eko K

'
: o- lœ t;':.41:% eetl.:
ATiANVlkkgjVA
FI
LEn

N2# 13 2215
IJNITED STATESDISTRICT COURT

JULIA
SY;
EP

DL
LE
N
c E

FOR THE W ESTERN DISTRICT 0F VIRGN A
Danvill:D ivision
The United StatesofAm ericw ex rel.Joseph

M .Thomas,BringingihisAction onBehalf
oftheUnited SltesofAmericw

Plaint@

CivilActionXo:4:13-cv-00017

Duke University,
DukeUniversity Health System ,Inc.
W illinm M .Foster,Ph.D.,
and
Erin N .Potls-Kant

Filed UnderSealPur#uantto

31U.S.C.j3730(b)(2)
JIJRY 'IQ IAL DEM ANDED

Defendants.

Am ended Com plaiht

1.

Relator Joseph M .Thom as brings this action on behalf of the United States of

AmericaundertheFalseClaimsActCFCA''),31U.S.C.jj3729-33,againstDefendantsDuke
University, Duke University Health System, Inc. (çCDUHS''I, W illiam M . Foster, Ph.D.

(lGFoster''l,and Erin N.Potls-KantCpotts-Kanf'lto recoverlosses sustained by thePublic
HeaIthService(t$PHS''),theNationalInstitutesofHealth($$N111,'),theEnvironmentalProtection

Agency CEPA''),and otherFederalagenciesresponsibleforadministering scientitk research
grants.

1.

Introduction

M edicalresearch seeks to im prove public health and medicaltreatment.Bec'ause
it advances the public good, m uch of medical research is ftmded by the United States

govermnent(the trovernmenf').Publicresearch dollars,however,are scarce,and th: pant
processis highly com petitive.Public F antscan only be awarded to them ostdeserving resemch

26907/1/728150*3

Case 4:13-cv-00017-JLK Document 25 Filed 11/13/15 Page 1 of 71 Pageid#: 1131

Filed U nderSealPursuant

to31U.S.C.j3730(b)(2)

projects.Andoncereceived,publicgrantfundsmustbespentresponsibly.
D efendants have abused the public trust. n ey have engaged in system atic
research m isconduct and gaud,and failed to comply w ith the term s,conditions,and assurances
oftheirgrantaw ards.Between 2006 and the present,the Defendantsused false and/orfabricated
research results to obtain m illions ofdollars in m edicalresearch grants from the NIH,the EPA

and other federal agencies, and the Defendants used grant funds to generate false and/or
fabricated research results.A AerM arch 2013,D uke University,DUH S and Foster attem pted to
concealand m inim ize the extentofthe wrongdoing.
4.

n ese research resultsw ere false,fabricated,and/orfraudulentbecause they were:

(i)simply madeup;(ii)reporteddatathathadbeen knowingly manipulated;or(iii)based on
experim ents that had been know ingly done incorrectly.D uke U niversity also m ade num erous
certifications- including certiticationsofaccuracy and completenessofthe grantdocum entsand
certitk ations of compliance with its policies and federal regulations governing research
m isconduct- to obtain and m aintain the grant funding. These certitk ations were false when
m ade.
The fraudulentresearch was conducted by Potts-Kant,w orking underthe prim ary
supervision of Foster. Its scope was vast, in part because Foster runs a laboratory w hich
functions asan experim entalhub forresearch acrossDuke University and forresearchersatother
institutions.

The research m isconductand fraud perpem ated itself.During the relevantyears,
researchers atDuke University- including,m ostprom inently,Fosterand Potts-Kant- authored

numerous scientific publications based on fraudulent research funded by public grants.'
Fhese

publicationswereusedtojustifyfuturegrantawards,moneywhichwouldthenbespentonmore
fraudulentresearch.
D uring these years, D efendants Foster, Duke University, and D UHS received
2
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 2 of 71 Pageid#: 1132
907/1/7281500v3

File'
d UnderSealPursuant

to31U.S.C.j3730(b)(2)
warnings and allegations that the research results reported by Potts-lfant and the airway
physiology laboratory supervised by DefendantFoster w ere the result of research m isconduct.
Nothing w as done to address the sim ation,untilPotts-Kant's em bezzlem entofDuke University

dollars(awholly separatefraud),sparked an intemalreview ofPotts-Kant'sreported research
resultsin M aroh 2013.
8.

After M arch 2013, Defendants intentionally concealed the full extent of the

research fraud.Defendants w ithheld inform ation from the governm ent,as w ell as 9om other

researchersand scientiticjournals.DukeUniversitycontinuedto submitgrantapplicationsand
progressreportsthatincluded false,fabricated,and/orfraudulentresearch results.
The grant fraud perpetrated by the Defendants has substantially dam aged the
integrity of the N IH grant process and the grant processes of other federal agencies. n e
Defendants'im proper acts have also dam aged the scientitk com m unity tllrough the continued
diversion of scarce grantfunds aw ay from universities perform ing honestresearch and through
the publication of fraudulentresearch. The D efendants'actions since M arch 2013 seeking to
concealtheir fraud have caused these negative impacts to ripple And w orsen,as this fraudulent
research continues to be cited and,relying upon this fraudulent research,other scientists have
em barked down fruitlessavenuesofstudy.
10.

U nder the FCA,Defendants are liable to the United States forthe ill-gotten and

m isspentgrantfunds,trebled,aswellasotherdam agesand civilpenalties.
H.

Jurisdiction and Venue

11. ThisCourthassubjectmatterjurisdictionunder28U.S.C.j 1331and31U.S.C.
jj3732and3730(b).

12. ThisCourthaspersonaljurisdictionoftheDefendantsunder31U.S.C.j37324a)
because Defendants Duke University and DUH S both can be found in and transactbusiness in
the W estem D istrict of V irginia.A m ong other things,Duke University solicited and elzrolled
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 3 of 71 Pageid#: 1133
907/1/728150* 3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

students from the D istric: advertised in the D istrict,participated in academ ic activities in the
D istrict,and participated in athletic activities in the District during alltim es relevant hereto.
Likew ise,DIJH S transacted businessatitsCardiovascularSurgery ofD anville clinic in Danville,
Virginia.

Venueisproperinthisjudicialdistrictunder31U.S.C.j3732(/)because,atall
tim esm aterialand relevanthereto,D efendants Duke'university and D UHS transacted business

in the W estern D istrictofV iyginia.
14.

Thom as's claim s and this A m ended Com plaint are not based on allegations or

transactions which are the subjectofa civilsuitoran administrative civilmoney penalty
proceedinginwhichthegovemmentisalreadyaparty,asenumeratedin31U.S.C.j3730(e)(3).
15.

To the extentthattherehasbeen a public disclosure unknown to Thom as,he isthe

GGoriginalsource''andmeetstherequirementsof31U.S.C.j3730(e)(4)(B).Thomashasdirect
and independentknowledge ofthe inform ation upon which the allegationsare based,and hehas
voluntarily provided this inform ation to the governm ent,priorto fling thisaction underseal,as

requiredby31U.S.C.j3730(b)(2),beforepubliclyproceedingwiththisaction.
IH .

Partiesand OtherK ey Players
A.

16.

Joseph M .Thom as

Thom as is a residentofN orth Carolina.At alltim es relevant hereto,he was an

employee ofDuke University.
From August 2008 until February 2012, Thom as worked in the Cell Biology
D epartm entofthe Duke University M edicalCenter.
18.

ln February 2012,n om as moved to the laboratory of Dr.M onica Kraft in the

Pulmonary,Asthma and CriticalCare Division (the ççpulmonary Divisiono).By thatpoint,
Thom as was em ployed as a Laboratory Research M alyst 11.In that capacity,he developed,
designed,and conducted experim entsforthe Pulm onary D ivision.
4
Case
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 4 of 71 Pageid#: 1134
2690
7/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
B.

19.

D uke U niversity

Defendant Duke University is a private university located in Durham , N orth

Carolina.D uke U niversity holds itself out as one of the prem ier research instim tions in the
U nited States.lt annually receives hundreds of m illions of dollars in F ant funding from the
federalgovem m ent.

è.
20.

ocks

Defendant D UH S is a health-care-services com pany located in Durham ,N orth

Carolina.D UHS is a subsidiary of Duke University,and it runs the D uke University M edical
Center.
21.

Em ployees ofDukeUniversity and D UH S share cross-appointm ents,emplom ent

duties,and em ploym entactivitiesbetween D uke University and DUH S.
D.

22.

Erin N.Potts-lfant

Defendant Potts-Kantw as an em ployee of Duke University and/or DUH S.She

was hired in or about 2005 and w orked w ith D efendant Foster in his Airway Physiology

Laboratory (the ETosterLab'').Potts-Kantwas approximately 25 yearsold when she began
working forD uke University.
Potts-K ant subsequently served as the Clinical Research Coordinator 11 in the
Pulm onary D ivision.The Job Description for this position is attached as Exhibit A .Am ong
otherthings,itcalled forthe ClinicalResearch Coordinator11to:
Rcoordinate and participate in a variety of com plex activities involved in the
collection,com pilation,docum entation and analysisofclinicalresearch datm''

b. Gslelnsurecompliancewithprotocolguidelinesandrequirementsofregulatory
agencies;identify problem sand/orinconsistencies.''

llgejvaluateand interpretcollected clinicaldatainconjunctionwith principal
investigatorts)asappropriate;prepareoralpresentationsorwrittenreportsand
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 5 of 71 Pageid#: 1135
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

analyses setting forth progress, trends and appropriate recom m endations or
conclusions.''

d. superviseand train morejuniorpersonnel,and tçllplrovideguidanceto lower
level personnel involved in planning, implem entation and evaluation of
clinicalstudies-''
E.

24.

W illiam M ichaelFoster,Ph.D.

D efendantFosteris aResearch ProfessorofM edicine in thePulm onary Division.

Foster w as Potts-Kant's direct supervisor, including for Potts-K ant's w ork in the Foster Lab.
Fosterisan em ployee ofDuke University,and m ay have a cross-appointm entw ith D UH S.
25.

D uke U niversity, DUH S, and Foster him self all held Foster out as a leading

authority on research into factors that affect airway inflamm ation, including the design of
experiments to evaluate respiratory resistance in m ice;the conduct of such experim ents;the
properm ethodsofdelivering intlam m atory agents;and the interpretation ofthe resulting data.
F.

O ther K ey Players

(i)TheFosterLab
'

26.

The Foster Eab primarily studied the effects of pathogens, chemicals,

m edications,and environm ent lfactors on the airways oflaboratory m ice,w ith the ultim ate goal
oftreating hum an pulm onary diseases.
27.

The FosterLab operated asa Eçcore laboratory''forDukeU niversity,m eaning that

m any other laboratories and researchers,both internally w ithin D uke University and from fellow
research institutions,w ould subm itexperim entsto the FosterLab to conducton theirbehalf
28.

In tul'
n,researchers in the Foster Lab asked to be credited as co-authors on the

publications stem m ing âom theirw ork,and,in som e ins/nces,to receive funding from fellow
researchers'grants.

6
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 6 of 71 Pageid#: 1136
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

(ii)ThePulmonaryDivision
The Pulm onary Division is w ithin the D epartm entofM edicine,and m ade up of
severalresearchers who possess eithera PIZ.D .oran M .D ,or both.These researchers are called
ifprincipalInvestigators,''because they direct,m anage,and supervise the research perform ed in
the laboratories atD uke University. PrincipalInvestigatorsare also the agents by which Duke
University appliesforand receivesfederalgrantfunding.

30.

The Foster Lab's research m isconduct and gaud directly affected research

conducted for Principal Investigators w ithin the Pulm onary Division. The instim tional chart
attached as Exhibit A-1 sets out the relationships am ong Duke University,D UH S, and the
relevantemployeesw ithin the Pulm onary Division. M any ofthese individuals and relationships
are also addressed below .

31.

Fosterisa PrincipalInvestigatorforthe Pulm onary Division.

32.

D r.M onica (
Kraftw aj a Principallnvestigator forthe Pulm onary Division,and

becam e Division Chiefin late 2012.
Dr.PaulW .N oble w as a Principallnvestigator forthe Pulm onary D ivision,and
wasD ivision Chiefuntilleavingthe Division in late2012.
D r. John W . H ollingsw orth was a Principal lnvestigator for the Pulm onary
D ivision,and w orked closely w ith Foster and Potts-K ant.D r.H ollingsw orth supervised Potts-

Kantonsignificantresearchprojects.
35. Dr.Loretta G.Que is a PrincipalInvestigatorforthe Pulmonary Division,and
w orked closely with Fosterand Potts-Kant.

36.

D r.Jerry Eu w asa PrincipalInvestigatorforthe Pulm onary Division.

37.

D r.Julia K .W alkerwasa PrincipalInvestigatorforthe Pulm onary Division.

38.

D r.Julie G .Ledford w as an A ssistant Research Professor,who worked for D r.

K raft.
7
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 7 of 71 Pageid#: 1137
907/1/728150* 3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

39.

D r.JenniferIngram isan A ssistantResearch Professor,who w orked forD r.Kraft.

40.

D r. D avid M . Brass w as an Assistant Research Professor in the Pediatrio

Departm entwho worked prim arily w ith Dr.Hollingsw orth.
41.

Barbara S.Theriotw orked in the laboratory ofDr.W alker.She wasPotts-Kant's

peerintermsofjobresponsibilitiesandexperience,andalsohersuccessorintheFosterLab.
42.

D ave Francisco wasa lab analyst,w ho functioned asDr.Kraft'slab m anager.

CharlesG iam beràndino wasa Lab Research A nalyst.

(iii)OtherResearchers
44.

The Pulm onary D ivision and the Foster Lab also conducted research in

conjunction with other laboratories,physicians, scientists, and researchers outside of the
Pulm onary Division.

45.

The FosterLab'sresearch fraud directly affected research conducted forPrincipal

Investigatorsoutside ofthe Pulm onary D ivision.
46.

A m ong these other Principal Investigators were:

Dr. Som an Abraham

O epartmentoflmmunology,Pathology,andM olecularGeneticsandMicrobiology);Dr.JoRae
Wright(Departmentof CellBiology);iDr.Mary Sunday (DepartmentofPathology); Dr.
M ichaelSo ee''Gunn(DepartmentofM edicine,Cardiology).Dr.RichardL.Auten(Department

of Pediatrics);Donald N.Cook (DepartmentofImmunology);Njira L.Lugogo (Assistant
ProfessorofMedicine);andAmyM .Paswa(AssistantProfessorofOrthopaedicSurgery).
IV.

LegalFram ework
TheFCA

47.

The FCA provides,in part,thatany person who:

(a)(1)(A) knowingly presents,orcausesto bepresented,a false orfraudulent
claim forpaym entorapproval;
1Dr. W rightpmssed away in 2012.

8
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 8 of 71 Pageid#: 1138
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

(a)(1)(B) lcnowinglymakes,usesorcausestobemadeorused,afalserecordor
statem entm aterialto a false orfraudulentclaim ;

Eorl
(a)(1)(G) knowinglymakes,uses,orcausestobemadeorused,afalserecordor
sOtem ent m aterial to an obligation to pay or transm it m oney or
property to the Governm ent,orknow ingly conceals orknow ingly and
improperly avoids ordecreases an obligation to pay ortransm itm oney

orpropeo totheGovemm ent.
is liable to the U nited States Governm ent for a civil penalty of not less than

$5,000 and notmorethan $10,000,asadjusted by the FederalCivilPenalties
IntlationAdjustmentActof1990,2plus3timestheamountofdamageswhichthe
Govem m entsusu insbecause oftheactofthatperson.
31 U .S.
C.j3729.3

48.

For purposes of the FCA ,the term s Gçknowing''and ûçknowingly''fsm ean that a

person,with respectto information- ti)hasactualknowledge ofthe information;(ii)actsin
deliberateignoranceofthetruthorfalsityoftheinformation;or(iii)actsinrecldessdisregardof
thetruth orfalsity oftheinformation-''31U.S.C.j3729(b)(1)(A).Noproofofaspecitk intent
to defraud isrequired to show know ledge. 31U.S.
C.j3729(b)(1)(B).4
49.

In relevantpart,forpup osesofthe FCA ,the term Gçclaim ''m eansGiany requestor

demand,whetherundera contractor otherwise,formoney orpropeo and whetherornotthe

UnitedStateshastitletothemoneyorproperty,that--ti)ispresentedtoanofticer,employee,or
agentoftheUnitedStates-''31U.S.C.j3729(b)(2).
50.

Forpurposesofthe FCA ,ltthetenn Em aterial'm eanshaving anaturaltendency to

intluence,orbe capable ofhltluencing,the paym entorreceiptofm oney orproperty.''31 U.S.C.
.

j3729(b)(4)).
2Thecivilpenaltyrangehasbeen increasedto$5,500to $11,000.
3 O n M ay 20, 2009, the FCA was am ended pursuant to the Fraud Enforcem ent and Recovery Act of 2009

CFERA''),PublicLaw 111-21.Totheextentwrongdoingoccurredpriorto May20,2009,thisAmendedComplaint
should bedeem ed to includeapplicableviolationsoftheFederalFalse Claim sActpriortothe2009 amendm ents.
4 Unless othem ise specifiedNuse ofKknow y''Kknew y''Kknowingy''Ilknowinglyy''or Kknowledge''in this Amended
Com plaint refersto this statutory definition,and thus one or more of the ways to esàblish knowledge under the
FCA.

9
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 9 of 71 Pageid#: 1139
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

For purposes of the FCA, the term tKobligation'' m eans çtan established duty,
w hetherornotfixed,arising from an expressorim plied contractual,grantor-grantee,orlicensorlicensee relationship,f'
rom a fee-based orsim ilarrelationship,from shtute orregulation,orfrom

theretentionofanyoverpayment.''31U.S.C.j3729(b)(3).
B.

M H Grants

(i)TherelationshipamongNWI,PHS,andHHS.
52. ThePHS isadivisionoftheDepartmentofHealth andHuman Services(::HHS''),
and w orksto adm inisterH HS program s.
53.

The M H isan HH S agency division and com ponentofthePHS.

54.

The NIH is m ade up of m ultiple institutes and centers, each with a specitk

research agenda. NIH institm esincludetheNationalCancerInstimte ((1NCI''),the National
Heart,Lung,and Blood Instimte(GçNHLBl''),theNationalInstitmeofAllergy and Infectious
Diseases(ççNIAID''),theEuniceKennedyShriverNationalInstituteofChildHealthandHuman
DevelopmentICGM CID ''I7theNationalInstituteofEnvironmentalHealth Sciences(ICNIEHS'')#
andtheNationallnstituteofDiabetesandDigestiveandKidneyDiseases(1WIDDK'').
(ii)ThepurposeofNIH grants.
55. The NlH investsover$30 billion annually formedicalresearch on behalfofthe
Am erican people.
56.

Through a com petitive application process,the N lll aw ards grants to research

institutionslike D uke University.
ln addition to directly funding scientific research in grants, N1H includes a
substantialGGindirectcost''am ountw ithin grantawardsto reim burseinstitutionsforadm inistering

thegrants.Among the indirectcosisarethecostsofcomplying with PHSregulations,including
fostering an environm ent of research integrity and dealing forthrightly w ith allegations of
research m isconductasrequired under42 C.F.R.Part93.
10
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 10 of 71 Pageid#: 1140
07/1/7281500v3

i'ile
'dbnkersealPursuant
to31U.S.C.j3730(b)(2)
58.

The NIEI GGis the steward of m edical and behavioral research'' for the llnited

States.@ IH GranisPolicy Statement(2013),Part1,j2,ûç'l'heNationalInstitutesofHealth asa
Grant-MakingOrganization,,p.1..28.ls
59.

The M H seeks to Giensure integrity and accountability in its grant award and

adm inistration processes by relying on a system of checks and balances and separation of
responsibilities within its ow n staffand by establishing a sim ilarsetofexpecttions for p antee

organizations-''@ IH GrantsPolicy Statement,Part1,j2.1,KRolesandResponsibilities,''p.128.)
(iii)Granteeinstitutionsm ustfosterresearch integrity,protectagainstresearch
m isconduct,and safeguard public funds.

60. GWIH grants are subject to requirements intended to ensure that recipient
organizations handle their Federal awards responsibly. Grantees are required to adopt and
enforce policies that m inim ize the opportunity for improper financial gain on the partof the
organization,its em ployees,and organizationsand individualswhom they m ay collaborate,and
thatlim itthepotentialforresearch resultsto betainted by possible financialorothergain.''

Grants Policy Statement,Part11,j 4,ç<public Policy Requirements,Objectives and Other
AppropriationM andates''p.IIA-3.)
61.

N o N IH grant funds can be used to dissem inate inform ation that is deliberately

falseormisleading.@ IH GrantsPolicy Statement,Part11,j4.2.3,çr issemination ofFalseor
DeliberatelyM isleadingInformation,p.1G -43.)
62.

Str
fhe grantee is responsible for the actions of its em ployees and other research

collaborators,including third parties,involved in the project-''@ IH GrantsPolicy Statement,
Part1I,j4.1.27,RResearchMisconduct''p.I1A-40.)
63. N1H grantprogramsare subjectto the HHS,PublicHealth ServicePolicieson
5citationsaremadeto thecurrentNIH GrantsPolicy Sltement effectiveOctober1, 2013. Upon infonnation and
belief,theNlH GrantsPolicy Statementseflkctive atotherrelevanttimesaresubsuntively the same.

11
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 11 of 71 Pageid#: 1141
907/1/7281500v3

Filed U nderSealPursuant

to31U.S.C.j3730(b)(2)

ResearchMisconduct,42C.F.R.Part93(thelçRegulations').@ IH GrantsPolicyStatement,Part

11j4.1.27,RResearçhMisconduct,''p.1G -40-41./
The Regulations define Ifresearch m isconduct''as:
fabrication, falsifk ation or plagiarism in proposing,
perform ing, or reviewing research, or in reporting research
results.

(a) Fabrication is making up data or results and
recording orreporting them .

(b) Falsitication is manipulating research materials,
equipm ent,orprocesses,orchanging orom itting data or
results such that the research is not accurately
represented in the research record.

(c)Plagiarism isthe appropriation ofanotherperson's
ideas, processes, results, or w ords without giving
appropriate credit.

(d)Research misconductdoesnotincludehonesterror
ordifferencesofopinion.

42 C.F.R.j93.103.
65.

E<ll.
esearch m isconduct involving PH S support is contrary to the interests of the

PH S and the Federalgovenlm entand to the health and safety of the public,to the integrity of

research,andtotheconservationofpublicfunds.''42C.F.R.j93.100(a).
66.

The Regulations establish an instim tion's çlaffirm ative dutv to protectPHS funds

from m isuse by ensurinz the integrity ofallPHS supported w orkeand prim ary responsibility for

responding to and reportinM alleaations of research misconduct.''42 C.F.R. j 93.1001)
(emphasisadded).
67.

The Regulations further require that institutions Eifoster a research environm ent

thatdiscourages m isconductin al1research and thatdeals forthrightly with possible m isconduct

assoclated with PHS supported research.''42 C.F.R.j 93.412(a)).See also 42 C.F.R. j
5 The Regulations apply to Gtany research proposed, performed, reviewed,or repoled, or any research record
generated from that research,regardless of whether an application or proposalforPHS funds resulted in a grant,

contrack cooperativeagreement,orotherform ofPHS suppolt''42C.F.R.j93.102(a)(2).
12
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 12 of 71 Pageid#: 1142
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

93.300(c).ln the context of this regulation,the directive in Sec.93.3004c) to foster an
environm ent that prom otes the responsible conduct of research m eans an environm ent that
prom otes com petent,ethicalresearch thatis free ofm isconduct.This is directly related to the

purposes of the regulation to establish the responsibilities of institm ions in responding to
research m isconduct issues and to prom ote the integrity of PH S supported research and the
research process.''Public H ealth Service Policies on Research M isconduct,FinalRule,70 Fed.

Reg.28378(May 17,2005)(amending42C.F.R.pts.50and93).
(iv)Granteeinstitutionsmustmaintain an assuranceofcomplianceto receivefunds.
68.

M assurance is necessary fora grantee instim tion to be eligible to receive PH S

funding.@ IH GrantsPolicy Statement,PartII,j4.1.27,GlResearchMiscondud,''p.lIA-40;see
also 42 C.F.R.j 93.101(d)(grantee institutions must RprovidlejHHS with the assurances
necessary to permitthe institutions to participate in PHS supported research');42 C.F.R.j
93.301(a)(PHSgrantfundsmaybepaidSdonlytoinstitutionsthathaveapprovedassurancesand
requiredrenewalsontilewithOR1'').
69.

An instim tion establishes an assurance when it signs a grant application or a

separate assurance fonn. @ IH Grants Policy Statement, Part ll, j 4.1.27, C'Researc,
h

M isconduct''p.IlA-40).
70.

To be in compliance underthe Regulations,an instimtion m ust:

(a) Have m itten policies and procedures for addressing
allegations of research m isconductthatm eet the requirem ents
ofthis part;

(b) Respond to each allegation of research misconduct for
w hich the instim tion is responsible under this part in a

thorough, competent, objective and fair manner, including
precautions to ensure that individuals responsible for carrying
outany partofthe research m isconductproceeding do nothave
unresolved personal, professional or snancial contlicts of
interestw ith thecom plainant,respondentorw im esses;

(c)Fosteraresearchenvironmentthatpromotestheresponsible
13
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 13 of 71 Pageid#: 1143
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

conductof research,research training,and activities related to
that research or research training, discoukages research
m isconduct,and deals prom ptly w ith allegations orevidence of
possibleresearch m isconduct;

(i)Haveanactiveassuranceofcompliance.
42 C.F.R.j93.300.

71. An institution mustalso providean assurancethatit:::()1)(hjaswritten policies
and procedures in compliance w ith this partfor inquiring into and investigating allegations of

research misconduct; and (2) (clomplies with its own policiés and procedures and the
requirementsofthispart-''42C.F.R.j93.301(b).
72.

A n instim tion can only com ply w ith itsassurance ifit:

(1)Establishes policies and procedures according to this parq
keeps them in com pliance with this part, and upon request,
providesthem to ORI,other HH S personnel,and m em bers ofthe
public;

(2)Takes a1lreasonable and practicalsgecitk stepsto foster
research integrity consistentwith j93.300,lncluding-

(i) Informs the instimtion's research members
'

participating in or otherwise invol#ed w ith PH S
supported biom edical or behavioralresearch, research
training oractivities related to thatresearch orresearch
training,including those applying for supportfrom any
PH S funding com ponent, about its policies and
procedures for responding to allegations of research
m isconduct, and the instimtion's com m itment to
compliancew ith the policiesand procedures;and

(ii)Complieswith itspoliciesandproceduresandeach
specific provision ofthispalt

42C.F.R.j93.302(/).
73.

Each year,a grantee instim tion m ust file an lnstitutionalA ssurance and A nnual

ReportonPossibleResearchM isconduct(dslnstitutionalAssuranceandAnnualRepof')withthe

14 11/13/15 Page 14 of 71 Pageid#: 1144
Case 4:13-cv-00017-JLK Document 25 Filed
26907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

OftkeofResearchlntegrity(::ORI'').742C.F.R.j93.302(19.
74.

A grantee institution maintains its assurance stat'
us by filing the Instimtional

Assurance and A nnualReport,and by otherwise com plying w ith the Regulations.

Grants

PolicyStatement,PartII,j4.1.27,çGResearchM isconduct,''p.IIA-40).

(v)Granteeinstitutionsmustreportandrespondtoallegationsofpossibleresearch
m isconduct.

75.

The Regulations im pose specific obligationson grantee instim tions to investigate

allegations of research m isconduct and to m ake certain disclosures to ORI under specitk

circum stances.8

IntheInstimtionalAssuranceandAnnualRepolt theinstitution mustdiscloseto
ORlany allegationsmade during the preceding calendaryearofpossible research m isconduct.

tForm PHS-6349.)Allinquiriesorinvestigationslaunched orcontinuedin thepreceding
calendaryearmustbereportedto0R1intheInstitm ionalAssuranceandAnnualReport.('
Form

P115-6349jII(B).)
77.

The institution m ust conduct an ûtinquiry'' if an allegation falls w ithin the

definition of research m isconduct and is EEsufficiently credible and specitk so'that potential
.

'

evidenceofresearchmisconductmaybeidentified.''42C.F.R.j 93.307($.K'I'
hepurposeofan
inquiry is to conduct an initial review of the evidence to determ ine whether to conduct an

investigation-''42C.F.R.j93.307(19.
78.

Upon com pleting an inquiry,the instim tion m ustprepare a written inquiry repolt

42 C.F.R.j 93.30740,including the name and position ofthe respondent,a description ofthe
allegations ofresearch misconduct,and thePHS supportaffected. 42 C.F.R.j 93.3094a). The
1The Oftke ofResearch Integrity ispartofthe HHS. Itoverseesand directsPH S research inter ity on behalfofthe
Secretary ofHea1th and Hum an Services.
B The Regulations define an çtallegation''ms a disclosure of possible research misconduct through any means of

communication,including writlen andoralsttements.42 C.F.R.j93.201.

15
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 15 of 71 Pageid#: 1145
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

inquiry reportm ustspecitk ally setforth allgrantnum bers,applications,and publicationslisting

PHSsupportthatmaybeaffectedbytheresearchmisconduct.42C.F.R.j93.309(a)(3).
The instim tion m ustprovide 0R.
I with a written inquiry reportupon finding that

an investigation is warranted. 42 C.F.R. j 93.309. The institution m ust then conduct an

investigation,which enGilsreviewingtheresearch record,conducting interviews,andjursuing
allleads thatare relevantto resolving the.
m erits ofthe allegation and any additionalinstances of

researchmiscondud.See42C.F.R.j93.310.
80.

Upon the com pletion ofthe investigation,the instim tion m ustsubm it,in writing,a

finalinstitutionalinvestigation reportwhich includes:(a) information ofthe allegations of
research misconduct;(b) the PHS supportincluding any grantnumbers,grantapplications,

contracts and publications listing PHS supporq (c)a summary ofthe research records and
evidence reviewed; and a statem ent of findings for each separate allegation of research

misconductidentifiedduringtheinvestigation.42C.F.R.j93.313(a)-(9.
The statement offindings must also:(a) identify the nature of the research
misconductandwhetheritwasintentional,knowing orinrecklessdisregard;(b)summarizethe

facts and analysiswhich supportthe conclusion;(c) identify the specific PHS support;(d)
identify whetherany publicationsneed correction orretraction;and (e)identify the persons
responsible forthe m isconduct;and listany currentsupportor known applications or proposals

for supportthatthe respondent has pending with non-PHS federalagencies.42 C.F.R.j

93.313(9.
82.

An instim tion m ustnotify 0Rlttim m ediately''ifithasreason to believe thatany

one ofseven conditionsexist,including:
HH S resourcesorintereks arethreatened,

(ii)

Thereisareasonableindicationofpossibleviolationsofcivilor

crim inallaw ;or
16
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 16 of 71 Pageid#: 1146
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

(iii) Theresearchcommunityorpublicshouldbeinformed.
42C.F.R.j93.318(b),(d),and(g).
83.

Once notified ofan allegation,OR.
Idoesnotneed to waitfora p antee instim tion

to conductan inquiry orinvestigation before lking action.Rather,KOR1m ay respond directly to

any allegation of research m isconduct at any tim e before, during, or after an institution's

responsetothematter.''42C.F.R.j93.400(a);scealso42C.F.R.j93.402.
84.

Once notified, 0 R.
I hms broad pow ers to address an allegation of research

m isconduct.
The0RIresponsem ay include,butisnotlim ited to-

(1)Conducting allegation assessments;

(2)Determining independently ifjurisdiction existsunder
thispartin any m atter;

(3)Forwarding allegationsofresearch misconductto the
appropriate institution or H HS component for inquiry
orinvestigation;

(4)RecommendingthatHHS shouldperform an inquiryor
investigation or issue fm dings and taking a1l

appropdate actions in response to the inquiry,
investigation,ortindings;

(5)Notifyingorrequestingassistanceandinformationfrom
PH S funding components orotheraffected Federaland
state oo ces and agenciesorinstim tions;

(6)Reviewinganinstitution'sfindingsandprocess;
(7)Makingafindingofresearchmisconduct;and
(8)ProposingadministrativeactionstoHHS.
42C.F.R.j93.400(a);seealso42C.F.R.j93.402.
j5*' In '
any'research m iscon'ductproceedlng,OR1can
' rev'iew a grantee'sinstitutional

assurancesandcompliancewiththeRegulations.42C.F.R.jj93.400(e)-(9.

Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 17 of 71 Pageid#: 1147
907/1/728150* 3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

(vi)Granteeinstitutionsmustcomplywith alItermsandconditionsofthegrantaward.
86.

Applicants approved for grant funding receive a ttNotice of Aw ard,'' a legally

binding docum ent signed by an N IH GrantsM anagem entOm certhatcontains orreferences al1
the term s and conditions ofthe grant.Am ong the term s and conditionsisthe N IH GrantsPolicy

StatementandtheNotice ofAward.INII-IGrantsPolicy Statement,PartII,j3,irverview of
Termsand Conditions,''p.11A-1.)
Accordingly,acceptance ofan award from the Nll-lobligates the grantee to know
and com ply w ith theterm s and conditions ofthe award.

(vii)Institutionalcertilkationsrelatingtograntawards.
88.

In connection with grantfunding,an institution m akes certiticationsrelated to its

requestfor,and proposed useof,federalfunds.
89.

For exam ple, by its signature on the grant application, the grantee instittltion

certifies to the N IH that ithas tçthe ability to provide appropriate adm inistrative and scientitk

oversightoftheprojectandagreestobefully accountablefortheappropriateuseofany funds
awardedand fortheperfonnanceofthegrant-supportedprojectoractivitiesresultingfrom the
application.'' (NIH Grants Policy Statement, liart

j 2.1.6, ûtegal Implic
'ations of

Applications,''p.1-36.)
90.

By its signam re on the grantapplication,the grantee institution also certifiesthat

it Kcom plies,or intends to com ply,w ith all applicable policies, certifications and assurances

referenced (and,in somecases,included)in the application instmctions-''(M H GrantsPolicy

Statement,PartIl,j4,GpublicPolicyRequirements,andObjectives''p.1> -3.)
91. TheNlllgrantapplication form (PHS 398)includesanexpresscertitkationthat
reads:
A PPLICAN T ORGAN M A TION CERTIFICATION AND
A CCEPTAN CE: l certify that the statem ents herein are true,
18
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 18 of 71 Pageid#: 1148
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
com plete and accurateto the bestofm y know ledge,and acceptthe
obligation to comply w ith Public Health Services terms and
conditionsifa grantisaw arded as a resultofthis application.1am
aw are that any false,fktitious,or âaudulent statem ents or claim s

maysubjectmetocriminal,civil,oradministrativepenalties.
92.

Over the tim e period at issue, the N1H transitioned from the PHS 398 Grant

ApplicationForm totheSF424(R&R)GrantApplicationForm,whichallowsfortheelectronic
subm ission ofgrantapplications.Sim ilarto fonn PH S 398,the SF 424 Form includesan express
certifkation which provides:

Bysigningthisagplication,lcertify(1)tothestatementscontained
inthelistofcertlficationslj,and(2)thatthestatementsherein are
true, com plete and accurate to the best of m y knowledge.l also
provide the required assurances and agree to com ply w ith any
resulting terms if 1 accept an aw ard.1 am aw are that any false,

fctitious or gaudulentsutements or claims may subjectme to
criminal,civil,oradministrative penalties.(U.S.Code,Title 18,
Section 1001).
93.

The TGlistofcertitk ations''and the ltrequired assurances''referenced in the SF 424

form are setforth in the U .S.D epartm entofHea1th and Hum an Services,Public Hea1th Service,

SupplementalGrantlnstnlctions ForA1lCompeting Applications and ProgressReports (the
çtsupplemental Grant Instructions'). Section 2.7 of the Supplemental Grant lnstructions
provides:

Each institution that receives or applies for a research, research
training,orresearch-related grantor cooperative agreem ent under
the Public Health Service Actm ustcertify thatthe institution has
esu blished adm inistrative policies as required by 42 C.F.R.Part
93,Sûpublic Hea1th Service Policieson Research M isconduct.''

Thesignatureoftheomcialsigjing fortheapplicantorganization
ontheFacePageoftheapplicatlon(orforelectronicapplications,
checkingthe1çIagreebox on line17oftheSF424(R&R)(Cover
Formlservesascertifkationthat:
The institution w illcom ply with the requirem ents of the PH S
regulations for dealing w ith reporting possible research
m isconductunder42 C.F.R.Part93;
The institution has established policies and procedures
19 11/13/15 Page 19 of 71 Pageid#: 1149
Case26
4:13-cv-00017-JLK
Document 25 Filed
907/1/728150* 3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

incorporating the provisionssetforth in 42 C.F.R.Part93;
3. The institm ion w ill provide its policies and procedures to the
Oftice ofResearch Integrity upon request;and
4. The institution w ill subm it an A nnual Report on Possible

Research MisconducttForm 6349).A copl of Form 6349,
covering the previous year, will be autom atlcqlly sent to all
PH S awardees by the Oftk e of Research lntegrity each
January.

TheM H requiresthatgrantees periodically subm itfinancialand progressreports.
Progress reports infonn the Nfll ofthe grantee's accom plishm ents,including publications and
inventions resulting from the award,personneland location changes,budgetupdates,and other

information pertaining to thegrantee'suseoffunds.@ IH GrantsPolicy Statement,PartIl,j
8.4.1,t:Reportingy''pp.1G -107-11A-111.)
95.

For m ultiyear funded aw ards,progress reports serve as the basis for the N lll's

continued supportforsubsequentbudgetperiods:
Grantees are required to subm it an annual progress report as a
prerequisite to M H approval and funding of each subsequent

budget period (non-competing continuation award) within an

approved project geriod (see Administrative Requirements-

M onitoring- Repodlng- N on-competing Coptinuation Progress

Report). A .decision to fund the.next budget.period will be
form alized by the issuance of the NoA indicating the new budget
period and the am ount of new funding.The NoA also willreflect
any rem aining future-year com m itments. N ll'
l m ay decide to
w ithhold support for one or m ore of the reasons cited in
Adm inistrative
Requirem ents- Enforcem ent
ActionsSuspension,Term ination,and W ithholding ofSupport.

INI11GrantsPolicyStatement,Part1I,j5.3,çTundingy''pp.1G -48;seealsoM H GrantsPolicy
Statement,PartII,j8.4.1.3,GIprogz'
essReportsforMultiyearFundedAwards,''p.1IA-111.)
96.

In subm itting a progress report,the grantee institm ion certifies compliance w ith

the term s and conditions of the want award, and verifies the accuracy and validity of a1l
adm inistrative,fiscal,and scientitk information in the progress report'
. The gr
antee instim tion
further certifies its accountability for the appropriate use of any funds aw arded and for the
20
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 20 of 71 Pageid#: 1150
907/1/728150* 3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

performanceofthegrant-supportedprojectoractivitiesresulting9om theprogressreport.
GrantsPolicyStatement,PartII,#8.4.1,çtReporting,''pp.1G -107-IIA-111.)

97. Atthe conclusion ofa funded project,the grantee is also required to submit
certain closeout docum ents to the N IH, including a final progress reporq tinal invention
statem ents and certitk ations,and a final financial stam s report.Again,the grantee institution
certifies com pliance with the teM s and conditions of the N otice of Aw ard and verises the

accuracy and validity ofa1linformation contained in thçfinalreports.INI11 GrantsPolicy
Statement,Part11j8.6,Grloseout,''p.114-120-11A-122).
At closeout, final progress reports sum m arize the grantee's accom plishm ents,

identify signitkantresults(positiveornegative),andlistpublicationsresulting from thegrant.
Again,the v antee instim tion certifies com pliance w ith theterm s and conditions ofthe Notice of
Award and verifes the accuracy and validity of all information contained in the finalreports.

@ 1H GrantsPolicyStatement,Part11j8.6.2,tTinalProgressReporq''p.1lA-121.)
99. Each grantprogress report(PHS 2590) includes an express certitication that
reads:

APPLICAN T ORGAM ZA TION CERTIFICATION A ND
ACCEPTAN CE: I certify that the statem ents herein are true,
com plete and accurate to the bestofm y know ledge,and acceptthe
obligation to com ply with Public Health Services term s and
conditions ifa r antisaw arded as a resultofthisapplication.1am
aw are thatany false,tictitious,orfraudulentstatem ents or claim s

maysubjectmetocriminal,civil,oradministrativepenalties.
100. Section V of the Instim tional A ssurance and Annual Report also contains a
certification.By m aking this certification,the grantee instim tion certifies that its lnstitutional
A ssurance and A nnual Report is accurate, as well as the institution's com pliance w ith the

Regulations.42C.F.R.j93.302(18;Form PHS 6349.
101. Under the controlling N IH policies and the Regulations,as reviewed above,the
v antee institution's certitk ationsarea condition ofF antapprovaland grantfunding.
21
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 21 of 71 Pageid#: 1151
907/1/7281500v3

Filed U nderSealPursuant

to31U.S.C.j3730(b)(2)

tviiilGranteeinstiotionsarerequiredtoidentifypublicationsandresearckresultsin
grantapplications and grantprogressreports,and to m ake published research funded
by NIH grants publicly available.

102. ln a grant application, the instim tion m ust provide a bibliography of any

referencescited intheGG
lkesearch Plan''and/orGGprojectNarrative''section.I1'
1HS,PHS,Grant
Application (PHS 398),Part1,j 5.5.5,ççBibliography and References CitedgrogressReport
PublicationList,''p.1-48;SF424(R&R);ApplicationGuideforNll-land OtherPHSAgencies,

Part1,j4.4RotherProjectInformationForm,''pp.58,63.)9
103. 'In a grant progress report, the grantee institution m ust provide com plete
references to the publications,m anuscripts accepted for publication,patents,and other printed

materialsthathaveresulted from theprojectsince itwaslastreviewed competitively.IHI-1S,
PHS,GrantApplication(PHS398),Part1,j5.5.5,ftBibliographyandReferencesCitedgrogress
ReportPublication List,''p.1-48;SF 424 (R&R);Application GuideforNIH and OtherPHS

Agencies,Part1,j5.5GTHS398ResearchPlanForm,''p.114.)
For non-com peting continuation progress reports, the grantee institution m ust
reportpublicationsresulting directly from the grant.lfthe grantee has no publicationsto report,

itmustinclude such a statement. IHHS,PHS,Non-competing Continuation ProgressReport
(PHS2590),j2.6(E)çcpublications,''p.16.)10
105. In a finalprogressreporq the grantee instimtion mustincludea listofsir ificant

results(positiveornegative),and a listofresulting publications.(HHS,PHS,FinalProgress
ReportInstnlctions,jB ççlnstnlctionsforAllFinalProgressReports(exclusiveofSBIW STTR
Phase11FinalT'1-ogressReportsl,''p.l.)ll
'

9Ciution tothese instructionsareto the currentversion. Upon informationandbelietlinstructionseffectiveatother
relevanttim esaresubsGntively the same.
10citztion istothe currentinstruction docum ent;upon inform ation and belief,instructionseffective atotherrelevant
timesaresubstntively the sam e.
11Ciution istothe currentinstruction document;upon inform ation and belief instructionseffective atotherrelevant
timesaresubstntively the same.

22
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 22 of 71 Pageid#: 1152
907/1/728150* 3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
106. A11research resultsthatare funded by the N lH and accepted forpublication by a

peer-reviewed journalmustbe made available to the public no laterthan 12 months aûer
publication.

PublicAccessPolicyDetails) Thispublicaccessrequirementisinplaceto

help advance science and improve public health,and has been an N ll'lrequirem entsince atleast
April2008.

(ix)Enforcementactionsandotherremediesforresearchmisconduct,thefailureto
foster an appropriate research environm ent,and the m isuse ofNIH grantfunds.

107. ççlfa grantisawarded on the basis of false orm isrepresented inform ation,orifa
grantee doesnotcom ply w ith these public policy requirem ents,NIH m ay take any necessary and
appropriate action, including using any of the rem edies described in A dm inistrative

Requirem ents- Enforcem ent A ctions or other available legal rem edies.''N ll-l Grants Policy

Statement,Part11, j 4,Ctpublic Policy Requirements,Objectives and Other Appropriation
M andates''p.1lA-4(emphasisaddedl.)
108. Am ong the legalrem ediesavailable to the United Statesfor fraud,w aste,orabuse

ofNll'
lgrantfundsareFCA actions.IN111GrantsPolicy Statement,Part1,j2,ûTraud,W aste
andAbuseofM H GrantFunds''p.1-47.)
109. ln connection with a finding ofresearch m isconduct,HH S çlm ay seek to recover

PHS funds spent in support of activities that involved research misconduct.''42 C.F.R. j

93.407(19.
110. OR1 can also determ ine that a grantee institution has not com plied with its
institutional obligations under the Regulations, including its obligation to Rfoster a research
environm entthatdiscouragesm isconductin allresearch and thatdealsforthrightly w ith possible

misconductassociatedwithPHSsupportedresearch.''42C.F.R.j93.412(a).
111. Accordingly,GCORIm ay decide thatan instim tion isnotcom pliantwith thispartif
the institution show s a disregard for,or inability orunw illingness to im plem ent and follow the

23
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 23 of 71 Pageid#: 1153
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

requirementsofthispartanditsassurance.''42C.F.R.j93.412(b).Inmakingadeterminationof
instim tionalnoncom pliance:
0(
R1m ay consider,butisnotlim ited to the follow ing factors-

(1)Failure to establish and comply with policies and
proceduresunderthisparq
'

(2)Failure to respond apgropriately when allegations of
'

feseal'
ch m isctmdtlctarlse;

'

(3)Failuretoreportto OR1allinvestigationsandfindings
ofresearch m isconductunderthisparq

(4)Failure to cooperate with OR1's review of research
m isconductproceedings;or

(5)Otheractionsoromissionsthathaveamaterial,adverse
effect on reporting and responding to allegations of
research m isconduct.

42C.F.R.j93.412(b).
Should a grantee institution failto com ply w ith its assurance and its obligations

under the Regulations, HHS may bring an enforcem ent action that results in debarment

suspensionoranyotherappropriateaction.42C.F.R.j93.413(c).
113. lf a grantee's Gtactionsconstitute a substantialor recurrentfailure to com ply.with ..

thispart,ORImay also revoketheinstitution'sassuranceunderjj93.301or93.303.9'42 C.F.R.

j93.413(d).
C.

EPA G rants

114. The EPA has established a process by which grants are paid to private research
institutions.The EPA grantprocess isgoverned by 40 C.F.R.Part40.

(i)CertiicationsRelatingtoEPA GrantAwards
115. To obtain EPA grant funding, an institution m akes certifications related to its
requestfor,and proposed use of,federalfunds.

116. TheEPA grantapplication form ('
F0rm SF 424)includesanexpresscertifkation
24
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 24 of 71 Pageid#: 1154
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
thatreads:

Bysigningthisapplication,Icertify(1)tothestatementscontained
in thelistofcertitkationsg)and (2)thatthestatementsherein are
true,com plete and accurate to the bestof m y know ledge. I also

provide therequired assurancesu and agree to comply with any
resulting term s if I accept an aw ard. I am aware that any false,

tktitious,or fraudulentstatementsor claimsmay subjectme to
crim inal,civil,oradm inistrativepenalties.
The EPA issues a N otice of A ward if an institution's grant application is
successful. A GrantAgreem entand A m rm ation ofA ward are enclosed with the N otice Award,
and mustbe signed and returned to the EPA by the grantee instim tion. These docum entscontain
instructionsregarding the subm ission ofa paym entrequest form .
118. To receive paym entofthe grantfunds,the grantee institution m ustsubm itan EPA
Paym entRequestform .

119. Once a grant has been aw arded, the EPA requires that grantees periodically
subm it financial and progress reports. Grantees receiving a m ultiyear award m ust subm it an
annualprogressreportand m ay berequired to subm itadditionalm onthly orquarterly reports. 40

C.F.R. j 40.160-1. n e grantee's progress reports infonn the EPA of the grantee's
accom plishments,'including publications resulting from the aw ard; personnel'and location.
changes,budget updates, and other information pertaining to the grantee's use of funds.40

C.F.R.j40.160-1.

Atthe conclusion ofa ftmded project,the grantee is also required to submit
certain closeout docum ents to the EPA, including a final report,a final invention reporq an

equipmentrepört,and a financialstatusrepolt 40 C.F.R.j 40.160-2 etseq. The granteemust
reportallpublicationsresulting from grantfunds in an Executive Summ aly thatisattached to the
finalreport.

Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 25 of 71 Pageid#: 1155
907/1/72:1500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

(ii)Granteeinstitutionsarerequired toidentifypublicationsand research resultsingrant
progress reports.

121. ln p antannualprogressreports,the grantee instim tion mustreportaIlpublications

resulting from the grant funded project. The grantee instimtion mustprovide copiesofall
publicationsthathave notpreviously been submitted to the EPA. (EPA Research and Related

TermsandConditions,j 8(A)(7)). Thepanteeinstitution mustalsoprepareanAnnualReport
Summ ary for display on the EPA w ebsite, which contains a list of a1l publications and

presenutionsarising outofthatgrant. (EPA Research and Related Termsand Conditions,j
8(A)(8).)
122. A tthe close ofthe funding period,the grantee instim tion m ustsubm itan Executive
Sum m ary to the EPA as a partof its fm al report. The p antee m ust report a1l publications

resulting from the grantin thatExecutive Sum m ary.

(iii)EPA policy m quiresreportingand responding to allegationsofresearch misconduct.
123. In 2003,the EPA established its Policy and Procedures for Addressing Research

Misconduct(IEPA ResearchM isconductPolicy').
124. The EPA Research M isconduct èolicy Rapplies to a1l rese'arch cqnducted,
sponsored orfunded,in w hole orin parq by EPA and to research proposals subm itted to EPA . lt
thus applies to research .. .funded by EPA and perform ed at research institm ions,including

universities ....'' (EPA Research M isconductPolicy j 3;see also EPA Research M isconduct

Policy j5(G)(detiningresearchinstitutionsl-)
125. The EPA Research M isconduct Policy defmes CEresearch m isconduct'' as
GEfabrication,falsification,or plagiarism in proposing,perform ing or reviewing research,or in
reporting research results .. .or ordering,advising or suggesting that subordinates engage in

researchmisconduct''(EPA ResearchMisconductPolicy j5(A).)
126. lçFabricationismakingupdataorresultsandrecordingorreportingthem.''(EPA
26
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 26 of 71 Pageid#: 1156
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

ResearchM isconductPolicyj5(C).)
ET alsitk ation is m anipulating research m aterials, equipm ent, or processes, or
changing or om itting data or results such thatthe research is notaccurately represented in the

researchrecord.''(EPA ResearchM isconductPolicy j5(D).)
128. Paralleling the M H Regulations,a research instim tion m ustçtim m ediately''notify

the EPA Office of lnspector General (GrIG'') if Slany allegation of research misconduct''
involvesany one ofseven factors,including:

(i)

Agencyresourcesorinterestsarethreatened;

(ii)

Thereisa reasonable indication ofpossibleviolationsofcivilorcriminal
law ;or

(iii) Circumstances where the research community or public should be
inform ed.

(EPA Research M isconductPolicy j 7(B),(D),and (G);see also EPA Research Misconduct
Policyj9(C)(i)(a);65Fed.Reg.76263(111).)
129. If an allegation of research m isconduct falls outside of these categories, the
research institution need not imm ediately notify the EPA . In such instances, the research

institutionmustconductitsown ipquiry into theallegation and mustnotifytheEPA ifith:s
GGdetermined thatthereissufficientevidencetoproceedwithan investigation-''(EPA Research

M isconductPolicyj9(C)(i)(b);seealso65Fed.Reg.762634111).)
130. The EPA hasthe tçultim ate oversightauthority forFederally funded research.'' 65

Fed.Reg.76263(111). ç:(A)t any time,the (EPA) may proceed with its own inquiry or
investigation-''65 Fed.Reg.762634111).
V .FactualA llegations

A.The purpose ofm edicalresearch and the potentialpitfalls in its pursuit.

131. Quality medicalresearch isan ongoing endeavor.Today'sresearch leadsto the
research oftom orrow ,and,ultim ately,to im proved public health and medicaltreatm ent.
27
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 27 of 71 Pageid#: 1157
07/1/7281500v3

Filed U nderSealPursuant

to31U.S.C.j3730(b)(2)

132. Research results m ust therefore be com m unicated to the m edical and scientitk

community.Typically,thisisdonethroughjoumalpublications.
133. In addition to serving the public interest,m edicalresearch can also advance and
benefitthe researchersand institutionsthatconductit.
134. This advancem ent and beneft can take m any form s.Tangibly,researchers and
institutions can receive m onetary benefit directly and indirectly, from research eflbrts. For
example, grants fund the costs of research, including salaries and instimtional support and
infrastnzcm re. Further,m edicalresearch can lead to the developm ent of lucrative patents for
researchersand institutions.

135. M edicalresearch can also havem any intangible benefits.Forresearchers,m edical
research can lead to prom otion and advancem ent.Forboth researchersand institm ions,m edical
research can increase professionalesteem ,prestige and reputations.
136. Journal publications are a prim ary conduit to achieve this advancem ent and
benetk, for both researchers and their institutions. The m ore publications, and the m ore

noteworthytheresulth themoreadvancementandbenefit.
137.''Thereisvarisk.'ofresearch fraud,misconductandabusebecause grant.funding for
m edicalresearch furthersthe individualand organizationalinterests ofthe investigatorsand the
instim tion.

138. In an effort to address these pitfalls,M H , PH S,H HS and EPA have created
policies,procedures,and regulations to m aintain research integrity.S'
om e of these have been .
referenced above.
B.

Duke University'sPolicy

139. 'Vesearch instituti/nsthemselvesrecor izetheriskpresented bythesepitfalls.For
this reason- and because of the requirem ents to receive grant funds under the Regulationsresearch instim tions havepoliciesand proceduresdirected towardsresearch m isconduct.
28
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 28 of 71 Pageid#: 1158
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
140. Effective N ovem ber 1995 and revised in January 2007,D uke University issued

the Duke University Policy and ProceduresGoverning M isconductin Research (the Gouke

Policy'').TheDukePolicyiscurrentlypartoftheDukeFacultyHandbookAppendixP:Policies
Related to Research Cr uke Faculty Handbook'') (available at http://provost.duke.edu/wpcontent/uploadsT lo A pp ppdf.
).
-

'

fàeDukePolicystatesthatçr ukeUniversity strivesto fosteran atmosphereof

honesty and trust in w hich pursuit of know ledge can occur. Intemity of research form s the
foundation of respect am ong scholars and students and between the academ ic world and the
public. Al1 m em bers of the university com m unity share responsibility for m aintaining this

climateoftrust.''(DukeFacultyHandbook,p.33(emphasisaddedl.)
142. Although any research m isconductis unacceptable,the Duke Policy states thatit
G:is especially serious in collaborative research,where the reputations of several researchers

pursuingdifferentcomponentsofan integratedprojectmaybedamagedbytheactionsofoneor
morepartners.(DukeFacultyHandbook,p.33).
143. According to the D uke Policy,responsibility to preventresearch m isqonduct and

ensure research integrity isshared:Cçprihcilalinvestigatorsmustbearprimàry responjibility for
ensuring the integrity of collaborative research perfonned under their supervision w hether by
faculty or non-faculty.lnvestiaators.departm entand division chaip ersonseand centerdirectors
are expected to m ake periodic and reasonable inquiries concernine the intecritv ofthe activities

'conductedundertheirsupervision.''(Dûk:FacultyHandbook,p.33(emphasisaddedl.)
144. Duke's Policy provides that any individual having reason to believe that a
researcher has com m itted m isconduct in research should report the m atter in writing to the

researcher'sdepartmentordivision chairperson,division chiet dean orappropriateM isconduct

Review Offker.(DukeFacultyHandbook p.35).
145. Sim ilarto the Regulationsand EPA Research M isconductPolicy,underthe Duke
29 11/13/15 Page 29 of 71 Pageid#: 1159
Case24:13-cv-00017-JLK
Document 25 Filed
6907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

Policy, externalresearch sponsors m ust be notified in writing Gtat any stage''of an inquiry or
investigation ifcertain conditions exist.One such condition is ifthere is a reasonable indication
of possible violations of civilor crim inallaw- in w hich case notifications w ithin G entp four

(24)hoursofobtainingtheinformationisrequired.(DukeFacultyHandbook,p.40,!6).
146. OukeadoptedthisPolicytocomplywiththeRegulations(42C.F.R.Part93)and
thereby m aintain its assurance stat'
usrequired asa condition ofpaymentforN IH grantawards.
C.The FosterLab engaged in system atic research m isconductand fraud.

Potts-Kant's work w ith the Foster Lab involved operating severalm achines that
m easured and assessed pulm onary physiology, along w ith perform ing laboratory assays. The

machinesthatPotts-Kantoperated included devicesknown asthe SWcxfvent''and the GçBio?ICX.''

148. TheWex/ventmeasurespulmonary function by force-ventilating a mouse and
m easuring the totalam ountof lung resistance and is capable of m easuring a num ber of other
physiological m easurem ents, such as elastance, com pliance, N ew tonian resistance, tissue
dampening,and pressmw volum e loops.

149. The Bio-plex analyzes samplesofbiologicalm aterial,and identifiesthe presence
ofspecific proteins,and quantities the am ountof those proteinsw ithin the sam ples.The Foster
Lab used the Bio-plex m achine to quantify cytokines,sm allcellsignaling proteins,implicated in
aim ay inflamm ation. ln som e of the exhibits to this A mended Com plaint,the Bio-plex is

referred to asthe Gt um inex''ordçm ultiplex''m achine. '
150. The ailw ay physiology and inflam m ation da> resulting from experim ents

performed on thejlexlNent and multiplex machines is fundamental in current pulmonary
research studies. It is unlikely that the N IH would aw ard any significant grant funding for

pulmonology research thatdoes not include preliminary studies based on Jcxfventand/or
m ultiplex experim ents.
30
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 30 of 71 Pageid#: 1160
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

151. ThePulmonary Division coordinated thepurchase ofthejlexl
N zntmachinefor
the Foster Lab around the tim e that Potts-Kantw as hired in or about 2005.Before that,Duke
University researchershad obtained a sim ilartype ofphysiologicalm easurem entusing an APTI
m achine.
152. W henPotts-Kantbeganoperati
ngthe#exfventmachine,sheobtainedresultsthat

wereinconsistentwiththepreviousresults9om iheAPTImachine.
153. Fosterand the Pulm onary Division dism issed thisdiscrepancy.
Throughout her em ploym ent w ith Duke University and/or DUHS, Potts-Kant

committedresearchmisconductandfraudonnearlyeveryexperimentorprojectwithwhichshe
wasinvolved.

Thisresearch m isconductand fraud was funded,in large part,by grants âom the

M H,theEPA and otherfederalagencies.
156. A s discussed below ,this m isconductand fraud took severalform s. Som etimes,
Potts-K antdid noteven run the experim entsthatshe waspurporting to conductin the firstplace,

deliberatelyfailingtomntheWcxfventandmultiplexmachinesorfailingtoexposethemiceto
the appropriate chemical,medical,orenvironmenGlconditions.Instead,she simply made ttp
data.

157. On other occasions,Potts-Kantwas m ore subtle.She som etimesactually ran the
experim ents,butlateraltered theresulting datato m ake itconform to the PrincipalInvestigator's
preconceived hypothesis or to increase its statisticalsignitk ance.To fabricate the data,Potts-

Kant downloaded source experimentaldata from theFcxfventormultiplex machines,then
im ported it into an Excel spreadsheet.O nce in Excel, Potts-K ant altered the data before
fom arding itto the relevantW incipalInvestigator.

158. Asaresult,Potts-Kantwasableto generategaudulentresearch resultsthat:(i)
supported researchers'hypotheses;(ii)were sàtistically sir itkant;and/or(iii)purported to
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 31 of 71 Pageid#: 1161
907/1/728150* 3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

have been consistently Gçreplicated.''This w asto herpersonaladvancem entand benest,as w ell
asthatofFoster,Duke University,DUH S,and the PrincipalInvestigators.
D.Based on false,fabricated,and fraudulentresearch results,Potts-khntand Foster

quicklyco-authored dozensofpublicationsin scientiscjournals.
159. Collaborating w ith a variety of Duke University faculty,DU HS appointees,and
others,betweçn 2007 and 2013,Potts-Kantused the fraudulentresearch resultsto co-authorover

38scientitk papersandjoumalarticles.Potts-Kantwas32yearsoldin2013.n esepublications
are attached in ExhibitB,which is incorporated by reference.Each ofthese publicationsreport
false and/orfabricated research data.
160. Collaborating w ith a variety of Duke University faculty,DUH S appointees,and
others, Foster used the fraudulent research results to co-author over 38 scientific papers and

joumalarticles.
Som eofthese publicationsare discussed in m ore detailbelow.

(i)PM m 17993584--42r- y5m00thM uscleRelaxationf,
çImpairedinM iceLackingthep47
SubunitOJNADIPIH Oxidase
162. In 2007, Potts-K ant and Foster perform ed experim ents that contributed to the

paperentitledAirway5m00thM uscleRelaxationisImpairedinM iceLackingthep47Subunitof
N.
ADIPJ.
J'
/Oxidase.(Ex.B,atRe1ator-000029.)
163. Potts-Kant falsified and/or fabricated data that went into Figures 9A and 98 of
thispaper.To the extentthatraw data exists,itdoesnotsupportthereported research results.
164. Thispaperwaspublished in January 2008 in the Am erican JournalofPhysiology.
Before it was published, a portion of the work contained in the paper was presented to the
A m erican n oracic Society.

165. This scientific article, prem ised upon fraudulent research, cites the fmancial
supportfrom N IH grantsH I-067021,111,075307 and 14L67281.

32
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 32 of 71 Pageid#: 1162
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

(ii)PM m 21684833- F:,RoleoftheExtracellularJfl/rfxProteinM indininWfrwcy
ResponsetoEnvironmentalAirwaysTZ#/rJ

166. Potts-KantandFosterco-authored apaperentitledn cRoleoftheExtracellular
M JP'
IY Protein M indin in W frwtz.v Response to Environmental ZI/ZW'CJ/J Injury.lEx.B,at

RelatorU 000
).
. 447.
.
.

.

167. ln contributing to this paper,Potts-Kant claim ed to perfonn experim ents on the

jlexlWentand multiplex machines.The data supposedly produced by these experimentsare
contained in Figure l (FexiMznt),Figure 3 (multiplex),Figure 4 Wexfvent),and Figure 6
(multiplex)ofthepaper.Potts-Kantalsoclaimedtoperform '
thelipopolysaccharide(çtPS'')and
ozone exposuresreported in the paper. Otherresearchers were unable to repeatthe FosterLab's
resultsand observed resultsthatw erecontrary to thepublished results.
168. Potts-Kant did not actually perform the experim ents at all,but rather falsified
and/orfabricated the data in the paper.
169. This scientific paper w as accepted for publication on June 17, 2011, by the

scientificjournalEnvironmenulHealthPerspectives.
170. This scientific paper,prem ised upon fraudulent research, cites financialsupport
from N IH grantsES016126,E5020426,E5016347 and 111,081825.

(iii)PM m zju37og%-llyaluronan FragmentsContributetotheOzonePrimedlmmune
ResponsetoLèopo%saccharide
171. Potts-Kant and Foster co-authored a scientitic paper entitled Hyaluronan

Fragmentsconoo uteto the ozonetrimedlmmuneResponsetoL+opol
ysacchaèide.(Ex.B,at
Relator 000169.
)
-

172. In contributing to this paper,Potts-Kant claim ed to perform experim ents on the

Wexfventmachine.'T'
hedatasupposedlyproducedbytheseexpedmentsarecontainedinFigures
1C,Figure2C,Figure4C and Figure5C (/lxfvent)ofthepaper. Potts-Kantalso claimedto

33
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 33 of 71 Pageid#: 1163
07/1/728150* 3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

perform theozoneandhyaluronan(ç:HA'')exposuresreportedinthepaper.
173. Potts-Kantfalsiqed and/orfabricated the data in thepaper.
174. A nother researcher later tried to repeat the Foster Lab's results but was
unsuccessfuland observed resultsthatwere contrary to thepublished results.

175. This scientitk paperw asaccepted forpublication on Septem ber 21,2010,by the
JournalofIm m unology.
176. This scientific paper,prem ised upon fraudulent research,cites tinancialsupport
from NII-IgrantsES016126,E5016659,E5016347,M 064789 and A 1081672.

(iv)PM ID 19494306--5T-,4Preservesxdfrwly HomeostasisDuringM ycoplasmapneumoniae
Infection inM ice
Potts-Kant and Foster co-authored a scientifc paper entitled SP-A Preselwes
Wfrwtz.y

Homeostasis During Mycoplasma pneumoniae Infection in Mice. (Ex. B, at

Re1ator 000437.)
-

178. ln contributing to this paper,Potts-Kant claim ed to perform experim ents on the

Wcxfventmachine.ThedatasupposedlyproducedbytheseexperimentsarecontainedinFigures
1,5A,and58 Wexfvent)ofthepaper.
179. Potts-Kantfalsitied and/orfabricated the data in the paper.

180. One of the paper's co-authors, D r. Ledford, has stated that the data in this
publication isfalse,and thatshe willhaveto retractthe paper.
181. This scientific paper w as accepted for publication on April 20, 2009, by the

JournalofIm m unology.
182. This scientitic paper,prem ised upon fraudulent research,cites tinancial support
from NIH grantsF32141-091642,ES011961,P111,073907 and 1-11,084917.

34
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 34 of 71 Pageid#: 1164
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

(v)PM m 18818374- F:,extracellularmatràproteinziaJfaregulatesfm-f/zcâfzlpofmurine
eosinophils into the airspace

183. Potts-Kant and Foster co-authored a scientitic paper entitled The extracellular

matrixproteinmindin regulatesrzwl ckïag ofmurine eosinophils into theairspace.(Ex.B,at
Relator 000120.
)
-

184. ln contributing to this paper,Potts-K ant claim ed to perform experip ents on the

Jlexjventand multiplex machines.The data supposedly produced by these experiments are
contained in Figure1B,IC and ID Wexïvent),Figure2(multiplex),andFigure4C (multiplex)
ofthepaper.Potts-Kantalsoclaimedtoperform theovalbumin(tOVA'')exposuresreportedin
the paper.
185. Potts-Kantfalsitied and/orfabricated the data in thepaper.
186. This scientific paper was accepted for publication on September 3,2008,by the
JournalofLeukocyte Biology.

187. This scientitic paper,prem ised upon fraudulent research, cites financialsupport
9om NIH grants ES11961,E512496,E516126 and N ationalH eart,Lung and Blood Institute
grant11L91335.

(vi)PMID 17878331-.4-/* a/OzonePrimes'IlllfltmlryInnateImmunityinM ice
188. Potts-Kant and Foster co-authored a scientific paper entitled Am bient Ozone

PrimesPulmonaryInnatelmmunity inMice.(Ex.B,atRelator-000052.)
l89. ln contributing to this paper,Potts-Kant claim'ed to perform experim ents on the

JlexlWzntmachine.The data supposedly produced by these experiments are contained within

Figure 1 fflexiYent)ofthe paper.Potls-Kantalso claimed to perform the ozone exposures
reported in the paper.

190. M otherresearchertried to re-nm this experim ent and observed resultsthatw ere
the opposite ofthe FosterLab'spublished results.
35
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 35 of 71 Pageid#: 1165
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

191. Potts-Kantfalsified and/orfabricated the data in the paper.
192. This scientific paperwasaccepted forpublication on July 18,2007,by theJournal
oflm munology.

193. This scientitic paper,prem ised upon gaudulentresearch,cites financial support
from Nll'
lgrants ES12717,ES11961,NationalInstim te ofAllergy and lnfectiousD isease grant
A 158161 and NationalHeart,Lung and Blood lnstitute grant111,91335.

(vii)PM m zzuD l7s- llyaluronanSignaling duringOzone-lhducedLungfa/llr.yRequires
TLR4,M yD 88,and Ff.
& 1#

194. Potts-Kant and Foster co-authored a scientific paper entitled Hyaluronan
Signaling during Ozonednduced Lung Jh-jvr.
pRequires TLR4,MyD88,and FfA4'.(Ex.B,at
Relator 000177.
)
-

195. In contributing to this paper,Potts-K ant claim ed to perform experim ents on the

Fexfventand multiplex machines.n e data supposedly produced by these experimentsare
contained in Figure 1 Wexfvent),Figure 3 (multiplex),Figure 6 VlexiMentj,and Figure 8
(multiplex) ofthe paper.Potts-Kantalso claimed to perform the ozone and 1tA exposures
described in the paper.

196. One D uke University researcherlaterfound thatthe da1 in this publication was
m anipulated,and anotherwas unable to repeattheFosterLab'sreported results.
197. Potts-Kantfalsitied and/orfabricated the data in thepaper.

198. This scientitk paper w as accepted for publication on October 11,2011,by the

scientificjournalFreeRadicalBiology& Medicine.
199. This scientific paper,prem ised upon fraudulentresearch, cites tinancialsupport

#om NIH pantsE5016126 andE5020426.

36
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 36 of 71 Pageid#: 1166
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

(viii)PMID zl77D7lg-AlveolarM acrophagesfrom tàzezwek/l//oâes'
eSubjectswithAsthma
DemonstrateaProinfammatoryPhenoype
200. Potts-Kantco-authored a scientitk paper entitled Alveolar Macrophagesfrom
Overweight/obeseSubjectswithAsthmaDemonstrateaProinjlammatory Phenotype.(Ex.B,at
Relator 000523.
)
-

201. ln contributing to this paper,Potts-K ant claim ed to perform experim ents on the
.

m ultiplex machine.n e data supposedly produced by these experim entsare contained in Table 3

(multiplex)ofthepaper.
202. A Duke University researcher re-ran the m ultiplex experim ents and could not
repeat the Foster Lab's reported results. He also identified m anipulated data and m issing
m ultiplex plate keys.
203. Potts-Kantfalsified and/orfabricated the datain thepaper.
204. This scientific paper wasaccepted forpublication in tinalform on M ay 27,2012,
by theA m erican JournalofRespiratory and CriticalCare M edicine.

205. This scientific paper,prem ised upon gaudulent research,cites fm ancialsupport

from American ThoracicSociety Grant07 012,and NIH grantsP50-111,-084917,11L-05-j09,
F/-086887,ES016126,and 4J081672.

(ix)PM m 22502799- 30 :/cellTNF receptorsregulateresponsestoM ycoplasma
pneumoniaeinsulfactantprotein.4 (SP-AI-/Lmice
206. Potts-Kant and Foster co-authored a scientific paper entitled M ast cell TAF

receptorsregulateresponsestoMycoplasmapneumoniaeinsulfactantproteinA (SP-A)-/-mice.
(Ex.B.,Re1ator-00202.)
207. ln contributing to this paper,Potts-Kantclaim ed to perform experiments on the

JlexiYentmachine.Thedatasupposedly produced by these experimentsarecontained in Figures

3A and3B,Figure4C,andFigure6A Wcxfvent)ofthepaper.

37
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 37 of 71 Pageid#: 1167
07/1/728150* 3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

208. Dr. Ledford, one of the co-authors of this publication, observed that its data
looked Kttoo clean''because the baseline response w as too consistentforthe num ber ofanim als
used.Dr.Ledford hasstated thatshe w illhave to retractthispaper.
209. Potts-Kantfalsitied and/orfabricated the data contained w ithin the paper.

210. This scientific paper w as accepted for publication on January 17,2013,by the
scientific Joum alofAllergy and ClinicalIm m'unology.
211. This scientifc paper,prem ised upon fraudulent research,cites financialsupport
from M H grantsF32-11L091642 and PO 1-A I81672.

(x)AdditionalPublications
ln addition to these publications listed above,otherpublications co-authored by
Foster and/or Potts-Kant were based on false and/or fabricated research data. Additional
examplesofthese publicationsare listed on ExhibitE.

(xi) Potts-KnntandFosterusedfalseand/orfabricatedresearchresultstopublish
scientilk papers- EPA grantfunding.

Collaborating w ith a variety ofD uke University faculty,DUH S appointees,and

others, Potts-Kant and/or Foster used false and/or fraudulent research results to co-author

scientific papersandjournalarticlesfunded by an EPA grant. Two ofthesepublicationsare
described in ExhibitE at!! 1through 5and 70through74.Each ofthesepublicationsreport
false and/orfabricated research dat .
E.The defendants used the false and/or fabricated research results,asw ellasthe
fraudulentpublications,to secure grantfunding.

Defendants' fraud w ent beyond using federal grant m oney to publish scientitk
research papersbased on false and fabricated research.Duke University also used the false and
fabricated research resultsto seek paym entthrough the N1H and EPA grantsystem s.
215. A s discussed above,the publication of articles and papers is centralto the N lll

andEPA grantsystems.A singleN1H orEPA grant(andparticularly amultiyeargrant)canpay
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 38 of 71 Pageid#: 1168
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
forresearch thatresults in m ultiplepublicationsoverseveralyears.
The N lH and the EPA fund m edicalresearch to advance the public good.To help
achieve this goal,the dissem ination ofM H and EPA f'
unded research results isrequired,and a1l
publications that include funded research m ust be m ade available to the public.In ttlrn,these

publications identify the grants that financially supported the reported research. ln addition,

research resultsand resultingpublicationsmustbe identiûed in grahtprogressrepcds.TheNlll
and theEPA rely on thisinform ation in deciding whetherto fund m ultiyeargrants.
217. Grantee instim tions are required to identify relevant publications in grant
applicationsand progressreports forseveralreasons.First,the publicationsmay supporttheneed
for proposed research.Second,the publications m ay establish the expertise and capabilities of
the researchersidentitied in the application.And third,the publicationsmay provide the basis for
continued oradditionalgrantfunding.
218. The interaction am ong grantapplications,grantprogressreports,and publications
establish thatDuke University m adethe sam e false reportsofresearch resultsto the M H and the

:PA as weré made in the publications funded by N1H and EPA grants.The sequepçe and
.

required content of grant progress reports required that Duke University report its claim ed
research results each yearand identify to the NIH and the EPA the publicationsthatw ere funded
by the grants. The false research results reported in Potts-K ant's and Foster's publications,
therefore,in m any cases,w ere also reported to theN IH and the EPA in Duke University's grant
progressreports.
219. D ue to the sequence of grant applications, grant progress reports, and
publications,Duke University m adethe sam ereportsoffalse and/orfabricated research resultsto

theM H,ingrantapplicationsand pr'ov ess reports, describedinparagraphs(16i,16t,171,177,
183,188,194,200,206)aboveandasdescribed inparagraphs(1,6,11,17,23,28,31,36,41,
47,52,60,65,72,77,82,87,92,97,102,107,112,118,123,128,133,138)ofExhibitE as
39 11/13/15 Page 39 of 71 Pageid#: 1169
Case 4:13-cv-00017-JLK Document 25 Filed
26907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

were m ade in the publicationsfunded by those NII'Igrants,thatare listed in Exhibits C and C-1.
220. For exam ple,in 2013,Potts-Kant and Foster published false reports of research
results in PM ID 22502799, M ast cell D F receptors regulate responses to M ycoplasma

pneumoniaeinsulfactantprotein,4(SP-A)-/-mice(describedabove).Thispublicationreports
thatthe research wasfunded by N 1H GrantP01-A 1081672.12 The NTI-IrequiresDuke University

to reportresearch results ftm ded by Grant P01-A1081672 in its grant progress reports.Duke
University,therefore,reported the sam e false research results to the N ll'
l as w ere reported in
PM ID 22502799,resultsthatprovided a basisforadditionalfunding.
Another exam ple, in 2009, Potts-K ant and Foster published false reports of
research results in PM ID : 19762564, M aternal Exposure to Particulate M atter Increases

PostnatalOzone-inducedAirway Hyperreactivity in JuvenileM ice. Thispublication reports that
the research was funded by EPA Grant 10 83329301. '
I'he EPA requires D uke University to
reportresearch results funded by 1m 83329301 in its grantprogressreports. D uke University,

therefore, reported the sam e false research results to the EPA as w ere reported in PM ID
19762564.

222. D uke University applied for and received at least 49 F ants, totalling over

$82,776,000 thatweredirectfy premised on and/orarose from theresearch misconductand fraud
ofPotts-K antand/orthe FosterLab,including false reports of research results in grantprogress
reports,asdescribed below . These grantsare identified in theattached asExhibitC.
223. In addition to those grantsm ade to D uke University listed in ExhibitC,the NIH
m ade 15 multi-year grants to p antee institutions other than Duke University,totalling over

$120,910,000,which werepremised on and/orarosefrom the research misconductand fraud of
Potts-Kànt and/o'
r the Foster Lab.'These grants are identitied in the attached Exhibit C-1.In

m any instances,the grantee instim tions assigned experim entalw ork to be perform ed at Duke
12Ntl'
lGrantP01-A1081672 istheKSP-A Grant,''discussedin m ore deu ilbelow.

40
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 40 of 71 Pageid#: 1170
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
University funded by these grants.In those instances,the grantapplications and grantprogress
reportssubm itted by the grantee institutionsnecessarily included the same reportsoffalse and/or
fabricated research resultsthatare stated in the publicationsin ExhibitB asdescribed above and
in ExhibitE.
F.D ukeU niversity m ade false certilk ations.

224. Certitk ations--express and/or im plied- in the applications and progress reports
forthe grants identified in ExhibitC were falsewhen m ade.D uke University wasnotcomplying
and did not com ply with the term s and conditions of the grant awards. For exam ple, Duke
University had know ledge offalse claim s,statem ents,and recordsincluded and/orreferenced in
the grantapplicationsand progressreports.In addition,Duke University failed to com ply with its

affirm ative duty to protect grant funds from m isuse, failed to ensure the integrity of work
supported by grantfunds,and failed to com ply with itsnotitk ationsdutiesand policies.
225. Duke University failed to fostera research environm entthatdiscouragesresearch

m isconduct,and failed to dealfortllrightly w ith possible research m isconductasrequired by the

Regulations(42C.F.R.jj93.3004c)and93.412(a)).
226. Certifications--express and/or im plied- in D uke University's Institutional
A ssurance and AnnualReportw ere false w hen m ade.For exam ple,D uke University w as not
com plying and did notcomply w ith its assurances underthe Regulations.Upon inform ation and

belietlDukeUniversity alsofailedtoreportallegationsofresearch misconductconcem ing Potts-

Kantand theFosterLab (discussedbelow)on itsInstitutionalAssuranceand AnnualReports,

renderingthesefalsewhenmabe.
G .Beginning in M arch 2013,the Pulm onary D ivision reviewed the Foster Lab's data and
found itto be false and/or fabricated.
In addition to comm itting widespread research m isconductand fraud,Potts-Kant
em bezzled fundsfrom Duke University to m ake personalpurchasesovera four-yearperiod from
41
Case26
4:13-cv-00017-JLK
Document 25 Filed
11/13/15 Page 41 of 71 Pageid#: 1171
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

2008 to 2012.ln furtherance ofthis schem e,she produced false invoices forscientific equipm ent

and suppliesforreimbursement.Upon information and belietlPotts-Kantembezzled m orethan
$14,000.
228. Som etim e between N ovem ber 2012 and M arch 2013, the Pulm onary Division

discovered'
potts-Kant'sem bezzlem ent.
229. Duke U niversity and/or DUH S placed Potts-Kanton leave in early M arch 2013.

'fhe Durham Police D epartm entcharged herw ith felony em bezzlem enton M arch 31,2013.
230. A fter Duke University and/or DUH S placed Potts-Kanton leave,the Pulm onary

D ivision initiated a review of the Foster Lab data thathad been reported in grantapplications,
grantprogress reports,and publications.This review included analyzing the raw data,trying to
recalculate the FosterLab'sresultsusing the raw data,re-running the experim ents in an attem pt
to repeat the reported results, and com paring the results of the re-run experim ents w ith the
Published results.
The review of Foster Lab data involved senior adm inistrators w ithin Duke

University and/or DUH S,inçluding:Dolma Cookm eyer,Ph.D .,the Research lntegrity Officer;
'

SallyA.Kom bluth,Phkb.,the ViceDean forBasic Science;M ary'E.Klotman,M .D.,theChair
of the Departm ent of M edicine; and N ancy Andrew s, M .D ., Ph.D ., D ean of the School of
M edidne.

232. Foster,Dr.Que,Dr.Ledford,Dr.Ingram,Dr.Brass,Ms.n eriot,Mr.Francisco,
Thom as,and othersparticipated in thisreview effort.

233. Thom ashasdiscussed thisreview with Dr.Ledford,Dr.Queand otherPulmonary
Division personnel.These individuals have explained to Thom as that upon review of Potts-

Kant'sresearch,allsuch research iseithernon-existent,falsified,m anipulated,unreliable,and/or
gaudulent in som e m anner.Based upon their statem ents to him ,Thom œs understands that all
work com pleted by Potts-Kant is false, fabricated, and/or fraudulent in som e way.A more
42
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 42 of 71 Pageid#: 1172
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
detailed description ofthe fraudulentdaà follow sbelow .

(i)Noraw dataexiststosupportmanyoftheFosterLab'sreported results.
234. For exam ple,researchers found that the raw data for m any of the Foster Lab
experim entsdid notexist.

235. M s.Theriothoted that only a'few ra* data files existed forthe FosteiLab's

Texjventexperiments.Dr.Ledford found thattherewasnoraw dataatal1fortheFosterLab

Fexjventexperimentsfrom before2009.Shefound noraw data filesforDr.Hollingsworth's
study ofozone and dieselexhaustexposure.
236. M r. Francisco also noted that raw dat files did not exist for two of the six
m ultiplex experim ents that he reviewed, and that original data could not be located for the
publication designated PM ID 22773729.

237. ln addition to thismissing raw data,Dr.Que found thatsomeofPotts-Kant's
records did not include liplate keys''for the experiments she had nm .Plate keys are records of
m ultiplex experim entsthatallow otherresearchersto contirm and com pare reported values.M r.
Francisco also noticed thatplatekeysw ere m issing.

238. TherekieWers'could notflnd faw data tè'sujporttheresultsreported'in PMID 21930959, PS4:3 22073274, PV D 22773729, PS4ID 21684833, P541D 21037098, PA4ID
17993584,and PM ID 17878331.The lack of raw data establishes that the results reported in
those publicationsw ere fabricated and false.
239. These publications state that the rèpbrted research w aj funded by Grants AI
081672, AI 064789, A I 58161,ES 016126, ES 020426, ES 016166, ES 016347, ES02046,

E5016659,ES 11961,ES12717,11T-05009,HL 086887,H I,081825,HL 067021,Hl,075307,
HL 67281,H1,91335,HT-77291,P50-1-11,084917,A TS 07-012.

43
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 43 of 71 Pageid#: 1173
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

(ii)In som ecases,theFosterLabdid notrun thereported experim ents.
240. ln som e cases,the Pulm onary Division review ers cqncluded thatthe Foster Lab
had never even run the experim ents itreported in the firstplace- potts-K anthad sim ply m ade
up theresults.

j41 Dr Quereachebthisco'nc'lusion.So too dtdDr.Leéforé whooàservedthatthe
da> reported for Dr.H ollingsworth's epigenetic w ork involving m aternaldieselexposure was
entirely made up.Dr.Ledford also noted thatDuke University had withdrawn a pending v ant
application because the underlying data wasfalse.

242. M.
r.Francisco identitied fabricated multiplex andJlexiYkntdata in cormection
w ith the publication PM m 22773729.

243. M s.Theriotobserved thattwo partsofFigure 2 (the cytokinesIL-6 and KC
results)inPMID 20543006weresimplyKmadeup.''
244. These facts est blish that the research results reported in the publications

designatedPM ID 22773729andPM ID 20543006were fabricated and/orfalse.
245. Those publications state that the reported research was funded by N lll Grants
141-82504,111,81763,1-1L36982,E516347,A181672,1-11-05009,111-086887,and ES016126.

(iii)TheFosterLabconductedexperimentsdifferentlythanwasreported.
246. ln other cases,the review show ed that Potts-Kant and the Foster Lab failed to
conduct experim ents as reported in the grant applications, grant progress reports, and
publications.
247. Forexam ple,when Dr.Ledford tried to re-nm certain experim ents,she observed

that the m ice died aRer being adm inistered an antigen but before the experim ents could be
perlbrmed.This show sthatadm inistering antigensatthe dosage called forand reported by PottsKantkilled the m ice before they could be tested and that any reported results were,therefore,

44 11/13/15 Page 44 of 71 Pageid#: 1174
Case 4:13-cv-00017-JLK Document 25 Filed
26907/1/728150* 3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
fabricated.
248. A s a resultofPotts-K ant'sactions,hundreds,ifnotthousands,oflaboratory m ice
w ere killed forno purpose.
249. Dr.Ledford also found thatPotts-K anthad adm inistered the wrong ozone dose in

sUmeofherexperiments,andthatthedatafrom experimentsinvolving LM P-420,an inhibitorof

ttlmôrnecrosisfadorà(i:'IW F-a''),forsömeofherexperiltientswasfràubuleht''
250. Dr.Ingram noted thatPotts-Kanthad notexposed m ice to the properantigensfor
som e studies.

251. These factsestablish thatthe research resultsreported in PM ID 22073274,PM ID
21930959, PM ID 21684833, PM ID 21037098, PM ID *17878331, and PM ID 19494306 were
fabricated and/orfalse.
252. These publications s/te that the reported research was funded by N IH Grants
ES016126, E5020426, E5016347, H1,081825, A10081672, E5016659, 41064789, 4J58161,

ES11961,ES12717,1.
11-91335,F-32-111,0911642,P141-073907,and 1.
11-084917.

(iv)Potts-Kantmanipulatedtheresultsofthoseexperimentsthatshedid rùn.
53.
.

The reviewersalso determineà thatPoits-ltànthad altered ormanipulated the

resultsofthe experim entsthatshe did run.

254. Dr.QueobservedthatPotts-Kant'sm ultiplexdatawaslikely false.
255. D r. Ledford identitied data that Potts-Kant had falsified. Am ong other things,

Potts-KanthadloWeredtherepoitedre'sistancekaluesintheRLPS/NOS''project.
256. M n Francisco identified data thatPotts-Kanthad m anipulated in the interleukin 8

(ççIL-8'') and 'IWF'-a cytokines results that were significant to the conclusions in PMID
22773729.

257. M s.Theliotfound thatthe FosterLab'sairway hyperresponsiveness(KAHR''I
resultsin thedieselparticle experim entswere tçallbad-''
45
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 45 of 71 Pageid#: 1175
907/1/728150* 3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

258. M s.Theriotalso found thatallofthe calculations in publication PM ID 20348208
were incorrect.

259. These facts are additional evidence that the research results reported in PM ID
19762564,PM ID 22052876, PM ID 22773729, PM ID 20543006, and PM ID 20348208 w ere

fabricated and/orfalse.
260. These publications statç that the reported research was funded by Grants

M 068822, A1081672, ES011961, E5016347, ES016126, HL05009, 111,086887, 141,82504,
141-81763, 11L36982, 141-084917, 111,068072, 1* 058795, 111.0841239 141-081285, 141,079915,

A TS 07-12,and EPA RD 83329301.

(v)ReviewerscannotrepeattheFosterLab'sresults.
261. Duke and/orDU HS re-ran experim ents in an attem ptto repeatthe resultsreported

in grantapplications,grantprogressreportsand publications.D r.Ledford,M s.n eriot,n om as,
and M r.Francisco participated in thisefrort.
262. M r.Francisco re-ran certain m ultiplex experim ents and was unable to repeatthe
published results.Thom as assisted in re-runningthese experim ents.
263. 'M s.Theriot re-ran certain experim ents related to D r.Hollingsw orth's w ork as

published in PM ID 17878331.N ot only w as she unable to repeat the published results, she
observed results that w ere exactly the opposite of the published results.Likew ise,when M s.
n eriotre-ran the Foster Lab's LPS experim ents,she observed results thatwere the opposite of
those thatthe FosterLab published.
264. M s.Theriotw as sim ilarly unable to getthe H ollingsworth Lab'sHA experim ents
to repeat.
265. Dr. Ingram desiribed efforts to re-nm HA experiments, and stated that the

observed resultsw ere the opposite ofthe published results.

266. Ms.Theriotalso re-rantheJlexlNentexperimentsreported in PM ID 20007931.
46
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 46 of 71 Pageid#: 1176
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
She found thatthe da< w ere inconsistentand did notcorrespond to the published results.
267. M s. n eriot re-ran experim ents related to Dr. Hollingsworth's ç:m indin''gene

projectandobservedresultsthatcontradictedthepublishedresults.
268. M s.Theriotre-ran experim ents using N 1rp3 m ice and observed resultsthatdid not
correspondto those thatwere published.

These factsestablish that'thereleàrch tesultstepofted in'PM ID 22773729,PM ID
17878331, Ps4tD 20007931, Ph41D 20348208, PsltD 23560245, P51DD 21684833, Ph4lD
18818374,and PM ID 23010656 w erefabricated and/orfalse.
270. These publications state that the reported research w as funded by NIH Grants
A 1081672,Al58161,A 1068822,M 089756,ES016126,ES11961,ES12717,E516347,E516659,

E5020426, E512496, E5020350, FH,05009, :/ ,086887, 111-91335, 111,084917, 111-068072,
F5,058795,FD2084123,HL079915,HL081285,:H -77291,F:L91335,P50-H 1,084917.

(vi)Dr.Ledfordidentiliesspeciiciçmanipulated''data.
271. ThedocumentsattachedasExhibitD (Relator-oool14-000119)identifyseveral
specificexam plesoffalse data created by Potts-K antand the FosterLab.13
272. D r.Ledford created these docum ents attached as Exhibit D in April2013.They
are copies of notes and spreadsheets that she m ade w hile review ing Potts-Kant's data. n e
experimentsreferenced in Exhibit D were conducted to understand the interaction between of
'IN F-a, a cytokine involved in lung iniam m ation, and m ast cells, m yeloid-derived cells

involved in the immune system.TheFexïventdata wasimportantin thiscontextbecause,if
accufate, it would have presented com pelling evidence of a novel paradin

in the lung's

response to bacterial infection whereby RN F-a binds the surface of m ast cells via the TNF
receptor.
13n omas hasseen additionaldocuments sim ilarto those in ExhibitD thatdem onstratethe discrepancies between
actualraw dat and the gaudulent data produced by Potts-Kant and used by Duke University and/or DUHS.
Becausehe doesnotpresently have accessto these docum entsaEo ibitD isprovided msa representativesample.

47
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 47 of 71 Pageid#: 1177
907/1/7281500v3

Filed U nderSealPursuant

to31U.S.C.j3730(b)(2)

Atpages 1-3 (Re1ator-000114 - 116),ExhibitD comparesraw datawith the
Foster Lab's m anipulated data. ExhibitD states thatPotts-K ant conducted the experim ents on
Novem ber 3,2009;January 29,2010;and M arch 2,2011.The colum n EW ctualNum
' bers''on

each page containsraw datafrom theWexfventmachine.Dr.Ledford comparedthesevalues
w ith the values in the GCR''colum n.CCR''stands forResistance,which isan im portantstandard of

measurementin the contextofthisexperiment.AsDr.Ledförd noteson themarginsofhefpage,
theR valueshave been RM anipulated.''
This m anipulated data w as reported in Figure 64.ofPM ID 22502799,M astcell

TSF receptorsrev lateresponsestoMycoplasmapneumoniaeinsufactantproteinA (SP-A)-/mice.(Ex.B,atRelator-000202(discussedabovel.)
275. At page 4 m elator oool17),Exhibit D contains a paph showing airway
-

resistance at varying levels of m ethacholine adm inistration,which is reproduced as Graph A
below .Graph A isthe raw data from the experim entperlbrm ed on M arch 2,2011.

276. Upon information and belietl Figure 6A of PM ID 22502799 contains the
m anipulated data produced by Potts-K ant.Itisreproduced asGraph B below .

G raph A :ActualD ata

48
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 48 of 71 Pageid#: 1178
907/1/725150* 3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
G raph B :Published M anipulated Data

A 2.
5

(34z)J

o

.*

t; 2 O

X
>*

<*

B

*.e(.'
:'
;.;
z)
e

*

0

10

(FNF.;.MG)+Mp g s

*

(263)

(194..
,-

W
.:.

*.

-

.
e.
.T. * .# .'
>... .,*
e é.
*.
. y *
-..
1-e'

1.0

0.5

*

-*

.
*
,
e
+
*

'

E..
''..
t'
'-n
'Xt'
u 1.
E
O
1
-.
(t

.-

*- sIxAV-+Mp** A
SP-AV-KitW shW sb
.

--

25

-

-

v- w r+M p A
SP-ZW-K tW'SW 'sh

* (FNF-Rw MC)+Mp $
.

* SP-AV-KlW-sW -sh+Mp** #
; SR-A-/-KitW-sl* sbS
'
&- W FS
--*-- sPA 4-S

100

Methacholine dose (mg/ml)

277. Graph A , based on the actual datw show s a high degree of variability in the
results, and the absence of any statistically sir ificant difference between the various

experimentalgroupsofmice.Graph B,based on the FosterLab'smanipulated data (and as
reportedasFigure6A inPM ID 22502799),showsalow degreeofvariabilitybehveenmice,as
evidenced by very sm all error bars and a high degree of significance be> een diflkrent

genotypes and treatmentsofmice. Furthermore,thisdatq presents clearevjdencethatairway

hyperresponsiveness'does rfot implicatè iiiast c'
éll èndogènous R'Nloa,'but'ràther throujh
exogenous'
IN F-a viathe'IN F receptor.

278. Dr. Ledford and M s. Theriot re-ran the Mycoplasma treatm ent experim ents

reported in PM TD 22502799,which includes Graph B,and they could notrepeatthe published
results.Thetiotobserved resultsthatw erethe'opposite ofwhatw aspublished.Thisis additional
evidence thatthe research results reported in F antprogressreports for GrantA1081672 and in

PM ID 22502799 w ere fabricated and/orfalse.
H .A fter M arch 2013,D uke failed to disclosew hatitknew aboutthe research fraud from
other researchersand the Governm ent.

279. D uring its review of the Foster Lab's reported research results,the priority for
49
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 49 of 71 Pageid#: 1179
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

Foster,Duke University,and/orDU HS was to concealthe Foster Lab's research m isconduct,
rather than m ake com plete and tim ely disclosures.These D efendants chose notto fully report

their know ledge of research m isconduct and gaud, and instead withheld and concealed
inform ation from thegovernm entand researchersoutside ofthe Pulm onary Division.

280. Senior m anagers at Duke University and/or DUH S had actual and specitic
knowledge ofresearch m isconducthw olving Potts-Kantand the FosterLab from atleastM arch
2013.

281. Dukeand/orD UHS assigned Fostera leadership role in thisreview--even though

the allegationsofresearch misconductquestioned work done underhisdirectsupervision,on
experim entshe had designed,and challenged the accuracy ofpublicationshehad co-authored.
282. In April2013,the Pulm onary D ivision held a laboratory m eeting.Dr.Krafttold
the assem bled researchers that w idespread research m isconduct and gaud was suspected on
Potts-Kant's experim ents,butthatthey should com m unicate aboutthe research m isconductand
gaud only in person oroverthe phone,in orderto avoid creating a Rpapertrail.''
On or about M ay 7, 2013,Duke's Oftk e of Research Adm inistration told the
Pulm onary D ivision that ifthe Sûtrends''reported in the publications held up thatno retractions
would have to be issued and thatthe Oflice ofResearch A dm inistration did notw antthe issue to
Gisnow ball''
284. Foster,D uke University,and/orDUH S repeated experim entsand recalculated raw
m achine da> in an attem ptto replicate the resultsthathad been reported to the NIH,EPA and in
publications.n e D efendantstook these stepswhen they had acm aland specific knowledge that
the resultsreported by Potts-K antand the FosterLab were false and/or âaudulent,in the hopes

ofavoidingsuchdisclosurestotlleNIH,EPA,andpublications.

50 11/13/15 Page 50 of 71 Pageid#: 1180
Case264:13-cv-00017-JLK
Document 25 Filed
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

(i)DukeUniversityand/orDUHSmisleadingly describedthePotts-Kantsituationas
an diem ploym entissue''.

285. ln April or M ay 2013, a GEscript''w as circulated with instructions on how to
comm unicate the research fraud sim ation outside ofDuke,i.e.,to co-authorsofscientific papers.
The script m isleadingly stated that Potts-Kantw as involved an em ploymentsituation and that

D uke was currently review ing the situation. The script did not provide accurate inform ation
aboutthe FosterLab'sresearch m isconductfraud.

(ii)Foster,DukeUniversity and/orDUHS delayed retractingpublications.
286. Joum alarticles affected by Potts-Kant's research m isconduct and fraud m ustbe
retracted.DukeU niversity researchersacknow ledged the need forrekactionsduring theirreview
ofPotts-Kant'sw ork.

287. These actions,asdescribed above,violate DukeUniversity'sobligationsunderthe

Regulations(42 C.F.R.jj93.300(c),93.318,and 93.412(a))and establish DukeUniversity's
failure to fosteran environm entthatprom otesthe responsible conductofresearch and respond
prom ptly and forthrightly with allegationsofresearch m isconduct.

(iii)InFall2013,DukeUniversityresubmitteditsSP-A grant,usingdataihatit
knew to be false and/or fabricated.

288. In ,2008,the NIH awarded Duke University a five-year grant to investigate the

roleofsurfactantproteinA (ççSP-A'')inthelung,GrantID P01M 081672 (theGISP-A Granf').
289. n eM H funded the SP-A Grantin tiscalyears 2009 through 2014.

290. Potts-Kant and the Foster Lab perfonned experim ents beG een 2009 and 2013
using the SP-A Grantfunding.
291. Potts-Kant and Foster reported the results of experim ents funded by the SP-A
Grantin publications listed in ExhibitB and identifed as:PM ID 20543006;PM ID 21037098;
PM JD 21255515;PM D 21252304;PM ID 21960548;PM ID 22241062;PM m 24273688;PM ID
22502799;P5TD3 22773729;PNfHD 22815821;P54fD 23029172;and PS4ID 23010656.
51
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 51 of 71 Pageid#: 1181
907/1/728150* 3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

292. Duke U niversity subm itted a grant progress reporton the SP-A Grant in June
2013 that included research reports based on experim ents perform ed by Potts-K ant and the
Foster Lab. n is was done intentionally,m onths after Potts-Kant was placed on leave,w ith

actualknow ledge thatnone ofherw ork wasreliable.

293. DukeUniversity and/orDUHS decided to seek renewalofthe SP-A projectin
orderto obtain an additionalfive yearsofgrantfunding.

294. Duke University subm itted its com peting renewalgrant application for the SP-A

projectinthefallof2013.
295. ln itsgrantapplicationforrenewedfundingoftheSP-A project,DukeUniversity
included research resultsbased on the çlrecalculation''ofdataproduced by Potts-K ant.
296. The GErecalculated''results thatDuke reported in fall2013 were inconsistentw ith

the results thatM s.Theriothad obtained w hen she tried to repeatthe Foster Lab's experim ents
earlierin 2013.

(iv)Duke'sprimaryinterest- inparticularthePulmonaryDivision- hasbeenselfpreservation.

Possessing actual know ledge of Potts-Kant's research fraud and m isconduct in

M arch 2013,asdescribed above,Foster,DukeVniversity,and/orDUHS soughtto protecttheir
institutionaland personalinterests.Thism indsetw asexem plified by a sG tem entDr.Kraftm ade
overa yearlater.

298. On M ay 17,2014,aftera lab-sponsored dirm er,Dr.'lkraftdiscussed the Potts-Kant
research m isconductissue with Thomas and others within the Pulm onary Division.In reference
to the existence of a Gtwhistleblowery''D r.Kraftstated thatwhile the Pulm onary Division had
experienced setbacks,Glnobody isgoing to takeusdown.''
299. Since M arch 2013,D r.K raft,Dr.Hollingsworth,Dr.Ledford,and M z.Francisco
have left the Pulm onary D ivision, resigning their em ploym ent with Duke University and/or

52
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 52 of 71 Pageid#: 1182
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
DU HS.
1.The Foster Lab research fraud and m isconductdid notoccurin a vacuum .

300. At tim es that overlapped w ith and preceded the Foster Lab events described
above,Duke University and/or DUH S w ere involved in other signitk ant incidents of research

misconduct.This experience should have made Foster,otherPrùfcipalhvestigators,and other
researchers sensitive to the prevention, detection, and reporting of any possible research
m isconduct.Duke University's and DUH S'failure to prevent or detectthe FosterLab research

fraud dem onstratesa system ic failure by Duke University to fosteran énvironm entconducive to
responsibleresearch.In fact,Duke University and/orD UH S m aintained a G%oxic environm ent''in
w hich itpushed its researchers for m ore grants and m ore publications while ir oring credible
w arningsofongoing and seriousresearch gaud.
Dr.Anil Pottiw as form erly a D uke University m edicalresearcher, focusing on
cancergenom ics. Dr.Pottiresir ed 9om D uke University in N ovem ber2010.

302. Published reportshaveaccused Dr.Pottioffalsifying data published injournal
articles,resultsthatpurported to show advancesforpersonalized cancertreatm ent.n isallegedly
false dataw asfirstpublished in 2006.
303. The Potti scandal has received widespread attention, both w ithin the scientitic
com m unity and in them edia.
304. Forexam ple,the eventssurrounding Dr.Potti'swork atD uke University werethe
catalystto the Institute ofM edicine'sform ation ofa com m ittee,which then published a 300 pa'ge

reporttitledEvolutionofTranslationalOmics.
.LessonsLearnedandthePathForward.
305. By w ay ofother exam ples,on Septem ber 10,2011,The Econom istpublished an
article aboutthe Pottiscandaltitled M isconductin science:An Jrrtz
.vo
ferrors;onFebruary 12,
2012,60M inutesran a story on the Pottiscandaltitled çr eception atDuke.''
306. ln The Econom ist article, D uke University's V ice-chancellor in Charge of
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 53 of 71 Pageid#: 1183
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

ClinicalResearch,is quoted assaying,Klajsweevaluated the issues,we had the chanceto
review our system s and w e believe w e have identiied, and are im plem enting, an im proved
aPProach.''

307. 0n January 26,2015,Dr.Califf- who has taken a leave of absence from Duke

University to serve asDeputy Com m issionerforM edicalProducts and Tobacco atthe U .S.Food
and D nzg A dm inistration- w as quoted in the Triangle BusinessJournalon the Pottiscandal. Dr.

Califl-saidthatHgtqhereweresystemsthatwerenotadequate,aswestated....Thatwmsatough
one,Ithink,forthew hole institution.''
308. D r.Califf is also quoted in the Triangle Business Journalarticle as stating that

Duke University had GGlearned the importance of high-quality evidence,and notjusttaking
som ebody'sw ord forit-''
309. n e Pulmonary Division was also faced with a separate instance of research
m isconductduring the relevanttim e period.
310. On October 14,2011,HH S issued a tinding ofresearch m isconduct against Dr.

Sham :rendra Sanyal,a form erpostdoctoralscholarw ithin the Pulm onary D ivision. Dr.Sanyal
'

w orked underthe supervision ofD r.Eu.
31l. The Oc ce of Research Integrity found that Dr. Sanyal engaged in research
m isconduct by falsifying daG in a p ant applications subm itted to the Nll'
l as w ellas another
federalagency.

312. The circum stances surrounding the research m isconduct of Dr. Sanyal further

evidence Duke University's failureto comply with itsassurancesunderthe Regulations (42

C.F.R.jj 93.3004c)and 93.412(a))to fosteran environmentthatpromotes the responsible
conductofresearch.
J.The Defendants'acts and om issions occurred u owingly.
313. At a1l relevant tim es, Potts-Kant and Foster were em ployees and/or agents of
54
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 54 of 71 Pageid#: 1184
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
Duke University and/or DUH S,and acting in the course and scope oftheir em ploym ent and/or
agency.

314. A t al1 relevant tim es, other Principal lnvestigators and researchers at Duke

University(bothwithinandoutsideofthePulmonaryDivision)wereemployeesand/oragentsof
Duke University and/orD UH S,and acting in the course and scope oftheir em ploym ent and/or
agency.

D efendants each lcnew that research results and related publications were
fundam entalto the grantsystem ,and reported in grantapplicationsand progressreportsto secure
grantfunding.
316. Potts-Kant knew that the reported research results in question were false and/or
fabricated,having generated the resultsherself.
317. Foster,Duke U niversity, and DUH S knew that the reported research results in
question were false and/orfabricated,forthe reasonsexplained below .

(i)Foster,DukeUniversits and DUH Signored repeatedwarningsand aboutthe
FosterLab'sresearch m isconduct.

318. W hen Potts-Kant presented a paper she had co-authored, Dr. W ayne M itzmer,
D irector of the Respiratory Biology& ung D isease Program at Johns H opkins University,
questioned the validity of the Foster Lab's data. Due to the low statistical error of the data
despite the low sample sizes,Dr.M itznerbelieved the data to bem anipulated ordoctored.Upon

information and belietlwithoutchecking the raw data,Fostervigorously defended Potts-Kant
and hisIaboratory.

319. Di.Jam ie Cypherq a researcherw ith the M EH S,also questioned the FosterLab's
data. D r. Cyphertw as unable to reproduce their results. She then requested a copy of the

experiment'sRscript''fortheFexl
v entmachinetotrytoreplicatetheexperimentandconfrm the
results.The FosterLab refused to providethe requested scriptto Dr.Cyphert.

55
Case24:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 55 of 71 Pageid#: 1185
6907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

320. In fact,Foster,Potts-Kant,andtheFosterLab refused to sharejlexl
Nkntscripts
w ith anyone.
321. ln 2010 or 2011,Dr.Eu advised Foster and Dr.H ollingsw odh that he suspected
Potts-Kantoffalsifying results.D r.Eu Rblinded''Potts-Kantto an experim entand confirm ed his
suspicions,and then told Foster and Dr.Hollingsworth whathe had found and they ignored his
COIICCO S.

322. O n inform ation and belief, M r. G iamberardino raised concerns of possible
research m isconduct involving Potts-Kant and the Foster Lab during the period between 2010
and 2012.M r.G iam berardino stated thatPotts-Kantshould have been tûblinded''from aspectsof
experim ents.

323. A ccordingly, Principal Investigators w ithin the Pulm onary Division were both
warned and gavew arningsaboutPotts-K ant'sand the FosterLab'sfraudulentresearch results.In
addition, D r. Eu confirm ed his suspicions and reported that inform ation to other Principal

Investigatorswithin the Pulm onary D ivision.
324. Underthe Regulations,thesew arningsconstituted allegationsofpossible research
m isconductthat-w ere required to'be reported on D uke University's InstitutionalA ssurance and
AnnualReport.

In addition, Duke University had actualknow ledge of research m isconduct by
Potts-Kantin M arch 2013.

(ii)Therewereobviousred llags.
aboutPotts-Kant'smethods.
326. The facts surrounding Potts-Kant'swork indicate thatFosterand othersw ithin the
Pulmonary Division knew thatPotts-K antwasengaging in research m isconductand fraud.

327. Potts-Kant's method of processing m ice tllrough the m achines grossly deviated
from acceptable scientitk standardsand research protocols.

328. Forexample,therewereonlytwo#exfventmachinesinthePulmonaryDivision:
56
Case24:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 56 of 71 Pageid#: 1186
6907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
one in the FosterLab,in one in the laboratory ofDr.W alker.M s.n eriotoperated the tlexiv ent

m achine in Dr.W alker'slab.

329. Potts-KantandM s.TheriotwereequallyexperiencedwiththeFcxl
Y entmachine.
330. IttookPotts-Kantabouttllreeminutesto processamousethrough theJexlvent
m achine.The sam e work took her cbunterpart,M s.Theriot,abotlt20 m inutesperm ouse.There
isno reasonable basisto believe thatPotts-Kantcould have correctly processed m ice so quickly.
Fosterw ould becom e defensive and refuseto cooperate with anyone w ho w asalso

collaborating w ith Dr.W alker'slab orM s.Therios.
332. The large num ber of publications Potts-K antco-authored was unusualin lightof
herrelative youth and inexperience.Further,the num berofpublications thatFosterhim self coauthored increased dram atically afterPotts-Kantw ashired in 2005.
The false and fabricated data reported by Potts-Kant w as also Ktoo good to be
true,''in that,in too m any instances,they supported the stated hypothesesand desired outcom e,
and/orw ere statistically significant.

(iii) FosterrecklesslydisregardedthetruthorfalsityofPotts-Kant'sresearch
results.

334. Foster wasresponsible for supervising Potts-Kant's work and he failed to do so.

H is supervision of her was,atbejt,reckless.Foster was purportedly one ofthe w orld's leading

expertsinhistield.Potts-Kantwasayounpjunioremployee.
335. During the tim e thatPotts-Kantworked in the Pulm onary Division,Foster either:

(i)failed to review Potts-Kant'sdataforaccuracy;(ii)failed to compareherreported da> with

the raw data produced and stored by themachines;(iii)failed to appropriately review PottsKant'sdata;or(iv)reviewedPotts-Kant'sdataand,therefore,wouldhaveunderstoodthatitwas
false and/orfabricated.

336. Likewise,otherPrincipalInvestigatorsandresearcherseither:(i)failedtoreview

Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 57 of 71 Pageid#: 1187
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

Potts-Kant's data for accuracy;(ii) failed to compare her reported data with the raw da>

produced and stored by themachines;(iii)failedto appropriately review Potts-Kant'sdata;or
(iv)reviewed Potts-Kant'sdataand,therefore,wouldhaveunderstoodthatitwasfalseand/or
fabricated.

337. A s explained above,the failure to supervise Potts-K ant occurred during a tim e

period when (among otherthings):(i)wamingsaboutPotts-Kant'swork had been madeand
received within thePulmonary Division;(ii)the significantPottiresearch misconductscandal
it5 system s,im plem entan
w as tmfolding,w hich purplm edly caused Duke U niversity to mview .
.

improved approach,and have Rlearned the importance ofhigh-quality evidence,and notjust
takingsomebody'swordforiq''and(iii)anotherresearcherinthePulmonaryDivisionhadbeen
found to haveengaged in research m isconduct.
338. The failures described above esG blish D uke University's failure to foster an
environm entthatprom otesthe responsible conductofresearch,discourage research m isconduct,
and dealprom ptly w ith allegations orevidence ofresearch m isconductas required in 42 C.F.R.

jj93.300(c).and93.412(a)andinviolationofDukeUniversity'sassuyanqqsofcompliancewith
theRegulations.

(iv)Summaryofknowledge/scienterthatthereportedresearchresultswerefalseand/or
fabricated forFoster,Duke,and D UH S.

339. Foster knew that the reported research results were false and/or fabricated for
reasonsthatinclude,butare notlim ited,to the following:
Foster w as responsible for designing experim ents Potts-Kant conducted,
supervising Potts-Kant's actual perform ance of the experim ents, and

intep reting the results.
b.

'
rhe sheer scope,duration,and differing types ofPotts-Kant's activities in
creating the false data over a period of years indicates that her direct

58 11/13/15 Page 58 of 71 Pageid#: 1188
Case26
4:13-cv-00017-JLK
Document 25 Filed
907/1/728150* 3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
supervisor was involved.These activities included Potts-K ant's failure to
perform certain experim ents,failureto preserve the raw data from m any of
the those experim ents thatshe did perlbrm ,failure to follow expelim ental
protocols, fabrication of certain research results,and alteration of other
research results.
C.

The false research resultsreported in grantapplicationsand p antprogress
reports, and reported in the publications funded by the grants,w ere too
com plex and required too m uch expertise for Potts-K ant to have
developed on herown,given herlim ited experience and training.
Fosterfailed to supervisePotts-Kant.
Raw data did notexistto supportsom e ofthe reported research results.
Foster received wam ings aboutPotts-K ant's w ork.H is failure to follow-

up indicates eitherthat:(i) he already understood thatthe work was
fraudulent;or(ii)heactedwithrecklessdisregardand/orwasdeliberately
ir orantto thetruth orfalsity ofPottsK ant'swork.
g.

The large numberofpublicationsthatPotts-K antco-authoredk

h.

The num ber of publications that Foster him self co-authored increased

.

dram atically afterPotts-Kantw ashired.
The datareported by Potts-K antw asIttoo good to be true.''
J-

Fosterrefusedtoprovideotherresearcherswiththe.raw dataor/cxivent
scriptsthatwould allow otherresearchers to attem ptto replicate orverify
the Foster Lab's results when those researchers requested such
inform ation.

340. Other Duke University and/or DUH S Principal lnvestigators, executives and

snanagers had actual and specitic know ledge that Potts-K ant's reported research results in
59
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 59 of 71 Pageid#: 1189
07/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

question were false and/or fabricated by no later than M arch 2013 after Potts-K ant leA D uke
University.
341. Even before that, other Duke University and/or D UH S Principallnvestigators,
executives,and m anagers knew thatPotts-Kantand FosterLab research resultsw ere false and/or
fabricated forreasonsthatinclude,butare notlim ited,to the follow ing:
a.

Principal lnvestigators were responsible for designing experim ents that
Potts-Kant conducted,supervising Potts-Kant's actualperform ance ofthe
experim ents,and intep reting the results.

b.

Principallnvestigatorsfailed to supervisePotts-Kant.

c. ' Raw data did notexistto supportsom e ofthe reported research results.
d.

Employees in the Pulmonary D ivision knew thatresultsreported by PottsKantand the FosterLab were notreliable.
W arningsaboutPotts-Kant'swork had been given and received.
Dr.Eu had confirm ed his suspicions thatPotts-Kantw as falsifying and/or
fabricating data and reported that contirm ation to other Principal
.

Investigatorsw ithin the Pulm onary D ivision.
The data reported by Potts-Kantwasçttoo good to betrue.''
A fter becom ing concerned that Potts-Kant m ay have falsified and/or
fabricated da1 in M arch 2013, the review team created by D uke
University put affected researchers- such as Foster- in leadership roles.
These appointments violated Duke University' obligations under 42

C.F.R.j93.300(19.
D uke University continued to use the false and/orfabricated data in grant
applications and grant activities after M arch 2013. For exam ple, Duke
U niversity had actualknowledge thatthe research results reported in the
60
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 60 of 71 Pageid#: 1190
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

grantapplicationfortheSP-A projectinthefallof2013werefabricated
and/orfalse when itsubm itted the application.
D uke University and/orDUH S refused to disclose to other researchers or
the govem ment know n problem s with the research results reported by

Potts-Kantand the FosterLab.
K .The D efendants'acts and om issionsw ere m aterial.

342. The previously identifed false sGtem ents and records m ade and used by the

D'
ifeiidiùtjWere'fnatériél,becau'
sethéyhàd a'nafural-téùdericy to influéizce,'orbecapable of
influencing,the M H 's and EPA 'S paym ent of grant funds.For exam ple,such false statements
and recordswere m aterialbecause:
'
They w ere m ade in the grant applications, progress reports, and the
Instim tionalA ssurance and A nnualReport.
b.

'
Fhey w ere required to be included in the grant applications, progress
reports,and the InstitutionalA ssurance and AnnualReport.
They related to the provision .
ofprelim inary data,other research results,
.

and experiments that had'allege'
dly 'bien p'erformed as the basis for
supporting the proposed research,and therefore were likely to aFect the
N1H 's and the EPA 'S funding decisions.Defendants knew thatthe report
offalse and/orfabricated prelim inary data and otherdata w ould cause the

applications to receive ârtificially high priority rankings, and be m ore
likely to cause theN 1H and the EPA to award the grant.

They falsely reported results ofexperim entsthatw ould,ifaccurate,prove
and/orsupportresearch hypotheses.

ThephysiologicalphenomenonthatwerethesubjectoftheFosterLab's
false and fabricated research resultsw ere centralto hypotheses asserted in
61
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 61 of 71 Pageid#: 1191
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

grant applications and discussed in the p ant progress reports. n ese
reported physiological results w ere convincing- but false and
gaudulent--evidence that the asserted hypotheses had been proven by
properly designed and conducted experim entswith observed,docum ented,

and reproducible results.
tl

They falsely reported results of experim ents that would, if accurate,
supporttheneed foradditionalresearch using additionalgrantfunding.

343. Defendant D uke University has knowingly m ade false statem ents and

representations to the Governmentby virtue of(1) providing false reports and summaries of

research results in grant applications and grant progress reports; (2) by citing gaudulent
scientific papers in supportof its grant funding and by representing thatthe results reported in

thepublicationshadbeen ftmded byM H grants;(3)by falsely certifying compliancewith its
assurancesand 42 C.F.R.Parts50 and 93 or40 C.F.R.PM 40,theN tI'IGrants Policy Statem ent,

or the EPA Research and Related Term s and Conditions,and allFederallaw s and regulations;

and(4)byfraudulrntlyandwrongfullyretaininggrantfundsaf
.tçrdiscoveripgth.efraudandlack
ofcom pliancew ith thep antterm sand conditions.
L.Failure to Disclose and Concealm ent.

344. Duke University,D UH S,and Foster acted to concealand withhold their actual

know ledge of widespread research fraud,grantfraud,and their obligationsto repay grant funds

' to N1H and EPA.ln addition,DukeUniversity,DUHS,and Fosterknowingly and imptoperly
soughtto avoid ordecrease theirobligationsto pay m oney to the Govem m ent.
345. n ese actions establish Duke University's failure to foster an environm entthat

prom otes the responsible conduct of research, discourage research m isconduct and deal

promptly with allegationsorevidenceofresearch misconductasrequired under42 C.F.R.jj

93.3004c)and93.4124a)andDukeUniversity'sassurancesofcompliancewiththeRegulations.
62
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 62 of 71 Pageid#: 1192
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
W .CausesofA ction
CountO ne:False or FraudulentClaim sin G rantApplicationsand G rantProgress

Reports(AIlDefendants),31U.S.C.j3729(a)(1)(A)
346. '
Fhom asincom oratesparagraphs 1-345 asiffully setforth in CountOne.

347. The United States seeksreliefagainstD rfendantsunder the False Claim sA ct,31

U.S.C.j3729(a)(1)(A).
348. From 2006-2013, Potts-Kant know ingly caused to be presented, false or
fraudulentclaim s forgrantpaym ents in applications and progress reports subm itted to the M H ,
the EPA ,and otherUnited Statesgrant-m aking agencies,w ith respectto grants listed in Exhibit
C.

349. From 2006-2013, Potts-Kant know ingly caused to be presented, false or
fraudulentclaim sforgrantpaym ents in applications and progress reports subm itted to the NIH,
the EPA ,and otherU nited Statesgrant-making agencies,w ith respectto grantslisted in Exhibit
C-1.

350. From 2006-2014,Foster know ingly caused to be presented,false or fraudulent

claimsforgrantpaymentsin applicationsand progressreportssubmitted to theNlH,the EPA,
.

'

and otherUnited Statesgrant-m aking agencies,w ith respectto grantslisted in ExhibitC .
351. From 2006-2014,Foster know ingly caused to be presented,false or fraudulent
claim sfor grantpaym entsin applications and progress reports subm itted to the N IH ,the EPA ,
and otherUnited States grant-m aking agencies,with respectto grantslisted in ExhibitC-1.
352. A s a result of Defendants'research m isconductand fraud,as wellas their other

actionsand om issions,D uke University know ingly presented false orfraudulentclaim sforgrant

paym ents in applications and progressreports subm itted to the N IH ,the EPA,and otherUnited
Statesgrant-m aking agencies,w ith respectto the grants listed in ExhibitC.
353. As a result of Defendants'research m isconductand âaud,as wellas their other

63
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 63 of 71 Pageid#: 1193
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

actions and om issions,D uke U niversity knowingly caused to be presented false or fraudulent
claim s for grantpaym ents in applications and progress reports subm itted to the N IH ,the EPA,
and otherUnited Sutes grant-m aking agencies,w ith respectto the grants listed in ExhibitC-1.

354. n ese claimswere false or fraudulentbecause they were:(i) based on false,

fabricated,and/orfraudulent statements of research results;(ii)based on publications lhat
includedfalse,fabricated,and/orfraudulentstatementsofreseârchresults;and/or(iii)included
falsecertitk ations.
The false or gaudulent statem ents of research results,publications that included
false,fabricated,and/or fraudulent statem ents ofresearch results,and false certifications w ere
m aterialto the grant-m aldng agencies'decision to fund the grants.
356. A sa resultofthe false orfraudulentclaim s,theU nited States sustained directand
substantialm onetary dam ages,in the am ountofthe federalfundspaid to Duke University on the
grants identified in Exhibit C .These dam ages include, at a m inhnum ,the total costs of the

pantsidentifiedinExhibitC,in an amountexceeding $82,000,000.
A sa resultofthe false orfraudulentclaim s,theU nited States sustained directand

substanlialmonetarydamages,in theamountofthefederalfundspaidonthegrantsidentifed in
Exhibit C-1.These dam ages include,at'
a m inimum ,the total costs ofthe grants identitied in

ExhibitC-1,in an amountexceeding $120,000,000.
358. The false or fraudulent claim s proxim ately caused additionaldam ages,deprived

otherresearchers of access to scarce N IH funds and EPA funds,and m isled other scientists to
obtain federalfundsforstudiesthatotherwisew ould nothave been pursued.
359. By reason of the false or fraudulent claim s, the United States has sustained
dam agesin a substantialam ountto be determ ined attrial,and is entitled to treble dam agesplusa
civilpenalty foreach violation.

64
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 64 of 71 Pageid#: 1194
907/1/728150* 3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
CountTw o:False Records or Statem entsin G rantApplications,G rantProgressR eports,

andInstitutionalAssuranceandAnnualReports(AlIDefendants);31U.S.C.j
3729(a)(1)(B)
360. Thom asincorporatesparagraphs 1-359 asiffully setforth in CountTw o.
361. n e United Statesseeks reliefagainstDefendantsunderthe False Claim sA ct,31

U.S.C.j3729(a)(1)(B).
362. D efendantskriow ingly m ade,used,orcaused to be m ade orused,false recordsor
statem ents m aterial to a false or gaudulent claim s for grant paym ents, that were m ade in
appliùaliöns ànd prögressreports subm itted to the N II-l,the EPA ,and otherUnited States grantm aking agencies,w ith respectto the grants listed in ExhibitC.
363. Defendantsknow ingly m ade,used,orc'
aused to be rflade orused,falserecordsor
statem ents m aterial to false or gaudulent claim s for grant paym ents, that w ere m ade in
applicationsand progressreports subm itted to the N IH ,the EPA ,and otherUnited States grantm aking agencies,w ith respectto the grantslisted in ExhibitC-1.

364. '
T'hefalserecordsorstatementsinclude:(i)false statementsofresearch results
madeingrantapplicationsorgranjprogressreports;(ii)falsepublicationsreportedintheFant
applicàtionsandprègressreportjj(iii)falsecertificationsirlthegrantapplicationsandprogress
reports; (iv) the grént applications and progress reports, as false records; and (v) false
certificationsin the lnstitutionalA ssurance and AnnualReports.
365. The false records or statements w ere m aterial to the grant-m aking agencies'
decision to fund the grants.
366. A s a resultof the false records or statem ents,the United States sustained direct

and subsG ntialm onetary dam ages,in the am ountofthe federalfunds paid to D uke University
on the p ants identitied in Exhibit C.n ese dam ages include,ata m inim um ,the totalcosts of

thegrantsidentitied inExhibitC;in an amountexceeding.
$82,000,000.
367. A s a result of the false records or sàtem ents,the United States sustained direct
65
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 65 of 71 Pageid#: 1195
07/1/7281500v3

Filed U nderSealPursuant

to31U.S.C.j3730(b)(2)

and subsGntial m onetary dam ages, in the am ount of the federal funds paid on the grants
identified in Exhibit C-1.These dam ages include,at a m inim um ,the toulcosts ofthe grants

identifiedin ExhibitC-1,inan amountexceeding $120,000,000.
368. The false recordsorsutem ents proximately caused additionaldam ages,deprived

otherresearchersofaccessto scarceNIFIfundsand EPA funds,and misled otherscientiststo
obtain federalfundsforstudiesthatotherwisew ould nothave been pursued.
369. By reason of the false records or statem ents, the United States has sustained
dam agesin a substantialam ountto be determ ined attrial,and isentitled to treble'dam agesplusa
civilpenalty foreach violation.

CountThree:ReverseFalseClaims(AlIDefendants);31U.S.C.j3729(a)(1)(G)
370. Thom as incorporates by reference paragraphs 1 through 369 above as iffully set

forth in Countn ree.
The United States seeksreliefagainstDefendantsunder the False Claim sA ct,31

U.S.C.j3729(a)(1)(G).
372. DukeUniversityhasanobligationtorepaygrantfunds:(i)whenDukeUniversity
failedtocomplywiththetermsandconditionsofthegrantaward;(ii)thatwerespentinsupport

ofactivitiesthatinvolvedresearchmisconduct;or(iii)thatwereusedtodisseminatedeliberately
false orm isleading inform ation.

Forthe grants identified in Exhibit C,Duke University failed to comply w ith the

tefmsa'ndc6nditions'oftlçègfàn
'tawàrds.
374. D efendants engaged in wide-spread research m isconduct, m isconduct that was
supported by grants identified in ExhibitC .
U sing grants identified in Exhibit C,Defendants dissem inated deliberately false
orm isleading inform ation in publications,grantapplications,ànd grantprogressreports.
376. Defendantshave know ingly m ade orused false recordsand sttementsm aterialto
66 11/13/15 Page 66 of 71 Pageid#: 1196
Case269
4:13-cv-00017-JLK
Document 25 Filed
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
DukeU niversity's obligation to repay grantfunds.
377. Defendants have also know ingly concealed or know ingly and im properly
attem pted to avoid ordecrease DukeU niversity'sobligation to repay grantfunds.
378. D uke University haswrongfully withheld repaym entofgrantfunds.
379. By reason ofD efendants'actions and om issions,the United States has sustained
dam ages in a substantialam ountto be determ ined attrial,and isentitled to treble dam agesplusa

civilpenalty foreach violation.
CoùntFour:False orFrauduleàtClaim sin G rantApplicationsand G rantProgress

Reports withRespecttoDuke'sAssuranceStatus(DukeUniversityandDUHSI;31U.S.C.
j3729(a)(1)(A)
380. Thomasincorporatesparagraphs 1-379 asiffully setforth in CountFour.
381. n eU nited States seeksreliefagainstDukeUniversity and DUHS underthe False

ClaimsAct,31U.S.C.j3729(a)(1)(A).
382. Duke University falsely certiGed its com pliance w ith its assurances to the
G overnm entw ith respectto the R egulations for som e oral1 ofthe calendaryears from 2007 to
2015. D uke University m adethe falsecertitk ationsknow ingly.

383. During thoseyears,Dulce University know ihgly failed tö reportto ORlallegations
ofpossible research m isconduct,and failed to conductw arranted and tim ely inquiriesand
investigations into the allegations.
384. D uring thoseyears,Duke University know ingly failed to fosteran appropriate
research environm ent.

385. During thoseyears,D uke University know ingly failed to otherwise comply w ith
the Regulations.

386. During those years,Duke University know ingly failed to forthrightly dealw ith
possible research m isconduct.

387. As a result Duke University knowingly m ade false or âaudulentclaim s forgrant
67
Case26
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 67 of 71 Pageid#: 1197
907/1/7281500v3

Filed Under SealPursuant

to31U.S.C.j3730(b)(2)

paym ents in allgrantapplications and allgrantprogress reports subm itted to the NIH afterthe
date on which D uke University failed to com ply with its assurances to the G overnm ent w ith
respectto the Regulations.
388. A llsuch claim sduring those years were false or fraudulentbecause they included

falsecertificationsthatDukeUniversity:(i)complieswithPHSregulationsconcerningreporting
possible research misconduct;(ii) fosters an appropriate research environment; (iii) deals
forthrightly w ith possible research misconduct; and (iv) otherwise complies with the
Regulationsu
389. The false or fraudulentcertiticationsw ere m aterialto the N ll-l's decision to fund
each grantpaid to Duke University during som eorallofthe calendaryearsfrom 2007 to 2015.

390. A sa resultofthe false orgaudulentclaim s,theU nited Statessustained directand
substantialm onetary dam ages, in the am ount of a1lfederalfunds paid to Duke University for
M H grantsduring som e ora1lofthe calendaryearsfrom 2007 to 2015.
391. By reason of the false or fraudulent claim s, the United States has sustained

damagesin asubstantialamounttobedeterm inedattrial,and isentijledtotrebledamagesplusa
civilpenalty foreach violation.

CountFive:FalseRekordsorStatementswithRespecttoDuke'sAssuranceStatus(Duke
UniversityandDUHSI;31U.S.C.j3729(a)(1)(B)
392. Thom asincorporates parar aphs 1-391as iffully setforth in CountFive.
393. The United States seeksreliefagainstDuke University and D UH S underthe False

ClaimsAct,31U.S.C.53729(a)(1)(B).
394. Duke University and DUH S knowingly m ade,used,orcaused to be m ade orused,
false records or statem ents m aterialto false orfraudulentclaim s for grantpaym ents,thatw ere
m ade in applicationsand progressreports subm itted to the NIH .

The false records or statem ents include the false certitications in Duke

68
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 68 of 71 Pageid#: 1198
907/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)
University'sInstim tionalA ssurance and M nualReports,subm itted to 0R1w ith respectto some
orallofthe calendaryearsfrom 2007 to 2015.

396. The false records or statem ents also include the false certifications in allDuke
University's grantapplications and grantprogress reports for allN 1H grants subm itted afterthe
date on w hich Duke University know ingly failed to com ply w ith its assurances to the
Govenzm entw ith respectto the Regulations.
397. D uke University'sfalse certifications in the InstitutionalA ssurance and Annual
Reportsw ere m adçknow ingly.
398. Duke University's false certifkationsin p antapplicationsand grantprogress
reportsw ere m ade know ingly.
399. The false certitk ationsin DukeUniversity'slnstitutionalA ssurance and A nnual
Reportswere m aterial.Based on the false certificationsfora11orsom e ofthe calendaryears
2007 through 2015,Duke University m aintained itsassurance status,which wasrequired for
Duke University to receive NIH grantfunding.
400. The false certitk ations in D uke University's N IH grant applications and grant

progressreportswerem aterialtotheNlll'sdecision to fund each grantphidtoDukeUniversity
during som e ora11ofthe calendaryearsfrom 2007 to 2015.
401. As a result of the false records or statem ents,the United States sustained direct
and substntialm onetary dam ages,in the am ountofthe federalfundspaid to Duke University

foral1NIH grantsduring som e orallthe calendaryears2007 through 2015.,

402. By reason of the false records or statem ents, the U nited States has sustained
dam agesin a substantialamountto be determ ined attrial,and isentitled to treble dam agesplusa
civilpenalty foreach violation.
V.
11.Prayer for Relief

WHEREFORE,Relator,onbehalfoftheUnitedSutes,praysthatjudm entbeenteredin
69
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 69 of 71 Pageid#: 1199
907/1/7281500v3

Filed U nder SealPursuant

to31U.S.C.j3730(b)(2)

theirfavorand againstD efendantsasfollow s:
1.

That D efendants pay the United States triple the am ount of its dam ages to be

determined,pluscivilpenaltiesofupto$11,000foreach falseclaim,statement,orrecord;
Thatthe Relatorbe awarded a1lreasonable attorneys'fees and costs,pursuantto

31U.S.C.jj3730(d)(1)and/or(d)(2);
That in the event the United States proceeds with this action, the Relator, for
bringing this action,be awarded an am ountofatleast15 percentbutnotm orethan 25 percentof
theprqçeedsofany aw ard orthe settlem eptofthe claim s;
.

That in the eventthe United States does notproceed with this action,the Relator
be aw arded an am ountthatthe Courtdecides is reasonable for collecting the civil'penalty and
damages,which shallbe notlessthan 25 percentnorm orethan 30 percentofthe proceedsofany
aw ard orsettlem ent;

5.

Thatthe Relatorbe aw arded them axim um am ountallow ed pursuantto 31 U .S.C.

j3730(d);
6.

ThattheRelatorbeawardedpre-judgmentandpost-judgmentinterest;and
TheCourtawardsuchotherandfurtherreliefasisjust,equitableandproper;

RelatorrequestsajuryonaIIissuessotriable.
N ovem ber12,2015.

QD-

.THO

By.
.

70
Case269
4:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 70 of 71 Pageid#: 1200
07/1/7281500v3

Filed UnderSealPursuant

to31U.S.C.j3730(b)(2)

M atthew Broughton(VSB No.25226)
GregoryJ.Haley(VSB No.23971)
M ichaelJ.Finney(VSB No.78484)
JohnR.n omas,Jr.(VSB No.75510)
DanielR.Sullivan(VSB No.81550)
Andrew M.Bowman(VSB No.86754)
GENTRY LOCKE
900 SunTrustPlaza
P.O.Box 40013
Roanoke,V irginia 24022-0013

(540)983-9300;
Fax:(540)983-9400

'

brouRhton@aentrylocke.com
haley@ aentrvlocke.com
finnev@aentrvlooke.com
ithomas@ gen> locke.com
sullivan@aentrylocke.com
bowman@ aentrvlocke.com
CounselforRelatorJosephM FJIO-J.
N

CERTIFICA TE O F SER W CE

l hereby certify thaton this 12th day ofN ovem ber,2015,a true and correctcopy of the
foregoing was served by hand delivery on A nthony P.Giorno,United States Attorney for the
W estern DistrictofV irginia and Itick A .M ountcastle and Sara Bugbee W inn,AssistantUnited
StatesAttorneys,310 1Ststreet,S.W .,Room 906,Roanoke,VA 24011.

Ifurthercertify that on the 12th day ofNovem ber,2015,a true and correctcopy of the
foregoing w as served via certified m ailon the United States Attorney Generalpursuantto Fed.

R.Civ.P.4(i).
Pursuantto 31U.S.C.j 3730(b)(2),and thisCourt'sOrderentered July 9,2015,the
m atter isundersealand,therefore,Defendantsw illnotbe served with these pleadings.

71
Case264:13-cv-00017-JLK
Document 25 Filed 11/13/15 Page 71 of 71 Pageid#: 1201
907/1/728150* 3