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NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC., SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS, MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, IN THE SPIRIT OF WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, IN THE SPIRIT OF WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., IN THE SPIRIT OF RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
SYSTEM FICTIONS FACTUAL FABRICATIONS AND FALSE MISREPRESENTATION OF FACTS
LEGAL STRATEGY MEMORANDUM
Navigating Subjective Intent and the Good Faith Defense Post-Ruan
To: Legal Partners and Federal Defense Counsel
From: Senior Constitutional Litigator and Federal Criminal Defense Strategist Date: May 22, 2025 Subject: Dismantling “Prosecution by Proxy”: Strategic Application of the Ruan Subjective Intent Standard
The Constitutional Re-Alignment
Contextualizing Ruan v. United States
The Supreme Court’s unanimous 9-0 ruling in Ruan v. United States represents a fundamental paradigm shift in federal criminal law, effectively decapitating the Department of Justice’s (DOJ) long-standing reliance on “objective negligence” to criminalize medical professionals.
For decades, the federal government exploited a constitutional overreach, utilizing judicial shortcuts to convict practitioners based on mere deviations from professional norms—essentially treating medical malpractice as a felony. Ruan dismantled this model by re-establishing the absolute necessity of mens rea (guilty mind), mandating that the government prove a defendant’s subjective state of mind rather than a failure to meet an external “standard of care.”
This decision is a strategic triumph over the “objective negligence” standard previously used by the DOJ to dismantle the medical profession, shifting the legal focus from “what a reasonable doctor would do” to the specific defendant’s internal knowledge and intent.

The Evolution of Liability Standards
| Feature | Pre-Ruan Model (Objective Negligence) | Post-Ruan Mandate (Subjective Knowledge) |
| Standard of Liability | Objective “Standard of Care” / Professional Norms | Subjective Knowledge / Mens Rea Requirement |
| Basis for Conviction | Deviations from guidelines or data-mined metrics | Evidence the defendant knew the act was unauthorized |
| Good Faith Defense | Often discarded as an irrelevant professional opinion | A robust, substantive legal shield and proof requirement |
| Prosecutorial Focus | “Pill numbers” and “Drug dealers in white coats” rhetoric | Specific, proven subjective criminal intent |
This legal victory for practitioners has met significant resistance within lower courts and executive agencies, where the “anti-narcotic zealotry” of the previous era persists in open defiance of the Supreme Court’s mandate.
Anatomy of the “Good Faith Defense” and the Burden of Proof
Post-Ruan, the “Good Faith Defense” is no longer a mere procedural affirmative defense; it is a substantive shield. The burden of proof remains squarely on the government to negate good faith beyond a reasonable doubt. At the heart of our defense strategy is the “Intent to Treat,” the primary legal differentiator between legitimate medical practice and illicit trafficking.
The Refined Disjunctive Standard
To secure a conviction under the Controlled Substances Act (CSA), the government must prove beyond a reasonable doubt that the practitioner:
- Subjectively knew the prescription lacked a legitimate medical purpose; OR
- Issued a prescription that was objectively not in the usual course of professional practice.
Strategic Nuance: While the standard is disjunctive, the Ruan holding dictates that the mens rea—knowingly or intentionally—applies to both prongs. The government cannot convict on the second prong simply by showing a deviation from a standard; they must prove the defendant subjectively knew the prescription was objectively outside the usual course of professional practice.
A practitioner’s formal education and professional status create an “intent to treat” that fundamentally distinguishes them from “street drug dealers.” Our strategy must leverage this status to prevent our clients from being branded as “drug dealers in white coats” for what are, at worst, medical disagreements or errors. Despite this high bar of proof, current enforcement tactics attempt to bypass these requirements through data-mined metrics.
Institutional Resistance: The Gap Between Mandate and Enforcement
Our strategy must account for the profound strategic friction between the Supreme Court’s mandate and the ongoing “anti-narcotic zealotry” of the DEA and DOJ. This has resulted in “prosecution by proxy,” where medical errors are intentionally treated as criminal acts. We are seeing a “Double Standard of Drug Enforcement” where the DEA utilizes Shady Academic Guesswork to create a standard of care that applies only to doctors, effectively creating a two-tiered system of justice.
Entities and Actors Disregarding the Ruan Mandate
- The DOJ and DEA: Accused of ignoring the Good Faith Defense and maintaining an “ideological crusade” that prioritizes conviction rates over the rule of law.
- Federal District Courts: Multiple courts continue to allow prosecutions that fail the subjective intent test to proceed to trial.
- Judge Chad F. Kenny: Specifically identified for discarding the Good Faith Defense and treating medical practice as a per se criminal enterprise based on volume.
The Mechanics of the Double Standard
- Ideological Zealotry: Prioritizing anti-narcotic goals over established constitutional standards.
- Naked Intimidation: Coercing practitioners into self-censorship through the threat of felony prosecution.
- Shady Academic Guesswork: Using flawed medical protocols to ignore the “lived reality of incurable suffering.”
- Criminalization of Errors: Treating professional mistakes as synonymous with illicit drug trafficking.

To combat this “naked intimidation,” defense counsel should utilize public accountability strategies. The blog youarewithinthenorms.com serves as a vital tool for “bearing witness” to these judicial abuses, drawing a parallel to the recording of the George Floyd murder as a means of holding a biased system accountable to the public record.




Case Analysis: Prosecutorial Tactics and the “Anand” Standard of Misrepresentation

In medical jurisprudence, a fundamental challenge is how to distinguish a conscientious physician treating complex pain from a criminal trafficker. To resolve this, the law looks beyond the physical act of writing a prescription to the practitioner’s internal mindset. Learners must recognize that under the Subjective Knowledge Standard, the legal system prioritizes what a doctor actually believed and intended over mere technical errors.

The “subjective intent” requirement has left prosecutors in a bind, often leading them to resort to factual fabrications to survive Rule 29 proceedings. In United States v. Dr. Neil Anand, Prosecutor Paul J. Koob allegedly made four specific “false representations of fact” on April 8, 2025, to secure a conviction where no subjective intent existed.
| The Fabrication | Prosecution’s “Flat Factual Assertion” | The Objective Evidence (Smoking Gun) |
| The Glasgow Fabrication | Witness Glasgow saw Dr. Anand sign a “whole pad” for unlicensed staff to fill “out the door.” | Glasgow testified Dr. Anand was at his desk “signing and stamping a book of prescriptions”—a routine administrative task. |
| The “Goody Bag” Records | Patient Tamara Gage “continued to get the bag [of non-opioids] every month.” | Government File 303 proved a mathematical impossibility; 9 consecutive months showed zero dispensing. |
| Medical Necessity | Documented basis for opioids was non-existent in patient files produced in discovery. | Files contained objective diagnostic findings: MRI reports(spinal stenosis) and EMG reports (radiculopathy). |
| Patient Use Testimony | Every patient testified they told staff they did not want or use the “Goody Bag” medications. | Records and testimony showed patients were voluntarily filling these medications at retail pharmacies outside the office. |
These fabrications are a symptom of the government’s inability to meet the high Ruan standard. Discovery evidence like “File 303” must be used as a “smoking gun” in Rule 29 motions to expose these factual misrepresentations.
Concept Primer
The ‘Intent to Treat’ Principle
The “Why” Behind the Rule: Mindset vs. Action
The government traditionally attempted to criminalize doctors based on “objective negligence”—the idea that if a doctor deviated from a standard of care, they were essentially acting as a drug dealer. However, the modern legal standard requires a deeper inquiry into the practitioner’s state of mind.
To secure a conviction under the Controlled Substances Act (CSA), the government faces a disjunctive standard, yet one where the subjective element now dominates the burden of proof. The government must prove beyond a reasonable doubt that the defendant:
- Subjectively knew the prescription was issued without a legitimate medical purpose; OR
- Issued a prescription that was objectively not in the usual course of professional practice.
In practice, a doctor cannot be convicted simply for making a mistake; the government must prove they knew their actions were unauthorized. This shift from focusing on external behavior to internal intent was codified in a landmark 9-0 Supreme Court decision that redefined the boundary between medicine and crime.
Defense Benchmarks: Successful Applications of the Ruan Standard
We must pursue early-stage motions to dismiss whenever the government lacks evidence of subjective knowledge. The primary precedent for this is United States v. James Barclay, where federal prosecutors moved to dismiss the indictment after acknowledging that the Ruan decision created “insurmountable legal hurdles.” Specifically, the government could not prove beyond a reasonable doubt that the doctor subjectively knew his actions were unauthorized.

Actionable Benchmarks for Discovery and Defense
- Subpoena Complete Diagnostic Histories: Secure all MRI reports and pathological findings to establish an incontrovertible medical basis for treatment.
- Neurological Verification: Utilize EMG reports to confirm objective conditions like radiculopathy, refuting claims of “lack of medical purpose.”
- Establish “Intent to Treat”: Document the practitioner’s adherence to professional diagnostic protocols to differentiate them from illicit distributors.
- Refute Volume Metrics: Assert that data-mined “pill numbers” are objective metrics that are legally insufficient to prove a defendant’s internal state of mind.
The Turning Point: Ruan v. United States
The landscape of medical prosecution was fundamentally altered by Ruan v. United States. This unanimous ruling effectively “decapitates the federal government’s ability to rely on objective negligence” in criminal proceedings against physicians. Before this ruling, the Department of Justice (DOJ) frequently employed “prosecution by proxy”—a tactic where prosecutors used objective deviations (such as high patient volume or “pill numbers”) as a substitute for proving actual criminal intent.
Conclusion:
Reasserting Medical Autonomy Against Judicial Zealotry
The Ruan decision provides the tools necessary to end the era of “prosecution by proxy.” This paradigm shift confirms that while the government may present data-mined “pill numbers,” such objective metrics are insufficient to prove a defendant’s internal state of mind. We must hold the legal system—and specifically Federal Judges like Chad Kenny, James P. Jones, Lance Africk, Callie V. Granade—accountable to the Supreme Court’s unanimous 9-0 mandate.
Learners must understand this as a total “Paradigm Shift.” The law now recognizes that medical disagreements are not crimes and that the practice of medicine—even in high-volume clinics—cannot be categorized as criminal without specific evidence of a practitioner’s subjective knowledge.

We must relentlessly challenge any attempt by the DEA or DOJ to substitute “shady academic guesswork” for the required proof of criminal intent. Defense counsel must use this memorandum as a roadmap to ensure the legal system honors the fact that medical autonomy is protected under the Constitution.
We must remain steadfast in the assertion that the practice of medicine is not a per se criminal enterprise.
The ruling emphasizes that the education, conduct, and “intent to treat” of a DEA-registered practitioner fundamentally differentiate them from street drug dealers. By requiring proof of subjective knowledge of illegitimacy, the decision protects practitioners from being prosecuted as “drug dealers in white coats” for what may actually be good-faith medical disagreements or errors.

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REFERENCES:

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