2008 D e c i sion s O p inion s of the U nit e d S t at e s C our t of Appe al s for the Thir d C ir c uit

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. G ay Pa t t e r s o n i s a c l a i ma n ts e e k i n g p a yme n tu n d e rt he N at i onal C l as s A ct i on Set t l ementA gr eement( “Set t l ement A gr eement ”) i n t hi s m ul t i

- di s t r i ctl i t i gat i on. U n dert he 1 S ett l ementA gr eement , W y eth, form er l yA m er i can H om e Pr oduct s C orpor at i on, has contr i but ed funds for t he paym entof cl ai m s . A H P S et t l ementT rus t( “Trus t ”) admi ni s t er s and r evi ew s the cl ai m s and aw ar ds benef i t s t o cl as s m ember s w ho q u a lif yu n d e r t h e te rm s o f

th e S e ttle m e n t A g re e m e n t. Pat t er s on cont ends s he s uffe r s fr om m oder at e mi t r al re g u rg itatio n , a m e d ic a l co n d iti o n th a t, i f a d e q u a tely demonstr at ed, w oul d qual i fyherforpaym ent

. Pat t er s on s ubm i t t ed hercl ai m t o t he T rus t , s uppor t i ng i t w i t h an att es t i ng ph y si ci an’s i nterpret at i on of an echo c a rdi og ram . T he T rust r efe r r ed hercl ai m t o an i ndepende ntaudi t i ng car di ol ogi s tw ho concl uded thatt he att es t i ng phy s i ci an’ s opi nion lacke d a4 r eas onabl e medi cal bas i s . A ccor di ngl y , t he Trus tdeni ed P a t t e r s o n ’ s c l a i m. T h e T ru st th e n a p p lied f o r a n o rd e r re q u irin g P a tters o n to show caus e w hy t he cl ai m s houl d be pai d. T he D i s t r i ct C o u rt i s su ed an or dert o s how caus e and r efe r r ed the mat t ert o a s peci al m as t er . A ft erthe s how caus e pr ocee di ngs , the D i s t r i ct C our tdeni ed r ecove r yfi ndi ng no r eas onabl e medi cal bas i s for P a tte rs o n ’s c la im . W e w ill a f f ir m . I

. A

. T hi s cas e i s par tof a mul t i

- di s t r i ctl i t i gat i on conce r ni ng di etdru g s pr evi ous l ys ol d byW y eth – fenf l ur ami ne ( m arket ed as “P o n d im in”), an d d ex fe n flu ram ine (m ark eted as “ R ed u x ”). I n pr evi ous deci s i ons , w e have pr ovi ded det ai l ed des cr i pt i ons of th e d ie t d ru g s litig a tio n . See, e. g. , I n r e Bris coe , 448 F. 3d 201, 2 0 6 -0 8 (3 d C ir. 2 0 0 6 ); I n r e D i et D r ugs , 401 F. 3d 143, 147- 48 (3 d C ir. 2 0 0 5 ); I

n r e D i et D r ugs , 3 8 5 F

. 3 d 3 8 6 , 3 8 9 -92 (3d C ir

. 2 0 0 4 ); I n r e D i et D r ugs , 2 8 2 F

. 3 d 2 2 0 , 2 2 5 -29 (3 d C ir

. 2 0 0 2 ). W e l i m i tourdi s cus s i on her e t o t he fact s per t i nent t o t he pr es ent a p p e a l.I n N o v em ber1999, W y eth and the r epr es ent at i ves for pl ai nt i ffs ent er ed i nt o t he Set t l em en t A gr eement

. A ft er conduct i ng fai r nes s proc ee d i ngs , t he D i s t r i ctC our tcert i fi ed a s et t l ement cl as s and appr oved the Set t l ementA gr eementw hi ch becam e fi nal upon exh aust i on of all app eal s.T he D i s t r i ctC our thas pr evi ous l ydes cr i bed mi t r al 2 r egur gi t at i on: [M i t r al regur gi t at i on] i nvol ves t he bac kw ar d or r ever s e fl ow of bl oo d thr ough a def ect i ve mi t r al v alve w h ich sep ara tes the l ef t atri u m o f th e h ea rt fr om t he l eftventr i cl e. T he hea r tcons i s t s o f fourchamber s : the r i ght atr i um , t he ri ght ventr i cl e, t he l eftatr i um and the l eftventr i cl e. T hes e cha m ber s ar e conne ct ed by v a lv e s c o n sis tin g o f

tw o lea f lets . T h e yo p e n to a llo w b lo o d to p a ss th ro u g h a n d th e n c lo se . T h is r api d pr oces s ens ur es t he pr operdi r ect i onal fl ow o f b lo o d th ro u g h th e h e a rt. T he cha m ber s of the hea rtfi l l and em ptyi n a s eaml es s , t w o- phas e ca r di ac c y cl e thatcompri s es di as t ol e, t he fi l l i ng cy cl e, and s y s t ol e, the empt y i ng cy cl e. I ni t i al l y , deoxy genat ed bl ood 5 T he amountof a c l ai m ant ’ s rec overyundert he Set t l ementA gr eementi s det erm i ned bydamage “mat r i ces ” that as s es s fac t or s s uch as s ever i t y of t he m edi cal condi t i on, age of cl a i ma n t , a n d l e n g t h o f i l l n e s s . Pa t t e r s o n s e e k s M a t r i x A

- 1, L e v e l II c o m p e n sa tio n in th e a m o u n t o f $ 4 7 3 ,0 3 2 . In o rd e r to r ecove r , a cl ai m antm us t d em o n s t r at e bya r eas onabl e medi cal b a s is th a t s h e h a s a q u a lif y in g c o n d itio n . T h e o n lyfa ctor in d isp u te i s the sev erityo f P att erso n ’s m edi cal condi t i on, i

. e. , w hether s he has m i t r al r egur gi t at i on at 2ent er s t he hea r tt hr ough t he r i ghtatr i um . D ur i ng d ias to le, t h e tricu sp id v a lv e o p e n s a n d b lo o d is p u m p e d in to th e rig h t v e n tricle w h e re it co llec ts befor e bei ng ex p el l ed. A s s y s t ol e begi ns , the r i g h tv e n t r i c l e c o n t r a c t s a n d t h e b l o o d i s e j ect ed i nt o t he pul m onaryar t er i es . T h e b lood i s t hen ca rri ed thro u g h thes e a rt eries into the lun g s w h ere i ti s r e- oxy genat ed bef

or e pas s i ng back i nt o t he left atri u m o f th e h ea rtth rou g h the p u lm o n ary vei ns . D ur i ng di as t ol e, t he mi t r al val ve opens and bl ood m oves fr om t he l eftatr i um i nt o t he l eft v e n t r i c l e . T h e r e a f

t e r , th e mi t r a l v a l v e s h u t s . As s y s t ol e begi ns , the lef

t ve ntr i cl e contr act s and expel s t he bl ood thr ough t he open a or t ic val ve in to th e a o rta a n d th e re st o f th e b o d y . T h e a o rtic val ve then cl os es t o pr eve n t anyexpel l ed bl ood fr om r etur ni ng t o t he l eftventr i cl e. M itral r e g u rg itatio n o c c u rs d u rin g th e sy sto lic pha s e a s t h e l e f

tv e n t r i c l e c o n t r a c t s a n d p u s h es b l oo d int o the aort a. B ecause the l eafl ets compri s i ng t he mi t r al v alve ha ve fa i l ed t o s hut properl y , blood leaks back w ard, or r e g u rgi t at es, i nto the leftat ri um . A s a r esul tof thi s r everse fl ow , t he hea r tm us tw or k har d er to pum p t he neede d bl ood thr ough o u t the hea r tand i nt o t he b o d y. 6In re D i etD rugs (P TO 2640 ) , 2 3 6 F. Su p p . 2 d 4 4 5 , 4 5 0 ( E

. D. P a. 20 0 2 ). R J A i n t he num er at or of t he fr act i on r epr es ent s R egur gi t ant 3 J etA r ea w hi l e LA A i n the d en o m ina t ors t ands forL eftA t r i al A re a . 7 a moder at e l evel

. T he D i s t r i ct C our t has not ed the i m por t ance o f m e a su rin g th e se v e rityo f re g u rg itatio n b e c a u se “ n o t all le v e ls of m i t r al r egur gi t at i on ar e medi cal l ys i gni fi cant

. ” PTO 2640 , 2 3 6 F

. S u p p . 2 d a t4 5 0

. “ M i l d a n d t r a c e r e g u r g i t a t i o n , two l es s ergr ades of val vul arr egur gi t at i on i dent i fi ed i n m edi cal l i t er atur e, ar e norm al and exi s t i n appr oxi m at el y ni netyper cent of the popul at i on. O nl yw hen mi t r al r egur gi t at i on r eac hes t he m oder at e l evel does i tbecome a s er i ous m edi cal condi t i on. ” I d. T he Set tl em en t A g ree m en t def ines m oder at e mi tr al r egur gi t at i on “as r egur gi t antj etar ea i n anyapi cal vi ew equal to orgr eat er t han 20% o f the l eftatr i al ar ea butl es s t han 40% ( 20 - 40% R J A /L A A ).” 3 B

. I n o r d e rt o ma k e a M a t r i x c l a i m un d e rt h e Se t t l e m ent Ag r e e me n t , t h e c l a i ma n tmu s ts u b mi ta th r e e - p a r t“ Gr e e n F o r m” t o t he T rus t

. T he G r een For m r equi r es di s cl os ur e of per s onal and medi cal i nform at i on as w el l as a phy s i ci an’ s cert i fi cat i on, bas ed on a r eading of an ec hocar di ogr am vi deot ape, of the claim a n t’ s leve l of

v alvu lar he art disea se. T h e D istri ct C o u rt has pr evi ous l ys t at ed: “[f ] orm oder at e m i t r al r egur gi t at i on t o be8 present , t he si ze of

t he reverse f

lo w in g jetof b l oo d at i t s m ost expans i ve poi ntm us t encompas s betw een tw entyper centand for typer centof the ar ea of the l eftatr i um . ” P TO 2640 , 23 6 F. Supp. 2d at450. S e v e ra l atto rn e y s, in c lu d in g P a tters o n ’s c o u n se l K ip Pet r off, i nt erpr et ed the Set t l ementA gr eementt o r equi r e a p h y s i c i a n ’ s r e p o r tt o i d e n t i f yo n l yo n e f

r a me o f an echoc ar di ogr am t ape s how i ng t w ent y - t o -fo r t yper cent r egur gi t at i on. O n D ece m ber19, 2000, M r . Petr off c i r cul at ed a m emora ndum des cr i bi ng “C urr ent D evel opm ent s ” i n the FenPhe n li ti gat i on. T he mem o art i cul at ed thi s expans i ve in terp re tatio n o f

th e S e ttl e m e n t A g re e m e n t: I ti s cl eart hatcar di ol ogi s t s w ho s t r i ct l yempl oy ed t he met hodol ogyi n t he N at i onal Set t l ement (m ax im u m re g u rgit an t j et/ o n e v iew o n ly ) are r o u t i n e l y o ver- r eadi ngthe ec hos byatl eas tone o rd e r o f m a g n itu d e . T h a t m e th o d o lo g yis acc ept abl e i n t he w or l d of t h e N at i onal Set t l e me n t , b u ti ti s n o te mpl o y e d i n t h e r eal w or l d. W e have car eful l ycons i d ere d t hi s r eeval uat i on, and i ti s abs ol ut el ycl eart hat empl oy i ng t he N at i onal Set t l ementcr it eri a l eads t o acr os s - t he-bo ar d overes t i m at es of val ve r egur gi t at i on, es peci al l yof the m i tr alval ve. E verycl i entw ho i s grad ed a moder at e M R by N a tio n a l S e t tle m e n t c ri te ri a is a m ild a t b e s t, a“ D u rin g th e f a irn e ss h e a rin g b e f

o r e th e D istric t C o u rt, 4 expert s t es t i fi ed as t o t hei r concl us i on t hat , aft er cons i der i ng ext ens i ve epi demi ol ogi cal and dem o g r aphi c evi dence , $3. 75 b i l l i o n wa s mo r e t h a n s u f f i c i e n tt o p a ya l l M a t r i x c l a i ms ant i ci pat ed underthe Set t l ement

. ” I n r e D i et D r ugs , 385 F. 3d at391. B ut“af

t erappr oval of the Set t l ementA gr eement , the T ru st w a s in u n d a ted w ith G re e n F o rm c laim s f o r M a trix b e n e f

its i n a vol um e notant i ci pat ed bythe ex p ert s w ho t es t i fi ed att he fai rne s s hear i ng. ” I

d. T h e D istric t C o u rt d e ter m in e d th a t a

9 s ever e i s a moder at e at best , etc . T h is w ill lea d to n u me r o u s mi t r a l v a l v e c a s e s g o i n g f r o m F DApos i t i ve t o FD A

- negat i ve, a n d t hatm aybe one r eas on t o opts uch a c l i entback i nt o t he N at i onal Set t l ementorhave a new echo done us i ng s t a n d a r d m e t h o d o l o g y. M e m o ra n d u m f

ro m K ip P e tro f

f a n d R o b e rt K iss e lb u rg h to A ll R e f e rr in g A tto rn e y s (D e c . 1 9 , 2 0 0 0 ). I n a di ffe r entbut r el at ed ca s e, the D i s t r i ctC our tr ej ect ed a s im ila r i n te rp re ta tio n . See P TO 2640 , 236 F. Supp. 2d at451 (h o ld in g th a t “[ o ]n lya f ter re v iew in g m u lti p le lo o p s a n d still f ra m e s c a n a c a rd io lo g ist re a c h a m e d ica llyre a so n a b le as s e s s me n t a s t o whe t h e r t h e t wen t y p e r c e n t t h r e s h o l d for m od e ra te m itral re g u rg itatio n h a s b e e n a c h iev e d ” ). B ut, becau se of M r . Pet r off’ s t heoryand otherdubi ous pr act i ces byot herl aw fi r m s , t he Trus tw as inu n dat ed w i t h G r een Form cl ai m s for M atr i x benef

i t s i n unant i ci pat ed vol um es . U nderthe P o li ci es 4s i gni fi cant pr opor t i on of t he subm i s s i ons came fr om a few l aw fi r m s w hi ch ca r r i ed outm as s s cr eeni ng p r ogr ams i n w hi ch cardi ologi st s r et ai ned byt he firm s “‘ m ade u nreason a b le j u d g m e n t s o n a b r o a d s c a l e ’ c o n c e r n i n g th e e x i s t e n c e , h i s t o r y, natur e, and degr ee of

heart

- val ve di s eas e cl ai m ed. ” I d. ( quot i ng P TO 2640 , 2 3 6 F

. S u p p . 2 d at 46 2 ). O n O ct ober15, 2002, the Trus t n o ti fi ed Pat t er s on t hather 5 cl ai m w as s el ect ed for audi t

. A ccor di ngl y , t he A uditPol i ci es an d P roc ed u res c o n tai n ed in P T O 2 4 5 7 ap p lyto P atte rso n ’s c la im

. 10 a n d P ro c e d u re s f

o r A u d it an d D isp o sitio n o f M a trix Comp e n s a t i o n Cl a i ms , a s a p p r o v e d i n PTO 2 4 5 7 ( M ay31, 2 0 02) , t he Trus tcoul d audi tup t o 5% of M atr i x cl ai m s per quar t er , and W y eth coul d d esig n at e up t o 10% of cl ai m s per quar t er , foran audi tbythe T rust. A s a r es ul t , the Trus tr i s ked pay i ng outm i l l i ons of dol l ar s t o clai m ant s i tbel i eved t o be in e lig ib le , b u t w h o se c laim s it c o u ld n o t au d it. W y e th a ss e rts t hatoutof the thi r ty claims s ubm i t t ed byPet r off & A s s oci at es and audi t ed under PT O 2457, t w enty - fi ve w er e notpay abl e – a fai l ur e r at e of 83%

. A ccor di ng t o W y eth, as of M ar ch 24, 2004, P etrof f & A sso ciates f

ail ed au d itm o re tha n 7 0 % o f th e ti m e. In or dert o amel i or at e the pr obl em, the D ist ri ctC our tor der ed a u d its f o r a ll M a tr ix c o m p e n s a tio n c la im s . See P T O 2 8 0 7 (M ar. 2 6 , 2 0 0 3 ). 5T he G r een For m r efl ect s t hat Pat t er s on s i g n ed the G reen 6 For m i n M ar ch 2002. T he G r een Form , how ever , w as m arked a s “ re c e iv e d ” in J u ly 2 0 0 2

. W y e t h a s s e r t s t h a tDr

. Ha r r i s h a s c e r t i f i e d 1 0 5 M a t r i x c l a i ms 7 undert he Set t l ementA gr eement

. A cc o rdin g t o W y eth, as of M ar ch 24, 2004, D r . H arr i s ’ audi t ed ce r t i fi cat i ons r es ul t ed i n a 8 2 % fa il u re rate (1 8 o u t of 2 2 w ere n o t pay ab le). 11 C

. In Ju ly2 0 0 2 , M r. P e tro f f su b m itt e d P a tters o n ’s c laim to 6 t he Trus t

. Pat t er s on’ s G r een For m r el i ed on t he ce r t i fi cat i on of the a tt esti n g p h y sici an R ee d H arris, D

. O

. B ase d o n a F eb rua ry 7 8, 2002 ec hocar di ogr am, D r . H arr i s concl uded thatPat t er s on had a moder at e m i t r al r egur gi t at i on r at i o of 20% and thatherl eft a tr iu m w a s m ild ly en la rg e d

. T he Trus ts el ect ed Patt er s on’ s cl ai m for audi t

. U ndert he A u d it P o licie s a n d P ro c e d u re s, P a tters o n h a d th irty d a y s to s ubm i t“anyaddi t i onal cr edi bl e medi cal i nfo rm at i on” for cons i der at i on byt he Trus tand th e Ind epende ntA udi t i ng C ar di ol ogi s t

. Pat t er s on di d nots uppl ementheri ni t i al s ubm i s s i on form s . O n D ece m ber14, 2 002, t he audi t i ng ca rdio log ist , K e ith B

. C h u rch w ell , M

. D

. , co n clud ed that there w as no r eas onabl e medi cal basis forD r . H arr i s ’ fi ndi ng of m oder at e mi t r al r egur gi t at i on beca us e the ec hocar di ogr am demonst r at ed “t r i vi al t o m i l d” mi t r al r egur gi t at i on.T h e D istric t C o u rt h a s d e sc rib e d “ e ye b a lli n g ” a s v isu a lly 8 i ns pect i ng an ec hocar di ogr am ra t herthan r etr aci ng t he regurgi t ant j etarea or the leftat ri al area w i t h a p reci se m e a s u ri n g d e v ic e . PTO 2 640 , 236 F. Supp. 2d at454. W hen conduct i ng a v isua l as s es s m ent , t he ca r di ol ogi s tr evi ew s t he e n tire e c h o c a rd io g r a m to d e ter m in e th e e x iste n c e a n d se v e rity of the condi t i on. Und e rt h e Aud i tPo l i c i e s a n d Pr o c e d u r e s a p p r o v e d i n PTO 9 2 4 5 7 , the sp e c ial m a ste r m a ya ss ig n a T e c h n ica l A d v iso r to re v iew th e re c o rd a n d p re p a re a re p o rt to th e C o u rt “ se tti n g f o rth h is /h e r o p in io n s re g a rd in g th e is s u e (s ) i n d i s p u te in th e a u d it.” A udi t Pol i ci es and Pr ocedur es , § V I

. J

. “Each Techni cal A dvi s or s hal l be a B oar d- C ert i fi ed C ar di ol ogi s t orB o ard- C ert i fi ed C a rd io th o ra c ic S u rg e o n w h o h a s le v e l 3 tra in in g in E choca r di ogr aphy

. . . . ” I d. § V I

. L

. T he cl ai m antm us tpaythe cos t s of the Techni cal A dvi s ori n advanc e of the r evi ew . “I f the T rustdo es n ot prevail on al l aspect s o f i t s A pp l i cat i on , t he T rust 12 “Ey ebal l i ng” t he echoca r di ogr am, D r . C hur chw el l det erm i ned

8 th a t th e “ [ m itral re g u rg itan t] jet a re a [ w a s] o v e re stim a ted in compar i s on t o [the l eftatr i al ] s i ze. < 20%

. ” O n J anuary6, 2003, t he Trus ti nform ed Pat t er s on t hather cl ai m had fai l ed au dit and at t ached D r. C hu rchw el l ’s fi nd i ng s. Pat t er s on chos e t o di s put e the P o s t

- A udi tD et erm i nat i on and p roc ee d to the S h o w C au se P roc ee d ing

. T h e D istri ct C o u rt g ran ted th e m o ti o n an d ref erred the m att er to a sp ec ial m aster. 9s h a ll r e im b u rs e th e C la im a n t f o r t h e T e c h n ic a l A d v is o r’ s c o s ts .” I d. § VI

. K. B o th th e T ru st a n d th e c laim a n t h a v e a n o p p o rtu n ityto s t at e a pos i t i on as t o w hether a “T echni cal A dvi s or ” shoul d be appoi nt ed. T he T rus t r eques t ed t he as s i s t ance of a T echni cal A dv i sor . Pa t t e r s on no t e d tha ts he di d “ no tfe e l i t[w as] nece s s aryt o hi r e a T echni cal A dvi s ort o r evi ew thi s cas e, ” but a c k n o w led g e d th a t s h e w o u ld n o t o b jec t to su c h a n a p p o in tm e n t. T h e s p e c ia l m a s te r d id n o t a p p o in t a T e c h n ic a l A d v is o r. 13 U n d e r th e A u d it P o li c ies a n d P ro c e d u re s, “ [ f ]o r a u d its b a se d

. . . o n th e g ro u n d s th a t n o re a so n a b le m e d ica l b a sis e x ists fors peci fi c ans w er ( s ) t o the A udi tQ ues t i on( s ) , t he C l ai m ant sh a ll h a v e th e b u rd e n o f p ro v in g th a t th e re w a s a re a so n a b le m edi cal bas i s t o s uppor t t he m at er i al r epr es ent at i on( s ) m ade by th e A tte s tin g P h y s ic ia n i n a n s w e ri n g th e A u d it Q u e s tio n (s ).” A udi tPol i ci es and Pr ocedur es , § V I

. D , PT O 2 457 ( M ay31, 2002)

. T o s uppor t t he at t es t i ng phy s i ci an D r . H arr i s ’ s opi ni on, P a t t e r s o n s u b m i t t e d t h e r e p o r to f c a r d i o l o g i s tF r a n k E

. S i l v e s t r y, M

. D

. D r . Si l ves t r yr evi ew ed the February2 , 2002 echoc ar di ogr am t ape and “i dent i fi ed t he maxi m um r egur gi t ant j et

. . . emanat i ng fr om t he m i t r al val ve i n s y s t ol e. ” B as ed upon t he maxi m al j et , dr aw n at1: 15: 38: 12 r ecor di ng t i m e, he concl uded thatPat t er s on had 20. 57% m i t r al r egur gi t at ion. Fur t her , D r . Si l ves t r ys ur m i s ed thatD r . C hur chw el l , the audi t i ng c a r d i o l o g i s t , “ ma y b e e x p r e s s i n g h i s . . . q u a l i t a t i v e o p i n i on of t he degr ee of

M i t r al r egur gi t at ion; how ever , the Set t l ement document s s peci fya s ci ent i fi c and qua nt i t at i ve degr ee of m i t r alT he D i s t r i ctC our t ’ s or derfi nal l yr esol ved the part i cul ar 10 cl ai m ati s s ue. A ccor di ngl y , w e tr eatthe cha l l enged or deras fi nal and exer ci s e appel l at e j ur i s di ct i on under 28 U

. S. C

. § 1291. W e re v iew a D istric t C o u rt’s ex e rc ise o f its e q u itab le a u th o rity t o ad m i nis t er and i m plem ent a cl ass act i on set t l em ent for abuse o f d is c re tio n . See I

n r e C endant C o rp. P r i des Li t ig. , 233 F. 3d 188, 192 ( 3d C i r . 2000)

. “[T] o fi nd an abus e of di s cr et i on t he 14 r eg u rgit at i on, a degr ee w hi ch i s cl ear l ys ubs t ant i at ed byt he e c h o c a rd io g ra m , a n d m yin d e p e n d e n t m e a s u re m e n ts .” T he D i s t r i ctC our t concl uded P att er s on “has notm ether bur den i n pr ovi ng that t her e i s a r eas onabl e medi cal bas i s for fi ndi ng t hats he had moder at e mi t r al r egur gi t at i on” beca us e s he fai l ed to r ebu tor chal l eng e t he co n cl usi on t hat D r. H arr i s’ d e te rm in a tio n w a s b a s e d o n im p ro p e r m e a s u re m e n ts

. I n r e D i et D r ugs , No

. 2 : 1 6 M D 1 2 0 3 , 2 0 0 7 W L 6 7 4 7 2 0 , a t* 2 , * 4 ( E

. D. P a. F eb

. 2 6 , 2 0 0 7 ). T h e c o u rtn o ted th a t, n o tw ith stan d ing D r. Si l ves t r y ’ s r epor t , Pat t er s on had “f ai l ed t o addr es s the i m pr oper m eas ur ement s under l y i ng t he fi ndi ng of [D r . H arr i s ]

. ” I d. at*3. Fur t herm or e, t he courtr ej ect ed P att er s on’ s s ugges t i on th a t sh e c o u ld re c o v e r M a trix B e n e f its b yid e n tify in g a sin g le m axi m um r egur g it antj etatt he r equi r ed l evel of m i t r al r egur gi t at i on. “[Patt er s on] has notes t abl i s hed t h at the ‘m a x im u m r e g u r g ita n t jet’ o f f e re d in su p p o rt o f

h e r c laim is r epr es ent at i ve of he r l evel of m i t r al r egur gi t at i on, t her efor e, on th is ba sis a s w e ll, [ P a tters o n ] h a s f a iled to e sta b lish a re a so n a b le m edi cal bas i s of hercl ai m . ” I d. at*4. 10D i s t r i ctC our t ’ s deci s i on m us tr es ton ‘a c l ear l yerr oneous fi ndi ng of fa ct , an err antconcl us i on of l aw oran i m pr oper appli ca t i on of l aw t o fac t

. ’ ” I n r e N utr aques t

, I nc. , 434 F. 3d 639, 645 ( 3d C i r . 2006) ( quot i ng I n r e O r thopedi c Bone Scr ew P r ods

. Li ab. Li t ig. , 2 4 6 F .3 d 3 1 5 , 3 2 0 (3 d C ir . 2 0 0 1 ))

.

15 II. Pat t er s on cont ends t hat t he D i s t r i ct C our t err ed i n s ever al re sp e c ts w h e n d e n y in g h e r c laim . F irst, P a tters o n c o n ten d s th a t, even i n a bor der l i ne cas e, m eas ur i ng a s i ngl e fr ame t o det erm i ne t he s ever i t yof m i t r al r egur gi t at i o n is a n acc ept abl e pr act i ce undert he Set t l ementA gr eement

. Second, s he as s ert s t hatthe audi t i ng car di ol ogi s t ’ s vi s ual as s es s m entof the ec hocar di ogr am w as i nsuff

i ci ent t o rebut her att est i ng ph y si c i a n’ s mea s ur e ment s. A c c o r d i n g t o P a t t e r s o n , th e S e t t l e m e n tA g r e e m e n ta l w a ys r e qu i r e s a qu a nt i t a t i ve mea s ur e mentof t he r e gu r gi t a ntj et s. Fi nal l y , Pat t er s on c o n t e n d s th a tthe D i s t r i ctC our tm i s appl i ed the rea so n ab le m ed ical b asis stan d ard b y ap p ly ing it to D r. S il ves t r y ’ s opi ni on, r athert han the att es t i ng phy s i ci an D r. R eed’ s opi ni on. A ccor di ngl y , Pat t er s on as s ert s i tw as i m pr oper fo r th e c o u rtto d en yh er c la im b ase d o n it s rejection o f D r. S i l v e s t r y ’ s m e t h o d o f

e v a l u a t i n g h e re c h o c a r d i o g r a m . We di s agr ee. A

. Pat t er s on cont ends t hat the i dent i fi cat i on, i n hercas e, ofSee, e. g. , Pat t er s on R epl yB r . at5 ( “O ne appr opr i at e pl ace 11 t o l ook forgui dance i n evalua t i ng a D i etD rug C l ai m i ncl udes th e O r d e r s th a t th e D istric t C o u rt h a s is su e d th u s f a r in th is le n g th ylitig a tio n .” ). 16 a sin g le f

ra m e o f a n e c h o c a rd io g ra m c o n stitu tes a re a so n a b le m ed ical b asis b ec au se he r d o ctor review ed th e en ti re echoc ar di ogr am. Pat t er s on as s ert s t hati n or dert o fi nd a “true” m axi m um j et , a ca r di ol ogi s tm us tr evi ew m ul t i pl e l oops and fram es and c om pare r egu rgi t ant j et s. W y et h a n d t he T rust co n tend that, ev en if P att erso n ’s do ctor rev iew ed the e n ti re echoc ar di ogr am, he fa i l ed t o i ndi cat e th at t he i dent i fi ed m axi m u m jet w as r epr es ent at i ve of he rcondi t i on and notan iso late d a n d n o n -re c u rrin g in c id e n t. I n det erm ining w hethera s i ngl e fr ame of an echoc ar di ogr am const i tut es a r eas onabl e medi cal bas i s for fi ndi ng m oder at e m i t r al r egur gi t at i on, the par t i es agr ee thatt he D i stri ctC ou rt ’s pri or de c isi on s ar e i nst ruct i ve. T hese 11 decis i on s i nd i cat e t hat the S et t lem e nt A greem ent r equ i res a car d iologi s tt o r evi ew the ec hocar di ogr am for a r egur gi t antj et t hati s rep rese nt at i ve of the s ever i t yof the cl ai m ant ’ s m edi cal condi t ion. T he i dent i fi cat i on of a s i ngl e j etw i t houtany expl anat i on ori ndi cat i on of i t s r epr es entati venes s w i l l not s at i s fyt he cl ai m ant ’ s bur den. I n P TO 2640 , t he D i s t r i ct C our texami ned s eventy - ei ght c laim s d e ter m in e d b yth e T r u st to b e m e d ica llyu n re a so n a b le beca us e the ec hocar di ogr ams s how ed no s i gni fi can t level s ofS e e a l so i d. a t 4 5 2 (“ T o c o n f ir m m itr a l re g u rg ita tio n , a 12 ca rdio log ist w il l h av e to re v iew n u m ero u s fra m es a n d loo p s. ”); i d. at45 4 (accepti ng t he “a n al y si s, con cl usi on s, and op i nions” o f a n e x p e rt w itn e ss , D r. D e n t, be c a u se “ [ h ] e d id n o t sim p ly l ook atone fr ame of an ec hocar d i ogr am and r eac h an opi ni on a b o u t th e se v e rityo f

m itral re g u rg itatio n ” ); i d. at457 ( not i ng t hatan att es t i ng phy s i ci an “f r equent l ym i s too k backf l ow and m il d m itral regu rgit ati o n f o r m o d era te or m o re se v ere re g u rg itatio n ” b e c a u se “ [ u ]n lik e D r. D e n t w h o b a se d th is as s es s m ent o n r evi ew s of both the di gi t i zed i m ages and the vi deot apes , [the att es t ing phy s i ci an] di d notanal y ze the vi de o t a p e s f

o r a l l o f t h e e c h o c a r d i o g r a ms t o whi c h s he att ested ”). 17 m i t r al r egur gi t at i on. T he courtnot ed that“[f ] orm oder at e mi t r al r egur gi t at i on t o be pr es ent , t he s i ze of t he r ever s e fl ow i ng j etof bl ood ati t s m os texpans i ve poi ntm us tencom pas s betw een tw e n ty p e rc e n t a n d f

o rt y p e rc e n t o f th e a re a o f th e le f t a tr iu m ,” P TO 2640 , 236 F. Supp. 2d at 450, and di s cus s ed the Set t l ement A g re e m e n t’s “ p r o to c o l” f o r m e a su rin g re g u rg itatio n . “O n ly aft er r eview i ng m ult i ple l oo ps and st i l l fram es can a cardi ologi st r eac h a m edi cal l yr eas onabl e as s es s m entas t o w hethert he t w entyper centt hr es hol d form o d era te m i t r al r egur gi t at i on has been a chi eved. ” I

d. at451. T he D i s t r i ct C our t hel d thateac h

12 o f th e d isp u ted c laim s lac k e d a re a so n a b le m e d ica l b a sis , an d in m os tcas es , t he meas ur ed j etw as nota true r egur gi t antj etbut ra th e r a p h a n to m je t o r a b a c k f lo w . I d. at454, 458.18 Si nce P TO 2640 , the D istric t C o u rt h a s re p e a ted ly cr i t i ci zed the us e of a s i ngl e fr ame of an ec hocar di ogr am as the so le ba sis fo r a c lai m o f m itral regu rgit ati o n . “ [ F ]or a re a so n a b le m e d ica l b a sis to e x ist, a c laim a n t m u st d e m o n stra te th a t a f in d in g o f

th e re q u isite le v e l o f re g u r g itatio n is r epr es ent at i ve o f the l evel of r egur gi t at i on t hr oughoutan echoc ar di ogr am. ” I

n r e D i et D r ugs , N o. 2 :16 M D 1203, 2007 W L 1 4 6 1 4 4 1 , at * 5 (E .D . P a . M a y 1 6 , 2 0 0 7 ); I n r e D i et D r ugs , N o. 2: 16 M D 1203, 2007 W L 1462407, at*4 ( E

. D

. Pa. M ay16, 2 0 0 7 ). “N o th in g in th e S e ttl e m e n t A g re e m e n t su g g e sts th a t itis perm i s s i bl e for a cl ai m ant t o r el y on i s ol at ed i ns t ance s of w hat a p p e a rs to b e th e re q u isite le v e l o f re g u rg itatio n to m e e t th is defi ni t i on. ” I

n r e D i et D r ugs , 2007 W L 1461441, at *5 n . 1 2. E v e n th o u g h “ o n e o f

th e e n d n o tes in th e G re e n F o rm re f e rs to obt ai ni ng t he r egur gi t antj etar ea f r om a ‘ m axi m um oraver age [ o f ] th re e p lan e s,’ th is d o e s n o t m e a n th a t a c laim is compensa bl e bas ed onl yon the maxi m um oraver age r egur gi t ant j etm eas ur ed. ” I

n r e D i et D r ugs , 2 0 0 7 W L 1 4 6 2 4 0 7 , a t* 4

. “ To concl ude otherw i s e w oul d al l ow cl ai m ant s w ho do n o thave m o d e ra te o r g r e a ter m itral re g u rg itatio n to re c e iv e M a trix B enef i t s , w hi ch w oul d be contr ary t o t he i nt ent of t he Sett l ement A gr eement

. ” I

d. T o ill u stra te, th e D istric t C o u rt h a s, in d isa g re e m e n t w ith t he audi t i ng car di ol og ist , aw ar ded M atr i x compensa t i on w hen t he evi dence s how s a r epr es ent at i ve r egur gi t ant j et of s uffi ci ent m agni tude. I n I

n r e D i et

D r ugs , N o . 9 9

- 2 0 5 9 3 , 2 0 0 7 WL 320407 ( E

. D

. Pa. J an. 29, 2 0 0 7 ), the att es t i ng phy s i ci an foundTh e Di s t r i c tCou r ta p p r o v e d th e tr a i n i n g c o u r s e i n PTO 13 2 8 2 5 (E

. D

. P a. A p r. 7 , 2 0 0 3 ). 19 a r egur gi t at i on r at i o o f 2 4 per centand conc l uded the cl ai m ant s uffe r ed fr om m oder at e m i t r al r egur gi t at i on. U pon r evi ew , t he au d it ing ca rdio log istco n clud ed that the a tt esti n g p h y sic ian ’s opi ni on l acke d a r eas onabl e medi ca l bas i s . D ur i ng t he s how c a u s e p r o c e e d i n g s , a t e c h n i c a l a d v i s o r c o n c l u d e d t he echoc ar di ogr am demonstr at ed moder at e mi t r al r egur gi t at i on. I m por t ant l y , t he t echni cal advi s orfound an aver age of 22 p e rc e n t m itr a l re g u rg ita tio n o v e r f o u r c a rd ia c c y c le s . I

d. at*3.

“ U n d e r th e se c irc u m sta n c e s, c la im a n t h a s m e t h e r b u rd e n in es t abl i s hi ng a r eas onabl e medi cal bas i s for hercl ai m . ” I d. ; s ee al s o I n r e D i et D r ugs , N o. 2: 16 M D 1203, 2007 W L 1118379, at*3- 4 ( E

. D

. Pa. A pr . 12, 2007) (ho lding thatcl ai m ant demonstr at ed r eas onabl e medical bas i s form oder at e mi t r al r egur gi t ati on and an a bnor m al l eftatr i al di m ens i on bas ed on T echni cal A dvi s or ’ s opi ni on, w hi ch exa m i ned t h r ee di ffe r ent v ie w s o f th e h e a rt ). In a d d iti o n to th e D istric t C o u rt’s in stru c tio n s o n w h a t is m edical l yreas on able, th e A u d iti n g C a rd io lo g istT rai ning C ou rs e i s i nst ruct i ve. T he tr ai ning cou rs e st at es: 13 Im p o rta n ce o f V iew ing M u lti p le H ea rtb ea ts and F ram es A s y o u a r e a war e f

r o m y o u r c l i n i c a l p r a c t i c e , an e c h o r e a d e r c a n n o tf

o c u s o n a s i n g l e f

r a meO n t he same page, t he cour s e ci t es an author i t at i ve medi cal 14 t ext , A

. E

. W ey m an , P ri n ciples a n d P rac ti ce of Echocar di ogr aphy 4 3 6 (1 9 9 4 ): W hen the dur at i on of s y s tole change s ( changi ng h e a rt ra te) o r w h e n re g u rg itan t f lo w is c o n f

in e d to o n l ya p o r t i o n o f

s y s t o l e ( i

. e . , mi t r a l v a l ve pr ol aps e) , t he re l at i ons hi p of t he peak ar ea t o the re g u rg itan t v o lu m e w ill v a ry . In p a tien ts w ith pr ematur e bea t s or atr i al fi br i l l at i on, t he col orj et ar ea mayvary fr om cy cl e t o cy cl e as t he dur at i on o f sy stole an d v en tric u lar pres su re c h an g e. In s uch ca s es , i ti s i m por t ant t o aver age the col orj et

20 w i t houtr efe r enc e t o t he over al l l evel of r egur gi t at i on as as s es s ed us ing m ul t i pl e fr ames a n d h e a rtb e a ts. O n lya f ter re v iew in g m u lti p le l oops and s t i l l fr ames c an a c ar di ol ogi s tr eac h a M edi cal l yR eas onabl e as s es s m entas t o w hether anyof the var i ous thr es hol ds es t abl i s hed bythe Set t l ementforthe di ffe r ents ever i t yl evel s of r egur g it at i on have be en ac hi eved, s uch as t he 20% t hr es hol d form oder at e mi t r al r egur gi t at i on. T h e in terp re te r o r a u d ito r th u s m u st p ro p e rly appre ciat e the l evel of r egur gi t at i on w her e a s ingl e fr ame m aynotappr opr i at el yr epr es entthe t rue vol um e of the r egur gi t at i on dur i ng s y s t ol e. P T O 2 8 2 5 (E

. D

. P a. A p r. 7 , 2 0 0 3 ). 14ar ea f r om a numberof bea t s t o at t ai n a r e p r e s e n t a t i v e me a s u r e o f r e g u r g i t a n tf

l o w. P T O 2 8 2 5 (E

. D

. P a. A p r. 7 , 2 0 0 3 ). 21 A s not ed , Pat t er s on cont ends thatthe Set t l ement A gr eemental l ow s a car di ol ogi s t t o m eas ur e a s i ngl e maxi m um j et

. Fur t herm or e, Pat t er s on as sert s t hat“[t ] her e i s no fac tual basi s for concludi ng t hat the m axim um regurg itan tj eti s not r epr es ent at i ve o f the reg u rgit ati o n t hr oughout t he echoc ar di ogr am or that[D r . Si l vestry ] di d notr evi ew al l t he lo o p s a n d f

ra m e s .” P a tte rs o n B r. a t 7

. D r. S ilv e s tr y ’s re p o r t i n d ic a te d : “ O n M a y7 , 2 0 0 3 , I r evi ew ed and a nal y zed M s . Pat t er s on’ s e c hocar di ogr aphi c s tudy

. . . and per form ed m y ow n m eas ur ement s of the l eftatr i al and r egur gi t an t je tar ea. I i dent i fi ed the maxi m um r egur gi t antj et and meas ur ed i t s ar ea us i ng E choA nal y s i s s oftw ar e. ” B as ed on t hi s s t at ement , Pat t er s on cont ends t hatD r . Si l ves t r ycoul d not have i dent i fi ed t he maxi m um r egur gi t antj etw i t houtr evi ew i ng mu l t i p l e l o o p s a n d c o mp a r i n g r e g u r g i t a n tj e t s . Bu te v e n i f we w er e t o as s um e thatD r . Si l vest ry r evi ew ed mul t i pl e l oops , the qu est i on of r epr es ent at i venes s r emai ns . U ndert he Sett l ement A gr eement , Pat t er s on has the bur den of pr oof t o d e m ons t r at e her ent i t l ementt o benef

i t s . A g en era l s t at ementt hata doct or r evi ew ed an e choca r di ogr am does notnece s s ar i l ym ean the m eas ur ed j eti s r epr es ent at i ve of the cl ai m ant ’ s true l evel of m itr a l r e g u rg ita tio n . W e ca nnotagr ee w i t h Pat t er s on’ s ar gum entthat , i n aB ec au se the m ea su rem en ts b y D r. H arris a n d D r. S il v estry 15 w er e ators l i ght l yabove the 20 per centt hr es hol d, w e nee d not add ress w hetheri ndi cat i ons of r epr es ent at i venes s ar e r equi r ed in a m o re c le a r- c u t c a s e o f m itr a l r e g u rg ita tio n . I n her br i ef, Pat t er s on al s o appea r s t o s ugges tt hats he w as 16 deni ed pr ocedur al fai r nes s , as s ert i ng t hat t he D i s t r i ctC our thas not concr et el y defi ned “r eas onabl e m edi cal bas i s ” and deci des t he mer i tof clai m s on a ca s e- by

- cas e bas i s . H ow ever , atthe t i m e of Pat t er s on’ s br i efs and D r . Si l ves t r y ’ s r epor ti n M ay 2 0 0 3 , th e D istric t C o u rt h a d c lea rly a n n o u n c e d th e re q u ire m e n ts f o r r e a d in g a n e c h o c a rd io g ra m , s ee PTO 2640 , and had ap p rov ed the A u d it ing C ard iolog istT raining C o u rs e , s ee PTO 2825. T hus , Pat t er s on and herat t orney s had s uffi ci entnot i ce of th e re a s o n a b le m e d ic a l b a s is s ta n d a rd

. 22 b o r d e r l i n e c a s e s u c h a s t h i s , t h e me a s u r e me n t o f a s i n g l e f r a me i n an echocar di ogr am, w i t houtevi dence s how i ng thatthe depi ct ed j eti s a true r egur gi t antj et , i

. e. , r epr es ent at i ve of the cl ai m ant’ s a c tual l evel of m i t ral regurgi t at i on , con st i tutes a r eas onabl e m edi cal bas i s for r ecove r i ng M atr i x compensa t i on. 15 T o h old ot herw i se w oul d pe r mi t cl ai m ants w ho se e c h o c a rd io g ra m s s h o w a n a b e rra n t jet in a s in g le f ra m e to re c o v e r p a ym e n t f

ro m th e T ru st. 16

B

. N ext, P at t ers on con ten ds t hat an aud i t i ng cardi ologi st m us tm ake qua nt i t at i ve m eas ur ement s i n or der t o det erm i ne theT he Set t l ement A gr eementi ncorpor at es the def i ni t i ons of 17 m itr a l r e g u rg ita tio n d e s c ri b e d in J .P . S in g h , e t a l., P r evalence of C lin ica l D e te r m in a n ts o f Mitra l, T

ric u sp id a n d A o rtic Reg u r g i ta t i o n (

Th e Fr a mi n g h a m He a r tS t udy) , 83 A m J. C ar di ol ogy897 ( 1999)

. “M i l d M i t r al R egur gi t at i on” i s defi ned in th e S e ttl e m e n t A g re e m e n t a s: “ (1 ) e ith e r th e R JA /L A A ra tio i s m or e than fi ve per cent( 5% ) ort he mi t r al reg u rgi t antj et hei ghti s gr eat ert han 1 cm fr om t he v al ve or i fi ce, and ( 2) t he R J A / L A A r at i o i s l es s than tw en t yper cent( 20% )

. ” A s not ed, R J A i n t he num er at or of t he fr act i on r epr es ent s R egur gi t antJ et A r ea w hi l e LA A i n t he denomi nat ors t ands forL eftA t r i al A r ea. Si ngh des cr i bes “tr ace ” or t r i vi al m i t r al r egur gi t at i on as a mi t r al r egur gi t antj ett hatr emai ns “w i t hi n 1 cm fr om t he val ve or i fi ce” 23 per cent age of

m i t r al r egur gi t at i on. She ar gues t hata vi s ual as s es s m ent i s not pr eci s e enough t o comput e the mi ni m um 20% r egur gi t at i on r equi r ed byt he S ett l ementA gr eement

. Pat t er s on as s e r t s b e c a u s e h e rc a s e i s a c l o s e o n e – Dr

. Harr i s me a s ur ed 20% reg u r gi t at i on and D r . Si l ves t r ym eas ur ed 20. 57% r egur gi t at i on – t he D i s t r i ctC our ts houl d n o t h ave r el i ed upon the a u d it ing ca rdio log ist ’s v is u a l a s s e s s m e n t to re je c t P a tte rso n ’s cl ai m . W y eth and t he T rus tdemur, cont endi ng t hatan audi t i ng car di ol ogi s t m ay vi s ual l y det erm i ne w hether a qual i fy i ng condi t i on exi s t s . T hati s , an audi t i ng car di ol ogi s tneed notm ake a q u a n tit a tiv e m e a su re m e n t w h e n th e e c h o c a rd io g ra m c lea rly s how s an amountof m i t r al r egur gi t at ion co ns i s t entw i t h the gener al popul at i on. A ccor di ng t o W y eth and t he T rust, s i nce D r . C hur chw el l found onl ytr i vi al t o m i l d m i t r al r egur gi t at i on, 17and occ upi es l es s t han fi ve per centof the l eftatr i al ar ea. 24 i tw as unn ecessaryt o take qu anti t at i ve m easurem ents

. W h il e c o n d u cti n g the a u d ito f P att erso n ’s claim , D r. C hur chw el l r evi ew ed the ec hocar di ogr am t ape, a copyof the G re e n F o rm , an d P a tters o n ’s m e d ica l re c o rd s. D r. C h u rc h w e ll co n d uct ed a vi s ual as s es s m entof the ec hocar di ogr am and con cl ud ed ther e w as no reasonab l e basi s for D r. H arr i s’ d e ter m in a tio n . D r. C h u rc h w e ll n o ted th a t D r. H a rris “over es t i m at ed” t he m i t r al r egur gi t ant j et ar ea i n r el at i on t o the l eftatr i al s i ze. Fur t herm or e, D r . C hur chw el l det erm i ned that Pat t er s on’ s m i t r al r egur gi t at i on w as “tr i vi al t o m i l d” and “< 2 0 % .” T h e p u rp o se o f

th e a u d iti n g c a rd io lo g ist re v iew is to exami ne the cl ai m ant ’ s m edi cal condi t i on us i ng nor m al cl i ni cal j udgm entand ac cept ed medi cal s t andar ds t o det erm i ne w hether t he att es t i ng phy s i ci an’ s concl us i ons had a r eas onabl e medi cal bas i s . T he D i s t r i ctC our thas , on num er ous occa s i ons , acc ept ed an audi t i ng car di ol ogi s t ’ s m edi cal opi ni on w hen bas ed upon a v isua l assessm en t of

an ec h o ca rdio g ram an d sti ll fr a m e s. In doi ng s o, t he D i s t r i ctC ou r tobs erved that“‘ [e] y ebal l i ng’ t he r egur gi t antj ett o as s es s s ever i t y i s w el l acc ept ed i n t he w or l d of car di ol ogy . ” P TO 2 6 4 0 , 236 F. Supp. 2d at 454. W e agr ee a nd under s t and that“ey ebal l i ng” i s pr oper w hen an echoc ar di ogr am cl ear l yi ndi cat es t hatt he cl ai m ant ’ s l evel of m i t r al r egur gi t at i on i s cons i s t entw i t h t he gene r al popul at i on.25 In o rd e r to d iag n o se a p a tien t, a c a rd io lo g ist w ill v isu a lly rev iew an ec h o ca rdio g ram tape to d eterm ine w h ethe r a condi t i on i s pr es ent

. A s not ed, m i l d an d t r ace r egur gi t at i on occurnor m al l yi n 90% of the popul at i on. A cc o rdin gl y , i f an e c h o c a rd io g ra m s h o w s a n o rm a l a m o u n t o f re g u rg ita tio n – i.e ., cl earl ybelow t he q uali fy i ng t hreshol d – an audit i ng cardi ologi st need notm eas ur e the maxi m um j et

. B uti f the amountof re g u rg itatio n is a t o r n e a r th e th re sh o ld , in th is c a se 2 0 % , it w o u ld a p p e a r to b e n e c e ss a r y t o m e a su re p a rticu lar f ra m e s to quant i fyt he s ever i t yof the condi t i on. A ft er rev iew i ng the ec h o ca rdio g ram , D r. C h u rch w ell v isua ll yd eterm ined that D r. H ar r i s ’ m eas ur em en t – 20% m i t r al r egur gi t at i on – “o v ere sti m ate d ” P att erso n ’s l ev el of reg u rgit ati o n an d D r. C h u rc h w e ll c h a ra c te ri z e d h e r s ym p to m s a s “ tr iv ia l to m ild .” A lth o u g h D r. C h u rc h w e ll co u ld h a v e b e e n m o re p re c ise , it appea r s t hat hi s l anguage – “over es t i m at ed” and “tr i vi al t o m i l d” – i ndi cat es he f

o u n d r egur gi t at i on w el l bel ow the 20% thr es hol d, m aki ng a quant i t at i ve meas ur ementunnece s s aryi n t hi s cas e. U nder o rdinaryci r cumst ance s , a vi s ual r evi ew bythe audi t i ng car di ol ogi s t i ndi cat i ng m i t r al r egur gi t at i on at o r near t he thr es hol d w oul d appea r t o cal l form or e than “e y ebal l i ng” by t he audi t i ng car di ol ogi s t

. N evert hel es s , even i f thi s cas e i s , as P att erso n asse rt s, clos e to th e thre sh o ld, D r. C h u rch w ell ’s d e te r m in a tio n d o e s n o t p re c lu d e re c o v e ryo f M a trix compensa t i on – i tm er el ys hif t s the bur den bac k t o Pat t er s on. A udi tPol i ci es & Pr ocedur es § V I

. D

. , P T O 2457 ( M ay31, 2002)

. I f t he audi t i ng doct or ’ s vi s ual as s es s m enti s w r ong, t heItap p ea rs th at D r. S il v est ry w a s in s tru cted b yP att erso n ’s 18 c o u n se l to re v iew th e e c h o c a rd io g ra m a c c o rd in g to th e ir interpre tat ion o f th e S ett lem en t A g ree m en t. D r. S il v estry ’s r epor ti ndi cat es t hathi s opi ni on w as “i nt ended t o pr ovi de l egal con sul t at i on ” and shou l d no t be rel i ed u po n “fo r the d i agn osi s, p ro g n o s is , o r t re a tm e n t” o f th e c la im a n t’ s m e d ic a l c o n d itio n . 26 cl ai m anthas t he oppor tuni t yt o offe ra r ebu tt al and pr es ent addi t i onal evi dence

. A s not ed, Pat t er s on s ubm i t t ed a r epor tby D r . Si l ves t r yi dent i fy i ng and meas ur i ng the maxi m um r e g u r g i t a n tj e t

. Ho we v e r , a r e p o r tb a s e d u p o n a s i n g l e fr a me m ea su rem en t do es n o t r eb u t an a u d it ing ca rdi o log ist ’s asse ssm en t of

the e n ti re e c h o ca rdio g ram . B ec au se D r. Si l ves t r y ’ s r epor tdoes noti ncl ude any i ndi cat i on of the m axi m um r egur gi t antj et ’ s r epr es ent at i venes s , Pat t er s on has fa il ed to m ee t her b u rde n . A cc o rdin g ly , w e reject P att erso n ’s 18 ar gum entt hatD r . C hur chw el l ’ s m ethod of re v i ew i ng her echoc ar di ogr am w as i ns uffi ci entt o s uppor t t he Trus t ’ s deni al of h e rc l a i m. C

. Fi nal l y , Pat t er s on cont ends thatthe D i s t r i ctC our terr ed beca us e i t r ej ect ed t he m edi cal r epor ts ubm i t t ed dur i ng t he s how caus e pr oce ed ings r athert han thatof the or i gi nal at t es t i ng do ct or. S he argu es that “the s tan d ard i s w hethert here i s a r eas onabl e medi cal bas i s forthe at t es t i ng phy s i ci an’ s opi ni on, nott he r evi ew i ng p h y s ic ia n ’s o p in io n .” P a tte rs o n B r. a t 7

.27 O n c e th e T ru st d e n ies a c laim a n d th e c laim a d v a n c e s to a s how caus e pr ocee di ng, t he cl ai m anthas t he bur den of pr ovi ng t her e w as a r eas onabl e medi cal bas i s forthe att es t i ng ph y si ci an’s r epresent at i on s. A ud itP oli ci es & P rocedu res § V I. D ., P T O 2 4 5 7 (M ay3 1 , 2 0 0 2 ). T h e D istri ct C o u rt acknow l edged a n d ap p l i ed the corr ects t andar d underthe Set t l ementA gr eement

. A ccor di ng t o t he D i s t r i ctC our t , “[t ] he i s s ue pr es ent ed forreso lut i on of thi s cl ai m i s w hether [P at t ers on ] has m ether burden i n p ro v ing thatt here i s a r eas onabl e medi cal bas i s fort he att es t i ng phy sic i an’ s fi ndi ng t h at she ha d m oder at e mi t r al r egur gi t at i on. ” I n r e D i et D r ugs , 2007 W L 674720, at*2. T he courtconcl uded t hat “the att es t i ng ph y si ci an’s answ er l acks a reasonab l e m edical basi s . . . becau se t he att es t i ng phy s i ci an’ s fi ndi ng fai l ed t o r efl ect t he actual l evel o f [P at t er s on’ s ] m i t r al r egur gi t at i on. ” I d. a t* 3

. I tf

a u l t ed P a tters o n f

o r f a ili n g to “ a d d re ss th e im p ro p e r m e a su re m e n ts under l y i ng t he fi ndi ng of herat t es t i ng phy s i ci an. ” I d. A s not ed, in an att empt t o s uppor thercl ai m , Pat t er s on subm i t t ed a ce rt i fi cat i on prepared by D r. S i l vest ry . B ut because D r . Si l v e s t r y ’ s r e p o r t i d e n t i f i e d th e ma x i mum r e g u r g i t a n t j et w ith o u t anyd is cu ssion o f it s rep rese n tat iven ess, th e c o u rt concl uded thatt he r eportdi d nots uppor tPat t er s on’ s cont ent i on th a t D r. H a rr is ’ o p in io n h a d a r e a s o n a b le m e d ic a l b a s is

. I d. at *4 ( “C l a i ma n th a s n o te s t abl i s hed thatthe ‘ m axi m um r egur gi t ant j et ’ offe r ed i n s uppor tof her cl ai m i s r epr es ent at i ve of he rl evel o f m itral regu rgit ati o n . . . . ”). D r . C hur chw el l found tr i vi al t o m i l d m i t r al r egur gi t at i on28 i n Pat t er s on’ s echoc ar di ogr am. U nderthe A u d itPol i ci es and P rocedu res , P at t ers on had the b urden to p rove t hat D r. H arr i s’ o p inion had a r eas onabl e medi cal bas i s . Pat t er s on had the oppor tuni t yt o s how thatD r . H arr i s ’ fi ndi ng rep rese nt ed the ac tual leve l of

P att erso n ’s m itral regu rgit ati o n . B u t D r. S ilv e stry ’s r e p o rt f

a iled to sa tisf

y P a tters o n ’s b u rd e n b e c a u se it onl yi dent i fi ed a s i ngl e maxi m um r egur gi t antjetw i t houtany i ndi cat i o n of the j et ’ s r epr es ent at i venes s . A ccor di ngl y , t he D istric t C o u rt p ro p e rly re jec ted D r. S ilv e stry ’s r e p o rt b e c a u se it fai l ed to r ebu tD r. C hu rchw el l ’s con cl usi on t ha t D r. H arr i s’ reportl acked a reas on able m edical basi s. III

. F o rt h e f o r e g o i n g r e a s o n s , we wi l l a f f i r m.