Horn v. Thoratec Corp

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Precedential or Non-Precedential: Precedential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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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-