I N T H E SUPR EM E C O UR T O F M I SS I SS I PPI NO. 2 0 0 9 - CA- 0 0 5 9 4 - S CT W I LL I AM S ANDERS v. AD VA N CED N

EU RO M OD U

LA TION

SYST EM S, I NC. D A T E O F JU D G M E N T : 04/ 03/ 2009 TRI AL J UDG E: HON . J AM ES LAM AR ROBERT S , J R. COURT F ROM W HI CH APP EAL ED: LE E COUNTY CI RCUI T COURT ATT ORNEY F OR APP EL LANT: D. L. J ONES , J R. ATT ORNEY F OR APP EL LE E: LE AH N I CHOLS LE DFORD NATURE OF THE CAS E: CI VI L - P ERS ONA L INJ URY D I SPO SI T I O N : A FFIRM E D - 09/ 30/ 2010 M OT I ON F OR RE HE AR I NG F I L E D: M ANDAT E I S S UE D:

B E F O R E W A L L E R , C . J. , D I C K I N SO N A N D C H A N D L E R , JJ. CH AND LER, J UST I CE, FOR TH E COU RT: ¶1. T hi s c as e i nvol ves w hetheratr i al c ourte rr ed by gr ant i ng s um m ary j udgm enti n f avor of A dvance d N eur om odul at i on S ys t ems, Inc . (A N S) on the bas i s of f eder al pr eempt i on f

or a m edi cal devi ce r egul at ed by the U ni t ed St at es F ood and D rug A dm i ni s tr at i on ( FD A ) . T he cas e turns on w hetherage nui ne i s s ue of m at er i al f

actexi s t s as t o cl as s i f

i cat i on of

the devi ce. A medi cal de vi ce des i gnat ed as ac l as s I I de vi ce i s s ubj ectt o s t at e l aw , w her eas am edi cal devi ce de s i gnat ed as a cl as s I I I devi ce i s ent i t l ed t o f eder al pr eempt i on. ¶2. W i l l i am Sander s (Sande r s ) fi l ed a compl ai ntagai ns tA N S, N orth M i s s i s s i ppi M edi cal C e n ter , In c . (N M M C ), D r. B e n jam in W ise m a n , a n d Jo h n D o e s o n e th ro u g h fiv e in th e C irc u it

### Th e trial court do cket in dicates th at the trial co urt grantedam o ti o nto d ismiss in 1 

### favor of NMMC and Dr . Wi seman on May 2, 2008. Medi cal Devic e Am endm ent s of 1976, 21 U. S.C. § 360k (2006) . 2 

### 2 C ourtof L ee County, M i s s i s s i ppi . Sander s al l eged thathe had a n oper at i on on Sept ember 1 4 , 2 0 0 5 , at N M M C to rem o v e the leftlead o f a s p inal-co rd stim u lat o r. A sp inal-co rd s t i m ul at ori s f

ortr eatm entof

chr oni c i ntr act abl e pai n of the trunk orl i m bs . D r . W i s eman and N M M C pur chas ed the s pi nal - cor d st i m ul at orfr om A N S, the manuf actur erand di s tr i but orof the medi cal devi ce us ed i n the pr ocedur e. D ur i ng the oper at i on t o r emove the l ef tl ead of the spi nal- cord st i m ulat or, the produ ctbroke, al l eged l y cau si ng S and ers ’s i njury an d d am ages. Sander s ’ s caus es of ac t i on i ncl uded ( 1) negl i gentm anuf actur e of the s pi nal - cor d s t i m ul at or by A N S; ( 2) di s tr i bu t i on of a de f e c t i ve a nd dange r ou s pr oduc ti n c omm e r c e by A N S, N M M C , and D r . W i s eman; and ( 3) s tr i ctl i abi l i ty f ori nj ur i es r es ul t i ng f

r om the manuf

actur e, s al e, and di s tr i but i on of a def ect i ve pr oductby A N S. A N S f i l ed i t s ans w erand af

f i rm at i ve 1 d e fe n se s. T h e re a fte r, A N S filed a m o tio n fo r su m m a ry ju d g m e n t an d m e m o ra n d u m in s upportof

i t s m ot i on. A f

t erc onduct i ng a hea r i ng, the tr i al courtgr ant ed s um m ary j udgm ent i n f avorof A N S, f i ndi ng thatSander s ’ s cl ai m s agai ns tA N S w er e barr ed by the M edi cal D evi ce A m endment s ( M D A ) pr eempt i on cl aus e and thatA N S w as ent i t l ed t o j udgm entas a m a tter o f la w . F o llo w in g th is d e c isio n , S a n d e rs a p p e a led to th is C o u rt. 2 FACTS ¶3. A N S m anu factures a s pinal -cor d st i m ulat or kno w n as a G enesi sX P Im plant able P uls e G e n e ra to r S y ste m (G e n e sis X P ). T h is d e v ice u se s lo w -in te n s ity e lec trica l im p u lse s to i nt er f er e w i th pai n s i gnal s s entt o the br ai n t o pre ventpai n t o a pat i ent . W hi l e thes e devi ces2 1 U .S .C . § 3 6 0 c sta tes , in p a rt: 3 ( f ) I ni t i al cl as s i f

i cat i on and r ecl as s i f

i cat i on of

cert ai n devi ces ( 1) A ny devi ce i nt ended f orhum an use w hi ch w as noti ntr oduced ordel i ver ed for introd u cti o n into inte rsta te co m m erc e fo r co m m erc ial d istri b u ti o n b efo re M ay 2 8 , 1 9 7 6 , is cl assifi ed in class III u n less-- (A ) th e d ev ice-- ( i ) i s w i thi n a type of devi ce ( I ) w hi ch w as in tro d u c e d o r d e liv e re d fo r in tro d u c tio n in to i nt er s t at e comm er ce f

orcomm er ci al di s tr i but i on bef or e s uch dat e and w hi ch i s t o be cl as s i f i ed p u rsua n t t o su b sec ti o n (b) o f th is secti o n , o r (I I) w h ich w as n o t so introd u ce d o r de li v ere d b efo re su ch d ate a n d h as b e en classifi ed in class I o r II , and ( i i ) i s s ubs t ant i al l y equi val entt o anotherdevi ce w ith in su ch typ e, or 

### 3 m a y b e e ith e r p a rtially o r to tally im p lan tab le in ap a tien t, th e G e n e sis X P a t issu e is a to tally i m pl ant abl e devi ce. I n F ebruary 2005, A N S s entN M M C a G enes i s X P, a Q uattr ode l ead, and a Pa t i e ntPr og r a mm e rf orthe G e ne s i s X P. ¶4 . T he FD A r egul at es drug s a ndd e vi c e s p ur s ua ntt o the Fe de r a l Food, D rug, and C o s m e tic A c t ( th e F D C A ). See 21 U . S. C . §§ 301 t o 399 ( 2006) . I n 1976, the F D C A w as a m e n d e d w ith th e M e d ic a l D e v ic e A c t ( M D A ). See ( Pub. L aw 94- 295) ; 21 U . S. C . § 360c (2 0 0 6 ). T h e M D A c la s s if ie d m e d ic a l d e v ic e s in to th re e c a te g o ri e s , c la s s I , I I, a n d I II . See 2 1 U . S . C . § 3 6 0 c (2 0 0 6 ). T h e classe s a re d ist ing u ishe d a s class I g en era l con tr o ls, class II s p e c ia l c o n tr o ls , a n d c la s s II I p re m a rk e t a p p ro v a l. See U. S . C. § 3 6 0 c ( a ) ( 1 ) ( A) , ( B) , a n d , ( C) ( 2006) . T he M D A aut om at i cal l y cl as s i f i es a devi ce a s a cl as s I I I devi ce i f i thas been in tro d u c e d in to th e m a rk e t af terM a y 2 8 , 1 9 7 6 . See 21 U . S . C . § 360 c(f )(1) (20 0 6 ). 3( B ) the Secr et ary i n r es pons e t o a pet i t i on s ubm i tt ed under p a ra g ra p h (3 ) h a s c la s s if ie d s u c h d e v ic e in c la s s I o r I I. A devi ce cl as s i f

i ed i n cl as s II I underthi s par agr aph sha l l be cl as s i f i ed i n that cl as s unt i l the ef

f ect i ve dat e of

a n or derof

the Secr et ary underpar agr aph ( 2) o r (3) classifying the d ev ice in c lass I or II. 2 1 U .S .C . § 3 6 0 c (2 0 0 6 ). 

### 4 H ow ever, a m anu facturerm ay p et i t i on the F D A t o recl assi fy a dev i ce f rom cl ass II I t o clas s I o r I I. See 2 1 U . S . C . § 3 6 0 c(f)(1)(B ) (20 0 6 ). ¶ 5 . T h e Ge n e s i s XP wa s p l a c e d o n th e m a rk e t a f t e r Ma y 2 8 , 1 9 7 6 . I n J u n e 1 9 9 9 , ANS pet i t i oned the FD A t o re cl as s i f y the t ot al l y i m pl ant ed s pi nal - cor d s t i m ul at orf orpai n r el i ef fro m a c las s II I d e v ice to a c las s II d e v ice . H o w e v e r, th e F D A d e n ied A N S ’ p e tit io n to r ecl as s i f y the devi ce f

r om ac l as s I I I t o a cl as s I I devi ce i n February 2001. I n i t s l ett er , the F D A descri bed the h i st ory and cl assi fi cat i on process, as f oll ow s: I n a c c or da nc e wi th s e c t i on s 5 13 ( f ) ( 1) o f the Fe de r a l Fo od , Drug , and C os m et i c A ct( act ) ( 21 U . S. C. 36 0c ( f ) ( 1) ) , devi ces thatw er e noti n comm er ci al di s tr i but i on pr i orto M ay 28, 1976 ( the dat e of enac tm entof

the M edi cal D evi ce A m endment s o f 1976 ( the amendm ent s ) ) , gener al l y r ef err ed t o as p o stam en d m en ts de v ices, are c lassif ied a u tom ati ca ll y b y statute into c lass III w ith o u t any F D A rulem ak ing . T h o se d ev ices rem ain in class III an d req u ir e prem arke t ap proval, un l ess and u nti l : (1) the d evice i s r ecl assi fi ed int o clas s I o r II; (2 ) F D A iss u e s a n o rd e r c las sify in g th e d e v ice in to c las s I o r II in acc or dance w i th new s ect i on 5 13( f ) ( 2) of the ac t( 21 U . S. C . 360c( f ) ( 2) ) , as amended by the Food and D rug A dm i ni s tr at i on M oderni zat i on A ctof 1997 (F D A M A ); o r (3 ) F D A iss u e s a n o rd e r fin d in g th e d e v ice to b e su b sta n tially eq u ivale n t, in ac co rda n ce w ith sec ti o n 5 1 3 (I) o f th e a ct (21 U . S . C . 3 6 0 c(I)), t o a pr edi cat e devi ce thatdoes notr equi r e pr emarketap proval . T he age ncy d e ter m in e s w h e th e r n e w d e v ice s a re su b sta n tially e q u iv a le n t to p re v io u sly m arket ed devi ces by m eans of pr emarketnot i f

i cat i on pr ocedur es i n s ect i on 51 0( k) of the a c t( 21 U . S. C. 36 0( k) ) a ndPa rt80 7 of the r e gu l a t i on s ( 21 CFR P art 80 7 ). A s you know , on J une 16, 1999, you s ubm i tt ed a pe t i t i on r eques t i ng

### 5

re c las sific iatio n o f t h e T o tally Im p lan ted S p in a l C o rd S tim u lato r fo r P a in R el i ef f r om a cl as s I I I i nt o cl as s I I . T he pet i t i on w as s ubm i tt ed unders ect i on 5 1 3 ( f ) ( 2 ) o f th e a c t , n o w s e c t i o n 5 1 3 ( f ) ( 3 ) o f th e a c t , a s a me n d e d b y F DAMA, and 21 C FR 860. 134 of

the age ncy’ s r egul at i ons . I n accordance w i t h se ct i on 5 1 3 (f)(1 ) o f th e a ct, t h e T o ta lly Im p la n te d S p in a l C o r d S tim u la to r fo r P a in R e l i e f was aut om at i cal l y cl as s i f i ed i nt o cl as s I I I becaus e t he devi ce was not w it h in a typ e o f d ev ice in tro d u ce d o r d eli v er ed for intr o d u ction into i nt ers t at e co m m erc e f or com m erc i aldi s t ri buti on bef ore M ay 28, 1976, and h ad not bee n f

ound t o be s ubst ant i al l y equi val ent t o a devi ce pl aced i n com m erc i aldi s t ri buti on af t er M ay 28, 1976, thath ad been rec l as s i f i ed in to c la s s I I o r c la s s I . (E m p h asis ad d ed . ) B y w ay o f th e F eb rua ry 2 0 0 1 F D A letter t o A N S ’ d ir ec tor o f reg u lat o ry affairs, D rew Jo h n so n , the F D A a ck n o w ledg ed tha t pu rsua n t t o the F D C A , A N S ’ spin al-co rd s t i m ul at orw as cat egor i zed a s a cl as s I I I devi ce aut om at i cal l y. T hi s w as becaus e the devi ce had notbeen i ntr oduced i nt o i nt er s t at e comm er ce f orc om m er ci al di s tr i but i on pr i ort o M ay 28, 1976, and i thad notbeen de t erm i ned t o be s ubs t ant i al l y equi val entt o a s i m i l ardevi ce pl ace d i nt o comm er ci al di s tr i but i on a f t erthatdat e w hi ch had be en des i gnat ed as a cl as s I or c la s s II d e v ic e . ¶6. I n i t s l at er - publ i s hed n oti ce o f A N S ’ pet i t i on to r ecl as s i f y the t ot al l y i m pl ant ed s pi nal - cor d s t i m ul at or , the FD A announce d thati thad deni ed the pet i t i on. I n s o doi ng, the FD A s t at ed that i tw as “announc i ng thati thas deni ed a pe t i t i on s ubm i tt ed by A dvance d N eu rom o d u lat ion S y stem s, Inc . (A N S ), to rec lassif y the to tal ly im p lanted sp inal-co rd sti m u lat o r ( S C S ) f

o r trea tm en t o f chro n ic i n tr ac table p ain o f th e trun ko r l im b s from class III in to c las s II . . . . A fte r c o n sid e rin g a ll th e a v a ilab le in fo rm a tio n , inc lu d in g th e p u b lic comm ent s of

the Panel ’ s r ecomm endat i on, FD A deni ed the r ecl as s i f i cat i on pet i t i on by or der in a lette r to th e p e titio n e r.” F u rth e r, th e F D A ’s s u p p lem e n tar y in fo rm a tio n in c lu d e d w ith the n oti ce descri bed the regu l at ory his t ory of the d evice, i n p art , as f oll ow s:

### 6 T he t ot al l y i m pl ant ed SC S [ s pi nal cor d s t i m ul at or ] i nt ended f or tre a tm e n t o f c h ro n ic in tra c tab le p a in o f th e tru n ko r lim b s is a p o sta m e n d m e n ts devi ce c l as s i f

i ed i nt o cl as s I I I unders ect i on 513( f ) ( 2) of the ac t . T her ef

or e, thi s d e vi c e c a nn otb e p l a c e d i n c omm e r c i a l d i s tr i bu t i on f ortr e a tmentof chr oni c i ntr act abl e pai n of the trunk orl i m bs unl es s i ti s r ecl as s i f i ed under s ect i on 513( f

) ( 2) of the act , or s ubj ectt o an appr oved PM A unders ect i on 515 o f th e a c t. A g a in , th e F D A d e s c ri b e d A N S ’ s p in a l- c o rd s tim u la to r a s a c la s s II I d e v ic e . ¶ 7 . A N S th e n so u g h t p re m a rk e t ap p ro v a l o f th e s p in a l-c o rd s tim u lato r in a c c o rd a n c e w ith the FD A pr emarketpr oces s . O n J ul y 16, 2002, the FD A not i f i ed A N S thati thad compl et ed i t s e v a l u a t i o n f

o rth e p r e ma rk e ta p p r o v a l a p p l i c a t i o n ( P M A) f o rth e Ge n e s i s XP . T h e F DA a p p r o v e d th e P M A ap p l i c a t i o n b y o r d e ra n d r e q u i r e d ANS t o c o mp l y wi th r e q u i r e d M DA c o n d itio n s . ¶8. In F ebruary 2 00 5, A N S shipped a G enesi sX P , a Q uat tr ode l ead, and a Pat i ent P ro g ra m m e r o f th e G e n e sis X P to N M M C fo r S a n d e rs. A fte r su rg e ry , S a n d e rs f ile d su it agai ns tA N S on Sept ember7, 2 00 7. In hi s compl ai nt , Sander s al l eged that , on orabout Sept ember14 , 2 00 5, h e was ap a t i e nta tNM M C. D ur i ng the s ur ge ry, the l e f tl e a d of the s p in a l- c o rd s tim u la to r b ro k e , a lle g e d ly c a u s in g S a n d e rs ’s in ju ry a n d d a m a g e s . ¶9 . O n Jan u ary 1 4 , 2 0 0 9 , the tri al co u rth ea rd a rgu m en ts on A N S ’ m o ti o n for su m m ary jud g m en t. F o ll o w ing the a rgu m en ts, the tri al c o u rtd eterm ined tha t S an d ers’s claim s w ere b a rre d b y th e M D A ’s p re e m p tio n c lau se a n d iss u e d a n o rd e r g ra n tin g su m m a ry ju d g m e n t in f avorof A N S. Sander s appea l ed, r ai s i ng thr ee i s s ues , w hi ch have been c ondens ed i nt o one: W hetherthe tr i al courterr ed by gr ant i ng s um m ary j udgm entt o A N S. W e f i nd thatthe tr i al courtdi d noterrand af

f i rm the j udgm entof

the C i r cui tC ourtof

L ee County. DI S CU S S I ON

### 7

¶10. O n appel l at e r evi ew , a tr i al court ’ s gr ant or deni al of s um m ary j udgm ent i s r evi ew ed d e n o v o . Mos s v. B ates vil le Cas ket

Co. , I nc. , 93 5 S o. 2d 39 3, 39 8-399 (M i ss. 20 06 ). M i s s i s s i ppi R ul e of

C i vi l Pr ocedur e 56( c) provi des thatsumm ary j udgm entshal l be r ender ed by a court“i f

the pl eadi ngs , depos i t i ons , ans w er s t o i nt err ogat or i es and admi s s i ons on f i l e, t ogetherw i th af

f i davi t s , i f any, show thatther e i s no genui ne i s s ue as t o any mat er i al f actand tha t th e m o v ing p arty is en ti tl ed to a ju d g m en t as a m att er o f l aw . ” M iss. R . C iv. P. 56 (c). ¶11 . T he cou rtr eview s the record bef ore i t , t ak ing “a ll the e v iden ce in the li g h t m ost f avor abl e t o the non- m ovi ng party. ” U n itedS ta tes Fid

. a n d G u a r. Co . o

f Miss . v. Ma rtin , 998 So. 2d 956, 962 ( M i s s . 2008) . A f f i rm ance i s r equi r ed w her e the r ecor d bef or e the tr i al courtdemonstr at es no genui ne i s s ue of m at er i al fa ct , and w her e the movanti s ent i t l ed t o a ju d g m e n t a s a m a tte r o f l a w . Id . W hi l e the movanthas the bur den of show i ng tha tno genui ne i s s ues of

mat er i al f

acte xi s t , di l i gence i s r equi r ed of the party oppos i ng the mot i on and “may notr estu po n the mer e al l egat i ons ordeni al s of the pl eadi ngs , buti ns t ead the r es pons e musts etf

orth s peci fi c fa ct s s how i ng thatther e i s a genui ne i s s ue of m at er i al f

act f ortr i al . ” H

arm on v. Regions Bank , 961 So. 2d 693, 697 ( M i s s . 2007) ( quot i ng H ar r is on v. Chandler-Sam

ps on Ins . , I

nc. , 891 So. 2d 224, 228 ( M i s s . 2005) ) . A mat er i al f acti s one th a t “ te n d s to re s o lv e a n y o f th e iss u e s p ro p e rl y ra is e d b y th e p a rt ie s .” P al m erv. A nders on In firm a ry B e n e v o len t A ss 'n , 656 So. 2d 790, 794 ( M i s s . 1995) . “The pr es ence of f acti s s ues i n the r ecor d does notpers e ent i t l e a pa rty t o avoi d s um m ary j udgm ent . ” Moss , 935 So. 2d at 39 8 -99 . “[T ] h e e x ist en ce o f a h u n d red c o n test ed issu es o f fac t w il l no t th w art sum m ary j udgm entw her e ther e i s no genui ne di s put e r egar di ng the mat er i al i s s ues of f act . ” Id . ( ci t i ng Sim m ons v. T

hom ps on Mach. of

Mis s . , I nc. , 6 3 1 S o . 2 d 7 9 8 , 8 0 1 (M iss. 1 9 9 4 )).

### 8

¶1 2. I n Harm on , this C ou rtst at ed thatpr eempt i on i s pr oper : “(1) w here C on gress expl i ci t l y pr eempt s s t at e l aw ; ( 2) w here preem pt i on i s i m pl i ed bec aus e C ongr es s has occupied the ent i r e f

i el d; or( 3) w her e pr eempt i on i s i m pl i ed bec aus e ther e i s an ac tual conf l i ctbetw een f

eder al and s t at e l aw . ” H arm on , 961 So. 2d at697-98 ( ci t i ng Cooperv. GMC , 7 0 2 S o . 2 d 4 2 8 , 4 3 4 (M iss . 1 9 9 7 )); see al so E nglis h v. G eneral

E lec. Co. , 49 6 U. S. 7 2 , 7 8 -9 , 1 1 0 S . C t. 2 2 7 0 , 1 1 0 L . E d . 2 d 6 5 (1 9 9 0 )) . W h eth er S a n d er s’s claim s a g a inst A N S a re b a rr ed b y th e M D A ’s preem pt i on cl ause . ¶1 3 . T h e tr ial co u rt g ran ted su m m ary jud g m en t in A N S ’ fav o r. In so d o ing , the tr ial co u rt di s t i nguis hed the G enes i s X P f r om the s pi nal - cor d- s t i m ul at ordef i ni t i on pr ovi ded by the re g u latio n s o n th e b a sis o f its c h a ra c ter istics . T h e trial c o u rt sta ted in p a rt:

U nderthe author i ty gr ant ed t o i tunderthe Feder al F oo d, D rug, and C o sm e tic A c t, th e F D A h a s p ro m u lg a ted c e rta in re g u la tio n s d e sig n e d to im p le m e n t th e A c t. R e lev a n t t o the p re se n t ca u se o f ac tio n , 2 1 C .F .R . § 88 2. 58 80 cl assi fi es an “i m plant ed sp i nal co rd st i m ulat or f or pai n rel i ef” as a cl as s I I devi ce. H ow ever , thi s r egul at i on s peci f i cal l y i dent i f

i es an “i m pl ant ed s pi nal cor d s t i m ul at orf

orpa i n r el i ef

” as ade vi ce cons i s t i ng of “an i m pl ant ed r ece i ver. . . and an externaltr ans m i t t er . . . ” Id . a t( a ) ( e mp h a s i s a d d e d ) . No reg u lat ion has bee n is sue d reg ard ing a fu ll y im p lantab le sp inal co rd stim u lat o r. C oupl ed w i th the f

actthatthe G enes i s X P w as i ntr oduced a f t erM ay 28, 1976, and thus , w as a u to m a tica lly c las sifie d a s a c las s II I d e v ic e , a n d th a t th e F D A d e n ied A N S ’ re q u e st to r ecl as s i f y the devi ce, w hi ch pr om pt ed A N S t o s t artthe pr emarketappr oval pr oces s , the tr i al c o u rtb a rr e d S a n d e r s ’ s c l a i ms . T h e tr i a l c o u rtb a rr e d th e c l a i ms b e c a u s e ( 1 ) th e F DA reg ard ed the s p inal-co rd stim u lat o r as a class III de v ice, an d (2) R iegel v. Medtr onic, I

nc. , 5 5 2 U. S . 3 1 2 , 1 2 8 S . Ct . 9 9 9 , 1 6 9 L. Ed . 2d8 9 2 ( 2 0 0 8 ) , p r e e mp t e d s t a t e - l a w c l a i ms chall eng i ng the safety an d eff ect i ven ess of

cl ass I II dev i ces.

### 9

¶14. O n appea l , S ander s ar gues that the tr i al court err ed by gr ant i ng s um m ary j udgm ent i n f avorof A N S. Sander s cl ai m s thatthe G enes i s X P i s a cl as s I I devi ce a s def i ned by f eder al r e g u l a t i o n s . F u rth e r , h e c l a i ms th a tth e tr i a l c o u rte rr e d b y b a s i n g i t s d e c i s i o n o n a F DA o rd e r w h ich w a s in c o n sis ten t w ith th e F D A ’s o w n re g u latio n s. T h a t o rd e r e ffe c tiv e ly des i gnat ed the G enes i s X P as a cl as s I I I devi ce. C ons equent l y, Sander s as s ert s thatthe tr i al courterr ed by f

i ndi ng thatthe devi ce had a cl as s I I I des i gnat i on, becaus e thatcl as s i f i cat i on s u b je c te d th e s ta te -c o u rtc a u s e s o f a c ti o n to p re e m p tio n u n d e r f e d e ra l la w . See R iegel v. Medtr onic, I

nc. , 5 5 2 U .S . 3 1 2 , 1 2 8 S . C t. 9 9 9 , 1 6 9 L . E d . 2 d 8 9 2 (2 0 0 8 ). ¶ 1 5 . On th e o th e rh a n d , ANS a r g u e s th a tth e tr i a l c o u rtc o rr e c t l y f o u n d th a tth e Ge n e s i s XP w a s a c las s II I d e v ice . A N S a rg u e s th a t fe d e ra l re g u latio n s h a v e n o t ad d re ss e d a to tally i m pl ant abl e s pi nal - cor d s t i m ul at or . N everthel es s , A N S m ai nt ai ns that , becaus e the devi ce h a d b e e n in tro d u c e d in to th e m a rk e t af terM a y 2 8 , 1 9 7 6 , p u rsu a n t to th e F D C A , it aut om at i cal l y r ece i ved a c l as s I I I des i gnat i on. In f urthersupportof i t s pos i t i on, A N S r el i es o n the F D A ’s de n ial o f A N S ’ req u est t o reclassify th e G en esisX P fr o m a class III t o class II statu s, the F D A ’s pre m ark et ap p rov al of the d ev ice, an d the U n it ed S tate s S u p rem e C o u rt hol di ng i n R iegel, 552 U . S. 312. 1. R e gul at i ons ¶16. Sander s ar gues thatC od e o f Fed eral R egu l at i ons Sect i on 882. 5880 i s contr ol l i ng a u th o ri ty fo r th e c la s s if ic a tio n o f th e G e n e s is X P , a n im p la n te d s p in a l- c o rd s tim u la to r. ¶ 1 7 . T h e C o d e o f F e d e ra l R e g u latio n s d e fin e s a n im p lan ted sp in a l-c o rd stim u lato r fo r p a in re lie f. See 21 C . F . R . § 8 82 . 58 80 (2010 ). T he regu l at i on st at es: (a) Ident i fi cat i on . A n im plant ed spinal cord st i m ulat or f or p ain reli ef i s a

### 10

devi ce thati s us ed t o s t i m ul at e el ectr oni cal l y a pat i ent ’ s spi nal cor d t o r el i eve se v e re in tra c tab le p a in . T h e s tim u la to r c o n sis ts o f a n im p lan ted re c e iv e r w ith el ectr odes that ar e pl ace d on the pat i ent ’ s s pi nal cor d and an e xt ernal tr ans m i tt erf

ortr ans m i tt i ng the s t i m ul at i ng pul s e ac r os s the pa t i ent ’ s s ki n t o the im p lanted rec eive r. (b) C lassif

icati o n . C lass II ( p erfo rm an ce stan d ard s). 2 1 C . F . R . § 8 8 2 . 5 8 8 0 (2 0 1 0 ). T h e fed era l reg u lat ion also d efine s an im p lanted sp inal-co rd s tim u la to r a s a c la s s II d e v ic e . 2 1 C .F .R . § 8 8 2 .5 8 8 0 (2 0 1 0 ). ¶1 8. A N S concede s thatno r egul at i on exi s t s f ora to ta lly im p lantab l e spina l- co rd s t i m ul at or . H ow ever , A N S ar gues thati t s devi ce i s di s t i ngui s habl e f r om the i m pl ant ed spi nal- cord st i m ulat or defi ned i n S ect i on 88 2. 58 80 becau se the G en esi sX P i s to ta lly i m pl ant abl e, m eani ng thatthe r ece i verand tr ans m i tt erar e both i m pl anted, w her eas the s pi nal - cor d s t i m ul at ordes cr i bed i n the r egul at i on ha s a n i m pl ant ed r ece i vera nd an external tr ans m i tt erf

ortr ans m i tt i ng the s t i m ul at i ng pul s e. T hus , the tw o de vi ces a r e di s t i ngui s habl e. 2. F D A O rder ¶1 9 . S an d ers a rgu es th at th e tri al co u rtinco rrectl y reli ed o n a F D A o rde r t o g ran t su m m ary j udgm entt o A N S. T he FD A i s s ued an or dert o A N S i n February 2001, i n w hi ch i tdeni ed A N S’ r eques tt o recl assi fy the s pi nal - cor d s t i m ul at orf r om a cl as s I I I t o a cl as s I I devi ce. S a n d e rs c o n ten d s th a t th e F D A o rd e r is inc o n sis ten t w ith the F D A reg u latio n s, w h ich c lea rly def i ne the s pi nal - cor d s t i m ul at oras ac l as s I I de vi ce. I n s upportof hi s pos i t i on, Sander s ci t es T h o m a s J e ffe rs o n U

n ive rs ity v. Sh a la la , 5 1 2 U. S. 5 0 4 , 5 2 0 , 1 1 4 S. Ct . 2 3 8 1 , 2 3 9 1 , 1 2 9 L. E d. 2d 405 ( 1994) , and W yom ing O utdoorCouncil v. U . S. For es t

Ser vice , 165 F. 3d 43, 45 (U . S . A pp . D . C . 1 99 9), b oth of w hich con cern an ag ency ’s i nterpret at i on of i t s r egu l at i on s. ¶20. I n T

hom as Jef

f ers on , the U ni t ed St at es Su prem e C ou rtcon si dered w hether the

### 11

Secr et ary of

H eal th and H um an Servi ces ' i nt erpr et at i on of m edi car e r egul at ory l anguage w as r eas onabl e. T

hom as Jef

f ers on , 512 U . S. at506, 1 14 S . C t . at2384. A hos pi t al s ought re im b u rs e m e n t f

o r g ra d u a te m e d ic a l- e d u c a tio n c o s ts . Id . a t5 0 7 . Th e Se c r e t a ry d e n i e d s o me o f th e e x p e n s e s a s a n i mp e rmi s s i b l e r e d i s tr i b u t i o n o f c o s t s , a n d th e h o s p i t a l s o u g h tr e v i e w. Id . at511. ¶21. T he U ni t ed St at es Supr eme C ourt hel d that s ubs t ant i al def er ence m us t be gi ven t o an a g e n c y ' s in te rp re ta tio n o f i ts o w n re g u la tio n s . T h om as Jef

f ers on , 51 2 U. S. a t51 2, 11 4 S. C t . at2386. T he C ourtnot ed thatdef err al t o the Secr et ary’s i nt erpr et at i on w as w arr ant ed unl es s an “a l t ernat i ve r eadi ng i s compel l ed by the r egul at i on' s plai n l ang uage orby other i ndi cat i ons of

the Secr et ary' s i nt enta tthe t i m e of the r egul at i on' s pr om ul gat i on. ” Id . ( quot i ng G arde bring v. Je nkins , 4 8 5 U . S . 4 1 5 , 4 3 0 , 1 0 8 S . C t. 1 3 0 6 , 1 3 1 4 , 9 9 L . E d . 2 d 5 1 5 (19 8 8 )). T h is p rin c ip le is m o re ju stifia b le w h e n “ th e re g u latio n c o n c e rn s ‘a c o m p lex a n d h ig h ly t echni cal r egul at ory p rogr am, ’ i n w hi ch the i dent i f i cat i on and cl as s i f

i cat i on of

r el evant

‘ cr i t er i a nec es s ar i l y re qui r e s i gni f i cantexpert i s e and e nt ai l the exe r ci s e of j udgm ent gr ounded i n pol i cy conc erns . ’ ” Id . ( quot i ng P auley v. B et h E ner gy Mines, I

nc. , 50 1 U. S. 6 8 0 , 6 9 7 , 1 1 1 S. Ct . 25 2 4 , 2 5 3 4 , 1 1 5 L. Ed . 2 d 6 0 4 ( 1 9 9 1 ) ) . Th e Un i t e d S t a t e s S u p r e me C o u rtu p h e ld th e S e c re ta ry ’s in te rp re ta tio n o f i ts o w n re g u la tio n s . Id . at518. ¶2 2. L i kew i s e, i n W y o m in gO u tdo o r Co u n c il , the C ou ncil app eal ed a dis tri ct -cou rt d e c i s i o n wh i c h a f

f i rm e d th e Un i t e d S t a t e s F o r e s tS e rv i c e ’ s i n t e rp r e t a t i o n o f i t s o wn re g u la tio n s . W

y o m in gO u tdo o r Co u n c il , 1 65 F . 3d at 45. T he C ou ncil argue d that the F orest S ervi ce’s authori zat i on of oi l and gas l easi ng o n l and locat ed i n the S ho shon e N at i on al F orest in W y o m in g v io la te d its o w n re g u la tio n s . Id . T h e co u rthe ld th at sub stan ti al de fer e n c e is

### 12

g iv e n to a n a g e n c y ' s in te rp re ta tio n o f i ts o w n re g u la tio n s . Id . at52. T he i nt erpr et at i on of an agenc y’ s r egul at i on i s contr ol l i ng “unl es s i ti s pl ai nl y err oneous ori ncons i s t entw i th the r egul at i on. ” Id . ( quot i ng U n itedS tates v. L a rion o

ff , 431 U . S. 864, 872, 97 S . C t . 2150, 53 L . E d . 2 d 4 8 ( 1 9 7 7 ) ) . Ag a i n , th e a p p e l l a t e c o u rtu p h e l d th e a g e n c y ’ s i n t e rp r e t a t i o n o f i t s o wn re g u la tio n s . Id . a t 5 4 . ¶23 . A N S con t end s that the tri al cou rt ’s order i s no t i nco nsi st ent w i th feder al regul at i on s. F irst, A N S c o n ten d s th a t 2 1 C .F .R . S e c tio n 8 8 2 .5 8 8 0 d e fin e s a stim u lato r th a t h a s b o th i n t e rn a l a n d e x t e rn a l c o mp o n e n t s . T h e Ge n e s i s XP , h o we v e r , i s t o t a l l y i mp l a n t a b l e . ANS ar gues that , w hen i ti ni t i al l y soug ht r ecl as s i f i cat i on of

the G enes i s X P f

r om a cl as s I I I t o a cl as s I I m edi cal devi ce, i ts etf orth the s peci f

i c di f f er ence s betw een the s t i m ul at ordef i ned by the regu l at i on and i t s st i m ulat or. N otw i thst and i ng the regu l at i on ’s cl assi fi cati o n o f a s t i m ul at oras a cl as s I I devi ce, the FD A ’ s or der de nied A N S’ pet i t i on t o r ecl as s i f y the s t i m ul at ora nd s t at ed that , be caus e the s t i m ul at orw as f ul l y i m pl ant abl e i n ahuman body, the FD A r equi r ed the devi ce t o r emai n as a cl as s I I I devi ce. 3. Pre e m pt i on, pr e m ar ke t appr ov al , and R iegel ¶24. Sander s cl ai m s thatthe tr i al courterr ed by f i ndi ng thatthe s pi nal - cor d s t i m ul at or w as a cl as s I I I devi ce. T hi s f i ndi ng, i n turn, pr ovi ded the tr i al c ourtw i th the means t o cons i der A N S’ a r gu menttha t , b e c a us e i ti s a s ac l a s s I I I d e vi c e , Sa nd e r s ’ s c l a i ms a r e p r e e m pt ed by f eder al s t atut e and by f

eder al cas el aw i n R iegel v. Medtr onic, I

nc. , 5 5 2 U .S . 3 1 2 , 1 2 8 S . C t. 9 9 9 , 1 6 9 L . E d . 2 d 8 9 2 (20 0 8 ). ¶ 2 5 . T h e fe d e ra l sta tu te a t issu e is S e c tio n 3 6 0 k , w h ich p ro v id e s in p a rt: (a ) G e n e ra l ru le

### 13

E xceptas pr ovi ded i n s ubs ect i on ( b) of thi s s ect i on, no St at e orpol i t i cal s ubdi vi s i on of

a St at e may es t abl i s h orcont i nue i n ef f ectw i th r es pectt o a d e v ice in ten d e d fo r h u m a n u se a n y re q u ire m e n t– ( 1) w hi ch i s di ff

erentf r om , ori n addi t i on t o, any r equi r ement appl i cabl e underthi s chapt ert o the devi ce, and ( 2) whi c h r e l a t e s t o the s a f e ty ore f f e c t i ve ne s s o f

the d e vi ce or t o any otherm at t er i ncl uded i n a r equi r ementappl i cabl e t o the d ev ice u n d er this ch ap ter. 2 1 U . S . C . § 3 6 0 k(20 0 6 ). ¶26. I n R iegel, the U nit ed S t at es Sup rem e C ou rtconsi dered w hetherthe p reem pti on cl ause i n the M D A ba rr ed comm on- l aw c l ai m s of s af ety a nd e f

f ect i venes s of

amedi cal devi ce that h a d p re m a rk e t a p p ro v a l b y th e F D A . R iegel, 5 5 2 U .S . at 3 1 5 ; see al so 2 1 U . S. C . § 360k (2 0 0 6 ). C h a rl e s R ie g e l h a d a c o ro n a ry a n g io p la s ty fo llo w in g a h e a rta tt a c k . Id . at320. D uri ng the pr ocedur e, the Ever gr een Bal l oon C athet er , m arket ed by M edtr oni c and d e s ig n a te d a s ac la s s II I d e v ic e , ru p tu re d , c a u s in g a h e a rtb lo c k . Id . R i egel s ubs equent l y had to h a v e e m e rg e n c y c o ro n a ry b y p a s s s u rg e ry . Id . R i egel fi l ed s ui ti n the N ew Y ork f eder al d is tr ic t c o u rt , a lle g in g th a t M e d tr o n ic ’s c a th e te rv io la te d N e w Y o rk c o m m o n la w . Id . H ow ever , the di s tr i ctcourthel d thatR i egel ’ s cl ai m s of s tr i ctl i abi l i ty; br eac h of i m pl i ed w arr anty; and negl i gence i n the des i gn, t es t i ng, i ns pect i on, di s tr i but i on, l abel i ng, m arket i ng, a n d s a le o f th e d e v ic e w e re p re e m p te d b y th e M D A . Id . a t 3 2 0 -2 1 . ¶ 2 7 . T h e U n ited S tate s C o u rt o f A p p e a ls fo r th e S e c o n d C irc u it aff irm e d th e d istric t c o u rt, h o ld in g th a t th e R ie g e ls ’ c la im s w e re p re e m p te d b y fe d e ra l la w . Ri egel , 5 52 U . S. at321. T h e b a sis o f th e a p p e llate c o u rt’s d e c isio n w a s th a t if the R ieg e ls’ c la im s w e re su c c e ss fu l, they w oul d i m pos e s t at e r equi r ement s thatdi f f erfr om , oradded t o the devi ce- s peci f i c f eder al

### 14

re q u ir e m e n ts . Id . a t 3 2 1 . See 2 1 U .S .C . § 3 6 0 k(2 0 0 6 ). ¶ 2 8 . T h e U n ite d S ta te s S u p re m e C o u rtg ra n te d c e rt io ra ri . R iegel, 552 U . S. at 321. T he C o u rt h e ldtha t th e F D A p re m a rk e t ap p ro v a l p ro c e ss im p o se s re q u ire m e n ts, a n d it i s s p e c ific to in d iv id u a l d e v ic e s . Id . a t32 3. The pr e marke ta pp r ov a l i s c on s i de r ed the fe d e ra l sa fe ty r evi ew of

the devi ce, w i th s af

ety, as oppos ed t o equi val ence , bei ng the key c ons i der at i on. Id . O nce pr emarketappr oval i s gr ant ed, the devi ce ha s “al m os tno devi at i ons f r om the s peci f i cat i ons i n i t s appr oval appl i cat i on, f orthe r eas on thatthe FD A has det erm i ned thatthe appr oved f

orm pr ovi des a r eas on abl e as s ur ance of s af ety and ef

f ect i venes s . ” Id . W hen anal yzi ng w hetherthe cl ai m s r el i ed on ar equi r ementthatw as “ di f f er entf r om , ori n addi t i on t o, any r equi r ement ” pur s uantt o the f eder al l aw f

orthe devi ce a nd that“r el at e[ d] t o the s af ety ore f f ect i venes s ” of

the devi ce, the U ni t ed St at es Supr eme C ourtdet erm i ned that s a fe ty a n d e ff

e c tiv e n e s s w e re th e e s s e n c e o f th e R ie g e ls ’ c la im s . Id . F u rth er, th e C o u rt det erm i ned that“the comm on- l aw caus es of act i on f ornegl i gence and s tr i ctl i abi l i ty do i m pos e ‘ r equi r ement [ s ] ’ and w oul d be pr e- empt ed by f eder al requi r ement s s peci f i c t o a m edi cal devi ce. ” Id . at323- 24. T he U ni t ed St at es Supr eme C ourtaf f i rm ed the C ourtof A p p e a l, w h ic h h a d d e te rm in e d th a t th e M D A p re e m p te d th e R ie g e ls ’ c la im s . Id . at330. ¶2 9 . W e find that the tri al co u rtd id n o t err b y find ing tha t th e G en esisX P w as a class III m edi cal devi ce, a nd a s s uch, Sande r s ’ s c l ai m s w er e barr ed, be caus e the cl ai m s w er e s ubj ect t o f eder al pr eempt i on. T he r ecor d show s thatthe FD A r egul at es m edi cal devi ces pur s uant to th e F D C A . T h e fe d e ra l g o v e rn m e n t am e n d e d the F D C A in r e g a rd to m e d ica l d e v ice s w ith th e M D A . T h is a c t p ro v id e d th a t d e v ice s in tro d u c e d a fte r M a y 2 8 , 1 9 7 6 , au to m a tica lly r ece i ved a c l as s I I I de s i gnat i on. I tw as undi s put ed thatthe G enes i s X P w as i ntr oduced a f t er

### 15

M ay 28, 1976. T he G enes i s X P, pur s uantt o the M D A , w as cl as s i f i ed as a cl as s I I I devi ce. ¶3 0 . In an att em p t to hav e the G en esisX P reclassifi ed fr o m a class II I dev ice t o a class II de vi c e , A N S pe t i t i on e d the FD A i n 1 999. T he r e c or d c on t a i ns the FD A ’ s de ni a l of A N S’ r eques tatr ecl as s i f

i cat i on. I n i t s 2001 deni al l ett er , the FD A uneq uivoca l l y s t at ed thatthe stim u lato r w a s “ a u to m a tica lly c las sifie d in to c las s II I.” T h e r e c o rd a lso h a s a F D A p u b lic not i ce. T he FD A agai n des i gnat ed A N S’ s t i m ul at oras ac l as s I I I de vi ce i n i t s publ i c not i ce of deni al of pet i t i on t o r ecl as s i f y the devi ce. T he FD A s t at ed thatA N S coul d notpl ace the devi ce i nt o comm er ci al di s tr i but i on unl es s i tw as r ecl as s i f i ed ors ubj ect ed t o pr emarket appr oval . A N S s oughtpr emarketappr oval . I n 2002, the FD A appr oved A N S’ appl i cat i on fo r p re m a rk e t ap p ro v a l. ¶3 1. Sand e r s do e s no t di s pu t e the FD A do c umen t a t i on ; r a the r he r e l i e s on the de f i ni t i on o f th e s tim u la to r a s d e s c ri b e d in t h e re g u la tio n s . See 21 C . F. R §882. 5880 ( 2010) . T he r egul at i on does pr ovi de a cl as s II desi gnat i on fors pi nal - cor d s t i m ul at or s thathave a n i nt ernal and ext ernal component . H ow ever , as the evi dence s how s and as the FD A w as aw ar e, the G enes i s X P i s a f

ul l y i m pl ant abl e devi ce. Fur ther , the FD A or der , the not i ce of deni al of p e tit io n , a n d the p re m a rk e t ap p ro v a l co rre sp o n d e n c e all m a k e cle a r th a t th e F D A itse lf cons i der ed A N S’ G enes i s X P s t i m ul at ort o be ac l as s I I I de vi ce. C ons equent l y, w hi l e other st i m ulat ors that m ay hav e an i nternal and external com po nen tare general l y co nsi dered clas s I I d e v i c e s , th e F DA d i d n o tv i e w th e G e n e s i s XP i n th e s a m e l i g h t , s o m u c h s o th a tANS s oughtthe ar duous pr emarketappr oval pr oces s f orthe devi ce. ¶32. V i ew i ng the evi dence i n the l i ght m os t f avor abl e t o Sander s , w e f i nd that no genui ne issue to an y m aterial fact as to w h ethe r th e G en eisX P i s a class III de v ice. F u rth er, Sa n d ers’s

### 16

cl ai m s ar e si m i l ari n natur e t o the cl ai m s as s ert ed by the R i egel s i n R iegel, 552 U . S. at320. L i ke the R i egels ’ cl ai m s, San ders’ s cl ai m s chall eng e the safety an d eff ect i ven ess of

a cl ass III d ev ice tha t has rec eive d p rem ark et a p p rov al b y the F D A , im p o sing req u ir em en ts th at are d if feren t or i n ad d it ion to M D A fed era l r eq u ir em en ts. T h ere fore , the tri al co u rtd id n o t err b y b a rr i n g S a n d e r s ’ s c l a i ms u n d e rth e M DA. CO NC L US I ON ¶33. For the above- s t at ed r eas ons , thi s C ourt af f i rm s the j udgm ent of the C i r cui t C ourtof L ee County. ¶ 3 4 . AFF I RM ED . W AL LE R, C. J . , CARL S ON, P . J . , DI CKI NS ON, RANDOL P H, LA M AR, KI T CH E NS AN D P I E RC E , J J . , CO NC UR . GR AV E S , P . J . , NO T P AR T I CI P AT I NG .