Sixth Circuit clarifies post-Ruan mens rea and upholds deliberate-ignorance instructions for pharmacists under § 841

Commentary on United States v. Hasna Bashir Iwas, No. 24-1234 (6th Cir. Oct. 20, 2025) (not recommended for publication)

Introduction

In this unpublished opinion, the U.S. Court of Appeals for the Sixth Circuit affirmed the conviction of a Michigan pharmacist, Hasna Bashir Iwas, for conspiracy and unlawful distribution of controlled substances under 21 U.S.C. § 841. The appeal centered on jury-instruction challenges: (1) whether the district court abused its discretion by giving a deliberate-ignorance (willful blindness) instruction; (2) whether, after the Supreme Court’s decision in Ruan v. United States, 597 U.S. 450 (2022), the elements instruction adequately captured the required mens rea for a § 841 pharmacist prosecution; and (3) whether references to “pharmacy” in defining the “usual course of professional practice” improperly expanded criminal liability to purely pharmacy-standards violations.

The case arose from a multi-year scheme in which Iwas, owner of Beacon Pointe Pharmacy, filled nearly 1,300 forged prescriptions connected to a single organizer, Rochelle Edwards. The record contained extensive “red flags” (patients using an abandoned house address, prescriptions for the deceased or incarcerated, inconsistent insurer/cash payments, and verification notes contradicted by prescriber testimony), additional concerns about prescriptions from Dr. Otis Crawford, and a DEA audit showing tens of thousands of missing controlled pills. The jury convicted Iwas on twenty-three unlawful-distribution counts, two aiding-and-abetting counts, and one conspiracy count (she was acquitted of maintaining a drug-involved premises). The district court imposed a 100-month sentence.

Summary of the Opinion

The Sixth Circuit affirmed. First, it held that the deliberate-ignorance instruction was warranted by the evidentiary record and, even applying the more defense-favorable abuse-of-discretion standard, there was no error. Second, reviewing for plain error the unpreserved challenge to the § 841 elements instruction, the court concluded the charge “as a whole” satisfied Ruan’s requirement that the government prove the defendant “knowingly or intentionally acted in an unauthorized manner.” The panel relied on prior Sixth Circuit decisions upholding similar instructions, emphasizing the instruction’s juxtaposition of “knowledge” against negligence/carelessness and its use of a deliberate-ignorance instruction to ensure the jury focused on the defendant’s subjective mindset. Third, the court rejected the argument that including “pharmacy” in defining “usual course of professional practice” misdirected the jury; read together, the instructions anchored “unauthorized” to whether the prescription was “issued” by the prescriber for a legitimate medical purpose in the prescriber’s usual course of professional practice, while acknowledging a pharmacist’s “corresponding responsibility” not to fill an unauthorized prescription.

Analysis

Precedents Cited and Their Role

• Ruan v. United States, 597 U.S. 450 (2022): Ruan held that § 841’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause. Thus, the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. Though Ruan addressed physicians, its logic governs healthcare practitioners charged under § 841, including pharmacists. The Iwas panel applied Ruan by examining whether the jury was adequately instructed to find that Iwas knew the prescriptions were not authorized.
• United States v. Anderson, 67 F.4th 755 (6th Cir. 2023): Post-Ruan, Anderson approved a jury charge that:
  • Explicitly required knowledge/intent as to the lack of authorization,
  • Directed the jury to the defendant’s subjective mindset, and
  • Juxtaposed knowledge against “carelessness, negligence, or foolishness,” using a deliberate-ignorance instruction to avoid diluting the mens rea.
  The Iwas court extended Anderson’s reasoning to a pharmacist, treating the same instructional architecture as sufficient for § 841 pharmacist prosecutions.
• United States v. Bauer, 82 F.4th 522 (6th Cir. 2023), and United States v. Stanton, 103 F.4th 1204 (6th Cir. 2024): These cases reinforce Anderson’s approach, recognizing that instructions are adequate when they properly contrast knowledge with lesser culpability and focus on subjective awareness of authorization.
• Deliberate ignorance cases: The panel cited United States v. Geisen, 612 F.3d 471 (6th Cir. 2010), United States v. Gullett, 713 F.2d 1203 (6th Cir. 1983), and United States v. Mitchell, 681 F.3d 867 (6th Cir. 2012), for the principle that a deliberate-ignorance instruction is proper when supported by evidence permitting an inference that the defendant intentionally avoided learning the truth. The court also noted United States v. Daneshvar, 925 F.3d 766 (6th Cir. 2019), which has held that an unsupported deliberate-ignorance instruction can be harmless error; while Iwas asked the court to revisit that rule, the panel declined, both because the instruction was supported here and because only the Supreme Court or the en banc Sixth Circuit can overrule circuit precedent (Post v. Trinity Health-Mich., 44 F.4th 572, 580–81 (6th Cir. 2022)).
• Standards of review: For unpreserved instructional challenges, the court applied plain-error review consistent with United States v. Xiaorong You, 74 F.4th 378 (6th Cir. 2023), and characterized the “grave miscarriage of justice” threshold with citations to United States v. Hofstetter, 80 F.4th 725, 730 (6th Cir. 2023) (quoting United States v. Stewart, 729 F.3d 517, 530 (6th Cir. 2013)).
• Regulatory backdrop: The district court drew language from 21 C.F.R. § 1306.04(a) regarding “legitimate medical purpose” and “usual course of professional practice,” and the pharmacist’s “corresponding responsibility.” On appeal, Iwas abandoned a separation-of-powers objection to the use of regulatory language.

Legal Reasoning

1) Deliberate-ignorance instruction

The court concluded that the evidence “reasonably raised” deliberate ignorance. Key facts included:

• Repeated forged-prescription “red flags” on their face (fuzzy logos, inconsistent fonts/colors, off-center text),
• Conflicting contact information where the pharmacy system had the correct prescriber phone numbers but Iwas claimed to verify using numbers printed on suspect prescriptions—a practice the court characterized as illogical where the suspect document could contain a fake number,
• Handwritten notes indicating verification that prescribers directly contradicted at trial,
• Video evidence of labels being removed or shredded before delivery to Ms. Edwards or her associate,
• Evidence of cash payments despite known insurance coverage and a MAPS query for “Patient paying cash … when they are insured,”
• DEA audit showing large quantities of missing controlled pills with no adequate explanation.

Against Iwas’s testimony that she was merely too busy to notice red flags, the panel held that the evidence supported an inference that she deliberately closed her eyes to an obvious risk of illegitimacy. On these facts, the instruction guarded against a defendant “escaping conviction merely by deliberately closing [her] eyes to the obvious risk” of unlawful conduct.

2) Mens rea for § 841(a)(1) after Ruan

Ruan requires proof that the defendant “knowingly or intentionally acted in an unauthorized manner.” The court examined the instructions “as a whole.” Two aspects were dispositive:

• The elements required the jury to find not only that Iwas knowingly distributed controlled substances, but also that:
  • “the particular prescription was unauthorized, that is, not issued for a legitimate medical purpose in the usual course of professional practice,” and
  • “the defendant knowingly or intentionally distributed an unauthorized prescription.”
  By tying “knowledge” to the unauthorized nature of the prescription, the charge aligned with Ruan’s directive.
• The court defined “knowingly” and contrasted it with “carelessness, negligence, incompetence, or foolishness,” while adding a deliberate-ignorance instruction—mirroring the approach approved in Anderson. Thus, the instructions directed jurors to assess Iwas’s subjective awareness of authorization and avoided convicting on mere negligence.

Because Iwas did not specifically object at trial to the Ruan mens rea formulation, the court reviewed for plain error and found none—indeed, the charge would have passed muster even under abuse-of-discretion review given Anderson, Bauer, and Stanton.

3) “Usual course of professional practice” and the role of the pharmacist

Iwas argued that the definition of “usual course of professional practice” improperly included “pharmacy,” potentially allowing conviction based solely on pharmacy-standards violations. The panel avoided deciding whether violating pharmacy standards alone could support a § 841 conviction. Instead, it held that, read in context, the instructions linked “authorization” to the prescriber’s conduct:

• The elements defined “unauthorized” as a prescription “not issued for a legitimate medical purpose in the usual course of professional practice.” Because only prescribers “issue” prescriptions, the phrase anchored “usual course” to the prescriber.
• The instruction immediately preceding the definition reiterated that a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice,” while acknowledging a pharmacist’s “corresponding responsibility … to not fill an unauthorized prescription.”
• The definitional paragraph itself closed by focusing on “when the doctor acts contrary to what a legitimate doctor would do,” further signaling the prescriber-centric nature of “authorization.”

Accordingly, the court found no clear error: the jury could not have convicted Iwas based solely on pharmacy-practice deviations without finding the prescriptions were not properly issued by the prescriber.

Impact

Although unpublished, the decision tracks and applies binding Sixth Circuit precedent and is likely to influence district courts within the circuit in pharmacist prosecutions under § 841. Practical implications include:

• Instructional templates post-Ruan for pharmacists: Courts can safely:
  • Define “unauthorized” via 21 C.F.R. § 1306.04(a)’s “legitimate medical purpose” and “usual course” language,
  • Explicitly require knowledge that the prescriptions were unauthorized,
  • Contrast knowledge with negligence and include a well-framed deliberate-ignorance instruction when supported by evidence.
• Evidence sufficiency for deliberate ignorance: Patterns of obvious red flags—fake identifiers, inconsistent contact data where the pharmacy system contains correct prescriber information, questionable cash transactions despite insurance, destruction/removal of labels, and unexplained inventory losses—can justify a willful-blindness instruction against a pharmacist.
• Preserver error or lose it: The opinion underscores the high hurdle of plain-error review for instructional challenges. Parties must make specific, grounded objections. General disagreement that “the parties dispute the instruction” will not preserve a Ruan-based mens rea argument.
• Unresolved question flagged but not decided: Whether a pharmacist’s independent violation of pharmacy professional standards (absent an unauthorized prescription by the prescriber) could, standing alone, sustain a § 841 conviction remains open. The panel avoided that question by construing the charge to require a finding of prescriber-issued illegitimacy.
• Consistency with Anderson/Bauer/Stanton: Iwas confirms the Sixth Circuit’s post-Ruan trajectory: instructions are adequate when they direct jurors to the defendant’s subjective knowledge that prescribing/dispensing was not “authorized,” and when they explicitly distinguish knowledge from negligence.

Complex Concepts Simplified

• “Except as authorized” under § 841: It is a crime to distribute/dispense controlled substances unless the conduct is “authorized” by the Controlled Substances Act and its regulations. For prescriptions, authorization generally depends on whether the prescription was issued by a prescriber for a legitimate medical purpose in the prescriber’s usual course of professional practice.
• Ruan’s mens rea rule: The government must prove the defendant knew or intended that their conduct was “unauthorized.” It is not enough that the defendant intentionally dispensed a controlled substance; they must also know it was not validly authorized.
• Deliberate ignorance (willful blindness): If a defendant suspects a high probability of illegality but deliberately avoids confirming it, the jury may treat that as knowledge. This is not mere negligence; it requires conscious avoidance.
• “Legitimate medical purpose” and “usual course of professional practice”: Regulatory terms (21 C.F.R. § 1306.04(a)) that anchor whether a prescription is “authorized.” They are generally applied to the prescriber’s actions in issuing a prescription. A pharmacist has a “corresponding responsibility” not to fill prescriptions they recognize as unauthorized.
• Standards of review:
  • Abuse of discretion: Deferential review of discretionary trial-court rulings (e.g., whether evidence supported a deliberate-ignorance instruction).
  • Plain error: For unpreserved objections, the appellant must show a clear or obvious error that affected substantial rights and seriously affected the fairness, integrity, or public reputation of judicial proceedings. It is a stringent standard.
• “Not recommended for publication”: The decision is not precedential under circuit rules, but it reflects and applies binding precedent, and can be persuasive in similar cases.

Conclusion

United States v. Iwas reinforces the Sixth Circuit’s post-Ruan instructional framework for § 841 prosecutions involving healthcare professionals, now expressly in the pharmacist context. The court held that:

• A deliberate-ignorance instruction is proper when the evidence supports an inference of conscious avoidance, and the Iwas record amply did so.
• Ruan’s mens rea requirement is satisfied where instructions require knowledge that prescriptions were “unauthorized,” emphasize the defendant’s subjective mindset, and distinguish knowledge from negligence—especially when paired with a deliberate-ignorance instruction as in Anderson.
• References to “pharmacy” in defining “usual course of professional practice” do not mislead where the charge ties “authorization” to what the prescriber “issued,” and separately recognizes a pharmacist’s “corresponding responsibility” not to fill unauthorized prescriptions.

The opinion’s most important takeaway is practical: in pharmacist prosecutions, jury instructions that (1) anchor “unauthorized” to prescriber issuance, (2) require knowledge of that lack of authorization, and (3) warn jurors not to convict for mere negligence, will be upheld against Ruan-based challenges—particularly where the factual record justifies a willful-blindness theory. Defense counsel must make targeted, specific objections at trial to preserve more exacting appellate review, and prosecutors will continue to rely on robust red-flag evidence to support both knowledge and deliberate-ignorance in health-care-related controlled-substances cases.