# Horn v. Thoratec Corp

> Court of Appeals for the Third Circuit · July 20, 2004

URL: https://www.frixlaw.com/law-library/cases/3013968

## Case

- **Court:** Court of Appeals for the Third Circuit
- **Decided:** July 20, 2004
- **Precedential status:** Published
- **Opinion:** Opinion
- **Cited by:** 0 later opinions in the Frix Law Library

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## Opinion text

Opinions of the United
2004 Decisions States Court of Appeals
for the Third Circuit

7-20-2004

Horn v. Thoratec Corp
Precedential or Non-Precedential: Precedential

Docket No. 02-4597

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Recommended Citation
"Horn v. Thoratec Corp" (2004). 2004 Decisions. Paper 434.
http://digitalcommons.law.villanova.edu/thirdcircuit_2004/434

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PRECEDENTIAL Allison Zeive (Argued)
Public Citizen Litigation Group
UNITED STATES COURT OF 1600 20 th Street, N.W.
APPEALS Washington, D.C. 20009
FOR THE THIRD CIRCUIT
__________ John M. Humphrey
Rieders, Travis, Mussina, Humphrey,
No. 02-4597 Harris, Waters & Waffenschmidt
__________ 161 West Third Street
P.O. Box 215
BARBARA E. HORN, Executrix Williamsport, PA 17703
of the Estate of Daniel Ray Horn,
Deceased, Attorneys for Appellant Barbara E. Horn

Gary A. Winters
Appellant Mayer, Brown, Rowe & Maw
1909 K Street, N.W.
v. Washington, D.C. 20006

THORATEC CORPORATION. Alan E. Untereiner (Argued)
__________ Robbins, Russell, Englert, Orseck &
Untereiner LLP
On Appeal from the United States 1801 K Street, N.W., Suite 411
District Court Washington, D.C. 20006
for the Middle District of Pennsylvania
Civil Action No. 00-CV-00779 Charles W . Rubendall, II
District Judge: Honorable James F. Keefer, Wood, Allen & Rahal
McClure, Jr. 210 Walnut Street
__________ P.O. Box 11963
Harrisburg, PA 17108-1963
Argued on
December 11, 2003 Arnd N. von Waldow
___________ Reed Smith
435 Sixth Avenue
Before: AMBRO, FUENTES, and Pittsburgh, PA 15219
GARTH, Circuit Judges
Attorneys for Appellee Thoratec
(Opinion Filed: July 20, 2004) Corporation

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

-1-
connects the pump to the aorta. The which Dr. Benjamin Sun discovered that
connection between the pump and the the suture on Mr. Horn’s HeartMate had
tube, called the “elbow,” is worn off and the screw ring linking the
pump to the output side elbow had
inserted into an adapter conduit, which is
disconnected. The disconnection had
screwed into the open port of the pump. A
allowed an air embolus to travel to Mr.
screw ring is secured over the elbow to
Horn’s brain. Although Dr. Sun
ensure that it remains connected to the
reconnected the screw ring and once again
adapter conduit and the pump. A suture is
linked the pump to the elbow, it was too
tied over the screw ring and secured to the
late. Mr. Horn suffered a brain
adapter conduit to ensure it will not
hemorrhage, and he was rendered brain
rotate.3 The HeartMate was approved by
dead. On May 8, 1998, his organs were
the FDA pursuant to the Pre-Market
donated for transplant and he was
Approval (“PMA”) process set forth at 21
pronounced dead.
U.S.C. § 360e(c) (discussed in depth,
infra). On April 28, 2000, Horn filed a
Complaint against TCI in the United
On January 17, 1998, Horn’s
States District Court for the Middle
husband, Daniel Horn, was admitted to
District of Pennsylvania. The Complaint
Williamsport Hospital suffering a heart
alleged defective design and manufacture
attack. He was later transferred to
of the HeartMate and failure to warn of
Hershey Medical Center. Doctors there
the alleged defects; it was based on Horn’s
determined that Mr. Horn required a heart
claim that the HeartMate’s output side
transplant, and they waited for a suitable
elbow was defectively designed. TCI
donor heart to become available. On
moved for summary judgment, arguing
January 22, 1998, Mr. Horn’s condition
that Horn’s state law claims are expressly
deteriorated and a HeartMate was
preempted by 21 U.S.C. § 360k(a).
implanted in him to provide circulatory
support. He was then transferred to an The District Court granted TCI’s
assisted living facility. motion on November 7, 2002, holding that
Horn’s state common law claims were
On May 3, 1998, Mr. Horn began
preempted. The District Court applied a
to bleed from the spot where the
two-prong test endorsed by the Sixth and
HeartMate tube exited his body.
Eleventh Circuits,4 which instructs that a
Thereupon, he underwent exploratory
state claim attacking the safety of a
surgery at Hershey Medical Center, during

3 4
The HeartMate arrives at the See Kemp v. Medtronic, Inc., 231
surgeon pre-assembled. The surgeon need F.3d 216, 224-25 (6th Cir. 2000); Goodlin
not manipulate the screw ring or suture v. Medtronic, Inc., 167 F.3d 1367, 1371
when he implants the HeartMate. (11th Cir. 1999).

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

-3-
device, and 15. . . . The continual
pumping action of the TCI
HeartMate, together with
(2) which relates to the natural body movements,
safety or effectiveness of caused the wearing away of
the device or to any other the suture so placed, and
matter included in a once the suture was worn
requirement applicable to through, said movement of
the device under this the pump caused the screw
chapter. ring to become unscrewed.
In this case, Horn contends that her
state common law claims would impose
16.Had the screw ring been
generally applicable duties to use good
of an appropriate and
care in manufacturing and to warn users of
feasible design which would
the product’s attendant risks. They would
not permit the screw ring to
not, she argues, impose specific
become unscrewed as a
requirements with respect to the
result of pump movement,
HeartMate. Paragraphs 15 and 16 of
or had something more
Horn’s Complaint set forth the gravamen
durable than a suture been
of her action as follows:5
used to secure the tightened
screw ring, or had the
5
The FDA has summarized Horn’s threaded sleeve with the
claims in the following manner: eyelet been placed in such a
way that the retaining suture
[P]laintiff makes two main did not run across the
claims: first, that TCI interior portion of the screw
should have employed a
[suture] design to prevent
the screw rings used to hold the product labeling or
the device in place inside correspondence to health
the patient’s chest from care professionals
becoming disconnected (commonly called “Dear
(plaintiff asserted that TCI Doctor letters”), against
overlooked better using the device if the
alternatives to the design it suture as placed in the
chose); [and] second, that device packaging would
TCI should have issued face the patient’s sternum.
warnings to docto rs,
through either revisions in FDA Amicus Curiae Letter Br. at 4-5.

-4-
ring directly beneath the A manufacturer can
underside of the sternum, obtain an FDA finding of
the disconnection which ‘substantial equivalence’ by
ultimately caused Mr. submitting a pre-market
Horn’s death would never notification to the agency in
have occurred. accordance with Section
510(k) of the [Act]. 21
U.S.C. § 360(k). A device
TCI responds that Horn’s state common found to be ‘substantially
law claims would impose state equivalent’ to a predicate
requirements that are specifically device is said to be ‘cleared’
applicable to the HeartMate, and as such by FDA (as opposed to
are expressly preempted. ‘approved’ by the agency
under a PMA). A pre-
Horn relies on Medtronic v. Lohr,
market notificatio n
518 U.S. 470 (1996), a Supreme Court
submitted under Section
case which involved the FDA’s approval
510(k) is thus entirely
of a pacemaker. In that case, which we
different from a PMA,
discuss in more detail later, the FDA’s
which must include data
approval of the device did not result in
sufficient to demonstrate to
preemption of the plaintiff Lohr’s state
FDA that the device is safe
law claims because the approval process
and effective. See Lohr,
involved in that case was not the same
518 U.S. at 478-79 (“The §
detailed approval process that was
510(k) notification process
employed by the FDA to approve the
is by no means comparable
HeartMate. In Lohr, the FDA determined
to the PMA process.”).
that the pacemaker was “substantially
equivalent” to an existing FDA-approved
device pursuant to § 510(k) of the Act,
The number of
and therefore did not undergo the far more
medical devices that receive
thorough and rigorous PMA approval
PMA review each year is
process under § 360e(c) of the Act. It was
dwarfed by the number of
this latter type of approval that the
those that are marketed
HeartMate received.
pursuant to cleared Section
The FDA, in its Amicus Curiae 510(k). In fiscal year 2003,
Letter Brief to this Court, contrasted the § for example, original PMAs
510(k) “substantial equivalence” approval represented only 54 of the
process with the § 360e(c) PMA process 9,872 major submissions
as follows: received. The previous
fiscal year, original PMAs

-5-
accounted for 49 of 10,323 of implied warranty of merchantability and
total submissions. 6 fitness for a particular purpose, breach of
express warranty, and fraud on the FDA.
Id. at 1321. The heart valve manufacturer
As it concerns the HeartMate, TCI argued that the Act preempted all of the
contends that because it received FDA plaintiff’s claims. Id. at 1322. On the
approval of the HeartMate through the issue of preemption, we stated that:
PMA process, and not under the
[S]ection [360k(a)]
“substantial equivalence” clearance
pre-empts only state
standard of § 510(k), and because Horn’s
imposed requirements.
reading and analysis of the “specificity” of
Further, it pre-empts those
the state law requirement in Lohr is
requirements only when
flawed, the Lohr decision is not
they differ from or add to a
controlling. We agree.
previously established FDA
IV. requirement and relate to
the safety or efficacy of the
This Court has addressed the issue
regulated device. When a
of the Act’s express preemption before,
state law differs from or
and those decisions guide us here. In Gile
adds to an FDA requirement
v. Optical Radiation Corp., 22 F.3d 540,
and when a state law relates
541 (3d Cir.), cert. denied, 513 U.S. 965
to the safety or effectiveness
(1994), the plaintiff brought a state
of a device approved by the
common law products liability and
FDA, the state law is
negligence action against an intraocular
pre-empted. Conversely,
lens manufacturer. We determined in Gile
when a state law neither
that state common law claims may impose
imposes requirements nor
state “requirements,” as that term is used
differs from or adds to an
in § 360k(a) of the Act, and that the state
FDA requirement nor
law requirements were preempted by the
relates to the safety or
FDA. Id. at 541-42.
effectiveness of the device
Thereafter, in Michael v. Shiley, or to any other matter
Inc., 46 F.3d 1316 (3d Cir. 1995), the included in an FDA
recipient of a heart valve brought an requirement, the state law is
action against the heart valv e not pre-empted by § 360k.
manufacturer for negligent manufacture
and design, strict products liability, breach
Id. at 1323. We concluded that Michael’s
claims for negligence, strict liability,
6
FDA Amicus Curiae Letter Br. at breach of implied warranties, and fraud on
12 (emphasis added).

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

-7-
1. The Federal Requirement the federal requirements
[imposed under § 510(k)]
A. General Analysis of the Federal
reflect important but
Requirement
entirely generic concerns
The primary element distinguishing about device regulation
Lohr from the instant case is the fact that generally, not the sort of
the HeartMate received FDA approval concerns regarding a
through the rigorous § 360e(c) PMA specific device or field of
process, not through the § 510(k) device regulation that the
“substantial equivalence” process. The statute or regulations were
Lohr decision did not address the issue of designed to protect from
whether the PMA process imposed federal potentially contradictory
requirements under state requirements.
§ 360k(a). It suggested, however, that the
analysis would have been significantly
518 U.S. at 501.
different if the device at issue in Lohr had
weathered a more exacting federal We hold that the requirements
investigation, such as the PMA process. imposed by the FDA upon the HeartMate
Lohr, 518 U.S. at 501. Indeed, the Lohr when it was granted PMA approval are
plurality distinguished the case from “a precisely “the sort of concerns regarding a
case in which the Federal Government has specific device” which the Supreme Court
weighed the competing interests relevant intimated would give rise to preemption
to the particular requirement in question, under
reached an unambiguous conclusion about
§ 360k(a). This portion of our decision in
how those competing considerations
Michael v. Shiley, Inc., 46 F.3d at 1324,
should be resolved in a particular case or
remains unchanged by the Lohr decision.10
set of cases, and implemented that
conclusion via a specific mandate on
manufacturers or producers.” Id.
10
In re Orthopedic Bone Screw
Furthermore, in response to the Prods. Liab. Litig., 159 F.3d 817, 825 (3d
pacemaker manufacturer’s argument that Cir. 1998), is not to the contrary.
Lohr’s state common law claims were Orthopedic, a § 501(k) case, in dealing
preempted by the FDA’s “good with the alternate holding of Michael
manufacturing practices” regulations, 21 respecting the claim of fraud on the FDA,
C.F.R. §§ 820.20-820.198 (1995), and by concluded that Lohr had overruled the
the FDA labeling regulations requiring alternate holding without affecting the
devices to carry warnings, 21 C.F.R. § preemption determination or any other
801.109 (1995), the Lohr plurality stated: holdings of the Michael opinion. This
aspect of Orthopedic came into question

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

-9-
1999).11 While we acknowledge that the
FDA’s interpretation of statutes that it has
B. The FDA’s Position12
been charged by Congress with enforcing

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

-10-
is not fully dispositive of the issues here, execution of the full
the Supreme Court has instructed us that purposes and objectives of
the FDA’s preemption determinations are Congress, and, therefore,
significant and should inform our whether it should be
interpretation of § 360k(a). Indeed, the pre-empted.
Supreme Court’s decision in Lohr was
“substantially informed” by the FDA, in
the context of § 510(k). Lohr, 518 U.S. at Lohr, 518 U.S. at 495-96 (internal
495. Hence, we have no hesitation in citations and quotations omitted).
looking to the FDA for its interpretation of
Horn, in her brief before us, relied
§ 360k(a) in the medical device context.
heavily on an FDA amicus curiae
Lohr stated:
submission filed with the Supreme Court
The FDA regulations in opposition to certiorari in Smiths
interpreting the scope of § Industries Medical Systems, Inc. v.
360k’s pre-emptive effect Kernats, 522 U.S. 1044 (1998). However,
support the Lohrs’ view, those views have been expressly
and our interpretation of the disclaimed and rejected by the FDA in its
pre-emption statute is Amicus Curiae Letter Brief to this Court.
substantially informed by In its current brief, the FDA has
those regulations . . . unequivocally expressed the opinion that
Congress has given the state common law claims such as those
FDA a unique role in made by Horn against a PMA-approved
determining the scope of § device are preempted. With great
360k’s pre-emptive effect . particularity, the FDA specifically
. . [I]n most cases a state addressed the HeartMate and concluded
law will be pre-empted only that because the device was the subject of
to the extent that the FDA PMA approval under § 360e(c), and not
has promulgated a relevant the subject of “substantial equivalence”
federal ‘requirement.’ clearance under § 510(k), the state law
Because the FDA is the claims asserted by Horn are preempted.13
federal agency to which
Congress has delegated its
13
authority to implement the This is the FDA’s present
provisions of the Act, the opinion. See FDA Amicus Curiae Letter
agency is uniquely qualified Br., Horn v. Thoratec Corp., No. 02-4597
to determine whether a (3d Cir. May 11, 2004). It is consistent
particular form of state law with the FDA’s statement of interest in
stands as an obstacle to the Murphree v. Pacesetter, Inc., in which it
a c c o mp l i s h me n t a n d argued that PMA approval by the FDA
“triggers preemption of a wide array of

-11-
The FDA, when PMA approval is (emphasis added).
granted, imposes federal requirements
The FDA also clearly distinguished
based on the highly detailed and
the PMA process from the § 510(k)
prescriptive nature of the PMA process
substantial equivalence process, which
and the approval order that results from it.
was the subject of the Supreme Court’s
In its Amicus Curiae Letter Brief at pages
decision in Lohr, writing:
23-24, the FDA writes:
Unlike a section
F D A can impose
510(k) clearance, which
requirements by rule or
only determines whether
order, regardless of whether
two products are
or not the requirements
substantially equivalent,
were initially suggested to
P M A a p p r o v al
the agency by an outside
consummates an exhaustive
party . . . . Although the
inquiry into the risks and
PMA approval order does
efficacy of a device. . . .
not itself expressly reiterate
all of the specific features
the d e v ice’s design,
In Lohr, not
labeling, and manufacturing
surprisingly, the Court
processes must have, it
premised its holding against
specifically approves as a
preemption on the fact that
matter of law those features
the device had been cleared
set forth in the application
only through the Section
and binds the manufacturer
510(k) process, a “limited
to produce and market the
form of review.” Lohr, 518
product in compliance with
U.S. at 478. A
the specifications as
manufacturer may change
approved by FDA.
the design and labeling of a
Section 510(k)-cleared
device as long as it
continues to be substantially
requirements imposed under state tort equivalent to its predicate.
law.” See Statement of Interest in Support 21 C.F.R. § 807.81. In
of Defendant Pacesetter’s Petition for direct contrast to the PMA
Certification for Interlocutory Appeal of regime, FDA does not
the United States of America at 5 & 7, ‘approve’ changes to a
Murphree v. Pacesetter, Inc. et al, No. Section 510(k)-cleared
005429-00-3 (Tenn. Circuit Ct. Dec. 12, device. Rather, the
2003). manufacturer simply has to

-12-
demonstrate that its device effectiveness only with
is still subst antiall y FDA’s authorization.
equivalent to its predicate.
Moreover, the range of
changes that a manufacturer Id. at 20-21 (emphasis added).
can make to a [§ 510(k)]
The dissent, in discussing Lohr v.
cleared device without
Medtronic (see Dissenting Op. at __), has
getting prior authority from
ignored the very salient fact that Lohr was
FDA is broader than for a
a § 510k “substantial equivalence”
[PMA] approved device. A
decision and not, as this case is, a
manufacturer of a cleared
§360e(c) PMA case. We have discussed
device must submit a
the dramatic difference between these two
Section 510(k) notice to
approval processes in both Sections III
FDA only for changes that
and IV of this opinion. We have
‘could significantly affect
emphasized that the PMA approval
safety or effectiveness of
process mandates that the manufacturer (in
the device,’ or that represent
this case, TCI) produce and market the
a ‘major change’ in the
HeartMate in compliance, and only in
intended use of the device.
compliance, with the requirements and
21 C.F.R. § 807.81.
specifications approved by the FDA. This
is a far cry from the § 510k process which
was the subject of Lohr, and which
. . . For [PMA
notably the Lohr Court held was “by no
devices], after a very
means comparable to the PMA process.”
lengthy process involving
Lohr, 518 U.S. at 478-79.
thousands of pages of
documentation and many This significant distinction is
hours of expert analysis, and understandably absent from the dissent’s
often including substantial discussion because, as we point out in this
give-and-take between the opinion, any effort by Horn to prove her
agency and the general common law claims of negligence,
m a nu f acturer, FDA labeling or deficient design would
approves a new device, necessarily differ from, or add to, the
including detailed design, manufacturing or labeling
specifications for its design, approved and pre-empted by the FDA.
manufacture, performance, See 21 U.S.C. § 360k(a); 21 C.F.R. §
labeling, and use. Any of 808.1(b) (see p. 17, infra, for text of
these specifications may be regulation); Kemp v. Medtronic, Inc., 231
changed in [a] way that F.3d 216 (6th Cir. 2000); Mitchell v.
affects safety and Collagen Corp., 126 F.3d 902 (7th Cir.

-13-
1997), Papike v. Tambrands, Inc., 107 Horn.
F.3d 737 (9th Cir. 1997), and Michael v.
The only state requirements
Shiley, Inc., 46 F.3d 1316, 1323 (3d Cir.
asserted by Horn are general requirements
1995).
stemming from state common law: the
Thus, the District Court’s position, HeartMate was designed in a defective
the FDA’s position, and our position are manner, it was manufactured in a
all in accord: the FDA’s PMA approval of defective manner, and the manufacturer
the HeartMate imposed specific federal had failed to warn of the alleged defects.
requirements upon the HeartMate under § The thrust of Horn’s Complaint was that
360k(a) which, as we explain infra, had the screw ring been of a better and
preempts Horn’s state common law more feasible design and had something
claims. Cf. Hawkins v. Leslie’s Pool more durable than a suture been used or
Mart, Inc., 184 F.3d 244, 250-51 (3d Cir. had the threaded sleeve with the eyelet
1999) (holding that labeling claims were been placed differently in Mr. Horn’s
preempted by similar preemption clause in body, his death would not have resulted.14
Federal Insecticide, Fungicide and
Horn has never claimed that
Rodenticide Act because, in contrast to
Pennsylvania has established a
§ 510(k) approval, the EPA had
requirement of specific device content
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
pertaining to the HeartMate.15 She has
requirements that could not be changed
never alleged that Pennsylvania requires
without pre-approval).
all sutures for the HeartMate to be
2. The State Requirement fabricated from a substance different than
the suture which the FDA has approved.
A. General Analysis of the State
Requirement
14
The remaining issue is whether Horn does not allege that TCI
Horn’s state common-law claims failed to comply with the requirements
constitute state requirements with respect imposed by the FDA when it approved the
to the HeartMate which are different from, HeartMate. At oral argument, counsel for
or in addition to, the federal requirements. Horn twice stated that Horn was not
See 21 U.S.C. § 360k(a). As we noted making such an allegation. Tr. at 7:20-
earlier, it is firmly established that a 8:12 & 10:12-14.
“requirement” under § 360k(a) can 15
Pennsylvania’s only medical
include legal requirements that arise out of device requirements which are specifically
state common-law damages actions. See exempt from preemption arise under the
Gile, 22 F.3d at 541-42. Consequently, Pennsylvania Hearing Aid Sales
the only matter that we must resolve is Registration Law, 35 P.S. §§ 6700-504(4),
whether § 360k(a) preempts the particular 6700-506, 6700-507(2), see also 21
state common law claims brought by C.F.R. § 808.88.

-14-
Nor has she ever alleged that there are regulations at 21 C.F.R. § 808.1(d).17
specific requirements mandated by the They have also considered the impact
Commonwealth of Pennsylvania as to how upon the FDA’s PMA approval of a
a medical device such as the HeartMate medical device when general state tort law
must be fabricated or designed or claims alleging negligence, design defects,
implanted within the patient’s body. failure to warn, and the like, are filed
Indeed, if Horn had alleged any against the manufacturer of the device.
“requirement” similar to these it would See, e.g., Martin v. Medtronic, 254 F.3d
have been fatal to her claims, because each 573 (5th Cir. 2001).
of them would have either been in
In Lohr, the plaintiff sued
addition to, or different from, the federal
Medtronic for negligent manufacture and
requirements imposed through the FDA’s
failure to warn, essentially the same claims
PMA approval of the HeartMate.
Horn has brought against TCI. The four-
In the absence of any specific judge plurality in Lohr concluded that
device requirements,16 we are left with those claims “escape[d] pre-emption, not
Horn’s general common law claims of because the source of the duty is a judge-
negligence, defective design, etc. The made common-law rule, but rather
question that remains is: can Horn’s because their generality leaves them
common law “general” claims, which are outside the category of requirements that
not specific “with respect to” the
HeartMate, constitute “requirements” that
17
survive preemption under 21 C.F.R. § 808.1(d) provides:
State or local requirements
§ 360k(a)? are preempted only when
Our analysis begins, as it must, the Food and Drug
with the Lohr decision. Both Horn and A d m i n i st r a t io n h a s
TCI, as well as the authorities that have e s t a b l i s h e d s p e ci f i c
considered FDA preemption under § counterpart regulations or
360k(a), have understandably read there are other specific
Medtronic v. Lohr as a starting point for requirements applicable to a
interpreting § 360k(a) and the FDA’s particular device under the
act, thereby making any
existing divergent State or
local r e q u i r ements
applicable to the device
different from, or in
16
In her June 2004 Letter Brief at addition to, the specific
10, Horn wrote: “In this case, Ms. Horn Food and Drug
does not rely on any device-specific Admi nistration
requirements.” requirements. . .

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

-16-
holding of the Court may be viewed as in other parts. Our dissenting colleague
that position taken by those Members who emphasizes that Justice Breyer joined in
concurred in the judgments on the Part V of the plurality opinion, in which
narrowest grounds . . . .’”); Planned Justice Stevens concluded that the Lohrs’
Parenthood of Southeastern Pa. v. common-law claims did not constitute
Casey, 947 F.2d 682, 693 (3d Cir. 1991) specific state requirements because they
(discussing in detail the “narrowest were not “specifically developed ‘with
ground” principle), modified on other respect to’ medical devices.” Lohr, 518
grounds, 505 U.S. 833 (1992). U.S. at 501. This was not a principle that
received Justice Breyer’s agreement. In
If the “narrowest ground” approach
his concurring opinion, Justice Breyer
is applied to Lohr, Justice Breyer’s
states that he must address two issues: (1)
opinion takes on added significance.
whether the FDA can “ever pre-empt a
Whereas Justice Stevens concluded that Ҥ
state-law tort action;” and (2) if so,
360(k) simply was not intended to pre-
whether the FDA pre-empts the claims
empt most, let alone all, general common-
brought by Lohr. Id. at 503 (Breyer, J.,
law duties enforced by damages actions,”
concurring in part and dissenting in part).
see Lohr, 518 U.S. at 491, Justice Breyer
concluded that “ordinarily, insofar as the
[FDA] pre-empts a state requirement In response to the first question,
embodied in a state statute, rule, Justice Breyer expressly states that he
regulation, or other administrative action, “basically agree[d]” with Justice
it would also pre-empt a similar O’Connor’s discussion of that point in her
requirement that takes the form of a dissenting opinion. Justice O’Connor
standard of care or behavior imposed by a concluded that “a fair reading of [§
state-law tort action.” Id. at 504-05 360k(a)] indicates that state common-law
(Breyer, J., concurring in part and claims are pre-empted, as the statute itself
dissenting in part). Thus, Justice Breyer’s states, to the extent that their recognition
rationale is the more narrow of the two would impose ‘any requirement’ different
because, although the Lohrs’ claims were from, or in addition to, FDCA
not preempted by § 360k(a), he was not requirements applicable to the device.”
prepared to join in Justice Stevens’ Id. at 512 (O’Connor, J., dissenting).
sweeping pronouncement that § 360k Interestingly, Justice O’Connor also
almost never preempts a state common observed that “[t]he statute itself makes no
law claim. mention of a requirement of specificity,
and there is no sound basis for
Of course, the splintered decision
determining that such a restriction on ‘any
in Lohr is unique because Justice Breyer
requirement’ exists.” Id.
joined in some parts of Justice Stevens’
plurality opinion (thus making it a Thus, on the state requirement
majority opinion at times), but did not join issue, Justice Breyer joined with the four-

-17-
member dissent to make a majority.18 It come unscrewed in spite of the presence
seems that he merely parted ways with of the suture. This claim unquestionably
Justice O’Connor when it came time to would require TCI to alter the
apply that rationale to the state common- HeartMate’s design by using either a
law claims (in a § 510(k) context) before different suture or screw ring. Yet the
the Court. HeartMate’s design as approved by the
FDA would remain approved by the FDA
Although in Lohr the plurality
for national distribution and sale, and any
opinion did not inform us of when
changes to the design would require
common law requirements may become
further FDA review and approval.20
substantive requirements, we are satisfied
that Horn’s general state law claims19
would impose substantive requirements on
20
TCI that would conflict with, or add to, The Product Liability Advisory
the requirements imposed by the FDA Council writes in its amicus curiae brief:
involved in the design, manufacturing, Even supposing one jury could
fabrication and labeling of the HeartMate. provide manufacturers with proper
For example, Horn’s Complaint alleges incentives to make its products
that the HeartMate was negligently safer, what about every jury? If the
designed such that the screw ring could PMA process does not preempt
state product liability suits [and
general common law claims]
18
This can be characterized as a imposing requirements at odds with
“dual majority” case because Justice the approved PMA, then juries in
Breyer joined with the plurality on the every state will influence device
result (i.e., no pre-emption), but joined regulation, in numerous and often
with the dissent as to the rationale (i.e., a conflicting ways. See Brooks [v.
state common law claim can be pre- Howmedica, Inc.], 273 F.3d at 797
empted by § 360k even though it was not (“The arguments advanced by
specifically developed “with respect to” a Brooks ignore the need for national
particular medical device). See Note, The uniformity in product regulation,
Precedential Value of Supreme Court one of the explicit goals of the
Plurality Decisions, 80 Colum. L. Rev. MDA.” (citing H.R. Rep. No. 853,
756, 767-69 (1980) (discussing dual 45 (1976) (“If a substantial number
majority cases). o f d i f f e r i n g r eq u i r e me n ts
applicable to a medical device are
19
Horn emphasized in her June imposed by jurisdictions other than
2004 Letter Brief at 7 that “the claims in the Federal government, interstate
this case are based on state law claims of commerce would be unduly
general applicability, not requirements burdened.”). Unless products
specific to devices.” liability claims [and general

-18-
As TCI has pointed out in its brief, with § 360k(a) in that they are either in
“[Horn’s] design defect claims . . . would addition to, or different from, the federal
require TCI either to use an entirely requirements established by the FDA in
different design than the screw ring to approving the HeartMate, they are
connect the outlet elbow to the pump, or necessarily preempted by federally
to use different materials instead of a imposed PMA requirements under §
suture, or to place the eyelet in a different 360k(a).22 See, e.g., Kemp, 231 F.3d at
position. Similarly, her failure-to-warn
claims would require TCI to provide
different warnings and instructions from 22
Similarly, Horn’s claim
those approved by the FDA.” TCI Br. at respecting TCI’s negligence in not
45. TCI is prohibited, however, by the furnishing a ‘Dear Doctor’ letter “warning
FDA’s PMA approval order from making that the heart pump shouldn’t be installed
any such changes. See 21 C.F.R. 814.80.21 if the sutures would face upward, toward
Because these state common law the sternum,” Horn, June 2004 Letter Br.
claims and duties are in severe tension at 9, is preempted as it would either add
to, or differ from, the federal requirement
common law claims] such as establishing the design of the HeartMate.
plaintiff’s are preempted, the See Mitchell v. Collagen Corp., 126 F.3d
FDA’s expert determinations will at 913-14 (“[T]o the extent that [the
be supplanted by a myriad of Mitchells’ mislabeling, misbranding and
common law regulators, each one adulteration] allegations claim that
less likely than the FDA to reach a Collagen has incurred liability under state
right result. law despite its conformity to the
requirements of the PMA, the state law
21
21 C.F.R. § 814.80 provides that claims must be considered preempted.”).
a device may not be manufactured, Insofar as Horn’s claim is premised
labeled, etc. in a manner inconsistent with on the adequacies of the warnings
any conditions to approval specified in the reviewed and approved by the FDA in its
PMA approval order. TCI would have to PMA approval order, it is also preempted.
submit a supplemental PMA application See Martin, 105 F.3d at 1100 (“To allow
setting forth its proposed changes and a state cause of action for inadequate
seeking FDA approval of those changes. warnings would impose different
21 C.F.R. § 814.3a(d). If the FDA were to requirements or requirements in addition
reject TCI’s application, TCI would be left to those required by federal regulations.”).
in the untenable and unenviable position The PMA includes specimens of the
of having to comply with conflicting state labeling proposed to be used for the
and federal requirements; precisely the device, 21 U.S.C. § 360e(c)(1)(F), and this
conflict the § 360k(a) preemption labeling must provide “adequate directions
provision is meant to avoid. for use.” 21 U.S.C. § 352(f). Moreover,

-19-
228-37; Mitchell, 126 F.3d at 911-15, requirement imposed by]
Papike, 107 F.3d at 741-42. FDA. . .
B. The FDA’s Position
Our preemption conclusion is There is no allegation
reenforced by the informed analysis found that the HeartMate’s design,
in the FDA’s amicus curiae brief. The labeling, or methods of
FDA has clearly expressed its view that manufacture deviated from
PMA approval in this particular case those set forth in the PMA
requires preemption. The FDA conceives approved by FDA.
of Horn’s state common law claims as Accordingly, any finding of
imposing a “requirement” which is liability based upon TCI’s
“different” from that imposed by the FDA failure to satisfy a standard
in the PMA process, and thus requiring differe n t f r o m those
preemption. In its Amicus Curiae Letter approved by FDA in the
Brief,23 the FDA wrote: P M A process w o u ld
necessarily rest upon an
. . . Here, plaintiff
implicit requirement that
seeks to impose liability
this device be designed,
based on asserted flaws in
manufactured or marketed
the design, labeling and
in a way that differs from
manufacture of the
the way approved by FDA.
HeartMate as approved by
FDA despite the fact that it (emphasis added).
c o mp l i e d w i t h F DA
With respect to the impact of state
requirements. Thus,
common law tort claims on the federal
plaintiff does attempt to
regulatory framework for medical devices,
impose a requirement
the FDA wrote:
different from [th e
State common law
tort actions threaten the
PMA approval expresses the FDA’s statutory framework for the
determination that the proposed labeling regulation of medical
meets the detailed labeling requirements devices, particularly with
set forth in its regulations. Any changes in regard to FDA’s review and
the design, labeling or manufacturing approval o f p r o d u ct
processes that affect safety and labeling. State actions are
effectiveness must receive FDA approval. not characterized by
centralized expert
23
FDA Amicus Curiae Letter Br. at evaluation of devic e
17-18.

-20-
regulatory issues. Instead, Id. at 25-26.24
they encourage, and in fact
The FDA’s views in its Amicus
require, lay judges and
Curiae Letter Brief in this case echo the
juries to second-guess the
opinion it has voiced in another recent
balancing of benefits and
case. In a brief submitted to the Circuit
risks of a specific device to
Court of Tennessee in Murphree v.
their intended patient
Pacesetter, Inc., et al., the FDA expressed
population – the central role
concerns about the consequences of not
of FDA – sometimes on
preempting state common law claims such
behalf of a single individual
as Horn’s:
or group of individuals.
That individualized [I]t is inappropriate
redetermination of the for a jury to second-guess
benefits and risks of a FDA’s scientific judgment
product can result in relief – on such a matter that is
including the threat of within FDA’s particular
significant damage awards expertise. FDA determines
or penalties – that creates the scope of a device,
pressure on manufacturers including the components it
to add warnings that FDA comprises, and the
has neither approved, nor appropriate regulatory
found to be scientifically pathway for the device. . . .
required, or withdrawal of FDA subsequently
FDA-approved products determines whether the
from the market in conflict device meets the PMA
with the agency’s expert approval standard. The
determination that such agency makes a reasoned
products are safe and and deliberate decision as to
effective. This situation can
harm the public health by
retarding research and 24
Martin v. Telectronics Pacing
developme n t and by Sys., Inc., 105 F.3d 1090 (6th Cir. 1997)
encouraging ‘defensive (“Thus, because under the federal
labeling’ by manufacturers requirement the FDA has determined that
to avoid state liability, the benefits of the device outweigh the
resulting in scientifically risks and, under the state requirement, a
unsubstantiated warnings jury in a state court action could conclude
and underutilization of that the risks outweigh the benefits, the
beneficial treatments. state requirement is different from the
federal requirement.”).

-21-
the correct pathway of that we should give no weight to the
regulation and whether to FDA’s interpretation because the FDA
approve the device. Juries previously argued that PMA approval did
l a c k t h e sc i e n t if ic not support preemption, and in any event,
knowledge and technical the FDA’s interpretation is entitled only to
expertise necessary to make “near indifference.” See Dissenting Op.
such judgments. . . . fn.2 and Maj. Op. fn.12, supra. We
cannot agree that the FDA’s position is
entitled to no deference, or “near
[T]he prospect of indifference” simply because it represents
hundreds of individual a departure from its prior position. In
juries determining the Chevron U.S.A. Inc. v. Natural Resources
propriety of particular Defense Council, Inc., 467 U.S. 837, 863-
device approvals, or the 64 (1984), the Supreme Court held that a
appropriate standards to revised interpretation by an agency is
apply to those approvals, is entitled to deference because “[a]n initial
the antithesis of the orderly agency interpretation is not instantly
scheme Congress put in carved in stone.” Accordingly, an agency
place and charged the FDA may change its course so long as it can
with implementing. justify its change with a “reasoned
analysis,” see Motor Vehicle Mfrs. Ass’n v.
State Farm Mut. Auto. Ins. Co., 463 U.S.
Such uncertainty as 29, 42 (1983), and we are fully persuaded
to the status of medical that this standard has been met.25
devices would create chaos
V.
for both the regulated
industry and FDA.

25
See United States v. Mead Corp.,
Statement of Interest of the United States 533 U.S. 218, 228 (2001) (“The weight
of America at 7-9, Murphree v. accorded to an administrative judgment in
Pacesetter, Inc. et al, No. 005429-00-3 a particular case will depend upon the
(Tenn. Circuit Ct. Dec. 12, 2003). thoroughness evident in its consideration,
As we discussed earlier, a majority the validity of its reasoning, its
of the Court in Lohr emphasized that the consistency with earlier and later
FDA is “uniquely qualified” to determine pronouncements, and all those factors
whether a particular form of state law . . . which give it power to persuade, if lacking
should be pre-empted” by § 360k. Lohr, power to control.”) (internal citations and
518 U.S. at 496. Horn contends, however, quotations omitted).

-22-
Horn has not asserted that TCI has (“When Congress has considered the issue
in any way failed to conform with the of pre-emption and has included in the
FDA enacted legislation a provision explicitly
addressing that issue, and when that
requirements prescribed by its PMA—nor
provision provides a reliable indicium of
that it deviated from, or violated, any of
congressional intent with respect to state
the FDA’s federal statutes or regulations.
authority, there is no need to infer
Because the design of the HeartMate, the
congressional intent to pre-empt state laws
labeling and the instructions for its use,
from the substantive provisions of the
and the specification of the suture and its
legislation.”) (citations and internal
location when the HeartMate is implanted,
quotations omitted). We therefore do not
as well as the other requirements imposed
address the dissent’s arguments predicated
by the PMA, were the subject of extensive
on “implied preemption.”
consideration by the FDA leading up to its
PMA approval, any finding in Horn’s As a consequence we, together with
favor based on her general claims of our sister Courts of Appeal who have read
negligence or defective design and Lohr in the same fashion as we have,26 and
manufacture—be it by a jury or a together with the FDA’s current position,
court—would necessarily amount to a hold that Horn’s claims are preempted by
state substantive requirement “different § 360k(a). We will affirm the judgment of
from, or in addition to, the federal the District Court granting summary
requirements imposed by the FDA.” Any judgment to TCI.
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 26
See Brooks v. Howmedica, Inc.,
claims, then there is no point in discussing 273 F.3d 785 (8th Cir. 2001); Martin v.
“implied preemption,” a doctrine which Medtronic, Inc., 254 F.3d 573 (5th Cir.
our dissenting colleague addressed at 2001); Kemp v. Medtronic, Inc., 231 F.3d
length in an attempt to bolster his 216 (6th cir. 2000); Mitchell v. Collagen
conclusion that Lohr, a § 510(k) opinion, Corp., 126 F.3d 902, 913-14 (7th Cir.
governs this case. See Cipollone v. 1997); Papike, 107 F.3d 737, 742 (9th Cir.
Liggett Group, Inc., 505 U.S. 504 (1992) 1997).

-23-
Barbara E. Horn v. Thoratec Corporation, I.
No. 02-4597
I have no quarrel with the
FUENTES, Circuit Judge, dissenting. majority’s conclusion that the PMA
process is a specific federal regulation
Following her husband’s death,
governing the HeartMate.27 I believe,
Barbara Horn filed a lawsuit in the U.S.
however, that the District Court erred by
District Court, under state common law,
looking only at whether the federal
alleging that her husband died as a result
regulation here (the PMA) was specific to
of TCI’s defectively designed heart pump.
a particular device, and not examining
In her complaint, she alleges that the
whether the state law under which Horn
suture on Mr. Horn’s HeartMate had worn
sued was device-specific. Horn argues
through and that the screw ring linking the
that a state common-law claim is
pump to the output side had disconnected.
preempted only if the state claim is device-
As a result, an air embolus traveled to Mr.
specific and the purportedly preempting
Horn’s brain, causing his death. The
federal regulation is device-specific. TCI
majority has concluded that Horn’s
responds that the District Court correctly
common-law claim s, grounded in
analyzed only the federal side of the
negligence and defective design, create
equation, because Medtronic, Inc. v. Lohr,
“specific requirements” under state law
518 U.S. 470 (1996), made that the only
and are therefore preempted by § 360k(a)
relevant inquiry. The Circuits are split on
of the MDA. I cannot agree, however, that
this question, with the Seventh and Ninth
Horn’s generalized common-law claims
Circuits holding that preemption requires
impose any spe cific sta te-law
only a device-specific federal regulation,
“requirements” on the HeartM ate. This is
Mitchell v. Collagen Corp., 126 F.3d 902,
because § 360k(a) preemption works only
912 (7th Cir. 1997); Papike v. Tambrands
against state requirements that are
Inc., 107 F.3d 737, 742 (9th Cir. 1997);
“different from, or in addition to” federal
and the Tenth Circuit holding that
requirements. In my view, because Horn’s
suit is not seeking to impose any specific
requirement on the HeartMate, it is not 27
For this reason, the majority’s
preempted. Additionally, I believe that
discussion of the difference between the
allowing common-law liability would
PMA process and the § 510k “substantial
simply have the effect of encouraging TCI
equivalence” process is not relevant. Maj.
and other device manufacturers to go
Op. at 13. That difference only speaks to
above and beyond FDA standards, and this
why the PMA process is a specific federal
effect would clearly not contradict the
requirement; my disagreement with the
MDA’s purpose of enhancing medical
majority is not over the federal side of the
device safety. I therefore respectfully
equation at all, but rather over whether
dissent.
Horn’s suit implicates the state-law
specificity requirement in Lohr.

-24-
preemption additionally requires a device- preempted state common-law claims
specific state law. Oja v. Howmedica, premised on the unsuitability of a medical
Inc., 111 F.3d 782, 789 (10th Cir. 1997). device under state standards more stringent
Although my colleagues acknowledge than the FDA standards governing the
some kind of state-law specificity device. Justice Breyer agreed with a four-
requirement, they effectively agree with Justice bloc (Stevens, Kennedy, Souter and
the Seventh and Ninth Circuits in holding Ginsburg) that the term “requirement” in §
that even the most generalized tort claims, 360k(a) is ambiguous, and does not entail
such as those in the case before us, are the preemption of all common-law tort
preempted under § 360k(a). suits holding manufacturers to higher
standards than the FDA. Id. at 488-89
I respectfully dissent from this
(Stevens, J., plurality (hereinafte r
conclusion. The FDA regulations
“plurality”))28 ; id. at 505-06 (Breyer, J.,
concerning preemption clarify that
concurring (hereinafter “Breyer”)). The
preemption only occurs when the FDA
remaining four Justices disagreed, opining
“has established specific counterpart
that § 360k(a) bars all state-law claims,
regulations or there are other specific
common-law or otherwise, that hold
requirements applicable to a particular
manufacturers to a higher standard than
device under the act.” 21 C.F.R. §
federal regulations. Id. at 511-12
808.1(d) (emphasis added). The
(O’Connor, J., concurring in part and
preemption clause does not “preempt State
dissenting in part (hereinafter “dissent”)).
or local requirements of general
applicability where the purpose of the The plurality and Justice Breyer
requirement relates either to other products turned to the above-quoted FDA
in addition to devices (e.g., [the UCC]) or regulations to help determine when a
to unfair trade practices in which the common-law claim constitutes a state
requirements are not limited to devices.” “requirement” under § 360k(a). Id. at 498-
21 C.F.R. § 808.1(d)(1) (emphasis added). 99; id. at 505-06 (Breyer). Relying on
these regulations, the five Justices
In 1996, the Supreme Court issued
concluded that preemption is only
Lohr, a fractured opinion that examined
triggered by specific FDA regulations
MDA preemption of state law. The
applying to a particular device, and not by
majority of the Lohr Court agreed that a
strong presumption exists in favor of a
narrow scope of preemption because 28
To be precise, I will only use the
policing health is the traditional province
term “plurality” in reference to portions of
of the states. 518 U.S. at 485. Another
Justice Stevens’s opinion in Lohr that
key factor in analyzing the scope of
were joined by only four Justices. The
preemption is Congress’s intent in passing
portions of the Lohr opinion joined by five
the legislation. Id. at 485-86. The Court
Justices will not be accompanied by any
split, however, as to whether the MDA
parenthetical reference.

-25-
generally applicable FDA regulations, i.e., device under the act.” 21 C.F.R. §
those governing the design or labeling of 808.1(d) (emphasis added). The
medical devices as a whole. Id. at 500-01. regulations go on to say that “there are
Part V of the plurality opinion, which other State and local requirements that
Justice Breyer joined, also stated that the affect devices that are not preempted by [§
MDA does not preempt generalized state- 360k( a ) ] b e c a u s e t h e y a r e n ot
law claims, such as negligence in ‘requirements applicable to a device’
manufacturing or failure to warn, as within the meaning of [§ 360k(a)],” id.,
opposed to state laws governing particular and lists as an example “State or local
medical devices. Id. at 501-02. requirements of general applicability
where the purpose of the requirement
Thus, Part V of the Lohr opinion,
relates either to other products in addition
which represents the views of five
to devices (e.g., [the UCC]) or to unfair
Justices, excepted generalized common-
trade practices in which the requirements
law claims like failure to warn and
are not limited to devices.” 21 C.F.R. §
negligent manufacture from the ambit of
808.1(d)(1). This reference to the
MDA preemption. Id. at 501-02. The
specificity of state regulations would be
Lohr majority reasoned that “general state
superfluous if all that mattered was the
common-law requirements” that “were not
specificity of the federal regulation.
specifically developed ‘with respect to’
Moreover, the exemption of generalized
medical devices . . . are not the kinds of
state requirements is never qualified by the
requirements that Congress and the FDA
further condition that those requirements
feared would impede the ability of federal
infringe on a generalized federal
regulators to implement and enforce
requirement. Finally, the regulations belie
specific federal requirements.” Id. at 501.
my colleagues’ conclusion that generalized
Here, Horn’s four claims of negligence,
state requirements can be preempted if
strict liability, breach of warranty and
they merely affect the manufacture of
failure to warn are all general common-
medical devices. See Maj. Op. at 16-18
law tort claims that were not crafted
(state-law claim is preempted if it has the
specifically to govern medical devices, and
effect of imposing a greater burden on a
so are excepted from the scope of §
device manufacturer than the FDA). In
360k(a).
short, the regulations support the view that
This conclusion is bolstered by the state-level device-specificity is a requisite
FDA regulations on preemption, relied for § 360k(a) preemption.
upon by the Lohr majority. As mentioned
TCI argues that the FDA has
above, the FDA has declared that
published regulations contravening the
preemption only occurs when the FDA
state specificity requirement, but the cited
“has established specific counterpart
regulations only state that in the context of
regulations or there are other specific
a particular California law “general
requirements applicable to a particular

-26-
requirements not applicable to specific The main argument against the state
devices . . . are not preempted unless they specificity requirement rests in the
are applied to a specific device in such a language of Justice Breyer’s concurrence
way as to establish requirements” for an in Lohr. After joining Part V of the
FDA-regulated device. 45 Fed. Reg. Stevens opinion, Justice Breyer wrote
67321, 67322. Thus, general requirements separately that common-law claims could
are still not preempted under this in fact be preempted where they imposed
regulation; the only state requirements that different standards for devices than the
are preempted are ones that affect specific c o u n te r pa r t d e v i c e -s p e c if i c F DA
devices. Even if TCI’s interpretation of regulations. Lohr, 518 U.S. at 504
this statement were correct, one isolated (Breyer). Justice Breyer raised the
statement in the Federal Register would example of a jury finding for a plaintiff in
not trump the actual regulations contained a negligence suit on the grounds that a
in the C.F.R., especially when those hearing aid wire was longer than 1 inch,
regulations have been adopted by the even though FDA regulations had
Supreme Court as instructive.29 approved wires up to 2 inches. Id. Justice
Breyer concluded that this jury award
would be preempted even though it was
29 based on the generalized state tort law of
My colleagues seem to put great
negligence because it effectively
emphasis on the FDA’s amicus brief,
established a device-specific state
which sides with TCI. Horn and Amicus
requirement of 1-inch wires for hearing
Product Liability Advisory Council have
aids. Id.
also both advanced arguments from
previous United States briefs on the scope My colleagues have found this
of 360k(a) preemption as evidence in language from Justice Breyer difficult to
favor of their views on preemption. As reconcile with his agreement with Part V
TCI has itself pointed out, however, of the majority opinion, which exempted
arguments advanced by the United States generalized state causes of action from
in a litigation brief are entitled to “near preemption. Maj. Op. at 16. The Seventh
indifference,” and are only as persuasive and Ninth Circuits also perceived a
as their own merits dictate. United States contradiction and chose to ignore Justice
v. Mead Corp., 533 U.S. 218, 228 (2001) Breyer’s vote for Part V, instead crediting
(cited in TCI Br. at 52). Notably, the Lohr the apparently contrary reasoning in his
court gave deference to the FDA’s concurrence. Mitchell, 126 F.3d at 912;
regulations in particular, not to an amicus Papike, 107 F.3d at 742. With all due
brief. 518 U.S. at 495-96. Consequently, respect to my colleagues and these two
I believe that Lohr mandates that we obey Circuit Courts, however, I do not believe
the regulations issued by the FDA, rather that Justice Breyer’s concurrence is in
than the amicus brief relied upon by the disagreement with Part V of the majority
majority.

-27-
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
30 device. For example, a plaintiff could sue
My colleagues find it
under a theory of negligence per se, where
incongruous that Justice Breyer would
the negligence is premised on deviation
“write separately to emphasize that duties
from a specific state requirement for a
arising under state law can regularly lead
device (like a 1-inch hearing aid wire).
to preemption, but simultaneously agree
Similarly, a judge could give a jury
with the plurality that tort duties are
instruction telling the jury that, as a matter
almost always too general to warrant
of law, it should find a manufacturer
preemption.” Maj. Op. at 16. Not only is
negligent if it violated a certain standard
this an overstatement of Justice Breyer’s
for a device (i.e., “you should find the
language (“I am not convinced that future
manufacturer negligent if it used a hearing
incidents of MDA pre-emption of
aid wire longer than 1 inch”). Both of
common-law claims will be ‘few’ or
these examples involve a specific
‘rare’”), it also depicts a false conflict: the
requirement being imposed upon a device
plurality expressed its views on the
by the state through its common law. A
frequency of preemption in Part VI of its
simple negligence action, in contrast, does
opinion, which Justice Breyer explicitly
not impose any specific requirement on the
refused to join. Lohr, 518 U.S. at 508
device, but simply alleges that the device
(Breyer). Indeed, the fact that Justice
was designed/manufactured improperly.
Breyer explicitly declined to join Part VI
of the majority opinion highlights his clear In this case, because Horn’s suit is
intent to join Part V in full. Similarly, the not seeking to impose any specific
majority somehow turns Justice Breyer’s requirement on the HeartMate, it is not
agreement with the Lohr dissent that “the preempted. It is true that Horn’s cause of
MDA will sometimes pre-empt a state-law action may have the indirect consequence
tort suit,” id. at 503 (Breyer) (emphasis of holding the HeartMate to a higher
added)–a statement that I entirely agree standard than does the FDA, but this
with–into an agreement with the Lohr consequence is sanctioned by Part V of the
dissent’s statement that there is no state- Lohr opinion and not expressly barred by
law specificity requirement whatsoever. Justice Breyer’s concurrence. Moreover,
Id. at 512 (dissent) (quoted in Maj. Op. at even if my colleagues were correct that the
17). To the contrary, Justice Breyer content of Justice Breyer’s concurrence
endorsed a state-law specificity
requirement by joining Part V of Justice
Stevens’s opinion, and this requirement the “narrowest ground” approach evoked
therefore “enjoys the assent of five by the majority is simply inapplicable to
Justices.” Marks v. United States, 430 evade the holding of Part V of the Lohr
U.S. 188, 192-93 (1977). Accordingly, opinion.

-28-
contradicted Part V, the correct course of reversed.31
action would be to follow Part V as the
II.
majority opinion of the Supreme Court,
not to elevate a one-justice concurrence Because I would find no express
above the five-justice majority. Cf. preemption here, I would reach TCI’s
Alexander v. Sandoval, 532 U.S. 275, 285 implied preemption argument, and
n. 5 (2001) (concurrence is not given as conclude that Horn’s claims are not
much precedential weight as majority impliedly preempted. Implied preemption
opinion, even if concurrence is compatible can exist in either of two situations: (1)
with majority opinion). when Congress intended federal law to
Finally, even if Justice Breyer’s
concurrence were given equal weight to
31
Part V, this jurisprudential “tie” should be TCI suggests in passing that Part
broken by reference to the presumption V does not actually require state-level
against a wide scope of preemption. Lohr, device-specificity, relying on the sentence:
518 U.S. at 485. TCI argues that this “Although we do not believe that this
presumption has since been discarded. statutory and regulatory language
However, all of the cases TCI cites for that necessarily precludes ‘general’ federal
proposition either (1) fou nd th e requirements from ever pre-empting state
presumption irrelevant because the requirements, or ‘general’ state
language was clear, Sprietsma v. Mercury requirements from ever being preempted,
Marine, 537 U.S 51, 62-63 (2002); Crosby . . . it is impossible to ignore its
v. National Foreign Trade Council, 530 overarching concern that pre-emption
U.S. 363, 374 n. 8 (2000); or (2) found the occur only where a particular state
presumption inapplicable to the particular requirement threatens to interfere with a
statute in question because it did not deal specific federal interest.” Lohr, 518 U.S.
with a traditional province of state law, at 500. This quoted language, however,
Buckman Co. v. Plaintiffs’ Legal Comm., only states that the relevant statutory and
531 U.S. 341, 347 (2001); United States v. regulatory texts do not compel the state-
Locke, 529 U.S. 89, 108 (2000). In level specificity requirement, but that the
conclusion, I would follow Part V of the Lohr majority inferred the state-specificity
Lohr opinion, as I feel we are bound to do, requirement from that language. Part V
and hold that a state common-law claim is later makes it clear that state-level
preempted only if it establishes a specific specificity is in fact a requirement for
requirement for a particular device, rather preemption. Id. at 502 (“These state
than alleging breach of a generalized duty requirements therefore escape pre-
of care. Accordingly, the District Court’s emption, . . . because their generality
finding of express preemption should be leaves them outside the category of
requirements that §360k envisioned to be
‘with respect to’ specific devices”).

-29-
occupy an entire field of law exclusively devices.” Id. at 490 (plurality).32 This
(“field preemption”), or (2) when state law clearly pro-regulatory, pro-consumer
actually conflicts with federal law safety purpose of the MDA compels the
(“conflict preemption”). E.g., Freightliner conclusion that state common-law suits are
Corp. v. M yrick, 514 U.S. 280, 287 not impliedly preempted by the MDA.
(1995). Conflict preemption can in turn be This conclusion is supported by the
shown in two ways: (1) it is impossible for presumption in favor of a narrow scope of
a party to comply with both federal and preemption, mentioned above. Moreover,
state requirements, or (2) the state law although the presence of an express
frustrates Congressional intent. Id. Here, preemption clause (§ 360k(a)) does not
the only implied preemption claim at issue conclusively rule out implied preemption,
is the frustration prong of conflict it does imply that “Congress did not intend
preemption: TCI and Amicus Curiae U.S. to pre-empt other matters.” Myrick, 514
Chamber of Commerce (“USCC”) do not U.S. at 288.
a r g ue that field preemption or
None of TCI’s or USCC’s
impossibility conflict preemption apply.
arguments are persuasive toward finding
Since there is no express language implied preemption here. TCI relies on
to rely on in a frustration conflict Buckman, 531 U.S. at 350, for the
preemption analysis, the key factor to proposition that the MDA allows for
consider is, unsurprisingly, Congressional implied preemption. Buckman, however,
purpose. E.g., Barnett Bank of Marion found implied preemption of a state-law
County, N.A. v. Nelson, 517 U.S. 25, 31 claim that the defendant had defrauded the
(1996). As the Lohr court observed, the FDA by sending it false § 501(k)
purpose of the MDA was to protect equivalency information. Id. at 343. The
consumers by ensuring the safety and conflict in Buckman existed because the
effectiveness of medical devices. Lohr, MDA had given the FDA full power and
518 U.S. at 476. Contrary to USCC’s and discretion to remedy acts of fraud
PLAC’s assertions, protection of the perpetrated on it; a state-law suit seeking
medical device industry from excessive to prosecute fraud against the FDA would
regulation was a minimal concern. Id. at necessarily conflict with the FDA’s
490-91 (plurality); see also id. at 476 discretionary decision to forego a fraud
(MDA was motivated by concern on the prosecution against itself. Id. at 349.
part of consumers and regulators, not
industry). The plurality specifically
32
disclaimed the idea of a Congressional Justice Breyer did not join the
“fear that product liability actions would plurality’s detailed discussion of statutory
hamper the development of medical purpose because he found it unnecessary
for analysis of the case; he made no
statement agreeing or disagreeing with it.
Id. at 508 (Breyer).

-30-
Indeed, the Buckman court distinguished Horn’s suit declaring that the HeartMate is
fraud-on-the-agency claims from suits designed defectively. USCC
based on “traditional state tort law mischaracterizes Barnett Bank, however:
principles of the duty of care,” which are the Supreme Court did not lay down any
the principles involved in this case. Id. at blanket rule on frustration conflict
352. preemption, but merely followed the
normal procedure of looking to the
TCI’s other argument, echoed by
legislature’s intent to determine if
USCC, is that allowing state-law tort suits
frustration conflict preemption existed.
conflicts with federal law because it allows
Id. at 32-37. The Barnett Bank court
juries to second-guess the FDA’s
concluded that a federal statute permitting
determination that the PMA-approved
banks to sell insurance in small towns
device is safe. There is not necessarily any
preempted a state statute banning such
conflict, however, between the FDA’s
sales because the purpose behind the
allowing TCI to market the HeartMate and
federal statute was to empower banks. Id.
a state finding that the HeartMate is
Here, in contrast, the MDA was not
unsafe: the natural way to reconcile these
created to empower industry, but to protect
two positions is to see the PMA process as
consumers by ensuring safe devices. Thus,
a “floor” of minimum standards for Class
the conflict that existed in Barnett
III devices, but not a “ceiling.” Under this
Bank does not exist here.
view, a state could still raise the standards
of safety within its own jurisdiction. Cf. The instant case is a lso
Barnett Bank, 517 U.S. at 31 (federal law distinguishable from Barnett Bank in that
permitting banks to sell insurance in small Barnett Bank dealt with a state’s outright
towns does not necessarily conflict with statutory ban of a permitted practice, while
state law banning such sales, since federal there is no corresponding ban here (i.e.,
law could be read as permitting sales to the the state of Pennsylvania outlawing heart
extent that they are permitted by state law). pumps). In this case, TCI is not prohibited
from marketing the HeartMate, but must
simply live with the possibility of liability
USCC argues that while Barnett
if the HeartMate does not live up to
Bank recognized that there was not
Pennsylvania’s applicable standards of
necessarily a contradiction between federal
care. Although the risk of liability may
permission and state prohibition of a
admittedly be a deterrent to TCI’s
practice, Barnett Bank produced a bright-
marketing efforts, the Supreme Court has
line rule that federal permission to engage
held that the incidental regulation incurred
in a practice preempts state law liability
by liability under generally applicable state
incurred by engaging in that practice.
law is less intrusive, and therefore less
Accordingly, USCC concludes, the FDA’s
prone to preemption, than “direct
permission to market HeartMate triggers
regulation on the operation of federal
frustration conflict preemption against

-31-
projects.” Goodyear Atomic Corp. v. safety. 33
Miller, 486 U.S. 174, 185-86 (1988).
IV.
USCC also cites to Pokorny v. Ford
Five Justices of the Supreme Court
Motor Co., 902 F.2d 1116, 1123-25 (3d
have joined an opinion that requires
Cir. 1990), to support its proffered bright-
specificity of state claims in addition to
line rule that federal permission to engage
specific federal requirements for the
in a practice preempts state law liability
triggering of preemption under the MDA.
incurred by engaging in that practice.
Specificity of state claims is also mandated
Pokorny, however, is distinguishable for
by the applicable FDA regulations, to
the same reason as Barnett Bank: the
which we must show deference. My
purpose behind the federal regulation in
colleagues, however, have rejected both
Pokorny was specifically to give
the binding instructions of the Supreme
automobile manufacturers flexibility to
Court in Lohr and the FDA regulations
choose to equip their automobiles with
based on their perception of a single
manual safety belts instead of automatic
Justice’s opinion in Lohr and the FDA’s
belts and/or airbags. Id. As Horn points
current litigation position, to which we
out, the Pokorny court rejected the
owe no deference. Accordingly, I must
manufacturer’s claim that the regulation
respectfully dissent.
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
33
beyond FDA standards, and this effect Of course, this only shows that
would clearly not contradict the MDA’s common-law liability is in no way
purpose of enhancing medical device impliedly preempted by the MDA;
obviously, the express preemption clause
does preempt some common-law liability
for state standards above and beyond FDA
standards.

-32-

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/3013968. Public record. Not legal advice.