Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Petitioner,
--- ------------x
Upon the annexed Petition, verified on the 23rd day of January, 2003 by Elliott
Bennett-Guerrero ("Be1x1ett-Guen,]ro"), and the Exlibits ainexed thercto: and all pdor proceediigs
had herein, an application will be made to the Nerv York SLLpteme Court, County ofNew york, in
Room 130, at the Courthouse, located at 60 Centre Street, New York, New york, on the l,lth day
ofFebruary, 2003, at 9:30 a.m., or as soon thercafter as counsel may be heard, for an Orcler-and
Judgement under New York Civil Praclice Larv and Rules ("CpLR") Anicle 78:
FELED
JUN 2 5 2003
orne s
couur{?uJu-!oJ.
(1) declaring that the sanctions imposed against Bennett-Guerero by Respondents
are arbitrary, capricious, an abuse ofdiscretion, illegaland invalid and restraining Respondents lio1n
ability to conduct, pursue, and publish all clinical resea-ch to the same extent as any other- faculty
men]ber and provided such research is in compliance with applicable mlcs and reglrlatiol1sl
(3) enjoining Coiumbia Univemity and Gerald Fischbach from inrposing aid/or
Division;
including his legal fees and disbursements incurred in this proceeding; and
(6) for sucl] other and furlher diflorcnt reliefas lhe Colut deems.just ar]d proper
Pursuant to CPLR 7804(c) answering papers, if :tny, shall bc scrved upon the
undersigned at least five (5) days p or to thc retum date ofthis petition.
New York Count] is designated as the \_etrue oi _rh; ptc=e .d1trs
ca rie tcss
You$, etc.,
FILED
JuN 2 5
?003
counr\E$Jffforrrce
SLTREI'IE COURT OF THE STATE OF NEW YORK
of N:w y:Rr(
::NlY _,__________________ _ x
ELLIOTT BENNETT-GLIERRERO, M.D.
Petitioner,
-against-
IAS Pafi
THE TRUSTEES OF COLUMBLA LNTV-ERSITY IN
Assigned to
THE CITY OF NEW YORK AND GERALD
FISCHBACH,
Hon I FILffi.M
JUN 2 5 2003
Rcspondellts
couu{?lJ#orner
Petitioner Elliott Bennetfcuerero, M.D. ("Bennett-Guerero"), by and through his
counsel, Morison Cohel Singer & Weinstein, LLP, respectl'ully alleges as follows:
liceised physician and boald certified cadiac anesthesiologist, who holds a facult) appoilitme t .tt
Iespondent Colmrbia University,r and ',r'ho until recentl), was rhe Chief of the Cardiac
Anesthcsiology Division at Columbia Presbyteri:ur Nledical Center. lor an Order and Judgement
pr-eventing respondents ColunbiaUnivelsity a,rd Gerald Fischbach ("Fischbach") from: (a) imposing
rDuring the relevant period, Bennett-Guerrero also held a medical staff appointment and
clinical admit'ting privileges at Columbia Presb)terian N,ledical Center, a hospital affiliated with
Columbia University. For puryoses of this veiilled petition, respondent Tmslees of Columbia
University in lhe City of New York, Columbia University, Columbia College of Physlcians and
Sugeons and all departnents thereof, and ColumbiaPresbltedanMedical Center will be collectively
ref,-laed to as "Columbia Univcrsity."
conncction \\ ith IRB approved resear-ch protocol +9256 (describcd more full\.belou ), because anv
such sanctjons are arbitrary, capicious, an abuse oldiscretion, illegal and inviLlid and ate, amone
other things, in complete violation ofhis due proccss dghts accorded by Columbia Lnivcrsity,s orvn
applicable policies and procedules as well as those nandated by federal regulations: and (b)
rcstricting in any manner Bennett-Guencro's abihty to conduct. jlut-sue. and publish all research to
the same extent as any other faculty memb er so long as such research complies rvith applicable ru1cs
and regulatiolls.z Bennett-GLrenerc also seeks continuation ofhis title and positio|r as Assistant
Professor, Deparlment ofAiesthesiology and rcinstatement oflis title and position as Chiefofthe
Cardiac ,\resthesioiogy Division, $'hich tities and positions were wrongfully and sumrrrarily
removed in early Januaty 2003 as a result of the Respondents, improper and u,rongful actions.
Finally, Bennett Guerrero seeks incidental danages, including r.easonabic attomeys, fces ancl costs.
2. At the crux ofthis proceeding, and lving in the balance, is nothing less than
the entire career and reputation of an e)itlemely dedicated and capable medical phlsicim and
tesearcher. Upon infonnation and bcliel with the exception of tlte facts containe.l herein, no
conccrns have erer been raised as to Beanett Gueneio,s professional credentials and intcgrity. or
his cadng. skill or character as a physician. or hjs cledicarion, ability and conduct as a clinical
instructor and nedical researcher'. Indeed, Bennett-Guen elo's reputation as aclinician andclinical
investigator and researcher was stellar botlt within and outside of Collrmbia University. Hc has
previouslv conducted numerous clinical rcsearch trials with other in\.cstigators ai plestigioLts
'?Bennett-Guerrero repeatedly offered to have his r.esearch subject to monitoring and such
requests havebeen dcnied. Heispreparedtoha!eamonjtorasacoidiiiontorcsurrinqallresearch.
institutions that resulted in publications in highly cited medical joumals and has, in lact, over one-
hundred (100) scientific publications to his credit. Hc x.as routinely inr'iLed ro give lecturcs atmajol
national and intemational scientific meetings and ar his still youl.lg age ltolds the promisc lor a long
career that will benefit patients rvorldwide, particularly tlTough his commitmcnt to pioieedn-s
clinical rcsearch with hopes to impro\.e thc rinderstanding of hrman illness that nay lead to
machinations of respondent Fiscl]bach and othors and rheir blatanl and intentional disr.egard ol
Columbia University's o*.n intemal policies and procedur.es, as well as thosc itnposed by fedcral
regulalions, including the deoial ofthe most basic and fundanrental procedural rights to which lre
was entitled, Bennell-Guenero no| slards at the eclge ofaprecipice in his careerwithltis r.eputation
unfairly and maliciously maligned. As is unfo Ltnately not uncommon, anonyrnolLs accusels:
believed to be nembers ofhis depar'tment rl,ith a personal aninrus against Bennett-Guenero as thc
sing star of the department, levied unfounded charges against hil11 in connoctjon \!ith one ofthe
lhe marmer required by Columbia University's own applicable procedur.es and fedcral regulations,
horvcver, Fischbach and Columbia University's IRB chose to pllrsue secret procecdings nowherc
justified in ColLrmbia Universily's applicable policies and plocedules. 'fhe anorrymous accusers
were never formallyidentified and Bennett-Guerrcro $'as not allowed to revierv, much less confront,
the alleged evidence against him. He was also intentionally misled about tlte process and ellectively
r-e tricd onthe samc cl]arges overand over untilrespondeit Fischbach achicved the resulthc \\,anted
- a result wl]ich he hoped rvould deflcct from his own responsibility arld that ofhis wife, who was
a member of Colunbia University's IRB, lor the failiigs in procedure and overcight by casting
bliunc rvhere it was not duc, i.e., on the shouldcls ofBeinert Gucrrero. Moreover- respondenl
Fischbach failed to identify or address l.iis own conflict of interest due to his wile being a nember
ofthe IRB.
inexplicable disdain, but he was singled our for rchibution when other physicians responsible lor
conduct and approval ofthe study at issue were ignored. He was also p unished in a manner, upon
infon'nalion and beliei u.l]ich is unprecedented and inconsistent with the tleahnent of other
physicians and rese.rchers both at Col'mbia university and at other similar educatiolal institLrtions
even if the charges $'ere true, which they are not. Indeed, \\,.ithout justification, hc has been
summarily baned indchnitely lrom pursuing clin;cal research, rvhich is tantanount l1l the medical
community to a finding that he has committed the nost eglegious fomt ofscientific ntisconduct e'cn
though Respondents have sepatately staled that he has not committed any scientific misconduct.
Perhaps worst ofall, the imposition ofsever-e, arbitrary, and unprccedented sanctions are based on
accusalions that were made in bad faith and are u,,rsupported by any fair reading ofthc recortl and
the applicable regulations. Such sanctiolls havc to date had and continue to have a serious
5. The Coud has j urisdiction over this pr oceeding pursuant to CPLR 3 01 , 7E0l
and 7803. Venue is ploper in this county pursuant to CPLR 506(b) and 780,1('tr).
The Rele\ rnr Parrier And Fnririi{
6. Bennell-Guereroisanindi\rduall\riira:.sr:r;s:::::;::;.1:\.r':a:lia::.-
New York. Bennett-Gueraerc is amedical doctor duly licenscd in the State ofNc\\'York. Acop!
privately suppoficd, nonsectarian educational instilution, charlered by the State ofNelv York, and
organized as a not-for-profit corporatjon, localed in the City ofNe\\' York. Columbia Univcrsity is
conprised of a liumber of schools of higher lcarning, one of lhich is the Columbia College oI
E. Fischbach is the executive vice president for Health aid Biomedical Sciences
at Columbia Universily and is thc Dear of the Faculty of Medicine at Columbia Unjversity.
Fischbachwas directly respon sible for directing the ploceedings at issuc and personally imposed all
ofthe relevant sanctions. Upon infomation and belief, his wife, Ruth L. Fischbach, Ph.D., M.P.E.,
is a Professor ofBioethics at Columbia Universit-\' aid Director ofthe Center for Biocthics :rnd in
at all rclevant times responsible for, among other things, evaluating all resoarch protocols lo be
implemented at Columbia University and assisting and advising rcsearchers regardirg compliance
10. Dr. Margaret Wood ("Dr. Wood") was at all relevant timcs a tenured
Bcnnen-Guerr.'ro.
humans in researclr.
and procedures ofthe public Health Sen.ice Act that are related to scientiflc
nrisconduct.
The Protocol
Depaltment of Anesthesiology.
Protocol #9256 lvas designed to address this equipoise through a single center randomized Lrlind
study ol the four (4) intravenous fluid rcginens in patients undergoing coronary artery bl'pass
15. Each of the four ('1) fluids to be utilized in the Protocol welc previously
approvcd by the U.S. Depatlment ofHcalth and Human Selviccs' Food and DIug Administration
16. Care lor paticnts included in the Prolocol \\'as roLLdne erccpt: (1) several
teaspoons ofblood \\'as withdra$r fron the palient; ard (2) patients received one (l) ofthe four (4)
l'7. Included in the initial Plotocol that x'as submitted to thc IRB for apploval
r,ere the olhcial packagc inserls for the lbur'(,1) fluids that would bc involved in the Pr-otocol, r\ hich
inserls identifiedthe risks and side-effects ofthe fluids. These insens has beenprc\ ious11' approved
by the FDA.
LE. The entire Prolocol was rcvjcwed and ultintately appro|ed by expcl1s from
the Coiumbia University depaitner'lts ofSurgery, Nfedictne and Aresthesiology, as recluired by the
]RB.
\\'as revised. Thc revisions included, anong othcr things, an expansion ofthe endpoints and a
change of the official title.
discussio[ ofthe potential inpact ofthese fluids on coagu]ation, thc protocol and patient consent
fomr, as revised afler presentation to the Columbia UniveNity Surgeois, rvas appr.oved by the full
22. The proposed patie11t conscnt fonn to be used in conncction with the protocol
was edited by the IRB and was subsequently lully approved by thc full board ol'the IRB.
was sent by the investigators to all Caldiac Anesthesia Attending physicians at Colunbia
Presbylerian Medical Centcr, pror,iding said attending phlrsicians with information concening
rhe
any of the Cardiac Anesthesia Atrending physicians that receivcd the email in Decelnber
of 1999.
25. Bascd on thc IRB's approval ofthe rcvised protocol and the lack ofcomncnt
or concem ftom the Cardiac Ancsthesia Altending physicians, the protocol was implementcd
in
Dccember 1999.
28. The Protocol thereafter enrolled an additional 100 patients, bringing the total
29. During this period, an jnlonn,ll independent safety analysis was also
completed. This independcnt saleiy analysis was suggestcdby Bennett Guenero amd implemenlecl
b-v the investigators as an additional sal'ety net fol the pafticipants in the Protocol. It $,as not
program began and after the study re11ewai, Bemeti-Gueraero assuned the role of the P ncipal
31. During this entile time period, no allegatiolls conceming the conduct ofthe
Protocol were expressed to Bcnnctt-Guerero or', upoi infollration and belie1, to his Chaiman.
32. Columbia Urriversity has a specific set ofpolicies and procedures that it is
appeaN as Appendix F to Columbia University's Facully Handbook). The lederal reglrlations related
to such research contain a similar-set olrequired procedures and protections (Exhibit C hereto).
ot otllef practices lhat setioasl! aleiate frorrt tltose tltttt tre connonly accepte.l x,ithin llte
scien rtc cotfituuni1tfor proposing, cotlducting, or rcpoftihg rcsealclr. It does not incllrde honest
al \ 5fi.102).
. The person alloging the nisconduct should "consult The Connnittee on the Conduct
ofScience."
"lT]he person alleging Inisconduct should bring his or her concem to the attention
ofthe faculty nember directly responsible lbr the individual whose actions arc in
question [Dr. Wood]."
"hr response to an allegation ofmisconduct the Vicc Prcsident lor l-Iealth Sciences
[Fischbach] rvi11 initiate a pleliminaly review {or inqrir'}) wlich may be followed by
an investigation. An inquirf consists of information gathedng and initial fact
inding to detcmine whether an allegation or apparcnt instance of misconducl
wafirrt5 dn ir' esrierLion. '
"Nluch as the accuser ]nay wish to ha!e his,/her anon\]nirv prorected, such protection
infiinges on the rights ofthe accused. . . . Ifan inquiry is initiatecl the Conmittce
must mako cvery elfo to protcct the dghts ofthe accuser but not his/het ideilily."
Thc accused "mlrst be protected Bom penalty and public knou{edge of any
accusation until.judged cu$ab1c. Therelore, the Lhiversity should do nothing to
impede the ability ofthe accused to continue rvith his'hcr u'or* during the period of
thc inquiry and investigation unless the Vice President lFischbach] dccms the inte m
action is lr,arrantcd such as ilterim suspcnsion of\1ork because ofpossib]c advcGe
conscquences ofcontinucd lesearch oi the weli-being ofhuman subjects. In this
instance, il will be necessdy lor thc Vice President [Fischbach] ro i.lbnr the
appropriate olfice ofthe Urlited StaLes Dep.rtment of Health and HunaD Sen,ices
that an inquiry in undq way. The accused must bc infomted ofthis notificarion."
"The chajryerson ofthe involved depaftr]]crt lDr. Wood] or the instituLe or center
dircctor \\'ill be infbnned" that an incllLiry has conmenced.
10
''The accused $ ill ha\ e ihe opplrrr[nrn io m--i \\ rih lile ood\ iond aii.! r'n; irqJi.,
to Leam the allcgalrons. !o respord to d1e allegalions boih orall) rn and \\nting tsrc]
and to leam the jdentity ofthe individual(s) making the allegalions."
"A wdtten report shall be prep:ued by the body conducting thc inquiry that states
what cvidence was reviewed, sunmaaizes relevant interyiews and sels fo h the
conclusions reached. A copy oflhe reporl shall be given to the accuscdto commcnt
upon it and any such cornments shall bc part ofthe record of the inqlLiry."
"Should review of the inquirl indicate that sulficient caLrse exisls for an
investigation. the Vice President [Fischbach] nust, in accordance riith ledetal
regulations, rellort that decision to the Depatment of Health and Human Services
and, in addition rvill pronptly notify the person(s) suspected of nisconduct, the
individual(s) naking the allegations, the individual(s) directly responsible lor the
person(s) suspecled of nlisconduct, lhe depaltnent chairpcrson [Dr. \\ ood] or
institute or centcr dircctor, the President, and the general counsel lo the Universitl,.
The Vice President lFischbach] nray suspend the investigator's research activities
during thc invcstigation. . . . If resealch activities are suspcnded, all sponsonng
agencies are to be infomed by the Vice Prcsident IFischbach]."
The accused has the right to appear before fie connittee to present testinlony on his
behall
Thc accused has the right to be acconpanied bycounsel for advisorypurposcs lvhen
appearing before thc cornnittee.
Thc accused has a rigl'rt to a copy ofa tape-recording which shail be nade ofhis owl1
testimony.
The accused has a right to "examine the comnittcc's lllc ofdocumcnts, to rcceive
a draft ofthe committee's final repofi, and lo comnent on it in \rriting and/or by
appearing belore lhe committec to prcsent arguments in rebuttal."
The accuscd has the right to a finding delermined by majority vote on the basis of
evidence r-eviewed."
11
"An expeditious solution ofthese nlatters is essenfial. In generul, an inatuitt shaultl
be completed within 60 days and tot iuyestigution shoul.l be contpterctl t, irhin l:0
dafs a-ftheir respectite inceptions. The accused m:1 requcst thc r rhc Vtte prestdent
IFischbach] acceleratetheproceedingsshouldtheprocessappeartobcurlrrecessarill/
prololged. Should the response ol the Vice presidcnt be unsatisfactofr' to tho
accuscd. he.ll. n,r)alpe"l oth<.\e\Lt,\e..on-.tteeo tl - Fr.ulrl r,.]i, I .
"A copy ofthe lindings ofthe investigation shall bc seit ro . . . the chairman ofthe
approp ate department [Dr. Wood] or instjtutc or center director to the accused and
lo lhe accuser "
. "The accused ret.lins rhe righl to appeal a1l findings to the provosl ofthe University.
ln the abscnce of such an appeal. the Vice prcsidenr [Fischbach] shall impose
sanctions in accordimcc with University Statutcs, bl, laws andpractices. Theaccused
shall also have the right to appcal such sanctions to the pro\,;st ofthe Universitv.,,
(Exhibit B).
35. Upon infomration and beliel, on Novenber 2g.2000 ifnot earlier, tlvo (2)
12
notllllormtheIRBandsrud\panicipanisoi;;t..;l::....,:l.--:.:i-:-.::--::::::-,:
puryose ofthe study tiom rhe IRB and studypa icipanrs by omirting marerial in[omalion itom !h-
Prctocol, the consent lo1m and the lalperson summary regarding the iltent to study tl]e impact ol
these FDA approved fluids on patients and not nerely a "TEG" tcst; (c) Bennett-GlLerrero lailed to
obtaill IRB pemission to modify the Protocol after initial approval by the IRB; (d) lhe approvecl
fluids administered during the Protocol were administered in an unsale manncr; (e) protocol
palticipants wereharmed; and (1) Bennett-Guerrcro lailed to repod ccrlain adveISe events to the IRB
37. It is beyond serious dispute that such allegations failu,ithin the dctinition of
"Scientific Misconduct" and ldggcredthe ColutrrbiaUnivcrsityprocedures set forlh in thepreceding
section and at Exhibit B. Yet, in vioiation ofthose procedurcs and thejr professional responsibility.
the accusers did not report their concems to Bennett Guerrero,s Chainnan, Dr. Wood. Moreover.
Columbia University failed to advise Bennctt-Guerrero ofthese allegations until more than eight (g)
months later. lnstead of follorving Columbia University's mandated procedutes jbr addlessing
allcgations of scientil'lc misconduct consistent with federal r.egulations (co pare Er6ibit B tdjll
Exhibit C), the IRB conducted an allegedly ,,random,, auclit of tl.ie prorocol soon theleafter
prcsumably as aresult ofthe allegations. That audit resr.rlted in afindingofno se ous issues *,ith
38. Upon inlbrmation and belief, unsatistied qith the t-esults ofthe allegedly
"random" audit, nearly eight (8) nonths later, on July 30, 2001, the anonlmous accusers apparently
t3
asain repcarcd their accusalions against Be rell-GuelTero lbmtally ln a $riiing djrecled Io
respot]del]t Fischbac]r.l
39. After receipt ofthe Ju1y, 2001 letter, Fischbach still lailed to 1bl1ow tle
applicab le proc edures andpolicies lor addrcssing allegations olScientific Misconduct. Instead, he
ignorcd the policies and procedures specifically designe.l to protect the dghts ofBcnnett-Guerrero
Ln recognition of the significant stigma and impact thal such allcgations have on a physiciim's
reputation ilnd career, and opted to design his o$r] whimsical procedures no\,/hcrc statcd in \\'rjting
40. Fischbach thus directed nn arbitrary audit process and immedialely halled
enrollment jn all of Bcnnett-Cucn-ero's research studies, thereby inflicting danage belore any
inquiry had cven bcen conductcd ir direct violation of thc applicable rules. Even so, Fischbach
laiied to provide Bennett-Cuerero $.ith the specilics of thc alicgations made by thc anon)mous
accuscrs or to afford him any ofthe protections set forth ii those policies and p|ocedures.
,11. Thus, from July, 2001 rhrough October 26, 2001, all ofBennett-GlLeraero's
research was haltcd. Upon inlbmration and belief, this intenm sanction in and of itself \\as far
greater than any punisl'ment neted out at Columbia Univercity and other siiilar institutions after
an investigation has concluded that therc has in fact been scientific misconduct, yct this sanctionwas
imposed belore any inquiD, had even takcn place lnuch less an investigation concludcd.
committee, \\'hosc melnbers Rcspondents relused to identify, alldxith whom Bcnnett-Guenero was
pennitted no direct contact. In Octobq, 2001, the fu]] IRB hcld a rrcctirg and adoptcd thc ropofi
rI1
is uncertain at this tirne ho\\' much Fischbach kne$' ofthe allegations prior to this lime.
14
and findings o lthe secret conlmittee which \\, erc not disclosed to Bennett Gu,irrq o. Indeed. he rvas
not allowed to review an.v ofthe evidence or findings and lvas not even infonlcd ofthe specific
allegations.
43. Based upon such report, the IRB permitted the re-opening ofcnroilment in
all ofBennett-Guerrero's studies, witlt certain modifications, on October 26, 2001, and the natter
appeared to be concluded.a
44. On February 19, 2002. howevel, apparently unhappy with the conclusion of
the sccrct committce and the result reached, Fischbach sent yet mother lctter to Bennett-Guenero
and Dr. \Vood advising them that Bennen-Guerrcro was prohibited lrom publishing the resuhs ol
thc Protocol "until this mattcr is resolved." Upon infonnation and belie l, after delivcrl ofthis lettcr,
Fischbach did nolhing to attenpt to resolve the matter or to furthe. conxnunicate l\,,ith Bennett-
Guerrero
raising specihc <luestions and concen]s regarding the app:rent lack ofdue process beilg alforde<1
to him and the lack ofnoticc to the OHRP (Exhibit D hereto). Aliet receiving no response lronr
Fischbach, on April 29, 2002, Bennett-Guenero sent a follo$Lup letter to Fischbach sceking a
response to fiis questions in the letter.dared April 14, 2002 (Exhibit E hereto).
Dr. Harvey Collen ("Coiten") would re-exanrine the endre matter, stating that the mattels will be
asignificantly, Bennett-Guenero
$,as subjcct to monitoring of lis research activitics
therea{ter lor a period of at least thee (3) nonths. Upon infonnation and belief, although
Respondents have refused to provide the monitoring roports. the monitor. lvho tvas a member oithe
lRB, had notling but positive renarks on Bennett-Guerrero,s rosearch activities.
l5
addressed qLrickly and resoh'cd, )er he still lailed to respoid direcrly to Berxrefi Cuenero s slated
questions and concoms (Exhibit F hereto). Fischbach clearly had an agenda in mind lor tlis third
review and a pre-ordained conclusion that he lvas bent on receiving.
4'1 . Aftel Bennett-Guerrcro expressed concems that tlis rvas auother attempt to
reopen issues previously resolved by the IRB on Octobcr 26, 2001 simply to obtair.t a result mote
favolable to the anon],utous accuscrc and Fischbach, Colten inlol1ned Dr. Wood, who relayed it to
Betulett-Guerrero, that the so,called "Colten Comnittee" was not a disciplilury contmittee and that
48. Upon information and beliei the Colten Conmittee was not conposed of
nisconduct allegations (see Exhibit B). Indeed, menbers of the Colren Coilmittee had ciear
conflicts ofinterest *'hich q'ere not addrcssed. Some mernbers had themselves padicipated inthe
review and approval process ofthe Pr.otocol. Fischbach himselfhad conflicts ofinterest since his
wile was a nember of the IRB and upon infomation and beliel \\,as inr,olr ed in fie ongoing
oversight and review of the Protocol, and upon infonnation and belicl he $,as responsible lor
supervision ofthe prior procedunl revir3lvs ofthe protocol. Ofcourse, oo noticc was evcrprovidcd
Bennett Cuerero was interrogatedbythe Colten Committee. The questioning \\,as disorganizeal and
he was effectively prevented fiom responding to the allegations that he belicved to have been made
against hin in what rvas a blatant ellorl to push lbr a predetermited resLrlt.
t6
50. The hnal reporl oflhe Colten Contmittee I'as dteD not issued lbr nore than
two (2) rnonths thereaftel, and when it was ultimately issued in September, 2002. it was not sharcd
with Bennett-Gue11ero or Dr. Wood, his Chairman, and Bemefl-Guerrero \1,as not permittcd to
comment orally or in writing on the same (in clear violation ofthe applicable procedures).
meeting, Fischbach stated that he had consultcd lvith yet another committcc regarding sanctions and
that he intended to impose sanctions against Bemett-Gueraero, includilig all those eventually
imposed as well as a tlreatened intent not to rene\v Bennett GuerrcLo,s en1plo)mcnt. Upon
inlbrmation and belief, such sanctions werebeing imposed over the objection ofDr. Wood, Benne[-
Guerrero's Chaimr;:n
52. Fischbach also indicated that a letter would be delivered to the OHRP rvitlin
da),s not$,ithstanding Bemett-Guerrero's concems about the acculacy ofthe inlormation that woulal
be contained in such lett€r. Bennett-Guerero was denied the oppofiunily to rcvie$, the lctter in
advance.
requested a meeling \\.ith Columbia Uni\, eIS ity,s counsel and requested a postponement ofthe letter
to the OHRP until the accuacy ofthe contents ofsuch letter could be verified. Columbia Universitl,
denicd the request to postpone sending the letter to the OHRP, but a$eed to mcet wilh BennetF
Cuenero and his counsel on October l, 2001. One day befbre thc scheduled nceting, Coluntbia
University dclivered fie disputed lettcl to the OHRp wlich letter cootained a number of
inaccuracies a]rd lailed to reflect lirlly and accwately the relcvant record.
11
5,+. Colunrbia Lnirersrtl s counscl dten rnrireti a subnlssion in thc natire oii
requesl fbr reconsideration ftom Bennett-Guenero and instrllcted Bctutett-Guelrelo that there was
thereafter made requcsts for cortain documents in an attempt to clarily the accusations that \\,ere
le'ied againsthim and forevidence supporting the findings ofthc'arious committees in counection
with the Protocol and the sanctions that were to be iltlposed against Bennett Cueuero. Ihc majo t),
ofthe requested infomtation was not loflhconting or was delivclcd in an incomplete and rcdacterl
mannef,
55. Mosr rccenlly, on January 7. 2003, through Dr. Woocl, Fischbach dcljvered
toBe rett-Guerrero a letter (dated December 27, 2002) which stated rhat in addition to the sanctions
pleviously imposed (which were never fomally irnposed), elfective June, 2003 Bennett Guenero
will be relnoved from his position as Assistant professor, Depallment ol ,Anesthesiology alld
demoted to a new position and title for a one yeaf pedod (Exhibit G hereto).
Fischbach deprived BennetFGucnero ofthe rolo$'ing fundamcntar rights to $hich he was entitrecl
nisconduct (Sgq'l11 32-3,1 above and Exhibit B) including, auong olher violations:
l8
ll. Bennett-Gucrrero was not protectcd lrom penalty and public
knowledge ofthe accusalions during inquiry and investigation
of the alleged misconduct and his research was impropeily
suspended;
t9
xt1. Betulett Cuenero $,as deried thc right to e\iuninc the
conmittee's hle of docrulents, including sumiraries of all
individuals intervi cwed:
5'7. Even separate and apa11 fiom the written procedur.al protections set fofih by
Colunbia University specifically lor addressing the allegations at issue, Respondents, treatnent
of
Beturett-Gue[ero is u'iprecedcnted and abhonent to anynotion ofdue process and r'air trcarnent and
58. Even after various recluests by Ber ett-Guerrero and his counsel and the
nlalicious violatiol'l ofan individual's stated rights. For a Dean ofaD edLrcational institution sLrch
as Columbia Ulivelsity to conduct himsclf in such a manner clearly cdes our fo1 judicial
inlen'cntion. Upon information and beliel Fischbach has willfully and inlenrionally engaged in the
abovc-referenced improper activities and imposed the arbitrary and rmsuppofted sanctions with
60. Given the nature of Columbia L-niversity's actions and tlte passage ofti e,
thc procedulal infinr'rities alone recluire that all the relief requested in this \reri1'icd petition be
grantod*ithout even addressing the substantive n''erits ofthe allegations h'ricd. Neverlheless, \\.hat
akes the conduct even mor-e outageous is that the subslantivo allegatjons ar-e not suppofled bythe
61. As set loith more fu11y belorv. each ofthe investigatoN, including Bcnnelr
Guerrero, attcmpted to follow in good faitrr arl appricable policics and proccdues to ensuie thc sarery
of the parlicipanrs and the integ ty of the research process. Bennett-Guerrero did in fact
.rb.tar i:lir cot_p.) \ ll a rppltc.Lhle -ule. . nd te3 tl"t o.,.
iUpon inlbmation
and belief, Respondents also rvillfully antl inrentionally disseminated
"confidential" infonnation co.ceming this matter to third paftjes in a funher a[empt to harm the
reputatioo ofBennett-Guerrero and in ftmhcr violation ofthe policies and procedues ofcolumbia
University and the fcderal rlrles and regulations. Specifically, it appears that photographs allegedly
clepicting "unsafe" worldng conditions during the protocol were shown to physicial1s and sulgeons
who were not in'olved in the Protocor or Coru'nbia uni'e'sity's impropcr re'iews olthe protocor.
21
A. The Consent Fo1m
62. The patient/pafiicipant consent loml for the plotocol \vas reviewed and
approved by the IRB prior to enrollment ofthe fiISt patient in the protocol.
63. Anong other things, the consent form identifies the fbllou mg:
Protocol;
Ifyou decide to participate in this stlrdy, we will give you one oflour
fluids during surgcry. The decisiou of whjch of these 4 approved
fluid to give you wiil be bascd on chance, that is you have a 25%
chance (1 i114 chance) ofreceiving any one olthese lbur approved
fluids. The four fluids are called Lacratod Ringers, 57u Albumin in
saline, 6% Hetastarch in saline, and Hextend rrr. As is clone routinelv
d rrng lteart 5urget). rll( lluid u ill be rorr nt.rere,t rnror gl dl ..1\:
(a catheter or plastic tube insefied into one ofJ'our veins as a routine
21
part olyour snrgery). Yourdoclo$ $.illgive youthrs tluidto rcplace
blood and fluid that is routinely lost dlr ng swgery. You \\'ill be
given lhe fluid based on inlormation from monitors that are routinely
used dudng srugery.
65. The consent fonn (apprc!ed by the IRB) identified certain "lotcseeable" dsks
66. The consenl fomt did not disclose the sks relating to the underl]'ing hearl
swgerv (which, of course, were many; for example, bleeding) since thesc dsks rvere t&l: both
6'l. Asdiscussed above, and upon information and belief, the accusatious included
allegations that: (i) the IRB was nisled as to the true puryose ofthe Protocol, (ii) the consent lomr
did not disclose certain loresecable dsks; (iii) ercess levels of fluids u'crc utilizedt (iv) Bennett
23
Guerrero faiLecl to repod celtaii adverse cvents to the IRB;
(\') there were advelse eflects to bunan
pa icjpants; and (vi) the fluids involved in the study were prepared in iul unsafe mamer'
no ellecl
68. Notably, the Colten Committee cletermined lhat thelc was 'dvcrse
to hunan health as a result ofthe Protocol and that there \\'as no scientific
nisconducl
69. Each of fhe unsuppofied accusations is untrue lor at lcast lhc lollowrng
reasons:
T0. Bennett-Guerero did not mislead the lRB because the lRB \\'as provided with
"TEG" study, butrather lhat one ofthe objectives was lo assess the lmpact
Protocol was not n]elely a
'71. Priolto the approval ofthe IRB' the investigators contactedthe surgeons and
at thrs meeting
presented the Prctocol to the Cardiac Surgeons at their $eekly meeting Discussion
resulted in an expansion of the 1ial into more of an outcome stud"v as it]dicated by the m:rny
'72. It is clear that pdor to approval, thc IRB knelv the Protocol lvas an outcone
lonn to reflect
study and did not ask the irlvestigators to revise tlle lalperson sumilary and consent
'73. Upon infomtation and beliel the anonlmous accusers allege that Bennell-
71
'14. The consent lom for this study, however, was approved by the IRB alier
extensive review and discussion over a four (4) month period. For example, priorto approval therc
rvas bothrvitten and verbal conmunication with members ofthe IRB and outside expefis about the
potential impact ofone ofthe Protocol's fluids, Hespan, on coagulation. This discrLssion took into
account infomution including but not limited to known clinical trials as well as lhe package inserls
75. In fact, the IRB requested at the beginning oftheir Protocol review that the
investigators submitthepackage inserts for-all four (,1) FDA approved fluids and theywereprovided.
76. Based on their reviell, the IRB nembers and experts from the departments
ofnedicine and surgery agreed with the investigators that the "theoretical elfects ofthis Iluid on
coagulation" did not make clinically signihcant bleeding a "forcseeable risk." Hence, they did not
request that the risk ofbleeding be addcd to the dsks section of the consenl fonn.
'7'7
. The investigators and the IRB at the time clealiy believed that all ''loreseeablc
7E. Finally, Protocol paticipants participated based on a consent fonn that was
79. Among other charges, it was alleged that though not cited in the Protocol, the
volun]e ofone ofthe fluids (6% Hetastarch in 0.9% NaCl) used in the study exceeded the amounts
25
E0. In fact, neither the FDA nor the manulactuer ofrhis fluid (as indicated by lhe
package insei for the fluid in question) state an upper volume iimit so rhis allcgation is without
merit.
(iv) RePQlllilgAdverseEvents
81. Arothercharge is thatDr. Beirett Guefforo failed to repolt all adversc events
82. At all times the investigators believed that they were conrplying rvith lRB
regulations regardjng adverse event reporting. Deaths were reported promptly. Other events werc
not repofted because none were believed to fulhll the IRB,s criteria of serious A41 uncxpected and
83. Ofsignificant note, the IRB did not complain $,hen Dr_ Manspeizer, tlte initial
Princjpal lnvestigator ofthe Protocol, did 1lot repod qq adverce elfects at thl] time ofthe sludy
renewal, at which time apprcaimately 100 patients had been eniolled.
care center with of these patients having any complications/adverse events to the caraliac
'rone
surgqJ.
85. In fact, all (100%) of patients bleed aftcr cardiac surgery so it would be
86. Moreover, the investigators looked at tlte results lor the fiIst 100 patients ( -25
patients per study group) in a blinded andlysis a11d there was no trend that$'ouid suggestthat patients
26
E7. ln fact, the evenl "takeback lor bleeding" is not even significantly differcnt
statistically at study completion (200 patients, !50 patients per study $oup).
88- Upon infonnation rind belief, the imonlanous accuserc allcgcd thai
the invostigation by the Colten Conmittee detemined thcre was no patieut hann.
90. [n fact, compiication rates il1 this study were the same or lower than the
complication rates obserr'ed inpaiients receiving similar treatments thal were not pafiicipants inthc
studv.
(vi) AllegationofunsafePreparatia4illui{1q
91. Upon information and beliei the anonyrous accusers alleged that Bennetl
92. No evidence was presented, ho*ever, that the study fluids were prepared in
93. The procedure used was approved by dre IRB with consultation {iom the
Research Phannacv
95. The IRB never requested that th,- study fluids be prepared by the Resealch
Ph:rnnacy.
21
96. The sinlple and sterilo protocol used lor preparing the fluids rvas perlormed
by trained in<lividua1s. FlLrid "preparation ' did not involve "mixing" or weighing out and addition
g'7. In fact, theProtocol involved tansfering the FDA approved fluid to asterile
bag (nranufaclrLred specifically for this purpose) using the includcd "spike alid key" systen which
insures sterility. A tiny amount (1 m1) ofyellorv FDA approved stedle multivilamin was added lo
98. In any event, tfiere is no evideDce that aliy patient was hanned by the use of
Respondents Sinsled O
the Protocol, only B ennetFcuerero was singled out for review, audit and sanctions as a rcsult oflhe
100. Upon infotmation a]1d belief, no other investigator who participaled in the
study, or who reviewed and approved it, has been subject to any inquiry or discipline.
101. Upon infonnation and belief, Respondents skewed the reality of the
teant$oup effolt in an attempl lo single out Bennett-Guelaero and deflect possible 'rilicism fronr
the IRB and the Respondents, including specifically the polential impact onFischbach and his wife
102. In fact, Resporrdents' ovelall tono and theme appeaN to evincc a deliberate
28
103. Recent jnvestigationsbythe OHRP regarding othcr Colunbia Linivcrsiry and
columbia Presblterian Medical center protocols that failed to comply with fbderal regulations
104. For example, in sevemi ofthese protocols, it appcars the investigators di.l not
even submit the protocols 10 the IRB for review and approval, ye1 upon infomratio[ and beiief, no
sanctions were imposed by Respondents o11lhephysicians at issue, much less the cxtreme sanctions
imposed on Bennett-Guenero.
respondent Fischbach and his rvife (who was a member of the [RB) were atvare
of the IRB,s
deficiencies rurd laiied to take approp ate action in a timely manne. to address them.
Then, in an
effot to dellect some ofthe {bcus and blame lol the IRB,s problems, respondent Fischbach chosc
107. As a lestament to the serious and now acknowledged deficiencies with the
IRB, Columbia University recently engaged in a systematic overhaul ofthe IRB, which overhaul is
ongoing. Indeed, due to such deficiencies, all protocols are now scnt ro wcstem rRB, an
outsi.le,
independent contractor lor review and processing. Such a drastic move is tantamount
to an
institutional admission ofthe extrene and gloss natLue ofthe IRB's probrems for which Bennett-
29
108. Upon inlomation and beliel noie olthese dcficicncies u'ere properly and
thoroughly considered during the various reviews ofthe Protocol or the investigation of Bennett-
Guerrero prior to the imposition ofsanclions against Bennett-Guerrero for alleged deliciencies in
siguificartly.broader than those suffered as a result ofthe sanclions imposed to date by Col nbia
Univel sity. For example, as early as October, 2002, rumors were circulatiig lhat Bennett Guerero
had been fired by Columbia University as a result of improp eties in his research. Based on thesc
rumors, third parties have reconsidered speaking engagenents and other endeavols they have
undcrtaken with Bennett-Guerrero. Moleover, as a result ofthe suspension ofhis rcsearch, he and
other physicians working with him have been deprived ol signi{icant research oppofiunities and
and/or implementing any previously imposcd sanctiot]s against Bennett-Cucrrcro, including (a)
pusue, md publish all clinical research to the samc cxtcnt as any othcr faculty lnembei and provided
such research is in compliance with applicable rules and regulatiolls; (b) enjoining Columbia
Guerrero by vidue of his pafiicipation in IRB approved Protocol #9256 or his i11s1i1ution of this
proceedilg; and (c) directing Respondents to reinstate Be1x1ett-Gueraero's positions and titlcs as
Division.
Respondents are arbitrary, capricious, an abuse of discretiot], illegal and invalid and Iestraining
3l
ero's
from resticting in any marmer Bemett-Gue
2 Restraining Respon'lents
extent as any other faculty
and publish a1l clinical research to the same
ability to conduct' pursue'
mles and regulations;
such research is rn compliatLce with applicable
menlber and provided
and Gerald Fischbach
ftom imposing and/or
University
3 Enjoining Colunbia
in
Bennett-Guerero by virtue of his parlicipation
sanctions against
implementing any further
ofthis ?roceeding;
Protocol # 9256 or his institution
positions and titles as
to rcinstate Bennett-Guenero's
4. Direoting Respondents
of the cardiac Anesthesiology
professor, Departnent of Anesthesioiogy and chief
Assistant
Division;
damages'
to pay Bennett-GuelTero's in'idental
5 Ordering Respondents
and
fees and disbursements incuned in this proceedirg;
ircluding bis legal
and proper
different relief as the Courl deems iust
further
6 For suci'l other and
JUN 2 5
?003
?50 Lering4on A\ enoe
New York, New York 10022
(212) ?3s-8600
counrlHJfffornce
32