United States v. Ball: Post-Ruan CSA Prescribing Liability Requires Objective Unauthorized Prescribing Plus Subjective Knowledge—“Her” Practice Not the Measure

I. Introduction

In United States v. Kirsten Van Steenberg Ball (4th Cir. July 14, 2026), the Fourth Circuit addressed a recurring post-Ruan question in Controlled Substances Act (“CSA”) prosecutions of physicians: how to draft jury instructions that properly capture the statute’s authorization requirement and the physician’s mental state.

Kirsten Ball, a licensed physician who practiced from a home office (2005–2022), was charged with (1) conspiracy to distribute oxycodone under 21 U.S.C. § 846 and (2) twenty substantive distribution counts under 21 U.S.C. § 841(a)(1). After trial, a jury convicted her of conspiracy and all but one distribution count. Ball did not contest that the Government’s evidence showed her prescribing deviated from standard medical practice. The appeal focused on whether the district court’s modification of the proposed jury instructions—removing the word “her” from phrases like “course of her professional practice”—improperly allowed conviction without proof that Ball knew her prescribing was unauthorized.

II. Summary of the Opinion

The Fourth Circuit affirmed. It held that the CSA framework after Ruan v. United States, 597 U.S. 450 (2022), has two distinct components:

  • Objective authorization boundary: whether a prescription was issued for a legitimate medical purpose in the usual course of professional practice is governed by professional standards.
  • Subjective mens rea: the Government must prove the physician knew the prescriptions were outside those objective bounds (or intended that result).

The panel concluded that deleting “her” did not transform the standard into “whatever this defendant usually does.” Read as a whole, the jury charge repeatedly required subjective knowledge/intent and defined “good faith” in expressly subjective terms, satisfying Ruan.

III. Analysis

A. Precedents Cited

1. Ruan v. United States, 597 U.S. 450 (2022)

Ruan is the controlling mens rea decision. The Supreme Court held that the “knowingly or intentionally” requirement in 21 U.S.C. § 841(a)(1) extends to the “except as authorized” clause. Thus, criminal liability cannot rest on what a hypothetical reasonable doctor should have known; the Government must prove the defendant’s subjective mental state regarding unauthorized prescribing. The Fourth Circuit in Ball emphasized that Ruan preserved an objective professional-standard boundary for what counts as authorized, while making the defendant’s knowledge/intent about crossing that boundary the critical mens rea question.

2. United States v. Naum, 134 F.4th 234 (4th Cir. 2025)

Naum supplied an important post-Ruan articulation: the Government must prove the defendant “subjectively believed his conduct was outside the bounds of professional practice” (or intended it). The Ball panel used Naum for the governing two-part structure, but distinguished Naum on the adequacy of the jury instructions: the instructions in Naum did not clearly require a finding that the defendant knew the prescriptions were outside objective professional bounds.

3. United States v. Smithers, 92 F.4th 237 (4th Cir. 2024)

Smithers was central to the instructional analysis. The Fourth Circuit there faulted instructions that effectively allowed conviction on an objective departure from medical practice and compounded the problem by defining good faith through “generally accepted standards” (an objective lens). In Ball, the panel contrasted the charge given: it repeatedly required subjective knowledge/intent and defined good faith as “subjective good intentions” and “what she subjectively believed to be proper medical practice.” This distinction allowed the court to treat Ball as an example of instructions that do satisfy Ruan when read in full.

4. United States v. Sanders, 146 F.4th 372 (4th Cir. 2025)

Sanders supplied the interpretive rule for reviewing instructions: appellate courts do not parse one sentence in isolation; they assess whether the charge “as a whole” fairly states the law. That principle was outcome-determinative in Ball, where one instruction standing alone could have been ambiguous, but the surrounding instructions repeatedly clarified the subjective mens rea.

5. Cheek v. United States, 498 U.S. 192 (1991)

The opinion relied on Cheek (via Ruan) for the idea that objective unreasonableness is evidentiary: even where the legal question is subjective belief, the more unreasonable the asserted belief, the more likely a jury will infer knowledge. Ball uses this to reinforce that objective professional standards remain relevant—though not as the ultimate mens rea test.

6. United States v. Moore, 423 U.S. 122 (1975)

Moore is the foundational CSA physician-liability case, recognizing that registered physicians can be prosecuted when they act outside professional practice. Ball invoked Moore to support that the “usual course of professional practice” concept is not individualized to a particular doctor’s idiosyncratic habits.

7. Persuasive out-of-circuit authorities: United States v. Hofschulz, 105 F.4th 923 (7th Cir. 2024); United States v. Lamartiniere, 100 F.4th 625 (5th Cir. 2024)

These cases were cited to show that other circuits have upheld instructions using similar subjective-knowledge requirements post-Ruan, supporting the Fourth Circuit’s conclusion that the instruction set in Ball fit the emerging consensus.

8. United States v. Sonmez, 777 F.3d 684 (4th Cir. 2015)

Sonmez governed Ball’s alternative argument: that the district court abused its discretion by refusing the jointly proposed instruction. Under Sonmez, reversal requires a correct proposed instruction not substantially covered and whose omission seriously impaired the defense. The Fourth Circuit held the charge substantially covered the required subjective-knowledge standard, and it rejected Ball’s “own practice defines the law” theory as incorrect.

B. Legal Reasoning

1. Two distinct inquiries: authorization (objective) vs. culpability (subjective)

The court’s core move was to separate (a) whether prescriptions were unauthorized from (b) whether the defendant is criminally responsible. It treated authorization as grounded in objective professional standards—the “legitimate medical purpose” and “usual course” criteria in 21 C.F.R. § 1306.04(a). Ruan did not, in the Fourth Circuit’s view, “subjectivize” authorization itself; instead, it subjectivized the mens rea about that objective boundary.

2. The “one-word deletion” (“her”) and why it did not change the legal standard

Ball argued that “usual course of her professional practice” means the Government must disprove her subjective view that her own prescribing patterns were within “her practice.” The Fourth Circuit rejected this reading on textual and structural grounds:

  • Regulatory context: the same subsection later uses “usual course of professional treatment” without the possessive, indicating the boundary is not personalized.
  • Interchangeable usage: the Supreme Court’s usage (including in United States v. Moore and the concurrence in Ruan) treats the phrases with/without the pronoun as expressing the same standard.
  • Grammar and function: the possessive links to the professional role (e.g., physician vs. pharmacist) rather than licensing each practitioner to define legality by personal custom.

3. “Read as a whole”: curing ambiguity through repeated mens rea clarifications

The panel acknowledged that a single sentence (“knowingly or intentionally distributed the substance not for a legitimate purpose or outside the usual course of professional medical practice”) was “not a model of clarity,” echoing concerns raised in United States v. Smithers and United States v. Naum. But applying United States v. Sanders, it held the full charge removed doubt by:

  • Requiring proof that Ball “knew she was acting, or she intended to act,” without authorization;
  • Defining good faith as “subjective good intentions” and “what she subjectively believed to be proper medical practice” (in contrast to the objective formulation faulted in Smithers);
  • Distinguishing negligence/mistake from criminal conduct and barring knowledge inferences from mere carelessness.

C. Impact

1. Jury-instruction drafting after Ruan in the Fourth Circuit

Ball is a practical precedent about instruction language, particularly when district courts alter agreed-upon text. It signals that Fourth Circuit review will focus less on a single potentially ambiguous clause and more on whether the charge repeatedly and clearly requires a finding that the defendant subjectively knew the prescriptions were unauthorized under objective professional standards.

2. Limiting the “idiosyncratic practice” defense

The decision sharply constrains a defense theory that a physician’s “usual course” can be defined by her personal prescribing habits. Post-Ball, defendants may still argue they sincerely believed their conduct complied with professional practice, but they cannot redefine “professional practice” as “whatever I typically do.”

3. Evidentiary consequences

By invoking Ruan’s discussion of Cheek v. United States, Ball underscores that objective medical evidence—guidelines, expert testimony, red flags, extreme dosages—remains highly relevant to proving subjective knowledge. The more extreme the deviation, the easier it may be for juries to infer knowing or intentional unauthorized prescribing.

IV. Complex Concepts Simplified

  • “Except as authorized” (21 U.S.C. § 841(a)(1)): A physician violates the CSA only if the prescription is not legally permitted—i.e., not “authorized” under the statute and regulations.
  • 21 C.F.R. § 1306.04(a): The key regulation explaining authorization: prescriptions must be for a “legitimate medical purpose” and in the “usual course of professional practice.”
  • Objective vs. subjective:
    • Objective = what professional medical standards permit (the legal boundary).
    • Subjective = what the defendant actually knew or intended about crossing that boundary (the mens rea).
  • Good faith (as used here): Not “reasonable doctor” good faith, but the defendant’s honest exercise of professional judgment—what she subjectively believed to be proper practice (while the jury may evaluate sincerity using objective evidence).
  • Negligence vs. crime: Medical malpractice or careless prescribing can be civilly wrongful, but after Ruan, CSA criminal liability requires proof beyond a reasonable doubt of knowing/intentional unauthorized prescribing.

V. Conclusion

United States v. Ball clarifies that post-Ruan CSA prosecutions of physicians require both (1) an objective showing that prescriptions fell outside the profession’s authorized bounds and (2) a subjective showing that the defendant knew or intended that unauthorized result. The Fourth Circuit further holds that the “usual course of professional practice” is not personalized to a defendant’s own habits; removing the word “her” from that phrase did not dilute the required mens rea where the charge, read in full, repeatedly required subjective knowledge and defined good faith subjectively. In the broader landscape of opioid-prescribing cases, Ball functions as an instruction-focused roadmap for aligning trial practice with Ruan while rejecting attempts to convert federal authorization into an idiosyncratic, doctor-by-doctor standard.