## F I LED United States C ourt of Appeals Tenth Circuit 

### A u gu s t21,2007 Elisab eth A. Shumaker C l erk of C ourt PU BL I SH UNI TED S TATES CO URT O F AP PEALS

T E N T H C IR C U IT
T M J I M PL A N T S, I N C . , a C ol or ado corpor at i on, P lain tiff

- A p p e llan t, v. N o. 06- 1020 N o. 06- 1146 A E T N A , IN C ., a P e n n sy lv a n ia c o rp o r a t i o n ; CI GNA; CO NNE CT I CU T G E N E R A L C O R P O R A T IO N , a F l o r i d a c o rp o r a t i o n ; CO NNE CT I CU T GENERAL LI F E I NSURANCE C O M PA N Y , a C onnect i cut c o rp o r a t i o n ; CI GNA DE NT AL H E A L T H , I N C . , a Fl or i da corpor at i on; C IG N A H E A L T H C O R P O R A T IO N , a D el aw ar e corpor at i on; H E A L T H SO U R C E , I N C . , a N ew Ha mp s h i r e c o rp o r a t i o n ; CI GNA DE NT AL HE AL T H OF CO L OR ADO, I NC . , a Co l o r a d o c o rp o r a t i o n ; CI GNA HE AL T HC AR E OF CO L OR ADO, I N C . , a C ol or ado corpor at i on,

D efen dan t s - A pp el l ees.

AP P EA L F ROM THE UNI TE D S TA TE S DI S TR I CT COURT

F OR THE DI S TR I CT OF COLORA DO ( D . C . N O . 05 - c v- 78 3 LT B- C BS) J os e ph J . M e l l on , Shu gh a r tThoms on & K i l r oy , P. C. , D e nv e r , Col or a do ( Pa ul S. S we d l u n d , S h u g h a r tTh o ms o n & K i l r o y , P . C. , a n d W a l t e rL. Ge r a s h , An d r e w B.T h e a me n d e d c o mp l a i n tfi l e d i n t h e d i s tr i c tc o u r tn a me d e i g h tCI GNA 1 d e fe n d a n t s : CI GNA C o rp o r a t i o n ; Co n n e c t i c u tGe n e r a l Co rp o r a t i o n ; CI GNA D e n tal H e a lth , In c .; C IG N A D e n tal H e a lth o f C o lo ra d o , In c .; C IG N A H e a lth C orpor at i on; H eal t hs our ce, I nc. ; C I G N A H eal thcar e of Col or ado, I nc. ; and C o n n e c ticu t G e n e ra l L ife In su ra n c e C o m p a n y . T h e a m e n d e d c o m p lain t re fe rs to t hes e defendant s col l ect i vel yas C I G N A , and theyhave f i l ed one br i ef a s t he CI GNA a p p e l l e e s . We a l s o r e fe rt o t h e m c o l l e c t i v e l ya s CI GNA. -2- R ei d, G er as h L aw Fi r m , D enver , C ol or ado, w i th hi m on the br i ef) , forPl ai nt i ff - A ppel l ant J ohn B . Shel y , A ndr ew s , K ur t h L L P, H ous t on, T exas ( J ohn M . Pal m er i , Fr anz H a rd y , W h ite & S tee le, D e n v e r, C o lo ra d o , an d Ja m e s C . C ru m lish , III, E lli o tt G ree n leaf

& S iesziko w sk i, P C , B lue B ell , P en n sy lvan ia, w ith h im o n the b ri ef), fo r D e fe n d a n t - A p p e lle e A e tn a In c . Da n i e l R. S a t r i a n a , J r . ( M a t t h e w Y. Bi s c a n wi th h i m o n th e b r i e f ) , Cl i s h a m, Sat r i ana & B i s can, L . L . C . , D enver , C ol or ado, forC i gna D efe ndant s - A ppel l ees B efo re HA RTZ , S EY M OUR , and O’ BRI EN , C i rcui tJudg es. HA RTZ , C i r cui tJ udge. T his app eal con cerns a sui tbyplai nti ff T M J I m plant s, Inc. (TM JI ) agai nst defe nd ants A et na, Inc. and C IG N A for defam at i on and rel at ed tor t s. T M JI i s a 1 C o lo ra d o c o rp o ra tio n th a t m a n u fa c tu re s p ro sth e tic to tal- a n d p a rtialt e m p o r o m a n d i b u l a r -j o i n t( T MJ ) i m p l a n t s fo ru s e i n p a t i e n t s s u ffe r i n g f r o m T MJ di s or der s . A etna and CIG N A pr ovi de hea l th and dent al i ns ur ance undervar i ous benef i tpl ans . B ot h compani es pr oduce bul l et i ns expl ai ni ng w hatt r eatm ent s and p r o c e d u r e s t h e yc o v e r . I n i t s b u l l e t i n d e s c r i b i n g c o v e r a g e fo rt r e a t me n to f TM J-3-

d i s o r d e r s , A e t n a s t a t e s t h a ti tw i l l n o tc o v e re i th e rth e t o t a l o rp a r t i a l T MJ im p lan ts m a n u fa c tu re d b yT M JI. In a sim ilar b u lletin C IG N A sta tes th a t itw ill notcoverT M J I ’ s par t i al -j oi ntdevi ce. T M J I cont ends thatthe cove r age bul l et i ns defa m ed and di s par aged i t s pr oduct s , t or t i ous l yi nt er fer ed w i th pr os pect i ve bus i nes s advant age, and t or t i ous l yi nt er fer ed w i th exi s t i ng and pr os pect i ve con t ract s. T M J I fi l e d s u i ti n De n v e rCo u n tyDi s tr i c tCo u r t , b u tAe tn a a n d CI GNA r emoved t he ca s e t o t he U ni t ed St at es D i s tr i ctC our tfort he D i s tr i ctof C ol or ado, s ee 2 8 U .S .C . § 1 4 4 1 (a ) (re m o v a l sta tu te) ; id . § 1 3 3 2 (d iv e rs ity ju ri s d ic tio n ). A etna and CIG N A t hen moved underFed. R . C i v. P. 12( b) ( 6) t o di s m i s s t he compl ai ntforfai l ur e t o s t at e a c l ai m . T he di s tr i ctcourtgr ant ed the mot i ons on th e g ro u n d th a t th e b u lle tin s w e re p ro te c te d s ta te m e n ts o f o p in io n . T M J I a p p e a ls . W e h a v e j u r i s d i c t i o n u n d e r2 8 U. S . C. § 1 2 9 1 a n d a ffi r m. I . BA CKGROUND W e s um m ar i ze the al l egat i ons of the amended compl ai nt : A ppr oxi m at el y30 m i l l i on A m er i cans s uffe rfr om T M J di s or der s , w hi ch ca n caus e j aw pai n and i n h i b i tn o r ma l j a w fu n c t i o n . Dr . Rob e r tChr i s t e n s e n d e v e l o p e d p r o s th e t i c TM J i m pl ant s t o r epl ace part s of the mandi bl e thathad bee n s ur gi cal l yr emoved. A ft er refining an d o b tai n ing p aten ts on h is de v ices, he estab li sh ed T M JI t o m an u fa cture a n d m a rk e t th e m . T h e to tal-jo in t p ro sth e sis is a v a ilab le in th re e siz e s (fo r b o th t he r i ghtand l efts i des of the j aw ) and ca n al s o be cus t om m ade; t he part i al -j oi nt-4-

p ro sth e sis is a v a ilab le in 4 4 p re m a d e siz e s (fo r b o th sid e s o f th e jaw ). T M JI is t he onl y m anufa ctur er of a par t i al -j oi nt pr os thes i s . A ppr oxi m at el y25, 000 of T M JI’ s d e v ice s h a v e b e e n im p lan ted in p a tien ts, 4 0 % o f w h ich h a v e b e e n p a rtialjo in t p ro sth e se s. C lin ica l stu d ies h a v e sh o w n th a t th e p a rtial-jo in t im p lan ts “r educe t he nee d forfur t hers i gni fi cants ur gi cal i nt ervent i on of a t ot al j oi nt re p la c e m e n t in o v e r 9 5 % o f th e c a s e s .” A p lt. A p p . a t 6 (A m e n d e d C o m p la in t) . Few ert han 10% of the part i al -j oi ntdevi ces i m pl ant ed i n pat i ent s have l at erbeen r emoved. T he t ot al and part i al pr os t hes es have “ been the s ubj ectof var i ous peer r evi ew s i n peer - r evi ew ed j our nal s . ” Id . at7. T her e have al s o been “ tw o cl i ni cal s tudi es conduct ed by[TM J I ] t hats uppor tt he s afe tyand effec t i venes s of the i m pl ant s . ” Id . T he Food and D rug A dm i ni s tr at i on ( FD A ) appr oved both the t ot al an d p arti al i m p lants in 2 0 0 1 . T h e F D A h as a p p rov ed o n e o ther m an u fa cture r, T M J C on cepts , t o m ake cu st om t otal -j ointprostheses. A etna has publ i s hed, i n s ever al edi t i ons , C l i ni cal Pol i cyB ul l et i n ( C PB ) 28, w h i c h d e s c r i b e s t h e l i m i t a t i o n s o n w h a ti tw i l l c o v e rfo rt r e a t m e n to f T MJ dis orders . CI GNA a l s o p u b l i s h e s a b u l l e t i n , Co v e r a g e P o s i t i o n Nu mb e r( CP N) 15 6, r e ga r di ng t he l i mi t a t i on s on w ha ti tw i l l c ov e rfo rTM J di s or de r s . Bot h CPB 28 and C PN 156 ar e ava i l abl e t o the publ i c overt he i nt ernet . T M J I chal l enges se v e ra l sta tem e n ts in A e tn a ’s C P B 2 8 re g a rd in g T M JI’ s to tal-jo in t an d p a rtialj oi ntpr os t hes es . Som e s t at ement s r efe rt o the pr os thes es as “expe r i m ent al ” and-5-

“ in v e s tig a tio n a l.” O th e rs q u e s tio n th e a d e q u a c yo f re s e a rc h s u p p o rt in g th e iru s e . T M JI also c h all en g es sim il ar statem en ts i n C IG N A ’s C P N 1 5 6 reg ard ing T M JI’s p a rtial-jo in t p ro sth e sis . T h e a m e n d e d c o m p lain t alle g e s th a t th e se sta tem e n ts aboutT M J I ’ s pr oduct s w er e fa l s e and de famat or y , di s par aged i t s pr oduct s by pu bli cat i on of i njur i ou s fal sehoo ds, and t ort i ou sl yi nter fered w i th it s busi ness adv antage and exis t i ng and prospecti ve co ntr act s. A e tn a a n d C IG N A m o v e d to d ism iss th e a m e n d e d c o m p lain t fo r fa ilu re to stat e a claim o n sev era l gro u n d s, inclu d ing that the a ll eg ed lyd efam atory sta tem e n ts w e re n o t d e fa m a to rya s a m a tter o f law a n d w e re p ro tec ted sta tem e n ts of opi ni on. A etna and CIG N A att ache d copi es of thei rbul l et i ns t o thei rm ot i ons t o di s m i s s , cont endi ng t hatbeca us e the bul l et i ns w er e ce ntr al t o T M J I ’ s amended com plai nt, t he d i stri ctcou rtshou l d co nsi der them i n d eci ding t he m oti on s. T M JI’s resp o n se a sserted the s u ffici en cyo f it s claim s an d arg u ed that the c o u rt s houl d notcons i dert he ver s i on of the bul l et i n pr offe r ed byA etna bec aus e i tw as an am en d ed v ersion . T h ree v ersion s o f C P B 2 8 an d o n e v ersion o f C P N 1 5 6 w ere at t ache d t o t he r es pons e. T h e d istric t co u rt c o n sid e re d th e b u lletin s a n d g ra n ted th e m o tio n s to d is m is s . I thel d t hatal t hough i tcoul d nots ayas a mat t erof l aw t hatt he bul l et i ns w e re in c a p a b le o f

d e fa m a to ry m e a n in g , th e s ta te m e n ts w e re n o t a c tio n a b le . Fol l ow i ng C ol or ado Supr eme C our topi ni ons , i tr eas oned thatA etna’ s and C I G N A ’ s s t at ement s t hatT M J I ’ s devi ces w er e expe r i m ent al and i nves t i gat i onal-6-

w er e pr ot ect ed s t at ement s of opi ni on beca us e theyw er e i ncapa bl e of be i ng pr oved fal s e and a r eas onabl e per s on r eadi ng the bul l et i ns w oul d concl ude thatt he s t at ement s w er e ones of opi ni on r athert han fa ct . I tfur therhel d thatt he s t at ement s w er e pr ot ect ed undert he Fi r s tA m endmentbeca us e theyw er e on a m at t erof publ i c conc ern and di d noti m pl yt he al l egat i on of undi s cl os ed d efam atoryfa cts. A s fo r th e re m ainin g tortclaim s, the c o u rth eld th at A etna ’s and C I G N A ’ s pr ot ect ed s t at ement s of opi ni on w er e noti m pr oper ; s o nei ther defe nd ant coul d b e l i able for di sparagem ent, t ort i ou s i nter ference w i th b usi ness advant age, ort or t i ous i nt er fer ence w i th contr act , eac h of w hi ch r equi r es t he c o m m iss io n o f

a n im p ro p e r a c t. T M J I appea l s , cont endi ng ( 1) t hatt he di s tr i ctcourtr es ol ved s ever al fac tual i s s ues agai ns ti tdes pi t e i t s dut yt o vi ew t he fa ct s i n the l i ghtm os tfavor abl e t o t he n o n m o v i n g p a r t y; ( 2) t hatC PB 28 and C PN 156 ar e notpr ot ect ed s t at ement s of op i nion bec ause t he term s ex p e rim e n ta l and in v e stig a tio n a l h a v e su fficie n tly defi ni t e meani ngs i n t he medi cal comm uni tyt o be pr oved true orfal s e and a n aver age r eade rw oul d under s t and the bul l et i ns t o be as s er t i ng fac t ; and ( 3) t hat A etna and CIG N A for fei t ed anypr i vi l ege a ccor ded thei rs t at ement s of opi ni on beca us e theyw er e bas ed on an i ncompl et e and i nacc ur at e eva l uat i on of out dat ed fac t s , w er e publ i s hed t o avoi d paym entof cl ai m s r athert han t o conveya cove r age determ i nati on , and w ere pub l i shed w i th m al i ce. W e rej ectt hese argum ents , subst anti al l yagreei ng w i t h the di stri ctcou rt ’s analy si s.-7-

I I . DI S CU S S I ON W e r evi ew de novo a di s m i s s al of a c om pl ai ntunderR ul e 12( b) ( 6) for fa ilu re to sta te a c laim , ap p ly in g th e sa m e sta n d a rd th a t th e d istric t co u rt sh o u ld h a v e a p p lie d . S e e C o u n t y o f Sa n ta Fe , N. M. v . P u b . S e r v . C o . o f N. M. , 311 F. 3d 1031, 1034 ( 10t h C i r . 2002) . W e ac ceptas t rue “a l l w el l - pl eade d fac tual al l egat i ons i n t he amended compl ai nt , ” and vi ew t hos e al l egat i ons “i n the l i ght m os tfavor abl e t o t he nonmovi ng party . ” Id . (i n te rn a l q u o ta tio n m a rk s o m itte d ). Al t h o u g h we o r d i n a r i l yl i mi to u rr e v i e w t o t h e a l l e g a t i o n s i n t h e c o mp l a i n t , we cons i derdocument s “i ncorpor at ed i nt o the compl ai ntbyr efe r ence . ” Tel labs , Inc. v. MakorI

s s ues & Rights , Ltd. , 127 S. C t . 2499, 2509 ( 2007) . O urr evi ew of the bul l et i ns s how s t hatthe di ffe r ence s betw een va r i ous edi t i ons ar e i m m at er i al t o t he fol l ow i ng anal y s i s . T o gi ve TM J I t he bene fi tof the doubt , how ever , w e have r el i ed on the edi t i ons of C PB 28 and C PN 156 thatT M J I r efe r ence s i n i t s openi ng b rie f o n a p p e a l. B eca us e thi s cas e ar i s es undert he fe der al court ’ s di ver s i tyj ur i s di ct i on, t he l aw go verni ng T M JI ’s causes of ac t i on i s the law t hat w ou l d b e app l i ed if the case h a d b e e n b ro u g h t in C o lo ra d o s ta te c o u rt . S e e Bu t tv . Ba n ko f Am. , N. A. , 477 F. 3d 1 1 7 1 , 1 1 7 9 (1 0 th C ir. 2 0 0 7 ) (“ W h e n e x e rc isin g d iv e rsityju risd ictio n , w e a p p ly sta te la w w ith th e o bjec tiv e o f o b tain in g th e re su lt th a t w o u ld b e re a c h e d in sta te cou rt . ”). “W here no con t rol l i ng st at e decis i on exis t s, t he fe deral cou rtm ust at t empt t o pr edi ctw hatt he s t at e’ s hi ghes tcourtw oul d do. ” Wade v. E m cas co-8-

In s . C o ., 4 8 3 F .3 d 6 5 7 , 6 6 6 (1 0 th C ir . 2 0 0 7 ) ( in te rn a l q u o ta tio n m a rk s o m itte d ). T he part i es agr ee thatt he appl i cabl e s ubs t ant i ve l aw i s thatof C ol or ado, al though s ubj ectt o anyr es t r i ct i ons on t he al l eged t or t s thatm aybe i m pos ed bythe U ni t ed St at es C ons t i tut i on. W e ther efor e as s um e thatthi s cas e i s governed byC ol or ado s u b s ta n tiv e la w (a n d , o f c o u rs e , th e fe d e ra l c o n s titu tio n ). See C lark v. Stat e Farm Mut . A ut o. Ins . C o. , 319 F. 3d 1234, 1240 ( 10th C i r . 2003) ( appl y i ng s ubs t ant i ve la w o f s ta te th a t p a rt ie s a g re e c o n tr o ls ). A . Is su e s D isp o se d o f S u m m a r ily W e can b ri efl ydis po se of t w o is sues r ai sed byt he p art i es on ap peal. T M JI cont ends t hatt he di s t r i ctcour tr es ol ved s ever al i s s ues of fa ctagai ns ti tand ig n o re d is s u e s o f

d is p u te d m a te ri a l fa c t. Bu tb e c a u s e o u rr e v i e w i s d e n o v o , we need notconce r n our s el ves w i t h anys uch al l eged mi s s t at ement s orerr or s byt he di s t r i ctcour t . Second, A etna appe ar s t o cont end thatT M J I has pr es ent ed no e v id e n c e to su p p o rt so m e a lleg a tio n s in its c o m p lain t an d is n o t en tit led to di s coveryt o el i ci ts uch evi dence . I tpoi nt s outt hatT M J I di d notas k the di s tr i ct cour tt o convertt he mot i ons fordi s m i s s al i nt o ones fors um m aryj udgm entand t o del ayi t s deci s i on pendi ng t he r es ul t s of di s covery . W e r ej ectA etna’ s appar ent c o n ten tio n b e c a u se T M JI h a d n o o b lig a tio n to p ro v id e e v id e n tiary su p p o rt fo r its al l egat i ons , nordi d i thave a n obl i gat i on t o r eques tt hatt he courtconvertt he m ot i ons i nt o ones fors um m aryj udgm ent . W hen A etna moved t o di s m i s s t he co m p lai n t un d er R u le 12 (b)(6 ), itco u ld n o t con testthe truth o f th e c o m p lai n t’ s-9-

fa c tu a l a lle g a tio n s . S e e C o u n t y o f Sa n ta Fe , N. M. , 311 F. 3d at1034. O f cour s e, i f the al l egat i ons ar e s uffi ci ent , s o thatdi s m i s s al i s i m pr oper , T M J I w oul d then n e e d to p ro v e th o se a lleg a tio n s. A t th a t sta g e o f th e p ro c e e d in g , d isc o v e ryw o u ld be pr oper . T M J I ’ s oppos i t i on t o the R ul e 12( b) ( 6) m ot i on har dl yw ai ved or for fei t ed i t s r i ghtt o conductdi s coveryata l at ers t age of the l i t i gat i on. B. De fa ma t i o n Cl a i ms 1. A ppl i cabl e L aw a. Sources of

L aw C l ai m s fordefa m at i on ar e dee pl yr oot ed i n the comm on l aw . Si nce New York Ti m es C o. v. Sul l i van , 3 7 6 U .S . 2 5 4 (1 9 6 4 ), h o w e v e r, co u rts h a v e h a d to su p p lem e n t th e ir c o m m o n -la w a n a ly sis w ith a fe d e ra l co n stitu tio n a l in q u iryto det erm i ne w hethera cl ai m can s ur vi ve. M or eover , a numberof s t at es , i ncl udi ng C o lo ra d o , h a v e in v o k e d s ta te c o n s titu tio n s to re s tr ic t d e fa m a tio n c la im s . See, e. g. , N B CSu bsi diary (

K CNC -TV

) , Inc. v. L i vi ngWi l lC tr. , 879 P. 2d 6, 9 ( C ol o. 1 9 9 4 ) (“[t]o d ec ide th e issu es . . . w e m u st fir st i d en ti fythe a p p rop ri ate stan d ard foreval uat i ng w hen defamat or ys t at ement s ar e cons t i tut i onal l ypr ot ect ed under t he Fi r s tA m endmentt o t he U ni t ed St at es C ons t i tut i on and art i cl e I I , s ect i on 10 of t h e Co l o r a d o Co n s t i tu t i o n . ” ) . Wh e n t h e r e a r e mu l t i p l e s o u r c e s o f a p p l i c a b l e l a w, w e m u s t b e c a re f

u l in d e te rm in in g w h a t d e fe re n c e is d u e to s ta te -c o u rt d e c is io n s . A fede r al courtm us tfol l ow t he s t at e’ s hi ghes tcourti n pr onounci ng orcons trui ng t he s t at e’ s comm on l aw , s t atut or yl aw , orcons t i tut i onal l aw . B uti tow es no-10-

d e fe re n c e to s ta te -c o u rt in te rp re ta tio n o f th e U n ite d S ta te s C o n s titu tio n . See Ace C ycle Wor ld, Inc. v. A m . Honda Mot orC o. , 7 8 8 F . 2 d 1 2 2 5 , 1 2 2 8 (7th C ir . 1 9 8 6 ). T hus , i f w e di s agr ee w i t h t he s t at e court ’ s vi ew thatthe fe der al cons t i tut i on i m pos es a part i cul arl i m i t at i on on defa m at i on cl ai m s , w e w i l l noti m pos e that l i m i t at i on . O n the ot her han d, i f st at e l aw i m po ses that l i m i t at i on , w e m ust re c o g n iz e th a t lim ita tio n e v e n if th e fe d e ra l c o n s titu tio n is n o t s o re s tr ic tiv e . A ccor di ngl y , w hen a s t at e- cour tdeci s i on i m pos es a l i m i t at i on on defa m at i on cl ai m s , part i cul ar l yw hen w e doubtw hetherthatl i m i t at i on i s r equi r ed bythe fe d era l con sti tuti o n , itis i m p o rt an t th at w e d eterm ine w h ethe r th e state c o u rt i mp o s e d t h a tl i mi t a t i o n a s a ma t t e ro f s t a t e l a w o rfe d e r a l c o n s t i tu t i o n a l l a w. U nfor tunat el y , t he t as k of det erm i ni ng t he s our ce of a l i m i t at i on i n a s t at ecour tdeci s i on can be r atherdi ffi cul t . B eca us e the comm on l aw of defamat i on, fede r al cons t i tut i onal l aw , and the cons t i tut i onal l aw of the var i ous s t at es r efl ect m anyof the s ame under l y i ng pr i nci pl es and adopts i m i l arpr opos i t i ons , i ti s oft en uncl eart o w hatext enta courtdeci s i on r el i es on eac h. W e have found thi s t o be tru e in so m e o f

th e lea d in g C o lo ra d o o p in io n s o n d e fa m a tio n . T o a ss ist u s in d e t e r mi n i n g t h e s o u r c e o f Co l o r a d o c o u r tp r o n o u n c e me n t s , we r e l yo n two obs ervat i ons . Fi r s t , t he C ol or ado Supr eme C our thas been w i l l i ng t o r ecogni ze l i m i t at i ons on t he defamat i on caus e of a ct i on thatar e notr equi r ed bythe fe der al cons t i tut i on. I n Walkerv. C ol or ado Spr i ngs Sun, Inc. , 538 P. 2d 450, 457 ( C ol o. 1 9 7 5 ), over r ul ed on othergr ounds by D i vers i f i ed Managem ent, Inc. v. D enve rSee D enve rP ub. C o. v. B ueno , 54 P. 3d 893, 899 n. 9, 900–01 ( C ol o. 2002) 2 ( ci t i ng R es t at ement( Second) of Tort s ( 1977) ( R es t at ement ) § 570 forcat egor i es of s t at ement s r ecogni zed a s defa m at or yas a mat t erof l aw and §§ 564 and 652E c m t. b to c o m p a re e lem e n ts o f d e fa m a tio n to e lem e n ts o f fa lse lig h t); In r e G r een , 11 P . 3d 10 78 , 10 84 (2000 ) ( st at i ng t hat opi nions that i m plyun dis cl osed fal se s t at ement s of fa ctar e notpr ot ect ed undert he Fi r s tA m endmentand ci t i ng R estatem en t § 5 6 6 fo r sup p o rt ); R ober tC . O z er, P . C . v. B or quez , 940 P. 2d 371, 3 7 9 (C o lo. 19 9 7 ) (r eferring to R estatem en t § 6 5 2 D cm t. a to d ist ing u ish the term “publ i cat i on” us ed i n t or tof defamat i on fr om t he t erm “publ i ci ty ” us ed i n t or tof inv asio n o f p ri v ac y ); L i vi ngWi l lC tr. , 879 P. 2d at15 ( ci t i ng R es t at ement§ 564 forpr opos i t i on t hat“al l egedl ydefa m at oryr emar k i s notact i onabl e i f i tcannot r eas onabl ybe under s t ood as an as s er t i on of ac tual fac tpert ai ni ng t o the pl ai nt i ff” (e m p h a sis o m itt e d )); Keoh an e v. Stew art , 882 P. 2d 1293, 1300 n. 10 ( C ol o. 1994) ( quot i ng R es t at ement§ 564 fors uppor tof pr opos i t i on thatdefa m at or ys t at ement notr efe r r i ng t o pl ai nt i ff byname i s act i onabl e i f l i s t ener s r eas onabl yunder s t ood sta tem e n t to b e a b o u t p lain tiff); C hur chey v. A dol ph C oors C o. , 759 P. 2d 1336, 1343–45 ( C ol o. 1988) ( cons t rui ng R es t at ement§ 577 cmt . k r egar di ng s el fp u b lica tio n ); D om i nguezv. B abcock , 727 P. 2d 362, 364, 365–66 ( C ol o. 1986) ( di s cus s i ng qual i fi ed pr i vi l ege i n R es t at ement§ 596, and l os s of pr i vi l ege unde r § 6 0 0 ); B ur ns v. McG r aw - Hi l lB r oad. C o. , 659 P. 2d 1351, 1357–59 ( C ol o. 1983) ( adopt i ng R es t at ement§ 559 and i t s cmt . e r egar di ng w hen s t at ementm aybe d efam atory , cit ing R estatem en t § 5 6 3 reg ard ing d eterm ination o f d efam atory m eani ng, and r el y i ng on R es t at ement§ 566 and i t s cmt . b r egar di ng pr ot ect ed o p inion s); B u c h e r v . R o b e rts , 595 P. 2d 239, 241–42 ( C ol o. 1979) ( r el y i ng on R estatem en t § 5 6 6 an d it s cm ts. c a n d e re g ard ing p rotec ted o p inion ). -11- P os t, Inc. , 653 P. 2d 1103 ( C ol o. 1982) , the courti m pos ed a mal i ce r equi r ement w hen the al l egedl ydefa m at or ys t at ementr el at ed t o a mat t erof publ i c conc ern, even though t he U ni t ed St at es Supr eme C our tr equi r es m al i ce onl yw hen the a lle g e d v ic tim is a p u b lic o ffic ia l o r p u b lic fig u re . See G er tzv. R ober tWelch, Inc. , 4 1 8 U .S . 3 2 3 , 3 4 2

– 4 3 (1 9 7 4 ). Second, t he C ol or ado Supr eme C our t , both i n i t s opi ni ons and i n the 2See C ol or ado J ur yI ns t ruct i ons , C i vi l , ch. 22. 1 ( 4th ed. 2007) ( ci t i ng 3 R es t at ement§§ 558–581 as s our ce a nd author i tyfori ns truct i on on defa m at i on per s e ), id . C h . 2 2 .2 (c iti n g R e sta tem e n t § § 5 6 6 c m t. c a n d 6 1 4 in d isc u ss io n o f lib e lp e r-q u o d in stru c tio n ); id . C h . 2 2 .6 (c iti n g R e sta tem e n t § § 5 7 7 a n d 5 7 8 in di s cus s i on of i ns t ruct i on defi ni ng publ is hed); i d. C h. 22. 7 ( bas i ng defi ni t i on of def am at or y o n R e sta tem e n t § 5 5 9 ); id . C h. 22. 8 ( ci t i ng R es t at ement§ 564 as so u rc e a n d a u th o rityfo r in stru c tio n o n a b o u t-th e -p lain tiff e lem e n t); i d. C h 2 2 .9 ( ci t i ng R es t at ement§ 563 fordi s cus s i on of i ns truct i on on m eani ng of a sta tem e n t); id . C h. 22. 10A ( ci t i ng R es t at ement§ 563 cmt . b i n s uppor tof in stru c tio n th a t sta tem e n t b e c o n sid e re d in c o n tex t); id . C h. 22. 12 ( ci t i ng R e sta tem e n t § 5 7 5 a s s o u rc e a n d a u th o rityfo r sp e c ial-d a m a g e s in stru c tio n ); id . C h. 22. 13 ( ci t i ng R es t at ement§§ 621–623 as s our ce a nd author i tyfordefi ni t i on o f a c tu a l d a m a g e s); id . C h. 22. 14 ( ci t i ng R es t at ement§ 581A i n s uppor tof in stru c tio n o n su b sta n tial-tru th d e fe n se ); id . C h. 22. 15 ( ci t i ng R es t at ement§§ 5 8 5

– 5 9 2 A in d isc u ss io n o f a b so lu te- p riv ileg e d e fe n se s); id . C h. 22. 16 ( ci t i ng R es t at ement§§ 599–605A fori ns truct i on on w hen qual i fi ed pr i vi l ege maybe lo st); id . C h. 22. 17 ( ci t i ng R es t at ement§ 611 fori ns truct i on on pr i vi l ege for re p o rts o f

o fficia l p ro c e e d in g s); id . C h. 22. 18 ( ci t i ng R es t at ement§ 612 for d isc u ss io n o f

p riv ileg e fo r p ro v id e r o f m e a n s o f

p u b lica tio n ); id . C h. 22. 20 ( ci t i ng R e s ta te m e n t § 5 8 3 fo r i n s tru c tio n o n a ffir m a tiv e d e fe n s e o f c o n s e n t) . See a lso Wi ls on v. Meye r , 126 P. 3d 276, 279 ( C ol o. C t . A pp. 2005) ( ci t i ng 4 R e sta tem e n t § 6 1 1 re g a rd in g p riv ileg e fo r re p o rt o f o fficia l p ro c e e d in g ); G or don v. B oyl es , 99 P. 3d 75, 78 ( C ol o. C t . A pp. 2004) ( ci t i ng R es t at ement§ 568A for stat em en t th at “rad io b roa d ca st of d efam atorym att er is de fa m ati o n b yli b el”); Hay e s v . Sm ith , 832 P. 2d 1022, 1024 ( C ol o. C t . A pp. 1991) ( di s cus s i ng s l ander p e r se w ith re fe re n c e to R e sta tem e n t § § 5 7 1

– 5 7 4 ); B r ooks v. Jacks on , 813 P. 2d 847, 848 ( C ol o. C t . A pp. 1991) ( quot i ng R es t at ement§ 559’ s defi ni t i on of w hen a c o m m u n ica tio n is d e fa m a to ry ); Tei lhaberM f g. C o. v. Unar co Mat er i als St or age, a D i v. of

Unar co Indus . , Inc. , 791 P. 2d 1164, 1167 ( C ol o. C t . A pp. 1989) ( ci t i ng R e sta tem e n t § 5 6 6 re g a rd in g w h e n sta tem e n ts o f o p in io n a re u n p ro tec ted in d e fa m a tio n a n d p ro d u c t-d isp a ra g e m e n t ac tio n s); L in dv . O ’R e ill y , 636 P. 2d 1319, (continued...) -12- U n ifo rm J u ry In s tru c tio n s it p ro m u lg a te s , s ee C o lo ra d o Ju ryIn stru c tio n s, C iv il ( 4t h ed. 2007) ( copyr i ght ed bySupr eme C our tof C ol or ado) , has di s pl ay ed gr eat 3 r es pectfort he form ul at i ons of the t or tof defamat i on i n the R es t at ement( Second) of Tort s ( 1977) ( R es t at ement ) . W e ther efor e thi nk i ta s afe pr es um pt i on ( though 4(...continued) 4 1321 ( C ol o. C t . A pp. 1981) ( quot i ng R es t at ement§ 575 cmt . b r egar di ng s peci al d a m a g e s); C o sta v . Sm ith , 601 P. 2d 661 ( C ol o. C t . A pp. 1979) ( ci t i ng R estatem en t § 5 8 3 cm t. d il lus. 2 reg ard ing co n sen t as a d efen se). -13- n o t an irre b u ttab le o n e ) th a t th e C o lo ra d o S u p re m e C o u rt w ill a d o p t as p a rt o f its c o m m o n law o f

d e fa m a tio n th e v a rio u s p ro v isio n s o f th e R e sta tem e n t, ev e n if th o se p ro v isio n s m a yim p o se re stric tio n s n o t re q u ire d b yc o n tro lli n g a u th o rity f ro m th e U n ited S tate s S u p re m e C o u rt.

b. Ex pr e s s i ons of O pi ni on T o s t at e a c aus e of a ct i on fordefa m at i on underC ol or ado l aw , t he pl ai nt i ff m us tal l ege “ ( 1) a defamat or ys t at ementconce rni ng another ; ( 2) publ i s hed t o a t hi r d par t y ; ( 3) w i t h faul tamount i ng t o atl eas tnegl i gence on the partof the publ i s her ; and ( 4) ei t heract i onabi l i tyof the s t at ementi rr es pect i ve of s peci al damages ort he exi s t ence of s peci al damages t o the pl ai nt i ff c aus ed byt he publ i cat i on. ” Will ia m s v . D ist. C t., S e c o n dJu d icia l D ist. , 8 6 6 P .2 d 9 0 8 , 9 1 1 n .4 (C o lo . 1 9 9 3 ). T h is c a s e tu rn s o n th e fir s t e le m e n t. T he s peci fi c i s s ue befor e us i s how t o di s t i ngui s h a defamat orys t at ement f ro m a p ro tec ted e x p re ss io n o f o p in io n . W e m u st c o n sid e r tw o so u rc e s o f law to r es ol ve the i s s ue. O ne i s t he R es t at ement . T he R es t at ementr ecogni zes t w o types o f d e fa m a to ry c o m m u n ic a tio n : ( 1 ) s ta te m e n ts o f fa c t, s ee R es t at ement§ 565, and ( 2) expr es s i ons of opi ni on, se e id . § 5 6 6 . O f th e latte r, th e R e sta tem e n t sta tes : “A defa m at or ycomm uni cat i on m aycons i s tof a s t at ementi n the form of an-14-

opi ni on, buta s t at ementof thi s natur e i s act i onabl e onl yi f i ti m pl i es the al l egat i on of undi s cl os ed defamat or yfac t s as the bas i s forthe opi ni on. ” Id . § 5 6 6 . T he others our ce i s t he U ni t ed St at es Supr eme C our t ’ s di s cus s i on i n Mi lkovi ch v. Lorai n Jour nalC o. , 497 U . S. 1 ( 1990) , of the cons t i tut i onal pr ot ect i on for e x p re s s io n s o f

o p in io n . I n r es ol vi ng cont ent i ons t hata s t at ementi s a pr ot ect ed expr es s i on of opi ni on, t he C ol or ado Supr eme C our thas r efe rr ed t o both the R es t at ementand Mi lkovi ch . T o th e e x ten t th a t ita d o p ts th e R e sta tem e n t as a m a tter o f sta te comm on l aw , w e ar e bound. T o t he ext entthati tr el i es on Mi lkovi ch , h o w ev er, we fo l l o w t h e Co l o r a d o c o u r t ’ s i n t e rp r e t a t i o n o f th e Un i t e d S t a t e s S u p r e me C our t ’ s Fi r s tA m endmentj ur i s prudence onl yi ns ofaras w e agr ee w i th that i nt erpr et at i on. A ccor di ngl y , i ti s i m por t antthatw e compar e Mi lkovi ch ’ s hol di ng t o t he R es t at ement ’ s pr ovi s i ons t o det erm i ne w hetherthe l at t erpr ovi des gr eat er pr ot ect i on t han Mi lkovi ch i n the ci rcum st ances o f t his case. If i tdo es, w e m ust pr edi ctw hethert he C ol or ado Supr eme C our tw oul d r ecogni ze thataddi t i onal r es t r i ct i on on defa m at i on cl ai m s . W e begi n w i th an ana l y s i s of Mi lkovi ch . T he Mi lkovi ch C our tr ej ect ed the s ugges t i on thati tadd t o pr evi ous doctr i ne “a w h o lesale d efam ati o n ex em p ti o n fo r an ything that m igh t be lab eled ‘op inion . ’” 4 9 7 U. S . a t1 8 . I n i t s v i e w, u s e o f th e t e r m opi ni on obs cur es anal y s i s , and the purpos es t o be s erved bys uch an e xempt i on w er e al r eadyw el l s erved byexi s t i ng-15-

doctr i ne. C oncerni ng t he fi r s tpoi ntthe C our tobs erved that“expr es s i ons of

‘ opi ni on’ m ayoft en i m pl yan as s er t i on of obj ect i ve fa ct . ” Id . I texpl ai ned: If a s peak er s ay s, “In m yop i nion John Jones i s a l i ar, ” he im pli es a know l edge of

fac t s w hi ch l ead t o the conc l us i on t hatJ ones t ol d an u n tru th . E v e n if

th e sp e a k e r sta tes th e fa c ts u p o n w h ich h e b a se s h is o p in io n , if th o se fa c ts a re e ith e r in c o rre c t o r in c o m p lete , o r if h is asses sm ent of t hem i s erroneou s, the st at em ent m ayst i l l i m plya fal se as s ert i on of fa ct . Si m pl ycouchi ng s uch s t at ement s i n t erm s of o p i n i o n d o e s n o td i s p e l t h e s e i mp l i c a t i o n s ; a n d th e s t a t e me n t , “ I n my opi ni on J ones i s a l i ar , ” ca n caus e as m uch damage t o r eput at i on as th e sta tem e n t, “J o n e s is a liar.” A s J u d g e F rie n d lya p tlysta ted : “[ It] w oul d be des t ruct i ve of the l aw of l i bel i f a w r i t ercoul d es cape l i abi l i t yforacc us at i ons of [de famat or yconduct ] s i m pl ybyus i ng, expl i ci t l yori m pl i ci t l y , t he w or ds ‘ I thi nk. ’ ” S e e C ia n c i [ v. New Ti m es P ub. C o. , 6 3 9 F .2 d 5 4 , 6 4 (2 d C ir. 1 9 8 0 )]. It is w o rth yo f n o te t hatatcomm on l aw , even the pr i vi l ege of fai rcomm entdi d not ext end t o “a fal s e s t at ementof fa ct , w hetheri tw as expr es s l ys t at ed ori m pl i ed fr om an expr es s i on of opi ni on. ” R es t at ement( Second) of T o rts, § 5 6 6 , C o m m e n t a (19 7 7 ). Mi lkovi ch a t 1 8

– 1 9 . T h e C o u rt th e n sta ted th a t ex istin g d o c trin e a d e q u a tely p r o t e c t e d f

r e e d o m o f

e x p r e s s i o n “ wi th o u tth e c r e a t i o n o f a n a r t i fi c i a l d i c h o t o my betw een ‘ opi ni on’ and fa ct . ” Id . at19. I n par t i cul ar , i tpoi nt ed t o pr ece dent providi ng “t hat a s t at em ent on m at t ers of p ub l i c con cern m ustbe p rovable as fal se b e fo re th e re c a n b e lia b ility u n d e r s ta te d e fa m a tio n la w , a t le a s t in s itu a tio n s . . . w her e a medi a defendanti s i nvol ved. ” Id . at19–20. A ccor di ngl y , i tcont i nued, “a s t at ementof opi ni on r el at i ng t o m at t er s of publ i c conc ern w hi ch does not cont ai n a pr ovabl yfal s e fa ctual connot at i on w i l l r ece i ve ful l cons t i tut i onal pr ot ect i on. ” Id . at 2 0 . T h e C o u rt f u rth e r o b se rv e d th a t “‘ rh e to ric a l h yp e rb o le’ ” is pr ot ect ed bydoctr i ne r equi r i ng t hatal l egedl ydefa m at orys t at ement s ( s uch as the-16-

char act er i zat i on of a uni on di s s i dentas a “tr ai t or ”) “r eas onabl ybe i nt erpr et ed as s t at i ng actual fac t s . ” Id . (b ra c k e ts o m itte d ). W e n o te fo u r differe n ce s b etw ee n § 5 6 6 an d the S u p rem e C o u rt ’s form ul at i on of the cons t i tut i onal s t andar d i n Mi lkovi ch . Fi r s t , § 566 r equi r es that t he s t at ement( i n t he form of an opi ni on) “i m pl [y ] the al l egat i on of undi s cl os ed defa m at or yfac t s . ” I n ot herw or ds , an opi ni on i s notact i onabl e i f i ti s bas ed on d e fa m a to ry fa c ts th a t a re d is c lo s e d . Mi lkovi ch , i n contr as t , obs erves that“[e ] ven if th e sp ea k er states the fa cts u p o n w h ich h e b ase s h is op inion , if th o se fac ts are ei t heri ncorr ectori ncompl et e, ori f hi s as s es s m entof them i s err oneous , the s t at ementm ays t i l l i m pl ya fa l s e as s er t i on of fa ct , ” id . at18–19, ther eby s ugges t i ng t hatt he opi ni on i s notcons t i tut i onal l ypr ot ect ed. T he di ffe r ence b e tw e e n th e tw o fo rm u latio n s, h o w e v e r, is m o re a p p a re n t th a n re a l. A s n o ted in t he comm ent s t o § 566, al t hough an opi ni on b a se d o n d isc lo se d d e fa m a to ryfa c ts i s noti t s el f s ubj ectt o l i abi l i t y , t he di s cl os ur e of the defamat oryfac t s on w hi ch t he opi ni on r es t s m ays t i l l cr eat e l i abi l i tyi f the fa ct s themsel ves ar e fa l s e; i ti s t he publ i cat i on of the defamat or yfac t s , how ever , r atherthan the expr es s i on of o p in io n , th a t is a c tio n a b le . See § 566 cmt . b ( w hen s peake rs t at es fac t s on w hi ch o p inion is ba sed , “[ t] h e statem en t of fa cts an d the e x p ression o f o p inion . . . are sep ara te m att ers . . . , an d at co m m o n law eith er o r bo th co u ld b e d efam atory ”); id . cmt . c i l l us . 5 ( “I f the defendantbas es hi s expr es s i on of a de r ogat or yopi ni on .

. . on hi s ow n s t at ementof fa l s e and de famat or yfac t s , he i s s ubj ectt o l i abi l i tyfor-17-

t he fa ctual s t at ementbutnotforthe expr es s i on of opi ni on. ”) ; § 578 ( l i abi l i tyof r epubl i s her ) . T hus , R es t at ement§ 566 i s no m or e pr ot ect i ve than Mi lkovi ch , and w e nee d notdeci de w hethert he C ol or ado Supr eme C our tw oul d i m pos e a lim itatio n o n th e d e fa m a tio n to rt b e y o n d w h a t Mi lkovi ch re q u ir e s in th is re g a rd . A s econd di ffe r ence betw een Mi lkovi ch a n d § 5 6 6 is th a t Mi lkovi ch p ro tec ts sta tem e n ts th a t ar e n o t p ro v a b lyfa lse o n lyif th e ya re “ o n m a tters o f p u b lic c o n c e rn .” 4 9 7 U .S . a t 1 9 . S e c tio n 5 6 6 h a s n o s u c h re s tr ic tio n , s ee § 566 cmt . c at 1 7 3 (“ A lth o u g h it i s . . . p o ss ib le th a t [ th e S u p re m e C o u rt w ill tre a t] p riv a te comm uni cat i ons on pr i vat e mat t er s . . . di ffe r ent l y , the l ogi c of the cons t i tut i onal pr i nci pl e w oul d appea rt o appl yt o al l expr es s i ons of opi ni on of the fi r s t , orpur e, t ype. ”) . T hatdi ffe r ence i s notm at er i al i n thi s cas e, how ever , beca us e the s ta te m e n ts b yA e tn a a n d C IG N A a re u n d o u b te d ly o n m a tte rs o f p u b lic c o n c e rn . I n t he cont extof the Fi r s tA m endment , a mat t eri s of publ i c conc ern w hen i ti s “a s ubj ectof l egi t i m at e new s i nt er es t ; thati s , a s ubj ectof gene r al i nt er es tand of val ue and c oncern t o t he publ i c atthe t i m e of publ i cat i on. ” C i t y of San D i ego, C al . v. R oe , 543 U . S. 77, 83–84 ( 2004) . “W hether. . . s peec h addr es s es a mat t er of publ i c conc ern m us tbe det erm i ned by[the expr es s i on’ s ] cont ent , form , and cont ext. . . as r evea l ed byt he w hol e r ecor d. ” D un & Brads tr eet, Inc. v. G r eenm os s B ui lders , Inc. , 4 7 2 U .S . 7 4 9 , 7 6 1 (1 9 8 5 ) (b ra c k e ts a n d e lli p se s in or i gi nal , i nt ernal quot at i on m arks om i t t ed) . A l though T M J I cont ends thatthe A e tn a a n d C IG N A b u lletin s w e re n o t o n m a tters o f p u b lic c o n c e rn , w e th in k th is-18-

c o n ten tio n u n ten a b le. In d e e d , it s p lea d in g s b e lo w a re in c o n sis ten t w ith its pr es entpos i t i on. T he amended compl ai nts t at es that“The act s of A etna and/ or C I G N A [i n publ i s hi ng t he bul l et i ns ] . . . deni ed s uffe r i ng and i nj ur ed per s ons t he avai l abi l i t yand us e of the C hr i s t ens en part i al pr os thet i c i m pl ant s and deni ed the publ i c a ne ces s arym edi cal devi ce . . . and . . . have, ther efor e, caus ed and cont i nue[d] t o caus e gr eatdi s t r es s , pai n, and s uffe r i ng t o the manyper s ons w ho coul d benef

i tfr om t he C hr i s t ens en part i al pr os thet i c i m pl ant . ” A pl t . A pp. at13 ( A m ended Com pl ai nt ) . I tadded that“dent i s t s , or al s ur geons , dent al and medi cal cl i ni cs , and hos pi t al s , and thei rpat i ent s , have r el i ed and c ont i nue t o r el yupon t he fac tual t rut hful nes s and ac cur acyof the . . . s t at ement s m ade a nd di s s emi nat ed by A etna and/ orC I G N A . . . r egar di ng [TM J I ] . ” Id . at 12 . E v en o n ap p ea l, T M JI’s o p e n i n g b r i e f

r e c i t e s t h a ta p p r o x i ma t e l y3 0 mi l l i o n Am e r i c a n s s u ffe rf r o m TM J di s or der s and thatatl eas t100, 000 pat i ent s had r ece i ved TM J i m pl ant s betw een 19 88 and 19 98 . T w enty -fi ve thousan d o f i t s devices have b een u sed byatl east 8 0 0 h o s p i t a l s a n d c l i n i c s . Be c a u s e th o u s a n d s o f p e o p l e , i n c l u d i n g th o s e wi th TM J di s or der s , t hos e w ho have r ece i ved orar e s eeki ng i m pl ant s , and phy s i ci ans and dent i s t s t r eat i ng T M J - di s or derpat i ent s , have a l egi t i m at e i nt er es ti n the ut i l i tyof T M J I ’ s devi ces , t he mat t eri s undoubt edl yof publ i c conc ern. A nydi s t i nct i on betw een the R es t at ementand Mi lkovi ch on thi s i s s ue i s ther efor e i ncons equent i al her e.-19-

T he thi r d di ffe r ence betw een § 566 a nd the Mi lkovi ch form ul at i on i s that Mi lkovi ch sta tes th a t th e n o t-p ro v a b ly -fa lse tes t m ay a p p lyo n ly“ w h e re a m e d ia defe ndanti s i nvol ved, ” 497 U . S. at19–20, w her eas § 566 cont ai ns no s uch r equi r ement . W e doubtt hatA etna and CIG N A coul d pr oper l ybe des cr i bed as m edi a defendant s . I n t hi s r es pect , then, § 566 m ayw el l i m pos e a r es tr i ct i on on T M JI ’s cl ai m no ti m po sed byt he fe deral con st i tuti on . A ccordi ng l y , w e m ust d e c id e w h e th e r th e C o lo ra d o S u p re m e C o u rt w o u ld e x ten d th is p ro tec tio n e v e n if n o t re q u ire d to d o so b yfe d e ra l co n stitu tio n a l law . W e a re c o n fid e n t th a t it w o u ld

— th a t is, tha t itw o u ld n o t co n fin e th e re a c h o f th e p ro tec tio n o f

n o tpr ovabl y - fal s e s t at ement s t o t hos e made bym edi a defendant s . I ndeed, i n a pr eMi lkovi ch o p in io n th e C o lo ra d o S u p re m e C o u rt a p p lied § 5 6 6 to a p riv a te d e fe n d a n t ( th e p la in tiff ’s s u p e rv is o r) . See Bucher , 5 9 5 P . 2 d at 24 1 . A n d m o re r ece nt l yt he C ol or ado Supr eme C our tdi s cus s ed Milko vich ’s no t -pr ov ably -fal se s t andar d w i t houta ment i on of the U ni t ed St at es Supr eme C our t ’ s pos s i bl e medi adefe ndantr es t r i ct i on and affi r m ed the di s m i s s al of a c l ai m agai ns ta defendant w ho had w r i t t en l et t er s t o t he edi t orw i thoutanydi s cus s i on of w hetherthe author o f s u c h le tte rs is a m e d ia d e fe n d a n t. See Keohane , 882 P. 2d 1293. T he fourt h and fi nal di ffe r ence w e not e betw een the § 566 and Mi lkovi ch fo rm u latio n s is in th e e x p re ss io n o f th e u lti m a te te st fo r w h e th e r a sta tem e n t is act i onabl e. T he R es t at ementas ks w hethera s t at ement“i m pl i es the al l egat i on of [ a n ] u n d is c lo s e d d e fa m a to ry fa c t[ ].” R e s ta te m e n t § 5 6 6 . Mi lkovi ch as ks w hether-20-

a s t at ementi s “pr ovabl e as fal s e” a nd i s not“rhet or i cal hyperbol e, ” Mi lkovi ch , 4 9 7 U .S . at 1 9

– 2 0 . A g a in , h o w e v e r, w e b e liev e th a t th e tes ts a re e ss e n tially i dent i cal i n appl i cat i on. I f no fa cti s i m pl i ed bya s t at ement , then ther e i s no w ay t o pr ove i tfal s e. A nd Mi lkovi ch ’ s rh e t o r i c a l - h yp e rb o l e s t a n d a r d i s s i m p l y a r ecogni t i on t hatan expr es s i on of opi ni on thatappea r s t o i m pl yan al l egat i on of fa c t (su c h a s, “ X is a tra ito r” ) m a y , in c o n tex t, be m e re h yp e rb o le th a t a r eas onabl e per s on w oul d notvi ew as a fa ctual as s er t i on. A ppar ent l ythe C ol or ado Supr eme C our tal s o vi ew s t he tw o form ul at i ons as congruent . I n tw o pr eMi lkovi ch o p in io n s th e c o u rt fo llo w e d § 5 6 6 a n d d e ter m in e d w h e th e r a n a lleg e d ly d e fa m a to ry st a te m e n t im p lie d u n d is c lo s e d d e fa m a to ry fa c ts . See Bucher , 595 P .2 d a t 2 4 1 ; B ur ns , 659 P. 2d at1358–60. T hen i n Keohane , 882 P. 2d 1293, the C ol or ado Supr eme C our ts t at ed thatthe s t andar d i n i t s pr ece dent s “w as s u b s e q u e n t l y fo r t i fi e d b y Mi lkovi ch , ” id . at1297. A s i texpl ai ned: Mi lkovi ch and B ur ns . . . p ro v id e th e n e c e ss a ryf ra m e w o rk to d e t e r mi n e i f

a s t a t e me n ti s p r o t e c t e d . T h i s f r a me wo r k i n v o l v e s two in q u iries . T h e first in q u iryis w h e th e r th e sta tem e n t is “ su fficie n tly fac tual t o be s us cept i bl e of be i ng pr oved true orfal s e. ” Mi lkovi ch , 4 9 7 U .S . at 2 1 . T h e se c o n d in q u iryis w h e th e r re a so n a b le p e o p le w o u ld c o n c lu d e th a t th e a s s e rt io n is o n e o f fa c t. Id . T h e fac tors r el evantt o t he s econd i nqui ryar e: ( 1) how the as s er t i on i s phr as ed; ( 2) t he cont extof the ent i r e s t at ement ; and ( 3) the ci r cumst ance s s ur r oundi ng t he as s ert i on, i ncl udi ng t he medi um thr ough w hi ch the i nform at i on i s di s s emi nat ed and the audi ence t o w hom the s t at ement is d ir e c te d . B ur ns , 659 P. 2d at1360. Keohane , 8 8 2 P . 2 d at 12 9 9 (fo o tno tes o m itted). T h e se co n d inq u iryis ne ce ssary o n ly if th e fir s t in q u ir yis a n s w e re d in th e a ffir m a tiv e . S e e a lso id . at1300–03;-21-

Wils o n , 126 P. 3d at280 ( ci t i ng Keohane forpr opos i t i on that“[c ] our t s det erm i ne w hethera s t at ementi s pr ot ect ed as opi ni on byi nqui r i ng fi r s tw hetherthe sta tem e n t is su sc e p tib le o f b e in g p ro v e d tru e o r fa lse . If th e a n sw e r is y e s, c o u rts t hen i nqui r e w hetherr eas onabl e per s ons w oul d concl ude thatthe as s er t i on i s one o f fa c t” ). I n s um , w e fi nd l i t t l e di ffe r ence betw een § 566 a nd the Mi lkovi ch s t andar d; and t o t he ext entt hatt he di ffe r ence s ar e r el evanti n thi s cas e, w e ar e conf i dent th a t C o lo ra d o w o u ld a p p lyth e m o re re stric tiv e § 5 6 6 fo rm u latio n . W e n o w a p p ly th e a b o v e a n a ly sis to th e p a rties ’ a rg u m e n ts o n a p p e a l.

2. TM JI ’ s A l l e ga t i ons a. T h e T erm s Ex

p e rim e n ta l and Inves ti gati onal T he hea r tof TM J I ’ s compl ai nti s t hatA etna and CIG N A defa m ed i tby cal l i ng i t s produc t s ex p e rim e n ta l and i nves t igat i onal . I n r es pons e t o A etna’ s and C I G N A ’ s defe ns e thatt heyw er e onl yexpr es s i ng opi ni ons , T M J I ar gues t hat w i t hin the m edical com m un i t yt he term s ex p e rim e n ta l and i nves t igat i onalhave d e fin ite m e a n in g s b a se d o n “ o bjec tiv e c riter ia,” a n d th a t sta tem e n ts la b e lin g its devi ces as exper i m ent al and i nves t i gat i onal ar e ther efor e notm er e mat t er s of o p in io n b u t ar e a ss e rtio n s o f fa c t. A p lt. B r. at 1 3

– 1 4 . In su p p o rt o f th is cont ent i on T M J I ’ s appel l at e br i efs di s cus s t hr ee c as es and ci t e s ever al m or e i n a footnot e. T heyal s o poi ntt o s om e FD A defi ni t i ons and a de fi ni t i on r etr i eved t hr ough an A etna w ebs i t e. W e ar e notper s uaded.-22-

T he fir stcase di scussed byT M JI i s L e o n h a r d tv . Ho ld e n B u s i n e s s Fo r ms C o. , 828 F. Supp. 657 ( D . M i nn. 1993) . Pl ai nt i ff Pene l ope Leonhar dthad s ought c o v e ra g e fo r a n a u to lo g o u s b o n e m a rr o w tr a n s p la n t ( A B M T ) t o tr e a t h e r c a n c e r. T he admi ni s t r at orof hergr oup heal th pl an deni ed the tr eatm enton the gr ounds t hatA B M T w as “expe r i m ent al ” and “ i nves t i gat i onal . ” Id . at662. M s . L eonhar dt s oughta pr el i m i naryi nj unct i on enj oi ni ng t he admi ni s tr at orfr om deny i ng c o v e ra g e b e c a u se th e p ro c e d u re h a d to b e p e rfo rm e d p ro m p tlyif sh e w a s to b e n e fit f u lly. S e e id . Fi r s t , t he di s t r i ctcour tfound thatthe admi ni s tr at or ’ s act i ons i n deny i ng cover age ha d vi ol at ed the t erm s of the pl an. N otonl ydi d the pl an noti ncl ude an e x c lu sio n fo r in v e stig a tio n a l p ro c e d u re s, b u t th e a d m in istra to r h a d fa iled to advi s e M s . L eonhar dtof “w hatdefi ci enci es herappl i cat i on had t o over come t o be s ucce s s ful on appea l , ” id . at 66 8 (bra ck ets an d interna l qu o tat ion m ark s o m itted), and had i m pr oper l ydeni ed her( 1) the r i ghtt o s ubm i tevi dence s uppor t i ng her pos i t i on t hatt he tr eatm entw as notexper i m ent al and ( 2) the r i ghtt o chal l enge the e v id e n c e o n w h ic h th e a d m in is tr a to r h a d re lie d , se e id . a t 6 6 9 . T h e d is tr ic t c o u rt th e n c o n s id e re d w h a t th e a p p ro p ri a te re m e d ys h o u ld b e . A l t hough i tacknow l edged thati tw oul d or di nar i l yr emand t o the admi ni s tr at orfor reconsi derat i on , i tsai d thatt o d o so in this case “w ou l d b e i nap propri at e” bec ause tim e w a s o f

th e e ss e n c e a n d th e a d m in istra to r’s c o n d u c t “c a ll[e d ] in to q u e stio n its abi l i t yt o pr oces s [M s . ] L eonhar dt ’ s cl ai m i m part i al l y , ” id . at 6 7 0 . T h e re fo re , it-23-

anal y zed w hetherM s . L eonhar dthad s at i s fi ed the s t andar ds forgr ant i ng a pr el i m i naryi nj unct i on. I n addr es s i ng w hethers he w as l i kel yt o s ucce ed on the m er i t s of hercl ai m , t he court“s t ep[pe d] i nt o the s hoes of the Pl an admi ni s tr at or [and made] a de novo det erm i nat i on of w hether[M s . ] L eonhar dt ’ s pr opos ed A B M T t r eatm ent[w as ] exper i m ent al underthe Pl an def i ni t i on. ” Id . T h e c o u rt di d not , as T M J I ’ s ar gum entw oul d s ugges t , s i m pl yappl ythe def i ni t i on of expe r i m entalp u rpo rt ed lyrec o g n ized thro u g h o u t th e m ed ical co m m u n ity . R athe r, i tappl i ed the Pl an’ s defi ni t i on of experi m entalm edicalproced ure as a p roc ed u re t hat“‘ i s ( a) notpr oven i n an obj ect i ve mannert o have ther apeut i c val ue or b e n e fit, (b ) re stric ted to u se a t m e d ica l fa c ili ties c a p a b le o f c a rry in g o u t sc ien tific s tudi es ; or( c) of ques t i onabl e medi cal effect i venes s . ’ ” Id . at670–71 ( quot i ng t he Pl an) . T he courtfound thatt he def i ni t i on had notbeen s at i s fi ed bec aus e the t r eatm enthad ac hi eved pa r t i al orcompl et e r emi s s i on i n 80% of pat i ent s tr eat ed, t he tr eatm entw as notr es t r i ct ed t o m edi cal fac i l i t i es capa bl e of c arry i ng out s c ie n tific s tu d ie s , a n d th e p la in tiff w a s a g o o d c a n d id a te fo r t h e tr e a tm e n t. T he courtr ej ect ed the admi ni s tr at or ’ s pr offe r s i nt ended t o s how thatthe t r e a t me n twa s e x p e r i me n t a l . An a ffi d a v i tf r o m a Dr . Al t ma n s t a t e d th a tABM T w o u ld b e c o n sid e re d e x p e rim e n tal “ u n til th e m e d ica l co m m u n ityis p re se n ted w ith atl eas tt w o r andomi zed, contr ol l ed s tudi es i ndi cat i ng a s i gni fi cants t at i s t i cal and p ra c tica l in c re a se in th e d ise a se -f re e su rv iv a l an d o v e ra ll su rv iv a l ra te fo r p a tien ts under goi ng [A B M T ] as oppos ed t o pat i ent s under goi ng s t andar d ther apy . ” Id .-24-

(i n terna l qu o tat ion m ark s o m itted). T h e o ther su p p o rtfo r th e a d m inistrator’s po si t i on w as a r epo rtfrom a m edical res earch i nfo rm at i on cl eari ng ho use concl udi ng t hatA B M T t r eatm entforM s . L eonhar dt ’ s type of c ance rw as ex p erim en tal . T h e c o u rtd id n o t r ejec t th is ev iden ce o n the g rou n d that the e x p ert and the r epor tus ed a de fi ni t i on of expe r i m entalc o n tra ryto a c c e p ted u sa g e . Its r eas on forr ej ect i ng t he evi dence w as s i m pl ythatthe P lan us ed a di ffe r ent d e fin itio n . S e e id . at671 ( “A l t hough thi s m aybe D r . A l t m an’ s under s t andi ng of the term ‘ex p erim en tal , ’ i t i s n o t th e d efinit ion arti cu lat ed in the P lan.”). L e o n h a rd t t h u s d o e s n o ts u p p o r tTM J I ’ s c o n t e n t i o n th a tth e t e r m ex p e rim e n ta l has a s in g le , u n iv e rs a l d e fin itio n . T he o t her opini on dis cussed i n T M JI ’s op ening bri ef i s B ucciv. B l ue C r os s - B l ue Shi eld of

C onnect i cut, Inc. , 764 F. Supp. 728 ( D . C onn. 1991) . T he defe ndanti ns ur erhad deni ed pl ai nt i ff’ s r eques tforcover age of a combi nat i on of hi gh- dos e che m ot her apy( H D C T ) and A B M T tr eatm entforherbr eas tcanc er . T he bas i s fort he i ns ur er ’ s deni al w as thatpl ai nt i ff’ s pol i cyexcl uded cove r age for s ervi ces “‘ w hi ch ar e expe r i m ent al ori nves t i gat i onal i n natur e; m eani ng any t r eatm ent , pr ocedur e . . . drugs , drug us age . . . notr ecogni zed a s acc ept ed m edi cal pr act i ce, ’ ” id . at729 ( quot i ng pol i cy , el l i ps es i n or i gi nal ) , and that H D C T / A B M T forbr eas tcanc erfel l i nt o thi s cat egory . A l though the courtnot ed th e s u b s ta n tia l r is k s o f th e tr e a tm e n t a n d th e lim ite d d a ta o n its e ffe c tiv e n e s s , s ee id . a t7 3 0

– 3 1 , i to r d e r e d t h e i n s u r e rt o c o v e rth e tr e a t me n t . F o ro u rp u rp o s e s , t wo-25-

component s of the court ’ s anal y s i s ar e s al i ent . Fi r s t , the courtdi d notdefi ne ex p e rim e n ta l o r i nves t igat i onal , butm er el yappl i ed the pol i cy ’ s defi ni t i on of th e s e te rm s . S e e id . a t7 2 9 . S e c o n d , i n c o n s tru i n g th e t e r m acce pt ed m edi cal pr act i ce i n t he pol i cydefi ni t i on, i tappar ent l yfel tcompel l ed t o m i ni m i ze the pl an admi ni s t r at or ’ s di s cr et i on i n det erm i ni ng cover age bys el ect i ng an obj ect i ve m e a n in g . S e e id . at 7 3 2

– 3 3 . It ap p e a re d to b e liev e th a t th e o n lyp o ss ib le defi ni t i on of acce

pt ed m edi calpr act i ce m eet i ng thats t andar d w as that a pr ocedur e maybe found nott o cons t i tut e ac cept ed medi cal pr act i ce onl yw her e ther e i s no r eas onabl ys ubs t ant i al , qual i fi ed, r es pons i bl e, r el evants egmentof the medi cal comm uni tyw hi ch ac cept s the pr ocedur e as pr oper l yw i t hi n the r ange of appr opr i at e medi cal t r eatm ent , undert he ci r cumst ance s of the ca s e, as j udged bythe s t a n d a r d s o f

t h e m e d i c a l c o m m u n i ty. Id . at732. T hus , t he courtw as har dl ypr ovi di ng w hati tthoughtt o be a de fi ni t i on of expe r i m entalo r i nves t igat i onalg e n e ra lly a c c e p te d in th e m e d ic a l c o m m u n ity. T h e th ir d c a s e d is c u s s e d b yT M J I, Whi t e v. C at er pi l lar, Inc. , 765 F. Supp. 1418 ( W . D . M o. 1991) , i s m ent i oned onl yi n the r epl ybr i ef. I t , t oo, pr ovi des T M J I no s uppor t . I n t hatcas e the pl ai nt i ff s oughta pr el i m i naryi nj unct i on aft er heri ns ur erdeni ed herr eques tforcover age of H D C T / A B M T tr eatm ent . T he o p i n i o n p r o v i d e s n o d e fi n i t i o n o f th e t e r m i nves t igat i onal , nordoes i tquot e any p lan p ro v isio n u sin g th e ter m . R a th e r, th e p lan ’s s tan d a rd fo r c o v e ra g e a p p e a rs to h a v e b e e n w h e th e r t h e p ro c e d u re w a s a “ g e n e ra lly a c c e p te d s u rg ic a l o p e ra tio n ,” id . at1420 ( i nt ernal quot at i on m arks om i t t ed) , al though the admi ni s tr at orhad-26-

d en ied c o v era g e o n the g rou n d that the p roc ed u re d id n o t m ee t th at st an d ard beca us e the pr ocedur e w as “i nves t i gat i onal , ” id . ( i nt ernal quot at i on m arks o mi t t e d ) . Th i s c a s e h a r d l ys u g g e s t s th a tth e t e r m i nves t igat i onalh a s a u n iv e rsa lly under s t ood defi ni t i on. L i kew i s e, the ca s es T M J I ci t es i n a footnot e i n i t s openi ng bri ef do no tsupp ortt he co ntent i on that the term s ex p e rim e n ta l and i nves t igat i onal h a v e d e fin ite m e a n in g s in th e m e d ic a l c o m m u n ity. T M J I al s o r el i es on defi ni t i ons of i nves t igat i onaldevi ce and i nves t igat i on i n t he FD A r egul at i ons governi ng “I nves t i gat i onal D evi ce Exem pt i ons . ” 21 C .F .R . p t. 81 2 . U n d e r th e re g u latio n s th e m a k e r o f m e d ica l d e v ice s m a yo b tain a p p ro v a l to c o n d u c t “c lin ica l in v e stig a tio n s o f d e v ice s to d e ter m in e [ th e ir] sa fe ty and effec t i venes s . ” Id . § 812. 2( a) . A n appr oved devi ce maybe s hi pped forthe purpos e of c onduct i ng i nves t i gat i ons w i thoutcompl y i ng w i th the us ual p e rfo rm a n c e a n d m a rk e tin g s ta n d a rd s . Id . S ect i on 81 2. 3 d efi nes i nves t igat i onal devi ce as “a de vi ce . . . t hati s t he obj ectof an i nves t i gat i on. ” Id . § 8 1 2 .3 (g ). Inves t igat i on i s defi ned as “a c l i ni cal i nves t i gat i on orr es ear ch i nvol vi ng one or m or e s ubj ect s t o det erm i ne the s afe tyoreffect i venes s of a de vi ce. ” Id . § 812. 3( h) . T hes e def i ni t i ons m aybe s ugges t i ve of ge ner al us age, buttheydo not p u rp o rt to b e u n iv e rsa llya p p lica b le. F o r re g u latio n s to p ro v id e a d e q u a te g u idan ce theym u st use term s w ith p rec isi o n . O ften , h o w ev er, no co m m o n w o rd has s uch a pr eci s e meani ng, s o t he r egul at i on m us tus e an i m pr eci s e w or d and g iv e it a p re c ise d e fin iti o n . T h is p ro c e ss is a c o m m o n o n e . F o r e x a m p le, th is-27-

ci r cui tus es t he adj ect i ve unpubl is hedt o r efe rt o opi ni ons w i th no pr ece dent i al for ce e ven though s uch opi ni ons ar e w i del y“publ i s hed” i n the us ual m eani ng of t he t erm . A ccor di ngl y , w e vi ew the FD A defi ni t i ons as author i t at i ve onl yi n the s peci al cont extof the r egul at i ons i n w hi ch theyar e us ed. F in a lly , T M JI r e lies o n a d e fin iti o n th a t ito b tain e d th ro u g h A e tn a ’s w e b site fo r h e a lth -c a re in fo rm a tio n , ht tp: //w w w . i nt el i heal th. com . T o the ext ent that TM JI i s s ugges t i ng t hatA etna has adopt ed thatdefi ni t i on fori t s cover age pol i cy bul l et i ns , w e ar e notper s uaded. Fi r s t , al l the w ebs i t e does i s pr ovi de a l i nk t o t he M err i am W ebs t erM edi cal D i ct i onary ; the def i ni t i ons ar e notones pr ovi ded by A etna i t s el f. Second, t he def i ni t i on r efe r ence d i s nota def i ni t i on of expe r i m ental o r i nves t igat i onal . R ather , i ti s t he fol l ow i ng defi ni t i on of i nves t igat i onalnew dr ug : “a drug t hathas notbeen appr oved forgener al us e bythe Food and D rug A dm i ni s t r at i on buti s underi nves t i gat i on i n cl i ni cal tr i al s r egar di ng i t s s afe tyand eff i cac yfi r s tbycl i ni cal i nves t i gat or s and then bypr act i ci ng phy s i ci ans us i ng s ubj ect s w ho have gi ven i nform ed cons entt o par t i ci pat e— abbr evi at i on I ND ; al so cal l ed i nves t igat i onaldr ug . ” A p lt . A p p . at 32 2 . A g ain, th e d efinit ion is an effo rt to ex p lai n the m ea n ing o f a tech n ical t erm u sed b ythe F D A fo r reg u lat o ry p u rp o s e s . See 21 C . F. R . § 312. 3 ( defi ni ng I ND and i nves t igat i onalnew dr ug ). It does notpurpor tt o be, and s houl d notbe r ead a s , a uni ver s al defi ni t i on of the t e r m i nves t igat i onal , o r e v e n a s p ro v id in g th e so le m e a n in g in a m e d ica l co n tex t.-28-

C ont r aryt o T M J I ’ s as s ert i on, s ever al cour t s have e xpr es s l ys t at ed the vi ew t hat the term s expe r i m entaland i nves t igat i onald o n o t h a v e a se ttl e d m e a n in g in th e in s u ra n c e -c o v e ra g e c o n te x t. See Heas l ey v . B elden & B lake Corp. , 2 F. 3d 1 2 4 9 , 1 2 6 0 ( 3 d Ci r . 1 9 9 3 ) ( i n i n s u r a n c e c o n t e x t , t e r m expe r i m entalis “ re sis tan t to p rec ise d efinit ion ”); D ahl

- E i m ers v. Mut . of O m aha Li

f e Ins . C o. , 986 F. 2d 1379, 1383 ( 11t h C i r . 1993) ( “[i ] n t he cont extof a maj orm edi cal i ns ur ance pol i cy , the ter m ‘e x p e rim e n tal,’ . . . is a m b ig u o u s w h e n it i s u n d e fin e d .”); Jo h n s o n v . D is t. 2 Ma rine E n g ’rs B en efi cial A ss’n , 857 F. 2d 514, 516 ( 9th C i r . 1988) ( “I n the cont extof m odern m edi ci ne, t he t erm ‘ exper i m ent al ’ s eems c l ear l yambi guous on its fa c e .”); R eed v . Wal

- Mar tSt or es , Inc. , 197 F. Supp. 2d 883, 888–89 ( E . D . M i ch. 20 02 ) ( t erm s expe r i m entaland i nves t igat i onalu sed in insu ran ce p lan a re a m b ig u o u s); St ei lv. Hum ana Kans as C i t y, Inc. , 1 2 4 F . S u p p . 2 d 6 6 0 , 6 6 5 ( D. K an . 2 0 0 0 ) ( expe r i m entalis a m b ig u o u s in m e d ica l co n tex t); Ni cho ls v. Trustm ark Ins . C o. , 1 F . S up p. 2d 68 9, 69 9 (N . D . O hio 199 7) ( t erm s i nves t igat i onaland expe r i m entalu s e d in in s u ra n c e p la n w e re a m b ig u o u s ). M or e i m por t ant l y , i ti s appar entfr om the ca s es thatthe t erm s ar e not appl i ed, as T M J I w oul d have us bel i eve, onl yt o m edi cal pr ocedur es and devi ces t hatar e under goi ng r es ear ch. I n par t i cul ar , perhaps as the r es ul tof gr ow i ng c o n c e rn th a t n e w , ex p e n siv e tre a tm e n ts a re n o b e tter th a n o ld sta n d b y s, it is appar ent l yunr emar kabl e forpl an def i ni t i ons and i ndepende ntexpert s t o cons i der a tre a tm e n t to b e e x p e rim e n tal o r in v e stig a tio n a l u n til it h a s e sta b lish e d its-29-

sup e rio rity to c u rr e n t tr e a tm e n t. S e e Ma r tin v . B lu e C r o s s & B lu e Sh ie ldo f Va ., Inc. , 1 1 5 F .3 d 1 2 0 1 , 1 2 0 8 (4 th C ir. 1 9 9 7 ) (p lain tiff ’s e x p e rt a g re e d w ith admi ni s t r at ort hatw hethert r eatm entw as exper i m ent al ori nves t i gat i ve depe nded o n w h e th e r it p ro d u c e d b e tter o u tco m e s th a n sta n d a rd a ltern a tiv e s); Hendr i cks v. C ent . R es er ve Li

f e Ins . C o. , 39 F. 3d 507, 513 ( 4th C i r . 1994) ( pr ofes s orof m edi ci ne t es t i fi ed thatbeca us e ca ncertr eatm enthad no demonstr at ed “s ur vi val a d v a n tag e ” o v e r c o n v e n tio n a l th e ra p y , itw a s in v e stig a tio n a l); P i nckney v. B l ue C r os s B l ue Shi eld of

Tenn. , Inc. , No . 3 : 0 5 - 0 0 9 6 2 , 2 0 0 7 WL 1 0 8 8 8 6 , a t* 3 ( M . D. T e n n . Ja n . 9 , 2 0 0 7 ) (p lan d e fin e s s e rv ice s a s e x p e rim e n tal o r in v e stig a tio n a l if “furt herr es ear ch i s nece s s aryi n or dert o defi ne s afe ty , t oxi ci ty , eff i cac y , or e ffe c tiv e n e ss o f

th a t S e rv ice c o m p a re d w ith c o n v e n tio n a l alte rn a tiv e s” ); R eed , 19 7 F . S up p. 2d at88 9 (one o f defend ant’ s expert s defi ned t erm s i nves t igat i onal and ex p e rim e n ta l as “w hethera s uffi ci entnum berof cl i ni cal tr i al s had bee n per form ed t o demonstr at e thatt he ther apyi s ei theri nfer i or , equi val ent , or su p e rio r to sta n d a rd tre a tm e n t”) ; Nich o ls , 1 F . S u p p . 2 d at 69 8 (plainti ff ’s ex p ert sta ted th a t trea tm e n t w a s n o t ex p e rim e n tal o r in v e stig a tio n a l b e c a u se its

“ e ffe c t i v e n e s s h a d p r e v i o u s l yb e e n e s t a b l i s h e d t o b e s u p e r i o rt o a n yo th e rk n o wn th e ra p y ” ) (in ter n a l q u o tatio n m a rk s o m itt e d ); Leonhar dt , 828 F. Supp. at671 (d e fe n d a n t’s e x p e rt sta ted th a t “p ro c e d u re w ill b e c o n sid e re d e x p e rim e n tal u n til t he medi cal comm uni t yi s pr es ent ed w i th atl eas ttw o r andomi zed, contr ol l ed s tudi es i ndi cat i ng a s i gni fi cants t at i s t i cal and pr act i cal i ncr eas e i n the di s eas e- fr ee-30-

s ur vi val and over al l s ur vi val r at e forpat i ent s under goi ng thi s ther apyas oppos ed to p ati en ts un d erg o ing stan d ard thera p y ”) (interna l qu o tat ion m ark s o m itted). I n s hor t , nei thert he author i tyci t ed byT M J I , noranyw e have found, su p p o rts its c o n ten tio n th a t expe r i m entaland i nves t igat i onalh a v e d e fin ite m eani ngs i n t he medi cal comm uni ty . B eca us e ther e i s no uni ver s al l yacc ept ed d e fin iti o n fo r th e se ter m s, w e m u st d isc e rn th e ir m e a n in g s f ro m th e c o n tex t in w hi ch the defendant s us e them. W e begi n w i th the A etna bul l et i n.

b. A et na C P B 28 i. D e sc r ip tio n o f th e B u lletin C P B 2 8 a d d r e s s e s A e t n a ’ s c o v e r a g e d e t e r m i n a t i o n s fo rt r e a t m e n to f T MJ syn d rom e a n d T M J d isord ers. I t con tai n s sev era l st atem en ts ab o u t T M JI’s p ro d u c ts th a t T M JI a lleg e s a re d e fa m a to ry . W e p ro c e e d to p u t th e se sta tem e n ts in cont extt o det erm i ne w hethert heyar e ac t i onabl e. I n ourquot at i ons fr om C PB 28, w e hav e i t al i ci zed the al l eged l ydefa m at oryst at em ents . T he bul l et i n begi ns w i t h an “I m port antN ot e” s t at i ng the s our ces on w hi ch A e tn a h a s re lied in re a c h in g th e c o n c lu sio n s th e b u lletin se ts fo rth . T h e n o te re a d s, in p a rt: T hi s C l i ni cal Pol i cyB ul l et i n expr es s es A etna’ s det erm i nat i on of w hethercert ai n s ervi ces ors uppl i es ar e medi cal l ynece s s ary . A etna h a s re a c h e d th e se c o n c lu sio n s b a se d u p o n a re v iew o f c u rre n tly a v a ilab le c lin ica l in fo rm a tio n (in c lu d in g c lin ica l o u tco m e stu d ies in t he pee r - r evi ew ed publ i s hed medi cal l i t er atur e, r egul at or ys t atus of th e tec h n o lo g y , ev id e n c e -b a se d g u id e lin e s o f p u b lic h e a lth a n d h e a lth r es ear ch age nci es , evi dence - bas ed gui del i nes and pos i t i ons of l eadi ng-31-

nat i onal heal t h pr ofes s i onal or gani zat i ons , vi ew s of phy s i ci ans p rac ti cing in relev an t cl inical area s, an d o ther relev an t fac tors). A pl t . A pp. at177. T he bul l et i n t hen ca ut i ons r eade r s thata conc l us i on i n C PB 28 t hatA etna cons i der s a pr ocedur e t o be medi cal l ynece s s arydoes notm ean thatt he pr ocedur e i s cover ed fora s peci fi c pol i cyhol der

— r ather , i ndi vi dual cover age det erm i nat i ons can be m ade onl yw i th r efe r ence t o the i ndi vi dual ’ s benef i tpl an, as t he i ndi vi dual benef i tpl an contr ol s overanydet erm i nat i on m ade i n the b u lle tin . A lth o u g h n o t sta ted e x p re ss ly , the im p lica tio n o f th is s tate m e n t is th a t a t r eatm entdet erm i ned i n t he bul l et i n nott o be medi cal l ynece s s aryw i l l neverbe co v ere d , b u t th e sp ec ifi c c ir cu m stan ce s d eterm ine w h ethe r th ere is co v era g e fo r a tr e a tm e n t th a t c a n b e m e d ic a lly n e c e s s a ry. T h e n e x t se c tio n , en tit led “ P o licy ,” s e ts fo rth A e tn a ’s m e d ica l-n e c e ss ity det erm i nat i ons . Fol l ow i ng t hats ect i on i s t he “Backgr ound” s ect i on, w hi ch e x p lain s th e b a se s fo r th o se d e ter m in a tio n s. W e n o w e x p lo re th e se se c tio n s in so m e d e tail. T h e P o li cysec ti o n li sts sev era l no n su rgica l trea tm en ts th at A etna co n side rs m e d ica llyn e c e ss a ry . F o r e x a m p le, th e u se o f in tra -o ra l d e v ice s s u c h a s b ite guar ds i s cons i der ed medi cal l ynece s s aryw hen the pat i enthas document ed e v i d e n c e o f

d i ffi c u l t y c h e w i n g b e c a u s e o f T M J p a i n o rl i m i t e d j o i n tf u n c t i o n a l i t y. P h y sic a l th e ra p yis c o n sid e re d m e d ica llyn e c e ss a ryw ith o u t th e n e e d to demonstr at e pai n orl ack of funct i onal i ty , butdocument at i on of nee d i s r equi r ed-32-

b e fo re c o v e ra g e w ill b e p ro v id e d fo r m o re th a n a s ix -w e e k c o u rs e o f 1 4 s e s s io n s . V ar i ous cat egor i es of drugs ar e al s o cons i der ed medi cal l ynece s s aryt o tr eat di ffe r entt ypes of TM J - r el at ed pai n, as ar e r el axat i on and beha vi or - m odi fi cat i on t her api es . T r eatm enti n s peci al i zed pa i n cent er s , how ever , i s cons i der ed m edi cal l ynece s s aryonl yfor“thos e fe w i ndi vi dual s w ho have be en unr es pons i ve t o l es s compre hens i ve i nt ervent i ons . ” Id . at 17 9 . O ther m ed icall yn ec essa ry p a in -m a n a g e m e n t tec h n iq u e s in c lu d e a c u p u n c tu re , inje c tin g p a in m e d ica tio n in to t he j oi nt , and dryneedl i ng ( s t i cki ng a nee dl e i nt o T M J - r el at ed muscl es w i thout injecti n g an ysu b stan ce ). S u rg ica l m a n a g e m e n t o p tio n s a re m u c h m o re re stric ted . T h e b u lletin r emi nds r eade r s t hatanyr eques tfors ur gi cal i nt ervent i on m us tbe r evi ew ed byt he O r al and M axi l l ofac i al U ni tand w i l l be gr ant ed onl yw hen the pat i enthas been u n re s p o n s iv e to n o n s u rg ic a l tr e a tm e n ts a n d s u rg e ry is th e o n ly re m a in in g o p tio n . A c c e p tab le s u rg ica l in ter v e n tio n s in c lu d e a rth ro c e n tes is (s u rg ica llyflu sh in g flu id f ro m th e T M J jo in t an d stre tch in g it), a rth ro sc o p y(u sin g a n in stru m e n t to d i a g n o s e a n d r e p a i rt h e j o i n t ) , a n d j o i n t - r e c o n s tru c t i o n s u r g e ry. T h e b u lle tin d e s c ri b e s T M J im p la n ts a s th e m o s t in v a s iv e s u rg ic a l o p tio n . R egardi ng such surgery , C P B 28 st at es: A etna co n side rs th e T M J C o n ce p ts pro sthe sis m ed icall yn ec essa ry w h e n u s e d a s a s a l v a g e d e v i c e fo rt r e a t m e n to f e n d - s t a g e T MJ d is e a s e , w h e n n o o th e r v ia b le th e ra p e u tic a lte rn a tiv e s a re a v a ila b le . The us e of

the C hr is t ens en TM

J Foss a- E m i nence P r os thes is Sys t em ( par t i alTM

J pr os thes is

) and the C hr is t ens en TM J Foss a--33-

E m i nence/C ondylarP r os thes is Sys t em (C hr is t ens en t otalj oi nt p ro sth e sis

) ar e c o n sid e re dex

p e rim e n ta l a n din v e stig a tio n a l. Id . ( emphasi s added a nd i nt ernal quot at i on m arks om i t t ed) . I n otherw or ds , us e of the T M J C o n ce p ts de v ice is stri ctl ycircu m scribe d , w h ere as T M JI’s de v ices a re notcons i der ed medi cal l ynece s s aryunderanyci r cumst ance s beca us e A etna has d e te rm in e d th a t th e ya re e x p e ri m e n ta l a n d in v e s tig a tio n a l. T M J I ’ s devi ces ar e notuni que i n thi s r egar d. T he l i s tof tr eatm ent s that A etna w i l l notcoverbeca us e i thas det erm i ned them t o be expe r i m ent al and i nves t i gat i onal i ncl udes 10 di agnos t i c pr ocedur es and 16 nons ur gi cal m anage m ent t r eatm ent s . Fours ur gi cal t r eatm ent s ar e cons i der ed “ expe r i m entaland i nvest iga t i on al f

or diagno sis andtreatm ent of T M J dis orders ”:

. . . • C h ris ten se n to ta l T M J p ro sth e sis • M odi fi ed condy l ot om y[( s ur gi cal di vi s i on of the condy l e) ] ori ntr aor al vert i cal r amus os t eot om y[( cutt i ng of the r amus) ] . . . w hen s ubm i t t ed w i th a di agnos i s of i nt ernal der angementof the t emporomandi bul arj oi nt • T re a tm e n t o f

a lv e o la r c a v ita tio n a l o s te o p a th o s is . . . • P art i al tempo rom an dibul ar j ointprostheses. Id . a t 1 7 9

– 1 8 0 (e m p h a s is a d d e d ). T he “Backgr ound” s ect i on cont ai ns a compr ehens i ve expl anat i on of A e tn a ’s P o lic yd e c is io n s . T he thrus tof the di s cus s i on i s t hatcaut i on s houl d be used in treat i ng T M J dy sfunc t i on , and surgeryof an ykind i s an op t i on of las t re so rt. T h e b u lletin e x p lain s th a t th e c a u se s o f T M J d y sf

u n c tio n a re g e n e ra lly un kn ow n, bu tt hat i ti s tho ug ht t o b e t he resul tof tr aum a t o the j oint . T he cau se-34-

of s om e TM J t r auma i s obvi ous , s uch as extr eme for ce appl i ed t o the j oi nt( as m ayoccuri n an ac ci dent ) , w her eas othercaus es , s uch as s tr es s , anxi ety , and s l eep di s or der s , cr eat e the damage overt i m e. A ccor di ng t o the bul l et i n, beca us e of “ a pauci t yof evi dence - bas ed out come r es ear ch and l ack of cons ens us on the a p p ro p ri a te m a n a g e m e n t o f [ T M J d y s f

u n c tio n ],” id . at180–81, ther e i s w i de var i at i on i n how cl i ni ci ans t r eatT M J dy s funct i on. I ts t at es thatther e i s a l ack of “[s ] ci ent i fi cal l yval i d cl i ni cal t r i al s ” form os tT M J ther api es and ther e i s no

“ o bj e c t i v e , g e n e r a l l ya c c e p t e d ” d i a g n o s t i c a p p r o a c h fo ri d e n t i f y i n g TM J d y s f u n c tio n . Id . at181. A s gener al s uppor tfori t s l i m i t at i ons on cover age, the bul l et i n quot es t he N at i onal I ns t i tut es of H eal th’ s ( N I H ) r ecomm endat i on that T M J t her api es be “CO N SE R V A T I V E & R E V E R SI B L E . ” Id . T he B ackgr ound s ect i on t hen pr ocee ds t o di s cus s s peci fi c s ur gi cal t r eatm ent s . A num berof s ur gi cal t echni ques ar e cons i der ed expe r i m ent al and i nves t i gat i onal beca us e of a l ack of evi dence s uppor t i ng thei reff i cac y . For e x a m p le, it sta tes : A etna cons i der s m odi fi ed condy l ot om yt o be expe r i m ent al and i nves t i gat i onal . T her e ar e no contr ol l ed s tudi es of m odi fi ed c o n d y lo to m y . C o n tro lled stu d ies a re im p o rta n t b e c a u se , ac c o rd in g to an N IH C o n sen su s C o n fe ren ce , u p to 9 0 p erc en t of T M J p ati en ts[’] s ym pt om s r es ol ve s pont aneous l y . I n addi t i on, the l i t er atur e on m odi fi ed condy l ot om ycomes a l m os texcl us i vel yfr om a s i ngl e gr oup, r ai s i ng ques t i ons aboutt he gene r al i zabi l i tyof fi ndi ngs . Fur therm or e, di s c di s pl ace m enti s extr emel ycomm on, and ther e i s no di r ect evidence thatdis c dis placem ent i s a cause of T M J sym ptom s. Id .-35-

T h e d isc u ss io n o f

th e p a rtial- a n d to tal-jo in t d e v ice s is len g th y : A par t i al T M J pr os t hes i s cons i s t s of a meni s cec t om yand pl ace m ent of a met al l i c gl enoi d fos s a met al pr os thes i s ( C hr i s t ens en fos s aemi nence pr os t hes i s , T M J , [s i c] I nc. , G ol den, C O ) i n pl ace of the m enis cus, such thata natur al con dy l e art i culat es w i th a m et al fossa p ro s th e s is . Ther e is i nadequat e ev i dence f r om publ is hed cl i ni cal out com e s t udi es of

the s af et y and ef f ect i vene s s of

par t i alj oi nt p r o s th e s e s in th e tr e a tm e n t o f [te mp o r o m a n d ib u la rd is o r d e rs ] . T he U . S. Food and D rug A dm i ni s tr at i on D ent al Pr oduct s A dvi s or yPanel r evi ew ed cl i ni cal s tudi es of the C hr i s t ens en fos s a pr os thes i s , and advi s ed the FD A t o appr ove the t ot al pr os thes i s , butt o notappr ove t he part i al j oi ntpr os t hes i s beca us e of a la c ko f clin ica l da ta o n its saf et y an d eff

ect i veness . The i nf

or m at i on s ubm i t t ed to the FD A on the s af et y and ef f ect i vene s s of

the par t i alTM

J pr os thes is is l i m i t ed a n dh a s n o t b e e n p u b lis h e din a p e e r -r e v ie w e djo u r n a l. I n an edi t or i al , L as ki n ( 2001) , form eredi t or - i n- chi ef of the J ournal of O r al and M axi l l ofac i al Sur gery , the off i ci al j ournal of the A m er i can A s s oci at i on of O r al and M axi l l ofac i al Sur geons , comm ent ed on the dat a on the part i al T M J pr os thes i s pr es ent ed t o the FD A D ent al P ro d u c ts A d v iso ryP a n e l: A tt hatm eet i ng [of the FD A D ent al Pr oduct s A dvi s oryPanel wh e r e t h e p a r t i a l T M J p r o s th e s i s wa s c o n s i d e r e d ] th e F DA sta ff p re se n tatio n e x p re ss e d c o n c e rn re g a rd in g th e lac k o f d a ta on t he effec tof the natur al condy l e art i cul at i ng agai ns ta met al fos s a, t he l i m i t ed numberof pat i ent s w i th l ong t erm fol l ow - up, and the br oad di agnos i s of i nt ernal der angementas an i ndi cat i on fori t s us e. T he pane l expr es s ed s i m i l arconce rns a b o u t th e se iss u e s, a s w e ll as th e fa c t th a t th e re g istryd a ta pr ovi ded i n s uppor tof the pr oductdi d noti ncl ude al l the pat i ent s t r eat ed and the s ampl e s i ze w as i ns uffi ci entforeac h of the i ndi vi dual i ndi cat i ons . T heyr ecomm ended c l ar i fi cat i on of the pat i enti ncl us i on cr i t er i a i n the cl i ni cal s tudy , eval uat i on o f fa ilu re s a n d a d d iti o n a l p a tien t fo llo w -u p , m o re c lea rly defi ned i ndi cat i ons forus e of the devi ce, and thata pow er anal y s i s of the cl i ni cal dat a be done t o pl ace the PM A i n an appr ovabl e form . H ow ever , des pi t e thes e cr i t i ci s m s , and the panel ’ s opi ni on t hatadequa t e s afe tyand effec t i venes s dat a for t he gi ven s ur gi cal i ndi cat i ons w er e l acki ng, the devi ce w as a p p ro v e d b yth e F D A fo r d is tr ib u tio n in F e b ru a ry 2 0 0 1 .-36- L a sk in (2 0 0 1 ) c o n c lu d e d th a t “th e re a re in su fficie n t d a ta” to ans w erques t i ons aboutt he s afe tyand effec t i venes s of the part i al T M J pr os t hes i s . “Forexampl e, how r el i abl e ar e cl i ni cal dat a bas ed on a r egi s t r yt hatdi d noti ncl ude al l pat i ent s tr eat ed w i th the devi ce, i n w hi ch ther e w as a verys m al l num berof t ot al pat i ent s w i th s er i al dat a and e ven s m al l ernum ber s i n eac h di agnos t i c s ubcat egory , and w her e i n 1 gr oup of 97 pat i ent s w i th a di agnos i s of i nt ernal derang em ent and/ or i nflam m at oryarthri t i s, on l y30 % (12 subject s) h a d a fo llo w -u p o f

3 o r m o re y e a rs a n d 7 0 % w e re e ith e r lo st to fol l ow - up, w i t hdr aw n, orpot ent i al l yl os tt o fol l ow - up. H ow can one ma k e a n i n fo r me d d e c i s i o n wi th s u c h i n fo r ma t i o n ?” A e tn a c o n sid e rs th e C h ris ten se n to ta l jo in t p ro sth e sis expe r i m entaland i nves t igat i onalbecaus e i thas notbeen s how n t o be a s e ffe c tiv e a s th e T

M J C o n c e p ts to ta l jo in t p r o s th e s is . An eval uat i on s tudyhas r eport ed s i gni fi cant l ybett erpos t - s ur gi cal out comes w i t h t he TM J C oncept s t ot al j oi ntpr os thes i s than the C hr i s t ens en t ot al j oi ntpr os thes i s . W ol for d, etal . ( 2003) r eport ed the re su lts o f

a stu d yc o m p a rin g th e C h riste n se n to tal jo in t p ro sth e sis (T M J, In c ., G o ld e n , C O ) w ith th e T M J C o n c e p ts to tal jo in t p ro sth e sis (T M J C o n ce p ts I n c., C am aril lo, C A ) i n 4 5 p ati en ts, 2 3 o f w h o m w ere t r eat ed w i t h t he C hr i s t ens en pr os thes i s , and 22 of w hom w er e tr eat ed w ith th e T M J C o n c e p ts P ro sth e sis . T h e in v e stig a to rs r e p o rte d th a t, al t hough s ubj ect s t r eat ed w i th ei thert ot al j oi ntpr os thes i s s how ed g o o d s k e l e t a l a n d o c c l u s a l s t a b i l i ty , th e s u bj e c t s tr e a t e d wi th th e TM J C oncept s Pr os t hes i s had s t at i s t i cal l ys i gni fi canti m pr oved out comes c o m p a re d to su bjec ts tre a ted w ith th e C h riste n se n p ro sth e sis w ith res pect t o [v ari ou s i nd i cat ors] . T he invest i gator s concluded “[a]s a res ultof o ur stud y , i tapp ears that [T M J C on cepts P rosthesi s] pr ovi des a more bi ol ogi cal l yacc ept ed and f unct i onal pr os thes i s than t he [Chri s t ens en pr os t hes i s ] forthe compl ex TM J pat i ent . ” Id . at181–82 ( emphasi s added) . Fi nal l y , the bul l et i n concl udes w i th a l i s tof 57 refer ences o n w hich A et na b ased i t s T M J treatm ent- cov erage determ i nati on s. ii . L iab il it y A etna is subject t o li ab il ityo n lyfo r th o se statem en ts i n C P B 2 8 that are fal s e s t at ement s of fa ctorexpr es s i ons of opi ni on thati m pl yt he exi s t ence of-37-

u n d is c lo s e d d e fa m a to ry fa c ts . See R es t at ement§§ 565, 566. T M J I chal l enges as d e fa m a to ryth re e sta tem e n ts in C P B 2 8 re g a rd in g T M JI’ s to tal-jo in t p ro sth e sis a n d fiv e re g a rd in g its p a rt ia l-jo in t p ro s th e s is : ( 1 ) “ [ t] h e u s e o f th e . . . C hr i s t ens en TM J Foss a- E m i nence / C ondy l arPr os thes i s Sy s t em (Chri s t ens en t ot al j oi ntpr os t hes i s ) [i s ] cons i der ed expe r i m ent al and i nves t i gat i onal , ” A pl t . A pp. at 179; ( 2) “A etna cons i der s t he [Chri s t ens en t ot al T M J pr os thes i s ] exper i m ent al and i nves t i gat i onal fordi agnos i s and tr eatm entof TM J di s or der s , ” id . ; ( 3) “A etna cons i der s t he C hr i s t ens en t ot al j oi ntpr os thes i s exper i m ent al and i nves t i gat i onal beca us e i thas notbeen s how n t o be as effect i ve as the TM J C oncept s t ot al j oi nt pr os t hes i s , ” i d. at182; ( 4) “[t ] he us e of the C hr i s t ens en TM J Foss a- E m i nence Pr os t hes i s Sy s t em (pa r t i al T M J Pr os thes i s ) . . . [i s ] cons i der ed expe r i m ent al and i nves t i gat i onal , ” id . at17 9; ( 5) “A et na co nsi ders [part i al T M J prostheses] e x p e ri m e n ta l a n d in v e s tig a tio n a l fo r d ia g n o s is a n d tr e a tm e n t o f T M J d is o rd e rs ,” id . ; ( 6) “[t ] her e i s i nadequa t e evi dence fr om publ i s hed cl i ni cal out come studi es of t he s afe t yand effec t i venes s of part i al j oi ntpr os thes es i n the tr eatm entof [t emporomandi bul ardi s or der s ] , ” i d. at181; ( 7) ther e i s “a l ack of cl i ni cal dat a on [the part i al -j oi ntpr os t hes i s ’ s ] s afe tyand effec t i venes s , ” id . ; and ( 8) “[t ] he i nform at i on s ubm i tt ed t o t he FD A on the s afe tyand effec t i venes s of the part i al T M J p ro s th e s is is lim ite d a n d h a s n o t b e e n p u b lis h e d in a p e e r- re v ie w e d jo u rn a l,” id . S tat em en ts 1, 2, an d 3 are fo rm u lat ion s o f A etna ’s de term ination that T M JI’s t ot al -j oi ntdevi ce i s exper i m ent al and i nves t i gat i onal , w hi l e s t at ement s 4 and 5-38-

expr es s i t s det erm i nat i on t hatt he part i al -j oi ntdevi ce i s al s o exper i m ent al and i nves t i gat i onal . St at ement s 6, 7, and 8 pr ovi de s uppor tfori t s det erm i nat i on r egar di ng t he part i al -j oi ntdevi ce. C P B 28 no w here provides an exp l i ci tdefini t i on of the t erm s expe r i m ental and i nves t igat i onal . T hus , i t s expl anat i on i n the B ackgr ound s ect i on of w hyi thas det erm i ned thatcert ai n t r eatm ent s ar e ex p e rim e n ta l and i nves t igat i onala m o u n ts t o i t s defi ni t i on of thos e t erm s as theyar e us ed i n the bul l et i n. Forexampl e, the b u lletin sta tes th a t “A e tn a c o n sid e rs th e C h riste n se n to tal jo in t p ro sth e sis exper i m ent al and i nves t i gat i onal beca us e i thas notbeen s how n t o be as effect i ve as t he TM J C oncept s t ot al j oi ntpr os thes i s . ” Id . at182. I n otherw or ds , w hen A et na say s that the tot al j ointprosthesi s i s ex p e rim e n ta l and i nves t igat i onal , itis say i ng t hat the tot al -j ointprosthesi s “has no tbeen show n to be as effecti ve as” t he TM J C oncept s pr os t hes i s . T he s t at ementthatthe pr os thes i s i s “expe r i m ent al and i nves t i gat i onal ” ther efor e i s defa m at oryonl yi f i ti s defa m at oryt o s aythat th e p ro sth e sis “ h a s n o t b e e n sh o w n to b e a s e ffe c tiv e a s” th e T M J C o n c e p ts pr os t hes i s . I n ourvi ew , t hi s l att ers t at ementi s notdefa m at or ybeca us e i ti s not p rov ab lyfa lse. D iffe ren t peo p le w il l m ak e d iffe ren t j u d g m en ts on w h ethe r a p ro d u c t “h a s b e e n sh o w n to b e a s e ffe c tiv e a s” a n o th e r. S o m e m a yre q u ire o n ly one s tudy ; ot her s m ayr equi r e the gol d s t andar d of a doubl e- bl i nd s tudy , oreven m ult i ple s uch stud i es.-39-

M o re o v e r, T M JI d o e s n o t ev e n c o n ten d th a t itw a s fa lse to sa yth a t it s p ro d u c t h a s n o t b e e n s h o w n to b e a s e ffe c tiv e a s th e T M J C o n c e p ts p ro d u c t. I ns t ead, T M J I compl ai ns t hatcompar i ng i t s pr os thes i s t o T M J C oncept s ’ cus t om p ro sth e sis is “ lik e sa y in g a M e rc e d e s-B e n z is n o t as g o o d a s a R o lls R o y c e ; o n e is as s embl y - l i ne pr oduced a nd t he othercus t om bui l tbutboth ar e s uper i or m a c h in e s.” A p lt. B r. at 2 9 . B u t w h e th e r th e c o m p a riso n is a n a p p ro p ria te o n e is b e sid e th e p o in t. Itis n o t d e fa m a to ryto sa yth a t a M e rc e d e s rid e s le ss sm o o th ly t han a Rol l s R oy ce j us tbeca us e a be t t ercompar i s on w oul d be betw een a M erc ed es a n d a Ja g u ar. T h u s, stat em en ts 1, 2, an d 3 , ex p ressing A etna ’s det erm i nat i on t hatT M J I ’ s t ot al -j oi ntdevi ce i s exper i m ent al and i nves t i gat i onal b ec au se ith as n o t bee n sh o w n to b e a s effe cti v e a s the T M J C o n ce p ts pro d u ct, are notact i onabl e bec aus e theyar e notpr ovabl yfal s e. S im ilarly , n e ith e r sta tem e n ts 4 a n d 5 , tha t A e tn a c o n sid e rs T M JI’ s p a rtialj ointprosthesi s expe r i m entaland i nves t igat i onal , n o r sta tem e n t 6 , tha t th e re is in a d e q u a te e v id e n c e o f th e d e v ic e ’s s a fe ty an d e ffe c tiv e n e s s , a re a c tio n a b le . St at ement6 amount s t o A etna’ s expl anat i on of w hyi thas r eac hed the det erm i nat i on i tm akes i n s t at ement s 4 and 5: “Ther e i s i nadequa t e evi dence fr om publ i s hed cl i ni cal out come studi es of the s afe tyand effec t i venes s of part i al j oi nt pr os t hes es i n t he tr eatm entof [TM J di s or der s ] . ” A pl t . A pp. at181. T o s aythat t he p art i al -j ointprosthesi s i s ex p e rim e n ta l and i nves t igat i onali s thus t o s aythat th e re is “ in a d e q u a te e v id e n c e ” s u p p o rt in g th e d e v ic e ’s s a fe ty an d e ffe c tiv e n e s s .-40-

Ag a i n , s u c h a s t a t e me n ti s n o td e fa ma t o ryb e c a u s e i ti s n o tp r o v a b l yfa l s e . As not ed above , w hetherone cons i der s evi dence t o be ade quat e i s a mat t erof in d iv id u a l ta s te . See Inf o. Sys . & Netw orks C or p. v . C ity o

f A tla n ta , 281 F. 3d 1 2 2 0 , 1 2 2 8 (1 1 th C ir. 2 0 0 2 ) (s tate m e n t th a t co m p a n yw a s fire d b e c a u se its per form ance w as i nadequa t e w as one of opi ni on notcapa bl e of be i ng pr oved fa ls e ). St at ement7, t hatther e i s “a l ack of cl i ni cal dat a on [the part i al -j oi nt d e v i c e ’ s ] s a fe t ya n d e ffe c t i v e n e s s , ” Ap l t . Ap p . a t1 8 1 , i s a p a r a p h r a s e o f th e F DA D ent al Pr oduct s A dvi s or yPanel ’ s r ecomm endat i on thatthe FD A notappr ove the p a rtial-jo in t p ro sth e sis . T o th e e x ten t th a t A e tn a m a yb e a rg u in g o n a p p e a l th a t it cannotbe l i abl e fort hi s s t at ementbeca us e i tw as m er el yr epea t i ng a det erm i nat i on m ade byot her s , i ti s i ncorr ect . C om m entb t o R es t at ement§ 578 m akes cl eart hatone w ho r epubl i s hes a defamat orys t at ementm aybe l i abl e t o t he sam e e x tent as th e o ri g inal sp ea k er b ec au se e ac h p u b li ca ti o n ca u ses a n ew h arm t o t he pl ai nt i ff’ s r eput at i on. B uta r epubl i s heri s l i abl e onl yi f the or i gi nal s t at ementi s defa m at or y , and i n t hi s i ns t ance the s t at ementi s not . T o s aythat t her e i s a “l ack of

cl i ni cal dat a” i n thi s cont exti s notpr ovabl yfal s e. L i ke the s t at ementt hatt her e i s i nadequa t e evi dence s uppor t i ng the devi ce’ s s afe tyand e ffe c tiv e n e s s , w h e th e r t h e re is a “ la c k o f c lin ic a l d a ta ” is a s ta te m e n t o f o p in io n . R eas onabl e peopl e maydi ffe ron how m uch dat a fr om cl i ni cal s tudi es they re q u ire b e fo re th e ya re sa tisfied th a t su c h d a ta a re n o lo n g e r w a n tin g o r d e ficie n t.-41-

W e re c o g n ize th a t in so m e c irc u m sta n c e s to sa yth a t th e re is a lac k o f d a ta i s t o i m pl yt hatanys uch dat a ar e abs ent , and thatw hethers uch dat a w er e i n fac t abs entcoul d t hen be pr oved true orfal s e. B utthati m pl i cat i on coul d notfol l ow fr om t he cont exti n w hi ch A etna’ s s t at ementappea r s . T he s ent ence cont ai ni ng t he al l egedl ydefa m at or ys t at emental s o s t at es thatthe FD A panel “r evi ew ed c lin ic a l s tu d ie s ” o f

th e p ro s th e s is . Id . A fe w li n es a fter the sen tenc e a re (1 ) a quot at i on fr om L as ki n expl ai ni ng the pane l ’ s r ecomm endat i on “thata pow er analy si s of

the cl i ni caldata be done, ” id . (em p h asis ad d ed ), an d then (2) L ask in’s concl us i on t hatt he dat a on the part i al pr os thes i s w er e i ns uffi ci entbeca us e “how r el i abl e ar e cl i ni cal dat a bas ed on a r egi s trythatdi d noti ncl ude al l pat i ent s . . . ?” Id. at182 ( i nt ernal quot at i on m arks om i t t ed) . I n thi s cont extno r eas onabl e r eade r cou l d infer that “l ack o f cl i nical data” m eans abs ence as oppos ed t o i ns uf f i ci ency . B eca us e A etna’ s s t at ementt hatt her e i s a l ack of cl i ni cal dat a ca nnotbe pr oved fal s e, i ti s notact i onabl e. T h e last st atem en t i n C P B 2 8 o f w h ich T M JI co m p lai n s is A etna ’s s t at ementt hat“[t ] he i nform at i on s ubm i t t ed t o the FD A on the s afe tyand effect i venes s of the part i al T M J pr os thes i s i s l i m i t ed and ha s notbeen publ i s hed i n a pee r - r evi ew ed j our nal . ” Id . at181. T he fi r s tpartof thi s s ent ence , thatthe “i nform at i on s ubm i t t ed t o t he FD A on the s afe tyand effec t i venes s of the part i al T M J pr os t hes i s i s l i m i t ed, ” i s notdefa m at or ybeca us e i ti s notcapa bl e of be i ng pr oved fa l s e. T o s ayt hati nform at i on i s l i m i t ed i s s i m pl yanotherw ayof s ay i ng-42-

t hati nform at i on i s “i nadequa t e” or“l ack[ i ng] . ” B utthe s t at ementthatthe “i nform at i on s ubm i t t ed t o t he FD A on the s afe tyand effec t i venes s of the part i al T M J pr os t hes i s . . . has notbeen publ i s hed i n a pee r - r evi ew ed j ournal ” is s us cept i bl e of be i ng pr oved fa l s e. T o m ake thatdet erm i nat i on, one w oul d need onl yt o l ook att he i nform at i on s ubm i t t ed t o the FD A and i nves t i gat e w hethert hat sam e i nfo rm at i on had been pu bli shed in a peer- revi ew ed journal . N evertheles s, T M JI h a s n o c laim b a se d o n th is s tate m e n t b e c a u se it d o e s n o t alle g e th a t th is stat em en t i s fa lse. W h at i t do es a ll eg e is th at “[ t] h e b u ll eti n s state th at th ere are no p u b lish e d p e e r-re v iew e d stu d ies ” o f its p ro sth e se s, A p lt. B r. at 2 8 (e m p h a sis added) , and thatt hi s s t at ementi s i nacc ur at e bec aus e s uch s tudi es do exi s t . B ut t hi s al l egat i on di s t or t s t he r ecor d. C PB 28 does nots t at e thatther e ar e no p ee rre v iew e d stu d ies o f

th e p ro sth e se s; it sta tes o n lyth a t “ [t ] he i nf or m at i on s ubm i t t ed t o th e FDA on . . . s afe t yand effec t i venes s , ” id . ( emphasi s added) , w as not publ i s hed i n a pee r - r evi ew ed j ournal . T M J I has notchal l enged the ac cur acyof th a t s ta te m e n t. T M JI m a yb e a rg u in g th a t A e tn a ’s s tate m e n t, ev e n if lit e ra llytru e , is nonethel es s defa m at or ybeca us e i tom i t s a r el evantm at er i al fac t( namel y , that p e e r r e v ie w s o f

its d e v ic e s e x is t) , a n d th e re fo re c a rr ie s a d e fa m a to ry im p lic a tio n . T he R es t at ementdoes notaddr es s thi s s i tuat i on, buta l eadi ng tr eat i s e not es that liab ili tyc a n b e fo u n d if th e p u b lica tio n g e ts th e fa c ts rig h t b u t th e “ g ist” w ro n g :-43-

[ I ] f t h e d e fe n d a n tj u x t a p o s e s a s e r i e s o f fa c t s s o a s t o i m p l y a d efam atoryco n n ec ti o n b etw ee n them , o r crea tes a d efam atory i m pl i cat i on byom i t t i ng fac t s , he maybe hel d r es pons i bl e forthe defa m at or yi m pl i cat i on, unl es s i tqual i fi es as an opi ni on, even though t he part i cul arfac t s ar e corr ect . O n the otherhand, the defendantw ho stat es a ll the p arti cu lar fac ts co rrectl y , d o es n o t om itfa cts n ec essa ry to p u t th em in co n text, an d d o es n o t j u x tapo se th e fac ts i n a farfet ched w ayt o cr eat e l i bel ous i m pl i cat i ons , i s notl i abl e. W . Page K eet on etal . , Pr os s erand K eet on on t he Law of Tort s § 116A , Supp. at 1 1 7 (W . P a g e K e e to n e d ., 5 th e d . 1 9 8 4 , S u p p . 1 9 8 8 ) (fo o tn o tes o m itt e d ); s ee Me mp h is P u b l’gC o . v. Nich o ls , 569 S. W . 2d 412 ( T enn. 1978) ( new s art i cl e that p lai n ti ff w as sh o t w h en assa il an t fo u n d h er h u sb an d w ith p lai n ti ff at plaintiff’s hous e i m pr oper l yi m pl i ed adul t er ous r el at i ons hi p beca us e pl ai nt i ff’ s hus band and o ther g u ests w ere also p rese n t) . W e b eli ev e tha t C o lorad o w o u ld ti g h tl yca b in li ab il ityin this co n text. In L iv in gWill C e n te r, 879 P. 2d 6, t he C ol or ado Supr eme C our ts t at ed thatthe om i s s i on of w hatt he pl ai nt i ff c ons i der ed t o be r el evanti nform at i on w oul d not convertan otherw i s e nonac t i onabl e s t at ementi nt o a defamat oryone. T he d e fe n d a n t h a d b ro a d c a st a re p o rt sta tin g th a t th e p lain tiff ’s p ro d u c t w a s n o t w o rth i t s pur chas e pr i ce. T he pl ai nt i ff a r gued, among ot herthi ngs , thatbeca us e the b ro a d c a st in w h ich th e sta tem e n t ap p e a re d h a d fa iled to d e sc rib e its p ro d u c t fu lly , t he s t at ementw as defa m at or y . T he courtdi s agr eed, s t at i ng, “[W ] e . . . fai l t o s ee how pr ovi di ng l i m i t ed, t hough acc ur at e, i nform at i on aboutthe [pr oduct ] can be r egar ded as a defamat i on of [pl ai nt i ff] underthe fa ct s of thi s cas e. ” Id . a t 1 5 .-44-

I n t hi s cas e the cont extof the al l egedl yl i bel ous s t at ementw as a di s cus s i on expl ai ni ng w hyt he FD A advi s or ycomm i t t ee r ecomm ended a gai ns tappr oval of t he TM J I par t i al -j oi ntpr os t hes i s . T he omi t t ed fa ct s w oul d notaffectthe gi s tof t hi s di s cus s i on. T he bul l et i n har dl y“j uxt apos e[d] the fa ct s i n a fa r - fet ched w ay to c re a te lib e lo u s im p lic a tio n s .” K e e to n e t a l., supra , S u p p . at 11 7 . A s the co u rt s ai d i n Li vi ng Wi l lC ent er , “w e fa i l t o s ee how [the omi s s i on] can be r egar ded as a defamat i on of [TM J I ] . ” L i vi ngWi l lC tr. , 879 P. 2d at15.

c. C I G N A C P N 156 H avi ng di s pos ed of the s t at ement s i n C PB 28, w e tur n t o T M J I ’ s al l egat i ons t hat C IG N A pu bli shed d efam at oryst at em ents abo ut TM JI produ ct s i n it s T M Js ur gerybul l et i n, C PN 156. T hatbul l et i n s t at es t hat“C I G N A H eal thC ar e does not cov er par t i al j ointrepl acem ent w i th the C hri st ensen F ossa E m i nen ce P rosthesi sTM ( T M J I m pl ant s , I nc. ) Par t i al T M J R epl ace m entSy s t em becaus e i ti s cons i der ed e x p e ri m e n ta l, in v e s tig a tio n a l, o r u n p ro v e n ,” A p lt. A p p . at 1 9 4 , an d th a t “[ t]h e re is i ns uffi ci entevi dence i n t he publ i s hed medi cal l i t er atur e t o es t abl i s h the cl i ni cal eff i cac yorl ong- t erm out come of i m pl ant at i on of part i al T M J pr os thes es , ” id . at 197. T M J I compl ai ns t hats ay i ng thati t s part i al -j oi ntdevi ces ar e “c ons i der ed exper i m ent al , i nves t i gat i onal , orunpr oven, ” id . at194, i s defa m at ory . T he bu l l et i n d oes no totherw i se define the term s expe r i m ental, i nves t igat i onal , or unpr oven ; w e mustt her efor e di s cern thei rm eani ngs fr om t he cont exti n w hi ch-45-

t heyar e us ed. O nce a gai n w e i t al i ci ze the al l egedl ydefa m at or ys t at ement s i n our q u o ta tio n s f

ro m th e b u lle tin . T he b ull et i n b egins w i t h a p aragr aph i nst ruct i ng the reader on h ow t o u se t he bul l et i n. L ik e A e tn a ’s b u lletin , ittells r e a d e rs th a t th e ir in d iv id u a l b e n e fit p lan s a lw a y s c o n tro l in th e e v e n t o f a c o n flict b e tw e e n a sta tem e n t o f c o v e ra g e in C P N 1 5 6 a n d o n e in th e in d iv id u a l p lan . It i n fo rm s re a d e rs th a t so m e b e n e fit p lans ex clud e T M J tr ea tm en t al tog ethe r. Itthen stat es th at C IG N A co v ers a rth ro c e n tes is, a rth ro sc o p y , an d a rth ro to m y(o p e n -jo in t su rg e ry ) w h e n c e rta in l i s t ed medi cal - nece s s i t ycr i t er i a ar e met . Fors uch a pr ocedur e t o be cove r ed, pai n m us thave pe r s i s t ed des pi t e atl eas ts i x m onths of “s ci ent i fi cal l yr ecogni zed non- i nvas i ve ther api es , ” i ncl udi ng pai n m edi cat i on, i ntr a- or al devi ces , and p h y s ic a l th e ra p y . Id . at193. I n addi t i on, cl i ni cal exami nat i ons m us tdocument speci fi c j ointcon dit i on s for each t reatm ent. T he b ull et i n then st at es: C I G N A . . . cover s ar t hr ot om yw i th t ot al pr os thet i c j oi ntr epl ace m ent us i ng T he TM J C oncept s Pat i ent - Fi t t ed TM J R econs truct i on Pr os t hes i s fort emporomandi bul ardi s or derw hen A L L t he fol l ow i ng m e d ica l n e c e ss ityc riter ia a re m e t an d in d ica tio n fo r su rg e ryis c o n fi r me d b yM RI , CT o rc o rr e c t e d t o mo g r a m:

• in flam m a to rya rth ritis in v o lv in g th e T M J n o t re sp o n siv e to ot herm odal i t i es of tr eatm ent • r ecurr entfi br os i s and/ orbonyanky l os i s notr es pons i ve t o other m odal i t i es of tr eatm ent • fai l ed t i s s ue gr aft • fai l ed al l opl as t i c j oi ntr econs truct i on • l os s of vert i cal m andi bul arcondy l arhei ghtdue t o bone r es orpt i on, t r auma, devel opm ent al abnorm al i tyorpathol ogi c l es i on-46-

CIG N A . . . does notcove rpar t i alj oi ntr eplacem entw i th the C h r is te n s e n Fo s s a E m in e n c e P r o s th e s is TM(T M J Imp la n ts , In c .) P ar t i alTM

J Repl acem entSys t em becaus e i tis cons i der ed expe r i m ental, i nves t igat i onal, orunpr oven. Id . at194 ( emphasi s added) . T he bul l et i n does notdi s cus s T M J I ’ s t ot al -j oi nt p ro s th e s is . CP N 1 5 6 t h e n p r o v i d e s a “ Ge n e r a l Ba c k g r o u n d ” th a td e s c r i b e s th e a n a t o my of the TM J and s et s for t h s ever al s ym pt om s thatm ayi ndi cat e the pr es ence of T M J di s or der s , i ncl udi ng pai n i n the fa ce orj aw , heada ches , di zzi nes s , l i m i t ed m o u th o p e n in g , a n d c lic k in g o r p o p p in g s o u n d s . I tdi s cus s es t he pr eval ence of T M J di sorder s, no t i ng t hat “[a] m aj ori tyof the gen eral po pu l at i on hav e atl east one s i gn of TM [J di s or der s ] . ” Id . T h e b u lletin sta tes th a t “[ t]h e re is n o w id e ly acc ept ed s t andar d t es tt o di agnos e TM [J di s or der ] , ” id . at195, butt hatphy s i cal exami nat i on combi ned w i t h r epor t ed s ym pt om s gener al l ypr ovi des s uffi ci ent i nform at i on fora di agnos i s . R egar di ng tr eatm entopt i ons t he bul l et i n s t at es t hat

“ [ n ] o n - i n v a s i v e , r e v e r s i b l e t h e r a p i e s a r e u s e d i n t h e i n i t i a l t r e a t me n to f [ TM J di s or der s ] . ” Id . T hes e i ncl ude pai n- contr ol drug ther api es , phy s i cal t her apy , and in tra -o ra l ap p lian c e s. W h e n th e se c o n se rv a tiv e th e ra p ies a re u n su c c e ss f u l, s u rg ic a l o p tio n s m a yb e c o n s id e re d . I n di s cus s i ng s ur gi cal t r eatm ent , t he bul l et i n s t at es t hat“the mosti nvas i ve s u rg ic a l te c h n iq u e to tr e a t” T M J d is o rd e rs is a rt h ro to m y , id . at196, w hi ch ca n i nv olve t otal - orpart i al -j ointreconstruct i on w i th p rostheti c i m plant s. B ecause-47-

“[t ] her e i s i nadequa t e gui dance i n the publ i s hed medi cal l i t er atur e r egar di ng pat i ent - s el ect i on cr i t er i a fort hes e pr ocedur es , ” thi s s ur gi cal opt i on s houl d be cons i der ed onl yw hen “a l l appr opr i at e cons ervat i ve tr eatm enthas fai l ed and m i ni m al l yi nvas i ve s ur gery. . . i s noti ndi cat ed. ” Id . C PN 156 expl ai ns that t her e ar e tw o FD A - appr oved pr os thet i c s y s t ems, the TM J C oncept s s y s t em and T M J I ’ s devi ces . T he TM J C oncept s devi ce i s appr oved fort ot al -j oi nt r econs t ruct i on i n cert ai n pat i ent s but“s houl d onl ybe cons i der ed forend- s t age [TM J di s or der s ] w hen no otherm edi cal ors ur gi cal opt i ons ar e ava i l abl e. ” Id . As t o T M J I ’ s p a r t i a l -j o i n tp r o s t h e s i s , th e b u l l e t i n a c k n o wl e d g e s th a tth e F DA a p p ro v e d it i n 2 0 0 1 fo r u se in p a tien ts w ith a n yo f fiv e in d ica tio n s a n d th a t a r etr os pect i ve s tudyr eport ed thatpat i ent s w ho had r ece i ved the i m pl ant exper i ence d s i gni fi cantpai n r el i ef. B uti tnot es thatthe s tudyal s o advi s ed that “r i gor ous l ycontr ol l ed pr os pect i ve s tudi es ” w er e nee ded t o i nves t i gat e the p ro c e d u re . Id . at 1 9 7 . C IG N A th u s c o n c lu d e s th a t “ [t ] her e is i ns uf

f i ci ent evi dence i n the publ is hed m edi call i t er at ur e to es tabl is h the cl i ni calef f i cacy or l ong- t er m out com e of

i mplantat i on of

par t i alTM

J pr os thes es . ” Id . (em p h a sis added) . T he bul l et i n ends w i t h a l i s tof 20 r efe r ence s r el i ed on forthe i nform at i on and det erm i nat i ons i n the bul l et i n. A s w i t h the A et na b ull et i n, the term s expe r i m ental, i nves t igat i onal, or unpr oven take o n m ea n ing o n lyas th e C IG N A b u ll eti n ex p lai n s w h ya p roc ed u re o r d e v ice m e rits th o se a djec tiv e s. T h e b u lletin ’s s tate m e n t th a t th e re is-48-

“i ns uffi ci entevi dence i n t he publ i s hed medi cal l i t er atur e t o es t abl i s h the cl i ni cal e ffica c yo r lo n g -te rm o u tco m e o f im p lan tatio n o f

p a rtial T M J p ro sth e sis ” a m o u n ts to its d e fin iti o n o f

th o se ter m s a s th e ya re u se d in C P N 1 5 6 . In o th e r w o rd s, in th e c o n tex t o f

th e b u lletin , to s a yth a t th e p a rtial-jo in t p ro sth e sis is e x p e rim e n tal, i nves t i gat i onal , orunpr oven i s t o s aythatther e i s i ns uffi ci entevi dence s uppor t i ng i t s eff i cac y . T he s t at ementt hatevi dence i s “i ns uffi ci ent , ” how ever , i s not defa m at or ybeca us e i ti s notpr ovabl yfal s e. A s w e s ai d i n the di s cus s i on of the A etna bul l et i n, peopl e maydi ffe ron the quant i tyorqual i tyof i nform at i on t hat t he yr e qu i r e be fo r e t he yde e m i ts uffi c i e nt . The c ha l l e ng e d s t a t e ment s i n CPN 1 5 6 a r e t h e r e fo r e n o td e fa m a t o r y.

3. Q ual i fi ed or C ondi t i onal P ri vi l ege T M JI a rg u e s th a t ev e n if th e sta tem e n ts in th e b u lletin s a re n o t p ro v a b ly fal s e, t heyar e affor ded onl ya qual i fi ed pr i vi l ege. I tcont ends t hatA etna and C I G N A l os tt he pr i vi l ege be caus e thei ropi ni ons w er e bas ed on an i ncompl et e and i nacc ur at e eva l uat i on of out dat ed fa ct s , w er e publ i s hed t o avoi d paym entof c laim s ra th e r th a n to c o n v e ya c o v e ra g e d e ter m in a tio n , an d w e re p u b lish e d w ith m a lice . B u t T M JI o ffe rs n o su p p o rt fo r its a ss e rtio n th a t u n d e r C o lo ra d o law n o tpr ovabl y - fal s e s t at ement s ( opi ni ons ) ar e ent i t l ed t o onl ya qual i fi ed pr i vi l ege; and w e h a v e fo u n d n o n e . T M J I has confus ed the conc ept s of ( 1) nondefa m at orys t at ement s and ( 2) defa m at or ys t at ement s t hatar e pr i vi l eged. W e have al r eadyconcl uded thatt he-49-

s t at ement s byA etna and CIG N A w er e notdefa m at or y . A ccor di ngl y , nei ther defe ndantneede d a pr i vi l ege t o es cape l i abi l i ty . A br i ef di s cus s i on of qual i fi ed (o r c o n d itio n a l) p ri v ile g e in th e d e fa m a tio n c o n te x t m a yh e lp c la ri f yth e m a tte r. R es t at ement§ 593 s t at es : “O ne w ho publ i s hes a defamat or ym at t er conce r ni ng anotheri s notl i abl e forthe publ i cat i on i f ( a) the mat t eri s publ i s hed u p o n a n o c c a sio n th a t m a k e s it c o n d iti o n a llyp riv ileg e d a n d (b ) th e p riv ileg e is notabus ed. ” C ondi t i onal pr i vi l eges pr ot ect , forexampl e, i nform at i on t hat “a ffec ts a su ffici en tl yim p o rt an t i n terest of the p u b li sh er, [if] . . . the re cipien t’ s know l edge of

t he defamat or ym at t erw i l l be of s ervi ce i n the l aw ful pr ot ect i on of t he i nt er es t , ” id . § 5 9 4 , an d sim il ar info rm ati o n that affe cts th e intere sts of thir d p e rs o n s , se e id . § 5 9 5 , o r fa m ily m e m b e rs , se e id . § 5 9 7 . T h e R e sta tem e n t se ts forth several ci rcum st ances i n w hich these co nd i t i on al pri vil eges are l ostbecau se of abus e. Forexampl e, i f the s peake rm akes the s t at ementw i th know l edge of or re c k le s s d is re g a rd fo r i ts tru th o r fa ls ity, se e id . § 600, orfora purpos e otherthan th a t fo r w h ic h th e p ri v ile g e w a s e x te n d e d , se e id . § 6 0 3 , there is no lon g er a pr i vi l ege. W hen ther e has been no de famat or ys t at ement , how ever , the publ i s her d o e s n o t n e e d th e p ro tec tio n o f a p riv ileg e a n d th e re fo re a b u se o f th e p riv ileg e is i r r el evant . I f the publ i s herl evel s a cha r ge forthe mostevi l of m ot i ves and w i t houtanyi nt er es ti n t he cha r ge’ s truth, the publ i s heri s notl i abl e i f the cha r ge tur ns outt o be true. T he publ i s her ’ s m ot i ve mayhave pr ecl uded a c l ai m of condi t i onal pr i vi l ege, butt he publ i s hercan pr evai l w i thouti nvoki ng a pr i vi l ege.-50-

W hatw e dec i ded above i s thatthe cha l l enged s t at ement s byA etna and C I G N A ar e s i m pl ynotdefa m at or ys t at ement s . A s t at ementi n the form of an opi ni on t hatdoes noti m pl yt he exi s t ence of undi s cl os ed defamat oryfac t s i s not a c tio n a b le a n d a p u b lis h e r o f s u c h a s ta te m e n t h a s n o n e e d fo r a p ri v ile g e . A ccor di ngl y , w e r ej ectT M J I ’ s cont ent i on thatA etna and CIG N A ar e l i abl e for abus e of a pr i vi l ege. C . Pro duc t D i s par ag e m e nt T M J I cl ai m s t hatt he s ame st at ement s byA etna and CIG N A t hatar e al l eged t o be defamat or yal s o cons t i tut e pr oductdi s par agement . T he C ol or ado C our tof A p p e a ls h a s a d o p ted th e e lem e n ts o f a p ro d u c t-d isp a ra g e m e n t cla im se t fo rth in R estatem en t § 6 2 3 A , stat ing that a p lai n ti ff m ak ing su ch a c lai m m u st sho w “(1 ) a fa lse stat em en t; (2) p u b li sh ed to a th ir d p arty ; ( 3 ) de rog atoryto the p lai n ti ff ’s bus i nes s i n gener al , t o t he t i t l e t o hi s pr operty , ori t s qual i ty ; ( 4) t hr ough w hi ch t he defendanti nt ended t o caus e harm t o the pl ai nt i ff’ s pecuni aryi nt er es t , or e ith e r re c o g n ize d o r sh o u ld h a v e re c o g n ize d th a t itw a s lik e lyto d o so ; (5 ) w ith m al i ce; ( 6) t hus , caus i ng s peci al damages . ” Tei lhaber , 791 P. 2d at1166. C i t i ng B os e C or

p. v. C ons um ers Uni on of Uni t ed Stat es , Inc. , 466 U . S. 485 ( 1984) , t he cour ti n Tei lha ber added that“[t ] he cons t i tut i onal pr ot ect i ons affor ded a defe ndanti n a defamat i on act i on ar e appl i cabl e t o a defendanti n a pr oduct di s par agementact i on. ” 791 P. 2d at1167. A ccor di ngl y , “a s t at ementof opi ni on [ a b o u t a p ro d u c t] w ill b e p ro tec ted e x p re ss io n ” u n les s “ th e lan g u a g e is-51-

defa m at or yand the under l y i ng defa m at oryfac t s w hi ch pr ovi de a ba s i s forthe opi ni on ar e fa l s e and a r e notdi s cl os ed i n cont ext . ” Id . W e bel i eve thatthe C o lo ra d o S u p re m e C o u rt w o u ld n o t re c o g n ize a p ro d u c t-d isp a ra g e m e n t cla im re lyin g e n tir e ly o n e x p re s s io n s th a t c o u ld n o t s u p p o rt a d e fa m a tio n c la im . See als o Unelko C or

p. v. R ooney , 912 F. 2d 1049, 1057–58 ( 9th C i r . 1990) ( s ubj ect i ng pr oduct - di s par agementcl ai m t o s ame Fi r s tA m endmentr equi r ement s as d e fa m a tio n c laim s); D ai r y St or es , Inc. v. Sent i nelP ubl ’g C o. , Inc. , 516 A . 2d 220, 2 2 6 ( N. J . 1 9 8 6 ) ( e x t e n d i n g c o mmo n - l a w p r i v i l e g e s a v a i l a b l e i n d e fa ma t i o n c l a i ms t o pr oduct - di s par agementcl ai m s ) ; R es t at ement§ 646A ( s ame) . T her efor e, T M J I’ s p ro d u c t- d is p a ra g e m e n t c la im fa ils . D . In ter fer en ce T o rts Fi nal l y , T M J I cl ai m s t hatt he s t at ement s i n the bul l et i ns cons t i tut ed in te n tio n a l in te rfe re n c e w ith p ro s p e c tiv e b u s in e s s re la tio n s a n d c o n tr a c ts . C ol or ado fol l ow s t he R es t at ementw i th r es pectt o the el ement s of both i nt ent i onal in ter fe re n c e w ith p ro sp e c tiv e b u sin e ss re latio n s a n d in ten tio n a l in ter fe re n c e w ith c o n tra c t: “O ne w ho i nt ent i onal l yand i mpr oper l y interfe res w ith an o ther’s p ro sp e c tiv e c o n tra c tu a l re latio n (e x c e p t a c o n tra c t to m a rry ) is s ubj ectt o l i abi l i t yt o t he otherforthe pec uni aryharm r es ul t i ng fr om lo ss o f th e b e n e fits o f

th e re latio n , w h e th e r th e in ter fe re n c e c o n sis ts of ( a) i nduci ng orot herw i s e ca us i ng a thi r d per s on nott o ent er into o r co n ti n u e the p rosp ec ti v e re lat ion o r ( b) pr event i ng t he otherfr om acqui r i ng orcont i nui ng the p ro s p e c tiv e re la tio n .”-52-

A m o c o O il C o . v. E rv in , 908 P. 2d 493, 500–01 ( C ol o. 1995) ( quot i ng R es t at ement § 766B ) ( emphasi s added) . A nd “[o] ne w ho i nt ent i onal l yand i mpr oper l y i nt er fer es w i th the per form ance of a c ont r act( exce pta contr actt o m arry ) betw een an o ther a n d a third p erso n b yind u cing o r oth erw ise ca u sing the th ir d per s on nott o per form t he contr act , i s s ubj ectt o l i abi l i tyt o the other fort he pec uni aryl os s r es ul t i ng t o the otherfr om the fa i l ur e of the t hi r d per s on t o per form t he contr act . ” Mem ’ lG ar dens , Inc. v. O l ympi an Sal es & M

gm t . C ons ul tants , Inc. , 690 P. 2d 207, 210 ( C ol o. 1984) ( quot i ng R es t at ement§ 766) ( emphasi s added) . T hus , forei t her c la im to p ro c e e d , th e in te rfe re n c e m u s t h a v e b e e n im p ro p e r. If th e a lleg e d im p ro p rie ty , h o w e v e r, is a n a lleg e d lyd e fa m a to rysta tem e n t, th e n th e in ter fe re n c e c laim m u st fa il i f th e sta tem e n t is n o t an a c tio n a b le defa m at i on. W e have addr es s ed thi s i s s ue i n a di ver s i tycas e governed by C ol or ado l aw . I n Je

ff erso n C o u n ty Sc h o o l D istrictNo . R -1 v . Mo o d y’s In ve stor’s Ser vi ces , 175 F. 3d 848, 856–58 ( 10th C i r . 1999) , the pl ai nt i ff ba s ed i t s cl ai m s for in ten tio n a l in ter fe re n c e w ith c o n tra c tu a l an d b u sin e ss re latio n s o n a lleg e d ly d e fa m a to rysta tem e n ts m a d e b yth e d e fe n d a n t. W e h e ld th a t law f u l sp e e c h c o u ld notform t he bas i s of the i nt er fer ence cl ai m s beca us e s uch ac t i vi tyw as not im p ro p e r. S e e id . at85 8. A l t ho ug h the speech in that cas e w as c o n stitu tio n a lly pr ot ect ed, w e s ee no r eas on t o di s t i ngui s h s peec h pr ot ect ed fr om a defamat i on cl ai m undert he comm on l aw . T he i nt er es t s s erved bythatpr ot ect i on w oul d be-53-

u n d e r mi n e d i f

t h e c o mmo n l a w r e c o g n i z e d a d i ffe r e n tt o r tb a s e d o n th e s a me s p e e c h . W e a re a w a re o f n o a u th o ri ty to th e c o n tr a ry. A ccordi ng l y , w e affirm t he d i stri ctcou rt ’s dis m i ssal of T M JI ’s t ort i ou si nter ference cl ai m s. I I I . CO NC L US I ON W e A F F IR M th e ju d g m e n t o f th e d istric t co u rt.