United States v. Williams
| Decision Date | 14 September 2011 |
| Docket Number | NO. CR-10-216-HE,CR-10-216-HE |
| Parties | UNITED STATES OF AMERICA, Plaintiff, v. ZACHARY WILLIAMS, MICHAEL A. FELS, SHARON L. DREW and HEALTH SOLUTIONS NETWORK, LLC, Defendants. |
| Court | U.S. District Court — Western District of Oklahoma |
Defendants Michael A. Fels and Sharon L. Drew are charged in a six count superseding indictment with violations of the Controlled Substances Act ("CSA"), 21 U.S.C. §§ 801-904, and the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-397. Defendants filed a motion to dismiss the indictment on the grounds it fails to state an offense and the court lacks subject matter jurisdiction. In a reply brief defendants assert an additional basis for the dismissal of Counts 1 and 3-6 - lack of fair warning.
The superseding indictment alleges that defendants Williams, Fels and Drew operated White Eagle RX ("White Eagle"), a pharmacy without a valid license, filling prescriptions for internet websites such as Health Solutions Network, LLC ("HSN").1 Count 1 charges all four defendants with conspiring to deliver, distribute and dispense fioricet, a controlled substance, by means of the internet in violation of 21 U.S.C. § 841(h)(1)(A). Count 2charges all defendants with conspiring to hold misbranded drugs for sale and to introduce misbranded drugs, specifically fioricet, a controlled prescription drug, and soma and tramadol, prescription drugs, into interstate commerce in violation of 12 U.S.C. §§ 331(a), (k) and 333(a)(2).2 Counts 3-6 charge all defendants with distributing Fioricet, a Schedule III controlled substance.3
Defendants Fels and Drew contend that Counts 1, 3-6 and the forfeiture count should be dismissed because Fioricet is not a controlled substance under the CSA and that Count 2 should be dismissed because Fioricet, Soma and Tramadol were dispensed "under a valid pharmacy license issued by the Ponca Nation Tribe." Defendants' motion, p. 2. They also argue that they are exempt from prosecution with respect to all charges as they are entitled to share in the sovereign immunity of the Ponca Nation as the agents of a tribal owned business.
Fioricet is a combination drug containing a Schedule III controlled substance.4 The Attorney General may "exempt any compound, mixture, or preparation containing a controlled substance from the application of all or any part" of Subchapter I of the CSA. 21 U.S.C. § 811(g). By regulation Fioricet has been designated an "exempted prescriptionproduct." 21 C.F.R. § 1308.32. The court previously considered the effect of that designation and concluded that because the exemption was "for administrative purposes only," the drug was not exempt from the application of Part D - Offenses and Penalties -of Subchapter I of the CSA (sections 401-422(a) of the Act). Having carefully considered defendants' arguments and evidentiary submissions, the court is not persuaded its initial determination was erroneous. Therefore, defendants are not entitled to dismissal of Counts 1 and 3-6 on the ground Fioricet is not a Schedule III controlled drug.
Citing Breakthrough Mgmt. Group, Inc. v. Chukchansi Gold Casino & Resort, 629 F.3d 1173 (10th Cir 2010) defendants claim that, as agents of White Eagle, a business owned by the Ponca Tribe, they are entitled to share in the tribe's sovereign immunity and avoid prosecution for all charges.
Defendants are not charged under any statute that is directed to Indian country, Indian tribes, or individual Indians or to situations or status unique to those circumstances. Rather, they are charged under various federal statutes of general applicability which, by their terms, apply to all persons coming within their scope. The statutes underlying the conspiracy and distributions charges are silent regarding their application to Indians or tribal entities. When a federal law of general applicability is silent on the issue of its applicability to an Indian tribe or to individual Indians, the law applies equally to Indians except where (1) the law touches "exclusive rights of self-governance in purely intramural-matters", (2) the application of the law to the tribe would "abrogate rights guaranteed by Indian treaties", or(3) there is proof "by legislative history or some other means that Congress intended [the law] not to apply to Indians on their reservations...." United States v. Fox, 573 F.3d 1050, 1052 (10th Cir. 2009), quoting Nero v. Cherokee Nation of Oklahoma, 892 F.2d 1457, 1462-63 (10th Cir. 1989), cert. denied, ____ U.S. ____ (2009). See generally United States. v. Bruce, 394 F.3d 1215, 1220 (9th Cir. 2005) (). Here, none of the grounds for exception are present. The licensing or operation of an internet pharmacy is not a matter of internal self-governance. There is no suggestion that a treaty gives the Ponca Tribe the authority to operate an internet pharmacy outside the application of the general criminal laws. And no basis has been suggested for a conclusion that Congress did not intend for these statutes to apply to Indians or Indian tribes. Indeed, the various provisions of Title 21 plainly suggest the contrary. 21 U.S.C. § 841(h) prohibits the distribution of controlled substances "except as authorized by this subchapter...." The subchapter does not include anything that suggests a general exception for Indian tribes or their agents. The subchapter does, however, include 21 U.S.C. § 831, which sets additional requirements for online pharmacies. The definitions applicable to the subchapter contain an exception from the definition of "online pharmacy" for Indian tribes in certain limited circumstances — involving health care facilities operated by a Tribe or tribal organization pursuant to aparticular act of Congress5 — but no other. 21 U.S.C. § 802(52)(B)(iv). Plainly, Congress knew how to carve out an exception for matters related to Indian tribes when it wanted to, but it did not do so as to the circumstances embraced by the indictment in this case.
Breakthrough, the case defendants rely on, is not to the contrary and is inapplicable. It is a civil case and has nothing to do with the reach of federal criminal laws of general applicability. Defendants are not entitled to have the charges dismissed on the basis of the Ponca Tribe's sovereign immunity.
Defendants Fels and Drew argue that the misbranding charge (Count 2) fails because White Eagle Rx held a valid pharmacy license issued by the Ponca Tribe.6 Defendants assert that the legal impact of the Ponca Pharmacy Act and the validity of the license present questions of law, not fact.
The superseding indictment charges defendants with engaging in a conspiracy to violate 21 U.S.C. § 331(a) and (k) by introducing misbranded drugs into interstate commerce and holding misbranded drugs for sale. "A drug is 'misbranded' unless dispensed upon a "'prescription of a practitioner licensed by law to administer such drug.'" United States v. Smith, 573 F.3d 639, 650 (8th Cir. 2009) (quoting 21 U.S.C. § 353(b)(1)(C)).7 Count 2alleges that the medications White Eagle mailed to customers were misbranded not just because the pharmacy was not properly licensed, but also because the drugs were not "dispensed pursuant to a valid prescription." Superseding Indictment, p. 4. A valid prescription requires a bona fide physician-patient relationship, id. at 652, and the superseding indictment alleges that "[t]he prescriptions were written by ... physicians who did not see or examine the customer." Superseding Indictment, p. 3. See United States v. Nazir, 211 F.Supp.2d 1372, 1375 (S.D.Fla. 2002) (). Therefore, even if White Eagle had a valid license, Count 2 nonetheless states a misbranding offense based on the alleged invalid prescriptions.
Defendants assert that, if the court concludes Fioricet is a controlled substance, their prosecution under the CSA is precluded because they were not provided fair warning that their alleged conduct was unlawful. They also claim that, because of the "DEA"s unequivocal position that Fioricet is not a controlled substance," defendants' reply, p. 6, the government should be equitably estopped from criminally prosecuting them.
"[T]he Due Process Clause demands that criminal statutes describe each particular offense with sufficient definiteness to 'give a person of ordinary intelligence fair notice that his contemplated conduct is forbidden.'" United States v. Hussein, 351 F.3d 9, 13 (1st Cir. 2003) (quoting United States v. Harriss, 347 U.S. 612, 617 (1954)). In urging the court to apply the fair-warning doctrine to the fioricet-related offenses, defendants rely heavily on United States v. Caseer, 399 F.3d 828 (6th Cir. 2005). The defendant in that case was convicted of conspiring to import, and aiding and abetting the importation of, cathinone. He appealed his conviction, claiming that the controlled substances schedules in 21 U.S.C. § 812 and 21 C.F.R. § 1308.11(f) failed to adequately put him on notice that possession of khat, a plant containing cathinone, was illegal. The Sixth Circuit noted that, while the federal regulations made it clear that cathinone is a controlled substance, neither...
To continue reading
Request your trial