UNITED STAT ES COURT OF AP P EALS FOR VETERANS CLAIMS

N O
. 07-1081
J A M ES A. H AL C OMB , A PP EL L ANT ,

v
. E RI C K. S H I N SEKI , S EC RE T A RY O F V ET ER A N S A FF A I RS , A PPEL L EE
. On Ap pe a l f ro m th e B oa

rd of Ve te ra ns ' Ap pe a ls

(Argued Apr il 15, 2009 Decided O ctober 20, 2009)

Z ach ar y M. Sto lz , w ith

wh om La n d

o n E. Ove rby (non-attorney prac titioner), was on the brief, bo th o f Wa sh ing ton , D .C. , f or the a pp e lla nt. Mark M . McNabb , w ithwh om Paul J. Hutter , G e ne ra l Co un se l; R. Ra nd all Cam pb e ll , Assistant Gener al Counsel; and J oa n E. M or iar ty , Deputy

Assistant Gener al Counsel, wer e on the brief, a ll of Washington, D.C., for the appellee

. Be fore GREENE, Chief Judge , and LANCE and DA VI S, Judges

. DAVI S, Judge : U

. S

. A r m y v e t e r an Jam e s A

. H a l c o mb a p p e a l s th r o u g h c o un s e l f r om a De c e mb e r

1 9 , 2 0 0 6 , B o ar d

o f V e t e r an s ' Ap p e a l s ( B o ar d ) d e c i s i o nth atd e n i e d e n t i t l e m e n tto compensation benef

its under 38 U.S.C. § 1151 for loss of vi sion in the l eft ey e. The issue be fore the Court is whether the a

ppellant has e stablished that VA' s car e and treatment proximately cause d an

a dd iti on a l qu ali fyingdis a bil ity un de r 3 8 U .S. C. § 11 51 (a ) a nd 38 C.F .R. § 3 .3 61 wh e re the on ly

e vid e nc e c on c e rn ingwh e the r V A o bta ine d in fo rm e d c on se nt pri or to the a pp e lla nt' s su rg e ry is a standard f orm signe d by

the appe llant that does not identify any specific risks that were discussed wi th h im. Th is C ourt

ha s juri sd ic tio n to r evi e w the B oa rd ' s d e c isi on

purs ua nt t o 3 8 U .S. C. §§ 7252(a) and 7266(a ). See F rankel v . Derwinski , 1 Vet.App. 23, 25- 26 (1990). F or the following

rea sons, the Court will affirm the B oard' s Dec ember 2006 decision." E n d o p h tha lm iti s" is d e fine d a s " infla m m a tio n inv o lvin g the o c u la r c a v iti e s a n d the ir a d ja c e n t stru c tur e s." 1 D OR L A ND ' S I L L US T R A T E D M E D I C A L D I C T I ONA R Y 6 2 7 (3 1 st e d . 2 0 0 7 ).

2 I. BACKG ROUND On April 10, 2002, t he appe llant underwe nt "same day " sur g ery at the Mar ion, I llinois , VA Medica l Center for

remova l of a lef

t-eye catara ct an d l en s repla ceme nt. After the surg ery , he de ve lop e d e nd op hth a lmi tis

. L ate r, at St. L ou is Univ e rs ity Ho sp ita l, h e un d e r

w e nt a v i t r e a l a nt i bio tic 1 inj e c tio n o f t

he le ft e y e and a se c on d s ur g e ry , k

no wn a s a " tr ans pa ra pla na vic tr e c tomy ," to a dd

re ss retinal de tachment that wa s discovere d in the course of his treatment. Since these proc edure s, the veter an has suf

fer ed lef t-eye blindness. Prior to underg oing his c atar act surg ery at the VA f

acility , the appel l an t s i g ned two documents re lating to his per mission for the proce dures. The firs t wa s a form statingthat "[t]he nature and purpose of the operation or proce dure, possible alternative methods of treatment, the risks involved and the possibility of complications have bee n fully explained to me." Rec ord (R.) at 426. The other document wa s a statement ty pewr itten on a VA prog ress note sheet that re ad, in re levant pa rt , a s f oll ow s: Th e re le va

nt a sp e c ts o f the a

bo ve state d p ro c e dure /tr e atme nt, the ind ic atio ns , r isk s, be ne fi ts, and

a lte rn ativ e s h ave be e n d isc us sed wit h th e patie nt i n und e rs tand a ble languag e. The patient was given opportunity to ask questions conce rningthe proce dure/tre atment. Comprehension of the discuss io n w a s in d ic a

te d , and the patient fre ely consente d to the proce dure/tre atment without duress or c oerc ion.

R. at 427. Both docume nts were co-sig ned by a phy sician and w itnessed by a nurse . Nei ther document conta ined any

itemiz ation, notations, or fur ther de scription of what risks or alternatives may have be en discussed. Be cause his left-e y e bli ndness resulted afte r t he catara cts surg ery and subseque nt proce dures

at St. L ou is Univ e rs ity

Ho sp ita l, t

he a pp e lla nt s ou g ht c omp e ns ation fro m VA un de r 3 8 U .S. C. § 1151(a) . In J anuar

y 2005, a VA reg ional office (RO) de nied that claim. He appea led and in June 2 0 0 6 , th e B o ar d

re m an d ed

th e m at t er fo r t h e R O t o o b t ai nan o p i n i o nas t o wh et h er an y o f ap p el l an t 's vi s i o n l o s s was due to c are lessness, neg lige nce, la ck of pr oper skill, err or in judg ment, or similar fault of VAin furnishing car e duringthe April 2002 ey e surge ry
. R. at 598. A VA ex aminer opine d3

that there was no c are lessness, neg lige nce, la ck of pr oper skill, err or in judg ment, or si milar fault of VA in furnishingcar e, and the RO ag ain denied the appellant' s cl ai m for c ompensation under 38 U.S.C. § 1151(a). The appellant a g ain appe aled to the B oard. In th e de c isi on

he re on a pp e a l, t he B oa rd de nie d e nti tle me nt t o b enef its un de r 3 8 U .S. C. § 1151(a) . Preliminarily , the B oard f ound that both the endophtalmitis and the retinal tea rs wer e
re a so n a b l y f o r e s e e a b l e c o n s e qu e n c e s o f th e a p p e l l an t ' s m e d i c a l p r o c e d ur e s
. T h e B o ar d b a s e d it s finding on a VA me dical examination report that state d that endophthalmitis "i s a ra re, but not unhear d of complication , " an d t hat " retinal tea rs ar e alwa

y s a possible complication" in such proce dures. R. at 618. The Boa rd further found that "the medical evidenc e ref l ec t s i n fo rmed consent on the ve tera

n' s behalf unde r 38 C.F.R § 17.32." R. at 10. Relying on the text and conte nt of the consent form, the Boar d stated that there was no indication that the vetera n' s consent wa s not an informe d one. This appe al followed.

II. CO NT EN TIO NS O F THE P AR TIES

A. Th e Ap pe lla

nt The a ppellant asser

ts that a g ener ic writ t en co nsent form fa ils to comply with the VA

re gu l at i o n s o n i n fo rm ed co n s en t an d es t ab l i s h es n egl i gen ce p er s e. He ar gu es th at th e B o a r d 's finding that endophthalmitis and retinal tears were reasona bly fore seea ble eve nts means that under 38 C.F.R.§ 17.32(c) , VA had a duty to specifica lly

inform him o f t h es e p o s s ible outcomes. The appellant a sserts that his VA hea lth care providers f ailed to tell him of these known r isks, that such failure constitutes neg lige nt car e under 38 U.S.C. § 1151 and 38 C.F.R. § 3.361(d)(1) (ii), and that this neg lige nce e ntitles him to VA bene fits. Cf. Ashley v . Derwinski , 2 Ve t

. App. 62, 66 (1992) (providingthat "the presumption [of official re g ularity ] operates in reve rse. I f [the action] appear s irregular, it is irregular, a

nd the burde n shifts to the proponent to show the contra ry " ( quoting United States v. Roses I

nc. , 706 F.2d 1563, 1567 ( Fe d. Cir. 1983))). The alleg ed failure to inform is based on the fa ct that these r isks were not expl icitly mentioned on the fa ce of the co n s en t fo rm , and the consent for

m is the only

evidenc e on which the Boa rd re lied to find informed consent. The a ppellant mai ntains that the vague stateme nt on the consent for m that the "r eleva

nt aspec ts of the proce dure/tre atment, t he indi cations, risks, benef its, and alternatives have been discussed," whichA s t he Secr et ar y ac kn owl edges , t he i nf ormed cons ent p r ogr es s not e (R. at 427 ) , on wh i ch t he B oard r el i ed as 2
e v id e n c e o f in fo rm e d c o n se n t, d o e s n o t c o n fo rm to th e re q u ire m e n ts o f V H A H an db oo k 1 0 0 4

. 1 i n s everal res p ect s. T here i s no i nd i cat i o n o f

the d at e o r t i m e. T here is no indi cat i o n of t he p at i ent ' s m ent al s t at us at t he t i m e t he i nf o rme d co nsent info rm a tio n w a s p ro v id e d , an d the p ra c tit io n e r d id no t i n d ic a te w h e the r th e p a tien t ha d d e c isio n m a k ing c a p a b ili ty.
M oreove r , t he r egu l at i on i t s el f r equi r es t he cons ent d i s cus s i on t o be conduct ed by "[t ] he prac t i t i oner wh o has p ri m ary res p o nsi b i l i t y f o r t he p at i ent o r who wi l l p erf o rm t he p art i cul ar p roce d ure. " 3 8 C

. F.R

. § 1 7

. 3 2 (c) (20 0 9 ). T he fo rm p ro v id e s n o e v id e n c e tha t t h is re q u ire m e n t wa s fulfil le d . T h e sign a tur e o f t h e p ra c tit io n e r w riti n g t h e n o te is ill e g ib le

. T h e fo rm a lso p ro v id e s n o e v id e n c e tha t t h e re w a s a n y d isc u ssio n o f " a n ticip a te d re su lts i f no thin g is d o n e ." Id

. T h u s, e v e n if

the S e c re ta ry w e re c o rr e c t t h a t co m p o rting w ith m a n u a l re q u ire m e n ts a c h ie v e s info rm e d c o n se n t, this f o rm m i gh t ha ve b ee n c ha l l en ge d o n sev era l b ase s. 4 does not expli citly

list t he speci fi c risks of e ndophthalmitis and re tinal tears, doe s not satisfy the

re g ulatio n' s r e qu ir e me nt. The a ppellant, howeve r, has pointed to no evidenc e in the record that he ever alleg ed that the informed c onsent discussion w as defe ctive in a ny way
. Rather, he states that "in his brief befor e the Boa rd, he a ddresse d the issues of n egl i gence and re asonable forse eability , both of which a re intertwined with the issue of informed consent." Appellant' s Supplemental Br ief (Supp. Br .) at 1. He fu rt he r p oints o ut t

hat th e B oa

rd disc us sed th e ad e qu a c y

of inf or me d c on se nt u

nd e r 3 8 C. F .R. § 17.32. Id. B. The Secre tary The Sec reta

ry asser ts that the appellant' s signe d consent form is the only evidenc e in the

rec ord bea

ringon the question. He contends that the g overningregulation and statute do not requir e complete doc umentati on of the infor med conse nt proce ss. Rather, the Sec reta ry insists that 38 C.F.R. § 17.32 require s only that the conse nt proce ss be " appropr iately documented." He pr offe rs that an esta

blished interpre tation of appropr iate docume ntatio n is found in the VHA Handbook 1004.1, Paragraph 6, which require s, among other thi ng s, "[a] statement t hat re levant aspe cts of the treatment or proce dure inc luding indications, risks, benefits, and altern ati ve options have be en di scu ss ed wi th th e pat ien t in lan guage t he pat ien t un ders to od ." Id. ¶6(b) (6). There fore , the Secr etar y conclude s that the informed c onsent document in this case constitutes appropriate docum en t at i on of the inf or me d c on se nt p ro c e ss u

nd e r 3 8 C.F .R. § 17. 32 , d e viatio ns fr om r e g ulator y re qu ir e me nts

n o twi th s t an d i n g. The Sec reta ry al s o co n t en d s t h at t h e s u ff iciency of the informed consent 2 proce ss documented in the gene ric consent form is g overne d by the presumption of administrative5

regularity . He a

rgues that applying this pre sumption, the ade quacy of an a ppropriate ly

documented informed c onsent proce ss can be overc ome only by submissi on of cle ar e vidence to the contra ry
.

III. AP P LICABLE LAW A veter an who believes that he has sustained a n additional disability

resultingfrom tre atment in a VAfa c ili ty

c an s e e k c ompens atio n in tw o w ay s. Th e ve te ra

n c a n s ub mit a c la im f or be ne fi ts under 38 U .S.C. § 1151(a). He may also seek c ompensation b y filing a claim ag ainst the g overnme nt, based on the pur ported ne g lige nce of

its employ ees, inc luding lac k of informe d consent befor e surg ery , under the Fe dera l Tort Claims Act (FTCA)

. See 38 U.S.C. § 1151(b). Under 38 U.S.C. § 1151(a), c ompensation " shal l b e awa rded f or a qua lifying a dditional d is a b il it y in th e s ame ma

n n e r a s if s u c h a d d it io n a l d is a b il it y w e r e s e r

v ic e [ ]c o n necte d" if

the dis a bil ity wa s (a) . . . not the result of the ve tera n' s willful mis conduct a

nd – (1) . . . wa s caus ed b y hospital care , medical or surg ical tre atment, or examination furnished the vete ran unde r any law ad m i n istered by

the Secre tary . . . and the pr ox imate ca use of the disa

bility or death was – (A ) ca rele ssness, neg lige nce, la ck of pr oper skill, err or in judg ment, or simil ar instanc e of f

ault on the par

t of [VA] in furnishi ngthe hospital car e, medical or

surg ical tre atment, or e x amination; or (B ) an e vent not rea sonably fore seea ble. 38 U. S.C. § 1 15 1; see Pub. L

. No. 104-204, § 422(b)(1), ( c), 110 Stat. 2926-27 ( 1996) (amending

s ec t i on 1151 to incorporate fa ult requireme nt and providingthat those amendme nts were made applicable to claims filed on or a fter O ctober 1, 1997). Thus, to obtain bene fits under 38 U .S.C. § 1151(a) , a cla imant must show: (1) A "qua lifying additional disability ," ( 2) ac tually cause d by

the treatment furnished by VA, and (3) a proxi mate or dire ct ca

use that is either a

fault on the pa

rt of VA

or an e vent not rea sonably fore seea ble. Id ; 38 C.F.R. § 3.361(c)( 1), (d) (1) ( 2009). A " qualifying a dditional disabili ty " is pr ox imately cause d by VA medical car e, treatment, or

e xami na tio n wh e n the dis a

bil ity re su lts fr om either the c are le ssn e ss, ne g lig e nc e , la c k o f p ro pe r s kil l,

err or in judg ment, or similar instance of fault on the pa

rt of the Depa

rtment in furnishing the medica l tr e atme nt; or the dis a

bil ity re su lts fr om " an e ve nt" that is " no t r e a so na bly fo re se e a ble ." 38 U. S.C.6

§ 1151(a) ; 38 C.F.R. § 3.361(d)(1) . To establish that the proximate cause of a di s ab i lity was the

re su lt o f c are le ssn e ss, ne g lig e nc e , la c k o f p ro pe r s kil l, e rr or in jud g me nt, or sim ila r ins tanc e of

fa ult on the par t of VA, the c laimant must show either (1) VA failed to e x erc ise the degree of ca re that would be expected of

a re asonable health ca

re provider; or (2) VA furnished the car e, tre atment, or examination without the veter an' s informed c onsent. 38 C.F.R. § 3.361(d)( 1). Section 3.361, the VA r egulation implementing 38 U.S.C. § 1151(a) , advanc es def initions perta ining to in fo rm ed consent a nd rea sonably

fore seea ble eve nts and rea ds, in releva nt part, as fo llo ws : (1) Care, treatment, or ex amination. To establish that ca rele ssness, neg lige nce, la ck of pr op e r s kil l, e rr or

in j ud g men t, or si mil ar i ns tanc e of fa ult on VA ' s p art

in fu rn ish ingho sp ita l c are , me dic a l or surg ic a l tr e atme nt, or

e xami natio n p ro ximate ly cause d a vete ran' s additional disability or death, it mus t b e s h o wn that the hospital car e, medic al or surg ical tre atment, or e x amination cause d the veter an' s additional disability or death (as explained in para g raph ( c) of this section); and (i) VA f ailed to exercise the deg ree of ca re that would be expected of a rea sonable he alth car e provide r; or (ii) VA f urnished the hospital ca re, me dical o r s u rgica l treatment, or examination without the veteran' s
. . . informed c onsent. To deter mine whether

there was inform ed conse nt, VA will consider whe ther the he alth car e provide rs substantially

complied with the re quirements of § 17.32 of this chap t er
. Minor deviations from the require ments of § 17.32 of t his chapte r t hat ar e immateria l under the circ umstances of a ca se will not defeat a findingof informe d consent. Consent may be express (i.e., give n orally or i n writing ) or implied under the circumstanc es specifie d in § 17.32(b) of this cha pter, a s in emerg ency

situations. ( 2 ) Eve nts not reasonably foreseeable

. W h et h er

th e p ro x i m at e c au s e o f av et er an 's a dd iti on a l di sa

bil ity or de ath wa s an e ve nt n ot r e a so na bly fo re se e a ble is i n e a c h c la im to be deter

mined based on what a r easona ble hea lth ca re p ro v i der w ould have fo re se e n. Th e e ve nt ne e d not be c omp le te ly un fo re se e a

ble or un ima g ina

ble but mu st be one that a re asonable health ca re pr ovider would not have consid er ed t o b e an ordinary risk of the tre atment provided. In deter mining whe ther a

n event wa s rea sonably

fore seea ble, VA will consider whether the risk of that eve nt was the ty pe of risk that a r easona

b l e hea lth care provider w ould have disclosed in c onnection with the informed c onsent proce dures of § 17.32 of this chapter

.7

38 C.F .R. § 3 .3 61 (d ); see also 69 Fe d. Reg

. 46,433 (2004). Be cause VA cited 38 U.S.C. § 1151

a s a uth or ity fo r 3 8 C.F .R. § 3. 36 1, it is app are nt the Ag e nc y re g ard e d la c k o f i nf

or me d c on se nt t o be a " simil ar instanc e of f ault" unde r that statute. There is another statute that bear s upon the regulatory structure perta ining to informe d

c on se nt. Sub c ha

pte r I I Iof tit le 38 , e nti tle d " Pr ote c tio n o f P atie nt R ig hts ," pr ov ide s th at [t ]he Secreta

ry . . . shall presc ribe re g ulations establishing proc edure s to ensure that . . . to the maxi mum ex tent prac ticable, all patient care furnished under this title sh a ll be ca rried out only

with the ful l an d in

for me d c on se nt of the patient . . . .
38 U. S.C. § 73 31 (em

ph a sis a dd e d) . Pe rt ine nt r e g ulatio ns re qu ir e that " [e]xc e pt a s o the rw ise pr ov ide d in thi s se c tio n, a ll p atie nt c are fu rn ish e d und e r t itl e 38 U. S.C. sh a ll b e c arr ie d o ut o nly wi th the full and infor

med conse nt of the patient or, in a ppropr i ate cases, a

repr esentative there of." 38 C.F.R. § 17.32(b). Concerningthe def

inition of and require ments for infor m ed consent, at the time of the

a pp e lla nt' s p ro c e dure , 3 8 C. F .R. § 1 7. 32 pr ov ide d: (c) Gene ral requirements for informed consent. Informed c onsent is the fre ely g iven consent that follows a

car eful e x planation by the pra ctitioner to the patient . . . of the proposed diagnostic or thera peutic procedure or course of treatment. The practitioner, who has primary re s p o nsibili ty for the patient or who will perf orm the par

ticular proc edure or provide the tre atment, must ex plain in lang uag e under standable to the patient .

. . [1] the natur e of a prop os e d p ro c e dure or tr e atme nt; [2] th e e xpe c te d b e ne fi ts; [3] r e a so na bly fo re se e a ble a sso c iate d r isk s, c omp lic atio ns or sid e e ff ect s; [ 4] r e a so na

ble and ava ila ble alternatives; and [5] anticipated r esults if nothing is done. The patient

. . . must be g iven the op po rt un ity to as k que sti on s, to ind ic ate c omp re he ns ion of the inf or matio n pro vid e d, and

to g rant pe rmission free ly

without coerc ion. (d) Docume ntation of i nformed conse nt. (1) The informed c onsent proce ss must be appropr iately

documented in the medical rec ord. In addition, signature c onsent is require d f o r a ll [s ur g ic a l p r o c e d

ur e s ]. 38 C.F.R. § 17.32(c) , (d) (2001). That reg ulation was promulgate d to implement 38 U.S.C . §§ 7331 throug h 7333. The re g ulation further define d "sig nature consent" as " [t ]he patient' s . . . signature on

a VA-a uthorized consent form, e.g. , a publi shed num bere d VA form (OF 522) or c ompara ble form approve d by

the local VAfac ility ." 38 C.F .R. § 17.32(a) ( 2001).8 IV . A NA LY SIS Th e Court is not

pe rs ua de d b y

the a pp e lla nt' s argume nt t

hat he is e nti tle d to VAbe ne fi ts under 38 U .S.C. § 1151 on t he basis that the c ontent of a g ener ic conse nt form containe d in the

rec ord establishes that VAwas ne g lige nt per se. As discussed below, the standard V A conse nt form does not constitute aff

irmative evide nce of

neg lige nce pe r se. Acc o rd i ng ly , the Court need not

re so lve the Se c re tary' s argume nts c on c e rn ingthe po te nti a l e vid e nti ary va lue of su c h a f

or m in a c a se wher e the a dequac y

of the c onsent is in disput e.

A. Th e Ev ide nc e in T his Ca se Gene rally , a cla imant seeking VA benefits has t he burden of pre senting evidenc e supporting his or h er cl aim , albeit with the statutorily mandated a ssistance of V A. See 38 U.S.C. § 5107(a); Skocze n v. Shinsek

i , 564 F.3d 1319 (2009). In this case, it is undisputed that the appellant introduc ed no evidenc e below—not e ven his own lay statements—that t h e informed consent discussion was defe ctive in any

way . Rather, he relies on the a bsence of a listing of

specific disclosed risks on the informed c onsent form a s evidenc e that VA did not obtain informe d consent. He ar gu es that the Boa rd' s finding that endophthalmitis and retinal tears w ere rea sonably fore seea ble eve nts require d their spec ific disclosure when VA obta ined his consent. He c ontends that the fa ct that the conse nt fo rm do e s n ot r e fe r t o th e se sp e c if ic ri sk s r a ise s a

pr e sumpt ion

that th ese reas on a

bly fo re se e a ble complications wer e not discussed, t hus contrave ning the regulatory require ments for infor

med consent. See 38 C.F.R. § 17.32(c) (2009). We observe that when dea ling with similar conse nt issues, some U

. S. d is tric t courts, applying state law, have re lied heavily on the lack of

written docume ntation of a mate rial risk in the informe d consent doc ument to find that informed c onsent was not obtained. See Parkins v. United States , 834 F. Supp. 569, 574 (D. Conn. 1993) ( fi n d i n g m ost significa nt evidence showing lack of informed

c on se nt t o b e a

bs e nc e of te xt in i nf

or me d c on se nt do cum e nt d isc us sin gpa ra ly sis a s p os sib le

c on se qu e nc e of

pr oc e dure ); Powers v. United States , 589 F. Supp. 1084, 1098 ( D. C onn. 1984) (findingthat consent for

m, which did not list para ly sis as risk of operation "ar g ues powe rfully and convincing ly

for the pr oposition t hat the plaintiff wa s never advised of the materia l risks inherent in the [procedure ].").D ur i ng t he Senat e hea r i ng s on 38 U

. S. C

. § 7331 , a V A of f i ci al t es t i f

i ed as t o t he i mp l ement at i on of i nf ormed 3
c o n se n t re fer re d to in the sta tute :
B ef or e a pat i en t h as a s u r g i ca l ope r at i on i t h as l on g been cus t omar y t o obt ai n h i s s i g n at u r e on s ome t y pe of do cumen t i ndi cat i ng hi s per mi s s i on t o un derg o t he out l i ned p r ocedur e. T hi s i s not a l ega l document an d do es l i t t l e more t han p r ot ect t he op er at i ng t eam f r om b ei ng char ged wi t h as s aul t

. I n re cen t ye ar s (197 3) [V A ] ha s cha ng ed t hi s operat i on permi t s o t hat i t i s now a "R eques t f or A dm i ni s t r at i on of A nes t hes i a a nd f or Perf ormanc e o f O p erat i o ns and O t her P roce d ures
. " In t hi s d o cum ent , the co unsel i ng p hy si ci an si gns hi s o r her nam e t o t he st ate m e n t th a t h e has " co unsel ed t hi s p at i ent as t o t he nat ure of t he p rop o sed p roce d ures , at t end ant ri sks inv o lve d a n d e x p e c te d re su lts, a s d e sc rib e d a b o v e ." It is o b v io u sly b o th i m p ra c tica l an d im p o ssib le to d e ta il eve r y pot ent i al ri s k i nv ol ved, an d i ndeed i f t hi s wer e done many pat i ent s mi gh t wel l become s o f r i gh t ene d t hat the y w o u ld d e c line to a c c e p t ne e d e d a n d ind ic a te d tre a tm e n t. N e v e rth e le ss, this d o c u m e n t ha s se e m e d to f unct i o n wel l and t o m y know l ed ge t here h ave b een f ew i f any pro b l em s ass o ci at ed wi t h i t s use over m any tho u sa n d s o f o p e ra tive p ro c e d u re s c a rr ie d o u t i n the syste m e a c h ye a r.
V e t e r a n s Omn i bu s Hea l t h Ca r e Ac t of 19 76 : Hea r i n g s Bef

or e t h e S u bc om m. on H e a l t h an d Hos pi t a l s of t h e S

. Com m. on V et er ans ' Af

f ai r s , 94t h C ong. 5 96

- 97 (197 6), at 5 97 (t es t i mo ny of G eorg e A. H i gg i ns , M

. D

. , Chi ef of t he Sur gi cal Se rvi ce o f

t he V et erans' A d m i ni st rat i o n H o spi t al , W ashi ngt o n, D

. C

. ). T he t i t l e o f t he d o cum ent ref

erred t o i n t he t es t i mon y i s t h at of

O pt i on al For m 522.

9 B . T he Con se nt F or

m in the Re g ulator

y Sc he me T h e r e ar e s e v e r a l di f

f ic u lt ie s , h o w e v e r , th at c o un s e l a g a in s t s u c hana p p r o a c hin

th e c o n te xt of the ve tera

ns benef its sy stem. Signi fica

ntly , to do so would ignore the statutory role of the Secre tary in pr escr ibing regulations to car ry out statutory

direc tives. "I f Cong ress ha s expl icitly left a g ap for the ag ency

to fill, there is an e x press de leg ation of authority to the ag ency

to el u ci d ate a sp eci fi c pro vi si on of th e st atu te b y regul ati on ." Che v ro n U. S. A. , I nc . v . Na tural R eso urc es D e fe ns e Counsel, Inc. , 4 67 U. S. 8 37 , 8 43 (1 98 4) . In th is i ns tanc e , Co ng re ss i ns tr uc te d th e Se c re tary

to

" pr e sc ri be re g ulatio ns e sta bli sh ingpr oc e dure s to e ns ur e that . . . all patie nt ca re fu rn ish e d und e r t

his tit le shall be car

ried out only with the full and informe d consent of t he patient." 38 U.S.C. § 7331. Th e Se c re tary

re sp on de d b y

imp le me nti ng a

re g ulatio n r e qu ir ingtha

t " the inf or me d c on se nt p ro c e ss must be appropr iately

documented in the he alth rec ord." 38 C.F.R. § 17.32(d)( 1) (2008)

. Moreove r, the Sec reta

ry ' s interpre tation of his own regulation is entitled to defe renc e whe re it"refl ect [ s] th e agency 's fai r andcon si dere d j ud gment on th e ma tt er i n ques ti on ." Auer v. Robbins , 519 U.S. 452, 462 (1997). The VHA handbook addre ssing the consent re quirements demonstrates that the Department has long reg arde d the use a nd completion of conse nt forms such as V A For m OF- 522 as appr opriate doc umentation of the c onsent proce ss. That view predates the c reation of the implementing statute. 310

Thus, both the manual and the leg islative history confirm that it is the Ag ency' s considere d judgme nt that the g ene ri c, standard f orm is the best overa ll approac h to acc omplishi ng d o cu m en t at i o no f t h e c o n s en tp ro ce s s
. Al th o u gh th e C o urtd o es n o ten t i re l y fo l l o w t h e S ec re t ary 's position wit h respe ct to the leg al ef fec t of the gene ric consent form, it will not disturb his judgment that such for

ms are be st suited to the overall nee ds of VA medic al fa cilities where s uch surg ical proce dures a

re p erf ormed. Give n that the Secr etar y ' s regulations and handbook do not re quire a detailed r ecitation of a ll of the information convey ed i n secur ing inf ormed c onsent, it cannot be pre s u m ed t h at the appe llant's c omplications were not discussed simply beca use they wer e not

rec o rd ed. Ac cording ly , the Court is not persuade d by the appe llant's r eliance upon a neg ative evidentiar y presumption. In the abse nce of

any evidenc e in support of the appellant' s section 1151–based claim on a theory of neg lige nce pe r se, his ar g ument fails. The a ppellant may seek to reope n his claim with new and materia l e vidence that raises specific questions a s to the adequa cy of the i n fo rm ed co n sent proce ss, which would have to include his lay asser tions that he indeed wa s not informed of the potential, rea sonably

fore seea ble complications that occ urre d in his case. Ba sed on this holding, the Court need not resolve the question of what evidentiar y value a g e ne ri c c on se nt f

or m mi g ht have in a c a se wh e re the c la ima nt int ro du c e d oth e r e vid e nc e tha t V A d id

n o to b t ai ni n fo rm edco n s en t

. Inth i s re gar d , th e C o urtn o t es th atan y p o t en t i al erro r i nth e B o ar d 's find in gth at " th e me d ic a l e v id e n c e r e f le c ts in f o r me d c o n s e n t o nth e v e te r an ' s b e h a lf under 38 C.F.R § 17.32" ( R. at 10) would not have be en pre judicial in this ca s e. Should the appellant introduce e vidence disputing the issue of c onsent, the Secr etar y wil l n ee d to make a de novo deter mination on that fac tual issue when the claim is r eopene d. The e videntiary signific ance of the consent for

m can be fully

addre ssed at that time.

IV . C ON CL USI ON Ba sed on the fore g oing rea soning, the Court A FF I RMS the Boa rd' s Dec emb er1 9 , 2 006, decision.