UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
Case No. 21-1262
United States Drug Enforcement Administration
STATEMENT OF ISSUES TO BE RAISED
Pursuant to the Court’s Order of December 20, 2021, and D.C. Circuit Rule 28(a)(1), Petitioners Norman Clement prose in Case No. 21-1262 hereby submits these Statement of Issues To Be Raised,
The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process.
One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a).
Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.
DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.
A. Reflecting the distinct roles of prescribers and pharmacists, § 1306.04 imposes liability only on pharmacists who “knowingly” fill an illegitimate prescription.
Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care. (See Amicus Curiae Brief National Association Chain Drug Stores,
US Supreme Court Case No. 20-1410, Ruan vs. the United States of America) Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs.
The pharmacist has neither examined nor diagnosed the patient and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.
The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a), and that they risk criminal and civil liability if they do, see id. §§ 841(a), (c), 842.
The CSA’s implementing regulations further explain that a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a).
The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.
Consistent with the division of responsibility be- tween prescribers and pharmacists, § 1306.04 limits when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a pharmacist knows a prescription is illegitimate:
The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.
An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.21 C.F.R. § 1306.04(a) (emphasis added).
A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.”
These critical limitations on a pharmacist’s possible liability under § 1306.04 are no accident. They were added to the regulation intentionally to avoid the un- warranted and counterproductive imposition of liability.
When first proposed in 1971, the regulation lacked the word “knowingly,” which would have allowed penalties for any “person filling [an illegitimate] prescription.” Purpose of Issue of Prescription, 36 Fed. Reg. 4847, 4948 (Mar. 13, 1971).
Pharmacists protested such an expansive rule, however, and during the comment period specifically “objected to the responsibility placed upon a pharmacist under § [1306.04] to determine the legitimacy of a prescription.”
Comments and Objections to Part 306, 36 Fed. Reg. 7776, 7777 (Apr. 24, 1971). The DEA agreed with these comments and changed the legal standard in the final regulations, noting the “language [was] revised to require knowledge.”
B. DEA displays a lack of knowledge and of pharmaceutical medical practices.
The warrant issued identified Items that are evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.
The intent of this law implies that it shall be unlawful for any person knowingly or intentionally— to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.
The DEA uses the law with intent to imply a license for Pharmacist and medical professionals as a person that illegally distributes, or dispense controlled substances.
The DEA has deliberately reinterpreted the law to support their effort to attack Pharmacist, in essence, the DEA willfully and knowingly misguided the courts that the petitioner a licensed pharmacist was in violation of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone. The officers should be charged under Giglio.
As a licensed pharmacist, the Petitioner carried out his fiduciary responsibility Norman Clement was acting in the capacity of a license’s pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drugs.
This definition and is a statute within the Florida Admirative Code & Florida Administrative Register. The officer acted upon an oath to enter the premises to secure evidence of violations of 21 U.S.C. §§ 841(a)(1) (possession with the intent to distribute and distribution of oxycodone and hydromorphone.
The DEA agents removed files with the intent of searching to discover items to suggest a criminal act took place or is taking place. This is not implied within the warrant and the act of looking to find a criminal act is not supported by probable cause.
Such act to search to find without stated cause for the search is an investigative function that violates the premise of a search warrant and violated the basis of Probable Cause, and elements of Reasonable Suspicion.
The search conducted was not specific in nature whereby the agents confiscated items not specific to the warrant.
The removal of such documents and items serves no purpose of criminal activity but only to develop a case beyond the scope and statutes of the search.
The intent is that a person and not a sold medication and criminalizing the job of a licensed Pharmacist.
The Fourth Amendment was intended to create a constitutional buffer between U.S. citizens and the intimidating power of law enforcement.
The officers failed to indicate within their search warrant the components of what was to be seized.
The officers exercised undue discretion when they choose to search and seize.
Therefore, the interest of the defendant was violated when the search and seizures became “unreasonable” and not authorized by the warrant based upon probable cause, to remove personal artifacts such as documents of academic research. This binder contained copyrighted academic research.
C. Pharmaceutical Compounding licensed by the State of Florida
“Compounding” is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S.
The term also includes the preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term “commercially available products,” as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are legally distributed in the State of Florida by a drug manufacturer or wholesaler.
(1) Compounding includes:
(a) The preparation of drugs or devices in anticipation of prescriptions based on routine, regularly observed prescribing patterns.
(b) The preparation pursuant to a prescription of drugs or devices which are not commercially available.
(c) The preparation of commercially available products from bulk when the prescribing practitioner has prescribed the compounded product on a per prescription basis, and the patient has been made aware that the compounded product will be prepared by the pharmacist.
The reconstitution of commercially available products pursuant to the manufacturer’s guidelines is permissible without notice to the practitioner.
If the officers were asked the difference between compounding and manufacturing, they must know what they are being asked. A reasonable officer could not support or testify to the facts of any item or file that was within the seized computer or secondary storage systems. In the warrant, the DEA deliberately misinterpreted compounding as manufacturing control substances.
D. THE CONDUCT OF DEA’S PECULIAR COURT SYSTEM NEEDS SERIOUS JUDICIAL REVIEW
The Court System of the Drug Enforcement Agency (DEA), has slipped through both Judicial review and Congressional oversight and operates outside the Federal Rules of Civil and Criminal Procedures not bounded by Giglio and in contempt and violation of those protections of the Constitution of The United States of America.
This Administrative Court acts in the capacity as both Criminal and Civil Court. The Judges of this peculiar court system make their own decision and rules which permits DEA Agents, and Diversion Investigators to act as rogues to which no Federal or Constitutional protection are they bound to respect or abide by.
Associate Supreme Court Justice Gorsuch wrote April 20, 2020, Ramos v Louisiana:
“Imagine a constitution that allowed a “jury trial” to mean nothing but a single person rubber-stamping convictions without hearing any evidence but simultaneously insisting that the lone juror come from a specific judicial district “previously ascertained by law….And if that’s not enough, imagine a constitution that included the same hollow guarantee twice—not only in the Sixth Amendment but also in Article III.8 No: The text and structure of the Constitution clearly suggest that the term “trial by an impartial jury” carried with it some meaning about the content and requirements of a jury trial”
The officers of this peculiar Court system, the mission is not to seek out the truth and but to promote injustice by eliminating the truth supporting junk science and unscientific bias.
Thus this DEA Court System has allowed this Federal Agency to gain powers over the entire field of medicine (healthcare science) and permitted the Agency to redefine medical procedures medical science.
E. Red Flags
In recent enforcement actions it has filed across the country, accusing pharmacists and pharmacies of unlawfully dispensing medicines, the U.S. Department of Justice (DOJ) has aggressively attempted to sidestep § 1306.04’s knowledge requirement. Citing pharmacists’ “corresponding responsibility,” DOJ has argued that pharmacists are liable for filling prescriptions that allegedly present so-called “red flags”—factors that do not necessarily bear on a prescription’s facial validity but that, in DOJ’s opinion, suggest the prescriber may have written it for an illegitimate purpose.
Under DOJ’s theory, the presence of one or more “red flags” not only proves that a prescription is illegitimate but that a pharmacist who fills it must be doing so “knowingly.” (see Amicus Curiae Brief National Association Chain Drug Stores, US Supreme Court Case No. 20-1410, Ruan vs. the United States of America)
The “red flags” advanced by DOJ include patients seeking to fill “[n]ew prescriptions for controlled sub- stances a patient has never received before”;(2) certain combinations of prescribed drugs; 3 providing physician-ordered refills when “one to three days of supply remained”;(4) late filing of prescriptions;5 dispensing the same medications “for the same patients over long periods of time”;6 prescriptions for doses above “90 [morphine milligram equivalents]/day”;(7) and prescriptions for more than one “immediate-release opioid[ ] …sufficiently close in time that the supplies would have overlapped.”(8)
Even though in many circumstances these supposed “red flags” have legitimate explanations (medical or otherwise), DOJ has gone so far as to argue that the presence of one or more of these elements is “near conclusive[ ] evidence of a prescription’s invalidity.”(9)
According to DOJ, when faced with a prescription presenting one or more “red flags,” a pharmacist must identify each issue, take steps to resolve it, and document in writing how it was resolved—no matter how many times the same patient has presented the prescription. Until and unless each “red flag” is resolved, DOJ says, a pharmacist must second-guess the prescription’s appropriateness, override the prescriber’s medical judgment, and refuse to fill it—or else face the threat of liability.
There are many problems with DOJ’s “red flags” theory. It has no basis in the CSA or its implementing regulations, or even in the DEA’s Pharmacist’s Manual. It imprudently dismisses the individualized, case-by-case approach that pharmacists take when filling prescriptions in favor of a categorical approach to culpability.(10)
And it traps pharmacists in an untenable position—either face liability under the CSA for filling a facially valid prescription that raises a “red flag,” or face state-based professional liability,(11) and even civil suits,(12) for refusing to fill such a prescription.
But the critical point here is that § 1306.04 pro-vides protection for pharmacists that the Court should not inadvertently eliminate: a pharmacist may only be held liable if the pharmacist “knowingly fill[s]” a “purported” prescription.
In other words, unless a pharmacist subjectively knows that a facially legitimate prescription has been prescribed for illegitimate reasons, the pharmacist should not face potential liability for dispensing medication based on that prescription.
Strict adherence to this knowledge element is critical to ensuring that pharmacists acting in good faith are not punished for filling facially valid prescriptions written by licensed and registered prescribers— a punishment that, if rendered, would chill other pharmacists from performing their duties.
In addressing the related issues raised in these cases, the Court should be careful not to undermine this important safeguard.
2 Compl. ¶ 79, United States v. Ridley’s Family Markets, Inc., No. 1:20-cv-00173-TS-JCB (D. Utah Dec. 4, 2020), ECF No. 2.
3 See, e.g., id. ¶¶ 68–72.
4 Compl. ¶ 67, United States v. Shaffer Pharmacy, No. 3:21- cv-00022-JZ (N.D. Ohio Jan. 6, 2021), ECF No. 1.
5 See, e.g., Compl. ¶ 72, United States v. Howen, No. 1:21-cv- 00106-DAB-SAB (E.D. Cal. Jan. 26, 2021), ECF No. 1.
6 Compl. ¶ 66, United States v. WeCare Pharmacy, LLC, No. 8:21-cv-00188-MSS-AEP (M.D. Fla. Jan. 26, 2021), ECF No. 1.
7 Compl. ¶ 75, United States v. Chip’s Discount Drugs, Inc., No. 2:20-cv-00010-LGW-BWC (S.D. Ga. Feb. 12, 2020), ECF No. 1.
8 Compl. ¶ 361, United States v. Walmart Inc., No. 1:20-cv- 01744-CFC (D. Del. Dec. 22, 2020), ECF No. 1.
9 Mem. in Opp’n to Def.’s Mot. to Dismiss at 5 (emphasis added), 8, United States v. Ridley’s Family Markets, Inc., No. 1:20- cv-00173-TS-JCB (D. Utah Mar. 8, 2021), ECF No. 31.
10 See Dispensing Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52716, 52720 (Sept. 6, 2006) (noting that “each case must be evaluated based on its own merits in view of the totality of circumstances”).
11 See, e.g., Wis. Pharmacy Examining Bd., Administrative Warning, Division of Legal Services and Compliance Case No. 17 PHM 095 (Dec. 6, 2018).
12 See, e.g., First Amended Compl. ¶ 2, Fuog v. CVS Pharmacy, Inc., No. 1:20-cv-00337-WES-LDA (D.R.I. Aug. 26, 2020), ECF No. 6 (challenging “corporate-wide discriminatory practices in refusing to fill, without a legitimate basis, valid and legal prescriptions for opioid medication”); Reasor v. Walmart Stores E., L.P., No. 3:19-CV-27-CRS, 2019 WL 5597302, at *3 (W.D. Ky. Oct. 30, 2019) (defamation suit by physician asserting that “the failure to fill his patient’s prescriptions necessarily imputed illegal conduct because pharmacists are required to fill prescriptions unless the Pharmacist has reason to know of some irregularity”).
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