IN
THE
UNITED
STATES
DISTRICT
COURTFOR
THE
DISTRICT
OF
COLUMBIAD
ONALD
E
DWARD
B
EATY
, )Arizona State Prison Complex – Eyman )P.O. Box 3400 )Florence, AZ 85232, )) Civil Action No.And ))D
ANIEL
W
AYNE
C
OOK
, )Arizona State Prison Complex – Eyman )P.O. Box 3400 )Florence, AZ 85232, ))And ))E
RIC
J.
K
ING
, )Arizona State Prison Complex – Eyman )P.O. Box 3400 )Florence, AZ 85232, ))And ))S
TEVE
L
IVADITIS
, )San Quentin State Prison )San Quentin, CA 94974, ))And ))B
RETT
P
ATRICK
P
ENSINGER
, )San Quentin State Prison )San Quentin, CA 94974, ))And ))S
TEPHEN
M
ICHAEL
W
EST
, )Riverbend Maximum Security Institution )7475 Cockrill Bend Boulevard )Nashville, TN 37209-1048, ))Plaintiffs, ))v. ))
(Additional Caption on the following page)
F
OOD AND
D
RUG
A
DMINISTRATION
, )10903 New Hampshire Avenue )Silver Spring, MD 20993, ))And )U
NITED
S
TATES
D
EPARTMENT
)
OF
H
EALTH AND
H
UMAN
S
ERVICES
, )200 Independence Avenue, S.W. )Washington, DC 20201, ))And ))K
ATHLEEN
S
EBELIUS
,
in Her Official Capacity as
)
Secretary of Health and Human Services
, )200 Independence Avenue, S.W. )Washington, DC 20201, ))And ))M
ARGARET
A.
H
AMBURG
,
M.D.,
in Her Official
)
Capacity as Commissioner of Food and Drugs,
)10903 New Hampshire Avenue, )Silver Spring, MD 20993, ))Defendants. ))
COMPLAINTFOR DECLARATORY, INJUNCTIVE, AND OTHER RELIEF
Of Counsel
Bradford A. Berenson (DC Bar No. 441981)Jon M. Sands Coleen Klasmeier (DC Bar No. 465050)Dale A. Baich Eric A. Shumsky (DC Bar No. 477926)O
FFICE OF THE
F
EDERAL
P
UBLIC
D
EFENDER
Sean C. Griffin (DC Bar No. 499537)
FOR THE
D
ISTRICT OF
A
RIZONA
S
IDLEY
A
USTIN
LLP850 West Adams Street, Suite 201 1501 K Street, N.W.Phoenix, Arizona 85007 Washington, DC 20005(602)
382-2816 (202) 736-8000(602) 889-3960 (fax) (202) 736-8711 (fax)dale_baich@fd.org sgriffin@sidley.com
Attorneys for Plaintiffs
– i –
TABLE OF CONTENTS
SUMMARY OF THE ACTION ......................................................................................................1
PARTIES .........................................................................................................................................8
I.
P
LAINTIFFS
...............................................................................................................8
II.
D
EFENDANTS
............................................................................................................9
JURISDICTION AND VENUE ....................................................................................................10
GENERAL ALLEGATIONS ........................................................................................................11
I.
T
HIOPENTAL
I
S
A
N
O
UTDATED
M
EDICATION
T
HAT
I
S
N
O
L
ONGER
A
VAILABLE
I
N
T
HE
U
NITED
S
TATES
. ......................................................................11
II.
T
HIOPENTAL
I
S
B
OTH
A
“D
RUG
”
A
ND
A
N
U
NAPPROVED
“N
EW
D
RUG
”
U
NDER
T
HE
FDCA. ................................................................................................12
III.
I
MPORTED
T
HIOPENTAL
I
S
M
ISBRANDED
U
NDER
T
HE
FDCA. ...............................15
IV.
I
MPORTED
T
HIOPENTAL
I
S
A
DULTERATED
U
NDER
T
HE
FDCA. .............................16
V.
T
HE
FDCA
P
ROHIBITS
T
HE
I
MPORTATION
O
F
A
NY
M
ISBRANDED
D
RUG
,
A
DULTERATED
D
RUG
,
O
R
U
NAPPROVED
N
EW
D
RUG
. ............................................17
VI.
T
HE
FDCA
M
ANDATES
T
HAT
FDA
D
ENY
A
DMISSION
T
O
A
NY
M
ISBRANDED
D
RUG
,
A
DULTERATED
D
RUG
,
O
R
U
NAPPROVED
N
EW
D
RUG
P
RESENTED
F
OR
I
MPORTATION
I
NTO
T
HE
U
NITED
S
TATES
. ..............................................................18
VII.
FDA
H
AS
C
ONSISTENTLY
M
AINTAINED
T
HAT
N
O
O
NE
—N
OT
E
VEN
S
TATE
G
OVERNMENTS
—M
AY
L
AWFULLY
I
MPORT
U
NAPPROVED
N
EW
D
RUGS
. ...............20
VIII.
FDA’
S
P
ROCEDURES
P
ROHIBIT
T
HE
C
OMMERCIAL
I
MPORTATION
O
F
U
NAPPROVED
N
EW
D
RUGS
A
ND
C
ONTROLLED
S
UBSTANCES
. ................................25
IX.
FDA
H
AS
A
LLOWED
S
TATE
C
ORRECTIONS
D
EPARTMENTS
T
O
I
MPORT
U
NAPPROVED
,
M
ISBRANDED
,
AND
P
OTENTIALLY
A
DULTERATED
T
HIOPENTAL
. ..........................................................................................................25
A.
Identified FDA Actions Admitting Unapproved, Unlisted,Unregistered, Misbranded, And Adulterated Thiopental Into TheUnited States ..............................................................................................27
B.
FDA’s Statement Dated January 4, 2011 ...................................................29
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