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IJNITED STATESDISTRICT COURT
JULIA
SY;
EP
DL
LE
N
c E
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.
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. (CDUHS''I, W illiam M . Foster, Ph.D.
1.
Introduction
26907/1/728150*3
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.
publicationswereusedtojustifyfuturegrantawards,moneywhichwouldthenbespentonmore
fraudulentresearch.
D uring these years, D efendants Foster, Duke University, and D UHS received
2
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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
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
U nder the FCA,Defendants are liable to the United States forthe ill-gotten and
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
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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
Thom as's claim s and this A m ended Com plaint are not based on allegations or
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 .
16.
Joseph M .Thom as
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
B.
19.
D uke U niversity
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.
.
20.
ocks
Carolina.D UHS is a subsidiary of Duke University,and it runs the D uke University M edical
Center.
21.
22.
Erin N.Potts-lfant
was hired in or about 2005 and w orked w ith D efendant Foster in his Airway Physiology
b. Gslelnsurecompliancewithprotocolguidelinesandrequirementsofregulatory
agencies;identify problem sand/orinconsistencies.''
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
24.
W illiam M ichaelFoster,Ph.D.
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.
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.
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 om theirw ork,and,in som e ins/nces,to receive funding from fellow
researchers'grants.
6
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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.
32.
D r.M onica (
Kraftw aj a Principallnvestigator forthe Pulm onary Division,and
Kantonsignificantresearchprojects.
35. Dr.Loretta G.Que is a PrincipalInvestigatorforthe Pulmonary Division,and
w orked closely with Fosterand Potts-Kant.
36.
37.
38.
K raft.
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39.
40.
peerintermsofjobresponsibilitiesandexperience,andalsohersuccessorintheFosterLab.
42.
(iii)OtherResearchers
44.
The Pulm onary D ivision and the Foster Lab also conducted research in
45.
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
LegalFram ework
TheFCA
47.
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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
48.
For purposes of the FCA ,the term s Gknowing''and knowingly''fsm ean that a
UnitedStateshastitletothemoneyorproperty,that--ti)ispresentedtoanofticer,employee,or
agentoftheUnitedStates-''31U.S.C.j3729(b)(2).
50.
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
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For purposes of the FCA, the term tKobligation'' m eans tan 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.
54.
The NIH is m ade up of m ultiple institutes and centers, each with a specitk
i'ile
'dbnkersealPursuant
to31U.S.C.j3730(b)(2)
58.
The NIEI GGis the steward of m edical and behavioral research'' for the llnited
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
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.''
N o N IH grant funds can be used to dissem inate inform ation that is deliberately
Str
fhe grantee is responsible for the actions of its em ployees and other research
11
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Filed U nderSealPursuant
to31U.S.C.j3730(b)(2)
ResearchMisconduct,42C.F.R.Part93(thelRegulations').@ IH GrantsPolicyStatement,Part
11j4.1.27,RResearhMisconduct,''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.
(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 laffirm ative dutv to protectPHS funds
from m isuse by ensurinz the integrity ofallPHS supported w orkeand prim ary responsibility for
The Regulations further require that institutions Eifoster a research environm ent
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
Reg.28378(May 17,2005)(amending42C.F.R.pts.50and93).
(iv)Granteeinstitutionsmustmaintain an assuranceofcomplianceto receivefunds.
68.
separate assurance fonn. @ IH Grants Policy Statement, Part ll, j 4.1.27, C'Researc,
h
M isconduct''p.IlA-40).
70.
(c)Fosteraresearchenvironmentthatpromotestheresponsible
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(i)Haveanactiveassuranceofcompliance.
42 C.F.R.j93.300.
research misconduct; and (2) (clomplies with its own policis and procedures and the
requirementsofthispart-''42C.F.R.j93.301(b).
72.
(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
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
OftkeofResearchlntegrity(::ORI'').742C.F.R.j93.302(19.
74.
Grants
PolicyStatement,PartII,j4.1.27,GResearchM isconduct,''p.IIA-40).
(v)Granteeinstitutionsmustreportandrespondtoallegationsofpossibleresearch
m isconduct.
75.
allegations of research m isconduct and to m ake certain disclosures to ORI under specitk
circum stances.8
P115-6349jII(B).)
77.
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 tallegation''ms a disclosure of possible research misconduct through any means of
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PHSsupportthatmaybeaffectedbytheresearchmisconduct.42C.F.R.j93.309(a)(3).
The instim tion m ustprovide 0R.
I with a written inquiry reportupon finding that
researchmiscondud.See42C.F.R.j93.310.
80.
Upon the com pletion ofthe investigation,the instim tion m ustsubm it,in writing,a
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
93.313(9.
82.
(ii)
Thereisareasonableindicationofpossibleviolationsofcivilor
to31U.S.C.j3730(b)(2)
(iii) Theresearchcommunityorpublicshouldbeinformed.
42C.F.R.j93.318(b),(d),and(g).
83.
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-
(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.
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(vi)Granteeinstitutionsmustcomplywith alItermsandconditionsofthegrantaward.
86.
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
(vii)Institutionalcertilkationsrelatingtograntawards.
88.
For exam ple, by its signature on the grant application, the grantee instittltion
certifies to the N IH that ithas tthe ability to provide appropriate adm inistrative and scientitk
Applications,''p.1-36.)
90.
it Kcom plies,or intends to com ply,w ith all applicable policies, certifications and assurances
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
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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 audulent 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,
form are setforth in the U .S.D epartm entofHea1th and Hum an Services,Public Hea1th Service,
Thesignatureoftheomcialsigjing fortheapplicantorganization
ontheFacePageoftheapplicatlon(orforelectronicapplications,
checkingthe1Iagreebox 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
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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
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
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Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
performanceofthegrant-supportedprojectoractivitiesresulting9om theprogressreport.
GrantsPolicyStatement,PartII,#8.4.1,tReporting,''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
@ 1H GrantsPolicyStatement,Part11j8.6.2,tTinalProgressReporq''p.1lA-121.)
99. Each grantprogress report(PHS 2590) includes an express certitication that
reads:
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
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,Bibliography 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
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,
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to31U.S.C.j3730(b)(2)
106. A11research resultsthatare funded by the N lH and accepted forpublication by a
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. lfa 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
ofNll'
lgrantfundsareFCA actions.IN111GrantsPolicy Statement,Part1,j2,Traud,W aste
andAbuseofM H GrantFunds''p.1-47.)
109. ln connection with a finding ofresearch m isconduct,HH S lm 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
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requirementsofthispartanditsassurance.''42C.F.R.j93.412(b).Inmakingadeterminationof
instim tionalnoncom pliance:
0(
R1m ay consider,butisnotlim ited to the follow ing factors-
feseal'
ch m isctmdtlctarlse;
'
(3)Failuretoreportto OR1allinvestigationsandfindings
ofresearch m isconductunderthisparq
(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 ..
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.
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
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.
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resulting from the grant funded project. The grantee instimtion mustprovide copiesofall
publicationsthathave notpreviously been submitted to the EPA. (EPA Research and Related
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
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
the EPA Office of lnspector General (GrIG'') if Slany allegation of research misconduct''
involvesany one ofseven factors,including:
(i)
Agencyresourcesorinterestsarethreatened;
(ii)
M isconductPolicyj9(C)(i)(b);seealso65Fed.Reg.762634111).)
130. The EPA hasthe tultim ate oversightauthority forFederally funded research.'' 65
Fed.Reg.76263(111). :(A)t any time,the (EPA) may proceed with its own inquiry or
investigation-''65 Fed.Reg.762634111).
V .FactualA llegations
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.
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
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.
).
-
'
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
'conductedundertheirsupervision.''(Dk: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
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
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
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.
deliberatelyfailingtomntheWcxfventandmultiplexmachinesorfailingtoexposethemiceto
the appropriate chemical,medical,orenvironmenGlconditions.Instead,she simply made ttp
data.
to31U.S.C.j3730(b)(2)
joumalarticles.
Som eofthese publicationsare discussed in m ore detailbelow.
165. This scientific article, prem ised upon fraudulent research, cites the fmancial
supportfrom N IH grantsH I-067021,111,075307 and 14L67281.
32
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to31U.S.C.j3730(b)(2)
RelatorU 000
).
. 447.
.
.
scientificjournalEnvironmenulHealthPerspectives.
170. This scientific paper,prem ised upon fraudulent research, cites financialsupport
from N IH grantsES016126,E5020426,E5016347 and 111,081825.
Wexfventmachine.'T'
hedatasupposedlyproducedbytheseexpedmentsarecontainedinFigures
1C,Figure2C,Figure4C and Figure5C (/lxfvent)ofthepaper. Potts-Kantalso claimedto
33
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perform theozoneandhyaluronan(: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.
Re1ator 000437.)
-
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
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183. Potts-Kant and Foster co-authored a scientitic paper entitled The extracellular
184. ln contributing to this paper,Potts-K ant claim ed to perform experip ents on the
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.
PrimesPulmonaryInnatelmmunity inMice.(Ex.B,atRelator-000052.)
l89. ln contributing to this paper,Potts-Kant claim'ed to perform experim ents on the
190. M otherresearchertried to re-nm this experim ent and observed resultsthatw ere
the opposite ofthe FosterLab'spublished results.
35
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195. In contributing to this paper,Potts-K ant claim ed to perform experim ents on the
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
36
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to31U.S.C.j3730(b)(2)
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.
receptorsregulateresponsestoMycoplasmapneumoniaeinsulfactantproteinA (SP-A)-/-mice.
(Ex.B.,Re1ator-00202.)
207. ln contributing to this paper,Potts-Kantclaim ed to perform experiments on the
3A and3B,Figure4C,andFigure6A Wcxfvent)ofthepaper.
37
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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.
others, Potts-Kant and/or Foster used false and/or fraudulent research results to co-author
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
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,
:PA as wer made in the publications funded by N1H and EPA grants.The sequepe 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
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
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
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
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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
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
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
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to31U.S.C.j3730(b)(2)
2008 to 2012.ln furtherance ofthis schem e,she produced false invoices forscientific equipm ent
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,inluding:Dolma Cookm eyer,Ph.D .,the Research lntegrity Officer;
'
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
detailed description ofthe fraudulentda follow sbelow .
235. M s.Theriothoted that only a'few ra* data files existed forthe FosteiLab's
238. TherekieWers'could notflnd faw data t'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 rpbrted research w aj funded by Grants AI
081672, AI 064789, A I 58161,ES 016126, ES 020426, ES 016166, ES 016347, ES02046,
43
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242. M.
r.Francisco identitied fabricated multiplex andJlexiYkntdata in cormection
w ith the publication PM m 22773729.
(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,
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
ttlmrnecrosisfador(i:'IW F-a''),forsmeofherexperiltientswasfrubuleht''
250. Dr.Ingram noted thatPotts-Kanthad notexposed m ice to the properantigensfor
som e studies.
ES11961,ES12717,1.
11-91335,F-32-111,0911642,P141-073907,and 1.
11-084917.
(iv)Potts-Kantmanipulatedtheresultsofthoseexperimentsthatshedid rn.
53.
.
Potts-KanthadloWeredtherepoitedre'sistancekaluesintheRLPS/NOS''project.
256. M n Francisco identified data thatPotts-Kanthad m anipulated in the interleukin 8
(IL-8'') and 'IWF'-a cytokines results that were significant to the conclusions in PMID
22773729.
to31U.S.C.j3730(b)(2)
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 stat that the reported research was funded by Grants
(v)ReviewerscannotrepeattheFosterLab'sresults.
261. Duke and/orDU HS re-ran experim ents in an attem ptto repeatthe resultsreported
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
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 :m indin''gene
projectandobservedresultsthatcontradictedthepublishedresults.
268. M s.Theriotre-ran experim ents using N 1rp3 m ice and observed resultsthatdid not
correspondto those thatwere published.
(vi)Dr.Ledfordidentiliesspeciicimanipulated''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
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
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48
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to31U.S.C.j3730(b)(2)
G raph B :Published M anipulated Data
A 2.
5
(34z)J
.*
t; 2 O
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25
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* SP-AV-KlW-sW -sh+Mp** #
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--*-- sPA 4-S
100
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
278. Dr. Ledford and M s. Theriot re-ran the Mycoplasma treatm ent experim ents
279. D uring its review of the Foster Lab's reported research results,the priority for
49
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to31U.S.C.j3730(b)(2)
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.
ofavoidingsuchdisclosurestotlleNIH,EPA,andpublications.
Filed UnderSealPursuant
to31U.S.C.j3730(b)(2)
(i)DukeUniversityand/orDUHSmisleadingly describedthePotts-Kantsituationas
an diem ploym entissue''.
D uke was currently review ing the situation. The script did not provide accurate inform ation
aboutthe FosterLab'sresearch m isconductfraud.
(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
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.
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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
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 lrecalculation''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.
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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
fraud dem onstratesa system ic failure by Duke University to fosteran nvironm 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.
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 r eception atDuke.''
306. ln The Econom ist article, D uke University's V ice-chancellor in Charge of
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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
Sham :rendra Sanyal,a form erpostdoctoralscholarw ithin the Pulm onary D ivision. Dr.Sanyal
'
312. The circum stances surrounding the research m isconduct of Dr. Sanyal further
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 .
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
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.
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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
(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:
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one in the FosterLab,in one in the laboratory ofDr.W alker.M s.n eriotoperated the tlexiv ent
(iii) FosterrecklesslydisregardedthetruthorfalsityofPotts-Kant'sresearch
results.
334. Foster wasresponsible for supervising Potts-Kant's work and he failed to do so.
expertsinhistield.Potts-Kantwasayounpjunioremployee.
335. During the tim e thatPotts-Kantworked in the Pulm onary Division,Foster either:
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
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Potts-Kant's data for accuracy;(ii) failed to compare her reported data with the raw da>
337. A s explained above,the failure to supervise Potts-K ant occurred during a tim e
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
'
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
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.
h.
The num ber of publications that Foster him self co-authored increased
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
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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.
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
.
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
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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
342. The previously identifed false sGtem ents and records m ade and used by the
D'
ifeiiditjWere'fnatril,becau'
sethyhd a'nafural-tdericy to influizce,'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,
.
ThephysiologicalphenomenonthatwerethesubjectoftheFosterLab's
false and fabricated research resultsw ere centralto hypotheses asserted in
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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
or the EPA Research and Related Term s and Conditions,and allFederallaw s and regulations;
and(4)byfraudulrntlyandwrongfullyretaininggrantfundsaf
.trdiscoveripgth.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
prom otes the responsible conduct of research, discourage research m isconduct and deal
93.3004c)and93.4124a)andDukeUniversity'sassurancesofcompliancewiththeRegulations.
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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.
'
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 aud,as wellas their other
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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.
substanlialmonetarydamages,in theamountofthefederalfundspaidonthegrantsidentifed in
Exhibit C-1.These dam ages include,at'
a m inimum ,the total costs ofthe grants identitied in
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.
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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
applialins nd prgressreports 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
applictionsandprgressreportjj(iii)falsecertificationsirlthegrantapplicationsandprogress
reports; (iv) the grnt 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
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
CountThree:ReverseFalseClaims(AlIDefendants);31U.S.C.j3729(a)(1)(G)
370. Thom as incorporates by reference paragraphs 1 through 369 above as iffully set
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'oftlgfn
'tawrds.
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,nd grantprogressreports.
376. Defendantshave know ingly m ade orused false recordsand sttementsm aterialto
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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
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.
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.
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.
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
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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 adknow 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
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
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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
theprqeedsofany 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.
j3730(d);
6.
ThattheRelatorbeawardedpre-judgmentandpost-judgmentinterest;and
TheCourtawardsuchotherandfurtherreliefasisjust,equitableandproper;
RelatorrequestsajuryonaIIissuessotriable.
N ovem ber12,2015.
QD-
.THO
By.
.
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(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.
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