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United States v. Stelmachowski

United States District Court, N.D. Illinois, Eastern Division

February 12, 2018



          AMY J. ST. EVE, District Court Judge.

         Defendant Stelmachowski has moved to dismiss Count One of the Superseding Indictment. (R. 86, 99.) For the following reasons, the Court denies his motion.


         I. The Superseding Indictment

         On November 16, 2017, a grand jury returned a twenty-five-count Superseding Indictment against David Stelmachowski and William Mikaitis. (R. 80.) According to Count One, under the Federal Food, Drug, and Cosmetic Act (the “Act”), “dispensing a prescription drug without a valid prescription by a licensed practitioner was deemed to be an act that resulted in the drug being misbranded while held for sale.” (Id. at 2.) Count One charges that Mikaitis, a physician, and Stelmachowski conspired to commit an offense against the United States in violation of 18 U.S.C. § 371 by dispensing or causing to be dispensed “prescription drugs without a valid prescription, ” in turn causing said drugs to be “misbranded” in violation of 21 U.S.C. §§ 353(b)(1), 331(k), and 333(a)(2), sections of the Act. (Id. at 3, 26.)

         Count One, in more detail, charges that Mikaitis issued over 620 prescriptions to Stelmachowski and an unnamed individual for Oxycodone, OxyContin, and Amphetamine Salt Combo, or Adderall, all of which are Schedule II Controlled Substances. (Id. at 1-3.) It alleges that Mikaitis wrote these prescriptions “without performing a thorough physical examination or ordering medical tests” on Stelmachowski, and without “monitor[ing]” Stelmachowski's and the unnamed individual's use of the drugs. (Id. at 3-4.) Count One charges as overt acts hundreds of instances, over the course of three years, in which Stelmachowski “filled and caused to be filled” a prescription written by Mikaitis. (Id. at 4-26.) In total, Count One charges, Stelmachowski filled prescriptions for approximately 37, 000 pills or tablets of the drugs. (Id. at 3). Count One also alleges that Stelmachowski filled those prescriptions “at 80 different Chicago-area pharmacy locations to avoid attracting undue attention to the number of prescriptions and pills prescribed by” Mikaitis. (Id. at 3.) Stelmachowski and Mikaitis did this, according to Count One, with “intent to defraud or mislead, ” in violation of Section 333(a). (Id.) The Superseding Indictment further alleges that Stelmachowski and Mikaitis's conduct constituted violations of the Controlled Substances Act. Specifically, it charges that Stelmachowski and Mikaitis conspired to acquire controlled substances by “misrepresentation, fraud, and deception” in violation of 21 U.S.C. § 846 (Count Two) (id. at 27); that Mikaitis “knowingly and intentionally distribute[d] a controlled substance . . . outside the usual course of professional practice and without legitimate medical purpose” in violation of 21 U.S.C. § 841(a) (Counts Three through Ten and Counts Nineteen through Twenty-Five) (id. at 28, 30); and that Stelmachowski “knowingly and intentionally possess[ed] with the intent to distribute a controlled substance” also in violation of 21 U.S.C. § 841(a) (Counts Eleven through Eighteen) (id. at 29).

         II. The Food, Drug, and Cosmetic Act

         The Act prohibits the misbranding of prescription drugs. That prohibition, as it is relevant to this case, lies in two provisions of the Act-Sections 353(b)(1) and 331(k) (together, the “Misbranding Statutes”). Section 353(b)(1) states that any prescription drug or drug “not safe for use except under the supervision of a practitioner” (a “covered drug”):

shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

21 U.S.C. § 353(b)(1). Section 353(b)(1) therefore protects the dispensing of a covered drug upon a “prescription” or a refilling upon “authorization”-but otherwise, “[t]he act of dispensing a [covered] drug” is “an act which results in the drug being misbranded while held for sale.” Id. While Section 353(b)(1) describes conduct that causes a drug to be misbranded, Section 331(k) criminalizes such conduct. It prohibits “any . . . act” to a drug that “results in such an article being . . . misbranded.” 21 U.S.C. § 331(k). The Act also provides that any person who violates Section 331 “with the intent to defraud or mislead” faces three years imprisonment and a fine of no more than $10, 000. 21 U.S.C. § 333(a)(2).


         A defendant may “raise by pretrial motion any defense, objection, or request that the court can determine without a trial on the merits.” Fed. R. Crim. P. 12(b)(1); see also Fed. R. Crim. P. 12(b)(3)(A)(v) (requiring motions regarding “an error in the grand-jury proceeding” to be filed via pretrial motion); Fed. R. Crim. P. 12(b)(3)(B)(v) (requiring the same for motions regarding an indictment's “failure to state an offense”). When considering a motion to dismiss, a court must view all allegations as true and in the light most favorable to the government. See United States v. Yashar, 166 F.3d 873, 880 (7th Cir. 1999); United States v. Moore, 563 F.3d 583, 586 (7th Cir. 2009). A court must also review indictments “on a practical basis and in their entirety, rather than in a hypertechnical manner.” United States v. Cox, 536 F.3d 723, 726 (7th Cir. 2008).


         Defendant Stelmachowski argues that the Court should dismiss Count One, which alleges a conspiracy to violate the Misbranding Statutes, for three alternative reasons: (1) because it fails to state a claim; (2) because the government erred in instructing the grand jury on what “prescription” means under Section 353(b)(1); and (3) because the Misbranding Statutes are unconstitutionally vague. Each argument, however, rests on the same predicate contention-that “prescription, ” as that term is used in Section 353(b)(1), should include the more than 620 alleged prescriptions written by Mikaitis, prescriptions which, according to the Superseding Indictment, were fraudulent and facilitated a drug conspiracy. The Court disagrees.

         I. Count One of the Superseding Indictment ...

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