IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF MISSOURI
CENTRAL DIVISION
EARL RINGO, et al., )
)
Plaintiffs, )
)
vs. ) No. 09-4095-CV-C-NKL
)
GEORGE A. LOMBARDI, et al., )
)
Defendants. )
Reply to Defendants’ “Reply to Plaintiff’s Supplemental Suggestions”
Concerning Cross-Motions for Summary Judgment
For the first time in these proceedings, Defendants advance a novel
argument that their protocol actually conforms with federal law, so that
compliance with both is not “impossible” for purposes of preemption. See “Reply
to Plaintiff’s Supplemental Suggestions,” (ECF Doc. 259), at 3-4. Defendants cite
a regulation under the Controlled Substances Act, which permits an individual
practitioner to “administer or dispense directly a controlled substance without a
prescription.” ECF Doc. 259, at 3, citing 21 C.F.R. § 1306.11(b). Defendants
argue that the definition of “administering” a drug under the CSA includes “the
direct application of a controlled substance by a practitioner, or in his presence by
his authorized agent.” Id., citing 21 U.S.C. § 802(2)(a). Therefore, the argument
goes, DEA-registered physician M3 may, without issuing a prescription, freely
administer the controlled substance sodium thiopental by watching his non-
Case 2:09-cv-04095-BP Document 262 Filed 07/18/11 Page 1 of 6
medical supervisee inject the drug. ECF Doc. 259, at 3-4. Defendants essentially
liken their protocol to what happens in hospitals or doctors’ offices, when a nurse
might give narcotic pills to a patient under a physician’s direction and supervision.
Defendants are wrong. They neglect to mention essential qualifying
language within the regulation they cite:
An individual practitioner may administer or dispense directly a
controlled substance listed in Schedule II in the course of his
professional practice without a prescription
21 C.F.R. § 1306.11(b) (emphasis added). The defense-omitted language is not1
mere surplusage. It is essential to the statutory and regulatory scheme of the CSA,
which makes it unlawful for medical practitioners to dispense and administer
controlled substances “when their activities fall outside the usual course of
professional practice.” United States v. Moore, 423 U.S. 122, 124 (1975); United
States v. Kanner, 603 F.3d 530, 533 (8th Cir. 2010). The regulation parallels
statutory language underlying these precedents. See 21 U.S.C.A. § 802(21)
(“practitioner” is a professional licensed to dispense, administer, or distribute
controlled substances “in the course of professional practice or research”); Moore,
423 U.S. at 141-42.
The point is that a licensed practitioner may not rely on just any “agent” to
medicate a patient with controlled substances. Rather, the drug must be dispensed
Plaintiffs will simply assume, arguendo, that the regulation applies as fully1
to Schedule III controlled substances as to those under Schedule II.
2Case 2:09-cv-04095-BP Document 262 Filed 07/18/11 Page 2 of 6
or administered in accordance with “a standard of medical practice generally
recognized and accepted in the United States.” Moore, 423 U.S. at 139; United
States v. Smith, 573 F.3d 639, 646-49 (8th Cir. 2009); United States v. Armstrong,
550 F.3d 382, 399 (5th Cir. 2008). Otherwise stated, “[A] licensed practitioner is
not immune from the act solely due to his status, . . . but rather, because he is
expected to prescribe or dispense drugs within the bounds of his professional
practice of medicine.” United States v. Collier, 478 F.2d 268, 271-72 (5th Cir.
1973). From this principle flows the restriction that a non-registered supervisee
may not administer controlled substances unless permitted to do so by the
jurisdiction in which he or she practices. See Drug Enforcement Administration,
Office of Diversion Control, Practitioner’s Manual: An Informational Outline of
the Controlled Substances Act (2006) (available at http://www.deadiversion.usdoj.
gov/pubs/ manuals/pract/ pract_ manual 012508.pdf), at 28.
Missouri’s protocol fails these requirements. It involves a controlled
substance administered for a medical purpose – and yet in a manner that is utterly
foreign to accepted medical practice: a non-medical prison employee administers
sodium thiopental through an IV-push. Quite unlike the act of a nurse handing off
a pill, the IV-push of anesthesia is a highly specialized medical procedure in which
the practitioner must rely on clinically-acquired “visual and tactile cues” to ensure
that the drug is properly administered so that it actually sedates the patient. See
3Case 2:09-cv-04095-BP Document 262 Filed 07/18/11 Page 3 of 6
Plaintiffs’ Opposition Ex. D (Affidavit of Dr. Heath), at 5-6; Plaintiffs’ “Statement
of Additional Material Undisputed Facts” ¶¶ 11-15 (ECF Doc. 226, at pp. 7-9).
The protocol is a stark deviation from the accepted practice of administering
anesthesia, and Defendants present no evidence to the contrary. Id. We also know
that Missouri law does not permit an IV-push to performed even by Nurse M2,
much less by non-medical prison employees. And we know that the protocol2
departs from anesthesiologist M3’s own medical practice, in which anesthesia is
always administered by M3 himself or by the anesthesia specialists he is
supervising. See Plaintiffs’ Ex. 5 (also Def. Ex. 2) (M3 Depo.), at 81, 123.
Defendants, then, find no refuge in 21 C.F.R. § 1306.11(b), or in their
attempt to launder the administration of a controlled substance through an “agent”
whose very actions are anathema to the accepted practice of medicine. Finally,
even if their novel argument were somehow sufficient for compliance with the
CSA, it does not even mention the Food, Drug, and Cosmetic Act or its
independent preemptive effect. Plaintiffs remain entitled to summary judgment.
See Plaintiffs’ Ex. 3 (also Defendants’ Ex. 1) (M2 Depo.), at 162-63; 202
Mo. CSR § 2200-6.030(7)(G) (“Graduate practical nurses and licensed practical
nurses shall NOT, under any condition . . . [a]dminister drug(s) via the intravenous
push or intravenous bolus mode of delivery except when life-threatening
circumstances require such administration.”); Mo. Rev. Stat. §§ 334.104.2,
334.104.7, 334.402.1, 334.424.1; 20 Mo. CSR §§ 2150-9.040, 2200-4.200.3(G)(9)
(providing only for administration by anesthesiologist, a nurse anesthetist, or a
licensed anesthesiologist assistant, other than in dental or veterinary settings).
4Case 2:09-cv-04095-BP Document 262 Filed 07/18/11 Page 4 of 6
Respectfully submitted,
/s/ Joseph W. Luby
Joseph W. Luby, Mo. 48951
Public Interest Litigation Clinic Jennifer Herndon, Mo. 37921
6155 Oak Street, Suite C 224 Hwy 67 North, # 122
Kansas City, MO 64113 Florissant, Mo 63031
816-363-2795 • FAX 816-363-2799 314-831-5531 • FAX 314-831-5645
Counsel for Plaintiff Winfield Counsel for Plaintiffs Nunley,
Ferguson, Clay, Nicklasson,
and Franklin
David Barron, Ky. Bar 90269 Michael J. Gorla, Mo. 26399
100 Fair Oaks Lane, Suite 301 720 Olive Street, Ste. 1630
Frankfort, KY 40601 St. Louis, MO 63139
502-564-3948 • FAX 502-564-3949 314-621-1617
Counsel for Plaintiffs Ringo, Bucklew, Counsel for Plaintiff Ferguson
Middleton, and Winfield
John William Simon, Mo. 34535 Christopher E. McGraugh, Mo 36301
Constitutional Advocacy, L.L.C. Leritz, Plunkert & Bruning
7413 Manchester Road, Suite 109 555 Washington Avenue, Suite 600
St. Louis, MO 63143 St. Louis, MO 63101
314-604-6982 • FAX 314-754-2605 314-231-9600 • FAX 314-231-9480
Counsel for Plaintiffs Bucklew, Counsel for Plaintiff Link
Middleton, and Michael Taylor
Cheryl Ann Pilate, Mo. 42266 Elizabeth Unger Carlyle, Mo. 41930
Rebecca L. Kurz, Mo. 40451 P.O. Box 30418
Morgan Pilate LLC Kansas City, MO 64112
142 North Cherry 816-525-6540 • FAX 866-764-1249
Olathe, KS 66061 Counsel for Plaintiffs Clay, Barnett,
913-829-6336 • FAX 913-829-6446 Clayton, and Leon Taylor
Counsel for Plaintiffs Bucklew, Middleton,
Ringo, and Smulls Eric W. Butts, Mo. 36184
720 Olive Street, Suite 1630
St. Louis, MO 63101
314-621-1617 • FAX 314-621-7448
Counsel for Plaintiffs Christeson
and Rousan
5Case 2:09-cv-04095-BP Document 262 Filed 07/18/11 Page 5 of 6
CERTIFICATE OF SERVICE
I hereby certify that a true and correct copy of the foregoing was forwarded
for transmission via Electronic Case Filing (ECF) this 18th day of July, 2011, to
Andrew W. Hassell, Michael J. Spillane, and Stephen D. Hawke, Office of the
Attorney General, P.O. Box 899, Jefferson City, Missouri 65101.
/s/ Joseph W. Luby
Joseph W. Luby
Counsel for Plaintiff John E. Winfield
6Case 2:09-cv-04095-BP Document 262 Filed 07/18/11 Page 6 of 6
