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215- 241- 1000 ~ 302- 571- 0510 ~ 610- 434- 8588 ~ 888- 777- 6690VERI TEXT NATI ONAL COURT REPORTI NG COMPANY

1 UNI TED STATES DI STRI CT COURTEASTERN DI STRI CT OF PENNSYLVANI A

2 UNI TED STATES OF AMERI CA, )

3 )

Pl ai nt i f f , ) 2: 09- cr- 00403- 3- LDD4 )vs. ) Phi l adel phi a, PA

5 ) November 21, 2011NORI AN CORPORATI ON, and )

6 MI CHAEL D. HUGGI NS )Def endant s. )

7 TRANSCRI PT OF SENTENCI NG MI CHAEL D. HUGGI NS

8 BEFORE THE HONORABLE LEGROME D. DAVI SUNI TED STATES DI STRI CT J UDGE

9 APPEARANCES:10 For t he Gover nment : MARY E. CRAWLEY, AUSA

GERALD B. SULLI VAN, AUSA11 OFFI CE OF THE UNI TED STATES ATTORNEY

615 Chest nut St r eet - Sui t e 125012 Phi l adel phi a, PA 1910613 LAURA PAWLOSKI , ESQUI RE

ASSOCI ATE CHI EF COUNSEL14 FOOD AND DRUG ADMI NI STRATI ON

10903 New Hampshi r e Avenue

15 Si l ver Spr i ngs, MD 20993- 000216 For t he Def endant : GREGORY L. POE, ESQ.Mi chael D. Huggi ns POE & BURTON PLLC

17 1030 15TH St r eet , N. W. Sui t e 580 West

18 Washi ngt on, DC 2000519 CATHERI NE M. RECKER, ESQ.

WELSH & RECKER20 2000 Mar ket St r eet - Sui t e 2903

Phi l adel phi a, PA 1910321

ESR OPERATOR: DONNA CROCE22 Proceedi ngs r ecorded by el ect r oni c sound r ecor di ng.

23Ver i t ext Nat i onal Cour t Report i ng Company

24 Mi d- At l ant i c Regi on1801 Market St r eet - Sui t e 1800

25 Phi l adel phi a, PA 19103

Case 2:09-cr-00403-LDD Document 207 Filed 01/03/12 Page 1 of 104


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1 I N D E X

2 PAGEFor t he Def endant 6

3 For t he Gover nment 17

Sent enci ng 764 RULI NG: PAGE LI NE

5 Def endant ' s mot i on under 18 U. S. Code 86 33143( b) ( 1) ( B) ( i v) , deni ed

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1 THE COURT: Al l r i ght . Thi s i s t he mat t er of t he

2 Uni t ed St at es of Amer i ca ver sus Mr . Mi chael D. Huggi ns, whi ch

3 i s 09- 403. Ms. Cr awl ey and Mr . Sul l i van ar e her e f or t he

4 gover nment . Mr . Poe i s her e f or t he def endant who i s, of

5 cour se, her e. And f ol l owi ng t he pl ea, whi ch was t ender ed i n

6 f r ont of J udge St engel , we ar e her e f or sent enci ng.

7 As ever yone i s f ami l i ar , we had a sever al day hear i ng

8 on sent enci ng gui del i nes and l ast week I i ssued a r ul i ng,

9 whi ch I bel i eve r esol ved al l of t he quest i ons, bot h f act ual

10 and l egal . I ' m not sur e i f t her e ar e any ot her l egal

11 i ssues - - f act ual i ssues; excuse me, t hat t he par t i es need t o

12 have r esol ved. Anyt hi ng f r om you, si r , Mr . Poe?

13 MR. POE: Your Honor , I di d not e one - - t he pr obat i on

14 of f i ce, I t hi nk, di d not accur at el y r ef l ect , i n t he f i nal

15 r epor t , one of Your Honor ' s - - one aspect of Your Honor ' s

16 or der , i n par agr aph 42.

17 THE COURT: Tel l me about i t .

18 MR. POE: Yes, si r .

19 Your Honor di r ect ed t he PO t o cor r ect PSR paragr aph

20 42 t o r ef l ect t hat ei ght of t he t hi r t y- f our cases i nvol ved t he

21 t r eat ment of VCFs.

22 THE COURT: Ri ght . I r emember t hat .

23 MR. POE: Yes, Your Honor . And t he second r evi sed

24 PSR st at es, "Not es f r om t he meet i ng show t hat t he par t i ci pant s

25 al so di scussed Synt hes' f ai l ur e t o f i l e an MDR on t he f i r st



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1 deat h, as wel l as t he f act t hat t her e al r eady had been t hr ee

2 adver se event s wi t h a Nor i an pr oduct i n ei ght out of t he

3 t hi r t y- f our VCF cases t o dat e".

4 So as t he Cour t may r ecal l , t went y- si x of t hose cases

5 wer e bur st f r actur es and t her ef or e, I t hi nk, i t j ust got l ost

6 i n t r ansl at i on a bi t , Your Honor . We j ust ask t hat t hat be

7 cor r ect ed.

8 THE COURT: Okay. And you woul d propose - - wel l ,

9 act ual l y, t he l anguage i s i n t he or der , r i ght ?

10 MR. POE: Yes, si r .

11 THE COURT: Okay. So any concer n about t hat ?

12 MS. CRAWLEY: No, Your Honor .

13 THE COURT: Al l r i ght . Any ot her f act ual f i ndi ngs

14 t hat needed t o be made, f r om ei t her par t y, t hat I mi ght have

15 over l ooked?

16 MR. POE: No, Your Honor .

17 THE COURT: Gover nment ?

18 MS. CRAWLEY: No, Your Honor .

19 THE COURT: Al l r i ght . So obvi ousl y t he concerns

20 t hat t he def endant r ai sed about t he gui del i nes, t hey' r e al l

21 pr eser ved. We don' t need t o, hopef ul l y, di scuss t hose agai n.

22 But wi t h t hat i n mi nd i t ' s a f our - one, t he gui del i ne r ange i s

23 zer o t o si x mont hs. That ' s wher e we st and, cor r ect ?

24 MR. POE: Agreed, Your Honor .

25 MS. CRAWLEY: Yes, Your Honor .



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1 THE COURT: And obvi ousl y, Mr . Poe, you have

2 di scussed t hi s pr e- sent ence wi t h your cl i ent on mul t i pl e

3 occasi ons, i s t hat cor r ect ?

4 MR. POE: That ' s cor r ect .

5 THE COURT: And he concur s t hat i n l i ght of my

6 det er mi nat i ons i n my or der t her e ar e no ot her f act ual

7 cor r ect i ons or amendment s t o be made?

8 MR. POE: We agr ee.

9 THE COURT: Al l r i ght . Government , you agr ee wi t h

10 i t ?


12 THE COURT: Al l r i ght . So l et us her e f r om t he

13 def ense on sent enci ng. Wi t nesses f i r st f or ei t her si de.

14 MR. POE: Woul d Your Honor l i ke me t o use t he podi um?

15 THE COURT: You r emember how t he acoust i cs ar e i n

16 t hi s r oom?

17 MR. POE: I do, Your Honor . I do r emember . Your

18 Honor , no wi t nesses.

19 THE COURT: Okay. How about f or t he gover nment?

20 MS. CRAWLEY: No wi t nesses, Your Honor .

21 THE COURT: Al l r i ght . So t hen we' l l j ust pr oceed t o

22 ar gument or di scussi on, r at her .

23 MR. POE: Good mor ni ng, Your Honor .

24 Your Honor , t he ent i r e l i f e of Mi chael Huggi ns has

25 been def i ned by t he same char act er i st i cs, f r om begi nni ng t o



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1 now. He' s a l ovi ng f at her . He' s a devot ed br ot her . He' s a

2 good f r i end. He' s a har d wor ker . He' s a compassi onat e,

3 decent man. Fr om t he t i me, as hi s f at her descr i bes, when he

4 bef r i ended a young boy wi t h l ear ni ng di sabi l i t i es acr oss t he

5 st r eet t o t he r ecent work t hat he di d wi t h a woman t o br i ng

6 cl ean wat er t o her vi l l age i n Kenya, Mi chael Huggi ns has been

7 def i ned by t he same char act er i st i cs.

8 Now, I r ecogni ze Your Honor ' s r ul i ngs wi t h r espect t o

9 t hi s case and t he of f ense conduct and t he r el evant conduct and

10 t hat , of cour se, i s an ext r emel y i mpor t ant aspect of Your

11 Honor ' s sent enci ng det er mi nat i on. But wi t h r espect t o Mr .

12 Huggi ns' char act er i st i cs and t he l i f e t hat he has l ed, we ask

13 Your Honor t o gi ve gr eat wei ght t o t hose char act er i st i cs and

14 t o t hat l i f e, especi al l y now, af t er Booker , of f ender

15 char act er i st i cs ar e wi de open f or t he Cour t t o consi der . And

16 we ask t he Cour t t o - -

17 THE COURT: Wel l , of f ender char act er i st i cs ar e an

18 ext r emel y val i d consi der at i on because, i f you l ook at t he

19 obj ect i ve f act s of a par t i cul ar cr i mi nal vi ol at i on, say dr ug -

20 - say a r obber y af f ect i ng i nt er st at e commer ce, t he act ual act

21 may be i dent i cal but i t may have been commi t t ed by di f f erent

22 per sons who pose ent i r el y separ at e sent enci ng consi der at i ons.

23 So of f ender char act er i st i cs, I absol ut el y agr ee wi t h you, ar e

24 r el evant , germane and i mpor t ant .

25 MR. POE: And Your Honor , wi t h r espect t o Mr .



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1 Huggi ns' f ami l y f r i ends, I j ust want t o i nf or m t he Cour t hi s

2 wi f e, hi s daught er s ar e pr esent i n cour t t oday. Fr i ends and

3 f ami l y, I won' t i nt r oduce ot her s, ar e pr esent .

4 THE COURT: Wel l , t he ent i r e cour t r oom i s f ul l .

5 MR. POE: Yes.

6 THE COURT: That ' s a f ai r st at ement . So i t ' s

7 pr obabl y somewher e bet ween f i f t y- f i ve and si xty- f i ve peopl e, I

8 woul d say.

9 MR. POE: And I can' t say t hat t hose ar e al l hi s

10 f r i ends and f ami l y, Your Honor , but I di d want t o l et t he

11 Cour t know t hat he has support here t oday.

12 THE COURT: Ri ght . And I woul d al so - - I t hi nk t he

13 r ecor d shoul d r ef l ect t hat I di dn' t actual l y count t he l et t er s

14 t hat were submi t t ed on hi s behal f but t here was pr obabl y

15 somewhere between si xt y- f i ve and ni net y, I woul d say.

16 MR. POE: That ' s cor r ect , Your Honor .

17 THE COURT: Ri ght .

18 MR. POE: Ei ght y- f i ve, act ual l y.

19 THE COURT: Ei ght y- f i ve?

20 MR. POE: I count ed.

21 THE COURT: Okay.

22 MR. POE: Your Honor , wi t h r espect t o t hose l et t er s,

23 one poi nt t hat I di d want t o make, i s t hat t he gover nment at

24 note 3, page 4 of i t s sent enci ng memorandum st ates t hat many

25 of t he l et t er s ref l ect an under st andi ng t hat t he case i s about



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1 of f - l abel mar ket i ng and of f - l abel pr omot i on. And t he

2 government suggest s t o t he Cour t t hat t hat , somehow,

3 t r ansl at es i nt o Mr . Huggi ns taki ng t hi s of f ense l ess

4 ser i ousl y. And I j ust - - we l ooked agai n, Your Honor , none of

5 t he l et t er s submi t t ed on behal f of Mr . Huggi ns ref l ect t hat

6 posi t i on t aken by t he gover nment .

7 So we - - t o t he ext ent t hat t he Cour t woul d put any

8 wei ght on t he government ' s ar gument , we r espect f ul l y suggest

9 t hat t her e i s no f act ual basi s f or what t he gover nment has

10 sai d i n t hat f oot not e.

11 The government al so, Your Honor , has sai d at page 16

12 of i t s memor andum, i t quest i ons Mr . Huggi ns' mot i vat i on f or

13 doi ng communi t y work i n t he l ast t wo and a hal f year s, si nce

14 he pl eaded gui l t y. Mr . Huggi ns has had t i me t o do t hat

15 communi t y work i n t he l ast t wo and a hal f years and what t hat

16 communi t y wor k r ef l ect s i s what he' s been doi ng hi s ent i r e

17 l i f e. So we j ust want ed t o poi nt t hat out as wel l .

18 Your Honor , on a - -

19 THE COURT: Wel l , but , sor t of , as we have t hi s

20 di scussi on, I under st and t hat you' r e r epr esent i ng t he

21 def endant and by def i ni t i on you' r e on t he def ensi ve, r i ght ?

22 And t he gover nment i s t aki ng t he i ni t i at i ve i n pr osecut i ng

23 t hi s mat t er and t hey say cer t ai n t hi ngs. And I l i st en t o

24 l awyer s, I l i st en t o how t hey anal yze t he case and t o t he

25 ext ent t hat I f i nd i t t o be r easonabl e and f ai r and j ust , I



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1 wi l l accept i t . But I t hi nk i t ' s mor e i mpor t ant f or you t o

2 t el l me t he af f i r mat i ve t r ut hs t hat you see f r om your si de,

3 t he t hi ngs t hat ar e i mpor t ant about Mr . Huggi ns as we - - as we

4 begi n t hi s pr ocess of det er mi ni ng a f ai r sent ence. And I ' m

5 not so sur e t hat t he best st r at egi c appr oach i s t o say what ' s

6 wr ong wi t h t he gover nment ' s pr esent at i on, i f you wi l l .

7 MR. POE: Your Honor - - I ' m sor r y, Your Honor .

8 THE COURT: Oh no, I ' m act ual l y t r yi ng t o be hel pf ul .

9 MR. POE: I under st and. I wi shed t o poi nt t hat out .

10 I al so do have a l egal obj ect i on t hat I woul d l i ke t o pose

11 wi t h r espect t o t he gover nment .

12 THE COURT: Okay. Yeah. As l ong as i t ' s j ust

13 i nt r oduct i on, as l ong as i t ' s not t he st r uctur e t hat ' s f i ne,

14 because I t hi nk you have more i mpor t ant t hi ngs t o say t han

15 where you di sagree wi t h t he gover nment , but go ahead.

16 MR. POE: I agr ee, Your Honor . Your Honor , t he

17 gover nment has made an ar gument t hat t he Cour t shoul d vary

18 above si x mont hs t o t wel ve mont hs under 3553( a) . The

19 gover nment has wai ved t hat argument . The st andi ng order of

20 t hi s Cour t , of t he East er n Di st r i ct of Pennsyl vani a, st at es

21 t hat obj ect i ons t o t he PSR ar e wai ved unl ess good cause i s

22 shown t hat excuses t he f ai l ur e t o make t he obj ect i on.

23 The gover nment , i t sel f , shows t hat good cause i s

24 l acki ng f or i t s ar gument because i t has sai d t hat i t has - -

25 t he def endant s have been on not i ce i n t hi s case f r om bef or e



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1 t he pl ea, t hat a t wel ve mont h sent ence i s possi bl e i n t hi s

2 case and t hat t her ef ore we - - no def endant - - Mr . Huggi ns

3 shoul d not be i n a posi t i on of compl ai ni ng about t he

4 possi bi l i t y, i n t hi s case, of an upwar d var i ance.

5 Now of cour se t he Cour t has aut hor i t y t o do what t he

6 Cour t wi shes t o do, i n l i ght of I r i zar r i and ot her

7 aut hor i t y. But I j ust do wi sh t o pose t hat l egal obj ect i on t o

8 t he gover nment ' s ar gument because we bel i eve i t ' s f orecl osed

9 f r om maki ng i t or shoul d be f or ecl osed f r om maki ng i t .

10 THE COURT: Wel l t he quest i on of whet her a var i ance

11 i s appr opr i at e, ei t her upwar d or downwar d, i s a j udi ci al

12 det er mi nat i on t hat has t o be made at t he t i me of sent enci ng

13 based upon t he r el evant f act ual consi der at i ons. And t he

14 par t i es argue f or upwar d and downwar d var i ances al l t he t i me

15 and t hose ar e j ust ar gument s, t hey' r e not - - t he gover nment i s

16 not i n t he busi ness of sent enci ng peopl e. The gover nment i s

17 i n t he busi ness of br i ngi ng pr osecut i ons wher e t hey t hi nk t hat

18 t he f act ual ci r cumst ances mer i t t hem. And I t hi nk we shoul d

19 al so under st and t hat t hi s ver y l engt hy pr e- sent ence r epor t

20 t hat we' ve seen i n sever al f orms now i s a r ecommendat i on,

21 r i ght . Li ke t he gover nment , t he pr e- sent ence of f i cer does not

22 sent ence peopl e. We went t hr ough a ver y l engt hy pr ocess

23 l ooki ng at t he l egal ef f ect of some of t he det er mi nat i ons or

24 st at ement s t hat were made i n t he pre- sent ence r epor t and some

25 of t hem I agr eed wi t h and some of t hem I di dn' t agr ee wi t h.



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1 But t he f act of t he mat t er i s, t he pr e- sent ence of f i cer i s not

2 t he ul t i mat e aut hor i t y on whet her an appr opr i at e basi s f or an

3 upward or a downward var i ance exi st s.

4 So what we have i n f r ont of us i s we have t wo

5 r ecommendat i ons, one by t he gover nment and one by t he pre-

6 sent ence i nvest i gat or - - by ent i t i es, r ecommendat i ons by

7 ent i t i es who don' t have ul t i mat e sent enci ng aut hor i t y. So I

8 wi l l consi der t hem and I wi l l make my own det er mi nat i on, al l

9 r i ght .

10 MR. POE: Underst ood, Your Honor .

11 THE COURT: But ul t i matel y my determi nat i on, t he

12 cent r al component of my det er mi nat i on wi l l be what I t hi nk i s

13 f ai r , j ust and r i ght .

14 MR. POE: Underst ood.

15 THE COURT: Your obj ect i on i s cer t ai nl y pr eserved,

16 however . But go ahead.

17 MR. POE: Thank you, Your Honor .

18 Now Your Honor , i n a case such as t hi s, of cour se, we

19 r ecogni ze t he i mpor t ance of t he pr i nci pl e of gener al

20 det er r ence. Det er r ence, wi t h r espect t o Mr . Huggi ns, we

21 r espect f ul l y submi t t hat a sent ence exceedi ng a pr obat i onar y

22 sent ence, and we' ve r equest ed i n t hi s case, i s not necessar y

23 t o det er Mr . Huggi ns f r om any f ur t her conduct , cr i mi nal

24 conduct , i n t he f ut ur e.

25 So we have f ocused our ar gument on t he gener al



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1 det er r ence poi nt . And wi t h r espect t o t he gener al det er r ence

2 poi nt , I can' t over - emphasi ze t he l i kel i hood of excl usi on f r om

3 t he i ndust r y by t he Depar t ment of Heal t h and Human Servi ces.

4 One - - i n t he mont h af t er Mr . Huggi ns pl eaded gui l t y I spoke

5 wi t h of f i ci al s at t he Depar t ment of Heal t h and Human Ser vi ces,

6 Your Honor , who i nf ormed me t hat t hey woul d wai t unt i l

7 sent enci ng t o i ni t i at e excl usi on pr oceedi ngs. So gi ven what

8 t he Depar t ment of Heal t h and Human Ser vi ces has done, gi ven

9 what t hey' ve sai d t o me, of f i ci al s of HHS have sai d t o me,

10 gi ven publ i c st at ement s by HHS of f i ci al s, we t hi nk i t ' s f ai r

11 t o say t hat Mr . Huggi ns i s f aci ng near cer t ai n pr oceedi ngs by

12 HHS t o excl ude.

13 That sanct i on, wi t h - -

14 THE COURT: And I ' l l accept t hat as a f act because I

15 t hi nk t hat ' s, i n al l l i kel i hood, what i s goi ng t o occur . But

16 cont i nue.

17 MR. POE: Thank you, Your Honor . That sanct i on,

18 i t sel f , sends an ext r aor di nar i l y power f ul message t o

19 execut i ves i n t he medi cal devi ce i ndust r y, t o t he publ i c at

20 l arge and t hat message has been get t i ng out i n ext r emel y

21 publ i c ways. I n l eadi ng newspaper s, l ocal , nat i onal , i n bl og

22 di scussi ons, i n ot her f or ms wher e t he i ndust r y i s

23 under st andi ng exact l y how ser i ous t he gover nment i s about i t s

24 enf or cement aut hor i t y and i t s wi l l i ngness t o t ake st eps wi t h

25 r espect t o i t s enf or cement aut hor i t y, st eps t hat l ead t o



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1 out comes l i ke t hi s case, Your Honor .

2 And so, wi t h r espect t o t he i dea t hat a sent ence of

3 i ncar cer at i on i s necessary t o det er , gener al l y, member s of t he

4 publ i c or any of f i ci al s or empl oyees i n t he medi cal devi ce

5 i ndust r y, we r espect f ul l y submi t t hat t hat excl usi on sanct i on

6 i t sel f i s suf f i ci ent t o get t he message across.

7 Wi t h r espect t o t he i ssue of t he f i ne, t hat ' s anot her

8 aspect t hat we woul d suggest t o t he Cour t does not r equi r e any

9 sent ence exceedi ng pr obat i on t o be associ at ed wi t h i t .

10 Because t he f i ne i n t he Food, Dr ug and Cosmet i c Act , t he

11 maxi mum f i ne as Congr ess passed t he l aw i n 1937, i s 1, 000

12 dol l ar s. That remai ns t he case t oday.

13 I n 1984 Congr ess, i n t he Sent enci ng Ref or m Act ,

14 i ncr eased t he maxi mum f i ne t o 100, 000 dol l ar s and t hat ' s

15 exact l y t he same act t hat addr essed t he i ssues of penal t i es

16 f or whi t e col l ar of f enses bei ng per cei ved as t oo l ow. And so

17 t he i dea t hat Mr . Huggi ns has now agr eed t o pay, i n t he pl ea

18 agr eement , t he Cour t wi l l do what t he Cour t t hi nks i s

19 appr opr i ate, but has agr eed t o pay i n t he pl ea agr eement a

20 100, 000 dol l ar f i ne i s anot her r eason t o suggest t hat

21 det er r ence of ot her s wi l l be sat i sf actor i l y achi eved wi t hout a

22 sent ence of i ncar cer at i on. I t i s a st i f f maxi mum penal t y and

23 i f t he Cour t i mposes i t t hen we suggest t hat no addi t i onal

24 penal t y, especi al l y i n l i ght of t he excl usi on pr oceedi ngs, i s

25 necessar y.



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1 Now Mr . Huggi ns al so, f or t he l ast t wo and a hal f

2 years, Your Honor , and I don' t want t o put t oo much emphasi s

3 on t he poi nt , but I t hi nk t hat i t i s a poi nt t hat I need t o

4 make. For t wo and a hal f years he has had some r est r i ct i ons

5 on hi s l i ber t y, and I t hi nk t hat t hat ' s a mat er i al f actor f or

6 t he Cour t t o consi der i n f ashi oni ng a sent ence. I don' t put

7 i t anywher e near t he st at us of t he excl usi on pr oceedi ngs or

8 t he maxi mum f i ne t hat he' s pai d but I do wi sh t o not e i t .

9 Real l y, Your Honor , t he i ssue of i ncapaci t at i on, t he

10 need t o pr ot ect t he publ i c f r om f ur t her cr i mes by Mr . Huggi ns,

11 we submi t t he r ecor d doesn' t suggest t hat ever wi l l happen.

12 I ncapaci t at i on i s not necessar y i n t hi s case. The need f or

13 cor r ect i onal t r eat ment , t her e i s no - - based on t he

14 i nf or mat i on bef or e t he Cour t we don' t bel i eve t hat

15 i ncar cer at i on i s necessar y t o af f or d Mr . Huggi ns cor r ect i onal

16 t r eat ment .

17 The Cour t ' s r equi r ed t o consi der , under t he st at ut e,

18 t he gui del i ne r ange, pol i cy st at ement s of t he sent enci ng

19 commi ssi on and t he Cour t , of cour se, has and wi l l do t hat .

20 And t hat r esul t s i n t he cal cul at i on t hat t he Cour t has

21 i dent i f i ed and we agr eed wi t h t hi s mor ni ng.

22 The i ssue of unwar r ant ed di spar i t i es, al l cases ar e

23 di f f er ent , Your Honor , but we woul d not e t hat , of cour se, a

24 sent ence exceedi ng pr obat i on i n t hi s case woul d be somethi ng

25 much di f f er ent f r om what has occur r ed i n ot her cases at ot her



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1 t i mes.

2 The i ssues of pr omot i ng r espect f or t he l aw, assur i ng

3 j ust puni shment , agai n, I t hi nk t hose f ol d back i nt o t he

4 Cour t ' s vi ews of t he case, t he need f or gener al det er r ence and

5 whet her , i n f act , t he ot her puni shment s t hat ar e - - Mr .

6 Huggi ns i s goi ng t o i ncur i n t hi s case ar e suf f i ci ent t o

7 achi eve t he pur poses of sent enci ng.

8 Your Honor , Mr . Huggi ns, at t hi s poi nt , i n l i ght of

9 Your Honor ' s rul i ngs l ast Tuesday, he st ands on t he l et t er

10 t hat he submi t t ed t o t he Cour t . We wi l l not comment f ur t her

11 on t he of f ense conduct or t he r el evant conduct . We cer t ai nl y

12 r espect t he Cour t ' s aut hor i t y and under st and t he Cour t ' s

13 rul i ng.

14 But I ask t he Cour t agai n t o consi der , as i t deci des

15 what an appr opr i at e sent ence i s i n t hi s case i s, whet her a

16 sent ence of i ncar cer at i on i s necessar y t o achi eve t he pur poses

17 of sent enci ng, t o send t he message t o t he publ i c t hat t he

18 conduct t hat t he Cour t has r ul ed occur r ed i n t hi s case. I t

19 needs t o be puni shed. We bel i eve t he puni shment of excl usi on,

20 t he f i ne and t he ot her col l at er al consequences as Mr . Huggi ns

21 has under gone i n t hi s case ar e suf f i ci ent t o achi eve t he

22 pur poses of sent enci ng. And f or al l t hose r easons, Your

23 Honor , we r espect f ul l y ask the Cour t t o i mpose t he sent ence of

24 pr obat i on we' ve r equest ed.

25 I f t he Cour t i s i ncl i ned t o i mpose a sent ence of



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1 i ncar cer at i on we woul d ask t he Cour t t o consi der subst i t ut i ng

2 home detent i on or communi t y conf i nement as an al t ernat i ve t o

3 i ncar cer at i on.

4 Thank you, Your Honor .

5 THE COURT: Thank you, si r . Let me hear f r om t he

6 gover nment , pl ease.

7 MS. CRAWLEY: Good mor ni ng, Your Honor . Mar y Cr awl ey

8 f or t he gover nment .

9 Your Honor , i n t hi s count r y we bel i eve i n pr ocess.

10 I t i s how we approach many of our most i mpor t ant probl ems. We

11 know t hat a f ai r pr ocess i s not goi ng t o, necessar i l y,

12 guar ant ee a good r esul t but we bel i eve t hat good r esul t s ar e

13 pr omoted when t here are f ai r pr ocedur es i n pl ace, when t hose

14 pr ocedur es ar e i nst i t ut ed and i nsi st ed on. And t hi s

15 phi l osophy of pr ocedur al f ai r ness i mposes on t he ci t i zens an

16 obl i gat i on of honest y. I t r ecogni zes t hat peopl e have sel f

17 i nt er est and t hey' r e goi ng t o act i n t hat sel f i nt er est but

18 t hat t hey must make t r ut hf ul di scl osur es t o each ot her and,

19 when necessar y, al so t o t he gover ni ng aut hor i t y.

20 And we bel i eve t he r equi r ement of t r ut hf ul di scl osur e

21 i s especi al l y i mpor t ant i n t he ar ea of medi cal devi ces and

22 especi al l y her e, i n connect i on wi t h a si gni f i cant r i sk medi cal

23 devi ce, wi t h t he FDA' s over si ght , because peopl e' s l i ves

24 depend on i t .

25 And I won' t r epeat here what t he Cour t al r eady knows,



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1 about how devi ces ar e di f f er ent f r om dr ugs. How dr ugs ar e al l

2 t est ed r i gor ousl y t o det er mi ne t hat t hey ar e saf e and

3 ef f ect i ve f or t hei r i nt ended use. Wher eas devi ces can be

4 cl ear ed by t he FDA upon t he i nf ormat i on pr ovi ded by t he

5 manuf act ur er t hat t he devi ce i s subst ant i al l y equi val ent t o

6 anot her devi ce t hat ' s al r eady on t he mar ket .

7 But i t i s cr uci al , especi al l y wi t h s i gni f i cant r i sk

8 devi ces, t hat FDA get t r ut hf ul i nf or mat i on f r om devi ce

9 manuf act ur er s and t hat t he devi ce manuf act ur ers deal honest l y

10 wi t h t he FDA at al l t i mes, and t hat i s what di d not happen

11 her e.

12 I n t hi s case, Your Honor , we bel i eve t her e wer e f our

13 ways i n whi ch t he def endant s subver t ed t he FDA pr ocess.

14 Fi r st , by l yi ng t o t he FDA about what t hei r t r ue i nt ended use

15 f or t he devi ce was. Second, by not obt ai ni ng t he FDA' s

16 per mi ssi on t o conduct cl i ni cal t r i al s on t he devi ce by means

17 of an i nvest i gat i onal devi ce exempt i on. Thi r d, by not f i l i ng

18 adver se event s r epor t s on t he f i r st deat h and t hen f i l i ng

19 vague r epor t s l at er , on t he second and t hi r d deat hs. And

20 f our t h, by l yi ng t o t he FDA i nvest i gat or i n J une - - i n May and

21 J une of 2005, af t er war ds, about t he f i r st t hr ee f ai l ur es t hat

22 had occur r ed.

23 So each of t hese act s, i n t he gover nment ' s vi ew,

24 mani f est ed an i nt ent t o under mi ne t he ent i r e syst em by whi ch

25 we saf eguar d peopl e' s heal t h and saf et y i n connect i on wi t h



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1 medi cal devi ces. And what di d def endant Huggi ns, Mr . Huggi ns

2 do?

3 The Cour t f ound t hat he knowi ngl y par t i ci pat ed i n a

4 busi ness pl an t o conduct unaut hor i zed cl i ni cal t r i al s of SRS,

5 t he pr edecessor devi ce, mi xed wi t h bar i um sul f at e t o t r eat

6 ver t ebr al compr essi on f r act ur es. And t hat he par t i ci pat ed i n

7 t he unaut hor i zed cl i ni cal t r i al s on SRS and t hen t he l at er

8 devi ce, XR, whi ch was t he - - and t hat he aut hor i zed - - t he

9 Cour t al so f ound t hat he aut hor i zed and/ or f ai l ed t o pr event

10 t he t est mar ket of XR, whi ch was t he second of t he t wo i l l egal

11 cl i ni cal t r i al s.

12 And t he Cour t f ound, f ur t her , t hat t he peopl e who

13 wer e t he subj ect s of t he unaut hor i zed cl i ni cal t est i ng wer e

14 di r ect l y and pr oxi mat el y har med by t he def endant ' s act i ons,

15 i ncl udi ng Mr . Huggi ns' act i ons. And t hat t hose peopl e wer e

16 subj ect ed, i n t hese cl i ni cal t r i al s, t o t hese r i sks, t he r i sks

17 of t hese devi ces wi t hout t hei r i nf or med consent and wi t hout

18 t he per mi ssi on of t he FDA. So some of t hose pat i ent s, as t he

19 Cour t f ound, wer e i nj ur ed, some of t hem di ed. And by

20 conduct i ng t hese cl i ni cal t r i al s, t he Cour t f ound t hat t he

21 def endant s, i ncl udi ng Mr . Huggi ns, di sr egar ded t he saf et y of

22 al l members of soci et y. And we woul d submi t t o t he Cour t t hat

23 Mr . Huggi ns t ook par t i n al l f our aspect s of t he cr i me t hat

24 I ' ve j ust out l i ned.

25 At t he end he l i ed t o t he FDA i nvest i gat or , Capt ai n



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1 J oseph Despi ns, who' s her e t oday i n Cour t .

2 THE COURT: Whi ch gent l eman i s Mr . Despi ns?

3 MS. CRAWLEY: Capt ai n Despi ns, i f you coul d st and,

4 pl ease.

5 THE COURT: Oh, he' s t he gent l eman wi t h t he uni f orm

6 and t he medal s. Okay. I f I coul d see - - i f I coul d have seen

7 hi m I woul d have known t hat . But go ahead.

8 MS. CRAWLEY: Capt ai n Despi ns, of cour se, br ought

9 t hi s al l t o l i ght because wi t hout hi s f i ve weeks at t he

10 company, f i r st bei ng t ol d t hat t here were no document s, t hen

11 bei ng t ol d t hat t her e was no cl i ni cal t r i al , t hen cont i nui ng

12 t o pr ess and f i ndi ng out t hat t her e wer e document s, t her e wer e

13 document s on t he comput ers of t he def endant s, document s t hat

14 t hey di dn' t want hi m t o f i nd but document s t hat showed t he

15 unaut hor i zed cl i ni cal t r i al s of t he t wo devi ces.

16 But we submi t , Your Honor , t hat Mr . Huggi ns l i ed t o

17 hi m when he t ol d Capt ai n Despi ns t hat t he XR t est market had

18 i nvol ved onl y cl ear ed - - excuse me - - i ndi cat i ons f or XR when

19 he knew t hat t he t est market , whi ch was the second

20 unaut hor i zed cl i ni cal t r i al , i nvol ved t eachi ng sur geons t o use

21 t he devi ce t o t r eat ver t ebr al compr essi on f r act ur es. And t hi s

22 concl usi on f l ows, i nescapabl y, f r om t he Cour t ' s ot her f i ndi ngs

23 i n i t s or der .

24 We al so submi t t hat Mr . Huggi ns had - - he di d bear a

25 r esponsi bi l i t y f or t he f ai l ur e of Synt hes t o f i l e an adver se



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1 event r epor t , an MDR on t he f i r st deat h, t he deat h of Dr .

2 Sachs' pat i ent because Mr . Huggi ns l ear ned, at t he J anuar y

3 2003 meet i ng, about t he - - t he meet i ng about XR t hat t he f i r st

4 death had occur r ed. And as t he Cour t i s awar e, Dr . Sachs'

5 pat i ent had di ed on t he oper at i ng t abl e af t er havi ng been

6 i nj ect ed wi t h SRS t hat had been back- t abl e mi xed wi t h bar i um

7 sul f at e. She suf f er ed a hypot ensi ve epi sode t hat was

8 consi st ent wi t h pul monary embol i sm and she di ed.

9 At t hat same meet i ng i n J anuary 2003, where Mr .

10 Huggi ns l ear ned of t he deat h, anot her def endant , Mr . Bohner ,

11 ment i oned t hat t here was a ver y shor t wi ndow of t i me t o f i l e

12 an adver se event r epor t . And as t he Cour t i s awar e, Dr .

13 Sachs, i n t al ki ng wi t h t he t hr ee empl oyees of Synt hes, af t er

14 hi s pat i ent had di ed, coul d not r ul e out t he SRS as a cause of

15 hi s pat i ent ' s deat h.

16 Now as t he Cour t i s aware, Synt hes was a hardware

17 company. I t di d not have a hi st or y of pr oduct - r el at ed deat hs.

18 And t hi s f i r st deat h, i n J anuar y 2003, was al ar mi ng t o t he

19 company and i t was al armi ng t o Mr . Huggi ns and t he ot her

20 def endant s and t hi s f ocused t hem on t he saf et y i ssues.

21 So t he gover nment submi t s t hat i f , af t er t hat f i r st

22 deat h, Mr . Huggi ns was - - di d not f ol l ow up by maki ng cer t ai n

23 t hat an adver se event r epor t was f i l ed f or t hat f i r st deat h,

24 i t was not due t o i nat t ent i on, i t was not due t o hi s many

25 ot her dut i es. I t was due t o f ear , per haps, of t ai nt i ng t he



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1 Synt hes br and by r epor t i ng t hi s deat h, f ear of af f ect i ng

2 pr of i t or per haps f ear of l osi ng hi s st at us at Synt hes.

3 Thus we woul d submi t , Your Honor , t hat Mr . Huggi ns

4 was i nvol ved i n al l f our of t he aspect s of t he cr i me f or whi ch

5 he st ands bef or e t hi s Cour t .

6 The Cour t ' s or der out l i nes, bet t er t han I coul d, t he

7 out come of t he unaut hor i zed cl i ni cal t r i al s. And t hese ar e

8 t he ki nds of f or eseeabl e consequences t hat vi ol at i ng t he l aws

9 t hat ar e desi gned t o pr ot ect t he publ i c' s heal t h and saf et y,

10 may have.

11 So as a r esul t of t he subver si on of t he FDA pr ocess,

12 Your Honor , al l of t hese def endant s made r i sky pr ocedur es more

13 dangerous. And at t he hear t of t he deci si on by Mr . Huggi ns

14 and t he ot her s t o go f or war d wi t h t he cl i ni cal t r i al , t he

15 unaut hor i zed cl i ni cal t r i al s, despi t e t he mount i ng saf et y

16 concer ns, despi t e t he l ack of FDA per mi ssi on, i t appear s t o be

17 t hat i t was si mpl y t he pur sui t of pr of i t . I t was t he desi r e

18 t o get t he devi ce t o t he mar ket f ast er , t o cut out t he FDA' s

19 over si ght .

20 So t hi s subj ect ed f r ai l , el der l y pat i ent s, who ar e

21 among t he most vul ner abl e peopl e i n our soci ety, t o gr ave

22 r i sk. They wer e not gi ven t he pr ot ect i ons t hat t hey wer e

23 ent i t l ed t o have. And as we poi nt ed out i n t he sent enci ng

24 memo f or Mr . Huggi ns and i n t he ot her memor anda, what t hey

25 wer e ent i t l ed t o have mi ght have made a di f f erence i n t hi s



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1 case. Because t he surgeons i n t hi s case t ol d t he government

2 t hat had t hey known of t he t hi ngs t hat t hey wer e not t ol d, t he

3 t hi ngs t hat were conceal ed f r om t hem, t hey woul d not have used

4 t hi s devi ce. They woul d not have used i t on t hei r pat i ent s.

5 The t wo ear l i er adver se event s t hat wer e not f at al ,

6 wi t h Dr . Del amar t er ' s pat i ent s i n 2001, t he pi l ot st udi es

7 conduct ed by t he Uni ver si t y of Washi ngt on r esear cher s and t he

8 deat h of Dr . Sachs' pat i ent bef or e t he t est mar ket began, t he

9 XR t est market began.

10 So beyond t hat , even, t he el der l y pat i ent s who wer e

11 put at r i sk her e - -

12 THE COURT: Let me j ust st op you f or a second.


14 THE COURT: The t wo non- f at al , I t hi nk t hey cal l t hem

15 hypot ensi ve event s.

16 MS. CRAWLEY: Yes, Your Honor ,

17 THE COURT: MDRs were f i l ed on t hose, i s t hat

18 cor r ect ?

19 MS. CRAWLEY: That i s absol ut el y cor r ect .

20 THE COURT: And t hey were f i l ed i n a t i mel y manner ,

21 whi ch I t hi nk i s t hi r t y days, i s t hat cor r ect ?

22 MS. CRAWLEY: They wer e.

23 THE COURT: And t hey were pr et t y expl i ci t i n t erms of

24 what t hey sai d, i s t hat r i ght ? They accur at el y and f ai r l y

25 capt ur ed t he f act ual event s t hat had happened dur i ng surger y,



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1 r i ght ?

2 MS. CRAWLEY: That i s cor r ect .

3 THE COURT: And t hen f i l ed by Synt hes, r i ght ?

4 MS. CRAWLEY: They were f i l ed by Synt hes. A - - t here

5 was a di f f er ent per son i n char ge of t he r epor t i ng at t hat t i me

6 who i nsi st ed.


8 MS. CRAWLEY: Dr . Sharp i nsi st ed t hat t hese r epor t s

9 be f i l ed.

10 THE COURT: Okay. So t hen we spi n f orwar d a per i od

11 of t i me and as f ar as t he f at al i t i es ar e concer ned t her e

12 doesn' t seem t o be t he same cl ear appr eci at i on and

13 under st andi ng of t he obl i gat i on t o f i l e r epor t s i n t hose

14 i nstances. I s t hat a f ai r - -

15 MS. CRAWLEY: That i s ver y f ai r .

16 THE COURT: Okay. Go ahead, ma' am.

17 MS. CRAWLEY: But i f - - i f someone had spoken up, i f

18 Mr . Huggi ns had t aken hi s cor por at e r esponsi bi l i t i es ser i ousl y

19 and deci ded t hat Synt hes woul d have t o conduct i t s cl i ni cal

20 r esear ch l egal l y, t hen Synt hes woul d have had t o obt ai n t he

21 FDA' s per mi ssi on ahead of t i me and t here woul d have been a

22 number of saf eguar ds i n pl ace f or pat i ent s i f t he FDA had

23 sai d, yes you can t est t he devi ce t o t r eat VCFs. I f t hat wer e

24 permi t t ed, t hen t her e woul d have been FDA r evi ew of an

25 i nvest i gat i onal pl an. Ther e woul d have been an i nst i t ut i onal



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1 r evi ew boar d at t he hospi t al s wher e t he t est s wer e car r i ed

2 out . And t he i mpor t ant t hi ng about i nst i t ut i onal r evi ew

3 boar ds, Your Honor , i s t hat t hey ar e not j ust doct or s, t hey

4 ar e a mi x of peopl e. They ar e - - t hey i ncl ude et hi ci st s who

5 ar e i n char ge of maki ng sure, among ot her t hi ngs, t hat t he

6 t est ar e adequat el y super vi sed, t hat adver se event s ar e

7 r epor t ed pr ompt l y and t hat pat i ent s ar e t ol d enough so t hat

8 t hey may gi ve t r ue, i nf or med consent because t hat i s what i s

9 at t he hear t of what happened her e. The t er r i bl e t hi ng t hat

10 was done was t hat t he pat i ent s, al l of t he pat i ent s who wer e

11 subj ect ed t o t hese t est s, wer e not t ol d. They di d not know

12 t hat t hey wer e t he subj ect of exper i ment al t r eat ment . They

13 coul d not gi ve i nf ormed consent because t hey di d not know of

14 t he r i sks t hat t he peopl e at Synt hes knew, t hat t he peopl e at

15 Synt hes, i ncl udi ng Def endant Huggi ns, di d not t el l t hem, di d

16 not t el l t he doctor s, di d not t el l t he FDA.

17 And t he r eason, t he speci f i c r eason, why per mi ssi on

18 f r om t he FDA t o conduct t hese t est s mi ght have made a

19 di f f er ence i n t hi s case i s t hat t he second and t hi r d deat hs i n

20 t hi s case, as the Cour t may be aware, bot h t ook pl ace at J ohn

21 Mui r Hospi t al i n Cal i f or ni a. And i t i s easy t o see t hat had

22 an I RB, an i nst i t ut i onal r evi ew boar d, been i n pl ace af t er t he

23 second deat h, t hat i t woul d have been ver y unl i kel y t hat t he

24 t hi r d per son woul d have been operated on wi t h Nor i an. And i f

25 t hey had, t hey woul d have been gi ven i nf ormat i on, perhaps even



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1 i ncl udi ng t hat anot her per son at t he hospi t al had di ed i n t hat

2 same sor t of t r eat ment . They woul d have been gi ven

3 i nf or mat i on t hat woul d have per mi t t ed t hem t o gi ve t r ue,

4 i nf or med consent . But as t he Cour t i s awar e, t hat di d not

5 happen.

6 So because t he pat i ent s wer en' t t ol d t he t r ut h,

7 i ncl udi ng t he r i sks t hat t he def endant s knew about , t hey

8 coul dn' t gi ve i nf ormed consent and t hey coul d not deci de

9 whet her or not t o par t i ci pat e i n exper i ment al t r eat ment .

10 To put i t most bl unt l y, Mr . Huggi ns and t he ot her

11 def endant s used t hese peopl e, t hese el der l y pat i ent s, as

12 gui nea pi gs and i gnor ed t i me honor ed pr i nci pl es of i nf or med

13 consent . He and t he ot her def endant s acted as i f t hese

14 pat i ent s' st at us was not deser vi ng of et hi cal debat e, as i f

15 t hey wer e subj ect s not pat i ent s, cl i ni cal mat er i al i nst ead of

16 si ck peopl e who wer e i n pai n, and t hat i s at t he hear t of what

17 was so t err i bl y wr ong about what Mr . Huggi ns di d.

18 Now, Mr . Huggi ns' counsel poi nt s t o hi s good works

19 and I woul d si mpl y poi nt out t hat when a person has so

20 deci si vel y and so aggr essi vel y t ur ned t he page on a chapt er i n

21 hi s l i f e, when af t er a pl ea he so cl ear l y changes hi s cour se

22 t o set about a concer t ed pr ogr am of good works, t hat may mean

23 t hat he i s t ur ni ng t he page on what he knows i s a ver y i mmoral

24 chapt er i n hi s l i f e. But f ar f r om r ef l ect i ng wel l on hi m, we

25 woul d poi nt out t hat Mr . Huggi ns' conduct onl y hi ghl i ght s hi s



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1 abj ect f ai l ur e t o acknowl edge what he has st eadf ast l y r ef used

2 t o admi t t o t he gover nment , t o t he pr obat i on of f i ce, t o t he

3 publ i c and t o t hi s Cour t .

4 And t he ot her possi bi l i t y, Your Honor , i s even l ess

5 at t r act i ve and t hat i s t hat what he has done i s a cyni cal

6 at t empt t o cur r y f avor wi t h t he Cour t i n an ef f or t t o buy hi s

7 way out of j ai l , t o make hi msel f appear r epent ant when he i s

8 not . I n t hat case, hi s act i ons woul d t hen be consi st ent wi t h

9 hi s wor ds but t he gover nment woul d hope t hat i t i s t he f i r st ,

10 t hat he i s si mpl y t ur ned - - he' s t ur ned t he cor ner .

11 THE COURT: Have you spoken t o hi m?

12 MS. CRAWLEY: Your Honor , we are not i n a posi t i on,

13 he i s r epr esent ed.

14 THE COURT: So you r eal l y don' t know what hi s

15 mot i vat i ons ar e, r i ght ?

16 MS. CRAWLEY: We don' t .

17 THE COURT: So t hi s i s bl i nd specul at i on, r i ght ?

18 MS. CRAWLEY: Your Honor , I am poi nt i ng out - -

19 THE COURT: Agr eed? Agr eed?

20 MS. CRAWLEY: I woul d - -

21 THE COURT: Agr eed?

22 MS. CRAWLEY: No, Your Honor . I woul d say t hat t hose

23 ar e t he t wo al t er nat i ves and I wi l l l eave t hat f or t he Cour t ' s

24 consi der at i on.

25 THE COURT: As you def i ne t hem, r i ght , t hat - -



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2 THE COURT: - - I woul d suggest t o you t hat t here are

3 ot her al t er nat i ves beyond what you see f r om your per spect i ve,

4 because r eal l y what we' r e doi ng her e i s we' r e t al ki ng about

5 per spect i ves, t hat ' s al l we' ve been t al ki ng about si nce t he

6 t i me t hat we met on t hi s case.

7 MS. CRAWLEY: Yes.

8 THE COURT: And t he way t hat you see t hi ngs as an

9 advocat e, t he way t hat Mr . Poe sees t hi ngs as an advocat e and

10 r eal l y t he t r ut hs t hat one sees ar e f r equent l y det er mi ned by

11 t he posi t i on i n whi ch one i s st andi ng when one l ooks at t hem.

12 Mr . Huggi ns has sai d i n hi s sent enci ng document s, a

13 coupl e of t i mes, t hat he wel comes t he oppor t uni t y t o t al k t o

14 me so we' l l get t her e and we' l l f i nd out what t he t r ut hs ar e.


16 THE COURT: But l i ke I sai d t o Mr . Poe, you have

17 bet t er t hi ngs t o t al k about so l et ' s speak about t hose. Go

18 ahead.

19 MS. CRAWLEY: Yes, Your Honor . I am near l y done and

20 al l I woul d suggest at t hi s poi nt i s t hat t he need f or

21 det er r ence her e i s very gr eat because t he pr of i t s t o be made

22 i n t hese si t uat i ons ar e so gr eat . And i t i s - -

23 THE COURT: That l ast poi nt you make i s f asci nat i ng,

24 because we bot h saw t he r el ease- t o- mar ket pl an. I f or get

25 whi ch of your - - your - - I don' t know what t o char act er i ze i t .



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1 I have t hr ee banker s' boxes of exhi bi t s and mat er i al s i n my

2 of f i ce and I r ead t hem al l . And somewhere al ong t he way we

3 saw t he r el ease- t o- mar ket pl an. I want t o say i t was dat ed i n

4 Febr uar y or somet hi ng, I t hi nk, ' 03. But i t sai d f or t he cost

5 of mat er i al s, whi ch wer e - - I t hi nk t hey' r e l ooki ng at

6 somewhere bet ween 6 and 700 sur ger i es pr oj ect ed over a year ,

7 f or t he cost of mat er i al s whi ch i s sl i ght l y under 100, 000

8 dol l ar s, t hey l ook t o r eal i ze, over si x mi l l i on dol l ar s i n

9 r evenue and t hey l ook t o r eal i ze an af t er - t ax pr of i t of over

10 t hr ee mi l l i on dol l ar s. I s t hat - - am I r emember i ng t hat

11 cor r ect l y?


13 THE COURT: Al l r i ght . So when t he gover nment i s

14 t r yi ng t o di scer n what t he mot i vat i ons f or t hi s behavi or ,

15 whi ch i s ver y di f f i cul t t o r econci l e, wi t h r esponsi bl e,

16 et hi cal behavi or by ver y i nt el l i gent peopl e, and t he

17 gover nment says t hat you - - you have t o l ook at t wo t hi ngs,

18 t he cul t ur e wi t hi n t he l ar ger f i el d and t he cul t ur e wi t hi n t he

19 par t i cul ar cor por at i on, and you have t o l ook at t he pr of i t s,

20 pot ent i al pr of i t s t o be r eal i zed as vi ewed by t he def endant s

21 at t he t i me t hat t hey wer e maki ng t he deci si on. So t hat ' s not

22 an abst r act concept i n t hi s case, t her e' s abundant evi dence i n

23 t he r ecor d t o suppor t t he gover nment ' s cont ent i on t hat t he

24 f i nanci al mot i ve per haps oper ated t o cl oud j udgment s whi ch had

25 been pr esent i n t hese hi ghl y successf ul l i ves t o t hi s poi nt



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1 but f or t hi s per i od of t i me seemed t o have been l acki ng.

2 MS. CRAWLEY: Yes, Your Honor . Because her e,

3 f or t unatel y, t he t est mar ket s were ended bef ore more peopl e

4 coul d di e but t he poi nt was t hat t he market t o be capt ur ed was

5 huge because, at t he t i me i t was bel i eved t hat t hi s was a

6 procedure that many peopl e woul d want because many peopl e of

7 our age are gr owi ng ol der and have spi nal probl ems and have

8 compr essi on f act ur es.

9 THE COURT: I ' m st i l l a young man. I beg your

10 par don.

11 MS. CRAWLEY: I beg your pardon?

12 THE COURT: I sai d I ' m st i l l a young man.

13 MS. CRAWLEY: Wel l , I can see t hat Your Honor .

14 THE COURT: As I t el l my l aw cl er ks, I have not hi t

15 my pr i me yet . But t he pr oj ect i on was, I bel i eve, about

16 700, 000 VCF sur ger i es per year , r i ght ?

17 MS. CRAWLEY: I t was, I bel i eve, t hat t her e was - -

18 THE COURT: I n t he ent i r e market .

19 MS. CRAWLEY: Yes.

20 THE COURT: Seven hundred t housand new cases.

21 MS. CRAWLEY: Ther e coul d be t hat many, yes. Ther e

22 coul d be t hat many new cases a year and a gr eat many of t hose

23 woul d be pai nf ul and t hen t he surger i es coul d be per f ormed.


25 MS. CRAWLEY: And of cour se we know now t hat t hi s



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1 surgery was not such a good t hi ng because, of cour se, i n

2 August of 2009 t he New Engl and J our nal of Medi ci ne publ i shed

3 t wo st udi es t hat suggest ed t hat ver t ebr opl ast y was not an

4 ef f ect i ve met hod of r el i evi ng pai n f r om ver t ebr al compr essi on

5 f r act ur es. And so when we ar e r ef l ect i ng on t he ef f ect s t hat

6 t he f our i ndi vi dual s' push f or pr of i t s, t o t he excl usi on of

7 saf et y concerns and i n derogat i on of t he FDA pr ocess, t hey

8 shoul d not be hear d t o say, of cour se, t hat t he sur gi cal r out e

9 was necessar i l y t he best r out e f or - - t he l ast best hope f or

10 t hese peopl e who wer e i n pai n, because now we know

11 di f f erent l y.

12 THE COURT: Wel l , one di dn' t know at t he t i me and, I

13 mean, obvi ousl y a number of appr oaches were bei ng consi der ed

14 and - - but t hat j ust spi r al s back t o your poi nt t hat si nce

15 t hi s i s such a r i sky mar ket , ver y di f f i cul t i ssue wi t h ver y at

16 r i sk pat i ent s, t hat t her e' s a need f or r egul at or y over si ght t o

17 make sur e t hat what occurs occurs consi st ent wi t h medi cal and

18 et hi cal st andar ds, ri ght ?


20 THE COURT: So go ahead.

21 MS. CRAWLEY: Fi nal l y, I want t o say a f ew t hi ngs

22 about t he peopl e who were most af f ect ed by t he def endant ' s

23 act i ons, t he peopl e who are not wi t h us any l onger . The

24 gover nment has obt ai ned t he per mi ssi on of t hei r r el at i ves t o

25 speak about t hem ver y br i ef l y.



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1 THE COURT: Ar e any of t he r el at i ves here or not?

2 MS. CRAWLEY: There were - - t he gr andson of one of

3 t he i ndi vi dual s was goi ng t o come down f r om New Yor k and I do

4 not bel i eve t hat t hey ar e her e yet . But i f I may have a

5 moment , Your Honor?

6 THE COURT: Sure.

7 ( Pause)

8 THE COURT: No one' s r espondi ng. Okay.

9 MS. CRAWLEY: What I wi l l do, Your Honor , t hen I wi l l

10 wai t unt i l t hose - -

11 THE COURT: Oh no, you can say whatever you - - t hey

12 have gi ven you per mi ssi on t o say and i f t he gr andson arr i ves

13 bef or e we f i ni sh, I ' d cer t ai nl y wel come hi s t hought s and

14 i ns i ght s .

15 MS. CRAWLEY: Yes, Your Honor . As t o Loi s Eski nd,

16 who was Dr . Sachs' pat i ent who had - - was - - who had di ed i n

17 J anuary of 2003, J anuar y 13t h; she was t he second pat i ent t hat

18 Dr . Sachs had per f ormed t he pr ocedur e upon usi ng Nor i an,

19 havi ng been t r ai ned i n t he SRS t est mar ket t o use t hat

20 pr ocedur e.

21 And Mr s. Eski nd was sevent y years ol d, she was a

22 homemaker and she l i ved i n Ant l er s, Okl ahoma. And she had,

23 l i ke al l of t hese i ndi vi dual s, a l ot of ot her medi cal pr obl ems

24 and she was i n pai n f r om her ver t ebr al compr essi on f r act ur es.

25 I bel i eve she was t he subj ect of a newspaper ar t i cl e



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1 t hat was wr i t t en by someone wr i t i ng f or t he "Phi l adel phi a

2 I nqui r er " and her r el at i ves had spoken t o t he newspaper . But

3 Dr . Sachs began t he sur gery. He was operat i ng on t wo l evel s

4 of her back and Mr s. Eski nd di ed on t he oper at i ng t abl e.

5 There was no aut opsy per f ormed.

6 Dr . Sachs t ol d a gr oup of Synt hes Spi ne empl oyees, i n

7 t he days r i ght af t er t he sur ger y, t hat Mr s. Eski nd had di ed of

8 a car di opul monar y event , myocar di al i nf ar ct i on, embol i sm of

9 some ki nd, unknown cause. And he di d not know whet her i t was

10 an ai r embol i sm, t he anest hesi ol ogi st t hought i t was a f at

11 embol i sm - - I ' m sor r y; t he anest hesi ol ogi st t hought i t was an

12 ai r embol i sm, Dr . Sachs bel i eved i t was mor e l i kel y a f at

13 embol i sm and he sai d t hat t her e was no choi ce but t o be

14 concer ned. And he sai d t hat goi ng f or war d, pat i ent sel ect i on

15 i s cr i t i cal . And t hi s i s t he case, Your Honor , wher e t he

16 company had deci ded not t o f i l e an adver se event r epor t . And

17 si gni f i cant l y t he company di d not - -

18 THE COURT: He sai d t o whom t hat pat i ent sel ect i on i s

19 cr i t i cal ?

20 MS. CRAWLEY: He sai d t o Synt hes empl oyees t hat

21 pat i ent sel ect i on i s cr i t i cal . So t hi s shoul d have had an

22 af f ect upon t he company' s behavi or goi ng f or war d, but i t di d

23 not . And si gni f i cant l y, t he company di d not ever have t he

24 event anal yzed by an out si de medi cal expert , al t hough t hey had

25 no r equi r ement - - t here was no r equi r ement t o do t hat i n t he



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1 l aw, necessar i l y, but t hi s woul d be, obvi ousl y, a pr udent

2 t hi ng t o do, t he best t hi ng t o do, t he saf est t hi ng t o do.

3 But i t was not done and i n f act t he company di d not even

4 obt ai n t he x- r ays of Mr s. Eski nd or medi cal r epor t s f or t he

5 event .

6 I n f act , t he f i r st t i me t hat t he x- r ays wer e - -

7 copi es were r evi ewed by personnel at Synt hes was i n connect i on

8 wi t h Dr . Sachs' pr esent at i on t hat he gave at t he f i r st t est

9 market event i n San Di ego and t hat was i n August of 2003. And

10 t hose x- r ays t hen r eappear ed, as t he Cour t i s awar e, at a

11 much - - at l at er event s and i n t he t echni que gui de f or Nor i an

12 XR whi ch, of cour se, t he Cour t i s awar e t he def endant s di d not

13 know t hat t hose were Mr s. Eski nd' s x- r ays t hat wer e bei ng put

14 i n t he t echni que gui de but t hi s i s what happens when t he l aws

15 are di sr egarded, when peopl e are not doi ng what t hey need t o

16 do t o br i ng saf ety event s t o t he gover nment ' s and t o other

17 peopl e' s at t ent i on.

18 The second pat i ent who di ed was Mr . Ki kuchi who had

19 been a f ormer pr of essor at UC Berkl ey and a physi ci st . He was

20 ei ght y- t hr ee when he was operated on by Dr . Not t i ngham and

21 t hat was, as I ment i oned, i n J ohn Mui r Hospi t al i n Cal i f or ni a.

22 And t hi s gent l eman had VCFs, ver t ebr al compr essi on f r actur es

23 at t hr ee l evel s and he was - - Mr . Ki kuchi was semi - r et i r ed and

24 he was an act i ve and ment al l y al er t per son. Up unt i l a mont h

25 bef or e t he surgery he had been wal ki ng on a dai l y basi s wi t h



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1 no pr obl ems f or t hi r t y t o f or t y mi nut es at a t i me. But he had

2 a hi st ory of degener at i ve spi ne di sease and he had had a

3 pr evi ous kyphopl ast y sur gery usi ng PMMA.

4 So, agai n, wi t h t hi s second sur ger y t her e was a - -

5 l i ke t he f i r st sur ger y, t her e had been a Synt hes Spi ne

6 consul t ant pr esent dur i ng t he sur ger y and soon af t er t he

7 Nor i an XR was i nj ect ed i nt o hi s back, Mr . Ki kuchi , hi s bl ood

8 pr essur e f el l qui ckl y, hi s hear t st opped and he coul d not be

9 r esusci t at ed. He di ed on t he oper at i ng t abl e and no aut opsy

10 was per f ormed.

11 And on September 23r d, 2003, a Synt hes compl ai nt

12 handl i ng manager t ol d - - wr ot e t hat t he Nor i an XR pr oduct

13 manager had t ol d hi m t he day bef or e t hat Dr . Not t i ngham had

14 r epor t ed t he event t o Synt hes and t hat he noted a cement l eak

15 dur i ng t he i nj ect i on and f eel s t hat t hi s was a cause of t he

16 i nci dent . Whi ch i s, of cour se, t he pr obl em wi t h t hi s devi ce

17 t o begi n wi t h, i s t hat t he saf et y concer ns had t o do wi t h

18 whet her or not i t coul d cause bl ood cl ot s. The pi l ot st udi es

19 showed t hat i t coul d, and t hose st udi es wer e i gnor ed.

20 The summar y t hat t he product manager wr ot e about t hi s

21 event i ncl uded t he notes t hat Dr . Not t i ngham not ed a cement

22 l eak dur i ng t he i nj ect i on and f eel s t hat t hi s was t he cause of

23 t he i nci dent . He t hi nks a cl i ni cal t r i al i s necessar y bef or e

24 r el easi ng cavi t y cr eat i on and XR. He cl ai ms t he sal es

25 consul t ant pushed t hi s pr oduct on hi m and was uncl ear about



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1 i t s st at us on t he mar ket .

2 So, agai n, meet i ngs were hel d and deci si ons were made

3 t o go f or war d.

4 THE COURT: I s t hi s t he r epor t whi ch says t hat t he

5 Synt hes empl oyee not es t hat t he doctor ' s obvi ousl y concerned

6 about med mal sui t ?

7 MS. CRAWLEY: Yes.

8 THE COURT: Thi s i s t he same one?

9 MS. CRAWLEY: Exact l y, Your Honor .

10 THE COURT: Okay.

11 MS. CRAWLEY: And t her e wer e not es f r om a meet i ng

12 t hat t ook pl ace i n l at e Sept ember and t he not es st at e t hat

13 "Mr . Huggi ns commented t wo MDR event s, r esear ch t he number of

14 MDRs f or kyphopl ast y PMMA. Pat i ent s ar e ver y f r ai l , need t o

15 assembl e t he dat a, l ook at t r ends, " et ceter a. And agai n,

16 Synt hes di d not ask an i ndependent medi cal exper t t o l ook at

17 t hi s deat h, t o r evi ew i t and t hi s i s, at t hi s poi nt - - even - -

18 agai n, t her e may not be a pr eci se l egal r equi r ement f or t hat

19 but at t hi s poi nt i t ' s i nconcei vabl e because t her e ar e t wo

20 deat hs i n a ver y smal l sampl e of i ndi vi dual s.

21 Even someone - - t he compl ai nt handl i ng manager at

22 Synt hes, at t hi s poi nt , e- mai l ed a manager about t he Dr .

23 Not t i ngham event s t at i ng, "Typi cal l y, f or MDR event s,

24 especi al l y one i nvol vi ng a deat h, we cont act a ' medi cal

25 consul t ant ' or ' exper t ' i n t he f i el d t o det er mi ne whet her t he



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1 al l egat i on i s val i d. I t i s i mper at i ve t hat we have an

2 obj ect i ve medi cal pr of essi onal avai l abl e f or consul t i ng f or

3 t hi s compl ai nt . " But t he company di d not do t hat .

4 And t he company, because i t had not f i l ed an adver se

5 event r epor t f or Dr . Sachs' pat i ent deat h, t r eat ed t hi s as the

6 f i r st deat h. And so t hat was t he f i r st - - t hey f i l ed a

7 basel i ne r epor t whi ch i t basi cal l y omi t t ed t he t r endi ng

8 i nf or mat i on t hat needed t o be pr ovi ded t o t he FDA so t hat t he

9 FDA coul d see t hat t hi s was not j ust an i sol at ed i nci dent .

10 Fi nal l y, as t o - - oh, I ' m sor r y. Ther e was an MDR

11 f i l ed, t he adver se event r epor t . I t st at ed "That sur geon

12 compl ai ned t hat pat i ent expi r ed dur i ng a t hr ee- l evel ver t ebr al

13 body augment at i on. No eval uat i on coul d be per f ormed, no

14 concl usi ons coul d be dr awn as no pr oduct was r etur ned f or

15 eval uat i on" whi ch, of cour se, i s opaque i n t he ext r eme because

16 i t doesn' t even use t he t er m ver t ebr al compr essi on f r act ur e.

17 I t doesn' t use t he t er m ver t ebr opl ast y. I t does not gi ve any

18 t er m t hat someone l ooki ng f or t hi s sor t of i nf or mat i on woul d

19 l ook f or i n or der t o f i nd t he r epor t .

20 Fi nal l y, as t o t he l ast deat h, t hat was of Dr . Bal l ' s

21 pat i ent i n J anuar y of 2004. And he - - Dr . Bal l - -

22 THE COURT: And t hat one was wher e?

23 MS. CRAWLEY: That was al so at J ohn Mui r Hospi t al ,

24 Your Honor , t he same one as the second deat h. Act ual l y, Dr .

25 Bal l was Dr . Not t i ngham' s par t ner .



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1 And Dr . Bal l had been - - act ual l y had been pr esent at

2 one of Dr . Del amar t er ' s surger i es back i n Febr uary 2001. And

3 he was cour t ed by Synt hes f or t he Nor i an XR t est market and he

4 at t ended t he 2003 - - t he August 2003 San Di ego t r ai ni ng

5 sessi on.

6 By J anuary of 2004 Dr . Bal l had per f ormed sever al VCF

7 surger i es wi t h Nor i an XR i n t he t est market , one of whi ch had

8 r esul t ed i n a l eak, a cement l eak. And t hen i n l at e 2003,

9 af t er hi s par t ner , Dr . Not t i ngham, had had hi s pat i ent di e,

10 Def endant Hi ggi ns sent Dr . Bal l a pr oposed consul t i ng

11 agr eement , t o become a consul t ant f or Synt hes i n r el at i on t o

12 Nor i an XR. And Dr . Bal l was schedul ed t o l ead a Nor i an XR

13 cavi t y cr eat i on sur geon f or um i n San Di ego on J anuar y 24t h and

14 25t h of 2004. I n Mar ch of 2004 he di d si gn t he consul t i ng

15 agr eement wi t h t he company.

16 But i t was al most on t he eve of t he J anuary 24t h San

17 Di ego f orum, Your Honor , t hat he per f ormed a t est market

18 sur gery on t he t hi r d person who di ed and t hat was a l ady who

19 was ei ght y- t hr ee year s ol d, Bar bar a Mar cel i no. She l i ved i n

20 Pl easant Hi l l , Cal i f or ni a. And t hi s was, agai n, at J ohn Mui r

21 Hospi t al .

22 Mr s. - - excuse me - - Mr s. Mar cel i no' s husband was, at

23 t hat t i me, l i vi ng i n assi st ed l i vi ng and she wor r i ed about

24 what woul d happen t o hi m i f she were not around because she

25 was hi s caretaker . She had t wo daught ers, age si xt y and



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1 si xt y- t hr ee, and she had l ongst andi ng l ower back pai n. And

2 she had been usi ng a wal ker f or about ei ght een mont hs. She

3 was st i l l f ai r l y act i ve and she was st i l l dr i vi ng.

4 The surgery di d not t ake pl ace; i t was schedul ed on

5 t he 19t h of J anuar y, because t here wer e i ssues about whether

6 she coul d be cl ear ed f or t he sur ger y. But i t di d go f or war d

7 on J anuar y 21st , i n t he eveni ng. And at 10: 30 at ni ght Dr .

8 Bal l began operat i ng. He per f or med a kyphopl ast y wi t h Nor i an

9 XR on her second l umbar ver t ebr ae. And t he same Synt hes

10 consul t ant , t he Synt hes Spi ne consul t ant who had been i n t he

11 oper at i ng r oom dur i ng t he deat h of Dr . Not t i ngham' s pat i ent

12 was i n t he oper at i ng r oom dur i ng t hi s sur ger y as wel l .

13 The sur ger y, accor di ng t o t he r ecor ds was - - t he

14 cement was i nj ect ed at appr oxi matel y 11: 10 p. m. Her hear t

15 r at e f el l , her bl ood pr essur e f el l i mmedi at el y. CPR began at

16 11: 12 t hat eveni ng. She was pronounced dead at t wel ve mi nutes

17 past mi dni ght and t hat was Thur sday, J anuar y 22nd, wi t h t he

18 f or um schedul ed t o st ar t on Sat ur day. The f or um was

19 cancel l ed.

20 Agai n, t her e was no i ndependent r evi ew of t hi s - -

21 THE COURT: So t he r eact i on st ar t at t he - - t he

22 physi ol ogi cal r eact i on st ar t ed t wo mi nut es af t er t he

23 i nj ect i on, i s t hat r i ght ?

24 MS. CRAWLEY: That i s cor r ect , Your Honor .

25 THE COURT: Al l r i ght . Go ahead.



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1 MS. CRAWLEY: Agai n, t here was no r evi ew by an

2 i ndependent medi cal exper t . Thi s t i me, however , an aut opsy

3 was per f ormed and t he pat hol ogi st r epor t noted t hat t her e was

4 f or ei gn mat er i al pr esent i n t he L2 ver t ebr al body and al so i n

5 mi cr oscopi c bl ood vessel s i n t he l ung. And t hi s f i ndi ng was

6 somet hi ng t hat coul d not necessar i l y be - - i nt er pr et at i on of

7 t he f i ndi ng i s obscur ed because Mr s. Mar cel i no was subj ect t o

8 CPR f or some t i me. So i t ' s not cl ear whether t he devi ce had

9 t r avel l ed i nt o t he mi cr oscopi c vessel s of her l ungs thr ough i t

10 l eaki ng or t hr ough t he CPR. But t he f act r emai ns t hat she had

11 had t he hypot ensi ve event al most i mmedi at el y upon bei ng

12 i nj ect ed.

13 So Your Honor , because what happened here - - wel l , i t

14 i s di f f i cul t t o f i nd wor ds t o say how egr egi ous t he behavi or

15 i s . And I wi l l - - at thi s poi nt I wi l l s top t ryi ng. But i n

16 t hi s count r y we don' t say - - we don' t say t hat you cannot do

17 cl i ni cal t est i ng wi t h a si gni f i cant r i sk devi ce. We say you

18 must obt ai n t he FDA' s permi ss i on. We say you must get t he

19 pat i ent ' s i nf or med consent . And when you don' t do t hi s, as

20 t he Cour t has f ound t hat Mr . Huggi ns and t he r emai nder of t he

21 def endant s di dn' t , t hen he has under mi ned, t hey al l have

22 under mi ned t he f undament al pr ocedur al pr otect i ons that

23 separ at e a ci vi l i zed soci et y f r om an unci vi l i zed soci et y when

24 i t comes t o human exper i ment at i on.

25 So we woul d ask t he Cour t , because of t hese r easons,



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1 t o gi ve a sent ence of a year i n pr i son, t he maxi mum t hat t he

2 l aw al l ows.

3 Thank you.

4 THE COURT: Bef or e you si t down, t hough, woul d you

5 check and see i f your wi t ness - - i f - - i f he happened t o

6 ar r i ve?


8 ( Pause)

9 THE COURT: The gent l eman' s goi ng t o l ook out si de?


11 THE COURT: Fi ne. We' l l wai t f or hi m.

12 ( Pause)

13 THE COURT: I was wonder i ng i f Capt ai n Despi ns woul d

14 be wi l l i ng t o be a cour t wi t ness? I t ' s posed as a quest i on

15 but you act ual l y have no choi ce. J ust t ake t he st and f or me,

16 pl ease, s i r . Pl ease.

17 THE REPORTER: Rai se your r i ght hand, pl ease. St at e

18 your name and spel l your f i r st and l ast name.

19 CAPTAI N DESPI NS: J oseph, J - O- S- E- P- H, Despi ns, D- E-

20 S- P- I - N- S.

21 COURT' S WI TNESS, CAPTAI N DESPI NS, SWORN

22 THE COURT: And pul l t he mi cr ophone i n f r ont of you

23 f or me, pl ease.

24 So where we are i s, Ms. Cr oce, t he young l ady you

25 wer e j ust t al ki ng t o, she' s maki ng an el ect r oni c sound



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1 r ecordi ng of everyt hi ng t hat we say and because of t he

2 pecul i ar i t i es of t he acoust i cs i n t hi s room, I need you t o

3 speak di r ect l y i nt o t he mi cr ophone. Because even t hough I can

4 hear you she' s not necessar i l y abl e t o r ecor d you unl ess you

5 speak i nt o t he mi cr ophone. Underst ood?

6 THE WI TNESS: Yes, Your Honor .

7 THE COURT: Al l r i ght . So have you ever t est i f i ed i n

8 cour t bef or e?

9 THE WI TNESS: No si r , t hi s i s my f i r st exper i ence.

10 THE COURT: Wel l , i t ' s a good t hi ng I di dn' t gi ve you

11 any not i ce, i sn' t i t , because you mi ght have got t en ner vous i f

12 I gave you not i ce, r i ght ?

13 Al l r i ght . So l et me j ust t el l you t he - - sor t of ,

14 t he way i t i s. Thi s i s a conver sat i on. I wi l l ask you

15 quest i ons and you' l l gi ve me your answer s. And i f you don' t

16 know somethi ng, j ust t el l me you don' t know because what I

17 l i ke t o deal wi t h ar e t he t r ut hs, t hi ngs peopl e cer t ai nl y

18 know. Underst ood?


20 THE COURT: And i f you need t o expl ai n somet hi ng j ust

21 l et me know and you can expl ai n i t .

22 So you work f or whom, exact l y?

23 THE WI TNESS: I wor k f or Food and Dr ug

24 Admi ni st r at i on.

25 THE COURT: And how l ong have you wor ked f or t he Food



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1 and Dr ug Admi ni st r at i on?

2 THE WI TNESS: Si nce Oct ober 14th, 1996.

3 THE COURT: And i n what capaci t y do you wor k f or t he

4 FDA?

5 THE WI TNESS: I work as a consumer saf ety of f i cer ,

6 ot her wi se known as an i nvest i gat or .

7 THE COURT: Al l r i ght . And what are your dut i es as

8 an i nvest i gat or or consumer saf et y of f i cer ?

9 THE WI TNESS: My dut i es are t o conduct i nspect i ons of

10 r egul at ed i ndust r y. I have conduct ed - - my f ocus, back at t he

11 t i me of - - i n 2004 was I conduct - - I conduct ed bi ol ogi c - -

12 bi o mo i nspect i ons, t hey' r e cal l ed. They' r e i nspect i ons of

13 var i ous cl i ni cal i nvest i gat or s, sponsor s of cl i ni cal r esear ch,

14 i ndependent i nst i t ut i onal r evi ew boar ds, I RBs as was r ef er r ed

15 t o by Ms. Cr awl ey, cl i ni cal i nvest i gat or s and non- cl i ni cal

16 l abor at or i es wher e t hey do eval uat i ons of saf et y of

17 par t i cul ar - - ei t her dr ug compounds or medi cal devi ces i n

18 ani mal s.

19 THE COURT: Very wi de r angi ng, r i ght ?

20 THE WI TNESS: Yes, si r .

21 THE COURT: And how di d t he FDA t r ai n - - what di d you

22 do bef ore you began t o work f or t he FDA?

23 THE WI TNESS: I was i n t he U. S. Ar my, U. S. Ar my

24 medi cal depart ment . I was t r ai ned as an ent omol ogi st , E- N- T-

25 O- M- O- L- O- G- I - S- T.



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1 THE COURT: I f or get what t hat i s.

2 THE WI TNESS: That ' s t he st udy of i nsects.

3 THE COURT: Okay.

4 THE WI TNESS: My degr ee i s i n entomol ogy and our

5 mi ssi on i s i n pr event i ve medi ci ne. We - - we - - our mi ssi on

6 was t o keep t he t r oops heal t hy and so t he cont r ol of i nsect s,

7 vect or s of di sease.

8 THE COURT: Sur e, dependi ng upon what par t of t he

9 wor l d you' r e i n t hat mi ght be a ver y si gni f i cant concer n.

10 THE WI TNESS: Yes, t hat ' s cor r ect .

11 THE COURT: And your educat i onal background i s what ,

12 si r ?

13 THE WI TNESS: I have a mast er ' s degree and a PhD i n

14 t he f i el d of ent omol ogy f r om Vi r gi ni a Tech.

15 THE COURT: Al l r i ght . So i n t erms of your

16 f ami l i ar i t y wi t h what ot her i nvest i gat or s f or t he FDA wer e

17 doi ng, al l r i ght , i s ther e some sor t of t r ai ni ng or exposur e

18 t hat t hey - - t hat t he agency pr ovi des t o you al l t o l et you

19 know what ' s devel opi ng i n t he f i el d, what compani es ar e doi ng?

20 Or do you j ust wor k on your i ndi vi dual cases? Do you shar e

21 i nf or mat i on; I guess i s what my quest i on i s.

22 THE WI TNESS: When we' r e assi gned an i nspect i on we

23 get backgr ound i nf or mat i on t hat comes i n wi t h t he assi gnment .


25 THE WI TNESS: And I can' t speak f or other



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1 i nvest i gat or s but what I do i s I l ook at what i s i n t he FDA

2 dat abases r egar di ng a par t i cul ar dr ug or devi ce. I l ook at - -

3 Googl e i s a wonder f ul t hi ng. I sear ch f or any i nf or mat i on

4 t hat may be out i n t he publ i c domai n.

5 THE COURT: Ri ght . So you' r e f ami l i ar wi t h t he

6 i nf or mat i on i n t he publ i c domai n and you' r e al so f ami l i ar wi t h

7 t he i nf or mat i on i n t he FDA' s dat abase.

8 THE WI TNESS: Yes.

9 THE COURT: I underst and t hat ' s what you j ust sai d.

10 Because as par t of your dut i es, and we underst and every case

11 i s di f f er ent , but as par t of your dut i es you want t o

12 f ami l i ar i ze your sel f wi t h t he knowl edge base t hat exi st s,

13 r i ght ?

14 THE WI TNESS: That ' s corr ect .

15 THE COURT: Okay. So t hen, as f ar as t est market s

16 ar e concer ned, and t hi s i s real l y what I ' m i nt er est ed i n, how

17 does t he FDA def i ne an i l l egal or i nappr opr i at e t est mar ket ?

18 Wel l , l et me j ust back up. St ar t by t el l i ng me what

19 an appr opr i ate t est mar ket i s, based upon your exper i ence and

20 exper t i se and knowl edge. What are you al l owed t o do i n a t est

21 mar ket ?

22 THE WI TNESS: You are al l owed t o - - you can gat her

23 i nf or mat i on about usabi l i t y of , i n t hi s case, medi cal devi ces,

24 how easy i t i s t o handl e by t he sur geon.

25 THE COURT: Usabi l i t y, t hat ' s what i t means i s ease



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1 of use?

2 THE WI TNESS: That ' s r i ght . Yeah.

3 THE COURT: Al l r i ght .

4 THE WI TNESS: For l abel ed i ndi cat i ons, i ndi cat i ons

5 t hat have been cl ear ed by t he Food and Dr ug Admi ni st r at i on.

6 THE COURT: So t here' s t wo component s t o t hat , ease

7 of use f or FDA appr oved i ndi cat i ons, r i ght ?

8 THE WI TNESS: That ' s cor r ect , si r .

9 THE COURT: So keep goi ng.

10 THE WI TNESS: I f i r st became aware of t est markets

11 when I r ecei ved t he assi gnment t o conduct t hi s i nspect i on i n

12 2004. At t hat t i me FDA t hought i t was - - i t wasn' t r eal l y a

13 mar ket i ng st udy, t hat an act ual cl i ni cal t r i al had been

14 i ni t i at ed and so I was appr oachi ng i t - - I got t he assi gnment

15 because my backgr ound i s conduct i ng t he f i nal i nspect i ons.

16 THE COURT: You' r e a sci ent i st , r i ght ?

17 THE WI TNESS: Yes.

18 THE COURT: Go ahead.

19 THE WI TNESS: And so i f you l ook at i t f r om t he

20 st andpoi nt of a r egul at ory body, why woul d - - why woul d a

21 company ease a product out i nt o t he market pl ace as what I saw

22 wi t h t he phase t wo t est mar ket . The - - accor di ng t o t he

23 r egul ar processes you have - - you have desi gn and desi gn

24 val i dat i on wher e t hey t est , you know, t he manuf act ur er i s

25 supposed t o t est t he pr oduct t o see i f i t meet s t he needs of



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1 t he end user s. And by doi ng a t est mar ket l i ke t hi s i t al most

2 l ooks l i ke you woul d have - - you woul d have - - you woul dn' t

3 have ver y much f ai t h i n what you - - t he pr eparat or y work t hat

4 you conduct ed.

5 THE COURT: So what you' r e sayi ng t o me i s t hat each

6 manuf act ur er , a subst ant i al amount of wor k shoul d occur bef or e

7 a t est mar ket i s i ni t i at ed. I t shoul d be wel l desi gned,

8 r i ght , nar r ow subj ect and al so nar r ow, sor t of , gr oup of

9 subj ect s, i f you wi l l , nar r ow t ar get popul at i on. But of

10 cour se t her e' s al so t he FDA appr oval , whi ch i s i nvol ved,

11 r i ght ?


13 THE COURT: I t ' s a car ef ul l y desi gned i nst r ument , i s

14 what you' r e sayi ng t o me, i n nor mal t est market .

15 THE WI TNESS: The t

us grand jury indictment synthes, inc

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