*1 LOHR vir MEDTRONIC, INC. еt v. 26, 1996* June 23, 1996 Decided April Argued 95-754.
No. certio on Inc., Medtronic, also v. vir et 95-886, Lohr No. *Together court. same rari *3 Stevens, J., announced the judgment of the Court and delivered the opinion of the Court with respect to I, II, Parts III, V, VII, and in which Kennedy, Souter, Ginsburg, Breyer, and JJ., joined, and opin- an ion with respect to Parts IV VI, and in which Kennedy, Souter, 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 part in dissenting part, Rehnquist, J.,C. Thomas, Scalia and JJ., joined, post, p. 509. Arthur Miller argued cause for Medtronic, Inc., in both cases. With him on the briefs were Daniel G. Jarcho, Donald Stone, R. Kenneth S. Geller, Roy Englert, T. Jr., Alan E. Untereiner, Dennis P. Waggoner, Ronald E. Lund, Borg, John W. and Sue R. Halverson. Brian argued cause for Lohr et vir in Wolfman both
cases. With him on the brief were Allison M. Zieve, Alan B. Morrison, Laurence H. Tribe, Robert L. Cowles, and Rob- Spohrer. ert F.
Deputy Solicitor General Kneedler argued the cause for the United States as amicus curiae. With him on the brief *4 Days, Solicitor General were Deputy Assistant Attorney General Preston, Richard H. Seamon, Douglas and N. † Letter. †Briefs of amici curiae were filed for the of State by California Daniel E. Lungren, Attorney General, Walston, Roderick E. Chief At Assistant torney General, Theodora Berger, Assistant Attorney General, and Susan S. Fiering, Deputy Attorney General; for the State of Florida et al. by Butterworth, Robert A. Attorney General Florida, of and F. Louis Hube- ner and Charley McCoy, Assistant General, Attorneys joined by the Attor t neys General for their respective jurisdictions as follows: Winston Bryan Arkansas, of Gale A. Colorado, Norton of Richard of Blumenthal Connect icut, Pamela Indiana, Carter of A. B. Chandler III of Kentucky, Andrew Maine, Ketterer of Curran, J. Joseph Jr., of Maryland, Mike Moore of Mississippi, Jeremiah W. of Missouri, Nixon Joseph P. Mazurek of Mon tana, Tom Udall Mexico, of New Dennis C. Vacco of York, New Michael Court the of judgment the announced Stevens Justice to Parts respect with Court of the opinion the delivered
and to Parts respect opinion an VII, and andV, III, II, I, Souter, Kennedy, Justice inVI, Justice and IV join. Ginsburg and Justice of Amendments Device Medical the enacted Congress for provide “to preamble, statute’s the of words 1976,in intended devices medical of effectiveness safety and presented question 539. Stat. use.” human for negli- a state pre-empts whether defec- allegedly anof manufacturer against gence action whether consider must we Specifically, device. medical tive may failed, pacemaker her injured when was Lohr, who Lora Med- damages from recover law common Florida rely on device. of manufacturer Inc., tronic, Dakota, Theodore North of Heitkamp Carolina, Heidi of North Easley F. Bur-W. Dakota, Charles South Barnett Mark Oregon, Kulongoski R. Jr., McGraw, V. Texas, Darrell and Morales Tennessee, Han son by al. et Persons of Retired Association American for Virginia; West Victor by al. et Association Insurance American for Halperin; David Behrens, and A. Charrow, Mark P. Onek, Robert N. Schwartz, Joseph E. by of America Lawyers Trial Association Amundson; for S. Jan Patient for Center for Liapakis; A. Pamela and White Robert Jeffrey W. Joe by Corp. Collagen Jr.; Roberts, for G. John by al. Advocacy et Motors Baker; for General D. Frederick Jones, and A. Jr., Redden, Keith Cappuccio, T. Paul Cordray, A. Starr, Richard W Kenneth by Corp. Durkin; for A. Landau, James and G. Heilbron, Leslie M. David Kuhlik, N. Bruce by al. et Association Manufacturers Industry Health Manufac- Device Medical Carter; for J. William and Maloney, J. Paul Beck; for the M. James and Phillips S. Stephen by Association turers Lee Ruda by Richard al. et Legislatures State Conference National by Docket,No. in MDL Committee Legal Plaintiffs’ Fennell; for Jr., Wendell Fayard, III, Calvin Cummings J. John Chesley, M. Stanley Prod- Fishbein; D. Michael Tschirn, J. Darryl Gauthier, F. Hugh N. Weiner Inc., Robert Council, Advisory Liability uct S. *5 C., by Jonathan Justice, P. Public for Lawyers Jr.; Trial for Young, by Foundation Legal Washington for Bryant; H. Arthur and Massey Liability Products Two for and Samp; A. Richard Popeo J. Daniel Pearson, se. pro N. Richard Professors Law HH
Throughout our history the several States have exercised
their police
powers
protect
the health and
safety
their
citizens. Because these are
“primarily,
historically,..
.
matter[s]
local concern,” Hillsborough County v. Auto-
mated, Medical Laboratories, Inc.,
Despite the prominence of the States in matters of public health and in safety, recent decades the Federal Government has played an increasingly significant role in the protection of the health of our people. Congress’ first significant enact- ment in the field of public health was the Food and Drug ofAct 1906, a broad prohibition against the manufacture or shipment interstate commеrce of any adulterated or mis- branded food or drug. 34 Stat. 768; Regier, The Strug- gle Federal Food and Drugs Legislation, 1 Law & Contemp. Prob. 1 (1933). Partly 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 the 1906 Act to include misbranded or adulterated medical devices and cos- metics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), §§501, 502, 52 Stat. 1049-1051; Cavers, The Food, Drug, Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Prob. (1939); H. R. Rep. No. 94-853, 6p. While the FDCA provided for premarket approval new drugs, Cavers, 6 Law & Prob., Contemp. 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 *6 medical of array vast aon degree increasing an to
relied kidney including brainscans,”1 bedpans “[f]rom equipment pacemakers,2 heart valves, and heart units, artificial dialysis the about concerned became the public and policymakers failure the from resulted injuries severe increasingly Effectiveness Finck, The generally See devices. such 293, 297- Rev. L.D.C. 7 U. Regulation, Device Medical at 7. 94-853, No. Rep. H. R. (1974); intrauterine an Shield, Daikon the example, 1970, for In public American the introduced was device, contraceptive effective and safe aas Touted world. the throughout and disturbingly ain resulted Shield Daikon contraceptive, infec- serious pregnancies, inadvertent percentage high Id., at 8; Regulation death. cases, fewa even, in tions, and Dеvices), Contraceptive (Intrauterine Devices of Medical Committee House a Subcommittee before Hearings In (1973). Sess. 1st Cong., 93d Operations, on Government catheters, devices, including other 1970’s, several early (includ- and defibrillators, pacemakers valves, heart artificial at- Medtronic), by petitioner manufactured pacemakers ing Ad- Drug and Food consumers, attention tracted risks. health as possible Congress and (FDA), ministration before Hearings Amendments, Device Medical Labor on Committee Senate Health on Subcommittee (1973). 270-361 Sess., 2d Cong., Welfare, 93d Public and con- regulatory consumer mounting response In Medical here: issue enacted cern, Congress 539. 90 Stat. Act), (MDA of 1976 Amendments Device based categories three devices medical classifies Act The that pre- Devices the public. pose they risk on (Committee Child Neglected FDA’s Regulation: Device Medical Investigations Oversight on Subcommittee compiled Print 98-F, Print Commerce), Comm. Energy on Committee House (1983). 1p. 94-33, 5p. No. Rep. 2 S. sent no unreasonable risk of illness or injury designated Class I and are subject only minimal regulation by “gen- *7 eral controls.” 21 U. S. §C. 360c(a)(l)(A). Devices that are more potentially harmful are designated Class II; although they be may marketed without advance approval, manufac-
turers of such devices must comply federal performance regulations known as “special § controls.” 360c(a)(l)(B). Finally, devices that either “presenft] a potential unreason- able risk of illness or or injury,” which are “purported or represented to be for a use in supporting sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” are designated Class § III. 360c(a)(l)(C). Pacemakers are Class III de- vices. See 21 §870.3610 CFR (1995).
Before a new Class III device be may introduced to the market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is both safe and ef- fective. See U. § S. 360e(d)(2). C. its Despite relatively innocuous phrasing, process of this establishing “reason- able assurance,” which is known as the “premarket ap- proval,” or “PMA” process, rigorous one. Manufactur- ers must submit detailed information regarding safety of their efficacy devices, which the FDA then reviews, an spending 1,200 average hours on each submission. before Hearings the Subcommittee on Health and the Envi- ronment of the House Committee on Energy & Commerce, 100th (Ser. 1st Sess. Cong., No. 100-34), (1987) (herein- p. after 1987 Hearings); see Kahan, generally Premarket Ap- proval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Cosm. Drug L. J. 510, 512-514 all,
Not nor even most, Class III on devices the market today have received premarket because approval of two im- portant to exceptions the PMA requirement. First, Con- gress realized that existing medical devices could not be its completed FDA while market from
withdrawn in- therefore devices. those analysis PMA pre-1976 allows provision “grandfathering” cludes until approval FDA without market on remain devices requisite completes initiates time such 814.1(c)(1) § 360e(b)(l)(A); 21 CFR S. C. U. See PMA. grandfathered manufacturers prevent Second, (1995).3 devices new while market monopolizing from devices improvements to ensure hurdle, and PMA clear market, into introduced rapidly can еxisting devices “substantially equiva- devices permits also Act process. PMA avoid devices pre-existing lent” 360e(b)(l)(B). §C.S.U. may devices III *8 Class equivalent” “substantially Although new such review, PMA rigorous the without marketed be devices, are II Class I and Class newall aswell devices, im- §360(k). section That of the subject to intend- every manufacturer on review form limited a poses “pre- submit toit requiring by device newa market ing to known also (the is process FDA notification” market the section the number the 510(k) after process,” “§aas the basis on concludes Act). FDA If original equiva- “substantially is device 510(k) § notification without marketed it can device, pre-existing ato lent” initiates FDA (at until least analysis regulatory further which to device pre-1976 underlying for process PMA 510(k) § The equivalent”). “substantially is device new PMA comparable by means no is process notification PMA aof initiation suggested 3 nor initiated yet has FDA see But devices. grandfathered other or most pacemakers for process Act Devices Medical Safe (1995) (pursuant 41984, 41986 Reg. Fed. February information for submission 4511, calling Stat. 1990, 104 process PMA initiate reclassify or lead may generators pulse pacemaker implantable future in the time some adapters). lead
process; in contrast to the 1,200 necessary hours complete 510(k) § a PMA review, the completed is review average an only 20 hours. Hearings, See 1987 at 384. As one com- mentator noted: “The attraction of equivalence substantial 510(k) manufacturers [Section] clear. notification re- quires little rarely information, negative elicits a response from the gets FDA, and processed very quickly.” Adler, The 1976Medical Device Step Amendments: A Right in the Direction Step Needs Another Right in the Direction, Drug Food (1988); Cosm. L. J. see also Kahan, 39 Drug Food Cosm. L. J., at 514-519.
Congress anticipated that the complete FDA would process PMA for Class III relatively devices swiftly. But because of the substantial energy investment time and necessary for the resolution of each application, PMA ever-increasing numbers of medical devices, and internal ad- ministrative and resource difficulties, simply the FDA could keep up rigorous with the process. PMA As a result, 510(k) premarket process notification became the means by which most new medical including III Class de- devices— approved vices—were for the market. In 1983,for instance, Report House concluded nearly 1,000of approximately 1,100 Class III devices that had been introduced to the mar- ket since 1976 were admitted as equivalents” “substantial *9 any and without PMA review. See Medical Regula- Device (Committee tion: The Neglected FDA’s Child compiled Print for the on Oversight Subcommittee Investigations of the House Energy on Commerce), Committee Comm. Print p. 98-F, 34 lopsidedness This apparently has despite evened out; an increasing effort the FDA to con- safety sider the efficacy of substantially equivalent de- vices, reported the House in 1990that 80% of new Class III devices being were introduced to the through market the §510(k) process and without PMA Rep. review. H. R. No. p. (1990); 101-808, 14 see also D. Pape, Kessler, S. &
480 317 Devices, Medical of Regulation Federal The Sundwall,
D. 510(k) notifications (55 § (1987) 357,359 Med. J. England New to response FDA average application; PMA each for filed PMA).4 ato time the response one-fifth is 510(k) notification § II manufacturers, device medical other many so have As §510(k)’s expedited of advantage took Medtronic petitioner that FDA the notified it 1982, when October process aas lead pacemaker Model its market to intended it already to devices “substantially equivalent” was that device aof pacemaker the portion is lead (The market. the on from signal electrical heartbeat-steadying transmits November itself.) On heart to generator” the “pulse “substantially was model found FDA 1982, 30, commerce” interstate into introduced devices to equivalent Medtronic advised Act, and date effective prior only subject its device market therefore could it found be could which Act, provisions control general Respondent’s See Regulations. Federal Code Judgment Summary for of Motion in Support Memorandum (Dec- Exh. A to Exh. 1,1993), Nov. Fla., (MD 93-482 in No. Substan- Swanson) (hereinafter H. Charles laration however, emphasized, Letter). agency Equivalence tial en- an construed should determination this Ibid. safety. lead’s the pacemaker dorsement on pacemaker dependent Lohr Lora Cross-petitioner In heart.. her functioning the proper technology equipped pacemaker Medtronic with implanted was she On leads. pacemaker Model company’s one de were MDA amendments enacted Congress In continu while 510(k) process on reliance FDA’s reduce signed review. PMA full received devices risky particularly ensure ing 1990. ofAct Devices Medical Safe *10 December 30,1990, pacemaker allegedly failed, resulting in a “complete heart block” required emergency surgery. Aсcording physician, to her a defect in the lead likely was the cause of the failure.
In 1993Lohr and her husband filed this action in a Florida state court. complaint Their contained both a negligence count and a strict-liability count. negligence count al- leged a breach of “duty Medtronic’s to use reasonable care design, manufacture, assembly, and sale of the subject pacemaker” in respects, several including the use of defec- tive materials in the lead and a failure to warn or properly plaintiff instruct the physicians her of the tendency of the pacemaker to despite fail, knowledge of other earlier failures. Complaint ¶ 5. The strict-liability count alleged that the de- vice was in a defective condition and unreasonably dangerous to foreseeable users at the (A time its ¶ Id., sale. 11. third count alleging breach of warranty was dismissed for failure to state a law.) claim under Florida
Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both negligence and strict-liability claims pre- were empted by §360k(a). 21 U. S. C. That section, which is at the core of the dispute parties between in this suit, provides:
Ҥ360k. State and local respecting devices
“(a) General rule
“Except provided (b) in subsection of this section, no or political State subdivision of a may State establish or continue in respect effect with a device intended any human use requirement— “(1) which is different from, inor any addition to, re- quirement applicable under this chapter to the device, *11 the of safety effectiveness or the “(2) to relates which requirement in a included matter any other toor
device
chapter.”5
this
under
device
the
to
applicable
motion,
Medtronic's
initially denied
Court
District
argu-
company’s
support the
to
statute
nothing
the
in
finding
liability manu-
exempted from
entirely
MDA
the
that
ment
regulations.
FDA’s
the
allegedly violated
had
who
facturer
decision,
that
long after
Not
5d.
Cert.
for
Pet.
App. to
See
Elev-
the
for
Appeals
of
Court
States
United
the
however,
of
required
§360k
concluded
Circuit
enth
manu-
the
against
brought
claims
some
least
exemptions
grant
FDA
the
authorizes
(b)
statute
the
of
Subsection
by subsection
pre-empted
be
otherwise
would
requirements
360k(b) provides:
(a). Section
“(b) Exempt
thereof,
Secre-
the
subdivision
a political
or
a State
of
application
“Upon
an
for
opportunity
and
notice
after
promulgated
regulation
by
may,
tary
condi-
such
section, under
(a)
this
of
subsection
from
exempt
hearing,
oral
State
such
a requirement
regulation,
such
in
prescribed
may be
as
tions
if—use
human
for
intended
device
ato
applicable
subdivision
political
this
under
requirement
than
stringent
is more
“(1)
requirement
the
were
exemption
anif
device
applicable
be
would
which
chapter
subsection; or
this
under
effect
in
“(2)
requirement—
the
conditions, and
local
compelling
“(A)
required
device
the
cause
would
requirement
with
compliance
“(B)
chapter.”
this
under
applicable
any
violation
in
regulations
has issued
FDA
authority,
grant
this
out
carry
To
360k(a)
address
§of
scope
construe
both
which
under
pre-emptive
to its
exemptions
grant
will
FDA
instances
(1995);n.
§ 808.1
infra.
CFR
effect.
authority,
this
exercises
it is
although
noteWe
Human
Health
Secretary
directly to
authority
gives
Act
See,
FDA.
authority
her
delegated
subsequently
Services, who
require-
exempt
may”
Secretary
(“the
§360k(b)
C.S.
21 U.
g.,
e.
Health
Secretary of
“the
defined
(“Secretary”
321(d)
§
ments),
“[t]he
is vested
Secretary
FDCA, the
Services”).
Under
Human
of”
enforcement
efficient
regulations
promulgate
authority
371(a).
21 U.S.C.
Act.
facturer
a medical device. See Duncan v.
Corp.,
Iolab
F. 3d 194
After reconsidering its ruling
light
Duncan, the District Court reversed its earlier decision and
dismissed the Lohrs’
complaint.
entire
The Court Appeals
part
reversed in
and affirmed in
*12
part.
(CA11 1995).
Under this the court concluded that the Lohrs’ negligent design claims were pre-empted. rejected It argument Medtronic’s that thе finding FDA’s of “substantial equivalence” any significance had respect pace- safety, maker’s or that the FDA’s continued surveillance of the device constituted a “requirement” design that its Id., maintained. at 1347-1349. On the other hand, it concluded that negligent manufacturing and failure to warn claims pre-empted were by general FDA’s “good manu- facturing practices” regulations, general which establish re- quirements steps for most in every device’smanufacture, see id., §§820.20-820.198 at 1350; 21 (1995), CFR var- bear require devices which regulations, labeling §801.109 21 CFR 1350-1351; 3d, at F. see warnings, ious strict- disposition parallel amade (1995). court inso- pre-emption nowas there holding that claims, liability design, dangerous unreasonably an alleged plaintiffs as far manufacturing or negligent revive they could but theory. 56 strict-liability a under claims warn failure 1351-1352. 3d, at
F. seeking review certiorari petition filed Medtronic Dis- it affirmed insofar decision Appeals’ Court seeking re- cross-petition filed Lohrs Court trict upheld itas insofar judgment of the view over are divided Appeals the Courts Because defense. pre-empted claims extent U. S. petitions. both granted we MDA,6 by the
Ill
*13
(1992),
504
S.U.
Inc., 505
Group,
Liggett
v.
Cipollone
inAs
statutory
interpreting
of
task
presented
arewe
While
law.
state
pre-empts
expressly
provision
go
not
need
360k(a)
we
means
of
language
pre-emptive
in-
Congress
whether
determine
language to
beyond that
id.,
law, see
some
least
at
pre-empt
the MDA
tended
expressly
“identify
domain
nonetheless
must
517, we
at
analysis
Although our
ibid.
language,
by that
pre-empted”
its
begin with
must
Management
pre-emption
scope of
of
Assn.,
Wastes
Solid
National
v.
Gade
text, see
510(k)
(§
1995)
(CA3
477
F. 3d
6
Corp.,
67
v. Mentor
English
g.,
e.
See,
61
Corp.,
Mentor
v.
Feldt
“requirements”);
pre-emptive
creates
process
“re
pre-emptive
create
not
does
(§510(k)
1995)
process
(CA5
3d 431
F.
(claim
1995)
alleg
(CA3
Inc., 46 F. 3d
1316
Shiley,
v.
Michael
quirements”);
(CA11
1335
F. 3d
56
pre-empted);
not
requirement
federal
violation
ing
may
violation
(claim alleging
below)
1995) (case
requirements;
pre-emptive
create
may
§510(k) process
pre-empted;
Corp.,
67
Collagen
Kennedy
v.
§360k(a));
by
covered
claims
360k(a)).
§by
all
covered
(common-law claims
1995)
(CA9
F. 3d
(1992)
First, because the States are independent sovereigns in system, our federal we long have presumed Congress does cavalierly pre-empt state-law causes of action. In pre-emption all cases, and particularly in those in which Con- gress “legislated has ... in a field which the States have traditionally occupied,”Rice v. Santa Fe Corp., Elevator (1947), 218, U. S. we “start with the assumption that the police powers historic of the States were not super- to be seded the Federal Act unless that was the clear and mani- purpose fest Congress.” Ibid.; Hillsborough Cty., 471 S., at U. 715-716; cf. Fort Packing Coyne, Co.v. Halifax 1, U. S. 22 Although dissenting argued Justices have this assumption apply only should question Congress whether any intended pre-emption at op- all, as posed questions concerning scope of its intended inval- idation of Cipollone, state law, see S., 505 U. at 545-546 concurring J., judgment in part dissenting (Scalia, part), “presumption we against used police power regulations” support a narrow inter-:? pretation of express such an Cipollone. command in Id., at approach 523. That is consistent with both federalism concerns and the primacy historic regulation of state mat- safety. ters health and *14 analysis
Second, our scope of the of pre- the statute’s emption guided by is oft-repeated our comment, initially made in Retail Clerks v. Schermerhorn, 375 96, S. U. 103 (1963), “[t]he purpose that Congress of is the ultimate touch- every stone” pre-emption in g., Cipollone, e. See, case. 505 S., at U. 516; Gade, S., (1978). 505 U. at 96; Malone v. White Motor Corp., 435 U. S. As a any result, under- standing scope of the of a pre-emption pri- statute must rest purpose.” congressional understanding of fair “a
marily on J.). of (opinion Stevens, 530, n. atS.,U. Cipollone, the from discerned is primarily course, of intent, Congress’ “statutory the and statute the of language atS.,U. (Ken- Gade, 505 surrounding it. framework” judgment). concurring in and part concurring in J., nedy, the of purpose and “structure the is however, relevant, Also J.), as of (opinion O’Connor, at 98 id., whole,” aas statute reviewing through the but text, only the in revealed Congress way which in understanding the of reasoned court’s scheme regulatory surrounding its and statute the intended law. the and consumers, business, affect con- ato first turn mind, we in considerations these With of Court the that claim Medtronic’s petitioner sideration and pre-empted action entire found have should Appeals cross-petition. Lohrs’ merits to the then > Appeals Court argues Medtronic petition, In its negligent alleging claims Lohrs’ concludingthat erred 360k(a). That §C.S.U. by 21 pre-empted design were aof subdivision political or “no State provides section a respect effect in continue or may establish State (1) which requirement any use human intended device applicable requirement (2) any to, addition inor from, different relates which device, chapter this under matter any other to or device safety effectiveness or this under device applicable a included cause any common-law suggests Medtronic chapter.” im- incentives alters “requirement” ais action generic to,” in addition from, “different duties poses response promulgated has standards ar- company essence, In MDA. under mandates any pre-empts language plain gues plaintiff injured by an brought claims all devices. medical a manufacturer against *15 argument Medtronic’s only is not unpersuasive, it is im- plausible. Under Medtronic’s view of the statute, Congress effectively precluded state courts from affording state con- any protection sumers injuries from resulting from a defec- tive medical device. Moreover, because there explicit is no private against cause of action manufacturers contained in suggestion MDA, and no that the Act implied created an private right of Congress action, would have barred most, if not all, persons relief for injured by defective medical de- §360k vices.7 Medtronic’s construction of would therefore perverse have the effect granting complete immunity from design liability defect to an industry entire judg- that, in the Congress, ment of needed stringent more regulation in order provide “to for the safety and effectiveness of medical de- vices intended for human use,” 90 (preamble Stat. 539 to Act). It say is, to the least, “difficult to believe that Con- gress would, without comment, judicial remove all means of injured by recourse illegal for those conduct,” Silkwood v. Corp., (1984), Kerr-McGee 238, U. S. and it would language take plainer §360k much than the text of to con- us Congress vince intended that result. Congress
Furthermore, if preclude intended all common-law causes of singularly action, it chose a odd word do it. The statute would have achieved an identical result, for precluded any instance, if it had “rem- edy” relating under state law “Require- medical devices. appears presume ment” imposing spe- the State is duty upon cific although manufacturer, we on have prior occasions concluded that a pre-empting certain
7The FDA’s authority recall, to require manufacturers replace, refund defective devices is of little injured use to plaintiffs, since is there no indication that the right is available to private parties, the remedy would not to recovery extend compensatory damages, author ity invoked, rarely Adler, if at all. See The 1976 Medical Device Amendments: A Step Right Direction Needs Another Step Right Direction, 43 Food Drug Cosm. L. J. 526-527
488 dam- common-law pre-empt also could “requirements”
state (opinion of 521-522 S., at U. Cipollone, claims, see ages broadly nearly as sweep not did J.), statute that Stevens, does. statute this that us believe have would Medtronic aat targeted was Cipollone8 in statute pre-emptive The smoking on “based requirements state of set limited —those possible the of subset limited only aat then health”—and “ad- involving the those of applications —those оf packages the cigarettes any of promotion vertising or the of” provisions the conformity with in labeled are which the giving context, that In 515. id., at See statute. meaning not did reasonable widest its “requirement” term potential on effect scope the nor pre-emptive nearly the have would term reading the of broad Medtronic’s that remedies peti- that held Cipollone in Court The this suit. in have common-law some maintain able was case in tioner of afoul run did case of the using theories actions however, Here, 524-530. at id., See statute. pre-emption would statute of interpretation sweeping Medtronic’s remedies, legal with interference greater far require sovereignty while into intrusion a serious producing remedy of possibility wiping out simultaneously first, The issue: at statutes pre-emptive two actually were There smoking relating statement “[n]o 1965, provided in enacted cigarette any inor package cigarette any on required” be shall ... health That S., 514. Inc., at U. Group, Liggett v. Cipollone advertising. petitioner’s of the any pre-empt concluded, did Court provision, superseded 1969, Congress In Id., 518-520. at claims. Smok Cigarette Health Public part with statute prohibition or “[n]o provided 1969, which Act ing re with law State under imposed shall health smoking on based packages cigarettes any promotion advertising spect Id., Act.” this provisions conformity in labeled statute; unless later this involved analysis Cipollone’s bulk 515. refer subsequent refer we to which statute stated, it this otherwise Cipollone. pre-emptive ences alleged Lohrs’ injuries.9 Given the ambiguities in the stat- ute scope and the preclusion of the that would occur other- wise, we cannot accept argument Medtronic’s using “requirement,” term Congress clearly signaled its intent deprive States any role in protecting consumers from dangers many inherent in medical devices.
Other differences between this statute and the one in Cipollone further convince us that Congress when enacted *17 it 360k, was primarily concerned with problem the spe- of cific, conflicting state statutes regulations and rather than general the duties by enforced common-lawactions. Unlike the at Cipollone, §360k issue in “require- refers to many ments” times throughout its text. In each instance, the word is linked with language suggesting that its focus is device-specific positive enactments of by legislative law administrative bodies, not the application general rules of by commonlaw judges juries. and For instance, subsections (a)(2) (b) and of the statute10 also refer to “requirements”— “requirements” but those only refer statutory regula- and tory law pursuant that exists to the MDA itself, suggesting that pre-empted “requirements” established or continued by States also refer primarily positive enactments of law. (b) Moreover, in subsection given FDA is authority to exclude “requirements” certain from scope pre- of the emption statute. Of the limited “exemptions” number of § 360k, Unlike 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 the text of the statute itself; text specified the precise warning to smokers that Congress deemed both necessary and sufficient. MDA, In the no such specifiсs exist until the provides FDA them. See also infra, (reliance at 495-496 on the FDA’s interpretation § of 360k warranted, alia, inter because of the FDA’s role in the §360k). administration of Moreover, the statute in Cipollone was clearly intended to have a broader pre-emptive effect than its 1965 predecessor. S., 515, U. at 520-521. 10The text of the statute quoted supra, at and n. 5. re- even none granted, has pre-emption
from claims.11 common-law motely resemble as legislation purpose basic examination An Med- rejection our supports entirely history its well pro- “to enacted was MDA position. extreme tronic’s in- devices medical effectiveness safety and for vide asserts Medtronic 539. 90 Stat. use.” human for tended innova- “protect however, intended, also was Act unnecessary being ‘stifled from technology in device tions (citing ” p. 3 95-754, in No. Petitioner Brief restrictions,’ extended interest 12), this 94-853, at Rep. No. H. R. Act While claims. legislative concerns,12 these some certainly reflects bur- regulatory regarding any fears history indicates additional risk of more related were dens duties pre-existing danger of than rather regulation (1976) Cong. Rec. g., 122 e. See, law. common under “redundant Collins) further (opposing Rep. (statement of (discussing id., requirements”); Federal burdensome from businesses *18 small protect toMDA in taken efforts in the Act). nowhere Indeed, the requirements additional discovered we history have Act’s relating to materials ham- would liability actions product fear ato reference extent theTo devices. medical development per industry, that protecting about concerned was Congress substantive through fewer primarily mаnifested was intent provision; pre-emption Act, under requirements by con- outweighed far was concern any such furthermore, exemptions (1995) are §§808.53-808.101 11 21 CFR at exemptions 22All aids. hearing sale regarding regulations statutes for (with vari permit example, for 12 exemptions, statutory Special devices experimental investigative, allow provisions) oversight ous equiva “substantial review PMA either without commerce used be Moreover, the 813 pt. CFR 21 §360j(g); S. C. U. lence.” concern some demonstrates very existence market interfere unduly may competing devices. medical
cerns about primary motivating issue the MDA’senact- ment: the safety of those who use medical devices. legislative history also confirms our understanding 360(k) simply was not intended pre-empt most, let
alone general all, common-law duties enforced damages actions. is, There to the best of our knowledge, nothing in hearings, Reports, Committee or the sug- debates gesting any proponent of legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of , defective devices. Congress
If intended such a result, its failure even to hint it is spectacularly odd, particularly since Members of both Houses were acutely aware product of ongoing liability litigation.13 Along with the less-than-precise language of §360k(a), that silence surely indicates that at least some against claims medical device manufacturers may be maintained after the enactment of the MDA.
13Furthermore, if Congress had intended the MDA to work this dra matic change in the availability of state-law remedies, one would expеct some reference to that change the extensive contemporary reviews of the legislation. We have been able to find no such g.,e. See, reference. Lesparre, Industry Spokesman Comments on Medical Device Amend ments 1976, 99, Hospitals 16, 1976); (Sept. Levine, A. 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 Hearings before the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, Ser. 94-39, No. 94th Cong., Sess., (1975) (statement 1st Anita Johnson, Public Citizen’s Health Research Group) (arguing that the pre-emption provision should not included, but making no mention of law, *19 common and specifically discussing only a positive California enact ment regarding safety the of intrauterine contraceptive devices); Medical Devices and Equipment (Frost Liability Avoidance & Sullivan pub. June 1977) (comprehensive 2-volume, 600-page review of published medical de product vice liability eases from 1910 to suggesting nowhere that MDA had mooted or even altered the longstanding ability of plaintiffs to seek and receive damages awards law). under state
V why, if even specific reasons several asserts Medtronic least claims, it at common-law all pre-empt § not does 360k contrast, the In suit. in this claims Lohrs’ the pre-empts rea- a survive complaint should their entire argue that Lohrs §360k(a). scope of pre-emptive of the evaluation sonable correctly Appeals Court that the claim Lohrs the First, pre-empted not were design claims nеgligent their that held imposes process 510(k) § notification premarket because pacemaker. design of Medtronic’s on “requirement” no rules general FDA’s if the even suggest that they Second, labeling “re- are practices manufacturing regulating requirements, pre-empt quirements” different duplicate merely rules 360k(a) pre-empt state § not does they Finally, requirements. federal those all some imposing' rules general State’s because argue that require- impose a not do upon Medtronic duties with they conflict do not device,” respect to “with ment labeling manufacturing and relating to rules general FDA’s pre-empted. not therefore Design Claim defec- Lohrs’ concluded Appeals Court The re- because pre-empted were design claims
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The FDA stressed this basic conclusion in its letter to Medtronic finding the 4011 lead “substantially equivalent” to already devices on the market. That letter only required Medtronic comply “general standards” —the lowest protection level of “applicable to all medical devices,” and including “listing of good devices, manufacturing practices, labeling, and the misbranding and provisions adulteration the Act.” It explicitly warned Medtronic that the letter did any “not in way denote official approval FDA your de- vice,” and “[a]ny representation that impres- creates an sion of approval official of this device compliance because of premarket with the regulations notification is misleading constitutes misbranding.” FDA Substantial Equivalence Letter.
Thus, though even may §510(k) well examine applications (as for Class III devices it examines the entire medical device industry) with a concern for safety effectiveness of the device, see Brief for Petitioner No. 95-754, at 22-26, it did “require” pace- Medtronics’ maker to any particular take form any pаrticular reason; the agency simply allowed pacemaker, aas device sub- stantially equivalent to one that existed before 1976, to be *21 process. PMA the gauntlet of running the without
marketed Congress review, to PMA exemption this providing In to com- freedom the give merely manufacturers intended terms same on the and degree, with limited pete, to a prior to 1976.14 that existed devices medical of manufacturers statutory scheme the either suggestion no There §510(k) process exemption history the that legislative the the status maintain anything other than to do intended was de- existing medical marketing of to the respect quo with quo status That equivalents. substantial their and vices device the of manufacturer the that possibility the included negli- of claims state-law against itself defend have would “substantial the behind background this Given design. gent of Con- purpose “[t]he fact exemption, the equivalence” every pre-emption touchstone” ultimate gress is cita- and (internal marks quotation atS.,U. case, pre-emption, against omitted), presumption and tions “substantial concluded properly Appeals Court design Lohrs’ pre-empt did provision equivalence” claims. Claims Requirements
Identity of exist “requirements” if even suggest next Lohrs The pace- labeling manufacturing and to the respect 510(k) provision “[T]he 1982: it in put Commissioner FDA theAs and make firms permits mechanism procompetition is a law appar Congress devices. pre-1976 versions me-too market quickly market be on happened whose device firma ently believed preclear subject never was and the amendments enactment before of other expense monopоly lengthy enjoy should FDA ance Devices, Medical Oversight: FDA consumer.” ultimately firms Investigations Oversight on Subcommittee before Hearing (1982). Sess., 9 2d Cong., Commerce, 97th Energy on Committee House Dif Notification: Premarket Versus Approval Kahan, Premarket also 510, 514-515 L. J. Drug Cosm. Market, 39 Food Same Routes ferent Regulation Federal Sundwall, The D.& Kessler, Pape, S. (1984); D. 357, 359 Med. J. England Devices, New Medical maker, and even if we can also consider state impose law to 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 pre cise contours of their theory of recovery yet have not been (the defined pre-emption issue was decided on the basis of the pleadings), it is clear that the Lohrs’ allegations may in clude claims that Medtronic has, to the they extent that exist, violated regulations. At least these they claims, suggest, can be maintained being without pre-empted by §360k, agree. and we *22 §360k Nothing in denies Florida right provide a damages traditional remedy for violations of common-lawdu- ties when parallel those duties requirements. federal Even may if it necessary be as a matter of prove Florida law to that those violations were the result negligent conduct, they or that created an unreasonable hazard for users of product, such additional elements of the state-law cause of action would make the state narrower, not broader, than the requirement. federal While such a nar- requirement rower might be “different from” the federal rules in a literal sense, such a difference surely pro- would strange vide a reason for finding pre-emption of a state rule insofar duplicates as it the federal rule. presence The damages a remedy does not amount to the additional or dif- “requirement” ferent that is necessary under the statute; merely rather, it provides another reason for manufacturers comply existing identical “requirements” under fed- eral law. regulations FDA interpreting §360k’s scope
pre-emptive support effect the Lohrs’ view, and interpre- our tation of the pre-emption statute is substantially informed by regulations. those The different expressed views by the Appeals Courts of regarding the appropriate scope of federal § under 360k demonstrate that language is section not entirely clear. In Congress addition, has scope of determining the unique role a the FDA given construed the statute Unlike § pre-emptive effect. 360k’s does pre-emption under MDA instance, Cipollone, statute; of the enactment of the directly result as a arise only to pre-empted will be law a state cases most rather, in a promulgated relevant has FDA that the extent agency to is the federal FDA Because “requirement.” authority implement the delegated its Congress has qualified to uniquely agency is Act,15the provisions “stands law form of particular a whether determine of the execution accomplishment and an obstacle Davido v. Congress,” Hines objectives of purposes full should (1941), it therefore, whether and, 52, 67 U. S. witz, 312 delegated explicitly Congress example, For pre-empted. from regulations exempt state authority to to the FDA authority neces MDA—an of the effect pre-emptive effect pre-emptive to assess the FDA sarily requires laws. on state will have regulations own its Act and grant of au implementing that 360k(b). regulations FDA individ or other by which States process thority establish regard advisory opinion from the may request an uals pre-empted particular ing whether *23 (1995). ambiguity in § The 808.5 21 CFR See statute. authority grant of congressional statute —and provide a “sound within contained the matter agency on it— concurring part and J., post, basis,” (O’Connor, weight to the giving substantial dissenting part), for Inc. v. A.S.U See Chevron statute. agency’s view of (1984); Inc., 467 S. Council, U. Resources Natural Hillsborough Defense 471 U. (considering under at 714 Cty., S., “dispositive”). regulations its effect of pre-emptive standing sup- expressly by the FDA promulgated regulations preempt §360k or State “does conclusion port the substantially identi- equal to, requirements that local 371(a). §C. supra; 21 U. S. n. 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 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, im posed” under federal law. Manufacturing and Labeling Claims
Finally, the Lohrs suggest that with respect to the manu- facturing 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 general federal regulations governing the labeling and manufacture of all medical de- vices, and therefore concluded that the claims pre- were empted altogether.
The requirements identified by the Court of Appeals in- clude labeling regulations that require manufacturers of every medical device, with a few limited exceptions, to in- clude with the device a label containing “information use,. .. any and relevant hazards, contraindications, side ef- fects, precautions.” §§ 21 CFR 801.109(b) (c) Similarly, manufacturers are required to comply with “Good Manufacturing Practices,” or “GMP’s,” which are set forth in 32 sections and less than pages in the Code of Federal Regulations.17 In certain circumstances, the Court Ap- 16We also note that the agency permits manufacturers of devices that have received PMA to make certain labeling, quality control, and manufac turing changes which would “enhanc[e] the safety of the device or the safety in the use of the device” prior without FDA approval. See 21 CFR §§814.39(d)(1) (2) (1995). 17Some GMP’s include the duty to institute a “quality assurance pro *24 gram,” §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, general re- these enforce will FDA recognized,
peals them. violate against manufacturers quirements 3d, at 1350-1351. F. Lohrs exist, the requirements these admitting that While pre-empt simply does nature general their suggest that comply with failed to manufacturer alleging that claims their support of In law. common state under duties other fed 360k(a)(1) a states that expressly § they note claim, ques device” to “applicable must requirement еral the label Because effect. pre-emptive any it has before tion host to a applicable are requirements manufacturing ing and satisfy this they do not argue they devices, different only re state because argue that They further condition. pre-empted, may be a respect to device” “with quirements safety or “relates requirement only if the then and matter included any other or device effectiveness 360k(a) § mandates device,” applicable requirement a specific between a conflict only there where to” “applicable requirement a federal and device. the same regulations, FDA by the supported theory is Lohrs’ pre-empted are requirements provide which counterpart “specific established has when the “only” applicable requirements specific other ... or regulations 808.1(d) (1995).18 They fur- 21 CFR device.” particular controls, equipment environmental buildings, to have §820.25, and 820.46, §§820.40, see product, a safe produce adequate quality aof 820.60. §360k(a) from is obvious scope of the understanding narrow FDA’s part: in relevant provides, regulation, text full Food only when preempted are “(d) requirements or local State or regulations counterpart specific established has Administration Drug device particular ato applicable requirements specific other are there local re- or State divergent existing any making act, thereby under to, the from, addition or in different device applicable quirements other are There requirements. Administration Drug Food specific preempted devices that affect local Stаte *25 ther note that the statute is not intended to pre-empt “State or requirements local general of applicability where pur- pose of the requirement relates either to products other addition to devices ... or to unfair practices trade in which the requirements are not § limited 808.1(d)(1). to devices.” regulations specifically provide, as examples permis- of general requirements, sible general electrical codes and the Uniform Commercial warranty Code of fitness would not pre-empted. See ibid. The regulations go even so far 360k(a) § as to state that generally “does preempt a state or requirement local prohibiting the manufacture adul- terated or misbranded devices” unless prohibition “such a has the effect of establishing a substantive for specific a §808.1(d)(6)(ii). device.” Furthermore, under its authority grant exemptions to the pre-emptive effect of §360k(a),the FDA granted, has never nor, to the best of our 521(a) section of the act because they are not ‘requirements applicable to a device’ within the meaning 521(a) of section of the act. The following are examples of State or local requirements that are not regarded as pre- empted by section 521 of the act: “(1) 521(a) Section does not preempt State or local requirements gen- eral applicability where the purpose the requirement relates either to other products in (e. addition to devices g., requirements such as general codes,
electrical and the Uniform Commercial Code (warranty fitnéss)), or to unfair trade practices in whiсh the requirements are not limited to devices. “(2) 521(a) Section does not preempt State local requirements that are equal to, or substantially to, identical requirements imposed by or under the act. “(6)(i) 521(a) Section does not preempt State or local requirements re- specting general enforcement, e. g., requirements that State inspection be permitted of factory records concerning all .... devices “(ii) 521(a) Generally, section does not preempt a State or local require- ment prohibiting the manufacture of adulterated or misbranded devices.
Where, however, such a prohibition has the effect establishing a sub- stantive requirement for specific device, a e. g., specific labeling re- quirement, then the prohibition [may] be preempted.” 808.1(d) 21 CFR ex- an granting, consider asked been
knowledge, even all applicability; general law emption specific excruciatingly apply to exemptions existing hearing aids. the sale regarding *26 §§808.53-808.101. regu- statutory and this that believe not do Although we re- federal “general” precludes necessarily language latory or requirements, state pre-empting ever from quirements being pre-empted, ever from requirements state “general” overarching its ignore to impossible it is VI, infra, Part see state particular only where occur that concern in- specificfederal awith interfere to threatens requirement medi- to” respect be “with must requirements State terest. to,” federal addition inor from, “different and devices cal “to the relate also must requirements State requirements. matter any other toor dеvice of the safety effectiveness or and device,” to applicable requirement ain included ap- “general requirements state provide regulations they “the have except where pre-empted not are plicability” specific afor requirement establishing a substantive effect “applica- must requirements Moreover, federal device.” regula- according to and, question, in device” ble counter- “specific they only if law state pre-empt tions, device.” “particular a “specific” or regulations” part compari- require a careful therefore, regulations, and statute requirement pre-empting allegedly between son deter- requirement pre-empted allegedly and pre-emptive intended within they fall whether mine regulations.19 and scope of the analysis a similar llone Cipo in concluded Court this plurality A of 1969. Act Smoking Cigarette Health Public under required was and smoking on based prohibitions requirements pre-empted Act That promo or advertising respect law State under “imposed health with that conformity in labeled were packages in cigarettes tion” misrepre fraudulent petitioner’s heldWe S., at 515. 505 U. Act. made statements false allegedly on based those including claims, sentation “predicated were they because pre-empted advertisements, were general a more on rather but health’ smoking on ‘based duty on a comparison Such a mandates a conclusion that the Lohrs’ common-law claims are not pre-empted by the federal label- ing and manufacturing requirements. The generality of requirements thоse make quite this unlike a case in which the Federal Government weighed has the competing inter- ests particular relevant question, reached an unambiguous conclusionabout how those compet- ing considerations should be particular resolved in a case set of cases, implemented specific conclusion via a mandate on producers. manufacturers or Rather, the fed- eral important reflect entirely but generic con- cerns about regulation device generally, not the sort of con- cerns regarding specific device or field of regulation device that the regulations statute or were designed protect from potentially contradictory requirements. *27 Similarly, general the state requirements common-law this suit were not specifically developed respect “with to” medical devices. Accordingly, they are not the kinds of re- quirements that Congress and the FDA feared impede would ability the of regulators federal implement to and enforce specific requirements. federal legal duty that is the predicate for negligent the Lohrs’ manufacturing claim is the general duty every manufacturer to use due care to avoid dangers foreseeable products. in its Similarly, predicate for the failure to warn general claim is the duty to inform purchasers users and potentially dangerous items risks involved in general their use. These obligations are no more a to requirements threat than would be a duty state-law comply to prevention with local fire regula- obligation duty not Id., to deceive.” at —the 528-529. The general common-law duty “not tо make fraudulent statements” was not within the specific category of requirements or prohibitions based on and smoking health imposed under state law “with respect or advertising promo- tion” of cigarettes that were pre-empted by the Id., 1969 statute. at 529. If anything, the language of the MDA’s pre-emption statute and its coun- terpart regulations require an even more searching inquiry into the rela- tionship between the federal requirement and the state requirement issue than was true under the statute in Cipollone. training in the care due use codes, or zoning and
tions These force. a work supervision and source because pre-emption, escape therefore because rather but rule, common-law judge-made duty ais require- category of outside them leaves generality their specific to” respect “with § envisioned 360k that ments Lohrs’ none of result, aAs pacemakers. such as devices label- manufacturing or defective allegedly on based claims by the MDA. pre-empted ing are
> argument, Anal present the Lohrs cross-petition, In their “require- never are duties common-law that suggesting statute §360k and meaning of within ments” The Lohrs actions. pre-empts never therefore dispositive is not Cipollone holding in our point out signifi- are there suggests, supra, IV, Part issue, this Cipollone between differences historical and textual cant always be must meaning words § 360k, they situated. are within by the environment informed regu- by resolved is issue think that doWe require- those applicable § 360k suggesting lation “estab- of law” effect “having force ments (1995); 808.1(b) CFR decision,” 21 court . . . lished decisions court refer intended was appears, it reference, Reg. Fed. regulations. statutes construing *28 95-886, No. in Petitioners (1977); for Brief p. 26, n. 7. argument directly this respond do not Nevertheless, we is claims Lohrs’ none since First, reasons. two for hypothetical resolve need suit, we this in pre-empted criti- given Second, future. in may arise cases FDA’s) (and the our specificity device importance of cal any, if few, apparent it §360k, construction statute. this pre-empted been have duties a common-law hearing court indeed rare bewill It cause of action to issue a decree that has “the effect of estab lishing a substantive specific for a device.” 21 §808.1(d)(6)(ii)(1995). CFR Until such a case arises, we see no need to determine whether the statute explicitly pre empts such a claim. Even then, the may issue not need to be resolved if the claim would also be pre-empted under conflict pre-emption analysis, Freightliner Corp. see Myrick, v. U. S. 280, 287
VII Accordingly, judgment of the Appeals Court of is re- versed insofar as it held any of the claims pre- were empted and affirmed rejected insofar as it the pre-emption defense. The cases are remanded for further proceedings.
It is so ordered. concurring part and concurring in Justice Breyer, judgment. This action questions. raises two First, do the Medical, Device (MDA) Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act ever pre-empt a state-law tort ac- tion? Second, if so, does pre-empt MDA particular state-law tort claims at issue here?
I My answer to question the first is that the MDAwill some- pre-empt times a state-law tort basically suit. I agree with discussion of point this and with her Justice O’Connor’s рost, conclusion. See at 510-512. language, statute’s literally, read supports that says: conclusion. It
“[N]o may State . . . establish . . . respect to a any [state] device .. . requirement... which is different from, or in any addition to, [federal] requirement. . . .” 360k(a) 21 U. S. C. (emphasis added). *29 includ- as “requirement” word reasonably read can One application, out grow legal
ing the law. tort State’s a circumstances, particular in S.U. Inc., Group, Liggett v. Cipollone in Moreover, “eas language similar clear made (1992),the Court can regulation “[state] because actions tort encompassed ily” damages as through an award effectively exerted as (plural Id., at relief.” preventive form through some omitted); id., at see marks (internal quotation ity opinion) and dis part in judgment concurring in J., 548-549 (Scalia, Easterwood, v. Transp., Inc. Accord, CSX part). senting in applica seem would rationale This 658, 664 S.U. here. issue circumstances similar quite ble conse anomalous have holding would contrary Finally, a hearing particular ato respect that, in Imagine quences. a 2-inch requires regulation MDA federal component, aid wire. 1-inch requires a regulation agency a state but wire, regulation, MDA “2-inch” embodied law, federal If the it why wbuld regulation, agency “1-inch” state pre-empts premises action tort a state-law pre-empt similarly not liability upon ause failure manufacturer’s defendant expert persuaded jury by a award (say, an wire 1-inch negligent)? is wire 1-inch than more a use testimony that tort state regulation agency state effects pre them between distinguish To identical. suit (to state set power greater grant would purposes emрtion stand to,” addition in or from, “different standards acting officials jury than ards) single ato proc lawmaking legislative administrative through state upon specifically focus likely did Congress Where esses. have to it take would 486-491, I ante, at matter, see result. anomalous this intended MDA ordinarily, insofar I believe Consequently, statute, a state embodied requirement a state pre-empts also would action, it administrative or other regulation, rule, aof form takes similar pre-empt
505 standard of care or imposed behavior by a state-law tort possible action. It is that the plurality agrees also on this point, although it say does not explicitly. so
HHt-H The answer to the question second turns Congress’ on in- g., tent. See, e. Barnett Bank Cty., Marion N. A. v. Nel- son, (1996); 517 U. 25, S. Allis-Chalmers Corp. v. Lueck, (1985); U. 202, S. ante, at 485-486. Although Con- gress has not stated whether the MDA does, or not, does pre-empt the tort claims here at issue, several considerations lead me to conclude that it does not.
First, the MDA’s provision highly is ambigu- ous. provision That makes clear that requirements federal may pre-empt state requirements, says but it next nothing just about when, where, they or may how do so. The words “any [state] requirement” “any [federal] requirement,” example, for do not tell us requirements are at issue, every for requirement that is not identical to even one federal is from, “different or in to,” addition single requirement; federal yet, Congress could not have intended that the existence of single one say, rule, federal about hearing a 2-ineh aid wire, pre-empt would every hearing law aid rule, even set a of rules only related packaging shipping or hearing aids. Congress Thus, must have intendеd that courts look elsewhere help just as to which pre-empt just which state re- quirements, as just well as they might how do so.
Second, this Court has previously suggested that, in the absence of a congressional clear command as to pre-emption, may courts infer that the relevant agency administrative possesses degree of leeway to determine which regu rules, lations, other administrative actions will pre-emptive have effect. See Hillsborough County v. Automated Medical Laboratories, Inc., (1985); 471 U. 707, S. Smiley cf. v. (South Dakota), Citibank A.,N. 517 U. 735, S. 739-741 Dist. School Lead-Deadwood County v.
(1996); Lawrence (1985); A. Inc. U S. Chevron 256, 261-262 S.U. 40-1, 469 No. S. Inc., 467 U. Council, Resources Natural v. Defense makes here inference similar To draw 842-845 ambiguity. statutory simply because sense, (FDA) respon fully Drug Administration Food *31 §393. C.S. 21 U. administering MDA. See for sible and, involvement agency informed means responsibility That impact both likely understanding of the special therefore, understanding anaswell as requirements, federal state may which) requirements (or to extent of whether Hillsborough, 471 objectives. See federal interfere understandings these translate can FDA The 721. S., at U. accompanying its intentions pre-emptive particularized into com can It 718. id., at regulations. rules various through statements example, intentions, those municate re statements, and interpretive preambles, “regulations, exercise through the as ibid., well comments,” to sponses require exempt state power designated explicitly of its 360k(b); also § see C. 21 U. S. see pre-emption, from ments exempt state authority to FDA’s (noting that ante, at FDA necessarily requires from requirements effect). pre-emptive laws’ federаl assess regulation specific promulgated has FDA Third, says: regulation help. That designed to only . .. when preempted are requirements . . . “State applicable requirements [federal] specific . . . there existing any making thereby . . . device particular to a de- applicable requirements . . . divergent State [fed- specific to, in addition from, different vice (1995) 808.1(d) (empha- CFR requirements.” eral] added). sis for its statutory gaps, all the fill not does regulation did than any more explain, “divergent” does
word device-related different just when statute, requirements are closely enough related to trigger pre- emption analysis. But the regulation’s “specific” word does narrow the universe of federal requirements that agency intends displace at least some state law.
Insofar as any there are applicable requirements here, requirements, those even if numerous, are “spe- cific” any relevant sense. See ante, at 497-498, 501. Hence, as the above-quoted FDA’s pre-emption rule us, tells the FDA does not intend requirements these pre-empt the state at issue here. present At least in no circumstances, law forces the FDA to require- make its pre-emptive ments if it does not think it appropriate. I cannot contrary infer a intent from Justice O’Connor’s
characterization of the federal applicable standards here as “comprehensive” and post, “extensive,” 514, both be- cause that is questionable, characterization see ante, at 497- 498, 501, and because this Court has previously said that it would solely infer, “seldom comprehensiveness from the *32 regulations, federal an intent to pre-empt entirety in its a field related to health safety.” and Hillsborough, supra, at 718. It therefore seems to me that the better indicator of the FDA’sintent pre-emption-related is its regulation. And regulation’s “specific” word would seem a reasonable leeway exercise of the that statutory language practical and administrative suggest circumstance Congress intended to grant agency. the ordinary
Fourth,
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emption point in the same direction.
principles
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require
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the state
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federal
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Florida Lime & Avocado Growers, Inc. v.
Paul,
U.
(1963),
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or because the state re
quirement “stands as an obstacle to
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Davidowitz,
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scheme for room no left Congress inference reasonable Corp., Elevator Fe v. Santa Rice it,” to supplement States Bank, 517 g., Barnett e. See, (1947). 230 218, S.U. 331 Management Wastes Solid National Gade v. 31; S.,U. J.); Wis- O’Connor, (1992) (opinion 88, Assn., S.U. 597, 604-605 Mortier, U. S. v. Intervenor Public consin Co., S.U. Elec. General English v. (1991); con- aof indication any absence sense, makes It the pre- read intent, (or agency) congressional trary in light regulation) (and pre-emption emption terms statutory principles. pre-emption basic these themselves lend readily to” “in addition and from” “different pre-emption parallels language their for reading, such from indication contrary any Without conсerns. basic law’s word regulation’s interpret also might one agency, basic same these in light “divergent” principles. interpre- court’s inform principles basic these Insofar conclu- support they regulation, the statute tation actual no find I can here. no pre-emption there sion any any between conflict tort state-law the plaintiffs’ premises liability-creating any I find can above, discussed reasons nor, suit; intended FDA Congress either indication relevant any entirely occupy regulations relevant field. I judgment. Court’s I concur reasons, these For I do VI. IV for Parts but opinion, Court’s join also *33 between differences emphasizes IV, Part join not Cipollone, in issue at statute pre-emption MDA in relevant view, in not, my differences those because I am because VI, Part join do I action. this MDA pre-emption incidents future convinced ante, 502. “rare,” “few” be will claims common-law Justice O’Connor, with whom The Chief Justice, Justice Scalia, and Justice Thomas join, in concurring part dissenting part. 360k(a),
Section the pre-emption provision of the Medical Device (MDA), Amendments of provides that no State may establish or continue in “any effect requirement” “which is different from, or in addition any requirement to,” applica- ble under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) to the As device. points Court out, because Congress expressly provided has a pre-emption provision, go beyond “we need not language to determine whether Congress intended the pre-empt” MDA to state law. Ante, agree, at 484. We then, on the task before interpret us: to Congress’ intent reading the accordance with its terms. This, however, the Court has failed to do. require
The cases us to determine whether the Lohrs’ state common-law claims § survive pre-emption under 360k.
I conclude that state damages actions do im- pose “requirements” and are therefore pre-empted where such would differ imposed from those by the FDCA. plurality acknowledges that a common-law ac- might impose tion “requirement,” suggests but that such a pre-emption would be “rare indeed.” Ante, at 502. To reach that opinion determination, explicitly re- —without lying Drug on (FDA) Food and regulations Administration offering any without sound why basis for deference would imports regulations the FDA inter- warranted — preting 360k to “inform” the reading. Court’s Accordingly, principal opinion states only occurs particular “where a threatens to interfere specific with a federal interest,” ante, at 500, and for 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 seem- ingly guiding without principle. *34 intent congressional § demonstrates 360k language The that by State requirement” “any pre-empt MDA to applicable to,” addition in from, or “different is various raised have Lohrs The FDCA. under device Medtronic’s with in connection claims common-law state begin with must therefore, Analysis, lead. pacemaker constitute can actions common-law whether question 360k(a). meaning of within “requirements” Cipollone, in question a similar recently addressed We require- “no phrase meaning of the examined we where Cigarette Health Public under prohibition” or ment Inc., 505 Group, Liggett v. Cipollone 1969. ofAct Smoking agreed the Court majority of (1992). A S.U. “requirements.” impose do actions damages common-law J., 548-549 id., at opinion); (Scalia, (plurality 521-522 Id., at part in judgment concurring in J., joined Thomas, explained: plurality theAs part). dissenting in sweeps prohibition’ or ‘[n]o phrase, “The en- positive between distinction no suggests
broadly and words contrary, those to law; common actments form take obligations encompass easily context, another noted weAs rules. common-law through effectively exerted asbe can regulation ‘[state] preven- form through some damages as award an be, can compensation pay obligation relief. tive governing method potent be, a designed to is indeed Building Diego San policy.’ controlling conduct (1959).” S. U. Garmon, v. Council Trades 521. Id., context. present applicable equally rationale That man- cigarettes labeling relating
Whether damages common-law devices, state medical ufacture comply manufacturers require operate actions answer declared, in Cipollone As duties. common-law actions here raised argument same *35 impose do not requirements, “such an analysis is at odds both plain with the words” of the statute and gen- “with the eral understanding of common-lawdamages actions.” Ibid. §If 360k’slanguage given is ordinary its meaning, it clearly pre-empts any state common-law action that impose would requirement different from, or in addition to, that appli- cable under the -just as it would pre-empt a FDCA— state regulation statute or that had that effect. Breyer Justice reaches the same conclusion. Ante, at (opinion 503-505 cоn- curring part and concurring judgment). plurality’s reasons for departing from this reading are neither persuasive. clear nor It fails to refute applica- bility of reasoning Cipollone. Instead, in Part IV, the plurality .essentially makes the case that the statute’s language, purpose, legislative history, as well as the con- sequences of a different interpretation, indicate that Con- gress did not “requirement” intend to include state common- law claims at all. The principal opinion proceeds to disclaim position, this however, in Parts V and VI and concludes, rather, that a state common-law might action constitute a requirement, but that such a case would be “rare indeed.” Ante, at 502. The Court holds that an “requirement” FDCA triggers pre-emption only when a conflict exists between a specific requirement state specific and FDCA applicable particular device. ante, at 498-502. (“[W]e But see ante, at do not believe that this statutory and regulatory language necessarily precludes 'general’ fed- requirements eral from ever pre-empting require- ments, ‘general’ 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 particularized its reading of the statute, imports Court interpretation put forth the FDA’s regulations. similarly relies on the FDA Breyer Justice
regulations to at arrive an understanding 360(k). Ante, deference Chevron recognizing Apparently
at 505-507. deferring admit does Court here, the is unwarranted “infor[m]” them merely permits but regulations, these certain is It 495. Ante, at interрretation. Court’s ef pre-emptive determining the regulation agency an Smiley cf. deference, entitled is statute any federal fect 743-744 U. S. Dakota), A.,N. (South Citibank v. here issue clear pertaining (1996), one but express an contains the statute “If surely not. first inmust statutory construction *36 task the clause, nec clause, wording plain on focus instance pre-emptive Congress’ evidence best essarily contains 658, 664 S.U. Easterwood, v. Transp., Inc. CSX intent.” resort clear, is statute language (1993). Where Chevron improper. is interpretation agency’s to Inc., 467 Council, Resources Defense Natural v. Inc.A.S.U. §360k(a)(l) di C.S. 21 U. (1984). Title 842-843 S.U. is “which requirement” [state] “any rects applicable requirement any to, addition from, or different above, explained As device.” FDCA] to [the under “re term 503-505, the ante, at agrees, Breyer as Justice action. causes common-law encompasses quirement” narrowing con agency’s an employs it when errs Court The warranted. deference such no where statute aof struction specificity, requirement aof no mention makes statute The re a such determining that basis sound nois there exists. requirement” “any on striction indicates 360k reading of fair I conclude itself pre-empted, are claims impose would recognition their extent states, FDCA to, addition from, or different requirement” “any premise, From device. applicable requirements requirements FDCA whether question proceed I Lohrs’ pre-empt here exist device applicable claims. state-law agree
I with the Court that the Lohrs’ defective design claim is not pre-empted by §510(k) the FDCA’s “substantial equivalency” process. §510(k) process merely evalu- ates 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 may device be also be §510(k) marketed. Because the process seeks merely to establish pre-1976 whether a device post- and a equivalent, 1976 device are places “requirements” no on a device, the Lohrs’ design defective claim is pre-empted. agree I also that the Lohrs’ claims not pre-empted by §360k to the they extent that damages seek for Medtronic’s alleged violation of requirements. Where a state cause of action seeks to an enforce requirement, FDCA claim impose does not that is “different from, or in requirements to,” addition under federal law. To be sure, the damages threat of a remedy give will manufactur- ers an additional cause comply, but the im- posed on them under state and federal law do not differ. Section preclude 360k does not imposing States from differ- ent or additional only remedies, but different or additional *37 requirements.
I disagree, however, with the Court’s conclusion that the Lohrs’ claims survive pre-emption they insofar as would compel Medtronic comply to requirements with different from imposed by those the FDCA. Because I do not sub- scribe to the reading Court’s into 360k the req- additional uisite “specificity,” my of determination what claims pre-empted are is broader. Some, if not all, of the Lohrs’ common-law regarding claims manufacturing and label- ing of Medtronic’s device compel would Medtronic to comply requirements different from, or in to, addition those re- quired by the FDA. The FDA’s Good Manufacturing Prac- (GMP) tice regulations impose comprehensive requirements relating every aspect of the device-manufacturing process, personnel, build- and organization
including a manufacturer’s process production and controls, component equipment, ings, holding, distribu- controls, labeling and packaging controls, recordkeeping. See and evaluation, device installation, tion, common-law Lohrs’ §§820.20-820.198 21 CFR impose successful, if would, manufacture regarding claims to,” addition from, or “different requirements In simi- pre-empted. therefore are requirements, GMP pre-empted is claim warn failure Lohrs’ fashion, lar by FDA. imposed requirements labeling by the extensive include (1995) labels to (requiring §801.109 g., 21 CFR e. See, fre- methods, routes, effects, indications, information such con- hazards, relevant administration, and duration quency exten- These precautions). effects, and traindications, side are labeling manufacturing and federal sive by Med- manufactured the device applicable certainly specificity than 360k(a) more no requires Section tronic. claims. common-law of state that §360k(a)’s “require- term I conclude summarize, To Because claims. common-law encompasses state ment” “requirement” indicate language does statutory I pre-empted, beor pre-empt “specific,” either must it if pre-empted is claim a state conclude from, different “which requirement” “any impose would device applicable any requirement to,” addition the Court judgment affirm I would FDCA. under pre-empted is not design claim Lohrs’ Appeals that warn failure manufacture MDA, judgment reverse I would pre-empted; claims a common-law pre-empts MDA Appeals Court requirements. alleging violation claim