# Amicus Curiae Brief — Smiths Industries Medical Systems, Inc. v. Kernats ex rel. Kernats

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 1997
- **Citation:** 520 U.S. 1208

## Text

No. 96-1405 : | |
t CILCREK i
In the Supreme Court of the Gnited States — —

OCTOBER TERM, 1997

SMITHS INDUSTRIES MEDICAL SYSTEMS, INC..
PETITIONER

U.

SARAH KERNATS, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE APPELLATE COURT OF ILLINOIS

BRIEF FOR THE UNITED STATES
AS AMICUS CURIAE

SETH P. WAXMAN
Solicitor General
FRANK W. HUNGER
Assistant Attorney General
DOUGLAS N. LETTER
THOMAS M. BONDY
Attorneys

Department of Justice
Washington, DC 20530-0001

(202) 514-2217

QUESTION PRESENTED

Whether the Medical Device Amendments of 1976
(MDA), which create a federal program for regulating
medical devices and prohibit the States from impos-
ing safety requirements that are “different from, or in
addition to,” federal requirements, 21 U.S.C. 360k(a), pre-
empt a State’s general common law remedies for injury
from defective products.

(I)

TABLE OF CONTENTS

Page
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TABLE OF AUTHORITIES
Cases:
American Airlines, Inc. v. Wolens, 513 U.S. 219
i RE ES EE EN TCC NAC RES TIS 16
Belknap, Inc. v. Hale, 463 U.S. 491 (1988) ....cccccccee. 12, 13
Calder v. Jones, 465 U.S. 783 (1984) cocccccocccccceeeee... 12
Chambers v. Osteonics Corp., 109 F.3d 1243 (7th
SPI SEE ea tntietiitiicts cients tenes 18
Cohen v. Beneficial Indus. Loan Corp., 337 U.S. 541
SITE Uliidiphid teiichpchitaiathcaawtticksinttaabaisiiidsecenasunionesis.ccoxicsiceins 10-11
Cox Broadcasting Corp. v. Cohn, 420 U.S. 469
ETN GES STRIPE Resa Sn elec PO a 10, 11, 12, 14
Duquesne Light Co. v. Barasch, 488 U.S. 299
RENE RET RE Se re A ee ll

Eddy v. Polymer Technology Corp., 674 A.2d 323

(Super. Ct. 1995), appeal denied, 692 A.2d 566 (Pa.

1997), petition for cert. pending, No. 97-26 ............. 18
Fiore v. Collagen Corp., 930 P.2d 477 (Ct. App.

1996), review denied, No. CV-96-0447-PR (Ariz. Jan.

14, 1997), petition for cert. pending, No. 96-1611 .... 18

Flynt v. Ohio, 451 U.S. 619 (1981) ......cccccceeeseceeeeees 11, 12
Fort Wayne Books, Inc. v. Indiana, 489 U.S. 46

So ESS SERN AECUED Ne rett cre bie SO Nee Seelam Area EE 12
Fry v. Allergan Medical Optics, 695 A.2d 511 (R.1.),

cert. denied, 118 S. Ct. $74 (1997) ...........ccccccccooccoee 18
Hines v. Davidowitz, 312 U.S. 52 (1941) ....ccccccccceee. 19
Jefferson v. City of Tarrant, No. 96-957 (Dec. 9,

WE ehrpe ita cdcrdptircintp scacitiuasaa xbchassnidusénisimadadaiiiucicissisesc-ciecs 10

(IIT)

Cases—Continued: Page
Local No. 438 Construction & General Laborers’
Union v. Curry, 371 U.S. 542 (1963) ................006. 13
Market St. Ry. v. Railroad Comm’n, 324 U.S. 548
CREED ciisiinisciccnscnpinccccdciuminacianiessatbeneaagiiniacccaiaes 10

Martin v. Telectronics Pacing Systems, Inc., 105
F.3d 1090 (6th Cir. 1997), petition for cert. pending,
NO, DE TTD vcvsncssssssocissonsdnatonvisnsasiacdeceibensaiaiensoniess 18
Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996) .... 2, 4, 5,
6, 7, 13, 14, 15, 17, 19
Mercantile Nat'l Bank v. Langdeau, 371 U.S. 555

CUED vniicvisccccnvkstiiacescsiaceksiscdeauantiacescisesaaasasemeaeeases 13
Miami Herald Publishing Co. v. Tornillo, 418 U.S.
BAY CPR] ccd ntitticcedcsccstceu nice 12
Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.
) sf ARIE, toate SEA PRO ay AR EMER. COIS 18
National Socialist Party of America v. Village of
Skokie, G08 t1F SE UIGTI) cccccccsisnctitsesssioeess 12
Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir.
TOOT) -csdicccscadatesuninscdansssctsdusauisl Alspbetepheucssaraeabucesies 18
Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir.),
cert. denied, 118 S. Ct. 166 (1997) ........cccccccccscsceseess 18
Shaffer v. Heitner, 433 U.S. 186 (1977) ...............008 12
Southland Corp. v. Keating, 465 U.S. 1 (1984) ........ 13
Urie v. Thompson, 337 U.S. 163 (1949) ..............0.02. 10
Statutes and regulations:
Federal Arbitration Act, 9 U.S.C. 1 et seq. ............000 13
Federal Food, Drug, and Cosmetic Act of 1938,
Bi USA. BE Ob BO cos cepecncconncessidonnncinatescveciiastacsinves 2
BE UTE, See. inwiinkéccncsncadbavecorseudsinccacatdesudaiiens 2
BF TEE), Bee aiicktseceohtasiathesesndeeiaainenees ass 2
A ES Sah ITNT capscunianncasnvitenanvens bovedsassbinemnas aed 3
SE UT BA, SI Te BERD) vncctsincscccecssintacnsticosesens 3, 4, 6
BE EE Fe eG cases iniscarsinieuncteuveluccdscszcerisuienebes 2
RTE © Ge RRR ake Wein cela rcean ne neta tey Hear” 2
BE TEBE S BR) Scrtcncarascecincsincssicciocsmeoscconn 2
BAU BRAT, Ge sess a cacinvinseccnspiiccesentactcenaces 2

V

Statutes and regulations—Continued: Page
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Mh WP einsy WN CE OL) Gacccscccssceccscscisnctiiciocdicnnd passim
21 U.S.C. 360k(a) (§ 521(a)) ............ccscecceceeee 4, 5, 7, 20
A RA IID itiadecs ice ect tas eae Sats ec apceashanc 4,5
Food and Drug Administration Modernization Act of
1997, Pub. L. No. 105-115, 111 Stat. 2296:
FR ici bs asain cds eddeidieiscasbehuilccchinsceccs, 20
BEE Gian idvissasnsvusesdicnnbieucikcipieik ees 20
Medical Device Amendments of 1976, Pub. L. No.
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ee SIs WOOT ntanechanniiciak dui ccltchdscidiyicciedk sauce sig desea 9, 10, 11
21 C.F.R.:
Pt. 808:
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Pt. 880:
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Regulations—Continued:

Pt. 886:
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NE TR TTI hss scetecauuebetiauibanccewnueushes

Miscellaneous:

Robert Stern, Eugene Gressman, Stephen Shapiro &
Kenneth Geller, Supreme Court Practice (7th ed.
PIPUET ihciabcinitidieninnrnennciatinnberaaniaaxsanabinaebaeuiaaitaabbans 6<¢

Page

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10
13

§n the Supreme Court of the United States

OCTOBER TERM, 1997

No. 96-1405

SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.,
PETITIONER

v.

SARAH KERNATS, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE APPELLATE COURT OF ILLINOIS

BRIEF FOR THE UNITED STATES
AS AMICUS CURIAE

This brief is filed in response to the Court’s order invit-
ing the Solicitor General to file a brief expressing the
views of the United States.

STATEMENT

Petitioner seeks review of a decision of the intermediate
Appellate Court of Illinois arising from three separate
tort suits in which respondents allege that they were in-
jured by a medical device manufactured by petitioner.
Petitioner moved for summary judgment in each case on
the ground that a federal statute, the Medical Device
Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat.
539, preempts respondents’ claims. The trial court in each
case granted petitioner’s motion for summary judgment.
Pet. App. 25-32. The Appellate Court of Illinois consoli-

(1)

2

dated respondents’ appeals, reversed the trial court judg-
ments, and remanded the cases for trial. Jd. at 1-19.

1. The Federal Food, Drug, and Cosmetic Act of 1938
(FDCA), 21 U.S.C. 301 et seg., empowers the Food and
Drug Administration (FDA) to regulate a wide variety of
medical and non-medical products. The MDA supplemenis
the FDCA’s original provisions by creating a federal pro-
gram to enhance “the safety and effectiveness of medical
devices intended for human use” (90 Stat. 539 (Preamble)).
See generally Medtronic, Inc. v. Lohr, 116 S. Ct. 2240,
2245-2246 (1996). The MDA authorizes the FDA to under-
take specified review, approval, and regulatory activities
for medical devices, which include instruments, implants,
and similar articles that are intended to affect the struc-
ture or function of the body or for use in medical applica-
tions. See 21 U.S.C. 321(h) (defining “device”), 360c-360/
(regulatory program).

a. The MDA provides for the classification of medical
devices into three categories based on the risk that they
pose to the public. 21 U.S.C. 360c(a). Class I devices are
articles, such as tongue depressors and sunglasses, that
present no unreasonable risk of illness or injury. See 21
C.F.R. 880.6230, 886.5850. The FDA subjects those devices
to limited regulation through the use of “general con-
trols,” 21 U.S.C. 360e(a)(1)(A), which involve measures
such as general labeling and manufacturing practices
requirements. See, e.g., 21 U.S.C. 352, 360}(f). Class II
devices are articles, such as breathing frequency monitors
and infvsion pumps, for which “general controls by them-
selves are insufficient to provide reasonable assurance of
the safety and effectiveness of the device.” 21 U.S.C.
360c(a)(1)(B); see 21 C.F.R. 868.2375, 880.5725. The MDA
subjects those devices to “special controls.” 2i U.S.C.
360::(a)(1)(B). In the case of both Class I and Class I
devices, the MDA does not require advance FDA approval
before the device may be marketed. The maker usually

3

must comply, however, with the FDA’s registration re-
quirements and provide the agency with a “premarket
notification” before distributing the device. See 21 U.S.C.
360(b) and (k).

Class UI devices are articles, such as cardiac pace-
makers and intraocular lenses, that present “a poten-
tial unreasonable risk of illness or injury.” 21 U.S.C.
360c(a)(1)(C); see 21 C.F.R. 870.3610, 886.3600. In general,
the makers of those articles are subject not only to
general and certain special controls, but also to the FDA’s
“premarket approval” (PMA). See 21 U.S.C. 360c(a)(1)(C),
360e(a). An application for PMA must contain detailed
supporting information, including full reports of any
clinical investigations respecting the safety and effective-
ness of the device, and a complete description of the
device’s components and method of manufacture. See 21
U.S.C. 360e(c). The FDA will approve the device unless it
finds that the applicant has failed to provide reasonable
assurance that the device is safe and effective for its
intended use or that the applicant has failed to satisfy
general manufacturing and labeling requirements. See 21
U.S.C. 360e(d); see also 21 C.F.R. Pt. 814.

b. The MDA provides that, in certain circumstances, a
Class III device may be made available for use without
obtaining a PMA. Of greatest practical importance, a
maker may be entitled to postpone the PMA process if it
proposes to market a Class III device that is substantially
similar to a device that was on the market before the
MDA’s enactment and for which premarket approval is
not required. The MDA contains a “grandfather” clause
that allows continued marketing of devices that were
on the market before the MDA’s enactment until the
FDA initiates and completes a rulemaking procedure
requiring the submission of a PMA for the device. See
21 U.S.C. 360e(b)(1)(A). To prevent the “grandfathered”
makers from monopolizing the market, the MDA provides

4

that other makers may distribute similar devices upon a
showing through the general premarket notification pro-
cess, 21 U.S.C. 360(k), that the devices are “substantially
equivalent.” 21 U.S.C. 360e(b)(1)(B). That procedure is
known as the “Section 510(k) process,” referring to the
section of the FDCA codified at 21 U.S.C. 360(k). See
Medtronic, 1168S. Ct. at 2247.

A maker may also defer the PMA process if it qualifies
for an “Investigational Device Exemption” (IDE). Under
that exemption, the FDA may approve an application for
use of the device in clinical investigations to study its
potential safety and effectiveness. See 21 U.S.C. 360j(g);
21 C.F.R. Pt. 812. Generally speaking, the FDA has pro-
vided by regulation that it may grant an IDE if it
determines, based on the application, that the risks to the
subjects of the investigations are outweighed by their
anticipated benefits and the importance of the knowledge
to be gained. 21 C.F.R. 812.30(b)(4).

c. The MDA contains a provision expressly addressing
the question of preemption of state law. Section 521(a),
21 U.S.C. 360k(a), states:

(a) General rule

Except as otherwise provided in subsection (b) of
this section, no State or political subdivision of a State
may establish or continue in effect with respect to a
device intended for human use any requirement—

(1) which is different from, or in addition to,
any requirement applicable under this chapter to
the device, and

(2) which relates to the safety or effective-
ness of the device or to any other matter included
in a requirement applicable to the device under
this chapter.

Subsection (b) then provides that a State or political sub-
division thereof may apply for an exemption for a require-

5

ment that would otherwise fall within the scope of Section
360k(a). See 21 U.S.C. 360k(b).

2. This Court addressed Section 360k’s preemptive
effect in Medtronic. The plaintiffs, husband and wife,
alleged that the wife was injured by a defective pacemaker,
a Class III device. The FDA had cleared the device for
distribution on the basis, noted above, that the product
was “substantially equivalent” to a pre-MDA device. The
plaintiffs sought damages for their injuries under state
tort law. They alleged that the manufacturer had negli-
gently designed, built, and labeled the device and also
sought recovery under a state law theory of strict prod-
uct liability. The manufacturer contended that the MDA
preempted the plaintiffs’ claims because Section 360k pro-
hibits a State from imposing a safety “requirement” that
is “different from, or in addition to,” any MDA require-
ment. The Court rejected the manufacturer’s argument.’

a. At the outset of its analysis, the Court recognized
the familiar presumption that the States retain their
historic police powers unless Congress expresses a “clear
and manifest purpose” to supersede those powers. Med-
tronic, 116 S. Ct. at 2250. The Court also acknowledged
the “oft-repeated” observation that congressional purpose
“is tle ultimate touchstone” in every preemption case
and that “a fair understanding of congressional purpose”
may be discerned not only from the text of the statute,
“but through the reviewing court’s reasoned understand-
ing of the way in which Congress intended the statute and
its surrounding regulatory scheme to affect business, con-
sumers, and the law.” Jd. at 2250-2251 (emphasis deleted).

1 Justice Stevens wrote an opinion in which Justices Kennedy,
Souter, and Ginsburg joined in full. 116 S. Ct. at 2245-2259. Justice
Breyer concurred in parts I through III, V, and VII of Justice Stevens’
opinion and concurred in the judgment. Jd. at 2259-2262. Justice
O’Connor, joined by the Chief Justice and Justices Scalia and Thomas,
concurred in part and dissented in part. Jd. at 2262-2264.

6

b. Turning to the maker’s specific arguments, the
Court first evaluated whether Section 360k preempted
state law claims alleging the manufacturer had defectively
designed the pacemaker. 116 S. Ct. at 2254-2255. It noted
that, while the MDA required the manufacturer to provide
the FDA with premarket notification, and the FDA may
have conducted the premarket notification process “with a
concern for the safety and effectiveness of the device,” the
FDA “did not ‘require’ Medtronic’s pacemaker to take any
particular form for any particular reason.” Jd. at 2254.
The Court accordingly concluded that the manufacturer’s
compliance with the PMA process “did not preempt the
[plaintiffs’] design claims.” Jd. at 2255; accord id. at 2264
(O’Connor, J., concurring in part and dissenting in part)
(Section 510(k) process “places no ‘requirements’ on a
device” and therefore does not preempt defective design
claim).

The Court next examined whether Section 360k pre-
empted state law claims that the manufacturer had
violated FDA requirements. 116 S. Ct. at 2255-2256. It
concluded that state law claims premised on a violation of
FDA requirements do not subject the manufacturer to
requirements that are “different from, or in addition to,”
the federal requirements. Jd. at 2255. The Court noted
that the FDA’s interpretive regulations “expressly sup-
port the conclusion that $360k ‘does not preempt State
or local requirements that are equal to, or substantially
identical to, requirements imposed by or under the act,’”
id. at 2256 (quoting 21 C.F.R. 808.1(d)(2)), and it observed
that the FDA’s views on the scope of Section 360k’s
preemptive effect are entitled to “substantial weight,”
ibid.; see also id. at 2260-2261 (Breyer, J., concurring in
part and concurring in the judgment).

2 Justice O’Connor agreed with the majority that state law claims
based on violations of federal requirements are not preempted, but

eS

7

The Court also examined whether Section 360k pre-
empted state law claims based on negligent manufactur-
ing and labeling. 116 S. Ct. at 2256-2258. The Court
recognized that the FDA had developed regulations that
set out general “requirements” for manufacturing and
labeling medical devices. Jd. at 2256. It concluded,
however, that Section 360k does not mandate preemption
unless, as the FDA had suggested in its interpretive
regulations, the federal requirements impose specific
requirements on a particular medical device. Jd. at 2257
(citing 21 C.F.R. 808.i(d)). The Court concluded that the
“entirely generic” federal manufacturing and labeling
requirements did not provide a basis for preemption of
the non-specific state common law duties at issue in that
case. Jd. at 2258. In his separate opinion, Justice Breyer,
agreeing with Justice O’Connor’s opinion for four Justices
(see id. at 2262-2263), concluded that, ordinarily, insofar as
the MDA preempts a state requirement embodied in a
state statute or regulation, it also preempts a similar
state requirement that takes the form of a standard of
care or behavior imposed by state tort law, id. at 2259-2260;
but he concurred in the Court’s holding that the
federal manufacturing and labeling requirements were not
sufficiently “specific” to trigger preemption, id. at 2260-
2261.

3. Petitioner manufactures and sells a “chorionic vil-
lus sampling” (CVS) catheter, a Class III device used to
sample fetal tissue to detect genetic abnormalities during
the early stages of pregnancy. From 1984 to 1990, peti-
tioner made the CVS catheter available for use through an

disagreed with the majority’s reliance on the FDA regulations inter-
preting the Act’s preemption provision. 116 S. Ct. at 2263, 2264.

8 The separate opinion of Justice O’Connor did not agree with the
majority’s conclusion that, as construed in the FDA regulations, only
“specific” federal requirements trigger preemption under Section
360k(a). See 116 S. Ct. at 2263, 2264.

8

exemption for use under the MDA’s IDE provisions. In
1990, petitioner completed the PMA process. Pet. App. 2-3,
6n.3. In the three cases at issue, respondents alleged that
the CVS catheter had caused prenatal injuries and sought
damages under state law theories of strict product
liability, breach of express and implied warranties, and
common law negligence. In two of those cases, the medical
procedures took place while the IDE was in effect. In the
third case, the medical procedure took place after peti-
tioner had received the PMA. In all three cases, the
district court granted petitioner’s motion for summary
judgment, concluding that, under Section 360k, the federal
regulatory process had resulted in preemption of respond-
ents’ state law tort claims. Jd. at 25-32.

The Appellate Court of Illinois consolidated respond-
ents’ appeals, reversed the judgments, and remanded the
cases for trial. Pet. App. 1-19. The court recognized that
“the facts in the present case are different from those
in Medtronic because the medical device here underwent
rigorous PMA scrutiny.” Jd. at 13. Although the court
observed that this Court did not consider in Medtronic
whether the PMA review process is sufficiently concrete
so as to constitute a “specific” requirement having pre-
emptive force, it held, following a number of pre-Medtronic
appellate decisions, that the PMA process is a specific
federal requirement. Jbid. The Court concluded, however,
that the generic state law tort duties that petitioner had
allegedly breached were not requirements specifically de-
veloped with respect to medical devices, and therefore
were not preempted. Jd. at 13-14.

The Appellate Court of Illinois explained its reasoning
as follows:

Here, [respondents’] common-law claims based on
the manufacture of the CVS catheter, the failure to
warn, and inadequate instructions, are also “general

9

obligations” applicable to all manufacturers and, un-
der the holding in Medtronic, are not requirements
specifically established for medical devices. Therefore,
they are not preempted under the MDA. [Respond-
ents’] claims based on defective design and inadequate
testing allege that defendant defectively designed and
failed to adequately test the CVS catheter. Although
these allegations relate to the specific medical device
at issue here, they arise, nevertheless, from general
duties applicable to every manufacturer.

Pet. App. 14. For similar reasons, the court rejected peti-
tioner’s argument that the MDA preempts state statutory
law claims based on an implied warranty of merchant-
ability and fitness. Id. at 16. It also rejected petitioner’s
assertion of preemption with respect to express warranty
claims, noting that those claims are based on “[petition-
er’s] own express representations” and are not state “re-
quirements” within the meaning of Section 360k. Jd. at 18.

The Supreme Court of Illinois denied discretionary
review. Pet. App. 20, 23.

DISCUSSION

Petitioner contends that the Appellate Court of Illinois
has incorrectly applied this Court’s decision in Medtronic,
which interpreted the preemptive effect of Section 360k.
As petitioner correctly points out, the state court’s deci-
sion in this case involves an issue of substantial impor-
tance that has divided the lower courts. This Court’s
review is unwarranted, however, in this case. First, as a
threshold matter, a proper jurisdictional basis is lacking
because the judgment is not final within the meaning of
28 U.S.C. 1257. Second, although we disagree with the
reasoning of the Appellate Court of Illinois, the judgment
below is correct. Third, the FDA will publish for pub-
lic comment a proposed interpretive rule on the statu-
tory provision at issue. Because this Court’s decision in

10

Medtronic is relatively recent, and the FDA is providing
an interpretive rule on the subject, there is no urgent
need for the Court to revisit the question of Section 360k’s
preemptive effect at this time.

1. This Court lacks jurisdiction to review the judg-
ment of the Appellate Court of Illinois because that judg-
ment is neither final in a strict sense nor included within
one of the exceptions to strict finality recognized by this
Court. Petitioner invokes this Court’s jurisdiction under
28 U.S.C. 1257. By its terms, that provision encompasses
“(flinal judgments or decrees rendered by” state courts.
Thus, as a general rule, interlocutory state court deci-
sions are not reviewable under Section 1257, and state
court rulings fall within the literal meaning of this provi-
sion only if they conclusively resolve the litigation and
represent “the final word of a final court.” Jefferson v.
City of Tarrant, No. 96-957 (Dec. 9, 1997), slip op. 5;
Market St. Ry. v. Railroad Comm’n, 324 U.S. 548, 551
(1945); see, e.g., Cox Broadcasting Corp. v. Cohn, 420 U.S.
469, 476-487 (1975); Urie v. Thompson, 337 U.S. 163, 171-
172 & n.10 (1949); see also Robert Stern, Eugene Gress-
man, Stephen Shapiro & Kenneth Geller, Supreme Court
Practice 92-111 (7th ed. 1993).

The judgment of the Appellate Court of Illinois is not
final in that strict sense. The court’s interlocutory ruling
reverses the trial courts’ grants of summary judgment
and remands for further proceedings. Petitioner may well
prevail on some or all claims on remand. And if the ulti-
mate result of the litigation is unfavorable to petitioner in
any respect, petitioner may at that time seek review of the
preemption issue in this Court, based on a more fully
developed record and any further rulings by the state
courts on preemption.

Adhering to the view that finality should be given “a
‘practical rather than a technical construction,’” Cox
Broadcasting, 420 U.S. at 478 n.7 (quoting Cohen v.

11

Beneficial Indus. Loan Corp., 337 U.S. 541, 546 (1949)),
this Court has recognized four categories of cases that
constitute exceptions to strict finality under 28 U.S.C.
1257. Cox Broadcasting, 420 U.S. at 476-487; Duquesne
Light Co. v. Barasch, 488 U.S. 299, 306 (1989). The first
three categories consist of situations, respectively, in
which: (1) the federal issue is conclusive or the outcome
on remand is pre-ordained; (2) the federal issue will sur-
vive and require decision regardless of the outcome of
proceedings on remand; and (3) the federal issue cannot
be reviewed after the conclusion of the proceedings on
remand. Cox Broadcasting, 420 U.S. at 479-481. As in
Flynt v. Ohio, 451 U.S. 619 (1981) (per curiam), “it is not
even arguable that the judgment involved here falls within
any of the first three categories identified in the Cox
opinion.” Jd. at 621.
The fourth category consists of situations that satisfy
two requirements. First, the state court judgment must
represent the final word within the state court system
on a federal issue, “with further proceedings pending in
which the party seeking review here might prevail on the
merits on nonfederal grounds, thus rendering unneces-
sary review of the federal issue by this Court, and where
reversal of the state court on the federal issue would be
preclusive of any further litigation on the relevant cause
of action.” Cox Broadcasting, 420 U.S. at 482-483. Second,
“a refusal immediately to review the state-court decision”
must risk “seriously erod[{ing] federal policy.” Jd. at 483.
In the United States’ view, the judgment of the
Appellate Court of Illinois does not fall within the fourth
Cox category. We may assume that, if the judgment peti-
tioner seeks to have reviewed were the judgment of the
Illinois Supreme Court, it would satisfy the first prong
of the two-part test, because the federal issues would
have been finally resolved (but see pages 17-18, infra) and
because petitioner might prevail on remand by establish-

12

ing that it is not liable under the state law standard. Here,
however, petitioner seeks review of the decision of an
intermediate appellate court. That judgment may not
represent the final word in the state court system on the
preemption issue because, although the Illinois Supreme
Court denied discretionary review at this interlocutory
stage, it might later choose to grant review of the fed-
eral questions on appeal from a final judgment. But see
Belknap, Inc. v. Hale, 463 U.S. 491, 497 n.5 (1983) (finding
jurisdiction without specifically addressing status of judg-
ment below as that of intermediate appellate court). There
is no need to decide whether an intermediate state appel-
late court judgment is a “final judgment” for purposes of
the fourth Cox exception, however, because petitioner falls
short of establishing, under the second prong of the fourth
exception, that postponing review will likely erode an im-
portant federal policy. In this case, an argument that the
situation falls within the fourth category, “although not
frivolous, is unsound.” Flynt, 451 U.S. at 621.

This Court has most frequently found a potential
erosion of federal policy when the state court ruling has
restricted the exercise of a fundamental constitutional
right. This case, however, does not involve such a
situation. The Court has also exercised jurisdiction when
the state court ruling could undermine a federal statutory
policy, particularly when the policy was furthered by
restricting the forum in which the merits of a dispute

4 See Fort Wayne Books, Inc. v. Indiana, 489 U.S. 46, 54-56 (1989)
(freedom of the press); National Socialist Party of America v. Village
of Skokie, 432 U.S. 48, 44 (1977) (per curiam) (freedom of speech); Cox
Broadcasting, 420 U.S. at 485-487 (freedom of the press); Miami Herald
Publishing Co. v. Tornillo, 418 U.S. 241, 247 n.6 (1974) (same); Calder
v. Jones, 465 U.S. 783, 788 n.8 (1984) (due process limitations on per-
sonal jurisdiction); Shaffer v. Heitner, 433 U.S. 186, 195 n.12 (1977)
(same).

13

could be resolved.° This case, however, does not present a
comparable threat to a congressional policy.

First, as this Court noted in Medtronic, the central
purpose of the MDA is “to provide for the safety and
effectiveness of medical devices intended for human
use,” 116 S. Ct. at 2245 (quoting 90 Stat.,439 (Preamble)),
in order to “safeguard the health of the American public,”
H.R. Rep. No. 853, 94th Cong., 2d. Sess. 12 (1976). Allow-
ing respondents’ tort suits to proceed will in no way
undermine that interest in protecting consumers and pro-
moting public health. On the contrary, allowing the suits
to go forward should, as a general matter, promote those
very interests by deterring manufacturers from distribut-
ing defective or unreasonably dangerous medical devices.

Second, to the extent that Section 360k of the MDA
expresses a federal policy to preempt state requirements
respecting the safety and effectiveness of medical devices,
that concern is “related more to the risk of additional
federal and state regulation rather than the danger of
preexisting duties under common law.” Medtronic, 116 S.
Ct. at 2253. There is no inherent conflict between regula-
tion of devices by the FDA (including the IDE and PMA
processes) and state law tort claims; the Federal Act does
not establish a rule of primary jurisdiction to adjudicate
individual disputes. Moreover, as we explain in greater
detail below, Section 360k does not, on the present record,
preempt respondents’ common law tort claims. Accord-

5 See Belknap, 463 U.S. at 497 n.5 (resolving labor-management
disputes before the NLRB); Local No. 438 Construction & General
Laborers’ Union v. Curry, 371 U.S. 542, 550 (1963) (same); Southland
Corp. v. Keating, 465 U.S. 1, 6-8 (1984) (resolving contractual issue
through arbitration under Federal Arbitration Act rather than through
adjudication); Mercantile Nat'l Bank v. Langdeau, 371 U.S. 555, 557-
558 (1963) (limiting venues within which suits against national banks
may be brought).

14

ingly, allowing respondents’ suits to proceed will not erode
the federal policy expressed in the MDA.°

2. Petitioner asserts that, because it secured an IDE
and PMA for the device at issue, it should not be subject to
product liability claims under state law. That contention
is incorrect. In the FDA’s view, as reflected in its notice
of proposed rulemaking for the issuance of an interpre-
tive rule under Section 360k (see App., infra, la-18a), the
agency’s decision to grant an IDE and PMA for the device
at issue here did not establish specific federal require-
ments within the meaning of Section 360k. Like its review
of the premarket notification in Medtronic, the FDA’s
review in this case established only that the manu-
facturer had complied with the applicable federal minimum
standards for use and marketing. As this Court indicated
in Medironic, Section 360k will generally result in pre-
emption of state tort claims only if the federal government
has imposed specific requirements on a particular medical
device and the state common law imposes a requirement on
the same device that is “different from, or in addition to,”
the federal requirement. See 1168S. Ct. at 2257-2258. In
these circumstances, the Appellate Court of Illinois ruled,
the general duties imposed by Illinois common law do not
impose state requirements respecting the device at issue
that are “different from, or in addition to,” any specific
federal requirement. Pet. App. 12-15.

a. The FDA’s decision to grant an IDE or a PMA for a
medical device does not, by itself, create specific federal
requirements within the meaning of Section 360k. We
therefore disagree with the Appellate Court on this point.
See Pet. App. 13a.

6 Although this point reflects a view of the merits, this Court has
long recognized that Coz’s fourth category frequently requires some
inquiry into the merits of the underlying claims. See Cox Broad-
casting , 420 US. at 486 n.13.

15

The FDA’s grant of an IDE signifies that the FDA has
examined the manufacturer’s application and determined
that the device meets the federal criteria for investigatory
use. See 21 U.S.C. 360j(g). Similarly, the FDA’s grant
of a PMA signifies that the FDA has examined the
manufacturer’s application and determined that the device
satisfies the federal criteria for marketing. See 21 U.S.C.
360e(d). The federal criteria are important, and the FDA
conducts a careful inquiry to ensure compliance. See 21
C.F.R.-Pts. 812 (IDE procedures), 814 (PMA procedures).
But in the typical case, the federal criteria for IDEs and
PMAs are the generally applicable threshold standards set
out in the MDA and the FDA regulations. See 21 C.F.R.
812.30(b) (grounds for denying an IDE), 814.45 (grounds
for denying a PMA). As in the case of the premarket
notification, labeling, and manufacturing requirements in
Medtronic, those general criteria establish minimum
standards that do not displace state law standards of care
or common law duties respecting the medical device.

The FDA may impose specific federal requirements for
a Class III device, above and beyond the general federal
criteria, that have preemptive force. For example, if the
FDA determines that precise design, manufacturing, or
labeling specifications are necessary to protect the public,
it may impose such requirements through promulgation
of specific regulations. See, e.g., 21 C.F.R. 861.1(b)(3) (pro-
viding for mandatory performance standards for Class II]
devices). A manufacturer that seeks an IDE or PMA
must satisfy those specific requirements, but they exist
independently of the IDE and PMA processes. We have
been informed by the FDA that it imposes such specific
requirements on Class III devices only in extraordinary
situations, and only after it has considered the preemptive
consequences o: its action under Section 360k. See
Medtronic, 116 S. Ct. at 2260 (Breyer, J., concurring in
part and concurring in the judgment) (the FDA must

16

consider “the likely impact of both state and federal
requirements”).

The FDA’s differentiation between agency review under
the general IDE and PMA criteria and agency imposition
of specific substantive requirements reflects its sensible
and long-standing approach to regulating medical devices.
Under the regulatory scheme, a manufacturer is respon-
sible for submitting an application demonstrating that
the proposed medical device satisfies federal minimum
standards. See, e.g.,21 C.F.R. Pts. 812, 814. If (as in this
case) the FDA has not set out specific federal require-
ments for the particular device, the manufacturer may
select any design, manufacturing, and labeling features
that will satisfy the general minimum standards in the
Act and regulations, and it may obtain an IDE or PMA
on the basis of that selection if the FDA approves the
application. Because the FDA has not imposed any speci-
fic substantive requirements on petitioner’s design of the
CVS in the course of the review process, that design does
not represent a specific federal requirement that preempts
state common law requirements. Cf. American Airlines,
Inc. v. Wolens, 513 U.S. 219, 229 (1995). But if the FDA
sets out specific requirements for the particular device in
the future, the manufacturer must also satisfy those re-
quirements, which would then preempt any different or
additional state requirements.

The FDA’s distinction between its review under fed-
eral minimum standards and its imposition of specific
substantive requirements is consistent with the MDA’s
underlying objective of promoting safe and effective
medical devices. For example, the FDA’s grant of a PMA
under the statutory criteria provides assurance, but not a
guarantee, that the device is safe and effective for its
specified use. Where the FDA has taken no further action,
the States are entitled to exercise their historic police
powers to provide their citizens with additional protec-

17

tion through positive enactments or through imposition of
common law duties. But where the FDA has specifically
identified a need to supplement the generalized minimum
standards in the Federal Act and FDA regulations with
additional federal requirements respecting the particular
device, those specific requirements should supplant any
state requirements that are “different from, or in addition
to,” the federal requirements. That approach zespects
the MDA’s “overarching concern that pre-emption occur
only where a particular state requirement threatens to
interfere with a specific federal interest.” Medtronic, 116
S. Ct. at 2257.

b. Section 360k is also inapplicable in the circum-
stances of this case because petitioner has not shown that
Illinois common law imposes a substantive requirement
specifically with respect to the medical device at issue
here.’ State courts can, of course, refine common law
duties in a way that actually imposes specific require-
ments respecting a particular medical device. For
example, a state court could provide, through its rulings
or jury instructions, that a particular design feature
breaches a common law duty. See Medtronic, 1168S. Ct. at
2259 (Breyer, J., concurring in part and concurring in the
judgment). But the Illinois courts thus far have not done
so in this case, and there accordingly would be no basis
at this point for holding that Section 360k necessarily
preempts state common law in this case—even if, contrary
to our submission in point 2.a, the FDA had imposed a
“specific” counterpart requirement with respect to the
device. Indeed, the fact that the state courts, in the course

7 The same reasoning holds true with respect to respondents’ claims
that petitioner breached an implied warranty of merchantability under
state law. Pet. App. 16. With respect to claims based on any express
warranties, the manufacturer’s obligations arise from its “express rep-
resentations, not by a state-imposed duty.” Jd. at 18. They do not
involve state “requirements” at all. /bid.

18

of further proceedings, can refine state common law duties
in light of experience and the circumstances of the partic-
ular cases, allows those courts to avoid creating conflicts
between federal and state requirements that would lead to
preemption.

3. As petitioner correctly notes, the lower courts, both
state and federal, have not reached a consensus on ques-
tions concerning Section 360k’s preemption of state
common or statutory law applied in tort suits. See
Pet. 7-10. The current division among the lower courts
on that issue would normally provide a strong justification
for this Court to grant review and definitively resolve
the conflict. The jurisdictional obstacle noted above (see
pages 10-14, supra) would, in our view, prevent the Court
from taking that action in this case. But even in the
absence of that obstacle, we believe that it would be
appropriate for the Court to defer review in light of the

8 See also, e.g., Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.
1997) (preemption of state law claims respecting a device that received
a PMA); Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997) (pre-
emption of state law claims respecting a Class II medical device);
Chambers v. Osteonics Corp., 109 F.3d 1243 (7th Cir.) (partial pre-
emption of state law claims respecting a device that received an IDE);
Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir.) (preemption of state
law claims respecting a device that received a PMA), cert. denied,
118 S. Ct. 166 (1997); Martin v. Telectronics Pacing Systems, Inc., 105
F.3d 1090 (6th Cir. 1997) (preemption of state law claims respecting a
device that received an IDE), petition for cert. pending, No. 96-1749
(filed May 1, 1997); Fry v. Allergan Medical Optics, 695 A.2d 511 (R.I.)
(preemption of state law claims respecting a device that received a
PMA), cert. denied, 118 S. Ct. 374 (1997); Fiore v. Collagen Corp., 930
P.2d 477 (Ct. App. 1996) (no preemption of state law claims respecting a
device that received a PMA), review denied, No. CV-96-0447-PR (Ariz.
Jan. 14, 1997), petition for cert. pending, No. 96-1611 (filed Apr. 10,
1997); Eddy v. Polymer Technology Corp., 674 A.2d 323 (Super. Ct.
1995) (Table) (preemption of state law claims), appeal denied, 692 A.2d
566 (Pa. 1997) (Table), petition for cert. pending, No. 97-26 (filed June
30, 1997).

19

FDA’s recent initiative to provide an interpretive rule on
Section 360k’s preemptive effect.

This Court concluded in Medtronic that the FDA’s
views should be given “substantial weight” in determining
the reach of the MDA’s preemption clause. 116 S. Ct. at
2256. As the Court explained, “Congress has given the
FDA a unique role in determining the scope of § 360k’s
pre-emptive effect,” because “in most cases a state law will
be pre-empted only to the extent that the FDA has
promulgated a relevant federal ‘requirement.’” Jd. at 2255.
“Because the FDA is the federal agency to which Con-
gress has delegated its authority to implement the
provisions of the Act, 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.’” Ibid. (footnote
omitted) (quoting Hines v. Davidowitz, 312 U.S. 52, 67
(1941)); see also id. at 2260-2261 (Breyer, J., concurring in
part and concurring in the judgment).

The FDA will issue, for notice and comment, a pro-
posed interpretive rule providing guidance on Section
360k’s preemptive effect with respect to product liability
claims under state law. That proposed rule explains that,
as a general matter, a state common law duty is preempted
only when: (1) the FDA has expressly imposed, by regu-
lation or order, a specific substantive requirement appli-
cable to a particular medical device; and (2) state common
law imposes a substantive requirement applicable to the
same medical device that is different from, or in addition
to, the FDA’s counterpart requirement. See App., infra,
la-18a.

Under the FDA’s interpretation, MDA minimum stan-
dards that are generally applicable to medical devices will
typically not result in preemption of state tort claims.
Accordingly, the FDA’s grant of an IDE or a PMA does
not, by itself, have preemptive effect. If the FDA imposes,

20

however, a substantive requirement for a particular medi-
cal device (such as a mandatory standard of performance,
see 21 C.F.R. 861.1), that requirement would preempt a
specific substantive requirement imposed by state statute,
regulation, or common law (as interpreted and applied)
that is “different from, or in addition to,” the federal
requirement. 21 U.S.C. 360k(a).

The FDA will publish its interpretive regulation for
notice and comment on December 12, 1997, and it may
modify and refine it in response to public comment before
issuing it in final form. Furthermore, although the FDA’s
guidance is entitled to “substantial weight,” it will not
bind the lower courts. Nevertheless, the FDA’s regula-
tion is likely to focus the judicial inquiry and reduce the
current uncertainty respecting Section 360k’s preemptive
effect. We therefore suggest that the Court should allow
the lower courts to consider the scope of Section 360k in
light of the FDA’s regulation before the Court undertakes
review of issues that it left open in Medtronic.®

CONCLUSION
The petition for a writ of certiorari should be denied.

Respectfully submitted.

SETH P. WAXMAN
Solicitor General

FRANK W. HUNGER
Assistant Attorney General

DOUGLAS N. LETTER
THOMAS M. BONDY
Attorneys

DECEMBER 1997

% The President recently signed amendments to the FDCA that,
inter alia, expedite the process for reviewing and approving PMA and
IDE applications. See Food and Drug Administration Modernization
Act of 1997, Pub. L. No. 105-115, §§ 201, 209, 111 Stat. 2296. Those
amendments make no changes to the MDA’s preemption provision.

APPENDIX

DEPARTMENT OF HEALTH AND HUMAN
SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 97N-0222]

Medical Devices; Preemption of State Product
Liability Claims

AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.

SUMMARY: The Food and Drug Administration (FDA)
is proposing to amend its regulations regarding preemp-
tion of State and local requirements applicable to medical
devices. This action is being taken to clarify and codify
the agency’s longstanding position that available legal
remedies, including State common law tort claims, gener-
ally are not preempted under the Federal Food, Drug, and
Cosmetic Act (the act).

DATES: Written comments by (insert 60 days after date
of publication in Federal Register).

ADDRESSES: Submit written comments to the Dockets
Management Branch (HFA-305), Food and Drug Ad-
ministration, 12420 Parklawn Dr., rm 1-23, Rockville, MD
20857.

FOR FURTHER INFORMATION CONTACT: Joseph
M. Sheehan, Center for Devices and Radiological Health

(la)

2a

(HFZ-215), Food and Drug Administration, 2094 Gaither
Rd., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION:
I. Introduction

Section 521 of the act (21 U.S.C. 360k) contains an
express preemption provision applicable to medical devices
regulated by FDA. The Supreme Court recently ad-
dressed whether section 521 of the act preempts State
common law tort claims arising from allegedly defective
medical devices. (See Medtronic, Inc. v. Lohr (Lohr), 116
S. Ct. 2240 (1996).) The Court concluded that section 521
of the act did not supplant the State law duties at issue in
that case. In reaching that conclusion, the Court noted
that FDA has provided interpretive guidance with respect
to section 521 of the act’s preemptive effect. (See id. at
2255-2256 (citing 21 CFR 808.1(d)(2) and 808.5(b)(1)(i)
(1995)).) The Court gave “substantial weight to the
agency’s view of the statute” (Jd. at 2256). (See also id. at
2257; id. at 2260-2261 (Breyer, J., concurring in part and
concurring in the judgment).)

The Court’s decision in Lohr construed section 521 of
the act in the context of a medical device that FDA had
cleared for distribution under section 510(k) of the act (21
U.S.C. 360k), which requires premarket notification for
certain types of medical devices. The Court did not defini-
tively decide whether section 521 of the act may preempt
State law claims in other circumstances. Since Lohr was
decided, the lower courts have interpreted section 521 of
the act inconsistently and have reached conflicting con-
clusions with respect to whether section 521 of the act
preempts State law claims for injuries allegedly resulting
from medical devices that have received premarket ap-
proval under section 515 of the act (21 U.S.C. 360e), or have

3a

received an investigational device exemption (IDE) under
section 520(g) of the act (21 U.S.C. 360}(g)).

In light of the confusion among the lower courts in
interpreting section 521 of the act since Lohr, and in
accordance with the Supreme Court’s recognition that
FDA’s interpretation of the preemptive effect of section
521 of the act is entitled to substantial weight, the agency
is issuing this proposed interpretive rule, which addresses
the circumstances in which section 521 of the act pre-
empts State common tort claims based on injury from
allegedly defective medical devices.

Il. Background

Congress enacted the Medical Device Amendments of
1976 (the amendments) (21 U.S.C. 360¢ et seq.) “to provide
for the safety and effectiveness of medical devices intended
for human use.” It enacted the amendments largely in re-
sponse to public concerns over injuries caused by medical
products, such as the Dalkon Shield intrauterine device.
(See S. Rept. No. 33, 94th Cong., Ist sess. 1 (1975); H. R.
Rept. No. 853, 94th Cong., 2d sess. 8 (1976); 122 Congres-
sional Record 13,779 (1976)). Congress sought “to assure
that the public is protected from unsafe and ineffective
medical devices, that health professionals have more con-
fidence in the devices they use or prescribe, and that
innovations in medical device technology are not stifled by
unnecessary restrictions” (H. R. Rept. No. 853, supra, at
12).

Section 521 of the act was included as part of the amend-
ments, and generally states that except as provided in
section 521(b) of the act 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 which is
different from, or in addition to, any Federal requirement

4a

applicable to the device, and which relates to the safety or
effectiveness of the device or to any other matter included
in a Federal requirement applicable to the device.

Section 521(b) sets forth the requirements if a political
subdivision thereof applies for an exemption from a
Federal requirement. The Secretary may issue a regula-
tion to exempt from section 521(a) of the act, under condi-
tions prescribed in the regulation, if the requirement is
more stringent than the Federal requirement which would
be applicable to the device if an exemption were not in
effect or the requirement is required by compelling local
conditions, and compliance with the requirement would
not cause the device to be in violation of any applicable
Federal requirement under this chapter.

FDA has interpreted the preemptive scope of section
521 of the act in light of its specific language and Con-
gress’s expressed objectives. Section 521(a) forbids a
State from subjecting a medical device to any “require-
ment” that is “different from, or in addition to,” any
Federal requirement imposed under the act; and relates to
“the safety or effectiveness of the device” or to “any other
matter” included in the Federal requirement. FDA has
indicated, through regulations that have been in place
since 1978, that section 521 of the act’s preemptive effect is
limited in light of the section’s precise terminology and
Congress’s declared intention to promote the safety and
effectiveness of medical devices. (See 21 CFR 808.1.)

When FDA issued its 1978 regulations, the regulated
community was primarily interested in the effect of sec-
tion 521 of the act on State or local requirements that
were expressed through positive enactments, such as
statutes or regulations. FDA’s regulations addressed the
question of preemption in that general context. Section
808.1(d), which has remained substantially unchanged for

5a

nearly 20 years, states that State or local requirements
are preempted only when FDA has established specific
counterpart regulations or there are other specific re-
quirements 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 FDA requirements. There are
other State or local requirements that affect devices that
are not preempted by 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.

FDA’s regulations (§ 808.1) provide nine examples of
State or local provisions that are not preempted, including:

(1) Generally applicable requirements not limited to
medical devices (e.g., general electrical codes and the Uni-
form Commercial Code (warranty of fitness));

(2) Requirements that are equal to or substantially
identical to requirements imposed by or under the act;

(3) Occupational licensing requirements;

(4) Specifications in government contracts for the
procurement of devices;

(5) Criteria for payment of State or local obligations
under Medicaid and similar Federal, State or local health
care programs;

(6) General enforcement requirements, including
State inspection and registration requirements, or a State
or local prohibition against the manufacturer of adulter-
ated or misbranded devices (except where the prohibition,
as interpreted and enforced, has the effect of establishing a
substantive requirement for a specific device);

(7) Provisions respecting delegations of authority
and related administrative matters respecting devices;

6a

(8) Fee and other revenue raising requirements; and

(9) State or local requirements issued under the
authority of other Federal statutes.

In 1992, the Supreme Court decided Cippolone v. Lig-
gett Group, Inc. (505 U.S. 504 (1992)). Among other things,
the Court ruled in that case that section 5(b) of the Public
Health Cigarette Smoking Act of 1969 (15 U.S.C. 1334(b))
could preempt State common law suits alleging that the
manufacturers breached their duty to warn about hazards
associated with smoking. Section 5(b) states that no re-
quirement or prohibition based on smoking and health
shall be imposed under State law with respect to the adver-
tising or promotion of any cigarettes the packages of
which are labeled in conformity with the provisions of this
chapter.

A majority of the Supreme Court concluded that the
phrase “([nJo requirement or prohibition,” as used in that
statute, describes both positive enactments and common
law duties. (See 505 U.S. at 521 (opinion of Stevens, J.); id.
at 548-549 (Scalia, J., concurring in the judgment in part
and dissenting in part).)

After the Supreme Court’s decision in Cippolone, a
number of lower courts interpreted section 521 of the act
to preempt tort actions respecting allegedly defective
medical devices in which the plaintiff sought to hold the
manufacturer liable based on State common law. Those
courts found preemption in a variety of contexts, including
situations in which FDA had allowed marketing of the de-
vice after “premarket notification” under section 510(k) of
the act (21 U.S.C. 360(k)), (e.g., Mendes v. Medtronic, Inc.,
18 F.3d 13 (1st Cir. 1994)); in which FDA had granted pre-
market approval of the device under section 515 of the act
(21 U.S.C. 360e), (e.g., King v. Collagen Corp., 983 F.2d

7a

1130 (1st Cir.) cert. denied, 510 U.S. 824 (1993)); and in
which FDA had granted an IDE under section 520(g) of the
act (21 U.S.C. 360j(g)), (e.g., Slater v. Optical Radiation
Corp., 961 F.2d 1330 (7th Cir.), cert. denied, 506 U.S. 917
(1992)).

The Supreme Court addressed the scope of section 521
of the act’s preemptive effect in Medtronic, Inc. v. Lohr,
116 S. Ct. 2240 (1996). That case arose out of Medtronic’s
marketing of a cardiac pacemaker that FDA found was
“substantially equivalent” to a medical device already on
the market and that was therefore subject to the pre-
market notification requirements of section 510(k) of the
act (21 U.S.C. 360(k)). The plaintiffs alleged that they
were injured by the device and sought damages under
Florida common law. They asserted that Medtronic
breached its common law duty “to use reasonable care in
the design, manufacture, assembly, and sale of the subject
pacemaker” and that Medtronic was strictly liable because
the device “was in a defective condition and unreasonably
dangerous to foreseeable users at the time of its sale” (116
S. Ct. at 2248).

The Court concluded that section 521 of the act did not
preempt the plaintiffs’ negligent design claim. It specifi-
cally rejected Medtronic’s contention that the company’s
compliance with its statutory obligation to demonstrate
through the premarket notification process that the pace-
maker was “substantially equivalent” to a preexisting de
vice preempted those claims (116 S. Ct. at 2254-2255). The
Court noted that, when FDA reviews a device under the
premarket notification provisions, it does so with “a
concern for the safety and effectiveness of the device” (id.
at 2254), but that FDA “did not ‘require’ Medtronics’
pacemaker to take any particular form for any particular
reason” (ibid). Rather, FDA simply allowed Medtronic

8a

to market the pacemaker based on the article’s equiva-
lence to the preexisting device (Jd. at 2254-2255). The
Supreme Court was unanimous on this point, since Justice
O’Connor’s separate opinion for four Justices agreed that
the section 510(k) premarket notification process “places
no ‘requirement’ on a device” and therefore does not pre-
empt a defective design claim (’d. at 2264).

The Court also concluded that section 521 of the act did
not preempt the plaintiffs’ State law claims that Medtronic
had violated FDA requirements (116 S. Ct. at 2255-2256).
The Court reasoned that State common law claims pre-
mised on Medtronic’s failure to comply with FDA require-
ments do not subject the manufacturer to requirements
that are “different from, or in addition to,” the Federal
requirements (Jd. at 2255). The Court noted that FDA’s
interpretive regulations “expressly support the conclu-
sion that [section 521] ‘does not preempt State or local
requirements that are equal to, or substantially identical
to, requirements imposed by or under the act.’” (Jd. at
2256 (quoting 21 CFR 808.1(d)(2) (1995))). It also observed
that FDA’s views on the scope of section 521 of the act’s
preemptive effect are entitled to “substantial weight.”
(Ibid).

The Court additionally concluded that section 521 of
the act did not preempt the plaintiffs’ State law claims
based on negligent manufacturing and labeling (116 S. Ct.
at 2256-2258). The Court recognized that FDA had devel-
oped regulations that set out general “requirements” for
manufacturing and labeling medical devices (Jd. at 2256).
It concluded, however, that section 521 generally does not
mandate preemption of a standard of care under State
common law unless, as FDA had suggested in its interpre-
tive regulations, FDA has issued “specific counterpart
regulations or * * * other specific requirements

9a

applicable to a particular device” (Jd. at 2257 (quoting 21
CFR 808.1(d) (1995))). The Court concluded that the
“entirely generic” Federal requirements did not provide a
basis for preemption of the nonspecific State common law
duties at issue in that case (Jd. at 2258). Justice Breyer,
agreeing with Justice O’Connor’s opinion (see id. at 2262-
2263), concluded that, insofar as the act preempts a State
requirement embodied in a statute or regulation, it also
preempts a similar State requirement that takes the form
of a standard of care imposed by State tort law (id. at 2259-
2260) but he concurred in the Court’s holding that manu-
facturing and labeling requirements issued by FDA were
not sufficiently specific to trigger preemption (id. at
2260-2261).

Since the Supreme Court’s decision in Lohr, the lower
courts have continued to reach contradictory determina-
tions respecting section 521 of the act’s preemptive effect,
particularly as it relates to medical devices that have re-
ceived premarket approval or an investigatory device ex-
emption. Compare, e.g., Fry v. Allergan Medical Optics,
695 A.2d 511 (R.I. 1997) (finding preemption), cert. denied,
No. 97-513 (U.S. Sup. Ct., Nov. 3, 1997) with Kernats v.
Smiths Indus. Med. Sys., Inc., 669 N.E. 2d 1300 (Ill. App.
Ct.) (finding no preemption), appeal denied, 675 N.E.2d
(Ill. 1996), petition for cert. pending, No. 96-1405 (U.S.
Sup. Ct., filed Mar. 4. 1997).

Ill. The Proposed Rule

FDA interprets section 521 of the act’s preemptive
effect on the basis of congressional intent. As the Su-
preme Court stated in Lohr, congressional purpose “is the
ultimate touchstone” in every preemption case, and “a fair
understanding of congressional purpose” may be discerned
not only from the text of the statute, but also through a
“reasoned understanding of the way in which Congress

10a

intended the statute and its surrounding resulatory
scheme to affect business, consumers, and the law” (116 S.
Ct. at 2250-2251 (emphasis deleted)). In addition, the
statutory text must be read in light of established pre-
sumptions respecting preemption. As the Supreme Court
stated in Lohr, the States are presumed to retain their
historic police powers unless Congress expresses a “clear
and manifest purpose” to supersede those powers (Jd. at
2250).

Section 521 of the act does not, as a general matter,
prevent a party who is injured by a defective medical
device from seeliing redress under a State’s common law.
Rather, section 521(a) of the act provides that a State may
not “establish or continue in effect with respect to a
device” a “requirement” that is “different from, or in
addition to,” a “requirement applicable under this chapter
to the device” that “relates to the safety or effectiveness
of the device” or to “any other matter included in” the
Federal requirement (21 U.S.C. 360k(a)). By its plain
terms, section 521 of the act does not prevent a State from
imposing common law duties on manufacturers of medical
devices unless those duties are “requirements” of the kind
described in the statute.

When FDA articulated its understanding of section
521 of the act in its 1978 regulations, it stated the general
rule to be that “State or local requirements are preempted
only when the agency hus established specific counter-
part regulations or there are other specific requirements
applicable to a particular device under the act, thereby
making any existing divergent State or local require-
ments applicable to the device different from, or in addition
to, the specific Food and Drug Administration require-
ments” (§ 808.1(d)). The Supreme Court explicitly en-
dorsed FDA’s position in the Lohr decision. (See 116 S.

lla

Ct. at 2257; id. at 2260-2261 (Breyer, J., concurring in part
and concurring in the judgment)). Similarly, the 1978
regulations provide that section 521 of the act does not
preempt a State or local requirement prohibiting the
manufacture of adulterated or misbranded devices, but that
where such a prohibition, as “interpreted and enforced
by the State and local government,” “has the effect of
establishing a substantive requirement for a specific
device, e.g., a specific labeling requirement,” it will be pre-
empted if it is different from, or in addition to, a spe-
cific requirement established by FDA for the device
(§ 808.1(d)(6)(ii)).

In 1978, FDA stated its understanding of section 521 of
the act in the general context of State requirements that
are imposed through positive law, such as statutes or
regulations. The same principles should govern, however,
in the case of State requirements that are imposed
through the common law. FDA has consistently con-
cluded that the same principles govern when it has
addressed the question of preemption through its
regulations, advisory opinions, and its judicial filings as
amicus curiae. The Supreme Court implicitly endorsed
that conclusion in the Lohr decision by applying the
principles that FDA has announced in its 1978 regulations
to the Lohrs’ common !aw suit (See 116 S. Ct. at 2255-2256,
2257-2258; id. at 2260-2261 (Breyer, J., concurring in part
and concurring in the judgment in part)).

In accordance with the principles that FDA articu-
lated in its 1978 regulations, to which the Supreme Court
in Lohr held that deference is owed, FDA believes that, as
a general matter, an FDA-imposed requirement will pre-
empt a State common law duty only when: (1) FDA has
expressly imposed, by regulation or order, a specific sub-
stantive requirement applicable to a particular medical

12a

device; and (2) the State common law, as interpreted and
applied, imposes a substantive requirement applicable to
the same particular medical device that is different from,
or in addition to, FDA’s counterpart requirement. Under
this approach, FDA requirements that are applicable to
devices in general, or that are established by means other
than through regulation or order, should generally not
result in preemption of State tort claims.

FDA bases its interpretation primarily on the lan-
guage of section 521 of the act and the agency’s past
regulatory interpretation set out in § 808.1. In addition, a
plurality of the Court noted in Lohr that there is no
indication in the legislative history of the amendments
that Congress intended to make a “dramatic change” in
the availability of State common law remedies (Jd. at 2253
n.13 (opinion of Stevens, J.)). The legislative history
indicates that Congress was aware of ongoing product
liability suits involving medical devices, but it contains no
indication that Congress intended that the amendments
would preempt those suits. See, eg., S. Rept. No. 33,
supra, at 1; H. R. Rept. No. 853, supra, at 8; 121 Congres-
sional Record 10,688 (1975) (Sen. Kennedy); id. at 10,689
(Sen. Nelson); 122 Congressional Record 5850 (1976) (Rep.
Abzug).

FDA’s interpretation is also founded in its experi-
ence and understanding gained through implementing the
amendments. FDA believes that its general regulatory
review and approval processes provide a significant mea-
sure of protection against the marketing of dangerous or
defective medical devices. FDA does not believe, however,
that those processes can guarantee the safety of such
devices. Accordingly, compliance with general FDA re-
quirements should not broadly preempt State commor. law
remedies, which provide an important (and frequently the

13a

only) mechanism for persons to seek redress for injuries
resulting from defective medical devices. FDA notes
below several situations in which the agency’s regulatory
activities will typically not preempt State law remedies.

First, FDA’s general clearance and approval pro-
cesses, such as the clearance for marketing under section
510(k) of the act; the grant premarket approval under
section 515 of the act; or the grant of an IDE under section
520(g) of the act, do not, by themselves, preempt State
common law claims. Section 521 of the act provides for
preemption of a State common law duty only if it imposes a
requirement that is different from, or in addition to, a
specific substantive requirement pertaining to the par-
ticular device that has been imposed by or under the act.
FDA’s action in clearing a product for marketing or
granting an application for a PMA or an IDE signifies that
the manufacturer’s proposal for 5 tamer or use of the
device in question satisfies the ftelevant statutory and
regulatory criteria for the clearance, approval, or exemp-
tion. It does not signify, however, that Congress or FDA
has established a specific Federal requirement (e.g., with
respect to the design of the device) that supplants a State
common law duty.

Second, FDA’s notification of deficiencies in, or pro-
posal of modifications to, an application for a PMA or an
IDE does not, as a general matter, create specific Federal
requirements that have preemptive effect. Under FDA’s
approval and exemption programs, the applicant bears re-
sponsibility for preparing an acceptable application. FDA
may notify the applicant of deficiencies and propose modi-
fications to ensure that the applicant has satisfied the
minimum standards for FDA approval or exemption, but
those actions do not relieve the applicant of its ultimate
responsibility for proposing the design, manufacturing,

l4a

and labeling of the device. For purposes of preemption
analysis, the applicant who modifies an application in
response to an agency notification of deficiency or pro-
posal for modification has simply achieved the same status
as an applicant who had submitted a satisfactory applica-
tion at the outset.

Third, as the Supreme Court concluded in Lohr, FDA’s
general requirements respecting labeling (21 CFR 801.1
through 801.16), and good manufacturing practices (21
CFR 820.1 through 820.198), do not preempt State require-
ments, because the general Federal requirements do not
pertain to specific devices. (See Lohr, 116 S. Ct. at 2256-
2258). The same controlling principle applies whether the
device subject to those requirements is a “grandfathered”
device that was marketed before the enactment of the
amendments, received FDA clearance for marketing under
section 510(k) of the act, received a PMA under section 515
of the act, or received an IDE under section 520(g) of the
act.

Fourth, even if FDA has imposed specific Federal re-
quirements respecting a particular medical device, those
requirements do not preempt all State common law claims
‘respecting the device. Section 521 of the act provides for
preemption only if the State common law duties are
“different from, or in addition to,” the specific Federal re-
quirements. In many cases, preemption will depend on the
plaintiff’s precise legal claims and theories of recovery.
For example, as the Supreme Court noted in Lohr, if the
State common law required the manufacturer to comply
with the Federal requirements, section 521 of the act
would not preempt that duty (116 S. Ct. at 2255-2256).
Furthermore, the courts may be able to reconcile an
apparent conflict between Federal and State requirements
by, for example, carefully formulating jury instructions to

lda

limit the bases for liability to substantive standards of
care that are consistent with any specific requirement
that FDA has made applicable to the device.

In every case, section 521 of the act’s preemptive effect
should be evaluated in light of the statute’s precise terms.
As the Supreme Court noted in Lohr, section 521 of the: act
and FDA’s regulations “require a careful comparison be
tween the allegedly preempting Federal requirement and
the allegedly preempted State requirement to determine
whether they fall within the intended preemptive scope of
the statute and regulations” (116 S. Ct. at 2257-2258). The
outcome of particular cases will frequently depend on the
character and circumstances of the particular state law
claim. FDA will continue to monitor the development of
the law in this area and provide additional guidance as the
need arises.

This proposed rule would make no change in the
agency’s prior or current construction of the scope of sec-
tion 521 of the act. Rather, the rule would simply clarify
and codify the agency’s longstanding interpretation of the
scope of section 521 of the act as generally not preempting
available legal remedies, including State common law tort
claims.

IV. Environmental Impact

The agency has determined under 21 CFR 25.34(b) that
this action is of a type that does not individually or cumv-
latively have a significant effect on the human environ-
ment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.

16a

Vv. Analysis of Impacts

FDA has examined the impacts of the proposed rule
under Executive Order 12866 and the Regulatory Flexibil-
ity Act (6 U.S.C. 601-612). Executive Order 12866 directs
agencies to assess all costs and benefits of available regu-
latory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net bene-
fits (including potential economic, environmental, public
health and safety, and other advantages; distributive im-
pacts; and equity). The agency believes that this proposed
rule is consistent with the regulatory philosophy and prin-
ciples identified in the Executive Order. In addition, the
proposed rule is not a significant regulatory action defined
by the Executive Order and so is not subject to review
under the Executive Order.

The Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize any sig-
nificant impact of a rule on small entities. Because this
rule only interprets the statute and does not establish any
requirements, the agency certifies that this proposed rule
will not have a significant impact on a substantial number
of small entities. Therefore, under the Regulatory Flexi-
bility Act, no further analysis is required.

VI. Request for Comments

Interested persons may, on or before (insert date 60
days after date of publication in the Federal Register),
submit to the Dockets Management Branch (address
above) written comments regarding this proposal. Two
copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in
the heading of this document. Received comments may be

17a

seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday.

List of Subjects in 21 CFR Part 808
Intergovernmental relations, Medical devices.

Therefore, under the Federal Food, Drug, and
Cosmetic Act and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21
CFR part 808 be amended as follows:

PART 808—EXEMPTIONS FROM FEDERAL PRE-
EMPTION OF STATE AND LOCAL MEDICAL DE-
VICES REQUIREMENTS

1. The authority citation for 21 CFR part 808 con-
tinues to read as follows:

Authority: 21 U.S.C. 360j, 360k, 371.

2. Section 808.1 is amended by adding new paragraphs
(d)(11) and (d)(12) to read as follows:

§ 808.1 Scope.

* * £ * *

(d) * * *
(11)G) An FDA imposed requirement will preempt a
State common law duty only when:

(A) FDA has expressly imposed, by regulation or
order, a specific substantive requirement applicable to a
particular device; and

(B) The State common law, as interpreted and
applied, imposes a substantive requirement applicable to
the same particular device that is different from, or in
addition to, FDA’s counterpart requirement.

18a

(ii) FDA requirements that are applicable to devices
in general, or that are established by means other than
through regulation or order, should not result in pre-
emption of State tort claims.

(12) The clearance or approval of a particular device
for marketing under section 510(k), 515, or 520(g) of the act
does not in itself constitute the imposition of a specific
substantive requirement with respect to that particular
device that preempts a State or local requirement, in-
cluding a standard of care imposed under State common
law, with respect to the same device.

Dated: December 8, 1997

/s/ WILLIAM B. SCHULTZ

WILLIAM B. SCHULTZ

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386013_0367%3A4. Public record. Not legal advice.