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Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 1 of 22

IN THE UNITED STATES DISTRICT COURT FILED


FOR THE EASTERN DISTRICT OF ARKANSA~~STERN
U.S. DISTRICT co~~...,.,
Dl5T~ A~,.,,..,,.~ ..
eAa

WESTERN DIVISION
PRili 2017
JAM
Jason McGehee, Stacey Johnson, By: J:> <11 '9t ~t DEP c~~-r,
Bruce Ward, Terrick Nooner,
JackJones, Marcel Williams,
Kenneth Williams, Don Davis,
and Ledell Lee Plaintiffs

v. Case No. 4:17-cv-179-KGB

Asa Hutchinson, Governor of the State of Arkansas,


in his official capacity, and Wendy Kelley, Director,
Arkansas Department of Correction, in her
official capacity Defendants

Brief in Support of Motion for Leave to File Amicus Brief

Fresenius Kabi USA, LLC, and West-Ward Pharmaceuticals Corp.

(the Manufacturers), for their brief in support of motion for leave to file

amicus brief, state:

1. The Court has authority and discretion to allow briefs from


amicus curiae with unique information or perspectives.

District courts have inherent authority and discretion to allow

amicus briefs when:

the amicus curiae has unique information or perspective that


can help the court;
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 2 of 22

the amicus curiae has an interest in another case that may be


affected by the decision in the present case; or

a party is not represented competently or not represented at


all. Jin v. Ministry of State Sec., 557 F. Supp. 2d 131, 136-37
(D.D.C. 2008).

A district court may therefore grant leave to file an amicus brief if it

1s "timely, useful, or otherwise." United Fire & Casualry Co. v. Titan

Contractors Service, Inc., 2012 WL 3065517, *6-7, 2012 U.S. Dist. LEXIS

104908, *17 (E.D. Mo. July 27, 2012) (quoting Mauso!f v. Babbitt, 158

F.R.D. 143, 148-49 (D. Minn. 1994)). For example, where the third

parties had knowledge, experience, and perspective related to the issues,

the court in United Fire & Casualry found that the case would be well-

served by letting them appear as amici curiae to help the court resolve the

dispute. Id.

The Manufacturers have knowledge, experience, and perspective

that go beyond that of the parties in this case. They manufacture

lifesaving medicines. But the State of Arkansas appears to be about to

use some of those medicines to end life rather than save it. This is so

despite the Manufacturers' implementation of distribution protocols to

prevent this and the public-health risk that could result from use of these

medicines for capital punishment.

2
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 3 of 22

2. The Companies are uniquely positioned to explain the


public-health risks of using the medicines for capital-
punishment purposes.

2.1. Fresenius Kabi USA, LLC (Fresenius Kabi)

Fresenius Kabi is focused on the care of critically and chronically ill

patients. One drug in its portfolio is potassium chloride, which is

marketed globally, including in the United States through Fresenius Kabi


1
USA, LLC. Fresenius Kabi supplies a significant portion of the

potassium chloride in the United States. Over the past several years, the

United States has faced shortages of potassium chloride - most recently

listed on April 4, 2017 2 - and Fresenius Kabi has worked closely with

the U.S. Food and Drug Administration during these times to ensure

supply of this drug.

Fresenius Kabi has sought to ensure that its medicines will not be

used for capital punishment. It has made its position clear in public, has

notified state authorities and departments of correction, and has

instituted distribution controls to ensure that the drugs are only used to

1
Fresenius Kabi USA, LLC was known until August 2012 as APP
Pharmaceuticals, LLC, when its name was changed. Certain of its drugs
still carry labeling and packaging referring to APP Pharmaceuticals. For
simplicity, we refer to Fresenius Kabi throughout this brief even where
labeling reflects the name APP.
2
See https: //www.ashp.org/Drug-Shortages I Current-Shortages /Drug-
Shortage-Detail.aspx?id =696 Oast visited on April 13, 2017).

3
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 4 of 22

save and sustain lives of patients. As more fully explained in the

proposed amicus brief, Fresenius Kabi has instituted measures to

safeguard supply of lifesaving medicines for patient care by prohibiting

the use of certain of its products for lethal injection.

If the State of Arkansas has obtained Fresenius Kabi-manufactured

potassium chloride to use in capital punishment-as appears to be the

case-it would have been contrary to and in violation of the company's

contractual supply-chain controls. See Exhibit A (redacted label and

package insert showing that the potassium chloride originated from

Fresenius Kabi, which has been represented to be the potassium

chloride that may be used in the impending lethal injections in Arkansas).

Fresenius Kabi seeks to appear in this matter as amicus curiae to share

with the Court the public-health risks of diverting these lifesaving

medicines from the healthcare industry to the Department of Correction

for capital-punishment purposes.

2.2. West-Ward Pharmaceuticals Corp. (West-Ward)

West-Ward, a wholly-owned subsidiary of Hikma PLC,

manufactures and supplies high-quality, generic medicines across the

United States, including midazolam. The World Health Organization has

included midazolam on its "List of Essential Medicines" as a sedative.

http://www.who.int/medicines/publications/essentialmedicines/EML

4
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 5 of 22

2015 FINAL amended NOV2015.pdf?ua=1 (last visited April 13,

2017). West-Ward is an important supplier of midazolam for not only

Arkansas but also the entire United States, supplying approximately one-

third of the United States market demand by volume for this critical

medicine.

West-Ward has also sought to ensure that its medicines will not be

used for capital punishment since, being committed to improving and

saving lives, it is inconsistent with West-Ward's mission and core values.

West-Ward has publicly made its position clear through the posting of

its position on its and its corporate parent's websites and through direct

correspondence with attorneys general, governors, and departments of

correction in various states. Further, West-Ward instituted distribution

controls to ensure that the drugs are not used in connection with lethal-

injection protocols, including instructing that such medicines be sold

only to pre-authorized customers who agree not to sell them to

departments of correction, other entities that intend to use them for

lethal injection, secondary distributors, or retail pharmacies.

Despite these controls, it appears as if West-Ward's midazolam

may have been obtained and is intended to be used in connection with

capital punishment in Arkansas. See Exhibit B (redacted label and

package insert of midazolam product alleged to be used in the

5
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 6 of 22

executions). This suggests a violation of the above-described contractual

controls. West-Ward seeks to appear in this matter as amicus curiae to

share with the Court the public-health risks of diverting this critical

medicine from advancing human health and quality of life to ending

human life.

As manufacturers of the drugs at issue, the Manufacturers are in a

unique position to highlight the public-health risk of using the drugs as

part of Arkansas's lethal-injection program. They respectfully ask the

Court to grant their motion for leave to file the amicus brief attached to

the motion.

Respectfully submitted,

BRETT D. WATSON,
ATTORNEY ATLAW,PLLC
P.O. Box 707
Searcy, Arkansas 72145-0707
(501) 281-2468
watr.occ.com
By: c) l,; y"J ---
Brett D. Watson
Ark.BarNo.2002182

6
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 7 of 22

Certificate of Service

A copy of the foregoing has been conventionally filed and notice of


filing has been sent to all counsel of record on April 13, 2017, via the
CM/ECF system.

~y;c~l,,~
""'""
Brett D. Watson

7
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 8 of 22
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 9 of 22

~pp

45 767FJRovi$od: Apri!2006
l l ll I
POTASSIUM CHLORlDE
FOR INJECTION CONCENTRATE, USP

Concentrate Must Be
Diluted Before Use
FOR INTRAVENOUS INFUSION ONLY
MUST BE DILUTED PRIOR TO /NJEC110N

WARNINGS:
W~ Tl$ product COf!!a1ri$,alumiriwn
" . . ~---:.+~''-'""~"""..A,.. 611 rni,.,1 m~ ~ fP.at::flJ~_ip
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 10 of 22

t"4 H:IUb:.l< tiUfiW.':Utt.hi:w-(1.J"'i.it~)Qtu ""'*' 01Ji"tV'M


Injection Concentrate is also available. Each
ml Of !Ills 1njlii1!1?n o
Chit1uiva!ont U> 224 '
aru:illilS1!!lle$mO!aril'
pH (4.U.O) mayba\11? been adJUll.llid wlih
hydrochloflcacid ar.d lfrnicessary. pCllili;sium
hydroxide.
Si>me packl'lges
dosu use anci coo

{!JPPropriatelyrlUutod) i
~yte replen\sher.

.CUNICAL PHARMACOLOf;IY:

PRECAUTIONS:
General
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 11 of 22

the presence of renal disease, and in such


instances, cardiac monitoring is recommended.
Solutions containing dex1rose should be
used wi.th caution 1n patients .1tr1 overt or known
$tll;letlnicaJ aiabete$ !b$111t0&;.<1r C11rbohydrate
m!Clernnw f()r a . . . . . .
if 11\trncimlnist
l!tg de\llee, Cfite
pumplng~on
or air embolism may rllsurt.

y Ca~.e.99iy C--
hlll'le' not been
cnloride. It is also
ssium chloride can
c.ause ietal harm When administered to a
pregnant woman or can '11f~; reprQd@tion
~city. Potassium chforldul\ollld be given
to a pregnant woman only if clearly needed.
ADVERSE REACTIONS:
Reactions which may occur because ol t11e
~inlstrallon
attheslte

cardiac arrest. Potas-


sium deficits result In disruption of neuro-
muscular function, and intestinal lieus and
dilatation.
If an adverse reaction does occur. disccn
tinue me 1'11usion, evaluate the patient, insti-
tute appropriate therapeutic countermeasures
and save the remainder of the fluid for exam-
ination if deemed necessary.
OVER DOSAGE:
In !he event of fluid ovel'loaPdtiring parenteral
lhel'iilpy, reevaluate the pslierli's condition, and
institute appropriate corrective treatment.
In the event of overdosage with potassium-
containing solutions, dis<:ontlnue the infusion
immediately and institute correotive therapy
to reduce serum potassium levels.
Treatment of hyperkalemia Includes the
folfowing:
1. Dextrose Injection, USP, 10% or25%, con-
taining 1O units of crystalline insulin per
20 grams of dextrose administered intra-
venously, 300 to 500 ml/hour:
2. Absorption a[](! exchange of potassju;n using
sodium or ammonlumcycleca!lcn exdhange
resin, orally and as retention enema.
3,

cause digitalis toxicity.


DOSAGE AND ADMINISTRATION:
Concentrate
ration. Care

ooriclirners a;-e:usoo,
The dose anih'ate of administration are
dependent upon the specif;c condltion of
eaehpatient.
ll the serum potassium ieve! is greaterfhan
2.5 mEq/L,.pota.<IBiUm can be given at a ratfl
not to exceed 10 mE:o1l10ur and in a concen-
tration of up to 40 mE:q/L The 24 hour totai
dose should not exceed 200 mEq.
II urgent treatment is ir\dicaied (serum potas-
sium level less than 2 mEq/L and electrooar-
dlograp!OO
potf!Mlum.
lk!(l~iyahL . _. ... .
cases, continuous cardiac monitoring Is essen-
tial. A.~ mue11 as 400 mEq may be administered
in a 24 hour period, In critical conditions,
pl)lassium chloride may be admiNfsl!!red In
~.line (unless contraindicated) rather than in
~ll;!S.t'i c~li!lning fluids. as dax!rose may
lb~~~~~_:~1~;,?,le~.:1.~~ ............. , k .. .
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 12 of 22

OVEADQSAGE:

2.Absorpliooanr;t.~~og&O!~ii'fl,l~fl9
llOdiom orarnnu:mrum cyclelllil'm ~e
r6$in, ooilly and as ratemlenooema,
3.

. . . .. .... of administration ae
dQpenuenH.ipon the speoifio condition ot
aactt patient.

nla!ner permit
HOW SUPPLIED:
The following are packaged in plastic vials.
Toia! Pctw!fwn
Proi!iJCI 1100 Po!Olslum C~.illridi
No. Na. loo perml V'8111!110
91150; iiXJ2JflS511S 10mEq\039g) 149!ll!l
9510 63323.<JOO.16 20mfQ(OJog) t49ma I0-01ii!n~
10ml!llll
9651> 03323.955.15 30llltq(1.l7g) 149mg 15mlii!a
iWllll""l
00520 6331395$-iW lmfq(t56ll) !49"ll 2amaa
2!lml\i!"

llll .~
P'ro!lusl llfl PO!a$gilm ~,.

llf. "" lM petml V-e


m10 B332Hlll7W S0m(q{2.3So} f4SIWJ 3ltmli1
dOm!.
'fial
Thi$ ls j with
0.1'5% ropyl-
panibe,
Store at 20' f0'25"C OOlr to 77"F) [see USP
Controlled Rocim T~urej.
Use only if solution is clear. seal intact and
undamaged.
Ilia! stoppers do no! contain natural rubber
taw.x.

45'167F
Revised: Aoril 2008
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 13 of 22
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 14 of 22
Case 4:17-cv-00179-KGB Document 43 Filed 04/13/17 Page 15 of 22

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