T hi s app eal was t r ansf er r ed t o t hi s C our t f r om t he Fi r st C our t of Appeal s byor derof t he T exas 1 S u p re m e C o u rt. See T EX
. G OV ’ T C OD E A NN . § 2 2 .2 2 0 (V e rn o n 2 0 0 4 ) (d e l i n e a ti n g th e ju ris d i c ti o n o f a p p e l l a te c o u rts ); T EX
. G OV ’ T C OD E A NN
. § 73. 001 ( Ver non 2005) ( gr ant i ng t he supr em e cour t t he aut hor i t y t o t r ansf er c a s e s fro m o n e c o u rt o f a p p e a l s to a n o th e r a t a n y ti m e th a t t h e re i s “g o o d c a u s e ” fo r th e tra n s fe r)

. 

### NU M BER 13- 07- 0009 0-C V 

## COURT OF A PP EA LS T H I R T E E N T H D I S T R I C T O F T E X AS CORPUS CHRI ST I -E DI NBURG
A LZA C ORP ORA

TION , A pp ellan t,

v . D OR IS T H OMPS ON , I N D IV ID U A L L Y, A ND TOWNSI FOULKROD AS LEGA L REPRESENTATIVE OF K EN Z EY T H OMPS ON , MIN OR , INDI VI DUA LLY A ND ON B EHA LF OF TH E ES TA

TE OF M ICH A EL YNN T HOMPSON, A pp ellees . On a p p ea l f ro m th e 11 3t h D is tr ic t C o u rt of H arris C ou nty , T exas . 1


### M EM ORA ND UM OPIN ION Be fo re Ju stice s Y añ ez, B en av ide s, an d Vela M emo rand um Opin ion b y Ju stice Ya ñe z“ W hi l e st r i ct l i abi l i t y f ocuses on t he co ndi t i on o ft he p r oduct , ‘ [ n] egl i gence l oo k s a t the act s of t he 2 m an ufa c t ure r and de t erm i ne s i f i t ex erc i s ed o rdi na ryc are i n d es i gn an d p rod uc t i on . ’ ” Am

. Tobacco Co. , I nc. v . G r in n e ll , 951 S. W

. 2d 4 20, 437 ( T ex. 199 7) ( quot i ng C aterpillar, I nc . v. S he ars , 911 S. W

. 2d 3 79, 384 ( T ex. 1 9 9 5 ))

. Al z a’ s br i efdescr i bes f ent any l as “ a power f ul nar cot i c pai nki l l er ” adm i ni st er ed b y a “ D ur agesi c pat ch

3 th a t re l e a s e s d o s e s o f th e m e d i c i n e i n to th e p a ti e n t’ s b l o o d s tre a m via th e s k i n .”

W e n o te th a t th e tri a l c o u rt w a s n o t th e firs t c o u rt to a d d re s s p u n i ti v e d a m a g e c l a i m s a g a i n s t A l za 4 b a s e d o n a l l e g e d l y d e fe c ti v e D u ra g e s i c fe n ta n y l p a tc h e s . See , e .g ., La ke
-All en v. Jo hn so n & J oh ns on , L

. P. , N o. 2: 08C V00930DA K, 200 9 U. S. D i st

. LE X I S 64860 , at * 9- 10 ( D

. U t ah Ju l y 27, 200 9) ( deny i ng d ef endan t s’ m oti on for su m m ary j ud gm en t on pu ni t i ve d am ag e c l ai m s ).

P l ai nt i ff s bel ow and appe l l ees h er ei n i ncl ude D or i s T hom pson, i ndi v i dual l y , and T ownsi Foul k r od a s 5 l egal r epr esent at i v e of Kenz ey T hom pson, m i nor, i nd i v i dual l y and on behal fof t he e st at e of

M i chael y nn T hom pson. 2 Al za Corp. ( “A lz a” ) appeal s a j udg ment on a j ur y v erdict rendered ag ain st iti n a
w ro ng ful deat h c ase inv olv ing al leg ati ons of neg ligen ce , str ict product s l iab il ity ma nufactu ring defects, a nd gross negligence regarding i ts ma nufactu re of the Duragesic 2 pat ch. T he m anu factu ring defect asse rted is a f law in the sea l of

the Duragesic pat ch
w hich a ll o w ed d eced ent , Michaelynn Th om pson , to receive a fata l ov erdo se of fent anyl, a pot ent n arcot ic

. The ne g li g ence and g ro ss neg li g ence cl aims i ncl ude c omplai nts that 3 Al z a c onti nued t o empl oy a v is ual i nspecti on proces s, int ended t o s pot ma n u fa ctu ri ng defects i n the D urag esi c p atc hes as they pas sed on a conv ey or bel t, ev en after Al z a k new that suc h a p ro ces s was ina deq uate to de tect t he flaw ed pat ches i n order to re mov e the m f rom d istribution to pat ients. 4 The pl ain ti ffs- appel lee s ( “t he Thompson famil y ”) tr ied thei r cl aims ar is ing from t he 5 dea th of Michaelynn Th om pson against Alz a b e fo re a j uryin the 11 3th Judicial District Court in Harris C oun ty, T exas, w ith the Honorab le Patr ic ia Hanco ck presiding. Th e jury found that there w as a manufactur ing defect in the D u ra gesi c p atc h wor n by Thompson
w hic h w as a c ause of her death, and further found thatAl z a w as neg li g ent, but d ecl ine d t o f in d A lza gro s s ly n e gl ig e n t

. T h e t ri a l c o u rtr e n d e re d ju d gm e n to n t h e ju ry’ s ve rd ic t

. Al zaT he e v i dence showi ng t hat T hom pson was wear i ng t hi s pat ch wi l l be di scussed l at eri n t hi s opi ni on. 6 T h e F D A u l ti m a te l y i d e n ti fie d e i g h t d i ff e re n t k i n d s o f d e fe c ts , w h i c h ra n g e d i n s e v e rit y fro m , e .g ., 7

“ st r i ngerl eaker s, ” wher e a st r and ofgel kept t he se al on t he p at ch f r om com pl et e cl osur e, t o t he def ect at i s s u e h e re i n , a “fo l d -o v e r” d e fe c t, w h i c h l e ft a n e n ti re s i d e o f th e D u ra g e s i c p a tc h u n s e a l e d

. 3 appeal s b y

fiv e i ss ues and mult ipl e sub- is sues , g enerall y ch all eng ing the suffici ency of the
ev i de nc e an d two ev i de nt i ar y r ul i ng s . W e affi r m. I. B A CKGRO UND T he Duragesic pa tch is a prescription pain pat ch utiliz ed to treat m ode rate to sev ere chroni c p ain

. It is a transde rmal syste m that adheres to a pati ent’ s s ki n and is des ig ned to provid e th e pa ti en t w i th a c on ti nu ou s , s y s te ma ti cd el i v er y o f fen ta ny l , a po te nto pioid anal g esi c, for a per iod of sev enty -tw o hours. This patc h i s c ompri sed of four l ay ers: an exter nal bac ki ng of

poly est er

f il m, a dr ug reser

v oir contai nin g fentany l and al cohol i n a g el sol uti on, a membrane t hat c ontrols the ra te of fentany l del iv er

y to the s ki n s ur

face, and an adh esive worn ne xt to the skin. The Duragesic patche s come in sev eral strengths. The Du ra g esi c 7 5 mcg /hr patc h wor n by

Thompson at t he ti me of her de a th w as

6 manufactured on Al z a’s Bodol ay machi ne. The patc hes at is sue w ere made at a rate o f about four per sec ond, and the q ual ity cont ro l proces s for the patc hes entail e d a v is ual
as s e s s me n t b y tw o i n s p e c t o rs a s t h e p a t c h e s w e n t b y o n a h i g h
- s p e e d c o n v e y o r bel t. From 2001 throug h 2004, Al z a doc umented many ins tanc es w here pat ien ts had recei v ed Durag esi c p atc hes manufactured on it s Bodol ay machi ne w it h flaw ed seal s that w ere not 7 detected b y

Al z a’s v is ual i nspecti on proces s. The number of pati ent c omplai nts reg ardin g defecti v e 75 mcg /hr

patc hes esc ala ted s har ply i n 2003 and ear ly

2004, ul ti matel y

i nv olv ing an insp ection bythe Unite d Sta tes Foo d an d Drug Adm inistration (“ FDA”) and the reca lls of four l ots of 75 mcg /hr

D urag esi c p atc hes. Rud olp h H oll and, a se nio r tec hni ci an on the B odol ay r unni ng the Durag esi c l ine for4

Al z a, te st if ied aboutthe spec ificmanufactur ing proces s a nd productco mponents that const itute the Duragesic pat ch. At tr ial, Holland testif ied that he w as not m e chan ically inc li ned, and t hat n o one e ver a sk e d him w hat c oul d hav e c ontr ibu ted t o the number of lea ki ng patc hes. Holland testif ied that he w as aware tha t Alz a had bee n no tif ied of a fold-over defect in a D urag esi c p atc h i n 2001. H oll and’ s s worn testi mony es tabl is hed t hat i n 2001, after lea rn ing thata fold -o v er oc cur re d, an d after

real iz ing how

the defect oc cur re d dur ing i ts
ma nufactu ring proce ss, the co mp any m ade n o chan ges to its q uality control proced ures; how ev er , Al z a di d i nst ru ct its e mploy ees to l ook for fold- ov er defects dur ing the v is ual ins pect ion proces s. H o lla n d tes ti fied th at A lz a’s v is ual i nspecti on proces s e ntai led
w atc hin g 120 li nes of productgo byper minute. H oll and t est ified thathe h as nev er se en a fold-over defect. Alz a’s v isual inspe ctions dete cted no prob lem s w ith the tw o-an d-a-ha lf mil li on D urag esi c p atc hes that w ere ul ti matel y recal led by

Al z a i n 2004 b e ca u se of the prev ale nce of fold -o v er defects

. In 2003 , Holland “thou ght everything w as f ine” regarding the co m p a n y ’s manufactur ing proces s, and thoug ht that the v is ual inspecti on proc ess w as suff ic ien t, but
conce ded in retrospectthat“w e cou ld have ma de s o m e c han ges,” and con clude d in his tes ti mony

before th e j u ry t hat a sk ing the employ ees to l ook harder for d efects w as not suffici ent t o prev ent p ro ductdefects

. Hol lan d tes ti fied th at A lz a i m p ro v ed and modified
som e of its inspection proced ures after the Duragesic recall in 200 4, so th at th e Duragesic pat ches n ow go through a w eight check, a p ressure check, a visual in spect ion, a nd qualipack te s t in g wit h a v acuu m. He fu rther test if ied th at quality assura nce e mp loyees also hol d “ li ne audi ts” ev er

y ei g ht ho urs. Hol lan d di d not know how many lea ki ng patc hes Al z a produce d; ho w ev er , bas ed onFor anot hercour t ’ s di scussi on o ft he FD A’ s Est abl i shm ent I nspect i on Repor t and i t s I nspect i onal 8 O bser v at i ons, pl ease see Mill er v . J an ss en Ph ar

m ac eu ti ca l

Pr od uc ts, L

. P. , No. 0 5- C V- 40 76
- D R H , 2 00 7 U

. S. D i s t

. LE X I S 31 86 3, at *8-9 (S

. D

. I l l

. M ay 1, 20 07 ) ( no t de s i gn ated for pu bl i c ati on ). 5 pati ent c omplai nts t o t h e c o mpany , 35 out o f 40 lo ts of 75 mcg patc hes manufactured betw een J anuar

y 1, 2003 an d J une 8, 2 0 0 4 co ntai ned l eaki ng patc hes. Ac cordin g to document s h e rev iewed attr ial , H oll and testi fied before the j ur y thatrepor

ts of leak ing p a t c h e s we re lo we r i n two o f t h e f ive re c a ll e d b a t c h e s t h a n in o t h e r b a t c h e s t h a tA lza
c h o s e n o tt o re c a ll

. Ho ll a n d e xp re s s ly a d m it t e d in t e s t im o n y t o t h e ju ry t h a th e wo u ld h a ve noti fied th e F DA

of the e sc ala ti ng number of fold- ov er

defects ear li er

than Al z a di d. As me ntion ed a bove, w hen comp laints f rom the p ublic abo ut th e Duragesic patch
esc ala ted s har ply

i n l ate 2 003 and 2004, the FD A inv est ig ated thi s probl em. Ac cordin g to the F DA ’s i nspecti on repor t, Al z a c haract er iz ed th e i nit ial probl em as an is ola ted i nci dent, 8 and Alz a’s app roach to the problem w as to re-train th e op erato rs: T he f irm f irst came across a fold over de fect f rom a f ield sam ple retu rn back in 10/01

. . . and ass ig ned a probabl e c ause as the p oly est er /EVA fil m bei ng folded ov er

dur ing a roll ch ang e or sta rt up. The fir m’s co rrect iv e acti on w as to t ra in operators t o “ hei g htened aw areness ” and that the fold ov er w as an “isolated inciden t.” T his corrective action did n ot prevent th e fold over defect from reocc ur ri ng . . . . The FD A’ s i nspecti on repor t found Al z a’s remedia l act ion s i nadeq uate:

• Cor re cti v e acti ons impl emented on 10/ 01 for Pouc hed Lot#01016 63 w ere inadeq uate to prev ent the fold ov er defectf ro m re occ ur ri ng as demonst ra ted i n Pouc hed Lot#’ s 0 327192 and 032 7294 on 02/0 4.

• Lack

of inc re ased acc eptanc e cri ter ia shou ld an i nspecti on fail a l ev el one i nspecti on.

• Firm did no t follow SOP 05-0 20-0 45 to discard pro ductaf ter a de fect w as found.

• Af ter awareness of fo ld over defect an d Volu nta ry Class 1 Recall, firm re lea sed Pouc hed Lot# 0330362 i nto c ommerc ial di str ibu ti on w it hout further i nspecti on.

• Pouc hed Lot# 03 2 7 7 11 w as re lea sed int o c ommerc ial di str ibu ti on6 even tho ugh it fa iled release specif ication s.

• In- proces s and QC chec ks w ere i nadeq uate to prev ent t he rele ase of the fol d ov er defect as demonst ra ted in Pouc hed Lot#’ s 0 327192 and 0327294.

• Fi rm did not follo w Sop 0- 109 t o j ust ify

co nti nuati on of product ion

. T he FDA’s inspe ction rep ort also spe cif ically add ressed Alz a’s training of the op erato rs: [T ]his app roach of reactio nary training of ope rators f rom f ield com plaint s did n o ta p p e a r t o a ll e via t e t h e s e typ e s o f p ro d u c td e fe c t s d u e t o t h is co rr e c t ive act ion bei ng se e n i n o ne Ex cept ion R epor t after anot her

. I ex press ed th e poss ibi li ty

of the fir m to i nst it ute a prev entat iv e train ing prog ra m for t he o p e ra to rs in ad d it io n to th e ir ro u ti n e GMP tr a in in g on a re gul a r ba sis th ro u gh the y ear . Al l par

ti es ag re ed th at t his w as a posi ti v e approach and prov ide d a memo reflect ing thi s p re v entat iv e train ing prog ra m . . . . T he FDA inspe ction rep ort also no ted thatthe “de fect w ould be incorp orate d into the pa tch and c oul d g o undet ect ed w it h c ur re nt Q A c heck s i n place .” Simi lar ly , t he F DA propose d
w ay s “ to prev ent thi s defect from re occ ur ri ng ,” and Al z a ag re ed th at “ eq uip ment c hang es and c ontrols are the bes t re medies for prev enti ng thi s d efect i n the future.” I n thi s c ontext, the F DA repor t doc umented numerous chang es in Al z a’s Bodol ay machi ne, w hic h w as at the end of

its usef ulne ss and sched uled for replace me nt, in ord er to redu ce the inciden ce of man ufactu ring defects. T he rep ort include s an evalu ation of this process wi th Alza’s manag ement: O n 6 / 0 8 / 0 4 , [ t h e FD Ar e p re s e n t a t ive ] h e ld a d is c u s s io n wit h [A lza represe nta tiv es] regarding the Bo dola y I FFS and [its] ab ility to prod uce q ua l i ty p rod uct or

s ho ul d th e ma c hi ne b e ret i red

. A l l t hree e x pres s ed t heir desire to improve ope ration s and thatt he imp lem ent ation o f t he HH FFS is on to p priorityto be validate d an d pu t in t o p ro d uction to be th e ma in manufactur ing l ine for Durag esi c a nd th erefore reser v e the Bodol ay

I FF S as a backup machi ne. Theyconti nued to ex press that the cha ng es made to the Bodol ay I FF S and the impl ementati on of t he v is ion syste m on t he Bod ola y I s houl d and w il l improv e the q ual ity of productproduce d.T h e F D A h a s s ta te d th a t: 9 R e c a ll is a n e ff e c tiv e m e th o d o fr e m o v in g o r c o r r e c tin g c o n s u m e r p r o d u c ts th a t a r e in vi ol ati on of l aw s ad m i n i s te re d b y t he F oo d a nd D rug A dm i ni s t rat i on . R ec al l i s a vo l un t ary a c ti o n th a t ta k e s p l a c e b e c a u s e m a n u fa c tu re rs a n d d i s tri b u to rs c a rr y o u t t h e i r re s p o n s i b i l i ty t o pr ot ect t he p ubl i c hea l t h an d wel l
- bei ng f r om pr oduct s t hat pr esent a r i sk of i nj ur y orgr oss decept i on o r ar e ot herwi se de f ect i v e. 21 C

. F

. R

. § 7. 40( a) ( 2009)

. A r ecal l i s an “ al t er nat i v e” t o a FD A- i ni t i at ed co ur t act i on, and t he a gency , by s e tti n g fo rth s p e c i fic p ro c e d u re s , c a n “ m o n i to r re c a l l s a n d a s s e s s th e a d e q u a c y o f a fi rm ’ s e ff o rts i n re c a l l .” I d. T he FD A ev al uat es t he h eal t h ha z ar d pr esent ed by a pr oduct bei ng r ecal l ed or consi der ed f or r ecal l and a s s i g n s th e re c a l l a c l a s s i fic a ti o n , i .e ., C l a s s I, C l a s s II , o r C l a s s II I, to i n d i c a te th e re l a ti v e d e g re e o f h e a l th h a z a r d o fth e p r o d u c t b e in g r e c a lle d o r c o n s id e r e d f o r r e c a ll: (1) C l as s I i s a s i t ua t i on i n w hi c h t he re i s a rea s on ab l e prob ab i l i t y t ha t t he us e o f, or ex po s ure t o, a v i ol at i v e pr oduct wi l l cause ser i ous a dv er se he al t h con sequen ces ordea t h. ( 2) C l ass I I i s a si t uat i on i n whi ch use of , orexpo sur e t o, a vi ol ati ve pro ductm ay cause t em por ar y orm edi cal l y re v er si bl e adv er se heal t h consequen ces or wher e t he p r obabi l i t y of ser i ous a dv er se he al t h con sequen ces i s r em ot e. (3 ) C l a s s II I i s a s i tu a ti o n in w h i c h u s e o f, o r e x p o s u re to , a v i o l a ti v e p ro d u c t i s n o t l i k e l y to cause adv er se he al t h con sequen ces. 21 C. F. R

. § 7. 41 ( 2009) ; 21 C

. F

. R

. § 7

. 3( m ) ( 1)
- ( 3) ( 2009)

. T he r ecal l of Al z a’ s D ur agesi c pat ches was o r ig in a lly c la s s if ie d a s a C la s s I r e c a ll a n d u ltim a te ly r e c la s s if ie d a s a C la s s II r e c a ll.

W e n o t e t h a t s o m e o fth e c a s e s in v o lv in g c la im s a g a in s t A lz a b a s e d o n f la w s in its D u r a g e s ic 10 fe n ta n y l p a tc h e s h a v e a l s o i n c l u d e d c l a i m s a g a i n s t t h e p re s c rib i n g d o c to r. S ee , e. g., B oro w i c zv. A l z a C orp ., N o . 1 :0 9 -C V -0 0 7 8 5 , 2 0 0 9 U .S . D i s t. L E X IS 5 3 5 8 9 , a t *1 -3 (N .D . O h i o J u n e 2 4 , 2 0 0 9 ); B row ning v. A l z a C orp ., N o . 1 :0 9 -0 4 4 0 2 0 0 9 , 2 0 0 9 U .S . D i s t. L E X IS 4 2 7 5 5 , a t *2 (S .D

. W

. V a . M a y 2 0 , 2 0 0 9 ). But see M i ddlebr

ooks v. John son & Joh nson C o. , N o. 4: 08- C V- 54 ( C D L) , 2008 U

. S. D i st

. LE X I S 75420 , at * 1- 2 M

. D

. G a. Aug. 26, 2008) ( not desi gnat ed f orpub l i cat i on) ( no cl ai m s r ai sed a gai nst pr escr i bi ng p hy si ci an i n con t ext of sui t aga i nst A l za a n d o th e r m a k e rs o f a l l e g e d l y d e fe c ti v e D u ra g e s i c fe n ta n y l p a tc h e s ); W or km an v. John son & Joh nson, , N o. 06- 2523 ( D M C ) , 200 7 U. S. D i st

. LEX I S 46214 , at * 1- 2 ( D

. N

. J. June 26, 200 7) ( not des i gn ated f or publ i cat i on) ( sam e)

. I n t hi s case, nei t herpar t y r ai sed a ny al l egat i on a gai nst t he p r escr i bi ng p hy si ci an.

Less t han a m ont h pa ssed f r om D r . Benham ou’ s pr escr i pt i on o ft he Du rag es i c p atche s and 11 T h o m p s o n ’s d e a th

. D u r in g th a t s a m e g e n e r a l tim e p e r io d , A lz a lo g g e d 2 1 c o m p la in ts a b o u t le a k in g D u r a g e s ic pat ches f r om one par t i cul arl ot i n ci r cul at i on wi t hi n t he h eal t h car e sup pl y sy st em . 7 As a resul t of thi s d efect, Al z a recal led about2,50 0,000 of i ts Durag esi c p atc hes in 2004. 9 Al so dur ing 2004, Dr. Eli as Benhamou, a pai n manag ement s peci ali st w ho i s b oardcer ti fied i n anes thes iol og y , presc ri bed Durag esi c patc hes for Mi chael y nn Thompson , w ho
w as suf fering chronic back pa in af ter a car c ra s h

. Dr. Ben ham ou p rescribed th ese 10 Durag esi c p atc hes dur ing the ti me perio d a fte r Al z a beg an i ts defect i nv est ig ati on but before A lz a i nit ia te d t h e r e call

. Attr ial , D r. Benha mou tes ti fied th at an ov erdose of 11 fent anyl results in sympto ms includ ing discomfort, dif f iculty brea thing, sw eat ing, diz z iness,A n e l e c tro c a rd i o g ra m , o r E K G , g ra p h i c a l l y re c o rd s th e e l e c tri c a l a c ti v i tyo f th e h e a rt. S e e C o lu m b ia 12 M ed. C tr. of

Las C olinas, I nc. v. H ogue , 271 S. W

. 3d 2 38, 244 ( T ex. 200 8) ( ci t i ng C ECI L E SSE N TI ALS O F M EDI CI NE 4 7 , 5 5 (T h o m a s E . A n d re o l i , M .D

. e t a l

. ed s . , 6t h e d. 20 04 ))

.

8 and nau sea, and thata Duragesic patch lea king an unco ntrolled amo unt of fent anyl could
re sul t i n the deat h of the pati ent. Dur ing the ear ly

mor nin g hours o f Febr uar y 13, 2004, Thompson beg an v omit ing and comp laining of

diz z iness an d ba ck pain. The v om iting continu ed o n an hou rly basis unt il m o rn in g. T h o m p s o n ’s t h irt e e n -ye a r o ld d a u gh t e r, K e n ze y Ma ri e T h o m p s o n , ultima tely cal led an ambula nce for her at approx imat ely

9:00 a.m. W hil e transpo rt ing Thompson to the e merg ency

room, t he emerg ency tec hni ci ans per

form e d an ele ctrocardio g ra m (“ EKG” ) on Thomps on s how ing nor mal re sul ts.

12 Thompson’ s medi cal records from F ort Ben d M e thodistH ospi tal st ate t hat Tho mp s on w as w ea r i ng a “ D urag es i cp at c h” u po n ad mi s s ion to the e me rg en cy roo m. T h e se rec o rd s in d ica te th a t T h o m p so n ’s co m p la in ts i n clu d e d di zz in e ss , n a u se a , vom it in g, abdomi nal pai n, an d l eft flank pai n. Nurse Cami ll e Green t est ified thatThompson compl ain ed of abdomi nal pai n and dizz ine ss . Kenz ey tes ti fied that her mother w as act ing “weird” at the h ospi tal

. Dr

. Don nie Ev ans, the emerg ency ro om phy si ci an, treated Thompson. He ordered
numerous tes ts , i ncl udi ng a c hestpai n ev alu ati on, a n el ect ro cardio g ra m, and cardia c enzy me tests. T he te sts showed no a rrhythm ia or hea rt dam age . Af ter T hom pson ’s compl ain ts of pain subs ide d, F ort Be nd beg an preparati ons to rele ase h e r. Kenz ey tel ephoned members o f t h e ir church to c ome pi ck them up from t he hos pit al, and Thompson an d Kenz ey w ait ed to b e rele ased. Ke nz ey tes ti fied th at he r mother tol d her that she w as re all y

ti re d and that she w as g oin g to tak e a nap. Kenz ey sl ept als o. U pon9

w aki ng , Ke nz ey

att empted t o w ake her mother but w as unabl e to do s o. She i nformed a
nurse, w ho tol d her that her mother w oul d hav e to be aw ake to be disc h a rge d . K e n z ey saw her m oth er, app aren tly asleep , ly ing on her stom ach. Kenzey note d tha t her mo the r’s leg s were bl uis h- pur ple w it h g oose bumps, and she w as ly ing face- dow n i n her pi ll ow w it h her hands up b y

her face, and her fing er nai ls w ere pur ple

. Kenz ey att empted t o rouse her mother bec ause the n urse had s aid they co uld l eav e i f she c oul d wa ke h e r, b u t Ke nz ey
w as unabl e to do s o. Kenz ey tes ti fied th at s he had seen a pat ch on her mother’s abdomen t he ni g ht before, and s he s aid her mother w as re all y g ood about g oin g to her doctor and chang ing out h er patc hes. Dur ing thi s p er iod , N urse Karen M ar ie Cot hran te sti fied th at K enz ey approache d her
som etim e before 3:5 0 p.m ., and t old her tha t her mo the r was slee ping a lo t. Cothran told Kenz ey thather mother w oul d hav e to w ake up before s he coul d be dis charg ed. Cot hran entered the ro om at 3:50 p.m. a nd found Thompson , w ho w as not b re athi ng , l ay ing on h er stom ach wi th he r fa ce in the p illow

. She m oved Th om pson and soun ded an em ergency code. Dr. Evans testif ied that w hen he ente red the room , Th om pson ’s back w as no ticeab ly blu e. He and a tea m beg an resus ci tati on efforts to no av ail

. He saw the patc h on Thompson’ s b ack

and ri pped it off becau se it w as “a n unk now n,” and threw i t away . On the same day that Thompson di ed, A lz a i nit iat ed th e i nit ial phas e of the re cal l, and sev eral days later, Dr. Ev a n s r eceived no tice of the reca ll. H e prom ptly cont acte d T hom pson ’s family so thatthey

co uld lo o k into w hether the patc h had any

ca usal rela ti onshi p to her death. Dr

. Ev ans tes ti fied that he had no conc er ns about dr ug tox ic ity , nor did he see si g ns thereof w hen he w as tr e a ti n g h e r, butat the s ame ti me, he did not re ali z e s he had theT he e xpect ed r ange offe nt any l i n T hom pson’ s bl ood, based on t he st r engt h of herD ur agesi c pat ch 13 p r e s c r ip tio n , w a s b e tw e e n 1 .0 to 2 .0 n g /m l, b u t t h e a c tu a l le v e l in h e r b lo o d w a s 1 1 .4 n g /m l. 10 patc h on. I n thi s reg ard, w e not e tha t t est imony at tr ial est abl is hed t hat s y mptoms of an
ov erdose of fentany l inc lud e, i nter al ia, naus ea, v omit ing , s lee pin ess , di z z ine ss , and
re spi ra tor

y depress ion

. As a result of

the con tact betw een Dr. Evans and the T hom pson fam ily , the fam ily repe ate dly re qu e s t e d the m edica l ex am iner to te st the lev el of fent anyl i n Michaelynn’s blo od. Des pit e the se re q uest s, the m edi cal ex aminer per formed a ro uti ne medi cal dr ug sc re en, w it h neg ati v e resul ts, but did not tes t Thompson’s blood for fentany l. Ev ide nce at tr ial co nfir med thati t i s n ot po ss ible to de ter mine w hether so meone has a t ox icl ev el of fenta n y l i n t h e i r

b l o o d w i t h o u tt e s t i n g fo r i t

. Th e m e d i c a l e x a mi n e r d i d s a v e a femoral blo od s ample and sent itto an out si de l aborator y , Ac cu- Che m, for tes ti ng at the Thomps on family ’s req uest

. This tes t s how ed that Thompson had a bl ood fentany l q uanti tati on of 11.4 ng /ml. A therapeuti c rang e for fentany l is 1.0 to 2.0 ng /ml, and a tox icrang e i s 3 .0 t o 5.0 ng /ml. Stat ed ot her

w is e, t he te st confir med thatThompson’ s b loo d s how ed a tox icl ev el of fe n t a n y l t h a t w a s o v e r t e n t i me s t h e l o w e n d o f t h e e x p e c t e d ra n g e based on h er fentany l presc ri pti on, a nd ov er fiv e ti mes t he uppe rmos t end of that ra ng e. 13 Havi ng not pe rforme d a testfo r fent anyl, the Harris C oun ty Medical Examine r’s
re por t show ed Thompson’ s caus e of de ath as “c ardio meg aly w it h bi v entr ic ula r hy per trophy
ass oci ated w it h obes ity ,” w hic h, ac cordin g to the t est imony at tr ial , s impl y

means that T h o m p s o n h a d a n e n la rg e d h e a rt

. A c c o rd in g t o t h e a u t o p s y re p o rt , T h o m p s o n wa s fo rt ytw o y ears o ld, si x

feet tal l, and w eig hed 367 pounds

. At t he tr ia l ar is ing from Thompso n’s deat h, M ik a Greenfiel d, A lz a’s co rp orate
re present ati v e and q ual ity as surance manag er , t est ified reg ardin g Al z a’s kn ow led g e of prod uct defects and i ts ma nufactu ring proce ss. She conce ded tha t fold-over defects exist11

w here an enti re si de of the patc h i s l eaki ng , and s h e agreed t hat fol d- ov er defects and str ing er lea kers tend to re lea se fentany l in an unc ontroll ed w ay . Des pit e the fact t hat s he was A lza’ s co rp o ra te represent ati v e, he r tes ti mony was conf lic ti n g rega rd in g he r kn o wled ge of w hether

fentany l w as a dang erous dr ug , and she w as unaw are w hether mor phi ne w as mo re pote nt th an fent anyl. Greenfiel d tes ti fied Al z a beg an recei v ing i ncreasi ng numbers o f p u b licrepor

ts of le a k in g p a t c h e s a s e a rl y a s Ja n u a ry 7 , 2 0 0 4

. Sh e t e s t if ie d t h a t , fo r i n s t a n c e , A lza confir med forty-tw o fold- ov er defects i n one of i ts lot s o f Durag esi c p atc hes. Sh e admi tted th att he s e de fects w ere or i g i na l l y fou nd b y

t he p ub l i c , an d no t by

A l z a or i ts e mp l oyees. She w as una ble to describe the safety proce ss utiliz ed by Alz a to f ind prod uct de fects in 2 0 0 3 , a n d c o n c e d e d t h a t A l z a ’ s t e c h n i c i a n s fo u n d n o fo l d
- o v e r d e fe c t s i n a n y of the Durag esi c p atc hes produce d dur ing the las t s ix months of 2003. Green f ield con f irmed t hatAlz a w as no tif ied of more than one fold-over defect in Durag esi c p atc hes in 2001. At that ti me, th e company ’s respo nse w as to hei g hten v is ual insp e cti on of the patc hes in a two- foot spac e on a c onv ey er bel t as the productw as trav el i ng t hrou g h th e Bo do l ay s y s te m. Greenfiel d tes ti fied th at s he di d not know w hat chang es w ere made on th e Bodo lay after the p ro ductrecal l to en sure tha t i t w as not p ro duci ng defecti v e product s e v en th oug h,
as par t of t he company ’s q ual ity ass urance team, her respon si bil ity

w as to en sure tha t t he
m a n u fa c t u ri n g p ro c e s s is c o m p le t e d wit h o u t d e fe c t s . S h e d id o f fe r swo rn t e s t im o n y, how ev er , admi tti ng thatal l chang es that w ere put in place after the prod uctrecal l, i ncl udi ng a mech ani cal vi sual sy ste m, different ev alu ati ng m ethods , equ ipmentmodi ficat ion s, and eq uip ment c lea nin g , woul d hav e been av ail abl e for use in 2001. Greenfiel d tes ti fied that Al z a di d notex amine the recal led patc hes to de ter mine howEv i dence at t r i al , i ncl udi ng t est i m onyf r om W i l l i am Par k s, t he d i r ect orof t r ade r el at i ons f orJansse n, 14 est abl i shed t hat Al z a m anuf act ur es t he Dur agesi c pat ch and Janssen sel l s and m ar k et s t he Dur agesi c pat ch. A l za a n d J a n s s e n a re b o th s u b s i d i a rie s o f J o h n s o n & J o h n s o n . 12 many of the re cal led patc hes act ual ly had defecti v e s eal s o r fold- ov er defects

. She
conc eded t hat after deter mini ng that there w as a fold- ov er defect probl em, Al z a rele ased add itiona l patch es for pub lic distribut ion w ithou t any add itiona l inspe ction of the patch es. Greenfiel d further tes ti fied that int er nal cor re spond ence at A lz a ac know led g ed th e fact that itw as keepi ng the Durag esic patches on t he mar ket , des pit e the defects , bec ause of prod uct sho rtages. Finally , she adm itted thatthe FDA’s inspe ction p rocesse s resulted in Al z a’s maki ng ch ang es to i mprov e i ts proces ses and eq uip ment. Juani ta H aw ki ns, the w or ldw ide v ic e presi dent of Qual ity As surance and Tech nic al Ope ration s for Cordis Corporation , w hich is a s u b s id iary of John son & Jo hnso n, also 14 provided test imo ny on b eha lf of Alz a. In 19 95, Haw kins w orked for Ja n s s e n a s the vice pr esi dent o f q u a l i ty a s s u ra n c e . H a w k i n s t e s t i fi e d t h a t A l z a w o u l d n o t a n d s h o u l d not know ing ly

rele ase a l ot that cont ain ed defect iv e product s; nev erthel ess , s he admi tted that the F DA co ncl uded that, and int er nal doc uments co nfir med that , t he c ompany co nti nued to rele ase product s for commerci al dis tr ibu ti on des pit e k now ing of productdefects therein

. Dr. Dav id Up m a li s a ls o t estif ied on beh alf of Alz a. He is a g ene ral practice phy si ci an w ho j oin ed th e phar maceut ic al ind ust ry , and now w or ks w it h Phar maceut ic al Res earch and Dev elo pment (“ PR D” ), a re search g ro up that “s uppor ts Al z a, among othe r compani es. ” H e does cl ini cal research in pai nki ll ers, “p ro v idi ng medi cal suppor t for Du ra g e s i c a n d a c o u p l e o f o t h e r p a i n k i l l e rs t h a t a re i n t h e ma r k e t p l a c e . ” H e handl es cor re sp o ndenc e w it h reg ula tor y ag enci es, i ncl udi ng the FD A, reg ardin g producti ss ues and
w orks to ob tain a ppro v al for drugs. He w orked w ith ped iatric clinical trials for the Duragesic patc h and hel ped der iv e l abel ing for t he pat ch.13

Dr. Upmalis testif ied ab outtw o general types of leaks tha t a Duragesic patch could
ex hib it

. A s tr ing er

l eaker i s a patc h tha t has a pie ce of ge l stu ck i n the se al. Ac cordin g to Dr . U pmali s, Al z a’s as ses sments co ncl uded that there w as no s ig nific ant h eal th r is k p osed by st ri ng er l eakers. D r. U pmali s a ls o tes ti fied abou t fold- ov er defects , w here the se al breach cov ers a n ent ire s ide of the p atc h. Dr . U pmali s t est ified that , i n respon se to t he es cal ati ng number of publ icco mplai nts about productdefects , Al z a formed a heal th ha z ard a ss e ss m e nt c ommitt ee w hic h w as ask ed to l ook at fo ld -o ver defects on P re si dent’ s D ay w eeken d, F ebr uar

y 14- 15, 2 004. Acc ordin g to Dr . U pmali s, the h eal th r is k i nv olv ed i n fold- ov er defect s was hig her

than for stringer l eake rs becau se mo re fent anyl g el could leak f rom a fold-over defect. Dr. Upma lis t e s t if ie d t h a t e a c h lo t o f Du ra ge s ic p a t c h e s c o n t a in e d a ro u n d 4 0 0 , 0 0 0 u n it s , a n d A l za ult imat ely

es tim a te d t hat a pprox imat ely 3,60 0 pat ches w oul d be affect ed by fold- ov er defects i n eac h l ot. D r. U p m a lis t e stified that Al z a uti li z ed M edl ine se arches and three stud ies, w hich w ere no t pee r review ed, in it s d e t ermin ation regarding the hea lth risks inc ide nt t o l eaki ng D urag esi c p atc hes. I n i ts re search, Al z a foun d many i nci dents of adv erse ev ents rela ted t o the rapi d rele ase of fentany l. Dr. Upmalis w as involv ed in wr iting the Physician’s De sk Referen ce (“PDR” )
ma terials on the Du ragesic pa tch. Th e w arning in the PDR state s: “D uragesic patch es are int ended for transde rmal us e on int actsk in onl y . Us ing damag ed or cu t D urag esi c p atc hes
c a n l e ad to t h e ra p i d re l e a s e o f t h e c o n t e n t s o f t h e D u ra g e s i cp a t c h a n d a b s o r p t i o n o f a potent ial ly

fatal dose of Fenta ny l. ” D r. U pmalis t e st ified thatthi s war nin g resul ted from peo ple’s “abu se” of , or dam age to, th e pa tche s. Despite th e e xp li c it text of th e PDR
w arning, Dr. Upmalis testif ied th at th e w arning o f a dverse health conse quence s therein
conc er ns the a bsor pti on of fentany l throug h muco us membrane s rather than sk in.W e no t e t hat t he j ur y was i nst r uct ed t hat ev i dence r egar di ng a dv er se ev ent s was r el ev ant on t he 15 i ssue o fnot i ce t o Al z a, but not on causat i on o r f oranyot herpur pose.

T est i m onyat t r i al i ndi cat ed t hat t he absor pt i on offe nt any l fr om a dam aged pat ch m ay be i ncr eased, 16 eve n w i t ho ut t he pa t c h s y s t em i n p l ac e, w he re, for ex am pl e, c l othe s c ove r t he pa t c h an d a c t as an oc c l us i ve l ay er , ort he p at i ent i s l ay i ng o n t he p at ch, t hus ca usi ng l ess ev apor at i on oft he ve hi cl e m edi um and a gr eat er absor pt i on o ff ent any l

. D r . Benet f ur t hert est i f i ed t hat t em per at ur e i ncr eases t he r at e of f ent any l abso r pt i on. 14 Dr . U pmali s e x pla ine d tha t t he adv erse dr ug repor ti ng syste m re qui res do cto rs to
re por t t o the co mpany

and to t he FD A if there is an adv erse dr ug ev ent. He admitted t hat under-repor

ti ng i s a kn ow n probl em, and he has h e ard tha t onl y one to t en percentof adverse reactio ns are repo rted. He ag reed t h a tt he FDA tho ught tha t und er-reporting is par ti cul ar ly hi g h w it h the D urag esi c p atc h bec ause of t he nature of t he pat ien t pop ula ti on utiliz ing the pat ch. Dr. Upmalis examine d Duragesic adverse eve n tr epo rts, w hich inc lud ed, i n 2002, f o r in st a n ce, 53 c ases of hy pov enti lat ion , 270 ca ses of dy spnea (s hor tnes s o f breat h) , 15 cas es of res pirator y ar re st, 33 c ases of re spi ra tor y depress ion , 8 c ases of re spi ra tor

y di sorder not other

w is e spec ified , 8 cas e of respi ra tor y dis tress , and 14 ca ses of

respiratory failure. Th e 20 03 a dverse ev entreport nu mb e rs we re similar. Acc ordin g to Dr . U pmali s, g iv en the inc ide nce of under-repor ti ng , t hese adv erse re act ion s
w ere j ust“ the t ip of the i ceberg .” 15 Dr . Les li e Benet, a phar macol og is t w ho is a professor at the Uni v ersi ty of Cal ifor nia , provided f urthe r testimo ny on A lza ’s b e h a lf . Dr . Ben et te stif ied th at he w orks for almo st all dr ug co mpanie s. W hil e Al z a does not pay hi m di re ctl y

for h is wo rk , Al z a pays t he uni v ersi ty

for w hic h he w or ks , w hic h i n tur n funds h is l aborator y . Dr

. Benet conc eded t hat the F DA did not concur

w it h the pharmaceu ti cal -i ndust ry f unded test s w hic h dow npl ay ed the h eal th r is ks from D urag esi c p atc h defects , and that the FD A had det er mined that the jus ti ficat ion present ed to su ppor t t he s afetyof lea ki ng patc hes w as ina deq uate. 16 Dr . Be net a dmitted t hat A lz a’s D urag esi c l abel s d o not cor ro borate h is tr ial tes ti mony15

regarding adv erse he alth risks associat ed w ith dam aged patche s. He atte mp ted to explain thi s d is crepancy

as a re sul t of t he fact that all l abel ing i s s uppos ed to i ncl ude al l potent ial toxic eventua lities w het her the y o ccur o r not: “And to day, beca use o f litig ation such as th is,
ev er y co mpany

l is ts ev er

ythi ng thatco uld pote nti all y l ead t o a l it ig iou s s it uati on.” D r. Benet
conc eded that Al z a knew about a number of l eaki ng patc hes before 2 005, and atthatti me, Al z a di d notpl ace a w ar nin g on t he Du ra ges ic p a ck ag ing

. Acc ordin g to Dr . Be net, the
w ar nin g thatAl z a ul ti matel y i ncl uded on the Du ra g esi c l abel s i s d irect ed to pati ent caregiv ers, and n ot to the p atch -users the mse lv es, be cause the care giv ers are mo re likely to ha v e a t ox icreact ion to ex posure. Upo n cros s- ex aminat ion , Dr . Be net a dmitted t hat t he Duragesic label stat es tha t it i s f or use on ly in opioid to lerantpatie nts, a nd th at be cause ser iou s o r li fe-threateni ng hy pov enti lat ion co uld oc cur , t he Durag esi c t ra nsder mal syste m is co ntrain dic ated in p a ti ents w ho are notopi oid -t ole ra nt. The l abel furth er st ates that damag ed or

cu t pat ches ca n lea d to ra pid re lea se of t he cont ents and abs or pti on of a fatal dose. Dr . Be net u lt imat ely co ncl uded that Alz a and Jans sen both knew thatfentany l w as a toxic substan ce an d the ex posu re of fent anyl at an un cont rolled rate might be dan gerous; howev er, Dr. Bene t testif ied th at in this case , gi v en th at T hom pson had b e en o n pa in medic ati on for a number of ye ars and had been w ear ing a pa tch for more tha n a mont h, he di d notb e lie ve that fentany l g el lea ki ng out on her sk in w oul d pos e a h eal th r is k t o a re asona ble deg re e of sc ien ti fic c ertai nty

. As me ntion ed a bove, the Th om pson fam ily ’s case w as tried be fore Jud ge Hancock in Har ri s C ounty , Tex as, and the j ur y retur ned affirmat iv e findi ng s c oncer nin g the
m a n u fa c t u ri n g d e fe c ta n d A lza ’s n e gl ig e n c e , b u td id n o tf in d A lza gro s s ly n e gl ig e n t

. Al za chal len g es Judg e H anco ck’s j udg ment on the v erdict by fiv e i ss ues. Al z a’s first three16

is sues co ncer n the su ff ic ien cy of the e v ide nce suppo rt ing the v erdict. II. S U FFI C I ENC Y OF TH E E VI D ENC E A. S TA NDA RD OF R EVI EW In re v iew ing the leg al suffici ency of t he ev ide nce, w e v iew the ev ide nce in the l ig ht most fav orabl e to the j ur y ’s findi ng s, g iv in g f u ll credi t t o al l fav orabl e ev ide nce if any
re asona ble person coul d, and dis re g ardin g cont ra ry ev ide nce unl ess reason abl e persons coul d not

. City of K

ell er v. Wils on , 168 S.W .3d 802 , 807 (Te x . 200 5). In Texas, the jury is the sol e j udge o f

the w it ness es’ credi bil ity , and thatti me-ho nored pr inc ipl e i s a par t of
o u r s t a n d a rd o f

re vie w: Jurors a re the sol e jud g es of t he credi bil ity of the w it ness es and t he w eig ht to g iv e the ir

tes ti mony . Theymay ch oose to be li ev e one w it ness and di s b e l i e v e a n o t h e r . R e v i e w i n g c o u rt s c a n n o ti mp o s e t h e i r o w n o p i n i o n s to the c ontrar

y . Mo st credi bil ity

q uest ion s a re i mpli ci t rather than ex p li ci t i n a jur y ’s ve rd ict. T hus, rev iew ing co urts must ass ume j urors d eci ded al l of them in fav or of the v erdict if reason abl e human bei ng s c oul d do so. C our ts re v iew ing al l the e v ide nce in a li g ht fav orabl e to t he v erdict t hus ass ume that jurors c re dit ed te sti mony fav orabl e to the v erdict and di sbel iev ed te sti mony cont ra ry to it

. Id. at 819 ( footnotes and parag ra ph break omitted)

. Acc ordin g ly , w e mustdeny a l eg al suffici ency

ch all eng e unl ess : (1 ) there i s a co mplet e abs ence of ev ide nce of a v it al fact; (2 ) all the ev iden ce offered to prov e a v it al fact amount s t o onl y a mere s ci nti ll a and no mo re; (3) the rules of

law or ev id e n c e c o m p letely fo rbid any conside ration of the on ly
ev ide nce offered to prov e a v it al fact; o r (4 ) the e v ide nce w hic h the j ur y w as compel led to
cons ide r and be li ev e c oncl usi v ely es tabl is hes the o pposi te of the v it al fact. See i d. at 81 0 & n. 15- 16. These v it al facts maybe p ro v ed by di re ct or ci rc umstan ti al ev ide nce. See Ford Mo tor C o. v . Ridg way, 135 S.W .3d 598, 601 ( Tex . 200 4) ; Russell v. Russell , 865 S.W .2d 929 , 933 (Tex. 1993 ). In review ing the factu al suf f iciency of the evidence, w e mu st consid er and w eigh all17

the e v ide nce, and we sh o u ld s e t asi de th e j udg ment onl y i f it is so co ntrar

y to the
ov er w hel ming w eig ht of the ev ide nce as to be cl ear ly w ro ng and manifest ly

unj ust

. Po ol
v. For d Motor C o. , 715 S.W .2d 629, 635 (Tex . 198 6) ; Cain v. Bain , 709 S.W .2d 1 75, 1 76 (Te x . 198 6). B. E V ID E N C E O F A M A NUF A CT URI NG D E FE CT A ND C A US A TI ON By it s firs t and thi rd is sues , Al z a chal len g es the leg al and factu al suffici ency of the
ev i d e n c e s u p p o rt i n g t h e j u r y ’ s fi n d i n g o f a ma n u fa c t u r i n g d e fe c t w h i c h w a s a produci ng cause of Th om pson ’s deat h. In th e insta nt case , t h e j uryfoun d tha t “there was a manufactur ing defect in a Durag esi c patc h w or n by Mi chael y nn Thompson at the ti me the pat ch lef t the posse ssion of

Alz a tha t w as a prod ucing cause of Michaelynn Th om pson ’s dea th.” In its f irst issue, Alz a cont end s tha t the re is legally and factu ally insuf f icient evidence to suppor

t the j ur y findi ng thata manufact ur ing defect, ex is ti ng at the t ime of manufact ure, caus ed T hompson’ s death. In conne cti on w it h this iss ue, Alz a arg ues: ( 1) there w as no proof o f proper use of anyD urag esi c p atc h i n q uest ion , and sp eci fical ly , no proof reg ardin g a 75 mcg /h patch; (2) there w as no ev ide nce to s uppor t a findi ng of malfunct ion ; and ( 3) the e v ide nce conc lus iv ely es tabl is hed that Thompson could not hav e been w ear ing a 75 mcg /h pa tch from a re cal led l ot w hen s he di ed. 1. Ma nu fa ct ur in g Def ect “A manufactur ing defect ex is ts wh e n a product dev iat es, i n i ts cons tr uct ion or quality , f rom th e spe cif ication s or plann ed o utp ut in a ma nne r th at rend ers it unreaso nab ly dan gerous.” Cooper

T ir e & Rub ber

C o. v . Mendez , 204 S.W .3d 797, 80 0 ( Tex . 200 6) ; see Bic Pen Cor

p. v . C ar ter , 251 S.W .3d 500, 509 (Tex

. 2008)

. A pla int iff mus t prov e that the productw as defecti v e w hen i t l eft the h ands of the manufactu re r and that the d efect w as18

a produci ng ca use of the p lai nti ff ’s i nju ri es. Ri dgway, 135 S.W .3d a t 600 ; Tor ri ngton Co.
v. Stut z m an , 46 S.W .3d 8 29, 8 44 ( Tex

. 2 0 0 0 ). A spec ificdefect “mus t be ide nti fied by
com pet entev iden ce an d oth er possible cause s mustbe ruled out. ” Fo rd Mo tor Co. v. L e de s ma , 2 4 2 S. W .3 d 32 , 4 2 (T e x. 20 0 7 ) (qu o ti n g N i s s a n Mo to r

C o . v . A r m s tr ong , 145 S.W .3d 1 31, 1 37 ( Tex . 200 4) ). Both directand ci rc umstan ti al ev ide nce maybe used to estab li sh any mater ial fact. Lozano v

. Loz ano , 52 S.W .3d 141, 149 (Tex . 200 1) ; Br owning- Fer

ri s, Inc . v . R eyna , 865 S

. W

. 2 d 9 2 5 , 9 2 8 ( Te x . 1 9 9 3 )

. To ra i s e a g e n u i n e i s s u e o f ma t e r i a l fa c t , h o w e v e r , t he
ev ide nce must transc end mere s uspi ci on. Ri dgway, 135 S.W .3d a t 601

. Ev ide nce that is so sl ig ht as to make any inferenc e a g uess is i n l eg al effectno e v ide nce. Id. ; Lozano , 52 S. W .3d a t 148

. 2. Pro per U se Al z a c ontends thatappel lee s’ cl aims are depen dent on “ proof o f proper us e of the p a tc h ,” cit in g Par

sons v. For d Motor C o. , 85 S.W .3d 323, 329- 30 (Tex

. App.–A ust in 2003, p e t

. d e n i e d ) ( cit in g Pl

as- Tex , Inc. v. U.S. Steel

C or p. , 7 7 2 S

. W

. 2 d 4 4 2 , 4 4 4 -4 5 (T e x. 198 9)). Alz a con ten ds tha t app ellees p resen ted no evidence of how any Duragesic pat ch
w as ha ndle d by Tho mp son o n the occasion i n q uest ion. Acco rding to Alz a, “[t]h e pa tch that w as re m o ved by

D r. Ev ans from [Thompso n’s ] bac k was re por tedl y unremark abl e. The st re ng th of the patc h found on her bod y a t th e time of her deat h w as nev er est abl is hed. The dec edent’ s d aug hter c lai med thatThompson had a patc h on her stom ach o n the day she died. ” Ma nufacturers face li abi li ty onl y for p ro duct s w hic h are defectiv e w hen used i n the in t e n d e d m a n n e r o r wh e n u s e d in a re a s o n a b ly fo re s e e a b le wa y. See Houston Li ghti ng & Power v

. R eynolds , 765 S.W .2d 784, 786- 87 (Tex

. 1998) ( li abi li ty i s “ li mite d to uses thatW e no t e t hat t he f or eseeab l e r i sk ofhar m due t o a m i suse o ft he p r oduct , r at hert han an i nt ended 17 use, i s n o t a n a b s o l u t e b a r t o l i a b i l i t y f o r t h a t p o r t i o n o f a n i n j u r y c a u s e d b y a p r o d u c t ’ s d e f e c t i v e de si gn; in s te a d , m is u s e o fa p r o d u c t i s a f a c to r th a t m u s t b e c o n s id e r e d in a llo c a tin g r e s p o n s ib ility f o r th e in j u r y. H ern an de zv. Tok ai

C orp . , 2 S

. W

. 3d 25 1, 25 8 (T ex . 19 99 ). D r. B e n h a m o u te s ti fie d th a t t h e D u ra g e s i c p re s c rip ti o n s c a m e w i th f i v e p a tc h e s in e a c h b o x w i th 18 di rec t i on s t o cha nge t he p at ches e v er y 72 hour s. Dr. Benham ou t est i f i ed t hat he pr escr i bed a bo x of f i ve D ur agesi c 50 m cg pa t ches t o T hom pson on Ja nuar y 13. O n Jan uar y 26, D r . B enham ou i ncr eased t he d osage and pr escr i bed a bo x of f i v e Dur agesi c 50 m cg pa t ches a nd a box off i v e 25 m cg pa t ches. O n Febr uar y 11, T hom pson was gi ven a p rescr i pt i on f ora box o ff i v e 75 m cg pa t ches. Ut i l i z i ng a cal endarand m edi cal r ecor ds, D r . Benham ou t est i f i ed t hat t he p r escr i pt i on d at es i ndi c ated p rop er usage oft he p r oduct and t he ti m i n g i n d i c a te d u s a g e o f th e 7 5 m c g p a tc h a t t h e ti m e o f T h o m p s o n ’ s d e a th

. 19 are objecti v ely

reaso nabl e to ex pect

. . . i t doe s n ot en compas s u ses . . . w hic h represent
w hol ly unex pect ed product mis use. ”) (c it ati ons omitted)

. I n thi s reg ard, a manufactur ing 17 defect ex is ts if a productdoes not confor m to t he des ig n s tandards and bl uepr int s o f the manufacturer , and the flaw makes the productmore dang erous and t herefore unfit for it s int ended o r re asona bly fores eeabl e us es. See B enavi des v. Cushm an, Inc ., 189 S. W .3d 875 , 881 (Tex. App. –Hou ston [1st Dist.] 20 06, no pe t.). Dr . Be nhamou, the p hy si ci an w ho treated Thompson for pai n manag ement and w ho presc ri bed D urag esi c for her , rev iew ed Thompson ’s medi cal records and t est ified
re g ardin g her

us ag e of the Durag esi c patc hes. Thompson had w or n D urag esi c p atc hes ten s eparate t imes , from Janua ry 13 unt il F ebr uar y 11, w it hout inc ide nt or

adv erse effect

. 18 The ti ming of her

presc ri pti on refill s for

D urag esi c p atc hes fit w it h the p re sc ri bed us ag e of the p ro duct , and t h e timin g w oul d al so il lus trate t hat Thomps on w as w ear ing one of the
new ly presc ri bed 75 mcg patc hes at t he ti me of her deat h. Thompson’ s medi cal records from the emerg ency ro om st ate t hat s he w as admitted
w it h a “ Durag esi c P atc h.” D r. Ev ans, the emerg ency room p h y si ci an, t est ified that Thompson t old hi m she someti mes us ed th e D urag esi c p atc h. He further testi fied th at he
saw the patc h on Thompson’ s b a ck and re mov ed i t w hen attempti ng to re sus ci tate her
w hen she code d beca use he “thou ght it ma y h ave inh ibited our resuscitat ion [e f forts] on lyW hi l e T hom pson' s dau ght ert est i f i ed t hat she was wear i ng t he pat ch on herst om ach, and m edi cal 19 r ecor ds an d t est i m onyi ndi cat e t hat she was w ear i ng t he pat ch on her back , t hi s di scr epancyi s not m at er i al to th e i s s u e o f w h e th e r o r n o t T h o m p s o n p ro p e rlyu s e d th e p ro d u c t.

As expl ai ned at t r i al , t he co ncept of post m or t em dr ug r edi st r i but i on i s based on dat a suggest i ng t hat 20 th e r e is a p o s t- m o r te m d iff u s io n o fd r u g s a lo n g a c o n c e n tr a tio n g r a d ie n t, f r o m s ite s o fh ig h c o n c e n tr a tio n in sol i d or gans and cent r al bl ood v essel s, t o si t es of t he l owest concent r at i on i n per i pher al v essel s such a s t he subcl av i an a nd f em or al v ei ns. Post m or t em r edi st r i but i on of a dr ug m ay be t he basi s f or el ev at ed or t oxi c dr ug con c ent r at i ons a f t erdea t h, and accor di ngl y , i n cer t ai n case s, post m or t em dr ug co ncent r at i ons m ay not 20 becau se itw as an unk now n factor .” In shor t, the e v ide nce ind ic ates thatThompson w as
w ear ing a 75 mcg D urag esi c p atc h at the t ime of her death. 19 Dr . Be nhamou t est ified thathe n ev e r had any i ndi cat ion thatThompson w as abusi ng D urag esi c d ur ing hi s c ourse of treati ng her. He f urther tes ti fied th at he nev er

had any i ndi cat ion thatsh e w as not fol low ing hi s i nst ru ctio n s with reg ard to the medi cat ion

. Fur ther , D r. Benha mou tes ti fied th at he had re q uired Thompson to e n te r a “ medic ati on cont ra ct” w it h hi m, ent ered i nto e v ide nce at t ri al, w hic h spell ed out T hompson’ s o bli g ati ons
w it h reg ard to the prop er usag e of

D urag esi c. D r. R ober

t C . Bu x , a phy si ci an and boardcer ti fied foren si c p athol og ist a n d medi cal ex aminer , w ho w as tes ti fyi ng on b ehal f of the Thompson famil y , c oncur re d tha t t here w as “n o ev ide nce” thatThompson had mi sus ed her medic ati on. Dr . Vi ncent DiM aio , a medic al ex aminer testi fyi ng on behal f of

Al z a, c onced ed tha t the re w as “no ph y sical ev iden ce” thatTh om pson abu sed th e pa tche s. Base d upon the fo re going , w e c oncl ude t hat t he j ur y had before i t l eg all y

and factual ly su ff ic ien t ev ide nce from w hic h i t may hav e c oncl uded t hat Thomps on w as w ear ing and proper ly

us ing a D urag esi c 7 5 mcg at the t ime of her death. 3. Malfunction Al z a next c ontends that there is no e v ide nce to s uppor t t he j ur y ’s findi ng thatthe Durag esi c patc h malfunct ion ed. In conne cti on w it h thi s i ss ue, A lz a arg ues that the A cc uChe m bl ood t esti s u nreli abl e bec ause it w as not per formed proper ly , and the 1 1.4 b loo d lev el re adi ng does not est abl is h a mal functi on bec ause of post mort em redi str ibu ti on. 20a c c u ra te l y re fle c t a n te m o rte m d ru g l e v e l s . 21

Al z a as ser

ts that Acc u- Che m dev iat ed f ro m it s prot ocol in performi ng its tes ti ng and further fai l e d t o p e r

fo r m t h e t e s t i n g c o r re c t l y . A l z a a l s o a t t a c k s t h e b l o o d t e s t i n i ts thi rd i ss ue, cont end ing th at: (1) th e Accu-Che m test w as notp erforme d prop erly ; (2) Accu-Chem did not v ali date it s met hodol og y ; ( 3) Ac cu- Che m’s methodo log y of re ly ing o n “ o nly

one” cal ibrator

w as not s how n to be reli abl e; ( 4) Ac cu- Che m’s tes t o n Thompson’ s b loo d had tech nical brea k-downs; (5) Accu-Che m ha d insuf f icient experience testing for fent anyl i n hum an b lood for the resu lts to be co nside red accu rate; and (6) the Accu-Che m te st is based on a n i nferenc e not su ppor ted b y the ev ide nce. As sta ted prev iou sl y , follo w ing Thompson’ s death, the coroner took bl ood s amples f ro m T h o m p so n ’s fe m o ra l a rt e ry an d se n t t h e sa m p le s t o Ac cu -Ch e m fo r te st in g. Acc ordin g to ex per

t tes ti mony at tr ial , blo od from the femoral arter y area i s n ot s ubj ectto cont aminat ion from g ast ri c c ontent s o r trauma and w il l re presentthe lev els and
conc entrati on of substan ces in the blood at the ti me of death. Ac cu- Che m, an ind ependent tes ti ng ag ency , ana lyz ed th e bl ood and de te rmi ned t hat Thomps on had 11.4 ng /ml of fentany l in her

body

. This amount is tox icand is w ell ov er three ti mes t he th erapeuti c l ev el of fentany l. Ac cu -Ch e m u ti lize d gas ch ro m a to gra p h y/m a ss sp e ct ro m e try (GC/ MS ) te ch n o lo gy to t estThompson’ s b loo d. W e may cons ide r pr ior j udi ci al opi nio ns all ow ing the admis si on of ev ide nce in deter mini ng w hether the under ly ing theo ry

of sc ien ti fic e videnc e i s v ali d. See E m er son v. State , 880 S.W .2d 759, 76 7- 68 ( Tex . C ri m. App. 1994) ; Com bs v. State , 6 S. W .3 d 3 1 9 , 322 ( Tex . Ap p.–H oust on [1 4th D is t.] 1999, no p et.) ; Jones v. Sta te , 716 S.W .2d 142, 147 (Tex . App.–Aus ti n 1986, pet. ref’d) . Such ev ide nce maybe c onsi dered for the f irst ti me on appeal

. Em er son , 8 8 0 S

. W

. 2 d a t 7 6 5

. T e xa s a n d fe d e ra l c o u rt s h a ve22

found the g as chromatog ra phy tes t t o be a rel iab le method for i denti fyi ng co mpounds, and it has been g enerall y

ac cept ed i n the sc ien ti fic c ommunity . See C om bs , 6 S.W .3d a t 322 ; W ri ght v . St ate , 853 S.W .2d 154, 155 (Tex

. App.–C or pus Chr is ti 1993, pet. re f’d) ; Jones , 716 S. W .2d at 145- 52; see als o U nited St ates v. By num , 3 F.3d 769 , 772 (4th Cir. 1993 ); Bol ieu v. Sta te , 779 S.W .2d 4 89, 4 90 ( Tex . Ap p.–Aus ti n 1989, no p et. ) (d isc u ss ing the GC / M S t e s t i n g a s “ t h e G o l d e n R u l e ” i n t h e fi e l d o f t o x i c o l o g y )

. T h e s c i e n t i fi ct h e o r y a nd pr inc ipl es under ly ing GC /M S te sti ng hav e been prov en to be reli abl e. The ex per ts in the ins tant cas e appeared to ag re e tha t t he GC /M S procedu re has been proper ly v ali dated and is conside red the mostaccurate met hod of ident if y ing and quant if

y ing drug levels. W e ne xt turn ou r atten tion to w het her the met hod ology of GC/MS w as reliably appl ied in this sp eci fic c ase. Guadalupe- Bl anco River

Aut h. v . Kr aft , 77 S.W .3d 805, 808 (Tex . 200 2) ; Me rr

ell Dow Phar

m s. v. Ha vn er

, 953 S.W .2d 7 06, 7 12 ( Tex . 199 7) ; In re S

. E

. W. , 168 S.W .3d 8 75, 8 84 ( Tex . Ap p.–D all as 2005, no pet .)

. In thi s reg ard, w e not e that the l aw

does not re q uire a “ cour t t o admi t opi nio n evid e n ce w hic h i s c onnected t o existing dat a only by the ipse dix it of the expert.” Ker r- Mc Gee C or

p. v . Helton , 133 S.W .3d 2 4 5 , 2 5 8 (T e x. 20 0 4 ) (qu o ti n g Gen. Elec. C o. v . Join er , 522 U.S. 136 , 146 (1997 )). Dr. Gary Harold W imb ish, a bo ard-certif ied foren sic to x icologist, t estif ied on beh alf of the T hom pson fam ily . H e ha s performe d mo re than a thou sand GC/MS t e s t s . He testif ied th at th e GC/MS test can be used t o det ermin e the le v el of fent anyl i n som eon e’s body , and i t i s an “e x cel len t ins tr ument” that is “c ommonly used” to deter mine the l ev el of fentany l in a sample of human blood. H e has us ed GC /M S on sev eral occ asi ons for th at purp ose. He testif ied th at w het her a drug level in a perso n’s bod y is at a fata l lev el is part
o f h is f ie ld o f

st u d y. Dr. W imb is h t e stif ied th at he is fam iliar w ith Accu-Che m an d its ope ration s. He23

tes ti fied th at A cc u- Che m is ce rt ified by the Amer ic an Soc iety of Laborator

y C hie fs of Po lic e , t h e Co lle ge o f

Am e ric a n Pa th o lo gy, an d th e C l i n i c a l So cie ty fo r Dru g T e st in g. Anal yti cal l aborator ies su ch as Acc u- Che m are ac credi ted b y v ar iou s o rg ani z ati ons and,
as par t of thei r acc re dit ati o n , a re reg ula rl y i nspected a nd par

ti ci pate in “p ro fici ency

st udi es, ” i n w hi c h i de nt i c al por

ti on s of th e s am e s am pl e are an al yz ed b y ma ny l ab s a t th e s am e ti me in order to chec k t he ac curacy of eac h p ro ce d ure as i t i s p er formed i n the i ndi v idu al par ti ci pati ng l abs. Ac cu- Che m par ti ci pate s in profici ency tes ti ng by

the Col leg e of Amer ic an Pat hol og y

and iti s c erti fied b y org ani z ati ons for per forming dr ug tes ti ng on parole es and probati oners. Dr. W imbi sh tes ti fied th at he i s p ersonal ly ex per ien ced w it h Acc u- Che m and t hat i t i s h is “ lab orator y of choi ce” for a forens icl aborator y . Accu-Che m ha d spe cif ically pas s e d t h e Co ll e ge o f

A m e ri c a n P a t h o lo gy’ s p ro f ic ie ncy tes t for fentany l, al thoug h Dr . John A rt hur Tarv er , t he di re cto r of Acc u- Che m, tes ti fied th at Acc u- Che m does not freq uentl y per form tes ts for fentany l. D r. Tarv er furth er tes ti fied th at an out si de org ani z ati on, t he Amer ic an Soc iety of Cr ime Laborator

y D irect ors, re v iew ed and app rov ed Accu -Chem ’s testing proced ures. Furthe r, the pa rticular proced ure use d to te st fentany l w as v ali dated exter nal ly w it h a profic ien cy

sample from the Col leg e of Amer ic an Pathol og is ts. Acc u- Che m sentthe Col leg e a p ro fici ency sa mple, and w it h tho se sta ndards and c ontrol sta ndards, Ac cu- Che m w as w it hin f iv e- tenth s stand ard dev iat ion s o f the mean of all the lab orator ies thatper formed th e tes t. Dr . G ra ham R ic hard J ones, a fore n sic tox ic olo g is t, tes ti fyi ng on b ehal f of Al z a, ack now led g ed th a t Acc u- Che m had pa ss ed th e profici ency tes t admi nis tered by

the Col leg e of Amer ic an Pat hol og is ts in Ma rc h 2004, before Acc u- Che m di d the tes t ati ss ue in thi s c ase, and had don e “ w ell ” on th e profici ency tes t. Accu-Che m’s repo rt of O c t o ber 18 , 200 4 sho w s a conce ntrat ion of fent anyl i nAccu- C hem i ni t i al l y t est ed a sam pl e of T hom pson’ s bl ood f orf ent any l i n Apr i l ; howev er , t hat t est 21 f ai l ed. Dr. T ar v erand D r . W i m bi sh, bot h t est i f i ed t hat t hi s i ni t i al t est was no t v al i d an d t he r esul t s wer e no t r el i abl e be cause t he sa m pl e ofbl ood pr ov i ded f ort est i ng was i nsuff i ci ent and Accu- C hem di d no t hav e t he
“ am ount of

speci m en tha t ourpr ot ocol r equi r es. ” Accu- C hem r ecei v ed si x- t ent hs of a m i l l i l i t erof

bl ood, wher eas t he st andar d oper at i ng pr ocedur e cal l ed f orfo urm i l l i l i t er s, and t he r esul t i ng a nal y t i cal dat a di d no t al l ow f orf or ensi c r esul t s. Dr. Jone s, t est i fy i ng o n be hal fof Al z a, st at ed t hat Accu- C hem ’ s f i r st t est f ai l ed because t he e nt i r e cal i br at i on f ai l ed “ m i ser abl y ” and t he f ai l ur e had “ absol ut el y not hi ng” t o do w i t h t he a m ount oft he sa m pl e. W e ne ed n ot f ur t herconsi dert hi s i ssue b ecause t he r esul t s of t hi s i ni t i al t est ar e not at i ssue i n t hi s case. W e do not e t hat D r . T ar v er st at ed t hat t he t est i ng m et hodol ogy ut i l i z ed by Accu- C hem di d no t c h a n g e b e tw e e n th e tw o te s ts

. 24 T hom pson ’s blood of

1 1.4 n ano gram s per milliliter. The therap eut ic range fo r fe nta nyl, 21 t h a ti s , t h e a m o u n tfo u n d in t h e b lo o d re la t e d t o t h e re li e f o f p a in , is f ro m o n e t o two n a n o g r a m s p e r

m i ll il it e r. T h e t o xicra n ge fo r fe n t a n yl, t h a tis , t h e ra n ge t h a two u ld h a ve toxicity or adverse and de leter io u s e f fects, is three to f iv e na nogram s per milliliter. D r. W imbi sh tes ti fied that 11.4 nanog ra ms w as a li ttl e more than tw o ti mes the upper l imi t of the toxi c range for fent anyl, and w as toxic eno ugh to be letha l. Specif ically , Dr. W imb ish tes ti fied th at w hil e Thompson mayhav e dev elo ped s ome tol erance to fentany l, the tes ted lev el of fentany l found in her bl ood w as nev erthel ess three to f o u r ti mes l arg er than an amount w hic h s he c oul d hav e tol erated. Base d on tes ti mony

at tr ial , t he GC /M S t e sti s p er formed by

anal yz ing and compar ing the unkno w n bl ood s ample, in thi s cas e, Thompson’ s femoral bl ood s peci men draw n by

the Harri s Co u n ty coroner , w it h oth er bl ood s amples w here the amount of the targ et s ubst ance is kn ow n. The resul ts for the unknow n sample are the n c ompared to the results for the kn own sample s in order to c alculat e the amo untof the ta rg et sub stan ce presenti n the bl ood s ample. The t est imony i n thi s c ase is co mpli cat ed by the v ar iou s nam es an d de scriptions the experts used w ith regard to these “ known sam ples,” of w hich
w e hav e been abl e to del ine ate t hree bas icca teg or ies

. The first cat eg or

y of know n s amples di sc uss ed by the ex per

ts is a s et of “c ali brators,” w hic h are s amples prepared i n a mat ri x of blo od, e thanol , or

so me other25

sol v e n t, e a ch o f

w hic h c ontai ns a k now n amountof the t arg et c ompound, in thi s c ase, fentany l. A setof

cali brati on s tandards inc lud es sev eral sampl es that cont ain v ar iou s know n amount s o f the targ et compound w it hin a s peci fic a nd broad rang e. The sec ond s et of known samp les inv olves “ ion ratios. ” T he ion rat io is the ratio be tw een the ab und ance of tw o dif feren t ions w ithin th e sam e chem ical, or tw o ions rep resen ting dif feren t chem icals,
suc h as fentany l, and the i nter nal st andard form of fentany l. Ion ra ti os can be used eit her q ual it ati v ely

or q uanti tati v ely ; i n oth er w ords, they

are empl oy ed i n ei ther i d e n ti fyi ng the
s u b s t a n c e o r i n m e a s u ri n g t h e a m o u n to f t h e su b s t a n c e . T h e t h ird ca t e go ry o f kn o wn sam ples are quality control sa mp les, w hich are u sed to check the reprodu cibility of results. A q ual ity co ntrol sampl e is a sample w hic h is pre pared in t he s ame ty pe of matr ix as the unkno w n s ample, but w hic h has a k now n c oncen trati on of the targ et c ompound t hat i s n ear the ex pect ed co ncen tration of the unkn own sam ple. Sam ples from prof iciency stud ies, if they are s uff ic ien tl y

st abl e, may

be u sed as exter nal q ual ity co ntrols

. In t he i nst ant c ase, Accu- Che m uti li z ed four cal ibrators a nd i on rati o tes ts in it s anal y si s o f the fentany l q uanti tati on i n Thompson’ s b loo d. The .5 c ali brator fail ed bot h the q uanti tati v e er ro r tes t and the ion rati o test. The 2.0 c ali brator pas sed the q uanti tati v e er ro r tes t and fail ed th e i on rati o tes t. The 5.0 ca li brator fail ed th e qu a n ti ta ti ve er ro r tes t and pass ed th e i on ra ti o tes t. The 20.0 cal ibrator pass ed both tes ts. U ti li z ing thi s d ata, Acc uChe m cal cul ated that Thompson’ s blood contai ned 11.4 ng/ ml of fentany l. The resul t of thes e c alc ula ti ons w as v ali dated by compari son to t he q ual ity co ntrol sampl es, w hic h had been v ali dated by

se parate p ro toc ols bef o re Thompson’ s t est

. Us ing the q ual ity co ntrol sampl es, Accu -Chem’s anal y si s o f Thompson’s bl ood s how ed a q uanti tati on of 10.48 ng /ml. D r . Tar

v er , th e di recto r of Ac c u- C he m, te s ti fi ed by de po s i ti on reg ardi ng the te st26

proto cols and results. Dr. Tarver has d egrees in biologyand ch em istry and a ma ster’s degree in bio me dical science . He i s a d ip lo ma t of the Am erican Bo ard of Forensic T oxicology

and a toxicological chem ist for the Nation al Registry of Certifie d Chem ists. Dr

. Tarv er tes ti fied th at t here are no m ethodol og y standards that re q uire a cer tai n number

of calibrato rs to w ork to prod uce a v alid test result. W hile Accu-Che m’s standa rd proced ure re q uired the use of

four cali brators, Dr . Tar

v er reje cte d two of thos e c ali brators. D r. Tarv er tes ti fied th at t he rej ect ed controls had no ef fect on his ulti mate concl usi ons becau se Acc uChe m v ali dated, throug h exter nal so urces , t he actual lot number of t he s tandard c ali brati on mater ial and the q ual ity co ntrol mater ial

. Dr . W imbi sh re v i e we d and ex pla ine d Ac cu- Che m’s w ri tten protoc ols for p ost mort em testin g for contro lled sub stan ces. Accu-Che m’s stan dard ope rating proced ures allow Dr. Tarv er , t he l ab di re cto r, to re v iew the anal yti cal protoc ol and prov ide t h a t Dr. Tarv er has the fin al author ity

on a ny anal yti ca l protoc ol in the l aborator y , par ti cul ar ly w it h reg ard to forens icspeci mens becaus e of their limi ted and uniq ue qual ity . W it h l imi ted s amples , t he labo ratory directo r has to m ake a decisi on a bou t reportin g results, an d often , as per his instructio ns in the stand ard op eratin g proce dure s, he c a n m o dif y those w ithin scien tif ic li mits as to the a cc eptabi li ty or reporta b ili ty o f a re sul t und er uni q ue c ircums tanc es. I n other w ords, Ac cu- Che m’s st andard operati ng procedu re s all ow Dr. T ar v er to dev iat e from thos e procedu re s. D r. W imbi sh tes ti fied th at i t i s n ot un usual for a l aboratory di re cto r to hav e tha t k ind of dis creti on w it h reg ard to forens icsa mples

. Dr. W imb ish testif ied th at Accu -Chem ’s test rend ered a reliable quant itation w ithin
re asona ble sc ien ti fic c ertai nty

. He ex pla ine d tha t Ac cu- Che m der iv ed i ts re sul ts by uti li z ing and c ompar ing two s eparate s ample set s, t h e n ex pla ine d hi s o w n c alc ula ti ons v er ify ing Accu-Che m’s results. Accu-Chem used tw o of the four calibrators to derive its results. Dr.27

W imbi sh v er ified Acc u- Che m’s mathemati cal anal y si s u ti li z ing thos e two c ali brators, then
re -e x amined the v eraci ty of Acc u- Che m’s resul ts uti li z ing z ero as an a ddi ti onal ca li brati on poi n t

. Dr. W imb ish testif ied th at ide ally , all fo ur of the calibra tors in Accu-Che m’s test
w ould have been f unct iona l; howev er, chan ging the nu mb er of calibrators af

fects th e test ’s preci si on, b ut no t i ts acc uracy . In c ontrast , i f all four cal ibrators fai l, then the re sul t i s n ot
v ali d bec ause there i s n o data w it h w hic h to under tak e any q uanti tati v e anal y si s. In shor t, Dr. W imb ish testif ied th at Accu -Chem ’s test rend ered test results wi th reaso nab le scientif ic
c e rt a in ty. Dr . G ra ham R ic hard J o n e s, a forensi c t ox ic olo g is t, tes ti fied on behal f of Al z a. Acc ordin g to Dr . Jones , the GC/M S is v er y pow er ful, but “i t i s b asi cal ly

a du mb i nst ru ment unl ess y ou . . . cal ibrate it .” Cal ibrators are blo od sampl es cont ain ing kn ow n amount s o f fentany l so that the mac hin e c an re lat e a si g nal to a conc entrati on of fentany l. Ac cordin g to Dr. Jone s, it is “critical” thatthe calibra tors are w orking. D r. Jones te stif ied th at m ultiple calibrato rs are utiliz ed in ord er to ob tain m ultiple d ata point s b ecau se the respon se across a c oncen trati on rang e i s n ot al w ay s c onsi ste nt, and di fferent c alibra to rs are us ed to est abl is h the reli abi li ty of the t est

. Ac co rd ing to Dr . J ones, the GC /M S mac hin e may “b ehav e” di fferentl y

at hig her

or low er concent ra ti ons; therefore, the cali brators s houl d be
ru n at a rang e of co n ce n tr a ti ons w it hin w hic h the bl ood s amples are ex pect ed to fall

. In h is la b , Dr

. Jo n e s re qu ir e s f ive o u to f si x c a li b ra t o rs t o b e wo rk in g t o p ro d u c e a qu a n t it a t ive
re s u ltfo r fe n t a n yl. In o t h e r t e s t i m o n y, Dr

. Jo n e s st a t e d t h a th e m ig h ta ll o w o n e o r two calibrato rs to fail; howev er, the calibrators must be drop ped at the “extrem e,” or at a place distan t f rom where the actua l quantita tion w as. In Dr. Jone s’s opinion , the Accu-Chem test faile d. Dr . J ones conc eded t hat D r. W imbi sh dis ag re ed w it h this analy si s, and28

ack now led g ed th at D r. W imbi sh is a reputabl e forens ictox ic olo g is t and that Dr . J ones had invi ted W imb ish to s p e ak at a se min ar on th e subject of postm ortem redistributio n. Dr. Jones f urther

agreed that, in the ins tant cas e, t he 10 q ual ity co ntrol sampl e read c los e to the target v alue , and f urthe r con cede d tha t a limited sa mp le of blood af fects w het her it is appropr iat e to drop a cal ibrator

. As lab di re cto r, he a ck now led g ed th at he has approv ed a tes t w here a d is tant cal ibrator w as dropped b ecaus e of a l imi ted q uanti ty of blo od. Alz a f urthe r cont end s tha t Accu-Che m’s test w as no t prope rly performe d be cause Acc u- Che m obtai ned i ts q ual ity co ntrol mater ial from t he s ame so urce that itobta ine d i ts calibrato rs. D r. W imb ish add ressed the “sam e sou rce issue” w ith regard to Accu-Che m’s tes ti ng . Dr

. W imbi sh tes ti fied that it is g enerall y re commended that a l aborator y obta in it s q ual ity co ntrol mater ial from a source s e p a rate from the s ource used to ob tai n the calibrato rs, but it is notrequired

. A lz a doe s n ot f urthe r explain or sh ow how this adv ersely affect ed th e q ual ity

of the t estor

the tes t resul ts it sel f. Finally , w e not e tha t Dr. W imb ish testif ied th at Accu -Chem also teste d T hom pson ’s blo od for the met abol it e of fentany l and found les s than 2 nanog ra ms per mil li li ter

. Bas ed on th e amountof fentany l in Thompson’ s s y ste m, D r. W imbi sh w oul d hav e ex pect ed 8 or 10 n ano gram s per milliliter, and th e discrepa n cy mea ns tha t the fent anyl i n T hom pson ’s sy stem came in acute ly , or ov er a short period of time

. Accordin g to Dr. W imb ish, the “only
wa y” to e xp la in t h e d is c re p a n cy b e twe e n t h e a m o u n t o f fe n t a n yl a n d t h e a m o u n to f fe n t a n yl
me tab olites is thatw ithin a da y ’s period, fe nta nyl cam e into Th om pson ’s sy stem in a “fa irly
ra pid ” fashion in a “b olu s amount,” w hic h is a “l arg e amount

. . . floodi ng i nto s omethi ng at the same — at the sam e time .” The tr ial co urt’ s g atek eepi ng functi on unde r Rul e 702 does not supplant
cro s s - e x a mi n a t i o n a s “ t h e t ra d i t i o n a l a n d a p p ro p r i a t e me a n s o f a t t a c k i n g s hakybut29

adm issible evi den ce.” Gam m il l v. Ja ck Will iam s Chevr

ole t , 9 7 2 S

. W

. 2 d 7 1 3 , 7 2 8 (T e x. 1 9 9 8 ) (ci ti n g Daub ert v. Merrell D ow Pharms. , 509 U .S. 579, 596 ( 1993) ); seeT EX . R. E V ID . 702 . Th e reaso ns giv en b y Alz a as to why

it thought th e Accu-Che m te st w as un reliable affectthe w eig ht and credi bil ity of t he tes t, but not i ts admis si bil ity . See Mo.-Kan. Tex. R.R. Co. v. M ay, 600 S.W .2d 7 55, 7 56 (T e x. 1980)

. Al z a and it s e x per t w it ness es had t he oppor tuni ty to ex plo re the cons eq uence s of thes e all eg ed defect s in the t est ing procedu re s and di d s o at g re at l eng th. Onc e the tr ial cour

t found that the sc ien ti fic pr inc ipl es and procedu re s u nder ly ing the test were g enerall y

ac cept ed i n the rele v ant s ci enti fic c ommunity , and the appl ic ati on of thi s t heor

y w as re li abl e, t he th re shol d det er minat ion of admis si bil ity of the testw as met, and the jud g e w as all ow ed, if not re q uired, to all ow the e x per ts to render

opi nio ns on th e presenc e of fentany l in Thompson’ s blo od, lea v ing for the jur y to deter mine the c re dib il ity of those ex per

t opi nio ns. S e e L e de s ma , 242 S.W .3 d a t 4 2

. The i ss ue of w hether the par ti cul ar anal y si s of

Thompson’ s b loo d by Ac cu- Che m w as per

formed i n the proper manner , i ncl udi ng w hether su ff ic ien t q ual ity

co ntrol procedu re s were used to en sure the
accura cy of the te st results, w as a quest io n o f credibility

and proba tiv e v alue for the jury to de ter mine, after

hear ing the tes ti mony

of all the ex per

ts. 4. Postmortem Redis tribution Al z a c ontends thate ven i f Ac cu- Che m’s bl ood t estw as acc urate, the l ev el of fentan y l i n T h o mp s o n ’ s b l o o d w a s t h e re s u l to f p o s t mo rt e m re d i s t r i b u t i o n ra t h e r t h a n an ov erdose. D r. W imbi sh tes ti fied th at po stmor tem redi str ibu ti on oc curs a fter d eath w hen body ti ss ue and org ans break dow n and dr ug conc entrati ons in one org an may lea k i nto,
or co ntami nate, othe r organ s. In o th er w ords, for i nst ance, i f a dr ug i s k now n to
conc entrate i n c ertai n ti ss ues, suc h as the lun g , after death, the dr ug conc entrati on may30

mig ra te or lea k from the lun g ti ss ue int o the hear t and c ause an ar

ti fici all y el ev ated lev el of the dr ug to be found i n a blo od sampl e tak en from the hear t. Dr

. W imbi sh tes ti fied th at all path olo g is ts hav e been tr a in ed th at t he bes t pl ace to c oll ecta bl ood s peci men to prev ent c ontami nati on i s t he femoral sp eci men, and i t is sc ie n ti fical ly reli abl e to form an opin ion abo ut levels of

fent anyl in som eon e’s bloo d at the t ime of dea th ba sed o n levels tak en pos tmor

tem from a femoral draw . Acc ordin g to Dr

. W imbi sh, “[ t]hat ’s been s tudi ed on many oc cas ion s, and t he femoral sp e cim e n i s b y far t he bes t.” D r. W imbi sh tes ti fied that dr ug s t hat a re hi g hly protei n bound and dr ug s that hav e hi g h v olu mes of di str ibu ti on are tho se that are mostsu sc epti ble to post mort em redi str ibu ti on. If post mort em re dis t r i b u t i o n w e re t o o c c u r , i t w o u l d b e s i g n i fi c a n t l y re d u c e d b y t h e re fr i g e ra t i o n p r i or to autops y . Dr . W imbi sh tes ti fied reg ardin g an a rt ic le enti tl ed “ Post mort em R edi str ibu ti on of Morphine and its Metab olites,” published in the Journ al of Forensic Sciences. D r. W imb ish tes ti fied th at fentany l and morphi ne are v er y si mil ar co mpounds and are bot h c onsi dered to be dr ug s t hat h av e reason abl y hi g h v olu mes of dist rib u ti on, a nd ac cordin g ly , a stu dy
re g ardin g the post mort em redi str ibu ti on of mor phi ne woul d render resul ts that coul d be used to an alyz e w hether fentany l w as sus cept ibl e to post mort em redi str ibu ti on. Acc ordin g to Dr. W imb ish, the morp hine study analyz ed b lood sam ples taken from the fem oral artery and from hear

t bl ood t o det e rm in e wh e ther mor phi ne i s s usc epti ble to post mort em redistribut ion an d de term ined thatthere was no significan t dif feren ce in the results; thu s, post mo rtem redistributio n of morp hine f rom a hum an fem oral draw w as un likely . Th is stu dy , l ik e al l others p ubl is hed in the Jour nal of F orensi c S ci ences , w as subj ect ed to peer re v iew , a cr it iq ue byother sc ien ti sts to ev alu ate and determi ne if the s ci enti fic i nteg ri ty and the p ro toc ol as desi g ned i n the st udy w oul d al low

a c oncl usi on on a s ci enti fic b asi s.31

Dr . W imbi sh test ified that the re are no peer rev iew ed, p ubl is hed ar ti cl es conc er nin g post mort em redi str ibu ti on of fentanyl fro m a human femoral draw ; ac cordin g ly , t heor ies that post mort em fentany l re dis tr ibu ti on i n humans reg ardin g femo ra l a n d hear t bl ood spec imens are s pecul ati on. Dr

. W im b is h a ls o t e s t if ie d a b o u ta s t u dy performe d by Janssen Resea rch Foun dati on, w hic h i nv olv ed th e appl ic ati on of D urag esi c patc hes to si x ra bbi ts. This st udy
w as not p ubl ish e d o r subject t o peer rev iew and w as ins tead a “ confide nti al” st udy by Jans sen, a pr iv ate company and a subsi dia ry

of the manufacturer

of the D urag esi c p atc h. Jans sen admini ste re d fentany l t o t h e s e ra b b i t s t h ro u g h D u ra g e s i c t ra nsder mal patc hes and col lected b loo d s peci mens from the ra bbi ts at different ti me i nter v als , bot h pr ior

to and after the d eath of the rabbi ts, to tr y to deter mine if pos tmor tem red is tr ibu ti on oc cur re d i n the
ra bbi ts. Al thoug h J a n ss e n c o ncl uded t hat t he s tudy i ndi cat ed th at s ome pos tmor tem
re dis tr ibu ti on oc cur re d w it h fentany l, D r. W imbi sh dis ag re ed. Dr . W imbi sh test ified that it w as not sci enti fical ly rel iab le to deri v e an opi nio n about the p ost mort em redi str ibu ti on of fentany l in human femoral bl ood from a tes t i nv olv ing the post mort em di str ibu ti on of fentany l in si x four-a nd- a- hal f-pound rab bit s and there w as not “a ny eq uiv ale nce” to all ow thatco rrela ti on. D r. W imbi sh offered s ome sca th in g and detai led cr it ic is ms of Ja nss en’ s s tudy , w hic h may be summar iz ed as foll ow s. This st udy
u t i l i z e d a h u ma n p a t c h o n t h e b o d y o f a 4

. 5 p o u n d ra b b i t

. Th e “ ra b b i t ” s a mple w as too limited , and the conce ntrat ions i n the bloo d and plasm a ranged from the rape utic to to x ic in three of the si x

rabbi ts. T he dosag es of fentany l w ere not adminis tered on a mi ll ig ra m per ki ll ig ra m basi s, w hereby the amount o f drug a d mini ste re d to the rabbi ts coul d be compared to the amount of drug ty pic all y presc ri bed t o a h uman. The sur face area of the pat ch prop ortion ally

c overed a mu ch larger portion of the rab bits tha n it doe s hum ans.32

Ut il iz ing the stu dy

data , D r. W imbi sh test ified that it shows no real di fference in the i nit ial bloo d con cent ration s and the alleged ly increased blood conce ntrat ions. W hile the re are som e increase s in conce ntrat ions, th e Duragesic patch es w ere lef t on th e rabb its af

ter the ir dea ths an d the contin ued inf usion of fent anyl c o u ld c a use a rise i n fent anyl l evels throug hout the b ody

after d eath. D r. W imbi sh sta ted t hat t his proces s c oul d notbe differenti ated from w hat A lz a’s ex per ts ide nti fied as pos tm ortem redi str ibu ti on. In s hor t, Dr . W imbi sh tes ti fied th at t his st udy g iv e s no su ppor

t t o the theo ry

thatpos tmor

tem
re dis tr ibu ti on of fentany l occ urs i n human femoral bl ood. Dr . W imbi sh further

tes ti fied abou t an arti cl e e n t i t l ed “ Durag esi c Transde rmal Pat ch: Post mort em Tis sue Di str ibu ti on of Fe ntany l in 25 C ases ,” pub lis hed i n the Jo ur nal of A n a lyt ic a l T o xic o lo gy b y A n d e rs o n a n d Mu t o . T h is p e e r- re vie we d s t u d y a n a lyze d twe n tyfiv e c ases i nv olv ing humans w ear ing fentany l patc hes w here deat h oc cur re d. Acc ordin g to D r. W imbi sh, thi s study did not show

that there w as any

pos tmor tem redi str ibu ti on. The authors r eferenc ed fiv e c ases i ndi cat ing thatthe post mort em l ev el of fentany l in the femoral bl ood w as hig her than in the cent ra l blo od. How ev er , acc ordin g to Dr . W imbi sh, the p aper

w as not desi g ned to t estw hether pos tmor tem redi str ibu ti on oc cur re d, an d i t doe s not supp ort a scientif ically reliable theory tha t it occurs. On cross-exami n a t io n , Dr. W imbi sh ag re ed th at t he s tudy st ates t h a t: “As w it h oth er dr ug s, the a mount of post mort em redi str ibu ti on appears to inc re ase as the Fent any l conc entrati on i ncreases .” Dr . J ones tes ti fied th at i n hi s opini on, t he Ac cu- Che m tes t w as not v ali d, an d ev en if the 11.4 lev el w as acc urate, that the blood l ev el show n 18 hours a fter d eath did not
accura tely ref lect the lev e l o f f e nta nyl in Th om pson ’s sy stem at the time o f dea th. Dr. Jones tes ti fied th at fentany l is sus cept ibl e to post mort em re dis tr ibu ti on, and t he And erson and M uto s tudy

st ands fo r the prop osi ti on th at t he amountof post mort em redi str ibu ti on33

app ears to increa se as the fent anyl concen tration increases. According to Dr . Jone s, post mo rtem redistributio n occu rs most stron gly arou n d t h e lu ngs and he art and less so periph erallyin locat io ns like the fem oral artery. How ever, draw s f rom th e fem oral artery
can sti ll be affect ed unl ess it is a “c los ed” draw . Acc ordin g to Dr

. Jones , the Anderson and Mu to s tudy

sh ow s t hat p ost mort em redist rib uti on oc curs w it h fentany l but “ may be i n not
ev er y ca se. ” H e ag re ed th at t he s ci enti fic c ommunity had not reache d a c oncl usi on as to
w hether pos tmor tem redi str ibu ti on ar

ti fici all y el ev ates fentany l conc entrati ons in human femoral bl ood. D r. Jo nes further tes ti fied th at resus ci tati on efforts can inc re ase the d eg re e of post mo rtem redistribut ion, and noted tha t testim ony f rom nurse Kat h ryn Nu Bourn ind ic ated that CP R w as per formed on Thompson for a pprox imat ely tw enty min utes pr ior to de ath. D r . J o n e s t e s t i fi e d t h a tt h e “ ra b b i t ” s t u d y p e r fo r me d b y

J a n s s e n i n d i c a t e s t hat fentany l conc entrati ons incr e a se after death, and “t he mos t l ik ely ca use or

co ntr ibu tor
w ould be po stm ortem redistributio n.” Dr. Jone s f irst be cam e aware of the Jan ssen rab bit stu dy w hen he w as prov ide d tha t stu d y b y J anss en’ s c ounse l. H e c onced ed th at i t w as unpubl is hed and w as not p eer-rev iewed, a nd th at i t w as per formed “ confide nti all y ” by the defendant t hat h as been sued in thi s cas e. He ack now led g ed that the four-t o- fiv e pound rabb its were su bjecte d to mo re t han tw ent y -tw o time s the level of fent anyl that is used in humans, and that th e D urag esi c p atc hes re mained on t he rabbi ts after death and cont inu ed to di str ibu te fentany l int o the rabbi ts. Dr. Jon e s was retaine d by Janssen a s an expert in at leastsixtee n case s. He
e xpe ct s t h a t in “ce rt a in ly mo stc a s e s ” h e w ill te st if y tha t t h e fe n ta n yl leve ls a re to o hi gh b e c a u s e p ostm ortem redistributio n “could h ave occurred.” He cann ot say how much Thompson’ s fentany l blo od lev el w oul d hav e been affect ed by pos tmor tem redi str ibu ti onW i l l i am Par k s, t he d i r ect orof t r ade r el at i on s fo r Jansse n an d t he l i ai son b et ween r et ai l and 22 whol esal e cust om er s and t he co m pany , was un abl e t o de t er m i ne whi ch l ot t hat t he p at ch T hom pson was w e a rin g c a m e fro m . 34 to c alc ula te w hat t he fentany l lev el w oul d hav e been at t he ti me of death. Base d on the foregoing te stimo ny, w e can notconclud e tha t Alz a’s evi den ce conc lus iv ely

es tabl is hed t hat t he l ev el o f f e n tany l in Thompson’ s b loo d w as the resul t of post mort em redi str ibu ti on. At mos t, the e v ide nce present ed in suppor t of this theo ry

w as spec ula ti v e in nature. Al z a’s ow n ex per t, Dr

. Jones , sta ted that post mort em redi str ibu ti on of fentany l in humans “c oul d hav e oc cu rre d ,” but “may be i n notev er y ca se, ” and he
conc eded t hat t he s ci enti fic c ommunity had not y et de ter mined if pos tmor tem redi str ibu ti on arti fici all y ele v ates fentany l conc entrati ons in human femoral blo od. The st udi es uti li z ed by Al z a to suppo rti ts theor y w ere eit her not direct ed at de ter mini ng w hether pos tmor tem redistribut io n o c c u rs w ith fent anyl, such as the Ande rson an d Muto stu dy, or w ere “c onfidenti al” st udi es, w hic h w ere notpeer rev iew ed, w hic h w ere per formed by Al z a or

i ts own subsidiaries or em ployees. T he stu dy tha t Alz a prima rily relies on to sup port its the ory of postm ortem redistribut ion relied solely on fe nta nyl testin g on six rabb its. Anim al stud ies, sta ndi ng al one, are g enerall y hel d to be i nadeq uate to prov e c ausat ion i n humans abs ent other co nfir ming epi demiol og ic al data. See, e.g., Havner , 953 S.W .2d a t 729 ( col lecti ng author it ies ). Acc ordin g ly , w e re ject Al z a’s cont enti on that Thompson’ s fentany l blo od l ev el of 11.4 ng /ml w as conc lus iv ely ca used by

pos tmor tem redi str ibu ti on. 5. Use of a Recal led Pa tch Al z a c ontends thatthe ev ide nce conc lus iv ely establ is hes that Thompson c oul d not h a ve b e e n we a ri n g a 7 5 m c g / h p a t c h f ro m a re c a ll e d lo twh e n sh e d ie d

. Fi rs t , A lza 22 argues tha t the Th om pson fam ily cann otp ro v e tha t Michaelynn Th om pson ’s Duragesic patc h w a s a mo n g t h e 2 , 5 0 0 , 0 0 0 p a t c h e s re c a l l e d e i t h e r d u r i n g t h e i n i t i a l re c a l l o r t heSee Tor r ingt on Co. v. St utz m an , 46 S. W

. 3d 829 , 838
- 39 ( T ex. 2000) ( di scussi ng ci r cum st ances 23 w he n a de fen da nt’ s po s t -sa l e de fec t i nve s t i ga t i on gi ves ri s e t o a du t y t o p erform t ha t un de rt ak i ng w i t h o rdi na ry car e)

. As we r ecogni z ed y ear s ago , T exas l aw i s gen er al l y not t he so ur c e of any dut y t o war n of pr oduct de fec t s un c ove red aft er s al e, bu t t he re i s su c h a du t y w he n t he m an ufa c t ure r h a s r e g a i ne d c on t rol of a pr oduct aft ert he d ef ect was l ear ned and t he m anuf act ure r fai l ed t o r em edya def ect bef or e r esel l i ng t he p ro d u c t. See Bell

H eli copt er

C o. v. Br

adshaw , 594 S

. W

. 2d 519, 531- 32 ( T ex. C i v . App. –C or pus Chr i st i 197 9, wr i t r ef ’ d n. r . e. )

. Al t hough T exas l aw i s not t he so ur ce of a m or e g en era l post
- sal e du t y , t her e ar e ot her po t en t i al so ur ce s of su ch a du t y wh i ch m i gh t be e nf or ce d un de r Texa s l aw . S ee , e . g., Lo w e v . G en . M otors C or p. , 624 F. 2d 1 373, 1 37 9-1 38 0 (5t h Ci r . 198 0) ( v i ol at i on o fFeder al M ot orVehi cl e Saf et y St andar ds can s erve as ba s i s for ne gl i ge nc e p er s e c l ai m ). 35 subs eq uent ex panded re cal ls thatAl z a had to pe rfor m w hen i t bec ame apparent that it s initial recall w as no t nea rly broad eno ugh. How ever , p ro o f t hatTh om pson ’s Duragesic pat ch w as itself

recalled is not a n elem entof the T hom pson fam il y’s cla ims an d is, therefore, immater ial

. Und er the Tex as Rul es of E v ide nce, “w ri tten noti ficat ion by a manufacturer of any defect in a prod uct prod uced bysuch m anu factu rer to purcha sers there of is admissible against th e ma nufactu rer on the issue of ex istence of

the de fect to t h e exten t tha t it is relevant.” T EX . R. E V ID . 407( b) ; Par sons , 85 S.W .3d a t 331 n.2; W right v. Gen eral Motors Corp ., 71 7 S.W .2d 153 , 155 (Tex. App. Housto n 1st D ist. 198 6, no w rit). W hile evidence tha t a prod uct fell w ithin a reca ll i s e v iden ce of a d efect, the co nverse is no t true: evidence that a m a n u fa ct u re r did not recall a produ ct or ev iden ce tha t the produ ct at issue fell out side th e recall is no evidence that the prod uct i s not defective. If the T hom pson fam ily had broug ht c lai ms t hat focus ed on an a lle gat ion thatAl z a had neg li g entl y ex ecut ed a recall w hich it unde rtook to perform, ev iden ce tha t Michaelynn Th om pson ’s Duragesic 23 patc h w as among the 2,500, 000 pat ches recal led m ig ht poss ibl y be of some rel ev ance, but Al z a’s arg ument i s w hol ly i rrele v ant t o the Thompson family ’s st ri ct productl iab il ity ma nufactu ring defect claim s (and also irrelevant to the fam ily ’s g ene ral neglig ence claims,
w hich focuse d on Alz a’s careless quality assura nce p rocesse s). Altho ugh the eme rg ency room do ctor remo v ed a nd d iscarded Th om pson ’sLi k ewi se, T hom ps on ’ s D uragesi c pat ch was m ade accor di ng t o t he sa m e con t r ol pr ocesses as 24 th o s e d e fe c ti v e p a tc h e s w h i c h e s c a p e d d e te c ti o n a n d w e re s h i p p e d to th e p u b l i c w i th fl a w e d s e a l s d e s p i te A l za ’ s vis u a l i n s p e c ti o n o f th e p a tc h e s a s th e y p a s s e d a l o n g a c o n v e y o r b e l t. 36 Durag esi c p atc h before i t c oul d be anal yz ed, i t has been a w ell ac cept ed pr inc ipl e of Tex as law for at least fo rty y ears that, i n prod ucts l iability cases, the claima nt need notof fer direct
ev ide nce to prov e a defect becau se suc h proof “ usual ly can onl y be made by ci rc umstan ti al evidence. ” Turner v. Gen. Motors Corp ., 5 8 4 S .W .2 d 8 4 4 , 8 4 8 (T e x. 19 7 9 ) (ci ti n g Darryl
v. For d Motor C o. , 440 S.W .2d 6 30, 6 32 ( Tex . 196 9) ); see Ri dgway, 135 S.W .3d a t 602 (H echt , J ., conc ur ri ng ) (s tati ng thatTex as law al lows p ro of of

pro d uctl iab il ity

by circumsta ntial evidence in certain case s); see als o S hau n T. Mian Corp. v. Hewlett- Pack

ar d C o. , 237 S.W .3d 8 51, 8 58 ( Tex . Ap p.–D all as 2007, pet. deni ed) (p ro v idi ng a t horoug h ex aminat ion of th e p rincip les under ly ing the use of ci rc umstan ti al
e v i d e n c e i n p ro d u c tl i a b i l i ty ca s e s )

. A c c o rd i n g l y , w h e n “ t h e pl a i n t i ff h a s n o e v i d e n c e o f a specif ic design defect or ma nufactu ring defect, h e m a y o f fer evi den ce of

the pro duct ’s malfunct ion as ci rc umstan ti al proof of the defect. ” Sipe s v. Gen. Moto rs Corp ., 946 S. W .2d 143 , 155 (Tex. App. –T exarkana 19 97, w rit denied ). In this case , it is und ispute d tha t Alz a’s Bod olay machin e w as the mach ine w hich
w oul d hav e m a d e T hompson’ s D urag esi c p atc h as w ell as the many patc hes w hic h had document ed defect s i n t h e ir se a ls

. Thi s B odol ay machi ne w as already

sc hedul ed for 24 replace me nt, b ut before it co uld be replace d, it h ad to und ergo se v eral mo dif ication s to try to reduce the number

of man u fa ct u ring defects i t w as produci ng . It is undi sput ed th at the se mo dif ication s w ere no t imple me nte d un til af ter the time p eriod when T hom pson ’s Duragesic patch w ould have been man ufactu red on Alz a’s Bodo lay ma chine . Moreover, the d ocument ar

y ev ide nce and Al z a’s ow n w it ness es co n firmed that publ icrepor ts of lea ki ng patc hes w ere hig her in some lot s of D urag esi c patc hes that w ere notrecal led than37

in som e of

the lots th at Alza recalled. Fina lly , Duragesic patch es w ith de fective seals are
a k n o wn c a u s e o f

p a t ie n t s re c e ivi n g a n o ve rd o s e o f fe n t a n yl, a n d a s st a t e d in A lza ’s o wn secon d recall not ice, it is undispu ted thatsuch fent anyl ex posu re can be fata l: Ex posure to the l eaked medi cat ion co u ld resul t i n . . . an i ncreased transde rm a l absor pti on of the opi ate c omponent fentany l, l eadi ng to pot ent ially

life -threat enin g com plication s. Base d on the foregoing, and othe r ev iden ce discusse d he rein, the jury had before it legally and factu all y

su ff ic ien t ev ide nce from w hic h it mayhav e c oncl uded t hat a manufactur ing d e fe c tin t h e Du ra ge s icp a t c h wo rn b y T h o m p s o n ca u s e d h e r d e a t h

. A c c o rd i n gl y, we ov er ru le Al z a’s first is sue and t hose subi ss ues therein

. C. C A US A TI ON In i ts t h ird i ss ue, A lz a c ontends thatthere w as leg all y and factual ly

i nsuffici ent
ev ide nce to s uppor

t t he j ur y ’s ca usat ion findi ng s. Al z a al so chal len g es the reli abi li ty of the
ex per t t estim o n y

su ppor ti ng the caus ati on findi ng . See Volksw age n of Am., Inc. v. Ram ir ez , 159 S.W .3d 897, 903 ( Tex . 200 4) (“ A par ty may rais e a p ro per ly

preser v ed
com plainton ap pea l that scientif ic evidence is unre liable and thus no e v iden ce to sup port
a j u d gm ent .”). F irst, w e ad dress the reliability of the expert test imo ny, and the n w e w ill separatel y

address the suffici ency of the e v ide nce. See Whir lpo ol Cor p. v . C am acho , 298 S.W .3d 6 31, 6 39 ( Tex . 200 9) ; Volkswage n of Am., Inc. , 159 S.W .3d a t 904

.

1. The Relia bility

of Thompson’s Ex pert Testimony on Causation Al z a arg ues that the test imony of fered byT hompson’ s ex per ts, Dr. R ober

t C . Bu x and Dr . Say ed Feg hal i, w as leg all y and factual ly

i nsuffici ent a nd i t v ar ied mater ial ly from th e actu al “ un di s pu te d” facts

. A l z a c on te nd s t ha t, b ec au s e of t he s e de fi c i en cies, T h om pson failed to produ ce expert testim ony that an y defect in a Duragesic pat ch w orn by T hompson w as a produc ing or prox imat e c ause of her death. Al z a furt her arg ues that38

the c ausat ion opi nions o f Thompson’s ex per ts are no ev ide nce becau se they are bas ed sol ely on t he Ac cu- Che m tes t. In thi s conte xt, Alz a arg ues that Thompson’ s e x per t opi nio n tes ti mony

fail s t he Rob ins on tes t and i s u nreli abl e. See E.I. du Pont de Ne mou rs & C o.
v. Rob ins on , 923 S.W .2d 549 , 557 (Tex. 1995 ). A tw o-pa rt test gov erns w het her expert testim ony is adm issible: (1) the expert mu st be q ual ified ; and ( 2) the tes ti mony mustbe rele vantand based on a reli abl e foundati on. He le n a Ch e m . C o. v. Wil ki ns , 47 S. W .3d 486 , 499 (Tex. 2001 ). W het her the trial court p ro p e rl y a d m it t e d e xp e rt t e s t im o n y is s u bje c t t o a n a b u s e o f d is c re t io n st a n d a rd o f

re vie w. Id. ; Rob ins on , 923 S.W .2d at 549, 558. The tes t for abuse of di sc re ti on is w hether the tr ial
cour t act ed w it hout re ferenc e to any g uid ing r ule s o r pr inc ipl es. Id. ; Downer v. Aquam ar

ine Op., Inc ., 701 S. W .2d 2 38, 2 41- 42 (Tex

. 1985)

. The tes t is not w hether “i n the o pin ion of the rev iew ing co urt, the fact s p re sentan a ppropr iat e c ase for th e tr ial co u rt ’s acti on.” Rob ins on , 932 S.W .2d a t 558

. A rev iew ing cour t c annot conc lud e tha t a tr ial co urt abu sed it s d is creti on merely

bec ause itw oul d hav e r ule d differentl y . Id

. The tr ial co urt has “ broad” dis creti on to deter mine the a dmis si bil ity of ex per t ev ide nce. Exxon Pi

pel ineC o. v . Z wahr , 88 S. W .3d 6 23, 6 29 ( Tex . 200 2) ; Sanchez , 997 S.W .2d at 59 0; Rob ins on , 923 S.W .2d a t 558. W e must uphol d the tr ial co urt’ s e v ide nti ar y r uli ng i f there i s a ny

l eg it imat e bas is for it

. Owens-Cor

n ing F ibe rglas C or p. v . M alo ne , 972 S.W .2d 3 5, 43 ( Tex . 199 8) ; Nor str ud
v. Tr inity Univer

sal Ins . C o. , 97 S.W .3d 7 49, 7 52 ( Tex . Ap p.–F o rtW o rt h 2003, no p et.)

. For an e x per

t’ s t est imony

to be admis si ble , i t mus t pos ses s a reli abl e foundati on. Cooper T ir e & Rub ber

C o. , 204 S.W .3d a t 800

. “A dmis si on of exp ert testi mony that does notmee tt h e r e li a b ility requirem entis an abu se of discretion. ” Id. Ex pert te stimo ny is
unre liable if

it is base d on unreliab le d a t a , o r if t he e x pert dra w s conclusio ns f rom h is und erly ing data “ba se d o n f la w ed m eth odo logy .” Hav ner , 953 S.W .2d at 714 . Ex pert39

tes ti mony

i s a ls o unreli abl e i f “the re i s s impl y too g re at an anal yti cal g ap betw een t he dat a and the op inion p rof

fered .” Gamm ill , 9 7 2 S. W .2 d at72 6 (quo ti n g Gen. Elec. C o. v . Join er , 522 U.S. 136 , 146 (1997 )). In E.I. du Pont de Nem our s &C o. v . R obi nson , the suprem e cou rt set outsix facto rs cour ts mayco nsi der

i n dec idi ng w hether

ex per t t est imony

i s reli abl e: 1. the e xtent to w hic h the theo ry has been or

ca n be tes ted; 2. t h e e xt e n tt o w h ic h t h e t e c h n iq u e re li e s o n t h e s u bje c t ive int er pretati on of the ex per t; 3. w hether the theor y ha s b e e n su bje ct e d to pe e r re view a n d/or publ ic ati on; 4. the techn ique’s pote ntial rate of error; 5. w hether

t h e u n d e rlyin g t h e o ry o r te ch niq ue g enerall y has been acc epted as v ali d by

the re lev ant s ci enti fic c ommunity ; and 6. the n o n ju d ici a l u se s whic h h a ve b e e n m a d e of the theor y or tec hni q ue. 923 S. W .2d a t 557

. These Rob ins on factors a re nonex cl usi v e, Cooper T ir e & Rub ber

C o. , 204 S.W .3d at 801 , and “are not alw ays usef ul in evaluating expert testim ony.” Id. at 802. W hen t he Rob ins on facto rs do notreadily lend t h e m s e lv es to a review of the expert tes ti mony , “ there mustbe s ome bas is for t he opi nio n of fe re d t o show

i ts re li abi li ty .” Gamm ill , 972 S.W .2d at 726 . An expert’s “bare opin ion” w ill notsuf f ice and is unreliable if “base d solely upo n his subje ctiv e interp retat ion of t h e fa cts.” Volkswage n of Am., Inc. , 159 S. W .3d a t 906

. Dr. Bux , a physician and boa rd cert if ied foren sic path ologist w ho p ractices as a medic al ex aminer

and the coroner

for El Paso County , Col orado, pro v ide d testi mony for the Thomps on family

. Base d on his re v iew and anal y si s of Thomps on’ s medic al re cords from the day

of her deat h, he r autops y

repor t and mic ro sc opi c p athol og y sl ide s, and t he40

Acc u- Che m data, D r. Bux tes ti fied th at Thomps on di ed from a fentany l ov erdose and not hear t di seas e. Thompson present ed to the emerg ency room w it h s y mptoms of nausea,
v omit ing , and bac k pai n, and lat er compl ain ed of di z z ine ss , but she w as ale rt and or ien ted. She w as on an EKG mon it o r d u ring her tran sporta tion to the ho spital by the em ergency me dical pe rsonn el, an d also while she w as in the eme rg ency room, and “those m onito rs do notrev eal any

kind of cardia c a bnor mali ty or r hythm di stu rb ance” but ins tead show “ her
re g ula r nor mal hear

tbeat .” Thompson’s m edi cal records from the day of her death do not sh o w t h a tsh e rep o rt e d an y symp to m s t h a t wou ld su gges t t h a t s h e w a s e xpe rie n cin g a cardio log y -rela ted p ro ble m, s uch as ches t pai n or sh ortnes s o f breat h. Dr. Bux f urthe r testif ied that a “cardiac pan el” test w as performe d on Th om pson ’s blo od. This panel i ncl uded an ar ra y of tes ts, w hic h, i nter

al ia, ch eck ed for h igh l ev els of
cer tai n enzy mes i ndi cat ing damag e to musc les , i ncl udi ng ca rd iacmusc le, and troponi n,
w hic h i s s peci fic for

ca rd iacmusc le. The resul ts of the c ardia c p ane l w ere “ all ei ther neg ati v e or w it hin nor mal li mits , w hic h tel ls me that at the ti me she came in, it d id not
a p p e a r f ro m a n e n zym e st a n d p o in tt h a t s h e h a d a n yt h in g go in g o n wit h h e r h e a rt

. ” F in a ll y, examinin g the auto psy dat a, Dr. Bux testi f ie d t h at, m icroscopica lly , Th om pson ’s heart
mu s c l e l oo k ed no r ma l ex c ep t for th e hy pe rtrop hy

. H e c on c l ud ed th ere w as no foren sic
ev ide nce in the rec ords on the daythat T hompson die d tha t s uppor ts a det er minat ion that Thompson di ed from s udden c ardia c a rrestand that sudde n c a rd ia c a rrestw as not a pla usi ble ca use of Thompson’s deat h. Acc ordin g to Dr . Bux , a larg e heart is not an actual
caus e of death. Dr . Bu x co n sid e red the other dr ug s t hat w ere admi nis tered to Thompson at t he hosp ital, includ in g Ant iv ert, Zof ran, an d Dilaudid , and ex clude d the m as facto rs in Thompson’ s d emis e bas ed on the d osag es g iv en, t he metho ds of i nfusion , and the t imi ngAs par t of t he T hom pson f am i l y ’ s bur den on sp eci f i c causa t i on, t heywer e r equi r ed t o off erev i dence 25 e x c l u d i n g o th e r c a u s e s o f M i c h a e l y n n ’ s d e a th w i th re a s o n a b l e c e rta i n ty

. M er rel l D owPhar

m s. v. H avner , 953 S

. W

. 2d 70 6, 72 0 (T ex . 19 97 ). 41 of thei r admini strati on. He found itsig nific ant that the emerg ency room physi ci an remov ed the Duragesic patch f rom T hom pson during his ef fort s t o r e s uscitat e he r and also admini ste re d N arcan, w hic h i s a n ant ido te for a na rc oti c o v erdose. Dr . Bu x tes ti fied th at A cc u- Chem ’s to x ic olo g ic al re por t s how ed a q uanti tati on of fent anyl at 11.4 ng/ml, w hich is a “lethal” level. He f u rt h e r te stif ied th at respirat ory depress ion due to a dr ug ov erdose occ urs i n the l astmin utes or hour b e fo re d eath, that iti s v er y di ff ic ultto “p ic k u p,” and that iti s c omplet ely fores eeabl e for Thompson t o not show si gns of

respiratory dep ression at 3:1 5 p.m ., bu t die f rom it thirty-five minute s later. Dr . Sa y ed F eg hal i, a c ardio log is t w ho wor ks at the Tex as He a rtI nst it ute a nd teac hes at Bay lor Scho ol of Medi ci ne, a ls o tes ti fied on behal f of the Thompsons reg ardin g
w hether or not Thompson c oul d hav e di ed from cardia c p ro ble ms. H e i s b oard c erti fied 25 in cardiology and interventiona l cardiology . Th is w as hi s f ir s tt im e to pro v ide expert tes ti mony

i n a l aw sui t. Acc ordin g to Dr

. Feg hal i, fentany l has a nar ro w therapeuti c marg in. H e has us ed iti ntrav enous ly

i n tho usand s o f patie nts

. After re v iew ing al l of T hompson’ s medi cal
re cords, i ncl udi ng EKG s from a sl eep stu dy that Thompson had par ti ci pated in, the EKG tak en by emerg ency

w or kers o n t h e dayThompson die d, an d the EKG s t aken dur ing attempt s to res usc it ate her, Dr. Feg hal i tes ti fied that Thompso n di ed from a n ov erdose of fent anyl, and T hom pson ’s mo rbid obe sity and sleep apn ea p layed a mino r part, if any, in h e r de a t h

. Dr

. F e gh a li t e s t if ie d t h a t o t h e r m e d ic a t io n s t h a t s h e wa s gi ve n c o u ld n o th a ve caus ed respi ra tor

y depress ion bec ause she w as g iv en appropr iat e dos es. Dr . F egha li c oncl uded t hat Thomps on c oul d nothav e di ed from a ca rd iacev ent42

beca use h er auto psy showed no dam aged he art tissue a nd t h e p ath ology report referen ced n o da ma ge to Th om pson ’s heart m uscle or a n y b lockage of her arteries. Acc ordin g to Dr

. Feg hal i, a sudde n mali g nant ar rh ythmi a does not come from now here and th e re sh o u ld be a ca u se fo r its o m e whe re i n t h e h e a rt , li ke he a rtda m a ge, he a rtsca rrin g, a bl o ck a ge, or a viral i n fe ct io n . I n o th e r word s, t h e h e a rtm u sc le will s h o w p rio r da m a ge of s om e k i nd

. D r . F eg ha l i fur th er b as ed hi s co nc l us i on tha t Tho mp s on d i d no t di e from a sudde n c ardia c e v ent b ecaus e el ect ri c d is crepanc ies di d notappear o n t h e EKG s performe d eith er while e n route t o the e me rg ency roo m, or saliently, w hile the eme rg ency team w as tr

y ing to re sus ci tate her

. Dr . Feg hal i tes ti fied that w hil e Thompson’ s h ear t w as la rg e , itwa s no rm a ll y si ze d fo r h e r b o d y. On ap pea l, Alz a do es no t challen ge Dr . Bux or Dr. F e gh ali’s credent ials. Th eir tes ti mony

analyti cal ly

link ed the data theyobs er v ed to thei r theor

y of how Thompson die d. Theybas ed their

tes ti mony

on w it ness tes ti mony , medi cal records, auto psy records, bl ood sampl es tak en atthe au to p sy, t he bl ood t est ing , and Al z a’s ow n l it erature and dr ug
w arnings. Th e test ing was ba sed o n gene ra lly accep tab le scientif ic principles. Th e jury
w as f ree to e x am ine th is ev iden ce. T he e x perts’ test imo ny doe s not pre senta case w here “t here i s s impl y

too g re at an anal yti cal g ap betw een t h e dat a and the o pin ion proffered,” Gamm ill , 972 S.W .2d a t 726 , or where the ex pert’s test imo ny am oun ted to not hing more than a reci tati on of hi s c re denti als and a s ubj ect iv e opi nio n. See Co ope r Ti re , 204 S.W .3d at 80 1. The Thompson family met it s burden to prov e Dr

. Bux and Dr . F eg hal i’ s t est imony
w as re le vantand re li abl e. See Whir lpo ol Cor

p. , 298 S.W .3d a t 638

. W e c oncl ude t hat Al z a’s co mp lai nts aboutthe ex per ts’ tes ti mony

g o to it s weig ht, not i ts admis si bil ity . The tr ial co urt t herefore di d notabus e i ts dis creti on in admitti ng the t est imony of eit her D r. Bux
or D r. F eg hal i.43 2. Suf fi cien cy o f th e C ausa ti on Ev id ence W e next ex amin e t h e l eg al and factu al suffici ency of the e v ide nce of caus ati on suppo rt ing the jur

y ’s findi ng . See i

d. In add ition to the ev iden ce an d test imo ny previously
recou nte d he rein, w e w ill examine t he testim ony of Alz a’s retaine d expert w itnesse s: Dr

. Vi ncentD iM aio , t he medi cal ex aminer i n Bex ar County ; Dr . J oseph Varon, w ho s peci ali z es in intern al me dicine, inten siv e care, pulmo nary and chest disea ses, sl e e p d isorders, g er iat ri cs , and emerg ency medi ci ne; a nd Dr . Aa ro n Kenn eth C alo dney , a medic al doct or and pai n manag ement s peci ali st. Dr . D iM aio tes ti fied th at Thomps on die d from a fatal c ardia c a rr hythmi a, an i rreg ula r bea ting of

the he art, produce d by the ma ssiv e enla rg em ent of her heart. Accordin g to Dr. Di Ma io, i t w as ess enti all y a “c oin ci dence ” that Thompson w ent t o the hos pit al and di ed of
an ar rh ythmi a. Dr . Di Ma io tes ti fied that thir teen percentof peopl e w ho di e s uddenl y and
une x pect edly hav e a large heart as the ca use of d eat h. Yet he co nced ed b efore the jury tha t one ca nno t perform a test for cardiom y opa thy and he is not a cardiolo gist. W hile Dr. Di Ma io ag re ed th at Thomps on’ s medi cal records and testi mony ev ide nce sl eepi ness , and sl eepi ness i s a si g n of fentany l tox ic ity , he state d t h at i f Thompson had re cei v ed a fatal dose of fentany l, sh e woul d hav e bec ome sl eepy and then gon e i n to a coma for two to three hours p ri or

to death, i n c ontras t to t he ev ide nce herein w hic h i ndi cat es that T hom pson w as foun d de a d t h irt y t o thirty- f iv e min ute s af ter bein g seen bya nurse. Dr

. Di Ma io tes ti fied th at t he onl y w ay a fe n ta ny l ov erdose ki ll s i mmediat ely i s i f it is i nfused int ra v enous ly

. Fi nal ly , D r. D iM aio tes ti fied th at, in re tr ospect, the medi cal ex aminer for Har ri s C ounty

sh oul d hav e tes ted Thomps on for fentany l. Dr . Va ro n tes ti fi e d i n c o u n ter poi nt t o D r. F eg hal i. W hil e D r. Varon c onced ed th at he i s n ot bo ard- cer

ti fied i n c a rd iolog y , he cl aimed that he i s t he “ number one g uy ” on44

sudde n c ardia c d eath

. H e wor ks at the medi cal ce nter i n H oust on and teac hes at t he Uni v ersi ty

of Tex as Hea lt h Sc ien ce Cen ter and other

pl aces . Acc ordin g to D r. Varon, s ig ns to l oo k for i n di ag no s i ng a fen ta ny l or na rc ot i c ov erdo s e i nc l ud e: c on s tr icted p upils,
sw eati ng , drow si ness or l etharg y , and the ces sat ion of breathi ng . Dr

. Varon te sti fied th at thes e sy mptoms appear fast w it h int ra v enous transfusi ons of fentany l or more s low ly

w hen the drug i s introdu ced o rally or through a skin pat ch. W ith a fent anyl ov erdo se, he w ould hav e ex pect ed Thompson to be l etharg ic , s lee p y, drow sy , and hav e depress ed
res pi rat i on s , y et he di d g av e s w or n te s ti mo ny th at he d i d no t rec al l a ny o f t he s e s y mp to ms in her medi cal records w hic h ex press ly doc ument s ome of thes e s y mptoms. Acc ordin g to Dr . Va ro n, i t t akes si xteen hours t o ac hie v e the full bl ood l ev el effect s of a fentany l patc h. Howev er , w hen q uest ion ed abou t proper fentany l dosag es, he t est ified tha t he do es no t follow the therap eut ic ranges on narco tics in the PDR, an d in respo nse to a q uest ion re g ardin g w hether his dosag es re g ardin g fentany l w ere “c atc h as ca tch ca n,” replied , “ex actly rig ht.” Dr. Va ro n t e stified that he i s famil iar w it h s udden c ardia c a rrest , and that500 to 1,000 cas es of s udden cardia c ar re st occ ur ev er y day in the Uni ted Stat es a n d th a t one epi sode of cardia c a rr hythmi a c an c ause death. The under ly ing arr hythmi a can be caus ed by the hea rt not getting eno ugh oxy gen or p ota ssium . According to Dr. Varon, th ere are sev eral ri sk

factors for a sudde n c ardia c a rr hythmi a, i ncl udi ng bl ock ag es in the h ear t, sl eep apnea, medic ati ons, probl ems w it h el ect ro lytes , t ra uma, or an e nla rg ed hear

t. Dr . Va ro n ex amined the autops y re por t, w hic h sta ted that Thompson was si x feet tal l and w eig hed 367 pounds , and tes ti fied th at ob esi ty al so car ri es a hig her ri sk for heal th probl em s l i k e ap ne a an d s ud de n c ardi acd ea th

. Th om ps on ’ s h ea rt w ei g he d 60 0 g ram s and had e nlarged cham bers, w here as a norm al hea rt weig hs betw een 350 to 500 g rams.45

Acc ordin g to Dr . Va ro n, t he more di lat e d the hear t i s, the h ig her

the chanc es of cardia c ar rh ythmi a. Dr

. Varon tes ti fied that in his opi nio n, Thomps on di d nothav e a h eal thy hear t, and he opi ned t hat s he ex pired from a su dden c ardia c d eath, w hich was th e r esul t of
ar rh ythmi a or

a de fibr il lat e. He als o tes ti fied th at i t w as jus t a coi nci dence that Thompson
w as in the h ospi tal w hen she die d of ar rh ythmi a. In thi s reg ard, he st ated that Thompson had par ti ci pated in a s lee p s tudy w hic h show ed s he had sl eep apn ea, a lt houg h he
conc eded t hat t he records from thatst udy sh o wed thatsh e had 144 i nst ances of apnea
w ith o u t any

co rrespon din g ar rh ythmi a. Dr . Va ro n tes ti fied th at Thomps on’ s medi cal
re cords from 2001 and 200 2 s how po te n ti a l h e art probl ems i n two i nst ances w here s he compl ain ed of che st pai ns and t ig htnes s, difficul ty bre a thing , nau sea, and g eneral
w eakne ss , al thoug h the records fail to s how any su ch dia g nosi s. Accordi ng t o D r . Va ron , an i nd i v i du al c an e x pe r i en c e a reg ul ar h ea rt rat e w hich prog re ss es to full ar rh ythmi a i n mi nutes

. How ev er , D r. Varon admi tted that th e EKG s
w hic h w ere per

formed on Thompson on the da te o f her deat h s how ed no abnor mali ti es
w it h reg ard to Thompson’ s h ear t v a lves , and her

auto psy sh ow ed no atherosc lerosi s o r other hear t damag e. He further

ag re ed tha t b ig peopl e c an hav e bi g , hea lt hy hear ts. Dr . Aa ro n K e n n e t h C a l o d n e y , a m e d i c a l d o c t o r a n d p a i n m a n a g e me n ts p e c i a l is t, prov ide d furt her

tes ti mony

on b ehal f of

Al z a. Dr . Ca lo d n e y

has w ri tten thous ands of prescription s for Duragesic patche s. He testif ied that D uragesic pat ches fa ll w ithin a “ class II” syste m of narcot ic s, and a cl ass II narcot ici s s omethi ng thati s “ [d]efin it ely ” dang erous if mis used. Dr

. Cal odney tes ti fied that he w oul d not s tar t an opi oid nai v e pat ien t on a 50 milligram patch beca use it cou ld pot ent ially be fa tal. H e testif ied that fen tan y l is an o pioid li ke morph ine , buti s a pprox imat ely 100 ti mes more pot ent t han mor phi ne. Dr. Calodne y

testif ied th at th e PDR is a comm on referen ce for profession als to use46

to as cer tai n the par

ti cul ar q ual it ies and proper

ti es of drug s, and furt her tes ti fied reg ardin g t h e P DR ’s s e c t io n o n t h e Du ra ge s icp a t c h

. T h e P DRst a t e s t h a t“s in c e t h e p e a kfe n t a n yl lev els oc cur

between 24 and 72 hours o f trea tment, presc ri bers sho uld be a w are tha t
ser iou s o r life -t h re a te n in g hyp o ven ti la ti o n m a y occ u r, eve n in op ia te to le ra n t p a ti e ntsdur ing the initial applicat ion pe riod.” It f urthe r states th a t“ [ o ] ve restima ting the Duragesic dose
w hen c onv erti ng pati ents from another opi ate medic ati on can re sul t in fatal o v erdose w it h the first dose. ” The 2005 PD R sta tes that using damaged or cu t pat ches ca n l ead t o the
ra pid rele ase of the c ontent s o f the pat ch and abs or pti on of a p o te n ti a ll y fatal dose of fentany l. Dr . C alo dney

has nev er

se en a damag ed patch, but he agreed t hat i f the pat ch w as dam aged an d the drug w ere to e scape , the n tha t could lead to a rapid relea se of fent anyl. He re fused to tes ti fy re g ardin g w hether a rapi d rele ase coul d l ead t o a fatal ov erdose, “ not know ing w hether

the stu ff

i nsi d e t h e patch c an actual ly be a bsor bed t hroug h the sk in”
w it hout the p atc h s y ste m it sel f. A c c o rd i n g t o Dr . Cal o d n e y , T h o mp s o n w a s a n a p p ro p r i a t e c a n d i d a t e fo r u s e o f a Du ra ge s icp a t c h

. Dr

. Ca lo d n e y st a t e d t h a tc o m p l i c a t io n s f ro m a n o ve rd o s e o f fe n t a n yl incl ude i tch ing , nau sea and v omit ing , di ff ic ulty ur ina ti ng , and respi ra tor y depress ion ; he
re v iewed Thompson ’s medi cal records and nev erthel ess stated that he s aw no s ig ns in her medic al records that ind ic ated the a ppearance of fentany l tox ic ity . He further tes ti fied th at if some one is receiving too much fent anyl, a ch a nge in their level of consciou sness is obser v abl e ov er

a peri od of

time; t he pat ien t w il l beg in to g et drow sy and dev elo p c hang es in re spi ra ti on after

that

. Acc ordin g to Dr . C alo dney , t hese chang es happen slow ly and g ra dual ly as the medic ati on is infused , presumabl y throug h a rate- cont ro ll ed membrane. W e not e at thi s j unct ure tha t, in cont ra st, D r. W imbi sh tes ti fied th at t he respi ra tor y ce nterW e n ote t ha t w e a re n o t th e fi rst c ou rt t o revi ew A l z a’ s cl ai m t ha t i t s ow n e x pe rt s ’ di s m i s s i ve 26 t est i m onyabo ut t he f l aws i n i t s D ur agesi c f ent any l pat ches i s aut hor i t at i v e orAl z a’ s ar gu m en t s t hat t he c l a i m a n t’ s e x p e rts ’ c o n tra ry o p i n i o n s s h o u l d b e w h o l l y d i s re g a rd e d

. See, e. g. , K unnem ann v. Jansse n Pha r m ac eu ti ca Pr

od uc ts, L

. P. , N o. 05 C 3211, 2008 U

. S. D i st

. LE X I S 10172 4, at * 8- 32 ( N

. D

. I l l

. D ec. 2, 200 8) (no t d esi gnat ed f orpub l i cat i on)

. Li k ewi se, we ar e no t t he f i r st cour t t o con cl ude “ [ t ] hese i ssues m ust be res ol ved by a j ury . ” See id. at * 32. 47 adapts to dr ug tolerance and a pati ent maynot ex per ien ce res pirator y depress ion unti l the threshol d for tol erance is ex ceede d, and it may be cl ose to the fatal ev ent in a to le rant ind iv idu al. I n other w ords, re spi ra tor y depress ion is not neces sar il y obs er v abl e i n a t ole ra nt ind iv idu al. Ac cordin g to Dr . W imbi sh, it coul d be “p ar t of the ter minal ev ent rat her than a harb inger of

some thing to com e.” To a s ig nific ant extent, deci din g w hether Thompson die d from an enl arg ed hear t or
a s udden a rr hythmi a, as al leg ed by Al z a, or an o v erdose of fentany l, a s a lle g ed by the Thompson famil y , t ur ned on the j ur y ’s ex aminat ion of the ev ide nce and it s a ss ess ment of the c re dib il ity

of the v ar iou s w it ness es. W e not e tha t t he j ur y w as, of course , entit led to
w eigh the credibility

of these w itnesse s. Le de s ma , 242 S .W .3d a t 41 (ho lding that th e jury
w as enti tl ed to tak e i nto a cc ount that an ex per t had w or ked for th e manufacturer and had never fo und a defect in a prod uct). 26 Cau sat ion may

be est abl is hed by ci rc umstan ti al ev ide nce. Ri dgway, 135 S.W .3d
a t 6 0 1 ; Ford Motor Co. v. Cam m ack , 9 9 9 S

. W

. 2 d 1 , 7 ( Te x . A p p . – H o u s t o n [ 1 4 t h D is t.] 1998, pet. deni ed) ; J.K

. and Susie L. Wadley

R esear ch Inst. & Blood Ba nk v. Bees on , 835 S.W .2d 6 8 9 , 6 9 8 ( Te x . A p p . – D a l l a s 1 9 9 2 , w r i t d e n i e d )

. Th i s p r i n c i p l e o f Te x a s l awhas been w ell recog niz ed for decad es. Glade wa ter v. Pike , 727 S.W .2d 5 14, 5 18 ( Tex . 198 7) (“ Ci rc umstan ti al ev ide nce and inferenc es therefrom are a suffici ent basi s for a findi ng of
caus ati on.” ); Far

ley v. M M C attle C o. , 529 S.W .2d 7 51, 7 55 ( Tex . 197 5) ( “P ro x imat e caus e, l ik e any

othe r ult imat e fact, may be es tabl is hed by ci rc umstan ti al ev ide nce. ”) ; Lynch
v. Rick etts , 158 Tex . 487 , 314 S.W .2d 2 73, 2 75- 76 ( Tex . 195 8) ( “I t i s w ell se ttl ed .

. . that48

neg li g ence and c ausat ion , li ke any othe r ult imat e fact, may be e sta bli shed by ci rc umstan ti al as well a s d irect ev ide nce. ”) ; Peve to v . Sm it h , 134 Tex . 308 , 133 S.W .2d 572 , 576 (193 9) (rely ing on circumsta ntial evidence to prove neglig ence and causa tion);
see a lso Tex. Elec. Coop. v. Dillard , 171 S.W .3d 201, 206 (Tex . App.–Ty ler 2005, no p et.) (“ Cau se in fact .

. . may be p ro v en b y

ci rc umstan ti al ev ide nce . . . .” ). The q uest ion of
caus ati on i s a fact q uest ion for t he j ur y , and the jur

y has broad l ati tude to i nfer c ausat ion from the ci rc um stances su rroundi ng an a cc ide nt, espec ial ly w hen i t i s n ot po ss ibl e to produce di re ct proof of caus ati on. J.K . and Susie L. Wadley, 835 S.W .2d a t 698 ; Far ley, 529 S. W .2d at 756. The pla int iff need not ex cl ude all possi bil ity thatthe acc ide nt oc cur re d other than as he all eg es. Far ley, 529 S.W .2d at 756. R ather , t he pl ain ti ff i s o nly req uired to con vi nce the j ur

y by a preponderance of the ev ide nce that the a cc ide nt oc cur re d as all eg ed. RenfroDrug Co. v. Lew is , 235 S.W .2d 6 09, 6 21 ( 1950) ; Gulf Sta tes Util. Co. v. Dr yden , 7 3 5 S

. W

. 2 d 2 6 3 , 2 6 7 (T e x. A p p . - Be a u m o n t 1 9 8 7 , n o wri t ). In t h e sp e c if icco n t e xt of a str ict product li abi li ty case, the cl aimant s can suppor t their theory of how the inc ide nt
occ ur re d w it h c irc u m sta nti al ev ide nce. See, e.g., Ridg way, 135 S.W .3d a t 601 ; Gen. Mo tor s C or p. v . Sa nchez , 997 S.W .2d 584 , 587 (Tex. 1999 ); Kindred v. Con/Ch em , Inc. , 650 S.W .2d 61, 63 (Tex.198 3). As state d previously , und er the T exas Sup reme Court’s articulat ion of the sta nda rd
o f r e view i n City of K

eller , i n rev iew ing the leg al suffici ency of the e v ide nce, w e v iew the evidence in the light mo st favorable to th e jury ’s fin dings, gi v ing fu ll credit to all fa v orab le evidence if

any reaso nab le person cou ld , and disregarding contrary ev iden ce un less all
re asona ble persons co uld not. City of K eller , 168 S.W .3d a t 807. The ev ide nce suppo rt ing the jury ’s fin ding on cau sation wa s n o tc o m plete ly lacking, nor w as it beyond th e cou rt’s author ity to admiti t, nor

w as ita mere s ci nti ll a, no r w as itco nclus iv ely di sprov ed by49

cont ra ry ev ide nce. See U

nir oyal Goodr

ich Ti re Co. v. Ma rt

ine z , 9 7 7 S

. W

. 2 d 3 2 8 , 3 3 4 (T e x. 1998) ; see als o Whir

lpo ol Cor p. , 298 S.W .3d a t 638

. M oreov er , c onsi der ing and w eig hin g all of the e v ide nce in the c ase, the v erdict w as n o t so agai nstthe g re at w eig ht an d prep ond eran ce of

the ev iden ce as to be ma nifestly unju st, shock the con science , or clearly dem onst rate bia s. Se e Golden Ea gleAr cher y, Inc . v . Jack son , 116 S.W .3d 7 57, 7 61- 62 (Tex . 200 3)

. Base d on the foreg oin g , w e ov er ru le Al z a’s thi rd i ss ue. III . E VI DENCE OF N E GL I GE NCE In i ts sec ond i ss ue, A lz a c ontends thatthere i s l eg all y i nsuffici ent e v ide nce to supp ort the subm ission or jury f inding tha t Alz a w as negligent beca use th ere w as no ex pert
ev ide nce on th e s tandard of care. As an ini ti al matter , w e not e tha t a par ty may pursue cl aims and seek damag es on alt er nati v e the or ies of li abi li ty

. T EX . R. C IV . P. 4 8; W aite Hill Servs., Inc. v. W orld Class Me tal W orks, Inc. , 9 5 9 S

. W

. 2 d 1 8 2 , 1 8 4 ( Te x . 1 9 9 8 )

. W h e n w e h a v e h e l d t h a tthe
e vide n ce i s leg all y

and factual ly

su ff ic ien t t o s uppor

t t he tr ial co urt’ s j udg ment on one of
mu ltiple alte rnative causes o f action , “it i s unn ecessa ry to add ress” the issues th at con cern alt er nati v e the or ies that mig ht hav e al so ser v ed as a ba si s t o aff ir m the jud g ment. A da ms v. H & H Meat

Pr ods. , Inc ., 41 S.W .3d 762, 771 (Tex

. App.–C or pus Chr is ti 2001, no p et.) (ci ti n g T EX . R. A PP . P. 47.1) ; see Nw. Mo rt gage, Inc . v

. Sa li nas , 9 9 9 S

. W

. 2 d 8 4 6 , 8 6 5 (T e x. App.–C or pus Chr is ti 1999, pet. deni ed) (st ati ng thatw hen “ the t ri al cour t’ s j udg ment c an be su ppo rted on the ba sis of” one of multip le the ories of

recovery , “w e ne ed n ot ad dress t h e s e re m a in in g p o in t s ” wh ic h a d d re s s a lt e rn a t ive t h e o ri e s o f re c o ve ry)

. Ac c o rd in gl y, we need no t add re ss Al z a’s se cond is sue, wh ich c hal len g es the l eg al suffici ency of the
ev ide nce suppo rt ing the jur y ’s f ind ing of

neg li g ence as an al ter nati v e bas is for a ff ir ming the50

jud g ment. SeeT EX . R. A PP . P. 4 7.1. Nev erthel ess , ev en i f w e w ere to find it neces sar y to address thi s is sue, w e not e tha t the j ur y w as ins tr uct ed th at: “N eg li g ence” means fail ure to use ordin ar y ca re , t hat i s, faili ng to do th at w hic h a phar maceut ic al manufacturer of ordin ar y pr udenc e woul d hav e done under the same o r si mil a r circums tanc es or doi ng thatw hic h a pha rm a ce uti cal manufacturer of ordin ar

y pr udenc e w oul d nothav e done und er the sa me or similar circum stan ces. W here an issue involv es on ly g ene ral knowl edge and experience rather tha n expertise, it is a matter entr ust ed to the jur y to deci de. See GTE Sw., Inc. v. Bruce , 998 S.W .2d 6 05, 620 (Tex. 1999 ). In cont rast, “[e]xpert testim ony is nece ssaryw hen the alleged neglig ence is of su ch a nat ure as no t to be w ithin th e experience of the layman .” FFE Transp. Se rvs.
v. Ful gham , 1 5 4 S .W .3 d 8 4 , 9 1 ( T e x. 20 0 4 ) (qu o ti n g Roa rk v. Al len , 633 S.W .2d 8 04, 8 09 (Tex . 198 2) ( hol din g thatdi a gno sis of sk ull fractures is not w it hin the ex per ien ce of the lay man)) ; see also Turbine s, Inc. v. Dardis , 1 S.W .3d 726, 73 8 ( Tex . Ap p.–Amar il lo 1999, pet. de n i e d ) ( h o l d i n g t h a ti n s p e c t i o n a n d re p a i r o f a n a i rc ra fte n g i n e a re n o tw i t h i n the
ex per ien ce of the l ay man); Hag er v. R om ine s , 913 S.W .2d 733 , 734 -35 (Te x . App .–Fo rt W orth 19 95, no w ri t) (hol din g that operat ion of an aircraft and aer ial appl ic ati on of her bic ide
are no t w ithin th e experience of the layman ). In dete rmining w het her expert testim ony is
neces sar

y to est abl is h neg li g ence, Tex as cour ts hav e c onsi dered w hether the cond uctat issue involv es the use of specia liz ed equipme nt and techniques unfam iliar to the ordina ry person. Ful

gham , 154 S.W .3d a t 91. In l ig ht of the tes ti mony and admis si ons by

Alz a’s empl oy ees and represent ati v es re g ardin g i ts manufactu rin g a nd q ual ity i nspecti on proces s for the Durag esi c p atc h, t he deter minat ion reg ardin g w hether Al z a breache d the st andard of care appl ic abl e to a reaso nab le pha rmace utical m a n u factu rer does no t ent ail specialized knowledge or ski llI n t hi s c on t ext , t he d et er m i nat i on whet herexpe r t t est i m onyi s nece ssar y i s r ev i ewed un dera de 27 n o v o s ta n d a rd o f re v i e w . See FF E Tra nsp. Ser vs. v. Fulgham , 15 4 S

. W

. 3d 84 , 90 (T ex . 20 04 ). 51 u n iqu e to a sc ie n ti f ic d isc ip lin e an d be yon d t h e k n o wled ge a n d e xpe rie n ce of th e ave ra ge jury . Se e , e .g, W

or shamv. A.H. R obi

ns Co. , 734 F .2d 6 76, 6 85 ( 11th Ci r. F la. 1984) (a ff ir ming a j udg ment ag ain st the manu facturer o f t h e D alk on Shi eld IU D on c lai ms of negligence de spite th e ab sence of ex pert te sti m o ny on th e du ty of care); Palm er v. A.H. Rob ins C o. , 684 P.2d 187, 209- 10 ( Col o. 19 84) ( same) ; cf. McNeil Phar m . v . Hawki ns , 686 A.2d 567, 585 ( D. C. 1996) (req uir ing competent ex per t testi mony

reg ardin g the v iol ati on o f t h e s t a t u t e s a n d r e gu la t io n s s u b m it t e d t o t h e j u ry in wa rn in gs c a s e ). O n t h e co n t ra ry, resolut ion of

t he negligence issue turns on an assessm ento f e v iden ce relating t o Alza’s d e c is io n t o m a n u fa c t u re t h e Du ra ge s icp a t c h o n a m a c h in e kn o wn t o p ro d u c e d e fe c t ive p a tc h e s and t o tes t i ts product s w it h a met hod k now n to be i nsuffici ent t o as cer tai n the absen ce of defect. The ul ti mate det er minat ion of w hether Al z a’s co nductco mport ed w it h that deg re e of care w h ich a reaso nabl y pr udent dr ug manufacturer w oul d us e under

the
sam e or similar circumsta nces was w ell w ithin t h e e xp e rie nce o f person s of

ordinary intelligence. Th us, expert op inion e v iden ce w as n o te s sent ial to the Th om pson fam ily ’s cl aim in neg li g ence. 27 How ever, ev en if

w e w ere to d ete rmine o t h erw ise, an d con clude thatex pert tes ti mony

w as neces sar

y , t his requirement woul d hav e been met by the tes ti mony proffered by

Al z a’s ow n represent ati v es and employ ees. W hil e the Thompson family mig ht nothave presen ted a retain ed ex pert on pha rmace utical m anu factu ring to est ablish th eir cl aim that Al z a w as neg li g ent i n i ts manufactur ing proces s, Al z a’s ow n represent ati v es and employ e e s, i n cl udi ng a s eni or tec hni ci an, t he c ompany represent ati v e, an d i ts q ual ity ass urance spec ial is t, offered ex per t opini on testi mony

reg ardin g Al z a’s acts and omi ss ion s52

w it h reg ard to the D urag esi c patc h, from w hic h credi ble and ex per t ev ide nce the j ur

y may hav e c oncl uded t hat A lz a w as neg li g ent. These w it n e ss e s tes ti fied th at A lz a rele ased lea ki ng patc hes to the publ ic and onl y lea rn ed that it s patc hes w ere defecti v e bec ause of
consu me r com plaint s; tha t Alz a w rongly det ermin ed that the 200 1 fold-over inciden ts w ere is ola ted ev ents and acc ordin g ly , did not tak e cor re cti v e act ion that w oul d hav e prev ented dis tr ibu ti on of the 2004 recal le d l o ts ; that A lz a’s i nspecti on pl an for the p ro ductl ots w as defici ent; that Al z a di d notfoll ow i ts ow n def ic ien t plan and al low ed di str ibu ti on of tray s o f patc hes that itkn ew

co ntai ned defect s; that Al z a c onti nued to re lea se patc hes after both lea rn ing of the l eaks and deter mini ng the manufactur ing flaw thatresul ted in the l eaks ; and that Al z a cont inu ed to impl ement a v is ual ins pect ion proces s despi te k now ing thati t w as ine ffect iv e to dis cov er

productdefects

. Ul ti matel y , i n the i nst ant c ase, the pr imar y facts w ere ac cu ra tel y

present ed to the jur y , and the jurors were as cap a b le of understa ndi ng and draw ing co rrectco ncl usi ons f rom th e facts as an ex pert wi tne ss. W hile the re are cases that would fail w ithou t expert testim ony becau se the techn ical and scientif ic aspe cts of the case w ould result in a jury ’s inab ility to com preh end the issue s, Alz a ha s not sho w n tha t the stan dard of care issue is, by def inition, a ma tter be y ond the jurors or tha t this is “one of the rare cau ses of

action in
w hich the law

predicat es recovery

upo n expert testim ony.” Salemv. U.S. Lin es Co. , 370 U. S. 3 1, 35 ( 1962)

. For the foreg oin g reason s, w e ov er ru le Al z a’s se cond is sue.

IV. E VI D ENT I A R Y R UL I NGS Al z a’s fourt h and fifth is sues att ack the tr ial cour

t’ s admis si on of ev ide nce re g ardin g Acc u- Che m’s tes t and i ts re cal l of the D urag esi c 7 5 mcg patc h. A. S TA NDA RD OF R EVI EW53

W e rev iew

the admis si on or e xclu sion of ev ide nce under

an a buse of dis creti on sta ndard. See In r

e J.P.B

. , 1 8 0 S. W .3 d 57 0 , 5 7 5 (T e x. 20 0 5 ). Th u s, evid e n ti a ry ruli n gs admitti ng or ex cl udi ng ev ide nce are c ommitt ed to the tr ial co urt’ s “ sound ” dis creti on. See Tex. De p ’

t o f Transp. v. Able , 35 S.W .3d 6 08, 6 17 ( Tex . 200 0) ; City of Brow nsville v. Al var ado , 897 S.W .2d 7 50, 7 53 ( Tex . 199 5) ; Gee v. Lib er ty Mu t. Fi reIns . C o. , 765 S.W .2d 394, 396 ( Tex . 198 9) . A tri al cour t abuses its dis creti on i f it act s w it hout re ferenc e to any g uid ing r ule s a nd pr inc ipl es or if the a ct compl ain ed of i s a rb it ra ry and unreason abl e. City of Brow nsville , 897 S.W .2d at 754; see a lso Carpen ter v. Cim arron Hydroca rbon s Corp ., 98 S. W .3d 682 , 687 (Tex. 2002 ). W e mu st uph old a trial court’s evidentia ry ruling if there is any l e git imate bas is i n the record to suppo rti t. Owens- Cor nin g F ibe rglas C or p. , 972 S.W .2d a t 43. For the ex cl usi on of ev ide nce to c onst it ute rev ersi ble er ro r, the compl ain in g par ty must show

that( 1) the tr ial co urt c omm it te d e rror , and ( 2) the er ro r probabl y ca used the
re ndi ti on of an i mprop er j udg ment. Sta te v. Cent . Expressway Sign Assocs ., No. 08- 061, 53 T ex . Sup. Ct. J. 134, 2009 Tex . LE X IS 9 67, a t * *5- 6 ( Tex . N ov . 30, 2009) ; McCraw v. Maris , 828 S.W .2d 7 56, 7 57 ( Tex . 199 2) ; seeT EX . R. A PP . P . 44. 1; Nis s an Moto r Co. v. Ar m str ong , 145 S.W .3d 1 31, 1 44 ( Tex . 200 4)

. A person seek ing to revers e a judg ment base d on ev iden tiaryerror need not pro v e tha t “but for” the error a dif feren t judgme nt w ould
neces sar il y

hav e been re ndered, but only that the error

probabl y

resul ted in an i mprop er jud g ment. State , 200 9 Tex . LE X IS 9 67, a t * 6; Cit y o f Brow nsville , 897 S.W .2d a t 754 ; Mc Cr aw , 828 S.W .2d at 758. A s ucc ess ful c hal len g e to ev ide nti ar y r uli ng s u sual ly

req uires the c omplai nin g party

to show thatthe jud g ment t ur ns on th e par ti cul ar ev ide nce ex cl uded
or admi tted. Bay Ar

ea Hea lt hcar e Gr oup, L td . v. Mc Shane , 2 3 9 S

. W

. 3 d 2 3 1 , 2 3 4 (T e x. 2007) ; Ni

ss an Motor

C o. , 145 S.W .3d a t 144

. In mak ing thi s d eter minat ion , w e rev iew the54

enti re record. Reliance Ste el & Alumi num Co. v. Sevcik , 267 S.W .3d 867 , 871 (Tex. 2008 ); Ni ss an Motor

C o. , 145 S.W .3d a t 144

. Th e s u p re m e cou rt has recognized the im possib ility of prescribing a specif ic test for har mles s e rro r re v iew and has charact er iz ed th e s tandard as “ more a matt er of judgme nt th an p recise me asure me nt.” Rel ian ce Steel , 267 S.W .3d a t 871 ( q uoti ng N is san Mo tor C o. , 145 S.W .3d a t 144 ). Ac cordin g ly , as st a te d by Ju sti ce O’ Nei ll , t hat det ermin ation is ent rusted “to t he soun d discretion o f the review ing court.” State , 2 0 0 9 T e x. L EXI S 9 6 7 , a t * 5 (cit in g Mc Cr aw , 828 S.W .2d a t 757 -5 8; Loru sso v. M e mb e rs Mut. Ins. Co. , 603 S.W .2d 818 , 821 (Tex. 1980 )). W e cons ide r sev eral factors in condu cti ng a har mles s er ro r re v iew for t he er ro neous admis si on of ev ide nce: the stat e of the ev ide nce, the streng th and w eakne ss of the cas e, and t he v erdict. Rel

ian ce Steel , 267 S.W .3d a t 871

. Stat ed ot her w is e, we co n sid e r the ef fect of the ad mission of the evidence; the role the ev iden ce played in the conte xt of trial; efforts by couns el to emphasi z e the er ro neous ev ide nce; and w hether the a dmis si on of the improper ev ide nce w as cal cul ated or ina dv ertent. See i d. at 871- 75. Thus, “t he ex cl usi on or adm ission is likely

harm less if

the evidence w as cum ulative, or the rest of the evidence
w as so on e-sided thatthe error likely mad e no dif

feren ce in the judgmen t.” State , 200 9 Tex . LE X IS 9 67, a t * 6; see Rel ian ce Steel , 267 S.W .3d at 87 3. But if er ro neous ly admi tted or excl ude d evidence w as “crucial” to a “keyissu e,” the e rror is likely to be foun d ha rmf ul. State , 20 09 Te x . LE X IS 9 67 , at* 6. W e fur th er c on s i de r

w he th er t he re w as c on trary ev ide nce that the i mprop er ly admi tted evid e nce w as cal cul ated to ov ercome. Id ; Ar m str ong , 145 S.W .3d a t 144

. B. A DM I SS I ON OF E VI D ENC E R E GA RDI NG F ENTA NYL L E V E LS I N T HOMP S ON ’ S B LO OD In its four th is sue, Alz a c ontends thatthe tr ial co urt c ommitt ed har mf ul er ro r re sul ti ng55

in an im prop er judgme nt by ad mitt ing th e results of t he Accu-Che m po stm ortem blood test that w as improperlyper formed and by

per mitt ing Thompson’ s e x per ts to op ine on t he
cause of dea th based solely on unreliable test results. W e ha v e previously add ressed this matter w it h re g ard to Al z a’s other is sues and need not fur ther address i t herein

. SeeT EX . R. A PP . P. 4 7.1. This i ss ue i s o v er ru led

. C. A DM I SS I ON OF E VI D ENC E R E GA RDI NG A LZA ’ S R ECA LL OF F ENTA NYL P A TC H ES I n it s f ift h is s u e , A lza c o n t e n d s t h a tt h e t ri a l c o u rt ’s a d m is s io n o f e vid e n c e t h a tA lza
re cal led se v eral lot s o f Durag esi c p atc hes constit u te d an abuse of dis creti on th at was re asona bly

ca lc ula ted t o and probabl y ca used the rendi ti on of an improper judg ment. In several sub-issues, Alza arg ues th at: (1) there is no evidence ind epe nde nt of the reca ll that Thompson was w ear ing a pa tch w it h the sa me defect; (2 ) the e v ide nce of rec all does not t end t o make a fact that is of c onseq uence to t he s uitany more or l ess probabl e; ( 3) the evidence of recall w as ou tw eighed b y prejudice and cause d a con f usion of the issue s; and (4) the adm ission of the reca ll ev iden ce w as re a s o n a b ly calculate d to an d prob ably
caus ed th e re ndi ti on of an improper jud g ment. Thompson count ers t hat t his ev ide nce w as both admis si ble and re lev ant. On Fe b ru a ry 17 , 2 0 0 4 , A lza re ca lle d o n e lo t o f 75 m cg Du ra ges ic p a tc h e s t h ro u gh an “ Urg ent C las s 1 D ru g R ecal l Not ific ati on.” This recal l noti ce sta ted t hat a “ potent ial se al breach on one edg e may al low dr ug to lea k from the p atc h.” The no ti ce further st ated that: Ex posure to the D urag esi c h y drog el cont ents co uld resul t i n an inc re ased absor pti on o f the opi oid co mponent, fentany l, l eadi ng to inc re ased dr ug effect , inc lud ing nause a, sedat ion , drow si ness , or pote nti all y

l ife threateni ng com plication s. On A pr il 7, 2004, Al z a recalled f o ur addi ti onal l ots of 75 mcg D urag esi c p atc hes in an “U rg ent E x panded Dr ug R ecal l Not ific ati on.” Thi s recal l w ar ned t hat: Ex posure to the l eaked m edi cat ion co uld resul t i n i nadv ertent ing est ion or an56

inc re ased transde rmal absor pti on of t he opi ate componen t, fentany l, l eadi ng to po ten tially

life -threat enin g com plication s. Tex as Rul e of Ev ide nce 407 prov ide s: A w ri tten noti ficat ion by a manufacturer of an y defect i n a p ro ductproduce d by su ch manufacturer

to purchas ers t hereof is admi ss ibl e ag ain st the ma nufactu rer on the issue of ex istence of

the de fect t o t h e e xten t it is re lev ant. T EX . R. E V ID . 407 (b ). Thi s C our t add re ss ed the admi ss ibi li ty of re cal l ev ide nce in Ford Motor Co. v. Durrill , 714 S.W .2d 329 (Te x . App .–Corp us Christi 1986 ), judgm ’ t v acated by agr eem ent , 754 S.W .2d 646 (Tex. 1988 ): In ap pellan t’s tw ent ieth poin t of e rror, Ford urges th at the t rial court erred in admitti ng the Pi nto rec all letter and tes ti mony

rel ati ng to the P int o recal l. The Dur ri ll s a rg ue th at t he ev ide nce w as re lev ant t o s how F ord’s co nsc iou s d is re ga rd fo r t h e p u b li csa fe ty. Ru le 4 0 7 (b ) a ll o ws a wri t t e n ra t if ic a t io n b y a manufacturer

of a product defect to be admi tted ag ain st the manu facturer on the issue of

ex istence o f

t he defect to the e xten t tha t it is relevant. Th e fact t h a tr e c a l l l e t t e rs a re a d mi s s i b l e i s s e t t l e d b y t h e e x i s t e n c e o f T EX . R. E V ID . 407( b)

. The ci rc umstan ces for a dmis si on i n thi s c ase are s omew hat u nusua l in that the let te r w as admitted t o s how both F ord’s fail ure to w ar n of an alleged similar de fect in the Mustang II and to show thata defect existed in the M ust ang II by

sh ow ing i ts si mil ar it ies to the recal led Pi nto. Dr . R ober

t Brenner

tes ti fied th at t he F ord Mo tor Compan y shoul d hav e s ent a recal l letter

l ik e the “P int o” l etter

to Mu sta ng ow ners a s well

. He tes ti fied that the s afetyrel ated defect w hic h prec ipi tated the Pi nto - Bobc at recal l w as v er y si mil ar , i f not ident ic al to the safetyrela ted d efect t hat F ord k new ex is ted in th e Pin to -B o b ca t a n d Mus ta n g. The e v i d e n c e o f t h e P i n t o re c a l l w a s re l e v a n t b o t h t o t h e d e fe c ti ss ue and the fai lure to w arn . I t was inc umbent u pon t he D ur ri ll s t o s how by inde pen den t evi den ce tha t the Mustang II w as defective a t the t ime of injury in order for the letter

to be admiss ibl e to show the ex is tenc e of

a defect. See Bl akel y , Ar

ticle IV : R ele vanc

y a nd It s L im it s , 20 H OUS
. L. R EV . 151 , 220 (1 983) . The Dur ri ll s e sta bli shed, by i ndependen t ev ide nce, thatthe Mu sta ng II w as defecti v e i n the same manner as the Pi nto. Additi onal ly , w e find that the e v ide nce w as admis si ble to il lus trate F ord’s fail ure to w ar n. See i d. at 340. Rule 40 7(b) clearly

state s thatthe evidence of t he reca lls i s adm issible in evi den ce on th e i ss ue of the ex is tenc e of the defect to the extent that iti s rele v ant. Spec ific all y , t he57

is sue of rec all i s, in the words of Tex as Rul e of Ev ide nce 407, “a dmis si ble ag ain st [Al z a] on th e iss ue of

ex is tenc e of

the defect to the ext ent it is rel ev ant.” The defect referenc ed in the recall is the sam e defect as alleged i n the instan t case, tha t is, an alleged bre ach in the seal of

the pa tch cau sing an unco ntrolled release o f fent anyl, and t h u s , the recall is
re lev ant. Al z a c ontends thatthere i s n o ev ide nce in d e p endent of the recal l that Thompson
w as w ear ing a pa tch w it h the sa me defect as re ferenc ed i n the recal l. As sumi ng w it hout deci din g thatThompson w as re q uired to sh ow some ind ependent proof t hat t he par ti cul ar producti n qu est ion su ffered from t he s ame defect, the re cord c ontai ned s uch ev ide nce. Thompson was presc ri b e d t h e sa me patc h tha t w as the s ubj ectof Al z a’s recal l, and her patc h w as manufactured dur ing the same per iod of t ime and on the s ame machi ne as the
rec al l ed p at c he s . P r i or t o an d up on a dm i s s i on t o th e ho s pi ta l , s he d i s pl ay ed s y mp to ms of ov erdo se includ ing nau sea, v om iting, sleepine ss, and diz z iness. T hom pson ’s blood test show ed an ov erdose of fentany l. Acc ordin g ly , there is inde pendentev ide nce of the al leg ed defect i n the i nv olv ed product

. Al z a c ontends t h a t th e ev ide nce of rec all does not tend to mak e a factthati s o f
conse quence to the suit any more or less proba ble. Howev er, recall letters are ad missible
as som e evidence thatthe de fect existed w hen the pro ductlef t the man ufactu rer. This is
an ele ment that Thompson w as re q uired to prov e. Ri dgeway, 135 S.W .3d a t 600 ( hol din g that the p lai nti ff

mustprov e tha t t he productw as defecti v e w h e n i t left t he hand s o f the
man u fa ct u re r and t hat t he defectw as a produci ng ca use of the pl ain ti ff ’s i nju ri es)

. Fi nal ly , Al z a c ontends thatt he ev ide nce of recal l w as outw eig hed by preju dic e and
cause d a con f usion of

the issues, and t he adm ission of t he recall e v iden ce w as reaso nab ly calcu l at ed to an d prob ab l y c au s ed th e ren di ti on of an i mp rop er j ud g me nt

. Becau se58

Thompson was req uired to prov e that the defectex is ted not only at the t ime of her death butalso at th e time w hen the Duragesic pat ch lef t Alz a’s han ds, th e relevancy of the reca ll letters o utw eig hs any

possi ble prej udi ce in thei r admis si on i nto e v ide nce. I n thi s reg ard,
w e no te th at “testim ony is notinadm issible on th e sole ground thatit is ‘prejud icial’ becau se in our adv ersar ial syste m, much of a proponent ’s ev ide nce is l e git im atel y i ntended to
w oun d the opp one nt.” Bay Ar ea Healthc ar

e Gr oup , 239 S.W .3d at 234. A jur y i s e nti tl ed to kno w that the existence of the defect in a pa rticular kind of Duragesic patch was l ikely and t hat s uch li kel iho od w as g re ater as t o t h e 7 5 mcg patc hes as to ot her patc hes
ma nufactu red by Alz a. Accordin gly , t h e p rejudicial imp act of the reca ll l ette rs is outw eig hed by

i ts re lev ance on th e i ss ue w hether the productw as defecti v e w hen i t l eft the han ds of the m anu factu rer. W e no te th at th e recall doe s n ot by itself m ake a prima facie
cas e, s hift t he burden of proof, or prov e tha t t he defectex is ted a t t he ti me of the i nci dent. See, e.g., F

ields v. Vol

ks wagen of Am ., Inc ., 555 P. 2d 4 8, 58 ( Okl a. 19 76) , W e conclu de tha t, und er t he circumsta nces of t his case, t he recalls w ere prop erly admis si ble i n ev iden ce f or the pur pose of deter mini ng w hether the defect i denti fied by T hom pson ’s ex pert wi tne sses existed w hen Alza p u t the patch into T hom pson ’s hand s. W e not e tha t to sustain a v erdict for a plaint if f base d upo n an ex isting defect, such recall evidence, stand ing alone, w ould be insuf f icient. Here, ho w ever, w e ha v e the credible testim ony of

Th om pson ’s ex perts, albeit con tr a d ic t e d by that of Alz a’s expert w itnesse s,
w hic h j ust ified the jur

y ’s co ncl usi on th at t he D urag esi c p atc h w or n by Thompson w as defecti v e and the defect caus ed her deat h. Acc ordin g ly , w e hol d tha t, in the c ircums tanc es of this ca se, the re cal l ev ide nce w as proper ly admi ss ibl e i n ev ide nce for th e l imi ted purp ose o f

dete rmining w het her the d efect iden tif ied by plaint if f ’s ex pert wi tne sses arose
w hil e the productw as in Al z a’s co ntrol. W e ov er ru le Al z a’s fifth i ss ue.59 V. C ONCL US I ON Hav ing ov er ru led eac h of Al z a’s i ss ues, w e af firm the j udg ment of the tr ial co urt.

_________

_________

___ Lin da R . Y añez J u s t i c e
Del iv ered and filed the 1 st day

of Apr il , 201 0.