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. Si l er , Seni or C i r cui t J udge forthe * U ni t ed St at es C our t of A ppeal s for the S i xth C i r cui t , s i t t i ng by d e s ig n a tio n . 2 B e f o re : S M IT H , C O W E N , a n d S IL E R , C i r cui tJudges , *

( Fi l ed: A ugus t17, 2007) C o u n se l: P a m e la S . T ik e lli s A
. Z acha r yN ay l or C h im icle s & T ik e lli s O n e R o d n eyS q u are P. O
. B ox 1035, Sui t e 500 W i l m i ngt on, D E 19899 B arb ara J. H art C h risto p h e r M c D o n a ld L abat on, Suchar ow & R udoff 100 Par k A venue, 12th Fl oor N ew Y or k, N Y 10017 T heodor e M
. L i everm an J eff r eyL
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. B erm an C r ai g R
. Spi egel ( A r gued)3 H ag en s B erm an S o b o l Sh ap ir o 1301 5t h A venue, Sui t e 2900 Seatt l e, W A 98101 C o u n se l fo r Ap

p e lla n ts Ja c k B . B lu m e n f

e ld R u d o lp h J . S c a g g s , J r. L i s a K
. W hi t t aker M o rris, N ich o ls, A rsh t & T u n n e ll 1201 N or th M arketSt r eet P. O
. B ox 1347 W i l m i ngt on, D E 19899 M ark E
. H addad ( A r gued) S id ley A u stin 555 W es t5t h St r eet , Sui t e 4000 L os A ngel es , C A 90013 C ouns el f orAppel l ee

_____________________ OPI NI ON O F THE COURT

_____________________ S M IT H , C i r cui tJudge
. T he Penns y l vani a Em pl oy ees B enef i tT rus tFund, J os eph M acke n, and Li nda W att er s ( “pl ai nt i ffs ”) s ued Z enec a, I nc. and A s tr aZeneca Phar m ace ut i cal s , L
. P. ( col l ect i vel yr efe rr ed t o as “Zeneca ”) i n the U ni t ed St at es D i s tr i ct C our t for the D i s tr i ctof D el aw ar e, as s ert i ng that Z en eca enga ged i n dece pt i ve conduc tTh e Di s tr i c tCo u r th a d d i v e r s i tyj u r i s d i c t i o n u n d e r2 8 U. S
. C. 1 § 1332 (d)(2) and ( 6) , w hi ch conf er s fede r al j ur i s di ct i on over cl ass act i on s w h e re “anym em ber of a clas s of plai nti ffs i s a ci t i zen of a St at e di ffe r entfr om any defe ndant ” and the amount i n contr over s yexce eds $5, 000, 000. T hi s C our t has j ur i s di ct i on 4 i n the adve r t i s i ng of i t s new drug N exi um . C lai m O ne al l eged unl aw ful advert i s i ng underthe D el aw ar e C ons um er Fr aud A ct ( “D C FA ”)
. T he s econd c l ai m al l eged vi ol at i ons of t he cons um er pr ot ect i on s t atut es of the 50 st at es forfal s e, m i s l eadi ng, and d e c e p tiv e a d v e r tis in g . C laim T h re e a lleg e d u n ju st e n ric h m e n t, and s t at ed cl ai m s underD elaw ar e comm on l aw forr es t i tut i on, di s gor gement , and cons truct i ve trus t
. T he fourth cl ai m w as for negl i g en tm i s r epr es ent at i on, and i tal l eged thatthe company r el eas ed mi s l eadi ng advert is ement s forthe pr es cr i pt i on drug N e x iu m . T h e D istric t C o u rt d ism iss e d th e c o m p lain t w ith p re ju d ic e . T hi s appea l pr es ent s tw o pr i nci pal ques t i ons : ( 1) w hether the D C FA exempt i on for a d v ert i s i ng r egul at ed bythe Feder al T r ade Com m i s s i on appl i es t o the fa ct s of thi s cas e; and ( 2) w hether fede r al l aw pr eempt s the pl ai nt i ffs ’ s t at e cons um er pr ot ect i on cl ai m s . T he pl ai nt i ffs al s o as s ertthatpri m ary j uri sdi ct i on w as an i m proper basi s for dis m i ssal , that theirun j ust enr i chment cl ai m w as i m pr oper l y di s m i s s ed on the ground that theyhad not pl ed i ndi vi dual r el i ance , and thattheys houl d have been a l l ow ed t o amend t hei rcompl ai nt
. W e w i l l aff i r m the ju d g m e n t o f

th e D istric t C o u rt. 1pur s uantt o 28 U
. S. C
. §§ 1291 and 1294. O n A pr i l 13, 2006, Z enec a fi l ed a mot i on t o di sm i s s the 2 appea l as t o s ev en o f the or i gi nal t en pl ai nt i ffs on the gr ound th a tthe n oti ce of

app eal i ncluded on l ythe P enn sy l v a n ia E m pl oy ees B enef

i tT rus tFund, J os eph M acke n, and L i nda W a tters . T h e th re e n a m e d p lain tiff s c o n tes ted th e m o tio n to di s m i s s , w hi ch i s now befor e us . B ecaus e of ourdi s pos i t i on of thi s cas e, w e nee d not r eac h thi s i s s ue. W e w i l l denythe mot i on to d ism iss a s m o o t. N e x iu m is th e p ro p rie tar y n a m e f o r e so m e p ra z o le 3 ma g n e s i u m. 5 I. O n F ebruary11 , 20 05 , the pl ai nti ffs fi l ed a p utat i ve clas s 2 act i on aga instZ enec a, al l egi ng thatZ enec a’ s m arket i ng c a m p a ig n f

o r N e x iu m w a s d e c e p tiv e b e c a u se it m is le a d in g ly

3 advert i s ed N exi um as an i m pr ovement on Pr i l os ec. N exi um and Pr i l os ec a r e both pr ot on- pum p i nhi bi t or s, drugs thattr eat gas tr oes ophagea l r efl ux di s eas e ( “G E R D ”) and er os i ve es ophagi t i s , condi t i ons that ar e comm onl y know n as aci d r efl ux di s eas e and f

r equentheartburn. Pr i l os ec w as a p rof it abl e drug for Z en ec a, and had s al es of $6 bi l l i on i n 2000. T he pat entfor Pr i l os ec w as due t o expi r e i n 2001, atw hi ch poi nti tw oul d be av ail ab le f

o r sa le a s the g en eric d rug o m ep raz o le. O n F eb rua ry 1 4 , 2 0 0 1 , Ze n e c a o b t a i n e d a p p r o v a l f r o m t h e Fo o d a n d D r ug A dm i ni s tr at i on ( “FD A ”) forfi nal l abel i ng on N exi um for6 heal i ng of er os i ve es ophagi t i s , m ai nt enanc e of he al ing of e ro s iv e e s o p h a g itis , a n d tr e a tm e n t o f s ym p to m a tic G E R D (i .e ., h e a rtb u rn ). O n e p u b lish e d c lin ica l stu d yo f N e x iu m c o m p a re d b o th 20 m g an d 4 0 m g do ses of N exium t o the app roved 2 0 m g d ose of Pr i l os ec. T he dat a fr om thi s s tudys h o w ed that 40 m g of N exi um had a s t at i s t i cal l y s i gni fi cant heal i ng r at e over20 m g of o me p r a z o l e . T h i s s tu d ywa s a mo n g th o s e u s e d t o o b t a i n F DA appr o v al of Zeneca ’ s new drug appl i cat i on forN exi um . T he FD A l at erdet erm i ned thatN exi um s houl d be appr oved at re c o m m e n d e d d o sa g e s o f 2 0 m g o r 4 0 m g o n c e d a ily , fo r f o u r to e i g h twe e k s , f

o r th e h e a l i n g o f e r o s i v e e s o p h a g i t i s , a n d a t2 0 mg forboth m ai nt enanc e of he al i ng of er o sive es ophagi t i s and s ymp t o ma t i c GE RD
. In th e ir c o m p lain t, pla in tiff s a lleg e d th a t th e lar g e -sc a le p ro m o ti o n a l ca m p a ig n f o r N e x iu m , w h ich in c lu d e d b o th p h y s i c i a n - d i r e c t e d ma r k e t i n g a n d di r ect - t o- cons um er advert i s i ng, w as m i s l eadi n g beca us e i ti ncorr ect l yr epr es ent ed thatN exi um w as s uper i ort o Pr i l o s e c . T he pl ai nt i ffs as s ert ed that a d o se o f

4 0 m g is n o t n e e d e d in m o st p a ti e n ts a n d a f a ir compar i s on of 20 m g of N exi um t o 20 m g of Pr i l os ec w oul d not hav e prove n N exium t o b e superi or. T he p l ai nti ffs al so cont ended that Z enec a i ni t i al l y s ol d N exi um at a pr i ce be l ow Pr i l os ec i n or dert o es t abl i s h br and l oy al ty , but“then r ai s ed the p r i c e o f Ne x i u m wh i l e th e p r i c e o f P r i l o s e c d r o p p e d
. [ Ne x i u m] now s el l s for$4. 09 perpi l l ver s u s $ 0
. 6 7 p erpi l l orl es s for7 Pr i l os ec. ” O n N ovember8, 2005, the D i s tr i ctC our tgr ant ed Ze n e c a ’ s mo t i o n t o d i s mi s s f o rf a i l u r e t o s t a t e a c l a i m. W e r evi ew the gr an t o f a mot i on t o di s m i s s de novo, a c c e p tin g a ll w e ll-p lea d e d a ll e g a tio n s a s tru e a n d d ra w in g a ll re a s o n a b le in f

e re n c e s in f

a v o r o f t h e p la in tif

f s . I n r e A da ms G ol f , Inc

. S ec. Li t ig. , 3 8 1 F .3 d 2 6 7 , 2 7 3 (3 d C ir. 2 0 0 4 ); In re A l phar m a Sec. Li t ig. , 372 F. 3d 137, 146 ( 3d C i r . 2004)
. R evi ew o f th e d e n ia l o f le a v e to a m e n d is f o r a b u s e o f

d is c re tio n . Hi l lv. C i t y of Scr ant on , 4 1 1 F .3 d 1 1 8 , 1 3 4 (3 d C ir . 2 0 0 5 ). II. The Appl i cat i on of

the D C F A E xem pt i on T he fi r s t i s s ue r ai s ed on appe al i s w hetherFD A appr oval of pr es cr i pt i on drug labe li n g an d reg u lat ion o f a d v erti sing b ri n gs the pl ai nt i ffs ’ cl ai m s w i thi n the D C FA exempt i on of “a ny a d v e rtisin g o r m e rc h a n d isin g p r a c tice ” th a t is c o m p lian t w ith Feder al T r ade Com m i ssion r egul at i ons . T he purpos e of the D C F A i s “t o p ro tectcon sum ers and l egit i m at e bu si ness e n terp rise s f

ro m u n f a ir o r d e c e p tiv e m e rc h a n d isin g p ra c tice s in th e c o n d u c t o f

a n ytra d e o r c o m m e rc e in p a r t o r w h o llyw ith in thi s St at e. ” 6 D EL . C OD E A NN . § 2 51 2. T he D C F A proscr i bes T he ac t , us e or empl oym ent by any per s on of any dece pt i on, fr aud, fal s e pr et ens e, fal s e pr om i s e, m i sr epresent at i on , or t he co ncealm e n t,8 su p p re ss io n , o r o m iss io n o f a n ym a ter ial f

a c t w ith in ten t th a t o th e rs r e lyu p o n su c h c o n c e a lm e n t, s upp ressi on orom i s s i on, i n connec t i on w i th the s al e, l eas e oradvert is ementof anym er chandi s e, w hetherornot any per s on has i n fac t been mi s l ed, d e c e iv e d o r d a m a g e d th e re b y .... 6 D EL . C OD E A NN . § 2513( a)
. T he exe m p ti o n la nguage i n the D C F A at i ssu e states tha t “[ t] h is se cti o n sh all n o t app ly
... [t]o a n ya d v e rtise m e n t o r m e rc h a n d isin g p ra c tice w h ich is su b jec t to and compl i es w i th the rul es and re gul at i ons , of and the s t atut es ad m ini s t er ed by , the Feder al T r ade Com m i s s i on... . ” 6 D EL . C OD E A NN . § 2 5 1 3 (b )(2 ). T h e D istric t C o u rt c o n c lu d e d th a t all o f th e a d v e rtisin g m a ter ials c ite d b yth e p lain tiff s in th e ir co m p lai n t “are relat ed to th e saf ety an d ef

fica cy o f N ex ium , are co n sist en t w ith the F D A -ap p rov ed labe li n g an d , there fo re, are n o t a c tio n a b le u n d e r th e D C F A p u rs u a n t to 6 D e l. C . § 2513( b) ( 2)
. ” P lai n ti ff s arg u e tha t th e e x em p ti o n sh o u ld b e re ad m o re n a rro w ly th a n th e D istric t C o u rt re a d it, a n d th a t, pr o p e rly co n stru ed , the ex em p ti o n d id no t p rotec t Z en ec a’s co n d u ct. In p a rticu lar , p lain tiff

s a ss e r t th a t (1 ) th e e x e m p tio n is lim ited to conductexpr es s l yappro v ed bythe FT C ; ( 2) the FD A di d not expl i ci t l yap p rove Z enec a’ s m arket i ng campai gn; and ( 3) Z enec a’ s m arket i ng devi at ed fr om s t at ement s appr oved bythe FD A forN exi um ’ s la bel
. Z enec a poi nt s t o the br oad pr ohi bi t i ons i n 15 U
. S. C
. §§ 45 and 52, w hi ch dec l ar e unl aw ful un fai r m et ho ds of com peti t i on and the di ssem i nati o n o f fal se9 a d v e rtise m e n ts, a s p ro o f th a t p re sc rip tio n d ru g a d v e rtisin g is s u b je c t to th e s ta tu te s a d m in is te re d b yth e F T C
. A s a pr e l i minarymat t e r , w e de c l i ne t o r e a d the D CFA exempt i on t o r equi r e thatan adve r t i s ementorm er chandi sing p ra c tice m u st b e e x p r e s slya p p ro v e d b yth e F T C in o rd e r to qual i fyforthe exc l us i on. T he pl ai n l anguage of § 25 1 3( b) ( 2) re q u ire s o n lyth a t th e c o n d u c t b e su b jec t to a n d c o m p lian t w ith rul es and r egul at i ons cr eat ed bythe FT C and the s t atut es adm i nis t ered byt hat agency
. A ccordi ng l y , the lac k o f exp res s F T C a p p ro v a l o f

th e N e x iu m m a rk e tin g c a m p a ig n is n o t a b a sis f o r d e c la ri n g th e s ta tu to ry e x e m p tio n in a p p lic a b le
. W e ar e l eft , then, w i th the t horni er ques t i on pr es ent ed by pl ai nt i ffs ’ as s ert i on that the exem pt i on’ s r eac h does notext end t o m att er s s ubj ectt o FD A over s i ght. B y congr es s i onal decr ee, the FT C and the FD A o ri gi nal l ys har ed j ur i s di ct i on over p re s c ri p tio n d ru g a d v e rt is in g . See P u b . L . N o . 8 7 -7 8 1 , 7 6 S tat. 7 9 1 -9 2 (1 9 6 2 ) (co d if

ied a s am e n d e d a t 2 1 U .S .C
. § 3 5 2 (n )); s ee al s o 15 U
. S. C
. §§ 45 and 52; 21 U
. S. C
. § 352( n) ( r emovi ng any “adve r t i s ementof a pr es cr i pt i on drug , publ i s hed af t erthe eff ect i ve dat e of r egul at i ons i s s ued un d erthi s par agr aph appl i cabl e t o advert i s ement s of pr es cr i pt i o n drugs , ” fr om the p u rv ie w o f

th e p ro v is io n s o f 1 5 U .S .C
. § § 5 2 -5 7 ); 2 1 U .S .C . § 3 9 3 (b )( 1 ) ( “ T h e [ F D A ] s h a ll ... p ro m o te th e p u b lic h e a lth b y... tak in g a p p ro p ria te a c tio n o n th e m a rk e tin g o f re g u late d p ro d u c ts i n a t i m el ym anner ”)
. B eca us e C ongr es s gave the age nci es concurr entj ur i s di ct i on w i th r es pectt o r egul at i ng pr es cr i pt i onT he FD A pr om ul gat ed pr el i m i naryr egul at i ons on 4 p resc ri p ti o n d rug ad v erti sing in 19 7 5
. 4 0 F ed
. R eg . 1 4 1 0 6 (M ar. 2 7 , 1 9 7 5 ). 10 drug advert i s i ng unt i l th e F D A pr om ul gat ed r egul at i ons , the FD A and FT C es t abl i s hed thei row n i nt er i m di visi o n of r es pons i bi l i t i es . I n t he W or ki ng A gr eementB etw een FTC and 4 Food and D rug A dm i ni s tr at i on, 36 Fed. R eg. 18, 539 ( Sept
. 16, 1971) , t he tw o agenc i es agr eed that“[t ] h e F ood and D rug A dm i ni s tr at i on has pr i m aryr es pons i bi l i tyw i th r es pectt o the r egul at i on of the truth orfal s i tyof pr es cr i pt i on drug advert i s i ng. ” Thi s s t at ementdoes notpr ecl ude FT C r egul at i on of p res cri pti on drug ad vert i si ng , bu trathe r n o tes the ag encies ’ m u tu a l u n d e rsta n d in g th a t th e F D A w ill tak e th e lea d in r egul at i ng s uch act i vi t i es , s ubj ect t o the conc urr entj ur i s di ct i on o f b o th ag en cies. T h e statem en t exp licit lyli m it s the F D A ’s pr i m aryr es pons i bi l i tyt o deter m i ni ng the ver aci tyof the a d v e rtisin g c laim s; it d o e s n o t su g g e st that r egu l atin g tec h n ica lly true, but pot ent i al l y m i s l eadi ng, advert i s ement s i s the exc l us i ve dom ai n of t he F D A
. A ccor di ngl y , thi s arr angemental one does notr emove t he cl ai m s r egar di ng N exi um advert i s i ng fr om the p u r v i e w o f

r e g u l a t i o n s a n d s t a t ut e s a d mi n i s t e r e d b yth e F TC. H ow ever , the FD A ’ s s ubs equentp r o mul g a t i o n o f r e g u l a t i ons for p resc ri p ti o n d rug ad v erti s in g ef fe cti v elyeli m inated the F T C ’s a u th o ri ty in th is a re a . E ven i f Z eneca can show that the m arket i ng w as al m ost i dent i cal t o the s peci fi cal l y author i zed l abel i ng, the FD A i s notI n Sandoz P har m aceut i cal s C or p. v. R i char ds on- V

i cks , I nc. , 5 902 F. 2d 222 ( 3d C i r . 1990) , w e s um m ar i zed the di vi s i on of r egul at oryauthor i tyi n thi s m anner : “the FD A r egul at es the l abel i ng of O T C drugs w hi l e t he F T C m oni t or s the adve r t i s i ng for thes e drugs . ” I

d. at 227. T he fac t s and l aw ati s s ue i n Sandoz ar e di s t i ngui s habl e and w e nee d notfol l ow i t s di ct a i n thi s cas e. I n Sandoz , the C our tw as concern ed w i th the ques t i on of w hethera Lanham A ct pl ai nt i ff ne eds t o s how onl ythatthe d e fend ant’ s advert i si ng cl ai m s of i t s ow n d rug’s effecti ven ess ar e i nadequa t el ysu b stan ti ated u n d er F D A g u ideli nes , orw hether the pl ai nt i ff m us t al s o s how thatthe cl ai m s ar e l i t er al l yfal s e or a re m is le a d in g to th e p u b lic
. I d. a t 2 2 4 , 2 2 9 . T h e d isp u te in Sandoz w as al s o overthe mar ket i ng of an ove r - the- coun t e rdrug. O T C drugs and pr es cr i pt i on drugs ar e s ubj ectt o di ffe r entrul es a n d re g u la tio n s . C o m

p a r e id

. a t 2 2 7 (“ T h e F T C h a s th e a u th o rity underSect i ons 5 and 12 of the FT C A ct , 15 U
. S. C
. §§ 45 & 52, to f in d th a t an in a d e q u a telysu b sta n tiate d a d v e rtisin g c laim r egar di ng a n o n -pr es cr i pt i on drug i s dece pt i ve orm i s l eadi ng, a n d th u s ille g a l.” ), w i th 2 1 C .F .R . § 2 0 2 .1 . T h u s, o u r o p in io n in Sa nd oz has l i t t l e appl i cabi l i tyt o thi s cas e. 11 m er el y act i ng as the FT C ’ s pr oxyi n r egul at i ng pr es cr i pt i on drug advert i s i ng. T he FD A has r es pons ibil ityforr egul at i ng the advert i s i ng of pr es cr i pti o n d rugs thati s i ndepende ntof any d e l e g a t i o n f

r o m th e F TC. 5 Al th o u g h th e r e i s a n a f f i n i tyb e twe e n F T C a n d F DAF o r e x a m p le, Z e n e c a p o in ts to F D A g u id a n c e th a t ex p re ss ly 6 perm i t s drug m anufa ct u rer s t o des cr i be new l yappr oved drugs as “new ” fors i x m ont hs aft ert hei r laun ch, s ee ht tp: //w w w . fda. gov/ cder/ ddm ac/ FA Q S. H T M ( expl ai ni ng that “D D M A C [the D i vi s i on of D rug M arket i ng, A dvert i s i ng and C o m m u n ica tio n s] g e n e ra llyc o n sid e rs th a t ‘ N e w ’ is a n a c c u ra te d e s c r i p t i o n o f

th e ma r k e t i n g p h a s e f

o rs i x mo n th s f

r o m th e t i me a pr oducti s i ni t i al l y m arket ed”) , and t he F T C ’ s s i m i l aropi ni on th a t th e re is a “ ten tativ e o u ter lim it fo r u se o f th e c laim [ th a t a pr oducti s ‘ new ’] ..
. [of] a per i od of t i m e no l ongerthan 6 m onths
. ” Perm i s s i bl e Per i od of Ti m e D ur i ng W h i ch N ew Pr oductM ay B e D es cr i bed as “N ew , ” 32 Fed. R eg. 6023, 6023 ( A pr . 14, 1967)
. T he mer e fa ctthatthe age nci es have s i m i l ar i nt erpr et at i ons onl y s how s i nt er - agenc y cons i s t ency ; i t does not s h o w th a t th e F T C w a s th e re g u la tin g e n tity. 2 1 C .F .R . § 2 0 2 .1 (e )(4 )(i)(a ) (“ T h e a d v e rtise m e n t sh a ll 7 pr es enti nform at i on fr om l abel i ng r equi r ed, appr oved, or perm i t t ed i n a new - drug appl i cat i on r e l a t i ng t o eac h s peci fi c s i de eff ectand contr ai ndi cat i on i n su ch label i ng thatr el at es t o the 12 gui dance and the s cope of the Feder al T r ade Com m i s s i on A ct 6 ( “FT C A ”) i s br oad, the r eas oni ng of the D i s tr i ctC our tr es t s on the pr emi s e thatadvert i s i ng thati s bas ed upon l abel i n g ap pr oved bythe F D A fa l l s w i thi n the D C FA exempt i on. T hi s i s an u n s u p p o rt a b le e x te n s io n o f th e la n g u a g e o f

§ 2 5 1 3 (b )( 3 ). T h e d istin c tio n b e tw e e n lab e lin g a n d m a rk e tin g is s i gni fi cantfor r egul at orypurpos es . A l though ther e i s oft en a s tr ong corr el at i on betw een a d rug’ s l abel i ng and mar ket i ng , 7u se s o f th e a d v e rtise d d ru g d o sa g e f o rm (s)
.. .. ” ); R e q u ire m e n ts on C ont entand F o rm at of Label i ng forH um an Pr es cr i pt i on D rug and B i ol ogi cal Pr oduct s , 71 Fed. R eg. 3922, 3960 ( J an. 24, 2 006) ( “[S] t at ement s m ade i n pr om ot i onal l abel i ng and advert i s ement s m us t be cons i s t ent w i th al l i nform at i on i ncl uded i n l abel i ng underpr opos ed § 201. 57( c) t o compl yw i th curr ent §§ 201. 100( d) ( 1) an d 202. 1( e)
. ”) ; Pr ofes s i onal Pr oduct L abel i ng; Publ i c M eeti n g , 60 Fed. R eg. 52196, 52196 ( O ct
. 5, 1995) ( “The appr oved l abel i ng s erves as the bas i s forful fi l l i ng th e re q u ir e m e n t o f

th e F e d e ra l F o o d , D ru g , a n d C o s m e tic A c t ... that pr es cr i pt i on drug advert i s i ng i ncl ude ‘ i nform at i on i n br i ef s um m ary rel at i ng t o s i de ef fec t s , contr ai ndi cat i ons , and e f f e c t i v e n e s s . ’ ( s e c t i o n 5 0 2 ( n ) o f th e A c t ( 2 1 U. S
. C. § 3 5 2 (n)). ”). 13 fede r al appr oval of l abel ing does notnece s s ar i l yauthor i ze m arket i ng pr act i ces . L abel i ng i s defi ned as “al l l abel s and other w r i t t en, pr i nt ed, or gr aphi c m att er ( 1) upon anyart i cl e oranyof i t s cont ai ner s orw r apper s , or ( 2) acc om pany i ng s uch art i cl e. ” 21 U
. S
. C
. § 3 21 (m ). Itfun ct i on s as “the p rim a rym echan i sm th ro u g h w h ich F D A a n d d ru g m a n u f a c tu re rs c o m m u n ica te esse n tia l, sci en ce -ba sed p resc ri b ing inf o rm ati o n to h ea lth ca re pr ofes s i onal s . ” R equi r ement s on C ont entan d For m atof L abeli ng for H um an P res cri pti on D rugs and B i ologi cs; R equi r ement s forPr es cr i pt i on D rug Pr oductL abel s , 65 F ed. R e g . 8 1 0 8 2 , 8 1 0 8 2 (D e c . 2 2 , 2 0 0 0 ); s ee al s o 2 1 C. F
. R. § 202. 1( l)( 2) ( st at i ng that m at eri al such as “ [ b ]ro chu res , bo ok l et s, m ai l i ng pieces , detai lin g p i eces, fi l e cards, bu l l et i ns, c a le n d a rs , p ri c e lis ts , c a ta lo g s , h o u s e o r g a n s , le tte rs , [ e tc .] ...14 des cr i pt i ve of a drug and r efe r ence s publ i s hed ( for exampl e, the ‘P h y sici an s D esk R ef

ere n ce ’) f

or use by m edicalpracti t i on ers, phar m acis t

s , o rn u r s es , cont ai ni ng drug i nform at i on s uppl i ed by the manufac turer, pa cker , ordi s tr i but orof the drug and w hi ch ar e di s s emi nat ed byoron behal f of i t s m anufa ctur er , packe r , or d istrib u to r a re h e r e b yd e ter m in e d to b e lab e lin g ” (e m p h a sis a d d e d ))
. In contr a st , adv ert i sem ents are pub l i shed in j ou rnal s, m a g azi nes, and new spapers, and are br oad castthroug h m e d ia s uch as tel evi s i on and r adi o. A dvert i s ement s al s o come i n the form of p hy si ci an-di rect ed p it ches bysal es r epresent at i ves, c o m p u te r p ro g ra m s , a n d e le c tr o n i c m e d ia
. See 2 1 C. F
. R. § 202. 1( l)( 1). A l tho ug h ad vert i si ng m ay al so serve as a m e c h a n ism to d istrib u te s a f e ty i n f o rm a tio n a b o u t a d ru g , it s pr i m arypurpos e–unl i ke l abel i ng–i s nott o pr om ot e safetybut rathe r t o p rom o te m ark et ex p an sion
. See, e. g. , A gency I nform at i on C ol l ect i on A ct i vi t i es ; Subm i s s i on forO ffice of M a n a g e m e n t an d B u d g e t R e v iew ; C o m m e n t R e q u e st; E xper i m ent al E val uat i on of Var i at i ons i n C ont entand For m atof th e B rie f S u m m a ryin D ire c t-to -C on sum er P rin t A d v e rtise m e n ts forPr es cr i pt i on D rugs , 72 Fed. R eg. 11889, 11889 ( M ar ch 14, 2007) ( “A l though advert i s i ng of pr es cr i pt i on dru g s w as once p rim a rilya d d re ss e d to h e a lth p ro f e ss io n a ls, in c re a sin g ly cons um er s have become a t ar getaudi ence , as D T C advert i s i ng h a s d r a m a t i c a l l y i n c r e a s e d i n th e p a s tf e w ye a r s . . . . F r e q u e n t l y, s pons or s pr i nti n s m al l type, verbat i m , the r i s k- r el at ed s ect i ons o f th e a p p ro v e d p ro d u c t lab e lin g (a lso c a lled th e p a c k a g e in se rt,15 pr ofes s i onal l abel i ng, orpr es cr i bi ng i nform at i on)
. T hi s l abel i ng is w r i tt en forheal th p rof

essio n als, u sing m ed ical t erm ino log y . ”). Z e n e c a h a s s h o wn , th r o u g h d o c u m e n t a rye v i d e n c e , th a tth e F DA appr oved i t s l abel i ng. H ow ev er, the pl ai nt i ffs cont end thatthe a d v e rtisin g d if

f e re d su f f icie n tlyf ro m th e lab e lin g su c h th a t it c a n n o ta l s o b e c o n s i d e r e d t o h a v e b e e n a p p r o v e d b yth e F DA. A ppr oval of a ne w drug appl i cat i on occur s “af t er[the FD A ] det erm i nes thatthe drug m eet s the s t atut ory s t andar ds for s a f e ty an d e f

f e c tiv e n e s s , m a n u f

a c tu ri n g a n d c o n tr o ls , and label i ng . . . . ” 21 C
. F. R
. § 314. 105( c) ( emphasi s added)
. T he F o o d , D ru g , a n d C o s m e tic A c t ( “ F D C A ” ), 2 1 U .S .C . § 3 0 1 , et s eq. , req u ire s th a t ap p lica n ts f o r n e w d ru g a p p lica tio n s s u b m it “[c ] opi es of the l abel and al l l abel i ng forthe drug pr oduct , ” 21 C .F .R
. § 3 1 4 .5 0 (e )(2 )(ii), a n d it sp e c if ica llyp r o h ib its m i s br andi ng of drugs . “A drug or devi ce s hal l be dee m ed t o be m i s br anded ..
. i f i t s l abel i ng i s fal s e orm i s l eadi ng i n any p a rticu lar .” 2 1 U .S .C . § 3 5 2 (a ) ; 2 1 C .F .R . § 1 .2 1 (a )(i)-(ii) (“ L a b e lin g o f a .. . d ru g .. . sh a ll b e d e e m e d to b e m isle a d in g if it fai l s t o r evea l fac t s that are : (1 ) M at er i al i n l i ghtof other r epr es ent at i ons m ade ors ugges t ed by s t at ement , w or d, des i gn, devi ce oranycombi nat i on ther eof; or ( 2) M at er i al w i th r es pect to co n seq u en ce s w h ich m ayresu ltfro m u se o f th e a rt icl e u n d er: (i ) T he condi t i ons pr es cr i bed i n s uch l abel i ng or( i i ) s uch condi t i ons of us e as ar e cus t om ary o r usual
. ”)
. T he FD A m ay r e f u s e t o a p p r o v e a n a p p l i c a t i o n o n th e g r o u n d s th a t“ [ t ] he pr opos ed l abel i ng i s fal s e orm i s l eadi ng i n an ypart i cul ar . ” 21 C
. F. R
. § 314. 125( b) ( 6)
. T hus , t o the ext entthatthe adve r t i s i ngT he FD A ’ s det erm i nat i on tha ta s t at ementi s notfal s e or 8 m i s l eadi ng i s , of cour s e, di s t i n ct f rom a det erm i nat i on thatthe pr es ent at i on of thats t at ement i s not m i s l eadi ng. T he r egul at i ons p ro v id e th a t A n a d v e rtise m e n t m a yb e f a lse , lac k in g in f

a ir b a lan c e , o r o th e rw ise m isle a d in g .. . if it .. . [f ]a ils t o pr es enti nform at i on r el at i ng t o s i de ef fec t s and cont r ai ndi cat i o n s wi th a p r o mi n e n ce a nd r eada bi l i ty r eas onabl ycompar abl e w i th the p re se n tatio n o f

in fo r m a ti o n re latin g to e f f e c tiv e n e ss o f

th e d ru g , tak in g in to a c c o u n t all im p lem e n tin g f

a c to rs su c h a s typ o g ra p h y , lay o u t, contr as t , headl i nes , par agr aphi ng, w hi t e s pace , and anyothert echn i qu es aptt o ach i eve em ph asi s. 21 C
. F
. R
. § 202. 1( e) ( 7) ( vi i i )
. T hr ough thes e r egul at i ons , the F D A h a s g o n e b e y o n d th e m e re su p e rv isio n o f v e ra c ityin a d v e rtisin g sta tem e n ts t o e x a m in e h o w th e in f o rm a tio n is p re s e n te d
. 16 sta tem e n ts re g a rd in g N e x iu m w e re c o n sis ten t w ith sta tem e n ts us ed i n the l abel i ng appr oved bythe FD A , the F D A has det erm i ned thattheyar e notfal s e orm i s l eadi ng. 8 T he FD A ’ s D i vi s i on of D rug M arket i ng, A dvert i s i ng and C om m uni cat i ons advi s es drug m aker s on pr opos ed adve r t i s i ng a n d p r o m o t i o n a l l a b e l i n g , i n a c c o r d a n c e wi th 2 1 C
. F
. R. § 2 0 2
. 1 ( j ) ( 4 )
. H o w e v e r , th i s r e v i e w p r o c e s s i s l a r g e l y v o l u n t a ry.17 I d. ( “A nyadvert i s ement m ay be s ubm i t t ed t o the Food and D rug A d m in istra tio n p rio r to p u b lica tio n f o r c o m m e n t.”); buts ee 21 C
. F. R
. § 314
. 81( b) ( 3) ( “The appl i cants hal l s ubm i ts peci m ens of m ai l i ng pi ece s and any other l abel i ng or advert i s i ng devi s ed for pr om ot i on of the drug pr oductatthe t i m e of i ni t i al di s s emi nat i on of the l abel i ng and atthe t i m e of i ni t i al publ i cat i on of the adve r t i s ementfora pr es cr i pt i on drug pr oduct
. ”)
. Sect i on 352( n) of the FD C A exempt s the cont entof anyadvert i s ementfr om pr e- r el eas e Secr et ar i al s crut i ny , exce pt in “ e x tr a o rd in a ry c ir c u m s ta n c e s .” 2 1 U .S .C . § 3 5 2 (n )( A ). W hetherZ enec a i s corr ecti n i t s as s ert i on thatthe compl ai nti s fundament al l y“bas ed on” the l abel i ng i s a l egal ques t i on. T he compl ai ntatt acks both th e a c tu a l ma rk e t i ng t act i cs u s e d b yZ e n e c a , a s wel l a s th e s tu d i e s u p o n wh i c h F DA appr oval w as bas ed. T o the ext ent that the com pl ai nt al l eges that Ze n e c a ma r ke t e d Ne x i u m a s s u p e r i o rt o P r i l o s e c , th o s e c l a i ms of s uper i or i ty m i ght be act i onabl e i nas m uch as s uch co m p arison s are n o t s u p p o rt ed b ythe lab eli n g an d there fo re m ig h t b e f

a lse o r m isle a d in g . A lth o u g h w e n e e d n o t d e c id e th is q u esti o n n o w , w e no te that the F D A ’s reg u lat ion s re q u ir e pr es cr i pt i on drug advert i s ement s t o com por tw i th appr oved la b e lin g . See, e. g. , 21 C
. F. R
. § 202. 1(e)(3)( i i i ) ( “The in f o rm a tio n re latin g to sid e e f f e c ts a n d c o n tra in d ica tio n s s h a ll d is c lo s e e a c h s p e c if

ic s id e e f

f e c t a n d c o n tr a in d ic a tio n ... co n tai ned i n r equi r ed, appr oved, orperm i t t ed l abel i ng forthe a d v e rt is e d d ru g ....” ); T h o m a s A . H a y e s , D r ug Label i ng and P r om ot i on: E vol ut i on and Appl i cat i on of R egulat or

y Pol i cy , 5118 F OO D & D R UG L
. J. 57, 62 ( 1996) ( expl ai ni ng that , underthe r egu la t i ons , “adve r t i s i ng cl ai m s m aybe bas ed ei theron s ubs t ant i al evi dence oron s ubs t ant i al cl i ni cal exper i ence , ” but th e sta n d a rd f

o r la b e lin g is s u b sta n tial e v id e n c e ); s ee 2 1 C. F
. R. § 201. 56( a) ( 3) ( di s al l ow i ng cl ai m s ors ugges t i ons of drug us e on la b e lin g if

th e re is a la c k o f

s u b s ta n tia l e v id e n c e ). C ongr es s expr es s l ygave the FD A author i tyover prescr i pti on drug ad vert i si ng i n the FD C A
. T he F D C A l i st s a num berof r equi r ed el ement s of pr es cr i pt i on drug advert i s i ng and s t at es that“no adve r t i s emen t o f a pr es cr i pt i on drug, p u b lish e d a f

ter th e e f f e c tiv e d a te o f re g u latio n s is su e d u n d e r th is paragraph ap pli cable t o ad vert i sem ents of p res cri pti on drugs, s hal l w i th r es pectt o the mat t er s s peci fi ed i n thi s par agr aph or cover ed bys uch r egul at i ons , b e su bj ectt o the pr ovi s i ons of s ect i ons 52 t o 57 of Ti t l e 15. ” 21 U
. S. C
. § 352( n)
. Sect i on 52 of T i t l e 15 declar es unlaw ful the d i ss e m in at i on of f al se a d v e rtise m e n ts. S u b s e c tio n 3 5 2 (n ) o f th e F D C A w a s a d d e d in 1 9 6 2 . P u b . L . 8 7 -7 8 1 , § 1 3 1 (a ). Th e DC FA be c a me l a w i n 1965. See Brandy w i ne V olks w agen, Ltd. v. Stat e D ept
. of C om m uni t y A f f ai rs and E con. D ev. , D i v. of C on sum er A f f air s , 312 A
. 2d 632, 633 ( D el
. 1973) (cit ing 5 5 D el. L
. , C h
. 4 6
. ). In e n ac ti n g this st atute, th e D elaw are G en era l A ssem b lyex p resse d it s inte n t “to p rotec t con su m ers and l egi t i m at e b u sine s s ent erpr i s es fr om unfai rordece pt i ve m erc h andi s i ng pr act i ces . ” 6 D EL . C OD E A NN . § 2512. T he l egi s l atur e al s o expl i ci t l ydecl ared i t s “i nt ent
. . . thats uch19 pr act i ces be s w i ft l ys top p ed and t hatthi s s ubchapt ers hal l be l i ber al l ycons trued an d appl i ed t o pr om ot e i t s under l y i ng purpos es and pol i ci es . ” I d. R e a d in g th e e x e m p tio n in § 2513( b) ( 2) t o excl ude fr om the s cope of the D C FA m arket i ng pr act i ces thatar e s ubj ect t o the rul es and r egul at i ons of the F D A , an d w h ich a re r e q u ire d to b e b a se d o n lab e lin g th a t is e x p re ss lya p p ro v e d a n d re q u ire d b yth e F D A , im p ro p e r ly b ro a d e n s th e re a c h o f th e e x e m p tio n b e y o n d its e x p licit l i m i t at i on t o pr act i ces that are co m pl i antw i th FT C rul es and re g u latio n s. W e w ill n o t re w rite th e tex t o f th e e x e m p tio n to in c lu d e re g u lat ion o f a cti v it ies th at are n o t w ith in the F T C ’s a u th o rity . A c c o rd in g ly , w e h o ld th a t th e D istric t C o u rt e rre d in rul i ng thatthe pl ai nt i ffs ’ claim s w er e notact i onabl e underthe D C F A
. III
. P r eem pt i on T he D i s tr i ctC our tfur th er c oncl uded thatthe N exi um advert i s ement s thatcompl i ed w i th the FD A
- appr oved l abel i ng we r e n o t a c t i o n a b l e u n d e r th e s t a t e c o n s u me r p r o t e c t i o n l a ws beca us e thos e l aw s w er e pr eempt ed by fede r al l aw . T he D i s tr i ct C o u r tcorr ect l yanal y zed thi s i s s ue underthe rubr i c of i m pl i ed co n fli ct pre em p ti o n . P lai n ti ff s ass ert th at th e D istr ic t C o u rt ’s a p p lica tio n o f

f e d e ra l p re e m p ti o n is in c o rre c t b e c a u se th e re is notan i r r econc i l abl e conf l i ct betw een the s t at e cons um erfr aud l aw s and the FD C A
. I n part i cul ar , the pl ai nt i ffs ar gue thatthe20 appr oval of N exi um ’ s l abel i ng di d not ext end t o an as s ert i on of N exi um ’ s s uper i or i tyoverPr i l os ec. I m pl i ed confl i ctpr eempt i on r ender s s t at e l aw “w i thout e f f e c t” w h e n , w ith o u t “e x p re ss c o n g re ss io n a l co m m a n d ,” s tate la w c o n f lic ts w ith f

e d e ra l la w . See Ci

pol l one v. Ligget tG r oup, I nc. , 505 U
. S. 504, 516 ( 1992)
. A s the Sup rem e C our thas expl ai ned, “[t ] hi s ques t i on i s bas i cal l yone of c ongr es s i onal in ten t. D id C o n g re ss , in e n a c tin g th e F e d e ra l S tatu te, i n ten d to exer ci s e i t s cons t i tut i onal l ydel egat ed author i tyt o s etas i de the law s o f a S tate ? If

so , the S u p re m a c yC lau se re q u ire s c o u rts to fol l ow fede r al , nots t at e, l aw . ” B ar net t B ank of Mar i on C ount

y, N

. A

. v. N el s on , 517 U
. S. 25, 30 ( 1996)
. T he C our t h as “found i m pl i ed conf

l i ctpr e- empt i on . . . w her e s t at e l aw ‘ s t ands as an o b s tac le to th e a c c o m p lish m e n t an d e x e c u tio n o f th e f u ll purpos es and obj ect i ves of C ongr es s . ’ ” Sp ri et sm a v. Me rcury Mar i ne, a D i v. of

B r uns w i ck Corp. , 537 U
. S. 51, 64- 65 ( 2002) ( quot i ng Fr ei

ght l i ner C or

p. v. M yr i ck , 514 U
. S. 280, 287 ( 1995) ( quot i ng Hin e s v . D a v ido w itz , 31 2 U
. S
. 52 , 67 (1941 )) ). T hu s, th e q u e s t i o n p r e s e n t e d h e r e i s wh e th e rs t a t e c o n s u me rf r a u d l a ws pos e an obs t acl e t o the FD A ’ s congr es s i onal l y - m andat ed r egul at i on of pr es cr i pt i on drug advert i s i ng. For purpos es of thi s cas e, the cr i t i cal char act er i s t i c of the FD C A i s thati tr egul at es the s afe tyof drugs . T he FD C A s t at es th a t th e m iss io n o f

th e F D A is to “ (1 ) p ro m o te th e p u b lic h e a lth bypr om pt l yand ef

fi ci ent l yr evi ew i ng cl i ni cal r es ear ch and tak in g a p p ro p ria te a c tio n o n th e m a rk e tin g o f re g u late d p ro d u c ts21 i n a t i m el ym anner ; ( 2) w i th r es pect t o s uch pr oduct s , pr ot ectthe publ i c hea l th by ens ur i ng that
. . . ( B ) hum an . . . drugs ar e s afe and eff ect i ve. ” 21 U
. S. C
. § 393( b)
. Pr i ort o the i ntr oduct i on of a ne w drug, the FD A m us t fi nd that the “drug i s s afe for us e underthe condi t i ons pr es cr i bed, r ecomm ended, orsu gges t ed i n the p ro p o se d lab e lin g th e re o f.” 2 1 U .S .C . § 3 5 5 (d ) (e x p lain in g in det ai l the s even- partt es tthatthe FD A uses i n det erm i ni ng w h e th e r to a p p ro v e a d ru g ); s e e a l s o Gr i n s p o o n v . DEA , 828 F
. 2 d 8 8 1 , 8 8 7 ( 1 s tCi r . 1 9 8 7 )
. As p a r to f th i s p r o c e s s , th e F DA m u st f in d th a t th e re is “ su b sta n tial e v id e n c e th a t th e d ru g w ill hav e the eff

ecti tpurpor t s ori s r epr es ent ed t o have.
. . . ” I d. D u ri n g the appr oval pr oces s , the Secr et arym aydet erm i ne,
“ ba s e d o n r e l e v a n ts c i e n c e , th a td a t a f r o m one adequa t e and w el l

- contr ol l ed cl i ni cal i nves t i gat i on an dc o n f i rma t o rye v i dence (o b tain e d p rio r to o r a f ter su c h in v e stig a tio n ) a r e su f f icie n t to es t abl i s h eff

ect i venes s . . . . ” I

d. ( emphasi s added)
. Such dat a and e v i d e n c e c o n s t i tu t e “ s u b s t a n t i a l e v i d e n c e ” u n d e r2 1 U
. S. C. § 3 5 5
. Se ct i on 352( n) l i s t s thr ee i t ems thatpr es cr i pt i on drug advert i s i ng m us ti ncl u d e: (1 ) t he ac tual name of t he drug, i f a tr ade orbr and name is us ed; ( 2) the i ngr edi entl i s tand quant i t at i ve form ul a foreac h i ngr edi ent ; and ( 3) a br i ef sum m aryof si de ef

fect s, con tra indicat i on s, and effecti ven ess. T h e su b sec ti o n is c a lle d the “ b ri ef su m m ary ” p rov isi o n . It r equi r es a true s t at ementof thes e thr ee i t ems i n the br i ef su m m a ryin c lu d e d in a d v e rtise m e n ts. T h e sta tu te e x p lain s th a t, t o t he ext entthatan advert i s ementcompl i es w i th s ubs ect i on ( n)22 i n l i s t i ng the thr ee i t ems, i ti s not s ubj ect t o the fa l s e adve r t i s i ng pr ovi s i ons of the FT C A
. H ow ever , as not ed above , § 352( n) re q u ire s o n lyp re -re lea se a p p ro v a l o f a d v e rtise m e n ts in
“ e x tr a o rd in a ry c ir c u m s ta n c e s .” Pur s uantt o i t s r eg u l a t o rya u thor i tyoverpr es cr i pt i on drug advert i s i ng, the FD A pr om ul gat ed r egul at i ons thatl ay outthe s p e c if ic re q u ir e m e n ts f

o r a d v e rt is in g p re s c ri p tio n d ru g s . See 21 C
. F. R
. § 202. 1. I n part i cul ar , the r egul at ion s s t i pul at e thatan adv ert i sem ent does no ti nclude a “true st at em ent” i f i ti s [F ]al se or m i sl eading w i th r espect t o s i de ef fect s, c o n tra in d ica tio n s, o r e f

f e c tiv e n e ss ; o r [ i]t f

a ils to pr es enta fa i rbal ance bet w ee n i nform at i on r el at i ng t o s i de eff

ect s and contr ai ndi cat i ons and i nform at ion r el at i ng t o eff ect i venes s of the drug in th a t th e in f

o rm a tio n re la tin g to e f

f e c tiv e n e s s ... i s notfai r l ybal ance d bya pr ese n tat i on of a s um m ary o f true i nform at i on r el at i ng t o s i de ef fe cts an d co n tra in d icati o n s o f th e d rug . . . ; [o r] [ i]t fa ils to re v e a l f

a c ts m a ter ial in th e lig h t o f its re p re se n tatio n s o r m a ter ial w ith re sp e c t to cons equenc es thatm ayr es ul t fr om the us e of the drug as r ecomm ended ors ugges t ed i n the a d v e rt is e m e n t. 21 C
. F. R
. § 202. 1( e) ( 5)
. T he r egul at i on incl udes an ext ens i ve, b u t no n -ex h au sti v e, 20 -fa ctor li st of rea so n s w h y“[ a]n a d v e rtise m e n t f

o r a p re sc rip tio n d ru g is f a lse , lac k in g in f

a irS u b se c tio n (e )(6 )(ii) d e e m s a n a d v e rtise m e n t m isle a d in g if 9 i t“[c ] ont ai ns a drug com par i s on thatr epr es ent s ors ugges t s that a d r u g i s s a f

e r o r m o r e e f

f e c t i v e th a n a n o th e r d ru g i n s o me p arti cu lar w h en it h as n o t b ee n d em o n str ated to b e saf er o r m o re eff ec ti v e in s u ch p arti cu lar bysu b stan ti al ev iden ce o r sub stant i al cl i ni cal exper i ence . ” 21 C
. F. R
. § 202. 1( e) ( 6) ( i i )
. A l though the F DA d i d n o te x p l i c i t l ya p p r o v e Z e n e c a ’ s a d v e r t i s i n g , th e F DA di d appr ove N exi um ’ s l abel i ng, w hi ch i ncl uded cl i ni cal s tudi es thats how ed s t at i s t i cal l ys i gni fica n t heal i ng r at es for40 m g of N exi um as compar ed t o 20 m g of om epr azol e. T he r egul at i ons e x p lain that the cli nical stud i es sect i on “m ustdis cuss tho se cl i ni cal s tudi es thatfac i l i t at e an unde r s t andi ng of how t o us e the drug s afe l yand ef

fec t i vel y . O r di nar i l y , thi s s ect i on w i l l des cr i be the s tudi es thats uppor teff ect i venes s forthe l abel ed in d ic a tio n (s )....” 2 1 C .F .R . § 2 0 1 .5 7 (c )( 1 5 ). 23 b alan ce , o r oth erw ise m isl ea d ing
. . . . ” 21 C
. F
. R
. § 2 0 2
. 1 (e)(6)(i)

- ( xx)
. T he s ubs equents ubs ect i on expl ai ns the ci r cumst ance s 9 u n d e r w h ich “ [ a ]n a d v e rtise m e n t m ay b e f a ls e , la c k in g in f

a ir bal ance , orotherw i s e mi s l eadi ng. . . . ” 21 C
. F. R
. § 202. 1( e)( 7) ( e mph a s i s a d d e d )
. Th e r e g u l a t i o n s f u r th e rs t a t e t hat
“ [ d ]i ssem i nati on of

a n a d v e rtise m e n t n o t in c o m p lian c e w ith th is par agr aph s hal l be dee m ed t o be an act that caus es the drug t o be m i s br anded.
. . . ” 21 C
. F. R
. § 202. 1( j ) ( 3)
. T he FD A expl ai ns that “[a ] nyadvert i s ementm aybe s ub m it ted t o the Food and D rug A dm i ni s tr at i on pr i ort o publ i cat i on forcomm ent , ” but does not r equi r e thatm anufa ctur er s s ubm i tthei rads forpr eappr oval
. 21 C
. F
. R
. § 2 0 2
. 1 (j )(4). H o w ev er, th e F D A d o es re q u ir e m anufa ctur er s t o s ubm i tadvert i s i ng s peci m en s “atthe t i m e ofC ongr es s di d notal w ay s conce de j u ri sdi ct i on over 10 pr es cr i pt i on drug advert i s i ng t o the FD A
. W hen the FD C A w as pas s ed i n 1938, C ongr es s l eft the author i ty t o pol i ce “ unfai ror dece pt i ve ac t s orpr act i ces in oraff ect i ng comm er ce” w i th the FT C
. Pub. L
. N o. 75- 717, 52 St at
. 1040 ( 1938) , as amended 21 U
. S. C
. § 301 et

s eq. ; W heel er - L ea A ct, 5 2 S ta t
. 111, ch. 49 ( 1938) ( amendi ng s ect i on 5 of the FT C A , Pub. L
. N o. 63- 203, 38 St at
. 717, 719 ( 1914) ( pr ohi bi t i ng “un fa ir m ethods of 24 i ni t i al p u b l i cat i on of the adve r t i s ementfora pr es cr i pt i on drug p r o d u c t
. ” 2 1 C. F. R. § 3 1 4
. 8 1 ( b ) ( 3 ) ( i ) ( r e q u i r i n g tr a n s mi t t a l of th e a d v e rt is e m e n t w ith F o rm F D A -2 2 5 3 ). T he d e g r e e o f

d i s c r e t i o n i n h e r e n ti n th e r e g u l a t i ons demonstr at es tha tthe FD A envi s i oned i t s el f occ upy i ng an ongoi ng and ext ens i ve r ol e i n the s upervi s i on of pr esc ri pt i on d ru g a d v e rt is in g . See, e. g. , 6 0 F e d
. R e g . a t 4 4 2 1 0 (“ In o rd e r to c a r r yo u tth e p u b l i c h e a l th p r o t e c t i o n p u rp o s e s o f th e a c t , F DA:

. . . ( 3) m oni t or s drug l abel i ng and pre s cr i pt i on drug advert i s i ng t o hel p ens ur e that they pr ovi de acc ur at e i nform at i on aboutdrug pr oduct s . ”) ; D i r ect - t o- C ons um erA dverti s i ng of Pr es cr i pt i on D rugs ; W i thdr aw al of M or at or i um , 50 Fed. R eg. 36, 677, 36, 677 ( Sept
. 9, 1 9 85) ( “FD A w i l l cont i nue t o r egul at e pr es cr i pt i on d ru g a d v e rtisin g , reg a rd les s o f its in ten d e d a u d ien c e , in acc or dance w i th s ect i on 502( n) of the Feder al Food, D rug, and C os m et i c A ct( 21 U
. S
. C
. 352( n) ) and the i m pl ement i ng r egul at i ons ( 21 C FR Par t202)
. ”)
. Fur therm or e, C ongr es s s har ed th a t v is io n . See 2 1 U
. S
. C
. § 3 5 2 (n ); 2 1 U
. S
. C
. § 3 9 3 (b)(1 ). 10co m p eti ti o n in com m erc e” )). It w as no t un ti l th e 1 9 6 2 K ef au v erH arr i s D rug A m endment s , w hi ch enac t ed s ect i on 502( n) of the FD C A , t hatr egul at oryauthor i tyoverpr es cript i on drug advert i s i ng w as tr ans ferr ed t o the FD A
. Pub. L
. N o. 87- 781, § 131( a) , 76 St at
. 791- 92 ( 1962)
. For a more compl et e r eci t at i on o f th e h i s t o r yo f d i r e c t - t o - c o n s u me r a d v e r t i s i n g , s e e F r a n c i s B. P a lu m b o a n d C
. D a n ie l M u llin s , The D eve l opm ent of D i r ect
- t oC ons um er P r es cr i

pt i on D r ug A dver t is i ng R egulat i on , 57 F OO D & D RUG L
. J. 4 2 3 , 4 2 4 -3 1 (2 0 0 2 ). T he di s s entcorr ect l ynot es that“w e start w i th the 11 as s um pt i on thatthe hi s t or i c pol i ce pow er s of the St at es w er e not t o be super s eded bythe Feder al A ctunl es s thatw as the cl earand m ani fes tpurpos e of Congre s s . ” R i ce v . Santa Fe El evatorC or p. , 331 U
. S. 218, 230 ( 1947)
. T he pre vent i on of consumer fr aud has tra d iti o n a llyb e e n w ith in th e p u r v iew o f th e sta tes . T h is hi s t or i cal pr efe rence doe s notfor ecl os e the pos s i bi l i tyof p re e m p tio n , w h e re a p p lic a b le
. See, e. g. , G en. Mot ors C or p. v. A b r a ms , 897 F. 2d 34, 36 ( 2d C i r . 1990) ( “W hi l e the pr ot ect i on of cons um er s fr om unfai rpr act i ce s is a tr adi t i onal s t at e pol i ce pow erf u n ct i on, fede r al l aw s and admi ni s tr at i ve r egul at i ons m ay

25 H ow ever , nei therthe l anguage of the FD C A northe r egul at i ons e x p lic itly p re e m p t s ta te c o n s u m e r f ra u d la w . T he ce ntr al tene t of

pr eempt i on anal y s i s i s that“‘ [t ] he purpos e of C ongr es s i s the ul t i m at e t ouchs t one’ ” i n det erm i ni ng w h e th e r s ta te l a w is p re e m p te d
. C i pol l one , 505 U
. S. at516 ( quot i ng R etail

C l erks v. Sch erm erhorn , 37 5 U
. S
. 96, 103 ( 1963) )
. H ow ever , the S upr eme C our t has l ong i ndi cat ed that

11oper at e i n t andem w i th–oreven pr ee m p t–st at e l aw underthe S u p re m a c yC la u s e ....” ). 26 a g e n c yre g u la tio n s a re a ls o a s o u rc e o f p re e m p tiv e la w . See, e. g. , L o u is i a n a Pu b l i c S e r v . Co mm’ n v . FCC , 476 U
. S. 355, 369 ( 1986) ( “Pr e- empt i on m ay r es ul tnotonl yfr om act i on t aken by C o n g re ss itse lf; a f

e d e ra l ag e n c ya c tin g w ith in th e s c o p e o f its c o n g re ss io n a llyd e leg a ted a u th o ritym a yp re -e m p t sta te r egul at i on. ”)
. I n Medtr oni c, I nc. v. Lohr , 5 1 8 U
. S
. 4 7 0 (19 9 6 ), th e C o u rt c o n sid e re d F D A re g u latio n s in th e c o u rse o f its p re e m p tio n a n a ly sis a n d n o ted th a t, u n d e r th e re g u latio n s, “ sta te r equi rem ent s ar e pr e- empt ed ‘ onl y ’ w hen the FD A has e sta b lish e d ‘sp e c if

ic c o u n terp a rt re g u latio n s o r ... o th e r sp e c if ic r equi r em en ts a ppl i cabl e t o a part i cul ardevi ce. ’ ” I d. at498 ( quot i ng 21 C
. F. R
. § 808. 1( d) )
. W hi l e the C ourtemphasi zed congr es s i onal i nt enti n det erm i ni ng w hetherpr eempt i on w as a p p ro p ri a te , i d. at 48 5 -86 , the C o u rt also loo k ed to the “statuto ry and re g u la t oryl anguage ” i n eval uat i ng “the al l egedl ypr ee m p tin g f

e d e ra l re q u ire m e n t a n d th e a lleg e d lyp re -e m p ted sta te r equi r ement
. . . . ” I

d. at500. Si m i l ar l y , i n G ei er v. A m er i can Honda Mot or C o. , I nc. , 529 U
. S. 861 ( 2000) , the C our texami ned w hetherthe N at i onal T raf fic a n d M o tor V eh icl e S af ety A ct of

1 9 6 6 , an d a stan d ard pr om ul gat ed under i t by the D epart m ento f T r ans por t at i on, pr eempt ed a s t at e comm on l aw t or t act i on “i n w hi ch the pl ai nt i ff c laim s th a t th e d e f

e n d a n t au to m a n u f

a c tu re r, w h o w a s in compl ianc e w ith the s tand ard , sh o u ld n o n ethe les s have e qui pped27 a 1987 aut om obi l e w it h airbags
. ” I d. at 86 5
. T h e C o u rt c o n c lu d e d th a t “ th e A c t, taken togetherw i th FM V S S 208 [the agenc y - pr om ul gat ed s t andar d] , pr e- empt s the l aw s ui t
. ” I d. ( emphasi s added)
. B oth Medtr oni c and G ei er s ugges tthe s or tof con fl uen ce betw een co ng res si on al pu rpose and agen cypu rpose thathad pr evi ous l ybeen r ecogni zed i n F i del i t y Feder alSavi ngs a n d L o a n A ss o c ia tio n v . de la C u e sta , 4 5 8 U
. S
. 1 4 1 (19 8 2 ): Feder al r egul at i ons have no l es s pr e- empt i ve eff ectthan fe der al s t at ut es . W her e C ongr es s has d ire c ted a n a d m in istra to r to e x e rc ise h is di s cr et i on, hi s j udgm ent s are s ubj ectt o j udi ci al r evi ew onl y to det erm i ne w hetherhe has exce eded hi s s t atut oryauthor i tyoract ed a rb itr a ri ly. U

ni t ed Stat es v. Shi m er , 367 U
. S. 374, 381- 82 ( 1961). W h en the adm i ni s t r at or pr om ul gat es r egul at i ons i nt ended t o pr e- empt s t at e l aw , the court ’ s i nqui ryi s s i m i l ar l yl i m i t ed. I d. a t 1 5 3 -5 4 ; s ee al

s o Hi l l s bor ough C ount

y, F la. v. A ut om at ed Med. Labs. , I

nc. , 471 U
. S. 707, 713 ( 1985) ( “[S] t at e l aw s can be pr e- em p ted b yfede r al r egul at i ons as w el l as byfede r al s ta tu te s .” ). Medtr oni c and G ei er a d d to th e p re e m p tio n a n a ly sis b ysu g g e stin g th a t s tate law s a re p re e m p ted w h e n th e yf ru stra te re g u latio n s th a t h a v e b e e n p ro m u lg a ted f o ll o w in g a sp e c if

ic i n q u i r yi n t o a p a r t i c u l a ra r e a o f a g e n c ya u th o r i t y . Le s l i e C. K endr i ck, F

DA ’s R eg u lati o n o

f P resc ripti o n D ru gL a b eli n g : A R ol ef or I m pl i ed Pree m

pt i on , 62 F OO D & D RUG L
. J. 227, 240- 41 (2 0 0 7 ).28 Fo l l o wi ng Medtr oni c and G ei er , the S u p rem e C o u rt exami ned conf

l i ctpr eempt i on i n B uckm an C omp a ny v. P lai nt i f f s ’ L egal C om m i t t ee , 5 3 1 U
. S
. 3 4 1 (20 0 1 ). T h e C o u rt d eterm ined that fra u d -on -th e-F D A claim s in st ate t o rtlaw w ere p r e e mp t e d b y th e M e d i c a l De v i c e Ame n d me n t s , 21 U
. S
. C. § 3 6 0 c , et

s eq . I d. at 3 4 8
. T he C our texpl ai ned that“[t ] he c o n f l i c ts t e m s f

r o m th e f

a c tth a tth e f

e d e r a l s t a tu t o rys c h e me ampl yempow er s the FD A t o puni s h and det erfr aud aga i ns tthe A dm i ni s trati on, and thatthi s author i tyi s us ed bythe A dm i ni s tr at i on to ac hi eve a s om ew hatdel i cat e bal ance of s ta tut oryobj ect i ves . ” I

d. I n s o hol di ng, the C our temphasi zed the f lexib il ityinh ere n t i n the s tatu toryan d reg u lat o ry fr amew or k, and not ed that s uch fl exi bi l i ty w as nece s s ary forthe FD A t o pur s ue “di ffi cul t ( and oft en compet i ng) obj ect i ves . ” I d. at349. T he C our tdi s t i ngui s hed Me d tro n ic , no ti n g that“the Medtr oni c claim s aro se fro m the m an u fa cture r’s all eg ed fa il u re t o us e r eason ab le car e i n the pr oduct i on of the pr oduct , not s ol el yfr om the vi ol at i on of FD C A r equi r ement s . ” I d. at352. B ec au se th e “ ex ist en ce o f th ese fe d era l ena c tm en ts [w as] a c ritica l ele m e n t in [ th e p lain tiff s’] c a se ,” th e C o u rt h e ld th a t to al l ow the cl ai m s t o pr ocee d “w oul d exertan extr aneous pul l on the s cheme es t abl i s hed byC ongr es s . . . . ” I d. at353. I n the pl ai nt i ffs ’ cl ai m s agai ns tZ enec a unders t at e cons um erfr aud l aw s, t he F D C A i s not as cl earl ya “cri t i cal el em ent, ” beca use p l a i n t i f f s ma yn o tn e e d t o s h o w n o n - c o mp l i a n c e wi th th e F DCA i n or dert o pr evai l
. H ow ever , al l ow i ng thes e cl ai m s t o pr ocee d wo u l d u n n e c e s s a r i l y f

ru s tr a t e th e F D C A ’ s p u rp o s e a n d F DA r egul at i ons , as t he ext entof age n cy i nvol vementi n r egul at i ng29 p re s c ri p tio n d ru g a d v e rt is in g is e x te n s iv e a n d s p e c if ic
. See 21 C
. F. R. § 2 0 2
. 1 ( e ) ( 6) ( i )

- ( xx) and ( e) ( 7) ( i )

- ( xi i i ) ; D r aftG ui dance s f o r In d u stryo n Im p ro v in g In f o rm a tio n A b o u t M e d ica l P ro d u c ts and H eal th C ondi t i ons ; W i thdr aw al ; A vai l abi l i ty , 69 Fed. R eg. 6308- 01 ( Feb. 10, 2004) ( “FD A has r es pons i bi l i ty underthe Feder al Food, D rug, and C os m et i c A ct( the ac t ) forr egul at i ng ad v erti sing fo r pre scripti o n d rug s. ”). An e v e n s tr o n g e rc a s e f

o rp r e e mp t i o n o c c u r s wh e n F DAappr oved l abel i ng i s the basis foral l egedl yfr audul ent r epr es ent at i ons m ade i n p r es cr i pt i on drug advert i s i ng. T he es s ent i al aff

i ni tybetw een a dvert i s i ng and l abel i ng i s cl ear i n the composi t i on o f the FD C A and i t s as s oci at ed r egul at i ons . 21 U
. S. C
. § 321( n) ( expl ai ni ng cr i t er i a for“det erm i ni ng w heth er the l abel i ng oradvert i s i ng i s m i s l eadi ng”) ; 21 U
. S. C
. § 352( n) ( r equi r i ng thatal l advert i s ement s i ncl ude “the form ul a s how i ng quant i t at i vel yeac h i ngr edi entof s uch drug t o the ext entr equi r ed f o r la b e ls” ); s ee, e. g. , 21 C
. F. R
. § 202
. 1( a) ( 2) ( “The or derof l i s t i ng of i ngr edi ent s i n the adve r t i s em en t sh all be the s ame as the or derof l i s t i ng of i ngr edi ent s on the l abel of t he produc t , and the i n form at i on pr es ent ed i n the adve r t i s ementconce rni ng the quant i tyof ea ch s uch i ngr edi ents hal l b e the s ame as the corr es pondi ng i nform at i on on the l abel of the pr oduct
. ”) ; 21 C
. F
. R
. § 2 02
. 1(e) (3) (i i ) ( “[W ]hen an adv ert i sem ent cont ai ns a br oad cl ai m that a drug i s an ant i bact er i al agent , the advert i s ements hal l name a type ortypes o f infec t i ons and m i cr oor gani s m s forw hi ch the drug i s eff ect i ve cl i ni cal l yas s p e c i f i c a l l y a s r e q u i r e d , a p p r o v e d , o r p e r mi t t e d i n th e dr ug30 packa ge l abel i ng. ”)
. A l th o u g h l abel i ng i s oft en di r ect ed at m edi cal pr act i t i oner s , the rul es thatg o vern l abel i ng form the b a s is f o r t h e a d v e rt is in g re g u la tio n s . See R equi r ement s on C ont entand For m atof La b eli ng forH um an Pr es cr i pt i on D rug and B i ol ogi cal Pr oduct s , 71 Fed. R eg. 3922, 3961 (Jan. 24, 2006) ( “The purpos e of pr es cr i pt i on drug l abel i ng i s t o pr ovi de heal th car e pr act i t i oner s i nform at i on nece s s aryfors afe and eff ect i ve us e. ”) ; Pr es cr i pt i on D rug A dvert i s i ng; C ont entand For m atforL abel i ng of H um an P r es cr i pt i on D rugs , 44 Fed. R eg. 37, 434, 37, 460 (Jun e 26, 1979) ( “The use of quant i t at i ve s t at ement s of s afe tyo r effec t i venes s i s perm i t t ed i n drug advert i s ement s w hen the r epr es ent at ion has been appr oved as partof the l abel i ng. . . . ”)
. A ccor di ngl y , the purpos e of pr ot ect i ng pr es cr i pt i on drug us er s i n the F D C A w oul d be frus tr at ed i f s t at es w er e al l ow ed t o i nt erpos e consum er fra ud l aw s thatperm i t t ed pl ai nt i ffs t o ques t i on the ver aci tyof s t at ement s appr oved bythe F DA. I mp l i e d c o n f

l i c tp r e e mp t i o n o f

s t a t e c o n s u me rf

r a u dl a ws i s r e q u i r e d i n th i s s e t t i n g b e c a u s e b o th t h e F DC A a n d F DA r egul at i ons pr ovi de s peci fi c r equi r ement s forpr es cr i pt i on drug a d v e rt is in g . C o n g re s s s p e c i f ic a lly d e te rm in e d th a t “ a ll ... pr ocee di ngs forthe enf

or cement , o rt o r es tr ai n vi ol at i ons , of [the FD C A ] s hal l b e b yand i n the name of the U ni t ed St at es . ” 21 U
. S. C
. § 337( a)
. T he hi gh l evel of s peci fi ci tyi n fede r al l aw and re g u latio n s w ith re sp e c t to p re sc rip tio n d ru g a d v e rtisin g is irre c o n c ilab le w ith g e n e ra l sta te la w s th a t p u rp o rt to g o v e rn a ll typ e s o f a d v e rt is in g . See, e. g. , 21 U. S
. C. § 3 5 2 ( n ) ; 2 1 C. F
. R.Pl ai nt i ffs al s o as s ert that the D i s tr i ctC our terr ed i n ut i l i zi ng 12 th e d o c tr i ne of pr i m aryj ur i s di ct i on i n di s m i s s i ng thei rcompl ai nt bec aus e theyhad no opportuni tyt o ar gue the appl i cabi l i tyof p ri m aryjuri sd ict ion to the irclaim s. A lth o u g h the p lai n ti ff s are corr ectthat a d ist r i ctcourtm aynotdi s m i s s a compl ai nton gr ounds thatthe pl ai n ti ffs ha d no oppor tuni tyt o addr es s , s ee Mor t ens en v. F i rs tFeder alSavi ngs and Loan A s s oci at i on , 549 F
. 2 d 8 8 4 , 8 9 3 n .1 8 (3 d C ir
. 1 9 7 7 ), inv o ca ti o n o f p ri m ary j u r i s d i c t i o n wa s , a tmo s t , a n a l t e r n a t i v e h o l d i n g . Be c a u s e “ we [c an ] af firm the d istri ct co u rto n an yb asis w h ich f ind s su p p o rt i n t he r ecor d, ” anyerr orthat m ay have oc curr ed i s harm l es s and d o e s n o t r e q u ir e re v e rs a l. U ni t ed Stat es v. Maker , 751 F. 2d 614, 627 ( 3d C i r . 1984) ( quot i ng B er ni t s ky v

. U ni t ed Stat es , 620 F. 2d 9 4 8 , 9 5 0 (3d C ir
. 1 9 8 0 )). L ikew ise, the p lai n ti ff

s’ u n just en ri ch m en t cl aim s are unt enabl e as a r es ul t of our hol di ng r egar di ng the pre empt i on of the D C FA
. T he un

j us tenr i chmentcl ai m s do notr es ton any soun der f

oo t i ng than the fraud cl ai m s. D el aw are d efi nes un j ust enr i chmentas “the unj us tr et ent i on of a be nefi tt o the loss of ano ther, or the r et enti on of m on eyor propertyof an otheragainst the fundam ent al pr i nci pl es of j us t i ce orequi tyand good cons ci ence . ” Sch ock v. N ash , 732 A
. 2d 217, 232 ( D el
. 1999) ( quot at i on om i t t ed)
. B eca us e no fr aud cl ai m exi s t s underthe D C FA due t o the oper at i on of pr eempt i on, ther e w as no dece pt i on byZ enec a cogni zabl e i n s t at e l aw and therefo re no r et ent i on of m oney agai ns t the fundam ent al pr i nci pl es of j us t i ce a t is s u e in th is c a s e . Se e Bobe rv . G lax o Wel l c ome PLC , 2 46 31 § 314. 81( b) ( 3)
. A ccor di ngl y , the p l a i n t i f f s ’ s t at e cons um erfr aud cl ai m s ar e pr eempt ed. 12F
. 3 d 9 3 4 , 9 4 3 (7th C ir
. 2 0 0 1 ). W e have consi d ere d the otherar gum ent s r ai s ed, and c o n c lu d e th a t th e y a re w ith o u t m e rit a n d c o m p e l n o s e p a ra te d is c u s s io n . 32 I V. Leave to A m end T h e d e c isio n w h e th e r to g ra n t lea v e to a m e n d is w ith in th e d i s c re tio n o f

th e d is tr ic t c o u rt
. R ol o v. C i t y I nves t i ng C o. L i qu i da t i ngT

rust , 155 F. 3d 644, 654 ( 3d C i r . 1998)
. T he S u p re m e C o u rt h a s e x p lain e d th a t I n the abs ence of anyappar ent ordecl ar ed rea so n
– su ch as u n d u e d elay , b ad fa ith o r dil atory m o ti v e o n the pa rt o f th e m o v an t, rep ea ted f ail u re to c u re d e f

icie n c ies b ya m e n d m e n ts p re v io u sly al l ow ed, undue pr ej udi ce t o the oppos i ng partyby vi r tue of al l ow ance of the amendm ent , fut i l i tyof amendm ent , et c. –the l eave s ought s houl d, as the rules re q u ir e, be ‘free lyg iven
. ’ F o m a n v . D a v is , 371 U
. S. 178, 182 ( 1962)
. T he D i s tr i ctC ourt d id n o t ru le o n a p p e lla n ts ’ r e q u e s t f o r l e a v e to a m e n d
. T he p l ai nti ffs am end ed thei r com plai nt on ce i n respon se t o a m ot i on t o di s m i s s dat ed M ar ch 31, 2005 thatadvanc ed the s ame ar gum ent s pr es ent ed i n the mot i on t o di s m i s s ati s s ue her e.33 P lain tiff s h a d a n o p p o rtu n ityto re v ise th e ir c o m p lain t in r es pons e t o the r enew ed obj ect i on s, b utfai l ed t o cur e the defi ci enci es . A ddi t i onal l y , al though the pl ai nt i ffs s ugges tthat so m e a d d iti o n a l f

a c ts m ig h t b e p led in o rd e r to c u re th e d e f e c ts of the compl ai nt , amendm ent w oul d be fut i l e. I n part i cul ar , the pl ai nt i ffs s t at e thattheycoul d all ege t hat“i n negot i at i ons betw een the FD A and A s tr aZeneca r egar di ng N exi um l abel i ng, the FD A s t at ed i tw oul d notappr ove anyr epr es ent at i ons by A s tr aZeneca t hatN exi um i s m o re effect i ve than Pr i l os ec, and A s tr a Z e n e c a re s p o n d e d it w o u ld n o t m a k e a n ys u c h s ta te m e n t.” T his w i l l no tov ercom e t he d efi ci encies i n the com plai nt because th e a d v e r t i s e me n t s a r e n o ts u b j e c tt o s t a t e c o n s u me r f r a u d l a w, as e x p lai n ed in p art II I. V. T he D C FA exempt i on foradvert i s ement s or m e rc h a n d isin g p ra c tice s w h ich a re su b jec tt o an d co m pli a n t w ith the rul es and r egul at i ons of, and the s t atut es admi ni s t er ed by , the FT C , 6 D EL . C OD E A NN . § 2513( b) ( 2) , does notpr ecl ude the pl ai nt i ffs ’ s ui t
. T he l anguage of the exe m pt i on c i r c u msc r i bes the f e d e ra l a g e n c ies to w h ich a d v e rtise rs m a y lo o k in se e k in g to excl ude thei r conductfr om the pr ohi bi t i on of § 2513( a)
. T he F DA i s n o tr e f

e r e n c e d i n s u b s e c t i o n ( b ) ( 2 ) , n o rd o e s th e F DA actas a pr oxyforthe F T C i n i t s r egul at i on of pr es cr i pt i on drug ad v ert i s i ng. W e ther efor e dec l i ne t o r ead thats ect i on m o re b ro a d lyth a n th e D e law a re G e n e ra l A ss e m b ly p lain ly d ra f ted it.34 A l though the D C FA exempt i on does notbarthe pl ai nt i ffs ’ s ui t , thei rs t at e cons um erfr aud cl ai m s ar e pr eempt ed b y f e d e ra l law
. B y sp e c if ica lly e x c lu d in g a d v e rtise m e n ts cover ed by21 U
. S. C
. § 352( n) and t he r egul at i ons pr om ul gat ed ther eunderfr om the s cope of 15 U
. S. C
. § 52, C ongr es s s i gnal ed its in ten t to g iv e th e F D A e x c lu siv e a u th o rityto re g u late p re sc rip tio n d ru g a d v e rtisin g . T h e F D A h a s e sta b lish e d sp e c if ic r egul ati ons r egar di ng s uch adve r t i s i ng. T o al l ow gener al i zed s t at e cons um erfr aud l aw s t o di ct at e the par amet er s of fal s e and m isle a d in g a d v e rtisin g in th e p re sc rip tio n d ru g c o n tex t w o u ld p o s e an u n d u e o b stacle to b o th C o n g ress’s a n d the F D A ’s obj ect i ves i n p rotec t i ng the n at i on ’s prescr i pti on drug u ser s. A cc or di ngl y , the s t at e cons um erfr aud l aw s ar e pr eempt ed by th e e x t e n s i v e f

e d e r a l l e g i s l a t i v e a n d r e g u l a t o ryf r a m e w o r k
. We w ill a f f ir m th e ju d g m e n t o f

th e D is tr ic t C o u rt
.35 P enns ylvani a E m

pl oyee s B enef

i tTrus tFund, etal

. v. Zeneca, In c ., e t a l., N o. 05- 5340

C ow en, C i r cui tJ udge, di s s ent i ng.

T he majorit y ’ s concl us i on thatthe FD C A and the i m p lem ent i ng r egul at i ons di s pl ace the D el aw ar e C ons um er Fr aud A ctand t he consumer pr ot ect i on s t atut es of the fi ftys t at es “i gnor e[s ] the t eac hi ng of th[e] [Supr eme] C our t ’s de ci s i ons w hi ch enj o in seeki ng outconfl i ct s betw een s t at e and f eder al r egul at i on w her e none c l ear l yexi s t s . ” H ur on P or t land C em ent C o. v. C i t

y of D et ro i t , Mi ch
. , 3 6 2 U
. S
. 4 4 0 , 4 4 6 (19 6 0 ). B eca us e the sta t e l aw s do not“s t and[] as an obs t acl e t o the acc om pl i s hm entand exe cut i on of the ful l purpos es and o b je c tiv e s ” o f

th e f e d e ra l la w , Hin e s v . D a v ido w itz , 312 U
. S. 52, 6 7 (1 9 4 1 ), I re sp e c tf

u llyd iss e n t.

I.

I n ar eas of tr adi t i onal s t at e r egul at i on, w e s t artw i th “the36 as s um pt i on thatthe hi s t or i c pol i ce pow er s of the St at es w er e not t o be s uper s eded by the Feder al A ct unl es s that w as the cl earand m ani fes tpurpos e of Congre s s . ” R i ce v. Santa Fe E levator C orp ., 3 3 1 U .S . 2 1 8 , 2 3 0 (1 9 4 7 ); see al so Med tron i c, I

nc. v. Lohr , 5 1 8 U
. S
. 4 7 0 , 4 8 5 (19 9 6 ) (“[B ]ec au se t h e S ta tes are i ndepende nts over ei gns i n ourfede ral s y s t em, [i t ] ha[s ] l ong [bee n] pr es um ed thatC ongr es s does notca v ali er l ypr e- empt stat e -l aw ca u ses o f a cti o n . ”). T h e p rotec ti o n o f c o n su m ers a g a in st d e c e p tiv e b u sin e ss p ra c tice s is a n a re a tra d iti o n a lly re g u la te d b yth e S ta te s . C ali f ornia v. A R CA m . C orp . , 49 0 U. S. 93, 101 ( 1989) ( “G i ven the l ong hi s t oryof s t at e comm on- l aw a n d sta tu to ryre m e d ies a g a in st . . . u n f a ir b u sin e ss p ra c tice s, it i s p la in th a t th is is a n a re a tr a d i t i o n a lly re g u la te d b yth e S ta te s .” (f o o tn o te o m itt e d )); F la. L i m e and Avocado G r ow ers , I nc. v. P aul , 373 U
. S. 1 3 2, 146 ( 1963) ( s t atut e t o “pr eventthe d ec ep ti o n o f co n su m ers” w ith in sco p e o f state’s p o li ce p o w ers); P l um l ey v. C om m on w ealth o f Mass . , 155 U
. S. 461, 467 ( 1894) (re c o g n izin g sta te’ s p o w e r to “ p re v e n t[ ] d e c e p tio n o r f ra u d in th e s a l e s o f p r o p e r ty w i th i n th e i rr e s p e c t i v e l i m i t s ” )
. S i m i l a r l y,
“ [ t]h ro u g h o u t o u r h isto ryth e se v e ra l S tate s h a v e e x e rc ise d th e ir p o lic e p o w e rs to p ro te c t th e h e a lth a n d s a f e ty o f th e irc itiz e n s .” Me d tro n ic , 5 1 8 U .S . at 4 7 5
. A s su c h , a p re su m p tio n a g a in st a fi ndi ng of pr eempt i on cl ear l y appl i es i n thi s cas e. A ppl y i ng the pr es um pt i on agai ns tpree m pt i on and gene r al pr i nci pl es of confl i ctpr eempt i on, I cannotagr ee w i th the maj or i ty ’ s fi ndi ng o f p r e e mp t i o n , a s d i s c u s s e d b e l o w.I nci dent al ly , the as s ert i on thatthe mer e “vol um e and 13 c o m p lex ity ” o f

a g e n c yre g u latio n s d e m o n stra tes a n im p licit

37 II.

A

. M y first p o int o f disag ree m en t li es w ith th e m a jori ty ’s heavy r el i ance upon the hi gh l evel of s peci fi ci ty i n th e f ed era l r egul at i ons as a bas i s fora fi ndi ng of pr eempt i on. W hi l e the p re sc rip tio n d ru g a d v e rtisin g re g u latio n s a re u n q u e stio n a b ly det ai l ed and e xt ens i ve, i ti s w el l

- es t abl i s hed thata pr eempt i on in q u iry“ c a n n o t b e ju d g e d b yre f e re n c e to b ro a d sta tem e n ts aboutthe ‘ compre hens i ve’ natur e of fede r al r egul at i on. ” Head v. N

. M

. B d. of Exa m ’r

s i n O ptom etry , 374 U
. S. 424, 429- 30 (1 9 6 3 ) (c itatio n s o m itt e d ); E ngl is h v. G en. E l ec. C o. , 49 6 U. S. 72, 8 7 ( 1 9 9 0 ) ( “ Or d i n a r i l y , th e me r e e x i s t e n c e o f a fede r al r egul at orys cheme, even one as det ai l ed as § 210, does notby itse lf im p lyp re -e m p tio n o f sta te r e m e d ies .”); Hi l l s bor ough C ount y, F la. v. A ut om at ed Med. Labs. , I nc . , 471 U
. S. 707, 718 ( 1985) ( “[I ] f an a gencydoes nots peak t o the ques t i on of p r e - e mp t i o n , we wi l l p a u s e b e f o r e s a y i n g th a tth e me r e v o l u me a n d c o m p lex ityo f

its re g u latio n s ind ica te th a t th e a g e n c yd id in fa ct i n tend to p re-em p t. ”). 13int ent t o d i spl ace al l st at e l aw i n a p art i culararea i s a f ield p re e m p tio n a rg u m e n t, G ei erv. A m . H onda Mot orC o. , 52 9 U. S. 861, 884 ( 2000) , w hi ch w as neverr ai s ed i n thi s cas e. T hi s i s not an ar ea of the l aw i nher ent l y r equi r i ng nat i onal 14 u n i f o r mi t y a nd o u s t i n g a l l r e l a t e d s t a t e l a w. As th e S u p r e me C our thas explai ned, “eve rys ubj ectthatm er i t s congr es s i onal l egi s l at i on i s , by defi ni t i on, a subj ect of nat i onal conce rn. T hat cannotm ean, how ever , that every fede r al s t atut e ous t s al l r el at ed s t at e l aw . ” Hi l l

s bor ough , 4 7 1 U .S . at 7 1 9 . T h u s w h ile prescr i pti on drug ad vert i si ng m eri t s nati on al con cern, C on gress has nott aken drug advert i s i ng fr om a hea l th an d s afe tyi s s ue in to a f ie ld o f in h e re n tly n a tio n a l c o n c e rn . See i d. at720- 22 ( fede r al r egul at i ons governi ng col l ect i on of bl ood pl as m a do not pr eemptl ocal or di nance s on the s ame subj ectm att er )
. I ndeed, even the FD A has acknow l edged that“r egul at ion of drug la b e li n g w ill notpr eemptal l St at e l aw act i ons . ” See L abel i ng R ul e, 71 Fed. R eg. 3922, 3934 ( J an. 24, 2 0 0 6) ( t o be codi fi ed at 21 C
. F
. R
. p ts. 2 0 1 , 3 1 4 , 6 0 1 ) (em p h asis ad d ed ). 38 D es p it e t he vol um e and s peci fi ci tyof the fe der al re g u latio n s, “ sta te s ta tu tes , o th e rw ise v a lid , m u st b e u p h e ld u n l e s s th e r e i s f

o u n d ‘ s u c h a c tu a l c o n f l i c tb e twe e n th e two s chemes of r egul at i on thatboth cannots t and i n the s ame ar ea, []o r ev iden ce o f a co n g ression al de sign to p re e m p t th e f iel d
. ’” Head , 374 U
. S. at430 ( quot i ng F la . L i me , 3 7 3 U .S . at 1 4 1 ); F la. L i me , 373 U
. S. at143 ( fi ndi ng “no i nevi t abl e col l i s i on betw een th e two s c h e me s o f

r e g u l a t i o n ” )
. As d i s c u s s e d f u r th e rb e l o w, 14 n o su c h a c tu a l co n f

lict h a s b e e n d e m o n stra ted o r f o u n d in th isE ven as s um i ng ar guendo that C ongr es s w anted label i ng 15 s t at ement s appr oved bythe FD A t o be i m m une t o att ack, that fede r al i nt er es tw oul d be s erved bypr eempt i ng s t at e l aw t o the ext entthat itaff

or ded r ecove ryt o pl ai nt i ffs att acki ng the l abel i ng. Si m i l ar l y , if C o n g ress w an ted a d v erti sem en ts appr oved b yth e F D A to b e im m u n e to a ttac k , tha t f e d e ra l in ter e st w o u ld be s erved bypr eempt i ng s t at e l aw t o the ext entthati taff or ded r ecove r yt o pl ai nt i ffs at tacki ng the adve r t i s ement s . H er e, plai nti ffs are notat t acking t he label i ng of N exium
. T here i s al so no r ecor d evi dence th atthe FD A appr oved the N exi um advert i s ement s w hi ch they are chal l engi ng. Speci fi cal l y , the 39 cas e.

B.

M y sec o n d p o int o f co n tention is w ith th e m ajority ’s s t at em en t, atl eas tw i thi n the cont extof thi s cas e, that C o n g re ss ’s p u rp o se o f p ro tec tin g p re sc rip tio n d ru g u se rs w o u ld b e f ru stra ted if

p lain tiff s w e re p e rm itt e d to q u e stio n th e v e ra c ity of s t at ement s appr oved bythe FD A
. I ti s u ndi s put ed thatthe FDA h a s n o ta p p r o v e d th e v e r a c i tyo f th e p a r t i cul ar a d v e rtise m e n ts in q u e stio n , an d , as d isc u ss e d in g re a ter d e ta il bel ow , pl ai nt i ffs ar e notatt acki ng, di r ect l yori ndi r ect l y , the l a b e l i n g a p p r o v e d b yth e F DA. 15FD A has notdet erm i ned t he ver aci ty of adver t i s ement s t out i ng N exi um ’ s eff

ect i venes s as “compar ed w i th Pr i l os ec ”and ind icati n g the b en ef

it s o f N ex ium in “e ff

icac yin sh o rt -t e rm h e a lin g ” a n d “ sy ste m c o n tro l” in h e a d -to -h e a d stu d ies w ith P ri lo s e c . 40 T he maj or i tyr efe r s t o the “es s ent i al aff i ni ty ” betw een advert i s i ng and l abel i ng i n s uppor tof it s pr eempt i on fi ndi ng. A d m itt e d ly , in d e f

in in g th e sc o p e a n d su b sta n c e o f c e rta in i n f o r ma t i o n t o b e i n c l u d e d i n d ru g a d v e r t i s e me n t s , th e F DA r egul at i ons r efe r t o the i nform at i on r equi r ed orperm i t t ed i n the a p p ro v e d la b e lin g . See, e. g. , 21 C
. F. R
. § 202. 1( a) ( 1) ( or derof l i s t i ng of i ngr edi ent s ) , ( e) ( 3 ) ( i i i ) ( s i d e e f f e c t s and co n tr aind icatio n s ), (e)(6)(x i) (co n d it ion s o f d rug u se). C ons equent l y , a s t at e- l aw cl ai m , al l egi ng thatan adve r t i s ement c o n sis ten t w ith th e a p p ro v e d lab e lin g c o n tain s in a d e q u a te disc lo sures or w arni ng s r egardi ng such m at t ers as i ng redi ents , s i de ef fec t s , contr ai n d icat i ons , and condi t i ons of us e, m i ght i n d i r ect l ypr es enta conf l i ctw i th the FD A ’ s l abel i ng d e ter m in a tio n . T h a t k in d o f c a se w o u ld p re se n t a m o re d if f icu lt pr eempt i on ques t i on than the one pr es ent ed her e.

I n the i ns t ant cas e, on the otherhand, pl ai nt i ffs cl ai m that advert i s ement s of N exi um cont ai n a fa l s e and mi s l eadi ng dr ug com par is on . T he l abel i ng of a pr es cr i pt i on drug does cont ai n or r equi r e a s how i ng of a drug’ s s uper i or i tyover other drugs on theT o be sur e, the appr oved l abel i ng for N exi um r epr oduces 16 the resul t s of cl i nical stud i es com pari ng the tw o tr eatm ents
. Acc o r d i n g t o FDA g u i d e l i n e s , h o wev e r , th e Cl i n i c a l Stu d i es s ect i on of l abel i ng i s i nt ended t o “fa ci l i t at e an under s t andi ng of how t o us e the drug s afe l yand ef fect ively
. ” Inc l us i on of the cl i ni cal s tudi es ar e noti nt ended to serve as an i m pl i ci tagenc y d e te rm in a tio n a b o u t th e s u p e ri o ri ty o f o n e d ru g o v e r a n o th e r. 41 m arket
. U ns urpr i s i ngl y , then, the FD A has notr ender ed an o f f icia l o p in io n a p p ro v in g o r d isa p p ro v in g a cl ai m of su p e rio rity o f N e x iu m o v e r P rilo se c . A s a r e s u lt , th e re is n o risk th a t a 16 su c c e ss f u l sta te- law c laim , alle g in g th a t N e x iu m a d v e rtise m e n ts cont ai n fal s e and mi s l eadi ng drug compar i s ons , w oul d confl i ct w i th the FD A ’ s ap p r oval of the s t at ement s i n the N exi um l abel i ng.

T he FDA ’ s o wn p r e s c r i p t i o n - d ru g a d v e rt i s i n g r egul at i ons demonstr at e as m uch. T h e re gul at i ons cat egor i ze a s fal s e and m i s l eadi ng anyadvert i s ement that “[c ] ont ai ns a drug compar i s on thatr epr es ent s ors ugges t s thata drug i s s afe ror m or e ef fec t i ve t han anot her drug i n s om e par t i cul ar w hen i thas notbeen d em o n s tr at ed t o be s afe rorm or e ef fec t i ve i n s uch part i cul arbys ubs t ant i al evi dence ors ubs t ant i al cl inic al exper i ence . ” 21 C
. F. R
. § 202. 1( e) ( 6) ( i i )
. U nl i ke the l abel i ngre la te d p ro v is io n s in th e re g u la tio n , s ee, e. g. , 2 1 C
. F .R . § 202. 1( a) ( 1) , ( e) ( 3) ( i i i ) , ( e) ( 6) ( xi ) , the fal s e and m i s l eadi ng drug42 compar i s on pr ovi s i on does notturn on the ap p rov ed l abel i ng, but o n the exi s t ence of “s ubs t ant i al evi dence ors ubs t ant i al cli n ical e x p erien ce . ” 2 1 C
. F
. R
. § 2 0 2
. 1 (e)(6)(ii ). T he “e s s ent i al aff i ni ty ” betw een a dvert i s i ng and l abel i ng, ther efor e, does not s ubs i s ti n a cl ai m att acki ng a s t at ement of drug s uper i or i ty i n an a d v e rtise m e n t.

I n s um m ary , beca us e the FD A has notappr oved or di s appr oved th e v er aci tyof the adve r t i s i ng s t at ement s that pl ai nt i ffs chal l enge i n thi s cas e, and pl ai nt i ffs ’ part i cul ar chal l enge doe s notques t i on the ver aci tyof any s t at ement s i n the l abe l i n g a p p r o v e d b yth e FDA , th e r e i s n o l i k e l i h o o d t hat p lain tiff s’ c laim s w o u ld c o n f

lict w ith th e F D A ’s r e sp o n sib ili ty i n pr ot ect i ng pr es cr i pt i on drug us er s . A s s t at ed bythe l at e C hi ef J us t i ce Rehnqui s t , “mer el yi dent i fy i ng a purpos e i s notenough [ f o r c o n f lict p re e m p tio n ]; it m u st a lso b e s h o w n th a t th e sta te l aw i nevi t abl yfrus tr at es thatpurpos e. ” Jones v. R ath P acki ng C o. , 4 3 0 U .S
. 5 1 9 , 5 4 5 (19 7 7 ) (R eh n q u ist , J. , d issen ti n g ). E m phas i zi ng thatpoi nt , he not ed:

W e m ustal so be ca reful t o d i st i ng uis h those s i tuat i ons i n w hi ch the concu rrentexer ci s e of a pow erby the Feder al G overnm ent and the St at es o r b yth e S tate s a lo n e m a yp o ss ib lylea d to43 c o n f licts a n d th o se situ a tio n s w h e re c o n f licts w ill n e c e ss a rilya rise . “It is n o t . . . a m e re p o ss ib ili ty of i nconveni ence i n the exe r ci s e of pow er s , butan i m m edi at e cons t i tut i onal r epugnanc ythatcan by i m pl i cat i on al i enat e and ext i ngui s h a pr e- exi s t i ng ri g h t o f (s ta te ) s o v e re ig n ty.”

I d. (qu o ti n g T h e F ed era li st N o . 3 2 , p . 2 4 3 (B
. W ri g h t ed. 19 6 1 )). O nl yi f the purpos e o f t he fe der al l aw cannotbe a c c o m p lish e d

– if its o p e ra tio n m u st b e f ru stra ted a n d its pr ovi s i ons be r efus ed thei rnatur al eff ect–m u stthe s t at e l aw y ie ld to th e re g u la tio n o f C o n g re s s . Savage v

. Jones , 22 5 U. S. 5 0 1 , 5 3 3 (19 1 2 ).

W hi l e the maj or i tyhas i dent i fi ed the congr es s i onal purpos e of pr ot ect i ng pr es cr i pt i on drug users, i thas not art i cul at ed how the s t at e l aw m ust i nevi t abl yfrus tr at e that purpos e. T her e i s cert ai nl yno “i m m edi at e cons t i tut i onal r epugnanc y ” betw een a n extr a- agenc yfi ndi ng thata cl ai m of drug s uper i or i ty i n an advert i s ement i s fal s e and mi s l eadi ng and the co ng res si on al pu rpose of p rot ect i ng prescr i pti on drug u ser s. Jones , 430 U
. S. a t 545 ( R ehnqui s t , J
. , di s s ent i ng) ( i nt ernal quot at i ons m arks and ci t at i on om i t t ed)
. A s s uch, I cannotagr ee w ith th e m a

jo ri ty’s f in d in g o f p re e m p tio n o n th a t b a s is
.44 C.

M ythi r d conce rn r el at es t o the maj or i ty ’s f indi ng that C ongr es s ’ s excl us i on of pr es cr i pt i on drug advert i s ement s fr om th e sc o p e o f 1 5 U .S .C
. § 5 2 sig n a ls a c o n g re ss io n a l in ten tio n to p re e m p t s t a te c o n s u m e r f ra u d la w s . T h e te x t o f 2 1 U .S .C . § 352( n) onl yexcl udes cover age u nder15 U
. S. C
. § 52 and does notpurpor tt o bars t at e- l aw t or t act i ons . N ordoes the l egi s l at i ve hi s t oryt o § 352( n) i ndi cat e a congr es s i onal purpos e t o s uppl ant s ta te -l a w a c tio n s . See E ng l ish , 49 6 U
. S
. at88
. M o st im p o rta n tly , the e x c lu sio n o f p re sc rip tio n d ru g a d v e rtise m e n ts fr om c o v e r a g e u n d e rth e f e d e r a l s t a tu t e d o e s n o ta p p r o a c h t he r equi r ed “c l earand mani fes t ” congr es s i onal purpos e t o pr eempt s ta te la w . See Ri ce , 331 U
. S. at230.

D.

Four th, I di s agr ee thatthe maj or i ty ’ s att empt t o anal ogi ze thi s cas e t o B uckm an C o. v. P lai nt i f f s ’LegalC om m i t t ee , 531 U
. S. 341 ( 2001) , w her e the Sup rem e C our tfound pr eempt i on bas ed upon s peci fi c conf l i ct s betw een cert ai n FD A obj ect i ves and s t at e-law fra u d -on -t h e-a g en cy cl ai m s and t he45 i n t e r de p e n d e n c yb e twe e n th e s t a t e c l a i ms a n d F DCA r equi r ement s . I n B uckm an , the C ou rtfou nd that the p l ai nti ffs’ fr aud- on- the- agenc ycl ai m s w oul d h av e had t he ef fec tof det err i ng benef

i ci al off- l abel us es , des pi t e the FD A ’ s obj ect i ve nott o r egul at e the pr act i ce of m edi ci ne, and w oul d have c aus ed a d e lu g e o f

in f o rm a tio n c o n c e rn in g o f f -la b e l u se s, re su ltin g in a d m in is tr a tiv e b u r d e n s a n d d e la y s . Id

. at350- 51. I n addi t i on, the C our tfound thatunl i ke the t r adi t i onal s t at e t or tcl ai m s , the f r a u d

- o n - th e - a g e n c yc l a i ms e xi s t e d s o l e l yb yv i r tu e o f F DCA di s cl os ur e r equi r ement s , w hi ch C ongr es s had gi ven t he FD A the e x c lu s iv e re s p o n s ib ility to e n f o rc e . I d. at35 2. F or these rea so n s, the C o u rth eld th at th e p lai n ti ff s’ st ate-law claim s w ere p re e m p te d
. I

d. at353.

U nl i ke the cl ai m s i n B uckm an , pl ai nt i ffs ’ cl ai m s her e do n o t exist byv ir tu e o f a v iolati o n o f F D C A d iscl o su re r equi r emen ts. T he s t at e cons um erpr ot ect i on s t atut es ati s s ue exi s t ed l o n g befor e the fe der al enac t m ent s . M or eover , the m aj or i tydoes noti dent i fyanyactual confl i ct s betw een the fede r al r egi m e and the s t at e s t atut es . T her e i s , forexampl e, no c ited risk th a t th e a v a ilab ili tyo f sta te- law re m e d ies w o u ld confl i ct w i th a part i cul arfede r al obj ect i ve ora ca r eful bal anci ng of i nt er es t s thatthe fe der al governm ent has achi eved i n pol i ci ng p re sc ri pti on drug ad vert i si ng . F or these reasons, the clai m s in th is c a s e c a n n o t b e re a so n a b lya n a lo g ize d to th e c laim s in B uckm an , an d , thu s, th e m a jo rity ’ s u s e o f

th e re a so n in g in46 B uckm an t o s uppor ti t s pr eempt i on fi ndi ng i s m i s gui ded.

E.

Fi fth, I di s agr ee w i th the m aj or i ty ’ s fi ndi ng of pr eempt i on t o t he ext enti t i s bas ed upon t he pr es ence of s t at el a w p a r a me t e r s f

o rf a l s e a n d mi s l e a d i n g a d v e r t i s e me n t s . As d isc u ss e d b e lo w , the m e re p re se n c e o f sta te la w sta n d a rd s w o u ld noti nevi t abl yl ead t o a col l i s i on w i th the fe der al r egi m e.

A s an i nit i al m at t er, the m aj ori ty charact eri zes pl ai nti ffs’ cl ai m s as both i nt erpos i ng s t at e- l aw s t andar ds and vi nd i cat i ng fede ral requi rem ents
. Im plic it i n thi s dual charact eri zat i on i s, nece s s ar i l y , the r ecogni t i on that the s t at e s t andar ds and fe der al r equi r ement s ar e noti ncons i s t ent
. Y et , i ti s w el l

- es t abl i s hed that th e m e re p re se n c e o f

sta te- law c laim s th a t par al l el fede r al r equi r ement s i s not s uffi ci ent t o s uppor t a pr eemp ti o n fi ndi ng. S e e Me d tro n ic , 518 U
. S. at 495 ( “The pr es ence of a d amages r emedydoes notamount t o the addi t i onal ord i ffe r ent ‘re q u ire m e n t’ th a t is n e c e ss a ryu n d e r th e sta tu te; ra th e r, it m e re lyp r o v id e s a n o th e r re a so n f o r m a n u f

a c tu re rs to c o m p ly w ith iden ti ca l existi n g ‘req u ir em en ts’ u n d er f ed era l l aw .” );47 C i pol l one v. Ligget tG r oup, I nc . , 505 U
. S. 504, 529 ( 1992) ( “St at e- l aw pr ohi bi t i ons on fal s e s t at ement s of m at er i al fac tdo n ot cr eat e ‘di verse, no nu nifor m , and con fusi ng ’ s t and ards. U n li k e state-law o b li g ati o n s co n ce rnin g the w arn ing n ec essa ry t o r ender a pr oduct ‘ r eas onabl y s afe , ’ s t at e- l aw pr os cr i pt i ons on i nt ent i onal fr au d rel yonl yon a s i ngl e, uni form s t andar d: fa lsi ty
. ”).

O n a n u m b e r o f

o c c a sio n s, th e S u p re m e C o u rt h a s u p h e ld stat e l aw s thatpr ovi de r emedi es par al l el t o the r emedi es p ro v id e d b yth e f

e d e ra l la w . See, e. g. , Si lkw ood v. Ker r - McG ee C orp . , 464 U
. S. 238, 257 ( 1984) ( “Pay i ng both fede r al fi nes and s t at e- i m pos ed puni t i ve damages forthe s ame i nci dent w oul d not a p p e a r to b e p h y sic a llyim p o ss ib le. N o r d o e s e x p o s u r e to puni t i ve damages frus tr at e any purpos e of the fe der al r emedi al sc h e m e .”); H

ayf i eld N

. R

. R

. C o. v. C hi

. and N

. W

. Trans p. C o. , 4 6 7 U .S . 6 2 2 , 6 3 6 ( 1 9 8 4 ) (“ A lth o u g h it m a yse e m u n f a ir to a llo w a sh ip p e r a ‘se c o n d b ite a t th e a p p le’ in sta te condem nat i on pr ocee di ngs . . . , thats econd opportuni tydoes n o t frustrate the p u rpo s e o f th e f ed era l valu ati o n sch em e.”); Kew an ee O il C o. v. B i cron C orp . , 416 U
. S. 470, 484 ( 1974) ( “[T] he pat entpol i cyof enc our agi ng i nvent i on i s notdi s turbed b y th e e x i s t e n c e o f a n o th e r f o r m o f i n c e n t i v e t o i n v e n t i o n . ” )
. As expl ai ned by the S upr eme C our t , “s t at e ca us es of ac t i on ar e not pr e- empt ed sol el y beca us e t heyi m pos e l i abi l i tyoverand above thatauthor i zed byfede r al l aw . ” C a lifo rn ia , 490 U
. S. at105;48 E ng l ish , 4 9 6 U .S . a t 8 9 ( s a m e ). B uts ee Capi talC i t i es C abl e, Inc. v . C risp , 4 6 7 U. S
. 6 9 1 , 7 0 6 ( 1 9 8 4 ) ( “ S i n c e th e Ok l a h o ma l aw . . . compel s conduct that fede r al l aw forbi ds , the st at e ban cl ear l ystands as an obs t acl e t o the ac compl i s hm entand exec u ti o n o f t he ful l purpos es and obj ect i ves of the fe der al r egul at orys chem e. ” ( i nt ernal quot at i on m arks and ci t at i on o m itt e d )); Frankli n N

at. B an k v. N

ew Y ork , 347 U
. S. 373, 378 ( 1954) ( fin d ing a “c l earconfl i ct ” betw een f eder al l aw , w hi ch author i zed na t i onal banks t o r ece i ve s avi ngs depos i t s but di d not s peci fi cal l yperm i t– m uch l es s r equi r e–adve r t i s i ng bysuch banks , and N ew Y or k l aw , w hi ch forbade them from usi ng the w o rd “ sav ing s” in their ad v erti sing o r bu sine ss).

T he s t at e statut orydamages r emedi es forfal s e and m i s l eadi ng adve r t i s ement s w oul d notfrus tr at e the fe der al pol i cy of pr ot ect i ng pr es cr i pt i on drug cons um er s . T he ver aci tyof drug a d v e r t i s e me n t s i s e s s e n t i a l t o th e p r o t e c t i o n o f c o n s u me r s . As s t at ed i n the l egi s l at i ve hi s t ory t o 21 U
. S. C
. § 352( n) , “w hen a doct ori s m i s l ed hi s pat i ent ’ s heal th i s endange r ed. ” S
. R ep. N o. 8 7
- 1 7 4 4 (1 9 6 2 ), re

p rin tedin 1962 U
. S. C
. C
. A
. N
. 2884, 2904. G i ven thatthere ar e l i m i t at i ons t o the FD A ’ s over s i ghtover p r e s c r i p t i o n d ru g a d v e rt i s e me n t s –both congr es s i onal l y - i m pos ed lim itatio n s, su c h a s th e lac k o f a u th o rityto re q u ire p re a p p ro v a l, 2 1 U
. S
. C
. § 352( n) , and pr act i cal l i m i t at i ons att endantt o the s h e e r v o lu m e o f d ru g a d v e rt is e m e n ts in th e m e d ia , s ee Do n n a U. V o g t, C R S R epor tf

orC ongr es s : D i r ect
- t o- C onsu m er49 A dver t is i ng of

P r es cr i pt i on D r ugs 20 ( C ongr es s i onal R es ear ch Ser vi ce, T he Li br aryof C ongr es s 2005) ( not i ng that in 2003 al one, the FD A r ece i ved 38, 000 adve r t i s ement s fr om drug sp o n so rs)

– th e su p p lem e n tatio n o f sta te- law re m e d ies w o u ld se e m to a id th e F D C A ’s o b jec tiv e s a n d p u rp o se s, n o t f ru stra te th e m.

Forthes e r eas ons , I cannot agr ee thatthe mer e pr es ence o f s ta te law sta n d a rd s f o r f a lse a n d m isle a d in g a d v e rtise m e n ts wo u l d p r e s e n ta c o n f

l i c twi th th e f

e d e r a l l a w.

F.

O f f in a l n o te, C o n g re ss ’s f a ilu re to p ro v id e a p riv a te r emedyforperso n s i nj ur ed byfal s e and mi s l eadi ng advert i s ement s fur therconvi nces m e that the s t at e l aw r emedi es ar e notpr eempt ed. A s the Supr eme C our ts t at ed i n Si lkw ood , “[i ] t i s di ffi cul t t o bel i eve that C ongr es s w oul d, w it h out com ment , r e move a l l mea ns of j ud i c i a l r e c ou r s e fo rt ho se in ju r e d b yill e g a l co n d u c t.” 4 6 4 U .S . at 2 5 1 ; s e e a l s o Ba t e s v. D ow Agr os c i e nc e s LLC
. , 5 4 4 U. S
. 4 3 1 , 4 5 0 ( 2 0 0 5 ) ( “ [ I ] ts e e ms unl i kel ythat C ongr es s cons i der ed a r el at i vel yobs cur e pr ovi s i on50 lik e § 1 3 6 v (b ) to g iv e p e stic id e m a n u f a c tu re rs v irtu a l im m u n ity fro m ce rt ain f

o rm s o f to rtli ab il ity . ”).

In addit i on , w h e re t he st at e l aw i n q uest i on provides a l ong avai l abl e for m of com pens at i on, i t w oul d be expe ct ed that C ongr es s w oul d expr es s an i nt entt o depr i ve i nj ur ed part i es of th a t c o m p e n s a tio n e v e n m o re c l e a r ly. See Bat es , 544 U
. S. at 449. H er e, the l ong hi s t ory of s t at e cons um erpr ot ect i on s t atut es i n this countr y( w hi ch, i nci dent al l y , w er e model ed af t erand coexi s t ed w i th the FT C A , the FD C A ’ s pr edec es s o r i ns ofaras pr es cr i pt i on drug advert i s i ng i s conce rned ) a dds for ce t o the b a s ic p re s u m p tio n a g a in s t p re e m p tio n . S e e id

. at 449- 50. T hat pr es um pt i on has notbeen r ebutt ed i n thi s cas e.

I n s um m ary , beca us e congr es s i onal i nt ent i on t o r emove al l j ud i ci al recourse for par t i es i njur ed b ydecep t i ve b usi ness pr ac ti ces i s farfr om cl ear , a fi ndi ng of pr eempt i on i s not p e rm itt e d u n d e r S u p re m e C o u rt p re c e d e n t.

III
.A p art fro m m y g e n e ra l d isag ree m en t w ith the m ajority ’s 17 p ree m p ti o n an aly s is , I also d isag ree w ith the m ajority ’s s um m aryconcl us i on thatthe FD A ’ s pr es cr i p ti o n drug adverti s i ng r egul at i ons pr eemptthe pl ai nt i ffs ’ cl ai m s t o the ext entb as ed upon fa l s e and mi s l eadi ng pr es ent at i ons and “detai l i ng , ” as i ti s not cl ear that the regu l at i on s applyt o those kinds of p rom oti on al act i vit i es. 51 B as ed upon the for egoi ng, I r es pect ful l ydi s s ent , i ns ofar as the maj or i tyconcl udes thatthe s t at e cl ai m s ar e pr eempt ed. 17