## In the



# U n ited S ta tes Co urt o f Ap p ea ls

F o rth eS e v e n th C ir cu it

N o. 07

- 3149 J ACQUE LY N G IL ES, i nd i vi du al l y a nd as Speci alA dm i ni str ato r ofthe Estate o f J e ffL. Gi l e s , De c e a s e d, Plai nt i f f

-Appe l l ant, v.

W YE TH, I NC
. , a nd W Y ET H P HARMACEUTICALS, f or m er l y know n as A MERI CAN H OM E P RODUC TS C OR PO RA T I ON, D efend a nts-A pp ellees

.

Appeal from the United States District Court fo r the S outhernDi stricto f Illino is. No . 04 C4245

—J. Phil Gilbert, Judge
.
A RG UE D F EB RU AR Y 14, 2008

— D ECI DE D F EB RU AR Y 12, 2009

Befo re M A NI ON, R OV NER, a nd W I L L I A MS, C ircu it Judges. W I LLI AMS, Cir cu i tJudg e . T h is c as e a ris es ou t o f a tr ag ic eve nt, the death o fJ effGil es, a f or ty- si x-y ear - ol d m ar ri ed f atherwh o too k hi s l i f e i n the f al l o f20 02. H i s widow filed a wrongful death sui t a gai nst W yeth, the m anufa c-2 N o. 07

- 3149
tu r ero fEff ex o r, th e an ti depr es sa ntM r . Gi l es b eg ant ak i ng two da y s be f o r e hi s dea th

. A j ur y f o und i n f av o r o fW y eth. On app eal, M rs . Gil es ar gues that she s houl d have be en al l owed to i ntro du ce warni ngs that a ccom panie d Effexor i n the yea rs f ol l owing M r. Gil es’ s death. Because th ese l ate r w ar ni ngs f ocuse d on the ri sk ofsui ci de i n yo unger per so ns , no t adul ts o fM r . Gi l es ’s age , a nd the r e i s no ev i den ce thatW y eth kne w ors ho ul d ha ve k no wn th e i n f o r ma t i o n c o n t a i n e d i n th e l a t e r w a r n i n g s a tth e t i me ofM r. Gi l e s ’ s de a th, the di s t r i c tc o ur tdi d n o tab use i t s d i s c r e t i o n w h e n i te x c l u d e d th e l a t e r w a r n i n g s . We ther ef or e a ffi rm the j ud gm ent o fthe dist ri ct c ourt
.

I . B AC KGR OUND J effGi l es wor k ed as a c o alminer. H e su ff er ed a se r i o us i nj ury on the j ob i n the m i d-19 90s, and, i n the yea rs that f o l l o we d , c o nt i nu e d t o e x p e r i e n c e n e c kp a i n th a tl i mi te d hi s ab i l i tyt o move . I n J ul y 2 002 , the c o almin e l ai d M r. Gil es offfro m his j ob. A few m onths l ate r, o n Se ptem ber12 , he ha d neck s urge ryi n an at tem pt to al l ev i at e th e eff ec ts of h is n ec ki nj ur y . Unf o r tu na te l y , he di d no t he ala s qui ck l y fr o m th e su r g er y a s he ho ped, a nd he al so l ea r ne d ar o und th e sa m e ti m e th at th e coal m i ne f ro m w hi ch he had been l ai d offwould cl ose per m anentl y. O n O ctob er 28, 2002 , M r. G iles visi ted his prim ary care physi ci an. M r. Gil es tol d him thathe fel t tire d and depress ed, l acke d m oti vati on, and h ad i nsom ni a. H i s doct or di a g no s e d hi m wi th maj o r de pr e s s i v e di s o r de r a nd pre scr ibed the anti depressa nt Ef f exor . M r. Gil es too k three Effexorpills ove r the ne xt two days. On the m or ni ng o fN o. 07

- 3149 3 October 30, 20 02, he pul l ed ove r to the s i de ofan i sol ate d r o a d a nd d i e d fr o m a s e l f

- i nfl i c t e d gun s ho two un d. M r. Giles w as f o r ty-six years old at th e tim e and l eft be hi nd a wi f e an d s o n. Vari ous w ar ni ngs acco m panie d the Effexor M r. G iles too k. A m ong them , i n acco rdance w i th a U nite d State s Foo d and D rug A dm i ni str ati on r eq uir em ent, was a s ui c i de p r e c a ut i o n tha ts t a t e d: S ui c i de

— T h e p os sib ility of a s u icid e a tt em p t is in h er en t in d ep re ss ion an d m a y p er sis t u n til si gni fi cant r em i ssi on o ccurs . Cl ose su pervi si on o f hi gh r i skpa ti en ts s ho ul d a cc o m pan y i ni ti aldr ug ther apy. Pre scr i pti ons f orEffexorsho uld be wri tte n f o r the s m al l es t qua nt i tyo f cap sul es c o nsi ste nt w i th goo d pat i ent m anage m ent in o rder to re du ce the r i sk ofo ver dose. I n J une 2 00 3, the F DA a nno unc ed i t was r ev i ewi ng re port s o f a possibl e re l ati onshi p between Paxi l, an a nti depres s a ntn o tma nu f a c t ur e d b y Wye th, a nd a n i nc r e a s ed ri sk ofsui ci dal thi nki ng and sui ci de att em p ts in chil dren an d a do l es ce nt s. The F DA ’ s st at ementa l so s ai d the re was no e vi den ce tha t P ax il was a ss o ci at ed wi tha n i ncre ase d ri sk ofsui ci dal thi nki ng i n adult s. The FDA then bega n col l ecting data f ro m anti depressa nt m anufa cture rs ’ pediat ri c cl i ni caltr i al s. I n A ug u st 2003 , W yeth changed Eff e xo r ’ s l a b e l i ngt o r e fl e c ttha ti t s p e di a t r i c c l i ni cal tr ials sh ow ed a n in c re as ed risk of su icid al id ea tio n in chi l dren usi ng the drug. I n the spri ng of2004, the FDA iss ued a new anti depressant w ar ni ng, and W yeth adj usted i ts Effex or warni ngs4 N o. 07

- 3149

acco rdi ngl y. Effexor ’ s 2 004 w ar ni ng st ate d th at “Pati ents w i th m aj ordepres si ve or der, bo th adul t a nd pedia tr i c, m ay experi ence w or sen i ng o f the i r depressi on a nd /o r the e m er gence o fsui ci dal i deati on a nd behav i or ( su i ci dal i ty ) , whethe r o r notthe y a r e ta k i nga nt i depr es sa nt m edi ca ti o ns , a nd thi s r i skmay per si stunt i l s i g ni fi ca nt re m i ssi on o ccurs . ” The wa rn in g a l so sta ted thatal though a ca usalr ol e f oranti depressa nts in in du ci ng sui ci dali ty had not be en es tabl i shed, “patien ts bei ng tr eat ed w i th anti depressa nts s houl d be o bser ved c losel y f orcl i ni cal tr i alwor se ni ng an d su i ci dal i ty, e spe ci al l y a t th e be g i nni ng of a co u rs e o f d ru g t h er ap y . . . .” I n A ugust o f20 04, the FDA co m ple ted i ts anal ysi s o f al l anti depressa nt m anufa cture rs ’ pedia tr ic cl i ni caltr i al dat a. As a r es ul t o fthi s an al y si s, i n J an ua ry 2 005 , the FDA i ssued a sui ci de-r el ate d “blac k b ox” warni ng f or an ti depr es sa nt s an d m o di fi ed th e an ti depr es sa ntwar nin gs ’ lan gu ag e. (T h e FD A re q u ire s th at ce rt ain co n tr ain d ica ti o ns o r s er i o us war ni ng s, pa r ti cul ar l y tho se thatmight l ead to death o r ser i ous inj u ry , b e present ed i n a b ox that expla i ns the r i sk and refer s t o m or e deta i l ed i nfo rm at i on els ew h er e i n t h e la b elin g. See 21 C

. F.R. § 201.57(c)(1) ). W yeth m odi fi ed the Effexorwarni ngs in com pli ance. Effexor ’ s 2 005 l abel i ng c ontained a bl ack box ca pti oned “Sui ci dali ty i n Chil dren and A dol esce nts. ” I nsi de the b l ack box, i n b old , the w ar ni ng st ate d that “ A nti depressa nts i ncre ase d the r i sk ofsui ci dal thi nki ng and behavi or (su ici dali ty) i n shor t- ter m stud i es i n chi l dren and adol escents w i th M aj or Dep re ssi ve Diso rder ( M DD ) and ot her psychi atr i c di sor ders. ” I t a l so sa id thatanal yse s o fsho rt
ter m pl acebo

- contr ol l ed tr i al s in chi l dren and adol esce ntsN o. 07

- 3149 5

w i th m aj ordepres si ve d i sor der, o bses si ve com pu l si ve diso rder, o r othe r psychi atr i c di sor ders re veal ed a g re ate r r i sko fa dve r se e ve nts r epr es en tings ui ci dal i tydur i ngthe fi rs t few m onths oftr eat m ent in thos e r ecei vinga nt i depressants
. Ou tsi de of the bl ack box, the 2005 warni ngs incl ud ed th at“ Ad ul ts wi thM DD o r c o - m o rbi d de pr es si on in the set ti ng o fo therpsychi atr i c i l l n es s bei ng tr eat ed w i th anti depressa nts s houl d be o bser ved si m i l ar l y f orcl i ni cal w or seni ng and sui ci dali ty, especi al l y du ri ng the ini ti alfew m onths ofa cour se ofdrug ther apy, or atti m es ofdose c h an ge s, eit h er inc re as es or d ec re as es .” The F DA final i ze d a s tu dy o fa l l a nt i depr es sa ntmanuf ac t u r e r s ’ c l i n i c a l t r i a l s i n v o l v i n ga d u l t s i n 2 0 0 6

. I tc o ncl ud ed that f oradul ts age d 25 t o 64, no i ncre ase i n sui ci dal behavi or w as dem onst ra ted am ong thos e t aki ng ant i depress ants. The next yea r, the FDA i ssued a new bl ack box w ar ni ng tha t e xpand ed i ts previ ous s uic i dali ty bl ack box war ni ngt o i nc l ud e adul ts y o ung ertha n t wenty - fi ve . The 20 07 bla c k b ox als o s ta te d th at“[s ]h or t-t er m st u d ies d id not show an i ncre ase i n the ri sk ofsuici dali ty w i th anti dep re ss an ts co m p ar ed t o p l a c eb o in ad u lts be yo n d ag e 2 4.” The war ni ng s se ct i o n a dvi sed th ata l l pa ti en ts b eing tr e a t e d wi th a nt i de pr e s s a nt s s ho ul d b e mo ni t o r e d f or su icid alit y a n d ot h e r c h an ge s in be h av ior, es p ec ially du ri ng the fi rs t few m onths on the drug. Befo re the tr i ali n thi s ca se, W yeth fil ed a m oti on i n l i m i ne aski ng the di str i ct c ourtto excl ud e: ( 1) al l sui ci derelated w arn ings th at acc om p an ied E ffe x or after M r. Gi l e s ’ s de a th i n 2 0 0 2 , a nd ( 2 ) s c i e nt i fi c da t a r e l ate d to su i ci dal i tyi n pe di at r i c pat i en t s t a k in ga n t i d e p r e s s an ts
. The6 N o. 07

- 3149 dist ri ct c ourtgr anted the m oti on i n part, r uling tha t evi dence ofpost
- 2002 sui ci de-r el ate d w ar ni ngs w as not adm i ssibl e. I t also denie d the m oti on i n partand al l owed th e u se of sc ien tific ev id en c e re lat in g t o p ed iat ric p atient s, includ ing su ch evid en ce from after M r . G iles’s dea th

. A fte r a t h re e-w ee k t r i a l, th e jur y re tu rn ed a ve rd ict in W yeth’s favo r. M rs . Gil es appeal s the j ud gm ent a gai nst he r o n h erc l ai m tha t W y eth w as st r i ct l y l i ab l e f o r f ai l i ng to p rovide ad eq ua te w arn ings for E ffex or.

II. A N A L Y S IS A . Basi s f orex cl usio n ofl at erw arnings M r s. Gi l es ’ s pr i nc i pala r g um en t o n a ppea l is tha t th e dist ri ct c ourtsho u ld not hav e pr ecl ud ed her fro m i ntro
du ci ng the warni ngs that a ccom panie d Effexorafter her hus band’ s dea th

. The pa r ti es fi r stdi sa g r ee abo utthe basi s o fthe dist ri ct c ourt ’ s d ec isio n to excl ud e the l ate r w arn in g s. M rs. G il es m aintain s tha t the district cou rt excl ud ed thi s e vi dence onl y upon i ts d eterm i nati on that FDA

- m andated w arning s were “subse quent r em edi al m eas ures ” withi n the sco pe ofFe deralRule o fEvi dence 407. This deter m i nati on, she ar gues, w as a l ega l one th at w e s houl d rev i ew de nov o. W yeth, o n the othe r hand , m ain ta i ns thatthe dist ri ct co ur t ex cl ude d the e vi den ce under not j us t Rul e 40 7, b ut a l s o u n d e r F e d e r a l R u l e o fE v i d e n c e 4 0 3 , wh i c h a l l o ws a di str i ct c ourtto excl ud e re lev an t e vi dence w hen i ts “pr o ba ti ve value i s su bs ta nt i al l y o ut wei g he d b y theN o. 07

- 3149 7 danger ofunfa i r prej ud i ce, co nfusi on o fthe i ssues , o r m isle adingthe j ury, o r by consi derat i ons ofundu e del ay, w ast e o fti m e, or n eedl ess pre senta ti on o fcum ula ti ve evi dence. ” W e a gr ee w i th W yeth. Bef or e tr i al, W yeth fi l ed a m oti on i n l i m i ne to excl ud e s uic i de-r el ate d w ar ni ngs giv en aft er M r. G iles ’s s u icid e a n d to ex c lu d e s c ien tific dat a r el at i ngt o s uici dal i tyi n pe di at r i c pat i en ts t ak i ng anti depressa nts. W yeth ar gued i n th e m oti on that Rule 403 an d Rule 40 7 e ach i nd ependentl y s up port ed ex clusion of both typ es of evi d en ce . Th e d istri ct cou rt h e a r d a rg u m en t o n th e m ot ion an d ru led ora lly. It denie d W yeth’s m otion i n part, as i t a l l owed the use o f sc i en ti fi c ev i den ce r el at i ngt o pe di atr i c pat i en ts
. The dist ri ct c ourtals o gr anted the m oti on i n part, st ati ng tha t “[ p]o st re m edi alm eas ures w ill no t be

— the y ’ r e n o ta dm i ssibl e. The Courti s e xerci si ng i ts d isc re ti on notto ad m it t h at .” Du ri ng tr i al, M rs . Gil es’ s counsel ask ed th e d i str i ct cour t t o re vi si t i ts pre- tr i alr uling tha t e xcl ud ed ev i dence of the w arn ings th at acc om p an ied E ffex or after M r. Giles’s death. The di str i ct c ourtdecl i ne d t o al l ow the ev i dence ofl ate r w ar ni ngs, st ati ng tha t i ts rul i ng was “the sa m e. Und e r 4 0 3 , a l tho ugh r e l e v a nt, the Co ur t ’ s g o i ngt o e xc l ud e th i s ev i den ce fi ndi ngtha t i ts pr o ba ti ve v al ue i s su bst an tiall y outw eighed by the confu sion of th e i ssu es before th is .

. . j ury.” I n its ruling at tri al, then , t h e d istrict cou rt in vo ke d R u le 4 03 by n am e a n d u se d th e la n gu ag e o f R u le 40 3 t o e xp l a i n i t s de c i s i o n t o k e e p o utthe l a t e r wa r ni ng s. Even i fthe dist ri ct c ourt ’ s pre - tr i alr uling co uld be ta ken to meani t ha d de cid ed on the b as i s o fRul e 40 7, the dist ri ct c ourtcl ear l y r ule d du ri ng tr i althatthe w ar ni ngs8 N o. 07

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w er e e xcl ud ed und erRule 40 3. W e procee d, then, to an alyze w he th er exc lusion u nd er Ru le 403 w as p rop er.

B. Excl usio n un der R ule 403 W e r e v i e w a di s t r i c t c o ur t ’ s de c i s i o n to e xc l ud e ev id en c e u n d er R u le 403 for an ab u se of d isc re tio n . C hlo pek v. Fe de r al Ins . Co. , 4 99 F

. 3d 69 2, 7 00 ( 7th Ci r . 2 00 7)

. I n do i ng so, w e give the d istri ct cou rt’s dec isi on sign ificant de fe ren c e. M il hailovich v. La atsc h , 359 F.3d 892 , 906 (7th C ir. 20 04 ). M rs . G iles ’s c laim is th at W y e t h is st ric tly liab le und erI l l i noi s l aw f orf ailu re to pro vi de adequate w ar ni ngs c oncer ni ng Ef f exor, and that tak i ng Ef f exor caused M r. Gil es to tak e hi s li fe. In a str i ct l i abi l i ty case base d on a failu re to warn i n I l l i noi s, “the pl ai nti ffm ust al l ege and prov e that defendant knew orsho uld have known o fthe danger and t h is is tes ted o n knowle dge exi sti ng atthe ti m e o fpro du cti on. ” S mith v. El iL i l l y & Co ., 560 N

. E.2 d 324, 34 4 ( I l l

. 19 90)

. W e fi nd no abuse ofdi scr eti on i n the dist ri ct c ourt ’ s deci si on to ex c lude the l ate r w ar ni ngs o n the basi s that thei r p ro bati ve val ue was su bs ta nt ial lyo ut wei g he d b y the da ng ero fc o nfus i ng the j ury. T he w arn ings th at acc om p an ied Effexor after M r. Giles’s death had l i ttle , ifany, pro bati ve val ue i n thi s ca se. Fir st, an d m os t s ign ifica n tly , th e ex c lu d ed w ar n in gs d id not hel p establ i sh thatW yeth knew or sho uld have known abo ut an i ncre ased ri sk ofsui ci dali ty i n adult s ofM r. Gil es’ s a ge. M r. Gil es w as fo rt y- si x yea rs o l d w hen h e t o o kE ff e x o r . T h e e x c l u d e d p o s t
- 2 0 0 2 wa r n i n g s , h o weve r, f ocuse d on chi l dren and adult s youngerthan tw enty-N o. 07

- 3149 9 fi ve yea rs o l d. The “blac k b ox” in the 2005 warni ng, f o r e xa m pl e, was e nt i tl ed “S ui ci dal i tyi n Chi ldre n a nd Ad o l es ce nt s” a nd war ne d tha t an ti depr es sa nt s ha d i nc re as ed th e ris k of s u icid al t h in kin g a n d be h av ior in ch ild ren a nd ad o lescents w i th m aj ordepres si ve diso rd er and otherpsychi atr i c di sor ders. But i t m ade n o such sta tem ent about adults

. The 2007 warni ng expanded th e 20 05 b l ac kb o x war ni ngt o “ y o unga dul ts , ” m ea ni ng perso ns yo unger than twenty- fi ve, but M r. Gil es did not fal l w ithin th is age group either. I ns te ad o f su g g es ting an i nc r ea se d r i sk o f su i ci dal i ty, the Effexorwarni ng s afte r 2002 actual l y m or e di re ctl y di scl ai m ed any i ncre ase d ri sk ofsui ci dali ty i n adult s o f M r. G iles’s ag e. The 20 07 bl ack box warni ng, the m ost re c en t o n e a t is s u e , m ad e e x p licit th at for a p er so n in M r. Gil es’ s a ge gr oup, no i ncre ase d risk o fsui ci dali ty ha d bee n s h ow n. I t un am biguou sly stated : “Short-term studie s d id n ot s how an i ncre ase i n the ri sk ofsui ci dali ty w i th a n ti depressa nts c om pared to pl acebo i n adult s beyond age 24. ” W ar ni ngs o fan i ncre ase d ri sk of su i ci dal i tytha t per taine d o nl y t o much y o ung erpe r so ns did notte nd to sho w W yeth’s know led ge of an i ncre ase d ri sk f orper sons ofM r. Gil es’ s a ge. M r s. Gi l es a l so p oints us t o o th erl an g ua g e i n the e xcl ud ed w ar ni ngs, unti ed to age , such as that sta tin g that “patie n ts” sho uld be o bser ved cl ose l y f orsui ci dali ty, especi al l y a t the be gin n i ng o fa cour se ofdrug ther apy. A nd i t i s t rue that M r. Gil es too k hi s l i fe tw o days a fter he b egan t ak i ngEff ex o r . The pr ec au ti o n i n pl ac e atthe ti m e M r. Gil es took E ff exor, however, al re ady warned th at th e p os sib ility of a su icid e a tt em p t w as inh er en t in10 N o. 07

- 3149 depr es si o n a nd tha t cl o se s upe r vi si o n s ho ul d a cc o m pan y i ni ti alther apy f orhi gh r i sk pati ents. Bu t e ven i fthe l ate r w ar ni ngs cou ld b e seen a s m ate ri al l y di ff er ent fro m the 2002 pre cauti on, M rs . Gil es i den ti fi es no e vi den ce tha t th e ex cl ude d p ost
- 20 02 war ni ngs were bas ed on i nfo rm ati on W yeth knew or r easo nabl y c o ul d ha ve k no wn at th e ti m e o fM r . Gi l es ’ s dea th

. Se eN

. Tr us tCo. v . Upjo hn Co. , 572 N .E .2d 10 30 , 103 8 (Ill. App. Ct

. 1 99 1)

. The 2 00 7 war ni ngwas b as ed o n conc l usi ons the F DA drew i n 200 6. M or eov er, i t dre w thes e concl usi ons f ro m a n anal ysi s o fadultcl i ni caltr i aldata f r o m all anti depressa nt m anufa cture rs , n ot j ust fro m W yeth. S i m i l ar l y, the base s f orthe 2004 w ar ni ng and 200 5 wa r ni ngwe r e p e di a t r i c t r i a l r e s ul t s a nd the 2 0 0 4 F DA Pedia tr i c An al ysi s, wh i ch the FDA di d not be gi n unti l after M r. Gil es ’s d ea th. Li ke the 2 006 FDA anal ysi s o fanti dep r e s s an t u se in a d u lts , th e 2 00 4 F D A P ed iat ric A n aly sis w as bas ed on an exam ina t ion of all a nt i depr es sa ntmanuf a c t u r e r s ’ c l i n i c a l t r i a l d a t a . An d th e r e wa s n o t e s ti m o ny that data o therthan that f or Effexorwas avai l abl e t o W yeth bef or e Octo ber20 02. Fi nal l y, al though M rs . G i l es ar gues that the b urden w as on W yeth to anal yze its d ata and then to add an appropri ate w ar ni ng of the ass oci ati on be tw een Ef f ex o r a nd i nc r ea se d s ui ci dal i ty, sh e d o es no t po i ntus to an y evide nc e sug gesting that ana lyzi ng Effexor’s cl i ni ca l t r i alda ta woul d ha ve y i el ded r es ul ts r equi r i ng add i ti onalwarni ngs f oradul ts ofM r. Gil es’ s a ge. The tendency of the l ate r w ar ni ngs t o prove thatW yeth knew ofan i ncre ased ri sk ofsui ci dali ty i n pers ons of M r. Gil es’ s a ge w as ess enti al l y ni l i n thi s ca se. A l thoughN o. 07

- 3149 11 the l ate r w ar ni ngs m i ght there f or e s eem to hel p W yeth i n that they disc l ai m any re l ati onshi p f oradults o f M r. Gil es’ s age, adm i tti ng the se w ar ni ngs which f ocuse d on chi l dren, adol esce nts, and pers ons w ho were m uch younge r than M r. Gil es coul d have co nfuse d the j ury. That i s, the j ury m i ght ha ve t h ou gh t that the warni ngs that an ti depr es sa nt s ha d i nc r ea se d s ui cid al thi nk i nga nd behavi ori n cer tai n adol es cents and young a du l ts al so had app l i cati on t o M r. G i l es, w hen there w as no e vi dence to supp or t that. A s a r esul t, we do not fi nd an abuse o f di sc r et i o n i n the di stri ct c o ur t’ s det er m i na ti o n tha t th e pr o ba ti ve v al ue o fthe po st
- 20 02 war ni ngs w as su bs ta nti al l y outw ei ghed by the danger ofco nfusi ng the j ury. See C hlo pek, 49 9 F

. 3d at 700 ( fi nd i ng no ab u se o fdi scr eti on in d istri ct c ou rt’s det erm ination th at evid en ce of a c h a n g e d w a r n in gla b e l w a s ex c lu d a b le a s u n fa ir ly p r ejud ici al)

.
C. A dm i ssi on ofsci enti f i c ev i den ce Finally, M rs. G il es argu es t h a t t he district cou rt’s ru lin gs p re ve n te d th e j u ry fro m h ea rin g “ th e w h ole tru th .” She m ai ntai ns thati t was e rro r to l et W yeth i ntro du ce sci enti fi c know l edge g ai ned afterM r. Gil es’ s s uic i de, i nc l udi ngthe F DA ’ s l at er da ta a na l y se s, b utno t th e subsequent w ar ni ngs. M rs . Gil es’ s cl ai m attria l was that tak i ng Ef f exorl ed her husband to com m it s uic i de on Oct o be r 3 0, 2 00 2. The j ur y the r ef ore h ad t o de te r m i ne w h et h er E ffex or ca u se d M r. G iles ’ s d ea th , an d sc ien tific evi dence after20 02 that showed no i ncre ase d risk o f sui ci dali ty w hen ad u l ts too k Eff exorwas re l evantto12 N o. 07

- 3149

W e note thatthe dist ri ctcourt denied W yeth’ s reques t that 1 i tbe gr ant ed s um m ar y j udgm en ton pr ee m pt i on gr ounds , an d W y e t h d id no t d ev elop a p reem p tion arg u m en t on ap p eal. “[P]reem p tion is a d efense a nd th u s d oe s no t affect su b jectm att er j uris dicti on, ” Bakerv. IBP , Inc. , 35 7 F .3d 685 , 68 7 (7th C ir . 2 0 0 4 ), so w e n ee d ed n o t a d d re ss it h er e. Cf

. W ye t h v

. Le vi ne, 128 S. Ct. 1118 ( 2008) ( granti ng p eti ti on f or w ri t ofce rt iorar i on qu estion o f w he the r FD A d ru g lab eling requ irem en ts im p o se d on m anufac turer s preem pt s tat e l aw cl aim s prem is ed on the theo ry that diff erentl abeli ng judg m ents w ere needed t o m ake the d ru g s re as ona bl y s afe f or us e)

. I n l i ghtofour (co n tin u ed ...) w hetherEffexorcause d M r. Gil es’ s suic i de. The questi on at tr i al w as n ot w hethersci enti fi c know l edge in exi ste nce i n 200 2 dem onst ra te d that Eff exorcause d M r. Gil es to tak e hi s l i f e, i t was wh etherE ffex or caused him to ta ke his l i f e. I fl at ers tu di es s he d l i g hto n tha t an swe r, a l l the bett er. W hetherEffexor ’ s warni ngs were ad equate, o n the othe r h an d , was t i me- de pe nd e nt
. I l l i no i s l a w h o l ds a manufactu r err es po ns ible f o r f ai l i ngt o war n o nl y r eg ar di ng d a n g e r s i t k n e w o r s h o u l d h a v e k n o wn a b o u t a t th e t i me i t m ad e t h e d ru g. SeeSm it h , 5 6 0 N. E. 2 d a t 3 4 4

. I t does not ho l d a manuf ac tu r erl i ab l e f o r f ai l ur e to w arn abo ut dangers thatm igh t be r eve al ed l ate r i fthe m anufa cture r ha d no r ea so n to f o r es ee th em. I t was th er efo r e no t i nc o nsis te n t to allo w p os t-2 00 2 ev id en c e on c au sa tio n w h ile kee ping out post-2 00 2 warni ngs that di d not per tai n to adult s a nd wa s n o tb a s e d o n i nf o r mat i o n k no wn w hen M r. Giles took Effexor. 1N o. 07

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(

. . . c on t i nu e d) 1 d ecis i on, we a l s o n ee d notaddr es s W ye t h’ s othe r ar gum en ts in fav or of up ho ld ing the v erd ict.

2- 12- 09 I I I . C ONC L US I ON The j ud gm ent o fthe dist ri ct c ourti s A FFI RMED
.