Ringo v. Lombardi, Case No. 09-4095-CV-C-NKL.

• Court: United States District Courts. 8th Circuit. Western District of Missouri
• Writing for the Court: NANETTE K. LAUGHREY
• Citation: 706 F.Supp.2d 952
• Parties: Earl RINGO, Jr., John Charles Middleton, Russell E. (Rusty) Bucklew, John Winfield, Dennis J. Skillicorn, Plaintiffs,v.George A. LOMBARDI, Steve Larkins, John Does 2-40, Defendants.
• Docket Number: Case No. 09-4095-CV-C-NKL.
• Decision Date: 02 March 2010

706 F.Supp.2d 952

Earl RINGO, Jr., John Charles Middleton, Russell E. (Rusty) Bucklew, John Winfield, Dennis J. Skillicorn, Plaintiffs,
v.
George A. LOMBARDI, Steve Larkins, John Does 2-40, Defendants.

Case No. 09-4095-CV-C-NKL.

United States District Court,
W.D. Missouri,
Central Division.

March 2, 2010.

706 F.Supp.2d 953

COPYRIGHT MATERIAL OMITTED

706 F.Supp.2d 954

John William Simon, Constitutional Advocacy, LLC, St. Louis, MO, Joseph Luby, Public Interest Litigation Clinic, Kansas City, MO, Cheryl Ann Pilate, Rebecca L. Kurz, Morgan Pilate LLC, Olathe, KS, David Barron, Frankfort, KY, for Plaintiffs.

Cheryl Ann Schuetze, Andrew William Hassell, Michael Joseph Spillane, Stephen D. Hawke, Missouri Attorney General's Office, Jefferson City, MO, for Defendants.ORDERNANETTE K. LAUGHREY, District Judge.

Plaintiffs Earl Ringo, Jr., John Charles Middleton, Russell Bucklew, John Winfield, and Dennis Skillicorn filed this action seeking a declaratory judgment that Missouri's lethal injection protocol violates the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301, et seq. (“FDCA”), as well as the Controlled Substances Act, 21 U.S.C. §§ 801, et seq. (“CSA”). Plaintiff Dennis Skillicorn is deceased, having been executed by lethal injection in 2009; the surviving Plaintiffs are prisoners of the State of Missouri sentenced to death. They name the following Defendants: Director of Missouri's Department of Corrections, George Lombardi; Warden, Eastern Reception Diagnostic & Correctional Center, Steve Larkins; and Anonymous Executioner, John Does 2-40. In essence, Plaintiffs assert that Defendants' use of lethal injection drugs (sodium thiopental, pancuronium bromide, and potassium chloride): (1) violates the CSA in that Defendants do not obtain the drugs lawfully; and (2) violates the FDCA in that the drugs are not prescribed by a licensed practitioner and have not been approved by the FDA for use in lethal injections. Pending before the Court is Defendants' Amended Motion to Dismiss [Doc. # 29]. For the reasons stated below, the Court denies the motion.

I. Background¹A. The Parties

Plaintiffs are death row inmates in Missouri state penitentiaries. Defendant Lombardi

706 F.Supp.2d 955

is the Director of the Department of Corrections for Missouri; as such, he is authorized to determine how the Department of Corrections of the State of Missouri carries out lethal injections See Mo.Rev.Stat. § 546.720. Defendant Steve Larkins serves as Warden of the Eastern Reception Diagnostic and Correctional Center (ERDCC) in Bonne Terre, Missouri, where Missouri conducts its executions. Plaintiffs state that they are unable to provide names for the John Doe Defendants because Missouri statute forbids the release of names and identities of those on the execution team See Mo.Rev.Stat. § 546.270.2.
B. The CSA and FDCA

The CSA classifies controlled substances into “schedules” and specifies how substances in each schedule may be distributed and regulated. 21 U.S.C. § 812. The CSA requires a medical practitioner to write a prescription for substances classified under “Schedule III” before that substance may be dispensed. 21 U.S.C. §§ 829(b), 842; see also 21 C.F.R. § 1308.13(c)(1)(iii). The CSA classifies sodium thiopental as a Schedule III drug. 21 U.S.C. § 829; see also 21 C.F.R. § 1308.13(c)(1)(iii).

The FDCA requires that “drugs” be dispensed only by a medical practitioner where they are not safe to use except under the supervision of a licensed practitioner. 21 U.S.C. § 353. The FDCA also requires that drugs be approved by the Food and Drug Administration (“FDA”) before they are administered, and proven effective for their intended purpose. 21 U.S.C. § 355. The FDCA provides that all proceedings to enforce or restrain violations shall be brought in the name of the United States or states. 21 U.S.C. § 337. Other than in prohibiting declaratory judgment suits regarding generic drugs, 21 U.S.C. §§ 355(c)(3)(D)(i)(I), (j)(5)(C)(i)(I), the statute does not expressly prohibit declaratory judgment actions. The parties do not appear to dispute that the FDCA prohibits obtaining pancuronium bromide and potassium chloride without a prescription; they also do not appear to dispute that the lethal injection chemicals have not been authorized by the FDCA for use in lethal injection.

The statutes have certain exemptions for certain types and uses of drugs by certain people. For example, the CSA allows agents of registered persons to dispense drugs, 21 C.F.R. §§ 1301.22(a), (b); it allows state officers enforcing controlled substance laws to possess such substances in the course of their duties, 21 C.F.R. § § 1301.24(a)(1), (a)(2). The parties appear to agree that the CSA, FDCA, and their corresponding regulations do not provide exceptions to their requirements for purposes of lethal injection executions.

C. Missouri's Lethal Injection Statute and Protocol

Missouri's lethal injection statute prescribes “lethal injection” or “lethal gas” as acceptable methods of execution. Mo.Rev.Stat. § 546.720. The statute does not dictate particularities like types of personnel or chemicals to be used in carrying out different aspects of the executions.

According to the Complaint-and as Defendants appear to concede-Missouri's protocol for lethal injection executions does set forth particularities, but does not set forth procedures which require compliance with the CSA and FDCA. Missouri's lethal injection protocol is not statutory-it is issued by the Department of Corrections and sets out technical procedures for carrying out lethal injections, and it is exempt from Missouri's typical notice and comment

706 F.Supp.2d 956

rulemaking requirements. Middleton v. Missouri Dep't of Corr., 278 S.W.3d 193, 195-96(Mo.), cert. denied, --- U.S. ----, 129 S.Ct. 2430, 173 L.Ed.2d 1331 (2009). The protocol does not require the lethal injection chemicals to be prescribed or dispensed by a medical practitioner; and those chemicals have not been approved for use in lethal injections. Defendants intend to execute Plaintiffs using the lethal injection chemicals under the protocol; a doctor will not be obtaining, prescribing or administering those chemicals.

The parties appear to agree that the intended use of thiopental in the lethal injection protocol is to render a prisoner unconscious so that the prisoner does not suffer pain in the administration of pancuronium bromide and potassium chloride.

D. Exhaustion of Administrative Remedies

According to the Complaint, to the extent they were required to do so, Plaintiffs have exhausted their administrative remedies with regard to their claims. They filed grievances with the Missouri Department of Corrections alleging their claims concerning the CSA and FDCA, requesting that the department comply with the statutes before proceeding with executions by lethal injections. The department issued an “Appeal Response” asserting that it is not subject to the statutes because its use of the chemicals is not a threat to public health and safety. See generally Bowling v. Haas, No. 07-CV-07-KKC, 2007 WL 403875, at *3 (E.D.Ky. Jan. 31, 2007) (dismissing declaratory judgment claims that Kentucky's lethal injection protocol violated the CSA and FDCA for failure to exhaust administrative remedies).

E. The Complaint

Plaintiffs assert that this Court has jurisdiction under: 28 U.S.C. § 1332, granting district courts jurisdiction to restrain violations of the FDCA; 28 U.S.C. § 1331, in that it arises under the laws of the United States; 28 U.S.C. § 1651, the All Writs Act; and 28 U.S.C. § 2201(a), in that the purpose of this action is to secure declaratory relief. Plaintiffs appear to concede that the CSA and FDCA provide no private right of action for enforcement. See Merrell Dow Pharmaceuticals v. Thompson, 478 U.S. 804, 817, 106 S.Ct. 3229, 92 L.Ed.2d 650 (1986) (stating that there is no private cause of action for violation of the FDCA). Plaintiffs clarify that they do not seek to force the FDA nor do they seek to have a United States governmental agency or official enforce the CSA or FDCA. Instead, Plaintiffs seek merely a declaration that Defendants' intended actions as applied to Plaintiffs would violate the CSA and FDCA.

I. DiscussionA. Standing

Defendants move under Rule 12(b)(1) of the Federal Rules of Civil Procedure to dismiss Plaintiffs' claims for lack of standing. Where a plaintiff lacks standing, a district court has no subject matter jurisdiction. Faibisch v. University of Minn., 304 F.3d 797, 801 (8th Cir.2002). To have standing to bring a declaratory judgment action, Plaintiffs must show a personal injury which would likely be redressed by a favorable decision. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). Defendants argue that Plaintiffs cannot meet this test.

Defendants focus their standing argument on redressability: they state that a favorable declaration would not benefit Plaintiffs. The Declaratory Judgment Act allows courts to “declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought.” 28 U.S.C. § 2201(a).

706 F.Supp.2d 957

Franklin v. Massachusetts demonstrates that suits for declaratory relief against government officials are appropriate even where other relief is not available, because it can be presumed that those officials will behave in compliance with a court's interpretation of a statute-even where injunctive relief is not available. See 505 U.S. 788, 803, 112 S.Ct. 2767, 120 L.Ed.2d 636 (1992). In Franklin, a divided Court considered the challenge of Massachusetts and two of its voters to Congress's reapportionment of seats in the House of Representatives as unconstitutional and inconsistent with the Administrative Procedures Act. See id. at 796, 112 S.Ct. 2767. The plurality found that plaintiffs had standing to seek a declaratory judgment, even if injunctive relief was not available,...