“Transcript-Reference Adequacy” – The Sixth Circuit Clarifies Rule 16 Expert-Disclosure Obligations in United States v. Thomas Romano

Introduction

The opioid epidemic continues to generate litigation testing the criminal liability of physicians who prescribe large quantities of controlled substances. In United States v. Thomas Romano, No. 24-3463 (6th Cir. July 23 2025), the Court of Appeals for the Sixth Circuit confronted two recurring appellate themes in “pill-mill” prosecutions:

1. Whether the evidence sufficed to prove that a licensed doctor knowingly or intentionally prescribed opioids “without a legitimate medical purpose and outside the usual course of professional practice” in violation of 21 U.S.C. § 841(a)(1).
2. Whether the Government’s expert-witness disclosures under Federal Rule of Criminal Procedure 16(a)(1)(G) were adequate.

Dr. Thomas Romano, a rheumatologist who operated a self-owned pain clinic in Martins Ferry, Ohio, was convicted after a second jury trial on 24 counts of unlawful distribution. On appeal he argued (1) that the jury lacked sufficient evidence of his intent and the illegitimacy of his prescribing, and (2) that the district court should have excluded three Government experts because the Rule 16 disclosures merely cross-referenced their first-trial testimony and one disclosure lacked a signature.

The Sixth Circuit affirmed. In doing so it articulated a notable clarification: a Rule 16(a)(1)(G) disclosure that identifies the subject matter of an expert’s anticipated testimony and points counsel to the witness’s prior sworn testimony can satisfy the rule, and any technical deficiency (including a missing signature) will not justify exclusion absent a showing of prejudice. This pronouncement—set against a backdrop of rich precedent on sufficiency standards in opioid cases—forms the core of the new guidance emanating from the decision.

Summary of the Judgment

• Convictions affirmed. The court held that a rational jury could find that Dr. Romano knowingly prescribed controlled substances outside the bounds of professional practice.
• Rule 16 challenge rejected. Even assuming the disclosures were imperfect, the district court did not abuse its discretion in admitting the experts because (i) Romano had full access to the witnesses’ prior testimony, (ii) he cross-examined them extensively, and (iii) he failed to demonstrate prejudice.
• No new trial warranted. The panel concluded that neither alleged error—evidentiary sufficiency nor discovery violation—undermined the fairness of the second trial.

Detailed Analysis

1. Precedents Cited

The court wove together longstanding Supreme Court, Sixth Circuit, and recent opioid-prescriber cases, showing a stable doctrinal trajectory:

• Jackson v. Virginia, 443 U.S. 307 (1979) – The bedrock sufficiency standard (“any rational trier of fact”).
• United States v. Hills, 27 F.4th 1155 (6th Cir. 2022) & United States v. LaVictor, 848 F.3d 428 (6th Cir. 2017) – Emphasize defendant’s heavy burden on sufficiency review.
• United States v. Anderson, 67 F.4th 755 (6th Cir. 2023); United States v. Bauer, 82 F.4th 522 (6th Cir. 2023); United States v. Stanton, 103 F.4th 1204 (6th Cir. 2024) – Recent opioid-prescriber cases clarifying “red flags,” knowledge, and course-of-practice determinations.
• United States v. White, 492 F.3d 380 (6th Cir. 2007); United States v. Ham, 628 F.3d 801 (6th Cir. 2011); United States v. Wells, 211 F.3d 988 (6th Cir. 2000) – Establish the abuse-of-discretion framework for reviewing Rule 16 expert issues and stress that disclosure rules aim to prevent unfair surprise, not to create technical traps.

By aligning the present facts with those precedents, the panel reinforced the emerging standard for opioid-related § 841 prosecutions: patterns of high-dose, long-term prescribing combined with ignored red flags firmly support conviction, even when the defense proffers a supportive expert.

2. Legal Reasoning of the Court

Sufficiency of the Evidence

1. Element 3 – No Legitimate Medical Purpose / Outside Course of Practice
   • Government experts testified that Dr. Romano issued extremely high Morphine Milligram Equivalent (MME) dosages, often >300 MME, combined them with benzodiazepines (an FDA “black-box” combination), used boiler-plate (“cloned”) charts, failed to order imaging or consider comorbidities, and continued prescriptions despite lack of therapeutic benefit.
   • The court held this “voluminous countervailing evidence”—mirroring Bauer—sufficed for a reasonable juror to find the prescriptions professionally indefensible.
2. Element 2 – Knowledge / Intent
   • Intent was inferred from circumstantial evidence: the flat-fee cash practice, long-distance patient travel, ignored pharmacist warnings, and Romano’s own admission that he “might get in trouble.”
   • The panel emphasized the accepted principle that subjective knowledge may be proven with “objective red flags” the physician disregarded.
3. Conflict of Experts
   • Romano’s own expert declaring the prescriptions legitimate merely created a credibility dispute for the jury, not a legal insufficiency.

Expert-Disclosure Issue

1. Content of the Disclosures
   • Each disclosure summarized topic areas and identified transcript page numbers from the first trial where the same witness had testified.
   • One disclosure (Dr. Le) lacked her signature; the Government detailed its failed attempts to secure it.
2. Rule 16(a)(1)(G) Requirements
   • The rule mandates “a complete statement of all opinions” and, since 2022, the witness’s approval/signature or an explanation of why it could not be obtained.
3. Harmlessness / Prejudice Analysis
   • Because Romano already had the entire first-trial transcripts, the Sixth Circuit found no surprise and therefore no prejudice.
   • The court invoked White and Ham to reaffirm that exclusion is disfavored when the defense is able to cross-examine effectively.
4. Key Holding
   • A disclosure that cross-references earlier sworn testimony may be adequate, and technical lapses (e.g., an absent signature) will not warrant exclusion absent a concrete showing of prejudice.

3. Impact of the Decision

a) Rule 16 Discovery Practice
The decision provides practical guidance for prosecutors and defense counsel in multi-trial or retrial settings:

• Referencing prior trial transcripts—where the expert has already laid out her opinions under oath—constitutes sufficient notice of “all opinions.”
• Courts will evaluate prejudice, not formality, when deciding whether to sanction discovery lapses.
• Signature requirement is flexible; a documented good-faith effort to obtain the expert’s approval suffices.

b) Opioid-Prescriber Litigation
The case cements the Sixth Circuit’s pattern of deference to jury verdicts based on red-flag evidence, reinforcing law-enforcement efforts against high-volume prescribers. Future defendants will face an uphill battle on sufficiency if:

• They prescribe well above CDC/State “pause-point” dosage thresholds;
• They combine opioids with benzodiazepines over extended periods;
• Patient files are cursory, cloned, or lack diagnostic support; and
• They ignore pharmacists’, insurers’, or colleagues’ warnings.

c) Trial Strategy
Defense counsel must move beyond mere “battle of the experts”; they must neutralize the Government’s circumstantial evidence of knowledge (cash-only policy, travel distances, etc.). On the prosecution side, documenting ignored red flags remains crucial.

Complex Concepts Simplified

• 21 U.S.C. § 841(a)(1) – Federal law making it a felony to “distribute” controlled substances unless authorized. For physicians, prescriptions count as “distribution,” and authorization exists only when the prescription is issued for a legitimate medical purpose in the usual course of practice.
• Morphine Milligram Equivalent (MME) – A conversion metric that puts all opioids on a morphine scale so doctors can compare potency. CDC warns caution at ≥90 MME.
• FDA “Black-Box” Warning – The agency’s most serious drug-label warning, signifying life-threatening risks.
• Rule 16(a)(1)(G) – Criminal-procedure rule requiring each side to give pre-trial written summaries of expert testimony, including opinions, bases, and the witness’s qualifications, to avoid trial-by-ambush.
• Red Flags (in pill-mill jurisprudence) – Objective indicators of diversion or illegitimate prescribing (e.g., cash-only payments, long-distance patients, simultaneous benzodiazepine scripts, missing diagnostics).
• Harmless-Error / Prejudice Standard – Even if a procedural error occurred, appellate courts will not reverse unless the defendant shows the error likely affected the verdict.

Conclusion

United States v. Romano both fortifies the Sixth Circuit’s opioid-prescriber jurisprudence and supplies fresh clarity on Rule 16 expert disclosures. The takeaways are two-fold:

1. Substantive Criminal Law – A mosaic of red-flag evidence, expert opinion, and circumstantial proof of knowledge can sustain § 841 convictions against physicians, even in the face of contrary defense experts.
2. Criminal Discovery – When an expert has already testified, a disclosure that directs counsel to the prior transcript effectively apprises the opponent of the expert’s opinions. Omission of a signature or other technical missteps will rarely warrant the drastic remedy of exclusion unless the defendant can demonstrate genuine surprise or inability to prepare.

In an era where opioid prescribing practices remain under intense scrutiny, the decision reinforces prosecutorial tools while cautioning both sides to focus less on procedural gotchas and more on substantive fairness and preparation. Its “transcript-reference adequacy” principle will likely echo in future retrials, multi-defendant cases, and any complex criminal litigation where expert testimony repeats across proceedings.