FIFTH DIVISION August 6, 2010

No. 1-09- 1790 WILLIA M RAL EIGH, ) Appe al fro m the ) Ci rcu i t Cou rt of Pl ai n ti f f -A pp el l an t, ) Co o k C o un t y.

) v. ) No. 06 L 5695 ) ALCON LABOR ATO RIE S, IN C. , a nd ) WEST SUBURBAN MEDICAL CENT ER, ) The Honorable ) E liza be t h B ud zin sk i, Defendan ts-Appellees. ) Judge Presidin g. JU STI CELA

VI N del i v ered th e op i n i on of th e c our t: Thi s appeal

in volv es the m edi cal and l egal sequel la e from a cataract surgery i

n wh ic h an in trao cul ar len

s was i mpl anted i n a sub urban m an’s ey e al most 10 y ears ago. On October 11, 2000, plai ntif f W il li am Ral ei gh, D.D.S., underwent surgery on h is righ t eye at the Wes

t Suburban Me di ca l Ce n ter (West Su b ur b an ) i n Oa k P ar k, I l l i n oi s. Dr . Sc ott Rose

n , a n oph th al mol ogist, perf orme d the procedu re an d i m pl an ted an AC RYSO F® i

ntraocu l ar len s (the

AC RYSO F® L en s), developed, de si

gne d, an d m an uf acture d by

Al con L ab oratorie s, In

c. (Al con), i

n pl ai ntif f ’sey e. W hi l e there we re n o com pl i ca ti ons dur i ng the su rge ry, pl ai nti f f l ate r ex pe ri en ce d pa i n a nd vi si on pr o ble ms in t he eye . We ek s la t er , a r ar e fu ng us , ph ae o ac r emo niu m ru br ige nu m, wa s fo un d in pla in tif f’ s righ t eye, requi

rin g the surgi cal

removal of the ey e. In the trial

court , plai

ntif f al le ged that t he product manuf

acturer should b e hel

d strictly li abl e, arguin g that t he l

ens i n questi on was in fected when i

t enter ed the st ream of comm erce, while sim

ultaneously

all egin g that West Su bur ban sho uld be h eld liable u nde r t he t heo ry o f res ipsa loquitur, arguin g that t he h

ospital was1-09-1790

2

in exclusive co nt ro l of t he inst ru menta lity tha t injured t he plaint iff . Aft er lengt hy disco ver y and
mo t io n p r ac t ice , t he t r ial c o ur t en t er ed dis po sit ive o r de r s in fa vo ro f t he de fen da nt s a nd t his appeal f ollowed. For r easons eluci dated below, we affi

rm i n al l respects. BACK GROUND ACRYS OF® An intr ao cular lens is defined in sect ion 8 86. 360 0( a) of t he Co de o f Fede ra l Regu latio ns (21 C.F.R. § 886.3600(a) (2000)) as a “de vice m ade of m aterial s such

as glass or plas

tic i ntended to be i m pl an ted to replace

the n atural l en s of an ey e.” In traocular len ses

are c l ass i f

i ed as Class III
medi cal dev i ces requi ri ng prem arket a pprov al prior to bei

ng c omm erci al l y di stri bute d. 21 C .F.R . §§886 .3600(

b), (c ) (2000 ). On Ma y 28 , 19 93 , Al con

su b m i tted a p re mar ke t ap pr ov al appl i ca ti on f or ACR YS OF ® to t he Unit ed S t at es Fo od and D ru g Administr at ion ( t he FDA) . Alco n’s ap plicat ion includ ed d esign,
man uf ac turi ng an d l ab el i ng sp ec i f i ca ti ons , f ul l rep orts of

al l kn own studiesan

d i nv es ti ga ti ons of ACRYSOF®’s saf

ety and ef fectiv eness, a stat emen

t o f A CRYSOF®’s components, pr oper ties,
an d it s p r inc iple s o f o pe r at io n, an d a de sc r ipt io n o f t he met ho ds , co nt r o ls, an d fa cilit ies us ed in
ma nuf acturing A

CRYSOF®. On

Decem ber 22, 1994, the FDA n

ot if ie d Al con that it had ap pr o ve d A CR YS OF ® a s a pr ema r ke t - ap pr o ve d C las s I I I med ica l de vic e s ub jec t t o ce r t ain cond i tions de scri

be d i n i ts appr oval l etter. ACRYSO F® re

mai ns on the market a s su

ch today
. Al con manuf

actur ed the ACRYSOF® Lens i n August 2000 and shipped i t t o West Suburban on Septembe

r 14, 2000. In its m

ot ion f or summ ary j udgme

nt, Alcon i

ncl uded an aff ida vi t from San

dra Budden, the regulator y c ompl ia nce m anager at Al

con, stating that it was h

er1-09-1790

3

op inion t hat Alcon c omp lied wit h t he fede ra l manufact ur ing spe cificatio ns and pr oc esse s du ring the manufactur e of t he ACRYSOF® Lens, a nd that it was not defective at the t im e it left Alcon’s
man uf ac turi n g f ac i l i ty . Al con ’s

man uf ac turi n g docu men ts d em on strate th at A l con com pl i ed wi th the FDA ma nuf acturing s peci fi cations f or ster il iz ation, ai r and surf ace m ic robiological
env ironm ental testing, and pa

ckagi ng. The ACRYSOF® Le ns was 1 of 5,176 in

trao cul ar len

ses f rom B atch

No. 0022 96 tha

t me t ma nuf acturi ng s peci f i cations f or rel eas e i

n A ugust 2000. Th

ere were no other compla

in ts of fun gal contami nation f rom Batch No. 002296. The Surgical Procedur

e at West Suburban Pl ai ntif f ’ssurg ery, perf

orme d by Dr. Rose n, l asted approx i matel y 30 m i nute s. Approxi ma tely 20 mi nutes i nto t he surgery

, the ACRYSOF ® Lens

was rem oved from

its sea le d pac kag ing and p laced on a plast ic dish, s t ill wr app ed in st er ile mater ial. The ACRY SO F® Le ns was t hen r emove d us ing for cep s. D r. Ro sen t hen plac ed t he ACRY SO F® Le ns in plaintiff’s right ey e usi ng the f orceps. The eye

was then s

utured and covered wi

th a patch and pl

ai ntif f was discha rg ed. Within 24 hou rs o f the sur ger y, plaint iff informed Dr . R os en t hat he wa s having diffi cult y seeing o ut of t he eye a nd exp er iencing pa in. On N ove mber 5 , 2 000 , D r. Fra nk LaF ranco perf

orme d a v i trectom y procedu re, duri ng w hi ch f l ui d was rem oved f rom th e ey e. A culture perfor med on the fl uid reveal ed the presence o f the af

orementioned fungus. Deposition T

estimony Presented to the Trial Cou rt Dr . Rose n testi f i ed th at h e h ad perf orm ed appr ox i mate l y 6,0 00 ca tarac t su rg eri es pri or to pla int iff’s pr o ce du r e. Fu ng al e nd o ph t ha lmit is, he t es t ified , is ve ry ra r e a nd o cc ur s in “ sig nific an t ly l ess than one p erce

nt” of catara ct surg eries. N o other pati en ts that h e perf orme d catar

act su rgery1-09-1790

4

on that day dev

el oped any

type of i nf ection i n the ey e. There was nothi

ng unus ual noted about the storage o r handl

in g of the AC RYSOF® Len s by West Suburb an. Dr. Rosen used approx i matel y 10 su rgical i nstrumen ts an d 9 oph thal m i c sol uti ons d uri ng a nd a f ter the procedur

e. Dr. Ros en

tes ti f i ed tha t an y of the se i ns trum en ts or s ol utions coul d have b een s ourc esof pl ai ntif f ’si nf ection. Dr. LaFranco t estifi

ed that “somethi

ng that o ccurred in the oper ating roo m was the cause of thi s i nf ection, whethe

r it was a n

onsteril e i nstrume nt, a nonsteril

e fl uid, a n onsteril e [in trao cul ar l en s] , an d n ons teri l e surg eon ’s

f i ng er. ” D r. L aFran

co h ad “ no way of kn owi ng ” that the i

nf ec ti on occurre d i n the opera

tin g room, b ut i t was h i s “ be l i ef i s tha t thi s organ

i sm wasput i nto Mr. Ral ei gh ’s ey e i n th e op era ti ng room .” D r. L aFran

co h ad no op i ni on to a rea son ab l e d egree

of medical ce rt ainty as t o t he so ur ce o f the fungu s. D r. LaFr anco t est ifi ed t hat t he fung us “is su ch a
r ar e o r ga nism [ he ] wo uld sp ec ula t e t ha t it s c au se wa s no t t he no r mal br ea kd o wn o f st er ile techni que.” Dr . Micha el Ber gman, plaint iff ’s exp er t , t est ifi

ed t hat “human er ro r w as invo lved in one way or the othe

r. [E]nv i ronm en tal mold s sh oul d not b e con

tam i na tin g prostheti c dev

i ces .” Assuming t hat t he ACRY SO F® Le ns wa s co nt aminate d by t he fo rc eps use d du ring t he procedu re, Dr. B ergm

an be li ev ed th at We st Sub

urb an dev i ated f rom th e stan dard of medi cal care in the manne r in which it st er ili zed t he fo rc eps , st at ing t hat “eithe r t he st er ili zat ion o f the inst rume nt wa s a pr o ble m o rt he ve nt ilat io n in t he un it wa s a pr o ble m. Ne it he ro f wh ich is pr oba ble but eithe r o f which co uld have happ ened .” Dr . B er gman o pined t hat beca use t he in fection predomi

nan tly origi nated i n the posterior cham

ber, “the probl

em began nearby whi ch1-09-1790

1 Pl ai ntif f origi na l l y f i l ed thi s ca

use of a cti on ag ai nst West Subu

rba n, A l con, a nd Dr. Rosen i n 2002. In Jun

e 2005, plai

ntif f v oluntarily dis mi ssed the case . In June 2006, pl ai ntiff refiled t his c au se ag ain st t ho se sa me t hr ee de fen da nt s. I n S ep t emb er 20 08 , Dr . Ro se n a nd his pr ac t ice gr o up , We st Su bu r ba n E ye As so cia t es , we r e g r an t ed su mmar y jud gme nt . T ha t o r de ris not a pa rt of th i s ap peal
. 5 would i ncri mi nate, num ber one, the lens an

d its m anuf acturing or postmanuf

acturing pac

kagi ng, or t wo *** the forceps.” Anot her expe rt for plaint iff , D r. Michael Rinaldi, t est ifi ed t hat t he mos t likely sour ce o f the fungu s wa s t he ACRY SO F® Le ns, bu t ack now ledge d t hat ot her so ur ces included t he o per at ing suit e pe rso nnel, o pht halmic solut ions u sed dur ing t he pr oc edu re , t he su rg ical instr ument s, a nd t he operating room env

ironm ent. Dr. Rin

al di testi fi ed that a funga

l i nf ection i s a ri sk of cataract
su rg er y th at d oes n ot n ec es sa

ri l y mea n th at s om eon e w as n eg l i gen t. The Pleadings and the Trial Court’s Dis positive Rulings On January

20, 2009 , plai

ntif f f il ed hi s amen

ded complai

nt, allegi ng two count s against each de f en da n t. 1 As to Alcon, p l ai

ntif f al l eged state l aw cl ai m s f or stri ct product l

i ab i l i ty (c ount I) and n egl ige nce (count II), asserting that the ACR YSOF® Lens contain

ed the fun gus whi ch
cau sed his infectio n at t he t ime it was manufact ur ed a nd pr ior t o t he t ime it was place d int o t he stream of c omm

erce. As to West Suburban, plai ntif f al le ged a count for medi

cal negl ige nce (c o unt II I) and a c o unt und er t he d o ct rine o f res ipsa loquitur, all egi ng that West Suburb an was in ex clusiv e co ntro l of al

l pot ential sourc es of t he fungus that led to and caused plain tiff ’s1-09-1790

6

subsequent in

juries (count IV). On May 15, 2009 , t he trial court ent ered t wo o rders, t he f irst
or der gr ant ing Alcon’ s mot ion fo r su mmary judgment as t o c ou nt s I a nd I I, and t he se co nd granting West Suburban’s m ot ion f or summary

judgm ent on co unt III and i

ts mot ion to dismi

ss count IV pursuant to section 2–615 o f the Code of Civi l Procedure ( 735 ILCS 5/2 –615 (West 20 00 ) )
. On Ju ne 12 , 20 09 , pla int iff filed a t imely no t ice o f ap pe al. Pla int iff su bmit s t hr ee iss ue s o n a pp ea l. Fir st , pla int iff co nt en ds t ha t t he t r ial c o ur t er r ed in dismissing co unt IV of his co mplaint bec aus e he e st ablished t hat he wa s injured while unde r t he excl usi ve control of W

est Suburban

and that the i

nj uries would not have occurred in the absen ce o f neg ligen ce as re qu ire d by t he d o ct rine o f res ipsa loquitur . N ext , p laintiff cont ends t hat t he t rial co ur t er re d in gr ant ing West Su bur ban’s mo t ion fo r su mmary judgment when t he
un con tra di cte d ev i den ce

estab l i sh ed th at W est Su b ur b an ’s con du ct w as n eg l i gen t an d th at i ts negligenc e ca use d injury t o him. T hird, plaint iff co nt ends t hat t he t rial co ur t er re d in gr ant ing A l con ’s moti on f or sum mar y j udgm en t wh en th e u n con tra di cte d ev i den ce

estab l i sh ed th at a pr o du ct man ufa ct ur ed by Alc o n c au se d in jur y t o him. AN AL YSIS Res Ispa Loquitur Plaint iff first co nt ends t hat t he t rial co ur t er re d in dismissing co unt IV of his co mplaint because he establ is hed that he was

in jured wh il e under the ex

cl usi ve control of W

est Suburban and t hat t he injuries w ou ld no t have o ccu rr ed in t he abs ence of ne gligence as r equ ired by the do ct rine o f res ipsa loquitur
. We review an order granting a section 2–615 motion to dism iss de
novo. Heastie

v. Roberts , 226 Ill . 2d 515, 530-31 (2007). Sim il arly , we revi ew whether the res1-09-1790

7

ipsa loquitur

doctri ne shoul d app l

y , whi ch pres en ts a que sti on of

l aw, de novo
. Heastie , 22 6 I ll. 2d at 53 1. “I n r ev iew ing t he su fficie nc y o f a c o mpla int , a c o ur t mus t ac ce pt as t rue all w ellple aded fa

cts and al l reas onabl

e i nf erences that m

ay be drawn from those facts.” Heastie , 22 6 I ll. 2d at 53 1. A c o ur t mus t als o co nst rue t he alle ga t io ns in t he co mpla int in t he ligh t mo st fav o r ab le to the pl ai nti f f an d s hou l d n ot di sm i ss a c au se of ac ti on “ un l es s i t i s c l ea rl y appa ren t tha t no s et of facts can be proved that would en

title the pl

ai ntif f to recovery.” Heastie , 226 Ill . 2d at 531. In medi cal mal pra cti ceca se s, w

he re th e p l ai nti f f rel i esupon the doc tri ne of res ipsa loquitur , t he court must determine wh ether t hat do ctrine is

appli cable. 735 I LCS 5/2–1113 (West 200 0) . T he co ur t may rely upo n co mmon kno wledg e o r e xper t medical t est imony in det er mini ng tha t the medi cal res ul t com pl ai ne d of wou l d n ot ha ve ordi na ril y occurred i n th e a bs en ceof
n eg l i gen ce

on th e p ar t of th e def en da n t. 7 35 IL CS 5/

2– 11 13 (West 20 00 ). A

pl ai n ti f f se ek i n g to rely on the res ipsa loquit ur doctr in e m ust plead an

d prove that he was i

nj ured: (1) in a

n occurrence tha

t ordi na ril y doe s n ot ha ppe n i n th e a bs en ceof ne gl i ge nc e, ( 2) b

y an ag en cy or i nstrumen tal i ty w i thi n the def endan t's exc l usi ve control
. Heastie , 226 Il

l . 2d at 53 1-32. “Bef ore res ipsa loquitur

ca n b e a pp l i ed , i t m us t b e sh own

th at th e i n j ur y ca n b e trac ed to a specifi c i nstrume ntali ty or cause f

or which the defe ndan t is responsi

ble or t hat the defe

ndan t was responsi ble for al l reas onabl

e causes to which the acci dent could b e attr ib

uted.” Napoli v. Hinsdale Hospital , 213 Il l . Ap p. 3d 38 2, 388 ( 1991) ( res ipsa loquit ur do ct r ine inapp lica ble where pl ai ntif f f ai le d to establ

is h that the possibil

ity of her i nj ury occurri

ng af ter arrivi ng at hospi tal was greater than the possi bi li ty i t o ccurred bef

ore her arrival); seeSmith v. Eli Lilly & Co. , 137 Ill. 2d 222 , 2 57 ( 199 0) (in res ipsa loquitur actions, “ al l pa

rties wh o could have b een t he1-09-1790

8

ca us e of the pl ai nti f f 's i njuri es are j oi ne d a s def

en da nts . Th i s h el psto pre serv e the i

de nti f i ca ti on element beca use liabil

ity will sure ly f

all on t he ac t ual wr ong do er ”) . “Wher e t her e ar e differing possibl e causes of an ac ci dent and a pl ai ntif f can not establish that i

t was defen

dant's actions whi

ch
caus ed th e ac ciden

t, res ipsa loquitur

wil l n ot be appl ic abl e.” Napoli , 213 Il

l . Ap p. 3d a t 388. A pla int iff’s failu r e t o na me a s d efe nd an t s a ll o f t he en t it ies wh o migh t ha ve ca us ed his in jur ies is fatal to the action si

nce the pl ai ntif f m ust “ ‘el im in ate the possib il

ity that t he acci

dent was caused by someone other than an

y de fen dant.’ ” Loizzo v. St. Francis Hospital, 121 Ill . App. 3d 172, 178 (1984), quo ting 3 J . Doo le y, Modern Tort Law § 48.19, a t 347 (197 7). We concl ude that plai

ntif f’ s own experts establ

is hed that pl ai

ntif f h as f ai le d to prove that hi s i njury wa s th e ty petha t woul d n ot ha ve nor mal l y occurred i n th e a bs en ceof ne gl i ge nc e on b eh al f of W est Su b ur b an . L ooki

n g a t th e s am e ev i den ce , i

t i s a pp ar en t th at p l ai n ti f f h as f ai l ed to prove that he was

i nj ured b y an i nstrumen tal i ty w i thi n W est Sub urb an ’sex cl

usi ve control
. Among o t her cau ses, Dr . B er gman t est ifi ed t hat t he lens may have be en infect ed w hen it left t he contro l of the ma nuf acturer. T hi s testim

ony, i n an d of i tself , would appear to render the res ipsa loquitur doctr in

e i nappl ic abl e as a m atter of law. Further, although Dr. Bergm an b el ie ved that hu man err or m ay ha ve ca us ed the i nf ec ti on, he al so state d that a

res ul ti ng i nf ec ti on d oesnot
n ec es sa ri l y mea n th at s om eon e w as n eg l i gen t du ri n g or af ter th e s urgery . Th

i s, to us , s ug ge sts that t hi s type of

in jury can occur i

n the ab sence of

negl ige nce, whi ch i s another fa

tal f la w when one attempts to util

iz e this le gal theory. Dr. Rin

al di, pl ai ntif f’ s other expert, agreed t hat a fun gal in fection is a ris k of cataract surgery an

d that its occurrence does not necessari ly me an that1-09-1790

9

som eon e w asne gl

i ge nt. Un de r th es e f

ac ts, we c an

not c onc l ude tha t plai nti f f ’s i njury wou l d n ot ha ve norm al l y occurre d i

n the ab sen

ce of ne gli gen ce on beha l f of W est Sub urb an . Wh il e pl ai ntif f’ s wi tnesses appea

red to agree that the in

fection was m

ost li kel y c aused dur ing t he su rg ical pr oc edu re , t hey also t est ifi ed t hat t her e we re multiple p ot ent ial sou rc es o f the fungus, including the sur gical suite, sur gical pers onnel, s urg ical i nstr uments, and t he ACRYS OF® Lens . Dr. Bergman’ s testim ony rev eal ed that he bel

ie ved the m ost pro bab le

source of the fun

gus was the m

anuf acturing or postmanuf

acturing of

the ACRYSOF ® Lens . That the surgical
en vir o nme nt wa s t he ca us e o f t he infe ct io n w as o nly “a r emo t e p o ss ibilit y.” Pla int iff did no t na me any ot her pot ential

defendan ts in hi s res ipsa cou

nt, i nc l udi ng A l con or th e m an uf ac ture rs or prov i de rs of an y of the othe r i ns trum en ts u se d du

ri ng the proc ed ure . Be ca

us e p l ai nti f f ca nn ot trac e the s ourc e of

the f un gus to a spe cif

i c i ns trum en tal i ty i n W es t Sub urb an ’s excl us i ve con trol
an d h as no t na med as de fe nd an t s a ll p o t en t ial e nt it ies t ha t may h av e r ea so na bly c au se d h is in ju r y, res ipsa is not app licable. Acc or dingly, t he t rial co ur t pr op er ly dism issed c ou nt IV of t he
am en de d c om pl ai n t. Negligence Plai nti f f ne xt c onte nds th at the tri al cou rt er red i n g ran ti ng W es t Sub

urb an ’s moti on f or sum ma ry j udgme nt when the uncontradicted evi dence establi shed that Wes

t Suburban’ s conduct
wasne gli gen

t and that i ts ne gli gen

ce c aus ed i

nj ury to hi m . We revi ew th e en

try of sum mary j udgm en t de novo and c ons t ru e all evidenc e st rict ly against t he mova nt and liber ally i n favo r o f the resp onde nt. Fitzgibbon v. National Broadcasting Co. , 314 Il l . Ap p. 3d 52 , 54 (20 00). Sum mary1-09-1790

10

j udgm en t i s a pp rop riate

i f th er e is n o gen ui n e iss ue of mate rial f ac t an d th e m ov an t i s e n ti tl ed to judgment as a mat te r o f law. 735 ILCS 5/2 –10 05( c) ( West 200 0); Fitzgibbon , 314 Ill . App. 3d at 54. A motion for summ

ary j udgment should be granted when the pleadi ngs, depositions, aff idav its, and admissions on f

il e show that there is no genuin e issue of m

aterial f act. 735 ILCS 5/2–1 005(c ) (We st 2000 ). In a m ed i ca l mal pr ac ti ce ac ti on , the p l ai

n ti f f m us t estab l i sh

th at th e def en da n t owe d a du ty t o t he plaint iff

, t hat t he du t y was br eac hed, and t hat an injury and damag es w er e dir ect ly and proxi matel y caus ed b y that breach. Siw

a v. Koch , 3 88 I ll. App. 3d 4 44, 447 (2 009 ). While the is sue of proxi

ma te cause is

ordinari ly a question of

fact f or t he j ury, sum

ma ry j udgme nt is proper as a matt er of law when t he plaint iff fails to pr ese nt affirmative e vidence t hat t he de fendant 's
ne gli gen ce was arg

uab l y a proxi mate ca use of the pl ai ntif f 's i nj uri es. Wiede

nbeck v . Searle , 385 Il l . Ap p. 3d 28 9, 292- 93 (20 08).

“ Prox i mateca us e m us t be es tab l i sh ed by ex pe rt testi mony to a re as ona

bl e d egree of
me dic al certainty .” Wiedenbeck

, 385 Ill . App. 3d at 293. “The causal connection between treat me nt, or a delay

and treatmen

t, and the clai

me d in jury ‘[m ust not be] contingen

t, speculati

ve, or merel y possi ble.’ [Ci tation.]” Wiedenbeck

, 38 5 I ll. A pp . 3d at 29 3. “An e xp er t 's o pin io n is onl y as v al i d asthe re ason s f

or the opi ni on. [Ci tations]. W

hi l e testi mony grounded i

n ‘ ex pert
anal y si s of the k nown phy sical f acts’ i s we l com

ed, con cl usory opi ni ons b ase d on she er, unsub stantiated specul

ation sh ould be considered irrel

evan t.” Wiedenbeck

, 385 Ill . App. 3d at 293, quot in

g Petraski v. Thed os, 382 Il l . Ap p. 3d 22 , 31 (20 08).1-09-1790

11

Plai ntif f rel ie s on the testim

ony of Dr. Bergman

in assertin g that t he “

undi sputed evidence
was t hat West Su bur ban medica l sta ff fail ed t o c omp ly with t he st anda rd of med ical car e by allo win g t he fun gu s t o be int r o du ce d in t o [ his] eye . ” T he r ec o r d in no wa y su pp o r t s t his
con ten ti on. Dr. Bergm

an tes ti f i ed tha t he ha d n o rea son to be l i eve that a

ny hos pi tal pol i cy or proc ed ure wa s def i ci en t or wa s a ca us e of pl ai nti f f ’s i njury. Dr . Be

rgm an tes ti f i ed tha t he di d n ot bel iev e Dr. Ro sen or either of the t wo nurses invol ved i n the proce dure, nurse Bando and nurse Sh alik o v, de via t ed fr o m t he st an da r d o f ca r e. I n fa ct , Dr . Be r gma n st at ed t ha t Dr . Ro se n “d id not hing t hat was a de viatio n fro m the s t anda rd . T hat eithe r he had r ece ived a c ont aminate d lens
or t hat t her e wa s co nt aminatio n [p os t manufact ur er ] o f the lens, bu t neithe r [ was ] a nything he could con trol b ut, unf ortunatel y , his nam

e was attached to the s

urgery .” An exam in ation of the m

ai n ex pert t estim

ony i n thi s m atter reveals that the opini ons that pla int iff se ek s t o ut ilize t o un do t he o r de r s o f t he t r ial c o ur t ar e b uilt up o n a ss ump t io ns. On ly aft er assu ming the ACRY SO F® Le ns wa s no t t he so ur ce o f the fungu s did D r. Ber gman o pine that t he f orceps were the source of the fun gus and that the hospi

tal staf f at We st Suburban pa

rted from the appli

cable standard o f m

edical care in the way

it sterili zed the forceps. In ot her word s, only when pla in tif f’ s counsel

asked Dr. Bergm

an to assum

e that the very

source he bel

ie ved contai ne d the f ung us– th e A CRY SOF ® Le

ns – was not the s ource of

the f ung us, c oul d Dr. Be r gma n c o nc lud e t ha t We st Su bu r ba n d ev iat ed fr o m t he st an da r d o f ca r e. Abs en t t his spe culat ion, Dr . B er gman co uld no t t est ify t o a re aso nable de gr ee o f medical cer t ainty t hat t he forceps were the source of the f ungus. Dr. Bergm

an’s bel ie f that i t was a remote possib il

ity that1-09-1790

12

the surgi cal

env ironm ent caused the i

nf ection does not satisf

y pl ai ntif f’ s burden in establ is hi ng a causal connecti on, much

le ss establ

is h that there was any

negl ige nce on the part of hospi

tal personnel durin g this procedure. Dr. Bergm

an coul d not t estif

y to a reasonabl

e degree of m

edi cal cert ainty that t he forcep s, t he surgical suite, Dr . Ro sen, o r any ot her entit y i n West Subur ban’s contr ol deviated fro m the standard of care o r caused t he i nj ury to plainti ff

. This evi dence is a wo efully i nsufficient basis up on w hich to pr oc eed in a claim of pr ofe ssio nal negligenc e and t he trial cou rt w as ri gh t to gran t su m mar y j udgm en t. Strict Liability and Express Fede ral Preemption Pl ai ntif f next con tend s tha t the tri al court erred

i n gr an tin g A l con’ s m

otion f or sum mary j udg men t when the un con trad i cte d e vi de nc e e sta

bl i sh ed tha t a p roduct m

an uf ac ture d by

A l con caused injury to him . Plain tiff all eged stat e law cl

aim s of strict li abili

ty and negl

igen ce agains t Al con. A l con m oved f or sum mary j udgm en t argui ng th at plai ntif f ’sstate-l aw cl ai m s we re preempted by

the Medical

Devi ce Am endm ents of 1976 (the Am

endm ents) (21 U.S.C. §360k (2006)) t o t he Fe deral F ood, Drug, and Cosm etic A ct (t he A ct ) (21 U.S .C. §301 et seq. (2006 )). In Riegel v. Medtronic, Inc. , 552 U .S. 312, 1 69 L. E d. 2d 89 82, 128 S. Ct. 999 ( 2008) , the Supreme C ourt considered whether the preem ption cl ause ena cted in the Am endm ents barred
comm on la w cl ai ms chal le ngi ng the saf ety an d eff ectiveness of a m edi cal devi ce gi ven premarket app ro val by the FD A. T her e, t he Co ur t co nclude d t hat plaint iff ’s st at e- law claims aga inst t he
man uf acturer of a

Class III prem arket a pprov ed b al

l oon cath eter us ed i

n h i s an gi opl asty were preem pted b y the A ct. Riegel , 552 U.S. at 330, 169 L. Ed. 2d at 906, 128 S. Ct. at 1011.1-09-1790

13

Under the Act’s am

ended regul

ator y s chem

e, there are three clas si fi

cations of me dic al dev i ce s, ca

teg ori ze d b y th e ri sk s th

ey pr es en t. Riegel , 552 U.S. at 316, 169 L. Ed. 2d at 898, 128 S. Ct. at 1003. Clas s III devi ces, such as the ACR YSOF® Lens, recei

ve the m ost federal
ov er si gh t. Riegel , 552 U.S. at 317, 169 L. Ed. 2d at 898, 128 S. Ct. at 1003. Af ter completi

ng a ri gorous rev

i ew proc ess , the F DA

may gran t or deny prem arket a pprov al
. Riegel , 552 U.S. at 31 9, 16 9 L
. E d. 2d at 89 9, 12 8 S
. Ct
. at 10 04
. “O nc e a de vic e h as r ec eiv ed pr ema r ke t ap pr o va l, [the Am endm ents] forbi

d[] the man

ufacturer to make, wi

thout FDA pe

rmission, change s i

n desi gn sp ec i f i ca ti on s, man

uf ac turi n g p roc es se s, l ab el

i n g, o r a n y oth er attr i b ute , that w oul

d a f f ec t sa f ety or eff ectiveness .” Riegel , 552 U.S. at 319, 169 L. Ed. 2d at 900, 128 S. Ct. at 1005. Section 360k(a) of the A

ct pro vi des the f oll owing e xpress preem

ption cl ause: “Exce pt as provided i

n sub section (b ) of thi s secti on, no Stat e or po li tical subdi vi si on of a State may

establ is h or continue i

n ef fect wi th respect to a devi

ce i ntended f or h um an us e a n y re qui re men t– ( 1) wh ich is d iffer en t fr o m, o rin a dd it io n t o , an y re qu ire men t ap plic ab le under thi s chapter to t he dev ic e, and (2) whi ch rel

ates to the saf

ety or eff ectiveness of the devi

ce or to any

ot her
matter i nc l uded i n a requi rem en t appl i cab l e to the de

vi ce un der thi s ch

apter.” 21 U.S.C
. §360k (a) (20 06). Pursuant to this

preemption cl ause, we m ust determi

ne (1) whether the f

ederal governm ent has es tabli shed requi

remen ts appli cabl e to ACRYSOF® and, i

f s o, (2) whether1-09-1790

14

pl ai n ti f f ’s com mon l aw cl ai m s f or s tri ct p rod uc t l i ab i l i ty an d n eg l i gen ce ar e b as ed on re qui re men ts i m pos ed by the State of Ill i noi s wi th res pe ct to ACR

YSO F® tha t are dif f ere nt f rom or i n a ddi ti on to the f edera l requi rem en ts an d rel ated to saf

ety and ef f ecti vene ss. Riegel , 552 U.S. at 321, 169 L. Ed. 2d at 901, 128 S. Ct. at 1006. Under the Act, stat e requirem ents are preem

pted only when the FDA has es tabli shed spe ci f i c requ i rem en ts appl i cab l e to a parti

cul ar dev i ce. Riegel , 552 U.S. at 322, 169 L. Ed. 2d at 901 , 1 28 S . C t . a t 100 6. Req uire ments co ncer ning device re gulat ion in gene ra l do not war ra nt preem pti on un der th e A ct. Riegel , 552 U .S. at 322, 1 69 L. E d. 2d a t 901-02, 1 28 S. C t. at 1006. In Riegel , t he Su pr eme Co ur t de t er mined t ha t pr ema r ke t ap pr o va l o f Cla ss I I I med ica l de vic es is speci fi c to indi vi dual devi ces and c onstitutes federal saf ety revi ew, expl ai ni ng that “the F DA req ui res a d ev i cetha t ha s r ec ei

ve d pr em ark et a ppr ova l to be mad e w i th a l most n o de vi ati ons f rom t he sp ecificat ions in its app ro val app licatio n, fo r t he r eas on t hat t he FDA ha s de t er mined t hat t he approved form

provides a reasonabl

e assuran ce of saf ety an d eff ectiveness .” Riegel , 552 U.S. at 323, 16 9 L. Ed . 2d at 90 2, 128 S . Ct. at 1007
. ACRYSOF ® is

a Cl ass III premarket approved devi ce, hav in g recei ved prem arket approval f rom the FDA

in 1994. The rigorous revi ew process conducted by the FDA constitutes a sp ecific feder al det er minatio n of t he sa fet y of ACRY SO F®. Like t he balloo n cat het er in Riegel , ACRYSOF ® was sub

je cted to , and was gi

ven , federal

approval. Pl

ai ntif f does n ot chal le nge that the F DA approv ed th e com

merci al di stri buti on of the A CRY SOF ® Le

ns . We turn, then, to t he second que stion: wh ether plai ntif f’ s comm on la w cl ai ms for strict1-09-1790

15

pr oducts l i ab i l i ty an d n eg l i gen ce ar e b as ed on re qui re men ts i m pos ed b y th e S tate of Il l i n oi s wi th
re spe ct t o AC RYS OF® t hat ar e differe nt fro m or in addit ion t o t he fede ra l req uire ments and related to safety

and ef fecti ven ess. The Riegel Cou

rt ex pl ai ne d “ tha t com mon- l aw ca us esof act ion fo r ne gligence and s t rict liabil ity do impose ‘re quir ement [s] ’ and wo uld be p re -e mpt ed by federal requirem ents speci fi c to a medical

devi ce.” Riegel , 552 U.S. at 323- 24, 169 L. Ed. 2d at 902, 128 S. Ct. at 1007. The Riegel Co ur t fou nd t hat co mmon law claims for st rict liabil ity and
ne gli gen ce c onsti tuted state re qui

rem en ts under th e A ct. Riegel , 552 U.S. at 324, 169 L. Ed. 2d at 902 , 1 28 S . C t . a t 100 7. As suc h, p laintiff’s st at e- law claims o f str ict p ro duc t s liabil ity and
ne glig en ce ar e p r ee mpt ed un de rt he Ac t , bu t “o nly t o t he ex t en t t ha t t he y ar e ‘ diffe r en t fr o m, o rin addi tion to’ the requirem

ents i mposed b y f ederal la w.” Riegel , 552 U.S. at 330, 169 L. Ed. 2d at 90 6, 12 8 S
. Ct
. at 10 11 , qu o t ing 21 U. S. C. §3 60 k( a) ( 1) ( 20 06 )
. T ha t is, pla int iff’s cla ims w o uld not b e p ree

m pte d if the y we re “ pa ral l el ” to the f ed era l req ui rem en ts, s uc h as i f the cl ai m s w ere f or dam ages prem i sed upon a vi ola tion of F DA regul ati ons. Riegel , 552 U.S. at 330, 169 L. Ed. 2d at 906 , 1 28 S . C t . a t 101 1. Her e, plaint iff do es no t allege t hat his inj ur ies we re pr emised u po n a vi olation of FDA regul

ations. Al

con has es

tabli shed that i

t compli ed wi th the FDA prem

arket approval process, recei

ved approval

in 1994, and that the ACRYSOF ® Lens was m anuf actured, pac kag ed, and s hipped in compliance wit h t he fede ra l req uire ments . Any co nclusio n hold ing Al con l ia ble under pl

ai ntif f’ s state-law cl

ai ms despi te Al con’s conf

ormance with the f

ederal requi rem en ts i m poses a state re qui

rem en t di f f eren t from the a ppl i cab l e f edera l requi rem en ts. Riegel , 552 U.S. at 330, 169 L. Ed. 2d at 906- 07, 128 S. Ct. at 1011.1-09-1790

16

Accor dingl

y, plai ntiff ’s clai ms are preempt ed by the Act and su mm ary judgment in

Alcon’s fav or was proper as a m

atter of law. CONCLUSION Wh il e i t is readi ly apparent that plai

ntif f s uff ered a signifi

cant i nj ury af ter t he surgi

cal implantat ion o f this int ra oc ular lens, it is also app ar ent t hat his st rict liabil ity claim is pree mpt ed by federal la w and that hi s attempt to util iz e res ipsa loquitur

to avoi d a

n u nd ers tan da bl e l ac k of pr o o f o f med ica l ne glig en ce is ma nife st ly impr o pe ras a ma t t er o f law
. T he jud gme nt o f t he cir cu it court is aff irm ed. Af fi rmed. TOOM IN, P.J., a

nd H OW SE, J., con

cur.1-09-1790

17 REPORT ER OF D ECI SION S – ILLI NOIS APPE LLATE COURT

(Front S heet to b e Attac

hed to Each C ase) WILLIA M RAL EIGH, ) ) Pl ai n ti f f -A pp el l an t, ) v. ) AL CON L

AB ORA TORIES, I

NC., ) and WE ST SU BUR BAN ME DI CAL ) CENTE R, )

Defendan ts-Appellees. )

No. 1-09- 1790 Appellate Cour t of Illinois Fir st D istr ict, FIF TH Division Aug ust 6, 2010 (Giv e mo nth, da y and y ear) JUSTICE LA VI N d el ivere d th e o pin io n o f th e c ourt: TOOMI N, P.J. , and

Hows e, J., co nc ur

Lo w er C ou rt and Tria l J udg e( s) in f

orm indi ca te d in t he m argi n: The Ho norable Elizabet h Bud zinski, J udg e Pr esiding

. Indicate if attorney represe nts APPELLANTS o

r APPELLEES and include attorneys o f co

unsel. Indicate the word NONE if not represe nted. Att orne y s f or Plaintiff/ Appellant : Mich ael T . Mul len, Richa rd J. Schr oeder William Raleigh Paul B. Epi scope, LLC 77 W. Washington St., Suite 300 Chicago, IL 60602 312.782.6636 Att orne y s f or Defen dan ts/A

ppel lees : And erson , Rasor Par tn ers, LLP West Subur ban Med ical C enter 100 S. Wacker Dr, Suite 1000 Chicago, IL 60606 312.673.7800 Alcon La borator ies, In c. C. Kin nier Lastimosa Plea se Use Following For m: Comple te TIT LE of Case

Dock et N o. COURT Opi ni on Filed

JU STICES

APPE AL from th e Ci rcu it Ct. of Co ok Co un t y.

For APPEL LA NTS, Joh n Doe , of Chi cago. For APPEL LEES, Smith and S mith of Chi cago, Joseph Brown, (of Co unsel) Also add at tor ne ys for third- party ap pe ll an ts or appellees.1-09-1790

18 Sedgwick, Detert , Mora n & Ar nold , LLP One North Wacker Dr., Ste. 4200 Chicago, IL 60606-2841 312.641.9050 Deb orah E. Lew

is, S. Vance

Wittie Sedgwick, Detert , Mora n & Ar nold , LLP 1717 Main Street, Ste. 5400 Dallas, TX 75201 469.227.8200