Riegel v. Medtronic, Inc.

(Slip Opinion) OCTOBER TERM, 2007 1

Syllabus

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

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
federal safety oversight for medical devices while sweeping back state
oversight schemes. The statute provides that a State shall not “es
tablish or continue in effect with respect to a device intended for hu
man use any requirement—. . . (1) which is different from, or in addi
tion 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 de
vice 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 undergo the premarket approval process. These de
vices may enter the market only if the FDA reviews their design, la
beling, and manufacturing specifications and determines that those
specifications provide a reasonable assurance of safety and effective
ness. 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 manufac
tured in a manner that violated New York common law. The District
Court held that the MDA pre-empted the Riegels’ claims of strict li
ability; breach of implied warranty; and negligence in the design,
2 RIEGEL v. MEDTRONIC, INC.

Syllabus

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 Circuit affirmed.
Held: The MDA’s pre-emption clause bars common-law claims challeng
ing the safety or effectiveness of a medical device marketed in a form
that received premarket approval from the FDA. Pp. 8–17.
(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
informed” by an FDA regulation, 21 CFR §808.1(d), which says that
state requirements are pre-empted only when the FDA “has estab
lished specific counterpart regulations or there are other specific re
quirements applicable to a particular device” under federal law.
Premarket approval 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 determined that those specifications provide a rea
sonable assurance of safety and effectiveness. Pp. 8–10.
(b) Petitioner’s common-law claims are pre-empted because they
are based upon New York “requirement[s]” with respect to Med
tronic’s catheter that are “different from, or in addition to” the federal
ones, and that relate to safety and effectiveness, §360k(a). Pp. 10–17.
(i) 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 con
tradicts this normal meaning. Pp. 10–12.
(ii) The Court rejects petitioner’s contention that the duties un
derlying 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. Ti
tle 21 CFR §808.1(d)(1)—which states that MDA pre-emption does
not extend to “[s]tate or local requirements of general applicability
[whose] purpose . . . relates either to other products in addition to de
vices . . . or to unfair trade practices in which the requirements are
not limited to devices”—does not alter the Court’s interpretation.
Pp. 14–17.
(c) The Court declines to address in the first instance petitioner’s
argument that this lawsuit raises “parallel” claims that are not pre
empted by §360k under Lohr, supra, at 495, 513. P. 17.
 Cite as: 552 U. S. ____ (2008) 3

Syllabus

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. STE
VENS, J., filed an opinion concurring in part and concurring in the
judgment. GINSBURG, J., filed a dissenting opinion.
 Cite as: 552 U. S. ____ (2008) 1

Opinion of the Court

NOTICE: This opinion is subject to formal revision before publication in the
preliminary print of the United States Reports. Readers are requested to
notify the Reporter of Decisions, Supreme Court of the United States, Wash
ington, D. C. 20543, of any typographical or other formal errors, in order
that corrections may be made before the preliminary print goes to press.

SUPREME COURT OF THE UNITED STATES
_________________

No. 06–179
_________________

DONNA S. RIEGEL, INDIVIDUALLY AND AS ADMINISTRA-

TOR OF THE ESTATE OF CHARLES R. RIEGEL,

PETITIONER v. MEDTRONIC, INC.

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE SECOND CIRCUIT

[February 20, 2008]

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
effectiveness 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
required 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 Medtronic, 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 notably, the Dalkon Shield intrauterine device,
introduced in 1970, was linked to serious infections and
several deaths, not to mention a large number of pregnan
2 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

cies. 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 demonstrated the inability of the common-
law tort system to manage the risks associated with dan
gerous devices. See, e.g., S. Foote, Managing the Medical
Arms Race 151–152 (1992). Several States adopted regu
latory measures, including California, which in 1970
enacted a law requiring premarket approval of medical
devices. 1970 Cal. Stats. ch. 1573, §§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) (identifying 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 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
requirement applicable under this chapter to the de
vice, and
“(2) which relates to the safety or effectiveness of
the device or to any other matter included in a re
quirement applicable to the device under this chap
ter.” §360k(a).
The exception contained in subsection (b) permits the
FDA to exempt some state and local requirements from

——————
1 Unqualified §360 et seq. numbers hereinafter refer to sections of 21

U. S. C.
 Cite as: 552 U. S. ____ (2008) 3

Opinion of the Court

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
requirements. §360c(a)(1)(A); FDA, Device Advice: Device
Classes, http://www.fda.gov/cdrh/devadvice/3132.html (all
Internet 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.,
is subject in addition to “special controls” such as perform
ance 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
generators, 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 pro
vide reasonable assurance of safety and effectiveness, and
the device is “purported or represented to be for a use in
supporting 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
premarket approval for new Class III devices, it grand-
fathered 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 com
ment, 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 undergo premarket approval if the
FDA finds it is “substantially equivalent” to another de
4 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

vice 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 section of
the MDA describing the review. Most new Class III de
vices enter the market through §510(k). In 2005, for
example, the FDA authorized the marketing of 3,148
devices under §510(k) and granted premarket approval to
just 32 devices. P. Hutt, R. Merrill, & L. Grossman, Food
and Drug Law 992 (3d ed. 2007).
Premarket approval is a “rigorous” process. Lohr, 518
U. S., at 477. A manufacturer must submit what is typi
cally a multivolume application. FDA, Device Advice—
Premarket Approval (PMA) 18, http://www.fda.gov/cdrh/
devadvice/pma/printer.html. It includes, among other
things, full reports of all studies and investigations of the
device’s safety and effectiveness that have been published
or should reasonably be known to the applicant; a “full
statement” of the device’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 installation of, such device”;
samples or device components required by the FDA; and a
specimen of the proposed labeling. §360e(c)(1). Before
deciding whether to approve the application, 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, supra, at 477, and grants premar
ket approval only if it finds there is a “reasonable assur
ance” 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 none
 Cite as: 552 U. S. ____ (2008) 5

Opinion of the Court

theless offer great benefits in light of available alterna
tives. It approved, for example, 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 Radiological Health, Sum
mary of Safety and Probable Benefit 20 (2004), online at
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 pro
posed labeling is neither false nor misleading,
§360e(d)(1)(A).
After completing its review, the FDA may grant or deny
premarket approval. §360e(d). It may also condition
approval on adherence to performance standards, 21 CFR
§861.1(b)(3), restrictions upon sale or distribution, or
compliance 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
proposed form, it may send an “approvable letter” indicat
ing that the device could be approved if the applicant
submitted specified information or agreed to certain condi
tions or restrictions. 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, manufactur
ing processes, labeling, 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,
6 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

and the FDA must approve, an application for supplemen
tal 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
reporting requirements. §360i. These include the obliga
tion to inform the FDA of new clinical investigations or
scientific studies concerning the device which the appli
cant 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 contributed to death or serious injury,
or malfunctioned in a manner that would likely cause or
contribute to death or serious injury if it recurred,
§803.50(a). The FDA has the power to withdraw premar
ket approval based on newly reported data or existing
information and must withdraw approval if it determines
that a device is unsafe or ineffective under the condi-
tions 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
diseased and heavily calcified. Riegel’s doctor inserted the
Evergreen Balloon Catheter into his patient’s coronary
artery in an attempt to dilate the artery, although the
device’s labeling stated that use was contraindicated for
patients with diffuse or calcified stenoses. The label also
 Cite as: 552 U. S. ____ (2008) 7

Opinion of the Court

warned that the catheter should not be inflated beyond its
rated burst pressure of eight atmospheres. Riegel’s doctor
inflated the catheter five times, to a pressure of 10 atmos
pheres; on its fifth inflation, the catheter ruptured. Com
plaint 3. Riegel developed a heart block, was placed on life
support, and underwent 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 per
manent injuries. The complaint raised a number of com
mon-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, distribution, labeling, marketing, and sale of
the catheter. App. to Pet. for Cert. 68a; Complaint 3–4. It
also held that the MDA pre-empted a negligent manufac
turing 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
——————
2 The District Court later granted summary judgment to Medtronic

on those claims of Riegel it had found not pre-empted, viz., that Med
tronic breached an express warranty and was negligent in manufactur
ing because it did not comply with federal standards. App. to Pet. for
Cert. 90a. It consequently granted summary judgment as well on
Donna Riegel’s derivative consortium claim. Ibid. The Court of Ap
peals affirmed these determinations, and they are not before us.
8 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

the federal, device-specific requirement of adhering to the
standards contained in its individual, federally approved”
premarket approval 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 certiorari.3 551 U. S. ___ (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 catheter. If so, we must then determine
whether the Riegels’ common-law claims are based upon
New York requirements with respect to the device that are
“different from, or in addition 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 require
ments are pre-empted “only when the Food and Drug
Administration has established specific counterpart regu
lations or there are other specific requirements applicable
to a particular device . . . .” 21 CFR §808.1(d). Informed
by the regulation, we concluded that federal manufactur
ing and labeling requirements applicable across the board
to almost all medical devices did not pre-empt the com
——————
3 Charles Riegel having died, Donna Riegel is now petitioner on her

own behalf and as administrator of her husband’s estate. 552 U. S. ___
(2007). For simplicity’s sake, the terminology of our opinion draws no
distinction between Charles Riegel and the Estate of Charles Riegel
and refers to the claims as belonging to the Riegels.
 Cite as: 552 U. S. ____ (2008) 9

Opinion of the Court

mon-law claims of negligence and strict liability at issue in
Lohr. The federal requirements, we said, were not re
quirements specific to the device in question—they re
flected “entirely generic concerns about device regulation
generally.” 518 U. S., at 501. While we disclaimed a
conclusion that general federal requirements 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 manufac
turer’s contention that §510(k) approval imposed device-
specific “requirements.” We regarded the fact that prod
ucts entering the market through §510(k) may be mar
keted only so long as they remain substantial equivalents
of the relevant pre-1976 devices as a qualification for an
exemption rather than a requirement. Id., at 493–494; see
also id., at 513 (O’Connor, J., concurring in part and dis
senting in part).
Premarket approval, in contrast, imposes “require
ments” under the MDA as we interpreted it in Lohr.
Unlike general labeling duties, premarket approval is
specific to individual devices. And it is in no sense an
exemption from federal safety review—it is federal safety
review. Thus, the attributes that Lohr found lacking in
§510(k) review are present here. While §510(k) is “ ‘fo
cused on equivalence, not safety,’ ” id., at 493 (opinion of
the Court), premarket approval is focused on safety, not
equivalence. While devices that enter the market through
§510(k) have “never been formally reviewed under the
MDA for safety or efficacy,” ibid., the FDA may grant
premarket approval only after it determines 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
10 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

equivalent “take any particular form for any particular
reason,” ibid., at 493, the FDA requires a device that has
received premarket approval to be made with almost no
deviations from the specifications in its approval applica
tion, 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
Riegels’ common-law claims rely upon “any requirement”
of New York law applicable to the catheter that is “differ
ent from, or in addition to” federal requirements and that
“relates to the safety or effectiveness of the device or to
any other matter included in a requirement applicable to
the device.” §360k(a). Safety and effectiveness are the
very subjects 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 im
pose “requirement[s]” and would be pre-empted by federal
requirements 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 (opinion of
BREYER, J.). We adhere to that view. In interpreting two
other statutes we have likewise 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, Fungicide, and Roden
ticide Act that said certain States “ ‘shall not impose or
continue in effect any requirements for labeling or packag
ing in addition to or different from those required under
 Cite as: 552 U. S. ____ (2008) 11

Opinion of the Court

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
Smoking 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 advertising 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 “require
ments” includes its common-law duties. As the plurality
opinion said in Cipollone, common-law liability is “prem
ised on the existence of a legal duty,” and a tort judgment
therefore establishes 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
legislation excluding common-law duties from the scope of
pre-emption would make little sense. State tort law that
requires a manufacturer’s catheters to be safer, but hence
less effective, than the model the FDA has approved dis
rupts 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 stat
ute, 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
12 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

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 dan
gerous design, and is not concerned with its benefits; the
patients who reaped those benefits are not represented in
court. As JUSTICE BREYER explained in Lohr, it is implau
sible that the MDA was meant to “grant greater power (to
set state standards ‘different from, or in addition to’ fed
eral standards) to a single state jury than to state officials
acting through state administrative or legislative lawmak
ing processes.” 518 U. S., at 504. That perverse distinc
tion is not required or even suggested by the broad lan
guage Congress chose in the MDA,4 and we will not turn
somersaults to create it.
B
The dissent would narrow the pre-emptive scope of the
term “requirement” on the grounds that it is “difficult to
believe that Congress would, without comment, remove all
means of judicial recourse” for consumers injured by FDA-
approved devices. Post, at 5 (opinion of GINSBURG, J.)
(internal quotation marks omitted). But, as we have
explained, 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
——————
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.
 Cite as: 552 U. S. ____ (2008) 13

Opinion of the Court

report on pain of judicial nullification. See, e.g., Connecti
cut 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 avail
able— 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 with
out 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 posi
tion taken by our opinion with regard to the meaning of
the statute. 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 6, 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 v. Mead Corp., 533
U. S. 218 (2001); Good Samaritan Hospital 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 5–6, 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 7–11. Two points render the conclusion

——————
5 Contrary to JUSTICE STEVENS’ contention, post, at 2, we do not “ad
vance” this argument. We merely suggest that if one were to speculate
upon congressional purposes, the best evidence for that would be found
in the statute.
14 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

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 negli
gence, strict-liability, and implied-warranty claims are not
pre-empted even if they impose “ ‘requirements,’ ” because
general common-law duties are not requirements main
tained “ ‘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 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

——————
6 The opinions joined by these five Justices dispose of the Riegels’

assertion that Lohr held common-law duties were too general to qualify
as duties “with respect to a device.” The majority opinion in Lohr also
disavowed this conclusion, for it stated that the Court did “not believe
that [the MDA’s] statutory and regulatory language necessarily pre
cludes . . . ‘general’ state requirements from ever being pre-empted
. . . .” Medtronic, Inc. v. Lohr, 518 U. S. 470, 500 (1996).
 Cite as: 552 U. S. ____ (2008) 15

Opinion of the Court

upon New York’s “continu[ing] in effect” general tort
duties “with respect to” Medtronic’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 purpose of the requirement relates either to
other products in addition to devices (e.g., requirements
such as general electrical codes, and the Uniform Com
mercial Code (warranty of fitness)), or to unfair trade
practices in which the requirements are not limited to
devices.” 21 CFR §808.1(d)(1). Even assuming that this
regulation could play a role in defining the MDA’s pre
emptive scope, it does not provide unambiguous support
for the Riegels’ position. The agency’s reading of its own
rule is entitled to substantial deference, see Auer v. Rob
bins, 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,
according to the FDA, because the regulation excludes
from pre-emption requirements that relate only inciden
tally to medical devices, but not other requirements.
General tort duties of care, unlike fire codes or restrictions
on trade practices, “directly regulate” the device itself,
including its design. Id., at 28. We find the agency’s
explanation less than compelling, since the same could
be said of general requirements imposed by electrical
codes, the Uniform Commercial Code, or unfair-trade
practice law, which the regulation specifically excludes
16 RIEGEL v. MEDTRONIC, INC.

Opinion of the Court

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
requirements 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 estab
lished by statute, ordinance, regulation, or court decision)
. . . .” (Emphasis added.) This sentence is far more com
prehensible 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 established 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 establish
ing 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 determi
nation 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 reject
ing the 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 requirements 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
 Cite as: 552 U. S. ____ (2008) 17

Opinion of the Court

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
damages remedy for claims premised on a violation of
FDA regulations; 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 dissenting 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 inter
preted the claims here to assert that Medtronic’s device
violated state tort law notwithstanding 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 conten
tion in their briefs before the Second Circuit, nor did they
raise this argument in their petition for certiorari. We
decline to address that argument in the first instance
here.
* * *
For the foregoing reasons, the judgment of the Court of
Appeals is
Affirmed.
 Cite as: 552 U. S. ____ (2008) 1

Opinion of STEVENS, J.

SUPREME COURT OF THE UNITED STATES
_________________

No. 06–179
_________________

DONNA S. RIEGEL, INDIVIDUALLY AND AS ADMINISTRA-

TOR OF THE ESTATE OF CHARLES R. RIEGEL,

PETITIONER v. MEDTRONIC, INC.

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE SECOND CIRCUIT

[February 20, 2008]

JUSTICE STEVENS, concurring in part and concurring in
the judgment.
The significance of the pre-emption provision in the
Medical Device Amendments of 1976 (MDA), 21 U. S. C.
§360k, was not fully appreciated until many years after it
was enacted. It is an example of a statute whose text and
general 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 4–11 (dissenting opinion), I
am persuaded that its text does preempt state law re
quirements 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 reme
dies had impeded the development of medical devices. Nor
is there any evidence at all to suggest that Congress de
cided that the cost of injuries from Food and Drug Admini
2 RIEGEL v. MEDTRONIC, INC.

Opinion of STEVENS, J.

stration-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 innovations.” Ante, at 13 (opinion of the
Court). That is a policy argument advanced by the Court,
not by Congress. As JUSTICE GINSBURG persuasively
explains, the overriding purpose of the legislation was to
provide additional protection to consumers, not to with
draw existing protections. It was the then-recent devel
opment of state premarket regulatory regimes that ex
plained 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 prob
lem of specific, conflicting state statutes and regulations
rather than the general duties enforced by common-law
actions”).
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
“requirements.”1 See Cipollone v. Liggett Group, Inc., 505
U. S. 504, 522 (1992) (“[C]ommon-law damages actions of
the sort raised by petitioner are premised on the existence
——————
1 The verdicts of juries who obey those rules, however, are not “re

quirements” 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 stan
dard that either conforms with or differs from a relevant federal stan
dard. I do not agree with the colorful but inaccurate quotation on page
12 of the Court’s opinion.
 Cite as: 552 U. S. ____ (2008) 3

Opinion of STEVENS, J.

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”
(plurality opinion) (emphasis added)). And although not
all common-law rules qualify as “requirements,”2 the
Court correctly points out that five Justices in Lohr con
cluded that the common-law causes of action for negli
gence and strict liability at issue in that case imposed
“requirements” that were pre-empted by federal require
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 effectiveness. I therefore join the Court’s judgment
and all of its opinion except for Parts III–A and III–B.

——————
2 See Cipollone v. Liggett Group, Inc., 505 U. S., 504, 523 (1992) (plu

rality 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 Ҥ136v(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 particular common-law rules at
issue in that case satisfied the conditions of pre-emption).
 Cite as: 552 U. S. ____ (2008) 1

GINSBURG, J., dissenting

SUPREME COURT OF THE UNITED STATES
_________________

No. 06–179
_________________

DONNA S. RIEGEL, INDIVIDUALLY AND AS ADMINISTRA-

TOR OF THE ESTATE OF CHARLES R. RIEGEL,

PETITIONER v. MEDTRONIC, INC.

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF

APPEALS FOR THE SECOND CIRCUIT

[February 20, 2008]

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
preemption 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 applica
tion for the design or label has gained premarket approval
from the Food and Drug Administration (FDA); a state
damages remedy, the Court instructs, persists only for
claims “premised on a violation of FDA regulations.” Ante,
at 17.1 I dissent from today’s constriction of state author
ity. Congress, in my view, did not intend §360k(a) to effect
a radical curtailment 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 premar
ket regulation of medical devices. Some States acted to fill
the void by adopting their own regulatory systems for
——————
1 TheCourt’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
premarket approval.
2 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

medical devices. Section 360k(a) responded to that state
regulation, and particularly to California’s system of
premarket approval for medical devices, by preempting
State initiatives absent FDA permission. See §360k(b).
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 omit
ted). Courts have “long presumed that Congress does not
cavalierly pre-empt state-law causes of action.” Med
tronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996).2 Preemp
tion 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 Con
gress.” Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230
(1947). “This assumption provides assurance that ‘the
federal-state balance’ will not be disturbed unintentionally
by Congress or unnecessarily 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 regulation 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 regulations,” Hillsborough County v.
Automated Medical Laboratories, Inc., 471 U. S. 707, 718
(1985).
Federal laws containing a preemption clause do not
——————
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 conveying the opinion of the Court.
 Cite as: 552 U. S. ____ (2008) 3

GINSBURG, J., dissenting

automatically 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,
however, courts may face the task of determining the
substance 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 es
tablish 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 this chapter to the de
vice, and
“(2) which relates to the safety or effectiveness of
the device or to any other matter included in a re
quirement applicable to the device under this chap
ter.” 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 11. 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 “re
quirement” should not prompt a sweeping preemption of
mine-run claims for relief under state tort law.3
——————
3 The very next provision, §360k(b), allows States and their political
subdivisions to apply for exemption from the requirements for medical
devices set by the FDA when their own requirements are “more strin
gent” than federal standards or are necessitated by “compelling local
4 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

A
Congress enacted the MDA “to provide for the safety
and effectiveness of medical devices intended for human
use.” 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 Litiga
tion, 693 F. 2d 847, 848 (CA9 1982); ante, at 1–2. Aggres
sively promoted as a safe and effective form of birth con
trol, the Dalkon 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 compensatory and punitive damages totaling more
than $400 million” had been filed. Ibid.6 Given the pub
——————
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.
4 Introducing the bill in the Senate, its sponsor explained: “The legis

lation 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)
(remarks 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 pacemak
ers, 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 example, 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 intrauterine devices.”); 122 Cong. Rec. 5859 (1976)
(remarks of Rep. Waxman) (“A 10-year FDA death-certificate search
found over 850 deaths tied directly to medical devices.”); 121 id., at
10689–10690 (1975) (remarks of Sen. Nelson). See also Medtronic, Inc.
v. Lohr, 518 U. S. 470, 476 (1996).
6 The Dalkon Shield was ultimately linked to “thousands of serious

injuries to otherwise healthy women.” Vladeck, Preemption and
 Cite as: 552 U. S. ____ (2008) 5

GINSBURG, J., dissenting

licity attending the Dalkon Shield litigation and Congress’
awareness of the suits at the time the MDA was under
consideration, I find informative the absence of any sign of
a legislative design to preempt state common-law tort
actions.7
The Court recognizes that Ҥ360k does not prevent a
State from providing a damages remedy for claims prem
ised on a violation of FDA regulations.” Ante, at 17. That
remedy, although important, does not help consumers
injured by devices that receive FDA approval but never
theless prove unsafe. 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 inde
pendent of FDA requirements. It is “difficult to believe
that Congress would, without comment, remove all means
of judicial recourse” for large numbers of consumers in
jured 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
——————
Regulatory Failure, 33 Pepperdine L. Rev. 95, 103 (2005). By October
1984, the manufacturer had settled or litigated approximately 7,700
Dalkon Shield cases. R. Sobol, Bending the Law: The Story of the
Dalkon Shield Bankruptcy 23 (1991).
7 “[N]othing in the hearings, the Committee Reports, or the debates,”

the Lohr plurality noted, “suggest[ed] that any proponent of the legisla
tion 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 Con
gress 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.”).
6 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

tort liability usually operate independently, each pro
viding a significant, yet distinct, layer of consumer
protection. FDA regulation of a device cannot antici
pate 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 protect against all possible injuries
that might result from use of a device over time. Pre
emption 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
——————
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
interpreting 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 consideration, 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 “consis
tency” 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 assessing 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 presumption against pre
emption 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.
 Cite as: 552 U. S. ____ (2008) 7

GINSBURG, J., dissenting

construction of §360k(a) has the “perverse effect” of grant
ing broad immunity “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
“presents 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 opposite: 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 anticipates “[court-awarded]
damages for economic loss” from which the value of any
FDA-ordered remedy would be subtracted. 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

——————
9 The Court regards §360h(d) as unenlightening because it “could not

possibly mean that all state-law claims are not pre-empted” and “pro
vides no guidance as to which state-law claims are pre-empted and
which are not.” Ante, at 12, n. 4. Given the presumption against
preemption operative even in construing a preemption clause, see
supra, at 2–3, the perceived lack of “guidance” should cut against
Medtronic, not in its favor.
8 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

§360k(a) has no bearing on tort suits involving drugs and
additives. But §360k(a)’s confinement to medical devices
hardly renders irrelevant 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 welfare. Congress’ experience regu
lating 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.
Starting in 1938, the FDCA required that new drugs
undergo preclearance by the FDA before they could be
marketed. 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
——————
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
exist[ed].” Hearings on S. 1944 before a Subcommittee of the Senate
Committee 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
personal 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); Roginsky v. Richardson-Merrell, Inc.,
378 F. 2d 832 (CA2 1967) (New York law); Cunningham v. Charles
 Cite as: 552 U. S. ____ (2008) 9

GINSBURG, J., dissenting

clause in the MDA was not motivated by concern that
similar state tort actions could be mounted regarding
medical devices.12 Rather, Congress included §360k(a)
and (b) to empower the FDA to exercise control over state
premarket approval systems installed at a time when
there was no preclearance at the federal level. See supra,
at 3, and n. 3; infra, at 10–11, and n. 14.
Between 1938 and 1976, Congress enacted a series of
premarket approval requirements, first for drugs, then for
additives. Premarket control, as already noted, com
menced with drugs in 1938. In 1958, Congress required
premarket approval for food additives. Food Additives
Amendment, §3, 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, §101, 76
Stat. 781, as amended, 21 U. S. C. §321 et seq. And in
——————
Pfizer & Co., Inc., 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. 695 (ED Wis. 1968). See also infra, at 12, 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 sugges
tion that . . . medical devices should receive an exemption from prod
ucts liability 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 Posi
tion, 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 intended by Congress . . . .”).
10 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

1968, it required premarket approval for new animal
drugs. Animal Drug Amendments, §101(b), 82 Stat. 343,
as amended, 21 U. S. C. §360b. None of these Acts con
tained 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
time of each enactment, no state regulations required
premarket 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. Edward 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
medical devices, some States have established their
own programs. The most comprehensive State regu
lation of which the Committee is aware is that of Cali
fornia, which in 1970 adopted the Sherman Food,
Drug, and Cosmetic Law. This law requires premar
ket approval of all new medical devices, requires com
pliance of device manufacturers with good manufac
turing practices and authorizes inspection of
establishments which manufacture devices. Imple
mentation of the Sherman Law has resulted in the re
quirement that intrauterine devices are subject to
premarket clearance in California.” H. R. Rep. No.

——————
13 The Drug Amendments of 1962 reiterated Congress’ intent not to

preempt 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 positive conflict between such amendments and such provi
sion of State law.” §202, 76 Stat. 793.
 Cite as: 552 U. S. ____ (2008) 11

GINSBURG, J., dissenting

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’
inclusion of a preemption clause in the MDA; no such
clause figures in earlier federal laws regulating drugs and
additives, for States had not installed comparable control
regimes in those areas.
C
Congress’ experience regulating drugs also casts doubt
on Medtronic’s policy arguments for reading §360k(a) to
preempt 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 11–12.
But the process for approving new drugs is at least as
rigorous as the premarket approval process for medical
devices.15 Courts that have considered the question have
——————
14 Congress featured California’s regulatory system in its discussion
of §360k(a), but it also identified California’s system as a prime candi
date for an exemption from preemption under §360k(b).
“[R]equirements imposed under the California statute,” the House
Report noted, “serve as an example of requirements that the Secretary
should authorize to be continued (provided any application submitted
by a State meets requirements pursuant to the reported bill).” H. R.
Rep. No. 94–853, p. 46. Thus Congress sought not to terminate all
state premarket approval systems, but rather to place those systems
under the controlling authority of the FDA.
15 The process for approving a new drug begins with preclinical labo

ratory 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); 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 complet
12 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

overwhelmingly held that FDA approval of a new drug
application does not preempt state tort suits.16 Decades of
——————
ing 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 de
scription of the drug’s manufacturing, processing, and packaging; and
the proposed labeling for the drug. 21 U. S. C. §355(b)(1).
16 See, e.g., Tobin v. Astra Pharmaceutical Prods., Inc., 993 F. 2d 528,

537–538 (CA6 1993); Hill v. Searle Labs., 884 F. 2d 1064, 1068 (CA8
1989); In re Vioxx Prods. Liability Litigation, 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 Pharmaceu
tical 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
ex rel. DeAngelis v. Pfizer, Inc., No. Civ. 05–1286 (JBS), 2006 WL
2819046, *5 (D. NJ, Sept. 26, 2006); Jackson v. Pfizer, Inc., 432
F. Supp. 2d 964, 968 (Neb. 2006); Laisure-Radke v. Par Pharmaceuti
cal, 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, *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 Pharmaceuti
cals 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 discuss
ing FDA’s recently adopted view that federal drug labeling require
ments preempt conflicting state laws); In re Bextra & Celebrex Market
ing Sales Practices & 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, No. 2004–
384, 2006 WL 3041078 (Vt., Oct. 27, 2006), cert. granted, 552 U. S. ___
(2008). The question presented in that case is: “Whether the prescrip
tion drug labeling judgments imposed on manufacturers by the Food
and Drug Administration (‘FDA’) pursuant to FDA’s comprehensive
safety and efficacy authority under the Federal Food, Drug, and Cos
 Cite as: 552 U. S. ____ (2008) 13

GINSBURG, J., dissenting

drug 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
premarket approval of Medtronic’s medical device applica
tion irrelevant to the instant suit. First, a “pre-emption
provision, by itself, does not foreclose (through negative
implication) any possibility of implied conflict preemp
tion.” Geier v. American Honda Motor Co., 529 U. S. 861,
869 (2000) (brackets and internal quotation marks omit
ted). See also Freightliner Corp. v. Myrick, 514 U. S. 280,
288–289 (1995). Accordingly, a medical device manufac
turer may have a dispositive 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 ques
tion. As currently postured, this case presents no occasion
to take up this issue for Medtronic relies exclusively on
§360k(a) and does not argue conflict 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 Pre
emption 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
——————
metic 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.
14 RIEGEL v. MEDTRONIC, INC.

GINSBURG, J., dissenting

evidence that it used due care in the design and labeling of
the product.
The Court’s broad reading of §360k(a) saves the manu
facturer from any need to urge these defenses. Instead,
regardless 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.