United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
ST. EVE, District Court Judge.
Stelmachowski has moved to dismiss Count One of the
Superseding Indictment. (R. 86, 99.) For the following
reasons, the Court denies his motion.
The Superseding Indictment
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.)
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).
The Food, Drug, and Cosmetic 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).
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).
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
Count One of the Superseding Indictment ...