FI L ED U.S. COURT OF APPEAL S EL EVENTHCI RCUI T AUGUST 12, 2010 J OHN L EY CL ERK [PUBLIS H] IN THE UN ITED STATES COURT OF APPEALS FOR THE ELE VENTH CIRCUIT

__ __ __ __ __ __ __ __ No. 0 9- 13 81 3

__ __ __ __ __ __ __ __ D.C. Dock etNo. 0 8- 10 05 2- CV-KMM DOUGLAS C. KILPATRICK, Pl ai nt iff -Ap pe ll an t, ve rs us BREG, INC., a Cal ifo rn iaCo rp or at io n fo r pr of it , Defen da nt -Ap pe ll ee.

__ __ __ __ __ __ __ __ __ _ App eal fro m

th e Uni te d S ta te s Di st ric t Co urt fo r th e So uthe rnDis tri ctof F lo rid a

__ __ __ __ __ __ __ __ __ _ (Au gu st12 , 20 10 ) Befo re BI RCH an d M ARCUS, Ci rcu itJu dg es , andHODGES,* Dis tri ctJu dg e. *Honora ble Wm. Terre ll Hodge s, U. S. District J udg e for the Middle District of F lorida, sitting by designation.HODGES, Dist ric t J ud ge :

Thi s i s a n eg li ge nc e an d p ro du ct s l iabi li ty acti on in vo lv in g the us e o f a p ai n pu m p m anuf actur edby Breg, In c. fo r us e dur in g a ndaft er s ur ge ry . The Pl ai nt iff , Dou gl as Kil pa tri ck , cla im in g t o h av e b een in jure d b y on e o f Bre g’s p um

ps , pr of fere d asi ng le ex pe rt wi tn es s o n t he is su e o f cau sa ti on – Dr. Gary Poeh li ng , M.D. The d is tri ctco urt d et erm in edth atth e m etho do lo gy use d b y Dr. Poe hl in g t o reac h h is co nc lu si on s was un rel iabl e an d, t he refo re, h is tes ti m on y was in adm is si bl e u nd er Fe de ral Ru le of Ev id en ce 7 02 an d Daube rt v . Merr el l Do w Ph arm aceu ti cal s, 5 09 U.S. 57 9 (1 99 3) . W it ho utth e te st im on y of Dr. Po eh li ng , th e di st ric t co urt fu rth er d et erm in edth atKil pa tri ck co ul d n otest ab li sh th e cau sa ti on el em en t i n a ny of h is cla im s, an d fi na l s umm ary jud gm en t was grant edin fav orof Breg . 1 Kil pa tri ckap pe al s t he ex cl us io n o f Dr. Po eh li ng ’s tes ti m on y . Upo n a rev ie w of t he reco rdan d t hi s C irc ui t’s p rece de ntest ab li sh in g ahi gh ly defer en ti al st an da rdof r ev ie w app li cab le to ev id en ti ary de te rm in at io ns , we fin d t ha t the di st ric t co urt d idno t ab us e it s d is cret io n i n e xc lu di ng Dr. Poe hl in g’s t es ti m on y . W e th eref

or e aff irm. Kilpatrick c oncede d that absent the e x pert testimony of Dr. Poehling , summary judgme nt 1 was prope r. 2I. Back gr ou ndFact s an d P ro cedur al His to ry

On Oct ob er 5 , 20 04 , Kil pa tri ckun de rwen t arth ro sc op ic surg ery on hi s ri gh t sh ou ld er t o re pa ir atea r of hi s l ab ru m , th e ri ng of t is su e th atsu rro un ds th e sh ou ld er s oc ke t, o r gl en oi d. In anatt em ptto all ev ia te po st -o pe rat iv e p ai n, Kil pa tri ck ’s su rg eo n i ns ert edin to Kil pa tri ck 's s ho ul de r joi nta pa in pu m p m anuf actur edby Breg. Th e cat he te r of th e p um p was im pl an te d i nt ra-a rti cu la rly (wit hi n t he joi ntsp ace) . Over t he ne xt48 ho ur s, the pa inpu m p d el iv ered12 0 c c's of th e an es th et ic .5% b up iv acai ne (tr ad e n am e Ma rcai ne ) in to Kil pa tri ck 's sh ou ld er. 2 At the ti m e o f hi s s ur ge ry in 20 04 , Kil pa tri ckwas 3 5 years o f ag e an d was a wor ldcla ss fla ts fis hi ng gu id e in th e Fl or id a Key s. He returne d t o wo rkforth e 20 05 fis hi ng sea so n. Whil e worki ng , Kil pa tri ckno ti cedso m e p op pi ng in hi s ri gh t sh ou ld er, b utfel t b ette r atth e en d o f th e se as on . Duri ng th e 2 00 6 s eas on , Kil pa tri ck

be ga n t o e xp eri en ce s ev ere s ho ul de r pa in an d l im it edm ot io n wh il e worki ng . Kilp atric k re tu rn edto hi s s ur ge on who co nduc te d a dd it io na l t es ti ng an d, in Octo be r 20 06 , di ag no se d g le no hu m eral ch on dr ol y si s –a co m pl et e b reak do wn

It is undisput ed that B regmanufa cture d the pain pump but did not manufac ture the 2 bupivaca ine. 3of

th e carti la ge in Kil pa tri ck 's s ho ul de r joi nt . On No ve m be r 13 , 20 06 , ano th er 3 orth op ed ic su rg eo n p erfo rm eda to ta l s ho ul de r rep la cem en t fo r Kil pa tri ck , and Kil pa tri ck

cla im s tha t h e wil l h av e to un de rg o s ev eral m or e su ch pro cedur es du rin g h is li fet im e. On J ul y 28 , 20 08 , Kil pa tri ckfil eda si x- co un t co m pl ai ntag ai ns t Br eg . Fou r of hi s cl ai m s as se rt t he or ie s o f st ric t p ro du ctli ab il it y forde si gn de fect , def

ectdu e to in ad equa te warn in g, d efec t due to no nc on fo rm an ce wi th rep res en ta ti on s, an d de fectdu e to fai lu re t o a de qu at el y tes t. Kil pa tri ckals o a ss ert eda ne gl ig en ce cl ai m , anda cl ai m

forvi ol at io n o f th e Fl or id a Dece pt iv e an d Un fai r Trad e Prac ti ces Act, § §5 01 .20 1- 21 3, Fl or id a St atut es . Kilp atric k a ll eg es th at , as adi rect res ul t o f be in g a dm in is te redbupi va cai ne us in g B reg 's p ai n p um p, h e n ow s uf

fers fro m de bi li ta ti ng sh ou ld er p ai n a nda pe rm an en t i nju ry th atha s s ev erel y

an d ne ga ti ve ly im

pa ct edhi s ab il it y

to work , res ul ti ng in eco no m ic ha rm in cl ud in g p as t an d fu ture m ed ic al ex pe ns es .

The Parties a gree that g lenohumera l chondroly sis – the complete destruc tion of the 3 car tilage of the shoulder

joint – is a medica l phenomenon that has e merg ed only rec ently , and that the first study

sug g estingits li nkag e with intra-a rticular pa in cathete rs appe are d as re cently as 2006. 4InApri l 2 00 9, Ki lp atric k d is cl os edDr. Poe hl in g a s h is so le ex pe rt o n

ge ne ral an d s pe ci fic cau sa ti on . Dr. Poe hl in g o pi ne d t ha t the us e o f in tra -art ic ul ar 4 pa in pu m ps to di sp en se an es th et ic di rect ly to the sh ou ld er joi ntcancau se gl en oh um eral ch on dr ol y si s, an d t ha t the us e o f Bre g’s p ai n p um p i n t hi s m an ne r cau se d Ki lp atric k’s i nju rie s. Fo ll owi ng Dr. Poe hl in g’s d ep os it io n, Br eg fil eda m ot io n t o e xc lu de hi s t es ti m on y , anda m ot io n fo r su m m ary jud gm en t o n t he gr ou ndth atKil pa tri ckha d n otsu ffi ci en tl y de m on st rat edth atBreg 's p ai n p um p co ul d a nddi d c au se th e type o f in jury Kil pa tri cksu ffer ed . On J un e 2 6, 2 00 9, t he di st ric t co urt g ran te d B reg ’s m ot io ns an d d is m is se d Kil pa tri ck ’s cas e wit h p reju di ce. The di st ric t co urt fo un d t ha t Dr. Po eh li ng was qu al ifi edto tes ti fy

as a n e xp ert , bu t tha t h is cau sa ti on tes ti m on y was s ci en ti fic al ly 5 un rel iabl e an d t he refo re i na dm is sabl e u nd er Fe d. R. Ev id . 70 2. In pa rti cu la r, th e

In order to preva il on his products liabili ty claims, Kilpatrick must offe r proof of both 4 g ener al ca

usation – that the device in question can c ause ha rm of the ty

pe Kilpatric k alleg es – and proof of spec ific ca

usation – that the device in fac t did cause Kilpatrick’s injury . See McClain v. Metabolife I

nt’l, Inc., 401 F .3d 1233, 1239 (11th Cir. 2005). To mee t this burden require s the use of e x pert testimony . Dr. Poehlingis an ac complished Boa rd Certified or

thopedic surg eon, author , profe ssor, 5 teac her, a nd lecture r. Since 1992 he has bee n the Editor In Chief of Ar throscopy – The Journal of Arthr oscopic a

nd Related Surg ery , a major, pe er- revie wed sc ientific publication. He has serve d as an a dvisory

editor of the Shoulder

J oint and Axi lla section of Elsevie r’s Intera ctive Anatomy J ournal, a

nd was the Chair

man of the D epar

tment of Orthopedic Surg ery at the Bowman Gra

y School of Medicine at Wake For est University from 1989 to 2007. Ther e is no question that he wa s qualified to testify as an e x pert. 5di st ric t co urt fo un d a fte r th or ou gh di sc us si on an d a na lysis th at : (1 ) th e m ed ic al

li te ratur e o n wh ic h Dr. Po eh li ng ba se d h is co nc lu si on s d idno t re li ab ly sup po rt h is ge ne ral cau sa ti on op in io n; (2) Dr. Poe hl in g d idno t re li ab ly con si de r th e true ba ck gr ou ndris k fo r gl en oh um eral ch on dr ol y si s; (3) Dr. Poe hl in g’s co nc es si on s ab ou t the hypo th et ic al an d s pe cu la ti ve na tu re o f th e m ed ic al sci en ce o n the cau se of ch on dr ol y si s “ se rio us ly und erm in e[d ]” the rel iabi li ty of hi s m etho do lo gy; (4 ) Dr. Poe hl in g’s u se of t he “ di ffer en ti al di ag no si s” m etho do lo gy to d et erm in e sp eci fic cau sa ti on was fl awedbe cau se itpre su m edth e ex is te nc e o f ge ne ral cau sa ti on ; an d (5 ) Dr. Po eh li ng ’s op in io n o n s pe ci fic cau sa ti on was i m pr op erl y ba se d s ol el y

ona te m po ral rel at io ns hi p b etweenth e u se of B reg ’s pai n p um p a nd Kil pa tri ck ’s in

juri es . On J ul y 15 , 20 09 , th e d is tri ctco urt en te redfin al jud gm en t i n fa vo r of Breg . Thi s ap pe al fol lo wed . II. St an da rdof R ev ie w Thi s C ou rt r ev ie ws a t ria l co urt’s d eci si on to ex cl ud e anex pe rt’s t es ti m on y pu rs ua ntto Daub ertun de r anab us e o f di sc ret io n s tand ard . Gener al Elec . Co. v . Jo in er, 5 22 U.S. 13 6, 1 40 (19 97 ); M cCl ai n v . Met ab ol ife Int ’l, Inc., 4 01 F.3d 12 33 , 12 38 (11 th Cir . 20 05 ); R in k v . Che m in ov a, In c., 40 0 F .3d12 86 , 12 91 (11 th Ci r. 20 05 ). “ Thi s s ta nd ardof r ev ie w requi res th atwe de fer t o t he di st ric t co urt’s 6ru li ng un le ss itis ‘ m an ife st ly erron eo us .’ ” Ri nk , 40 0 F .3dat 1 29 1 (q uo ti ng Qui et

Tech . DC-8 , Inc . v. Hu rel -Dubo is UK Ltd., 3 26 F.3d13 33 , 13 40 (11 th Cir . 20 03 )).

“ Bec au se th e ta skof e va lu at in g the rel iabi li ty of ex pe rt t es ti m on y is un ique ly en tru st edto th e d is tri ctco urt u nd er Daube rt . . . we gi ve th e d is tri ctco urt ‘con si de rab le lee way ’ in th e ex ecu ti onof i ts du ty.” Id. (quo ti ng Kumho Tire C o., Ltd . v. Carm ic ha el , 52 6 U.S. 1 37 , 15 2 (1 99 9) ). Thi s d efer en ti al st an da rdis no t rel ax edev enth ou gh a ru li ng onth e ad m is si bi li ty of ex pe rt e vi de nc e m ay be ou tc om e d et erm in at iv e. Jo in er, 5 22 U.S. at 1 42 -4 3. Inad di ti on , we no te th at“ [t]he bu rd enof l ay in g t he pro pe r fo un da ti on for th e ad m is si on of e xp erttes ti m on y is on th e p arty

off eri ng th e ex pe rt, andth e adm is si bi li ty m

us t b e sh own by a prep on de ran ce o f th e ev id en ce.” M cCo rv ey v. Bax te r Heal th care Co rp ., 29 8 F .3d12 53 , 12 56 (11 thCir . 20 02 ) (quo ti ng All is on v. McGh anMed . Cor

p., 1 84 F.3d13 00 , 13 06 (11 th Cir . 19 99 )). III. The Daub ertSta nd ard Daube rt r equi res th attri al co urts actas “ ga te ke ep ers ” to en su re tha t sp ecu la ti ve , un rel iabl e ex pe rt t es ti m on y do es no t re ach th e jury. 58 9 U.S. at59 7, n. 7 . The tria l co urt m

us t “ m ak e certa in th atanex pe rt, wh ethe r ba si ng tes ti m on y up on pro fes si on al stud ie s o r pe rs on al ex pe rie nc e, em pl oys in th e co urtro om

th e

7sa m e le ve l o f in te ll ectua l ri go r th atch arac te riz es th e p ract ic e o f anex pe rt i n t he

rel ev an t fi el d.” Kum

ho , 52 6 U.S. at15 2. Fed eral Ru le of Ev id en ce 7 02 go ve rn s t he adm is si onof e xp erttes ti m on y in fed eral co urt, an d p ro vi de s t ha t:

If s ci en ti fic , tec hn ic al , or o th er s pe ci al iz edkn owl ed ge wil l as si stth e tr ie r of

factto un de rs ta ndth e ev id en ce o r to de te rm in e a fac t i n i ss ue , a witne ss qu al ifi edas a n ex pe rt b y kn owl ed ge , sk il l, ex pe rie nc e, tr ai ni ng , or educ at io n, m ay

tes ti fy th eret o i n the form

of a n o pi ni on orot he rwis e, if

(1) th e te st im on y

is ba se d upo n s uf

fic ie nt fact s o r da ta , (2) th e te st im on y is th e p ro du ctof r el iabl e pr in ci pl es an d m etho ds , and(3) th e witne ss ha s ap pl ie d th e p rin ci pl es an d m etho ds rel iabl y to th e fac ts of t he cas e. App lying th es e p rin ci pl es , th is Co urt h as pre vi ou sl y he ldth atex pe rt te st im on y m ay be adm it te d i f th ree r equi rem en ts are m et . Firs t, the ex pe rt m us t b e qu al ifi edto tes ti fy

co m pe te nt ly regar di ng th e m at te r he or s he in te nd s t o a dd res s. Seco nd , th e m etho do lo gy use d m us t b e rel iabl e as de te rm in edby a Daub ert in qu iry. T hi rd , th e te st im on y m us t as si stth e tr ie r of

factth ro ug h t he ap pl ic at io n o f ex pe rti se to un de rs tandth e ev id en ce o r de te rm in e a fac t i n i ss ue . Tus cal oo sav. Harcr os Ch em ic al s, In c., 15 8 F .3d54 8, 5 62 (11 th Cir . 19 88 ). Thi s ca se hi ng es on whet he r th e m etho do lo gy use d b y Dr. Poe hl in g was rel iabl e u nd er Daube rt. In de ci di ng th e que st io n o f rel iabi li ty, th e Supr em e Co urt art ic ul at eda no n- ex haus ti ve li stof r el ev an t fa ct or s t o c on si de r: (1 ) whe th er the 8ex pe rt’s the ory canbe an d h as be entes te d; (2) whethe r th e th eo ry ha s b een subjec te d t o p eer r ev ie w andpubl ic at io n; (3) th e kno wn o r po te nt ia l ra te of e rro r of th e p art ic ul ar s ci en ti fic tec hn ique ; an d (4 ) whe th er the tec hn ique is ge ne ral ly acce pt edin th e sc ie nt ifi c co m m un it y . Daub ert , 50 9 U.S. at59 3- 94 ; M cCo rv ey , 29 8 F .3dat 1 25 6. Th e co urt m us t d o “ a p rel im in ary as se ss m en t o f whe th er the reas on in g o r m etho do lo gy un de rlyin g t he tes ti m on y is sci en ti fic al ly val idan d o f whe th er tha t re as on in g o r m etho do lo gy pro pe rly can b e ap pl ie d t o t he fact s i n is su e.” Daube rt, 5 09 U.S. at 5 93 -9 4. IV. Dr. Poeh li ng ’s Test im on y Kil pa tri ckfir starg ue s t ha t the di st ric t co urt i m pr op erl y foc us edon Dr. Po eh li ng ’s con cl us io ns in st eadof h is m etho do lo gy. Thi s ar gu m en t i s s im pl y wit ho utm eri t; ev ena cu rs ory rev ie w of t he di st ric t co urt’s l en gthy andde ta il ed de ci si on refu te s t he cla im . The d is tri ctco urt fo cu se d e xc lu si ve ly on t he m at eri al s 6 an d m etho ds Dr. Poe hl in g u se d t o fo rm hi s o pi ni on s ( i.e. hi s m etho do lo gy). T hi s is ex act ly wha t the di st ric t co urt was supp os edto do . Kil pa tri ckne xtco nt en ds th atbe cau se th e m etho ds Dr. Poe hl in g u se d t o reac h h is co nc lu si on s (r ev ie win g m ed ic al li te ratur e an d the “ di ffer en ti al di ag no si s” See Kilpatric k v. Br eg , Inc., No. 08- 10052-CIV, 2009 WL2058384 (S.D. Fla . J un. 25, 6 2009). 9m etho do lo gy) were n otne w or n ov el , th e d is tri ctco urt s ho ul d h av e ref rai ne d 7 fro m ass es si ng th e rel iabi li ty of th es e m etho ds an d s ho ul d h av e fo cu se d s ol el y on whe th er Dr. Po eh li ng was qua li fie d t o t es ti fy as a n e xp ert– t es ti m on y th atwou ld ha ve be enhe lp fu l t o t he jury. Suc h a n app ro achgo es ag ai ns t the law o f th is Ci rcu it , whi ch ha s re ve rs edtri al co urts who ab di cat e th ei r ga te ke ep er ro le an d refu se to ass es s re li ab il it y . See Mc Cl ai n, 4 01 F.3dat 1 23 8. To be su re, the re ar e in st an ces in whi cha di st ric t co urt m ay de te rm in e th e rel iabi li ty pro ng un de r Daube rt b as edpri m ari ly upo n an e xp ert ’s exp eri en ce an d g en eral kn owl ed ge in th e fi el d, e.g ., Uni te d S ta te s v . Bro wn, 4 15 F.3d12 57 (11 th Cir . 20 05 ); b utat a ll ti m es th e d is tri ctco urt m us t s ti ll de te rm in e th e rel iabi li ty of th e o pi ni on , no t m erel y th e qua li fic at io ns of t he ex pe rt wh o o ffer s i t. See Kumho Tire, 5 26 U.S. at 14 9 (“ W e co nc lu de th atDaub ert ’s gen eral pri nc ip le s ap pl y to th e ex pe rt m at te rs de sc rib edin Ru le 70 2. Th e Ru le , inres pe ctto all su chm atte rs , est ab li sh es a st an da rdof e vi de nt ia ry

rel iabi li ty.”); s ee al so Rid er v . San do z Ph arm aceu ti cal s Co rp ., 29 5 F .3d11 94 , 11 97 (11 th Cir . 20 02 ) (n ot in g t ha t the Supr em e Co urt i n Kumho “ m ad e itcle ar tha t t es ti m on y ba se d s ol el y

on th e ex pe rie nc e o f anex pe rt wou ldno t b e ad m is si bl e.”). The “ differ ential diagnosis” methodology “is a standa

rd scientific technique of 7 identifying the cause of a me dical proble m by eliminating the likely

cause s until the most probable one is isolated.” Westberr y v. Gislaved Gummi AB , 178 F.3d 257, 262 ( 4th Cir. 1999).

10Dr. Poe hl in g t es ti fie d t ha t h e fo rm edhi s o pi ni on s af te r rev ie win g m ed ic al li te ratur e an d app lying th e d iff eren ti al di ag no si s m etho d. Th us , itwas e nt ire ly pr op er – in de edne ces sa ry

– fo r th e d is tri ctco urt t o fo cu s o n t he rel iabi li ty of th es e so ur ces an d m etho ds . To ho ldot he rwis e wou lden co ur ag e tr ia l co urts to si m pl y rubb er s ta m

p t he op in io ns of e xp ertwitne ss es on ce the y are d et erm in edto be an ex pe rt. Se e All is on v. Mc Gha n M ed ic al Co rp ., 18 4 F .3d13 00 , 13 16 -1 7 (1 1t h C ir. 19 99 ) (“ Und er the reg im e o f Daube rt . . . a d is tri ctjud ge ask edto adm itsci en ti fic ev id en ce m

us t d et erm in e whe th er the ev id en ce i s g enui ne ly scie nt ifi c, as di st in ct fro m be in g u ns ci en ti fic sp ecu la ti on off eredby a genui ne sci en ti st .”). A. Gen era l Ca us at io n Tes timony Dr. Poe hl in g t es ti fie d a t h is de po si ti onth atth e u se of p ai n p um ps to adm in is te r bupi va cai ne in tra -art ic ul arl y cancau se gl en oh um eral ch on dr ol y si s. In reac hi ng th is co nc lu si on , Dr. Poe hl in g a dm it te d t ha t h e d idno t co nduc t an y tes ts hi m se lf, a nddi d n otrel y

on an y ep id em io lo gi cal stud ie s o f hu m anbe in gs th at co nn ectin tra -art ic ul ar p ai n p um ps or t he us e o f bupi va cai ne with g le no hu m eral ch on dr ol y si s. The ab se nc e o f su ch ev id en ce i s n otfat al , bu t m ak es hi s t as k t o

8 sh ow g en eral cau sa ti on m or e d iff ic ul t. See Rid er, 2 95 F.3dat 1 19 8- 99 . In “Epidemiology , a fie ld that conce rns itself with findingthe ca usal nexus between 8 external fac tors and disea se, is g ener ally considere d to be the best e vidence of ca usation in tox ic tort actions.” Rider, 295 F .3d at 1198. 11pa rti cu la r, th e b as ic m etho do lo gy em pl oyed t o re ach th e co nc lu si on s m us t b e rel iabl e an d s ou nd . W el ls v. Ortho Ph arm aceu ti cal Co rp ., 78 8 F .2d74 1, 7 45 (11 th Ci r. 19 86 ) (ci ti ng Fere be e v . Che vr on Ch em ic al Co ., 73 6 F .2d15 29 , 15 35 -3 6 (D.C. Ci r. 19 84 )). 9 Dr. Poe hl in g re vi ewedfiv e so ur ces to m ak e h is ge ne ral cau sa ti on as se ss m en t. All of the so ur ces are arti cl es fro m va rio us m ed ic al jou rn al s, n on e o f whi chwere b as edonep id em io lo gi cal stud ie s. Th e d is tri ctco urt co ns id eredfou r of th es e it em s o f li te ratur e b ot h s ep arat el y an d i n c om

bi na ti on , andfou ndth em in su ffi ci en t t o s at is fy

th e rel iabi li ty requ ire m en t o f Fed . R. Evi d. 7 02 . The di stric t co urt b eg anby loo ki ng at the art ic le s i n c om bi na ti onan d n ot ed th aton ly one of t he art ic le s was a co m pa rat iv e stud y

of h um an s wh o h ad un de rg on e art hr os co pi c su rg ery in vo lv in g p ai n p um ps . Non e o f th e art ic le s ex pl ai ne d t he m ech an is m by whi ch bupi va cai ne da m ag es cart il ag e, an d n on e o f th em off eredanul ti m at e co nc lu si on as t o t he ge ne ral cau sa ti on of g le no hu m eral ch on dr ol y si s i n h um an s. A rev ie w of t he se art ic le s co nf irms th e d is tri ctco urt’s fin di ng s, an d Ki lp atric k d oe s n otdi sp ut e th em . Kilpatrick’s a

rgument that conductingany epidemiolog ical studies would be une thical, 9 beca use it would requirethe potential destruc tion of a per son’s shoulder c artilag e, has some merit. But in the a

bsence of such studies, the nature of the other e vidence (ca se re ports, animal studies, in vitro studi es) be comes that much more important, and the c ourt’s consider ation of such evide nce a

nd the methodolog ies used must be that much more sear ching . 121. The Hans enStu dy

The di stric t co urt fi rs t co ns id ereda 20 07 art ic le fro m th e Am eri can Jo urna l of Sp orts Med ic in e (the “ Han se n s tu dy”). The Han se n s tu dy anal y zedth e 1 0 m ed ic al reco rd s o f 15 2 p at ie nt s wh o h adun de rg on e 1 77 arthr os co pi c sh ou ld er su rg eri es . Of th es e 1 52 pa ti en ts , on ly nin et een sh ou ld ers in sev en te enpa ti en ts ha d bupi va cai ne -d is pe ns in g p ai n p um ps in se rte d i nt o the m , andof tho se , on ly twelv e sh ou ld ers in ten pa ti en ts de ve lo pe d c ho nd ro lysis . Accor di ng to Dr. Poe hl in g, t hi s 63 % (twel ve ou t o f ni ne te ensh ou ld ers ) in ci de nc e o f ch on dr ol y si s was th e

“ st ro ng es t” ev id en ce o f a co nn ect io n b etweenin tra -art ic ul ar p ai n p um ps an d ch on dr ol y si s. The di stric t co urt co nc lu de d t ha t the Hans enstudy was u nr el iabl e b ecau se it di d n otin cl ud e an y

st at is ti cal an al y si s an d d idno t ex pl ai n wh ethe r itwas st at is ti cal ly m ean in gf

ul to ex trapo la te fro m

su ch a sm al l s am

pl e si ze. The stud y al so di d n otacco un t fo r ot he r cau se s o f ch on dr ol y si s – sp eci fic al ly not in g tha t “ [i]t is li ke ly tha t o th er u nr eco gn iz edfact or s ar e al so in vo lv ed . . . . [an d t ha t o th er fact or s] m ay

ha ve pl ay eda ro le no t yet co m pl et el y un de rs to odat t hi s t im e.” The study als o fa il edto ex pl ai n wh y sev enof the pa ti en ts (al m os t 4 0%) tre at edwith

Br ent P. Hansen et al. , Postarthroscopic Gle nohumera l Chondroly sis, 35 Am. J . Sports 1 0 Med. 1628-34 ( J uly

2007). The H ansen study was fir st presente d in 2006 to the America n Aca demy of Orthope dic Surg ery . 13pa in pu m

ps di d n otde ve lo p c ho nd ro lysis – a r es ul t tha t Dr. Po eh li ng hi m se lf co ul d n otex pl ai n. Mo re i m po rtant ly, th e stud y

di d n otreac h aco nc lu si on as t o th e g en eral cau sa ti on of c ho nd ro lysis , st at in g tha t “ [n ]o eti ol og y [of ch on dr ol y si s] ha s b eenfirm ly ide nt ifi ed. . .” andth atfurth er re se arch was n eed ed . All t ha t the au th or s wer e ab le to st at e was th atpa in pu m ps elu ti ng Marc ai ne “ ap pe ar h ig hl y as so ci at edwith p os t-arth ro sc op ic gl en oh um eral ch on dr ol y si s.” Insu m , th e Han se n s tu dy was m erel y a co m pi la ti on of c as e rep orts witho ut an y st at is ti cal co nt ex t. Su ch stud ie s “ la ckco nt ro l[] an d t hu s d o n otpro vi de as m uc h i nf orm at io n a s co ntro ll edep id em io lo gi cal stud ie s d o . . . Cau sa l at tri bu ti on ba se d o n c as e stud ie s m

us t b e reg ard edwith c au ti on .” McC la in , 40 1 F .3dat 1 25 3 (in te rn al cit at io ns om it te d) . See al so Rid er, 2 95 F.3dat 1 19 9 (“ [W] hi le th ey m ay supp ort o th er p ro of

of c au sa ti on , cas e rep orts alo ne ord in ari ly cann otpro ve cau sa ti on .”). Face d wi th a stud y

th atfai le d t o e xp la in why 40 % of p at ie nt s t reat edwith in tra -art ic ul ar p ai n p um

ps di d n otde ve lo p c ho ndro lysis , th e la ckof any sta ti st ic al an al y si s d is cu ss in g the rel at iv e im po rta nc e o f th is stud y , th e fai lu re t o a cco un t fo r ot he r cau se s o f ch on dr ol y si s, an d t he om is si on of a ny con cl us io n o n g en eral cau sa ti on , th e d is tri ctco urt d idno t ab us e it s d is cret io n i n fi nd in g t ha t the Hans en study was n ota so ur ce upo n wh ic h Dr. Po eh li ng co ul d re as on ab ly rely un de r Fed . 14R. Evi d. 7 02 . Kilp atric k’s fo cu s o n t he au th or s’ des cri pt io n o f an“ as so ci at io n”

be twee n p ai n p um

ps an d g le no hu m eral ch on dr ol y si s i s u na va il in g. “ [S]ho win g [an ] as so ci at io n i s fa r rem ov edfro m pro vi ng cau sa ti on .” All is on , 18 4 F .3dat 13 15 n. 1 6 (e m

ph as is in ori gi na l). 2. The Gom ol l Stud y The di stric t co urt n ex t co ns id ereda 20 06 art ic le di sc us si ng a co ntro ll ed study of r ab bi ts (th e “ Gom ol l s tu dy”). The au th or s o f th is study adm in is te red 1 1 Mar cai ne to li ve rab bi ts co nt in uo us ly thro ug h acathe te r ov er 4 8 h ou rs , whi le ot he r rab bi ts rece iv edsal in e o ve r th e sa m e ti m e p eri od . The an im al s wer e eu th an iz edon e weeklat er an d t he ir c art il ag e was ex am in ed . The au th or s o f th e Gom ol l s tu dy con cl ud edth at“ [c]on ti nu ou s i nt ra-a rti cu la r in fu si on of b up iv acai ne (Mar cai ne ), with a ndwitho utep in ep hr in e, le d t o si gn ifi can t h is to pa th ol og ic an d m et ab ol ic ch an ge s i n a rti cu la r carti la ge .” Howev er, the au th or s wer e car efu l t o l im itth is co nc lu si on to rab bi ts , anddi d n ot ex trapo la te th ei r fi nd in gs to hu m an s, n ot in g t ha t fu rth er s tu dy was warrant ed :

One li m it at io n o f ou r stud y , whi ch itsh ares with m os t an im al m od el s, s ho ul d b e co ns id ered ; al th ou gh we were ab le to sh ow the de tri m en ta l ef fect s o f bupi va cai ne on Andre s Gomoll et al. , Chondroly sis After Continuous Intra-Articular B upivaca ine 1 1 Infusion: An Ex perimenta l Model Investig atingChondrotox icity in the Rabbit Shoul der, 22 Arthrosc opy

813-19 (Aug

ust 2006). 15th e cel lu la r an d t is su e le ve l i n arab bi t m od el , itrem ai ns to be de te rm in edwhet he r hu m ancart il ag e is equa ll y su sc ep ti bl e an d wh ethe r th es e h is to pa th ol og ic an d fu nc ti on al ch an ge s re su ltin th e subs eque ntde ve lo pm en t of rap id ly pro gr es si ve os te oa rth rit is . . . . Becau se ep id em io lo gi c stud y

of c ho ndro lysis in hu m an s wi ll requi re an ex tre m el y

lar ge sample s iz e b ecau se of the lo w in ci de nc e an d p rev al en ce o f th is co nd it io n, ad di ti on al stud ie s i n l arg er an im al m od el with l on ge rte rm fol lo w-up, as well as i n v it ro stud ie s wi th co nt in uo us ex po su re o f hu m ancart il ag e to bupi vi cai ne , are n eces sa ry

to pro vi de furth er u nd ers tand in g. Thu s, b y it s o wn wo rd s, the Gom ol l s tu dy at m os t s ug ge st s a c on ne ct io n b etween th e u se of i nt ra-a rti cu la r pa in pu m ps , bupi va cai ne , andch on dr ol y si s i n rabb it cart il ag e. Thi s d oe s n otequa te to a co nc lu si on of d ire ctcau sa ti on (ora co nn ect io n of an y de gr ee) b etweenth e u se of s uc h p ai n p um ps an d c ho nd ro lysis in hu m an s. The au th or s o f th e Gom ol l s tu dy furt he r ackno wled ge d t ha t “ no da taex is ts reg ard in g t he hu m an -equi va le ntdo si ng of i nt ra-a rti cu la r bupi va cai ne in a rab bi t sh ou ld er m od el . . . . ” Dr. Po eh li ng als o c ou ldno t ex pl ai n t he po ss ib le di ffer en ces in do se -res po ns e rel at io ns hi p b etweenhu m an s an d rabb it s. As th e d is tri ctco urt co rrec tl y no te d, a d os e-re sp on se rel at io ns hi p i s “ th e si ng le m os t i m po rta ntfact or to co ns id er i n e va lu at in g wh ethe r anall eg edex po su re caus eda sp eci fic adve rs e effe ct .” McC la in , 40 1 F .3dat 1 24 2 (c it in g Dav idEato n, Sc ie nt ifi c Ju dg m en t an d Tox ic Tort s: A Prim er i n To xi co lo gy for Jud ge s an d Lawyers, 1 2 J . L. & Pol ’y 1,

1611 (20 03 )). The l ackof a ny dat a o r an y expl an at io n b y

Dr. Poe hl in g o n t hi s 1 2 po in t p ut s t he m etho do lo gy of b ot h t he Gom ol l s tu dy, andDr. Poe hl in g’s g en eral cau sa ti on op in io ns in qu es ti on . “ The ex pe rt wh o a vo id s o r ne gl ect s [t he do se res po ns e] pri nc ip le of t ox ic to rts witho utjus ti fic at io n c as ts su sp ic io n o n t he rel iabi li ty of hi s m etho do lo gy.” McCl ai n, 4 01 F.3dat 1 24 2. The di stric t co urt d idno t ab us e it s d is cret io n i n fi nd in g t he Gom ol l s tu dy un rel iabl e u nd er Fe d. R. Ev id . 70 2. Se e Jo in er, 5 22 U.S. at 1 44 -4 5 (f in di ng no ab us e o f di sc ret io n wh ere t he tri al co urt re jecte d a n e xp ert ’s rel ia nc e o n a ni m al stud ie s t ha t wer e d is si m il ar t o the fact s o f th e cas e). 3. The Grei s R ep ort The th irdart ic le th e d is tri ctco urt ad dr es se d was a 20 08 cas e stud y of t wo te en ag e fem al e swi m

m ers who un de rwen t arth ro sc op ic surg ery an d s ub se qu en tl y de ve lo pe d c ho ndro lysis (th e “ Grei s re po rt” ). Bot h p at ie nt s re cei ve d b up iv acai ne 1 3 us in g i nt ra-a rti cu la r pa in pu m ps fol lo win g s ur ge ry . The d is tri ctco urt fo un d t hi s study to be un rel iabl e fo r two reas on s. Fi rs t, the stud y on ly anal y zedth es e two pa ti en ts ’ sp eci fic cas es – t he re was no st at is ti cal an al y si s an d t he stud y di d n ot Dose-r esponse r elationship is “[a] relationship i n which a c hang e in amount, intensity , 1 2 or duration of exposure to an ag ent is associate d with a cha ng e – either

an incr easeor dec rea se – in risk of disease .” McClain, 401 F .3d at 1242-42 (c itations omi tted). Patrick Gre is et al. , Bilate ral Shoulder Chondroly sis Following Arthroscopy : A Report 1 3 of Two Case s, 90 J . Bone & Joint S urg ery 1338-44 (June 2008). 17dr aw an y

m ed ic al ly val idco nc lu si on s. Th e d is tri ctco urt’s d eci si on co m po rts with th e la w of t hi s C irc ui t. Mc Cl ai n, 4 01 F.3dat 1 25 4 (“ cas e rep orts rai se qu es ti on s; th ey do no t an swe r th em .”); Rid er, 2 95 F.3dat 1 19 9 (“ co urts m us t co ns id er tha t cas e rep orts are m erel y

acco un ts of m ed ic al ev en ts . They refl ecton ly repo rte d da ta , no t s ci en ti fic m etho do lo gy.”). Ind eed , Dr. Poe hl in g h im se lf a ckno wled ge d th atcas e rep orts su ch as t he Grei s re po rt are “ way do wn atth e v ery bo tt om as f ar as m ed ic al st ren gt h o f anart ic le ” an d c an no t es tabl is h m ed ic al cau sa ti on . The di stric t co urt al so fou ndfau ltwith p la ci ng rel ia nc e upo n t he Grei s rep ort b ecau se itex pr es sl y reco gn iz edth at“ th e ex actcau se of t he ch on dr ol y si s rem ai ns un kn own ” an d l is te d am ul ti tu de of f

act or s t ha t co ul d h av e cau se d t he se pa ti en ts ’ ch on dr ol y si s. Th e rep ort wen t o n t o h y po th es iz e ab ou t the vario us fact or s, wi th ou t drawi ng an y co nc lu si on s. As a res ul t, the di st ric t co urt fo un d t ha t Dr. Poe hl in g’s d ep en de nc e upo n a n a ne cd ot al cas e rep ort t o c on cl ud e th atin tra art ic ul ar p ai n p um

ps adm in is te rin g b up iv acai ne ge ne ral ly caus es ch on dr ol y si s co ul d n otsat is fy

th e rel iabi li ty stan dard s o f Fed . R. Evi d. 7 02 . The co urt fi nd s n o erro r inth is de te rm in at io n.

184. The Lub owi tz Edi to ria l

Last ly, th e d is tri ctco urt co ns id ereda on e-p ag e ed it or ia l tha t Dr. Po eh li ng co -au th or edwith Dr. J am es Lob owi tz (th e “ Lub owi tz ed it or ia l” ) in 20 07 . The 1 4 ed it or ia l i s n ota cas e rep ort o r stud y bu t, as Dr. Poe hl in g a dm it te d “ is ge ne ral in na tu re an d d oe s n otpre se ntan y factua l co nt ex t tha t wo ul d a ll ow t he co urt t o di sc ern it s re le va nc e to th is cas e.” The ve ry ti tl e o f th e ed it or ia l s ta te s t he ne edfor fu rth er re se arch . W it h re sp ectto th e cau se s o f gl en oh um eral ch on dr ol y si s, the Lub owi tz ed it or ia l s ta te d t ha t “ [t]he eti ol og y of g le no hu m eral ch on dr ol y si s m ay be m ul ti fact or ia l. Fu tu re re se arch is requi redto de te rm in e th e cau se , andpro pe r pr ev en ti on , of s ho ul de r ch on dr ol y si s.” Dr. Po eh li ng adm it te d t ha t thi s s ta te m en t rem ai ne d c orrecttwo y ears lat er atth e ti m e o f hi s d ep os it io n. Th e ed it or ia l al so reco gn iz edth e ex is te nc e o f ch on dr ol y si s caus edby unkno wn fa ct or s –

“ id io pa th ic ” ch on dr ol y si s. As Dr. Poe hl in g h im se lf a dm it te d, t hi s ed it or ia l i s cl earl y in ad equa te as aba si s fo r a s ci en ti fic jud gm en t ab ou t the ge ne ral cau sa ti on of ch on dr ol y si s.

J ames L ubowtiz & Gar

y Poehling, Editorial: Glenohume ral The rmal Capsulorrha phy I s 1 4 Not Recommende d – Shoulder Chondroly sis Requires Additional Resear ch, 23 Ar throscopy 687 (Jul y 2007). 195. The Dis tri ctCo urt’s Co nc lu si on

The di stric t co urt ex erci se d i ts di sc ret io n a ndfou ndth ateachof t he se art ic le s, b ot h t ak ento ge th er an d s ep arat el y , were n otsu ffi ci en tl y rel iabl e to supp ort Dr. Po eh li ng ’s op in io n o n g en eral cau sa ti on . Kilp atric k c ha ll en ge s t he di st ric t co urt’s fi nd in gs with re sp ectto th is li te ratur e o n s ev eral gro un ds . Firs t, Kil pa tri ck

cla im s tha t the art ic le s d o i n fa ctest ab li sh a di rectcau sa l l in k b etween th e u se of i nt ra-a rti cu la r pa in pu m ps to di sp en se bupi va cai ne an d c ho nd ro lysis . As the di st ric t co urt co nc lu de d, h owe ve r, th is arg um en t i s b el ie d b ot h b y th e p la in la ng ua ge of t he art ic le s an d b y Dr. Poe hl in g’s o wn t es ti m on y th atno ne of t he art ic le s h e rel ie d upo n –

in de edno li te ratur e in ex is te nc e atth e ti m e o f hi s de po si ti on – es tabl is he s s uc h adi rectcau sa l l in k. Dr. Po eh li ng ’s adm is si on th at th e li te ratur e is sp ecu la ti ve in na tu re i s b y it se lf s uf fic ie ntto warran t a f

in di ng of un rel iabi li ty. Seco nd , Kil pa tri ckli st s s ev enad di ti on al art ic le s an d s tu di es th athe co nt en ds Dr. Poe hl in g re li edup on in reac hi ng hi s co nc lu si on s, an d wh ic h t he di st ric t co urt wro ng fu ll y

fai le d t o t ak e in to acco un t. Acco rd in g t o Ki lp atric k, th es e o th er arti cl es co nc lu si ve ly establ is h adi rectcau sa l l in k b etweenth e u se of in tra -art ic ul ar p ai n p um

ps , bupi va cai ne , andch on dr ol y si s. Onth is po in t, Kil pa tri ck

is pa rti al ly corre ct– a r ev ie w of Dr. Po eh li ng ’s dep os it io n t es ti m on y 20sh ows th athe m en ti on edon e ad di ti on al art ic le – a J anuary 20 08 stud y

of c ow an d hu m ancart il ag e b y

Dr. Con st an ce Ch u a ndot he rs (th e “ Ch u s tu dy”). Howev er, 1 5 th is stud y su ffer s fr om

th e sa m e d efi ci en ci es as t he Gom ol l s tu dy – th e au th or s o f th e Ch u s tu dy no te d tha t the ir “ in vi tro ass es sm en ts do no t ac co un t fo r di lu ti on al effe ct s o r invi vo rep arat iv e p ro ces se s.” The Ch u s tu dy wenton to st at e th at“ in 1 6 vi tro res ul ts can no t b e d ire ct ly extrap ol at edto cli ni cal pra ct ic e” an d c on cl ud ed th at“ th e in vi tro bo vi ne ch on dr oc yte da ta. . . supp ort the ne edforco m pr eh en si ve ad di ti on al stud ie s.” In ot he r wor ds , th e au th or s co ul d n otst at e h ow t he ir t es t res ul ts wou ldtra ns fer wh enco nduc te d o n ali ve hu m ansubjec t. Thu s, ev enif t he di st ric t co urt h adco ns id eredth e Ch u s tu dy tog ethe r wit h th e o th er fo urpi eces of l it eratur e itex am in ed , itis cle ar tha t the co urt wo ul d n ot ha ve alt eredit s co nc lu si on . See All is on , 18 4 F .3dat 1 31 3- 14 (affi rm in g e xc lu si on of cau sa ti on tes ti m on y

ba se d upo n a ni m al stud ie s b ecau se th e ex pe rt “ fai le d t o ex pl ai n t he co rrel at io n o f th e res ul ts of Li gh tfo ot e’s ratstud ie s i n wh ic h t he rat s were d ire ct ly inject edwith s il ic on e to sym pt om s i n ahu m anpa ti en t.”) . One ad di ti on al an im al stud y

di sc us si ng th e d iff

eren ces be twee n i n v it ro an d i n v iv o Constance Chu, et al. , The In Vitro Effe cts of B upivaca ine on Articula r Chondrocy

tes, 1 5 90 J . Bone & Joint S urg . 814, 820 (Jan. 2008). “In vitro” re fer s to procedur es per formed in a controlled e nvironment, such as a test 1 6 tube or pe tri dish. “In vivo” studies ref ers to experiments usingan entire , living org anism, such as a live huma

n subject. 21res ul ts , andth e n eedforfurth er s tu di es do es no t co m e cl os e to sat is fy in g R ul e 70 2's rel iabi li ty requ ire m en ts , anddo es no t es tabl is h a n abu se of d is cret io n o n t he pa rt o f th e d is tri ctco urt. 1 7 The ot he r si x a rti cl es Kil pa tri ckli st s i n h is bri ef ar e n owh ere m en ti on edin Dr. Poe hl in g’s d ep os it io n t es ti m on y de sp it e ex te ns iv e an d re pe at edreque st s b y Breg ’s cou ns el ex ho rti ng Dr. Poe hl in g t o i de nt ify every si ng le art ic le an d s tu dy he rel ie d upo n. In st ead , Kil pa tri ckpo in ts to a st at em en t b y Dr. Poe hl in g a t h is de po si ti on th athe co ns id eredva rio us ot he r art ic le s wh ic h wer e o n h is co m pu te r at ho m e. Su ch a va gu e ref

eren ce t o o th er u nn am edart ic le s i s n otsu ffi ci en t t o supp ort Dr. Po eh li ng ’s con cl us io n o n g en eral cau sa ti on , anddo es no t re nd er h is m etho do lo gy reli ab le . Dr. Poeh li ng ha d a m pl e o pp ortuni ty to i de nt ify all of t he ba se s fo r hi s co nc lu si on s an d t o e xp la in hi s m etho do lo gy in re ach in g tho se co nc lu si on s. Itwas n otanab us e o f di sc ret io n fo r th e d is tri ctco urt t o i gn or e al lu si on s t o o th er arti cl es . Last , Kil pa tri ckarg ue s tha t the di st ric t co urt erredwhen itco ns id eredeach id en ti fie d p ie ce o f li te ratur e se pa rat el y , rathe r th aninco m bi na ti on . Firs t, i t i s
Whil e the district cour

t did not specifically

identify the Chu study

in its order, the trial 1 7 court did state that it re viewed the entire voluminous rec ord in this case, inc luding Dr . Poehling’ s expert repor

t, his deposition t estimony , and the medic al literature upon which he ba sed his opinions. Thus, itis not entirely clea r that the district cour

t ignor ed the Chu study , and in any event, the district c ourt did not abuse its discretion. 22cl ear t ha t the di st ric t co urt d idco ns id er al l o f th e art ic le s t og ethe r, an d s pe ci fic al ly

co ns id eredDr. Poe hl in g’s o wn ad m is si on th atno li te ratur e ex is ts co nc lu di ng th at in tra -art ic ul ar p ai n p um

ps are t he cau se of g le no hym eral ch on dr ol y si s. Ra th er, al l of th e art ic le s m erel y

st at edpo te nt ia l as so ci at io ns an d s pe cu la te d tha t s uc h p ai n pu m ps m ed ic al ly caus e g le no hu m eral ch on dr ol y si s. Th e d is tri ctco urt al so no te d th atno ne of t he art ic le s ex pl ai ne d t he m ech an is m by whi ch bupi va cai ne da m ag ed hu m ancart il ag e. The fa ctth atth e d is tri ctco urt the n fu rth er an al yzedeach art ic le in de ta il an d fo un d e ach to be un rel iabl e was a pr op er ap pr oa ch to th e is su e. See Jo in er, 5 22 U.S. at 1 45 -4 6. Insu m m ary, th e d is tri ctco urt d idno t ab us e it s d is cret io n i n fi nd in g t ha t the li te ratur e Dr. Po eh li ng ba se d h is co nc lu si on s upo n was in su ffi ci en t t o c reat e a rel iabl e m etho do lo gy whic h p as se s Daube rt m us te r. See M cCl ai n, 4 01 F.3dat 12 45 (“ [t]he Daub ertrequi rem en t tha t the expe rt t es ti fy to sci en ti fic kn owl ed ge – co nc lu si on s s up po rte d b y go odgro un ds foreach st ep in th e an al y si s –m ean s t ha t an y st ep th atren de rs th e an al y si s u nr el iabl e u nd er the Daub ertfact or s re nd ers th e ex pe rt’s t es ti m on y

in adm is si bl e.”) (i nt ern al cit at io ns an d quo ta ti on s o m it te d) . 1 8 The c ourt does not intend to sug g est that in order to survive Daube rt revie w, a 1 8 methodology

based on a

revie w of e x isting literatur e on the subjec t must rely on article s that draw a dire ct, conc rete , and absolute c ausal c onnection. Howe ver, in this case , g iven the pauc ity of re liable evidenc e and the specula tive natureof the a

rticles Dr . Poehling r elied upon, the c ourt cannot disagree to the point of finding a n abuse of

discretion in the district cour t’s conclusion (continued...) 236. Bac kg ro un d R is k

The di stric t co urt was furth er p ers ua de d b y th e fac t tha t n on e o f th e art ic le s to okin to acco un t the ba ck gr ou ndris ks forch on dr ol y si s: “ [t]he ris k apl ai nt iff an d ot he r m em

be rs of t he ge ne ral publ ic ha ve of s uf feri ng th e d is eas e o r in

jury that pl ai nt iff all eg es witho utex po su re t o t he dru g o r ch em ic al in qu es ti on .” McC la in , 40 1 F .3dat 1 24 3 (e m

ph as is in ori gi na l). Se ve ral of t he art ic le s Dr. Po eh li ng rel ie d up on ex pr es sl y

no te d tha t the cau se of c ho nd ro lysis rem ai ns un kn own , andth at id io pa th ic cau se s co ul d p la y a fact or . Dr. Poeh li ng ig no redsu ch ba ck gr ou ndris ks . Whi le reco gn iz in g t he ex is te nc e o f id io pa th ic (or un kn own ) cau se s o f ch on dr ol y si s, h e d is m is se d the m by m erel y

st at in g t ha t the ris k o f id io pa th ic ch on dr ol y si s i s es se nt ia ll y zero . The fai lu re t o t ak e in to acco un t the po te nt ia l fo r id io pa th ic al ly occu rri ng ch on dr ol y si s –pa rti cu la rly whengl en oh um eral ch on dr ol y si s i s a r el at iv el y ne w ph en om en onin ne edof f urth er s tu dy – pl acedth e rel iabi li ty of Dr. Po eh li ng ’s con cl us io ns in furth er d oubt . McCl ai n, 4 01 F.3dat 12 43 -4 4 (“ A rel iabl e m etho do lo gy sho ul d t ak e in to acco un t the ba ck gr ou nd ris k.” ).

(...continued)

1 8 that Dr. Poehling ’s methodology on g ener al ca

usation was not re liable for pur poses of Rule 702. 24B. Spec ifi c Cau sa tio n Tes timony

Dr. Poe hl in g a ls o o pi ne d t ha t the co nt in uo us in tra -art ic ul ar i nf us io n o f bupi va cai ne th ro ug h B reg ’s pai n p um p c au se d Ki lp atric k’s ch on dr ol y si s. When as ke d t he ba si s fo r th is co nc lu si on , Dr. Poe hl in g c ou ldpo in t t o n ot hi ng ot he r th an th e li te ratur e an d t he tem po ral rel at io ns hi p b etweenKil pa tri ck ’s in it ia l s ur ge ry an d hi s ch on dr ol y si s.

. . . I thi nkan y

sci en ti stwou ldsi t d own an d l oo k a t thi s cas e an d o bs erv e th e fac to rs of wh athapp en edto th is pa ti en t, wh athe lo ok edli ke be fo re an d wh athe lo ok s li ke no w wou ldco m e to th e co nc lu si on th atbi pu va cai ne is whatcau se d i t, an d I d on ’t th in k t ha t tha t’s jus t m e o r — I thi nkan y

real sci en ti st . Su ch sp eci fic cau sa ti ontes ti m on y ha s b een fou ndto be in he ren tl y un rel iabl e in th is Cir cu it . McCl ai n, 4 01 F.3dat 1 25 4 (“ [T]he te m po ral co nn ect io n b etween ex po su re t o c he m ic al s an d a n o ns etof s ym pt om s, s ta nd in g a lo ne , is en ti tl edto li tt le weig htin de te rm in in g c au sa ti on . It i s al so subjec t t o t he pro bl em of as su m in g wh atth e witne ss is trying to pro ve .”). Dr. Poe hl in g t es ti fie d t ha t h e u se d t he “ di ffer en ti al di ag no si s” m etho do lo gy to fin d s pe ci fic cau sa ti on . This m etho d i nv ol ve s a p ro ces s o f co m pi li ng , or ru li ng in , a co m pr eh en si ve li stof p os si bl e cau se s t ha t ar e g en eral ly capab le of c au si ng th e il ln es s o r di se as e atis su e, an d t he n s y st em at ic al ly andsci en ti fic al ly ruli ng ou t

25sp eci fic cau se s u nt il a fi na l, s us pe ct edcau se rem ai ns . McCl ai n, 4 01 F.3dat 1 25 3.

It a ss um es th e ex is te nc e o f ge ne ral cau sa ti on , andfoc us es in st eadonsp eci fic cau sa ti on . The ex pe rt m

us t s ho w th ro ug h re li ab le ev id en ce tha t the rem ai ni ng cau se rul edin as a ctua ll y be in g c ap ab le of c au si ng th e co nd it io n. Kil pa tri ckis co rrec t tha t d iff eren ti al di ag no si s i ts el f ha s b een reco gn iz edas a v al idan d re li ab le m etho do lo gy. Bu t tha t i s n otth e is su e ab ou t wh ic h t he di st ric t co urt fo un d faul t. Rathe r, th e d is tri ctco urt fo un d tha t Dr. Po eh li ng ’s app li cat io n of th is m etho do lo gy was fl awed . In o rd er t o c orrect ly app ly thi s m etho do lo gy, D r. Po eh li ng m

us t h av e co m

pl ie d aco m

pr eh en si ve li stof p ot en ti al cau se s o f Kil pa tri ck ’s in

jury andm

us t h av e ex pl ai ne d wh y

po te nt ia l al te rn at iv e cau se s wer e ru le d o ut . Howev er, Dr. Po eh li ng on ly rule d o uttwo cau se s –th erm al en erg y an d ge nt ia n v io le t co nt ras t dy e. He cle arl y tes ti fie d t ha t h e co ul d n otex pl ai n wh y po te nt ia ll y

un kn own , or i di op athi c al te rn at iv e cau se s wer e n otrul edou t. Dr. Po eh li ng als o a dm it te d t ha t n ei th er h e n or an y on e el se in th e m ed ic al co m m un it y

“un de rs ta nd s t he ph y si ol og ic al pro ces s b y whi ch[ch on dr ol y si s] dev el op s an d wha t fa ct or s caus e th e p ro ces s t o o ccu r.” Thu s, the ke y fou nd at io n fo r ap pl y in g di ffer en ti al di ag no si s was m is si ng , andba se d o n t he se de fic ie nc ie s, the di st ric t co urt fo un d t ha t Dr. Po eh li ng fai le d t o app ly the di ffer en ti al di ag no si s m etho do lo gy reli ab ly. The d is tri ctco urt d idno t ab us e it s d is cret io n i n s o 26co nc lu di ng . McCl ai n, 4 01 F.3dat 1 25 3 (a n “ ex pe rt d oe s n otest ab li sh th e

rel iabi li ty of hi s t ech ni qu es or t he va li di ty of hi s co nc lu si on s s im pl y by clai m in g th athe pe rfo rm eda di ffer en ti al di ag no si s o n t he pa ti en t.”) . Kil pa tri ckcan no t o ve rco m e th e fac t tha t Dr. Po eh li ng ’s sp eci fic cau sa ti on te st im on y is roo te d i n atem

po ral rel at io ns hi p. “ [P]rov in g atem po ral rel at io ns hi p . . . doe s n otest ab li sh a cau sa l re la ti on sh ip . . . . [S]im pl y be cau se a pe rs on tak es drug s an d t he n s uf

fers anin jury doe s n otsh ow caus at io n.” McCl ai n, 4 01 F.3dat 12 43 (em ph as is in ori gi na l). Th is is a cl as si c “po stho c erg o p ro pt er h oc ” fal la cy whi ch“ as su m es cau sa ti on fro m tem po ral seq ue nc e. It l it eral ly m ean s ‘aft er tha t, be cau se of thi s’ . . . . It is cal le d afal la cy be cau se itm ak es anass um pt io n b as ed on th e fal se in fere nc e th ata te m po ral rel at io ns hi p p ro ve s a c au sa l re la ti on sh ip .” Id . Dr. Poeh li ng m ad e cl ear t ha t h e rea ch edhi s co nc lu si on s wi th res pe ctto Kil pa tri ck ’s in

juri es m erel y

by loo ki ng at Ki lp atric k’s s ho ul de r be fo re an d a fte r th e u se of B reg ’s pai n p um p. Th e d is tri ctco urt d idno t ab us e it s d is cret io n i n fin di ng Dr. Poe hl in g’s m etho do lo gy to e st ab li sh sp eci fic cau sa ti on un rel iabl e un de r Daube rt. V. Con cl us io n The di stric t co urt co nduc te d a n e xh au st iv e an d t ho ro ug h re vi ew of th e ev id en ce Ki lp atric k s ub m it te d t o s up po rt c au sa ti on , andco nc lu de d t ha t h is ex pe rt 27wit ne ss di d n otem pl oy a reli ab le m etho do lo gy to s up po rt h is co nc lu si on s. Th is co urt h as care fu ll y

rev ie wedth e sa m e ev id en ce an d fi nd s t ha t the di st ric t co urt d id no t ab us e it s b ro adjud ic ia l d is cret io n i n s o h ol di ng . W e are aware t ha t co urts in ot he r ci rcu it s h av e ta ke n am or e ex pa ns iv e ap pr oa ch an d p erm it te d e xp ert te st im on y in si m il ar s itua ti on s. See McCl el la n v . I-Fl ow Co rp ., __ _ F . Sup p. 2 d

__ _, 2 01 0 WL 17 53 26 1 (D. Or. Ap r. 29 , 20 10 ); S ch ot t v . I-Fl ow Co rp ., __ _ F . Supp . 2d__

_, 2 01 0 WL 10 08 47 8 (S .D. Ohio Mar. 1 6, 2 01 0) . Howev er, Kil pa tri ck ’s bri efs su fferfro m a pauc it y of b in di ng pre ced en t t o s up po rt h is po si ti on , andwith g oo d re as on . The l aw of th is Cir cu itis cle ar tha t the di st ric t co urts are g iv enbro addi sc ret io n wi th wid e la ti tu de in co nduc ti ng a Daube rt a na lysis an d c on cl ud in g t ha t m etho do lo gi es ba se d o n s pe cu la ti ve li te ratur e an d t em

po ral pro xi m it y

an al y si s s uc h a s t he type rel ie d upo n b y Dr. Po eh li ng are n otsu ffi ci en t t o p as s Daube rt r ev ie w. W e h av e p rev io us ly hel d t ha t “ th e ab us e o f di sc ret io n s ta nd ardall ows ‘ a ran ge of c ho ic e fo r th e d is tri ctco urt, s o l on g a s t ha t ch oi ce d oe s n otco ns ti tu te a cl ear e rro r of

jud gm en t.” Ra sb ury

v. In te rn al Rev enue Serv ic e (Inre Ras bu ry ), 24 F.3 d 1 59 , 16 8 (1 1t h C ir. 1 99 4) (qu ot in g Un it edSta te s v . Kell y , 88 8 F .2d73 2, 7 45 (1 1t h C ir. 1 98 9) ). The s iz e o f th atran ge – p art ic ul arl y when de al in g wi th ev id en ti ary is su es – i s s ig ni fic an t, an d we d eferto a di st ric t co urt’s ev id en ti ary 28ru li ng s t o aco ns id erab le ex te nt . Bro wn, 4 15 F.3dat 1 26 5. In parti cu la r, th e ab us e

of di sc ret io n s ta nd ard“ th riv es ” whe n a dd res si ng Daub ertis su es . Id. at12 65 -6 6. See Ku m ho ti re, 5 26 U.S. at 1 52 -5 3; Uni te d S ta te s v . Abre u, 4 06 F.3d13 04 , 13 05 - 07 (11 thCir . 20 05 ); M cCl ai n, 4 01 F.3dat 1 23 8. Gi ve n t he fact s o f th is cas e, th e la w of t hi s C irc ui t, an d p art ic ul arl y in li gh t o f th e d efer en ti al st an da rdof r ev ie w affo rd eddi st ric t co urts in th es e cas es : “ th e h eav y th um b – real ly a thu m

b a nda fin ge r ortwo – t ha t i s p uton th e d is tri ctco urt’s s id e o f th e sc al e,” the co urt co nc lu de s t ha t i t was no t an ab us e o f di sc ret io n t o e xc lu de th e ex pe rt o pi ni on of Dr. Poe hl in g i n t hi s ca se . Brown , 41 5 F .3dat 1 26 8. AFFIR MED

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