OPINION OF THE COURT RIEGEL V. MEDTRONIC, INC. 552 U. S. ____ (2008) 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 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 demonstrated the inability of the
common-law tort system to manage 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 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. ,[ Footnote 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 requirement 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 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 performance 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 provide
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 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 undergo premarket approval if the FDA finds it
is “substantially 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 section of the MDA describing the review. Most new Class
III devices 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 typically 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 premarket approval 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 benefits in
light of available alternatives. 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, Summary 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 proposed 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 regulation. §360j(e)(1).

															   If the FDA is unable to approve a new device
in its proposed 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
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, manufacturing 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, and the FDA must approve, 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 reporting 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 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 premarket
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 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 atmospheres; on its fifth inflation, the
catheter ruptured. Complaint 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 Medtronic’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,
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 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.[ Footnote 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 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.[ Footnote 3 ]
551 U. S. ___ (2007).

															II

															   Since the MDA expressly pre-empts
only state requirements “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
requirements are pre-empted “only when the Food and Drug
Administration has established specific counterpart regulations or
there are other specific requirements applicable to a particular
device . . . .” 21 CFR §808.1(d). Informed by the regulation, we
concluded that federal manufacturing and labeling requirements
applicable across the board to almost all medical devices did not
pre-empt the common-law claims of negligence 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 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
manufacturer’s contention that §510(k) approval imposed
device-specific “requirements.” 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
requirement. 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 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 “ ‘focused 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 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 application,
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
“different 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 impose “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 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 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
“requirements” includes its common-law duties. As the plurality
opinion said in Cipollone, common-law liability is
“premised 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 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
represented 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,[ Footnote 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 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.[ Footnote 5 ]

															   In the case before us, the FDA
has supported the position 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
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 general 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.).[ Footnote 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 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 Commercial 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. 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, according to the FDA, because the regulation excludes
from pre-emption requirements that relate only incidentally 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 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 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 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 regulation’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 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 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 interpreted 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. Footnote 1 Unqualified §360 et seq. numbers
hereinafter refer to sections of 21 U. S. C. Footnote 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 Riegel’s derivative
consortium claim. Ibid . The Court of Appeals affirmed
these determinations, and they are not before us. Footnote 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. Footnote 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. Footnote 5 Contrary to Justice Stevens’ contention, post, at 2, we do not “advance” 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. Footnote 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 precludes . . . ‘general’ state requirements from ever
being pre-empted . . . .” Medtronic, Inc. v. Lohr, 518 U. S. 470 , 500 (1996). OPINION OF STEVENS, J. RIEGEL V. MEDTRONIC, INC. 552 U. S. ____ (2008) 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 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 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 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”).

															   But the language of the provision reaches
beyond such regulatory regimes to encompass other types of
“requirements.” Because common-law rules administered
by judges, like statutes and regulations, create and define legal
obligations, some of them unquestionably qualify as
“requirements.”[ Footnote 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 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,”[ Footnote 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 requirements 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. Footnote 1 The verdicts of juries who obey
those rules, however, are not “requirements” 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 on page 12 of the
Court’s opinion. Footnote 2 See Cipollone v. Liggett Group, Inc., 505 U. S., 504, 523 (1992) (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 “§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 particular common-law rules at issue in that
case satisfied the conditions of pre-emption). GINSBURG, J., DISSENTING RIEGEL V. MEDTRONIC, INC. 552 U. S. ____ (2008) 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 application 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.[ Footnote 1 ] I dissent from today’s constriction of state
authority. 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
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 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 omitted). Courts have “long
presumed that Congress does not cavalierly pre-empt state-law
causes of action.” Medtronic, Inc. v. Lohr , 518 U. S. 470 , 485 (1996).[ Footnote 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 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 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
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 requirement 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.” 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
indication” is not “[a]bsent.” Contextual examination of the Act
convinces me that §360k(a)’s inclusion of the term “requirement”
should not prompt a sweeping preemption of mine-run claims for
relief under state tort law.[ Footnote 3 ]

															A

															   Congress enacted the MDA “to
provide for the safety and effectiveness of medical devices
intended for human use.” 90 Stat. 539 (preamble).[ Footnote 4 ] A series of high-profile medical
device failures that caused extensive injuries and loss of life
propelled adoption of the MDA.[ Footnote 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 1–2. Aggressively promoted as a safe and
effective form of birth control, 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.[ Footnote 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 informative the
absence of any sign of a legislative design to preempt state
common-law tort actions.[ Footnote
7 ]

															   The Court recognizes that “§360k
does not prevent a State from providing a damages remedy for claims
premised 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 nevertheless 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
independent of FDA requirements. It is “difficult to believe that
Congress would, without comment, remove all means of judicial
recourse” for large numbers 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 providing a significant, yet distinct, layer of consumer
protection. 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 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. Kernats , 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).[ Footnote 8 ] The Court’s construction of §360k(a) has the
“perverse effect” of granting 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.[ Footnote 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 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 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.

															   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.[ Footnote 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.[ Footnote 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.[ Footnote 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, commenced 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 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 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.[ Footnote 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 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 manufacture devices.
Implementation of the Sherman Law has resulted in the requirement that intrauterine devices are subject to
premarket clearance in California.” H. R. Rep. No. 94–853,
p. 45 (emphasis added).[ Footnote 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.[ Footnote
15 ] Courts that have considered the question have
overwhelmingly held that FDA approval of a new drug application
does not preempt state tort suits.[ Footnote 16 ] Decades of 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
application irrelevant to the instant suit. First, a “pre-emption
provision, by itself, does not foreclose (through negative
implication) 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
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 question. 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 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 manufacturer 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
ordered 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. Footnote 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 premarket
approval. Footnote 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. Footnote 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 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. Footnote 4 Introducing the bill in the Senate, its
sponsor explained: “The legislation 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). Footnote 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 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). Footnote 6 The Dalkon Shield was ultimately linked to
“thousands of serious injuries to otherwise healthy women.”
Vladeck, Preemption and 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). Footnote 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.”). Footnote 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 “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
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 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. Footnote 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 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. Footnote 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.”). Footnote 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
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). Footnote 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
that … medical devices should receive an exemption from products
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 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 intended by Congress … .”). Footnote 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 provision of State law.” §202, 76 Stat.
793. Footnote 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 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. Footnote 15 The process for approving a new drug begins
with preclinical laboratory 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
completing the clinical trials, the sponsor files a new drug
application containing, 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). Footnote 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 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 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
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, *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 FDA’s recently adopted view that
federal drug labeling requirements preempt conflicting state laws); In re Bextra & Celebrex Marketing 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 prescription 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 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.

Summary: In the case of Riegel v. Medtronic, Inc., the Supreme Court ruled that common-law claims challenging the safety and effectiveness of a medical device are pre-empted by federal law, specifically the Medical Device Amendments of 1976, if the device has received premarket approval from the Food and Drug Administration (FDA). This ruling sets a precedent for the pre-emption of state-level tort claims related to medical devices that have undergone FDA approval.