. Congress explicitly found that “the illegal importation, manufacture, distribution and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.” 21 U.S.C § 801(2). In enacting the CSA, Congress “devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.”

Counsel for H.D. Smith briefed the 8 2:08-cv-11564-DML-MKM Doc # 173 Filed 04/12/12 Pg 15 of 21 Pg ID 2514 "willful blindness" issue and then successfully defended H.D. Smith under the more exacting willful blindness standard as set forth in Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. (2011). Moreover, given the Government's trial strategy, the issues presented relative to that determination involved a comprehensive understanding of the regulatory framework (Controlled Substances Act, 21 U.S.C. § 801 et. seq. and the regulations promulgated there under) governing H.D. Smith's obligations as a licensed national wholesaler of pharmaceuticals.

2 Plaintiffs also seek to rely on Touby v. United States, 500 U.S. 160 (1991), but that decision, if anything, supports the Government. In Touby, the Supreme Court rejected the argument that the Controlled Substances Act, 21 U.S.C. § 801 et seq., had unconstitutionally delegated authority to the Attorney General to temporarily designate drugs as “controlled substances,” subject to the statute’s five “schedules” of regulation—even though Congress had authorized the Attorney General to do so “determined” that a new explosive should be covered; he could always decline to make such a formal determination with respect to a particular explosive, thus keeping it outside the statute’s coverage indefinitely. The scope of the delegated authority at issue in Womack, in reality, is thus on all fours with the authority delegated to the FDA in 21 U.S.C. § 387a(b).

The Complaint purports to assert two claims against the Distributor Defendant—unjust enrichment and parens patriae. Both claims relate solely to the Distributor Defendant’s alleged failure to “report suspicious orders of opioids” in violation of the Controlled Substances Act, 21 U.S.C. § 801 et seq. (the “CSA”), and settlement agreements between the Distributor Defendant and the U.S. Department of Justice regarding CSA compliance. (Compl.

Gonzales, 545 U.S. at 22. “Given the enforcement difficulties that attend distinguishing between marijuana cultivated locally and marijuana grown elsewhere, 21 U.S.C. § 801(5), and concerns about diversion into illicit channels, we have no difficulty concluding that Congress had a rational basis for believing that failure to regulate the intrastate manufacture and possession of marijuana would leave a gaping hole in the CSA.” Id.

United States v. Funds in the Amount of Thirty Thousand Six Hundred Seventy Dollars, 403 F.3d 448, 455 (7th Cir.2005). III. STATEMENT OF LAW AND ARGUMENT The Government has not proven, and in fact cannot prove by a preponderance of evidence, that the defendant property was “furnished or intended to be furnished by a person in exchange for a controlled substance, or [constitutes] proceeds traceable to such an exchange, or property used to facilitate a violation of 21 U.S.C. § 801 et seq.” Compl. ¶ 7.

CR 14-380 (CRB) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 prescribers and dispensers are required to register with the DEA, and registrants’ activities are governed by a detailed series of regulations. See 21 U.S.C. §§ 801 et seq.; 21 C.F.R. §§ 1300.01 et seq.

DEA established through the Declaration of Katherine L. Myrick that the documents containing this information were compiled for law enforcement purposes and thus meet the threshold requirement of FOIA Exemption 7. The declaration establishes that all of the responsive documents processed in response to EPIC’s FOIA request were compiled for law enforcement purposes, specifically, DEA’s enforcement of the Controlled Substances Act, 21 U.S.C. §§ 801–971. Def.

DEA established through the Declaration of Katherine L. Myrick that the documents containing this information were compiled for law enforcement purposes and thus meet the threshold requirement of FOIA Exemption 7. The declaration establishes that all of the responsive documents processed in response to EPIC’s FOIA request were compiled for law enforcement purposes, specifically, DEA’s enforcement of the Controlled Substances Act, 21 U.S.C. §§ 801–971. Def.

3 Motion for Bill of Particulars No. CR 14-380 (CRB) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 III. FACTS A. FedEx, a Common Carrier The distribution of controlled substances by manufacturers, wholesalers, prescribers and dispensers is regulated by the Drug Enforcement Administration (“DEA”) as part of a “closed system” under the Controlled Substances Act (“CSA”), 21 U.S.C. § 801 et seq. See H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N. at 4566; 116 Cong. Rec. 977-78.