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UNIT ED STA TES C OURT OF

APPEALS FO R T HE TH IRD CIR CU IT

__________
No. 02-4597

__________
BA RB AR A E . HO RN , Exe cutrix of the E state of D anie l Ra y Ho rn, De cea sed
,

Appellant

v.

THORATE C CORPOR ATI ON.

__________ On Appeal from the United St ates

District Cou rt for the M iddle D istrict of P enns ylvania Civil Act ion No. 00-CV-00779 Distric t Ju dge: Honorabl e James F.

Mc Clure, Jr.

__________ Argued on December 11, 2003

___________
Before: AMBR O, FUEN TES, and GA RT H, Circu it Judges
(Opinion Fi led: J uly 20, 2004) Allis on Zeive (Argued) Public Cit

izen Litigati on Group 1600 20 th Str ee t , N. W. Washington, D.C. 20009
John M. Humphrey Riede r s, Tr av is, M us sin a, H um ph re y, Harris, Waters & Waffenschmidt 161 West Third Street P.O. Box 215 Willi amsport, PA 17703

Attorneys for Appellant Barbara E. Horn

Gary A. W inters Mayer, Brown, Rowe & Maw 19 09 K St

r ee t , N. W. Washington, D.C. 20006

Alan E. Unterei ner (Argued) Robbins, Rus s ell, Englert , Orseck & Unte rei nerLLP 1801 K Street, N.W., Suit e 411 Washington, D.C. 20006

Charles W . Ruben dall, II Keefer, Wood, All en & Rahal 210 Walnut Stre et P.O. Box 11963 Harrisbur g, PA 17108-1963

Arnd N. von Waldow Ree d Sm ith 435 Sixth Avenue Pitt sburgh, PA 15219

Attorney s for Appel lee Thoratec Corporation-1-

Douglas Lett er, Appell ate Litigati on Counsel Peter R. Maier, Att orney Civil Divi sion, Room 9012 60 1 D Str ee t , N. W. Department of J usti ce Washington, D.C. 20530-0001

Attorney s for Amicus Curi ae United States of America

Robert N. Weiner Arnold & Porter 55 5 1 2th S t r ee t , N. W. Washington, D.C. 20004

Attorney s for Amicus Curi ae Product Liabi lit

y Advisory Counci l, I

nc.

Daniel G. Jarcho McKenna Lo ng & Aldridg e LLP 19 00 K St

r ee t , N. W. Washington, D.C. 20006

Attorney s for Amicus Curi ae Chamber of Comm erce of t he United Stat

es of America

__________
OPI NION

__________

Ga rth, Circu it Judge : Barbara Hor n (“Horn”) ap peals from the Dist

rict Cour

t’s grant of summary judgment t

o Thoratec

Corp. (hereinafter “TCI” 1 ), based on it s determinat

io n that Horn’s claims aga inst TCI are pr

eemp ted by the express preem ptionp rov ision in t

he Food Drug and Cosmetic A c t (the “Act”), 21 U.S.C. § 360k(a). 2 We affirm.

I.
TCI manufactured and distributed the left ventricular as sist device known as the HeartMate. Th e HeartMate is a pump that assists the b lood flow between the heart’s ventric le and the

aorta in p at ients with cardiac cond itions. The inlet s ide tube is surgically attached to the heart via the ventric le, and c arrie s blood from the heart into the pum

p. The outle

t side t ube brings blo od from the pu mp to the aorta, where it is dispersed

to the bod y. There is

atube attached to the pump th at exits th e body and connects to an external console. The consol e containsan air c ompres sor which powers the HeartMate.
The facts under lying this case pe rta in to the outlet side tube, which

1 Thora tecCorporati on, fo rm erly knownas Thermo Cardio systems, Inc., is referred to b y t he parties and the Distri ct CourtJudge as TCI . Therefor e, we will also refer to defendant-appellee a s TCI.

2 The Medical Device Amendm ent s to the Act a

llow the Food a

nd Drug Administrati on (“FDA”) to r egulate medical devices. See 21 U.S.C. §§ 360c et seq. For ease of referencethrough out this opinion, we refer to the Act as the source of preem ption.-2-

connects the pump t

o the aort

a. The connecti on between the pump an d the tube, called the “ elbow,” is
inserted into an ada

pter con d uit, which is screwedinto the open portof the pump. A

screw ring is sec u red over the elbow to

ensure that it

rema ins conne cte d to the adapter conduit and t

he pump. A suture is tiedover the screw ring and secured to t he adapter conduit to e

nsure it will not rotate. 3 The Heart

Mate wasapprove d b y the FDA pu rsuant to th e Pr e-Market Approval (“PMA”) process set forth at 21 U.S.C. § 360e(c) ( discuss ed in depth, infra ).
On January

17, 1998, Horn’s hu sba nd, Daniel Horn , was admitted to William sport

Hospital suffering a heart attack. He was later transf erred to Hershey Medical Center. D o ctors there determined

that Mr. Horn required a heart transplant, and they waited fo r a suitable dono r hear t to become ava

ila ble. On January 22, 1998, Mr. Hor

n’s condit

ion det eriorated

and a HeartMate

wa s implanted

in him to provide ci rc ulatory

su p port. He was then transferred to an

as si st ed li vi ng fa ci li ty.
On May 3, 199 8, Mr. Horn began to bleed from the sp ot w he re the Hear tMate tube exit ed hi s body

. Ther eu pon, he underwent exploratory surgery at Hershey Medical Center, during which Dr. Benjam in S un discovered that the suture on M r. Horn’s He artMate h ad

worn off and the screw ring lin kin g the pump to the output side elbo w had disconnected. The disconnec ti on had allowed an air embolus t o travel to Mr. Horn’s brain. Alt houg h Dr. Sun reconnectedthe scr

ew ring and

once again linked the pump t

o the elbow
, it was t

oo late. Mr. H or n suffere d a brain hemorrhage, and he was ren dered brain dead. On May 8, 1998 , h is orga ns were donated for transplan t an d he was pronounced dea

d.
On April 28, 2000 , Ho rn filed a C omplaint

against TCI in the Unit e d States D i strict Court fo r the Middle Dist rict of Pennsy

lvania. The Compla

int allegeddefective design a nd manufacture of the Heart Mate and fa

ilure t o warn of the allegeddefects; it was based on Horn’s cla im that the HeartMa

te’s out put side elbow was defectivel y d esigned. TCI movedf o r summ ary judgment, arguing that Horn’s state lawclaims are expressly preempted by

21 U.S.C. § 360k(a).
The District

Co urt granted TCI’s motion on November 7, 2002, holding that Horn’s stat e common law claims were pree mpte d. The Distr

ict Court applied a two-prong te st e ndorsed by the Sixth a

nd Eleventh Circuits, 4 whic h instructs that a state cla im a

tta ckingthe s afet

y of a

3 The Heart

Mate ar rive s at the surgeon pr e -assemble d. The surgeon need not manipulate th e screw ring or suture when he implants the HeartMat e. 4 See Kemp v. Medtronic, Inc., 231

F.3d216, 224-25 (6th Cir. 20 00); Goodlin

v. Medtroni c, In c., 167 F.3d 1367, 1371 (11th Cir. 1 999).-3-

medical de vice is pree

mpted if (1) the FDA has established sp ecif i c federal req uirements that are applicab le to th a t particular device, and ( 2) the state claim is different from, or in add iti on to , the specific fed eral requirements.
In gra nti ng TCI’s m

otion for summary judgment on expre ss pree mption grounds, the District

Court found that

(1) the HeartMate’s PMA approval p rocess imposes a specific feder a l requir ement appli cabl e to the HeartMa te, and (2) if Horn were succes s ful on her state law claims, “any

judgment

that the HeartMa te
was unsa fe or otherwise substandard would be in dir

ect confl ict [with ]— i.e., different from—the

FDA’s dete

rmina tion that the product was suitable for use.” Dist. Ct. Op. at 20. This timely appeal followed.
II.
We have juris diction t

o hea r this appeal pursuant t

o 28 U.S. C . § 1291. Review of a district cou rt’s decision to grant a motion for su mmary

judgment is plen a ry. Goodman v. Mead Johns on & Co., 534 F.2d 566, 573 (3d Cir . 19 76 ), cert. denied, 4 2 9 U.S. 1038 (1977); Hilfirty v. Shipma n, 91 F.3d 573, 577 (3d Cir. 1996 ).
Summ a ry judgment is ap propriate only when there is no genu ine is sue as to
a ny materia l fact and the moving part y i s entitled to a ju dgment asa ma

tte r of la w. See Fed. R. Civ . P. 56(c); see also Armbruster

v. Unisys Corp., 32 F.3d 768, 777 (3d Cir. 1994) . In exam ining the

reco rd
, the court

gives the

nonmoving partythe b enefit of a ll reasonable

inferences from the record. Saldana v. KmartCorp., 260 F.3d 228, 23 2 (3d Cir. 2001); Gray v. Yo rk Newspap ers, Inc., 957 F.2 d 1070 , 1078 (3 d Cir. 199 2).
This Court als o exercises plenar y review overa d istri ct court ’s preemption determ ination, as it i s a quest

ion o f law. Travitz v. Northeast Dep’t ILGWU Hea lth & Welfare Fund, 13 F.3d 704, 708 (3d Cir. 1994), cert. denied, 5 1 1 U.S. 1143 (1994); Michael v. Sh iley, Inc., 46 F.3d 1316, 1 321-22 (3d Cir. 19 95).

III.
At issue i s whether

Hor n ’s suit agai ns t TCI, alleging caus es of act ion

u nderPennsylvania common law, i s expressly preempted. We nee d not examin e the doctrine o f implie d preem ption, because the Act

under which the FDA pree mp ted the s tate c auses of action containsan expres s pr eem ption clause, which obviat

es any reference to the doctrine of impli ed pr eem

ption. The express preempti on clause, 21 U.S .C. § 360k(a), p rovides: [N]o State or poli tica l subd i vision

of a State may establi sh or continu e in effect with re sp ect to a d evice intended for

hum a n use any requirement –

(1) whi ch is differe nt f

rom,
or in additi on to, any req uirem ent applica bl e underthis cha

pter to t he-4-

device, and

(2) which relates to the safetyo reffectiveness of the de vice or to any other matter inc luded in a requirement

applicable to t he device und er thi s chapter.
In this case, Horn contends that her st ate common law claims would impose generally applic ab le dutie s to use good

carein manufacturing and to warn users of the product’sattenda

nt risks. They

would not, she argue s, im pos e spec ifi c requirements with resp ect to th e HeartMa t e. Paragra

phs 15 and 16 of Horn ’s C omplaint set forth the gravam en of her actio n as follow s: 5 15. . . . The c ontinual pumpi n g action of t

he TCI HeartMate, together with natural body movements, causedthe wear

ing away of the suture so pla ced , and

once th e suture was worn through, said m

ovement of th e pump caused the screw ring to bec ome unscrewed.

16.Had the s c rew ring been of an appro priate an d f easible desi gn which woul d not permit the screw ring to beco me unscrewe d a s a resultof pump mov ement,
or had something more durable than a sut

ure be e n used to securethe tightened

screw ring
, or had the threadedsleev e with the eyelet been placed in such a way that the retaining suture did not run acro ss the interi or portion of

the screw 5 The FDA has summari zed Horn’s claims in the following manner:
[P]la inti ff makes t wo main claims: first, t hat TC I should have em

ploy ed a [suture] des i gn to prevent the screw rings used to hold the devi c e in plac e inside the pa t ient’schest fr

om becomi ng di sconne cte d (pla inti ff asserted that T C I overl o oked bette r alternatives to the design it chose); [and] sec ond, th at TCI should h ave issued warnings to docto r s , thro ug h either revisions in the product la beling or

corres pond e nce to health

care professio nal s (commonlycalled “Dear Doctor letters”), against using the de vice if t he

su ture as plac ed in the de v ice packaging would face the p atien t’s st ernu m.

FDA Amicus Curi

ae Letter Br. at 4- 5.-5-

ri ng direct

ly beneath t

he under s ide of t he st ernu m, the disconnection which ultim ately c aused Mr

. Ho r n’s death would never have occur

red.

TCI responds that Horn’s state c omm on l aw claims would i mpose stat e requirements that are specifical l y applicable to the HeartMa te, a nd a s such are expressly preempted.
Horn relie s on Medtronic v. L ohr, 518 U.S. 470 (1996), a Sup reme Court

case which involve d the FDA’s approval of a pacem aker. I n that cas e, whi ch we discuss in more detail later, th e FDA’s approval of the devic e did not r esult in pre empti on of the plain tiff Loh r’s sta t e law claims becaus e the appro val process involved in that case was not t he sa me detailed approval process that was employed by t

he FDA to app rove the HeartMate. In Lohr, the FDA determined that the pacemaker was “su bstantially equivalent” to an existing FDA-approved device pursuant t

o § 510( k) of

the Act, and therefore did not undergo the far more thoroughand ri gorous PMA approval process under § 360e(c ) of the Act. It was this l atter

ty pe of approval

that the HeartMa te rec eived.
Th e FDA, in its Amicus Cu ria e Letter Brief to this C ourt, contrasted the § 510(k) “sub stanti al equiva lenc e” approva

l p rocess with the § 360e(c) PMA pro ces s as follows: A manufactur e r can obtain an FDA finding of ‘substantial

equivalence’ by submit ting a pre-market notifica tionto the agency in accordancewith Sect

ion 510(k) of the [Act]. 21 U .S.C. § 360(k). A de vic e found to be ‘substan ti ally equivalent’ to a p re dicate device is said to be ‘cl eared’ by FDA (as opposed to ‘approved’ by the agency undera PMA). A prem a r ket notificatio n submitted under Sect

ion 510(k) i s thus entirely differ ent from a

PM A
, whi c h must includ e data suffic ient to demon strate to FDA that the device is sa fe and effective. See L ohr, 518 U.S. at 478- 79 (“ The § 510( k ) notification process i s by no m

eans com parabl e to the PMA process.”).

The number o f medical devices that

receive PMA review each year i s dwarfed by t

he nu mber of tho se that are ma

rketed pursuant to clea red Sect ion 510(k). In fisca

l y ear 2003, for exam ple, original PM As represented

only 54 of the 9,872 major submissi o ns received. The previous fiscalyea r, original PM As-6-

accounted for 49 o f 10,323 total submissions. 6

As it conce

rns the HeartMate, TCI contends that beca

use it r ece ived F

DA approval of the Hear

tMate t hrough the PMA process , and not under the “substan tial equ ivalenc e” cle aranc e standardof § 510(k), and because Horn’s readingand analysis of

the “specificity ” of the state law requirement in Lohr is flawed
, the Lohr decis ion is no t controlling . We agree.

IV.
This Court has address ed the is sue of the Act ’s express preem ption before, and those decision s guide us h ere. In Gile

v. Optical Rad

i ation Co rp., 22 F.3d 540, 541 (3d Cir.), cert. denied, 513 U.S. 965 (1994), the plaintiff

brough t asta te
comm on law product s liability and negligence action against an intraocula r lens manufacturer. We d etermined in Gile that state comm

on law claims may im

pose state “req uirem ents,” as that t erm is used in § 360k(a) of the

Act, and that t he state law requirements wer

e pree mpted by

the FDA. Id. at 541-42

. Thereafter, in Michael v. S hiley, Inc., 46 F.3d 1 316 (3d Cir. 1995) , the recipi ent of a heart

va lve b rought an action aga inst the heart valv e manufacturer

for negligent manufacture and design, st ri ct pr od uc ts li ab il it y, breach of implied warr anty of merchantability

and fitn e ss for a part

icular purpose, br

each of express warranty , and f

raud o n the F

DA. Id. at 1321. The heartvalvemanufacturer argued that the

Act preempted a

ll of the plaintiff’s claims. Id. at 1322. On the issue of pree mption, we stated th at: [S]ecti o n [360 k(a) ] p re-empts only sta t e impo sed require ments

. Further, it pre-empts those requirements only when they differ from

or add to a previously established

FDA requireme nt

and relate to th e s afety or effica cy of the regula te d device. When a state law differs f

rom or adds to an FDA requirement and when a state law rela

tes to the safety or

effectiven ess of a device approved by

the FDA, the st ate law is pr e-em pted. Conve rsely
, w hen a state law neith e r impose s requirementsnor differs from or adds to an FD A req uirem ent no r relate s to the sa

fety or effectiven ess of the device

or to any other matter inc luded in an FD A requirement, the state law is not pre-empted by

§ 360k.

Id. at 1323. We concluded that Michael’s cl aim s fo r n eg li ge nc e, st ri ct li ab il it y, breach of implied warrant ies, a nd fraud on 6 FDA AmicusCuriae Letter Br. at 12 (emphasis add ed).-7-

the FDA were pre empte d. Id. at 1325-31. 7 Most significantl

y, we held tha

t the PMA process, as well as the

labeling and “good manufac turing” requirements to which the heart valve was sub jected, c o nstituted properbases for pre emption under § 360k(a). Id. at 1324.
Th e following year, t

he Suprem e Courtdecided Med tronic v. Loh r, 518 U.S. 470 (1996). In that case, to which we referr ed earlier, t

he plaintiff asserted

comm on law negligence and strict liability claims and st ate law d e fectiv e manufactureand mislab elin g cla ims against the ma

nufacture r of a pacemaker that was given FDA clearance under the § 510(k) “ substant

ial equ ivalence ” process. Lohr’s complai nt st emmed from a de fec tive l ead in h er p ace ma ker

. A plural ity

of t he Lohr Co urt held that Loh r’s claim s aga inst th e
m a nufactur er of the § 510(k) -approved pacemaker were not p reem pted. K ey to th is holding was t he plural ity ’s opini on that t he § 510(k) proc ess does not impose any federal “req uirement ” appli cable t o the device, but is rather

a “g en eric f

ederal stan dar d.” Lohr, 518 U.S. at 486-87. The Lohr Court did not

consider

whether the

more rig orous PM A p rocess unde r § 360e(c )

— as dist inct f rom the § 510(k) process

— consti tutes “a speci fic feder al regulat ion of the prod uct” 8 (in this case the HeartM ate), which, i n turn, imposes st rict FDA requ i r ements upon t h e
manu facturer. 9

7 Michael’ s claims for brea ch of express warranty (base d on the heart valve’s packaging material s) and frau d (based on the manufac turer ’ s adve rtisements a nd promoti ona l materia ls), neit her of which we re the subject of the FDA’s PMAapproval, were held not to be p reempted because th ose claims ari sing o ut of priva t e representations—as d i stinct from state requirements—were merely st ate- enf orce d

comm on law remedies , and not stateim p osed comm on law rem

edies. 46 F.3d at 1325-31. 8 Mitchell v. Colla gen Corp
., 126 F.3d 902, 911 (7th Cir. 1997 ).

9 Most circuits ha ve foll owed Justi ce Breyer ’s concurrence i n Lohr, which sugg est s that § 3 60k (a) pre emp ts
some, but not all, commo n law claims. 518 U.S. at 506 (Breyer, J., concurring);

se e, e.g., M artin v. M edtr oni c, 254 F. 3 d 573 (5t h Ci r. 200 1); Brooks v. Howmedica, Inc
., 273 F.3d 285 ( 8th C ir. 2001 ); Kemp

v. M edtr oni c, In c., 23 1 F.3d 2 16 (6th C ir. 2000); Mitchell v. Collagen Corp
., 1 26 F.3d 902 (7th Cir . 1997). Where the federal requir ement at issue is spec ifically applic able to a particular d ev ice, Justi ce Breyer concluded, any s tate common law claim impli cati ng that de vice is pr eempted. Id. at 505

. Justi ce Brey er concurred with the plurality’s decisi on that a common law claim against

a § 510(k)- approved devi ce is not preempted, because § 510(k) does not

impose a feder al requir ement that

is spec ifically app licable to a part icular device

.-8-

1. The Feder

al Requirement
A. General Analy sis of the Federal

Requirem ent
The pr im ar y elem

ent distinguish ing Lohr fr om t he instant case isthe fact that the H ea rtMate received FDA approval throughthe rigorou s § 3 60e(c) PMA process, not thro ugh the § 510(k) “substantial

equivale nce” proc ess. The Lohr decisi on did not addre ss the issue of whether the PMAprocess imposed federal requirements under § 360k(a). I

t suggest ed, however, that

the anal ysi s would h ave been sign ificantly different if the device at issue in Lohr had weathereda more exacting federal investi gation, such a s the PMA p ro cess. Lohr, 518 U.S. at 501. Indeed , the Lohr p luralitydist ing uish ed th e case fro m “ a
case in which the Federal Government has weighed the co mpe ting inte restsreleva

nt to the part

icular requirement in question, reachedan unambi guo us conclus ion about how those competin g consider ations should be resolved in a par ticula r case or
se t of cases, and implem ented that conclusi on via a specific mandate o n manufacturers or producers.” Id. Furthermore, in response to t he pacemaker

manufacturer’s a rg ument that Lohr’s s tat e common law cla ims were preempte d by the FDA’s “goo d manufac turing practi ces” r egulati ons, 21 C.F.R. §§ 820.20-820.198 (1995), and by the FDA labeling reg u lationsrequiring devices to carr

y wa rnings, 21 C. F. R. § 801.109 (1995), the Lohr plurality state d: the fe d eral requirements

[imposedunder § 510(k)] reflect im porta nt bu t entirelyge n eric c oncerns about device regulation ge ne ra ll y, not the sor

t of

concerns r egarding a specific de vice or fi eld of device regulation th a t the statute or regula

tion s were designed to pr o tect fr

om potentiall y con tradic tor y state requirements.

518 U.S . at 501.
We h o ld that the requ irements imposed by the FDA up on the Hear tMate when it wa s gr anted PMA approval are precisely“the sor

t of concernsregarding a specific device” which the Supreme Court intimated would give ri se to pr

eem ption under § 360k(a). This porti on of our d ecision in M icha el v. Shiley, Inc., 46 F.3d at 1324, remain s unc hanged by the Lohr decisi on. 10

10 In re Orthopedic Bone Screw Prods. Liab. Litig
., 159 F.3d 817, 825 (3d Ci r

. 19 98 ), is no t t o t he co nt ra ry. Orthopedic, a § 501(k) case , in dealing with the alternate h oldin g of Michael respec ting the cla

im o f frau d on the

FDA, concluded that L o hr had overrul ed the alternate holding without af f ecting t he preem ptionde t ermination or any other holdings of the Michael opinion

. Thi s aspect of Orthoped ic c ame into quest ion-9-

In this case, the HeartMate’s PMA pr oces s began in 1 975 wh en its basic design was com pleted. In 19 8 5, after ten yea rs of live animal and human cadaver studies, the HeartMate was granted an investigationaldevice exemption (“IDE”) by th e FDA in order to begin clinical trials. Over the next seven ye ars, clinica l trials of the Hea rtMate were conducted at various hospitals. Du ring this period, TCI sub mitted mo re th an ni ne ty supplements t o the FDA, andt he FDA made numerous i nquiries about the He artMat e andit s clinical trials, incl

uding correspondence concerning a leak from the Heart Mate’s

screw ring and approval of s ubsequent design changes ( i .e., t

he additi on of the bonding agent and s uture). In 1992, TCI submitted its PMA a pplicat

ion to the FDA, and supplem

ented it in the ens uing th ree y ears with a subst antial amount of amendments and re spons es to FDA q uestions. In 1994 , after exte nsiv e review of TCI’ s applica tion, the FD A approved the HeartMate for co mme rcial sale in the form

spe cified in the applica tion.
There is no dou bt that, as a pr act icalreality, the PMA process imposed requirements t hat we r e specifically applicable to the Hea rtMate, and that triggered p reempti on under § 360k(a). It

imposed mandatory condi tions

—creat ed through

a decades-lon g process of correspond ence, clinical test in g and device alter

ation — p er taining t

o the HeartMate’s manufacturing, pa ckaging,

s torage , labeling, distribution an d adverti sing. See 21 C.F.R. §§ 8 1 4.39, 814.80 (setting forth requirem ent that PMA approval be obtained before device

ma y be manufactu red or marketed, a n d method for sup pleme nting PM A application). Other

Courts of Appeal have held that PMA appr

oval b y the FD A constitutes approval of the product’s design, testin g, intend ed use
, manufacturing method s, pe rformance standar ds and labeling that is speci f ic to the product. See Brooks v. Howmedica, In c., 273 F.3d 785, 795-96 (8t h Ci r

. 2001); Kemp v. Medtronic, Inc., 231 F.3d 21 6, 2 26-27 (6 th Cir. 200 0); Mitchell v. Collagen Corp.
, 126 F.3 d 902, 9 13 (7th Cir. 1997). But see Goodlin v. Medtronic, I nc. 1 67 F.3d 1367, 13 77 (11th Cir. when the S upr eme Court in Buckman Co.

v. Plain tif fs' Legal C

omm. , 5 31 U.S. 341 (2001), held that

a fraud on the FD A claim brought as a state cause of act ion was impliedlypreempt

ed wi t hout expres sing any vi ew on whether such a claim was expressly preempted

by § 360k(a). See id. at 348 n.2.

See also M artin v. M edtr oni c, 254 F.3d 573, 583 (5t

h Cir. 2001) , which held that Lohr

did not ove rrule the Fifth Circuit’s prior preced ent establis h ed in Stamps v. Collagen Corp., 984 F.2d 1416 (5th C ir . 1993), and that the state law claims asserted in Martin were pre empte d.-10-

1999). 11
B. The FDA’s Position 12 While we acknowle dge that t he FDA’s interpretation of statute s that it has been charged b y Congress with enforcing

11 The Eleventh Cir cuit was al one among the Courts of Appeals when it ruled in Go odlin that § 360k( a) does not preempt

common la w cl ai ms i nvo lv in g PMAapproved dev ices

. Goodlin, 16 7 F.3d at 1368. The Tenth Circui t has ruled that t he Ac t did no t preem pt a plaintiff’s common law tort clai m agains t a medical de vice

ma nufacture r, but the de vice at issue i n that case did not under go the § 360e(c ) PMA analysis, but rather u nderwent the far less rigor ous Invest igati ve De vic e Except io n (ID E) p roc ess. Oja v. Howm edica, 111 F .3d 782 (1 0th Cir. 1997).

12 The dis s ent in its footnote 2 argues that the F DA’s posit ion on preem ptionis entitled only to “near indifferen ce,” thereby

contendingthat

we should disrega

rd theFDA’s interpr

etati on of Lohr as well as its unique

qualific ation to d eterm ine whethe

r its r egulati ons and i nterpre tation of the FDA sta

tute (21 U.S.C. § 360k (a)) fulfill the purpose s and objectives of Congress. In deny ing t he import of the FDA’s position, which it has particularize d in it s Amicus Brief with respect to the HeartMate, the dis sent has not given wei g ht to the instruct ion furnished to us by the Supreme Cou rt in Lohr. ThatCourt stated that “Con gress has given the FDA a u nique role in determ ining the scope

of § 3 60k’s preemptive effect.” Lohr, 51 8 U.S . at 495- 96. Here, the FDA ’s positio n has been expr ess ly authoriz ed by

the Solic itor General of the Uni ted S tates. Justi ce B re yer was pres cient in acknowledging the FDA’s position when he wrote: Th e . . . FDA is f

ull y
r e sponsi ble fo r admini stering the [A ct]. Thatresponsibilit ymeans inf orme d ag enc y involvem ent and, therefore, specialundersta

nding of the likelyimp act

of b oth state and federal requirem

ents, as well as anundersta

nding of whether (or th e extent to which) state

requ i rements may interfere with federal objec ti ves. The FDA can t ranslate the s e understan dings int o particularize d pre-em

ptive intenti ons accom

panying its

v arious rul es an d

re gula tions. It ca n
com municate thos e intentions, for ex ample
, through state ment s i n regulations, prea mb l es , interpr etive state ments , and responses to co mments.

Id. at 505-06 (Br

ey er, J. , con cu rring in p art) (internal citations an d quotatio n s omitted).-11-

is not fully dispositive o f the issues here, the Supreme Court has instructed us that the FDA’s preemption

determinati ons are sig nificant

and sho uld inform

our interpreta tio n of § 360k(a). I ndeed, the S upr eme Court’s decision in Lohr w a s “su bsta ntiallyinformed” by the FDA , in the context of

§ 510(k ). Lohr, 518 U.S. at 495. Hence, we h ave no hesitati on in looking to the

FDA for its int erpretation of § 360k(a) in the medic al device con text. Lohr state d:
The FDA re gul ation s interpr eting the s cope o f § 360k’s pre-emptive effect supportth e Lohrs ’ view, and our interpr etati on of the pre- emp tion st atute i s substantially inform e d by thos e regulations . . . Congress has given t he FDA a unique r o le in determinin g t he sc ope of § 360k’s pre-emptive ef

fect .

. . [I]n most ca ses a state law will be

pre-empted only to the extent

that the FD A ha s promulga

ted a relevant federal ‘requ i rement. ’ Because th e FDA is the federal a g ency t

o which Congress has deleg a ted its authority to imp l ement

the provisionsof the Act, the agency is uniquely qualified to determ ine whether a part icular form of state law stands as an obsta c le to the

accom plishm ent an d e xecut ion of the ful l purposes and objectives of Congress, and, therefore, whethe r it should b e pre-empted.

Lohr, 518 U.S. at 495-96 (internal citations and quotations omitt ed). Horn, in her brief before us, relied hea vily on an FDA amicus cur iae sub miss ion filed wit

h the Suprem

e Court in opposition t

o certi orari in Smiths IndustriesMedical Systems, Inc. v. Kernats, 522 U.S. 1044 (1998). However, those views havebeen e xpres sl y disclaime d and rejec ted by the FD A in its AmicusCuriae Letter Brie f to this Cou rt. I n its cur

rent bri ef, the FD A ha s unequiv ocallyexpr e ssed the opinion that state common law claims such as t hose made by Horn against a PMA-ap prov ed device are preempte d. With great parti cular it y, the FDA sp ecificall y addressedthe HeartMate an d c oncluded that because the device was the subject of PMA approval unde

r § 36 0e( c), and not th e subject of “substantial equivalence” clearance under § 510(k), the stat e law claims asser

ted by Horn are pr

eempt ed. 13

13 This i s the

FDA ’s p resent op inion

. See FDA Amicus Curi ae Letter Br., Horn v. Thoratec C orp., No. 02-4597 (3dCir. May

11, 2004 ). It is c onsiste nt with the FD A’s s tat

eme nt of in terest in Murphree v. Pacesetter, Inc., i n which it argued that PMA appr

ova l b y the FD A “triggers preem

ption o f a wide arr

ay of-12-

The FDA, when PMA approv al is granted, imposes federal requirements based on the highly de t ailed a

nd prescr iptive n at ure of the P MA process and the approval order that resu lts from it. In its Amicus Curi

ae Letter Brief at pages 23-24, th e FDA writes:
F D A can im pos e requirements by rule or order, regardless of whether

or not the requ irements

were initially suggeste d to the agency

b y a n outside party

. . . . Although the PMA appr o val order does not itself expressly reiterate all of the spec ifi c features th e devi ce’s de sign
, l abe ling, and manufa

cturing proc es ses must have, it specifically a

p proves as a matter of law those features set forth in t

he applicat

ion and binds themanufacturer to produce an d

market t he product in complia nce with the specifica tion s a s approv ed by F

DA. (emphasis added)

. The FDA also clearly dis tinguished the PMA process from the § 510( k) substantialequivalence process, which

was the subject of the Sup reme Court’s decisi on in Lohr, writing:

Unlike a sect

ion 510(k) clea

r ance, which

o n ly determines whether two pr oducts ar e sub stantia lly equivale nt , PMA approva l consummatesan exhaust

ive inquiry in to the ri sks and efficacy of a device. . . .

I n Loh r , no t surprisi ng ly, th e Cour t premised its holding against preem ptionon the fact that the device hadbeen cleared only through the Secti o n 510(k) process, a “lim

ited form of review.” Lohr, 518 U.S. at 47 8

. A manufacturer

may change the desi gn and labeling of a Section 510(k)-clea re d de vice as lon g as i t continues to be substan tially equivale nt to it s predicate. 21 C.F.R. § 80 7. 81. In direct contras t to t

he PMA

re gi me, FDA does not ‘approve’ change s to a Section 51 0( k)-cleare d device

. Rather, th e manufactur e r

simply has to requirements imposed under state tort law.” See Statem

ent of Interest in Support of Def e ndant Pace sette

r’s Pet ition for Certificatio n for Inter

locutory Appeal of t he United Sta

tes of Am

erica at 5 & 7 , Murphr ee v. Pacesetter, Inc. et a l, No. 005429-00-3 (Tenn . Ci rcuit Ct . Dec. 12, 2003).-13-

demonstra

t e that its device is still subst antiall y equivale nt t o its predicate. Moreover, the range

of changes that a manufacturer

can make t o a [§ 510(k)] cleare d device w ithou t gettingprior aut

hority from F DA is broader than for a [PMA] approved device. A manufacturer

of a cleared device mus t submit a Section 510(k) not

ic e to FDA only for changes that ‘could significantly

affect safetyor ef

f ective ness of the device, ’ or that

repres ent
a‘major change’ in the intended use of th e d evice. 21 C.F.R. § 807.81.

. . . Fo r[PMA devic es], afte r a ver y lengthy processinvolving t housands of p ages o f document ation and many hours of exp er

t analy sis, a

nd of t en including substantial give-and- take b etween t he agency a n d th e
man ufa cture r , FD A

a pproves a new device, includi n g de taile d specifi cationsfor its de sign, manufacture, performance, labeling, and use. Any

of these specifi cations may

be changed in [a] way that affect s safety an d effectiven ess onl y with FDA’s authori

zation.

Id. at 20-21 (emphasis added).
The dissent , in discussing Loh r v. Medtronic ( see Dissenting Op. at __), has ignored the very

salie nt fact that Lohr

was
a§ 510k “substantial equivalence” decisi on and not, as th is case is, a §360e(c) P MA case. We have discus sed the dramatic difference between these two approval processes in both Sections III and IV of this opinion. We ha ve emphasized that the PMA approval process ma ndates that t

he manufactu rer (in this case , TCI) produc e and ma rket the HeartMate in compliance, a n d only in

co mpliance, with the requ irements a n d specifi cationsappro ved by the FD A. This is a far cr y fr om the § 510k process which

was the s ubjec t of Lohr, and which notably the L ohr

Court held wa s “by

no
meanscom

pa rable to the PM A process.” Lohr, 518 U.S . at 478-79

. Thi s significant d istinction is understand ablyabs ent

from the dissent’s discuss ion beca

use, as we point ou t in this

o pinion, any effort by

Horn to pro ve he r ge neral com

mon law claim s of negligence, labeling or deficien t desi gn would necessaril ydif

fer from , or add to, the des ign, manufacturing or l abelin g approved and pre-em

p ted by the FD A. S ee 21 U.S.C . § 360k (a); 21 C. F. R. § 808.1(b) ( see p . 17 , infr a, for text

of regulation); Kemp v. Medtroni c, Inc
., 231 F.3d 216 (6th C ir. 200 0); Mitchell v. Collagen Co rp., 126 F .3d 902 (7 th Cir.-14-

1997), Papi ke v. Tambra nds, Inc., 107 F.3d737 (9th Cir. 1997), and Micha el v. Shi ley, Inc., 46 F.3d 1316, 13 23 (3d Cir. 1995). Thus, the District

Court’s pos ition, the FD A’s p osition, and our position are all in accord: the FDA’s PMA approval of the HeartMate impose d s pecific federal requirements upon the HeartMate under § 360 k(a) which, aswe explain infra , preempts Horn’s state co mmon law claims. Cf. Hawkins

v. Lesl ie’s Poo l Mart, Inc., 184 F.3d 244, 250-51 (3d Cir. 1999) (holding tha

t labeling c la ims were preempted

by sim ilar preem ptionclause in Federal Insect icide, F ungicide an d Rodentici de Act becau s e, in contrast to § 510(k) approval, the EPA had incorp orat ed specific labelin g requirements that coul d not be chang e d without pre-approval).
2. The State

Requireme nt
A. General An alysis of the State Requirem ent
The remain in g issue is whether Horn’s state commo n-la w claim s constitute state requirements with respect to the HeartMate which are differe nt f

rom,
or in addition to, the federa l requirements. See 21 U.S.C. § 360k (a). As we noted

e arlier, it is firml

y es tablished that a “requirement” u n der § 360k(a) can include legal requirements that ar ise out of state common-law damages actio ns. See Gile, 22 F.3d at 541- 42. Co ns eq ue nt ly, the only matter that we must resolve is whether § 360k(a) p reempts the particular stat e c ommon l aw claims brought by Horn.
The only state requirements

asserted by Hornare general requ irements

s temm ing from st

ate com mon law: the HeartMate was desig ne d in a defec tive manner, it

wa s manufa

ctured in a defective manner , a nd the manufacturer had failed to war n of the alleg ed defects. The thrus t of Horn’s Complaint was that had the screw ri n g been of a bet ter and

morefeasible design and had somet h ing

moredurable t

han a sutur

e been use d or had the th reade d sleeve with the eyelet been placed differently

in Mr. Horn’s bo dy, his death would not have re sulted. 14
Horn has never

claim ed tha t Pennsylvania has e stablished a requir e ment

of specifi c device

content pertaining to the Heart

Mate

. 15 She has

ne v er alleged that Pennsy

lvania requires all suturesfor the Hea rtMate to be fabricated

from a substance

different than the s uture which the FDA has a pproved.

14 Horn do es not allege th a t TCI failedt o comply with the requirements imposed by the FDA when it approve d the HeartMate. At oral argument, counsel for Horn twice s tated t

hat Horn wasnot
makin g such an allegati on. Tr. at 7:20- 8:12 & 10:12-14.

1 5 Pennsylvania’s only medic a l devic e requirements whic h are specif icall y exempt from preemption ari se u nder the Pe nnsylvania Hearing A id Sale s Registr ation Law, 35 P.S. §§ 67 00-5 04(4), 6700-506, 6700-507(2), se e also 21 C.F.R. § 808.88.-15-

Nor has she e

ve r all eged that there are specific requ iremen ts ma nda ted by the Comm onwe alth of Pennsy

lvania a s to how

amedic al devi ce su ch as the HeartM ate
m ustbe fabric ated or de signed o r implanted

within the

patient ’s bod y

. Indeed, if H orn had alle ged an y “requirement” simi lar to these it wou ld have been fatal to her claims , because each of them would h ave either been in ad diti on to, or different from, the federal requirements impose d throughthe FDA’s PMA approval of the HeartMate.
In the absence o f any specific dev ice requirements, 16 we are left wit h Horn’s general common law claim s o f negligence, defective d esign, e tc. The question that rema ins is: can Horn’s

comm on law “general” c l aims, which are not specif ic “with r

espe ct to” the HeartMate, constitute “requirements” that survive preemption under § 360k(a )?
Our analysis begins, as it must, with th e Lohr

decisi on. Both Horn and TCI, as well as the authoritie s that ha ve
cons id eredFDA preemption under § 360k(a), have und erst andably re a d Medtronic v. Lohr

as a st arting point for interpr eting § 360k(a) and

t he FDA’s regulat ions at 21 C. F.R . § 808.1(d). 17 Th eyh ave also considered the im pact upon the F D A’s PM A approval o f a medical device when general state tort la w
c laims allegi

ng ne gligence, desig n defects, fa il ure to warn, and the like, are file d ag ainstthe ma

nufacture r of the devi ce

. See, e.g., Martin v. Med tronic, 254 F.3d 573 (5th Cir . 2001)

. In Lohr, the plaintiff sued Medtronic for

negligent

manufacture and failure to warn, essen tiall y the same claimsHorn has brought against TCI. The fourj udge plurality

in Lohr concluded that those claims “ esca

p e[d] pre-emption, not because the source of the duty is a judgemade commo n -law rule, but rather because th ei r g en er al it y l eav es them outside the category

of requirements that

16 In her Ju ne 200 4 Letter Brief at 10, Ho r n wrote: “In this case, Ms. Horn does not rely on any devic e-s pecific requirements. ” 17 21 C.F.R . § 808.1 (d) provid es: State or l ocal requirements

are p re empted only

when the Food and Dr u g Adminis trati o n ha s
e s tabli shed spec ifi c counterp a rt

regulat ions or there are other sp e cific requirements applica

ble to a particu l ar device unde

r the act, thereby

maki n g any existing divergent

State or loca l require ment s applicable to the de vice di fferen t from, or i n addition to, the specific F ood and Dru g Admi nist ratio n requirements. . .-16-

§ 360k envisione d to be ‘wit h r esp ect to’ specific devices such a s pacemakers.” Lohr, 518 U.S . at 502. AlthoughJustice Breyer joined in the secti on of the plura

lity ’s op i nion in which that statement appeared , he wrote separatelyto e mphasi ze that , unlike t he plura l it y, he was “not convinced that future incidents of [§ 360k(a)] pree mption of common-law c laims will b e ‘f ew’ or ‘rare.’” Id. at 508 (Breyer, J., concurring in part). As we read Justi ce Breye r’s concurring op i nion, a state

comm on law cla

im nee d not be developed specifically “with re spect to” a particular medical device in order to be

preem pted. It would make little se

nse for J usti ce Breye r to write separately t

o em ph asize that d uties arising under stat e law can reg ularly lead to pree mption, bu t simultaneously agree with the plurality that tort duti es are

almos t alway s too general to warrant pr eemption. See Papike v. Tambra nds, Inc., 107 F.3d 737, 742 (9th Cir. 1997). The more logical readin g o f Justic e Brey er’s c oncurring opinionis tha

ta court shou ld carefully examine the st ate common law claim in order to determine wheth er th at c laim would impose a substanti ve requirement that conflicts with, or adds a greate r burden to, a specific f ederal requirement. See Mitchell v. Coll

ag e n Corp., 126 F.3d 902, 911-1 2 ( 7th Cir. 1997); Kemp v. Medtronic, 231 F.3 d 216 , 230 (6th Cir. 20 00); Martin v. M edtr oni c, 254 F.3d 573, 581-83 ( 5th Cir. 2001)

. The dissent

citesto Alexand

er v. Sando val, 532 U

. S. 275, 285 n.5 (2001 ), forthe proposition that the lower federal courts do not g i ve “much precedential weight” to a concurr

ing opinion of the United States Supreme Court, even where the concurring opinion is compatible with the majority opinion. See Dissent ing Op. at ___. We disagree, as this principle has

no ap plication to th is case. Sandoval bears little resemblanc e to the situation in Loh r. In Sando val, Justice Scalia merely observed that the

op inio n of a threememb er concurrence in Lau v. Nich ols, 414 U. S . 563 (1974), wa s not binding precedent on an issue th at the f

ive-mem ber majorityin Lau did not reach. In Lohr, by contrast, Justic e Brey

er cas t theso- called “swing vote, ” wh ich was cruc ial to t he out come of the case an d with out which there cou ld be no majority . Moreover, JusticeBreyer did not

discuss issues in h is concurring opinion that Justice Steven s, writ ing on behalf of the four-judge plurality , did not re ach. Sp lintered

opinion s by the Suprem e Courtoften result in some confusio n as to which opinion or ra

tionale is binding on the lower federalcourts. In an att empt to providesome guidance in such situation s, the Suprem

e Court hasinstructed that the lower courts shou ld follow the rationale “taken by those M e mbers who concurred in the ju d gments on the n arrowest ground s.” Gre gg v . Georgia, 428 U.S. 153, 169 n.15 (1976) (p lu rality opinion);

see also Marks v. United

States, 430 U.S. 188, 192-93 (1977) (stating that, “[w]hen

afragmented Court decides a case and no single rationale explaining the r esult

en jo ys the assent

of five Just

ices, ‘the-17-

holding of the Court may be viewed as that position taken by t hose Mem

bers who

concurr ed i n the judgme nts on the narrowest ground s . . . .’ ”); Planned Parenthood

of Southeastern Pa. v. Casey, 947 F.2d 682, 693 (3d Cir. 1991) (discus sing in det ai l the “narrow est ground” princip l e), modified on other ground s, 505 U.S . 833 (19 92).
If the “na rrowest ground” approach is applied t

o Lohr
, Justice Brey

er’s op in ion takes on added significance. Wh ereas Justic e Stevens

conclude d that “ § 360(k) simpl

y wa s not inte

nd ed to preempt most, let alone all, gener

al commonlaw duties enforced by

damages actions,”

see Lohr, 5 18 U.S. at 491, Justice Brey er concluded that “ordinar

ily , insofar

as the [FDA] pre-em

pts a st ate requirem

ent embodiedin a state sta tute, rule, regulat ion, or other

admini strat

ive action, itw ould also pr

e-em pt a similar requir emen t

that take s the

form of a standardof care or behavior imposedby a state-lawtort action.” Id. a t 504-05 (Brey er, J., con curr ing in part and dissent ing in part). Thus, Justice Brey er’s rationale is the more nar r ow of the

two because, although the Lohrs’ claims were not preem pted by § 360k( a), he was not preparedto join in Ju sti ce Stevens’ sweepingpronouncem

ent that § 360k almost never preempts a st ate comm on law c laim.
Of course, the splintered decision in Lohr is unique b ecause Just ice Breye r joined in some parts of Ju stice Stevens’ plural ityopinion (thus making it a majorityopinionat times), but did not join i n other par ts. Our di ssenting collea gu e emphasizes t hat Justice Breyer joined in Part V of the plurality

opinion, in which JusticeStevens con cluded that th e Lohrs’ common-lawclaims did not con stitute sp ec ific state requirem

ents because they

were not “specifically

devel o ped ‘with respect to’ medica

l devices.” Lohr, 518 U.S. at 501. Thiswas not aprinciple that received Justice Brey

er’s agreem

en t. In his conc urr ing opinion, Justice Breyer states that he m ust a ddres s twoissues : (1) whether the FDA can “ever pre-empt a state-lawtort action;” a nd (2) if so, whether the F DA p re-emp ts th e clai ms brought by Lohr. Id. at 503 (Bre yer, J., concurring in part and dissenting in part).

In response to th e firstqu estion, JusticeBreyer expre ssly state s that he “basi cally agre e[d]” with Justic e O’Connor’s discussion of that point in her dissent ing opinion. Justice O ’Connor

co nclu ded that

“a fa ir r eading of [§ 360k(a)] indicates that st

ate comm on-law claims are pre-empted, as the statu te itself states, to the ext

ent that the

ir rec ognition would impose

‘any requirement’ different fro m, or in a dditi on to, FDC A

re qu irements applicable to th e device.” Id. at 512 (O’Connor, J., dissenting). In te re st in gl y, Jus t ice O’Conn or also observed that “[t

]he stat ute its elf ma

kes no menti on of

a re qu ir em en t o f s pe ci fi ci ty, and there i s no sound basi s for determ ining that sucha rest

ricti on on ‘any requirement’ exists.” Id. Thus, on the sta t e requir ement issue, JusticeBreye

r joined with the four--18-

member dissent to make a ma jo ri ty. 18 It

seems that he merel

y par t ed ways with Just ice O’Conn or when it came time to apply that ra

tionale to the st ate commonlaw claims (in a § 510(k) context) before the Court.
Alth ou gh in Lohr

the plurality opiniondid not in f

orm us of when

comm on law re qui remen ts may bec ome substant ive requirements, we are satisfie d that Horn’s general stat

e law c laims 19 would impose s ubstanti

ve require mentson TCI that would conflic t with , or add to, the requi rem entsimp osed b y

the FD A invo l ved in the des ign, ma nufacturing, fabrica tionand labeling of

the HeartMate. For exampl e, Horn’s Complaint alleges that the HeartMate w as negligently desi gned such that the scre w ring cou ld come unsc r ewed in spite of the presence of the su ture. This claim unq uestionably woul d require TCI to alter th e HeartMate’s design by using either a d ifferent suture or screw ring. Y et th e HeartMate ’s design asapproved by the FDA would remain appro ved by the FD A for national distri butionand sale , andany changes to the d esig n would require further FD A review an d approv al. 20

18 This can be c haracte rize d as a “dual majority” case b eca use Justice Bre yer joined with t

he plural ity on th e result( i.e., no pre-empti o n), but joined with the dissent as to the ra tionale ( i.e., a state com

mon l aw c la im can be preempted by § 360k ev en thoug h itwas not specifically developed “with respect to” a particular medical device). See Note, The Precede nti al

Value of S upreme Co urt Plurality Decisions, 80 C olu m. L . Rev. 756, 767-69 (1980) (d iscussing dual majority cases).

19 Horn emphas ize d in her June 2004 Letter Brief at 7 that “the claims i n this ca se are

based on st

ate la w claims of general applicability, not requirements specific to dev ices.” 20 The Pr oduct Liability Advisory Council w rites in its amicus curiae brief: Even su p posing o ne jury could providemanufacturers with proper incen ti ves to make its produ cts safer, whatabout ever

y jur y? If the PMA proces s does not preempt state product li abilit

y s uits [and general common law cla im s] imposing require ments at odds with the approv e d PMA, th en juries in every state will influen ce devic e regulat ion, in numer

ous and of

ten conflict ing ways. See B roo ks [ v. Howmedica, Inc. ], 273 F.3d at 797 (“Theargume

nts advanc ed by Brooks ignore the need for national uniformity in product r

egulati on,
one of the expli cit goal s of the MDA.” (citing H.R. Rep. No. 853, 45 (1976) (“If a substantialnumber of dif fering re quirem ent s applicable to a medical device are imposed by jur isdict ions other than the Federal gov ernment, intersta t e
commerc e would be und ul y burde n ed.”). Unless prod ucts liabili tyclaims [and genera l-19-

As TCI has pointed out in its brief, “[Horn’s] design defectclaims . . . would require TCI either to u se an entirely different des ign than th e screw ring to connectthe ou tlet elbow to the pump, or to use differ ent materials inst ead of a suture, or to place the eyelet in a different position. Similarly , her failure-to-warn claims would req ui re TCI to pr ovide different warn ing s and inst

ructionsfrom those approved by the FDA.” TCI Br. at 45. TCI is prohi

bi ted , however, by t

he FDA’s PMA approval orderfrom making any such chang es. See 21 C.F.R. 814.80. 21 Becau se these state c ommon law claims and duties are in sev ere tension wi th § 360k(a) in that they a re either i n addi tion to, or different from, the federal requirements established by the FDA in approving the HeartMate, they are
nece ssarily preem

pted by federall y imposed PM A requirements under § 360k(a). 22 See, e.g., Kemp , 231 F.3d at

comm on law claims ] such as plaintiff’s are pre empte d, t he FDA’s expert determinatio ns will be supplante d by a

my riad of

comm on law regul ators, each on e les s likely than t he FDA to reach a right result.

21 21 C.F.R. § 814.80

provides that

adevice may not be manufactu red
, labele d, etc. in a manner

inconsistent w ith any conditionsto approval

specifi ed in the PMA approval or

der. TCI would have to submita suppl e menta

l PMA applic ation setting forth itsproposed cha nges and seekingFDA appr o val of tho se changes. 21 C.F.R. § 814.3a (d). If the FDA were to reject TCI’sappli cat

ion, T CI woul d be left in the untena

ble and unenvi able po siti on of having to comply with conflicting state and fe der al requi

reme nts; precisel

y t he conflict the § 360k(a) pre empti on provision is meant to avoid. 22 S imilarly, H orn’s clai m respecti ng TCI’s negligence in not furnishinga ‘Dear

Doctor’ letter

“warning that the heart pump shouldn’t be installed if t he sut ureswould fa

ce upw ard, towa

r d the st er num,” Horn, June 2004 Letter Br. at 9 , is preempte d as it woul d either add to, or differ from, the federal requirement establishing t he design of the HeartMate. See Mitchell v. Colla gen Corp
., 126 F. 3 d at 913 -14 (“[T]o the

extent t hat [the Mitchell s’ misl abeling, misbr anding and adulteration] allegati ons claim t ha t Collagen has incurred liabilityunder state law despite

its confor

mity to the requirements of the PMA, the stat e law claims must be

considered preempted.” ). Insofar as Horn’s claim

is premise d

on the adequa

cies of t

he warnings reviewe d and approved by the FD A in its PMA approval or

der, it is als o preem

pted. See Martin, 105 F.3d at 1100 (“ To allow

astate caus e of action f or inadequ ate warnings w ould im pose differen t
r equirements or requirements in a dditi o n to those required by federal regulations.”). The PMA includ es s pecim ens of the la beling proposed to be used for t h e device, 21 U.S.C. § 3 60e(c)(1)(F ), and this labeling must provide “adequ ate dir ections foruse.” 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 preem ption concl

us io n is reenforcedby t

he informed analysis found in the FDA’s amicu s curiaebrief. The FDA has clearly e xp ressed its view that PMA approval in this p ar ticular case requires preemption. The FDA conceives of Horn’s state comm

on law claims as imposing a “requirement” wh ich is “differen t” from tha

t impos ed by

the FD A in the PMA proce ss, and t hus requir

ing preem ption. I n it s Amicus Curi ae Letter Brief, 23 the FDA wrote:

. . . Here , plaint

i ff seeks to impose l ia bility based on asserted flaws in the design, l abeling a nd manufactu re of th e HeartMate a s approved by FD A de spite the fact that it

com plied w ith FD A require ment s. Thu s , plaintiff does a tt empt to impose a requi reme n t diff erent f rom [th e requirement impose d by ] FDA. . .

Ther e is no allegatio n that the HeartMate’s design, labeling , or met

hods of manufacturedevia

ted fr o m those set fort

h in the PMA approved by FDA

. Ac co rd in gl y, any finding of liability base d

upon TCI’s failure to satisfy a stan dard differ ent from thos e approved by FDA i n the PMA process woul d necessarily re s t upon an implicitrequirement that this d ev ice be de signed, manufactured

o r marketed in a way tha t differs f

rom the wa y appr oved b y FDA. (emphasis added)

. With respect to the impact o f state

comm on law tort claim s on the federal regula tory framework fo r medical devices, the FDA wrote:

State c ommon law tort actionsthreat

en the statutory framework for the regula tion of medica l devices, particularly with regardto FDA’s review a nd

a ppro val of produc t labeling. Sta t e actions are not characteri zed b y centra lize d exper t evaluat ion o f devic e PMA ap pro val expresses the FDA’s determ ination that the prop ose d labeling
me ets the detailed labeling requiremen t s set forth in its re gulations . Any changes in t he design, labelin g or manufac turin g proces ses that affect safetyan d effectiven ess must

receive FDA app roval.

23 FDA AmicusCuriae Letter Br. at 17-18.-21-

regulatory

issues . Inste ad, th ey encourage, and in fact require, lay

judge s and juries to second- guess the balancing of b e nefits a nd risks of a s pecific dev ice to the ir intended p atien t population

– the central ro le

o f F DA – somet

imeson behalf of a single individual

or group o f individ uals. That i n d ividualize d

re determinatio n of th e benefits and ri sks of

a productcan r

esult in r eli ef – includingthe thre at of

s ignifica nt damage awards

or penalties – that cre at e s pressu r e on manufacturers to ad d warnings t

hat FD A has neither ap proved, nor found to be scientifically

r equired, or withdraw al o f FDA- approv ed product s fro m the market in conflict wi th the agency ’s expert dete rmin ationthat suc h products are safe an d effective. This situation can harm the public

health by retardin g researc h an d developm ent a nd b y encouragi ng ‘d efensiv e labeling’ by manufacturers to a v oi d s ta te li ab il it y, resulti n g in scientifically unsubstan tiated

warning s and underutil izati on o f beneficial treatments. Id. at 25-26. 24
The FDA’s view s in its Amic u s Curiae Letter Brief in th is case e cho the opinionit has voi ced in ano therrecent
case. In a brief su bmitted to the C ircuit Courtof Tennesse e in Murphree v. Pacesetter, Inc., et al., the FDA expressed

concernsabout the consequence s of not preempti ng state comm on law claimssuch as Horn’s: [I]t

is inapprop riate for a j ur y t o second-gu ess FDA’s scientific judgment

o n such a matter that i s within FDA’s particular expertise. FDA determines the scope of a device, includingthe components it

com prises, and th e appropriate re gulat or y pathway fo rthe device. . . . FDA su bsequen t l y de term ines whether th e device meets t

h e PMA approval standar

d. The agency makes a r easoned and deliberate decisio n as to

24 Martin v. Telectronics Paci n g S ys. , Inc., 105 F.3d 1090 (6th Cir . 1997) (“Thus, because under the federa l requirement

the FDA has determined that the be nef its of the device out

weigh the risks and, under the sta te requirement, a juryin a state court

action could concl

ude that the risks outweigh the ben ef its, t he state requi r ement

is differ ent from the federal requ irement.”).-22-

the corr ect pathw a y of regul at ion and wheth er to approvethe device. J uri es lack the s c i enti f i c knowledgeand technical expertise necessary

to make such jud gments. . . .

[ T]he prospect

of hundre ds of individua l juries determining th e pr opriety of particula r de v ice approvals , or the appropriate standards to apply to those a

pprova ls, is the antithesis of the ord e rly sche me Congress pu t in place and ch arge d the F

DA with im pleme nting.

Such uncer t ainty

as to the sta t us of medical devices would crea te chaos for bo th the regulate d indus try and FDA.

Statem ent of Int e rest of the United States of America a

t 7-9 , Murphree v

. Paces e tter, Inc. et al, No. 005429-00-3 (Tenn. Circu it Ct. Dec. 12, 2 003).
As we discussed ea rlier, a majority of the Court in Lohr

emphasized that t h e FDA is “uniquely

qualifie d” to deter

mine whether apart icul ar for m of s tat e la w .

. . should be pre-empted” b y § 360k. Lohr, 518 U.S. at 496. Horn contends, however, that we should giv e no w eight to t he FD A ’s inte

rpretat ion be caus e the

FDA previously argued tha

t PMA approval did not support p reemption, and in any event, the FDA’s inte

rpreta tionis entitled only to “near indifference.” See Dissent ing Op. fn.2 an d Maj. Op . fn.12, supra. We cannot a gree that the FDA ’s position is entitl ed to no deference, or “near indifference” simply because it represents

a dep arture from itsprior position. In ChevronU.S.A

. Inc. v. Natural Resources Defense Council, In c., 467 U.S. 837, 863- 64 (1984), the

Supreme Cou r t held that a revisedin te rp re ta ti on by an a gency is entitled to def ere nce becaus e “[a]n i nitial agency interpret at ion is not in stantly carvedin st on e. ” A cc or di ng ly, an agency may change i ts course so long as it can justify its cha nge with a “reasoned analysis,” s ee Motor Vehicle Mfr s. Ass’n v. State Farm Mut. Auto. Ins. C o., 463 U.S. 29, 42 (1983), and we are fully pers uaded that this standard has been met. 25

V.

25 See United States v. Mead Co rp., 533 U.S. 218, 228 (2001) ( “The weight accordedto an admini strat ive judgme

nt in

aparticular ca se will

depend upon the thoroug hness evident in its consider ation, the va li di ty of its reasonin g, it s consistency

with ear lier and la te r pronou ncements, a nd all those factors which give it power to persuade, if lacking powerto control.”) (inter nal cit ations a nd quotations omitted).-23-

Horn has not as serte d that TCI has in any way failed t o con formwith the FDA requirements prescrib ed by its PMA—nor that it devia ted from , or viol ate d, any of the FDA’s federal statutes or r e g ulations. Because the de sig n of the Hear tMate, the labeling and the instru ctions for it s use, and the s peci fica

tion o f the su ture and its locati on when the HeartMate is im planted,

as well as the other requirements imposed by the PMA, were the

subject of extensive consider ation by t he FDA leading up to its PMA approval, any finding in Horn’s favor based on her general claims of negligence or defectiv e d esign and manufac ture—be

it by a ju ry or a court—wo uld necess arily amount t

o a state substantive req uirement “d ifferent fro m, or in additi o n to, the federal requirements impose d by the FDA.” Any such finding w ou ld “stand as an o bstacle to the a ccom plis hment and

exec ution

of” t he ob je ct iv e o f t he sa fe ty a n d effective ness of the HeartMate specifically and would co nfli c t with the federal requirements impose d by

the PMA. Geier

v. American Ho nda Motor Co. , 529 U.S. 861, 873 (2000). If, as we hold, th e FDA’s e x press preem ptionclause foun d at 21 U.S .C. § 360k(a) pre-empts Horn ’s s t ate law claims, then there is no point in dis cussing “implied preemption,” a doctrine which

our dissenting colleague addresse d at length in an attempt to bolster h is conclusi on that Lohr, a § 510(k) opini on, governs th i s case. See Cipollone v. LiggettGroup, Inc., 505 U.S. 504 (1992) (“When Congress has consider ed theissue

o f pre-emption and has included in th e
enac ted legislation a pro vision exp licitly addres sing that issue, and when that provision provides a

relia ble indic ium of congressio nal intent with resp ect to state
au th or it y, there is no nee d to infer congressional intent to pre- emp t state laws from the substanti v e provisi ons of the legislation.” ) (citations and in ternal quotationsomitted). We thereforedo not address the dissent’s ar

guments p redicated on “implied preemptio n.”
As a consequ ence

we, t ogeth er wit

h

our siste r 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 Hor

n’s cla ims a re preempted by § 360k(a). We will affirm the judgme

nt of the District Court g ran ting summary judgment to TCI.

26 See Brooks v. Howmedica
, Inc., 273 F.3d 78 5 (8th Cir. 2 001); Martin v. Medtro nic, Inc., 254 F.3d 573 (5th C ir. 2001); Kemp v. Medtronic, In c., 231 F.3d 216 (6th cir. 200 0); Mitch el l v. Collagen Corp. , 126 F. 3 d 902, 913-14 (7th Cir. 1997); Papike, 107 F.3d 73 7, 742 (9 th Cir. 1997).-24-

Barbara E. Horn v. Thoratec Corporati on , No. 02-4597

FU EN TE S, Circuit

Judge , dis senti ng. Following her husband’ s death, Barba ra Horn filed al aws uit in the U.S. Distri ct Cou rt , u nde r s ta te co mmon la w, alle ging that her husb and d ied as a result of TC I’s defectively designe d heart pump. In her complai nt, s he alle ges that the suture on M r. Horn’s HeartMate had worn through and that t

he screw ri ng linki ng the pump to the output s ide had di sconnecte d. As a resul t, a n air embol us travel ed to M r. Horn ’s brain, causing hi s death. The majo rity has con cluded tha t Horn’s common-law c laim s, g rounded i n neglige nce and d efec tive de sign, cre ate “spe cific requir ements” under stat e law and are the ref

ore preempted by§ 360k(a) of the MDA . I cannot

agree, however, tha t Horn ’s gen er al iz ed c ommon -l aw cl ai ms impos e any spe cific sta te-la w “requirements” on t he H eartM ate. This is because § 360k(a) pr eemption works only against stat e requir em ents th at are “differ ent from, or i n additi on to” feder al requirements. In my view , because H orn’s suit is not se ek ing to im pose any spe cific requir ement on the Hea r t Ma te, it i s not preempted. Additional ly, I beli eve that allowing co mmon -l aw li ability wo uld simp ly have the effe ct of enc our agi ng TCI and other devi ce manufactur ers t o go above and b eyond F DA stand ards, an d this effectwou ld c learl y not contradi ct the MD A’s purpose of enhanci ng medical device safety. I the refor e resp ectfu lly dissen t. I.

I ha ve no quarrelwith the majority’s co nc l us i on t ha t t he PMA process is a spe cifi c federal regulat ion governing the HeartMate. 27 I beli eve, how ever, that t

he Distr ict Court

erred by looking only at whether the fede ra l regulat ion here (t

he PMA ) was spec ific to

a parti cular de vice, and not examini ng whether the state law un der wh ich Ho rn sued was device-s pecifi c. Horn arg ues that a s tat e com mo n-law claim is preempted only if

the state claim is devi cespec ific and the pu r portedl y pr eempting federal regulat

ion is devi ce-speci fic. TCI responds that the Distric t Cou rt correc tly

ana ly zed only the f edera l side of th e equati on, because Medtronic, Inc. v. Lohr
, 518 U.S. 47 0 (1996 ), made that t he o nly releva nt inq uiry. The Circu its are spl it on t his que stio n, wit

h t he Sev en th an d Ni nt h Ci rcu its holding t

hat pree mption requi res only a dev ice-sp ecific federal regulat ion, M itchell v. Coll agen Corp. , 126 F.3d 902, 912 (7th Cir. 1997) ; Papike v. Tambrands Inc. , 107 F.3d 737, 742 (9th C ir. 1997); and the T enth C ircuit ho ld ing that

27 For this reaso n, th e ma jori ty’ s discuss ion of the differenc e between the PMA process and the § 510k “substantial equivalence” processis not relevant. Maj. Op. at 13. T hat differe nce only speaks to why the PMA pro cess is a specific federal requirement; my dis agreem ent with t

he majorityis not over

the feder al side of the equation at all , but rat

her ov er whether Horn’s suit implica

tes the state- law specifi city

requirement in Lohr

.-25-

preempti on additi onally requir es a devicespec ific state law

. Oja v. Howm edica, Inc. , 111 F.3d 782 , 789 ( 10th Cir. 1997 ). Although my coll eagu e s acknowledge

som e kind of

stat e-law speci fici ty requ ireme nt, they effe ct ively agre e w ith the Seventh and Ninth Circ uits in holdi ng that even the most generalized tort claims, such a s thos e in the case b efore us, are preemp ted unde r § 360k (a).

I respectfully

dissent from this conclusi on. The FDA r egulat ion s
conc ernin g p reempti on clari fy t ha t preempti on only occu r s wh en th e FD A “has establ ished spec ific counterpa rt regulat ions or there are othe r spec ific requ ireme nts applic ab le to a parti cular device un der the a ct.” 2 1 C .F.R . § 808.1(d) (em phasis a dded) . Th e preempti on clause doe s not “pree mp t State

or local requir ement s of genera l app licability where the pu rpo se of the

re qui re me nt relates e ither to o ther pr odu cts in additi on to devic es (e. g., [ the UCC]) or to unfair t

rade prac tice s in w hich the requ ireme nts ar e no t limit ed to dev ices .” 21 C.F.R. § 8 08.1(d)(1) (em phasis add ed). In 1996, the Supreme Court is sued Lohr
, a frac tured o pin ion that e xamined MDA preempti on of stat e law

. The majo rity of the Lohr Court agr ee d that a strong presu mp ti on ex ist s in favor of a

narrow scope of preemption because polici ng health is th e tradi tionalprovince

o f the s tates . 518 U.S

. at 485. Another key fa ctor in anal yzi ng the scope of preempti on is Congress ’s intent in passi ng the legis latio n. Id. at 485-86 . The C ourt split, how ev er , a s t o wh ethe r t he MDA pre e mpted st at e co mmon- la w cl ai ms

premised on the unsuit abili ty of a medical dev ice under state standar ds more stringent than t he FDA standards governi ng the device. Justice Breyer agree d with a f ourJusti ce bl oc (Stevens, Kennedy, Sout er and Ginsburg) that the term “ requ ireme nt” in § 360k(a) is ambiguous, and does not en tail the preemp tion of all com mon -law tort sui ts holding manufact urers t o higher standard s than the F DA

. Id. at 488-89 (Stevens, J., pluralit y ( herei nafte r “plurality”)) 28 ; id. at 505-06 ( Brey er, J., concurri ng (herei nafter “B r eyer ”)). The remaini ng four Justices disagr eed, opining that § 360k(a) bar s all stat e-law cla ims, common-law or oth erw ise, that h old

m an ufacturers to a highe r sta ndard than f e deral reg ulati ons

. Id. at 511-12 (O’C onnor, J., concurri ng i n part and dissenting in pa rt (hereinafter “dissent”)).
The plural ity

and Justi ce Brey er turned to th e above-quot ed FD A

re gu lati ons to help de termine when a common-law claim const i tutes a s tate “requ ireme nt” under § 360 k(a ). Id. at 498- 99; id. a t 505-06 ( Breyer ). Rel yi ng on these regu la tions , the five Jus tice s concluded th atpr eemp tion i s on ly tri ggered by spe cifi c FDA regulations apply ing to a parti cular de vice, and not by

28 To be prec ise, I will only use the term “plurality” in reference to port ions of JusticeStevens’ s opinion in L oh r that

were joined by

only four Justi ces. The portions of the Lohr

opinion joined by

five Justices wi ll not be acc ompanie d by a ny parenthetical reference.-26-

gene rally ap pl ic ab le FDA regulations, i.e., t hose gov erning the de sign o r labeli ng o f medical devices a s a whole. Id. at 500-01. Part V of the plura lit y opi nion, whic h Justi ce Breyer

joined, also st ated that the MDA does notpreempt gener aliz ed stat elaw clai ms, such as negl i genc e in manufacturi ng or fail ure to warn, as opposed to st at e l aws governing par ticul ar
me dica l dev ices

. Id. at 501-02. Thus, Part V of the Lohr opinion, which repres ents t

he vie ws of five Justices, exce pt ed general ized commonlaw clai ms like fa ilur e to warn and neglige nt manufacture fr om the ambit of MDA pr eemp tion. Id. at 501-02. The Lohr majo rity reasoned t hat “gener al state common-law requir ements” that “w e re not spec ifically developed ‘ with r es pect t o’ medical dev ices

. . . are not t he kinds of requ ireme nts tha t C ong re ss an d t he FDA feared would impede the ability of federal regulators to imp lem ent and enfor ce spec ific fed eral r equ irem ents .” Id. at 501. Here, Horn’s four cl aims of negl igence, stri ct li abili ty , breac h of warranty and failure to war n are all ge neral c ommonlaw tort clai ms that were not craft ed speci fically t o govern medicaldevices, and

so are except ed from the sc ope of § 360k(a ).
This concl usion i s bolst ered by the FDA regulat

ions on pre emption, reli ed upon by the Lohr majority. As mentioned above, the FDA has declare d that preempti on only occ urs w hen th e FDA “has establ ished spec ific counterpa rt regulat ions or there are othe r spec ific requ ireme nts ap pli cable t o a parti cular device un der the a ct.” 2 1 C .F.R . § 808.1(d) ( em pha sis ad ded ). Th e regulat ions go on to say that “there are oth e r State a nd local requir ements tha t affectdevices that are not preempt ed by [§ 360k(a )] be cause they are no t ‘requ ireme nts applic able t o a device’ with in the meaning o f [§ 360k(a)] ,” id.
, and lis ts as a n exa mple “ State or local requ ireme nts of g enera l applic ability wh ere the purpos e of the r equirement relates eithe r to ot

her product s in addi tion to dev ices (e.g ., [the UC C]) o r to un fair trade practic es in w hic h the req uirem ents

are not limite d to dev ices .” 21 C. F.R . § 80 8. 1(d)(1). This refe rence t o the spec ificity of state regu lations w ould be superfl uous if all thatmatter ed was the spec if ici ty of the feder al regul ation. Mo reover, the exempt ion of general ized state requ ireme nts is never qualif ied by the further cond ition tha t those r equire men ts infri nge on a genera lized federa l requ ireme nt. Fina lly, the regula tions b elie my col leagues’ conclusi on that ge nerali zed state requ ireme nts can be pr eem pted if they merelyaffect t

he manufacture of medical dev ices

. See Maj. Op. at16 -18 (sta te-l aw claim is pr eempted if i t has t he effectof imposing a gr eater burde n on a device man ufac turer th an the FD A). In short, the regul ations support t he view that stat e-leve l devic e-spe cificity is a requ isite for § 360k(a) preempti on.
TCI argues that the FDA has publis hed regulat

ions cont

ravening t

he state specifi city

requir ement, but

the cite d regulat ions only stat e that

in the context

of

a particular C a lifornia la w “general-27-

requ ireme nts no t applic able to spec ific devices . . . are not pr eempted unless they

are appli ed to a spec ific device i n such a way as to establ ish re quirement s” for an FDA-regulated device. 45 Fed . Re g. 67321, 673 22. Thu s, gen eral req uirem ents

are still not preempted u nder t his regulat ion; the on ly state requir ements tha t

are preempted ar e ones that affe ct spec ific devices. Even if TCI’s i nterpr etat i on of t his statem ent w ere co rrect, on e isolate d stat ement in the Fe de ral Re gister w ould not trump the a ctual regulat ions cont ained in the C .F.R ., especiallywhen those

re gulati ons ha ve be en ad op ted by t h e Supreme Court as i nstruc tive. 29 The mai n argum ent ag ainst the state sp e cificity requir ement rest s in the language of Justi ce Brey er’s c oncurrence in Lohr . A fter j oining Part V of the Stevens opin ion, Ju stice B reyer w rote sepa rately that co mm on-la w claim s cou ld in fact be pr eempted where the y i mpo se d differe nt standard s fo r device s than t he count erpart device- speci fic FD A regulations. Lohr , 518 U.S. a t 504 (Breyer). Justi ce Brey er rai sed the

exam ple of a juryfinding f or a plai ntiff

in

a neglige nce suit

on the grou nds th at a hearing aid wire was l onge r t han 1 inch,

even th oug h FDA r egulations h ad approved wire s up to 2 in che s. Id. Justi ce Breyer conc lu ded that this jury award

wo uld be preempted eve n thou g h it was based on th e gen eralized state tort la w of neglige nce because i t effe ctive l y estab lis hed a device- specifi c stat e requ ir em ent of 1-inch wir es for hearing aids

. Id. My collea gues have fou nd th is language from Justi c e Bre yer diffic ult to

recon cile with hi s a gr eeme n t with P art V of the majority

opinion, which exempted general ized stat e c au ses of action from preempti on. M aj. Op . at 16. T he S even th and Nin th Circui ts al so percei ved a contradi ctio n and chose to i gnore Justice Breyer’s vote for Part

V, inst ead credi ting th e a ppar ently con trary reaso ning in his

concurrenc e. M itchell , 126 F.3d at 912; Papike
, 107 F.3d at 742. With all due resp ect to my co ll ea gue s a nd t he se two Circu it Courts, however, I do not belie ve that Justi ce Breyer’s conc urren ce is in di sa gr eeme nt w ith Part V of the majo rity 29 My colleagues seem to put great emphas is on the

FDA’s ami cus br

ief, whi ch sides with TCI. Horn a nd Amicus ProductLiability

Advisor y Council have also both ad van ced argum ents from previous United States briefs on t he scope of 360k(a) preemption as evidence i n favor of t heir view s on pree mp tion. As TC I ha s itself pointed out, however, arguments adv a nced by the United Stat es in a liti gation bri ef are entitle d t o “ near indifferen ce,” and are onl y a s persua sive

as theirown merits dictate. United States v. Mead Corp. , 533 U.S. 218, 228 ( 2001) (cited in TCI Br. at 52). Notably, t he Lohr

c ou rt gave deference to the FDA’s regulations in parti cular, not to an am icus brief. 518 U.S. at 495- 96. Co ns eq ue nt ly, I believe that Lohr

mandates that

we obey the regulations issued

by t he FDA, rather than the am

icus br ie f relie d upon by t

he

ma jo ri ty.-28-

opinion. 30 Justi ce Breyer’s opi ni on s how s concern that in certain si tuations a st at e could fash i on, t hro ugh its co mm on l aw , a spec ific requ ireme nt for a parti c ular device. For e xam ple, a p laintiff c ould sue under a theory of negligen ce per se, w here the negligence is premise d o n deviat ion fro m a specif

ic st ate re quirement

fo r a device (like a 1-i nch hearing aid w ire). Sim ila rly, a judg e cou ld give a ju r y inst ructi on tell ing the jury tha t, as a matt er of law, i t shoul d fi n d a manufacture r neglige nt if it vi olated a certai n st andar d for a device ( i.e

. , “ you shoul d find the manufacturer

neglig ent ifit used a heari ng aid wir e longer t

han 1 inch”) . Both of these e xa mples invol ve a speci fi c requir ement being imposedupon a device b y the s tate th rou gh i ts co mm on l aw . A simp le neglige nce action , in contras t, doe s not impose any specifi c requir ement on the device, but si mply al leges t hat the devi c e
wa s de sign ed/m anu fac ture d im pro per ly.

In this case, be ca use Ho rn’s su it is not se eki ng t o i mp os e any sp ecific requir ement on th e H eartM ate, it i s not preemp ted. It is t

rue that Horn’s cause of acti on may have the indir ect consequence of holding the HeartMate to a hi gher standard than does t

he FDA, bu t t his consequence is sanc tionedby Part V of the Lohr opinion and not

expressl y bar

red by Justi ce Breyer ’s concurrence. Mor e over,
even if my colle agues were corr ect that the content of Justi ce Brey er’s c oncurrence 30 My coll eagu es find i t incongruous that

Ju stice Breyer would “write separatelyto emphasize that duties arising under state la w can regularly lead to preemption, but sim

ultaneously

agree with the plurality

that tort duties are almost alway s too gene

ra l to warr

ant preemption.” Maj. Op. at 1 6. Not only is this an overstatement of Justice Breyer’s language (“I am not convinced

that future incidents o f MDA pre-em ption of common-lawclaims wil l be ‘few’ or ‘rare’”), it also depicts a false conflict : the plurality expresse d its views on the freq u ency of preemption in Part VI of its opinion, which Jus t ice Breyer explicitly ref us ed to join. Lohr , 518 U.S. at 508 (Brey er). Indeed, the f act that J u stice Breye r expli cit ly declined t

o join Pa rt VI of the majority

opinion highlights his clear intent to join Part V in full. Sim ilarl y, the majoritysomehow turns Justice Brey er’s agreem ent with the Lohr

dissent that “t he MDA will sometimes pre-empt a state-law tort suit,” i d

. at 503 (Breyer) (emphasis added)–a state ment tha t I entirely

agree with–into an agreement wit h the Lohr dissent’s stateme

nt that there is no stat

elaw specificity

requirement whatsoever

. Id. at 512 (disse

nt) (quote d in Maj. Op. at 17). To the con trary, Justi ce Breye r endorsed a state-l aw specificit y requirement

by joini ng Par

t V of Jus tice Stevens’s opinion , and this requ ir em ent theref or e “enjoy s the as sent of five Justices.” Marks v. United States , 430 U.S. 18 8, 19 2- 93 (1 97 7) . A cc or di ng ly, the “n arr owest ground” approach evoked by the ma jority is sim ply inapp l icable to evadethe h olding of Part V of the Lohr opinion.-29-

co ntradi cted Part V, t

he correc t cours e of acti on wou ld be to fo ll ow Par t V as the majo rity opin ion o f the S upre me C ourt, notto e levat e a one-j usti ce concurr ence
a bov e the f ive- justic e m ajor ity. Cf. Alexander v. Sandoval , 532 U. S. 275, 285

n. 5 (2001) (c oncurrence is not given as

mu ch prece dentia l weig ht as m ajority opinion, even if concurrence is com patible wit h m ajor ity opin ion ).
Fi na lly, even if Ju stice Breyer’s

concurrenc e we re give n equ al we ight to Part V, this juri sprudent ial “ tie” should be broken by r eference t o the p re sumption against a wide scope of

pre em ptio n. Lohr
, 518 U.S . at 48 5. TC I a rgue s that this presu mp tio n has sinc e been disc arded. How ever, all of the cas es TCI cit es for that proposit ion eithe r (1) fou nd th e pr es ump tion irreleva nt b ecau se th e language was clear, Sprietsma v . Mercu ry Marine
, 537 U.S 51, 62-63 ( 2002) ; Crosby

v. Na tional F oreign Trad e Co uncil , 530 U.S. 363, 374 n. 8 (2000); or (2) f ound the presumpti on inapp licable to the parti cular statute in question because it di d not deal with a traditio nal p ro vi nc e o f s ta te la w, Buckman Co. v. Pl ai nt if fs ’ Le galComm. , 531 U.S. 341, 347 (2001); United States v. Loc ke
, 52 9 U.S . 89, 108 (20 00). In

conc lu sio n, I would foll ow Part V of the Lohr opinion, as I fee l we are bound to do, and hold that

a stat e common-law claim is pr eempted only if it estab lishes a spec ific requir ement for a particular device, rather than alle ging breac h of a g enera lized d uty of care

. Accordingly , the District Cou rt’s finding of express preempti on should be revers ed. 31

II.
Be ca use I would find no express preempti on here, I w ould rea ch TC I’s impli ed pree mption argument , an d

con cl ude that Horn’ s clai ms are not implie dly pre em pted

. Implied preemption

can exist in e ither of two situations : (1)

w h en Co ngre ss inten ded f edera l law to

31 TCI sugg ests in passingthat Part V does no t a ctually

require state- level device- spe ci fi ci ty, rel ying on the sentence : “Although

we do not b elieve that this statutoryand regulatory langua g e necessarilypr e cludes ‘general’ federal requirements from

ever pre-em pting state requirements, o r ‘general’ sta t e requirementsfrom eve

r being preempte d,

. . . it is impossible to ignore its

overarching concern t

hat pre- empti on
occur only where a particula r st ate require ment

threat ens to int erfere with a specific federal interest .” Lohr , 518 U.S.

a t 500. Thi s quot

ed la nguage , howe ver , only states that the relevan t st atutory and regulatory

texts do no t com

pelthe statelevel specificity

requirement, but that t

he Lohr majority inferred the state- s pe cificity requirement fro m that languag e. Part V la ter makes it clear that stat e-level specificity is in fact a requ irement f o r pr eempt ion. Id. at 502 (“These state requirements therefore esca pe pr e

empti on, . . . because their g enerality le aves them out side the categor y of requirementsthat §360k envi sioned to be ‘with respect to’ spec ific devices”).-30-

occupy an en ti re fi el d of la w e xclu sively (“field preempti on”), or (2) w hen s tate law actua lly conf licts with federal law (“confl ict

pre em ptio n”)

. E.g. , Freightliner Corp. v. M yr ick , 514 U.S. 280, 287 (1995). Conflict

preempti on can in turn be sh own in two ways: (1) it is impossi ble for

a partyto com p ly with both fe deral a nd state requ irement s, or

(2) the stat e law frustrates Co ngr essio nal in tent. Id. Here, the only impli ed preempti on clai m at iss ue is the fru s tration prong of confl ict preempti on: TCI and Amicus Curiae U.S. Chamber of Co mmer ce ( “USCC ” ) do not argu e that field preempti on o r im po ss ib ilit y co nf lic t p re em pt io n a pp ly.
Since there i s no express language to relyon in a frustrati on confli ct preempti on analysis, the key fac tor to consider is, unsurpri singl y, Congressiona l purpose. E. g. , B arnett Bank of Marion Count y, N.A. v. Nelson , 517 U.S . 25, 3 1 (1996). As the Lohr court obs erved, t he purpose of

th e MDA w as to protect

consum ers by ensuri ng the safe ty and effect iven ess of m edic al de vice s. Lohr
, 518 U.S . at 476 . Con trary to USCC ’s and PLA C’s assert

ions, protect

ion of the medical de vi ce indust

ry from excessi ve regulat ion wa s a m inim al co nce rn. Id. at 490-91 (plura lity); see also id. at 476 (MDA w as m otivated by conc ern on the part of consumers and r eg ulator s, not indu str y). The plurality spe cifically discl aimed the ide a of a Congressi onal “fear th at prod uct liab ility actions w ould hamper the devel opment of medical de vice s.” Id. at 490 (plurality). 32 This cl early pro-r egu la to ry , p ro -c ons ume r safety purpose of the MD A compel s the

conc lu sion th at state comm on-law suits are not implie dly preem pted b y th e MDA. This conclusi on is supported by the presumpti on in favor of a narrow scope of preempti on, mentioned above. Mo reover, although the presence of an express preempti on clause ( § 360k(a)) do e s not

conc lusively rule out

impli ed preempti on, it does imply tha t “Co ngre ss did not int end to pre-emp t other matte rs. ” Myrick , 514 U.S. at 288.

None of TCI’s o r USC C’s argu me nts are pers uasive t oward finding impli ed preempt ion h ere. TCI r elie s on Buckman
, 531 U.S. at 350, for the proposit ion that t

he MD A allow s f or impli ed pr eem ptio n. Buckman , howe ver, found imp li ed p re emp tio n of a state-law claim that t

he defendant haddefrauded the FDA by se n di ng it fa lse § 501( k) equival ency informat ion. Id. at 343. The confli ct in Buckman exist ed because the MDA ha d g iven the FDA full power and discr etion to remedyacts of fraud perpetr ated on it; a stat e-law sui t seeki ng to prose cute fraud again st the F DA wo uld

nec es sarily conflict w ith the FD A’s discretionary decisi on to forego afraud prosecution aga inst its elf. Id. a t 349.

32 Justic e Brey

er di d notjoin the plurality ’s detailed discus sionof statutory purpose because he f ound it un necessary for analysis of th e ca se; he m ade no state ment a greeing or

disagreeing with it. Id. at 508 (Breye

r).-31-

Indeed, the Buckman court di sti nguished fraud-on- the-age ncy claim s from suits based on “tradi tionalstat e tort law princi ple s of the du ty of care,” which are the p rinc iples inv olv ed in this c ase

. Id. at 352

. TC I’s other ar gument, echo e d by USCC, is that al lowing state-law tort suits conf licts with fe de ra l l aw b ec au se it al lo ws ju ries to second-guess th e FD A’ s determi nation that th e PMA -approved device is saf

e. There i s not neces sari ly any conf lict, however, bet w een the F DA ’s allowing TC I to ma rket the He artM ate and

a stat e findi ng th at the H eartM ate is unsafe: th e natural way to reconcil e these two po s i t i on s i s t o s ee t he PMA process a s
a “floor” of minimum standards for Class III devices, but not a “ ceil ing.” Un der this vi ew, a state co uld still rais e the st andards of safety w it hin its ow n ju risdi ction

. Cf. Barnett Bank
, 517 U.S. at 31 ( federal law permitt ing banks to se ll i nsurance in sm all towns does not nece ssari ly con f lict with state law banning such sales, since fe deral law could be re ad as permit ting s ales to the extent that t hey ar e permitted by state law).

USCC argues that while Barn ett Bank rec ogni zed that there was not

nece ssarily a contra dict ion between federa l p ermissi on and stat e prohibi tion of a practi ce, Barnett

Bank produced a brigh tline rule t

hat feder al permi ssion t o engage in a prac tice pre emp ts state law liability incurr ed by engagi ng in that pr acti ce. A cc or di ng ly, USCC concludes, the FD A’s permissi on to marke t HeartM ate triggers frustrati on con fl ict preemption against Horn ’s suit dec laring th at the H eartM ate is designed defe ctively . USC C mischarac teri zes Barnett Bank
, h owe ver: the Supreme Court did no t l ay down any blanket rule on fr

ustra tion conf

lict preempti on, but m ere ly followed the normal proc edur e of lo o king to t he legislature’s intent

to de termin e if frustrati on confli ct pree m pt ion exis ted. Id. at 3 2-37. The Barnett Bank court concluded that a federal stat ute permi tti ng banks to sel l ins uranc e in smalltowns preempted a state st atute banning su c h sales because the purpose beh ind the federal statu te w as to em pow er b ank s. Id. Here, in contr ast, the MDA was not creat ed to empower indust ry , but t o protect

consum ers by ens uring sa fe devices

. Th us, the conf lict that ex ist ed in Barn ett Bank does not exi st her e.
Th e i nstan t case is a ls o dist ingu ishab le fr om Barnett Bank in that Barn ett Bank dealt

with a st ate’s outri ght statutory ban o f a pe rmitted practic e, wh ile there is no corresp ond ing ban her e (i.e., the stat e of Pennsy lvani a o utlawing h eart pum ps). In this case, TCI i s not prohibi ted from marketing the HeartMate, but must simp ly live wit

h the poss ibility of liability if t he He ar

t Ma t e doe s not liv e up to Pennsyl van ia ’s applic able st andards of

care. Althou gh th e ris k of liabili ty may adm ittedly be a deterrent to TC I’s marketi ng ef forts , the Supreme Court has held that t

he incide ntal regulat

ion incur red by liabi lit

y under general ly app licable s tate law is l ess int

rusive , and therefore l es s prone to pree mp tio n, tha n “direc t regu lati on on the opera tion of f ederal-32-

projec ts. ” Goodyear Atomic Corp. v. Miller , 486 U .S. 174, 185 -86 (198 8).
USCC also ci tes t o Poko rny v. Ford Motor Co. , 902 F.2d 1116, 1123-25 (3d Cir. 199 0), to supp ort its pro ffere d brig htline rule t

hat feder al permi ssion t o engage in a p ra ct ic e p re emp ts st at e l aw l iabi lity incurr ed by engagi ng in that pr acti ce. Pokorny
, however, is dist ingui sh able for the same reason as Barnett Bank : t h e purpos e be hind the fe deral re gulatio n in Pokorny was specifi cal ly to giv e autom obile man ufac turers f lexibility to choose to equ ip th ei r a ut omo bile s with manual safety

belts inst ead of automat i c belts and/ or airb ags

. Id. As H orn p oints out, the Pokorny co urt rejec ted the

manu facturer’s cl ai m t hat the regul ation also preem pted a claim based on a lack of p rotect ive netting, because ther e was n o evidence that

Congress or t

he Department of Transport ation c ontemplat ed protec tive nett ing when the regul ation wa s promulgate d. Id. at 1126. Indeed, the Pokorny court al lowed co mmon-law liability as a permis sibl e way fort he state to “‘encoura ge’ autom obile manu facturers to provide sa fety feature s in add ition to those l ist ed in” the fed eral r egu latio n. Id. Si m ila rly, in the i nstant case, a llowing

com mon-law liabi lit

y would si mply have the effect of e ncourag ing TC I and other device manufacturer s to go abo ve and bey ond FDA standards, and t his effec t

wo uld clearly no t co ntradict the M DA ’s purpose of enhancing medi cal devi ce sa fe ty. 33

IV.
Five Justices of the S uprem e Cou rt have joined a n opinion t hat requir es spec ific it y of state clai ms in ad dition to spec ific federal requir ements for t he trig ge ri ng o f p re emp ti on u nde r t he MDA. Spe cificity of state claims is als o mandated by th e a ppl ic ab le FDA regulat ions , to which we mu s t s ho w d ef er en ce

. My colleagues, how ever, h ave re jected both the bind ing ins tructio ns of t he S upr eme Cou rt in Lohr and the FDA regulat ions based on the ir pe rceptio n of a sing le Justice’s opinion i n Lohr and the F DA ’s current li ti ga ti on p os it

io n, to whi ch we
owe no deference. According ly, I must respe ctfully disse nt.

33 Of course, this only

show s that common-lawliabili ty i s in no way impliedly preem

pted by the MD A ; ob vi ou sl y, the express pr eemption clause does preem

pt some common-law liability for state standar ds above and

beyond FDA standards.