Understanding Pain and Drug Regulations: Lessons from Neumann's Case

youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF WILLIE GUINYARD BS., IN THE SPIRIT OF ERLIN CLEMENT SR., JOSEPH WEBSTER MD., MBA, IN THE SPIRIT OF RICHARD KAUL, MD., BEVERLY C. PRINCE MD., FACS., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, IN THE SPIRIT OF WALTER F. WRENN III, MD., ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

HOW THE COURT RULED THAT D.E.A. HAS FLUNKED GRAMMAR SCHOOL

Judge Don Willett stripped away an ambitious layer of “regulatory drift,” making it clear that an agency cannot simply “quietly rewrite” its own regulations in the heat of an enforcement action.

The Grammar of Guilt: The Fifth Circuit Grounds the DEA’s Regulatory Sleight of Hand

In the enduring theater of the American “War on Drugs,” the Drug Enforcement Administration (DEA) often views itself as the ultimate arbiter of public safety, tasked with patrolling the thin line between medicine and misery.

A judge in a black robe sits at a courtroom bench, reviewing documents with a serious expression, while a faint figure of a lawyer is visible in the background. — The U.S. Court of Appeals for the Fifth Circuit recently reminded the agency in *Neumann’s Pharmacy v. DEA* that even the most righteous crusade must remain anchored by the rule of law.

It is a vital role, but as the U.S. Court of Appeals for the Fifth Circuit recently reminded the agency in Neumann’s Pharmacy v. DEA, even the most righteous crusade must remain anchored by the rule of law. In a sharp, linguistically rigorous opinion, Judge Don Willett stripped away an ambitious layer of “regulatory drift,” making it clear that an agency cannot simply “quietly rewrite” its own regulations in the heat of an enforcement action.

A meeting taking place in Neumann's Pharmacy, featuring a man in a suit sitting behind a counter, while three individuals listen attentively. The pharmacy shelves display various medications and products. — The court’s ruling serves as a jurisprudential anchor, preventing the DEA from substituting a “reason to know” negligence standard for the actual knowledge required by federal law.

The case of Neumann’s Pharmacy is more than a dispute over a small-town Louisiana drugstore; it is a fundamental lesson in administrative humility. The court’s ruling serves as a jurisprudential anchor, preventing the DEA from substituting a “reason to know” negligence standard for the actual knowledge required by federal law.

The Grammar of Guilt

Regulatory Drift: How One Word Saves Neumann’s Pharmacy and the Manipulation, Misapplication of Drug Dosing Medical Protocols: Holy Trinity Drug Cocktails

The core of the DEA’s overreach lay in its attempt to lower the legal bar for pharmacist liability under 21 C.F.R. § 1306.04(a). For years, the agency has operated under the assumption that a pharmacist is liable for filling an invalid prescription if they have “reason to know” it was illegitimate—an objective standard that smells of simple negligence.

Judge Willett, however, returned to the basic rules of English grammar to dismantle this interpretation. The regulation punishes a person who “knowingly fills” an invalid prescription. Relying on the Supreme Court’s logic in Flores-Figueroa v. United States, the court noted that “knowingly” is an adverb modifying the transitive verb “fills.” In ordinary English, such an adverb extends to the entire action, including the object of the sentence.

A young child playing with a toy car on a scale model in front of a neoclassical building, symbolizing justice or law, during twilight. — Supreme Court’s logic in *Flores-Figueroa v. United States*, the court noted that “knowingly” is an adverb modifying the transitive verb “fills.”

To illustrate, the court invoked the “child and the toy” analogy: if a child “knowingly takes a toy that belongs to his sibling,” we assume the child knows not only that he is taking an object, but specifically that it is a toy and that it belongs to a sibling.

A young child holding a miniature model of a courthouse, sitting in a courtroom filled with an audience. — “We assume the child knows not only that he is taking an object, but specifically that it is a *toy* and that it *belongs to a sibling*.”

Applying this to the pharmacy: a pharmacist must have actual, subjective knowledge that the prescription is invalid. By rejecting the DEA’s “reason to know” standard, the court protected professionals from being turned into felons for what may amount to nothing more than “willful blindness” or professional oversight.

A courtroom scene featuring several individuals seated at a long wooden table. In the foreground, two men in formal attire listen intently, while the background shows a judge presiding over the proceedings, flanked by multiple audience members and legal documents. — In *Neumann’s*, the DEA skipped this analysis entirely, focusing only on the pharmacy’s “red flag” failures. The Fifth Circuit corrected this course, reaffirming that the primary responsibility for proper prescribing remains with the physician. You cannot punish the person who fills the order without first adjudicating the order itself as a legal nullity.

The Invalidity Prerequisite

The Invalid Prerequiste: How One Word Saves Neumann’s Pharmacy and the Manipulation, Misapplication of Drug Dosing Medical Protocols: Holy Trinity Drug Cocktails

Beyond the mental state of the pharmacist, the DEA committed a “straightforward” procedural error regarding the “corresponding responsibility” rule. The agency’s logic was essentially circular: it sought to punish the pharmacy for filling prescriptions without first proving that the prescriptions themselves were “invalid when issued.”

Under the law, a pharmacist’s liability is derivative. A prescription is only invalid if it was written by a physician acting outside the usual course of professional practice.

In Neumann’s, the DEA skipped this analysis entirely, focusing only on the pharmacy’s “red flag” failures. The Fifth Circuit corrected this course, reaffirming that the primary responsibility for proper prescribing remains with the physician. You cannot punish the person who fills the order without first adjudicating the order itself as a legal nullity.

A judge in a black robe presides over a courtroom, with a gavel positioned on the desk in front. The background features wooden paneling and blurred figures of people seated in the courtroom. — The court rejected this leap with a lesson in legal history. The phrase “course of professional practice” is a term of art with “old soil,” transplanted from the 1914 Harrison Act.

The “Old Soil” of Professional Practice

Perhaps the most significant blow to the DEA’s “regulatory sleight of hand” came in the court’s interpretation of 21 C.F.R. § 1306.06, which requires pharmacists to act in the “usual course of professional practice.” The DEA argued that any deviation from a state-level “standard of care” (i.e., negligence) meant the pharmacist was no longer acting in the “usual course.”

The court rejected this leap with a lesson in legal history. The phrase “course of professional practice” is a term of art with “old soil,” transplanted from the 1914 Harrison Act. As the Supreme Court established in United States v. Moore and the Fifth Circuit echoed in United States v. Collier, this phrase refers to bona fide medical practice. As long as a practitioner acts “as a pharmacist”—even if they are a “bad” or negligent one—they stay within that course.

A pharmacist in a white coat checking a mobile device while standing in an aisle filled with shelves of medication. — The Fifth Circuit agreed, noting that the Controlled Substances Act manifests no intent to regulate the practice of medicine generally. A “bad pharmacist” is a matter for a state licensing board; a “drug pusher” is a matter for the DEA.

Equating a state-level malpractice standard with a federal felony is, as Justice Alito has warned, a “dangerous legal leap” that could “convert every act of negligence under state law into a federal felony.”

The Fifth Circuit agreed, noting that the Controlled Substances Act manifests no intent to regulate the practice of medicine generally. A “bad pharmacist” is a matter for a state licensing board; a “drug pusher” is a matter for the DEA. The agency, the court ruled, cannot use adjudicatory alchemy to turn the former into the latter.

Infographic summarizing the Fifth Circuit ruling in Neumann's Pharmacy v. DEA, highlighting issues of DEA regulatory overreach, 'reason to know' standards, and implications for pharmacist liability. — The DEA attempted to punish Neumann’s for filling a prescription written by the owner’s father. The court pointed out the glaring irony: the law in question explicitly regulates the *act of prescribing* by a physician, not the *act of filling* by a pharmacy.

Absurdity in the Bayou

The DEA’s enforcement zeal reached the level of the absurd when it cited a Louisiana administrative rule to justify the pharmacy’s deregistration. The rule (La. Admin. Code tit. 46, pt. XLV, § 7603(A)(11)) prohibits physicians from prescribing controlled substances to their own children.

The DEA attempted to punish Neumann’s for filling a prescription written by the owner’s father. The court pointed out the glaring irony: the law in question explicitly regulates the act of prescribing by a physician, not the act of filling by a pharmacy. In a final twist of administrative cynicism, the DEA had cited Ms. Neumann’s “lack of knowledge” of this inapplicable law as an “aggravating factor” warranting punishment. The court found it untenable to penalize a professional for being ignorant of a rule that did not even apply to her.

A judge sitting at a courtroom desk, holding a gavel, with a serious expression. The background features wooden paneling and legal documents.

Fifth Circuit Rejected DEA’s corresponding responsibility and usual course of profesional practice interpretations.Download

The Facts vs. The Law: The “Red Flags” in Context

The DEA’s case was built on a series of “red flags” that, while concerning, could not bridge the gap created by flawed legal standards. These included:

“Drug Cocktails”: The pharmacy filled combinations of opioids and benzodiazepines for patients like C.E., which increase overdose risk.
Cash Payments: Patients like J.H.R. and S.W. paid out of pocket for controlled substances while using insurance for other drugs, a classic sign of avoiding monitoring.
Therapeutic Duplication: Patient S.W. received three different formulations of butalbital-based medications for similar symptoms.

While these indicators might justify an investigation or even state-level discipline, the court held that they do not grant the DEA the power to bypass the statutory requirements of knowledge and invalidity. Facts are not a substitute for the law. The dispute over medical standards versus prosecutorial definitions centers on the government’s use of law enforcement slang and expanded definitions to reframe legitimate medical care as criminal activity.

Clinical Practice vs. Law Enforcement Slang

A primary point of contention is the use of the term “Holy Trinity.” While the government presented this as a “common sense” medical term, the sources state it is actually “dangerous law enforcement slang” used to misidentify pain and anxiety treatments.

Medical Testimony: A world-class pain expert from Harvard testified that the term had no medical meaning to her and that prescribing such drug combinations is “absolutely within the usual course of professional practice”.
Law Enforcement Admission: Several government witnesses, including DEA agents and a deputy, admitted under cross-examination that “Holy Trinity” was a slang or “law enforcement term” that medical staff and patients would not use.
Scientific Intuition vs. Ignorance: Critics argue that what law enforcement views as criminal is often necessary specialized healthcare for chronically sick patients, where doctors must use medications off-label or in combination based on medical science and intuition rather than rigid “box” definitions used by the DEA or CDC.

Pope Leo XIV’s pharmacological comprehension of the holy trinity

THE BIBLICAL INTERPRETATION OF THE HOLY TRINITY

On the Solemnity of the Most Holy Trinity, June 15, 2025, Pope Leo XIV described the Trinity as a dynamic communion of love—Father, Son, and Holy Spirit—that invites humanity into a relationship with God. Celebrating the Mass for the Jubilee of Sport, he emphasized that the divine life is a “dance of mutual love” and a model of unity.

Key themes from Pope Leo XIV’s discussion of the Holy Trinity include:

Divine Love as Community: The Trinity is presented as a model of love and unity, with three persons living in deep, shared communion.
Connection to Sport: In his homily, Pope Leo linked the Trinity to sports, describing both as activities that should encourage relationships, dialogue, and “giving of oneself” (gratuitousness).
Reflecting God’s Image: He noted that humans, created in God’s image, are designed to reflect this love and to experience the “dynamic” of the divine inner life.
Encouragement for Youth: Addressing young people, the Pope spoke of the Trinity as a source of strength and community during challenging times

A group of law enforcement officers in tactical gear discussing documents during a nighttime protest in an urban environment. — **Purpose of the Expansion:** The sources argue that the primary purpose of this expanded definition—published 16 months after the defendants’ arrest—was to **aid the prosecution** by allowing a larger number of patients to be labeled as recipients of this “addictive cocktail.”

The Expansion of Medical Definitions for Prosecution

“THE HOLY TRINITY DRUG COCKTAIL“

The dispute also involves the literal definition of these drug combinations.

Original Medical Definition: At the time of the defendants’ arrest in 2015, the only authoritative scientific reference (the Forrester paper) defined the “Holy Trinity” (or “Houston Cocktail”) strictly as a combination of hydrocodone, carisoprodol, and alprazolam.
Prosecutorial Expansion: To encompass more of the defendants’ patients, the government hired Dr. Jon E. Sprague, who published an article 16 months after the arrest that expanded the definition to include any opioid, any benzodiazepine, and carisoprodol.
Impact: This allowed prosecutors to apply a “criminal” label to prescriptions that did not meet the original medical definition of the “cocktail,” effectively using a “straw man” to prove the doctors were acting outside professional standards.
Let me know if there is anything else I can help you with.

The 2016 article by Dr. Jon E. Sprague and Joseph Horsfall, titled “The Pharmacology and Toxicology of the ‘Holy Trinity’,” significantly expanded the medical definition of the term to include a much broader range of drug combinations than previously recognized in scientific literature.

According to the sources, the definition changed in the following ways:

From Specific Drugs to General Classes: Before this article, the only authoritative scientific reference (the 2011 Forrester paper) strictly defined the “Holy Trinity” as the combination of hydrocodone, carisoprodol, and alprazolam. The Sprague article expanded this to include any opioid (not just hydrocodone) and any benzodiazepine (not just alprazolam), while maintaining carisoprodol as the third component.
Broadening the Scope of “Criminal” Activity: This shift allowed the government to apply the “Holy Trinity” label to prescriptions that did not meet the original definition. For example, the sources note that a patient receiving Klonopin, Soma, and Opana could be labeled as receiving the “Holy Trinity” under Sprague’s expanded definition, even though it did not fit the original Forrester criteria,.
Purpose of the Expansion: The sources argue that the primary purpose of this expanded definition—published 16 months after the defendants’ arrest—was to aid the prosecution by allowing a larger number of patients to be labeled as recipients of this “addictive cocktail”,. While the original definition was limited, the new definition meant that more patients from the defendants’ clinic could be characterized as receiving prescriptions that were “outside the usual course of professional practice”,.

The sources highlight that the Sprague article cited the original Forrester paper as its sole support for this “newly expanded definition,” despite Forrester’s work being much narrower in scope.

A diverse group of medical professionals, including doctors and nurses, with some wearing masks, standing closely together in a serious pose. — The Holy Trinity of pharmacological pain care is consistent with incorporating the teachings of Pope Leo XIV’s understandings.

Pope Leo XIV described the Trinity as a dynamic communion of love—Father, Son, and Holy Spirit—that invites humanity into a relationship with God. Celebrating the Mass for the Jubilee of Sport, he emphasized that the divine life is a “dance of mutual love” and a model of unity.

THE PHARMACOLOGICAL UNDERSTANDING OF THE HOLY TRINITY

Group of healthcare professionals, including diverse doctors and a patient, smiling together in a medical office setting.

The Holy Trinity of pharmacological pain care is consistent with incorporating the teachings of Pope Leo XIV’s understanding. On the Solemnity of the Most Holy Trinity, June 15, 2025, Pope Leo XIV described the Trinity as a dynamic communion of love—Father, Son, and Holy Spirit—that invites humanity into a relationship with God. Celebrating the Mass for the Jubilee of Sport, he emphasized that the divine life is a “dance of mutual love” and a model of unity.

Two healthcare professionals wearing masks and scrubs are engaged in a discussion about hand hygiene, while a third person, likely a priest, watches in the background.

The Synergy of Combination: Neuroleptanalgesia

The intentional combination of an opioid and a benzodiazepine is termed neuroleptanalgesia. When these agents are used in conjunction, they produce additive or synergistic effects (Dupras et al., 2001; Green et al., 1981). Synergy occurs when the combined pharmacological impact is greater than the mere sum of the individual agents, allowing the clinician to achieve therapeutic goals using lower doses of each drug.

A group of medical professionals dressed in white lab coats, including doctors and nurses, gather around a man in ceremonial attire with a bishop's hat, symbolizing a special collaboration or event in a hospital setting.

The primary benefits of neuroleptanalgesia include:

Reduction of Adverse Effects: Lowering the required dose of each agent minimizes the dose-dependent side effects typically seen with high-dose monotherapy.
Prolonged Duration: The combination often extends the effective timeframe of sedation or anesthesia, providing a more stable clinical window.
Enhanced Muscle Relaxation: The GABAA mediated relaxation complements the opioid’s antinociception to ensure physical stability and comfort.

An illustration titled 'The Pharmacological Trinity' showing three figures resembling angels or divine beings engaged in a discussion around a central bowl, alongside a graphic representation of synaptic activity related to pain management, including neurotransmitter release and receptor binding.

The clinical success of this medical “unity” serves as a practical reflection of the broader philosophical and theological concept of the Trinity.

A doctor in a white coat stands next to a religious leader in ceremonial robes and a crown, with a woman in a hijab, all smiling together. The background features shelves with books.

The “Pharmacological Trinity” and Holistic Outcomes

This pharmacological synergy finds a profound metaphor in the teachings of Pope Leo XIV. On June 15, 2025, during the Mass for the Jubilee of Sport, the Pope described the Holy Trinity as a “dynamic communion” and a “dance of mutual love” that invites humanity into a relationship with the divine. This model of unity—where three distinct persons exist in one shared life—parallels the way distinct pharmacological agents work in harmony to restore the human person.

A group of medical professionals, including a leader in a religious outfit, pose together in a healthcare setting, showcasing diversity in attire and backgrounds.

Just as the Pope linked the Trinity to the “gratuitousness” (the giving of oneself) found in sport and dialogue, successful pain management aims to restore the patient’s capacity for self-gift. When the “Pharmacological Trinity” of care is applied, the outcomes are measured by the patient’s return to communion:

Ambulation: Transitioning from being home bound or bedridden to active physical movement.
Employment: Re-entering the workforce, thereby restoring a sense of purpose and reducing economic burden.
Social Interaction: Moving from isolation to active relationship, engaging in the “giving of oneself” to family and friends.

A group of healthcare professionals, including doctors and nurses, joyfully interacting with a smiling religious leader in a hospital setting.

Ultimately, this pharmacological “dance” of combined agents serves the highest goal of medicine: restoring the patient’s capacity for dialogue and human connection, echoing the invitation to community inherent in the divine life.

A group of five DEA agents in tactical uniforms, holding firearms, looking serious and intense. The agents are positioned closely together against a dark background.

D.E.A. Manipulation of Legal Standards

The core of the legal dispute rests on the phrase “outside the usual course of professional practice” (21 C.F.R 1306.04).

Calculated Misconduct: The defense argued that introducing these terms under the guise of “common sense” while using them to signify a “crime element” was a calculated effort to substitute the government’s rhetoric for the jury’s independent judgment of medical necessity.

Two men in suits sit in a formal hearing room, appearing serious and focused. Other individuals are seated in the background, and a clock is visible on the wall. — DOJ PROSECUTORS

Lack of Statutory Definition: The sources argue that because there is no clear statutory definition for what constitutes “outside the usual course,” the government can easily manipulate and exploit the standard.

A row of brown wooden jury chairs inside a courtroom, facing forward with a wooden railing in front. — Mislead Juries

Substituting Jury Judgment: Prosecutors used “Holy Trinity” as a rhetorical device to lead the jury to a legal conclusion of guilt. By asking expert witnesses if a “Holy Trinity” prescription was “within the usual course of practice,” the government prompted experts to draw legal conclusions for the jury, which is a violation of federal rules of evidence.

A close-up view of a legal document with the letters 'DEA' prominently displayed, next to a gavel and a set of golden scales, symbolizing law and justice. — this-partnership-conspiracy-between-dea-and-blue-cross-blue-shield. PERRY DEA, See Pompy vs DEA

The Limits of Agency Discretion

The Neumann’s Pharmacy ruling is a vital reminder that administrative authority is not infinite. While the DEA possesses broad discretion to protect public health, that power is tethered to the “governing text.” If an agency finds its existing regulations too cumbersome for the current crisis, it must change them through transparent rulemaking, not through the “quiet rewriting” of standards during an enforcement hearing.

The Fifth Circuit has drawn a line in the sand: “even the most urgent regulatory goals” do not excuse an agency from following its own rules. This leads to a larger, more provocative question for the future of administrative law: If an agency can redefine the “usual course” of a profession to mean whatever its current enforcement priorities demand, does the professional’s license belong to the state, or to the law?

🔓 🔓 🔓

ALL WATCHED OVER BY MACHINES OF LOVING GRACE

HUNTED BY DOJ-DEA