2004 Decisions

Opinions of the United

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Precedential or Non-Precedential: Precedential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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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
-1-

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.
-2-

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). 
-3-

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
-4-

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

overl o oked bette r

alternatives to the design it

chose); [and] second, that

TCI should have issued

warnings to doctors,

through either revisions in

the product labeling or

correspondence to health

care professio nals

(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.
-5-

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 prem a r ket notificatio 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
-6-

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 valve

manufacturer for negligent manufacture

and design, strict products liability, breach

ofimpliedwarranty 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]ecti o n [360 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). 
-7-

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 claims aga inst the

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

FDA requ i r ements upon t h e

manufacturer.9

7

 Michael’s claims for breach of

express warranty (based on the heart

valve’s packaging materials) and fraud

(based on the manufacturer’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—weremerelystate-enforced

common law remedies, and not stateimposed 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., Martin 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.
-8-

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
-9-

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 supplementsto

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, intended 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.
-10-

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 PMAapproved 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 preemptive 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 sponsi ble fo r

administering the [Act].

That responsibility means

inf orme d ag enc 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 ranslate the s e

understan dings into

particularized pre-emptive

intentions accompanying its

v arious rul es an d

regulations. It can

communicate thos 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).
-11-

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

accomplishment an 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
-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 can im pos 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

two pr oducts ar e

substantially equivalent,

PMA approva l

consummates an exhaustive

inquiry into the risks and

efficacy of a device. . . . 

I n Loh r , no 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. at 47 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).
-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

agency a n d th e

man ufa cture r , FD A

approves a new device,

includi n g de taile d

specifications for its design,

manufacture, performance,

labeling, and use. Any of

these specifications may be

changed in [a] way that

affects safety an 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 mandatesthatthe 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.
-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

incorporated specific labelin 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.
-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 fourjudge plurality in Lohr concluded that

those claims “escape[d] pre-emption, not

because the source of the duty is a judgemade 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

Administratio n ha s

e stablished specifi c

counterpart regulations or

there are other specific

requirements applicable to a

particular device under the

act, thereby making any

existing divergent State or

loca l require ments

applicable to the device

different from, or in

addition to, the specific

F ood and Dru g

Admi nist ratio n

requirements. . .
-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)] preemption 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 threemember 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 bytheSupreme

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
-17-

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). 

Ifthe “narrowest ground” approach

is applied to Lohr, Justice Breyer’s

opinion takes on added significance.

Whereas Justice Stevens concluded that “§

360(k) simply was not intended to preempt most, let alone all, general commonlaw 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-
-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 commonlaw 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 preempted 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 oddswith

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 differing 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
-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. 

22 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

labelingmust provide “adequate directions

for use.” 21 U.S.C. § 352(f). Moreover,
-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

manufactu re of th e

HeartMate as approved by

FDA despite the fact that it

complied with FDA

requirements. Thus,

plaintiff does attempt to

impose a requirement

different from [th 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

approved by FDA.

Accordingly, any finding of

liability based upon TCI’s

failure to satisfy a standard

different from those

approved by FDA in the

PMA 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

regulatoryframework 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

centra lize d exper t

evaluation of device

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.
-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.

That i n d ividualize 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

comprises, and th e

appropriate regulatory

pathway for the device. . . .

FDA su bsequen 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.”). 
-22-

the correct pathway of

regulation and whether to

approve the device. Juries

lack the s c i entif 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).
-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 oftheHeartMate 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).
-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

impos e any spe cific sta te-law

“requirements” on the HeartMate. 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 devicespecific 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.
-25-

preemption additionally requires a devicespecific 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 understate standards more stringent

than the FDA standards governing the

device. Justice Breyer agreed with a fourJustice 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-

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 statelaw 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 commonlaw 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 commonlaw 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 )] because they are not

‘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-

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

counterpart device-specific FDA

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.
-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

30 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 statelaw 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.
-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) found the

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 statelevel 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 preemption, . . . because their generality

leaves them outside the category of

requirements that §360k envisioned to be

‘with respect to’ specific devices”).
-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. Myrick, 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).
-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 brightline 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

designed defe ctively . USCC

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 also

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
-32-

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 brightline 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.