Court Opinion

ID: 4219137
Source: CourtListenerOpinion
Date Created: 2017-11-09 17:02:08.605684+00
Date Added: 2024-06-11T14:41:51.767204
License: Public Domain

Cite as 2017 Ark. 300

                 SUPREME COURT OF ARKANSAS
                                        No.   CV-17-788

                                                  Opinion Delivered: November   2, 2017

ARKANSAS DEPARTMENT OF
CORRECTION AND WENDY KELLEY,                      APPEAL FROM THE PULASKI
IN HER OFFICIAL CAPACITY AS                       COUNTY CIRCUIT COURT,
DIRECTOR OF THE ARKANSAS                          SEVENTEENTH DIVISION
DEPARTMENT OF CORRECTION                          [NO. 60CV-17-4931]
                      APPELLANTS
                                                  HONORABLE MACKIE M. PIERCE,
V.                                                JUDGE

STEVEN SHULTS
                                   APPELLEE AFFIRMED IN PART; REVERSED
                                            AND REMANDED IN PART.

                     COURTNEY HUDSON GOODSON, Associate Justice

        Appellants, the Arkansas Department of Correction and Wendy Kelley, in her official

 capacity as Director of the Arkansas Department of Correction (“ADC”), appeal from the

 Pulaski County Circuit Court’s order requiring the ADC to provide appellee Steven Shults

 with the pharmaceutical package inserts and labels for its supply of midazolam, one of the

 drugs in the State’s execution protocol. For reversal, the ADC argues that the lethal-drug

 information requested by Shults is confidential and not subject to disclosure under the

 Method of Execution Act (“MEA”), Arkansas Code Annotated section 5-4-617 (Supp.

 2015). In the alternative, the ADC contends that, even if the information is not confidential

 under the MEA, it is still required to redact certain information from the drug labels to

 protect the confidentiality of sellers and suppliers in the chain of distribution. We affirm in

 part and reverse and remand in part.
                                   Cite as 2017 Ark. 300

       Shults, an Arkansas resident and attorney, filed a complaint against the ADC on

September 7, 2017, after it refused to provide him with public records pertaining to the

State’s supply of midazolam pursuant to his Arkansas Freedom of Information Act

(“AFOIA”) request. According to the allegations in the complaint, Shults submitted an

AFOIA request to the ADC on August 21, 2017, seeking, in part, documents and records

held by the agency after May 1, 2017, containing “the name of chemicals or substances

intended or considered for use in lethal injection executions, manufacturer/compounder,

concentration, expiration date(s) and/or lot numbers of all chemicals or substances intended

or considered for use in executions currently in the possession of the ADC.” On August

24, 2017, the ADC responded to the request by providing records revealing that on August

4, 2017, Kelley had acquired 4 vials of midazolam, a drug listed in its execution protocol.

The ADC refused, however, to disclose the package inserts or labels for the newly acquired

supply of midazolam because, it stated, these documents could be used to identify the sellers

or suppliers of the drug in violation of the MEA.           Shults alleged that the ADC’s

interpretation of the MEA was in violation of the clear language of the statute and of his

rights under the AFOIA, that the ADC was not substantially justified in its refusal to provide

the requested records, and that he was entitled to unredacted copies of the drug labels and

package inserts.

       On September 18, 2017, the ADC filed a motion to dismiss the complaint under

Arkansas Rules of Civil Procedure 12(b)(1), 12(b)(6), and 12(b)(8) or, alternatively, for a

stay of the proceedings pending the final resolution of a related case filed by Shults. The

ADC argued that Shults had failed to state an AFOIA claim because the records he sought

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were specifically exempted from public disclosure by the MEA. According to the ADC,

the lethal-drug labels and package inserts readily identify the drug manufacturers, who are

also sellers and suppliers that are protected by the confidentiality provisions in the MEA.

The ADC further argued that interpreting these provisions to include manufacturers

comports with both legislative intent and public policy. In the alternative, the ADC asserted

that, even if the circuit court concluded that Shults had stated a cognizable AFOIA claim,

the court should order information such as lot and batch numbers to be redacted from the

drug labels because it could lead to the identification of downstream sellers and suppliers.

       In support of its motion, the ADC attached the affidavit of Rory Griffin, the deputy

director of Health and Correctional Programs with the ADC. Griffin stated that the ADC

had attempted to comply with both the disclosure and confidentiality provisions of the MEA

in response to past AFOIA requests; however, even when the ADC had provided redacted

copies of lethal-drug labels and package inserts, some recipients had been able to determine

the identity of the drug manufacturers by comparing the redacted labels and inserts to

publicly available information. Griffin indicated that this is because each manufacturer’s

labels and package inserts are unique with respect to format, style, diction, font,

organization, grammar, spelling, size, shape, coloring, and appearance. Given the unique

character of drug labels and package inserts, Griffin stated that the only way for the ADC to

comply with the confidentiality provisions of the MEA is to decline disclosure of these

records entirely. In addition to the fact that the labels and inserts reveal the identity of the

manufacturer, Griffin asserted that the lot and batch numbers on the drug labels can be used

to trace the drug through the distribution and supply chain all the way to the end user,

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which in this case is the ADC. Thus, Griffin averred that the MEA absolutely prohibits the

ADC from disclosing this information when responding to AFOIA requests.

       A hearing was held on Shults’s complaint on September 19, 2017, and on September

22, 2017, the circuit court entered an order denying the ADC’s motion to dismiss and

granting Shults’s request that he be provided with the unredacted midazolam labels and

package inserts. The court disagreed with the ADC’s interpretation of section 5-4-617 of

the MEA, finding that the General Assembly did not intend to protect the identity of

manufacturers of drugs used in the ADC’s lethal-injection protocol. The ADC filed a notice

of appeal the same day, and on September 27, 2017, this court granted its request for an

emergency stay of the order pending appeal. We also granted Shults’s motion to expedite

the appeal.

       The ADC argues that the circuit court erred by ordering it to provide Shults with

copies of the midazolam labels and package inserts because these records are not subject to

disclosure under the MEA’s confidentiality provisions. Thus, the issue presented on appeal

is strictly one of statutory interpretation.

       We review issues of statutory interpretation de novo, as it is for this court to

determine the meaning of a statute. Dep’t of Ark. State Police v. Keech Law Firm, P.A., 2017
Ark. 143, 516 S.W.3d 265. However, in the absence of a showing that the circuit court

erred, its interpretation will be accepted as correct on appeal. Hendrix v. Alcoa, Inc., 2016
Ark. 453, 506 S.W.3d 230.

       The primary rule of statutory interpretation is to give effect to the intent of the

legislature. Keep Our Dollars in Independence Cnty. v. Mitchell, 2017 Ark. 154, 518 S.W.3d
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64. We first construe the statute just as it reads, giving the words their ordinary and usually

accepted meaning in common language. Id. Statutory language is ambiguous if it is open

to two or more constructions, or if it is of such obscure or doubtful meaning that reasonable

minds might disagree or be uncertain as to its meaning. Dickinson v. SunTrust Nat’l Mortg.

Inc., 2014 Ark. 513, 451 S.W.3d 576. When a statute is ambiguous, we must interpret it

according to legislative intent, and our review becomes an examination of the whole act.

Id. In conducting this review, we reconcile statutory provisions to make them consistent,

harmonious, and sensible in an effort to give effect to every part. Id.

       The MEA’s confidentiality provisions relied upon by the ADC are contained in

Arkansas Code Annotated section 5-4-617(i) and (j):

       (i)(1) The procedures under subdivision (g)(1) of this section, the implementation of
       the procedures under subdivision (g)(1) of this section, and the identities of the
       entities and persons who participate in the execution process or administer the lethal
       injection are not subject to disclosure under the Freedom of Information Act of 1967,
       § 25-19-101 et seq.
       (2) The department shall keep confidential all information that may identify or lead
       to the identification of:
       (A) The entities and persons who participate in the execution process or administer
       the lethal injection; and
       (B) The entities and persons who compound, test, sell, or supply the drug or drugs
       described in subsection (c) of this section, medical supplies, or medical equipment
       for the execution process.
       (3) The department shall not disclose the information covered under this subsection
       in litigation without first applying to the court for a protective order regarding the
       information under this subsection.
       (j) The department shall make available to the public any of the following
       information upon request, so long as the information that may be used to identify
       the compounding pharmacy, testing laboratory, seller, or supplier is redacted and
       maintained as confidential:
       (1) Package inserts and labels, if the drug or drugs described in subsection (c) of this
       section have been made by a manufacturer approved by the United States Food and
       Drug Administration;
       (2) Reports obtained from an independent testing laboratory; and

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       (3) The department’s procedure for administering the drug or drugs described in
       subsection (c) of this section, including the contents of the lethal-injection drug box.

       The ADC contends that the drug labels and package inserts at issue here could not

be disclosed under the confidentiality provisions in subsections (i) and (j) because they could

lead to the identification of lethal-drug sellers and suppliers. More specifically, the ADC

argues that lethal-drug manufacturers are protected by the plain language of these

confidentiality provisions because they “sell” or “supply” lethal-injection drugs––such as

midazolam–– to distributors and place the drugs into the stream of commerce. The ADC

therefore asserts that, because it presented evidence to show that even redacted copies of

these records could lead to the identification of the midazolam’s manufacturer, it was

justified in refusing to provide the records to Shults.

       As the ADC argues, the definitions of both “seller” and “supplier” could be

interpreted to include a manufacturer. See, e.g., Black’s Law Dictionary (10th ed. 2014)

(defining a “seller” as “someone who sells or contracts to sell goods” and a supplier as a

“business engaged, directly or indirectly, in making a product available to consumers).

However, the term “manufacturer” also has its own distinct meaning and is defined as “[a]

person or entity engaged in producing or assembling new products.” Id. Thus, it is unclear

from the plain language in the confidentiality provisions of the statute whether the legislature

intended for drug manufacturers to be included within the terms “seller” or “supplier.”

       A review of the entire statute, however, reveals that the legislature explicitly referred

to a “manufacturer” of lethal drugs in two different subsections. See Ark. Code Ann. § 5-

4-617(d)(1) & (j)(1). As the circuit court found, this demonstrates that the legislature was

aware of the differences between the terms “manufacturer,” “seller,” and “supplier” and

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that it could have easily included “manufacturer” among the entities whose identity was

confidential for purposes of the MEA had it intended to do so. We have repeatedly held

that we will not read into a statute language that was not included by the legislature. E.g.,

Mitchell, supra; Scoggins v. Medlock, 2011 Ark. 194, 381 S.W.3d 781; Potter v. City of

Tontitown, 371 Ark. 200, 264 S.W.3d 473 (2007).

       Furthermore, we agree with the circuit court that, under the ADC’s interpretation

of the statute, subsection (j)(1) would be rendered meaningless. This subsection expressly

states that “so long as the information that may be used to identify the compounding

pharmacy, testing laboratory, seller, or supplier is redacted and maintained as confidential,”

the ADC “shall make available to the public . . . [p]ackage inserts and labels, if the drug or

drugs . . . have been made by a manufacturer approved by the United States Food and Drug

Administration.” If the ADC’s argument is correct that manufacturers are included within

the terms “seller” or “supplier” and that disclosure of even redacted labels and inserts would

lead to the identification of those manufacturers, then these records would never be

disclosed to the public despite the express mandate to the contrary in this subsection. In

addition, this interpretation would defeat the purpose of section 5-4-617(d)(1), which

requires that the ADC use drugs that are made by an FDA-approved manufacturer. As the

circuit court noted, the public has no way to verify whether the ADC is complying with

that requirement if drug manufacturers are protected by the confidentiality provisions in the

statute. Thus, the ADC’s position would violate our rule of construction that we interpret

a statute in such a way as to give effect to every provision. Dickinson, supra.

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       The ADC’s argument that protecting the identity of manufacturers supports the

State’s interest in carrying out death sentences is also unpersuasive. As the ADC asserts, the

General Assembly adopted the confidentiality provisions of the MEA “to address the

problem of drug shortages.” Act of April 6, 2015, No. 1096, § 1(b), 2015 Ark. Acts 4932.

However, the evidence presented in this case demonstrated that many manufacturers of

lethal-injection drugs already prohibit the use of these drugs in executions and that these

manufacturers often have contracts in place with their distributors that prevent the

downstream sale of the drugs to prison officials. It is therefore the confidentiality of the

sellers and suppliers of these drugs to the ADC that the confidentiality provisions were

intended to protect.

       We interpret AFOIA liberally to promote free access to public information. Keech

Law Firm, supra. In addition, we interpret any exemptions to AFOIA narrowly and in favor

of disclosure. Id.; Ark. State Police v. Wren, 2016 Ark. 188, 491 S.W.3d 124. Based on the

foregoing principles, we conclude that the circuit court was correct in determining that the

identity of drug manufacturers is not protected under the confidentiality provisions of

section 5-4-617, and we affirm this ruling.

       The ADC also argues, however, that even if we agree with the circuit court that the

confidentiality of manufacturers is not protected under the statute, it is still required to redact

certain information such as lot, batch, and/or control numbers that could lead to the

identification of other sellers and suppliers in the chain of distribution. We agree.

       Pursuant to section 5-4-617(j), if package inserts and drug labels are made available

to the public, any information that could be used to identify the seller or supplier must be

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redacted and maintained as confidential. The ADC presented evidence through Griffin’s

affidavit that drug labels contain unique identifying information in the form of lot and/or

batch numbers that can be used by the manufacturer to trace the drug through the

distribution and supply chain, all the way to the end user. The ADC’s argument is also

supported by FDA regulations, which require that drug labels contain information revealing

“the complete history of the manufacture, processing, packing, holding, and distribution of

a batch or lot of drug product[.]” 21 C.F.R. § 210.3(b)(11) (2011).

       While Shults disputes the ADC’s claim, he has provided no evidence to refute it. At

the hearing, the circuit court agreed with the ADC that Griffin’s testimony with regard to

the lot, batch, and/or control numbers was unrebutted, and the court further indicated that

it believed that Griffin’s testimony was correct. Despite this discussion, the circuit court

then stated in its order that there were no facts before it to indicate that the package inserts

and labels would identify the sellers and suppliers. This finding is clearly contrary to the

unrefuted evidence presented by the ADC.

       Accordingly, because disclosure of information such as lot, control, and/or batch

numbers could lead to the identification of the seller and/or supplier of the midazolam, the

ADC is correct that it is required to redact and maintain this information as confidential

under section 5-4-617(j). We therefore reverse that portion of the circuit court’s order

requiring disclosure of the unredacted records and remand for the court to determine, based

on the evidence presented by the parties, which information must be redacted on the

midazolam labels and/or package inserts at issue. Due to the expedited status of this appeal,

we order the mandate to issue within three days of this opinion unless a petition for

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rehearing is filed. If a petition for rehearing is filed, any response will be due on an expedited

basis to be set by the clerk.

        Affirmed in part; reversed and remanded in part.

        KEMP, C.J., and WOOD, WYNNE, and WOMACK, JJ., concur in part and dissent in

part.

        JOHN DAN KEMP, Chief Justice, concurring in part and dissenting in part.

I join the majority’s holding that the circuit court was correct in determining that the

identity of the drug manufacturers is not protected under the confidentiality provisions of

Arkansas Code Annotated section 5-4-617 (Supp. 2015).

        I respectfully dissent from the majority’s decision to reverse that portion of the circuit

court’s order requiring disclosure of the unredacted records, pursuant to Arkansas Code

Annotated section 5-4-617(j) (Supp. 2015), and to remand for the circuit court to determine

which information must be redacted on the midazolam labels and package inserts. In my

view, this issue has already been decided by the circuit court.

        Arkansas Code Annotated section 5-4-617(j) provides,

                (j) The department shall make available to the public any of the following information
        upon request, so long as the information that may be used to identify the compounding
        pharmacy, testing laboratory, seller, or supplier is redacted and maintained as confidential:
                (1) Package inserts and labels, if the drug or drugs described in subsection (c) of this
        section have been made by a manufacturer approved by the United States Food and Drug
        Administration;
                (2) Reports obtained from an independent testing laboratory; and
                (3) The department’s procedure for administering the drug or drugs described
        in subsection (c) of this section, including the contents of the lethal-injection drug
        box.

(Emphasis added.)

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       In the case at bar, the Arkansas Department of Correction (ADC) presented an

affidavit of Rory Griffin, an ADC employee, that “ADC declined to provide copies of the

package insert and label for the recently-acquired midazolam” because he believed that the

sellers and suppliers would be identified. The circuit court ruled,

                [T]he court holds the AMEA [Arkansas Method of Execution Act] does not
       make the identity of manufacturers of FDA-approved drugs used in the lethal
       injection method-of-execution (“MOE”) protocol confidential. The court further finds
       that there are no facts before the court that the package inserts and labels of lethal injection drugs
       manufactured by FDA-approved manufacturers would identify (i) the entities and persons who
       participate in the execution process, (ii) the identities of persons who administer the lethal
       injection drugs, or (iii) the compounder, testing laboratory, seller, or supplier of the lethal
       injection drugs.

(Emphasis added.) In making this determination, the circuit court found that the evidence

before it was not compelling. ADC had the burden of proving that the records were exempt

from disclosure. See Young v. Rice, 308 Ark. 593, 596, 826 S.W.2d 252, 254 (1992) (“[T]he

keeper of the requested records [] has the burden of proving the records are exempt from

disclosure”). Clearly, the circuit court found that ADC had not met its burden. Thus, I

cannot say that the circuit court erred in determining that the unredacted records must be

provided. To remand to the circuit court for a second determination on this issue is wholly

unnecessary. Accordingly, I would affirm the circuit court’s ruling on this point.

       WYNNE, J., joins.

       SHAWN A. WOMACK, Justice, concurring in part and dissenting in part. I

concur with the majority’s holding that, to the extent the labels and package inserts of

midazolam are subject to disclosure, the circuit court erred in ordering that the Arkansas

Department of Correction (“ADC”) disclose the documents without redacting the lot,

control, and batch numbers. The affidavit of Rory Griffin stated that these numbers may be

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used to identify the proximate sellers and/or suppliers of midazolam. Even Shults does not

contest that the Method of Execution Act (“MEA”) requires the ADC to refuse disclosure

of information that “may identify or lead to the identification of” these entities. See Ark.

Code Ann. § 5-4-617(i)(2) (Supp. 2015). The circuit court was not entitled to accept the

unsupported conjecture of Shults that this information would not lead to identification over

the affidavit of the ADC that it would.

       I write separately to dissent from the majority’s conclusion that manufacturers are

not included in the general confidentiality provision of the MEA protecting those who

“sell” or “supply” drugs “for the execution process.” Ark. Code Ann. § 5-4-617(i)(2)(B).

The majority opinion faithfully recounts our principles of statutory interpretation, but I

believe that it too eagerly discards the clear “ordinary and usually accepted meaning” of the

statutory terms and reaches a contrary result by relying on two unpersuasive factors it finds

in an “examination of the whole act.”

       As the definitions set out in the majority demonstrate, manufacturers fall squarely

within the commonly understood meanings of both seller and supplier. Pharmaceutical

manufacturers exist to sell or supply drugs, and the ADC intends to use these drugs “for the

execution process.” The majority’s observation that “manufacturer” has a more specific

meaning separate from “seller” or “supplier” does not negate the fact that manufacturers are

commonly understood to “sell” and “supply” as written in the statute. To hold otherwise

is to find ambiguity in any statute using a general term for an activity rather than a list of

specific terms for entities engaging in that activity. General terms—no less than specific

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terms—should be “accorded their full and fair scope,” not “arbitrarily limited.” Antonin

Scalia & Bryan A. Garner, Reading Law: An Interpretation of Legal Texts 101 (2012).

       Even admitting the ambiguity claimed by the majority, the two factors identified in

the rest of the MEA to exclude manufacturers from the general confidentiality provision are

unpersuasive. First, the majority notes that the legislature used the term “manufacturer” in

two subsections of the MEA; this is used to support the inference that the legislature knew

how to say manufacturer when it meant manufacturer. That inference would be warranted,

however, only if the circuit court or the majority were comparing like sections. If the

legislature had kept its “compound, test, sell, or supply” language in the general

confidentiality provision but in another section granted a different protection to entities

who “compound, test, sell, supply, or manufacture” drugs, the majority would be absolutely

correct to read manufacturers out of the general “sell” and “supply” in the confidentiality

provision. But that is not the case here. The two uses of manufacturer in the MEA are each

in identical instances of the fixed phrase “made by a manufacturer approved by the United

States Food and Drug Administration.” Ark. Code Ann. § 5-4-617(d)(1), (j)(1). This is not

the legislature denying that manufacturers are sellers and suppliers; it is instead the

legislature using the specific term where the general one would be inaccurate. The federal

regulatory approval referred to in these subsections only applies to manufacturers, and

therefore mirroring the federal regulatory language makes eminent sense.

       The second factor cited by the majority to exclude drug manufacturers from the

common understanding of entities selling or supplying drugs is the assertion that including

manufacturers in the confidentiality provision would render subsection (j)(1) of the MEA

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meaningless. This ignores the structure of the provision, however. On its face, the

subsection is a contingent requirement. The ADC must disclose the specified materials, but

only if that disclosure can be performed without imperiling the confidentiality of protected

entities. The majority asserts that the subsection would be surplusage if manufacturers were

intended as a protected entity because any portion of the labels or package inserts would

reveal the manufacturer of the drugs and therefore the specified materials would never be

disclosed. It is an unwarranted logical leap, however, to assume that the legislature had that

information at the time of drafting. As the ADC argued before the circuit court and on

appeal, the legislature’s inclusion of section (j)(1) can be read harmoniously with the

common understanding of manufacturers as sellers or suppliers. At the time of enactment,

the legislature could have reasoned that labels and package inserts would not identify

manufacturers after being stripped of logos, names, and other obvious identifying

information. After experience has taught that no amount of redaction will prevent

identifying the manufacturer of a drug from these materials, however, the legislature’s safety

valve operated as intended and the ADC must refuse disclosure.

       I would hold that manufacturers are included in the MEA confidentiality provision

protecting those who sell or supply drugs used for the execution process. Because any

portion of the labels or package inserts requested by Shults would identify the manufacturer,

I would reverse the circuit court’s order that the ADC must produce the documents. If any

materials are to be disclosed, however, I agree with the majority’s analysis that the lot,

control, and batch numbers must be redacted to protect the indisputably shielded proximate

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sellers and/or suppliers of the midazolam. Therefore, I respectfully concur in part and dissent

in part.

       WOOD, J., joins.

      Leslie Rutledge, Att’y Gen., by: Lee P. Rudofsky, Solicitor Gen.; Nicholas J. Bronni,
Deputy Solicitor Gen.; and Jennifer L. Merritt, Sr. Ass’t Att’y Gen., for appellants.

       Williams & Anderson PLC, by: Philip E. Kaplan, Heather G. Zachary, and Alec Gaines,
for appellee.

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