OCTOBER TERM, 1995
Syllabus
MEDTRONIC, INC.
v. LOHR ET VIR
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE
ELEVENTH CIRCUIT
No. 95-754. Argued April 23, 1996-Decided June 26,1996*
Enacted "to provide for the safety and effectiveness of medical
devices intended for human use," the Medical Device Amendments of
1976 (MDA or Act) classifies such devices based on the risk that
they pose to the public. Class III devices pose the greatest risk
and, thus, are subject to a rigorous premarket approval (PMA)
process. However, most Class III devices on the market have not
been through the PMA process due to two statutory exceptions.
Realizing that existing devices could not be withdrawn from the
market while the Food and Drug Administration (FDA) completed PMA
analyses, Congress included a provision allowing pre-1976 devices
to remain on the market without FDA approval until the requisite
PMA is completed. The Act also permits devices that are
"substantially equivalent" to pre-existing devices to avoid the PMA
process until the FDA initiates the process for the underlying
device. The FDA uses a "premarket notification" submitted by all
manufacturers (§ 510(k) process) to determine substantial
equivalence for Class III devices. Petitioner Medtronic, Inc.'s
pacemaker is a Class III device found substantially equivalent
under the § 510(k) process. Cross-petitioners, Lora Lohr and her
spouse, filed a Florida state-court suit alleging both negligence
and strict-liability claims in the failure of her Medtronic
pacemaker, but Medtronic removed the case to the Federal District
Court. That court ultimately dismissed the complaint as having been
pre-empted by 21 U. S. C. § 360k(a), which provides that "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 [the MDA] 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 [the Act]." The Court of Appeals reversed in part and
affirmed in part, concluding that the Lohrs' negligent design
claims were not pre-empted, but that their negligent manufacturing
and failure to warn claims were.
*Together with No. 95-886,
Lohr et vir v.
Medtronic,
Inc., also on certiorari to the same court.
471
Held: The judgment is reversed in part and affirmed in
part, and the cases are remanded.
56 F.3d
1335, reversed in part, affirmed in part, and remanded.
JUSTICE STEVENS delivered the opinion of the Court with respect
to Parts I, II, III, V, and VII, concluding that the MDA does not
pre-empt the Lohrs' common-law claims. Pp. 484-486; 492-502;
503.
(a) While the Court need not go beyond § 360k(a)'s pre-emptive
language to determine whether Congress intended the MDA to pre-empt
at least some state law, see
Cipollone v.
Liggett Group,
Inc., 505 U. S.
504,517, "the domain expressly pre-empted" by that language
must be identified,
ibid. Interpretation of the text is
informed by the assumptions that the States' historic police powers
cannot be superseded by a Federal Act unless that is Congress'
clear and manifest purpose,
Rice v.
Santa Fe Elevator
Corp., 331 U. S.
218, 230, and that any understanding of a pre-emption statute's
scope rests primarily on "a fair understanding of
congressional
purpose," Cipollone, 505 U. S., at 530, n.27. Pp.484-486.
(b) The Lohrs' negligent design claims are not pre-empted. The
FDA's "substantially equivalent" determination as well as its
continuing authority to exclude a device from the market do not
amount to a specific, federally enforceable design requirement that
would be affected by state-law pressures such as those imposed
here. Since the § 510(k) process is focused on
equivalence,
not safety, substantial equivalence determinations provide little
protection to the public. Neither the statutory scheme nor
legislative history suggests that the § 51O(k) process was intended
to do anything other than maintain the status quo, which included
the possibility that a device's manufacturer would have to defend
itself against state-law negligent design claims. Pp. 492-494.
(c) Section 360k(a) does not pre-empt state rules that merely
duplicate the FDA's rules regulating manufacturing practices and
labeling. That the state requirements may be narrower than the
federal rules does not make them "different" under §360k. Nor does
the presence of a damages remedy amount to an additional or
different "requirement"; it merely provides another reason for
manufacturers to comply with identical existing federal law
"requirements." This view is supported by the regulations of the
FDA, to which Congress has delegated authority to implement the
MDA. Pp. 494-497.
(d) The Lohrs' manufacturing and labeling claims are not
pre-empted.
Although the statutory and regulatory language may not preclude
"general" federal requirements from ever pre-empting state
requirements, or "general" state requirements from ever being
pre-empted, it is impossible to ignore its overarching concern that
pre-emption occur only
472
Syllabus
where a particular state requirement threatens to interfere with
a specific federal interest. State requirements must be "with
respect to" medical devices and "different from, or in addition
to," federal requirements. They must also relate "to the safety or
effectiveness of the device or to any other matter included in a
requirement applicable to the device," and the regulations provide
that state requirements of general applicability are pre-empted
only where they have "the effect of establishing a substantive
requirement for a specific device." Federal requirements must be
"applicable to the device" in question, and, according to the
regulations, pre-empt state law only if they are "specific
counterpart regulations" or "specific" to a "particular device."
The federal manufacturing and labeling requirements at issue
reflect important but entirely generic concerns about device
regulation generally, not the sort of concerns regarding a specific
device or field of device regulation which the statute or
regulations were designed to protect from potentially contradictory
state requirements. Similarly, Florida's commonlaw requirements
were not specifically developed "with respect to" medical devices
and, thus, are not the kinds of requirements that Congress and the
FDA feared would impede implementation and enforcement of specific
federal requirements. Pp. 497-502.
JUSTICE STEVENS, joined by JUSTICE KENNEDY, JUSTICE SOUTER, and
JUSTICE GINSBURG, concluded in Part IV that Medtronic's argument
that any common-law cause of action is a "requirement" under §
360k(a) is implausible, for it would grant complete immunity from
design defect liability to an entire industry that, in Congress'
judgment, needed more stringent regulation. It would take language
much plainer than § 360k's text to do that. The word "requirement,"
which appears to presume that the State is imposing a specific duty
upon the manufacturer, would be an odd term to use to indicate the
sweeping pre-emption Medtronic urges here.
Cipollone, 505 U.
S., at 521-522, distinguished. The legislation's basic purpose and
history entirely support the rejection of such an extreme position.
Pp. 486-491.
JUSTICE BREYER concluded that, although the MDA will sometimes
pre-empt a state-law tort suit, it does not pre-empt the claims at
issue here. First, since the MDA's pre-emption provision is highly
ambiguous, Congress must have intended that courts look elsewhere
for help as to just which federal requirements pre-empt just which
state requirements, as well as just how they might do so. Second,
in the absence of a clear congressional command as to pre-emption,
courts may infer that the relevant administrative agency possesses
a degree of leeway to determine which rules, regulations, or other
administrative actions will have pre-emptive effect. See
Hillsborough County v.
Automated Medical Laboratories,
Inc., 471 U. S.
707, 721. Third, the FDA's regula-
473
tions indicate that the FDA does not consider that its
requirements pre-empt the state requirements at issue here. Fourth,
ordinary principles of "conflict" and "field" pre-emption support
the conclusion that plaintiffs' tort claims are not pre-empted. Pp.
503-508.
STEVENS, J., announced the judgment of the Court and delivered
the opinion of the Court with respect to Parts I, II, III, V, and
VII, in which KENNEDY, SOUTER, GINSBURG, and BREYER, JJ., joined,
and an opinion with respect to Parts IV and VI, in which KENNEDY,
SOUTER, and GINSBURG, JJ., joined. BREYER, J., filed an opinion
concurring in part and concurring in the judgment,
post, p.
503. O'CONNOR, J., filed an opinion concurring in part and
dissenting in part, in which REHNQUIST, C. J., and SCALIA and
THOMAS, JJ., joined,
post, p. 509.
Arthur Miller argued the cause for Medtronic, Inc., in both
cases. With him on the briefs were Daniel G. Jarcho, Donald R.
Stone, Kenneth S. Geller, Roy T. Englert, Jr., Alan E. Untereiner,
Dennis P. Waggoner, Ronald E. Lund, John W Borg, and Sue R.
Halverson.
Brian Wolfman argued the cause for Lohr et vir in both cases.
With him on the brief were Allison M. Zieve, Alan B. Morrison,
Laurence H. Tribe, Robert L. Cowles, and Robert F. Spohrer.
Deputy Solicitor General Kneedler argued the cause for the
United States as amicus curiae. With him on the brief were
Solicitor General Days, Deputy Assistant Attorney General Preston,
Richard H. Seamon, and Douglas N. Letter.t
tBriefs of
amici curiae were filed for the State of
California by
Daniel E. Lungren, Attorney General,
Roderick E. Walston, Chief Assistant Attorney General,
Theodora Berger, Assistant Attorney General, and
Susan S.
Fiering, Deputy Attorney General; for the
State of Florida et al. by
Robert A. Butterworth, Attorney
General of Florida, and
Louis F.
Hubener and
Charley McCoy, Assistant Attorneys General, joined by the
Attorneys General for their respective jurisdictions as follows:
Winston Bryant of Arkansas,
Gale A. Norton of
Colorado,
Richard Blumenthal of Connecticut,
Pamela
Carter of Indiana,
A. B. Chandler III of Kentucky,
Andrew Ketterer of Maine,
J. Joseph Curran,
Jr., of Maryland,
Mike Moore of Mississippi,
Jeremiah
W Nixon of Missouri,
Joseph P. Mazurek of Montana,
Tom Udall of New Mexico,
Dennis C.
Vacco of
New York,
Michael
474
JUSTICE STEVENS announced the judgment of the Court and
delivered the opinion of the Court with respect to Parts I, II,
III, V, and VII, and an opinion with respect to Parts IV and VI, in
which JUSTICE KENNEDY, JUSTICE SOUTER, and JUSTICE GINSBURG
join.
Congress enacted the Medical Device Amendments of 1976, in the
words of the statute's preamble, "to provide for the safety and
effectiveness of medical devices intended for human use." 90 Stat.
539. The question presented is whether that statute pre-empts a
state common-law negligence action against the manufacturer of an
allegedly defective medical device. Specifically, we must consider
whether Lora Lohr, who was injured when her pacemaker failed, may
rely on Florida common law to recover damages from Medtronic, Inc.,
the manufacturer of the device.
F.
Easley of North Carolina,
Heidi Heitkamp of
North Dakota,
Theodore R. Kulongoski of Oregon,
Mark
Barnett of South Dakota,
Charles W Burson of Tennessee,
Dan Morales of Texas, and
Darrell V. McGraw, Jr., of
West Virginia; for the American Association of Retired Persons et
al. by
David Halperin; for the American Insurance
Association et al. by
Victor E. Schwartz, Joseph N. Onek, Robert
P. Charrow, Mark A. Behrens, and
Jan S.
Amundson;
for the Association of Trial Lawyers of America by
Jeffrey
Robert White and
Pamela A. Liapakis; for the Center for
Patient Advocacy et al. by
John G.
Roberts, Jr.; for
Collagen Corp. by
Joe W Redden, Jr., Keith A. Jones, and
Frederick D. Baker; for General Motors Corp. by
Kenneth W
Starr, Richard A. Cordray, Paul T. Cappuccio, David M. Heilbron,
Leslie G.
Landau, and
James A. Durkin; for the
Health Industry Manufacturers Association et al. by
Bruce N.
Kuhlik, Paul J. Maloney, and
William
J. Carter; for the Medical Device Manufacturers
Association by
Stephen S.
Phillips and
James M.
Beck; for the National Conference of State Legislatures et al.
by
Richard Ruda and
Lee Fennell; for the Plaintiffs'
Legal Committee in MDL Docket No. 1014 by
Stanley M. Chesley,
John J. Cummings III, Calvin Fayard, Jr., Wendell
Gauthier, Darryl J. Tschirn, and
Michael D.
Fishbein; for the Product Liability Advisory Council, Inc., by
Robert N. Weiner and
Hugh F.
Young, Jr.; for
Trial Lawyers for Public Justice, P.
C., by
Jonathan
S.
Massey and
Arthur H. Bryant; for the Washington
Legal Foundation by
Daniel J. Popeo and
Richard A. Samp; and for Two Products Liability Law
Professors by
Richard N. Pearson, pro se.
475
I
Throughout our history the several States have exercised their
police powers to protect the health and safety of their citizens.
Because these are "primarily, and historically, ... matter[s] of
local concern,"
Hillsborough County v.
Automated Medical
Laboratories, Inc., 471 U. S. 707, 719
(1985), the "States traditionally have had great latitude under
their police powers to legislate as to the protection of the lives,
limbs, health, comfort, and quiet of all persons,"
Metropolitan
Life Ins. Co. v.
Massachusetts, 471 U. S. 724, 756 (1985)
(internal quotation marks omitted).
Despite the prominence of the States in matters of public health
and safety, in recent decades the Federal Government has played an
increasingly significant role in the protection of the health of
our people. Congress' first significant enactment in the field of
public health was the Food and Drug Act of 1906, a broad
prohibition against the manufacture or shipment in interstate
commerce of any adulterated or misbranded food or drug. See 34
Stat. 768; Regier, The Struggle for Federal Food and Drugs
Legislation, 1 Law & Contemp. Prob. 1 (1933). Partly in
response to an ongoing concern about radio and newspaper
advertising making false therapeutic claims for both "quack
machines" and legitimate devices such as surgical instruments and
orthopedic shoes, in 1938 Congress broadened the coverage of the
1906 Act to include misbranded or adulterated medical devices and
cosmetics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA),
§§501, 502, 52 Stat. 1049-1051; Cavers, The Food, Drug, and
Cosmetic Act of 1938: Its Legislative History and Its Substantive
Provisions, 6 Law & Contemp. Prob. 2 (1939); H. R. Rep. No.
94-853, p. 6 (1976).
While the FDCA provided for pre market approval of new drugs,
Cavers, 6 Law & Contemp. Prob., at 40, it did not authorize any
control over the introduction of new medical devices, see S. Rep.
No. 93-670, pp. 1-2 (1974); H. R. Rep. No. 94-853, at 6. As
technologies advanced and medicine
476
relied to an increasing degree on a vast array of medical
equipment "[f]rom bedpans to brainscans," 1 including kidney
dialysis units, artificial heart valves, and heart pacemakers,2
policymakers and the public became concerned about the increasingly
severe injuries that resulted from the failure of such devices. See
generally Finck, The Effectiveness of FDA Medical Device
Regulation, 7 U. C. D. L. Rev. 293, 297301 (1974); H. R. Rep. No.
94-853, at 7.
In 1970, for example, the Dalkon Shield, an intrauterine
contraceptive device, was introduced to the American public and
throughout the world. Touted as a safe and effective contraceptive,
the Dalkon Shield resulted in a disturbingly high percentage of
inadvertent pregnancies, serious infections, and even, in a few
cases, death.
Id., at 8; Regulation of Medical Devices
(Intrauterine Contraceptive Devices), Hearings before a
Subcommittee of the House Committee on Government Operations, 93d
Cong., 1st Sess. (1973). In the early 1970's, several other
devices, including catheters, artificial heart valves,
defibrillators, and pacemakers (including pacemakers manufactured
by petitioner Medtronic), attracted the attention of consumers, the
Food and Drug Administration (FDA), and Congress as possible health
risks. See Medical Device Amendments, 1973, Hearings before the
Subcommittee on Health of the Senate Committee on Labor and Public
Welfare, 93d Cong., 2d Sess., 270-361 (1973).
In response to the mounting consumer and regulatory concern,
Congress enacted the statute at issue here: the Medical Device
Amendments of 1976 (MDA or Act), 90 Stat. 539. The Act classifies
medical devices in three categories based on the risk that they
pose to the public. Devices that pre-
1 Medical Device Regulation: The FDA's Neglected Child
(Committee Print compiled for the Subcommittee on Oversight and
Investigations of the House Committee on Energy and Commerce),
Comm. Print 98-F,
2 S. Rep. No. 94-33, p. 5 (1975).
477
sent no unreasonable risk of illness or injury are designated
Class I and are subject only to minimal regulation by "general
controls." 21 U. S. C. § 360c(a)(1)(A). Devices that are
potentially more harmful are designated Class II; although they may
be marketed without advance approval, manufacturers of such devices
must comply with federal performance regulations known as "special
controls." § 360c(a)(1)(B). Finally, devices that either "presen[t]
a potential unreasonable risk of illness or injury," or which are
"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," are
designated Class III. § 360c(a)(1)(C). Pacemakers are Class III
devices. See 21 CFR § 870.3610 (1995).
Before a new Class III device may be introduced to the market,
the manufacturer must provide the FDA with a "reasonable assurance"
that the device is both safe and effective. See 21 U. S. C. §
360e(d)(2). Despite its relatively innocuous phrasing, the process
of establishing this "reasonable assurance," which is known as the
"pre market approval," or "PMA" process, is a rigorous one.
Manufacturers must submit detailed information regarding the safety
and efficacy of their devices, which the FDA then reviews, spending
an average of 1,200 hours on each submission. Hearings before the
Subcommittee on Health and the Environment of the House Committee
on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34),
p. 384 (1987) (hereinafter 1987 Hearings); see generally Kahan, Pre
market Approval Versus Pre market Notification: Different Routes to
the Same Market, 39 Food Drug Cosmo L. J. 510, 512-514 (1984).
Not all, nor even most, Class III devices on the market today
have received premarket approval because of two important
exceptions to the PMA requirement. First, Congress realized that
existing medical devices could not be
478
withdrawn from the market while the FDA completed its PMA
analysis for those devices. The statute therefore includes a
"grandfathering" provision which allows pre-1976 devices to remain
on the market without FDA approval until such time as the FDA
initiates and completes the requisite PMA. See 21 U. S. C.
§360e(b)(1)(A); 21 CFR §814.1(c)(1) (1995).3 Second, to prevent
manufacturers of grandfathered devices from monopolizing the market
while new devices clear the PMA hurdle, and to ensure that
improvements to existing devices can be rapidly introduced into the
market, the Act also permits devices that are "substantially
equivalent" to pre-existing devices to avoid the PMA process. See
21 U. S. C. § 360e(b)(1)(B).
Although "substantially equivalent" Class III devices may be
marketed without the rigorous PMA review, such new devices, as well
as all new Class I and Class II devices, are subject to the
requirements of § 360(k). That section imposes a limited form of
review on every manufacturer intending to market a new device by
requiring it to submit a "premarket notification" to the FDA (the
process is also known as a "§ 510(k) process," after the number of
the section in the original Act). If the FDA concludes on the basis
of the § 510(k) notification that the device is "substantially
equivalent" to a pre-existing device, it can be marketed without
further regulatory analysis (at least until the FDA initiates the
PMA process for the underlying pre-1976 device to which the new
device is "substantially equivalent"). The § 510(k) notification
process is by no means comparable to the PMA
3 The FDA has not yet initiated nor suggested the initiation of
a PMA process for pacemakers or most other grandfathered devices.
But see 60 Fed. Reg. 41984, 41986 (1995) (pursuant to Safe Medical
Devices Act of 1990, 104 Stat. 4511, calling for submission of
information by February 1997 which may lead the FDA to reclassify
or initiate PMA process at some time in the future for implantable
pacemaker pulse generators and lead adapters).
479
process; in contrast to the 1,200 hours necessary to complete a
PMA review, the § 510(k) review is completed in an average of only
20 hours. See 1987 Hearings, at 384. As one commentator noted: "The
attraction of substantial equivalence to manufacturers is clear.
[Section] 510(k) notification requires little information, rarely
elicits a negative response from the FDA, and gets processed very
quickly." Adler, The 1976 Medical Device Amendments: A Step in the
Right Direction Needs Another Step in the Right Direction, 43 Food
Drug Cosmo L. J. 511, 516 (1988); see also Kahan, 39 Food Drug
Cosmo L. J., at 514-519.
Congress anticipated that the FDA would complete the PMA process
for Class III devices relatively swiftly. But because of the
substantial investment of time and energy necessary for the
resolution of each PMA application, the ever-increasing numbers of
medical devices, and internal administrative and resource
difficulties, the FDA simply could not keep up with the rigorous
PMA process. As a result, the § 510(k) premarket notification
process became the means by which most new medical
devices-including Class III devices-were approved for the market.
In 1983, for instance, a House Report concluded that nearly 1,000
of approximately 1,100 Class III devices that had been introduced
to the market since 1976 were admitted as "substantial equivalents"
and without any PMA review. See Medical Device Regulation: The
FDA's Neglected Child (Committee Print compiled for the
Subcommittee on Oversight and Investigations of the House Committee
on Energy and Commerce), Comm. Print 98-F, p. 34 (1983). This
lopsidedness has apparently not evened out; despite an increasing
effort by the FDA to consider the safety and efficacy of
substantially equivalent devices, the House reported in 1990 that
80% of new Class III devices were being introduced to the market
through the § 510(k) process and without PMA review. H. R. Rep. No.
101-808, p. 14 (1990); see also D. Kessler, S. Pape, &
480
D. Sundwall, The Federal Regulation of Medical Devices, 317 New
England J. Med. 357, 359 (1987) (55 § 510(k) notifications are
filed for each PMA application; average FDA response to § 510(k)
notification is one-fifth the response time to a PMA).4
II
As have so many other medical device manufacturers, petitioner
Medtronic took advantage of § 510(k)'s expedited process in October
1982, when it notified the FDA that it intended to market its Model
4011 pacemaker lead as a device that was "substantially equivalent"
to devices already on the market. (The lead is the portion of a
pacemaker that transmits the heartbeat-steadying electrical signal
from the "pulse generator" to the heart itself.) On November 30,
1982, the FDA found that the model was "substantially equivalent to
devices introduced into interstate commerce" prior to the effective
date of the Act, and advised Medtronic that it could therefore
market its device subject only to the general control provisions of
the Act, which could be found in the Code of Federal Regulations.
See Respondent's Memorandum in Support of Motion for Summary
Judgment in No. 93-482 (MD Fla., Nov. 1, 1993), Exh. A to Exh. 1
(Declaration of Charles H. Swanson) (hereinafter FDA Substantial
Equivalence Letter). The agency emphasized, however, that this
determination should not be construed as an endorsement of the
pacemaker lead's safety.
Ibid.
Cross-petitioner Lora Lohr is dependent on pacemaker technology
for the proper functioning of her heart. In 1987 she was implanted
with a Medtronic pacemaker equipped with one of the company's Model
4011 pacemaker leads. On
4 In 1990, Congress enacted amendments to the MDA which were
designed to reduce the FDA's reliance on the § 510(k) process while
continuing to ensure that particularly risky devices received full
PMA review. See Safe Medical Devices Act of 1990.
481
December 30, 1990, the pacemaker failed, allegedly resulting in
a "complete heart block" that required emergency surgery. According
to her physician, a defect in the lead was the likely cause of the
failure.
In 1993 Lohr and her husband filed this action in a Florida
state court. Their complaint contained both a negligence count and
a strict-liability count. The negligence count alleged a breach of
Medtronic's "duty to use reasonable care in the design,
manufacture, assembly, and sale of the subject pacemaker" in
several respects, including the use of defective materials in the
lead and a failure to warn or properly instruct the plaintiff or
her physicians of the tendency of the pacemaker to fail, despite
knowledge of other earlier failures. Complaint' 5. The
strict-liability count alleged that the device was in a defective
condition and unreasonably dangerous to foreseeable users at the
time of its sale.
Id.,' 11. (A third count alleging breach
of warranty was dismissed for failure to state a claim under
Florida law.)
Medtronic removed the case to Federal District Court, where it
filed a motion for summary judgment arguing that both the
negligence and strict-liability claims were preempted by 21 U. S.
C. § 360k(a). That section, which is at the core of the dispute
between the parties in this suit, provides:
"§ 360k. State and local requirements respecting devices
"(a) General rule
"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
482
"(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." 5
The District Court initially denied Medtronic's motion, finding
nothing in the statute to support the company's argument that the
MDA entirely exempted from liability a manufacturer who had
allegedly violated the FDA's regulations. See App. to Pet. for
Cert. 5d. Not long after that decision, however, the United States
Court of Appeals for the Eleventh Circuit concluded that § 360k
required pre-emption of at least some common-law claims brought
against the manu-
5 Subsection (b) of the statute authorizes the FDA to grant
exemptions to state requirements that would otherwise be pre-empted
by subsection (a). Section 360k(b) provides:
"(b) Exempt requirements
"Upon application of a State or a political subdivision thereof,
the Secretary may, by regulation promulgated after notice and
opportunity for an oral hearing, exempt from subsection (a) of this
section, under such conditions as may be prescribed in such
regulation, a requirement of such State or political subdivision
applicable to a device intended for human use if-
"(1) the requirement is more stringent than a requirement under
this chapter which would be applicable to the device if an
exemption were not in effect under this subsection; or
"(2) the requirement-
"(A) is required by compelling local conditions, and
"(B) compliance with the requirement would not cause the device
to be in violation of any applicable requirement under this
chapter."
To carry out this grant of authority, the FDA has issued
regulations under the statute which both construe the scope of §
360k(a) and address the instances in which the FDA will grant
exemptions to its pre-emptive effect. See 21 CFR § 808.1 (1995); n.
18,
infra.
We note that although it is the FDA that exercises this
authority, the Act gives that authority directly to the Secretary
of Health and Human Services, who subsequently delegated her
authority to the FDA. See,
e. g., 21 U. S. C. §
360k(b) ("the Secretary may" exempt state requirements), § 321(d)
("Secretary" defined as "the Secretary of Health and Human
Services"). Under the FDCA, the Secretary is vested with "[t]he
authority to promulgate regulations for the efficient enforcement
of" the Act. 21 U. S. C. § 371(a).
483
facturer of a medical device. See
Duncan v.
Iolab
Corp., 12 F.3d
194 (1994). After reconsidering its ruling in light of
Duncan, the District Court reversed its earlier decision and
dismissed the Lohrs' entire complaint.
The Court of Appeals reversed in part and affirmed in part.
56 F.3d
1335 (CAll 1995). Rejecting the Lohrs' broadest submission, it
first decided that "common law actions are state requirements
within the meaning of § 360k(a)."
Id., at 1342. It next held
that pre-emption could not be avoided by merely alleging that the
negligence flowed from a violation of federal standards.
Id., at 1343. Then, after concluding that the term
"requirements" in § 360k(a) was unclear, it sought guidance from
FDA's regulations regarding pre-emption. Those regulations provide
that a state requirement is not pre-empted unless the FDA has
established" 'specific requirements applicable to a particular
device.'''
Id., at 1344 (citing 21 CFR § 808.1(d) (1995)).
Under these regulations, the court concluded, it was not necessary
that the federal regulation specifically deal with pacemakers, but
only that the federal requirement "should, in some way, be
'restricted by nature' to a particular process, procedure, or
device and should not be completely openended," 56 F. 3d, at 1346
(footnote omitted), and that the specific device at issue should be
subject to its requirements.
Under this approach, the court concluded that the Lohrs'
negligent design claims were not pre-empted. It rejected
Medtronic's argument that the FDA's finding of "substantial
equivalence" had any significance with respect to the pacemaker's
safety, or that the FDA's continued surveillance of the device
constituted a federal "requirement" that its design be maintained.
Id., at 1347-1349. On the other hand, it concluded that the
negligent manufacturing and failure to warn claims were pre-empted
by FDA's general "good manufacturing practices" regulations, which
establish general requirements for most steps in every device's
manufacture, see
id., at 1350; 21 CFR §§ 820.20-820.198
(1995), and by the
484
FDA labeling regulations, which require devices to bear various
warnings, see 56 F. 3d, at 1350-1351; 21 CFR §801.109 (1995). The
court made a parallel disposition of the strictliability claims,
holding that there was no pre-emption insofar as plaintiffs alleged
an unreasonably dangerous design, but they could not revive the
negligent manufacturing or failure to warn claims under a
strict-liability theory. 56
Medtronic filed a petition for certiorari seeking review of the
Court of Appeals' decision insofar as it affirmed the District
Court and the Lohrs filed a cross-petition seeking review of the
judgment insofar as it upheld the pre-emption defense. Because the
Courts of Appeals are divided over the extent to which state
common-law claims are pre-empted by the MDA,6 we granted both
petitions. 516 U. S. 1087 (1996).
III
As in
Cipollone v.
Liggett Group, Inc., 505 U. S. 504 (1992), we
are presented with the task of interpreting a statutory provision
that expressly pre-empts state law. While the pre-emptive language
of § 360k(a) means that we need not go beyond that language to
determine whether Congress intended the MDA to pre-empt at least
some state law, see
id., at 517, we must nonetheless
"identify the domain expressly pre-empted" by that language,
ibid. Although our analysis of the scope of the pre-emption
statute must begin with its text, see
Gade v.
National
Solid Wastes Management Assn.,
6 See,
e. g., English v.
Mentor Corp., 67 F.3d
477 (CA3 1995) (§ 510(k) process creates pre-emptive
"requirements");
Feldt v.
Mentor Corp., 61 F. 3d 431
(CA5 1995) (§ 510(k) process does not create pre-emptive
"requirements");
Michael v.
Shiley, Inc., 46 F.3d
1316 (CA3 1995) (claim alleging violation of federal
requirement not pre-empted);
56 F.3d
1335 (CAll 1995) (case below) (claim alleging violation of
federal requirement may be pre-empted; § 51O(k) process may create
pre-emptive requirements; common-law claims covered by § 360k(a));
Kennedy v.
Collagen Corp., 67 F. 3d 1453
(CA9
1995) (common-law claims not covered at all by § 360k(a)).
485
505 U. S. 88,
111 (1992) (KENNEDY, J., concurring in part and concurring in
judgment), our interpretation of that language does not occur in a
contextual vacuum. Rather, that interpretation is informed by two
presumptions about the nature of pre-emption. See
ibid.
First, because the States are independent sovereigns in our
federal system, we have long presumed that Congress does not
cavalierly pre-empt state-law causes of action. In all pre-emption
cases, and particularly in those in which Congress has "legislated
... in a field which the States have traditionally occupied,"
Rice v.
Santa Fe Elevator Corp., 331 U. S. 218, 230
(1947), we "start with the assumption that the historic police
powers of the States were not to be superseded by the Federal Act
unless that was the clear and manifest purpose of Congress."
Ibid.; Hillsborough Cty., 471 U. S., at 715-716; cf.
Fort
Halifax Packing Co. v.
Coyne, 482 U. S. 1, 22 (1987).
Although dissenting Justices have argued that this assumption
should apply only to the question whether Congress intended any
pre-emption at all, as opposed to questions concerning the
scope of its intended invalidation of state law, see
Cipollone, 505 U. S., at 545-546 (SCALIA, J., concurring in
judgment in part and dissenting in part), we used a "presumption
against the pre-emption of state police power regulations" to
support a narrow interpretation of such an express command in
Cipollone. Id., at 518, 523. That approach is consistent
with both federalism concerns and the historic primacy of state
regulation of matters of health and safety.
Second, our analysis of the scope of the statute's preemption is
guided by our oft-repeated comment, initially made in
Retail
Clerks v.
Schermerhorn, 375 U. S. 96, 103 (1963),
that "[t]he purpose of Congress is the ultimate touchstone" in
every pre-emption case. See,
e. g., Cipollone, 505 U. S., at
516;
Gade, 505 U. S., at 96;
Malone v.
White Motor
Corp., 435 U. S.
497, 504 (1978). As a result, any understanding of the scope of
a pre-emption statute must rest pri-
486
Opinion of STEVENS, J.
marily on "a fair understanding of
congressional purpose."
Cipollone, 505 U. S., at 530, n. 27 (opinion of STEVENS, J.).
Congress' intent, of course, primarily is discerned from the
language of the pre-emption statute and the "statutory framework"
surrounding it.
Gade, 505 U. S., at 111 (KENNEDY, J.,
concurring in part and concurring in judgment). Also relevant,
however, is the "structure and purpose of the statute as a whole,"
id., at 98 (opinion of O'CONNOR, J.), as revealed not only
in the text, but through the reviewing court's reasoned
understanding of the way in which Congress intended the statute and
its surrounding regulatory scheme to affect business, consumers,
and the law.
With these considerations in mind, we turn first to a
consideration of petitioner Medtronic's claim that the Court of
Appeals should have found the entire action pre-empted and then to
the merits of the Lohrs' cross-petition.
IV
In its petition, Medtronic argues that the Court of Appeals
erred by concluding that the Lohrs' claims alleging negligent
design were not pre-empted by 21 U. S. C. § 360k(a). That section
provides that "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." Medtronic suggests that any
common-law cause of action is a "requirement" which alters
incentives and imposes duties "different from, or in addition to,"
the generic federal standards that the FDA has promulgated in
response to mandates under the MDA. In essence, the company argues
that the plain language of the statute pre-empts any and all
common-law claims brought by an injured plaintiff against a
manufacturer of medical devices.
487
Medtronic's argument is not only unpersuasive, it is
implausible. Under Medtronic's view of the statute, Congress
effectively precluded state courts from affording state consumers
any protection from injuries resulting from a defective medical
device. Moreover, because there is no explicit private cause of
action against manufacturers contained in the MDA, and no
suggestion that the Act created an implied private right of action,
Congress would have barred most, if not all, relief for persons
injured by defective medical devices.7 Medtronic's construction of
§ 360k would therefore have the perverse effect of granting
complete immunity from design defect liability to an entire
industry that, in the judgment of Congress, needed more stringent
regulation in order "to provide for the safety and effectiveness of
medical devices intended for human use," 90 Stat. 539 (preamble to
Act). It is, to say the least, "difficult to believe that Congress
would, without comment, remove all means of judicial recourse for
those injured by illegal conduct,"
Silkwood v.
Kerr-McGee
Corp., 464 U. S.
238, 251 (1984), and it would take language much plainer than
the text of § 360k to convince us that Congress intended that
result.
Furthermore, if Congress intended to preclude all common-law
causes of action, it chose a singularly odd word with which to do
it. The statute would have achieved an identical result, for
instance, if it had precluded any "remedy" under state law relating
to medical devices. "Requirement" appears to presume that the State
is imposing a specific duty upon the manufacturer, and although we
have on prior occasions concluded that a statute pre-empting
certain
7 The FDA's authority to require manufacturers to recall,
replace, or refund defective devices is of little use to injured
plaintiffs, since there is no indication that the right is
available to private parties, the remedy would not extend to
recovery for compensatory damages, and the authority is rarely
invoked, if at all. See Adler, The 1976 Medical Device Amendments:
A Step in the Right Direction Needs Another Step in the Right
Direction, 43 Food Drug Cosmo L. J. 511, 526-527 (1988).
488
Opinion of STEVENS, J.
state "requirements" could also pre-empt common-law damages
claims, see
Cipollone, 505 U. S., at 521-522 (opinion of
STEVENS, J.), that statute did not sweep nearly as broadly as
Medtronic would have us believe that this statute does.
The pre-emptive statute in
Cipollone8 was targeted at a
limited set of state requirements-those "based on smoking and
health"-and then only at a limited subset of the possible
applications of those requirements-those involving the "advertising
or promotion of any cigarettes the packages of which are labeled in
conformity with the provisions of" the federal statute. See
id., at 515. In that context, giving the term "requirement"
its widest reasonable meaning did not have nearly the pre-emptive
scope nor the effect on potential remedies that Medtronic's broad
reading of the term would have in this suit. The Court in
Cipollone held that the petitioner in that case was able to
maintain some common-law actions using theories of the case that
did not run afoul of the pre-emption statute. See
id., at
524-530. Here, however, Medtronic's sweeping interpretation of the
statute would require far greater interference with state legal
remedies, producing a serious intrusion into state sovereignty
while simultaneously wiping out the possibility of remedy for
the
8 There were actually two pre-emptive statutes at issue: The
first, enacted in 1965, provided that "[n]o statement relating to
smoking and health ... shall be required" on any cigarette package
or in any cigarette advertising. See
Cipollone v.
Liggett
Group, Inc., 505 U. S., at 514. That provision, the Court
concluded, did not pre-empt any of the petitioner's common-law
claims.
Id., at 518-520. In 1969, Congress superseded the
1965 pre-emption statute with part of the Public Health Cigarette
Smoking Act of 1969, which provided 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 the packages of which are labeled in conformity with the
provisions of this Act."
Id., at 515. The bulk of
Cipollone's analysis involved this later statute; unless
otherwise stated, it is this statute to which we refer in
subsequent references to the pre-emptive statute in
Cipollone.
489
Lohrs' alleged injuries.9 Given the ambiguities in the statute
and the scope of the preclusion that would occur otherwise, we
cannot accept Medtronic's argument that by using the term
"requirement," Congress clearly signaled its intent to deprive
States of any role in protecting consumers from the dangers
inherent in many medical devices.
Other differences between this statute and the one in
Cipollone further convince us that when 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. Unlike the statute at issue
in
Cipollone, § 360k refers to "requirements" many times
throughout its text. In each instance, the word is linked with
language suggesting that its focus is device-specific enactments of
positive law by legislative or administrative bodies, not the
application of general rules of common law by judges and juries.
For instance, subsections (a)(2) and (b) of the statute 10 also
refer to "requirements"but those "requirements" refer only to
statutory and regulatory law that exists pursuant to the MDA
itself, suggesting that the pre-empted "requirements" established
or continued by States also refer primarily to positive enactments
of state law. Moreover, in subsection (b) the FDA is given
authority to exclude certain "requirements" from the scope of the
preemption statute. Of the limited number of "exemptions"
9Unlike §360k, the pre-emptive effect of the statute in
Cipollone was not dependent on the issuance of any agency
regulations. The territory exclusively occupied by federal law was
defined in the text of the statute itself; that text specified the
precise warning to smokers that Congress deemed both necessary and
sufficient. In the MDA, no such specifics exist until the FDA
provides them. See also
infra, at 495-496 (reliance on the
FDA's interpretation of § 360k warranted,
inter alia,
because of the FDA's role in the administration of § 360k).
Moreover, the statute in
Cipollone was clearly intended to
have a broader pre-emptive effect than its 1965 predecessor. See
505 U. S., at 515, 520-521.
10 The text of the statute is quoted
supra, at 482, and
n. 5.
490
Opinion of STEVENS, J.
from pre-emption that the FDA has granted, none even remotely
resemble common-law claims.ll
An examination of the basic purpose of the legislation as well
as its history entirely supports our rejection of Medtronic's
extreme position. The MDA was enacted "to provide for the safety
and effectiveness of medical devices intended for human use." 90
Stat. 539. Medtronic asserts that the Act was also intended,
however, to "protect innovations in device technology from being
'stifled by unnecessary restrictions,'" Brief for Petitioner in No.
95-754, p. 3 (citing H. R. Rep. No. 94-853, at 12), and that this
interest extended to the pre-emption of common-law claims. While
the Act certainly reflects some of these concerns,12 the
legislative history indicates that any fears regarding regulatory
burdens were related more to the risk of
additional federal
and state regulation rather than the danger of pre-existing duties
under common law. See,
e. g., 122 Congo Rec. 5850
(1976) (statement of Rep. Collins) (opposing further "redundant and
burdensome Federal requirements");
id., at 5855 (discussing
efforts taken in MDA to protect small businesses from the
additional requirements of the Act). Indeed, nowhere in the
materials relating to the Act's history have we discovered a
reference to a fear that product liability actions would hamper the
development of medical devices. To the extent that Congress was
concerned about protecting the industry, that intent was manifested
primarily through fewer substantive requirements under the Act, not
the pre-emption provision; furthermore, any such concern was far
outweighed by con-
11 All 22 exemptions at 21 CFR §§ 808.53-808.101 (1995) are
exemptions for state statutes and regulations regarding the sale of
hearing aids.
12 Special statutory exemptions, for example, permit the FDA
(with various oversight provisions) to allow investigative,
experimental devices to be used in commerce without either PMA
review or "substantial equivalence." See 21 U. S. C. §360j(g); 21
CFR pt. 813 (1995). Moreover, the very existence of the pre-emption
statute demonstrates some concern that competing state requirements
may unduly interfere with the market for medical devices.
491
cerns about the primary issue motivating the MDA's enactment:
the safety of those who use medical devices.
The legislative history also confirms our understanding that §
360(k) simply was not intended to pre-empt most, let alone all,
general common-law duties enforced by damages actions. There is, to
the best of our knowledge, nothing in the hearings, the Committee
Reports, or the debates suggesting 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.13 Along with the less-than-precise language of §
360k(a), that silence surely indicates that at least some
common-law claims against medical device manufacturers may be
maintained after the enactment of the MDA.
13 Furthermore, if Congress had intended the MDA to work this
dramatic change in the availability of state-law remedies, one
would expect some reference to that change in the extensive
contemporary reviews of the legislation. We have been able to find
no such reference. See,
e. g., Lesparre, Industry
Spokesman Comments on Medical Device Amendments of 1976, 50
Hospitals 99, 103 (Sept. 16, 1976); A. Levine, Device Failure and
the Plaintiff's Lawyer, in Proceedings of the Second Annual
AAMI/FDA Conference on Medical Device Regulation 54 (1975); Medical
Device Amendments of 1975, Hearings before the Subcommittee on
Health and the Environment of the House Committee on Interstate and
Foreign Commerce, Ser. No. 94-39, 94th Cong., 1st Sess., 271 (1975)
(statement of Anita Johnson, Public Citizen's Health Research
Group) (arguing that the pre-emption provision should not be
included, but making no mention of common law, and specifically
discussing only a positive California enactment regarding the
safety of intrauterine contraceptive devices); Medical Devices and
Equipment Liability Avoidance (Frost & Sullivan pub. June 1977)
(comprehensive 2-volume, 600-page review of published medical
device product liability cases from 1910 to 1976, suggesting
nowhere that MDA had mooted or even altered the longstanding
ability of plaintiffs to seek and receive damages awards under
state law).
492
v
Medtronic asserts several specific reasons why, even if § 360k
does not pre-empt all common-law claims, it at least pre-empts the
Lohrs' claims in this suit. In contrast, the Lohrs argue that their
entire complaint should survive a reasonable evaluation of the
pre-emptive scope of § 360k(a). First, the Lohrs claim that the
Court of Appeals correctly held that their negligent design claims
were not pre-empted because the § 510(k) premarket notification
process imposes no "requirement" on the design of Medtronic's
pacemaker. Second, they suggest that even if the FDA's general
rules regulating manufacturing practices and labeling are
"requirements" that pre-empt
different state requirements, §
360k(a) does not pre-empt state rules that merely duplicate some or
all of those federal requirements. Finally, they argue that because
the State's general rules imposing common-law duties upon Medtronic
do not impose a requirement "with respect to a device," they do not
conflict with the FDA's general rules relating to manufacturing and
labeling and are therefore not pre-empted.
Design Claim
The Court of Appeals concluded that the Lohrs' defective design
claims were not pre-empted because the requirements with which the
company had to comply were not sufficiently concrete to constitute
a pre-empting federal requirement. Medtronic counters by pointing
to the FDA's determination that Model 4011 is "substantially
equivalent" to an earlier device as well as the agency's continuing
authority to exclude the device from the market if its design is
changed. These factors, Medtronic argues, amount to a specific,
federally enforceable design requirement that cannot be affected by
state-law pressures such as those imposed on manufacturers subject
to product liability suits.
The company's defense exaggerates the importance of the § 510(k)
process and the FDA letter to the company regard-
493
ing the pacemaker's substantial equivalence to a grandfathered
device. As the court below noted, "[t]he 510(k) process is focused
on
equivalence, not safety." 56 F. 3d, at 1348. As a result,
"substantial equivalence determinations provide little protection
to the public. These determinations simply compare a post-1976
device to a pre-1976 device to ascertain whether the later device
is no more dangerous and no less effective than the earlier device.
If the earlier device poses a severe risk or is ineffective, then
the later device may also be risky or ineffective." Adler, 43 Food
Drug Cosmo L. J., at 516. The design of the Model 4011, as with the
design of pre-1976 and other "substantially equivalent" devices,
has never been formally reviewed under the MDA for safety or
efficacy.
The FDA stressed this basic conclusion in its letter to
Medtronic finding the 4011 lead "substantially equivalent" to
devices already on the market. That letter only required Medtronic
to comply with "general standards"-the lowest level of protection
"applicable to all medical devices," and including "listing of
devices, good manufacturing practices, labeling, and the
misbranding and adulteration provisions of the Act." It explicitly
warned Medtronic that the letter did "not in any way denote
official FDA approval of your device," and that "[a]ny
representation that creates an impression of official approval of
this device because of compliance with the premarket notification
regulations is misleading and constitutes misbranding." FDA
Substantial Equivalence Letter.
Thus, even though the FDA may well examine § 510(k) applications
for Class III devices (as it examines the entire medical device
industry) with a concern for the safety and effectiveness of the
device, see Brief for Petitioner in No. 95-754, at 22-26, it did
not "require" Medtronics' pacemaker to take any particular form for
any particular reason; the agency simply allowed the pacemaker, as
a device substantially equivalent to one that existed before 1976,
to be
494
marketed without running the gauntlet of the PMA process. In
providing for this exemption to PMA review, Congress intended
merely to give manufacturers the freedom to compete, to a limited
degree, with and on the same terms as manufacturers of medical
devices that existed prior to 1976.14 There is no suggestion in
either the statutory scheme or the legislative history that the §
510(k) exemption process was intended to do anything other than
maintain the status quo with respect to the marketing of existing
medical devices and their substantial equivalents. That status quo
included the possibility that the manufacturer of the device would
have to defend itself against state-law claims of negligent design.
Given this background behind the "substantial equivalence"
exemption, the fact that "[t]he purpose of Congress is the ultimate
touchstone" in every pre-emption case, 505 U. S., at 516 (internal
quotation marks and citations omitted), and the presumption against
pre-emption, the Court of Appeals properly concluded that the
"substantial equivalence" provision did not pre-empt the Lohrs'
design claims.
Identity of Requirements Claims
The Lohrs next suggest that even if "requirements" exist with
respect to the manufacturing and labeling of the pace-
14 As the FDA Commissioner put it in 1982: "[T]he 510(k)
provision of the law is a procompetition mechanism that permits
firms to make and quickly market me-too versions ofpre-1976
devices. The Congress apparently believed that a firm whose device
happened to be on the market before enactment of the amendments and
was never subject to preclearance by FDA should not enjoy a lengthy
monopoly at the expense of other firms and ultimately the
consumer." FDA Oversight: Medical Devices, Hearing before the
Subcommittee on Oversight and Investigations of the House Committee
on Energy and Commerce, 97th Cong., 2d Sess., 9 (1982). See also
Kahan, Premarket Approval Versus Premarket Notification: Different
Routes to the Same Market, 39 Food Drug Cosmo L. J. 510, 514-515
(1984); D. Kessler, S. Pape, & D. Sundwall, The Federal
Regulation of Medical Devices, 317 New England J. Med. 357, 359
(1987).
495
maker, and even if we can also consider state law to impose a
"requirement" under the Act, the state requirement is not
pre-empted unless it is "different from, or in addition to," the
federal requirement. § 360k(a)(1). Although the precise contours of
their theory of recovery have not yet been defined (the pre-emption
issue was decided on the basis of the pleadings), it is clear that
the Lohrs' allegations may include claims that Medtronic has, to
the extent that they exist, violated FDA regulations. At least
these claims, they suggest, can be maintained without being
pre-empted by § 360k, and we agree.
Nothing in § 360k denies Florida the right to provide a
traditional damages remedy for violations of common-law duties when
those duties parallel federal requirements. Even if it may be
necessary as a matter of Florida law to prove that those violations
were the result of negligent conduct, or that they created an
unreasonable hazard for users of the product, such additional
elements of the state-law cause of action would make the state
requirements narrower, not broader, than the federal requirement.
While such a narrower requirement might be "different from" the
federal rules in a literal sense, such a difference would surely
provide a strange reason for finding pre-emption of a state rule
insofar as it duplicates the federal rule. The presence of a
damages remedy does not amount to the additional or different
"requirement" that is necessary under the statute; rather, it
merely provides another reason for manufacturers to comply with
identical existing "requirements" under federallaw.
The FDA regulations interpreting the scope of § 360k's
pre-emptive effect support the Lohrs' view, and our interpretation
of the pre-emption statute is substantially informed by those
regulations. The different views expressed by the Courts of Appeals
regarding the appropriate scope of federal pre-emption under § 360k
demonstrate that the language of that section is not entirely
clear. In addition, Congress has
496
given the FDA a unique role in determining the scope of § 360k's
pre-emptive effect. Unlike the statute construed in
Cipollone, for instance, pre-emption under the MDA does not
arise directly as a result of the enactment of the statute; rather,
in most cases a state law will be pre-empted only to the extent
that the FDA has promulgated a relevant federal "requirement."
Because the FDA is the federal agency to which Congress has
delegated its authority to implement the provisions of the Act,15
the agency is uniquely qualified to determine whether a particular
form of state law "stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress,"
Hines v.
Davidowitz,
312 U. S. 52, 67 (1941),
and, therefore, whether it should be pre-empted. For example,
Congress explicitly delegated to the FDA the authority to exempt
state regulations from the pre-emptive effect of the MDA-an
authority that necessarily requires the FDA to assess the
pre-emptive effect that the Act and its own regulations will have
on state laws. See § 360k(b). FDA regulations implementing that
grant of authority establish a process by which States or other
individuals may request an advisory opinion from the FDA regarding
whether a particular state requirement is pre-empted by the
statute. See 21 CFR § 808.5 (1995). The ambiguity in the
statute-and the congressional grant of authority to the agency on
the matter contained within it-provide a "sound basis,"
post, at 509 (O'CONNOR, J., concurring in part and
dissenting in part), for giving substantial weight to the agency's
view of the statute. See
Chevron U. S.
A. Inc. v.
Natural Resources Defense Council, Inc., 467 U. S. 837 (1984);
Hillsborough Cty., 471 U. S., at 714 (considering FDA
understanding of pre-emptive effect of its regulations
"dispositive").
The regulations promulgated by the FDA expressly support the
conclusion that § 360k "does not preempt State or local
requirements that are equal to, or substantially identi-
15 See n. 5,
supra; 21 U. S. C. § 371(a).
497
cal to, requirements imposed by or under the act." 21 CFR §
808.1(d)(2) (1995); see also § 808.5(b)(1)(i).16 At this early
stage in the litigation, there was no reason for the Court of
Appeals to preclude altogether the Lohrs' manufacturing and
labeling claims to the extent that they rest on claims that
Medtronic negligently failed to comply with duties "equal to, or
substantially identical to, requirements imposed" under federal
law.
Manufacturing and Labeling Claims
Finally, the Lohrs suggest that with respect to the
manufacturing and labeling claims, the Court of Appeals should have
rejected Medtronic's pre-emption defense in full. The Court of
Appeals believed that these claims would interfere with the
consistent application of general federal regulations governing the
labeling and manufacture of all medical devices, and therefore
concluded that the claims were preempted altogether.
The requirements identified by the Court of Appeals include
labeling regulations that require manufacturers of every medical
device, with a few limited exceptions, to include with the device a
label containing "information for use, ... and any relevant
hazards, contraindications, side effects, and precautions." 21 CFR
§§ 801.109(b) and (c) (1995). Similarly, manufacturers are required
to comply with "Good Manufacturing Practices," or "GMP's," which
are set forth in 32 sections and less than 10 pages in the Code of
Federal Regulations.17 In certain circumstances, the Court of
Ap-
16We also note that the agency permits manufacturers of devices
that have received PMA to make certain labeling, quality control,
and manufacturing changes which would "enhanc[e] the safety of the
device or the safety in the use of the device" without prior FDA
approval. See 21 CFR §§ 814.39(d)(I) and (2) (1995).
17 Some GMP's include the duty to institute a "quality assurance
program," § 820.5, to have an "adequate organizational structure,"
§ 820.20, to ensure that personnel in contact with a device are
"clean, healthy, and suitably attired" where such matters are
relevant to the device's safety,
498
peals recognized, the FDA will enforce these general
requirements against manufacturers that violate them. See 56 F. 3d,
at 1350-1351.
While admitting that these requirements exist, the Lohrs suggest
that their general nature simply does not pre-empt claims alleging
that the manufacturer failed to comply with other duties under
state common law. In support of their claim, they note that §
360k(a)(1) expressly states that a federal requirement must be
"applicable to the device" in question before it has any
pre-emptive effect. Because the labeling and manufacturing
requirements are applicable to a host of different devices, they
argue that they do not satisfy this condition. They further argue
that because only state requirements "with respect to a device" may
be pre-empted, and then only if the requirement "relates to the
safety or effectiveness of the device or to any other matter
included in a requirement applicable to the device," § 360k(a)
mandates pre-emption only where there is a conflict between a
specific state requirement and a federal requirement "applicable
to" the same device.
The Lohrs' theory is supported by the FDA regulations, which
provide that state requirements are pre-empted "only" when the FDA
has established "specific counterpart regulations or ... other
specific requirements applicable to a particular device." 21 CFR
§808.1(d) (1995).18 They fur-
§ 820.25, and to have buildings, environmental controls, and
equipment of a quality adequate to produce a safe product, see §§
820.40, 820.46, 820.60.
18 FDA's narrow understanding of the scope of § 360k(a) is
obvious from the full text of the regulation, which provides, in
relevant part:
"(d) State or local requirements are preempted only when the
Food and Drug Administration has established specific counterpart
regulations or there are other specific requirements applicable to
a particular device under the act, thereby making any existing
divergent State or local requirements applicable to the device
different from, or in addition to, the specific Food and Drug
Administration requirements. There are other State or local
requirements that affect devices that are not preempted by
499
ther note that the statute is not intended to pre-empt "State or
local requirements of general applicability where the purpose of
the requirement relates either to other products in addition to
devices ... or to unfair trade practices in which the requirements
are not limited to devices." § 808.1(d)(1). The regulations
specifically provide, as examples of permissible general
requirements, that general electrical codes and the Uniform
Commercial Code warranty of fitness would not be pre-empted. See
ibid. The regulations even go so far as to state that §
360k(a) generally "does not preempt a state or local requirement
prohibiting the manufacture of adulterated or misbranded devices"
unless "such a prohibition has the effect of establishing a
substantive requirement for a specific device." § 808.1(d)(6)(ii).
Furthermore, under its authority to grant exemptions to the
pre-emptive effect of § 360k(a), the FDA has never granted, nor, to
the best of our
section 521(a) of the act because they are not 'requirements
applicable to a device' within the meaning of section 521(a) of the
act. The following are examples of State or local requirements that
are not regarded as preempted by section 521 of the act:
"(1) Section 521(a) does not preempt State 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.
"(2) Section 521(a) does not preempt State or local requirements
that are equal to, or substantially identical to, requirements
imposed by or under the act.
"(6)(i) Section 521(a) does not preempt State or local
requirements respecting general enforcement, e. g., requirements
that State inspection be permitted of factory records concerning
all devices ....
"(ii) Generally, section 521(a) does not preempt a State or
local requirement prohibiting the manufacture of adulterated or
misbranded devices. Where, however, such a prohibition has the
effect of establishing a substantive requirement for a specific
device, e. g., a specific labeling requirement, then the
prohibition [may] be preempted." 21 CFR § 808. 1 (d) (1995).
500
knowledge, even been asked to consider granting, an exemption
for a state law of general applicability; all 22 existing
exemptions apply to excruciatingly specific state requirements
regarding the sale of hearing aids. See §§ 808.53-808.10l.
Although we do not believe that this statutory and regulatory
language necessarily precludes "general" federal requirements from
ever pre-empting state requirements, or "general" state
requirements from ever being pre-empted, see Part VI,
infra,
it is impossible to ignore its overarching concern that pre-emption
occur only where a particular state requirement threatens to
interfere with a specific federal interest. State requirements must
be "with respect to" medical devices and "different from, or in
addition to," federal requirements. State requirements must also
relate "to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device,"
and the regulations provide that state requirements of "general
applicability" are not pre-empted except where they have "the
effect of establishing a substantive requirement for a specific
device." Moreover, federal requirements must be "applicable to the
device" in question, and, according to the regulations, pre-empt
state law only if they are "specific counterpart regulations" or
"specific" to a "particular device." The statute and regulations,
therefore, require a careful comparison between the allegedly
pre-empting federal requirement and the allegedly pre-empted state
requirement to determine whether they fall within the intended
pre-emptive scope of the statute and regulations.19
19 A plurality of this Court concluded in
Cipollone that
a similar analysis was required under the Public Health Cigarette
Smoking Act of 1969. That Act pre-empted requirements and
prohibitions based on smoking and health "imposed under State law
with respect to the advertising or promotion" of cigarettes in
packages that were labeled in conformity with that Act. 505 U. S.,
at 515. We held that the petitioner's fraudulent misrepresentation
claims, including those based on allegedly false statements made in
advertisements, were not pre-empted because they were "predicated
not on a duty 'based on smoking and health' but rather on a more
general
501
Such a comparison mandates a conclusion that the Lohrs'
common-law claims are not pre-empted by the federal labeling and
manufacturing requirements. The generality of those requirements
make this quite unlike a case in which the Federal Government has
weighed the competing interests relevant to the particular
requirement in question, reached an unambiguous conclusion about
how those competing considerations should be resolved in a
particular case or set of cases, and implemented that conclusion
via a specific mandate on manufacturers or producers. Rather, the
federal requirements reflect important but entirely generic
concerns about device regulation generally, not the sort of
concerns regarding a specific device or field of device regulation
that the statute or regulations were designed to protect from
potentially contradictory state requirements.
Similarly, the general state common-law requirements in this
suit were not specifically developed "with respect to" medical
devices. Accordingly, they are not the kinds of requirements that
Congress and the FDA feared would impede the ability of federal
regulators to implement and enforce specific federal requirements.
The legal duty that is the predicate for the Lohrs' negligent
manufacturing claim is the general duty of every manufacturer to
use due care to avoid foreseeable dangers in its products.
Similarly, the predicate for the failure to warn claim is the
general duty to inform users and purchasers of potentially
dangerous items of the risks involved in their use. These general
obligations are no more a threat to federal requirements than would
be a state-law duty to comply with local fire prevention
regula-
obligation-the duty not to deceive."
Id., at 528-529. The
general common-law duty "not to make fraudulent statements" was not
within the specific category of requirements or prohibitions based
on smoking and health imposed under state law "with respect to the
advertising or promotion" of cigarettes that were pre-empted by the
1969 statute.
Id., at 529.
If anything, the language of the MDA's pre-emption statute and
its counterpart regulations require an even more searching inquiry
into the relationship between the federal requirement and the state
requirement at issue than was true under the statute in
Cipollone.
502
Opinion of STEVENS, J.
tions and zoning codes, or to use due care in the training and
supervision of a work force. These state requirements therefore
escape pre-emption, not because the source of the duty is a
judge-made common-law rule, but rather because their generality
leaves them outside the category of requirements that § 360k
envisioned to be "with respect to" specific devices such as
pacemakers. As a result, none of the Lohrs' claims based on
allegedly defective manufacturing or labeling are pre-empted by the
MDA.
VI
In their cross-petition, the Lohrs present a final argument,
suggesting that common-law duties are never "requirements" within
the meaning of § 360k and that the statute therefore never
pre-empts common-law actions. The Lohrs point out that our holding
in
Cipollone is not dispositive of this issue, for as Part
IV,
supra, suggests, there are significant textual and
historical differences between the
Cipollone statute and §
360k, and the meaning of words must always be informed by the
environment within which they are situated. We do not think that
the issue is resolved by the FDA regulation suggesting that § 360k
is applicable to those requirements "having the force and effect of
law" that are "established by ... court decision," 21 CFR §
808.1(b) (1995); that reference, it appears, was intended to refer
to court decisions
construing state statutes or regulations.
See 42 Fed. Reg. 30383, 30385 (1977); Brief for Petitioners in No.
95-886,
Nevertheless, we do not respond directly to this argument for
two reasons. First, since none of the Lohrs' claims is pre-empted
in this suit, we need not resolve hypothetical cases that may arise
in the future. Second, given the critical importance of device
specificity in our (and the FDA's) construction of § 360k, it is
apparent that few, if any, common-law duties have been pre-empted
by this statute. It will be rare indeed for a court hearing a
common-law
503
cause of action to issue a decree that has "the effect of
establishing a substantive requirement for a specific device." 21
CFR § 808.1(d)(6)(ii) (1995). Until such a case arises, we see no
need to determine whether the statute explicitly preempts such a
claim. Even then, the issue may not need to be resolved if the
claim would also be pre-empted under conflict pre-emption analysis,
see
Freightliner Corp. v.
Myrick, 514 U. S. 280, 287
(1995).
VII
Accordingly, the judgment of the Court of Appeals is reversed
insofar as it held that any of the claims were preempted and
affirmed insofar as it rejected the pre-emption defense. The cases
are remanded for further proceedings.
It is so ordered.
JUSTICE BREYER, concurring in part and concurring in the
judgment.
This action raises two questions. First, do the Medical Device
Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic
Act ever pre-empt a state-law tort action? Second, if so, does the
MDA pre-empt the particular state-law tort claims at issue
here?
I
My answer to the first question is that the MDA will sometimes
pre-empt a state-law tort suit. I basically agree with JUSTICE
O'CONNOR'S discussion of this point and with her conclusion. See
post, at 510-512. The statute's language, read literally,
supports that conclusion. It says: "[N]o State ... may establish
... with respect to a device ... any [state]
requirement ...
which is differentfrom, or in addition to, any [federal]
requirement .... " 21 U. S. C. § 360k(a) (emphasis added).
504
Opinion of BREYER, J.
One can reasonably read the word "requirement" as including the
legal requirements that grow out of the application, in particular
circumstances, of a State's tort law.
Moreover, in
Cipollone v.
Liggett Group, Inc.,
505 U. S. 504
(1992), the Court made clear that similar language "easily"
encompassed tort actions because "[state] regulation can be as
effectively exerted through an award of damages as through some
form of preventive relief."
Id., at 521 (plurality opinion)
(internal quotation marks omitted); see
id., at 548-549
(SCALIA, J., concurring in judgment in part and dissenting in
part). Accord,
CSX Transp., Inc. v.
Easterwood,
507 U. S. 658,
664 (1993). This rationale would seem applicable to the quite
similar circumstances at issue here.
Finally, a contrary holding would have anomalous consequences.
Imagine that, in respect to a particular hearing aid component, a
federal MDA regulation requires a 2-inch wire, but a state agency
regulation requires a i-inch wire. If the federal law, embodied in
the "2-inch" MDA regulation, pre-empts the state "i-inch" agency
regulation, why would it not similarly pre-empt a state-law tort
action that premises liability upon the defendant manufacturer's
failure to use a i-inch wire (say, an award by a jury persuaded by
expert testimony that use of a more than i-inch wire is negligent)?
The effects of the state agency regulation and the state tort suit
are identical. To distinguish between them for preemption purposes
would 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. Where Congress likely did not
focus specifically upon the matter, see
ante, at 486-491, I
would not take it to have intended this anomalous result.
Consequently, I believe that ordinarily, insofar as the MDA
pre-empts a state requirement embodied in a state statute, rule,
regulation, or other administrative action, it would also pre-empt
a similar requirement that takes the form of a
505
standard of care or behavior imposed by a state-law tort action.
It is possible that the plurality also agrees on this point,
although it does not say so explicitly.
II
The answer to the second question turns on Congress' intent.
See,
e. g., Barnett Bank of Marion Cty., N.
A. v.
Nelson, 517 U.
S. 25, 30 (1996);
Allis-Chalmers Corp. v.
Lueck,
471 U. S. 202,
208 (1985);
ante, at 485-486. Although Congress has not
stated whether the MDA does, or does not, pre-empt the tort claims
here at issue, several considerations lead me to conclude that it
does not.
First, the MDA's pre-emption provision is highly ambiguous. That
provision makes clear that federal requirements may pre-empt state
requirements, but it says next to nothing about just when, where,
or how they may do so. The words "any [state] requirement" and "any
[federal] requirement," for example, do not tell us
which
requirements are at issue, for
every state requirement that
is not identical to even
one federal requirement is
"different from, or in addition to," that single federal
requirement; yet, Congress could not have intended that the
existence of one single federal rule, say, about a 2-inch hearing
aid wire, would pre-empt
every state law hearing aid rule,
even a set of rules related only to the packaging or shipping of
hearing aids. Thus, Congress must have intended that courts look
elsewhere for help as to just which federal requirements pre-empt
just which state requirements, as well as just how they might do
so.
Second, this Court has previously suggested that, in the absence
of a clear congressional command as to pre-emption, courts may
infer that the relevant administrative agency possesses a degree of
leeway to determine which rules, regulations, or other
administrative actions will have pre-emptive effect. See
Hillsborough County v.
Automated Medical Laboratories,
Inc., 471 U. S.
707, 721 (1985); cf.
Smiley v.
Citibank (South
Dakota), N.
A., 517 U. S. 735,
739-741
506
Opinion of BREYER, J.
(1996); Lawrence County v.
Lead-Deadwood School Dist.
No. 40-1,
469 U.
S. 256, 261-262 (1985);
Chevron U. S.
A. Inc. v.
Natural Resources Defense Council, Inc., 467 U. S. 837, 842-845
(1984). To draw a similar inference here makes sense, and not
simply because of the statutory ambiguity. The Food and Drug
Administration (FDA) is fully responsible for administering the
MDA. See 21 U. S. C. § 393. That responsibility means informed
agency involvement and, therefore, special understanding of the
likely impact of both state and federal requirements, as well as an
understanding of whether (or the extent to which) state
requirements may interfere with federal objectives. See
Hillsborough, 471 U. S., at 721. The FDA can translate these
understandings into particularized pre-emptive intentions
accompanying its various rules and regulations. See
id., at
718. It can communicate those intentions, for example, through
statements in "regulations, preambles, interpretive statements, and
responses to comments,"
ibid., as well as through the
exercise of its explicitly designated power to exempt state
requirements from pre-emption, see 21 U. S. C. § 360k(b); see also
ante, at 496 (noting that FDA's authority to exempt state
requirements from pre-emption necessarily requires FDA to assess
federal laws' pre-emptive effect).
Third, the FDA has promulgated a specific regulation designed to
help. That regulation says: "State ... requirements are preempted
only when ... there are ...
specific [federal] requirements
applicable to a particular device ... thereby making any existing
divergent State ... requirements applicable to the device
different from, or in addition to, the
specific [federal]
requirements." 21 CFR § 808.1(d) (1995) (emphasis added).
The regulation does not fill all the statutory gaps, for its
word "divergent" does not explain, any more than did the statute,
just when different device-related federal and state
507
requirements are closely enough related to trigger preemption
analysis. But the regulation's word "specific" does narrow the
universe of federal requirements that the agency intends to
displace at least some state law.
Insofar as there are any applicable FDA requirements here, those
requirements, even if numerous, are not "specific" in any relevant
sense. See
ante, at 497-498, 50l. Hence, as the FDA's
above-quoted pre-emption rule tells us, the FDA does not intend
these requirements to pre-empt the state requirements at issue
here. At least in present circumstances, no law forces the FDA to
make its requirements pre-emptive if it does not think it
appropriate.
I cannot infer a contrary intent from JUSTICE O'CONNOR'S
characterization of the federal standards applicable here as
"comprehensive" and "extensive,"
post, at 513, 514, both
because that characterization is questionable, see
ante, at
497498, 501, and because this Court has previously said that it
would "seldom infer, solely from the comprehensiveness of federal
regulations, an intent to pre-empt in its entirety a field related
to health and safety."
Hillsborough, supra, at 718. It
therefore seems to me that the better indicator of the FDA's intent
is its pre-emption-related regulation. And that regulation's word
"specific" would seem a reasonable exercise of the leeway that
statutory language and practical administrative circumstance
suggest Congress intended to grant to the agency.
Fourth, ordinary principles of "conflict" and "field" preemption
point in the same direction. Those principles make clear that a
federal requirement pre-empts a state requirement if (1) the state
requirement actually conflicts with the federal requirement-either
because compliance with both is impossible,
Florida Lime
&
Avocado Growers, Inc. v.
Paul, 373 U. S. 132, 142-143
(1963), or because the state requirement "stands as an obstacle to
the accomplishment and execution of the full purposes and
objectives of Congress,"
Hines v.
Davidowitz,
312 U. S. 52, 67
(1941)-or (2) the
508
Opinion of BREYER, J.
scheme of federal regulation is "so pervasive as to make
reasonable the inference that Congress left no room for the States
to supplement it,"
Rice v.
Santa Fe Elevator Corp.,
331 U. S. 218,
230 (1947). See,
e. g., Barnett Bank, 517 U. S., at 31;
Gade v.
National Solid Wastes Management Assn.,
505 U. S. 88, 98
(1992) (opinion of O'CONNOR, J.);
Wisconsin Public
Intervenor v.
Mortier, 501 U. S. 597, 604-605
(1991); English v.
General Elec. Co., 496 U. S. 72, 79
(1990).
It makes sense, in the absence of any indication of a contrary
congressional (or agency) intent, to read the preemption statute
(and the pre-emption regulation) in light of these basic
pre-emption principles. The statutory terms "different from" and
"in addition to" readily lend themselves to such a reading, for
their language parallels pre-emption law's basic concerns. Without
any contrary indication from the agency, one might also interpret
the regulation's word "divergent" in light of these same basic
pre-emption principles.
Insofar as these basic principles inform a court's
interpretation of the statute and regulation, they support the
conclusion that there is no pre-emption here. I can find no actual
conflict between any federal requirement and any of the
liability-creating premises of the plaintiffs' state-law tort suit;
nor, for the reasons discussed above, can I find any indication
that either Congress or the FDA intended the relevant FDA
regulations to occupy entirely any relevant field.
For these reasons, I concur in the Court's judgment. I also join
the Court's opinion, but for Parts IV and VI. I do not join Part
IV, which emphasizes the differences between the MDA and the
pre-emption statute at issue in
Cipollone, because those
differences are not, in my view, relevant in this action. I do not
join Part VI, because I am not convinced that future incidents of
MDA pre-emption of common-law claims will be "few" or "rare,"
ante, at 502.
509
JUSTICE O'CONNOR, with whom THE CHIEF JUSTICE, JUSTICE SCALIA,
and JUSTICE THOMAS join, concurring in part and dissenting in
part.
Section 360k(a), the pre-emption provision of the Medical Device
Amendments of 1976 (MDA), provides that no State may establish or
continue in effect "any requirement" "which is different from, or
in addition to," any requirement applicable under the Federal Food,
Drug, and Cosmetic Act of 1938 (FDCA) to the device. As the Court
points out, because Congress has expressly provided a pre-emption
provision, "we need not go beyond that language to determine
whether Congress intended the MDA to pre-empt" state law.
Ante, at 484. We agree, then, on the task before us: to
interpret Congress' intent by reading the statute in accordance
with its terms. This, however, the Court has failed to do.
The cases require us to determine whether the Lohrs' state
common-law claims survive pre-emption under § 360k. I conclude that
state common-law damages actions do impose "requirements" and are
therefore pre-empted where such requirements would differ from
those imposed by the FDCA. The plurality acknowledges that a
common-law action might impose a "requirement," but suggests that
such a pre-emption would be "rare indeed."
Ante, at 502. To
reach that determination, the opinion-without explicitly relying on
Food and Drug Administration (FDA) regulations and without offering
any sound basis for why deference would be warranted-imports the
FDA regulations interpreting § 360k to "inform" the Court's
reading. Accordingly, the principal opinion states that pre-emption
occurs only "where a particular state requirement threatens to
interfere with a specific federal interest,"
ante, at 500,
and for that reason, concludes that common-law claims are almost
never pre-empted,
ante, at 502-503, and that the Lohrs'
claims here are not pre-empted. This decision is bewildering and
seemingly without guiding principle.
510
Opinion of O'CONNOR, J.
The language of § 360k demonstrates congressional intent that
the MDA pre-empt "any requirement" by a State that is "different
from, or in addition to," that applicable to the device under the
FDCA. The Lohrs have raised various state common-law claims in
connection with Medtronic's pacemaker lead. Analysis, therefore,
must begin with the question whether state common-law actions can
constitute "requirements" within the meaning of § 360k(a).
We recently addressed a similar question in
Cipollone,
where we examined the meaning of the phrase "no requirement or
prohibition" under the Public Health Cigarette Smoking Act of 1969.
Cipollone v.
Liggett Group, Inc., 505 U. S. 504
(1992). A majority of the Court agreed that state common-law
damages actions do impose "requirements."
Id., at 521-522
(plurality opinion);
id., at 548-549 (SCALIA, J., joined by
THOMAS, J., concurring in judgment in part and dissenting in part).
As the plurality explained:
"The phrase, '[n]o requirement or prohibition' sweeps broadly
and suggests no distinction between positive enactments and common
law; to the contrary, those words easily encompass obligations that
take the form of common-law rules. As we noted in another context,
'[state] regulation can be as effectively exerted through an award
of damages as through some form of preventive relief. The
obligation to pay compensation can be, indeed is designed to be, a
potent method of governing conduct and controlling policy.' San
Diego Building Trades Council v. Garmon, 359 U. S. 236, 247
(1959)." Id., at 521.
That rationale is equally applicable in the present context.
Whether relating to the labeling of cigarettes or the
manufacture of medical devices, state common-law damages actions
operate to require manufacturers to comply with common-law duties.
As
Cipollone declared, in answer to the same argument raised
here that common-law actions
511
do not impose requirements, "such an analysis is at odds both
with the plain words" of the statute and "with the general
understanding of common-law damages actions."
Ibid. If §
360k's language is given its ordinary meaning, it clearly pre-empts
any state common-law action that would impose a requirement
different from, or in addition to, that applicable under the
FDCA-just as it would pre-empt a state statute or regulation that
had that effect. JUSTICE BREYER reaches the same conclusion.
Ante, at 503-505 (opinion concurring in part and concurring
in judgment).
The plurality's reasons for departing from this reading are
neither clear nor persuasive. It fails to refute the applicability
of the reasoning of
Cipollone. Instead, in Part IV, the
plurality essentially makes the case that the statute's language,
purpose, and legislative history, as well as the consequences of a
different interpretation, indicate that Congress did not intend
"requirement" to include state commonlaw claims at all. The
principal opinion proceeds to disclaim this position, however, in
Parts V and VI and concludes, rather, that a state common-law
action might constitute a requirement, but that such a case would
be "rare indeed."
Ante, at 502. The Court holds that an FDCA
"requirement" triggers pre-emption only when a conflict exists
between a specific state requirement and a specific FDCA
requirement applicable to the particular device. See
ante,
at 498-502. But see
ante, at 500 ("[W]e do not believe that
this statutory and regulatory language necessarily precludes
'general' federal requirements from ever pre-empting state
requirements, or 'general' state requirements from ever being
pre-empted ... "). The plurality emphasizes the "critical
importance of device specificity" in its understanding of the
pre-emption scheme.
Ante, at 502.
To reach its particularized reading of the statute, the Court
imports the interpretation put forth by the FDA's regulations.
JUSTICE BREYER similarly relies on the FDA regulations to arrive at
an understanding of § 360(k).
Ante,
512
Opinion of O'CONNOR, J.
at 505-507. Apparently recognizing that
Chevron deference
is unwarranted here, the Court does not admit to deferring to these
regulations, but merely permits them to "infor[m]" the Court's
interpretation.
Ante, at 495. It is not certain that an
agency regulation determining the pre-emptive effect of
any
federal statute is entitled to deference, cf.
Smiley v.
Citibank (South Dakota), N.
A., 517 U. S. 735, 743-744
(1996), but one pertaining to the clear statute at issue here is
surely not. "If the statute contains an express pre-emption clause,
the task of statutory construction must in the first instance focus
on the plain wording of the clause, which necessarily contains the
best evidence of Congress' pre-emptive intent."
CSX Transp.,
Inc. v.
Easterwood, 507 U. S. 658, 664
(1993). Where the language of the statute is clear, resort to the
agency's interpretation is improper. See
Chevron U. S.
A.
Inc. v.
Natural Resources Defense Council, Inc., 467 U.
S. 837, 842-843 (1984). Title 21 U. S. C. § 360k(a)(1) directs the
pre-emption of "any [state] requirement" "which is different from,
or in addition to, any requirement applicable under [the FDCA] to
the device." As explained above, and as JUSTICE BREYER agrees,
ante, at 503-505, the term "requirement" encompasses state
common-law causes of action. The Court errs when it employs an
agency's narrowing construction of a statute where no such
deference is warranted. The statute makes no mention of a
requirement of specificity, and there is no sound basis for
determining that such a restriction on "any requirement"
exists.
I conclude that a fair reading of § 360k indicates that state
common-law claims are pre-empted, as the statute itself states, to
the extent that their recognition would impose "any requirement"
different from, or in addition to, FDCA requirements applicable to
the device. From that premise, I proceed to the question whether
FDCA requirements applicable to the device exist here to pre-empt
the Lohrs' state-law claims.
513
I agree with the Court that the Lohrs' defective design claim is
not pre-empted by the FDCA's § 510(k) "substantial equivalency"
process. The § 510(k) process merely evaluates whether the Class
III device at issue is substantially equivalent to a device that
was on the market before 1976, the effective date of the MDA; if
so, the later device may be also be marketed. Because the § 510(k)
process seeks merely to establish whether a pre-1976 device and a
post1976 device are equivalent, and places no "requirements" on a
device, the Lohrs' defective design claim is not pre-empted.
I also agree that the Lohrs' claims are not pre-empted by § 360k
to the extent that they seek damages for Medtronic's alleged
violation of federal requirements. Where a state cause of action
seeks to enforce an FDCA requirement, that claim does not impose a
requirement that is "different from, or in addition to,"
requirements under federal law. To be sure, the threat of a damages
remedy will give manufacturers an additional cause to comply, but
the requirements imposed on them under state and federal law do not
differ. Section 360k does not preclude States from imposing
different or additional
remedies, but only different or
additional
requirements.
I disagree, however, with the Court's conclusion that the Lohrs'
claims survive pre-emption insofar as they would compel Medtronic
to comply with requirements different from those imposed by the
FDCA. Because I do not subscribe to the Court's reading into § 360k
the additional requisite of "specificity," my determination of what
claims are pre-empted is broader. Some, if not all, of the Lohrs'
common-law claims regarding the manufacturing and labeling of
Medtronic's device would compel Medtronic to comply with
requirements different from, or in addition to, those required by
the FDA. The FDA's Good Manufacturing Practice (GMP) regulations
impose comprehensive requirements relating to every aspect of the
device-manufacturing process,
514
Opinion of O'CONNOR, J.
including a manufacturer's organization and personnel,
buildings, equipment, component controls, production and process
controls, packaging and labeling controls, holding, distribution,
installation, device evaluation, and recordkeeping. See 21 CFR §§
820.20-820.198 (1995). The Lohrs' common-law claims regarding
manufacture would, if successful, impose state requirements
"different from, or in addition to," the GMP requirements, and are
therefore pre-empted. In similar fashion, the Lohrs' failure to
warn claim is pre-empted by the extensive labeling requirements
imposed by the FDA. See,
e. g., 21 CFR § 801.109
(1995) (requiring labels to include such information as
indications, effects, routes, methods, frequency and duration of
administration, relevant hazards, contraindications, side effects,
and precautions). These extensive federal manufacturing and
labeling requirements are certainly applicable to the device
manufactured by Medtronic. Section 360k(a) requires no more
specificity than that for pre-emption of state common-law
claims.
To summarize, I conclude that § 360k(a)'s term "requirement"
encompasses state common-law claims. Because the statutory language
does not indicate that a "requirement" must be "specific," either
to pre-empt or be pre-empted, I conclude that a state common-law
claim is pre-empted if it would impose "any requirement" "which is
different from, or in addition to," any requirement applicable to
the device under the FDCA. I would affirm the judgment of the Court
of Appeals that the Lohrs' design claim is not pre-empted by the
MDA, and that the manufacture and failure to warn claims are
pre-empted; I would reverse the judgment of the Court of Appeals
that the MDA pre-empts a common-law claim alleging violation of
federal requirements.
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