09-1832-c v

HiFi DNATec h L L C v. United States Dept. of He alth & Human Svcs
U N IT E D S T A T E S C O U R T O F A P P E A LS F O R T H E S E C O N D C IR C U IT SUM M AR

Y O RD ER RULINGS BY SUMM ARY O RDER DO NOT H AVE PRECEDENTIAL EF F ECT. CITATION TO SUMM ARY O RDERS F ILED AF TER JANUARY 1, 2007 , IS P ERMI TTED AND IS GOVERNED B Y THIS COURT’S LOCAL RULE 32.1 AND F EDERAL RULE OF AP P ELLATE PRO CEDURE 32.1 . IN A B RIEF OR OTH ER P AP ER IN WH ICH A L ITIGANT CITES A SUMM ARY O RDER, IN EA CH PAR

AG RA PH IN WHICH A CIT AT ION APP EA RS , AT LEA ST O NE C ITA TION MUS T EITH ER BE TO THE F EDERAL APP ENDIX O RB E ACCOM P ANIED BY THE NOTATI ON: “( S U MMA R

Y OR D E R). ” APA R T Y C IT IN GASU MMA R Y ORD E R

MUS T SE R

V E A C OPY OF THAT SUM MARY ORDER TO GE T H E RWITH THE P AP ER IN WHI CH TH E SUMM ARY ORD E R I S C IT E D ON A N Y PA R T Y N OT RE PRE S E N T E D BY C OU N S E L U N L E S S T HE SUMM ARY O RDER IS AVAILAB LE IN AN ELECTRONIC DATABASE W HI CH IS PUB LICLY ACCESSIB LE WITH OUT P AY MENT O F F E E ( S U C H AS TH E DATABASE AVAILAB LE AT HT T P://WW W. C A 2. U S C OU R T S . G OV/) . I F N O C OPY I S S E R V E D BY RE A S ON OF T HE AVAILAB ILITY O F TH E O RDER O N SUCH A D ATABAS E, THE CITATIO N MUST INCLUDE REF ERENCE TO TH AT DATAB ASE AND THE DOCK ET NUM B ER O F TH E CASE IN WH ICH THE O RDER WAS ENTERED. At a stated te rm of the United States Court of A ppeals for the Second Circuit, held at the Daniel Patric k Moy

nihan Courthouse, 500 Pear l Street, in the City of Ne w York, on the 17 day th of De cembe r, two thousand nine. Pr e se nt: ROBERT A. K ATZ MANN, J OSEPH M. McLAUGHL I N, GERARD E. LYNCH,

Circuit Judges
.

________________________________________________ HI FI DNA TECH L L C,

Plain tif f- Ap pe lla nt,
v. No. 09-1832-c v UNI TED STATES DEPARTMENT OF HEAL TH AND HUMAN SERVI CES, UNI TED STA TE S F OO D & DR

UGAD MI

NI STR AT I ON , K

AT HL EEN SE B EL IUS, SEC . O F U. S. HEAL TH AND SVCS ., MARGARET HAMB URG, COMM. OF U.S. F OOD & DRUG ADMI N.,-2- Defendants-A

ppellees
.

________________________________________________ F or Pla int if f- Ap pe lla nt: ANTHONY J. M US TO , F a ir fi e ld, CT F or De fe nd ants -A

pp e lle e s: D RAKE C UTI NI , Offic e of Consumer L itigation, U.S. Depa rtment of J ustice (Tony

West, Ann M. Ravel, Eug ene M. Thir olf, L aure n H. Be ll, U.S. Department of Justice, David Cade , Michae l M. L anda, Eric M. B lumberg , Claudia J . Z ucker man, U.S. Depa

rtment of Hea lth and Human Servic es, of counsel), Was hin g ton , D C Appea l from the United States District Court for the District of Connec ticut (Covello, J .). ON CO NSI DE RA TIO N W HEREOF , i ti s h e r e b y OR DE RE D , AD JU DG ED , and DE CREED that th e jud g me nt o f t he dis tr ic t c ourt

be and he re by is AF F IRM ED
. Plaintiff-Appellant HiF i DNA Te ch L L C (“HiF i”) a ppeals fr om the decision of the dis tr ic t c ourt

g ra nti ngDe fe nd ants -A

pp e lle e s’ mot ion

fo r j ud g me nt o n th e ple a din g s. We a ssume the par ties’ familiarity

with the fac ts and proce dural history of the c ase. HiFi argues that the district cour t erre d by not allowing H iFi to introduce e vidence outside of the administrative r ecor d and by concludingthat the Food a nd DrugAdministration (“ F DA ” ) h a d n ot a c te d a

rb itr ari ly and c a pr ic iou sly in d e nyingHi F i’ s p e tit ion to r e c la ssi fy

its
me dic a l de vic e . H iF i’ s argume nt f a ils on bo th c ounts . As an initial matter, HiF i has waive d its argument that the district court e rre d by not allowingHiFi to introduce evidenc e outside of the a dminist rative r ecor d beca use HiF i never reque sted to do so in the district court. See Paese v . Hartford Li fe Acc ident Ins. Co. , 449 F.3d 435, 446-47 (2d Cir. 2006) ( holding that this Court will not gene rally consider a

n issue that was not raised be fore the district court, pa rticularly when that issue is a f

actua l one). Eve n if HiFi ha d-3-

raised this ar gument, the district court would not have abused its discre tion in rejectingit. See Nat’l Audubon Soc’y v . Hoffman , 132 F.3d 7, 14 ( 2d Cir. 1997) (“G ener ally , a cour t review ing a

n ag ency decision is confine d to the administrative re cord c ompiled by that ag ency

when it made the dec ision.”). Recor d supplementation is only appropriate in ce rtain circ umstances, suc h as wher e ther e is bad fa ith or improper be havior on the pa rt of ag ency

decisionmake rs. Id . Her e, HiFi does not a lleg e fa cts that would support a findingof bad f aith or improper

behavior
. HiFi’s a rgument on the merits also fa ils. The FDA ’s denial of HiFi’s pe tition i s review ed under the Administrative Procedur es Ac t, which re quires the c ourt to hold unlawful and se t aside
a g e nc y a c tio ns that it

fi nd s to be “ arb itr ary , c a

pr ic iou s, an a

bu se of dis c re tio n, or

oth e rw ise no t in
a c c or da nc e wi th l aw. ” 5 U .S. C. § 70 6( 2) (A ). Th e c ourt ’s re vie w o f a sc ie nti fi c de te rm inatio n is particula rly defe rential. Envtl. Def. v . U.S. EPA , 369 F.3d 193, 204 ( 2d Cir. 2004). HiFi a rgues pr inc ipa lly

that th e F DAa c te d a

rb itr ari ly and c a pr ic iou sly by re vie wi ngHi F i’ s d e vic e a s a
canc er- detec tion device instea d of a virus- detec tion device. B ased on the intended uses f or the de vic e a s d e fi ne d b y

Hi F i in the ir a pp lic atio n to the F DA , h ow e ve r, the F DAre a so na bly deter mined that the device was mea nt to inform a clinician’ s medical a ssessment of a w oman’s ri sk of de ve lop ingc e rv ic a l c anc e r a nd the re fo re re a so na

bly e va luate d th e de vic e wi th r e sp e c t to that us e . H iF i a lso argue s th at th e F DAarb itr ari ly and c a pr ic iou sly de nie d it s p e tit ion

be c a us e its device , when c ombined with DNA seque ncing , outperfor med the F DA’s c urre ntly

approve d device beca

use it detec ted more c ases of the virus. B ut, as defe ndants-appe llees point out, there is n o b a sis fo r a ssumin gthat H iF i’ s d e vic e ’s re su lts we re c or re c t and the oth e r d e vic e ’s re su lts
wer e not. We have c onsidered the rema inder of H iFi’s arguments that the FD A ac ted ar bitrarily and-4-

c a pr ic iou sly and c on c lud e that th e y

la c k me ri t. Acc ording ly , for the f

oreg oing r easons, the judgment of the district cour t is hereby AF F IRM ED
. FOR THE COURT: CA TH ERI

NE O’ HA GA

N WO L F E, CL ERK By :_________________________________