T hi s di s pos i t i on i s notappr opr i a t e f orpubl i c a t i on and i s notpr e c e de nt * e xc e pta s pr ovi de d by9th C i r . R . 36- 3. NOT F OR P UB L I CAT I ON UN I TE D STATE S C OU RT OF APPE ALS FOR T HE NI NTH CI RC UI T UN I T E D S T AT E S OF AME R I C A, P l ai nt i ff

- A pp el l ee , v. VI NO D C HA ND R AS HE KM P AT WAR DH AN , D e f

e n d a n t - A p p e lla n t. N o. 09- 50487 D . C . N o. 5: 08 -c r- 00 17 2-V A P -1 ME MOR AN DU M *

A pp ea l fr om the U ni t ed S t at es D i stri ctC ou rt f o rth e C e n tr a l D is tr ic t o f C a lif o rn ia V i r gi ni aA . P hi l l i ps , D i s tr i c tJ udge , P r e s i di ng A r gue d a nd S ubm i tt e d F e brua ry8, 2011

P a s a d e n a , C a lif

o rn ia B efo re: P R E G E R S O N , W A R D L A W , an dB E A , C i rcu i tJu d g es. V i nod C . P a tw a r dha n appe a l s hi s c onvi c t i on f ol l ow i ng aj urytr i a l f

or( 1) c o n s p ir a c y , 1 8 U .S .C . § 3 7 1 , ( 2 ) in tr o d u c in g m is b r a n d e dd ru g s in to in te r s ta te com m er ce w i th i nt entt o d ef raud or m i sl ea d, 21 U . S . C . §§ 33 1(a) , 33 3(a) (2), 352( c ) , 352( f

) ( 1) , ( 3) s m uggl i ng goods i nt o the U ni t e d S t a t e s , 18 U . S . C . § 545, ( 4) 

# FI LED MA R 18 2011 M OLLY C. DW Y ER, CLERK U . S. C O U R T OF APPE ALSB ec ause the part i es ar e f am i l i arw i th the fa ct s of the ca se , w e r epea tthem 1 he r e onl yt o the e xt e ntne c e s s a ryt o e xpl a i n ourde c i s i on. 2 a i di ng a nd abe tt i ng s m uggl i ng, 18 U . S . C . § 2( a ) , ( b) , a nd ( 5) c r i m i na l f or f e i tur e , 18 U . S . C . §§ 98 1(a) (1)( C ), 98 2(a) (2)( B ), 21 U . S . C . § 8 53 (p), 28 U . S . C . §§ 85 3(p), 2 4 6 1 ( c ) . W e h a v e j u r i s d i c t i o n u n d e r2 8 U . S. C. § 1 2 9 1 , a n dw e a f f i rm. 1

I. C on vi ct i on of In tr od u ci n g M i sb ran d ed D ru gs i n to In te rs tate C om m er ce P a tw a r d h a n w a s c o n v ic te d o f in tr o d u c in g m is b r a n d e dd ru g s in to in te r s ta te com m er ce w i th i nt entt o d ef raud or m i sl ea d. 21 U . S . C . §§ 33 1(a) , 33 3(a) (2), 352( c ) , 352( f

) ( 1) . W e r e

j e c tP a tw a r dha n’ s ar gum e nttha the c a nnotbe c onvi c t e d of th e s e c h a r g e s . U n d er th e rel ev an tst atu t o ry sch em e, p rescri p t i o n d ru g s are p er se m is b r a n d e d . See 2 1 C .F .R . § 2 0 1 .5 ; s e e a ls o E v e rs v . U n ite d S ta tes , 643 F . 2d 10 43 , 10 51 (5th C i r. 19 81 ) ( ac ce pt i ng the F D A ’ s a ss ert i on that“ si nce a p r e s c r ip tio n d ru g b yd e f in itio n c a n b e u s e do n lyu n d e rap h y s ic ia n ’s s u p e rv is io n . .

. i ti s i m pos s i bl e t o pr ovi de ‘ a de qua t e di r e c t i ons f orus e ’ t o al a y m a n” ) ( c i t i ng U n ite d S ta tes v . A r tic les o

f D r u g, 62 5 F . 2d 66 5, 67 3-75 (5th C i r. 19 80 )) . P r e s c r ip tio n d ru g s le g a llyf lo w th r o u g h in te r s ta te c o m m e r c e o n lyw h e n th e yf a llE x c e p tio n 1 : U n d e r2 1 C .F .R . § § 2 0 1 .1 0 0 , 2 0 1 .1 1 5 , ap r e s c r ip tio n d ru g is 2 no tconsi dere d m i sbrand ed i f the drug i s i n the po ss es si on of som eone w ho can la w f u llye n g a g e in th e d is p e n s in g o f d ru g s , a n dth e lab e l c o n ta in s , in te ra lia , the s t a t e m e nt“ R x onl y , ” the r e c om m e nde d dos a ge , the r out e of a dm i ni s tr a t i on, the a m o u n t o f

e a c h a c tiv e in g r e d ie n t, th e n a m e s o f in a c tiv e in g r e d ie n ts ( if

th e d ru g is for ora l use) , and a l otor control nu m ber. E xc e pt i on 2: U nde r21 U . S . C . § 353( b) ( 2) , “ [ a ] nydrug di s pe ns e d byf i l l i ng or r e f illin g aw r itte n o ro r a l p r e s c r ip tio n o f ap r a c titio n e rlic e n s e db yla w to a d m in is te rs u c h d ru g s h a ll b e e x e m p t f r o m th e r e q u ir e m e n ts o f [ 2 1 U .S .C . § 3 5 2 ]. .

. i f the drug be a r s al abe l c ont a i ni ng the na m e a nd a ddr e s s of the di s pe ns e r , the s e r i a l num be ra nd da t e of the pr e s c r i pt i on orof

i t s f i l i ng, the na m e of

the pr e s c r i be r , a nd, i f

s t a t e d i n the pr e s c r i pt i on, the na m e of the pa t i e nt , a nd the d ir e c tio n s f

o ru s e a n d c au tio n a rys ta te m e n t, if a n y , c o n ta in e din s u c h p r e s c r ip tio n .”

3 u n d er o n e o f tw o ex cep t i o n s. See 2 1 C .F .R . § § 2 0 1 .1 0 0 , 2 0 1 .1 1 5 ; 2 1 U .S .C . § 2 3 5 3 ( b ) ( 2 ) ; s e e a ls o E v e rs , 6 4 3 F .2 da t 1 0 5 1 . P atw ar dh an do es no tar gu e, no r does an i nd ependentre vi ew of the re cord s upportthe c onc l us i on, tha tthe non- F D A appr ove d f or e i gn m e di c i ne he br ought i nt o the U ni t ed S t at es for l at erdi stri bu t i on t o h i s pat i ent s qual i fi es for e i ther e xc e pt i on. T hus , P a tw a r dha n c a n be c onvi c t e d of i ntr oduc i ng m i s br a nde d drugsP a tw a r dha n r e l i e s on the F i f th C i r c ui t ’ s de c i s i on i n E v e rs , 6 4 3 F .2 d1 0 4 3 , to 3 a r gue tha ti ti s l e ga l l yi m pos s i bl e f oraphy s i c i a n w ho a dm i ni s t e r s pr e s c r i pt i on m e d ic in e to h is p a tie n ts to b e c o n v ic te du n d e rth e m is b r a n d in g s ta tu te . H is r e l i a nc e i s m i s pl a c e d. E ve r s w a s c ha r ge d unde radi f f e r e ntpr ovi s i on, s e c t i on 33 1(k), w hi ch proh i bi t s c ausi ng a drug t o b ec om e m i sbrand ed w hi l e hel d aft er s h ip m e n t in in te r s ta te c o m m e r c e . I n c o n tr a s t, P a tw a r d h a n w a s c h a r g e dw ith in tr o d u c in g m is b r a n d e d d ru g s in to in te r s ta te c o m m e r c e u n d e rs e c tio n 3 3 1 ( a ) . 4 i nt o i nt er st at e c om m er ce i n v i ol at i on of 21 U . S . C . §§ 33 1(a) , 33 3(a) (2), 35 2(c) , 35 2(f) (1). 3 F urthe r , the r e w a s s uf

f i c i e nte vi de nc e pr e s e nt e d a ttr i a l , vi e w e d i n the l i ght m o st fa v o rab le to th e p ro se cu ti o n , fo r “‘ any r a tio n a l tr ie ro f f a c t [ to f in d ] . . . be y ond ar e a s onabl e doubt ’ ” tha tP a tw a r dha n a c t e d w i th the i nt e ntt o de f r aud or m is le a d . U

n ite d S ta tes v . N

e v ils , 598 F . 3d 1158, 1161 ( 9th C i r . 2010) ( quot i ng J a c k s o n v . V ir g in ia , 44 3 U . S . 30 7, 31 9 (19 79 ) ( em ph as i s i n o ri gi nal )) . P atw ar dh an to ldh is staf

f n o t t o g iv e p atien ts fo re ig n m ed icin e f o r a t-h o m e u se af

ter a p atien t’ s m o th e re x p r e s s e d c o n c e rn ab o u t o n e lab e l, w h ic h w a s w r itte n in H in d i. P a tw a r dha n ne ve ri nf

orm e d hi s pa t i e nt s tha tthe drugs a dm i ni s t e r e d t o the m dur i ng in - o f f ic e tr e a tm e n ts w e r e n o t F D A - ap p r o v e d . T o th e c o n tr a ry , th e I V b a g s u s e d to adm i ni st erthe forei gn m edi ci ne cont ai ned o nl y the nam es of the F D A -app roved c ount e rpa rt s . A ddi t i ona l l y , the r e w a s e vi de nc e tha tP a tw a r dha n’ s s t a f f hi d f or e i gn m edi ci ne du ri ng an audi t , and u se d the codes corr es po nd i ng t o the F D A -app roved5

drugs , notthe f

or e i gn m e di c i ne s tha tha d a c tua l l ybe e n us e d, w he n bi l l i ng M e d ic a r e f

o rr e im b u r s e m e n t.

I I . Ex pe r t Te s t i m o ny W e a l s o c onc l ude tha tthe di s tr i c tc ourt ’ s m i d- tr i a l rul i ng e xc l udi ng the t e s t i m onyof

e xpe rtw i tne s s P a tr i c k E ga n a f t e rtha tt e s t i m onyw a s r e f e r e nc e d i n the d e f e n s e o p e n in g s ta te m e n t d o e s n o t w a rr a n t an e w tr ia l. “E v id e n tia ryru lin g s w ill b e r e v e r s e d f

o rab u s e o f

d is c r e tio n o n lyif

s u c h n o n c o n s titu tio n a l e rr o rm o r e lik e ly than n otaf

fe ct ed the verdi ct . ” U

. S. v. H an ke y , 20 3 F . 3d 11 60 , 11 67 (9th C i r. 2000) . P a tw a r dha n, how e ve r , ha s notde m ons tr a t e d tha the w a s pr e j udi c e d bythe d is tr ic t c o u rt’s ru lin g . O verw hel m i ng evi dence s up po rt ed the gu i l ty ver di ct , and thu s the di stri ct c o u rt’s ru lin g d idn o t a f f e c t th e o u tc o m e o f

th e tr ia l. Se e id . M o r e o v e r , U ni ted State s v . G onz alez -M

aldonado , 11 5 F . 3d 9 (1stC i r. 19 97 ), up on w hi ch P atw ar dh an re l i es t o argue thathe suff er ed prej ud i ce as a r es ul tof the di stri ctcourt ’ s m i d-tri al rul i ng, i s di s t i ngui s habl e . I n G onz alez -M aldonado , the di stri ctcourt ’ s m i d-tri al rul i ng pr e ve nt e d the de f e ns e f r om i ntr oduc i ng i m port a nti m pe a c hm e ntt e s t i m ony o f th e p r o s e c u tio n ’s k e yw itn e s s , te s tim o n yth a t d e f e n s e c o u n s e l h a dp r o m is e din hi s ope ni ng s t a t e m e ntthe j uryw oul d he a r . I n c ontr a s t , E ga n’ s t e s t i m onyw a s not6

cr i t i ca l t o P atw ar dh an’ s def ense , because P atw ar dh an never s ug gest ed thathe w as confused by the part i cul arl aw s E gan w as go i ng t o add re ss . D ef ense coun se l m ent i on ed E gan o nl y bri ef l y i n h i s openi ng st at em ent , and the di stri ctcourt p r o h ib ite d th e p r o s e c u tio n f r o m a r g u in g th a t d e f

e n s e c o u n s e l h a db r o k e n its pr om i s e byf

a i l i ng t o i ntr oduc e E ga n’ s t e s t i m ony . T hus , P a tw a r dha n ha s not d em o n stra ted th at th e d istrict co u rt’s m id -trial d ec isio n to ex clu d e E g an ’s te s tim o n yp r e

ju d ic e d h im a s to r e q u ir e an e w tr ia l. AF F I RME D.