BARBARA E. HORN, Executrix of the Estate of Daniel Ray Horn, Deceased v. THORATEC CORPORATION. On Appeal from the United States District Court for the…

1
PRECEDENTIAL
UNITED STATES COURT OF
APPEALS
FOR THE THIRD CIRCUIT
__________
No. 02-4597
__________
BARBARA E. HORN, Executrix
of the Estate of Daniel Ray Horn,
Deceased,
Appellant
v.
THORATEC CORPORATION.
__________
On Appeal from the United States
District Court
for the Middle District of Pennsylvania
Civil Action No. 00-CV-00779
District Judge: Honorable James F.
McClure, Jr.
__________
Argued on
December 11, 2003
___________
Before: AMBRO, FUENTES, and
GARTH, Circuit Judges
(Opinion Filed: July 20, 2004)
Allison Zeive (Argued)
Public Citizen Litigation Group
1600 20th Street, N.W.
Washington, D.C. 20009
John M. Humphrey
Rieders, Travis, Mussina, Humphrey,
Harris, Waters & Waffenschmidt
161 West Third Street
P.O. Box 215
Williamsport, PA 17703
Attorneys for Appellant Barbara E. Horn
Gary A. Winters
Mayer, Brown, Rowe & Maw
1909 K Street, N.W.
Washington, D.C. 20006
Alan E. Untereiner (Argued)
Robbins, Russell, Englert, Orseck &
Untereiner LLP
1801 K Street, N.W., Suite 411
Washington, D.C. 20006
Charles W. Rubendall, II
Keefer, Wood, Allen & Rahal
210 Walnut Street
P.O. Box 11963
Harrisburg, PA 17108-1963
Arnd N. von Waldow
Reed Smith
435 Sixth Avenue
Pittsburgh, PA 15219
Attorneys for Appellee Thoratec
Corporation

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Douglas Letter, Appellate Litigation
Counsel
Peter R. Maier, Attorney
Civil Division, Room 9012
601 D Street, N.W.
Department of Justice
Washington, D.C. 20530-0001
Attorneys for Amicus Curiae United
States of America
Robert N. Weiner
Arnold & Porter
555 12th Street, N.W.
Washington, D.C. 20004
Attorneys for Amicus Curiae
Product Liability Advisory Council, Inc.
Daniel G. Jarcho
McKenna Long & Aldridge LLP
1900 K Street, N.W.
Washington, D.C. 20006
Attorneys for Amicus Curiae
Chamber of Commerce of the
United States of America
__________
OPINION
__________
Garth, Circuit Judge:
Barbara Horn (“Horn”) appeals
from the District Court’s grant of
summary judgment to Thoratec Corp.
(hereinafter “TCI”1), based on its
determination that Horn’s claims against
TCI are preempted by the express
preemption provision in the Food Drug
and Cosmetic Act (the “Act”), 21 U.S.C.
§ 360k(a).2 We affirm.
I.
TCI manufactured and distributed
the left ventricular assist device known as
the HeartMate. The HeartMate is a pump
that assists the blood flow between the
heart’s ventricle and the aorta in patients
with cardiac conditions. The inlet side
tube is surgically attached to the heart via
the ventricle, and carries blood from the
heart into the pump. The outlet side tube
brings blood from the pump to the aorta,
where it is dispersed to the body. There is
a tube attached to the pump that exits the
body and connects to an external console.
The console contains an air compressor
which powers the HeartMate.
The facts underlying this case
pertain to the outlet side tube, which
1 Thoratec Corporation, formerly
known as Thermo Cardiosystems, Inc., is
referred to by the parties and the District
Court Judge as TCI. Therefore, we will
also refer to defendant-appellee as TCI.
2 The Medical Device Amendments
to the Act allow the Food and Drug
Administration (“FDA”) to regulate
medical devices. See 21 U.S.C. §§ 360c et
seq. For ease of reference throughout this
opinion, we refer to the Act as the source
of preemption.

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connects the pump to the aorta. The
connection between the pump and the
tube, called the “elbow,” is
inserted into an adapter conduit, which is
screwed into the open port of the pump. A
screw ring is secured over the elbow to
ensure that it remains connected to the
adapter conduit and the pump. A suture is
tied over the screw ring and secured to the
adapter conduit to ensure it will not
rotate.3 The HeartMate was approved by
the FDA pursuant to the Pre-Market
Approval (“PMA”) process set forth at 21
U.S.C. § 360e(c) (discussed in depth,
infra).
On January 17, 1998, Horn’s
husband, Daniel Horn, was admitted to
Williamsport Hospital suffering a heart
attack. He was later transferred to
Hershey Medical Center. Doctors there
determined that Mr. Horn required a heart
transplant, and they waited for a suitable
donor heart to become available. On
January 22, 1998, Mr. Horn’s condition
deteriorated and a HeartMate was
implanted in him to provide circulatory
support. He was then transferred to an
assisted living facility.
On May 3, 1998, Mr. Horn began
to bleed from the spot where the
HeartMate tube exited his body.
Thereupon, he underwent exploratory
surgery at Hershey Medical Center, during
which Dr. Benjamin Sun discovered that
the suture on Mr. Horn’s HeartMate had
worn off and the screw ring linking the
pump to the output side elbow had
disconnected. The disconnection had
allowed an air embolus to travel to Mr.
Horn’s brain. Although Dr. Sun
reconnected the screw ring and once again
linked the pump to the elbow, it was too
late. Mr. Horn suffered a brain
hemorrhage, and he was rendered brain
dead. On May 8, 1998, his organs were
donated for transplant and he was
pronounced dead.
On April 28, 2000, Horn filed a
Complaint against TCI in the United
States District Court for the Middle
District of Pennsylvania. The Complaint
alleged defective design and manufacture
of the HeartMate and failure to warn of
the alleged defects; it was based on Horn’s
claim that the HeartMate’s output side
elbow was defectively designed. TCI
moved for summary judgment, arguing
that Horn’s state law claims are expressly
preempted by 21 U.S.C. § 360k(a).
The District Court granted TCI’s
motion on November 7, 2002, holding that
Horn’s state common law claims were
preempted. The District Court applied a
two-prong test endorsed by the Sixth and
Eleventh Circuits,4 which instructs that a
state claim attacking the safety of a
3 The HeartMate arrives at the
surgeon pre-assembled. The surgeon need
not manipulate the screw ring or suture
when he implants the HeartMate.
4 See Kemp v. Medtronic, Inc., 231
F.3d 216, 224-25 (6th Cir. 2000); Goodlin
v. Medtronic, Inc., 167 F.3d 1367, 1371
(11th Cir. 1999).

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medical device is preempted if (1) the
FDA has established specific federal
requirements that are applicable to that
particular device, and (2) the state claim is
different from, or in addition to, the
specific federal requirements.
In granting TCI’s motion for
summary judgment on express preemption
grounds, the District Court found that (1)
the HeartMate’s PMA approval process
imposes a specific federal requirement
applicable to the HeartMate, and (2) if
Horn were successful on her state law
claims, “any judgment that the HeartMate
was unsafe or otherwise substandard
would be in direct conflict [with]—i.e.,
different from—the FDA’s determination
that the product was suitable for use.”
Dist. Ct. Op. at 20. This timely appeal
followed.
II.
We have jurisdiction to hear this
appeal pursuant to 28 U.S.C. § 1291.
Review of a district court’s decision to
grant a motion for summary judgment is
plenary. Goodman v. Mead Johnson &
Co., 534 F.2d 566, 573 (3d Cir. 1976),
cert. denied, 429 U.S. 1038 (1977);
Hilfirty v. Shipman, 91 F.3d 573, 577 (3d
Cir. 1996).
Summary judgment is appropriate
only when there is no genuine issue as to
any material fact and the moving party is
entitled to a judgment as a matter of law.
See Fed. R. Civ. P. 56(c); see also
Armbruster v. Unisys Corp., 32 F.3d 768,
777 (3d Cir. 1994). In examining the
record, the court gives the nonmoving
party the benefit of all reasonable
inferences from the record. Saldana v.
Kmart Corp., 260 F.3d 228, 232 (3d Cir.
2001); Gray v. York Newspapers, Inc.,
957 F.2d 1070, 1078 (3d Cir. 1992).
This Court also exercises plenary
review over a district court’s preemption
determination, as it is a question of law.
Travitz v. Northeast Dep’t ILGWU Health
& Welfare Fund, 13 F.3d 704, 708 (3d
Cir. 1994), cert. denied, 511 U.S. 1143
(1994); Michael v. Shiley, Inc., 46 F.3d
1316, 1321-22 (3d Cir. 1995).
III.
At issue is whether Horn’s suit
against TCI, alleging causes of action
under Pennsylvania common law, is
expressly preempted. We need not
examine the doctrine of implied
preemption, because the Act under which
the FDA preempted the state causes of
action contains an express preemption
clause, which obviates any reference to the
doctrine of implied preemption. The
express preemption clause, 21 U.S.C. §
360k(a), provides:
[N]o State or political
subdivision of a State may
establish or continue in
effect with respect to a
device intended for human
use any requirement –
(1) which is different from,
or in addition to, any
requirement applicable
under this chapter to the

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device, and
(2) which relates to the
safety or effectiveness of
the device or to any other
matter included in a
requirement applicable to
the device under this
chapter.
In this case, Horn contends that her
state common law claims would impose
generally applicable duties to use good
care in manufacturing and to warn users of
the product’s attendant risks. They would
not, she argues, impose specific
requirements with respect to the
HeartMate. Paragraphs 15 and 16 of
Horn’s Complaint set forth the gravamen
of her action as follows:5
15. . . . The continual
pumping action of the TCI
HeartMate, together with
natural body movements,
caused the wearing away of
the suture so placed, and
once the suture was worn
through, said movement of
the pump caused the screw
ring to become unscrewed.
16.Had the screw ring been
of an appropriate and
feasible design which would
not permit the screw ring to
become unscrewed as a
result of pump movement,
or had something more
durable than a suture been
used to secure the tightened
screw ring, or had the
threaded sleeve with the
eyelet been placed in such a
way that the retaining suture
did not run across the
interior portion of the screw
5 The FDA has summarized Horn’s
claims in the following manner:
[P]laintiff makes two main
claims: first, that TCI
should have employed a
[suture] design to prevent
the screw rings used to hold
the device in place inside
the patient’s chest from
becoming disconnected
(plaintiff asserted that TCI
o v e r l o o k e d b e t t e r
alternatives to the design it
chose); [and] second, that
TCI should have issued
warnings to docto rs,
through either revisions in
the product labeling or
correspondence to health
c a r e p r o f e s s i o n a l s
(commonly called “Dear
Doctor letters”), against
using the device if the
suture as placed in the
device packaging would
face the patient’s sternum.
FDA Amicus Curiae Letter Br. at 4-5.

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ring directly beneath the
underside of the sternum,
the disconnection which
ultimately caused Mr.
Horn’s death would never
have occurred.
TCI responds that Horn’s state common
law claims would impose state
requirements that are specifically
applicable to the HeartMate, and as such
are expressly preempted.
Horn relies on Medtronic v. Lohr,
518 U.S. 470 (1996), a Supreme Court
case which involved the FDA’s approval
of a pacemaker. In that case, which we
discuss in more detail later, the FDA’s
approval of the device did not result in
preemption of the plaintiff Lohr’s state
law claims because the approval process
involved in that case was not the same
detailed approval process that was
employed by the FDA to approve the
HeartMate. In Lohr, the FDA determined
that the pacemaker was “substantially
equivalent” to an existing FDA-approved
device pursuant to § 510(k) of the Act,
and therefore did not undergo the far more
thorough and rigorous PMA approval
process under § 360e(c) of the Act. It was
this latter type of approval that the
HeartMate received.
The FDA, in its Amicus Curiae
Letter Brief to this Court, contrasted the §
510(k) “substantial equivalence” approval
process with the § 360e(c) PMA process
as follows:
A manufacturer can
obtain an FDA finding of
‘substantial equivalence’ by
submitting a pre-market
notification to the agency in
accordance with Section
510(k) of the [Act]. 21
U.S.C. § 360(k). A device
found to be ‘substantially
equivalent’ to a predicate
device is said to be ‘cleared’
by FDA (as opposed to
‘approved’ by the agency
under a PMA). A pre-
m a r k e t n o t i f i c a t i o n
submitted under Section
510(k) is thus entirely
different from a PMA,
which must include data
sufficient to demonstrate to
FDA that the device is safe
and effective. See Lohr,
518 U.S. at 478-79 (“The §
510(k) notification process
is by no means comparable
to the PMA process.”).
The number of
medical devices that receive
PMA review each year is
dwarfed by the number of
those that are marketed
pursuant to cleared Section
510(k). In fiscal year 2003,
for example, original PMAs
represented only 54 of the
9,872 major submissions
received. The previous
fiscal year, original PMAs

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accounted for 49 of 10,323
total submissions.6
As it concerns the HeartMate, TCI
contends that because it received FDA
approval of the HeartMate through the
PMA process, and not under the
“substantial equivalence” clearance
standard of § 510(k), and because Horn’s
reading and analysis of the “specificity” of
the state law requirement in Lohr is
flawed, the Lohr decision is not
controlling. We agree.
IV.
This Court has addressed the issue
of the Act’s express preemption before,
and those decisions guide us here. In Gile
v. Optical Radiation Corp., 22 F.3d 540,
541 (3d Cir.), cert. denied, 513 U.S. 965
(1994), the plaintiff brought a state
common law products liability and
negligence action against an intraocular
lens manufacturer. We determined in Gile
that state common law claims may impose
state “requirements,” as that term is used
in § 360k(a) of the Act, and that the state
law requirements were preempted by the
FDA. Id. at 541-42.
Thereafter, in Michael v. Shiley,
Inc., 46 F.3d 1316 (3d Cir. 1995), the
recipient of a heart valve brought an
action against the heart valv e
manufacturer for negligent manufacture
and design, strict products liability, breach
of implied warranty of merchantability and
fitness for a particular purpose, breach of
express warranty, and fraud on the FDA.
Id. at 1321. The heart valve manufacturer
argued that the Act preempted all of the
plaintiff’s claims. Id. at 1322. On the
issue of preemption, we stated that:
[ S ] e c t i o n [ 3 6 0 k ( a ) ]
pre-empts only state
imposed requirements.
Further, it pre-empts those
requirements only when
they differ from or add to a
previously established FDA
requirement and relate to
the safety or efficacy of the
regulated device. When a
state law differs from or
adds to an FDA requirement
and when a state law relates
to the safety or effectiveness
of a device approved by the
FDA, the state law is
pre-empted. Conversely,
when a state law neither
imposes requirements nor
differs from or adds to an
FDA requirement nor
relates to the safety or
effectiveness of the device
or to any other matter
included in an FDA
requirement, the state law is
not pre-empted by § 360k.
Id. at 1323. We concluded that Michael’s
claims for negligence, strict liability,
breach of implied warranties, and fraud on
6 FDA Amicus Curiae Letter Br. at
12 (emphasis added).

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the FDA were preempted. Id. at 1325-31.7
Most significantly, we held that the PMA
process, as well as the labeling and “good
manufacturing” requirements to which the
heart valve was subjected, constituted
proper bases for preemption under §
360k(a). Id. at 1324.
The following year, the Supreme
Court decided Medtronic v. Lohr, 518
U.S. 470 (1996). In that case, to which we
referred earlier, the plaintiff asserted
common law negligence and strict liability
claims and state law defective
manufacture and mislabeling claims
against the manufacturer of a pacemaker
that was given FDA clearance under the
§ 510(k) “substantial equivalence”
process. Lohr’s complaint stemmed from
a defective lead in her pacemaker.
A plurality of the Lohr Court held
that Loh r’s claim s aga inst th e
manufacturer of the § 510(k)-approved
pacemaker were not preempted. Key to
this holding was the plurality’s opinion
that the § 510(k) process does not impose
any federal “requirement” applicable to the
device, but is rather a “generic federal
standard.” Lohr, 518 U.S. at 486-87. The
Lohr Court did not consider whether the
more rigorous PMA process under
§ 360e(c)—as distinct from the § 510(k)
process—constitutes “a specific federal
regulation of the product”8 (in this case the
HeartMate), which, in turn, imposes strict
F D A r e q u i r e m e n t s u p o n t h e
manufacturer.9
7 Michael’s claims for breach of
express warranty (based on the heart
valve’s packaging materials) and fraud
( b a s e d o n t h e m a n u f a cturer’ s
advertisements and promotional
materials), neither of which were the
subject of the FDA’s PMA approval, were
held not to be preempted because those
claims arising out of private
representations—as distinct from state
requirements—were merely state-enforced
common law remedies, and not state-
imposed common law remedies. 46 F.3d
at 1325-31.
8 Mitchell v. Collagen Corp., 126
F.3d 902, 911 (7th Cir. 1997).
9 Most circuits have followed
Justice Breyer’s concurrence in Lohr,
which suggests that § 360k(a) preempts
some, but not all, common law claims.
518 U.S. at 506 (Breyer, J., concurring);
see, e.g., M artin v. Medtronic, 254 F.3d
573 (5th Cir. 2001); Brooks v. Howmedica,
Inc., 273 F.3d 285 (8th Cir. 2001); Kemp
v. Medtronic, Inc., 231 F.3d 216 (6th Cir.
2000); Mitchell v. Collagen Corp., 126
F.3d 902 (7th Cir. 1997). Where the
federal requirement at issue is specifically
applicable to a particular device, Justice
Breyer concluded, any state common law
claim implicating that device is preempted.
Id. at 505. Justice Breyer concurred with
the plurality’s decision that a common law
claim against a § 510(k)-approved device
is not preempted, because
§ 510(k) does not impose a federal
requirement that is specifically applicable
to a particular device.

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1. The Federal Requirement
A. General Analysis of the Federal
Requirement
The primary element distinguishing
Lohr from the instant case is the fact that
the HeartMate received FDA approval
through the rigorous § 360e(c) PMA
process, not through the § 510(k)
“substantial equivalence” process. The
Lohr decision did not address the issue of
whether the PMA process imposed federal
requirements under
§ 360k(a). It suggested, however, that the
analysis would have been significantly
different if the device at issue in Lohr had
weathered a more exacting federal
investigation, such as the PMA process.
Lohr, 518 U.S. at 501. Indeed, the Lohr
plurality distinguished the case from “a
case in which the Federal Government has
weighed the competing interests relevant
to the particular requirement in question,
reached an unambiguous conclusion about
how those competing considerations
should be resolved in a particular case or
set of cases, and implemented that
conclusion via a specific mandate on
manufacturers or producers.” Id.
Furthermore, in response to the
pacemaker manufacturer’s argument that
Lohr’s state common law claims were
preempted by the FDA’s “good
manufacturing practices” regulations, 21
C.F.R. §§ 820.20-820.198 (1995), and by
the FDA labeling regulations requiring
devices to carry warnings, 21 C.F.R. §
801.109 (1995), the Lohr plurality stated:
the federal requirements
[imposed under § 510(k)]
reflect important but
entirely generic concerns
about device regulation
generally, not the sort of
concerns regarding a
specific device or field of
device regulation that the
statute or regulations were
designed to protect from
potentially contradictory
state requirements.
518 U.S. at 501.
We hold that the requirements
imposed by the FDA upon the HeartMate
when it was granted PMA approval are
precisely “the sort of concerns regarding a
specific device” which the Supreme Court
intimated would give rise to preemption
under
§ 360k(a). This portion of our decision in
Michael v. Shiley, Inc., 46 F.3d at 1324,
remains unchanged by the Lohr decision.10
10 In re Orthopedic Bone Screw
Prods. Liab. Litig., 159 F.3d 817, 825 (3d
Cir. 1998), is not to the contrary.
Orthopedic, a § 501(k) case, in dealing
with the alternate holding of Michael
respecting the claim of fraud on the FDA,
concluded that Lohr had overruled the
alternate holding without affecting the
preemption determination or any other
holdings of the Michael opinion. This
aspect of Orthopedic came into question

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In this case, the HeartMate’s PMA
process began in 1975 when its basic
design was completed. In 1985, after ten
years of live animal and human cadaver
studies, the HeartMate was granted an
investigational device exemption (“IDE”)
by the FDA in order to begin clinical
trials. Over the next seven years, clinical
trials of the HeartMate were conducted at
various hospitals. During this period, TCI
submitted more than ninety supplements to
the FDA, and the FDA made numerous
inquiries about the HeartMate and its
clinical trials, including correspondence
concerning a leak from the HeartMate’s
screw ring and approval of subsequent
design changes (i.e., the addition of the
bonding agent and suture). In 1992, TCI
submitted its PMA application to the
FDA, and supplemented it in the ensuing
three years with a substantial amount of
amendments and responses to FDA
questions. In 1994, after extensive
review of TCI’s application, the FDA
approved the HeartMate for commercial
sale in the form specified in the
application.
There is no doubt that, as a
practical reality, the PMA process
imposed requirements that were
specifically applicable to the HeartMate,
and that triggered preemption under §
360k(a). It imposed mandatory conditions
— created through a decades-long process
of correspondence, clinical testing and
device alteration — pertaining to the
HeartMate’s manufacturing, packaging,
storage, labeling, distribution and
advertising. See 21 C.F.R. §§ 814.39,
814.80 (setting forth requirement that
PMA approval be obtained before device
may be manufactured or marketed, and
method for supplementing PMA
application). Other Courts of Appeal have
held that PMA approval by the FDA
constitutes approval of the product’s
design, testing , i n t e n ded use ,
manufacturing methods, performance
standards and labeling that is specific to
the product. See Brooks v. Howmedica,
Inc., 273 F.3d 785, 795-96 (8th Cir.
2001); Kemp v. Medtronic, Inc., 231 F.3d
216, 226-27 (6th Cir. 2000); Mitchell v.
Collagen Corp., 126 F.3d 902, 913 (7th
Cir. 1997). But see Goodlin v. Medtronic,
Inc. 167 F.3d 1367, 1377 (11th Cir.
when the Supreme Court in Buckman Co.
v. Plaintiffs' Legal Comm., 531 U.S. 341
(2001), held that a fraud on the FDA claim
brought as a state cause of action was
impliedly preempted without expressing
any view on whether such a claim was
expressly preempted by § 360k(a). See id.
at 348 n.2.
See also Martin v. Medtronic, 254
F.3d 573, 583 (5th Cir. 2001), which held
that Lohr did not overrule the Fifth
Circuit’s prior precedent established in
Stamps v. Collagen Corp., 984 F.2d 1416
(5th Cir. 1993), and that the state law
claims asserted in Martin were preempted.

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1999).11
B. The FDA’s Position12
While we acknowledge that the
FDA’s interpretation of statutes that it has
been charged by Congress with enforcing
11 The Eleventh Circuit was alone
among the Courts of Appeals when it ruled
in Goodlin that § 360k(a) does not preempt
common law claims involving PMA-
approved devices. Goodlin, 167 F.3d at
1368. The Tenth Circuit has ruled that the
Act did not preempt a plaintiff’s common
law tort claim against a medical device
manufacturer, but the device at issue in
that case did not undergo the § 360e(c)
PMA analysis, but rather underwent the far
less rigorous Investigative Device
Exception (IDE) process. Oja v.
Howmedica, 111 F.3d 782 (10th Cir.
1997).
12 The dissent in its footnote 2
argues that the FDA’s position on
preemption is entitled only to “near
indifference,” thereby contending that we
should disregard the FDA’s interpretation
of Lohr as well as its unique qualification
to determine whether its regulations and
interpretation of the FDA statute (21
U.S.C. § 360k(a)) fulfill the purposes and
objectives of Congress. In denying the
import of the FDA’s position, which it has
particularized in its Amicus Brief with
respect to the HeartMate, the dissent has
not given weight to the instruction
furnished to us by the Supreme Court in
Lohr.
That Court stated that “Congress
has given the FDA a unique role in
determining the scope of § 360k’s pre-
emptive effect.” Lohr, 518 U.S. at 495-
96. Here, the FDA’s position has been
expressly authorized by the Solicitor
General of the United States. Justice
Breyer was prescient in acknowledging
the FDA’s position when he wrote:
The . . . FDA is fully
r e s p o n s i b l e f o r
administering the [Act].
That responsibility means
i n f o r m e d a g e n c y
involvement and, therefore,
special understanding of the
likely impact of both state
and federal requirements, as
well as an understanding of
whether (or the extent to
which) state requirements
may interfere with federal
objectives. The FDA can
t r a n s l a t e t h e s e
u n d e r s t a n d i n g s i n t o
particularized pre-emptive
intentions accompanying its
v a r i o u s r u l e s a n d
regulations. It can
c o m m u n i c a t e t h o s e
intentions, for example,
through statements in
regulations, preambles,
interpretive statements, and
responses to comments.
Id. at 505-06 (Breyer, J., concurring in
part) (internal citations and quotations
omitted).

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is not fully dispositive of the issues here,
the Supreme Court has instructed us that
the FDA’s preemption determinations are
significant and should inform our
interpretation of § 360k(a). Indeed, the
Supreme Court’s decision in Lohr was
“substantially informed” by the FDA, in
the context of § 510(k). Lohr, 518 U.S. at
495. Hence, we have no hesitation in
looking to the FDA for its interpretation of
§ 360k(a) in the medical device context.
Lohr stated:
The FDA regulations
interpreting the scope of §
360k’s pre-emptive effect
support the Lohrs’ view,
and our interpretation of the
pre-emption statute is
substantially informed by
those regulations . . .
Congress has given the
FDA a unique role in
determining the scope of §
360k’s pre-emptive effect .
. . [I]n most cases a state
law will be pre-empted only
to the extent that the FDA
has promulgated a relevant
federal ‘requirement.’
Because the FDA is the
federal agency to which
Congress has delegated its
authority to implement the
provisions of the Act, the
agency is uniquely qualified
to determine whether a
particular form of state law
stands as an obstacle to the
a c c o mp l i s h me n t a n d
execution of the full
purposes and objectives of
Congress, and, therefore,
whether it should be
pre-empted.
Lohr, 518 U.S. at 495-96 (internal
citations and quotations omitted).
Horn, in her brief before us, relied
heavily on an FDA amicus curiae
submission filed with the Supreme Court
in opposition to certiorari in Smiths
Industries Medical Systems, Inc. v.
Kernats, 522 U.S. 1044 (1998). However,
those views have been expressly
disclaimed and rejected by the FDA in its
Amicus Curiae Letter Brief to this Court.
In its current brief, the FDA has
unequivocally expressed the opinion that
state common law claims such as those
made by Horn against a PMA-approved
device are preempted. With great
particularity, the FDA specifically
addressed the HeartMate and concluded
that because the device was the subject of
PMA approval under § 360e(c), and not
the subject of “substantial equivalence”
clearance under § 510(k), the state law
claims asserted by Horn are preempted.13
13 This is the FDA’s present
opinion. See FDA Amicus Curiae Letter
Br., Horn v. Thoratec Corp., No. 02-4597
(3d Cir. May 11, 2004). It is consistent
with the FDA’s statement of interest in
Murphree v. Pacesetter, Inc., in which it
argued that PMA approval by the FDA
“triggers preemption of a wide array of

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-12-
The FDA, when PMA approval is
granted, imposes federal requirements
based on the highly detailed and
prescriptive nature of the PMA process
and the approval order that results from it.
In its Amicus Curiae Letter Brief at pages
23-24, the FDA writes:
F D A c a n i m p o s e
requirements by rule or
order, regardless of whether
or not the requirements
were initially suggested to
the agency by an outside
party . . . . Although the
PMA approval order does
not itself expressly reiterate
all of the specific features
the device’s design,
labeling, and manufacturing
processes must have, it
specifically approves as a
matter of law those features
set forth in the application
and binds the manufacturer
to produce and market the
product in compliance with
the specifications as
approved by FDA.
(emphasis added).
The FDA also clearly distinguished
the PMA process from the § 510(k)
substantial equivalence process, which
was the subject of the Supreme Court’s
decision in Lohr, writing:
Unlike a section
510(k) clearance, which
only determines whether
t w o p r o d u c t s a r e
substantially equivalent,
P M A a p p r o v a l
consummates an exhaustive
inquiry into the risks and
efficacy of a device. . . .
I n L o h r , n o t
surprisingly, the Court
premised its holding against
preemption on the fact that
the device had been cleared
only through the Section
510(k) process, a “limited
form of review.” Lohr, 518
U . S . a t 4 7 8 . A
manufacturer may change
the design and labeling of a
Section 510(k)-cleared
device as long as it
continues to be substantially
equivalent to its predicate.
21 C.F.R. § 807.81. In
direct contrast to the PMA
regime, FDA does not
‘approve’ changes to a
Section 510(k)-cleared
device. Rather, the
manufacturer simply has to
requirements imposed under state tort
law.” See Statement of Interest in Support
of Defendant Pacesetter’s Petition for
Certification for Interlocutory Appeal of
the United States of America at 5 & 7,
Murphree v. Pacesetter, Inc. et al, No.
005429-00-3 (Tenn. Circuit Ct. Dec. 12,
2003).

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-13-
demonstrate that its device
is still substantially
equivalent to its predicate.
Moreover, the range of
changes that a manufacturer
can make to a [§ 510(k)]
cleared device without
getting prior authority from
FDA is broader than for a
[PMA] approved device. A
manufacturer of a cleared
device must submit a
Section 510(k) notice to
FDA only for changes that
‘could significantly affect
safety or effectiveness of
the device,’ or that represent
a ‘major change’ in the
intended use of the device.
21 C.F.R. § 807.81.
. . . For [PMA
devices], after a very
lengthy process involving
thousands of pages of
documentation and many
hours of expert analysis, and
often including substantial
give-and-take between the
a g e n c y a n d t h e
m a n u f a c t u r e r , F D A
approves a new device,
i n c l u d i n g d e t a i l e d
specifications for its design,
manufacture, performance,
labeling, and use. Any of
these specifications may be
changed in [a] way that
a f f e c t s s a f e t y a n d
effectiveness only with
FDA’s authorization.
Id. at 20-21 (emphasis added).
The dissent, in discussing Lohr v.
Medtronic (see Dissenting Op. at __), has
ignored the very salient fact that Lohr was
a § 510k “substantial equivalence”
decision and not, as this case is, a
§360e(c) PMA case. We have discussed
the dramatic difference between these two
approval processes in both Sections III
and IV of this opinion. We have
emphasized that the PMA approval
process mandates that the manufacturer (in
this case, TCI) produce and market the
HeartMate in compliance, and only in
compliance, with the requirements and
specifications approved by the FDA. This
is a far cry from the § 510k process which
was the subject of Lohr, and which
notably the Lohr Court held was “by no
means comparable to the PMA process.”
Lohr, 518 U.S. at 478-79.
This significant distinction is
understandably absent from the dissent’s
discussion because, as we point out in this
opinion, any effort by Horn to prove her
general common law claims of negligence,
labeling or deficient design would
necessarily differ from, or add to, the
design, manufacturing or labeling
approved and pre-empted by the FDA.
See 21 U.S.C. § 360k(a); 21 C.F.R. §
808.1(b) (see p. 17, infra, for text of
regulation); Kemp v. Medtronic, Inc., 231
F.3d 216 (6th Cir. 2000); Mitchell v.
Collagen Corp., 126 F.3d 902 (7th Cir.

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-14-
1997), Papike v. Tambrands, Inc., 107
F.3d 737 (9th Cir. 1997), and Michael v.
Shiley, Inc., 46 F.3d 1316, 1323 (3d Cir.
1995).
Thus, the District Court’s position,
the FDA’s position, and our position are
all in accord: the FDA’s PMA approval of
the HeartMate imposed specific federal
requirements upon the HeartMate under §
360k(a) which, as we explain infra,
preempts Horn’s state common law
claims. Cf. Hawkins v. Leslie’s Pool
Mart, Inc., 184 F.3d 244, 250-51 (3d Cir.
1999) (holding that labeling claims were
preempted by similar preemption clause in
Federal Insecticide, Fungicide and
Rodenticide Act because, in contrast to
§ 510(k) approval, the EPA had
i n c o r p o r a te d s p e c i f i c l a b e l i n g
requirements that could not be changed
without pre-approval).
2. The State Requirement
A. General Analysis of the State
Requirement
The remaining issue is whether
Horn’s state common-law claims
constitute state requirements with respect
to the HeartMate which are different from,
or in addition to, the federal requirements.
See 21 U.S.C. § 360k(a). As we noted
earlier, it is firmly established that a
“requirement” under § 360k(a) can
include legal requirements that arise out of
state common-law damages actions. See
Gile, 22 F.3d at 541-42. Consequently,
the only matter that we must resolve is
whether § 360k(a) preempts the particular
state common law claims brought by
Horn.
The only state requirements
asserted by Horn are general requirements
stemming from state common law: the
HeartMate was designed in a defective
manner, it was manufactured in a
defective manner, and the manufacturer
had failed to warn of the alleged defects.
The thrust of Horn’s Complaint was that
had the screw ring been of a better and
more feasible design and had something
more durable than a suture been used or
had the threaded sleeve with the eyelet
been placed differently in Mr. Horn’s
body, his death would not have resulted.14
Horn has never claimed that
Pennsylvania has established a
requirement of specific device content
pertaining to the HeartMate.15 She has
never alleged that Pennsylvania requires
all sutures for the HeartMate to be
fabricated from a substance different than
the suture which the FDA has approved.
14 Horn does not allege that TCI
failed to comply with the requirements
imposed by the FDA when it approved the
HeartMate. At oral argument, counsel for
Horn twice stated that Horn was not
making such an allegation. Tr. at 7:20-
8:12 & 10:12-14.
15 Pennsylvania’s only medical
device requirements which are specifically
exempt from preemption arise under the
Pennsylvania Hearing Aid Sales
Registration Law, 35 P.S. §§ 6700-504(4),
6700-506, 6700-507(2), see also 21
C.F.R. § 808.88.

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-15-
Nor has she ever alleged that there are
specific requirements mandated by the
Commonwealth of Pennsylvania as to how
a medical device such as the HeartMate
must be fabricated or designed or
implanted within the patient’s body.
Indeed, if Horn had alleged any
“requirement” similar to these it would
have been fatal to her claims, because each
of them would have either been in
addition to, or different from, the federal
requirements imposed through the FDA’s
PMA approval of the HeartMate.
In the absence of any specific
device requirements,16 we are left with
Horn’s general common law claims of
negligence, defective design, etc. The
question that remains is: can Horn’s
common law “general” claims, which are
not specific “with respect to” the
HeartMate, constitute “requirements” that
survive preemption under
§ 360k(a)?
Our analysis begins, as it must,
with the Lohr decision. Both Horn and
TCI, as well as the authorities that have
considered FDA preemption under §
360k(a), have understandably read
Medtronic v. Lohr as a starting point for
interpreting § 360k(a) and the FDA’s
regulations at 21 C.F.R. § 808.1(d).17
They have also considered the impact
upon the FDA’s PMA approval of a
medical device when general state tort law
claims alleging negligence, design defects,
failure to warn, and the like, are filed
against the manufacturer of the device.
See, e.g., Martin v. Medtronic, 254 F.3d
573 (5th Cir. 2001).
In Lohr, the plaintiff sued
Medtronic for negligent manufacture and
failure to warn, essentially the same claims
Horn has brought against TCI. The four-
judge plurality in Lohr concluded that
those claims “escape[d] pre-emption, not
because the source of the duty is a judge-
made common-law rule, but rather
because their generality leaves them
outside the category of requirements that
16 In her June 2004 Letter Brief at
10, Horn wrote: “In this case, Ms. Horn
does not rely on any device-specific
requirements.”
17 21 C.F.R. § 808.1(d) provides:
State or local requirements
are preempted only when
the Food and Drug
A d m i n i s t r a t i o n h a s
e s t a b l i s h e d s p e ci f i c
counterpart regulations or
there are other specific
requirements applicable to a
particular device under the
act, thereby making any
existing divergent State or
l o c a l r e q u i r e m e n t s
applicable to the device
different from, or in
addition to, the specific
F o o d a n d D r u g
A d m i n i s t r a t i o n
requirements. . .

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-16-
§ 360k envisioned to be ‘with respect to’
specific devices such as pacemakers.”
Lohr, 518 U.S. at 502.
Although Justice Breyer joined in
the section of the plurality’s opinion in
which that statement appeared, he wrote
separately to emphasize that, unlike the
plurality, he was “not convinced that
future incidents of [§ 360k(a)] pre-
emption of common-law claims will be
‘few’ or ‘rare.’” Id. at 508 (Breyer, J.,
concurring in part). As we read Justice
Breyer’s concurring opinion, a state
common law claim need not be developed
specifically “with respect to” a particular
medical device in order to be preempted.
It would make little sense for Justice
Breyer to write separately to emphasize
that duties arising under state law can
regularly lead to preemption, but
simultaneously agree with the plurality
that tort duties are almost always too
general to warrant preemption. See
Papike v. Tambrands, Inc., 107 F.3d 737,
742 (9th Cir. 1997). The more logical
reading of Justice Breyer’s concurring
opinion is that a court should carefully
examine the state common law claim in
order to determine whether that claim
would impose a substantive requirement
that conflicts with, or adds a greater
burden to, a specific federal requirement.
See Mitchell v. Collagen Corp., 126 F.3d
902, 911-12 (7th Cir. 1997); Kemp v.
Medtronic, 231 F.3d 216, 230 (6th Cir.
2000); Martin v. Medtronic, 254 F.3d
573, 581-83 (5th Cir. 2001).
The dissent cites to Alexander v.
Sandoval, 532 U.S. 275, 285 n.5 (2001),
for the proposition that the lower federal
courts do not give “much precedential
weight” to a concurring opinion of the
United States Supreme Court, even where
the concurring opinion is compatible with
the majority opinion. See Dissenting Op.
at ___. We disagree, as this principle has
no application to this case. Sandoval
bears little resemblance to the situation in
Lohr. In Sandoval, Justice Scalia merely
observed that the opinion of a three-
member concurrence in Lau v. Nichols,
414 U.S. 563 (1974), was not binding
precedent on an issue that the five-member
majority in Lau did not reach. In Lohr, by
contrast, Justice Breyer cast the so-called
“swing vote,” which was crucial to the
outcome of the case and without which
there could be no majority. Moreover,
Justice Breyer did not discuss issues in his
concurring opinion that Justice Stevens,
writing on behalf of the four-judge
plurality, did not reach.
Splintered opinions by the Supreme
Court often result in some confusion as to
which opinion or rationale is binding on
the lower federal courts. In an attempt to
provide some guidance in such situations,
the Supreme Court has instructed that the
lower courts should follow the rationale
“taken by those Members who concurred
in the judgments on the narrowest
grounds.” Gregg v. Georgia, 428 U.S.
153, 169 n.15 (1976) (plurality opinion);
see also Marks v. United States, 430 U.S.
188, 192-93 (1977) (stating that, “[w]hen
a fragmented Court decides a case and no
single rationale explaining the result
enjoys the assent of five Justices, ‘the

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holding of the Court may be viewed as
that position taken by those Members who
concurred in the judgments on the
narrowest grounds . . . .’”); Planned
Parenthood of Southeastern Pa. v.
Casey, 947 F.2d 682, 693 (3d Cir. 1991)
(discussing in detail the “narrowest
ground” principle), modified on other
grounds, 505 U.S. 833 (1992).
If the “narrowest ground” approach
is applied to Lohr, Justice Breyer’s
opinion takes on added significance.
Whereas Justice Stevens concluded that Ҥ
360(k) simply was not intended to pre-
empt most, let alone all, general common-
law duties enforced by damages actions,”
see Lohr, 518 U.S. at 491, Justice Breyer
concluded that “ordinarily, insofar as the
[FDA] pre-empts a state requirement
embodied in a state statute, rule,
regulation, or other administrative action,
it would also pre-empt a similar
requirement that takes the form of a
standard of care or behavior imposed by a
state-law tort action.” Id. at 504-05
(Breyer, J., concurring in part and
dissenting in part). Thus, Justice Breyer’s
rationale is the more narrow of the two
because, although the Lohrs’ claims were
not preempted by § 360k(a), he was not
prepared to join in Justice Stevens’
sweeping pronouncement that § 360k
almost never preempts a state common
law claim.
Of course, the splintered decision
in Lohr is unique because Justice Breyer
joined in some parts of Justice Stevens’
plurality opinion (thus making it a
majority opinion at times), but did not join
in other parts. Our dissenting colleague
emphasizes that Justice Breyer joined in
Part V of the plurality opinion, in which
Justice Stevens concluded that the Lohrs’
common-law claims did not constitute
specific state requirements because they
were not “specifically developed ‘with
respect to’ medical devices.” Lohr, 518
U.S. at 501. This was not a principle that
received Justice Breyer’s agreement. In
his concurring opinion, Justice Breyer
states that he must address two issues: (1)
whether the FDA can “ever pre-empt a
state-law tort action;” and (2) if so,
whether the FDA pre-empts the claims
brought by Lohr. Id. at 503 (Breyer, J.,
concurring in part and dissenting in part).
In response to the first question,
Justice Breyer expressly states that he
“basically agree[d]” with Justice
O’Connor’s discussion of that point in her
dissenting opinion. Justice O’Connor
concluded that “a fair reading of [§
360k(a)] indicates that state common-law
claims are pre-empted, as the statute itself
states, to the extent that their recognition
would impose ‘any requirement’ different
from, or in addition to, FDCA
requirements applicable to the device.”
Id. at 512 (O’Connor, J., dissenting).
Interestingly, Justice O’Connor also
observed that “[t]he statute itself makes no
mention of a requirement of specificity,
and there is no sound basis for
determining that such a restriction on ‘any
requirement’ exists.” Id.
Thus, on the state requirement
issue, Justice Breyer joined with the four-

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-18-
member dissent to make a majority.18 It
seems that he merely parted ways with
Justice O’Connor when it came time to
apply that rationale to the state common-
law claims (in a § 510(k) context) before
the Court.
Although in Lohr the plurality
opinion did not inform us of when
common law requirements may become
substantive requirements, we are satisfied
that Horn’s general state law claims19
would impose substantive requirements on
TCI that would conflict with, or add to,
the requirements imposed by the FDA
involved in the design, manufacturing,
fabrication and labeling of the HeartMate.
For example, Horn’s Complaint alleges
that the HeartMate was negligently
designed such that the screw ring could
come unscrewed in spite of the presence
of the suture. This claim unquestionably
would require TCI to alter the
HeartMate’s design by using either a
different suture or screw ring. Yet the
HeartMate’s design as approved by the
FDA would remain approved by the FDA
for national distribution and sale, and any
changes to the design would require
further FDA review and approval.20
18 This can be characterized as a
“dual majority” case because Justice
Breyer joined with the plurality on the
result (i.e., no pre-emption), but joined
with the dissent as to the rationale (i.e., a
state common law claim can be pre-
empted by § 360k even though it was not
specifically developed “with respect to” a
particular medical device). See Note, The
Precedential Value of Supreme Court
Plurality Decisions, 80 Colum. L. Rev.
756, 767-69 (1980) (discussing dual
majority cases).
19 Horn emphasized in her June
2004 Letter Brief at 7 that “the claims in
this case are based on state law claims of
general applicability, not requirements
specific to devices.”
20 The Product Liability Advisory
Council writes in its amicus curiae brief:
Even supposing one jury could
provide manufacturers with proper
incentives to make its products
safer, what about every jury? If the
PMA process does not preempt
state product liability suits [and
general common law claims]
imposing requirements at odds with
the approved PMA, then juries in
every state will influence device
regulation, in numerous and often
conflicting ways. See Brooks [v.
Howmedica, Inc.], 273 F.3d at 797
(“The arguments advanced by
Brooks ignore the need for national
uniformity in product regulation,
one of the explicit goals of the
MDA.” (citing H.R. Rep. No. 853,
45 (1976) (“If a substantial number
of dif fering requirements
applicable to a medical device are
imposed by jurisdictions other than
the Federal government, interstate
commerce would be unduly
burdened.”). Unless products
liability claims [and general

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-19-
As TCI has pointed out in its brief,
“[Horn’s] design defect claims . . . would
require TCI either to use an entirely
different design than the screw ring to
connect the outlet elbow to the pump, or
to use different materials instead of a
suture, or to place the eyelet in a different
position. Similarly, her failure-to-warn
claims would require TCI to provide
different warnings and instructions from
those approved by the FDA.” TCI Br. at
45. TCI is prohibited, however, by the
FDA’s PMA approval order from making
any such changes. See 21 C.F.R. 814.80.21
Because these state common law
claims and duties are in severe tension
with § 360k(a) in that they are either in
addition to, or different from, the federal
requirements established by the FDA in
approving the HeartMate, they are
necessarily preempted by federally
imposed PMA requirements under §
360k(a).22 See, e.g., Kemp, 231 F.3d at
common law claims] such as
plaintiff’s are preempted, the
FDA’s expert determinations will
be supplanted by a myriad of
common law regulators, each one
less likely than the FDA to reach a
right result.
21 21 C.F.R. § 814.80 provides that
a device may not be manufactured,
labeled, etc. in a manner inconsistent with
any conditions to approval specified in the
PMA approval order. TCI would have to
submit a supplemental PMA application
setting forth its proposed changes and
seeking FDA approval of those changes.
21 C.F.R. § 814.3a(d). If the FDA were to
reject TCI’s application, TCI would be left
in the untenable and unenviable position
of having to comply with conflicting state
and federal requirements; precisely the
conflict the § 360k(a) preemption
provision is meant to avoid.
2 2 Similarly, Horn’s claim
respecting TCI’s negligence in not
furnishing a ‘Dear Doctor’ letter “warning
that the heart pump shouldn’t be installed
if the sutures would face upward, toward
the sternum,” Horn, June 2004 Letter Br.
at 9, is preempted as it would either add
to, or differ from, the federal requirement
establishing the design of the HeartMate.
See Mitchell v. Collagen Corp., 126 F.3d
at 913-14 (“[T]o the extent that [the
Mitchells’ mislabeling, misbranding and
adulteration] allegations claim that
Collagen has incurred liability under state
law despite its conformity to the
requirements of the PMA, the state law
claims must be considered preempted.”).
Insofar as Horn’s claim is premised
on the adequacies of the warnings
reviewed and approved by the FDA in its
PMA approval order, it is also preempted.
See Martin, 105 F.3d at 1100 (“To allow
a state cause of action for inadequate
warnings would impose different
requirements or requirements in addition
to those required by federal regulations.”).
The PMA includes specimens of the
labeling proposed to be used for the
device, 21 U.S.C. § 360e(c)(1)(F), and this
labeling must provide “adequate directions
for use.” 21 U.S.C. § 352(f). Moreover,

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-20-
228-37; Mitchell, 126 F.3d at 911-15,
Papike, 107 F.3d at 741-42.
B. The FDA’s Position
Our preemption conclusion is
reenforced by the informed analysis found
in the FDA’s amicus curiae brief. The
FDA has clearly expressed its view that
PMA approval in this particular case
requires preemption. The FDA conceives
of Horn’s state common law claims as
imposing a “requirement” which is
“different” from that imposed by the FDA
in the PMA process, and thus requiring
preemption. In its Amicus Curiae Letter
Brief,23 the FDA wrote:
. . . Here, plaintiff
seeks to impose liability
based on asserted flaws in
the design, labeling and
m a n u f a c t u r e o f t h e
HeartMate as approved by
FDA despite the fact that it
comp l i e d w ith FDA
requirements. Thus,
plaintiff does attempt to
impose a requirement
d i f f e r e n t f r o m [ t h e
requirement imposed by]
FDA. . .
There is no allegation
that the HeartMate’s design,
labeling, or methods of
manufacture deviated from
those set forth in the PMA
a p p r o v e d b y F D A .
Accordingly, any finding of
liability based upon TCI’s
failure to satisfy a standard
different f r o m those
approved by FDA in the
P M A process would
necessarily rest upon an
implicit requirement that
this device be designed,
manufactured or marketed
in a way that differs from
the way approved by FDA.
(emphasis added).
With respect to the impact of state
common law tort claims on the federal
regulatory framework for medical devices,
the FDA wrote:
State common law
tort actions threaten the
statutory framework for the
regulation of medical
devices, particularly with
regard to FDA’s review and
approval of product
labeling. State actions are
not characterized by
c e n t r a l i z e d e x p e r t
evaluation of devic e
PMA approval expresses the FDA’s
determination that the proposed labeling
meets the detailed labeling requirements
set forth in its regulations. Any changes in
the design, labeling or manufacturing
processes that affect safety and
effectiveness must receive FDA approval.
23 FDA Amicus Curiae Letter Br. at
17-18.

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-21-
regulatory issues. Instead,
they encourage, and in fact
require, lay judges and
juries to second-guess the
balancing of benefits and
risks of a specific device to
their intended patient
population – the central role
of FDA – sometimes on
behalf of a single individual
or group of individuals.
T h a t i n d i v i d u a l i z e d
redetermination of the
benefits and risks of a
product can result in relief –
including the threat of
significant damage awards
or penalties – that creates
pressure on manufacturers
to add warnings that FDA
has neither approved, nor
found to be scientifically
required, or withdrawal of
FDA-approved products
from the market in conflict
with the agency’s expert
determination that such
products are safe and
effective. This situation can
harm the public health by
retarding research and
development and by
encouraging ‘defensive
labeling’ by manufacturers
to avoid state liability,
resulting in scientifically
unsubstantiated warnings
and underutilization of
beneficial treatments.
Id. at 25-26.24
The FDA’s views in its Amicus
Curiae Letter Brief in this case echo the
opinion it has voiced in another recent
case. In a brief submitted to the Circuit
Court of Tennessee in Murphree v.
Pacesetter, Inc., et al., the FDA expressed
concerns about the consequences of not
preempting state common law claims such
as Horn’s:
[I]t is inappropriate
for a jury to second-guess
FDA’s scientific judgment
on such a matter that is
within FDA’s particular
expertise. FDA determines
the scope of a device,
including the components it
c o m p r i s e s , a n d t h e
appropriate regulatory
pathway for the device. . . .
F D A s u b s e q u e n t l y
determines whether the
device meets the PMA
approval standard. The
agency makes a reasoned
and deliberate decision as to
24 Martin v. Telectronics Pacing
Sys., Inc., 105 F.3d 1090 (6th Cir. 1997)
(“Thus, because under the federal
requirement the FDA has determined that
the benefits of the device outweigh the
risks and, under the state requirement, a
jury in a state court action could conclude
that the risks outweigh the benefits, the
state requirement is different from the
federal requirement.”).

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-22-
the correct pathway of
regulation and whether to
approve the device. Juries
l a c k t h e s c i e n t i f i c
knowledge and technical
expertise necessary to make
such judgments. . . .
[T]he prospect of
hundreds of individual
juries determining the
propriety of particular
device approvals, or the
appropriate standards to
apply to those approvals, is
the antithesis of the orderly
scheme Congress put in
place and charged the FDA
with implementing.
Such uncertainty as
to the status of medical
devices would create chaos
for both the regulated
industry and FDA.
Statement of Interest of the United States
of America at 7-9, Murphree v.
Pacesetter, Inc. et al, No. 005429-00-3
(Tenn. Circuit Ct. Dec. 12, 2003).
As we discussed earlier, a majority
of the Court in Lohr emphasized that the
FDA is “uniquely qualified” to determine
whether a particular form of state law . . .
should be pre-empted” by § 360k. Lohr,
518 U.S. at 496. Horn contends, however,
that we should give no weight to the
FDA’s interpretation because the FDA
previously argued that PMA approval did
not support preemption, and in any event,
the FDA’s interpretation is entitled only to
“near indifference.” See Dissenting Op.
fn.2 and Maj. Op. fn.12, supra. We
cannot agree that the FDA’s position is
entitled to no deference, or “near
indifference” simply because it represents
a departure from its prior position. In
Chevron U.S.A. Inc. v. Natural Resources
Defense Council, Inc., 467 U.S. 837, 863-
64 (1984), the Supreme Court held that a
revised interpretation by an agency is
entitled to deference because “[a]n initial
agency interpretation is not instantly
carved in stone.” Accordingly, an agency
may change its course so long as it can
justify its change with a “reasoned
analysis,” see Motor Vehicle Mfrs. Ass’n v.
State Farm Mut. Auto. Ins. Co., 463 U.S.
29, 42 (1983), and we are fully persuaded
that this standard has been met.25
V.
25 See United States v. Mead Corp.,
533 U.S. 218, 228 (2001) (“The weight
accorded to an administrative judgment in
a particular case will depend upon the
thoroughness evident in its consideration,
the validity of its reasoning, its
consistency with earlier and later
pronouncements, and all those factors
which give it power to persuade, if lacking
power to control.”) (internal citations and
quotations omitted).

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-23-
Horn has not asserted that TCI has
in any way failed to conform with the
FDA
requirements prescribed by its PMA—nor
that it deviated from, or violated, any of
the FDA’s federal statutes or regulations.
Because the design of the HeartMate, the
labeling and the instructions for its use,
and the specification of the suture and its
location when the HeartMate is implanted,
as well as the other requirements imposed
by the PMA, were the subject of extensive
consideration by the FDA leading up to its
PMA approval, any finding in Horn’s
favor based on her general claims of
negligence or defective design and
manufacture—be it by a jury or a
court—would necessarily amount to a
state substantive requirement “different
from, or in addition to, the federal
requirements imposed by the FDA.” Any
such finding would “stand as an obstacle
to the accomplishment and execution of”
the objective of the safety and
effectiveness of the HeartMate specifically
and would conflict with the federal
requirements imposed by the PMA. Geier
v. American Honda Motor Co., 529 U.S.
861, 873 (2000).
If, as we hold, the FDA’s express
preemption clause found at 21 U.S.C. §
360k(a) pre-empts Horn’s state law
claims, then there is no point in discussing
“implied preemption,” a doctrine which
our dissenting colleague addressed at
length in an attempt to bolster his
conclusion that Lohr, a § 510(k) opinion,
governs this case. See Cipollone v.
Liggett Group, Inc., 505 U.S. 504 (1992)
(“When Congress has considered the issue
of pre-emption and has included in the
enacted legislation a provision explicitly
addressing that issue, and when that
provision provides a reliable indicium of
congressional intent with respect to state
authority, there is no need to infer
congressional intent to pre-empt state laws
from the substantive provisions of the
legislation.”) (citations and internal
quotations omitted). We therefore do not
address the dissent’s arguments predicated
on “implied preemption.”
As a consequence we, together with
our sister Courts of Appeal who have read
Lohr in the same fashion as we have,26 and
together with the FDA’s current position,
hold that Horn’s claims are preempted by
§ 360k(a). We will affirm the judgment of
the District Court granting summary
judgment to TCI.
26 See Brooks v. Howmedica, Inc.,
273 F.3d 785 (8th Cir. 2001); Martin v.
Medtronic, Inc., 254 F.3d 573 (5th Cir.
2001); Kemp v. Medtronic, Inc., 231 F.3d
216 (6th cir. 2000); Mitchell v. Collagen
Corp., 126 F.3d 902, 913-14 (7th Cir.
1997); Papike, 107 F.3d 737, 742 (9th Cir.
1997).

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-24-
Barbara E. Horn v. Thoratec Corporation,
No. 02-4597
FUENTES, Circuit Judge, dissenting.
Following her husband’s death,
Barbara Horn filed a lawsuit in the U.S.
District Court, under state common law,
alleging that her husband died as a result
of TCI’s defectively designed heart pump.
In her complaint, she alleges that the
suture on Mr. Horn’s HeartMate had worn
through and that the screw ring linking the
pump to the output side had disconnected.
As a result, an air embolus traveled to Mr.
Horn’s brain, causing his death. The
majority has concluded that Horn’s
common-law claims, grounded in
negligence and defective design, create
“specific requirements” under state law
and are therefore preempted by § 360k(a)
of the MDA. I cannot agree, however, that
Horn’s generalized common-law claims
i m p o s e a n y s p e c i f i c s t a t e - l a w
“requirements” on the HeartM ate. This is
because § 360k(a) preemption works only
against state requirements that are
“different from, or in addition to” federal
requirements. In my view, because Horn’s
suit is not seeking to impose any specific
requirement on the HeartMate, it is not
preempted. Additionally, I believe that
allowing common-law liability would
simply have the effect of encouraging TCI
and other device manufacturers to go
above and beyond FDA standards, and this
effect would clearly not contradict the
MDA’s purpose of enhancing medical
device safety. I therefore respectfully
dissent.
I.
I have no quarrel with the
majority’s conclusion that the PMA
process is a specific federal regulation
governing the HeartMate.27 I believe,
however, that the District Court erred by
looking only at whether the federal
regulation here (the PMA) was specific to
a particular device, and not examining
whether the state law under which Horn
sued was device-specific. Horn argues
that a state common-law claim is
preempted only if the state claim is device-
specific and the purportedly preempting
federal regulation is device-specific. TCI
responds that the District Court correctly
analyzed only the federal side of the
equation, because Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996), made that the only
relevant inquiry. The Circuits are split on
this question, with the Seventh and Ninth
Circuits holding that preemption requires
only a device-specific federal regulation,
Mitchell v. Collagen Corp., 126 F.3d 902,
912 (7th Cir. 1997); Papike v. Tambrands
Inc., 107 F.3d 737, 742 (9th Cir. 1997);
and the Tenth Circuit holding that
27 For this reason, the majority’s
discussion of the difference between the
PMA process and the § 510k “substantial
equivalence” process is not relevant. Maj.
Op. at 13. That difference only speaks to
why the PMA process is a specific federal
requirement; my disagreement with the
majority is not over the federal side of the
equation at all, but rather over whether
Horn’s suit implicates the state-law
specificity requirement in Lohr.

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-25-
preemption additionally requires a device-
specific state law. Oja v. Howmedica,
Inc., 111 F.3d 782, 789 (10th Cir. 1997).
Although my colleagues acknowledge
some kind of state-law specificity
requirement, they effectively agree with
the Seventh and Ninth Circuits in holding
that even the most generalized tort claims,
such as those in the case before us, are
preempted under § 360k(a).
I respectfully dissent from this
conclusion. The FDA regulations
concerning preemption clarify that
preemption only occurs when the FDA
“has established specific counterpart
regulations or there are other specific
requirements applicable to a particular
device under the act.” 21 C.F.R. §
808.1(d) (emphasis added). The
preemption clause does not “preempt State
or local requirements of general
applicability where the purpose of the
requirement relates either to other products
in addition to devices (e.g., [the UCC]) or
to unfair trade practices in which the
requirements are not limited to devices.”
21 C.F.R. § 808.1(d)(1) (emphasis added).
In 1996, the Supreme Court issued
Lohr, a fractured opinion that examined
MDA preemption of state law. The
majority of the Lohr Court agreed that a
strong presumption exists in favor of a
narrow scope of preemption because
policing health is the traditional province
of the states. 518 U.S. at 485. Another
key factor in analyzing the scope of
preemption is Congress’s intent in passing
the legislation. Id. at 485-86. The Court
split, however, as to whether the MDA
preempted state common-law claims
premised on the unsuitability of a medical
device under state standards more stringent
than the FDA standards governing the
device. Justice Breyer agreed with a four-
Justice bloc (Stevens, Kennedy, Souter and
Ginsburg) that the term “requirement” in §
360k(a) is ambiguous, and does not entail
the preemption of all common-law tort
suits holding manufacturers to higher
standards than the FDA. Id. at 488-89
(Stevens, J., plurality (hereinafter
“plurality”))28; id. at 505-06 (Breyer, J.,
concurring (hereinafter “Breyer”)). The
remaining four Justices disagreed, opining
that § 360k(a) bars all state-law claims,
common-law or otherwise, that hold
manufacturers to a higher standard than
federal regulations. Id. at 511-12
(O’Connor, J., concurring in part and
dissenting in part (hereinafter “dissent”)).
The plurality and Justice Breyer
turned to the above-quoted FDA
regulations to help determine when a
common-law claim constitutes a state
“requirement” under § 360k(a). Id. at 498-
99; id. at 505-06 (Breyer). Relying on
these regulations, the five Justices
concluded that preemption is only
triggered by specific FDA regulations
applying to a particular device, and not by
28 To be precise, I will only use the
term “plurality” in reference to portions of
Justice Stevens’s opinion in Lohr that
were joined by only four Justices. The
portions of the Lohr opinion joined by five
Justices will not be accompanied by any
parenthetical reference.

-- 26 of 33 --

-26-
generally applicable FDA regulations, i.e.,
those governing the design or labeling of
medical devices as a whole. Id. at 500-01.
Part V of the plurality opinion, which
Justice Breyer joined, also stated that the
MDA does not preempt generalized state-
law claims, such as negligence in
manufacturing or failure to warn, as
opposed to state laws governing particular
medical devices. Id. at 501-02.
Thus, Part V of the Lohr opinion,
which represents the views of five
Justices, excepted generalized common-
law claims like failure to warn and
negligent manufacture from the ambit of
MDA preemption. Id. at 501-02. The
Lohr majority reasoned that “general state
common-law requirements” that “were not
specifically developed ‘with respect to’
medical devices . . . are not the kinds of
requirements that Congress and the FDA
feared would impede the ability of federal
regulators to implement and enforce
specific federal requirements.” Id. at 501.
Here, Horn’s four claims of negligence,
strict liability, breach of warranty and
failure to warn are all general common-
law tort claims that were not crafted
specifically to govern medical devices, and
so are excepted from the scope of §
360k(a).
This conclusion is bolstered by the
FDA regulations on preemption, relied
upon by the Lohr majority. As mentioned
above, the FDA has declared that
preemption only occurs when the FDA
“has established specific counterpart
regulations or there are other specific
requirements applicable to a particular
device under the act.” 21 C.F.R. §
808.1(d) (emphasis added). The
regulations go on to say that “there are
other State and local requirements that
affect devices that are not preempted by [§
360k(a )] b e c a u s e t h e y a r e n ot
‘requirements applicable to a device’
within the meaning of [§ 360k(a)],” id.,
and lists as an example “State or local
requirements of general applicability
where the purpose of the requirement
relates either to other products in addition
to devices (e.g., [the UCC]) or to unfair
trade practices in which the requirements
are not limited to devices.” 21 C.F.R. §
808.1(d)(1). This reference to the
specificity of state regulations would be
superfluous if all that mattered was the
specificity of the federal regulation.
Moreover, the exemption of generalized
state requirements is never qualified by the
further condition that those requirements
infringe on a generalized federal
requirement. Finally, the regulations belie
my colleagues’ conclusion that generalized
state requirements can be preempted if
they merely affect the manufacture of
medical devices. See Maj. Op. at 16-18
(state-law claim is preempted if it has the
effect of imposing a greater burden on a
device manufacturer than the FDA). In
short, the regulations support the view that
state-level device-specificity is a requisite
for § 360k(a) preemption.
TCI argues that the FDA has
published regulations contravening the
state specificity requirement, but the cited
regulations only state that in the context of
a particular California law “general

-- 27 of 33 --

-27-
requirements not applicable to specific
devices . . . are not preempted unless they
are applied to a specific device in such a
way as to establish requirements” for an
FDA-regulated device. 45 Fed. Reg.
67321, 67322. Thus, general requirements
are still not preempted under this
regulation; the only state requirements that
are preempted are ones that affect specific
devices. Even if TCI’s interpretation of
this statement were correct, one isolated
statement in the Federal Register would
not trump the actual regulations contained
in the C.F.R., especially when those
regulations have been adopted by the
Supreme Court as instructive.29
The main argument against the state
specificity requirement rests in the
language of Justice Breyer’s concurrence
in Lohr. After joining Part V of the
Stevens opinion, Justice Breyer wrote
separately that common-law claims could
in fact be preempted where they imposed
different standards for devices than the
c o u n terpart d e v i c e -s p e c if i c F DA
regulations. Lohr, 518 U.S. at 504
(Breyer). Justice Breyer raised the
example of a jury finding for a plaintiff in
a negligence suit on the grounds that a
hearing aid wire was longer than 1 inch,
even though FDA regulations had
approved wires up to 2 inches. Id. Justice
Breyer concluded that this jury award
would be preempted even though it was
based on the generalized state tort law of
negligence because it effectively
established a device-specific state
requirement of 1-inch wires for hearing
aids. Id.
My colleagues have found this
language from Justice Breyer difficult to
reconcile with his agreement with Part V
of the majority opinion, which exempted
generalized state causes of action from
preemption. Maj. Op. at 16. The Seventh
and Ninth Circuits also perceived a
contradiction and chose to ignore Justice
Breyer’s vote for Part V, instead crediting
the apparently contrary reasoning in his
concurrence. Mitchell, 126 F.3d at 912;
Papike, 107 F.3d at 742. With all due
respect to my colleagues and these two
Circuit Courts, however, I do not believe
that Justice Breyer’s concurrence is in
disagreement with Part V of the majority
29 My colleagues seem to put great
emphasis on the FDA’s amicus brief,
which sides with TCI. Horn and Amicus
Product Liability Advisory Council have
also both advanced arguments from
previous United States briefs on the scope
of 360k(a) preemption as evidence in
favor of their views on preemption. As
TCI has itself pointed out, however,
arguments advanced by the United States
in a litigation brief are entitled to “near
indifference,” and are only as persuasive
as their own merits dictate. United States
v. Mead Corp., 533 U.S. 218, 228 (2001)
(cited in TCI Br. at 52). Notably, the Lohr
court gave deference to the FDA’s
regulations in particular, not to an amicus
brief. 518 U.S. at 495-96. Consequently,
I believe that Lohr mandates that we obey
the regulations issued by the FDA, rather
than the amicus brief relied upon by the
majority.

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-28-
opinion.30 Justice Breyer’s opinion shows concern that in certain situations a state
could fashion, through its common law, a
specific requirement for a particular
device. For example, a plaintiff could sue
under a theory of negligence per se, where
the negligence is premised on deviation
from a specific state requirement for a
device (like a 1-inch hearing aid wire).
Similarly, a judge could give a jury
instruction telling the jury that, as a matter
of law, it should find a manufacturer
negligent if it violated a certain standard
for a device (i.e., “you should find the
manufacturer negligent if it used a hearing
aid wire longer than 1 inch”). Both of
these examples involve a specific
requirement being imposed upon a device
by the state through its common law. A
simple negligence action, in contrast, does
not impose any specific requirement on the
device, but simply alleges that the device
was designed/manufactured improperly.
In this case, because Horn’s suit is
not seeking to impose any specific
requirement on the HeartMate, it is not
preempted. It is true that Horn’s cause of
action may have the indirect consequence
of holding the HeartMate to a higher
standard than does the FDA, but this
consequence is sanctioned by Part V of the
Lohr opinion and not expressly barred by
Justice Breyer’s concurrence. Moreover,
even if my colleagues were correct that the
content of Justice Breyer’s concurrence
3 0 My colleagues find it
incongruous that Justice Breyer would
“write separately to emphasize that duties
arising under state law can regularly lead
to preemption, but simultaneously agree
with the plurality that tort duties are
almost always too general to warrant
preemption.” Maj. Op. at 16. Not only is
this an overstatement of Justice Breyer’s
language (“I am not convinced that future
incidents of MDA pre-emption of
common-law claims will be ‘few’ or
‘rare’”), it also depicts a false conflict: the
plurality expressed its views on the
frequency of preemption in Part VI of its
opinion, which Justice Breyer explicitly
refused to join. Lohr, 518 U.S. at 508
(Breyer). Indeed, the fact that Justice
Breyer explicitly declined to join Part VI
of the majority opinion highlights his clear
intent to join Part V in full. Similarly, the
majority somehow turns Justice Breyer’s
agreement with the Lohr dissent that “the
MDA will sometimes pre-empt a state-law
tort suit,” id. at 503 (Breyer) (emphasis
added)–a statement that I entirely agree
with–into an agreement with the Lohr
dissent’s statement that there is no state-
law specificity requirement whatsoever.
Id. at 512 (dissent) (quoted in Maj. Op. at
17). To the contrary, Justice Breyer
endorsed a state-law specificity
requirement by joining Part V of Justice
Stevens’s opinion, and this requirement
therefore “enjoys the assent of five
Justices.” Marks v. United States, 430
U.S. 188, 192-93 (1977). Accordingly,
the “narrowest ground” approach evoked
by the majority is simply inapplicable to
evade the holding of Part V of the Lohr
opinion.

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-29-
contradicted Part V, the correct course of
action would be to follow Part V as the
majority opinion of the Supreme Court,
not to elevate a one-justice concurrence
above the five-justice majority. Cf.
Alexander v. Sandoval, 532 U.S. 275, 285
n. 5 (2001) (concurrence is not given as
much precedential weight as majority
opinion, even if concurrence is compatible
with majority opinion).
Finally, even if Justice Breyer’s
concurrence were given equal weight to
Part V, this jurisprudential “tie” should be
broken by reference to the presumption
against a wide scope of preemption. Lohr,
518 U.S. at 485. TCI argues that this
presumption has since been discarded.
However, all of the cases TCI cites for that
proposition either (1) fou nd th e
presumption irrelevant because the
language was clear, Sprietsma v. Mercury
Marine, 537 U.S 51, 62-63 (2002); Crosby
v. National Foreign Trade Council, 530
U.S. 363, 374 n. 8 (2000); or (2) found the
presumption inapplicable to the particular
statute in question because it did not deal
with a traditional province of state law,
Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 347 (2001); United States v.
Locke, 529 U.S. 89, 108 (2000). In
conclusion, I would follow Part V of the
Lohr opinion, as I feel we are bound to do,
and hold that a state common-law claim is
preempted only if it establishes a specific
requirement for a particular device, rather
than alleging breach of a generalized duty
of care. Accordingly, the District Court’s
finding of express preemption should be
reversed.31
II.
Because I would find no express
preemption here, I would reach TCI’s
implied preemption argument, and
conclude that Horn’s claims are not
impliedly preempted. Implied preemption
can exist in either of two situations: (1)
when Congress intended federal law to
31 TCI suggests in passing that Part
V does not actually require state-level
device-specificity, relying on the sentence:
“Although we do not believe that this
statutory and regulatory language
necessarily precludes ‘general’ federal
requirements from ever pre-empting state
requirements, or ‘general’ state
requirements from ever being preempted,
. . . it is impossible to ignore its
overarching concern that pre-emption
occur only where a particular state
requirement threatens to interfere with a
specific federal interest.” Lohr, 518 U.S.
at 500. This quoted language, however,
only states that the relevant statutory and
regulatory texts do not compel the state-
level specificity requirement, but that the
Lohr majority inferred the state-specificity
requirement from that language. Part V
later makes it clear that state-level
specificity is in fact a requirement for
preemption. Id. at 502 (“These state
requirements therefore escape pre-
emption, . . . because their generality
leaves them outside the category of
requirements that §360k envisioned to be
‘with respect to’ specific devices”).

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-30-
occupy an entire field of law exclusively
(“field preemption”), or (2) when state law
actually conflicts with federal law
(“conflict preemption”). E.g., Freightliner
Corp. v. M yrick, 514 U.S. 280, 287
(1995). Conflict preemption can in turn be
shown in two ways: (1) it is impossible for
a party to comply with both federal and
state requirements, or (2) the state law
frustrates Congressional intent. Id. Here,
the only implied preemption claim at issue
is the frustration prong of conflict
preemption: TCI and Amicus Curiae U.S.
Chamber of Commerce (“USCC”) do not
argue that field preemption or
impossibility conflict preemption apply.
Since there is no express language
to rely on in a frustration conflict
preemption analysis, the key factor to
consider is, unsurprisingly, Congressional
purpose. E.g., Barnett Bank of Marion
County, N.A. v. Nelson, 517 U.S. 25, 31
(1996). As the Lohr court observed, the
purpose of the MDA was to protect
consumers by ensuring the safety and
effectiveness of medical devices. Lohr,
518 U.S. at 476. Contrary to USCC’s and
PLAC’s assertions, protection of the
medical device industry from excessive
regulation was a minimal concern. Id. at
490-91 (plurality); see also id. at 476
(MDA was motivated by concern on the
part of consumers and regulators, not
industry). The plurality specifically
disclaimed the idea of a Congressional
“fear that product liability actions would
hamper the development of medical
devices.” Id. at 490 (plurality).32 This
clearly pro-regulatory, pro-consumer
safety purpose of the MDA compels the
conclusion that state common-law suits are
not impliedly preempted by the MDA.
This conclusion is supported by the
presumption in favor of a narrow scope of
preemption, mentioned above. Moreover,
although the presence of an express
preemption clause (§ 360k(a)) does not
conclusively rule out implied preemption,
it does imply that “Congress did not intend
to pre-empt other matters.” Myrick, 514
U.S. at 288.
None of TCI’s or USCC’s
arguments are persuasive toward finding
implied preemption here. TCI relies on
Buckman, 531 U.S. at 350, for the
proposition that the MDA allows for
implied preemption. Buckman, however,
found implied preemption of a state-law
claim that the defendant had defrauded the
FDA by sending it false § 501(k)
equivalency information. Id. at 343. The
conflict in Buckman existed because the
MDA had given the FDA full power and
discretion to remedy acts of fraud
perpetrated on it; a state-law suit seeking
to prosecute fraud against the FDA would
necessarily conflict with the FDA’s
discretionary decision to forego a fraud
prosecution against itself. Id. at 349.
32 Justice Breyer did not join the
plurality’s detailed discussion of statutory
purpose because he found it unnecessary
for analysis of the case; he made no
statement agreeing or disagreeing with it.
Id. at 508 (Breyer).

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-31-
Indeed, the Buckman court distinguished
fraud-on-the-agency claims from suits
based on “traditional state tort law
principles of the duty of care,” which are
the principles involved in this case. Id. at
352.
TCI’s other argument, echoed by
USCC, is that allowing state-law tort suits
conflicts with federal law because it allows
juries to second-guess the FDA’s
determination that the PMA-approved
device is safe. There is not necessarily any
conflict, however, between the FDA’s
allowing TCI to market the HeartMate and
a state finding that the HeartMate is
unsafe: the natural way to reconcile these
two positions is to see the PMA process as
a “floor” of minimum standards for Class
III devices, but not a “ceiling.” Under this
view, a state could still raise the standards
of safety within its own jurisdiction. Cf.
Barnett Bank, 517 U.S. at 31 (federal law
permitting banks to sell insurance in small
towns does not necessarily conflict with
state law banning such sales, since federal
law could be read as permitting sales to the
extent that they are permitted by state law).
USCC argues that while Barnett
Bank recognized that there was not
necessarily a contradiction between federal
permission and state prohibition of a
practice, Barnett Bank produced a bright-
line rule that federal permission to engage
in a practice preempts state law liability
incurred by engaging in that practice.
Accordingly, USCC concludes, the FDA’s
permission to market HeartMate triggers
frustration conflict preemption against
Horn’s suit declaring that the HeartMate is
d e s i g n e d d e f e c t i v e l y . U S C C
mischaracterizes Barnett Bank, however:
the Supreme Court did not lay down any
blanket rule on frustration conflict
preemption, but merely followed the
normal procedure of looking to the
legislature’s intent to determine if
frustration conflict preemption existed.
Id. at 32-37. The Barnett Bank court
concluded that a federal statute permitting
banks to sell insurance in small towns
preempted a state statute banning such
sales because the purpose behind the
federal statute was to empower banks. Id.
Here, in contrast, the MDA was not
created to empower industry, but to protect
consumers by ensuring safe devices. Thus,
the conflict that existed in Barnett
Bank does not exist here.
The instant case is a lso
distinguishable from Barnett Bank in that
Barnett Bank dealt with a state’s outright
statutory ban of a permitted practice, while
there is no corresponding ban here (i.e.,
the state of Pennsylvania outlawing heart
pumps). In this case, TCI is not prohibited
from marketing the HeartMate, but must
simply live with the possibility of liability
if the HeartMate does not live up to
Pennsylvania’s applicable standards of
care. Although the risk of liability may
admittedly be a deterrent to TCI’s
marketing efforts, the Supreme Court has
held that the incidental regulation incurred
by liability under generally applicable state
law is less intrusive, and therefore less
prone to preemption, than “direct
regulation on the operation of federal

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projects.” Goodyear Atomic Corp. v.
Miller, 486 U.S. 174, 185-86 (1988).
USCC also cites to Pokorny v. Ford
Motor Co., 902 F.2d 1116, 1123-25 (3d
Cir. 1990), to support its proffered bright-
line rule that federal permission to engage
in a practice preempts state law liability
incurred by engaging in that practice.
Pokorny, however, is distinguishable for
the same reason as Barnett Bank: the
purpose behind the federal regulation in
Pokorny was specifically to give
automobile manufacturers flexibility to
choose to equip their automobiles with
manual safety belts instead of automatic
belts and/or airbags. Id. As Horn points
out, the Pokorny court rejected the
manufacturer’s claim that the regulation
also preempted a claim based on a lack of
protective netting, because there was no
evidence that Congress or the Department
of Transportation contemplated protective
netting when the regulation was
promulgated. Id. at 1126. Indeed, the
Pokorny court allowed common-law
liability as a permissible way for the state
to “‘encourage’ automobile manufacturers
to provide safety features in addition to
those listed in” the federal regulation. Id.
Similarly, in the instant case, allowing
common-law liability would simply have
the effect of encouraging TCI and other
device manufacturers to go above and
beyond FDA standards, and this effect
would clearly not contradict the MDA’s
purpose of enhancing medical device
safety.33
IV.
Five Justices of the Supreme Court
have joined an opinion that requires
specificity of state claims in addition to
specific federal requirements for the
triggering of preemption under the MDA.
Specificity of state claims is also mandated
by the applicable FDA regulations, to
which we must show deference. My
colleagues, however, have rejected both
the binding instructions of the Supreme
Court in Lohr and the FDA regulations
based on their perception of a single
Justice’s opinion in Lohr and the FDA’s
current litigation position, to which we
owe no deference. Accordingly, I must
respectfully dissent.
33 Of course, this only shows that
common-law liability is in no way
impliedly preempted by the MDA;
obviously, the express preemption clause
does preempt some common-law liability
for state standards above and beyond FDA
standards.

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