UNITEb STASESbISTRICY COJJRT

SOUTHERN DISTAICT OFPLORIDA

è@seNo.22-cf=20471-w1t,LIAMs/McALILtv

'UyITED,. STATESOFAM EW CA

ANGELA M AAIX GIAON, - . .

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D,efshdant.

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FAC*IJALplzoFêERINsllppolt'roFGtllartkfLEA ,y.

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ThçUnitehStatesAttolme#.in,andfortheSoutherùDistrictofFlofidaitheDepartlurpt.qf

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lusticç.,, ConsumerProtecsiönBranch(thrgokernment),aridthedefendqntXngelaMal'iqt'Girol) .y . . # . q 1 1..

jkithedçfqhdanf'),âgreethatiftàis.mattçrweretoproceed'totri,althe.goyermpe.ntF, ouldbçallç . - . ;.., . .:. . . .. . .. i$ .. .. j...y:,.yt . ,.,,

toprovsthefollowing.factsbeyol;dareasohabledoubt.Thepqftiesfurtlaeragreqthatatlejqarg

pota1o.fth. e'fqctsthattaegovernment'wouldproveifthecaaselroceed.edt6trialbutju'e. Fuffi. ciqrg . , ' :.. . . . . . . , ' . ' ) .

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l'oprèvethechargeofçonspiracyas>lleg'edintheInfoimationinthiscqse. '. .

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Ffom in oraboutSeptember2015,ihrough in oraboutMarch 1018,inMianti-Dade

County,WithihtheSouthernDistrid ofPlofida,mldelsewheri,thedefendant,AngelaM ariaGiron,

didwilfully,thatis,withthespeéificintenttofurthertheobjects(jftheconspiracy,2,ndknoWingly

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combine,conspire,confedrrate,andagreewithpersonsknpwhandunlmowntothegovermuent

'. tocommitanoffenseéjainsttheUnitectStatesbyknowinglyandwithintenttodbfrauddevising,

.andintendingtodevisè,aschemeahdarttficçtodefraudandtoobtainmcmeyandpl.opel.tjj;y

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meansofmat.eri@lyfalseandi-rét.lctuléltpfbtehsej,representations,andpromises,knowingthat

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they werefals'eand fraudulentwhen m ade,and transm itting and càuiing to betransntitted,by

Case 1:22-cr-20471-KMW Document 24 Entered on FLSD Docket 01/09/2023 Page 1 of 7
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m- eans ofwire communlcationsin interstate and foreign commerce,w'ritings,signs,signals, . ,

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picturesj-and, sounds,forthepurposeofexecuting iheschemeain violationofTitle 18,Ultited

gtatesCude,Section1343. .

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.,. .Duringtheconspiracy,thedefendantwasalicensedphysicianin. Florida... AM B Rpseqrçh jy .y.aj.. ,. z:, .

Center,Ipc.(GCAMB R. es.earchCenter'')'',wa7amedicalclinicloçatedJ o.nW'.est.sFlag. ler.S. treetip .. . .- .. . . ... 2 .. 2#,-k.. ..--jj.7'-.(.-: ....

. M iami,Florida,thatconducted clihicaltrials ofnew drugs forpharmaceuticalcplppàniejapd,

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sponsors. .co-conspirqtor 1,co-ownerofAV B

Directorapdl.eads.tudy''' coo' rdinator.Cocconsb'*'irator2,co.-ownerofAM BResearchCentéJr,*ser'ved'

inrolesincludincDirecto'randstùdycoordinator.Co-conspirator3seyvediùroles'includingdata

entryspeciàlistandphafm acist. . . ,

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Thesponspr,apharm 'aceuticalcompâny,developed and'initiated @.clinicaltrialdekigned . ' .

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to eyaluqte the safety and efficacy of an investigationaldrug intend.ed tp tlyat,persol)s Fith

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Clostridium difficilé-qksociatéd diarrhea ((CDAD clinicaltrial,ù'). Contraçy.'Rçce

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Organizatipn(&.CRO'')wasanorganizationthatmanagrdandoyersaw$hçCDAD cliqiqaltrialtQr

thesponsor. Co-conspirator1,onbehalfofAVBkesearchUentey,entçredintoadlinicalTrial

Agreement(t(CTA'')withtheCRO,whichwasactingonbehalfofthesponsor,fortheCDAD

clinicaltrial.

Research Center,j,drved ip röles including . . ., : . '$ ,

Thepurposeoftheconspifacyincludedthedefehdantandtheco-conspiratorsuiAlawfully

emichingthemselvesby:(a)causingthesponsorand/ortheCRO tomakepaymentsonthe

. dqntpctsforthe. CDXD clinicaltrial,bymakingmaterialfalseandfréudqlentrepresentatiorià

regarding,amopgothertkngs,subjecteligibilityfofandparticipationintheCDAD qlinicaltrial,

and(bl.falqifyinganLfabrièatinjdoctinents,zàta,andotheritemsrelattlïgtotheCDAD clinical

trialincludingsubjectinformedconsentforms,casehistories,anddata.

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InoraboutOctöber2015,thedefendantmetCo-conspkator1,Co-copspirgtpr2,apdCciConspiratqr3.('collectively''' EtheC' o-cons'p''b' irators''.)'' andaMreedtobethec'linicâlinvestigatpr,.also

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linicaltrialatA'M B Research Center.

' klwwnqsthepri.ncipalinvestigator,fortheCDAD c the

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dçfendansdidùotppyiouslyltnöw theCo-conspiratorsandwasùotfamiliaiwithAM BRçpearch '

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Center.. Thçdefend. qiltyignedtheFoodahdDrugAdministration((TbA'')Form 1572,Sta'temeùt..

pfInyestigator,forjheCDAD clinical'trial.BysigningtheF.orm 1572,thedefçndantkflew thatas

theclin. lcalinvestig''''-atorshewas' req-u.iredto,amongotherthings,(1)conductthe.CDAD çlinical . .

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trialaccordingtothestudyprotocol.>pdincomjliancdwithal1qpplicablefeèeralrejtlations;(2)

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prrsonalyconductandsupelwisetheCDAD clinicaltria.l;(3)obtainipformedconsent'frpm the

su.bjects;an, d(4)complywiththeclinicaltrialprotocôlandfederalre, gula. tipnrequirç.mepts.

.re,l''ating

toobtaininginfoimedconsentandtheinformedconsentproqels.

The. defendqnt'srespohsibilitiesalsoincludeda1lreqtliremehtstegardilm .thecltlqlitiçatiqi'l

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. ofthesubjects;dispensingstudymedicàtion;colectingandreportingdata;rrporting.ad.yerse

events;and ensuring théta11employeesworking onthestudy metthosesameobligations.In

addition,thedefehdantwasrequired,byregulatipn,topfepareandmaintaiù casrMstorieswhich

wererècord:relatingtotheC1)AD clinicaltrial.Thecalehistoriesinclubedinfonuedconsept

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formsand medicaltecordsforeach subjectparticipating in theCDAD clinicaltrial,drug

dispensationrecords,and. recofdsofa1lobselwationsandotherdatapertinenitotheCDAD clinical

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trialforeachsubjectadmiltisteredthesmdytedication.

Thedefehdanthadtheauihoritytodelegatecertain'responsibiliiesrelatiné'tb'the'dbXD

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clinicàltiia1tötheCu-con'spirators.ThedefeùdaùtdelegatedvariousresponsibilltiestoylaèCo-

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Conspiratorsincluding.(1)toCo-cohjjifâtof to c/mpletg/coirectcasefeportformsanb

electrpniccasereportforms(eCRFs),màintain.essentialdocuments,admiristerandreceive

Case 1:22-cr-20471-KMW Document 24 Entered on FLSD Docket 01/09/2023 Page 3 of 7
quéstionnaires,reconcile.stooldiaries,

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' conductjubjectinterviews,obtaip vitàlsigns,handle.

laboratorysamplesorperform ECGS,andscribe',(2)toCo-conspiptor2tomaintainessential

documeéts,administef.andfeceivçquestiolmaires,andrzconcilestooldiaries',and(3)toCpu .

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Conso''-iraior3todisoensemedication-comnlete/con-ectcasèreportformsandecR17s,mainlaitn .... ..

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essrni.ia,ldocum ents,andhqndlelaboratorysamplesorperform ECGS.

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Thedefeùdantknew thptsheandAMB ResearchCenterhadbeenrètainedtoperfonhthe

CDAD clinicaltrialhonestlyandaccurately.Thedefendantalsolcnew thesponsorcotlldconduct

ànauditoftheAM B ResearchCentertrialsitetandthatthedefendantandAMB ResearchCenter . . 7 . . .

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staffwererrquired.tocooperatewiththeauditorsandallow accesstoa11sfudydqcumentationand

facilities.

Thè'défend. antand the co-conspiratorslcnew thatthesubjectsdiànotpartiçipgteinthç .

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C. DAD. .çl'inicaltria.là.ccordingtothestudy. protocolandfederalregulatioh' s.F, o. r-. jp' ptol.1s..e''.s..6of.

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obtainirig inonèy by mebnsofmaterially falseand fraudulentpretenses,representations,and

' promises,thedefendant.andthecoaconspiratorscrçatedfrauduleàtandfalsel'ecqrds,inctuding

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eledronicwcase.recordùles.(t$eCR.Fs''),whichfalselyrepresentedthatthesubjeçtscompletedthe

ihfbrmectconsentformttlcF'')procerswhichrequir4edthedefen.danttoreviewtheICFwithe.ach

subjectandpergonalyobtainthesubject'swritten informedconsent.YhedefendantalsoWas

rçquiredioalwaysbeinvolvedinandhavçoversightoftheinformedconsentptocess. lhtruth

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..andfact,thedefendantdidnotobtainwritteninformedconsentforanyofthe22sùbjèctseniollçd

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intheCDAD cliniçaltrialandneverWenttoAM B ResearchCenter.A1th, oughthedéfendantdid

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nothaveknowledgèofij,aspal4oftheconspiradytenormoreindividuals'.meansofidentification

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wereusedunlawfullyorwithputauthorityinilrthefanceoftheconspiracy,

Case 1:22-cr-20471-KMW Document 24 Entered on FLSD Docket 01/09/2023 Page 4 of 7
Thedefendàntandtheco-conspiratorsfalsifedthedataofenzoledsubjçt'ctstheylu'tewdi.d

lmtparticipasç in the CDAD clinicaltrialin compliance with the protocol.Forexample,the

defendantlm eF shedidnotconducttherequiredclinicalirivestigrlorassessm entsajvisits2,44nd

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. 5,Tofurtherfacilitatçihefraudulentscheme,thedçfqndantknew thatfalsified alpdfraudulent

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infplw at. ionwasstibmittectipcasereportformsandeckFsfalselyrepresentingth. à'ltth,edefehdaht

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, hadcompletédthosçrequiredassessem entsaccordingtotheprotocôl.Thedefendantalsoknew that

falsrinformation and c.tatawassubmitedin thecakereportfiormsand eclt'f'sincludilig false , .

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. inf.ol-.mqtionanddatarepresentihgthatsubje.cts'hadsatisied.

'.eligibilitycyiteriatopa. rticipateint'he '-

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CDAD clinicaltrial,rqceivçd and taken the study medication,an2 completed .th.ç requitèct

documeùtsahdjournals.

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Follöwingan on-siteauditbythesponsorofAM B Relearch Centerin April2017,thç

sponsor.notifiédtheFD. A inwritiltgofpotentialscientifcmisconductbyAV B Révjearqh.Cep. t.er,

' Theins. ti'tutiona'lReview Boazd('tIRB'')' fortheCDAD clinitaltiial,anorganizationdesighéted.

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tomoniorandreview theclinicaltrial,sentAMB Resea'rchCenteracopy ofthespopsor's

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notiticationtotheFDA.Thedefendantand'co-conspirator1personally'sigriedaleterdatèdVay

' 7,2017,titled çtslte responseto theNotification ofPotentialScientificMisconduct''(sic)

(CltesponseLetter'')

Conspirator1andk'new thatitcontainedmatefialfalseandfraudulentrepresentations,including,

amongothzrthings,thp.t(1)thqdefendantwaspresentforal'subjectj'informedcohsentandgave

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4qchstlbaj:ctthetimetounders'tand,reqd,andresolveaùyquestippspriortosi.gnihjtheinformed

'PriortosigningtheResponseLeter,thedefendahtrevieweditwitlkCo-

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consentfonn;(2)AMBResearchCentertooksp- ecialcarewith' 1CIisighaturesandtheICFpfocess .

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toensurethatsubjectsunderstoodtilesttdyanditsrisks:ndcouldmalw aninfoimeddqcision

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wheihprtoparticipate;(3).al1parti,cipatingsizbjectshadcompletedthestudytreatmentapdfollow

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upvisits;and(4)thedrfendantanàAMVResearchCentersitesiaffactedipqccofzandewithtle

ëtldyprotocoltothebestoftheirknowledge.OnMay 8,2017,Co-consplrator1emailedthé

ResponseLetterfrom theSouthèinDistrictofFloridatoanemployeeoftheIIRB inN. qrthCarblina;

thedefendantwascopledontha:temail.

. Thedefendantkhew thatthèC2.O,önbehalfofthesponsor,madethepaymentstoAM B

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Redearch Centerto qpnductthe CDAD clihicaltrial.Thedefendantfprtherltnew thatAM B

RzsearchCenterwasresponsibleforpayingthedefendantfortheCDA; clinicalxtriûl,Onorabout.

October),2017,Co-conspiratoy1sentanemailfrom theSouthernDistriçtofFlorida'toa'CRO

çmployeeinNorthCaiolinarequestingAMB'Sfihalsitepaymentwhich,base'donCo-conspirayor

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1'sprioriequestforthattzïalsitepayment,ihcludedpaymentsforsubjectswhodidn' otpal-ticipate .

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inthgCDAD clinicaltfialincompliancewiththestudyprotocol.Thatsanïemonth,afterAV B

Research Centerreceived from the.CROthefinalCDAD clintcaltrialpayfnent,thedefendànt

receivedfrom AM B ReseafchCenterhèrtinalcheckinthéamountof$29,525.78fortheCDAD

clinicaltrial.ônoraboutoctober20,2017,thedefehdqntnegotiatedthatcheck.Thetdefelndani

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receivqdatotalamotmtof$58,119.60,f0rtheCDAD clinicaltrial.AM BReîearchCenterfeceived

' kover$2'50,000butlessthan$556,000fortheCbADclinicaltrial.

Asaphysiciaù,thedefendantabtlsed. .herpositionofpublicorprivatetrustandusèdher

speciali4edskillasamedicaldoctorthatsignificahtlyfacilitatedthecomGissionandconcçalmeht

ofthe'fyaudschem'eapd conspiraéy. ' < .. . . ' v .

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Case 1:22-cr-20471-KMW Document 24 Entered on FLSD Docket 01/09/2023 Page 6 of 7
The,forec*- oin':G .fabtsdo notdescribe a11th'edetailjofthe scheme,,ofthedefen.déùt's'

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.èon,tyleteknowlçdgeofthejcheme,butareofferedforthelirpitedpuposeofestablisjajuga

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sufscienibasistosupjortthedefendpnt'spleaofguiltytothecilargeofeonspiracy.

JUAN ANTONIO. GUN/ALE' Z

UnitedState'sAttorney

Jzaww . (a)

. Am e G , Ctsu nDidector

U.S.Departm entofJustice

ConsuperProtectionBranch

oate,l/c/lzzp

Date:l ? 7:7.7

Date:'l ? c J

Bv.Y,..'

+J-:e

RLA-DEECLARIS

JE9ïICA C.HARVEY

TRIALATTQRNEYS

U.S.DSPARMENTOFJUSTICE

CONSUM ER PROTZCTION BRANCH

BA y1.WA

ATTORNEY FORDEFENbANT

By:

By: * tda.

A GEL MARIA GIRUN

DEFE ANT

Case 1:22-cr-20471-KMW Document 24 Entered on FLSD Docket 01/09/2023 Page 7 of 7