Harmlessness of Pre-Ruan “Objective Good-Faith” Instructions in § 841 Prescriber Cases; Admissibility of State Medical Standards and Expert Norms Testimony

I. Introduction

United States v. Parasmo is the Second Circuit’s post-Ruan v. United States decision affirming a physician’s convictions under 21 U.S.C. § 841 despite concededly erroneous jury instructions on mens rea. The defendant, Frank Parasmo, a New York-licensed medical doctor authorized to prescribe opioids, was convicted after a jury trial in the Eastern District of New York on thirty-two counts of unlawful distribution (prescribing) of controlled substances (oxycodone and hydrocodone).

The appeal presented three core issues:

  1. Whether the district court’s pre-Ruan instruction improperly invited the jury to use an objective “reasonableness” conception of “good faith” rather than the subjective knowledge/intent requirement Ruan later held governs the “except as authorized” clause of § 841.
  2. Whether the district court improperly admitted (a) expert testimony on New York’s generally accepted opioid-prescribing standards and (b) evidence of New York State medical regulations/standards, thereby usurping the jury’s function.
  3. Whether trial counsel rendered ineffective assistance—an issue the panel declined to resolve on direct appeal.

The panel (Sullivan, J., joined by Kearse, J.) affirmed, holding that the instruction was erroneous under Ruan but harmless beyond a reasonable doubt given overwhelming evidence of Parasmo’s subjective awareness that he was prescribing in an unauthorized manner. Judge Robinson dissented, arguing the mens rea element was the only truly contested issue and could not be taken from the jury as “harmless” on this record.

II. Summary of the Opinion

The court’s holdings can be summarized as follows:

  • Jury instruction error: The district court’s “good faith” instruction—defining good faith as “acting reasonably” and “reasonably believed” compliance with New York standards—was inconsistent with Ruan v. United States, which requires proof that the physician knew or intended that the prescribing was unauthorized. The charge blended correct “knowing and intentional” language with an impermissible objective gloss.
  • Harmlessness: Applying the Second Circuit’s harmless-error standard, the panel held it was “clear beyond a reasonable doubt” that a rational jury would have convicted even under a proper Ruan instruction, based on extensive patient-specific red flags, repeated warnings, and evidence Parasmo continued prescribing anyway.
  • Expert testimony (Rule 704): The admission of Dr. Seth Waldman’s testimony about accepted medical practice in New York, and whether conduct aligned with those norms, did not violate Fed. R. Evid. 704(b) because he did not opine on Parasmo’s actual mental state; he supplied objective professional context the jury could use as circumstantial evidence.
  • State standards evidence: Evidence of New York medical rules/standards was properly admitted (and in any event not plain error) because federal authorization analysis under § 841 and its regulations turns on objective concepts like “legitimate medical purpose” and “usual course” that necessarily depend on professional practice in the jurisdiction of licensure.
  • Ineffective assistance: The panel declined to reach the ineffective-assistance claim on direct appeal, leaving it for a 28 U.S.C. § 2255 motion.

III. Analysis

A. Precedents Cited

1. Mens rea after Ruan v. United States

The case pivots on Ruan v. United States, 597 U.S. 450 (2022). In Ruan, the Supreme Court held that once a physician produces evidence that he is authorized to dispense controlled substances, the government must prove beyond a reasonable doubt that the physician knew he was acting in an unauthorized manner (or intended as much). The Court rejected an “objectively reasonable good-faith effort” approach as inconsistent with the statutory “knowingly or intentionally” mens rea.

Parasmo’s trial preceded Ruan. The Second Circuit acknowledged that at the time, its own precedent, United States v. Wexler, 522 F.3d 194 (2d Cir. 2008), approved a similar instruction tying “good faith” to what the doctor “should have reasonably believed” to be proper practice. Post-Ruan, that objective gloss is defective.

Importantly, the panel also emphasized a nuance in Ruan: the Supreme Court did not exclude objective criteria altogether. Rather, objective benchmarks (“legitimate medical purpose,” “usual course of professional practice”) can function as circumstantial evidence from which a jury may infer subjective knowledge. The panel cited United States v. Bauer, 82 F.4th 522 (6th Cir. 2023), to underscore that Ruan permits such objective evidence while forbidding an objective liability standard.

2. Review of jury instruction error and harmlessness

The opinion relies on familiar Second Circuit standards:

  • United States v. Wilkerson, 361 F.3d 717 (2d Cir. 2004): an instruction is erroneous if it misleads as to the correct legal standard or inadequately states the law.
  • United States v. Moses, 109 F.4th 107 (2d Cir. 2024): de novo review of challenged instructions; reversal only for prejudicial error when viewing the charge as a whole.
  • United States v. Ng Lap Seng, 934 F.3d 110 (2d Cir. 2019): harmlessness requires the government to show it is “clear beyond a reasonable doubt” that a rational jury would have convicted absent the error.
  • United States v. Sabhnani, 599 F.3d 215 (2d Cir. 2010): instructions are erroneous if they fail to inform or mislead about the correct standard.

The dissent’s harmless-error framing draws on Supreme Court and Second Circuit authority emphasizing the constitutional centrality of the jury: Neder v. United States, 527 U.S. 1 (1999) (instructional omission/misdescription can be harmless only where the reviewing court can conclude beyond a reasonable doubt the verdict would be the same), and United States v. Speare, 297 F.2d 408 (2d Cir. 1962) (intent inference is ordinarily for the jury).

3. Comparators for “objective reasonableness” good-faith errors

Parasmo relied on two Second Circuit decisions:

  • United States v. Pabisz, 936 F.2d 80 (2d Cir. 1991), which reversed where a tax defendant’s good-faith defense was improperly conditioned on objective reasonableness in light of Cheek v. United States, 498 U.S. 192 (1991).
  • United States v. Tureseo, 566 F.3d 77 (2d Cir. 2009), which held an erroneous mens rea instruction was not harmless where evidence did not “all flow in one direction” on the required knowledge element.

The panel distinguished both: unlike Pabisz, Parasmo did not testify to his subjective beliefs (so the panel saw less risk the jury convicted merely because it found an honestly held belief “unreasonable”); and unlike Tureseo, the panel found the record overwhelmingly demonstrated subjective awareness.

The dissent also invoked out-of-circuit post-Ruan reversals—United States v. Duldulao, 87 F.4th 1239 (11th Cir. 2023), and United States v. Kahn, 58 F.4th 1308 (10th Cir. 2023)—to caution against appellate substitution for a jury’s mens rea finding. The majority distinguished them as not involving overwhelming evidence of the impacted element and as involving different trial records and government proof theories.

4. Expert testimony and the “ultimate issue”

The admissibility analysis is anchored in the Federal Rules and Second Circuit precedent:

  • United States v. Romano, 794 F.3d 317 (2d Cir. 2015), and United States v. Jones, 965 F.3d 149 (2d Cir. 2020): abuse-of-discretion review; “manifestly erroneous” threshold.
  • Fed. R. Evid. 704(a) permits opinions embracing ultimate issues; Fed. R. Evid. 704(b) bars expert opinions on whether a defendant had the mental state constituting an element.
  • United States v. DiDomenico, 985 F.2d 1159 (2d Cir. 1993): Rule 704(b) does not bar all testimony that allows an inference about mental state; the expert simply may not “expressly state” that inference.
  • Diaz v. United States, 602 U.S. 526 (2024): Rule 704(b) is not violated where the expert does not opine on the defendant’s own mental state.

The panel treated Dr. Waldman’s testimony as classic “context” evidence: he described professional norms and risks; the jury, not the expert, drew any conclusion about Parasmo’s knowledge.

5. State standards as relevant “objective criteria” and plain error

The court’s acceptance of New York standards is grounded in the statutory/regulatory structure: 21 C.F.R. § 1306.04(a) defines an authorized prescription as one issued for a legitimate medical purpose in the usual course of professional practice. The Controlled Substances Act’s definition of “practitioner,” 21 U.S.C. § 802(21), incorporates licensure “by the jurisdiction in which he practices.” The panel thus treated state professional rules as relevant to the “usual course” and “legitimate medical purpose” framework.

Because Parasmo did not preserve a particular objection to state-standard evidence, review was for plain error under United States v. Al Kassar, 660 F.3d 108 (2d Cir. 2011), and the panel found none.

6. Ineffective assistance on direct appeal

The decision follows the Second Circuit’s usual practice of reserving ineffective-assistance claims for collateral review: United States v. Adams, 768 F.3d 219 (2d Cir. 2014) (options include decline, remand, or decide); United States v. Gaskin, 364 F.3d 438 (2d Cir. 2004), quoting Massaro v. United States, 538 U.S. 500 (2003) (district court best suited to fact development); and United States v. Laurent, 33 F.4th 63 (2d Cir. 2022), as well as United States v. Morris, 350 F.3d 32 (2d Cir. 2003), supporting deferral where the record is undeveloped.

B. Legal Reasoning

1. Why the instruction was defective

The panel’s instructional analysis is notable for its granular approach to how mixed language can mislead. The charge contained correct phrases (“knowingly and intentionally,” more than “negligence, malpractice, carelessness or sloppiness”), but the “good faith” definition—“acting reasonably” and “reasonably believed” compliance with New York standards— risked converting subjective mens rea into an objective malpractice-like benchmark. Under Ruan, the government must prove that the defendant knew the conduct was unauthorized; it cannot win merely by showing the defendant acted “unreasonably.”

The key doctrinal move is the distinction between:

  • Objective criteria as evidence (permitted): professional norms and deviations can support an inference about what the defendant knew.
  • Objective criteria as the standard of guilt (forbidden): defining guilt by what a reasonable physician would do, rather than what this defendant believed/understood.

2. Why the error was harmless (majority’s account)

The majority’s harmlessness holding rests on a record it characterizes as overwhelming, emphasizing:

  • Repeated “red flags”: negative screens for prescribed opioids (suggesting diversion), positive tests for illicit substances, early refill requests, “doctor shopping,” and patient admissions implying diversion.
  • External warnings: letters and communications from insurers, pharmacies, the New York State Medical Society, other physicians, and law-enforcement interactions.
  • Persistence and escalation: continued high-dose prescribing even after Parasmo himself documented addiction concerns and “wean” intentions, and even after specialists asked him to stop prescribing opioids to shared patients.
  • Consciousness-of-problem evidence: testimony that Parasmo acknowledged being in the “top 10 percent” of oxycodone prescribers in New York, felt nervous about it, and posted a sign he would stop prescribing controlled substances—yet continued prescribing.

In effect, the panel found that the evidence did not merely show substandard practice; it showed repeated prescribing in the face of information that made unauthorized prescribing obvious—supporting an inference of subjective knowledge under Ruan. On that basis, the court concluded the verdict would have been the same under a correct instruction.

3. The dissent’s core objection

Judge Robinson’s dissent is a cautionary statement about appellate harmless-error review where mens rea is the “only real issue.” The dissent stresses that:

  • The jury was affirmatively told it could convict under an objective theory; the government reinforced that in summation (“objective standard,” “not subjective”).
  • The record contained evidence consistent with good-faith medical treatment: exams, detailed notes, testing, referrals, attempts to wean, and non-opioid alternatives.
  • Under Neder v. United States, harmlessness is a “tall order” when the element is contested; appellate certainty risks usurping the jury’s constitutional role.
  • The jury’s acquittals on some counts suggested the case was not a “slam dunk,” and thus the instruction may have mattered.

The dissent’s bottom line is institutional: when the jury never properly decided the central contested element, an appellate court should be reluctant to substitute its own view of how a properly instructed jury would decide.

4. Evidentiary holdings as post-Ruan guidance

The opinion’s evidence rulings provide practical guidance for post-Ruan prosecutions:

  • Expert testimony on standards is admissible where it explains professional norms, the significance of red flags, and whether conduct aligns with “usual course” practice—so long as the expert does not opine that the defendant had the criminal mental state.
  • State medical standards are relevant to the “usual course” inquiry because authorization for practitioners is tied to licensure and professional practice in the jurisdiction; their role is to supply objective context that can bear on subjective knowledge.

C. Impact

United States v. Parasmo is significant less for announcing a new substantive mens rea rule—Ruan did that—than for clarifying how the Second Circuit will manage the transitional period of pre-Ruan trials and instructions:

  • Harmless-error pathway is real and robust: Even where a trial court used now-impermissible “objective good faith” language consistent with pre-Ruan Second Circuit precedent (notably Wexler), convictions may be affirmed if the record strongly supports subjective knowledge.
  • Proof strategy implications: The majority’s emphasis on patient-by-patient documentation, third-party warnings, and the defendant’s own acknowledgments signals what kinds of evidence are most likely to sustain harmlessness (and ultimately guilt) under Ruan.
  • Expert/state standards evidence is endorsed: The decision rejects the argument that professional standards evidence inherently imposes objective liability; instead, it positions such evidence as permissible context that helps juries evaluate intent.
  • Dissent flags appellate risk: The dissent provides a roadmap for future defendants to resist harmless-error affirmance by emphasizing (a) contested intent, (b) mixed evidence, (c) prosecutor’s reliance on objective arguments, and (d) partial acquittals.

In practice, Parasmo likely becomes a leading Second Circuit citation for the proposition that an erroneous objective good-faith instruction in a § 841 doctor case can be harmless where the record makes subjective knowledge difficult to dispute—while also giving litigants a detailed dissent to argue the opposite where the evidence is more equivocal.

IV. Complex Concepts Simplified

  • “Except as authorized” under § 841: Doctors are generally “authorized” to prescribe controlled substances, but only if prescriptions are for a legitimate medical purpose and issued in the usual course of professional practice (a federal regulatory concept).
  • Subjective vs. objective intent: “Objective” asks what a reasonable doctor would have believed/done; “subjective” asks what this doctor actually knew or intended. Ruan requires subjective knowledge/intent for criminal liability.
  • Harmless error: Even if the trial court made a legal mistake, the conviction stands if the appellate court is convinced beyond a reasonable doubt the jury would have convicted anyway under correct instructions.
  • Rule 704(b): Experts can testify about professional standards and facts that bear on intent, but cannot tell the jury the defendant “had” the criminal mental state. The line is: explain context; don’t opine on the defendant’s mens rea.
  • Plain error: If a party did not object at trial, reversal requires a more demanding showing: an obvious error affecting substantial rights and the fairness/integrity of proceedings.
  • § 2255 ineffective assistance: Ineffective-assistance claims often require evidence outside the trial record (strategy, omissions, prejudice), so appellate courts usually defer them to collateral proceedings.

V. Conclusion

United States v. Parasmo confirms three practical propositions for § 841 prosecutions of medical prescribers in the Second Circuit after Ruan: (1) pre-Ruan “objective reasonableness” good-faith language is now erroneous; (2) such error may nonetheless be affirmed as harmless where the record overwhelmingly supports subjective knowledge of unauthorized prescribing; and (3) expert testimony and state medical standards remain admissible to explain professional norms, provided the expert does not directly opine on the defendant’s mental state.

The majority’s opinion, paired with a detailed dissent, also illustrates the fault line that will likely define future litigation: how confidently an appellate court can say a properly instructed jury would have found subjective intent beyond a reasonable doubt when the original trial invited conviction under an objective standard.