion of the Court of Appeals. The
device at issue is an Evergreen Balloon Catheter marketed
by defendant-respondent Medtronic, Inc. It is a Class III
device that received premarket approval from the FDA in
1994; changes to its label received supplemental approvals in
1995 and 1996.
Charles Riegel underwent coronary angioplasty in 1996,
shortly after suffering a myocardial infarction. App. to Pet.
for Cert. 56a. His right coronary artery was diffusely dis
eased and heavily calcified. Riegel’s doctor inserted the Ev
ergreen Balloon Catheter into his patient’s coronary artery
in an attempt to dilate the artery, although the device’s label
ing stated that use was contraindicated for patients with dif
fuse or calcified stenoses. The label also warned that the
catheter should not be inflated beyond its rated burst pres
sure of eight atmospheres. Riegel’s doctor inflated the cath
eter five times, to a pressure of 10 atmospheres; on its fifth
inflation, the catheter ruptured. Complaint 3. Riegel de
veloped a heart block, was placed on life support, and under
went emergency coronary bypass surgery.
Riegel and his wife Donna brought this lawsuit in April
1999, in the United States District Court for the Northern
District of New York. Their complaint alleged that Med
tronic’s catheter was designed, labeled, and manufactured in
a manner that violated New York common law, and that
these defects caused Riegel to suffer severe and permanent
injuries. The complaint raised a number of common-law
claims. The District Court held that the MDA pre-empted
Riegel’s claims of strict liability; breach of implied warranty;
and negligence in the design, testing, inspection, distribu
tion, labeling, marketing, and sale of the catheter. App. to

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Pet. for Cert. 68a; Complaint 3–4. It also held that the
MDA pre-empted a negligent manufacturing claim insofar as
it was not premised on the theory that Medtronic violated
federal law. App. to Pet. for Cert. 71a. Finally, the court
concluded that the MDA pre-empted Donna Riegel’s claim
for loss of consortium to the extent it was derivative of the
pre-empted claims. Id., at 68a; see also id., at 75a.2
The United States Court of Appeals for the Second Circuit
affirmed these dismissals. 451 F. 3d 104 (2006). The court
concluded that Medtronic was “clearly subject to the federal,
device-specific requirement of adhering to the standards con
tained in its individual, federally approved” premarket ap
proval application. Id., at 118. The Riegels’ claims were
pre-empted because they “would, if successful, impose state
requirements that differed from, or added to,” the device
specific federal requirements. Id., at 121. We granted cer
tiorari.3 551 U. S. 1144 (2007).
II
Since the MDA expressly pre-empts only state require
ments “different from, or in addition to, any requirement
applicable . . . to the device” under federal law, § 360k(a)(1),
we must determine whether the Federal Government has
established requirements applicable to Medtronic’s cathe
ter. If so, we must then determine whether the Riegels’
2 The District Court later granted summary judgment to Medtronic on
those claims of Riegel it had found not pre-empted, viz., that Medtronic
breached an express warranty and was negligent in manufacturing
because it did not comply with federal standards. App. to Pet. for Cert.
90a. It consequently granted summary judgment as well on Donna Rie
gel’s derivative consortium claim. Ibid. The Court of Appeals affirmed
these determinations, and they are not before us.
3 Charles Riegel having died, Donna Riegel is now petitioner on her own
behalf and as administrator of her husband’s estate. Post, p. 804. For
simplicity’s sake, the terminology of our opinion draws no distinction be
tween Charles Riegel and the Estate of Charles Riegel and refers to the
claims as belonging to the Riegels.

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common-law claims are based upon New York requirements
with respect to the device that are “different from, or in ad
dition to,” the federal ones, and that relate to safety and
effectiveness. § 360k(a).
We turn to the first question. In Lohr, a majority of this
Court interpreted the MDA’s pre-emption provision in a
manner “substantially informed” by the FDA regulation set
forth at 21 CFR § 808.1(d). 518 U. S., at 495; see also id., at
500–501. That regulation says that state requirements are
pre-empted “only when the Food and Drug Administra
tion has established specific counterpart regulations or there
are other specific requirements applicable to a particular
device . . . .” 21 CFR § 808.1(d). Informed by the regula
tion, we concluded that federal manufacturing and labeling
requirements applicable across the board to almost all medi
cal devices did not pre-empt the common-law claims of neg
ligence and strict liability at issue in Lohr. The federal
requirements, we said, were not requirements specific to
the device in question—they reflected “entirely generic con
cerns about device regulation generally.” 518 U. S., at 501.
While we disclaimed a conclusion that general federal re
quirements could never pre-empt, or general state duties
never be pre-empted, we held that no pre-emption occurred
in the case at hand based on a careful comparison between
the state and federal duties at issue. Id., at 500–501.
Even though substantial-equivalence review under § 510(k)
is device specific, Lohr also rejected the manufacturer’s con
tention that § 510(k) approval imposed device-specific “re
quirements.” We regarded the fact that products entering
the market through § 510(k) may be marketed only so long as
they remain substantial equivalents of the relevant pre-1976
devices as a qualification for an exemption rather than a re
quirement. Id., at 493–494; see also id., at 513 (O’Connor,
J., concurring in part and dissenting in part).
Premarket approval, in contrast, imposes “requirements”
under the MDA as we interpreted it in Lohr. Unlike gen

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eral labeling duties, premarket approval is specific to individ
ual devices. And it is in no sense an exemption from federal
safety review—it is federal safety review. Thus, the attri
butes that Lohr found lacking in § 510(k) review are pres
ent here. While § 510(k) is “ ‘focused on equivalence, not
safety,’ ” id., at 493 (opinion of the Court), premarket ap
proval is focused on safety, not equivalence. While devices
that enter the market through § 510(k) have “never been for
mally reviewed under the MDA for safety or efficacy,” ibid.,
the FDA may grant premarket approval only after it deter
mines that a device offers a reasonable assurance of safety
and effectiveness, § 360e(d). And while the FDA does not
“ ‘require’ ” that a device allowed to enter the market as a
substantial equivalent “take any particular form for any par
ticular reason,” 518 U. S., at 493, the FDA requires a device
that has received premarket approval to be made with al
most no deviations from the specifications in its approval ap
plication, for the reason that the FDA has determined that
the approved form provides a reasonable assurance of safety
and effectiveness.
III
We turn, then, to the second question: whether the Rie
gels’ common-law claims rely upon “any requirement” of
New York law applicable to the catheter that is “different
from, or in addition to,” federal requirements and that “re
lates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the de
vice.” § 360k(a). Safety and effectiveness are the very sub
jects of the Riegels’ common-law claims, so the critical issue
is whether New York’s tort duties constitute “requirements”
under the MDA.
A
In Lohr, five Justices concluded that common-law causes
of action for negligence and strict liability do impose “re
quirement[s]” and would be pre-empted by federal require

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ments specific to a medical device. See 518 U. S., at 512
(opinion of O’Connor, J., joined by Rehnquist, C. J., and
Scalia and Thomas, JJ.); id., at 503–505 (Breyer, J., con
curring in part and concurring in judgment). We adhere to
that view. In interpreting two other statutes we have like
wise held that a provision pre-empting state “requirements”
pre-empted common-law duties. Bates v. Dow Agrosciences
LLC, 544 U. S. 431 (2005), found common-law actions to be
pre-empted by a provision of the Federal Insecticide, Fungi
cide, and Rodenticide Act that said certain States “ ‘shall not
impose or continue in effect any requirements for labeling
or packaging in addition to or different from those required
under this subchapter.’ ” Id., at 443 (discussing 7 U. S. C.
§ 136v(b); emphasis added). Cipollone v. Liggett Group,
Inc., 505 U. S. 504 (1992), held common-law actions pre
empted by a provision of the Public Health Cigarette Smok
ing Act of 1969, 15 U. S. C. § 1334(b), which said that “[n]o
requirement or prohibition based on smoking and health
shall be imposed under State law with respect to the adver
tising or promotion of any cigarettes” whose packages were
labeled in accordance with federal law. See 505 U. S., at 523
(plurality opinion); id., at 548–549 (Scalia, J., concurring in
judgment in part and dissenting in part).
Congress is entitled to know what meaning this Court will
assign to terms regularly used in its enactments. Absent
other indication, reference to a State’s “requirements” in
cludes its common-law duties. As the plurality opinion said
in Cipollone, common-law liability is “premised on the exist
ence of a legal duty,” and a tort judgment therefore estab
lishes that the defendant has violated a state-law obligation.
Id., at 522. And while the common-law remedy is limited
to damages, a liability award “ ‘can be, indeed is designed to
be, a potent method of governing conduct and controlling
policy.’ ” Id., at 521.
In the present case, there is nothing to contradict this
normal meaning. To the contrary, in the context of this leg

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islation excluding common-law duties from the scope of pre
emption would make little sense. State tort law that re
quires a manufacturer’s catheters to be safer, but hence less
effective, than the model the FDA has approved disrupts the
federal scheme no less than state regulatory law to the same
effect. Indeed, one would think that tort law, applied by
juries under a negligence or strict-liability standard, is less
deserving of preservation. A state statute, or a regulation
adopted by a state agency, could at least be expected to apply
cost-benefit analysis similar to that applied by the experts at
the FDA: How many more lives will be saved by a device
which, along with its greater effectiveness, brings a greater
risk of harm? A jury, on the other hand, sees only the cost
of a more dangerous design, and is not concerned with its
benefits; the patients who reaped those benefits are not rep
resented in court. As Justice Breyer explained in Lohr,
it is implausible that the MDA was meant to “grant greater
power (to set state standards ‘different from, or in addition
to,’ federal standards) to a single state jury than to state
officials acting through state administrative or legislative
lawmaking processes.” 518 U. S., at 504. That perverse
distinction is not required or even suggested by the broad
language Congress chose in the MDA,4 and we will not turn
somersaults to create it.
4 The Riegels point to § 360k(b), which authorizes the FDA to exempt
state “requirements” from pre-emption under circumstances that would
rarely be met for common-law duties. But a law that permits an agency
to exempt certain “requirements” from pre-emption does not suggest that
no other “requirements” exist. The Riegels also invoke § 360h(d), which
provides that compliance with certain FDA orders “shall not relieve any
person from liability under Federal or State law.” This indicates that
some state-law claims are not pre-empted, as we held in Lohr. But it
could not possibly mean that all state-law claims are not pre-empted, since
that would deprive the MDA pre-emption clause of all content. And it
provides no guidance as to which state-law claims are pre-empted and
which are not.

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B
The dissent would narrow the pre-emptive scope of the
term “requirement” on the grounds that it is “difficult to be
lieve that Congress would, without comment, remove all
means of judicial recourse” for consumers injured by FDA
approved devices. Post, at 337 (opinion of Ginsburg, J.) (in
ternal quotation marks omitted). But, as we have ex
plained, this is exactly what a pre-emption clause for medical
devices does by its terms. The operation of a law enacted
by Congress need not be seconded by a committee report on
pain of judicial nullification. See, e. g., Connecticut Nat.
Bank v. Germain, 503 U. S. 249, 253–254 (1992). It is not
our job to speculate upon congressional motives. If we were
to do so, however, the only indication available—the text of
the statute—suggests that the solicitude for those injured by
FDA-approved devices, which the dissent finds controlling,
was overcome in Congress’s estimation by solicitude for
those who would suffer without new medical devices if juries
were allowed to apply the tort law of 50 States to all
innovations.5
In the case before us, the FDA has supported the position
taken by our opinion with regard to the meaning of the stat
ute. We have found it unnecessary to rely upon that agency
view because we think the statute itself speaks clearly to
the point at issue. If, however, we had found the statute
ambiguous and had accorded the agency’s current position
deference, the dissent is correct, see post, at 338, n. 8, that—
inasmuch as mere Skidmore deference would seemingly be
at issue—the degree of deference might be reduced by the
fact that the agency’s earlier position was different. See
Skidmore v. Swift & Co., 323 U. S. 134 (1944); United States
5 Contrary to Justice Stevens’ contention, post, at 331 (opinion concur
ring in part and concurring in judgment), we do not “advanc[e]” this argu
ment. We merely suggest that if one were to speculate upon congres
sional purposes, the best evidence for that would be found in the statute.

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327 Cite as: 552 U. S. 312 (2008)
Opinion of the Court
v. Mead Corp., 533 U. S. 218 (2001); Good Samaritan Hospi
tal v. Shalala, 508 U. S. 402, 417 (1993). But of course the
agency’s earlier position (which the dissent describes at some
length, post, at 337–338, and finds preferable) is even more
compromised, indeed deprived of all claim to deference, by
the fact that it is no longer the agency’s position.
The dissent also describes at great length the experience
under the FDCA with respect to drugs and food and color
additives. Post, at 339–342. Two points render the conclu
sion the dissent seeks to draw from that experience—that
the pre-emption clause permits tort suits—unreliable. (1) It
has not been established (as the dissent assumes) that no tort
lawsuits are pre-empted by drug or additive approval under
the FDCA. (2) If, as the dissent believes, the pre-emption
clause permits tort lawsuits for medical devices just as they
are (by hypothesis) permitted for drugs and additives; and
if, as the dissent believes, Congress wanted the two regimes
to be alike; Congress could have applied the pre-emption
clause to the entire FDCA. It did not do so, but instead
wrote a pre-emption clause that applies only to medical
devices.
C
The Riegels contend that the duties underlying negligence,
strict-liability, and implied-warranty claims are not pre
empted even if they impose “ ‘requirements,’ ” because gen
eral common-law duties are not requirements maintained
“ ‘with respect to devices.’ ” Brief for Petitioner 34–36.
Again, a majority of this Court suggested otherwise in Lohr.
See 518 U. S., at 504–505 (opinion of Breyer, J.); id., at 514
(opinion of O’Connor, J., joined by Rehnquist, C. J., and
Scalia and Thomas, JJ.).6 And with good reason. The
6 The opinions joined by these five Justices dispose of the Riegels’ asser
tion that Lohr held common-law duties were too general to qualify as
duties “with respect to a device.” The majority opinion in Lohr also disa
vowed this conclusion, for it stated that the Court did “not believe that

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328 RIEGEL v. MEDTRONIC, INC.
Opinion of the Court
language of the statute does not bear the Riegels’ reading.
The MDA provides that no State “may establish or continue
in effect with respect to a device . . . any requirement”
relating to safety or effectiveness that is different from, or
in addition to, federal requirements. § 360k(a) (emphasis
added). The Riegels’ suit depends upon New York’s “contin
u[ing] in effect” general tort duties “with respect to” Med
tronic’s catheter. Nothing in the statutory text suggests
that the pre-empted state requirement must apply only to
the relevant device, or only to medical devices and not to all
products and all actions in general.
The Riegels’ argument to the contrary rests on the text of
an FDA regulation which states that the MDA’s pre-emption
clause does not extend to certain duties, including “[s]tate or
local requirements of general applicability where the pur
pose of the requirement relates either to other products in
addition to devices (e. g., requirements such as general elec
trical codes, and the Uniform Commercial Code (warranty of
fitness)), or to unfair trade practices in which the require
ments are not limited to devices.” 21 CFR § 808.1(d)(1).
Even assuming that this regulation could play a role in de
fining the MDA’s pre-emptive scope, it does not provide un
ambiguous support for the Riegels’ position. The agency’s
reading of its own rule is entitled to substantial deference,
see Auer v. Robbins, 519 U. S. 452, 461 (1997), and the FDA’s
view put forward in this case is that the regulation does not
refer to general tort duties of care, such as those underlying
the claims in this case that a device was designed, labeled,
or manufactured in an unsafe or ineffective manner, Brief
for United States as Amicus Curiae 27–28. That is so, ac
cording to the FDA, because the regulation excludes from
pre-emption requirements that relate only incidentally to
medical devices, but not other requirements. General tort
[the MDA’s] statutory and regulatory language necessarily precludes . . .
‘general’ state requirements from ever being pre-empted . . . .” 518 U. S.,
at 500.

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Opinion of the Court
duties of care, unlike fire codes or restrictions on trade prac
tices, “directly regulate” the device itself, including its de
sign. Id., at 28. We find the agency’s explanation less than
compelling, since the same could be said of general require
ments imposed by electrical codes, the Uniform Commercial
Code, or unfair-trade-practice law, which the regulation spe
cifically excludes from pre-emption.
Other portions of 21 CFR § 808.1, however, support the
agency’s view that § 808.1(d)(1) has no application to this
case (though still failing to explain why electrical codes, the
Uniform Commercial Code, or unfair-trade-practice require
ments are different). Section 808.1(b) states that the MDA
sets forth a “general rule” pre-empting state duties “having
the force and effect of law (whether established by statute,
ordinance, regulation, or court decision) . . . .” (Emphasis
added.) This sentence is far more comprehensible under the
FDA’s view that § 808.1(d)(1) has no application here than
under the Riegels’ view. We are aware of no duties estab
lished by court decision other than common-law duties, and
we are aware of no common-law duties that relate solely to
medical devices.
The Riegels’ reading is also in tension with the regula
tion’s statement that adulteration and misbranding claims
are pre-empted when they “ha[ve] the effect of establishing a
substantive requirement for a specific device, e. g., a specific
labeling requirement” that is “different from, or in addition
to,” a federal requirement. § 808.1(d)(6)(ii). Surely this
means that the MDA would pre-empt a jury determination
that the FDA-approved labeling for a pacemaker violated
a state common-law requirement for additional warnings.
The Riegels’ reading of § 808.1(d)(1), however, would allow a
claim for tortious mislabeling to escape pre-emption so long
as such a claim could also be brought against objects other
than medical devices.
All in all, we think that § 808.1(d)(1) can add nothing to our
analysis but confusion. Neither accepting nor rejecting the

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330 RIEGEL v. MEDTRONIC, INC.
Opinion of Stevens, J.
proposition that this regulation can properly be consulted to
determine the statute’s meaning; and neither accepting nor
rejecting the FDA’s distinction between general require
ments that directly regulate and those that regulate only
incidentally; the regulation fails to alter our interpretation
of the text insofar as the outcome of this case is concerned.
IV
State requirements are pre-empted under the MDA only
to the extent that they are “different from, or in addition
to” the requirements imposed by federal law. § 360k(a)(1).
Thus, § 360k does not prevent a State from providing a dam
ages remedy for claims premised on a violation of FDA regu
lations; the state duties in such a case “parallel,” rather than
add to, federal requirements. Lohr, 518 U. S., at 495; see
also id., at 513 (O’Connor, J., concurring in part and dissent
ing in part). The District Court in this case recognized that
parallel claims would not be pre-empted, see App. to Pet. for
Cert. 70a–71a, but it interpreted the claims here to assert
that Medtronic’s device violated state tort law notwithstand
ing compliance with the relevant federal requirements, see
id., at 68a. Although the Riegels now argue that their law
suit raises parallel claims, they made no such contention in
their briefs before the Second Circuit, nor did they raise this
argument in their petition for certiorari. We decline to ad
dress that argument in the first instance here.
* * *
For the foregoing reasons, the judgment of the Court of
Appeals is
Affirmed.
Justice Stevens, concurring in part and concurring in
the judgment.
The significance of the pre-emption provision in the Medi
cal Device Amendments of 1976 (MDA), 21 U. S. C. § 360k,

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331 Cite as: 552 U. S. 312 (2008)
Opinion of Stevens, J.
was not fully appreciated until many years after it was
enacted. It is an example of a statute whose text and gen
eral objective cover territory not actually envisioned by its
authors. In such cases we have frequently concluded that
“it is ultimately the provisions of our laws rather than
the principal concerns of our legislators by which we are
governed.” Oncale v. Sundowner Offshore Services, Inc.,
523 U. S. 75, 79–80 (1998). Accordingly, while I agree with
Justice Ginsburg’s description of the actual history and
principal purpose of the pre-emption provision at issue in
this case, post, at 335–342 (dissenting opinion), I am per
suaded that its text does pre-empt state-law requirements
that differ. I therefore write separately to add these
few words about the MDA’s history and the meaning of
“requirements.”
There is nothing in the preenactment history of the MDA
suggesting that Congress thought state tort remedies had
impeded the development of medical devices. Nor is there
any evidence at all to suggest that Congress decided that
the cost of injuries from Food and Drug Administration
approved medical devices was outweighed “by solicitude for
those who would suffer without new medical devices if juries
were allowed to apply the tort law of 50 States to all innova
tions.” Ante, at 326 (opinion of the Court). That is a policy
argument advanced by the Court, not by Congress. As Jus
tice Ginsburg persuasively explains, the overriding pur
pose of the legislation was to provide additional protection
to consumers, not to withdraw existing protections. It was
the then-recent development of state premarket regulatory
regimes that explained the need for a provision pre-empting
conflicting administrative rules. See Medtronic, Inc. v.
Lohr, 518 U. S. 470, 489 (1996) (plurality opinion) (“[W]hen
Congress enacted § 360k, it was primarily concerned with the
problem of specific, conflicting state statutes and regulations
rather than the general duties enforced by common-law
actions”).

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332 RIEGEL v. MEDTRONIC, INC.
Opinion of Stevens, J.
But the language of the provision reaches beyond such
regulatory regimes to encompass other types of “require
ments. ” Because common-law rules administered by
judges, like statutes and regulations, create and define legal
obligations, some of them unquestionably qualify as “require
ments.” 1 See Cipollone v. Liggett Group, Inc., 505 U. S.
504, 522 (1992) (plurality opinion) (“[C]ommon-law damages
actions of the sort raised by petitioner are premised on the
existence of a legal duty, and it is difficult to say that such
actions do not impose ‘requirements or prohibitions.’ . . . [I]t
is the essence of the common law to enforce duties that are
either affirmative requirements or negative prohibitions”).
And although not all common-law rules qualify as “require
ments,” 2 the Court correctly points out that five Justices in
Lohr concluded that the common-law causes of action for
negligence and strict liability at issue in that case imposed
“requirements” that were pre-empted by federal require
1 The verdicts of juries who obey those rules, however, are not “require
ments” of that kind. Juries apply rules, but do not make them. And
while a jury’s finding of liability may induce a defendant to alter its device
or its label, this does not render the finding a “requirement” within the
meaning of the MDA. “A requirement is a rule of law that must be
obeyed; an event, such as a jury verdict, that merely motivates an optional
decision is not a requirement.” Bates v. Dow Agrosciences LLC, 544 U. S.
431, 445 (2005). It is for that reason that the MDA does not grant
“ ‘a single state jury’ ” any power whatsoever to set any standard that
either conforms with or differs from a relevant federal standard. I do not
agree with the colorful but inaccurate quotation in the Court’s opinion,
ante, at 325.
2 See Cipollone, 505 U. S., at 523 (plurality opinion) (explaining that the
fact that “the pre-emptive scope of § 5(b) cannot be limited to positive
enactments does not mean that that section pre-empts all common-law
claims” and proceeding to analyze “each of petitioner’s common-law claims
to determine whether it is in fact pre-empted”); Bates, 544 U. S., at 443–
444 (noting that a finding that “[7 U. S. C.] § 136v(b) may pre-empt judge
made rules, as well as statutes and regulations, says nothing about the
scope of that pre-emption,” and proceeding to determine whether the par
ticular common-law rules at issue in that case satisfied the conditions of
pre-emption).

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Ginsburg, J., dissenting
ments specific to a medical device. Moreover, I agree with
the Court’s cogent explanation of why the Riegels’ claims are
predicated on New York common-law duties that constitute
requirements with respect to the device at issue that differ
from federal requirements relating to safety and effective
ness. I therefore join the Court’s judgment and all of its
opinion except for Parts III–A and III–B.
Justice Ginsburg, dissenting.
The Medical Device Amendments of 1976 (MDA or Act),
90 Stat. 539, as construed by the Court, cut deeply into a
domain historically occupied by state law. The MDA’s pre
emption clause, 21 U. S. C. § 360k(a), the Court holds, spares
medical device manufacturers from personal injury claims
alleging flaws in a design or label once the application for
the design or label has gained premarket approval from the
Food and Drug Administration (FDA); a state damages rem
edy, the Court instructs, persists only for claims “premised
on a violation of FDA regulations.” Ante, at 330.1 I dis
sent from today’s constriction of state authority. Congress,
in my view, did not intend § 360k(a) to effect a radical curtail
ment of state common-law suits seeking compensation for
injuries caused by defectively designed or labeled medical
devices.
Congress’ reason for enacting § 360k(a) is evident. Until
1976, the Federal Government did not engage in premarket
regulation of medical devices. Some States acted to fill the
void by adopting their own regulatory systems for medical
devices. Section 360k(a) responded to that state regulation,
and particularly to California’s system of premarket ap
proval for medical devices, by preempting State initiatives
absent FDA permission. See § 360k(b).
1 The Court’s holding does not reach an important issue outside the
bounds of this case: the preemptive effect of § 360k(a) where evidence of a
medical device’s defect comes to light only after the device receives pre
market approval.

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334 RIEGEL v. MEDTRONIC, INC.
Ginsburg, J., dissenting
I
The “purpose of Congress is the ultimate touchstone of
pre-emption analysis.” Cipollone v. Liggett Group, Inc.,
505 U. S. 504, 516 (1992) (internal quotation marks omitted).
Courts have “long presumed that Congress does not cava
lierly pre-empt state-law causes of action.” Medtronic, Inc.
v. Lohr, 518 U. S. 470, 485 (1996).2 Preemption analysis
starts with the assumption that “the historic police powers
of the States [a]re not to be superseded . . . unless that was
the clear and manifest purpose of Congress.” Rice v. Santa
Fe Elevator Corp., 331 U. S. 218, 230 (1947). “This assump
tion provides assurance that ‘the federal-state balance’ will
not be disturbed unintentionally by Congress or unnecessar
ily by the courts.” Jones v. Rath Packing Co., 430 U. S. 519,
525 (1977) (citation omitted).
The presumption against preemption is heightened “where
federal law is said to bar state action in fields of traditional
state regulation.” New York State Conference of Blue
Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U. S.
645, 655 (1995). Given the traditional “primacy of state reg
ulation of matters of health and safety,” Lohr, 518 U. S., at
485, courts assume “that state and local regulation related
to [those] matters . . . can normally coexist with federal regu
lations,” Hillsborough County v. Automated Medical Labo
ratories, Inc., 471 U. S. 707, 718 (1985).
Federal laws containing a preemption clause do not auto
matically escape the presumption against preemption. See
Bates v. Dow Agrosciences LLC, 544 U. S. 431, 449 (2005);
Lohr, 518 U. S., at 485. A preemption clause tells us
that Congress intended to supersede or modify state law to
some extent. In the absence of legislative precision, how
ever, courts may face the task of determining the substance
2 In part, Lohr spoke for the Court, and in part, for a plurality. Unless
otherwise indicated, citations in this opinion refer to portions of Lohr con
veying the opinion of the Court.

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Ginsburg, J., dissenting
and scope of Congress’ displacement of state law. Where
the text of a preemption clause is open to more than one
plausible reading, courts ordinarily “accept the reading that
disfavors pre-emption.” Bates, 544 U. S., at 449.
II
The MDA’s preemption clause states:
“[N]o State or political subdivision of a State may estab
lish or continue in effect with respect to a device in
tended for human use any requirement—
“(1) which is different from, or in addition to, any re
quirement 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 require
ment applicable to the device under this chapter.” 21
U. S. C. § 360k(a).
“Absent other indication,” the Court states, “reference to
a State’s ‘requirements’ includes its common-law duties.”
Ante, at 324. Regarding the MDA, however, “other indica
tion” is not “[a]bsent.” Contextual examination of the Act
convinces me that § 360k(a)’s inclusion of the term “require
ment” should not prompt a sweeping preemption of mine-run
claims for relief under state tort law.3
A
Congress enacted the MDA “to provide for the safety and
effectiveness of medical devices intended for human use.”
3 The very next provision, § 360k(b), allows States and their political sub
divisions to apply for exemption from the requirements for medical devices
set by the FDA when their own requirements are “more stringent” than
federal standards or are necessitated by “compelling local conditions.”
This prescription indicates solicitude for state concerns, as embodied in
legislation or regulation. But no more than § 360k(a) itself does § 360k(b)
show that Congress homed in on state common-law suits and meant to
deny injured parties recourse to them.

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336 RIEGEL v. MEDTRONIC, INC.
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90 Stat. 539 (preamble).4 A series of high-profile medical
device failures that caused extensive injuries and loss of
life propelled adoption of the MDA.5 Conspicuous among
these failures was the Dalkon Shield intrauterine device,
used by approximately 2.2 million women in the United
States between 1970 and 1974. See In re Northern Dist. of
Cal., Dalkon Shield IUD Prods. Liability Litigation, 693
F. 2d 847, 848 (CA9 1982); ante, at 315. Aggressively pro
moted as a safe and effective form of birth control, the Dal
kon Shield had been linked to 16 deaths and 25 miscarriages
by the middle of 1975. H. R. Rep. No. 94–853, p. 8 (1976).
By early 1976, “more than 500 lawsuits seeking compensa
tory and punitive damages totalling more than $400 million”
had been filed. Ibid.6 Given the publicity attending the
Dalkon Shield litigation and Congress’ awareness of the suits
at the time the MDA was under consideration, I find infor
4 Introducing the bill in the Senate, its sponsor explained: “The legisla
tion is written so that the benefit of the doubt is always given to the
consumer. After all it is the consumer who pays with his health and his
life for medical device malfunctions.” 121 Cong. Rec. 10688 (1975) (re
marks of Sen. Kennedy).
5 See, e. g., H. R. Rep. No. 94–853, p. 8 (1976) (“Significant defects in
cardiac pacemakers have necessitated 34 voluntary recalls of pacemakers,
involving 23,000 units, since 1972.”); S. Rep. No. 94–33, p. 6 (1975) (“Some
10,000 injuries were recorded, of which 731 resulted in death. For exam
ple, 512 deaths and 300 injuries were attributed to heart valves; 89 deaths
and 186 injuries to heart pacemakers; 10 deaths and 8,000 injuries to intra
uterine devices.”); 122 Cong. Rec. 5859 (1976) (remarks of Rep. Waxman)
(“A 10-year FDA death-certificate search found over 850 deaths tied di
rectly to medical devices.”); 121 id., at 10689–10690 (remarks of Sen. Nel
son). See also Medtronic, Inc. v. Lohr, 518 U. S. 470, 476 (1996).
6 The Dalkon Shield was ultimately linked to “thousands of serious inju
ries to otherwise healthy women.” Vladeck, Preemption and Regulatory
Failure, 33 Pepperdine L. Rev. 95, 103 (2005). By October 1984, the manu
facturer had settled or litigated approximately 7,700 Dalkon Shield cases.
R. Sobol, Bending the Law: The Story of the Dalkon Shield Bankruptcy
23 (1991).

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mative the absence of any sign of a legislative design to pre
empt state common-law tort actions.7
The Court recognizes that Ҥ 360k does not prevent a State
from providing a damages remedy for claims premised on a
violation of FDA regulations.” Ante, at 330. That remedy,
although important, does not help consumers injured by de
vices that receive FDA approval but nevertheless prove un
safe. The MDA’s failure to create any federal compensatory
remedy for such consumers further suggests that Congress
did not intend broadly to preempt state common-law suits
grounded on allegations independent of FDA requirements.
It is “difficult to believe that Congress would, without com
ment, remove all means of judicial recourse” for large num
bers of consumers injured by defective medical devices.
Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 251 (1984).
The former chief counsel to the FDA explained:
“FDA’s view is that FDA product approval and state
tort liability usually operate independently, each provid
ing a significant, yet distinct, layer of consumer protec
tion. FDA regulation of a device cannot anticipate and
protect against all safety risks to individual consumers.
Even the most thorough regulation of a product such as
a critical medical device may fail to identify potential
problems presented by the product. Regulation cannot
7 “[N]othing in the hearings, the Committee Reports, or the debates,”
the Lohr plurality noted, “suggest[ed] that any proponent of the legislation
intended a sweeping pre-emption of traditional common-law remedies
against manufacturers and distributors of defective devices. If Congress
intended such a result, its failure even to hint at it is spectacularly odd,
particularly since Members of both Houses were acutely aware of ongoing
product liability litigation.” 518 U. S., at 491. See also Adler & Mann,
Preemption and Medical Devices: The Courts Run Amok, 59 Mo. L. Rev.
895, 925 (1994) (“To the extent that Congress mentioned common law tort
claims, it was not to criticize them or to suggest that they needed to
be barred once a federal regulation was in place. Rather, it was to note
how they demonstrated that additional protections for consumers were
needed.”).

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338 RIEGEL v. MEDTRONIC, INC.
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protect against all possible injuries that might result
from use of a device over time. Preemption of all such
claims would result in the loss of a significant layer of
consumer protection . . . .” Porter, The Lohr Decision:
FDA Perspective and Position, 52 Food & Drug L. J. 7,
11 (1997).
Cf. Brief for United States as Amicus Curiae on Pet. for
Cert. in Smiths Industries Medical Systems, Inc. v. Ker
nats, O. T. 1997, No. 96–1405, pp. 17–18; Dept. of Health and
Human Services, Public Health Service, Advisory Opinion,
Docket No. 83A–0140/AP, Letter from J. Hile, Associate
Comm’r for Regulatory Affairs, to National Women’s Health
Network (Mar. 8, 1984).8 The Court’s construction of
§ 360k(a) has the “perverse effect” of granting broad immu
nity “to an entire industry that, in the judgment of Congress,
needed more stringent regulation,” Lohr, 518 U. S., at 487
(plurality opinion), not exemption from liability in tort
litigation.
The MDA does grant the FDA authority to order certain
remedial action if, inter alia, it concludes that a device “pre
8 The FDA recently announced a new position in an amicus brief. See
Brief for United States as Amicus Curiae 16–24. An amicus brief inter
preting a statute is entitled, at most, to deference under Skidmore v.
Swift & Co., 323 U. S. 134 (1944). See United States v. Mead Corp., 533
U. S. 218, 229–233 (2001). The weight accorded to an agency position
under Skidmore “depend[s] upon the thoroughness evident in its consider
ation, the validity of its reasoning, its consistency with earlier and later
pronouncements, and all those factors which give it power to persuade, if
lacking power to control.” 323 U. S., at 140. See also Mead, 533 U. S., at
228 (courts consider, inter alia, the “consistency” and “persuasiveness” of
an agency’s position); Good Samaritan Hospital v. Shalala, 508 U. S. 402,
417 (1993) (“[T]he consistency of an agency’s position is a factor in assess
ing the weight that position is due.”). Because the FDA’s long-held view
on the limited preemptive effect of § 360k(a) better comports with the pre
sumption against preemption of state health and safety protections, as
well as the purpose and history of the MDA, the FDA’s new position is
entitled to little weight.

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339 Cite as: 552 U. S. 312 (2008)
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sents an unreasonable risk of substantial harm to the public
health” and that notice of the defect “would not by itself
be sufficient to eliminate the unreasonable risk.” 21 U. S. C.
§ 360h(b)(1)(A). Thus the FDA may order the manufacturer
to repair the device, replace it, refund the purchase price,
cease distribution, or recall the device. § 360h(b)(2), (e).
The prospect of ameliorative action by the FDA, however,
lends no support to the conclusion that Congress intended
largely to preempt state common-law suits. Quite the oppo
site: Section 360h(d) states that “[c]ompliance with an order
issued under this section shall not relieve any person from
liability under Federal or State law.” That provision antici
pates “[court-awarded] damages for economic loss” from
which the value of any FDA-ordered remedy would be sub
tracted. Ibid.9
B
Congress enacted the MDA after decades of regulating
drugs and food and color additives under the Federal Food,
Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended,
21 U. S. C. § 301 et seq. The FDCA contains no preemption
clause, and thus the Court’s interpretation of § 360k(a) has
no bearing on tort suits involving drugs and additives. But
§ 360k(a)’s confinement to medical devices hardly renders ir
relevant to the proper construction of the MDA’s preemption
provision the long history of federal and state controls over
drugs and additives in the interest of public health and wel
fare. Congress’ experience regulating drugs and additives
informed, and in part provided the model for, its regulation
of medical devices. I therefore turn to an examination of
that experience.
9 The Court regards § 360h(d) as unenlightening because it “could not
possibly mean that all state-law claims are not pre-empted” and “provides
no guidance as to which state-law claims are pre-empted and which are
not.” Ante, at 325, n. 4. Given the presumption against preemption op
erative even in construing a preemption clause, see supra, at 334–335, the
perceived lack of “guidance” should cut against Medtronic, not in its favor.

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340 RIEGEL v. MEDTRONIC, INC.
Ginsburg, J., dissenting
Starting in 1938, the FDCA required that new drugs un
dergo preclearance by the FDA before they could be mar
keted. See § 505, 52 Stat. 1052. Nothing in the FDCA’s
text or legislative history suggested that FDA preclearance
would immunize drug manufacturers from common-law tort
suits.10
By the time Congress enacted the MDA in 1976, state
common-law claims for drug labeling and design defects had
continued unabated despite nearly four decades of FDA
regulation.11 Congress’ inclusion of a preemption clause in
the MDA was not motivated by concern that similar state
tort actions could be mounted regarding medical devices.12
10 To the contrary, the bill did not need to create a federal claim for
damages, witnesses testified, because “[a] common-law right of action ex
ist[ed].” Hearings on S. 1944 before a Subcommittee of the Senate Com
mittee on Commerce, 73d Cong., 2d Sess., 400 (1933) (statement of W. A.
Hines). See also id., at 403 (statement of J. A. Ladds) (“This act should
not attempt to modify or restate the common law with respect to per
sonal injuries.”).
11 Most defendants, it appears, raised no preemption defense to state
tort suits involving FDA-approved drugs. See, e. g., Salmon v. Parke,
Davis & Co., 520 F. 2d 1359 (CA4 1975) (North Carolina law); Reyes v.
Wyeth Labs., 498 F. 2d 1264 (CA5 1974) (Texas law); Hoffman v. Sterling
Drug, Inc., 485 F. 2d 132 (CA3 1973) (Pennsylvania law); Singer v. Sterling
Drug, Inc., 461 F. 2d 288 (CA7 1972) (Indiana law); McCue v. Norwich
Pharmacal Co., 453 F. 2d 1033 (CA1 1972) (New Hampshire law); Basko
v. Sterling Drug, Inc., 416 F. 2d 417 (CA2 1969) (Connecticut law); Parke
Davis & Co. v. Stromsodt, 411 F. 2d 1390 (CA8 1969) (North Dakota law);
Davis v. Wyeth Labs., Inc., 399 F. 2d 121 (CA9 1968) (Montana law); Rogin
sky v. Richardson-Merrell, Inc., 378 F. 2d 832 (CA2 1967) (New York law);
Cunningham v. Charles Pfizer & Co., 532 P. 2d 1377 (Okla. 1974); Stevens
v. Parke, Davis & Co., 9 Cal. 3d 51, 507 P. 2d 653 (1973); Bine v. Sterling
Drug, Inc., 422 S. W. 2d 623 (Mo. 1968) (per curiam). In the few cases
in which courts noted that defendants had interposed a preemption plea,
the defense was unsuccessful. See, e. g., Herman v. Smith, Kline &
French Labs., 286 F. Supp. 694 (ED Wis. 1968). See also infra, at 343–
344, n. 16 (decisions after 1976).
12 See Leflar & Adler, The Preemption Pentad: Federal Preemption of
Products Liability Claims After Medtronic, 64 Tenn. L. Rev. 691, 704, n. 71
(1997) (“Surely a furor would have been aroused by the very suggestion

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Cite as: 552 U. S. 312 (2008) 341
Ginsburg, J., dissenting
Rather, Congress included § 360k(a) and (b) to empower the
FDA to exercise control over state premarket approval sys
tems installed at a time when there was no preclearance at
the federal level. See supra, at 335, and n. 3; infra, at 342,
and n. 14.
Between 1938 and 1976, Congress enacted a series of pre
market approval requirements, first for drugs, then for ad
ditives. Premarket control, as already noted, commenced
with drugs in 1938. In 1958, Congress required premarket
approval for food additives. Food Additives Amendment,
§ 4, 72 Stat. 1785, as amended, 21 U. S. C. § 348. In 1960,
it required premarket approval for color additives. Color
Additive Amendments, § 103(b), 74 Stat. 399, as amended, 21
U. S. C. § 379e. In 1962, it expanded the premarket approval
process for new drugs to include review for effectiveness.
Drug Amendments, § 102, 76 Stat. 781, as amended, 21
U. S. C. §§ 321, 355. And in 1968, it required premarket ap
proval for new animal drugs. Animal Drug Amendments,
§ 101(b), 82 Stat. 343, as amended, 21 U. S. C. § 360b. None
of these Acts contained a preemption clause.
The measures just listed, like the MDA, were all enacted
with common-law personal injury litigation over defective
products a prominent part of the legal landscape.13 At the
that . . . medical devices should receive an exemption from products liabil
ity litigation while new drugs, subject to similar regulatory scrutiny from
the same agency, should remain under the standard tort law regime.”);
Porter, The Lohr Decision: FDA Perspective and Position, 52 Food & Drug
L. J. 7, 11 (1997) (With preemption, the “FDA’s regulation of devices would
have been accorded an entirely different weight in private tort litigation
than its counterpart regulation of drugs and biologics. This disparity is
neither justified nor appropriate, nor does the agency believe it was in
tended by Congress . . . .”).
13 The Drug Amendments of 1962 reiterated Congress’ intent not to pre
empt claims relying on state law: “Nothing in the amendments . . . shall
be construed as invalidating any provision of State law which would be
valid in the absence of such amendments unless there is a direct and posi
tive conflict between such amendments and such provision of State law.”
§ 202, 76 Stat. 793.

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342 RIEGEL v. MEDTRONIC, INC.
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time of each enactment, no state regulations required pre
market approval of the drugs or additives in question, so no
preemption clause was needed as a check against potentially
conflicting state regulatory regimes. See Brief for Sen. Ed
ward M. Kennedy et al. as Amici Curiae 10.
A different situation existed as to medical devices when
Congress developed and passed the MDA. As the House
Report observed:
“In the absence of effective Federal regulation of med
ical devices, some States have established their own pro
grams. The most comprehensive State regulation of
which the Committee is aware is that of California,
which in 1970 adopted the Sherman Food, Drug, and
Cosmetic Law. This law requires premarket approval
of all new medical devices, requires compliance of device
manufacturers with good manufacturing practices and
authorizes inspection of establishments which manu
facture devices. Implementation of the Sherman Law
has resulted in the requirement that intrauterine de
vices are subject to premarket clearance in California.”
H. R. Rep. No. 94–853, p. 45 (emphasis added).14
In sum, state premarket regulation of medical devices, not
any design to suppress tort suits, accounts for Congress’ in
clusion of a preemption clause in the MDA; no such clause
figures in earlier federal laws regulating drugs and addi
tives, for States had not installed comparable control re
gimes in those areas.
14 Congress featured California’s regulatory system in its discussion of
§ 360k(a), but it also identified California’s system as a prime candidate for
an exemption from preemption under § 360k(b). “[R]equirements im
posed under the California statute,” the House Report noted, “serve as an
example of requirements that the Secretary should authorize to be contin
ued (provided any application submitted by a State meets requirements
pursuant to the reported bill).” H. R. Rep. No. 94–853, p. 46. Thus Con
gress sought not to terminate all state premarket approval systems, but
rather to place those systems under the controlling authority of the FDA.

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C
Congress’ experience regulating drugs also casts doubt on
Medtronic’s policy arguments for reading § 360k(a) to pre
empt state tort claims. Section 360k(a) must preempt state
common-law suits, Medtronic contends, because Congress
would not have wanted state juries to second-guess the
FDA’s finding that a medical device is safe and effective
when used as directed. Brief for Respondent 42–49. The
Court is similarly minded. Ante, at 324–325.
But the process for approving new drugs is at least as
rigorous as the premarket approval process for medical de
vices.15 Courts that have considered the question have
overwhelmingly held that FDA approval of a new drug appli
cation does not preempt state tort suits.16 Decades of drug
15 The process for approving a new drug begins with preclinical labora
tory and animal testing. The sponsor of the new drug then submits an
investigational new drug application seeking FDA approval to test the
drug on humans. See 21 U. S. C. § 355(i) (2000 ed. and Supp. V); 21 CFR
§ 312.1 et seq. (2007). Clinical trials generally proceed in three phases
involving successively larger groups of patients: 20 to 80 subjects in phase
I; no more than several hundred subjects in phase II; and several hundred
to several thousand subjects in phase III. 21 CFR § 312.21. After com
pleting the clinical trials, the sponsor files a new drug application contain
ing, inter alia, “full reports of investigations” showing whether the “drug
is safe for use and . . . effective”; the drug’s composition; a description of
the drug’s manufacturing, processing, and packaging; and the proposed
labeling for the drug. 21 U. S. C. § 355(b)(1) (2000 ed., Supp. V).
16 See, e. g., Tobin v. Astra Pharmaceutical Prods., Inc., 993 F. 2d 528,
537–538 (CA6 1993); Hill v. Searle Labs., Div. of Searle Pharmaceuticals,
Inc., 884 F. 2d 1064, 1068 (CA8 1989); In re Vioxx Prods. Liability Litiga
tion, 501 F. Supp. 2d 776, 788–789 (ED La. 2007); In re Zyprexa Prods.
Liability Litigation, 489 F. Supp. 2d 230, 275–278 (EDNY 2007); Weiss v.
Fujisawa Pharmaceutical Co., 464 F. Supp. 2d 666, 676 (ED Ky. 2006);
Perry v. Novartis Pharma. Corp., 456 F. Supp. 2d 678, 685–687 (ED Pa.
2006); McNellis v. Pfizer, Inc., No. Civ. 05–1286 (JBS), 2006 WL 2819046,
*5 (D. N. J., Sept. 29, 2006); Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964,
968 (Neb. 2006); Laisure-Radke v. Par Pharmaceutical, Inc., 426 F. Supp.
2d 1163, 1169 (WD Wash. 2006); Witczak v. Pfizer, Inc., 377 F. Supp. 2d
726, 732 (Minn. 2005); Zikis v. Pfizer, Inc., No. 04 C 8104, 2005 WL 1126909,

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344 RIEGEL v. MEDTRONIC, INC.
Ginsburg, J., dissenting
regulation thus indicate, contrary to Medtronic’s argument,
that Congress did not regard FDA regulation and state tort
claims as mutually exclusive.
III
Refusing to read § 360k(a) as an automatic bar to state
common-law tort claims would hardly render the FDA’s pre
market approval of Medtronic’s medical device application
irrelevant to the instant suit. First, a “pre-emption provi
sion, by itself, does not foreclose (through negative implica
tion) any possibility of implied conflict preemption.” Geier
v. American Honda Motor Co., 529 U. S. 861, 869 (2000)
(brackets and internal quotation marks omitted). See also
Freightliner Corp. v. Myrick, 514 U. S. 280, 288–289 (1995).
Accordingly, a medical device manufacturer may have a dis
*3 (ND Ill., May 9, 2005); Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876,
885–886 (ED Tex. 2005); Eve v. Sandoz Pharmaceutical Corp., No. IP
98–1429–C–Y/S, 2002 WL 181972, *1 (SD Ind., Jan. 28, 2002); Caraker v.
Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1018, 1044 (SD Ill. 2001);
Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085, 1087 (CD Cal. 2000); Kociemba
v. G. D. Searle & Co., 680 F. Supp. 1293, 1299–1300 (Minn. 1988). But see
71 Fed. Reg. 3933–3936 (2006) (preamble to labeling regulations discussing
the FDA’s recently adopted view that federal drug labeling requirements
preempt conflicting state laws); In re Bextra and Celebrex Marketing
Sales Practices and Prod. Liability Litigation, No. M: 05–1699 CRB, 2006
WL 2374742, *10 (ND Cal., Aug. 16, 2006); Colacicco v. Apotex, Inc., 432
F. Supp. 2d 514, 537–538 (ED Pa. 2006); Needleman v. Pfizer Inc., No. Civ.
A. 3:03–CV–3074–N, 2004 WL 1773697, *5 (ND Tex., Aug. 6, 2004); Dusek
v. Pfizer Inc., No. Civ. A. H–02–3559, 2004 WL 2191804, *10 (SD Tex., Feb.
20, 2004). But cf. 73 Fed. Reg. 2853 (2008) (preamble to proposed rule).
This Court will soon address the issue in Levine v. Wyeth, 183 Vt. 76,
944 A. 2d 179 (2006), cert. granted, post, p. 1161. The question presented
in that case is: “Whether the prescription drug labeling judgments im
posed on manufacturers by the Food and Drug Administration (‘FDA’)
pursuant to FDA’s comprehensive safety and efficacy authority under the
Federal Food, Drug, and Cosmetic Act, 21 U. S. C. § 301 et seq., preempt
state law product liability claims premised on the theory that different
labeling judgments were necessary to make drugs reasonably safe for
use.” Pet. for Cert. in Wyeth v. Levine, O. T. 2007, No. 06–1249, p. i.

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positive defense if it can identify an actual conflict between
the plaintiff ’s theory of the case and the FDA’s premarket
approval of the device in question. As currently postured,
this case presents no occasion to take up this issue for Med
tronic relies exclusively on § 360k(a) and does not argue con
flict preemption.
Second, a medical device manufacturer may be entitled to
interpose a regulatory compliance defense based on the
FDA’s approval of the premarket application. Most States
do not treat regulatory compliance as dispositive, but regard
it as one factor to be taken into account by the jury. See
Sharkey, Federalism in Action: FDA Regulatory Preemption
in Pharmaceutical Cases in State Versus Federal Courts, 15
J. Law & Pol’y 1013, 1024 (2007). See also Restatement
(Third) of Torts § 16(a) (Proposed Final Draft No. 1, Apr. 6,
2005). In those States, a manufacturer could present the
FDA’s approval of its medical device as evidence that it used
due care in the design and labeling of the product.
The Court’s broad reading of § 360k(a) saves the manufac
turer from any need to urge these defenses. Instead, re
gardless of the strength of a plaintiff ’s case, suits will be
barred ab initio. The constriction of state authority or
dered today was not mandated by Congress and is at odds
with the MDA’s central purpose: to protect consumer safety.
* * *
For the reasons stated, I would hold that § 360k(a) does
not preempt Riegel’s suit. I would therefore reverse the
judgment of the Court of Appeals in relevant part.