UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
Aaron Howard,
Petitioners,
vs. Case No. 22-1010
United Staes Drug Enforcement Administration
Respondents.
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STATEMENT OF ISSUES TO BE RAISED
Pursuant to the Court’s Order of January 22, 2022, and D.C. Circuit Rule 28(a)(1), Petitioner’s Aaron Howard pro se in Case No. 22-1010 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 inter- changeable, 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. 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 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 licensed Pharmacists and medical professionals as persons that illegally distribute, 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 violations 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 Aaron Howard was acting in the capacity of a licensed pharmacist. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense the medicinal drug.
This definition and is a statute within the Florida Administrative 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.
In this and other cases, DEA Diversion Investigator falsely established diversion based solely on the use of googles maps and performed absolutely no follow up investigation as found in Wheatland Pharmacy, 78 FR 69441, 69445 (2013) to establish diversion or evidence that any patients had diverted any prescription medication filled by pharmacists from At Cost Pharmacy.
Similar misconduct by DEA Diversion Investigation is on the record in investigations of Pronto Pharmacy LLC., Tampa Fl, Lincourt Pharmacy LLC, Clearwater Florida, Superior Pharmacy, Tampa, Fl., Gulf-Med Pharmacy, Cape Coral, Florida.
Such acts 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. IMPROPER DOSING FOR PAIN MANAGEMENT AND CONSTRUCTION OF THE CSA THAT CRIMINALIZE MEDICAL ERROR IMPROPERLY INTRUDES ON THE STATES’ POWER TO REGULATE THE PRACTICE OF MEDICINE.
(See BRIEF OF AMICI CURIAE PROFESSOR OF HEALTH LAW AND POLICY IN SUPPORT OF PETITIONER DR. XIULU RUAN V. UNITED STATES OF AMERICA CASE NO. 20-1410, IN THE SUPREME COURT OF THE UNITED STATES …..24)
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.
However, as noted from the record both federal and Florida law require a pharmacist to identify and address red flags of drug abuse or diversion including over-utilization and under-utilization. See 21 CFR 1306.04(a); 21 CFR 1306.06; Fla. Admin. Code. Ann. r. 64B16–27.810.
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 limitations sensibly reflect the very real constraints on pharmacists presented with prescriptions for controlled substances. To be sure, pharmacists can do things like inspect prescriptions for indicia of facial invalidity to determine if they can be filled—e.g., tampering, missing or incorrect information, a forged signature, or a prescribing physician who is not DEA-registered. See 21 C.F.R. § 1306.05(a).
When presented with a facially valid prescription, however, a pharmacist cannot be expected to second-guess the prescriber’s medical judgment that the prescribed medicine is appropriate, to interrogate the patient re- regarding whether they actually need the prescribed medication, or to obstruct the patient’s care by withholding it.
The law should not unduly chill a pharmacist’s performance of her/his duties to make medications safely available to patients who need them. The knowledge requirement in § 1306.04 properly reflects this circumscribed role.
Any construction of Section 841(a)(1) that permits the federal government to criminalize good-faith medical errors raises alarming federalism implications.
The states that have primary authority to regulate the practice of medicine under their reserved Tenth Amendment police powers. See, e.g., Linder v. United States, 268 U.S. 5, 18 (1925) (“[D]irect control of medical practice in the states is beyond the power of the federal government.”); Barsky v. Bd. of Regents, 347 U.S. 442, 449 (1954) (“The state’s [broad power to establish and enforce standards of conduct within its borders relative to health] extends naturally to the regulation of all professions concerned with health.”); Hillsborough Cty. v. Automated Med. Labs., Inc., 471 U.S. 707, 719 (1985) (The regulation of health and safety is “primarily, and historically, a matter of local concern[.]”); Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 387 (2002) (espousing that establishing “standards of reasonable medical care” is a “quintessentially state-law” function).
The preservation of a proper balance between federal and state powers is central to our constitutional design and the protection of fundamental liberties. As this Court has explained:
This federalist structure of joint sovereigns preserves to the people numerous advantages. It assures a decentralized government that will be more sensitive to the diverse needs of a heterogenous society; it increases opportunity for citizen involvement in democratic processes; it allows for more innovation and experimentation in government; and it makes government more responsive. . . . Just as the separation and independence of the coordinate branches of the Federal Government serve to prevent the accumulation of excessive power in any one branch, a healthy balance of power between the States and the Federal Government will reduce the risk of tyranny and abuse from either front.
Gregory v. Ashcroft, 501 U.S. 452, 458 (1991).
Consequently, the federal-state balance of power cannot be dramatically reconstrued by either judicial supposition or a federal law enforcement agency’s in- interpretation of a statute that runs afoul of its plain text. Raygor v. Regents of University of Minnesota, 534
U.S. 533, 543 (2002) (“When Congress intends to alter the usual constitutional balance between the States and the Federal Government, it must make its intention to do so unmistakably clear in the language of the statute.”).
The federal government has no right to interfere with a state’s authority to regulate medical practice without “a clear indication that Congress in- tended that result.” Solid Waste Agency of Northern Cook County v. United States Corps of Engineers, 531 U.S. 159, 172 (2001); Pegram v. Herdrich, 530 U.S. 211, 237 (2000) (“[I]n the field of health care, a subject of traditional state regulation, there is no . . . preemption without clear manifestation of congressional purpose.”).
In cases involving “Congressional regulation of core state functions,” the clear statement canon has been characterized as a “super-strong rule” of statutory construction that carries weightier force than ordi- nary preemption. William N. Eskridge, Jr. & Philip P. Frickey, Quasi-Constitutional Law: Clear Statement Rules as Constitutional Lawmaking, 45 Vand. L. Rev. 593, 623-24 (1992); see also Pa. Dep’t of Corr. v. Yeskey, 524 U.S. 206, 208–09 (1998) (“[A]bsent an unmistakably clear expression of intent . . . we will interpret a statute to preserve rather than destroy the States’ substantial sovereign powers.”) (quotation marks and citations omitted).
The rule of lenity, a “time-honored interpretive guideline,” also applies when Courts construe an ambiguous criminal statute. United States v. Kozminski, 487 U.S. 931, 952 (1988).
Under the rule, when choosing between two constructions of a crime, the statute shall be construed in favor of the defendant. United States v. Universal C.I.T. Credit Corp., 344 U.S. 218, 221-22 (1952) (“We should not derive criminal out- lawry from some ambiguous implication”). The rele- vant provision of the CSA at issue here, however, is unambiguous.
CSA Section 841(a)(1) cannot be interpreted as criminalizing good-faith medical mistakes under per- tinent precedent because the statute lacks any suggestion that Congress intended to delegate to the Department of Justice (DOJ) breathtaking authority over the practice of medicine. Instead, Congress ex- plicitly left to the states the authority to regulate the medical professions. See 21 U.S.C. § 823(g)(2)(H)(i) (“Nothing in such regulations or practice guidelines may authorize any Federal official or employee to ex- ercise supervision or control over the practice of medicine or the manner in which medical services are provided.”). This Court has long recognized that the state’s protection of “the health of its citizens . . . is at the core of its police power,” Sporhase v. Neb. ex rel. Douglas, 458 U.S. 941, 956 (1982), and has expressly rejected the notion that the CSA grants either DOJ or DEA the broad authority to regulate the practice of medicine:
[t]he [CSA] and our case law amply support the conclusion that Congress regulates medical practice insofar as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood. Beyond this, however, the statute manifests no intent to regulate the practice of medicine generally. The silence is understandable given the structure and limitations of federalism, which allow the [s]tates “[ ]great latitude un- der their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.[ ]”
Gonzales, 546 U.S. at 269-70 (emphases added).
Not only does Congress know how to explicitly delegate the authority to regulate controlled substance prescribing to a federal agency, it has done so in one— and only one—narrow category: opioid use disorder (OUD) treatment. Id. at 271 (holding that 42 U.S.C. § 290bb-2a is the only arena in which Congress has set federal medical standards and “indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute”); see also Anderson et al. at 98 (“Despite the longstanding norm of federal noninterference in medicine, . . . the federal government can regulate medical practice if it makes its intention to do so clear and un- ambiguous.”).
And even then, Congress expressly delegated the authority to set federal medical standards regarding OUD treatment to the Department of Health and Human Services (HHS) and not a federal law enforcement agency. 42 U.S.C. § 290bb-2a (“The Secretary of Health and Human Services, after consultation with the Attorney General . . . shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction. . . .”).
Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.”
21 U.S.C. § 801(1). Congress, therefore, did not even leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances— without health care agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before in- itiating proceedings . . . [to schedule or reschedule a drug] . . . request from the [HHS] Secretary a scientific and medical evaluation, . . . The recommendations of the Secretary to the Attorney General shall be binding . . . as to such scientific and medical matters.”).
Furthermore, this Court has expressly held that DOJ cannot criminally prosecute OUD prescribers under CSA Section 841(a)(1) unless they sell “drugs, not for legitimate purposes but ‘primarily for the profits to be derived therefrom’ ” and are acting outside the usual course of professional practice such that their behavior is akin to that of a “large-scale [drug] pusher, not as a physician.” Moore at 345.
Congress’s refusal to permit a federal agency to regulate the practice of medicine beyond illegal trafficking is further evidenced by the Narcotic Addict Treatment Act (1974) (NATA), which amended the CSA to permit HHS to regulate OUD treatment. NATA’s legislative history demonstrates that the Senate Judiciary Committee carefully weighed the states’ long-standing authority to regulate “the general practice of medicine” against “the specialized circumstances within the purview of the bill [e.g., OUD treatment], which entail inordinate risks of diversion and unethical profiteering.” S. Rep. No. 93-192, at 13 (1973).
The Committee report further explains that the purpose of the NATA amendments was to “re-affirm the commitment Congress made to the nation when it passed the [CSA] by . . . facilitating the prosecution of those who engage in the criminal distribution of legitimate narcotic drugs for profit.” Id. at 15.
In sum, the CSA permits the federal prosecution of prescribers who operate as drug traffickers as traditionally understood and, thereby, knowingly or intentionally engage in prescribing conduct that exceeds the bounds of professional practice. Congress never intended to delegate to law enforcement the authority to regulate the practice of medicine by criminalizing good-faith medical mistakes. See 21 U.S.C. § 903.
The CSA also depends on state law to determine which medical professionals constitute “practitioners” acting “in the course of professional practice” and are, therefore, presumptively eligible for federal controlled substance registration. 21 U.S.C. § 823(f ) provides that “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled sub- stances under the laws of the State in which he practices”) (emphasis added); id. § 802(21) (defining “practitioner” to include “a physician . . . licensed by the United States or the jurisdiction in which he practices . . . to . . . dispense . . . a controlled substance in the course of professional practice”) (emphasis added).
The CSA further mandates that DOJ defer to state medical licensing authorities before denying, suspending, or revoking a state-licensed prescriber’s registration. Id. § 823(f )(1) (explaining that the Attorney General may deny, suspend, or revoke a state-licensed prescriber’s registration if doing so is in “the public interest” and that the first of the five factors that the Attorney General must consider in making such a de- termination is “[t]he recommendation of the appropriate State licensing board or professional disciplinary authority”).
In a 1998 letter to the House Judiciary Committee Chairman, Attorney General Janet Reno explained that the CSA was not “intended to displace the states as the primary regulators of the medical pro- fession or to override a state’s determination as to what constitutes legitimate medical practice.” Oregon v. Ashcroft, 368 F.3d 1118, 1123 (2004).
Consistent with Congress’s long-standing policy of leaving the regulation of medical practice to the states was its refusal to enact the Pain Relief Promotion Act (PRPA), which would have made illicit the controlled substances used in physician-assisted suicide and, thus, delegated to the DEA the authority to regulate medicine. Pointing to the DEA’s lack of requisite medical and scientific expertise, Congress rejected PRPA. S. Rep. No. 106-299, at 61 (2000) (“[T]his poorly written, poorly thought-out statute would wreak havoc on States’ traditional police authority to regulate their own doctors—an authority they have enjoyed for more than 200 years. . . . In our view, the DEA is not qualified to handle investigations into allegation [sic] of the misuse of pain management drugs.”) (emphasis added).
Congress has refused to extend the right to interfere with the states’ regulation of medical practice even to those federal agencies with significant scientific and medical expertise.
The Food Drug and Cosmetics Act (FDCA) expressly provides that it should not “be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device . . . within a legitimate health care practitioner-patient relationship.” 21 U.S.C. § 396; see also United States v. Regenerative Sci., LLC, 878 F. Supp. 2d 248, 255 (D.D.C. 2012).
This express limitation of the FDCA is of significant practical import. If the FDCA pre-empted the regulation of medical practice, prescribers would be stripped of their traditional right to prescribe Food and Drug Administration (FDA) approved drugs “off-label,” that is, for non-approved uses to benefit their patients.
The Supreme Court has expressly endorsed the off-label practice of medicine. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (off-label use is an “accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine”). The United States Congress has taken precisely the same view:
In general, the FDA has no authority to regulate how physicians prescribe approved drugs in the context of their medical practice.
Physicians prescribing off-label uses of approved drugs is not within the jurisdiction of the FDA.
H.R. Rep. No. 105-310, at 60 (1997).
The Social Security Amendments of 1954 also make clear federal non-interference with the states’ health-related police powers, providing that “[n]othing in this title shall be construed as authorizing the Commissioner of Social Security . . . to interfere in any way with the practice of medicine. . . .” 42 U.S.C. § 416.
The federal Medicare statute, the Fertility Success Rate and Certification Act of 1992, and the Drug Addiction Treatment Act of 2000 each included similar expansive and express prohibitions on federal interference with the practice of medicine. 42 U.S.C. § 1395 (“Nothing in [the Medicare statute] shall be construed to authorize any Federal officer or employee to exercise any super- vision or control over the practice of medicine.”); 42 U.S.C. § 263a-2(i)(1) (“[HHS] may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine”); 21 U.S.C. § 823(g)(2)(H)(i) (“Nothing in such regulations or practice guidelines may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the manner in which medical services are provided.”).
Congress’s long-standing and express prohibition on federal interference with state authority to regulate the medical professions is grounded in the un- controversial notion that it is the states that are the laboratories of inventive “social and economic experiments” in our dual sovereignty system of government. New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932) (Brandeis, J., dissenting) (“It is one of the happy incidents of the federal system that a single courageous State may, if its citizens choose, serve as a laboratory; and try novel social and economic experiments without risk to the rest of the country.”).
Permitting state heterogeneity in medical practice bolsters medical innovation and benefits public health. Gregory, 501 U.S. at 458 (explaining that the very purpose of the clear statement rule is to preserve a “federalist structure of joint sovereigns . . . that will be more sensitive to the diverse needs of a heterogeneous society” and that “in- creases opportunity for citizen involvement in democratic processes; [and] allows for more innovation and experimentation in government”).
Medical innovation is necessarily wrought from medical practitioners’ discretion to deploy their specialized training and expertise to pioneer new treatment approaches that may improve patients’ well-being. This is likely why there is not a single federal statute that indicates that Con- gress intended to permit a federal law enforcement agency to criminalize good faith yet mistaken attempts to revolutionize medical practice. United States v. Lopez, 514 U.S. 549, 583 (1995) (Kennedy, J., concur- ring) (cautioning against “foreclos[ing] the States from experimenting in an area to which States lay claim by right of history and expertise”).
D. Eliminating the Mens Rea Requirement from 841(a)(1) Stifles Innovation, Harms Patients, and Compromises Practitioners’ Ethical Integrity
In the absence of a mens rea requirement, the national standards of practice used in Section 841(a)(1) prosecutions to determine the usual course of professional practice is a dangerous precedent for criminal liability. Standard of care inquiries in civil matters evaluate the reasonableness of practitioner treatment decisions and measure prevailing customs, with tolerance for “respectable minority” approaches, including innovative medical practices. Sandra H. Johnson, Customary Standards of Care, 43 HASTINGS CTR. REP. 6, 9-10 (2013). In civil matters, liability does not implicate more than reputational and pecuniary interests.
On the other hand, using one component of a civil standard to determine criminal liability will further fuel practitioners’ reasonable fears of the kinds of legal scrutiny that can end not only practitioners’ careers but deprive them of basic liberties. Dineen & DuBois. In self-interest, practitioners are incentivized to avoid innovation and the care of patients with unique or complex needs. Instead of comporting with the ethical duties to maximize their patients’ well-being, practitioners over-comply with perceived legal norms to avoid any possible legal entanglement at those patients’ expense. Id.; Dineen, Definitions Matter.
The fear of criminal scrutiny, including the deter- rent effect of investigations alone, motivates practitioners to avoid prescribing controlled substances as well as the care of the patients who might benefit from them. Sandra H. Johnson, Regulating Physician Behavior: Taking Doctors’ “Bad Law” Claims Seriously, 53 ST. LOUIS U. L.J. 973 (2009); see also Cara L. Sedney et al., “The DEA Would Come In And Destroy You”: A Qualitative Study of Fear And Unintended Consequences Emerging From Restrictive Opioid Prescribing Policies In West Virginia (Oct. 25, 2021), https://www.researchsquare.com/article/rs-991531/ v1 (conducting qualitative interviews with prescribers who repeatedly identified the fear of the DEA as motivating patient avoidance). According to Michael Barnes,
DOJ raids and searches . . . interrupt the de- livery of health care, put patients’ lives at risk, and unjustly destroy careers and livelihoods. They also create confusion and fear among professionals serving or considering serving similar patient populations. A reluctance to practice and prescribe controlled medications when medically necessary is especially troublesome given rising rates of suicide, the availability of increasingly lethal black-market alternatives, and in the case of OUD, the federal objective of increasing, rather than decreasing, prescribing.
Michael C. Barnes, A More Sensible Surge: Ending DOJ’s Indiscriminate Raids of Healthcare Providers, 8 LEG. & POLICY BRIEF 7, 21 (2019).
See BRIEF OF AMICI CURIAE PROFESSOR OF HEALTH LAW AND POLICY IN SUPPORT OF PETITIONER DR. XIULU RUAN V. UNITED STATES OF AMERICA CASE NO. 20-1410, IN THE SUPREME COURT OF THE UNITED STATES…….14 )
E. 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 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.
G. 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. 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 it’s 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 provides a 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.
A 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— 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.
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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”).
FOR NOW, YOU ARE WITHIN
THE NORMS
