Holiday Cvs, L.L.C. v. Holder

839 F. Supp. 2d 145, 2012 WL 883123, 2012 U.S. Dist. LEXIS 35201
District Court, District of Columbia·Decided March 16, 2012·No. Civil Action No. 2012-0191·Published·Cited by 13 cases

Opinion

MEMORANDUM OPINION

REGGIE B. WALTON, District Judge.

The plaintiffs, 1 Holiday CVS, L.L.C., doing business at two of its pharmacies as CVS Pharmacy Numbers 219 and 5195, bring this action under the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 551-706 (2006), challenging two Orders to Show Cause and Immediately Suspend Registrations issued by the Drug Enforcement Administration (“DEA”) on February 2, 2012. Amended Complaint (“Am. Compl.”) ¶ 1. The case came before the Court on March 13, 2012, on (1) the Plaintiffs’ Motion to Strike or, in the Alternative to Cross Examine Affiant, and (2) the Plaintiffs’ Motion for a Preliminary Injunction. Both motions were opposed by the government. After carefully considering the parties’ submissions and the arguments made by counsel at the first hearing on the plaintiffs’ motions on March 2, 2012, and the second hearing on March 13, 2012, 2 the Court denied the plaintiffs’ motions at the *151 March 13, 2012 hearing. This memorandum opinion memorializes the oral rulings issued at that hearing and explains further the reasons for the Court’s denial of the plaintiffs’ motions.

I. Background

A. The Controlled Substances Act

The Controlled Substances Act (“CSA” or the “Act”) and its implementing regulations create restrictions on the distribution of controlled substances. See 21 U.S.C. §§ 801-971 (2006); 21 C.F.R. pts. 1300-1321 (2009). The Act authorizes the DEA to establish a registration program for manufacturers, distributors, and dispensers of controlled substances designed to prevent the diversion of legally produced controlled substances into the illicit market. See 21 U.S.C. §§ 821, 822. Any entity that seeks to become involved in the production or chain of distributing controlled substances must first register with the DEA. 21 U.S.C. § 822; 21 C.F.R. § 1301.11.

Under the DEA’s regulations, registered pharmacies must “provide effective controls and procedures to guard against theft and diversion of controlled substances.” 21 C.F.R. § 1301.71(a). And while “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner,” a “corresponding responsibility rests with the pharmacist who fills the prescription.” Id. § 1301.04(a). Pharmacies are therefore required to ensure that prescriptions for controlled substances are “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Id.

The DEA has authority to revoke or suspend a registration it has issued for a variety of reasons, including on the grounds that a registrant “has committed such acts as would render his [or its] registration ... inconsistent with the public interest.” 21 U.S.C. § 824(a)(4). Generally, before suspending or revoking a registration, the DEA must issue an order to show cause containing its basis for the proceedings and provide an administrative hearing within 30 days. See id. § 824(c). DEA regulations direct that an “order to show cause shall ... contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.” 21 C.F.R. § 1301.37(c).

In cases where the DEA has reason to believe that a registrant’s continued operation would pose “an imminent danger to the public health or safety,” it can suspend that party’s registration immediately, prior to an administrative hearing, by issuing an immediate suspension order (“ISO”). See 21 U.S.C. § 824(d) (“The Attorney General [and the DEA Administrator by designation] may, in [her] discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where [she] finds that there is an imminent danger to the public health or safety.”). DEA regulations direct that “an order of immediate suspension ... shall contain a statement of [the Administrator’s] findings regarding the danger to public health or safety.” 21 C.F.R. § 1301.36(e). An immediate suspension order under § 824(d) remains “in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.” 21 U.S.C. § 824(d).

B. Factual and Procedural Background

Plaintiff Holiday CVS, L.C.C. is a subsidiary of CVS Caremark Corporation, which is the largest pharmacy health care *152 provider in the United States and is ranked twenty-first in the Fortune 500 list for 2011. Gov’t’s Opp’n at 30. At issue in this case are two CVS retail pharmacy stores located in Sanford, Florida (“CVS 219” and “CVS 5195”; collectively, the “CVS pharmacies”). Pis.’ Mem. at 6. The CVS pharmacies are registered to dispense Schedule II-V controlled substances, as classified by the CSA. Id. Neither pharmacy has previously been the subject of disciplinary action for failing to comply with the controlled substance laws. Id.

The DEA’s investigation of CVS 219 and CVS 5195 evolved from the agency’s investigation of the pharmacies’ main distributor, Cardinal Health, Inc. (“Cardinal”). 3 Gov’t’s Opp’n at 8. This investigation revealed that from January 1, 2008, to October 31, 2011, Cardinal’s distribution facility in Lakeland, Florida, sold over 12.8 million dosage units of oxycodone (a Schedule II drug) to its top four pharmacy customers. Id. Two of these top four customers were the CVS pharmacies. Id.

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Holiday Cvs, L.L.C. v. Holder, 839 F. Supp. 2d 145, 2012 WL 883123, 2012 U.S. Dist. LEXIS 35201 (D.D.C. 2012).

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