U.S. v. Cap Quality Care, Inc., Civil No. 05-163-P-H.

Decision Date02 May 2007
Docket NumberCivil No. 05-163-P-H.
PartiesUNITED STATES of America, Plaintiff v. CAP QUALITY CARE, INC., Defendant.
CourtU.S. District Court — District of Maine
486 F.Supp.2d 47
UNITED STATES of America, Plaintiff
Civil No. 05-163-P-H.
United States District Court, D. Maine.
May 2, 2007.

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Evan J. Roth, Helene Kazanjian, U.S. Attorney's Office, Portland, ME, for Plaintiff.

George T. Dilworth, Michael A. Cunniff, Kimberly L. Murphy, McCloskey, Mina & Cunniff, LLC, Portland, ME, Jay P. McCloskey, McCloskey, Mina & Cunniff, LLC, Bangor, ME, for Defendant.


HORNBY, District Judge.

Can the government recover Title 21 civil penalties from a methadone maintenance clinic that dispenses methadone in split doses (half the dose under supervision at the clinic; the other half unsupervised at home) when the clinic has not followed the "time-in-treatment" regulations that the Secretary of Health and Human Services has adopted under Title 42 for takehome methadone treatment?

Following oral argument on March 15, 2007, I conclude that Title 21 civil penalties are available for the Title 42 regulatory violation. I therefore GRANT partial summary judgment (liability only) for the government on Count 4 of the Amended Complaint, contrary to the Magistrate Judge's recommendation. In all other respects, I ADOPT the Magistrate Judge's Recommended Decision on Motions for Partial Summary Judgment (Docket Item 163) ("Recommended Dec.").


The basic facts are undisputed for purposes of this ruling. Cap Quality Care Inc. ("CAP") is a methadone maintenance treatment clinic. Cap Quality Care's Additional Material Facts (Docket Item 144) ¶ 2 ("CAP Additional SMF"); Gov't Reply to CAP's Additional Statement of Fact (Docket Item 151) ¶ 2 ("Gov't's Additional Responsive SMF"). CAP uses methadone to treat patients who have been diagnosed with an opioid addiction. Id. CAP's position is that although most methadone patients require only one daily dosage of methadone, a single daily dose does not work well for patients who metabolize methadone rapidly. Id. ¶ 7. Accordingly, CAP has administered what it calls a "split-dose" to those patients: the patient ingests half the methadone dose at the clinic and takes the other half away from the clinic to, ingest later in the day outside the clinic setting. Id. ¶ 10. CAP admits that it did not follow the Title 42 time-intreatment regulations that govern unsupervised or take-home use, insisting instead that the "split-dose" is distinct from take-home or unsupervised use.1


The Controlled Substances Act states that any person who violates 21 U.S.C. § 829 is subject to a civil penalty of up to $25,000 per violation. 21 U.S.C.

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§ 842(a)(1), (c)(1)(A). Section 829 provides:

Except when dispensed directly by a practitioner ... to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 301 et seq.], may be dispensed without the written prescription of a practitioner. ...

21 U.S.C. § 829(a). The parties agree that methadone is a schedule II controlled substance prescription drug. CAP Additional SMF ¶ 4; Gov't's Additional Responsive SMF ¶ 4. The issue on the cross motions for summary judgment on Count 4 is whether CAP's "split-doses" of methadone fit into either of the two statutorily enumerated exceptions to liability: dispensing methadone pursuant to a practitioner's written prescription; or a practitioner dispensing directly to an ultimate user.


Magistrate Judge Cohen denied summary judgment to the government on Count 4 because the record did not establish whether CAP had used written prescriptions in dispensing the methadone. In response, the government argues that the use of written prescriptions would have been illegal, thus still resulting in civil penalties. In the alternative, the government requests permission to reopen the record to establish that there were no written prescriptions. CAP resists reopening the record. It does not assert that there were written prescriptions, but argues that if the record is reopened, the clinic should also be permitted to raise new factual issues. Def.'s Response to Pl.'s Partial Obj. to the Recommended Dec. (Docket Item 175) at 5.

The Title 21 regulations are clear on the illegality of written prescriptions for methadone used in detoxification or maintenance:

A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for "detoxification treatment" or "maintenance treatment" ....

21 C.F.R. § 1306.04(c)(2002).2 I conclude that the government, therefore, is correct on the law (prescriptions for methadone are illegal)3 and that there is no need to reopen the record. I reject the Magistrate Judge's recommendation that summary judgment on Count 4 should be denied for lack of record evidence regarding written prescriptions for methadone.


I therefore decide the question that Magistrate Judge Cohen did not address: do CAP's "split-doses" fit the other Section 829 exception to liability — a practitioner dispensing methadone directly to an ultimate

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user? I agree with the Magistrate Judge that CAP's "split-doses" of methadone violated the Title 42 regulations. I conclude that, as a result, CAP has violated 21 U.S.C. § 829 and is subject to civil penalties under 21 U.S.C. § 842. Because there appear to be no reported cases on the availability of Controlled Substances Act civil penalties for a violation of a Title 42 regulation (as the government admitted at oral argument), some elaboration is appropriate.

Section 829 of the Controlled Substances Act permits a Schedule II controlled substance such as methadone to be "dispensed directly by a practitioner ... to an ultimate user." 21 U.S.C. § 829. It defines "dispense" as "deliver a controlled substance to an ultimate user ... by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance ..." 21 U.S.C. § 802(10).4 It defines "practitioner" as "a physician licensed, registered or otherwise permitted ... to distribute, dispense, ... [or] administer ... a controlled substance in the course of professional practice. ..." Id. § 802(21) (emphasis added). According to the Supreme Court, "the scheme of the statute, viewed against the background of the legislative history, reveals an intent to limit a registered physician's dispensing authority to the course of his `professional practice.'" United States v. Moore, 423 U.S. 122, 140, 96 S.Ct. 335, 46 L.Ed.2d 333 (1975) (emphasis added). Defining the scope of the limitation, therefore, is critical. The Supreme Court said that in the Controlled Substances Act, Congress "understandably was concerned that the drug laws not impede legitimate research and that physicians be allowed reasonable discretion in treating patients and testing new theories." Id. at 143. According to the Court, Congress's solution to that concern is found in 42 U.S.C. § 290bb-2a:5

That section requires the Secretary of [Health and Human Services], after consultation with the Attorney General and national addict treatment organizations, to "determine the appropriate methods of professional practice in the medical treatment of ... narcotic addiction...." It was designed "to clarify for the medical profession" ... the extent to which they may safely go in treating narcotic addicts as patients.... Under the new Act, "(t)hose physicians who comply with the recommendations made by the Secretary will no longer jeopardize their professional careers...." The negative implication is that physicians who go beyond approved practice remain subject to serious criminal penalties. In the case of methadone treatment the limits of approved practice are particularly clear.

Moore, 423 U.S. at 144, 96 S.Ct. 335 (1975) (emphasis added). Accord United States v. Badia, 490 F.2d 296, 298 (1st Cir.1973) ("[t]he combined effect of these statutory definitions in the present context is to limit the meaning of `dispense' to delivery of controlled substances by a physician who is acting in the course of professional practice or research") (emphasis added). Moore was a criminal case, but that distinction was immaterial to the Supreme Court's analysis:

[W]e think it immaterial whether Dr. Moore also could have been prosecuted for his violation of statutory provisions

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relating to dispensing procedures. There is nothing in the statutory scheme or the legislative history that justifies a conclusion that a registrant who may be prosecuted for the relatively minor offense of violating § 829 [the violation the government has charged in the current proceeding against CAP] is thereby exempted from...

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