Transcript of Washington State Court Hearing on 10-30-2015

7/23/2019 Transcript of Washington State Court Hearing on 10-30-2015

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4579e767-0cc6-4585-9d5f-45onically signed by Marjie Jackso n (601-293-514-5743)

Hear i ng on Mot i ons Oct ober 30, 2015

Reed J ackson Wat ki ns Cour t Cer t i f i ed Tr anscr i pt i on 206. 624. 3005

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THE SUPERI OR COURT OF THE STATE OF WASHI NGTON

I N AND FOR THE COUNTY OF KI NG

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

CYNTHI A WI LSON, I ndi vi dual l y and as )

Per sonal Repr esent at i ve of t he Est at e )

of Reba Gol den, Deceased, and on behal f ) No. 13- 2- 29535- 1 SEA

of St at ut or y Benef i ci ar i es VI CTORI A )

MARI NCI N and PAUL D' OYLEY; and VI CTORI A )

MARI NCI N and PAUL D' OYLEY; I ndi vi dual l y, )

et al , )

Pl ai nt i f f s, )

v. )

J ens R. Chapman, M. D. , et al . )

Def endant s. )

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

HEARI NG ON MOTI ONS

Oct ober 30, 2015

The Honorabl e Dean Lum Presi di ng

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Transcr i bed by: Reed J ackson Wat ki ns, LLC

Cour t - Cer t i f i ed Tr anscr i pt i on

206. 624. 3005


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1 A P P E A R A N C E S

2

3 Counsel f or Pl ai nt i f f s:

4 DANI EL L. HANNULA

5 HAROLD THADDEUS DODGE, J R

6 Rush Hannul a Harki ns & Kyl er

7 4701 Sout h 19t h St r eet , Sui t e 300

8 Tacoma, Washi ngt on 98405- 1177

9

10

11 Counsel f or Def endant Hansj org Wyss:

12 STEVEN J . BORANI AN

13 Reed Smi t h

14 101 Second St r eet , Sui t e 1800

15 San Fr anci sco, Cal i f or ni a 94105

16

17

18 Counsel f or Def endant J ens Chapman, M. D.

19 J OHN A. ROSENDAHL

20 Fai n, Ander son, Van Der hoef , Rosendahl , O' Hal l or an, Spi l l ane

21 1301 "A" St r eet , Sui t e 900

22 Tacoma, Washi ngt on 98402- 4299

23

24

25


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1 Counsel f or Def endant s Huggi ns, Hi ggi ns, Bohner , and Wal sh:

2 J ASON LEVI N

3 St ept oe & J ohnson, LLP

4 633 West Fi f t h St reet , Sui te 300

5 Los Angel es, Cal i f orni a 90071

6

7 Counsel f or Def endant s St at e of Washi ngt on, et al . :

8 MI CHAEL MADDEN

9 WI LLI AM J . LEEDOM

10 Bennet t , Bi gel ow & Leedom, P. S.11 1700 Sevent h Avenue, Sui t e 1900

12 Seat t l e, Washi ngt on 98101

13

14 Counsel f or Def endant s Synt hes, I nc. , Nor i an Cor p. , and Kensey

15 Nash Cor p. :

16 CHRI STOPHER W. TOMPKI NS

17 Bet ts , Pat terson & Mi nes, P. S.

18 701 Pi ke Str eet , Sui t e 1400

19 Seat t l e, Washi ngt on 98101- 3927

20

21 J AMES T. SMI TH

22 Bl ank Rome, LLP

23 130 Nor t h 18t h St r eet

24 Phi l adel phi a, Pennsyl vani a 19103- 6998

25


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1 - o0o-

2 October 30, 2015

3

4 THE COURT: Thank you, pl ease be seat ed. Good af t ernoon,

5 Counsel .

6 MULTI PLE SPEAKERS: Good af t ernoon, Your Honor.

7 THE COURT: Al l r i ght . We' r e bei ng r ecor ded. We don' t

8 have a cour t r epor t er her e, but we' r e on t he r ecor di ng

9 syst em.

10 Let ' s go ahead and have counsel ent er t hei r appear ances11 star t i ng wi th pl ai nt i f f ' s counsel .

12 MR. HANNULA: Your Honor , my name i s Dan Hannul a, one of

13 the at t orneys f or the pl ai nt i f f .

14 MR. DODGE: Harol d Dodge, Your Honor, one of t he at t orneys

15 f or t he pl ai nt i f f .

16 MR. ROSENDAHL: Excuse me, Your Honor . J ohn Rosendahl f or

17 Dr . Chapman.

18 MR. BORANI AN: Good af t ernoon, Your Honor . St ephen

19 Bor ani an f or Def endant Hansj or g Wyss.

20 MR. SMI TH: Good af t er noon, Your Honor . J i m Smi t h f or

21 Synt hes and Nor i an.

22 THE COURT: Okay.

23 MR. MADDEN: And, Your Honor , Mi ke Madden f or t he

24 Uni ver si t y of Washi ngt on, Har bor vi ew Medi cal Cent er , Doctor s

25 Dai nes and Mor set t e.


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1 THE COURT: Thank you.

2 MR. LEVI N: Good af t er noon, Your Honor . J ason Levi n of

3 St ept oe & J ohnson f or Def endant s Huggi ns, Hi ggi ns, Bohner

4 and Wal sh.

5 MR. LEEDOM: Bi l l wi t h LeedomMi ke Madden and UW.

6 MR. TOMPKI NS: Chr i s Tompki ns r epr esent i ng Synt hes, Nor i an

7 and Mr . Wyss.

8 THE COURT: Counsel , good af t er noon.

9 And t hen do we al so have ot her i nt er est ed par t i es,

10 Counsel ?11 MR. HANNULA: Yes, Your Honor . These ar e t he chi l dr en of

12 Reba Gol den.

13 MS. WI LSON: Hi , Your Honor , I ' m Ci ndy Wi l son.

14 MR. D' OYLEY: Hi , Your Honor , I ' m Paul D' Oyl ey.

15 MS. MARI NCI N: I ' m Vi ct ori a Mari nci n.

16 THE COURT: And otherwi se we j ust have observer s. And

17 member s of t he publ i c ar e compl et el y wel come.

18 So we - - l et ' s see. We have sever al mot i ons on and l et ' s

19 see i f we can f i gur e out a l ogi cal way f or us t o di vi de up

20 our t i me. We have t he mot i on f or part i al summary j udgment

21 t o di smi ss Cr i mi nal Pr of i t eer i ng Act Cl ai m, Count No. 9, I

22 bel i eve, and Leadi ng Or gani zed Cr i me Cl ai m, Count No. 10.

23 Ther e have been sever al j oi nder s - - ther e had been a j oi nder

24 of t hat par t i cul ar mot i on and obvi ousl y opposi t i on and

25 r epl y.


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1 We al so have - - i s i t pr onounced Wei ss, Wi ess ( phonet i c) ?

2 MR. BORANI AN: I t ' s Mr . Wyss, Your Honor .

3 THE COURT: Wyss; I ' m sor r y. Mr . Wyss' s mot i on f or

4 summary j udgment on Count No. 10.

5 And t here' s essent i al l y a j oi nder on - - a request - - a

6 separ at e mot i on t o di smi ss t he out r age cause of act i on

7 ment i oned i n Count No. 11. Ther e have been j oi nder s i n t hat

8 part i cul ar mot i on. The pl ai nt i f f has f i l ed an opposi t i on t o

9 t he out r age cl ai m on summar y j udgment , ther e' s been a r epl y,

10 and agai n, ther e have been j oi nder s by Uni ver si t y of11 Washi ngt on and Harborvi ew, Chapman, St ate of Washi ngt on.

12 And t hen t her e' s a t hi r d subst ant i ve mot i on i s Def endant s'

13 mot i on f or summary j udgment t o di smi ss t he puni t i ve damages

14 por t i on of t he cl ai m t hat woul d r el at e t o par agr aph, I

15 bel i eve - - or Count No. 14. Ther e was a pl ai nt i f f s'

16 oppos i t i on as wel l as a repl y f i l ed.

17 We al so have sever al pr ocedur al mot i ons. Ther e' s a mot i on

18 t o str i ke por t i ons of Mr . Hannul a' s decl ar at i on. And t hen

19 t here' s al so a mot i on t o str i ke several of t he pl ai nt i f f s '

20 doctors ' decl arat i ons as wel l .

21 Counsel , t he - - i n t er ms of t he doctor s' mot i on t o str i ke,

22 you may - - honest l y, gi ven t he vol ume of mat er i al her e, t hat

23 was t he one par t ther e I f el t I had t o go l i ne by l i ne and I

24 j ust di d not compl et e wi t h goi ng t hr ough t hat . But you

25 shoul d pr oceed wi t h or al ar gument wi t h t he assumpt i on t hat


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1 t he Cour t may di sregar d cer t ai n por t i ons of t hat par t i cul ar

2 decl arat i on - - t hose part i cul ar decl arat i ons. But you

3 shoul d pr oceed, I guess, ar gui ng i n t he al t er nat i ve.

4 Si mi l ar l y, on t he mot i on t o str i ke Mr . Hannul a' s

5 decl arat i on, I don' t f i nd that there' s a bas i s to s t r i ke,

6 f or exampl e, t he actual document s t hat wer e at t ached t o i t .

7 Ther e' s been an ar gument t hat Mr . Hannul a was descr i bi ng t he

8 si gni f i cance of t hese document s. He' s not r eal l y pr of f er ed

9 as a f act expert or a f act wi t ness, he' s j ust descri bi ng

10 what document s wer e di scl osed i n di scover y.11 And t here' s been an ar gument t hat t hi s was a ci r cumvent i on

12 of t he br i ef i ng l i mi t s, but I ' m abl e t o separat e out what

13 was descri pt i ve as opposed t o subst ant i ve evi dence. I don' t

14 t hi nk Mr . Hannul a was at t empt i ng t o be a f act wi t ness or

15 anythi ng el se l i ke that . I thi nk I ' m capabl e of

16 di sr egar di ng what was st at ed - - what was essent i al l y

17 ar gument i n t he decl ar at i on.

18 But l et ' s not do t hat agai n, okay, Mr . Hannul a?

19 Al l r i ght . Counsel , l et ' s - - we have t hr ee maj or mot i ons.

20 Have f ol ks f i gur ed out - - have you di scussed what or der you

21 want to handl e thi s i n?

22 Mr. Madden?

23 MR. MADDEN: We have, Your Honor. I t hi nk we are i n

24 agr eement ; of cour se, what we agr ee on doesn' t mat t er .

25 THE COURT: Makes a di f f er ence t o me.


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1 MR. MADDEN: The RI CO mot i on i s t he most pr obabl y

2 i mpor t ant and shoul d be t aken f i r st . And t hen I thi nk we' ve

3 agr eed t hat we woul d t ake t he out r age mot i on and t he

4 puni t i ve damages l ast .

5 Our f ur t her di scussi on was, however much t i me we had, t hat

6 i t be di vi ded hal f and hal f : Pl ai nt i f f and Def endant s.

7 THE COURT: Sur e.

8 MR. MADDEN: And we' r e r esponsi bl e f or moni t or i ng our own

9 t i me on t hat .

10 THE COURT: Al l r i ght . So do we have a 4: 00?11 THE CLERK: No.

12 THE COURT: So you have about - - a l i t t l e bi t over t wo

13 hour s. But we shoul d pr obabl y t ake a l i t t l e t i me f or peopl e

14 t o go t o t he r estr oom i n ki nd of t he mi ddl e of i t . So we

15 have about - - wel l , you coul d pr obabl y - - you coul d pr obabl y

16 spend your 20 mi nut es a si de pl us, you know, br i ef j oi nder s

17 f romf ol ks who j oi ned. I ' mcer t ai nl y l et t i ng f ol ks tal k i f

18 t hey' ve j oi ned. But , you know, t he pr i me ar gument i s f or

19 the f ol ks si t t i ng at t he t abl e.

20 But l et ' s go ahead and - - l et ' s go ahead and st ar t wi t h

21 t he f i r st mot i on, and t hen we' l l see wher e we get and see

22 how much t i me we have l ef t on t he ot her s.

23 So your mot i on.

24 MR. HANNULA: Your Honor .

25 THE COURT: I s t hat f i ne?


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1 MR. HANNULA: And what everybody has st ated here i s f i ne

2 wi t h one except i on, Your Honor . I woul d ask t hat on t he

3 RI CO mot i on, we may go more t han 20 mi nut es, but we wi l l not

4 go 20 mi nut es on t he ot her t wo.

5 THE COURT: That ' s f i ne. That ' s f i ne.

6 MR. MADDEN: Thank you, Your Honor. May i t pl ease t he

7 Cour t , agai n I ' m Mi ke Madden. I r epr esent t he Uni ver si t y of

8 Washi ngt on and af f i l i at ed def endant s. Thi s i s our mot i on

9 f or summar y j udgment on t he pl ai nt i f f s' cri mi nal

10 pr of i t eer i ng cl ai m.11 The key i ssue as we see i t i n t hi s case i s - - i n t hi s

12 mot i on i s : I s t here some l evel of al l eged f ai l ure t o

13 di scl ose t he r i sks of sur ger y t hat conver t s r un of t he mi l l ,

14 l ack of i nf or med consent cl ai m under RCW Chapt er 7. 70 i nt o a

15 cr i me?

16 And i n t hi s r egar d what I under st and t he pl ai nt i f f s t o say

17 i s t hat t he r i sks associ at ed wi t h Nor i an cement wer e so

18 sever e t hat Dr . Chapman' s al l eged - - al l eged, I emphasi ze - -

19 f ai l ure t o di scl ose t hem convert s t hei r l ack of i nf ormed

20 consent c l ai m i nt o an assaul t cl ai m.

21 The case l aw i n Washi ngt on ver y cl ear l y pr ecl udes t hi s

22 ef f ort by the pl ai nt i f f s . I n f act , there' s no case i n the

23 count r y t hat we' ve been abl e t o f i nd t hat per mi t s such a

24 cl ai m t o go f orward. And what I ' d l i ke t o do i s j ust t o

25 br i ef l y wal k t hr ough t he r el evant stat ut es, because t hi s i s


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1 a st at ut or y cl ai m, and t hen t ur n t o a di scussi on of t he

2 cases and t hen t he f act s.

3 THE COURT: Okay. So I have some quest i ons f or you, but

4 I ' l l hol d of f f or about t en mi nut es and l et you go ahead - -

5 MR. MADDEN: Your Honor, as you know, t he best t hi ng t hat

6 can happen t o a l awyer i n f r ont of t he Cour t her e i s t o get

7 quest i ons f r om t he Cour t and answer t hem. That ' s t he most

8 i mpor t ant thi ng I can do her e t oday because I know you' ve

9 read the mater i al s.

10 THE COURT: Yeah, and t her e wer e a l ot of mat er i al s. But11 I guar ant ee you, as you f ol ks know, I - - i t ' s amazi ng t o me

12 t hat some l awyer s t hi nk we don' t r ead al l thi s st uf f . And

13 maybe i n t he ol d days, j udges di dn' t r ead i t , but I - -

14 Mr . Leedom knows I r ead ever y si ngl e t hi ng you put i n f r ont

15 of me. So I spent a l ot of t i me on t hi s case.

16 But , Counsel , why don' t you j ust go t en mi nut es and t hen

17 I ' l l hop i n and ask you some quest i ons.

18 MR. MADDEN: Al l r i ght . So we' l l see wher e we ar e i n t en

19 mi nut es.

20 THE COURT: Al l r i ght . Okay.

21 MR. MADDEN: Wel l , t hi s i s t he st at ut e. And, of cour se,

22 i t speaks of an act of cr i mi nal prof i t eeri ng t hat i s part of

23 a pat t ern of cr i mi nal prof i t eeri ng act i vi t y. And t hose

24 t er ms ar e def i ned i n t he st at ut e. The key t hi ng her e i s

25 under t he pl ai nt i f f s' t heor y of t he case, t he acts of


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1 cri mi nal pr of i t eer i ng ar e assaul t and second- degr ee f el ony

2 mur der . And I ' m not goi ng t o t ar r y ver y l ong her e because

3 you know t hi s bet t er t han I , but t hese ar e t he st at ut or y

4 def i ni t i ons, and we come t o t he key one: Second- degr ee

5 assaul t .

6 What ' s i mpor t ant t o emphasi ze her e, t hough, i s t hat t hi s

7 case i sn' t j ust a case about whet her Pl ai nt i f f s can make out

8 a ci vi l bat t er y cl ai m. I t ' s about whet her t he def endant s,

9 Dr . Chapman and col l eagues, can be deemed t o have commi t t ed

10 t hese cri mes: Second- degr ee assaul t , second- degr ee f el ony11 mur der .

12 Secondari l y - - I ' m goi ng t o come back t o t hi s - - t he

13 pl ai nt i f f s have t o pr ove t hat t hese al l eged acts wer e par t

14 of a pat t er n. And as I sai d, I am goi ng t o come back t o

15 t hi s.

16 Let ' s t al k about second- degr ee assaul t . Bat t er y i s a

17 compl et ed assaul t . And under t he cr i mi nal case l aw,

18 second- degr ee assaul t by bat t er y r equi r es an i nt ent i onal

19 t ouchi ng t hat r eckl essl y i nf l i cts substant i al bodi l y har m.

20 Those ar e t he el ement s of the cr i me. What we on wi t h t he

21 pl ai nt i f f s - - or t hey agree wi t h us - - i s t hat consent

22 negat es assaul t . Wher e t her e i s consent , t her e i s no

23 assaul t . And i n t he ci vi l cont ext t hey have t o - - t he

24 pl ai nt i f f s woul d have t o pr ove what ' s cal l ed medi cal bat t er y

25 as a pr edi cat e t o t hei r cri mi nal char ge, to t hei r cri mi nal


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1 t heor y. And under t he case l aw, under our case l aw and t he

2 r ul e across t he count r y, a medi cal bat t er y occur s onl y wher e

3 t here i s - - and t hi s i s a quot e f rom Bundr i ck - - a t ot al

4 l ack of consent t o t he pr ocedur e per f or med. And as I sai d,

5 t her e' s no case i n t he count r y t hat ' s been ci t ed or t hat

6 we' ve been abl e t o f i nd t hat per mi t s a medi cal bat t er y cl ai m

7 based on t he al l eged f ai l ur e t o di scl ose t he r i sk of a dr ug

8 or devi ce.

9 Bundr i ck, sor t of t he key case f r om our Cour t of Appeal s

10 2005, thi s i s a case wher e t he pl ai nt i f f cl ai med t hat she11 di dn' t consent t o a r esi dent per f or mi ng a par t of t he

12 pr ocedur e. The Cour t actual l y r ej ected t hat cl ai m sayi ng

13 t hat t he pl ai nt i f f had not expr essed t hat condi t i on. That

14 becomes a condi t i onal consent case, somet hi ng el se I ' m goi ng

15 t o t al k about a l i t t l e bi t i n a f ew mi nut es.

16 Bundr i ck r el i es on an ear l i er case, Mi l l er v. Kennedy.

17 Mi l l er was one of the pr e- st at ut or y cases t hat was t r yi ng t o

18 dr aw t he l i ne bet ween medi cal bat t er y and i nf or med consent .

19 And t he r eason t hat was i mpor t ant and t he r eason t hi s i s

20 sort of i mport ant here, usual l y you see pl ai nt i f f s t ryi ng t o

21 pl ead medi cal bat t er y f or t wo r easons: One, i s t o get

22 ar ound t he r equi r ement of exper t t est i mony. Second,

23 part i cul ar l y i n Cal i f orni a, i s to get around l i mi ts on

24 damages and avai l t hemsel ves i n Cal i f or ni a of puni t i ve

25 damages t hat ar e avai l abl e under Cal i f or ni a l aw.


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1 Now, we have a si mi l ar t hi ng goi ng on her e. The

2 pl ai nt i f f s want t o avai l t hemsel ves of t he avai l abi l i t y of

3 doubl e damages and f ees and cost s under t he cr i mi nal

4 prof i t eer i ng stat ut e. So t hat ' s t he mot i vat i on. I don' t

5 t hi nk t her e' s any doubt about t hat .

6 Now, what const i t ut es consent ? Thi s case t hat we ci t ed - -

7 I t hi nk we - - I hope we pr ovi ded you a copy f r om t he New

8 Mexi co Supr eme Cour t bui l ds on t he case act ual l y t hat Mi l l er

9 ci t ed whi ch i s Cobbs v. Gr ant f r om t he Cal i f or ni a Supr eme

10 Court . I t ' s , agai n, a semi nal deci s i on t hat ' s wri t t en by11 J ust i ce Mosk. And i t , agai n, i s t ryi ng t o descri be i n a

12 pr e- st at ut or y er a t he di f f er ent i at i on bet ween medi cal

13 negl i gence, l ack of i nf or med consent , and bat t er y. And

14 Cobbs cl ear l y says, agai n, t ot al l ack of consent , t hat ' s a

15 bat t er y; anyt hi ng el se, t hat ' s medi cal negl i gence or

16 i nf ormed consent .

17 So we come down t o t hi s Gerety case f r omt he New Mexi co

18 Supr eme Cour t , whi ch agai n, i s based on Cobbs and t hi s i s

19 what t hey sai d: To def eat a bat t er y cl ai m, t he i nf or mat i on

20 whi ch must be di scl osed i s qui t e nar r ow. The physi ci an onl y

21 has t o i nf or m t he pat r on of t he nat ur e of the pr ocedur e;

22 t hat i s, what t he doctor pr oposes t o do.

23 Now, I sai d I ' d t ur n t o t he f acts and I ' m a f ew mi nut es

24 i n. Her e' s what t he r ecor d shows. Thi s i s Ms. Wi l son' s

25 deposi t i on t est i mony and she says - - she acknowl edges t hat


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1 her mother consent ed t o a surgery by Dr . Chapman on her

2 spi ne i nt ended t o r espond t o t he i ssues r el at ed t o t he f al l

3 t hat she had i n Hondur as. The r ecor d al so shows t hi s

4 preoperat i ve vi s i t . And none of t hi s i s di sput ed.

5 THE COURT: Ri ght . So t he ar gument i s t hat i t ' s a

6 di f f er ent - - ther e' s - - she consent ed t o X, but you di d Y,

7 r i ght ; i sn' t that the argument?

8 MR. MADDEN: Wel l , i f t hat ' s t he ar gument , i t doesn' t f i t

9 t he f act s.

10 THE COURT: Al l r i ght .11 MR. MADDEN: I consent ed t o X and you di d X. You di dn' t

12 t el l me, accor di ng t o t he pl ai nt i f f , that you wer e goi ng t o

13 use t hi s par t i cul ar devi ce dur i ng t he sur ger y t hat has t hese

14 al l eged r i sks associ ated wi th i t .

15 That i s not enough t o t ake you out of t he ci vi l ar ena and

16 i nt o t he cri mi nal ar ena. I t i sn' t even enough t o t ake you

17 f r om i nf or med consent t o medi cal bat t er y because t he r ul e

18 i s: Di d you consent t o t he sur ger y? And her e, we can

19 see - - her e' s t he descr i pt i on of t he sur ger y. The

20 pl ai nt i f f s don' t di sagr ee t hat t hi s was t he sur ger y t hat was

21 cont empl ated. They al so acknowl edged t hat t her e was

22 di scussi on about a f or m of cement . They say wel l - -

23 Ms. Wi l son says, Wel l , I don' t r emember Nor i an bei ng

24 ment i oned, and i f i t was, I sur el y woul d have. But I do

25 r emember t hi s ot her cement .


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1 Her e' s t he consent f or m si gned by Ms. Gol den on t he day of

2 sur ger y; descr i bes t he oper at i on t hat ' s t o be done: A T9 L2

3 poster i or spi nal f usi on, L1 cor pectomy, T9, T10, L2, L4

4 ver t ebr opl asty. Recei ved t he f ol l owi ng i nf or mat i on:

5 Bl eedi ng, i nf ecti on, neur ovascul ar damage, need f or f ur t her

6 pr ocedur es, and si gned by t he decedent .

7 When you get to the pl ai nt i f f s ' cl ai m, i t i s cl ear l y f or

8 l ack of i nf or med consent . She sai d, Had t her e been anythi ng

9 r el ayed as f ar as usi ng t hi s par t i cul ar dr ug and i f he had

10 t ol d her and I t he det ai l s behi nd i t , i t woul d never have11 been consent ed t o.

12 Wel l , t hat i s a st at ut or y i nf or med consent cl ai m. Pur e

13 and si mpl e.

14 The next t hi ng I woul d poi nt out t hi s i s not , as t he

15 pl ai nt i f f s woul d have i t , a condi t i onal consent case. Under

16 t he Condi t i onal Consent Doct r i ne, Bundr i ck i s an exampl e,

17 the pl ai nt i f f has the r i ght - - a pat i ent has a r i ght , I

18 shoul d say, t o condi t i on t hei r consent : No r esi dent , don' t

19 use a cer t ai n dr ug; that ' s t he Duncan case f r om Ar i zona.

20 But t he condi t i ons have t o be communi cat ed and t he physi ci an

21 has t o wi l l f ul l y di sregar d t he condi t i ons. No such evi dence

22 her e. No evi dence of any condi t i ons pl aced on t he consent ,

23 no evi dence of any wi l l f ul di sregard.

24 Now, t he pl ai nt i f f s want t o make an ar gument under t he

25 Rest at ement - - sever al ar gument s under t he Rest at ement . But


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1 t he f i r st under Rest at ement ( Second) 892( b) , t hat t he

2 consent i s i nef f ecti ve. But her e' s what t he Rest at ement

3 says: Fi r st, t her e has t o be a substant i al mi stake

4 concer ni ng t he ext ent of t he har m t o be expected and t he

5 mi st ake i s known t o t he ot her or i nduced by t he ot her ' s

6 mi srepr esent at i on. Nei t her of t hose el ement s i s pr esent .

7 Ms. Gol den knew t hat t he sur ger y coul d r esul t i n deat h.

8 I n bl ock here, thi s i s f rom her di ary, and thi s i s her

9 handwr i t i ng: What ar e t he possi bl e pr obl ems I coul d

10 encount er f r om t hi s t ype of sur ger y? Deat h, et cet er a.11 Thi s i s f r om t he consent t hat I showed you bef or e. What

12 ar e t he f ol l owi ng addi t i onal det ai l ed i nf or mat i on she

13 r ecei ved? Bl eedi ng, neur ovascul ar damage.

14 She al so knew - - t hi s i sn' t - - t hi s i sn' t necessary, but

15 i t adds t o t he st r engt h of our case. She knew about t he

16 r i sk of cement embol i zi ng i nt o t he bl ood st r eam. And t he

17 Cour t wi l l under st and by now t hat t he pl ai nt i f f s' theor y of

18 t he case i s t hat Nor i an cement as opposed t o PMMA t he

19 l ogi cal - - whi ch i s the l ogi cal cul pr i t here, i f there i s

20 one. But t hat Nor i an cement got i nt o t he bl ood st r eam,

21 caused bl ood cl ot s. Okay. Wel l , accor di ng t o Ms. Wi l son,

22 Ms. Gol den knew about that and was advi sed of t hat ri sk

23 pr i or to surgery, accepted i t .

24 Thi s i s - - l et ' s l ook at t he stat ut e, t he i nf or med consent

25 st at ut e, because I t hi nk when you have t hose f act s i n mi nd,


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1 you' l l see that t he pl ai nt i f f s' cl ai mf i t s per f ect l y, r i ght .

2 These ar e t he el ement s of a st at ut or y i nf or med consent

3 cl ai m: The heal t h care pr ovi der f ai l ed t o i nf orm t he

4 pat i ent of a mat er i al f act. The pat i ent consent ed wi t hout

5 bei ng awar e or f ul l y i nf or med of such mat er i al f act. That

6 stat ut e, whi ch i s i nt ended by t he l egi sl at ur e t o be t he

7 excl usi ve r emedy f or per sonal i nj ur y damages r el at ed t o

8 heal t h care i n Washi ngt on, i t f i t s perf ect l y on our f act s.

9 THE COURT: So what - - what do you make of - - I mean,

10 t her e' s an al l egat i on t hat what we - - t he i nj ur i es caused11 her e ki nd of wer e at t he j unctur e of t he ent r epr eneur i al

12 ver sus - - ent r epr eneur i al pr acti ce - - t he ent r epr eneur i al

13 aspect of the pr acti ce of medi ci ne ver sus t he pr acti ce of

14 medi ci ne. And so t her e ar e obvi ousl y pur e cases i n whi ch

15 pur el y, you know, the pr acti ce of medi ci ne, di agnosi s, t hat

16 ki nd of t hi ng are i nvol ved. The f l avor of t hi s part i cul ar

17 l awsui t i s we' r e at t he j unctur e or al l eged j unctur e of t he

18 pr act i ce of medi ci ne and t he ent r epr eneur i al aspect of t he

19 pr act i ce of medi ci ne. What do you have t o say about t hat ,

20 t he l egi s l at i ve i nt ent on t hat part of t he - - t hat j unct ure?

21 MR. MADDEN: Wel l , t hat woul d be a r el evant consi der at i on

22 i f t he pl ai nt i f f s wer e pl eadi ng a cl ai m under t he Consumer

23 Pr ot ect i on Act .

24 And I apol ogi ze, I have a t er r i bl e t i me wi t h case names,

25 but I bel i eve i t ' s the J eckl e v. Wr i ght case that ' s ci ted i n


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1 our mat er i al s. Because J eckl e says, you know, as par t of

2 i nf or med consent , a physi ci an doesn' t have t o i nf or m t he

3 pat i ent about f i nanci al mot i vat i on t hat t hey may have. But

4 t hey may be l i abl e under t he Consumer Pr ot ect i on Act f or t he

5 entr epreneur i al aspects .

6 But t hat ' s not r el evant when we' r e t r yi ng t o f i gur e out

7 t he l i ne bet ween, you know, medi cal bat t er y/ cri mi nal assaul t

8 and l ack of i nf or med consent . And t he r eason i s t hi s: The

9 pl ai nt i f f s' theory - - whi ch I thi nk they can' t real l y

10 art i cul at e a s toppi ng poi nt f or i t - - i t essent i al l y ends up11 consumi ng al l of i nf or med consent . Because what t hey say

12 i s, wel l , you know, thi s i s a r eal l y danger ous pr oduct.

13 Okay. We di sput e t hat . The doctor had a r el at i onshi p wi t h

14 t he manuf actur er of t he pr oduct , al t hough unl i ke t he J eckl e

15 case wher e t he doctor i s benef i t t i ng, you know, i t em f or

16 i t em by pr omot i ng t he par t i cul ar dr ug, t her e' s no such

17 evi dence her e. I mean, Dr . Chapman di dn' t get pai d mor e or

18 l ess based on how much Nor i an he used.

19 And so what you end up, Your Honor, i f you come back t o

20 your poi nt i s what our cour t s have r epeat edl y r ej ected i s

21 t he physi ci an doesn' t have t o say t o t he pat i ent and oh, by

22 t he way, you know, I ' m r ecommendi ng t he sur ger y, I t hi nk you

23 need t hi s sur ger y, and you shoul d know t hat I st and t o make

24 $2, 000 f r om doi ng your sur ger y. Why? Because i t ' s not a

25 mat eri al r i sk of t reat ment nor i s i t rel evant t o t he


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1 basel i ne i ssue f or medi cal bat t er y whi ch i s: Do I - - do I

2 have t he pat i ent ' s consent t o t hi s par t i cul ar t ouchi ng?

3 THE COURT: I guess my quest i on was r eal l y desi gned t o - -

4 desi gned t o ki nd of t est t he l i mi t s of your excl usi vi t y

5 ar gument . You' r e sayi ng, wel l , t he i nf or med consent cause

6 of acti on, medi cal mal pr acti ce cause of acti on, t hose

7 were - - t hat ' s a l egi s l at i ve i ntent , you say, to gi ve

8 pl ai nt i f f s causes of act i on f or these ki nds of i nj ur i es .

9 MR. MADDEN: Cor r ect .

10 THE COURT: And so t he excl usi vi t y por t i on of your11 ar gument . But when you' r e deal i ng wi t h, agai n,

12 al l egat i ons - - di sput ed al l egat i ons, but wher e you' r e

13 deal i ng wi t h al l egat i ons of ent repreneuri al conf l i ct of

14 i nt er est, ent r epr eneur i al -- t he busi ness of medi ci ne, and

15 so you have i ssues where, you know, ar guabl y Consumer

16 Pr ot ecti on Act mi ght be t r i gger ed. So i s t hat t he onl y

17 t r i gger or coul d i t go over at a cert ai n poi nt to a l i t t l e

18 RI CO, bi g RI CO, l ead t o or gani zed cri me?

19 MR. MADDEN: No. Because i f we go back t o t he ver y f i r st

20 case i n Washi ngt on, the Mi l l er v. Kennedy case, i t sai d,

21 l ook, t he l i ne i s now cl ear bet ween medi cal bat t er y and l ack

22 of i nf or med consent . I f t her e' s any f or m of consent t o t hat

23 sur ger y, then i t f al l s on t he negl i gent si de of t he l i ne and

24 i t ' s not an i nt ent i onal t or t .

25 THE COURT: Ri ght . So t hat ' s your t ouchst one r i ght t her e,


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1 whi ch i s pr esumabl y i s wher e you st ar t ed wi t h t hat poi nt .

2 MR. MADDEN: Absol ut el y. I mean, I - - you know, I don' t

3 t hi nk I coul d do anyt hi ng except ci t e t he Washi ngt on cases

4 t hat have been set t l ed now f or many year s.

5 THE COURT: Ri ght . So can I ask you quest i ons?

6 MR. MADDEN: I ' ve now been goi ng a l ong t i me.

7 THE COURT: So l et ' s t al k about your f i ve year - -

8 MR. MADDEN: Yep.

9 THE COURT: - - f i ve year - - you have pr esumabl y a sl i de.

10 I t mi ght be eas i est t o t al k about t hat .11 MR. MADDEN: Let me go down her e t o t he very end.

12 THE COURT: So I r ead t he statut e about - - l i t er al l y, a

13 dozen t i mes, and i s i t ambi guous? Or - - I mean, I read i t

14 and i t says, A patt ern of cr i mi nal prof i teer i ng act i vi t y

15 means engagi ng i n at l east t hr ee act of cri mi nal

16 pr of i t eer i ng t he l ast of whi ch occur red wi t hi n f i ve year s.

17 And pr esumabl y - - and af t er t he commi ssi on of t he ear l i est

18 act of cr i mi nal prof i t eer i ng.

19 MR. MADDEN: Ri ght .

20 THE COURT: So i f I under st and i t , your ar gument i s t hat

21 the ear l i es t act of cr i mi nal prof i teer i ng i s the ear l i es t

22 anybody knows of ?

23 MR. MADDEN: Thi s i s not - -

24 THE COURT: Doesn' t i t have t o be t he pl ai nt i f f ?

25 MR. MADDEN: I don' t mean t o i nt er r upt , Your Honor , but


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1 t hi s i s not my ar gument , thi s i s t he pl ai nt i f f s' ar gument .

2 THE COURT: Ri ght .

3 MR. MADDEN: So t he pl ai nt i f f s' ar gument , and t hey' ve

4 art i cul at ed i t i n thei r br i ef i ng, i s that 2002 when

5 Dr . Chapman i s f i r st document ed usi ng Nor i an and t he l ast i s

6 i n J ul y 2009, and t hey have t o use J ul y 2009 because t hey

7 have anot her cl i ent whose sur ger y occur r ed i n J ul y 2009.


9 MR. MADDEN: So t hi s i s not my t heor y of t he f act s. Thi s

10 i s t he pl ai nt i f f s' t heory of t he f act s .11 THE COURT: Wel l , i s t hat - - he doesn' t have t o choose t he

12 2003 act , does he? He can choose t he one t hat occur r ed i n

13 2008, so l ong as t her e' s t hr ee of t hem, r i ght ? I sn' t

14 t hat - - i sn' t t hat anot her constr uct i on of t he stat ut e?

15 MR. MADDEN: Wel l , her e' s hi s pr obl em, i t agai n i s

16 conf i ned by t he pl eadi ngs - - and I shoul dn' t say he, but

17 t hei r probl em. I s t hei r c l ai m i s predi cat ed ent i rel y on t he

18 f eder al char ges t hat t hey at t ached t o t hei r compl ai nt and

19 i ncor por at ed. And t hose f eder al char ges say t hat scheme t o

20 mar ket Nori an XR of f - l abel began i n 2002 and ended i n t he

21 f al l of 2004. So t hey' r e stuck wi t h t hat . They can' t j ust

22 say, oh, wai t , we i ncor por at ed t hat , we pl ed t hat 2002, but

23 now we want to pi ck anot her year t hat f i t s f i ve year s back

24 f r om J ul y 2009.

25 And, you know, I know t he pl ai nt i f f s say, l ook, t hi s l eads


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1 t o an absur d r esul t , but as t he ADA comment at or poi nt ed out ,

2 t hi s l anguage her e essent i al l y ser ves as a secondar y st at ut e

3 of l i mi tat i ons , and I thi nk the l egi s l ature coul d rat i onal l y

4 have bel i eved t hat beyond f i ve year s t he connect i ons become

5 t oo r emot e and t he pot ent i al f or abuse i s t oo hi gh.

6 THE COURT: Wel l , i f I const r ue i t your way, somebody who

7 onl y engages i n t hr ee acts of cri mi nal pr of i t eer i ng coul d

8 be - - they' d have - - the pl ai nt i f f s woul d have a cause of

9 act i on. But somebody who engaged i n cri mi nal pr of i t eer i ng

10 f or t he l ast 30 year s coul dn' t br i ng a cause of acti on - -11 MR. MADDEN: That - - but t hat - -

12 THE COURT: - - and t her e woul d be hundr eds of pl ai nt i f f s

13 and - -

14 MR. MADDEN: That i s t he nat ur al i mpl i cat i on of t hi s - -

15 THE COURT: Woul d t he l egi sl at ur e r eal l y woul d have

16 i ntended that ?

17 MR. MADDEN: Wel l , I can onl y say t hi s: Okay, RI CO

18 stat ut es i n t he ci vi l cont ext are not ori ousl y subj ect t o

19 abuse. And t he l egi sl at ur e, because t hey devi at ed f r om t he

20 f ederal l aw i n t hi s regard, I thi nk coul d rat i onal l y have

21 t hought , you know, i t woul d be obvi ousl y easy t o say, wai t a

22 mi nut e, r emember , we had a RI CO - - an ent er pr i se i n Pi er ce

23 Count y year s ago wi t h t he sher i f f and pr osecut or and now

24 somet hi ng' s happened t o me, and i t ' s 25 - - i t ' s 30 year s

25 l at er , but thi s guy got some of t he same peopl e i nvol ved,


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1 l et me tag that together .

2 THE COURT: But t hat coul dn' t happen because - - because

3 t her e woul d have t o be at l east one wi t hi n t he l ast f i ve

4 year s, r i ght ?

5 MR. MADDEN: There woul d be t o be - -

6 THE COURT: Or t hr ee - -

7 MR. MADDEN: - - wel l , t he l anguage i s - -

8 THE COURT: - - t hr ee wi t hi n t he l ast f i ve year s, r i ght ?

9 MR. MADDEN: I s i t has t o be t hr ee, t he ear l i est no mor e

10 than f i ve years f romt he l ast .11 THE COURT: Ri ght .

12 MR. MADDEN: So i f you coul d pi ck t he l ast one and say,

13 wel l , thi s i s when t he ent er pr i se star t ed and now I ' m wi t hi n

14 f i ve year s wi t h t he l ast act and j ust r andoml y pi ck t he

15 st ar t i ng poi nt , I don' t t hi nk t hat makes any sense - - and i t

16 al so def i es t r ut h.

17 THE COURT: Wel l , I mean, i t may be a secondar y st at ut e of

18 l i mi t at i ons, but t he stat ut e of l i mi t at i ons coul d be

19 t r i gger ed f r om now l ooki ng back f i ve year s as opposed t o

20 your t ypi cal st at ut e of l i mi t at i ons whi ch i s t r i ggered at

21 the begi nni ng, r i ght?

22 MR. MADDEN: Wel l , cor r ect. Thi s i s a l ook back - - t hi s

23 i s l ooki ng back.


25 MR. MADDEN: Coul d I j ust - - I want t o - - I know I bur ned


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1 up some t i me.

2 THE COURT: Sur e.

3 MR. MADDEN: But I want t o go r i ght back t o j ust t he

4 patt ern i ssue because I thi nk thi s i s actual l y - -

5 THE COURT: Sur e, sur e. Go ahead.

6 MR. MADDEN: - - act ual l y t ur ns out t o be ver y easy. So we

7 have t he f eder al char ge t hat t he pl ai nt i f f s ar e r el yi ng on

8 t hat descri bes t hi s scheme t o i l l egal l y mar ket Nor i an XR f or

9 ver t ebr al compr essi on f r act ur es bet ween 2002 and t he f al l of

10 2004. The FDA began i nvest i gat i ng i n May 2004. Nor i an XR11 was pul l ed of f t he mar ket i n l at e 2004. 2007, Synt hes sends

12 out a "dear sur geon" l et t er t hat says, you know, pl ease

13 under st and t hat t he ot her f or ms of Nor i an, SRS and CRS, ar e

14 not i nt ended f or use i n t he spi ne, and t hen we have t he

15 Gol den sur ger y i n August of 2007.

16 And, you know, t he i ssue I t hi nk her e i s t hat t her e' s no

17 r at i onal mot i ve f or anyone, Synt hes, Dr . Chapman or anyone

18 t o at t he t i me t he f eds ar e cont i nui ng t o i nvest i gat e,

19 t her e' s a gr and j ur y goi ng on, t o be i nvol ved and cont i nui ng

20 t o mar ket t hi s devi ce f or an of f - l abel use wher e t he devi ce

21 i s no l onger even bei ng suppl i ed. And so I thi nk t hat

22 t hat - -

23 THE COURT: Do you get t hat i nf erence on summary j udgment ?

24 MR. MADDEN: Wel l , i t ' s not an i nf er ence. I t ' s an absence

25 of - - i n order f or the pl ai nt i f f s - - so thi s i s what the


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1 MR. MADDEN: I woul d l i ke t o save some t i me. I t hi nk my

2 col l eagues ar e l ooki ng at me l i ke I bur ned up mor e t han I

3 shoul d have.

4 THE COURT: Okay. Counsel .

5 MR. HANNULA: Your Honor - -

6 MR. TOMPKI NS: J ust a coupl e poi nt s.

7 MR. HANNULA: Oh, sor r y.

8 MR. TOMPKI NS: I di dn' t r eal i ze you wer e ( i naudi bl e) .

9 THE COURT: And j ust when ever ybody speaks, j ust i dent i f y

10 yoursel f f or the f i rs t t i me on the record, so. . .11 MR. TOMPKI NS: Yes, Your Honor , Chr i s Tompki ns f or Synt hes

12 and Nor i an.

13 THE COURT: Synt hes, yeah.

14 MR. TOMPKI NS: And I want t o j ust addr ess t wo poi nt s t hat

15 we r ai sed i n our r epl y on t hi s mot i on. The f i r st goes t o

16 what you j ust asked about , t he adver se i nf er ence and t he

17 asser t i on of t he Fi f t h Amendment . And i t was f or mer

18 empl oyees of my cl i ent who di d make t hat asser t i on. But as

19 we' ve ci t ed bot h i n Washi ngt on st at e i ncl udi ng t he I keda

20 case t hat t he pl ai nt i f f s r el y on, a f ederal court case

21 appl yi ng Washi ngt on l aw and ot her cases f r om ar ound t he

22 count r y, an adver se i nf er ence st andi ng al one wi t hout

23 cor r obor at i ng evi dence t o suppor t i t i s not adequat e t o

24 creat e an i ssue of mat er i al f act t o pr event summar y

25 j udgment .


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1 THE COURT: So what ' s - - what i s cor r obor at i on? I s i t

2 enough t hat you have some document s whi ch al l egedl y

3 cor r obor at e i t ?

4 MR. TOMPKI NS: Wel l , l et me t al k about t hat , Your Honor ,

5 because t hat was t he ot her poi nt I want ed t o make. The

6 document s bef or e you, Mr . Madden poi nt ed out t hat t he

7 f eder al i ndi ctment says t hat t he i mpr oper mar ket i ng at

8 Synt hes went on f r om 2002 t o 2004. I f t he Cour t l ooks at

9 t he document s bef or e i t - - we r ai sed t hi s i ssue i n our r epl y

10 as wel l - - t hey ar e f r om pr i or t o up t hr ough 2004. Ther e i s11 no document whi ch suggest s t hat t here was any ongoi ng

12 conspi r acy or i l l egal mar ket i ng or ot her i mpr oper acti vi t y

13 l eadi ng t o Dr . Chapman' s sur ger y on Ms. Gol den i n 2007.

14 I n f act , t he onl y document s bef or e t he Cour t f r om 2007 ar e

15 t he Synt hes l et t er t o al l sur geons sayi ng Nor i an CRS and SRS

16 ar e not i nt ended f or use i n t he spi ne. The FDA says t hat

17 use i n the spi ne i s i nt r i ns i c to the st ructure - - or the

18 stabi l i t y, rat her , of t he spi ne and t hey can' t be used.

19 Ther e' s al so a cal - - - t wo ot her document s f r om 2007

20 bef or e you ar e t he r epor t to t he FDA of Ms. Gol den' s deat h

21 and a cal endar of t he sal es r epr esent at i ve f or Synt hes. But

22 t her e' s a gap, Your Honor , bet ween - - oh, and by t he way t he

23 al l eged conspi r acy i n t he f eder al i ndi ctment and t he

24 ar gument s t hat t he pl ai nt i f f s have r ai sed wer e r el at ed t o a

25 pr oduct named Nor i an XR whi ch was or i gi nal l y devel oped f or


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1 use i n t he spi ne. Nor i an XR was r emoved f r om t he mar ket i n

2 2004. So t her e' s no connect i on or t i e, Your Honor , bet ween

3 anyt hi ng af t er 2004 and Ms. Gol den' s sur ger y i n 2007.

4 And so t o come back t o your quest i on about what ' s

5 cor r obor at i ng evi dence. Ther e woul d have t o be enough

6 evi dence, Your Honor , to creat e an i ssue of f act t hat t her e

7 was ongoi ng conspi r at or i al acti vi t y bet ween my cl i ent s,

8 Mr . Bor ani an' s cl i ent s and Mr . Lavi ne' s cl i ent s and t he UW

9 def endant s t o t i e t hat t o t he Reba Gol den sur ger y i n or der

10 t o al l ow t he Fi f t h Amendment i nvocat i on t o creat e an i ssue11 of f act and def eat summar y j udgment , and t her e si mpl y i s

12 not .

13 THE COURT: Thank you ver y much.

14 And, Counsel ?

15 MR. MADDEN: Not yet , Your Honor. Thank you.

16 THE COURT: Al l r i ght . Thank you.

17 Al l r i ght . Let ' s see. Mr. Hannul a. And thi s i s the one

18 you want t o t ake some addi t i onal ti me on? Okay.

19 MR. HANNULA: Yes, I do, Your Honor .

20 THE COURT: Whi ch i s f i ne.

21 MR. HANNULA: I ' m a l i t t l e bi t concer ned t hat t hi s was

22 br ought by t he Uni ver si t y of Washi ngt on, and now we' ve had

23 Synt hes addr ess t he Cour t , t oo. And so I j ust want t o have

24 some addi t i onal t i me i f ot her s ar e goi ng t o addr ess mot i ons

25 that I di dn' t ant i ci pate, Your Honor .


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1 Your Honor , I ' m goi ng i t - - i n t er ms of t he ar gument t hat

2 I was goi ng t o make, I ' m goi ng t o go a l i t t l e bi t out of

3 or der her e. And I wi l l addr ess f i r st t hi s i ssue of whet her

4 or not Reba Gol den gave consent t o t hi s pr ocedur e. And,

5 Your Honor, I thi nk t hat t hat i s real l y t he crux of t hi s

6 mot i on. I thi nk t he evi dence cl ear l y, i n t er ms of have we

7 rai sed a mat eri al f act , I thi nk t he evi dence i s cl ear t hat a

8 cri mi nal ent er pr i se cont i nued at l east t hr ough t he sur ger y

9 of J oan Br yant on J ul y 6t h of 2009, and cl ear l y was ongoi ng

10 as of August 17t h, 2007, when Reba Gol den di ed on t he11 operat i ng t abl e. And I wi l l address t hat f urt her i n a

12 moment .

13 Fi rst of al l , Your Honor , t he l aw i n t he stat e of

14 Washi ngt on i s cl ear t hat t her e i s a separ at e cl ai m f or

15 medi cal bat t er y i f t he pl ai nt i f f does not gi ve consent t o

16 t he sur ger y actual l y per f or med by t he physi ci an who i s

17 per f or mi ng t he pr ocedur e.

18 I n t hi s case, Your Honor , Cynt hi a Wi l son has t esti f i ed - -

19 and l et ' s t al k about t hi s. The t hi r d i ssue i s whet her t he

20 pl ai nt i f f s have demonst r at ed genui ne i ssue of mat er i al f act

21 t hat Reba Gol den and t he ot her vi ct i ms i n t he pr edi cat e act s

22 suf f er ed medi cal bat t er y amount i ng t o assaul t i n t he second

23 degr ee.

24 Fi rst of al l , t he decl ar at i on of Cynt hi a Wi l son stat es

25 t hat her mot her never gave consent t o any sur ger y i nvol vi ng


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1 t he use of Nor i an cement i n her spi ne. The decl ar at i ons of

2 pl ai nt i f f s ' medi cal expert s, Dr. Fal l er and Dr. Kowal ski

3 st at e i n no uncer t ai n t er ms t hat ther e was no consent by any

4 of the vi cti ms of the pr edi cat e acts under our RI CO cl ai m t o

5 any surgery by Dr . Chapman wherei n he used Nori an cement i n

6 t hei r spi nes.

7 Your Honor , as I ' ve st at ed, Washi ngt on i s one of a number

8 of j ur i sdi cti ons t hat r ecogni zes t hat a sur geon who per f or ms

9 sur ger y on a pat i ent wi t hout t he pat i ent ' s consent can be

10 f ound l i abl e f or medi cal bat t er y and cri mi nal assaul t i n11 Washi ngt on. And whet her or not a pat i ent consent ed t o a

12 surgery i s usual l y a quest i on of f act f or t he j ury.

13 Now t hey' ve ci t ed t he Bundr i ck v. St ewar t case, Your

14 Honor , and I know t hat t he Cour t i s f ami l i ar wi t h t hose

15 f act s. But Your Honor, i n t hat case, i t was t he pl ai nt i f f ' s

16 posi t i on t hat she di d not gi ve per mi ssi on f or a par t i cul ar

17 doctor t o assi st i n her sur ger y. I n t hat case, the Cour t of

18 Appeal s hel d t hat t he t r i al cour t ' s summar y j udgment

19 di smi ssal of pl ai nt i f f ' s assaul t cl ai m agai nst Dr . J ai n was

20 er r or i n t he f ace of pl ai nt i f f ' s evi dence t hat she gave no

21 consent f or Dr . J ai n t o t r eat her . She cl ear l y gave consent

22 t o t he pr ocedur e, and t hat ' s what Mr . Madden i s hangi ng hi s

23 hat on - - he' s cl i ngi ng t o i t i n t hi s case, Your Honor . But

24 i n t hat case she cl ear l y agr eed t o t he pr ocedur e t hat she

25 under went . She di dn' t agr ee t o t he pr ocedur e per f or med by


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1 thi s par t i cul ar physi ci an.

2 Your Honor , t he consent f or m si gned by Reba Gol den makes

3 absol ut el y no ment i on of Nor i an cement bei ng used i n t hi s

4 pr ocedur e. Counsel showed you t hat document , Your Honor.

5 But i f you l ooked at what she agr eed t o, i t doesn' t say

6 anythi ng about Nor i an cement . Ther e' s no ment i on of Nor i an

7 cement . I n f act , t her e' s no ment i on of any cement , but

8 part i cul ar l y Nor i an cement .

9 Now, t he consent f or m t hat she si gned i s a consent f or m

10 t hat any of us woul d si gn i f we went to get our br oken11 f i nger oper at ed on or i f we went to have a doctor wi t h a

12 scope l ook at our knee or our shoul der t o see i f anyt hi ng

13 was wr ong. Thi s i s not a consent f or m t hat you woul d si gn

14 i f you had agr eed vol unt ar i l y t o an exper i ment i n an

15 i nst i t ut i on i n whi ch t he doctor who was per f or mi ng t he

16 pr ocedur e woul d have t o answer t o an i nt er nal r evi ew boar d

17 made up of physi ci ans, l awyer s, medi cal et hi ci st s, and

18 ot her s at t he i nst i t ut i on t o make sur e t hat pat i ent s who

19 under go human exper i ment at i on ar e pr ot ect ed. That cl ear l y

20 di d not happen i n t hi s case.

21 Cynt hi a Wi l son was pr esent at ever y doct or ' s vi si t wher e

22 t hi s sur ger y was di scussed, has t est i f i ed t hat t her e was

23 never a di scussi on of t he use of Nor i an bone cement , and her

24 mother gave no consent whatsoever t o t he i mpl ement at i on of

25 Synt hes Nor i an cement i nt o her spi ne.


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1 Fur t her , as I ' ve stat ed, t he decl ar at i ons of Dr . Kowal ski

2 and Dr . Fal l er bot h stat e unequi vocal l y t hat nei t her

3 Ms. Gol den or t he ot her vi cti ms of t he cri mi nal pr of i t eer i ng

4 acti vi t y gave any consent at al l t o t he sur ger i es i n whi ch

5 Dr . Chapman i nj ect ed Nor i an cement i n t hei r spi nes. They

6 t est i f i ed f ur t her t hat once Dr . Chapman made t he deci si on t o

7 use Nori an cement under ci r cumst ances where he knew t hi s was

8 a non- FDA appr oved use, wher e he knew t he FDA had determi ned

9 t hat i t was cont rai ndi cat ed f or spi nal use - - t hat l et t er

10 t hat Mr . Madden r ef er ences i n J anuar y of 2007 st at ed11 unequi vocal l y: The FDA has det er mi ned t hat Nor i an cement ,

12 SRS or CRS or XR f or t hat mat t er , was not t o be used i n t he

13 spi ne.

14 That ' s a ver y i mpor t ant di st i ncti on, Your Honor , because

15 not onl y - - you know, doct or s can do some t hi ngs of f - l abel

16 when i t ' s t hei r under standi ng t hat t her e' s no pr ohi bi t i on

17 agai nst t hat . But her e t hi s doctor knew t hat he was

18 cont r ai ndi cat ed f or use i n t he spi ne whi ch he used i n t he

19 Reba Gol den case.

20 They f urt her t est i f i ed - - t hat i s Dr. Kowal ski and

21 Dr . Fal l er - - t hat once Dr . Chapman made t he deci si on t o use

22 Nor i an cement under t hose ci r cumst ances, agai n, wher e i t was

23 non- appr oved by t he FDA and i n f act , cont r ai ndi cat ed by t he

24 FDA, and under t he ci r cumst ances where Dr . Chapman, who had

25 done r esear ch on pi gs wi t h t hi s pr oduct , knew how danger ous


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1 i t was, under t hose ci r cumst ances, Dr . Chapman was no l onger

2 act i ng i n t he pat i ent ' s best i nt erests; and t heref ore, any

3 consent t hat she gave was vi t i at ed by t hat because t her e i s

4 no l onger a physi ci an/ pat i ent rel at i onshi p.

5 I wi l l get t o t hi s mor e i n t he t or t of out r age ar gument ,

6 Your Honor , but cl ear l y t he Hi ppocrat i c Oat h i n and of

7 i t sel f says t hat t he doctor i s t o do no har m.

8 And i n t he t or t of out r age, I ' l l t al k a l ot mor e about how

9 i nvi ol at e t hi s count ry and ot her ci vi l i zed count r i es

10 consi der t he pr ot ecti ons t hat pat i ent s ar e ent i t l ed t o when11 t hey ar e bei ng exper i ment ed on.

12 Your Honor , i n t he Uni t ed St at es of Amer i ca and, i n f act ,

13 t he rest of what I woul d cal l ci vi l i zed soci et y, doct ors

14 cannot experi ment on human bei ngs wi t hout t hei r knowl edge

15 and consent and wi t hout al l of the saf eguar ds r equi r ed by

16 t he Food and Dr ug Admi ni st r at i on. And any i nst i t ut i on,

17 i ncl udi ng t he Uni ver si t y of Washi ngt on, t hat engages i n

18 human experi ment at i on can onl y do so under t he auspi ces of

19 t he r ul es and r egul at i ons of t he FDA. And doctor s at t hose

20 i nst i t ut i ons ar e r equi r ed t o be super vi sed and cont r ol l ed by

21 an i nvest i gat or y r evi ew boar d, whi ch I ' ve al r eady di scussed,

22 t hat ' s made up of not onl y doctors but et hi ci st s, l awyer s

23 and ot her s who ar e t her e t o pr ot ect t he pat i ent s and t o make

24 sur e t hat the doct or i s not engagi ng i n an exper i ment beyond

25 what has been appr oved and consent ed t o.


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1 Pat i ent s, Your Honor , who under st and and consent t o be a

2 par t of a human exper i ment know what t hey' r e get t i ng i nt o.

3 Reba Gol den and t hese ot her pat i ent s, i ncl udi ng J oan

4 Br yant - - who I al so r epr esent her f ami l y - - wer e never

5 gi ven t hat oppor t uni t y and never pr ot ected as t he l aw

6 r equi r es.

7 Agai n, Bundr i ck v. St ewar t cl ear l y stands f or t he posi t i on

8 t hat nor mal l y whet her or not a pat i ent gave consent i s an

9 i ssue of f act and t hat i n Washi ngt on t her e i s cl ear l y a case

10 of medi cal bat t er y i f a doctor per f or ms a pr ocedur e whi ch11 t he pat i ent di d not consent t o.

12 Your Honor , we have ci t ed ot her j ur i sdi cti ons t hat have

13 establ i shed t he wel l - r ecogni zed pr i nci pl e t hat a pat i ent ' s

14 consent t o sur ger y i s not a f r ee l i cense f or t he sur geon t o

15 do any and ever ythi ng he or she chooses t o do. The

16 di st i ncti on was cl ear l y dr awn by t he Cal i f or ni a Supr eme

17 Cour t i n Cobb v. Gr ant , ci t ed i n our br i ef , wher e t he cour t

18 st at es: Wher e a doctor obt ai ns consent f r om t he pat i ent t o

19 per f or m one t ype of t r eat ment and subsequent l y per f or ms a

20 subst ant i al l y di f f er ent t r eat ment f or whi ch consent was not

21 obt ai ned, t here i s a cl ear case of bat t ery.

22 THE COURT: So i s t hi s a si t uat i on wher e a di f f er ent t ype

23 of sur ger y was per f or med or t her e was a non- di scl osur e t hat

24 a par t i cul ar mat er i al was goi ng t o be used whi ch was per haps

25 cont r ai ndi cat ed or , under your wor ds, exper i ment al ? So i n


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1 ot her wor ds - -

2 MR. HANNULA: Yes.

3 THE COURT: - - shoul d - - t her e was cl ear l y consent t o a

4 sur ger y.

5 MR. HANNULA: We agr ee, yes.

6 THE COURT: And t her e was cl ear l y - - she cl ear l y knew t hat

7 t her e wer e r i sks of t he sur ger y. She di dn' t know - -

8 MR. HANNULA: Cor r ect .

9 THE COURT: - - t hat t he par t i cul ar t ype of cement was

10 goi ng t o be used. So i s t hi s mor e an al l eged11 mi srepr esent at i on case or i s t hi s a st r ai ght l ack of consent

12 case?

13 MR. HANNULA: I ' l l answer t hat i n a coupl e of ways.

14 THE COURT: Sur e.

15 MR. HANNULA: Fi r st of al l , Dr . Kowal ski and Dr . Fal l er i n

16 t hei r decl arat i ons have bot h t est i f i ed t hat - - and t here' s

17 evi dence f r om Ci ndy Wi l son t hat Dr . Chapman i n one of the

18 di scussi ons - - even t hough he di dn' t put i t i n hi s consent

19 f or m - - di scussed wi t h Reba Gol den usi ng an acryl i c cement ,

20 PMMA. Your Honor , t hi s i s a ver y di f f er ent cement f r om

21 Nori an cement . Thi s i s acryl i c, i t ' s an acryl i c- based

22 pr oduct . Nor i an cement i s a cal ci um phosphat e- based

23 pr oduct . And even bef or e Synt hes l aunched t hei r i l l egal

24 t est mar ket , whi ch Dr . Chapman was a par t of , Synt hes and

25 Dr . Chapman knew t hat t hi s pr oduct , because i t was cal ci um


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1 phosphat e- based, f or med and accel er at ed cl ot s.

2 And as t he Cour t can i magi ne, once t hi s get s i nt o t he

3 bl ood st r eam and st ar t s f or mi ng and accel er at i ng cl ot s and

4 maki ng t hem bi gger , they' r e goi ng t o go i nt o t he hear t and

5 l ungs and t hey' r e goi ng t o ki l l someone. What Dr . Fal l er

6 and Kowal ski have t est i f i ed t o i s when Dr . Chapman advi sed

7 Reba Gol den and her daught er t hat he was goi ng t o use PMMA,

8 t hat was a U. S. FDA appr oved pr oduct f or use i n t he spi ne.

9 We know t hat not onl y was Nori an cement not appr oved, t he

10 FDA had made a det er mi nat i on t hat i t was cont r ai ndi cat ed f or11 use i n t he spi ne. Dr . Fal l er and Dr . Kowal ski have bot h

12 t est i f i ed, Your Honor , t hat t hat was a compl et el y di f f er ent

13 pr ocedur e t han t he one consent ed t o; and t her ef or e, t her e

14 was no consent .

15 Your Honor , we' ve ci t ed not onl y t he Cobb case i n

16 Cal i f or ni a, but we ci t ed t he Duncan case i n Ar i zona. And i n

17 t he Duncan case, t he pl ai nt i f f was goi ng t o have an MRI and

18 she consent ed t o t he MRI but she advi sed t he doct or that she

19 woul d onl y agr ee t o demer ol or mor phi ne t o basi cal l y r ender

20 her unconsci ous or at l east unawar e of what was goi ng on.

21 When she got t o t he hospi t al , t he nur se sai d we' r e goi ng

22 t o use f ent anyl . She sai d, no, I wi l l not agree t o t hat . I

23 wi l l onl y consent t o demer ol or mor phi ne. The nur se sai d,

24 okay, we wi l l - - we' l l use demer ol or mor phi ne. I nst ead she

25 went and used f ent anyl .


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1 The Supr eme Cour t i n - - t he t r i al cour t was i n t he

2 posi t i on t hat Mr . Madden has asked you t o be i n, i n t hat the

3 t r i al court rul ed that the pl ai nt i f f i n the Ar i zona case di d

4 not have a cl ai m f or assaul t , bat t er y, on t he basi s t hat she

5 had consent ed t o t he pr ocedur e. The Supr eme Cour t of St at e

6 of Ar i zona r ever sed i t , and t hei r cl ear hol di ng i n t hat case

7 was: You cannot mi sr epr esent what you' r e goi ng t o do. I f

8 you mi sr epr esent what you' r e goi ng t o do and someone

9 consent s t o a pr ocedur e based upon t he mi sr epr esent at i on,

10 t hen you have not gi ven consent and you have a cl ai m f or11 assaul t , per i od. That ' s what t hat case stands f or .

12 And, you know, i t ' s - - you know, t hey want t o di st i ngui sh

13 t hi s case because t hey want t o say, wel l , you know,

14 Dr . Chapman never mi sr epr esent ed anythi ng t o Reba Gol den.

15 Oh, he j ust never ment i oned or tol d Reba Gol den t hat he was

16 goi ng t o use a pr oduct t hat was not appr oved by t he FDA and,

17 i n f act , t he FDA had det er mi ned i t was cont r ai ndi cat ed f or

18 t he ver y use t hat he used i t on Reba Gol den.

19 So our expert s bel i eve, f i rst of al l , t hat t here was - -

20 f i r st of al l , at t he t i me t hat Dr . Chapman per f or med t hi s

21 pr ocedur e, he was not acti ng i n t hei r best i nt er est s; and

22 t her ef or e, any consent was vi t i at ed. They al so say t hat t he

23 pr ocedur e t hat was done was not t he pr ocedur e t hat she

24 consent ed t o. And I t hi nk t he cases i n our j ur i sdi cti ons

25 t hat have medi cal bat t er y ar e ver y cl ear t hat under t hose


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1 ci r cumst ances, that i s t he medi cal bat t er y and t hat i s not

2 an i ssue of i nf or med consent .

3 Your Honor , I ' l l touch br i ef l y on thi s pos i t i on that the

4 def ense has t aken whi ch, candi dl y, I f i nd ver y har d t o

5 under st and and accept . But what t hey' r e t r yi ng t o t el l t hi s

6 Cour t i s t hat wel l , the t hr ee pr edi cat e acts have t o be

7 wi thi n a f i ve- year per i od.

8 THE COURT: Counsel , why don' t you go t o t he next i ssue

9 whi ch i s t he - -

10 MR. HANNULA: Okay.11 THE COURT: I ' m i nt er est ed i n hear i ng f r om you on t he

12 Fi f t h Amendment i nf er ences.

13 MR. HANNULA: Yes, Your Honor .

14 THE COURT: So you have t he Fi f t h Amendment bei ng

15 i nvoked - -

16 MR. HANNULA: Ri ght .

17 THE COURT: - - by i ndi vi dual s - -

18 MR. HANNULA: Ri ght .

19 THE COURT: - - who - - l et ' s put asi de t he - - you know, t he

20 non- medi cal def endant s.

21 MR. HANNULA: Yes.

22 THE COURT: You have Mr . Madden, who i s r epr esent i ng t he

23 hospi t al , and - - at a mi ni mum l et ' s say t he hospi t al - -

24 MR. HANNULA: Yes.

25 THE COURT: - - and t he Uni ver si t y of Washi ngt on. So how


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1 i s t hat i nf erence t r i ggered agai nst hi s cl i ent s? That ' s t he

2 cl eaner anal ysi s.

3 MR. HANNULA: Yes.

4 THE COURT: The ot her def endant s ar guabl y have di f f er ent

5 ar gument s. But l et ' s t ake t hat - - t hose def endant s.

6 MR. HANNULA: I n ot her wor ds, you' r e r eal l y speaki ng of

7 Dr . Chapman and Hansj or g Wyss - -


9 MR. HANNULA: - - t he CEO and maj or st ockhol der of Synt hes,

10 I ncor por at ed bef or e he sol d i t t o J ohnson & J ohnson. But11 yes, t hose t wo bot h answer ed quest i ons.

12 Fi rst of al l , you know i t ' s our posi t i on t hat t hey are

13 co- conspi r at or s, and quest i ons t hat wer e di r ected t o t he

14 f our cr i mi nal def endant s who woul d not answer any quest i ons

15 and t ook t he Fi f t h i n t hi s case wer e par t of that conspi r acy

16 and we can t ake t he i nf er ences f r om t hat .

17 But , Your Honor , we have what I woul d ar gue i s an

18 abundance of evi dence t hat cl ear l y creat es a mat er i al f act

19 as t o whet her t her e was, i n f act, a conspi r acy, how l ong i t

20 l ast ed and - - and, Your Honor , t hat each one of t hese peopl e

21 was a par t of i t and i t was f or t he pur pose, obvi ousl y, f r om

22 Hansj or g Wyss' s posi t i on, to cont i nue t o gr ow hi s company

23 and t o i ncrease t he val ue of hi s company.

24 And he r ecrui t ed Dr . Chapman and Dr . Chapman - - and I am

25 st i l l somewhat shocked as t o why he di d what he di d, but he


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1 had a consi der abl e f i nanci al basi s t o do so. And I can

2 di scuss t hat f urt her, Your Honor.

3 Your Honor , and I want t o go back f or j ust a mi nut e

4 because i n t hese mot i ons, the def endant s have r epr esent ed

5 t hat t hi s i s mer el y a pr oducts l i abi l i t y case and mer el y a

6 medi cal mal pr acti ce cl ai m. They' r e aski ng you t o sani t i ze

7 t hi s case and wash away t hei r out r ageous and cr i mi nal

8 conduct whi ch caused t he deat h of Reba Gol den.

9 I n sent enci ng, t he f our cri mi nal def endant s who ar e par t

10 of t hi s case, Your Honor , J udge Legr ome gave a st at ement and11 I quot e: The var i ance - - i n t er ms of how much j ai l t i me

12 t hey wer e gi ven - - i s war r ant ed because t he gui del i ne

13 sent ence woul d not adequat el y addr ess t he unpr ecedent ed

14 nat ur e of t he cri mi nal conduct of Huggi ns and hi s

15 co- def endant s. The scope of t hei r scheme i s wi t hout

16 par al l el . The r i sk creat ed f or an unsuspecti ng publ i c wer e

17 gr ave and t he scal e and t he decept i on of t he Food and Dr ug

18 Admi ni st r at i on can onl y be char acter i zed as ext r eme.

19 He went on t o say, The ext r eme r i sk cr eated by t he Synt hes

20 pr oduct, i ndeed t he uncer t ai n nat ur e of t he pr oduct i t sel f ,

21 was r epeat edl y br ought t o t he at t ent i on of Huggi ns and hi s

22 f el l ow execut i ves by medi cal consul t ant s, r esear cher s and

23 sur geons who had used t he pr oduct onl y t o exper i ence seri ous

24 compl i cat i ons. These st r i dent and abundant war ni ngs wer e

25 expr essl y consi der ed and i gnor ed. Huggi ns and hi s


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1 conf eder at es cl osed t hei r eyes t o t he deat h of t wo

2 unsuspecti ng pat i ent s, who, as i t t ur ned out , wer e l i t t l e

3 mor e t han subj ect s i n a Synt hes exper i ment .

4 Your Honor , t he def endant s, al l of t hem, have r epr esent ed

5 t o you t hat i f ther e was a cri mi nal conspi r acy, i t ended

6 when t he FDA began i t s i nvest i gat i on i nt o Synt hes mar ket i ng

7 of Nor i an cement s f or use i n t he spi ne i n t he spr i ng of

8 2004.

9 Your Honor , we have Exhi bi t 124 whi ch i s a par t of our

10 document s. Thi s i s a document pr oduced by t he Uni ver si t y of11 Washi ngt on set t i ng f or t h t he dat es and t i mes Dr . Chapman and

12 ot her Uni ver si t y of Washi ngt on spi nal sur geons i nj ected

13 Nor i an cement i nt o t he spi nes of t hei r pat i ent s. The

14 document r ef l ects t he f act t hat af t er t he FDA i nvest i gat i on

15 began i n 2004, Dr . Chapman i nj ect ed Nor i an cement i nt o t he

16 spi nes of 33 pat i ent s bet ween J ul y of 2004 t hr ough J ul y 6t h,

17 2009.

18 At t hi s pr ocedur es, Your Honor , t her e i s document ed pr oof

19 t hat Synt hes r epr esent at i ve - - a Synt hes r epr esent at i ve was

20 pr esent i n t he oper at i ng r oom wi t h Dr . Chapman, i ncl udi ng

21 dur i ng Reba Gol den' s sur gery on August 17t h, 2007 and J oan

22 Br yant ' s sur ger y on J ul y 6t h, 2009.

23 Now, we asked t he def endant , Synt hes t o pr ovi de

24 i nf or mat i on as t o who was pr esent i n each of t hose

25 pr ocedur es. They di dn' t answer t hat i nt er r ogat or y


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1 compl et el y, but t hey di d gi ve us t he cal endar of Synt hes

2 r epr esent at i ve, J ef f Hunt . And f or ever y pr ocedur e t hat

3 Dr . Chapman used Nor i an cement at Har bor vi ew f r om Febr uar y

4 of ' 05 t hr ough Reba Gol den' s sur ger y, through J oan Br yant ' s

5 sur ger y on J ul y 6t h of ' 09, that r epr esent at i ve was t her e i n

6 t he oper at i ng r oom wi t h hi m ever y si ngl e t i me.

7 The i nvest i gat i on st ar t ed i n 2004. The i ndi ctment s di d

8 not come down - - i n ot her wor ds, the f our cri mi nal

9 def endant s i n t hi s case wer e not char ged wi t h cr i mes nor was

10 Synt hes char ged wi t h a cri me unt i l J une of 2009,11 appr oxi matel y t hr ee weeks bef ore Dr . Chapman operated on

12 J oan Br yant and she di ed on t he oper at i ng t abl e on J ul y 6t h

13 of 2009.

14 We' ve t al ked about i n our br i ef t he f act t hat we ar e

15 ent i t l ed t o cer t ai n i nf er ences, Your Honor . But I ' d ask t he

16 Cour t t o l ook at t he document s t hat have been pr esent ed.

17 Exhi bi t 1 est abl i shes t hat al most i mmedi at el y af t er

18 Hansj org Wyss pur chased t he Nor i an company and i t become a

19 par t of t he Synt hes Cor por at i on, Synt hes was awar e t hat t he

20 FDA consi der ed bone cement use i n t he spi ne t o be an, i n

21 quot at i on mar ks, hot but t on i ssue. And Synt hes r ecogni zed

22 i f t hey wer e goi ng t o be abl e t o mar ket Nor i an cement f or

23 use i n t he spi ne, i t woul d r equi r e f or mal FDA appr oval and

24 t hey woul d have t o go t hr ough t he ent i r e FDA appr oval

25 pr ocess, whi ch i s cost l y and t akes t hr ee t o f i ve year s and


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1 somet i mes l onger.

2 Exhi bi t 2, Your Honor , a document dat ed Febr uar y 2000

3 r ecor ds a meet i ng i n whi ch Hansj or g Wyss t ol d al l t he

4 Synt hes at t endees t hat Synt hes woul d be doi ng a st r ong push

5 f or ver t ebr opl ast y. Ver t ebr opl ast y i s one of t he pr ocedur es

6 t hat Reba Gol den consent ed t o as r ef er enced i n t he consent

7 document . Thi s i s one of t he ways t o t r eat ver t ebr al

8 compressi on f ractures .

9 Exhi bi t 3 i s an emai l of Febr uar y 24t h, 2000, f r om t he

10 def endant , Tom Hi ggi ns t o Hansj or g Wyss out l i ni ng t he11 f or mat i on of a pl an t hat pr oposes an i l l egal t est mar ket f or

12 Nori an cement .

13 Exhi bi t 4 i s a Synt hes mar ket i nvest i gat i on st udy al so i n

14 2000 di r ected t o t he huge pr of i t pot ent i al f or usi ng Nor i an

15 cement t o t r eat ver t ebr al compr essi on f r actur es of t he

16 spi ne.

17 Exhi bi t 6 i s a cr i t i cal document , Your Honor, i t i s a

18 management revi ew boar d meet i ng of August 15t h, 2000, l ed by

19 CEO Hansj org Wyss. CEO Hansj org Wyss was at every

20 management r evi ew boar d meet i ng. He' s t he CEO, he' s t he

21 maj or i t y st ockhol der . Thi s company was sol d t o J ohnson &

22 J ohnson i n 2011 f or $20 bi l l i on. Hansj or g Wyss' s shar e of

23 t hat publ i c company was $10 bi l l i on.

24 Each of t hose management r evi ew boar d meet i ngs were

25 at t ended by upper management , i ncl udi ng Mr . Huggi ns, the


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1 pr esi dent of Synt hes of Nor t h Amer i ca, and Mr . Hi ggi ns, the

2 pr esi dent of Synt hes spi ne. I n t hat meet i ng, i f you l ook at

3 page 2, t he deci si on was made t o l aunch an i l l egal t est

4 mar ket f or t he pur pose of get t i ng sur geons t o t r eat pat i ent s

5 wi t h Nor i an cement i nj ected i nt o t hei r spi ne.

6 Exhi bi t 10, Your Honor , i s a management r evi ew boar d

7 meet i ng on November 15t h, 2001, appr oxi matel y one year

8 l at er . Agai n l ed by Hansj or g Wyss wi t h upper management i n

9 at t endance, i ncl udi ng Huggi ns and Hi ggi ns, i n whi ch t he

10 deci si on t hat had been made i n t he pr i or MRB meet i ng, whi ch11 i s Exhi bi t 6, was reaf f i rmed.

12 I n f act, i n t hat meet i ng t her e was a di scussi on - - i t ' s on

13 page 3. Ther e' s a di scussi on, Tom Hi ggi ns, t he pr esi dent of

14 Synt hes spi ne, br i ngs up t he f act t hat oh, do you t hi nk we

15 shoul d do or consi der a l ong t i me I DE, that ' s an

16 i nvest i gat i onal devi ce except i on; t hat ' s part of t he

17 process. Act ual l y, i t ' s t he part of t he process t hat t akes

18 t hree t o f i ve years t o get the FDA t o appr ove i t i f i t ' s

19 f ound t o be saf e. But t hat ' s a par t of the pr ocess t o get

20 FDA approval .

21 The I DE st udy - - Your Honor , was t hey r ej ected t he I DE

22 st udy. I n ot her wor ds, Your Honor , t he t opi c was r ai sed at

23 t hi s management r evi ew boar d meet i ng as t o whether t hey

24 shoul d pr oceed wi t h at t empt i ng t o get Nor i an cement i nt o t he

25 spi ne l egal l y and l awf ul l y and t he deci si on of Hansj or g Wyss


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1 and t he management r evi ew boar d was: No, we wi l l not

2 pr oceed l awf ul l y, we wi l l get sur geons t o do 60 t o 80

3 pr ocedur es and we' l l hel p t hem publ i sh t hei r r esul t s.

4 That , Your Honor, i s an i l l egal t est mar ket and i t real l y

5 f or ms t he basi s f or t he cri mi nal char ges agai nst Synt hes,

6 Nor i an, and al l t he cri mi nal def endant s.

7 Exhi bi t 17A i s an emai l f r om Synt hes medi cal di r ector,

8 Dr . Ken Lambert to Ms. Thongpr eda dated J une 2nd of 2002.

9 She was t he pr oj ect gr oup manager of t he Nori an cement

10 spi nal pr oj ect. I n t hat emai l Dr . Lamber t makes r ef er ence11 t o t he upcomi ng t est mar ket and t el l s her i n no uncer t ai n

12 t er ms t hat what t hey ar e doi ng i s human exper i ment at i on.

13 Exhi bi t 17A al so r ef l ects t he f act t hat Dr . Lamber t sent

14 t hat emai l t hat he had sent to t he gr oup pr oj ect manager

15 di rect l y t o Hansj org Wyss.

16 Your Honor , Exhi bi t 27 i s a document t hat was pr epar ed by

17 t he Uni ver si t y of Washi ngt on r esear cher s, i ncl udi ng Dr . J ens

18 Chapman, wher e t hey advi sed Synt hes t hat t hey bel i eved t hat

19 Nor i an cement was a t hr ombogeni c agent ; t hat i s, i t pr oduced

20 an accel er at ed cl ot f or mat i on. And t hey had done

21 pr el i mi nar y st udi es on t he pi gs - - t hey di dn' t compl et e any

22 st udi es, but t hey di d pr el i mi nar y st udi es on t he pi gs and

23 t hey wer e ver y concer ned t hat that coul d pose ext r eme danger

24 i f i t was pl aced i nto pat i ents ' spi nes .

25 Thi s l et t er was wr i t t en on J une 28t h of 2002 - - and, Your


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1 Honor , l ater I woul d t al k about t he Nur ember g document t hat

2 says i f you' r e goi ng t o put - - i f you' r e goi ng t o do human

3 exper i ment at i on wi t h a devi ce or dr ug you don' t know what

4 t he r eact i on i n a human bei ng i s goi ng t o be, you do i t wi t h

5 ani mal s f i rst . That ' s a part of t he process of saf et y.

6 Thi nk about t hi s, Your Honor , i n J une of 2002 - - t he end

7 of J une of 2002, Synt hes, f i rst of al l , has recei ved a

8 l et t er f r omt hei r - - f r omt hei r - - f r omt hei r medi cal

9 di r ector sayi ng, what you' r e about t o do i s human

10 exper i ment at i on, and t hey' r e al so pr ovi ded wi t h a l et t er11 t hat says, l ook, we haven' t compl et ed any st udi es, we

Transcript of Washington State Court Hearing on 10-30-2015

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Transcript of Transcript of Washington State Court Hearing on 10-30-2015