Th e pa pe rs su bmi tte d in

c onne c tio n w iththi s matte r i nc lud e : D e fe nd ants ’ 1 Objections to the Mag istrate Judge’ s Proposed Finding s and Recommendations (“Def s. Obj.”); Plaintiffs’ Opposition to Defenda nts’ Objections to Mag istrate Judge K ay ’s September 17, 2008 Report and Rec ommendation (“Pls. Opp.”) ; defe ndants’ re ply ; and plaintiffs’ sur- reply
. Plaintiffs’ objections to Mag istrate Judge K ay ’s re port and re commendation ar e not discussed beca use, as e x plained below, the Court addre ssed plaintiffs’ objec tions in a prior opinion.

UN I TE D ST AT ES D I STR I CT C OU RT F O R T H E D IS T R IC T O F C O LU M B IA

____________________________________ ) FEL I CE I . I ACANGEL O, e t al

. , ) ) Pla int if fs , )

) v. ) Ci vi l A cti on No. 05 -20 86 (P L F) ) GEORGETOWN UNIVERSI TY, e t al

. , ) ) De fe nd ants
. ) ____________________________________)
MEMORANDUM OPI

NI ON AND ORDER T h i s m at t er

i s b ef o re th e C o urt o n

d ef en d an t s ’ o b

j ec t i o n s t o M agi s tra t e J u d ge Alan Ka y ’s re port and re commendation of Septe mber 17, 2008 (“ Report”)
. 1
I . BA CKGROUND In this diversity

action, plaintiffs a ssert cla ims based on medica l treatment provided to Ka

ry n Ker ris. Plaintiffs’ alleg ations cente r on three embolization procedure s perf ormed on Ms. Ke rris betwe en 1998 and 1999 by Dr. Va nce Watson at Ge org etown Un ive rs ity

Ho sp ita l. T ho se pr oc e dure s invo lve d tw o s ub sta nc e s – Hi sto a c ry

l and L ipi od ol – which we re injec ted into Ms. Kerris’ br ain to treat a def ect known a s arter iovenous malformation. Plaintiffs claim that af ter the third e mboliz ation, Ms. Kerr is “bec ame ve ry2

letharg ic and then stoppe d eating , communicatingor showingsigns of beingawake . . . [and] ultimately

beca me and r emains catatonic.” Pls. Opp. at 2 (inter nal quotation marks omitted). Pla int if fs br ou g ht s uit

on Oc tob e r 2 4, 20 05 . A c c or din g to d e fe nd ants , [p] laintiffs have two basic theor ies of liability . First, Plaintiffs alleg e that embolization its elf should not have be en attempted a t all. . . . Plaintiffs [ also] assert that it was . . . neg lige nce per se for Dr . Watso n to us e Hi sto a c ry l and L ipi od ol, be c a

us e [tho se substances] wer e not FD A appr oved (Counts VI Iand VI I I ) and Geor g etown alleg edly

should have submitted an investig ation device exemption (I DE) a pplication to the FDAbefor e usingthem (Count I X). Def s. Obj. at 5.On Fe bruar

y 14, 2008, defe ndants filed a motion (1) se ekingjudgme nt on the pleading s or dismissal with respect to Counts VI , VI I , VI I Iand IX of plaintiffs’ Second Amende d Complaint, and (2) askingthe Court to strike cer tain alleg ations in the Second Amende d Complaint. The undersig ned re fer red that motion t o Mag istrate Judge A lan Kay for a repor t and
re c omm e nd a tio n p ur su ant t o L oc a l Civ il Ru le 72 .3 (a ). On Se pte mbe r 1 7, 20 08 , M a g ist rate J u d ge K ay

re co m m en d edth atth i s C o urt gra n td ef en d an t s ’ m o t i o nfo r j u d gm en to nth e p l ea d i n gs with respec t to Count VI

(a f ree -standingclaim for punitive damag es), Count VI I(a ne g lige nce per se claim base d on violations of 21 U.S.C. § 360c, a provision of the F eder al Food, D rugand Cosmetic Act, 21 U.S.C. § 301, et seq. (“F DCA”), a nd 21 C.F.R. § 812.20, a re g ulation intended to implement the investigational device e x emption of the F DCA) and Count IX (a neg lige nce per
se claim base d on violations of 21 C.F.R. § 812.20). Mag istrate Judge K ay further rec ommended that this Court deny

without prejudice de fenda nts’ motion with respect to Count VI I I(a neg lige nce per se claim base d on violations of 21 U.S.C. § 331, another provision of the F DCA)Plaintiffs objected to Mag istrate Judge K ay ’s re commendation to dismiss C ount 2 VI and Count VI I . See g ener ally Plaintiffs’ Objections to Mag istrate Judge K ay ’s September 17, 2008 Report and Rec ommendation. They also disag ree d with Mag istrate Judge K ay ’s re c omm e nd a tio n to dis mis s Co un t IX, but of fe re d n o s e pa

ra te argume nt r e sp e c tin g that c ount. 3 and deny without prejudice de fenda nts’ motion to s trike. O nS e p t e mb e r

2 7 , 2 0 0 8 , p l a i n t i f

f s f i l e d o b j e c t i o n s t o th e R e p o rt
. T h r e e d ays 2 later, the Court issued a Memora ndum Opinion rejec ting a ll of plaintiffs’ objec tions and adopting and appr oving Ma g istrate Judge K ay ’s Report. In that Memorandum Opinion, the Court ob se rv e d th a t “ [d]e fe nd ants have no t, at th is wri tin g , f ile d o bje c tio ns to t

he Re po rt , a

nd the ir tim e to do so has expired. . . . The Court there fore assumes that they acc ept Mag istrate Judge K ay ’s
rec ommendations [i ncluding his recommendation not to di smiss C ount VI I I ].” I aca ng elo v. Geor g etown Univ., Civil Action No. 05-2086, Memora ndum Opinion at 2 n.2 (D.D.C. Sept. 30, 2008). On Oc tober 1, 2008, de fenda nts filed a motion for re consideration of the Court’s Se pte mbe r 3 0, 20 08 Me mor and um O pin ion , a

rguin g that it

wa s is su e d p re matur e ly

be c a us e defe ndants’ time to object to the Report ha d not y et expired. See De fenda nts’ Motion for Reconsider ation of the Septembe r 30, 2008 Memora ndum Opinion Adopting and A pproving Report and Rec ommendation of Mag istrate Judge K ay at 1. Def endants simultaneously

filed the ir ob je c tio ns to M a g istrate Judg e Ka y ’s Re po rt , in

wh ic h th e y

ob je c te d o nly

to M a g istra

te J udg e Ka y ’s re commendation to re tain Count VI I I
. On Octobe r 10, 2008, the Court ac knowledg ed that it had issued the Septembe r 30, 2008 decision pre maturely . See I aca ng elo v. Geor g etown Univ., Civil Action No. 05-2086, Memorandum Opinion and O rder at 3 (D.D .C. Oct. 10, 2008). The Court theref ore a nnounced that it wo uld c on sid e r d e fe nd a

nts ’ o bje c tio ns to M a g ist

rate Judg e Ka

y ’s Re po rt

(a nd pla int if fs ’4

re sp on se s th e re to) and , if ne c e ssa ry , mo dif y its Se pte mbe r 3 0, 20 08 de c isi on a c c or din g ly . T ho se objections, plaintiffs’ opposition to them, defenda nts’ reply , and plaintiffs’ sur -re ply are now be fo re the Court
.

When a par

ty files written objec tions to any part of the mag istrate judg e’s
re c omm e nd a tio n w ithre sp e c t to a dis po sit ive mot ion , th e Court c on sid e rs de novo those portions of the re commendation to which objec tions have bee n made, a nd “may acc ept, re ject, or modify the re commended disposition.” F ED . R. C IV . P. 72(b)(3).
I I . DI SCUS SI ON As noted above , Count VI I Iof plaintiffs’ Sec ond Amended Complaint sets forth a claim of ne g lige nce per se based on c erta in provisions of the FDCA. See Second Amende d Complaint ¶¶ 60-68. Count VI I Ihinge s on the idea that defe ndants ac ted neg lige ntly – i.e. , violated a substantive standa rd of c are – by

obtaining a

nd using de vices that the F DCA define s as

“ a du lte rate d” or

“ mis br and e d. ” Pla int if

fs po int to t he fo llo wi ngsp e c if

ic pr ov isi on s o f t

he F DC A as the ba sis for their ne g lige nce per se c l a i mi nC o un tV III :

The followingacts a

nd the ca using the reof

are prohibited: (a ) T he int

ro du c tio n o r d e liv e ry

fo r i ntr od

uc tio n into int e rs tate c omm e rc e of

any fo od , d ru g , d e vic e , o r c os me tic that is adulterate d or misbrande d. (b ) T h e a d

u l t er at i o no r m i s b ra n d i n g o f an y fo o d , dru g, device , or cosmetic in inter state commer ce. (c ) T h e r ec ei p ti ni n t er s t at e c o m m er ce o f a n y fo o d , dru g, device , or cosmetic that is adulterated or misbranded, a

nd the deliver

y or prof fer ed deliver

y there of for

pay or otherwise.5 * * * (g) T h e m an u fa ct ure wi th i nan y T erri t o ry o f a n y fo o d , dru g, device , or cosmetic that is adulterated or misbranded. * * * (k) The alteration, muti lation, destruction, obliteration, or remova l of the whole or

any part of the labelingof, or the doing of any other a ct with respe ct to, a food, dr ug , device , or cosmetic, if

such ac t is done while such ar ticle is held for sa le (whe the r o r n ot t

he fi rs t sa le ) a ft e r s hip me nt i n interstate c ommerce and re sults in s uch ar ticle being adulterated or misbrande d. 21 U. S.C. § 3 31 (a ), (b ), (c ), (g ) a nd (k ). Ac c or din g to p la int if fs , d e fe nd ants vio late d th e se provisions, and there by

committed neg lige nce pe r se , beca use they (a) introduced a

nd or ca used introduction of, Histoac ryl and L ipi od ol, bo th a du lte rate d a nd mis br and e d d e vic e s, int o inte rs tate commerc e, (b) a dulterate d both Histoacryl and L ipiodol by mix ing a nd/or compounding the two device s toge ther, (c) rec eived a

misbranded a

nd adulterated device , (d) manuf actur ed a “ new” Class I I Iadulterated and misbrande d de vic e wh e n th e y

mixe d H ist oa c ry

l w ithL ipi od ol, (e ) i g no re d th e wa

rn ing s a nd /or de str oy e d th e la

be lin g on the Cla ss I I Ide vic e Hi sto a c ry

l. Second Amende d Complaint ¶ 65.

Re lyingpr inc ipa lly

on Ca bir oy v. Sc ipi on e , 7 67 A. 2d

10 78 , 1 08 0- 81 (P a . Su

p. Ct. 20 01 ), Ma g istrate Judg e Ka y c on c lud e d th a t th e c ite d p ro vis ion s o f 2 1 U .S. C. § 33 1 c ou ld support plaintiffs’ neg lige nce per se claim in Count VI I Ibeca use those provisions set forth a discernible sta

ndard of car e. See Re port at 13. Having r eviewe d the pape rs consider ed by6

Ma g istrate Judg e Ka

y , M a g istrate Judg e Ka

y ’s Re po rt , b oth

pa rt ie s’ ob je c tio ns to M a g ist

rate J udg e Ka y ’s Report, all of the filings by the par ties relatingto defe ndants’ objec tions, and the
re le va nt c a se law, the Court

c on c lud e s th a t it

mus t r e je c t Ma g ist

rate Judg e Ka

y ’s c on c lus ion

wi th respe ct to Count VI I I . The provisions of Sec tion 331 on which plaintiffs base Count VI I Icannot support a neg lige nce per se claim for two r easons: (1) those provisions do not set forth a substantive standard of

car e the violation of whic h amounts to the violation of a duty in tort, and (2) plaintiffs c annot demonstrate a ca usal relationship between the una pproved status of Histoacry l and L ipiodol and Ms. Kerris’ injurie s. A. Negligence Pe r S e “As a g ener al rule, the plaintiff in a neg lige nce a ction bear s the burden of proving the applica

ble standar d of ca

re, a deviation from that standa rd by the def endant, a nd a ca usal relationship between that de viation and the plaintiff’ s injury .” McN eil Pharmac eutical v. Hawkins, 686 A.2d 567, 577 ( D.C. 1996) (c itation and internal quotation marks omitted). The doctrine of

neg lige nce per se r e p r e s e n t s a “ s l i g h tv ar i a t i o n [ ] o nth i s g e n e r a l r u l e . ” Id
. a t5 7 8
. In
some ca ses, that doctrine permits a plaintiff to “r ely on a statute or r egulation as proof of the applicable standard of

car e.” I d. In the District of Columbia, [t ]he “g ener al [neg lige nce pe r se ] rule” . . . is that “whe re a particula r statutory

or re g ulatory

standard is e nacte d to protect persons in the plaintiff’ s position or to prevent the ty pe of a ccide nt that occur red, a nd the plaintiff ca

n establish his relationship to the statute, unexplained violation of that standard r ender s the d e f e n d an tn e g l i g e n ta s a

m a t t e r o f l aw . ” R i c h ar d s o nv . G r e g o r y, 28 1 F .2 d 6 26 , 6 29 (D .C. Cir . 1 96 0)
. . . . I f a pa rt y c ha rg e d w ith statutory or re g ulatory

neg lige nce pr oduces c ompetent evidenc e tending to expl ain or e x cuse his or he r violation of the statutory or regulatory

standard, the jury

is properly

instructed, upon prope r7 reque st of the par

ty , that the violation is evidence of neg lige nce but not neg lige nce a s a matter of law. Ceco Corp. v. Coleman, 441 A.2d 940, 945 ( D.C. 1982) (some c itations omi tted); see a lso J oy v. B e ll H e lic op te r T e xtro n, Inc ., 99 9 F .2 d 5 49 , 5 57 (D .C. Cir . 1 99 3) (s ame ). In a dd iti on , th e statut e
or re g ulation in question must impose specific duties on the defe ndant. See id. at 558. Ultimately , “[t] he dec ision to adopt from a statute a sta ndard of car e to be a

pplied in determining common law neg lige nce is pure ly a judicial one, f

or the c ourt to make.” McNe il Pharmace utical v. Hawkins, 686 A.2d at 579; see also RongYao Z hou v. J ennife r Mall Restaura nt, I nc., 534 A.2d 1268, 1274 (D.C. 1987).
B. No S ub sta nti v e Sta nd

ar d o f Ca re Plaintiffs argue that Section 331 sets for th a substantive standar d of ca re a nd there fore supports Count VI I Ibeca use Section 331 “obviously g overns be havior.” Pls. Opp. at 7. T h e qu e s t i o nb e f

o r e th e C o urt , h o w e v e r , i s n o tw h e th e r S e c t i o n3 3 1 “ g o v e r

n s b e h av i o r . ” It
sure ly do e s – a s d oe s a lmo st e ve ry

statut e and

re g ulatio n. Th e qu e sti on be fo re the Court

is wh e the r S e c tio n 3 31 e mbo die s “ a le g isl a tiv e jud g me nt a s to the sta nd ard of c are ” a pp lic a ble to this case, a

nd thus whether the violation of the cited provisions of Sec tion 331 amounts to t he violation of a duty

g iving r ise to an ac tion in tort. Talley v. Dane k Medica l, I nc., 179 F .3d 154, 161 (4th Cir. 1999). The Court c oncludes that the a nswer to that que stion is “no.” The princ ipal problem with plaintiffs’ attempt to base claims of ne g lige nce pe r se
on Se c tio n 3 31 is that Se c tio n 3 31 sim ply se ts f or th – in p ro hib ito ry

te rm s – “ the ba sic require ment [of the FDCA a nd its im plementing regulations] that FDAapprova l is required f or
commerc ial distribution [ and use of Class I I Imedical de vices like Histoac ryl and L ipiodol] .”Th e F DC A c la ssi fi e s d e vic e s a s Cl a ss I , I Ior I I Ide vic e s. 3 A Class I I Idevice is subject to the statutory require ment of pre

marke t approva l. . . . A Class I I Idevice that is introduced, or delivere d for introduc tion, into i nterstate c ommerce without such approva l violates the statute bec ause it is [“adulterate d” under 21 U.S.C. § 351 and “misbrande d” under 21 U.S.C. § 352]
. . . . The status of a

device as unappr oved and unc lear ed . . . does not nece ssarily

mean that the de vice is unsaf e, def ective, or unrea sonably

dang erous. It means simply that the FD A has not y et conclude d that the device should be approve d or cle are d. M an y lawf ull y mark e te d me dic a l pr od

uc ts h ave “ of

f- la be le d u se s” (u na pp ro ve d a nd un c le are d) that th e me dic a l c omm un ity is satisfied ar e saf

e and e ffe ctive and to whic h the FD A has no objection. B ake r v . Sm ith& Ne ph e w R ic ha rd s, Inc ., No . 9 5- 58 73 7, 19 99 WL81 13 34 , at *6 (T e x. D. Ct. 1999). 8 D e f s . O b j
. a t7
. T h a tb a s i c r e qu i r e m e n td o e s n o te mb o dy a substantive sta nd

ar d o f c ar e , but 3 rathe r an administrati ve requireme nt aimed at f

urtheringthe FD CA’s reg ulatory g oals. In other
wo rd s: The a dminist rative r equire ment that a g iven device be appr oved by

the F DAbe fo re be ingmark e te d – a s o pp os e d to a

sp e c if ic su bs tanti ve re qu ir e me nt t

hat a de vic e be sa fe and

e ff e c tiv e – is on ly a tool to fac ilitate administration of the underly ing r egulatory sc he me . B e c a

us e it l a c ks any

ind e pe nd e nt s ub sta

nti ve c on te nt, it does not impose a standa

rd of c are , the bre ach of

which could f

orm the basis of a

neg lige nce per se c la im. T a ll e y v . D an e k M e d ic a l, In c . , 1 7 9 F
. 3 d

a t 1 6 1
. Se e a ls o K in g v . D an e k M e d ic a l, In c . , 3 7 S. W. 3d 429, 456-60 (Te nn. Ct. App. 2000) (same) ; Morton v. Georg e Washing ton Univ., No. 99- 4599, Orde r at 9 (D .C. Sup. C t. Nov. 30, 2001) (r ejec ting ne g lige nce per se claims for use of unapprove d device s based on 21 U.S.C. § 331, 21 U.S.C. § 360c and 21 C.F.R. § 812.20; char acte rizing those provisions as “a dminist rative in nature” and conc luding that they do not “set9

forth a sta ndard of conduct, the br eac h of which w ould constitute neg lige nce pe r se ” ). Thus , Count V I I Imus t be dis mis se d b e c a us e 21 U. S.C. § 3 31 re fl e c ts a n a dmi nis tr a tiv e re qu ir e me nt – not a substantive standar d of ca re that can support plaintiffs’ neg lige nce per se claim.
C. N o Ca us al R e lat ion sh ip Plaintiffs’ attempt to base ne g lige nce per se claims on alleg ed violations of 21 U.S.C. § 331 suffers f

rom another

flaw. A n essential ele ment of any neg lige nce c laim is proof that the alleg ed bre ach of duty at issue proxim ately

cause d the har

m at issue. Thus, to succe ed on neg lige nce per se c la ims , “ pla int if fs mus t pr ov e that the statutory violation wa s th e pr oximate
cause of their injuries.” Rong Y ao Z hou v. J ennife r Mall Restaura nt, I nc., 534 A.2d at 1277 (empha sis added). H ere , the statutory violation at issue is the use of “a dulterate d” and/or

“ mis br and e d” de vic e s. Pla int if fs the re fo re wo uld

ha ve to s ho w that th e me re fa c t th a t de fe nd ants used “a dulterate d” and/or “misbrande d” devic es contributed to Ms. Ke rris’ injuries. This they cannot do. As pla intiffs acknow ledg e, Histoac ryl and L ipiodol were de emed “ adulterated” and/or “ misbranded” not beca use of a ny aff irmative dete rmination of dang erousne ss or imp ro pr ie ty , b ut m e re ly

be c a us e the y la c ke d F DAa

pp ro va l. A s a

re su lt, it i s n o mo re log ic a l to inf e r a c a us a l c onne c tio n b e tw e e n H ist oa c ry l’ s a nd L ipi od ol’ s una

pp ro ve d s tatus and

Ms. Ke rr is’ injuries than it is to i nfer

a ca usal conne ction betwee n a drive r’s lac k of a dr ivers license and injuries he ca

uses while driving . See KEE TON E T AL ., P ROSSER & KEE TON ON T O RT S § 36, at 223-24 (5th ed. 1984) (obser ving that “[w] hen a c ar is drive n without a license, the act of driving the ca r ce rtainly

cause s a collision; the absenc e of the license, or the exist ence of the statute, of
course does not”). I

n short, plaintiffs have not shown and ca nnot show “that the bre ach of the10

FDAapprova l require ment proxi mately cause d” the injuries to Ms. Ker ris. Talley

v. Dane k Medica l, I nc., 179 F .3d at 161; see a lso id. (“I f the qua lity or prope r labe ling of

the device , rathe r tha n it s f or ma l a pp ro va l, w e re a t is su e , th e n c a us a tio n mi g ht [b e ] a q

ue sti on of fa c t. B ut t

hat [is]
n o tth e c i r c u m s t an c e s h e r e . ” )
. A c c o r d i n g l y, i ti s h e r e b y

ORDE RED that th e Court ’s Me mor and um O pin ion

of Se pte mbe r 3 0, 20 08 is modified in the manner

set forth in this Memorandum Opinion and its Orde r of Judgment of September 30, 2008 is ame nded to provide that Count VI I Iof plaintiff’s Sec ond Amended Complaint i s DI SMI SSED.

SO ORDERED. / s / PAULL . FRI EDMAN DA T E : Fe b ru ary

3 , 2 0 0 9 Un i t edS t at es Di s tri ctJ u d ge