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.