Introduction

The Sixth Circuit’s published decision in United States v. Getachew addresses recurring issues at the intersection of opioid‑use‑disorder treatment and federal controlled‑substances prosecutions. Dr. Eskender Getachew, a Columbus addiction‑medicine physician, was convicted on eleven counts of unlawful distribution under 21 U.S.C. § 841(a) based on prescribing practices centered on buprenorphine products (Suboxone and Subutex). On appeal, he challenged the sufficiency of the evidence under the Supreme Court’s decision in Ruan v. United States, attacked the district court’s deliberate‑ignorance instruction (both its use and its wording), claimed a violation of his right to be present when the verdict was returned, and argued the district court erred by denying an evidentiary hearing on his Rule 33 new‑trial motion premised on ineffective assistance in plea negotiations.

The court’s opinion does more than simply affirm the conviction. It clarifies two doctrinal points of broad importance:

• For Rule 33 motions alleging ineffective assistance (including at the plea stage), district courts are not bound by § 2255’s hearing mandate; instead, an evidentiary hearing is discretionary and requires the defendant to proffer at least a “modicum of evidence” of both deficient performance and prejudice.
• The Sixth Circuit once again endorses the pattern deliberate‑ignorance instruction—including its “carelessness or negligence or foolishness” language—as consistent with Ruan, rejecting a hyper‑textual argument that “foolishness” must be replaced with “mistake.”

Against the backdrop of the opioid crisis and the complexities of medication‑assisted treatment, the decision also illustrates how circumstantial evidence, documentation irregularities, and ignored red flags can sustain a finding of subjective knowledge of unauthorized prescribing.

Summary of the Opinion

The Sixth Circuit affirmed across the board:

• Sufficiency of the evidence (plain sufficiency review heightened to “manifest miscarriage of justice”): Ample circumstantial evidence supported the jury’s finding that Dr. Getachew knew his prescriptions were unauthorized under Ruan.
• Use of a deliberate‑ignorance (willful blindness) instruction (plain error): Even assuming arguendo error, any problem was harmless because the government presented sufficient proof of actual knowledge.
• Content of the deliberate‑ignorance instruction (plain error): The pattern instruction—stating that “carelessness or negligence or foolishness” is insufficient—accurately states the law and complies with Ruan.
• Absence at return of verdict (plain error): No effect on substantial rights where the verdict had been reached and the defendant’s absence (due to defense counsel’s advice) could not have altered the outcome.
• Denial of an evidentiary hearing on a Rule 33 new‑trial motion alleging ineffective assistance in plea bargaining (abuse‑of‑discretion review): No abuse of discretion. Rule 33 does not import § 2255’s hearing standard; a hearing requires a proffer, and Dr. Getachew offered none (including no assertion he would have accepted the plea).

Detailed Analysis

Precedents Cited and Their Roles

• Ruan v. United States, 597 U.S. 450 (2022): Establishes that, in § 841 prosecutions of physicians, the government must prove the defendant knew (or intended) that his prescribing was unauthorized—i.e., not for a legitimate medical purpose and outside the usual course of professional practice. Getachew applies Ruan to sustain conviction based on circumstantial evidence of subjective knowledge.
• Jackson v. Virginia, 443 U.S. 307 (1979): Governs sufficiency review—view evidence in the light most favorable to the government.
• United States v. Sherer, 770 F.3d 407 (6th Cir. 2014): Because the defendant failed to move for acquittal, the court applies the “manifest miscarriage of justice” standard (record must be “devoid” of guilt evidence).
• United States v. Bauer, 82 F.4th 522 (6th Cir. 2023): Confirms that subjective knowledge can be proven circumstantially post‑Ruan.
• United States v. Agrawal, 97 F.4th 421 (6th Cir. 2024): Articulates the sparing use of deliberate‑ignorance instructions and confirms harmlessness when evidence suffices for actual knowledge; also repeatedly validates Sixth Circuit’s pattern willful‑blindness instruction.
• United States v. Stanton, 103 F.4th 1204 (6th Cir. 2024): Endorses deliberate‑ignorance instructions in “pill‑mill” settings to prevent defendants from “closing [their] eyes to the obvious,” and reiterates the instruction stands well above negligence and mistake. Getachew explains that Stanton itself used the “foolishness” formulation.
• United States v. Daneshvar, 925 F.3d 766 (6th Cir. 2019): Collects cases upholding the pattern instruction.
• United States v. Anderson, 67 F.4th 755 (6th Cir. 2023), and United States v. Hofstetter, 80 F.4th 725 (6th Cir. 2023): Both approve instructions using “carelessness or negligence or foolishness.”
• Brown v. Davenport, 596 U.S. 118 (2022): Caution against parsing judicial opinions as if statutory text—used to reject the “foolishness vs. mistake” semantic argument.
• Plain‑error framework: United States v. Henry, 797 F.3d 371 (6th Cir. 2015), and United States v. You, 74 F.4th 378 (6th Cir. 2023), along with Fed. R. Crim. P. 30(d) and 52(b), set preservation and plain‑error standards; Greer v. United States, 593 U.S. 503 (2021), addresses prejudice (“reasonable probability” of a different outcome).
• Right to be present: Fed. R. Crim. P. 43(a)(2) recognizes a right to be present at the verdict; Rice v. Wood, 77 F.3d 1138 (9th Cir. 1996) (en banc), and United States v. Novaton, 271 F.3d 968 (11th Cir. 2001), inform the prejudice analysis and remedies for involuntary absence.
• Rule 33 evidentiary hearing standard: United States v. Bass, 460 F.3d 830 (6th Cir. 2006), and United States v. Anderson, 76 F.3d 685 (6th Cir. 1996), establish that hearings are discretionary; United States v. Allen, 254 F. App’x 475 (6th Cir. 2007), requires at least a “modicum of evidence” to justify a hearing. Getachew relies on these and distinguishes § 2255’s hearing regime.
• Ineffective assistance in plea bargaining: Strickland v. Washington, 466 U.S. 668 (1984) (deficiency and prejudice); Logan v. United States, 910 F.3d 864 (6th Cir. 2018) (adequacy of plea advice).
• § 2255 hearing cases (not controlling for Rule 33): Villa v. United States, 56 F.4th 417 (6th Cir. 2023), and Monea v. United States, 914 F.3d 414 (6th Cir. 2019), which implement 28 U.S.C. § 2255(b)’s “grant a prompt hearing unless conclusively shown no relief” standard—explicitly not imported into Rule 33.
• Contextual backdrop: Harrington v. Purdue Pharma L.P., 603 U.S. 204 (2024), notes the magnitude of the opioid crisis; the panel references it to emphasize the public‑health stakes.

Legal Reasoning and Application

1) Sufficiency of the Evidence under Ruan (and the “Manifest Miscarriage” Standard)

Because the defense did not move for a judgment of acquittal, the court reviewed for a “manifest miscarriage of justice,” meaning reversal only if the record is “devoid” of evidence of guilt. Viewed favorably to the government (Jackson), the evidence readily supported subjective knowledge of unauthorized prescribing (Ruan).

Key factual anchors included:

• Systemic deviations from medical norms: extraordinarily high Subutex (buprenorphine‑only) prescribing (40–50% of patients) despite “exceedingly rare” naloxone allergies—coupled with warnings from pharmaceutical representatives and pharmacists about red flags (patients requesting specific pill colors/brands).
• Documentation anomalies: identical exam notes for every appointment and, tellingly, male patients’ charts containing copy‑pasted language about menstrual cycles—evidence the jury could treat as makeweight documentation rather than genuine clinical evaluation.
• Ignored red flags: continuation of Subutex even after urinalysis showed naloxone in a supposed “naloxone‑allergic” patient (flagged as “highly suspect!” in the chart); continued prescribing to a patient reported for selling pills; prescribing Suboxone to an undercover agent whose drug screens used synthetic urine and showed no corroboration of the claimed opioid use disorder.

The “compounding” of these circumstances allowed the jury to infer knowledge rather than mistake or negligence. Post‑Ruan cases like Bauer validate using such circumstantial patterns to meet the mens rea element.

2) Deliberate‑Ignorance (Willful Blindness): Use and Harmlessness

The panel applied plain‑error review because the defense’s trial objection referenced Ruan generally but did not alert the court to the evidentiary‑foundation argument now pressed on appeal. Under Rule 30(d), objections must state “specific” grounds; raising one theory does not preserve another.

On the merits, the court noted that the defense put Dr. Getachew’s knowledge squarely at issue (“did he know what he was doing was wrong?”), making a willful‑blindness instruction at least debatable. But the panel ultimately avoided deciding whether giving the instruction was error. Relying on Agrawal, it held any error was harmless: where the government’s proof suffices for actual knowledge, a deliberate‑ignorance instruction does not affect substantial rights.

3) Content of the Deliberate‑Ignorance Instruction: “Carelessness or Negligence or Foolishness”

Also under plain‑error review, the panel rejected the argument that the word “foolishness” in the pattern instruction misstated the law or conflicted with Ruan.

• The Sixth Circuit has “repeatedly” described its pattern willful‑blindness instruction as accurate (Agrawal; Daneshvar), and sister decisions (Anderson, Hofstetter) specifically upheld the “foolishness” formulation.
• Stanton used the “mistake” descriptor in describing the instruction’s threshold but approved an instruction that, in fact, used the same “carelessness or negligence or foolishness” language challenged here.
• Invoking Brown v. Davenport, the panel cautioned against overreading single words in opinions; “mistake” and “foolishness” convey the same core concept here—conduct below the knowledge threshold—and either formulation is adequate to satisfy Ruan’s insistence on subjective knowledge.

4) Defendant’s Absence at Return of the Verdict

Although Rule 43(a)(2) grants a right to be present at the return of the verdict, the panel (under plain‑error review) found no effect on substantial rights. By the time the jury entered, it had reached its decision; polling occurred; nothing suggests the defendant’s presence could have altered the outcome (Greer). The court underscored that the right is easily preserved: defendants must simply attend, and involuntary absences can be remedied if timely objected to (cf. Novaton).

5) Rule 33 Evidentiary Hearing on Ineffective Assistance in Plea Negotiations

This is the opinion’s principal doctrinal clarification. The defendant sought a new trial under Rule 33, claiming ineffective assistance during plea discussions and requesting an evidentiary hearing. The district court denied a hearing and the motion. The Sixth Circuit affirmed.

• Standard of review and governing rule: Whether to hold an evidentiary hearing on a Rule 33 motion is within the district court’s discretion (Bass, Anderson). A defendant must proffer at least a “modicum of evidence” to justify a hearing (Allen).
• Express rejection of importing § 2255’s hearing mandate: The appellant argued for the § 2255(b) standard (a hearing unless the record conclusively forecloses relief) based on cases like Villa and Monea. The panel held those standards do not apply in the Rule 33 posture; § 2255’s statutory command is not a rule for new‑trial motions. This is a published, clear statement disentangling Rule 33 from § 2255.
• Application under Strickland:
  • Deficient performance: The record (counsel’s email) showed thorough advice: the plea’s terms; realistic sentencing exposure (including the judge’s discretion and statutory maxima); trial risks; collateral consequences; and that the decision was the client’s. The defendant offered no evidence that a follow‑up call was constitutionally required. The panel found the submission undermined, not supported, the deficiency claim (cf. Logan).
  • Prejudice: Critically, the defendant never asserted he would have accepted the plea but for counsel’s performance. No affidavit; no statement in the moving papers. Without a proffer on this essential element, there was no basis for a hearing.

Holding: A Rule 33 movant alleging ineffective assistance—particularly in plea bargaining—must come forward with evidence supporting both Strickland prongs; absent at least a modest proffer, the district court does not abuse its discretion by denying an evidentiary hearing. And § 2255’s hearing standard does not apply to Rule 33.

Impact and Practical Consequences

A. Criminal prosecutions of medical professionals post-Ruan

• Circumstantial proof of “subjective knowledge” remains pivotal: Patterned documentation irregularities, ignored lab anomalies, and responses to diversion reports can collectively establish knowledge that prescriptions were unauthorized—even in the specialized addiction‑medicine context.
• Clinical compliance matters: The court’s reliance on standard‑of‑care testimony and documentation gaps (e.g., lack of verified naloxone allergies; Subutex overuse) signals that providers should rigorously adhere to verification protocols, especially where patient incentives to misrepresent are high.

B. Jury instructions in healthcare‑fraud and pill‑mill cases

• Willful blindness instruction remains available post‑Ruan: Where knowledge is disputed and the record contains red flags, district courts may give the instruction, though the Sixth Circuit continues to counsel sparing use.
• Pattern wording safe harbor: The Sixth Circuit again blesses the “carelessness or negligence or foolishness” language. Challenges premised on swapping “foolishness” with “mistake” are unlikely to succeed.
• Harmlessness cushion: Prosecutors who present robust direct or circumstantial proof of actual knowledge reduce the risk that a willful‑blindness instruction will create reversible error.

C. Preservation and appellate review

• Specificity is essential: Objecting “under Ruan” does not preserve unrelated challenges (e.g., the evidentiary basis for a willful‑blindness instruction). Rule 30(d) demands the specific ground.
• Plain error is a steep hill: Multiple issues here failed at the “prejudice” step (e.g., absence at verdict; instruction content), illustrating the difficulty of post‑hoc relief without contemporaneous objections and concrete prejudice.

D. Rule 33 vs. § 2255: What practitioners must do

• Do not rely on § 2255 hearing standards when filing a Rule 33 motion: After Getachew, Sixth Circuit district courts have reinforced discretion to deny hearings absent an evidentiary proffer.
• Bring a proffer: To seek a Rule 33 hearing on ineffective assistance at the plea stage, submit sworn declarations from the defendant and, where appropriate, counsel. The defendant must plainly assert that he would have accepted the plea and explain why counsel’s acts or omissions were objectively unreasonable.
• For defense counsel: Maintain clear, contemporaneous records of plea offers and advice—accurately conveying terms, sentencing exposure (statutory maxima and realistic ranges), judicial discretion, collateral consequences, and an unequivocal statement that the decision is the client’s. Such records, as in this case, can be outcome‑determinative.

Complex Concepts Simplified

• Ruan mens rea: In prosecutions of doctors under § 841, the government must prove the physician knew or intended that the prescribing was unauthorized (not just that the doctor deviated from best practices).
• Legitimate medical purpose / usual course of professional practice: Regulatory standards (e.g., 21 C.F.R. § 1306.04(a)) require prescriptions to be for legitimate medical purposes and within normal medical practice; the government can use expert testimony and records to show departures.
• Deliberate ignorance (willful blindness): A jury may find knowledge where a defendant consciously avoids confirming what is obvious. The instruction warns that mere negligence or “foolishness” does not suffice.
• Plain‑error review: Appellate relief for unpreserved errors requires: (1) error; (2) that is plain; (3) affecting substantial rights (a reasonable probability of a different outcome); and (4) seriously affecting the fairness, integrity, or public reputation of proceedings.
• “Manifest miscarriage of justice” sufficiency review: Applies when a defendant fails to move for acquittal; reversal only if the record lacks any evidence of guilt.
• Rule 33 vs. § 2255 hearings: Rule 33 new‑trial motions are discretionary with the district court and require an evidentiary proffer. By contrast, § 2255(b) instructs courts to hold a hearing unless the record conclusively shows no entitlement to relief.
• Strickland standard: To prove ineffective assistance, a defendant must show deficient performance (below objective reasonableness) and prejudice (a reasonable probability of a different result—e.g., that he would have taken a plea offer).
• Suboxone vs. Subutex: Suboxone contains buprenorphine plus naloxone (to deter injection abuse); Subutex is buprenorphine‑only, used when verified naloxone allergy exists. Because true allergies are rare, high Subutex rates and unverified allergy claims can be red flags.

Conclusion

United States v. Getachew delivers two durable guideposts in Sixth Circuit criminal practice. First, Rule 33 is not § 2255: defendants seeking a new trial on ineffective‑assistance grounds must furnish an evidentiary proffer to obtain a hearing, including a clear statement that they would have accepted a foregone plea and concrete facts showing deficient performance. Second, the court reaffirms the availability and content of the deliberate‑ignorance instruction in post‑Ruan prosecutions of physicians—particularly in cases saturated with red flags—while emphasizing that robust proof of actual knowledge will typically render any instructional dispute harmless.

More broadly, the opinion underscores the continued vitality of circumstantial proof to establish subjective knowledge in controlled‑substances cases against medical professionals, the critical importance of rigorous clinical documentation and verification protocols, and the necessity of precise preservation at trial. In the shadow of the opioid epidemic, Getachew offers a clear roadmap for courts, counsel, and clinicians navigating the boundary between legitimate addiction treatment and criminally unauthorized prescribing.