United States v. Stelmachowski

Decision Date12 February 2018
Docket NumberCase No. 15 CR 339-1
PartiesUNITED STATES OF AMERICA v. DAVID STELMACHOWSKI
CourtU.S. District Court — Northern District of Illinois

Hon. Amy J. St. Eve

MEMORANDUM OPINION AND ORDER

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.

BACKGROUND
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 ActSections 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).

LEGAL STANDARD

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 theirentirety, rather than in a hypertechnical manner." United States v. Cox, 536 F.3d 723, 726 (7th Cir. 2008).

ANALYSIS

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 Sufficiently States a Claim

Defendant Stelmachowski first submits that Count One fails to state a claim. Federal Rule of Criminal Procedure 12(b)(3)(B) allows a defendant to make a pretrial motion that challenges the sufficiency of the indictment. See United States v. Boender, 691 F. Supp. 2d 833, 837 (N.D. Ill. 2010). A defendant may challenge the indictment's sufficiency by arguing that it fails to state an offense. Fed. R. Crim. P. 12(b)(3)(B)(v). Federal Rule of Criminal Procedure 7(c)(1) requires an indictment to "be a plain, concise, and definite written statement of the essential facts constituting the offense charged." Fed. R. Crim. P. 7(c)(1).

The Seventh Circuit has explained that an indictment is sufficient where it (1) states the elements of the crimes charged, (2) adequately informs the defendant of the nature of the charges brought against him, and (3) enables the defendant to assert the judgment as a bar to future prosecutions for the same offense. See United States v. Vaughn, 722 F.3d 918, 925 (7th Cir.2013); see also United States v. Gerebizza, --- Fed. Appx. ---, 2017 WL 6540505, at *3 (7th Cir. Dec. 21, 2017) (stating the same standard). "To successfully challenge the sufficiency of an indictment, a defendant must demonstrate that the indictment did not satisfy one or more of the required elements and that he suffered prejudice from the alleged deficiency." Vaughn, 722 F.3d at 925; see also United States v. Castaldi, 547 F.3d 699, 703 (7th Cir. 2008). A court may dismiss an indictment, or a portion of one, if its allegations do not state a violation of the governing statute. See United States v. Hollnagel, No. 10 CR 00195, 2011 WL 3664885, at *8 (N.D. Ill. Aug. 19, 2001) (citing United States v. Risk, 843 F.2d 1059, 1061 (7th Cir. 1988)).

In this case, Stelmachowski argues that because Section 353(b)(1) protects the dispensing of a covered drug pursuant to a "prescription," and because the Superseding Indictment states that he had prescriptions—albeit allegedly fraudulent ones—for the transactions at issue, Count One does not state a claim. The issue before the Court thus turns on the definition of "prescription" under the Act, and more precisely, whether the allegedly fraudulent prescriptions described in the Superseding Indictment fall under that definition.

A. The plain language and ordinary meaning of "prescription" exclude the fraudulent prescriptions alleged in the Superseding Indictment

"The cardinal rule of statutory interpretation is that courts must first look to the language of the statute and assume that its plain meaning accurately expresses the legislative purpose." United States v. Miscellaneous Firearms, Explosives, Destructive Devices & Ammunition, 376 F.3d 709, 712 (7th Cir. 2004); accord United States v. Turner, 836 F.3d 849, 861 (7th Cir. 2016) ("We start by examining the language of the statute and regulations underlying [the] offense."). The relevant language of Section 353(b)(1) states that a covered drug "shall be dispensed only (i) upon a written prescription of a practitioner licensed by law toadminister such a drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist . . . ." 21 U.S.C. § 353(b)(1)(B).

As an initial matter, Stelmachowski submits that Congress gave "extensive definition" to "prescription" within Section 353(b)(1) itself, and because that "extensive definition" did not...

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