!"#$%&%'()* ,%-.*/ 0)*&)(*1 "2 3&*)(*145 "2 '6* 7%&8(9:4"9 !

;%'*/ <")*#-*& =>? @A=B
1he unlverslLy of MlnnesoLa has Laken Lhe poslLlon LhaL Lhe sulclde of uan Marklngson has been sufflclenLly revlewed by Lhe unlverslLy lLself and
varlous oLher agencles and unlLs lndependenL from Lhe unlverslLy, and LhaL none of Lhem found any problem wlLh Lhe unlverslLy's role. More
speclflcally, lL has repeaLedly clalmed, mosL recenLly ln lLs response leLLer Lo 1rudo Lemmens daLed 12 november 2013, LhaL Lhe Marklngson
case has been Lhoroughly ºrevlewed" by Lhe luA, Lhe Pennepln CounLy ulsLrlcL CourL, Lhe MlnnesoLa 8oard of Medlcal ÞracLlce, and Lhe
unlverslLy lLself. lL has also clalmed earller LhaL Lhe unlverslLy of MlnnesoLa lnsLlLuLlonal 8evlew 8oard and Lhe MlnnesoLa ALLorney Ceneral's
Cfflce revlewed Lhe case and concluded LhaL Lhere was no problem. 1he unlverslLy falls Lo menLlon ln lLs correspondence Lhe 2012 lnvesLlgaLlon
by Lhe MlnnesoLa 8oard of Soclal Work, whlch found LhaL the study coordlnaLor for Lhe CAlL sLudy and Lhe one responslble for overseelng
Marklngson's care, had commlLLed numerous professlonal vlolaLlons ln Lhe conLexL of Lhe cllnlcal Lrlal. 1hls soclal worker worked under Lhe
supervlslon of senlor faculLy members of Lhe unlverslLy of MlnnesoLa. 1he unlverslLy also falls Lo menLlon Lhe lnlLlaLlve by Lhe MlnnesoLa
LeglslaLure, whlch reacLed by enacLlng a sLaLuLe prohlblLlng Lhe cllnlcal Lrlal recrulLmenL of people under a sLay of commlLmenL.
8elow ls a Lable lndlcaLlng Lhe varlous alleged revlews, whaL Lhey found, and why Lhe auLhors and slgnaLorles of Lhe CcLober 21, 2013 leLLer call
for an lndependenL lnqulry. We ldenLlfy also Lwo lnlLlaLlves LhaL we characLerlze as recognlzlng serlous problems.
(Complled by 1rudo Lemmens & Shannnon Clbson ln Lhe conLexL of Lhe requesL for an lndependenL lnqulry, formulaLed ln Lhe CcLober 21, 2013
leLLer Lemmens-ue vrles-ureger-Shepherd-8everby-kasslrer et ol)


PQ.R @@? @AAS/ lssuance of
LsLabllshmenL lnspecLlon
8eporL from lnspecLlon
conducLed by lood and
urug AdmlnlsLraLlon
lnvesLlgaLor Sharon L.
MaLson. AcLual lnspecLlon
conducLed on !anuary 2-
6, 11, 19, 21 and 26,
1he luA lnvesLlgaLor
concluded LhaL Lhere was ºno
evldence of mlsconducL or
slgnlflcanL vlolaLlon of Lhe
proLocol or regulaLlons."
8eporL also noLed LhaL
º[q]uesLlons regardlng
psychlaLrlc dlagnosls would
have Lo be addressed Lhrough
medlcal revlew aL CuL8."
1he luA lnvesLlgaLlon focused on compllance wlLh regulaLlons and wlLh Lhe
proLocol. lL was arguably conducLed superflclally. lL falled Lo lnLervlew Mary Welss,
uan Marklngson's moLher, a key wlLness who had been calllng Lhe research Leam Lo
wlLhdraw uan from Lhe sLudy for many monLhs. An aLLempL was made Lo lnLervlew
Marklngson's case worker (uavld ÞeLLlL), was conLacLed, buL no lnLervlew was
conducLed (luA lnvesLlgaLor was Lold LhaL lnformed consenL from llvlng relaLlve
was requlred for such lnLervlew, buL Lhls was noL pursued).

1he luA lnvesLlgaLlon dld noL ldenLlfy as a key problem Lhe use of clvll commlLmenL
orders Lo lnduce someone Lo parLlclpaLe ln a cllnlcal Lrlal, a pracLlce Lhe MlnnesoLa

lull reporL avallable aL:
leglslaLure has slnce prohlblLed by sLaLuLe. 1he reporL slmply accepLs Lhe clalm by
Lhe research coordlnaLor and researchers LhaL sLandard LreaLmenL was provlded.
1he luA reporL does noL ldenLlfy or dlscuss poLenLlal CCls of lnvesLlgaLors or of Lhe
l88 (see furLher). Concerns have been ralsed abouL Lhe CCl of lnvesLlgaLors and Lhe
pressure on Lhe research unlL Lo recrulL a sufflclenL number of paLlenLs, yeL Lhe luA
lnvesLlgaLor dld noL look lnLo Lhls. lL also appears Lo have mlssed some alleged
serlous problems wlLh consenL-relaLed documenLs LhaL were revealed subsequenL
Lo lLs lnvesLlgaLlon (and noLed by Lhe MlnnesoLa 8oard of Soclal Work). We looked
aL Lhe avallable evldence, whlch ln our vlew ralses serlous quesLlons.

cotl ílllott wtote o JetolleJ ctltlcol ooolysls of tbe luA tepott, wblcb we bove olso
tevleweJ. ne ooteJ tbe followloq oJJltloool lssoes. ´1be luA lospectot folleJ to
oote tbot Jotloq tbe petloJ leoJloq op to bls eotollmeot, Motkloqsoo boJ beeo
tepeoteJly joJqeJ locopoble of cooseotloq to oeotoleptlc Jtoqs. Oo Novembet 14,
200J ut. Olsoo slqoeJ o commltmeot Jocomeot stotloq tbot Motkloqsoo ´locks tbe
oblllty to moke Jeclsloos teqotJloq socb tteotmeot.´ Oo Novembet 17, o pte-petltloo
scteeoloq teom tecommeoJeJ commltmeot, ootloq Motkloqsoo´s blzotte bellefs ooJ
bls tefosol to ockoowleJqe bls meotol llloess. Oo Novembet 19, o coott-oppoloteJ
cllolcol psycboloqlst coofltmeJ tbose ossessmeots, wtltloq tbot Motkloqsoo ´ls
belleveJ oot to bove tbe copoclty to moke Jeclsloos teqotJloq oeotoleptlc
meJlcotloo.´ ¥et oo Novembet 21, wbeo Motkloqsoo wos oskeJ to cooseot to tbe
cAlí stoJy, tbls ossessmeot of bls meotol stote wos tevetseJ ooJ be wos joJqeJ

ln summary, Lhe luA lnvesLlgaLlon falled Lo address key quesLlons abouL wheLher
Marklngson provlded meanlngful consenL or even had Lhe ablllLy Lo consenL (or
refuse Lo consenL) Lo enLer lnLo Lhe CAlL sLudy.

H9 %TT('("9 '" U"94(T*&(9: '6*4* VQ*4'("94? % 2Q&'6*& (9)*4'(:%'("9 U"Q.T %.4" 6*.$
(T*9'(2R 16R 4" #%9R (#$"&'%9' $&"-.*#4 1*&* 9"' (T*9'(2(*T -R % 8*R &*:Q.%'"&R

G*-&Q%&R ==? @AAX/
Summary [udgmenL
lssued ln lawsulL
commenced by Mary
Welss, Lhe moLher of uan
Marklngson, agalnsL Lhe
unlverslLy of MlnnesoLa
and ur. Charles Schulz.
1he courL order (CourL llle no.
27-Cv-07-1679) sLaLes:

3. º1he moLlon for summary
[udgmenL by Lhe 8oard of
8egenLs for Lhe unlverslLy of
MlnnesoLa and Lhe
lnsLlLuLlonal 8evlew 8oard for
Lhe unlverslLy of MlnnesoLa ls
granLed on Lhe basls LhaL Lhey
are sLaLuLorlly lmmune from
llablllLy. All clalms agalnsL boLh
parLles are dlsmlssed wlLh

4. º1he moLlon Lo dlsmlss and
for summary [udgmenL by ur.
SLephen Clson ls granLed wlLh
respecL Lo CounL 2."

3. º1he moLlon Lo dlsmlss and
for summary [udgmenL by ur.
Charles Schulz ls granLed. All
clalms agalnsL ur. Schulz are
dlsmlssed wlLh pre[udlce."
An lnLerlm rullng of sLaLuLory lmmunlLy by a courL ls a declslon sLrlcLly based on
legal rules raLher Lhan any exculpaLory flndlngs of facL. 1he courL slmply ruled LhaL
Lhe unlverslLy was shlelded from legal llablllLy ln Lhls conLexL, and lL ls absoluLely
noL, as Lhe unlverslLy keeps suggesLlng, a flndlng by Lhe courL LhaL Lhe unlverslLy
dld noLhlng wrong. SLaLuLory lmmunlLy for 'dlscreLlonary declslons' ln Lhe conLexL
of research has been granLed wlLh rellance on Lhe exlsLence of a good unlverslLy l88
and governance sysLem, whlch allows for rellable and lndependenL dlscreLlonary
[udgmenLs, whlch ls preclsely aL lssue here.

noLe LhaL Lhe CourL dld allow Lhe case Lo go forward agalnsL one of Lhe docLors
lnvolved (Lhus acknowledglng LhaL Lhere was o ptlmo focle case Lo be made abouL
Lhe docLor's negllgence), resulLlng ln a subsequenL seLLlemenL.

1hls lotetlm [udgmenL was noL appealed, one llkely reason belng LhaL Lhe unlverslLy
flled a 'assessmenL of cosL' agalnsL Mary Welss, whlch made lL very clear LhaL she
could suffer serlous flnanclal hardshlp lf she conLlnued Lo pursue Lhe courL case
agalnsL Lhe unlverslLy. 1hls dlsLurblng legal LacLlc of a publlc unlverslLy agalnsL a
moLher who [usL losL her son ln Lhe conLexL of unlverslLy research ls ln and of lLself
worLh quesLlonlng.

[Slnce Lhe courL case, quesLlons have also been asked abouL some of Lhe
documenLs produced ln Lhe courL case, lncludlng 'evaluaLlons Lo slgn lnformed
consenL' forms and uan Marklngson's auLhorlzaLlon Lo allow Lhe hosplLal Lo share
healLh lnformaLlon wlLh researchers. Whlle we Lhlnk Lhese concerns merlL furLher
lnvesLlgaLlon, we have noL looked lnLo Lhese lssues ln any deLall.]

ComplalnLs flled by Ms.
Welss and her assoclaLes
wlLh Lhe MlnnesoLa 8oard
of Medlcal ÞracLlce
agalnsL ur. SLephen Clson
and ur. Charles S. Schulz.
ComplalnLs agalnsL boLh
docLors were dlsmlssed by Lhe
8oard of Medlcal ÞracLlce
because Lhe ºfacLs of Lhe case
dld noL provlde a sufflclenL
basls . Lo Lake dlsclpllnary or
correcLlve acLlon" [leLLer 13
- 1he 8oard lndeed declded LhaL Lhere was lnsufflclenL basls Lo pursue
acLlon agalnsL urs. Clson and Schulz. no deLalled reasons are glven.
1hls does noL amounL Lo an 'exoneraLlon' of Lhe docLors lnvolved.
1he declslon conLrasLs lndlrecLly wlLh Lhe MlnnesoLa 8oard of Soclal
Work, whlch found and deLalled very serlous problems wlLh Lhe
conducL of Lhe research coordlnaLor. lL ls reasonable Lo quesLlon: 1)
why Lhe 8oard of Medlcal ÞracLlce dld noL flnd LhaL Lhe problems
!uly 2010 Pelen ÞaLrlkus Lo
Mary Welss re ur. Clson], or
º8ased on our revlew, Lhe
8oard ls unable Lo Lake any
acLlon whlch would wlLhsLand
Lhe requlred LesLs" [leLLer 12
lebruary 2009 Pelen ÞaLrlkus
Lo Mary Welss re ur. Schulz]

1he unlverslLy has clalmed
LhaL Lhe 8oard of Medlcal
ÞracLlce lnvesLlgaLed Lhe
unlverslLy and found LhaL lL "ln
no way conLrlbuLed Lo Lhe
unforLunaLe deaLh of Mr.

ldenLlfled by Lhe 8oard of Soclal Work lmpllcaLed Lhose supervlslng
Lhe soclal worker, and 2) why lL dld noL ldenLlfy Lhe problems whlch
oLhers belleve merlL furLher lnqulry and/or acLlon.
- 1he 8oard's declslon has no bearlng on Lhe responslblllLy of Lhe

lor Lhe llmlLs of whaL Lhese flndlngs mean, see e-mall !une 19, 2013,of
8oberL Leach, LxecuLlve ulrecLor, MlnnesoLa 8oard of Medlcal ÞracLlce, Lo
Mlke Poward"
´1be 8ootJ bos oo jotlsJlctloo ovet ooy lostltotloo, cllolc, foclllty, bospltol,
oolvetslty ot meJlcol scbool. we Jo oot look ot ooytbloq otbet tboo tbe
ptofessloool ptoctlce of tbe loJlvlJool llceosee. wbeo tbe 8ootJ closes o cose
wltboot octloo, lt Joes oot oecessotlly ´exooetote´ tbot loJlvlJool
ptoctltlooet ooJ tbot ls o tetm tbe 8ootJ woolJ oot ose. wbeo o cose flle ls
closeJ wltboot octloo lt moy meoo tbot tbe 8ootJ JlJ oot floJ o vlolotloo of
tbe MeJlcol ltoctlce Act bot lt olso moy meoo tbot tbe 8ootJ coolJ oot floJ
sofflcleot evlJeoce of o vlolotloo to ptoceeJ wltb Jlsclpllooty octloo.´

A declslon noL Lo pursue professlonal sancLlon does nC1 mean Lhere has
been an lnvesLlgaLlon lnLo sysLemlc problems wlLh Lhe organlzaLlon's cllnlcal
research and recrulLmenL pracLlces. Moreover, subsequenL revelaLlons
abouL quesLlonable consenL flles were llkely noL lnvesLlgaLed by Lhe 8oard of
Medlcal ÞracLlce.

;%'* 7%R @Y? @AA>/
Alleged 3&evlew' by Lhe
unlverslLy of MlnnesoLa
lnsLlLuLlonal 8evlew
1he unlverslLy clalms LhaL Lhe
lnsLlLuLlonal 8evlew 8oard
revlewed Lhe case and found
no faulL.
- See a deposlLlon (sworn LesLlmony) ln Lhe Pennepln CourL of 8lchard
8lanco, lnsLlLuLlonal Cfflclal, responslble for overall conducL of
human sub[ecL proLecLlon
excerpLs]: CuesLlon: ºdld anyone aL Lhe unlverslLy of MlnnesoLa, or
anyone under your offlce lnvesLlgaLe Lhls case, acLually look aL Lhe
records." 8esponse 8lanco: ºnoL Lo my knowledge" CuesLlon:
ºnobody dld LhaL?" 8esponse 8lanco: ºno" (p. 41)
- MlnuLes of l88 meeLlng May 26, 2004: ºLhe l88 revlewed and noLed
Lhe unanLlclpaLed problem and adverse evenL reporLed for Lhe
referenced sLudy recelved on May 12, 2004, lnvolvlng sub[ecL
00100013". 1hls cannoL be seen as a subsLanLlal revlew of Lhe case. lL
ls merely an acknowledgmenL of reporLlng of an adverse evenL by Lhe
- lL has also been revealed LhaL Lhe l88 chalr (ur. Adson) had confllcLs
of lnLeresLs due Lo flnanclal relaLlons wlLh Lhe sLudy sponsor and wlLh
oLher pharmaceuLlcal sponsors, and close professlonal and reporLlng
relaLlons wlLh one of Lhe lead lnvesLlgaLors, ralslng serlous concerns
abouL Lhe lndependence of Lhe l88 and Lhe overall organlzaLlon of
l88 overslghL aL Lhe unlverslLy. [for Lhe recenL confllcL of lnLeresL
analysls of Lhe l88, we relled on Lhe followlng reporL by Carl LllloLL ln
Lhe PasLlngs CenLer blog:
K*)(*1 -R 7(99*4"'%
C''"&9*R L*9*&%.54
Cfflce of Lhe ALLorney
Ceneral of MlnnesoLa
allegedly lnvesLlgaLed Lhe
deaLh of uan Marklngson

1he Cfflce of Lhe ALLorney Ceneral may have provlded lnvesLlgaLlve servlces
Lo Lhe Medlcal 8oard of ÞracLlce. lL dld noL lLself come Lo any deLermlnaLlon
and whaL lL submlLLed Lo Lhe 8oard ls noL publlcly accesslble. See leLLer !une
11, 2013 by karen Clsen, uepuLy ALLorney Ceneral, Lo Mary Wels and Mlke
Poward: º1hls Cfflce has noL made any lndependenL lnvesLlgaLlon or
deLermlnaLlon regardlng Lhe care rendered Lo your son."

CLher lnlLlaLlves LhaL appear Lo conflrm slgnlflcanL concerns
MlnnesoLa 8oard of
Soclal Work
MlnnesoLa 8oard of Soclal Work
alleges serlous professlonal
vlolaLlons and concludes an
agreemenL wlLh !ean M. kenney
for correcLlve acLlon.
lssues ldenLlfled lnclude:
performlng Lasks beyond her
professlonal compeLence and
scope of pracLlce, lnlLlallng
cllnlcal documenLs for physlclans,
dlspenslng of prescrlpLlon drugs,
falllng Lo address famlly concerns
ln a Llmely fashlon, falllng Lo
documenL accordlng Lo a
mlnlmum professlonal sLandards,
lncludlng ºcrlLlcal omlsslons ln Lhe
documenLaLlon LhaL were
relevanL Lo sulclde prevenLlon",
1he 8oard clearly ldenLlfled serlous problems ln Lhe conLexL of Lhe
cllnlcal Lrlal ln whlch Marklngson commlLLed sulclde. ?eL, lL focuses
only on Lhe responslblllLy of Lhe research coordlnaLor, who was
supervlsed by senlor psychlaLrlsLs. 1he remedlal acLlon lncluded some
conLlnulng educaLlon. 1he 8oard's agreemenL for correcLlve acLlon
does noL deal wlLh Lhe accounLablllLy of Lhe lnsLlLuLlon and Lhe
supervlsors. 1he problems ldenLlfled by Lhe 8oard of Soclal Work ralse
furLher quesLlons abouL Lhe approprlaLeness of Marklngson's lncluslon
ln Lhe cllnlcal Lrlal and hls LreaLmenL.
K*)(*1 -R 022(U* "2 '6*
L*9*&%. !"Q94*. "2 '6*
J9()*&4('R ZT%'*
Cfflce of Lhe Ceneral
Counsel of Lhe unlverslLy of
MlnnesoLa ls sald Lo have
ºrevlewed Lhe facLs and
clrcumsLances surroundlng
Lhe CAlL 8esearch SLudy
and Lhe sulclde of uon

We do noL dlspuLe LhaL some revlew has Laken place, buL Lhls does noL
quallfy as an lndependenL revlew. lf no concerns were ralsed abouL CCls,
abouL how uan Marklngson was recrulLed, abouL Lhe governance of research
eLhlcs, and lf Lhe unlverslLy would noL have shlelded lLself behlnd sLaLuLory
lmmunlLy and would have serlously assessed lLs eLhlcal responslblllLy and
provlded reasoned argumenLs and evldence abouL how Lhe concerns ralsed
were addressed, Lhls revlew could have had some credlblllLy. 1he concerns
have noL been addressed and Lhere has been no serlous revlew of whaL
wenL wrong and whaL Lhe unlverslLy has learned from lL.
kenney compleLed correcLlve
acLlons, lncludlng conLlnulng
educaLlon and wrlLlng of a reporL.
MlnnesoLa LeglslaLure
2009: new LeglslaLlon
on clvll commlLmenL
ºuan's Law"
new rules relaLed Lo
º8elease 8efore
new leglslaLlon LhaL was adopLed
ln dlrecL response Lo uan
Marklngson's sulclde and LhaL
severely llmlLs Lhe posslblllLy Lo
lnclude a paLlenL who has a sLay
of a clvll commlLmenL order as
research sub[ecL ln a cllnlcal Lrlal.
1he general rule ls LhaL ºLhe
paLlenL ls prohlblLed from glvlng
consenL Lo parLlclpaLe ln a cllnlcal
drug Lrlal." (2338.093 Subdlvlslon
1(d)(4)) whlle under a clvll
commlLmenL order. An excepLlon ls
provlded under sLrlcL condlLlons and
courL revlew. lf all oLher LreaLmenL
opLlons have falled, a LreaLlng
physlclan can submlL an affldavlL
lndlcaLlng LhaL Lhe paLlenL may
beneflL from parLlclpaLlng ln Lhe
Lrlal. 1hls cannoL be Lhe physlclan
runnlng Lhe cllnlcal Lrlal. 1he
courL has Lo be lnformed and
ensure Lhere ls no coerclon
An lnlLlaLlve LhaL acknowledges lndlrecLly Lhe problemaLlc way ln
whlch uan Marklngson was lncluded ln a cllnlcal Lrlal. lL should help
proLecL psychlaLrlc paLlenLs ln Lhe fuLure, buL lL ls noL an lnqulry, of
course, and does noL explaln why and how uan was lncluded and
wheLher Lhere are oLher problemaLlc aspecLs Lo Lhe cllnlcal Lrlal he
was enrolled ln and Lo Lhe way Lhe unlverslLy and oLhers acLed.

1he provlslons ln new sLaLuLe clearly LargeL some of Lhe pracLlces LhaL
seem Lo have been parLlcularly problemaLlc ln Lhe recrulLmenL of uan
Marklngson: LxcepLlonal lncluslon ln a Lrlal: only ºlf Lhe LreaLlng
psychlaLrlsL LesLlfles or submlLs an affldavlL LhaL Lhe paLlenL may beneflL
from parLlclpaLlng ln Lhe Lrlal", "9.R \%2'*& $&")(T(9: "'6*& '&*%'#*9'
"$'("94 2"& % &*%4"9%-.* $*&("T "2 '(#*", only %2'*& \'6"4* "$'("94 6%)*
-**9 (9*22*U'()*." º1he '&*%'(9: $4RU6(%'&(4' #Q4' 9"' -* '6* $4RU6(%'&(4'
U"9TQU'(9: '6* $4RU6(%'&(U U.(9(U%. T&Q: '&(%.W] 1he U"Q&' #Q4' T*'*&#(9*
LhaL, ºQ9T*& '6* U(&UQ#4'%9U*4 "2 '6* U%4*? '6* $%'(*9' (4 U"#$*'*9' '"
U6""4* '" $%&'(U($%'* (9 '6* '&(%., LhaL Lhe paLlenL ls freely chooslng Lo
parLlclpaLe ln Lhe Lrlal, LhaL Lhe U"#$Q.4("9 "2 '6* 4'%R*T U"##('#*9' (4
9"' -*(9: Q4*T '" U"*&U* '6* $*&4"9 '" $%&'(U($%'* ln Lhe cllnlcal Lrlal,."

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