REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, 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 THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, 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
“WE ARE NOT POWERLESS AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY OF UNITED STATES DRUG ENFORCEMENT AGENCY
JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG DARNELLA FRAZIER, BORE WITNESS TO THE MURDER OF GEORGE FLOYD THE BLOG youarewithinthenorms.com BARES WITNESS AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE”
JULY 15, 2019: DEA LETTER TO RICHARD LAWHERN Ph.D.:
“DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.”
THE CHRONIC PAIN GAME PROSECUTIONS
The dosage amounts of any prescribed medications from a practitioner are based upon factors such as age, gender, size, and most importantly the disease and the disease state of the individual patient.
MR. BEERBOWER:
“Thank you, Your Honor, and good morning. The evidence in this matter is
very straightforward. The evidence will show that there was a series of subpoenas and inspections. DEA obtained records, including dispensing records and patient profiles for Respondent’s dispensing activities; that records were reviewed by a pharmacy expert retained by
DEA (Donald Sullivan Ph.D.).
” The evidence will show that the expert concluded that the Respondent’s dispensing activity showed a number of suspicious patterns, including the fact that 99 percent of prescriptions filled at Respondent’s pharmacy was paid for in cash”
Mr. Beerbower stated;
“The evidence will show that at least through May 2019 Respondent continued to dispense unjustifiably large quantities of compounded medications to patients who had no legitimate need for them. That is, that respondent manufactured these controlled substances without being registered with the DEA as a manufacturer.”
Pronto pharmacy was a facility license to compound medication.
These statements by the DEA clearly demonstrated the lack of knowledge of pharmaceutical procedures and pharmacology. There is a clear distinct difference between manufacturing and compounding. Mr. Beerbower further made a presentation in court to support the DEA’s intentions to prosecute, suspend licenses, and/or imprison Dr. Norman Clement. The DEA used its Power of the Badge to raid and enforce their perception of wrongdoing.
Mr. Beerbower then stated, “The Government would ask that the Tribunal recommends that Respondent’s registration be revoked and any pending applications are denied because its continued registration would be inconsistent with the public interest.”
CHRONIC THE PAIN GAME(4)
PHYSICIAN AGAINST ABUSE LLC
Physicians Against Abuse, (“PAA”) was founded in 2019 articulated in their Amicus Curia Brief in Xilu Ruan vs the United States:
” In response to the astronomical number of convictions against physicians involving “scope of practice” charges that have sprung up in the past two decades. PAA is made up of five Board Members and is a Florida Corporation in the process of gaining nonprofit status.
Physician Board Members of PAA are uniquely situated in identifying the root cause of criminal prosecutions against physicians because either they have been themselves previously subjected to criminal prosecution and/or have had exposure to the criminal court system. Prior to founding the organization, the Board members conducted a review of 211 convictions against physicians over a ten-year span involving prescription and/or health care fraud.
The inescapable conclusion from a review of trial transcripts, including but not limited to opening and closing statements and testimony of expert witnesses, was that the prosecutions against physicians amounted to nothing short of ‘blind leading the blind’- where one blind is the prosecutor and the other blind is the physician’s own attorney.
CHRONIC THE PAIN GAME(5)
In analyzing the root cause of the near 99% percent success rate of convictions against physicians, PAA concluded that what it all boiled down to was a prosecutor with a hunch hiring an expert using the deep pockets of the government, often not even in the same field as the accused physician, to criminalize the behavior of the accused physician. While this may be acceptable in the context of medical malpractice litigation, it is not acceptable where the consequences are loss of freedom for the accused physician.
Relying on a three-pronged approach, (1) the phrase, “not for a legitimate medical purpose”, (2) hired government expert, and (3) ability to show substantial wealth for the accused physician, federal prosecutors have been successfully getting the jury to return a guilty verdict in 9 out of 10 “scope of practice” cases all over the country.
These circumstances combined with the vague statutory language relied upon by prosecutors to convict health care professionals by misapplying the phrase “outside the scope of professional practice” or “not for a legitimate medical purpose” have placed health care professionals on a battlefield where prevailing in a criminal prosecution essentially has a zero chance.
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CHRONIC THE PAIN GAME(3)
This formula has made the US the only country in the world mass incarcerating physicians. This is not because all the criminal doctors miraculously reside in the United States, but rather, because there is something significantly wrong in the manner federal prosecutors have been allowed to litigate these cases as if they are in the “Wild West”. Prosecutors are able to easily appeal to the emotions of the jury all over the country where there is an ongoing opioid crisis such that it is estimated that at least 1 in every 4 individuals knows of a person who has died of an overdose.
JULY 15, 2019: DEA LETTER TO RICHARD LAWHERN Ph.D.:
“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.”
BEERBOWER’S HIGH DOSE OF OPIOIDS BULLSHIT
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 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:
Leo Beletsky of Northeastern calls the government crackdown on prescribers getting low-hanging fruit.
“The DEA measures success based on the number of arrests and prosecutions. Doctors are minor players. 263 physicians were convicted by the DEA on charges between 2003-2017, and over 3000 were forced to surrender their licenses. Data mining billing records and prescription databases have become the hunting ground. The DOJ has partnered with insurance companies to share data.
They create their targets. Who is the biggest prescriber in a region, state, and nationwide? They are investigated. Who does the most procedures? They use ‘flags’ like distance traveled forgetting that by disincentivizing and terrorizing prescribers there is no one left to prescribe, and patients must travel farther for the same services. The flags created during the pill mill era are now self-perpetuating. If you mine data enough you might find something and law enforcement can access data without individualized suspicion, probable cause, or any judicial review.”
DEA TYRANNY AND ABUSES
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 heterogeneous society; it increases the 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 ordinary 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 relevant 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 allows 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, but it has also 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.”).
CHRONIC THE PAIN GAME(2)
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- initiating 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).
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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 regu- late how physicians prescribe approved drugs in the context of their medical practice.
Physicians prescribing off-label uses of ap- proved 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 supervision 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 Congress 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”).
LOW HANGING FRUIT
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