CONFRONTING THE DEA’s CRIMINALIZATION OF PAIN: GREAT IS THY FAITHFULNESS MORNING BY MORNING NEW MERCIES I SEE “ALL I HAVE NEEDED MY HANDS HATH PROVIDED”

“I never dreamed I’d live to see such evil rising again. My mom tried to warn me”

UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT 

Norman Clement, pro se

Petitioner 

Case: No. 21-1262 

Drug Enforcement Administration, 

Respondent

___________________________________________

Petitioners ADDENDUM  Motion REQUESTING  THIS COURT UNDER HIS DISPOSITIVE MOTION TO VACATE DEA’s ADMINISTRATIVE ORDER FOR REVOCATION OF CONTROL SUBSTANCE CERTIFICATE AND DECLARED UNCONSTITUTIONAL Pharmacist Corresponding Responsibility requirement  under 21 CFR 1306.04 as a VIOLATIONS OF PATIENT CONSTITUTIONAL HEALTHCARE RIGHTs

OUT OF A MOUNTAIN OF DESPAIR COMES A METEORITE OF HOPE

The Petitioner, Norman J Clement, pro-se Pursuant to the Court’s Order of  January 09, 2022, and D.C. Circuit Rule 28(a)(1), Case No. 21-1262 submits this additional response in support of his Dispositive Motion and hereby further states,

Statement of Facts

The Petitioner is a licensed Pharmacist, Dentist not a drug street dealer engaged in drug trafficking. The Petitioner began this entire Appeal involving two other pharmacists having cases before this court, Ricardo Fertil Case No. 22-1003 Gulf Med Pharmacy Cape Coral Florida (ricpharm@gmail.com) and Aaron Howard Case No. 22-1010 AARRIC pharmacy (At Cost Rx) of Ft. Myers Florida (alhoward77@yahoo.com) they both have chosen to not pursue their cases. The Petitioner was left standing alone.

PHARMACEUTICAL DEFENSE ATTORNEY

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Efforts to Subjugate

The DEA conducted devious and deceptive means to gain entry into African American own and operated pharmacies.   In several incidents, the members of the DEA appeared as inspectors, and in other entries, they appeared as law enforcement.  The Warrant for Inspection lacks sufficient means to establish probable cause. In fact, to obtain a Warrant for Inspection, the DEA Agents only need to establish ‘Reasonable Cause.’ 

“MORNING BY MORNING NEW MERCIES I SEE”

What is most disastrous, the DEA Agents have full knowledge that no elements of probable cause exist when they obtain the inspection warrant.    The DEA agents used methods of inspection to gain warrantless entry into pharmacies. Once inside the DEA had two choices to make. To gather evidence then get a warrant based on what they confiscated and or observed.  If the pharmacist denied the DEA Agents entry, the agents walk away and seek out a search warrant based on the perceived information.  

PAIN ON TRIAL

Norman Clement, the owner-operator of Pronto’s Pharmacy denied the DEA entry on the inspection.  Three months later, the DEA returned with a search warrant.  Knowing that in many situations involving inspections, the DEA uses this technique to gain entry.  If the owner refuses to allow the inspection, the DEA Agents later return with a search warrant.  However, in both the search warrant and warrant for inspection the element to establish probable cause and or reasonable suspicion is lacking.  

GLINDA DAMES FINCHER SICKLE CELL

In essence, the DEA is conducting a ‘Choice Warrant’ whereby they select an African American-owned pharmacy. The apply US. Criminal codes to justify a search to confiscate and enter.      

MARK IBSEN MD TARGETTED

Under Sec. 1316.07 the Requirement for Administrative Inspection Warrant, In all cases where an inspection is contemplated, an administrative inspection warrant is required pursuant to section 510 of the Act (21 U.S.C. 880), except that such warrant shall not be required for establishments applying for initial registration under the Act, for the inspection of books and records pursuant to an administrative subpoena issued in accordance with section 506 of the Act (21 U.S.C. 876) nor for entries in administrative inspections (including seizures of property):

WALTER R. CLEMENT ADVOCATES PAIN VICTIM

(a) With the consent of the owner, operator, or agent in charge of the controlled premises as set forth in 1316.08;

(b) In situations presenting imminent danger to health or safety;

(c) In situations involving inspection of conveyances where there is reasonable cause to obtain a warrant;

(d) In any other exceptional or emergency circumstance or time or opportunity, to apply for a warrant is lacking; or

(e) In any other situations where a warrant is not constitutionally required.

EXPOSING DEA WRONG DOING WALL STREET JOURNAL 2015

Mr. Harvey Silverglate, a Boston criminal-defense, and civil-liberties litigator, is the author of “Three Felonies a Day: How the Feds Target the Innocent” (Encounter, second edition 2011).

“Federal drug-enforcement officials have made it a serious felony for doctors to overprescribe painkillers or, as the applicable law states, to prescribe controlled substances “other than for a legitimate medical purpose and in the usual course of professional practice.” But the line between legitimate and illegitimate prescription—as drawn by the Drug Enforcement Administration (DEA) and the Justice Department—is far from clear. This puts physicians in great legal jeopardy and too often leaves their patients to suffer needless agony. 

ALL IN FEDERAL PRISON

Last month (MAY 15, 2015) a federal jury in Boston acquitted pain-relief specialist Dr. Joseph Zolot and his nurse-practitioner Lisa Pliner of overprescribing oxycodone, methadone and fentanyl. This prosecution shows why drug warriors need either to clarify the currently indecipherable line between treating pain and unlawfully feeding drug addicts’ habits, or get out of the business of policing and terrorizing physicians. Unfortunately, the government uses legal ambiguity for tactical advantage and will not readily clarify the lines it expects doctors to follow at their peril.

Dr. Zolot and Ms. Pliner were indicted in 2011 for their treatment of six patients between 2004 and 2006. They faced lengthy, consecutive sentences of up to 20 years for each count if convicted. Prosecutors alleged that the two providers recklessly dispensed narcotic painkillers without legitimate medical purpose and were, in effect, dealing. The two pleaded not guilty, maintaining that their prescription practices were proper, and that they were not responsible for their patients’ subsequent abuses. The jurors unanimously agreed. The jury’s rebuke is not likely to end the harassment of physicians who specialize in pain management. Drug warriors collect the scalps of doctors whom they accuse of violating the laws; they have no concern in aiding in the relief of patients’ suffering.”

_______________________________________________________

1. https://www.wsj.com/articles/when-treating-pain-brings-a-criminal-indictment-1434148923

DEA WITHDREW GUIDANCE FOR THE ADMINISTRATION OF NARCOTIC ANALGESICS

In August 2004, after repeated urging, the DEA finally released guidance for the administration of narcotic analgesics. Its pamphlet, produced in cooperation with the medical community, was titled “Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel.” Even if physicians disagreed with the line between legitimate medical practice and criminal over-prescription, at least they had notice of where the government drew the line.

Jeff Singer MD, Cato Advocate

But the DEA’s support of the guidelines was withdrawn less than two months after they were posted on the government’s website. And so doctors were left with no official guidance about how much OxyContin is enough to relieve their patient’s pain, and how much could land them in prison. The DEA’s retraction coincided with the federal prosecution of Virginia pain physician Dr. William Hurwitz, who was eventually convicted. The timing struck many observers as suspicious—did prosecutors realize that Dr. Hurwitz’s lawyers could claim that his prescribing practices conformed to its guidelines? 

STEPHEN HENSON MD NATURAL LIFE IN FEDERAL PRISON

The DEA has refused to explain why it withdrew its support, and the agency has issued no further guidance. The prosecutions of Drs. Hurwitz and Zolot, nurse Pliner and others have ramifications that extend beyond the medical professionals unlucky enough to be caught in the DEA’s web. Doctors are increasingly afraid to prescribe certain drugs to patients who might seriously need them.”

RAGE AND THE WAR ON DRUGS

WHITE RAGE:

CAROL ANDERSON AUTHOR

DEA TACTICS TARGETING PHARMACIES PROCEDURAL AND DECEPTIVE BACKGROUND

The acts and actions of the DEA are baseless. This agency’s law enforcement actions violate the basic elements of investigatory practices.  “The Government obtained the immediate suspension and sought revocation based on allegations that Petitioner had repeatedly filled prescriptions for controlled substances despite obvious red flags of drug abuse and diversion in violation of federal and state law and had engaged in the manufacture of controlled substances without the appropriate DEA registration. Id. at 64,714”.

The DEA has not articulated the facts to support an investigation to establish probable cause and or reasonable suspicion.  When a government agency seeks to remove and undermine the pharmaceutical business based on an allegation, violates the very principles of the 4th amendment.

STEVE ARIENS PHARMACIST

The tactics of the DEA give carte blanche in accessing any facility without limitations or restrictions.  In the administration Warrant for Inspection for AARRIC Pharmacy and Oak Hill Hometown Pharmacy on both inspection warrants, there were variances in the application. The ARRIC inspection warrant, “Arricc’s DEA COR should be revoked, and any pending application should be denied because AARRIC has committed such acts as would render it registration inconsistent with public interest under 12 U.S.C 823(f) see 21 U.S.C 824(a)(4). 

RICHARD KAUL MD TARGETTED

OHHP inspection warrant, “OHHP DEA COR should be revoked, and any pending application should be denied because OHHP has committed such acts as would render its registration inconsistent with the public interest as that term is defined under the Controlled Substance Act, See 12 U.S.C 824(a) see 21 U.S.C  823(f).

In both inspection warrants, the DEA presented the exact document with only a slight variance on the wording.  In either of the statements. The DEA has not articulated the facts to support an investigation to establish probable cause and or reasonable suspicion. 

CHRISTINE BLACK MD VICTIM AND ADVOCATE

The Search and Seizure Warrant issued for Pronto’s Pharmacy was more structured as an administrative warrant for Inspection.  This search warrant lacked sufficient cause to support the probable cause and or reasonable suspicion.  In as such in both Administration inspection Warrant and the Search warrant there were demands of what to seize.  

Wheatland Pharmacy; Decision and Order

On November 3, 2009, a DEA Diversion Investigator (DI) conducted a pre-registration investigation of the Applicant. GX B, at 2. On November 13, 2009, the Applicant was issued a DEA Certificate of Registration FW1734309, which authorized it to dispense controlled substances in schedules II through V as a retail pharmacy. GX 2.

“Morning by morning new mercies I see

All Have needed Thy hand hath provided

“Great is Thy faithfulness,” Lord, unto me!

“Ms. Clark told a DEA Diversion Investigator (DI) that she had contacted the PA and was told that the prescriptions were valid. GX B, at 2-3. However, the DI later determined that Ms. Clark’s statement was false. Id. at 3. During the conversation, the DI advised Ms. Clark that “she could decline to fill such prescriptions” and also reminded her “of a pharmacy’s corresponding responsibility” under the Controlled Substances Act. Id”.

Red Flags – Distance

The term Red Flag has no statutory meaning in the areas of pharmaceutical and or within the medical profession.  

“DEA registration authorizing it to dispense controlled substances in schedules II through V3 and proposed its revocation and denial of any pending applications for renewal, because Pronto Pharmacy, LLC’s continued registration was “inconsistent with the public interest.” (citing 21 U.S.C. §§ 824(a)(4) and 823(f)). 86 Fed. Reg. at 64,714, 64,726. Norman Clement (Petitioner) is the owner and pharmacist-in”.

NABURUN DASGUPTA PH.D. RESEARCHER

When emergency circumstances arise, such imminent danger to life, a law enforcement officer is permitted to forcibly enter a property, without a search warrant, for effecting a rescue of the person endangered or to prevent a person from causing imminent danger to the public.   The DEA officers did not articulate the elements that imminent danger exists; the DEA officers did not articulate the elements that Pronto Pharmacy LLC, was inconsistent with the public interest.  Without factual evidence how could anyone know that Pronto Pharmacy LLC, was inconsistent with the public interest? The DEA did not properly describe or present any documents or evidence to support their accusation.

CHRISTOPHER RUSSO MD/ FACING 10 YEARS PRISON

“The evidence established that Petitioner repeatedly filled controlled substances prescriptions for eleven customers that raised numerous red flags”

What this federal agency is doing is monitoring, “the point of sales from the point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level – hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions.”   In essence, this agency is doing is monitoring and prosecuting medical professionals for performing their licenses medical fiduciary responsibilities to patients.    In either case Oak Hill pharmacy, ARRIC pharmacy, or Pronto’s Pharmacy it is not stated within any document or testimony that a pre-registration investigation took place.  No indication of any surveillance, criminal interviews of witnesses, or perpetrators to determine or establish that a criminal act by either pharmacist or pharmacist staff took place.   

PAIN PROTEST

Most withstanding within the acts of the DEA are the clams that people drive distances to obtain medication. The DEA classifies this as a Red Flag. Due to the DEA’s aggressive policing of community pharmacies, most of them are reluctant to fill legitimate narcotic analgesic prescriptions for non-acute pain patients.  Some patients are known to spend days on end looking for a pharmacy to fill their prescriptions to no avail.  This has caused massive concern in the medical community thousands have died an equal amount of healthcare providers fear targeting by DEA.  

Importantly, one of the goals of therapy is continual treatment without gaps.  When gaps in therapy occur many of the deleterious effects occur.  Indeed, pain management is much more difficult when anxiety and diminished mobility complicate the treatment plans.  The real-world consequence is that when patients find a place that will treat their pain with dignity and respect, they will often share that information with others.  Only pharmacies that understand that have the bravery to treat these patients in the face of obvious peril of the DEA agents and their lack of understanding of the basics of medical care.  These brave souls are few and far between, leading to ever greater distances for patients in chronic pain to travel.  

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DEA MALICE IN TARGETTING PRONTO PHARMACY LLC, TAMPA FLORIDA

 The actions of DEA were gross negligence in that this agency sought to enter and secure records and then cause the individual pharmacies to shut down.  The DEA then causes the loss of licenses by fabricating a case to support false allegations.     

It was clearly shown that “Dr. Sullivan never reviews the seized prescriptions’ records. 

The expert opinion is that the above was an apparent attempt to mask scores of improper opioid prescriptions. The relevant medical records were not reviewed; the prescriber’s justifications for the prescriptions were not considered by Dr. Sullivan, nor was the patient’s input as to the subject prescriptions considered. I find Dr. Sullivan’s subject opinion, on the basis of this record, to be improperly speculative and unjustified as an expert opinion.”  

BRENT STONE CPP, SUICIDE

Therefore, the development of probable cause was based on a contrived rationale that a crime or sets of crimes were committed, based on a GOOGLE search.  However, there are no reasonable rational thoughts of criminal acts to support the DEA accusations.

Through the negligence of the DEA not to consider or investigated the patient and to determine why they responded to a Florida pharmacy.  Had the DEA not used Google Maps to determine the distance a person drove and had they investigated the actual reasons they could have discovered something different. 

CATHLEEN LONDON MD (TARGETED)

Perhaps a possible reason for driving to at a Florida pharmacy.  The DEA never considered that “Florida’s tourism industry was responsible for welcoming 131.4 million visitors in 2019. Based on the latest economic impact study, Florida’s visitors contributed $91.3 billion to Florida’s economy and supported over 1.5 million Florida jobs in 2018. According to the Office of Economic and Demographic Research, for every $1 the state invests in VISIT FLORIDA; $2.15 in state tax revenue is generated.”

What the DEA did was to rely on a non-governmental investigative tool and applied, and the assumption that a violation took place.  

 We must bear in mind the DEA applied canned techniques in both ARRIC Pharmacy and Gulf Med Pharmacy to support their acquisitions that African American Pharmacies are drug dens.  

Great is My Faithfulness

The DEA listed and name a licensed medical and pharmaceutical practice as Cocktail Medications. Without medical and scientific reasoning, the DEA claimed that both ARRIC Pharmacy and Gulf Med Pharmacy created a mixture of drugs so that their combined effect would be more potent than that of any of the drugs used individually.  The DEA agents failed to display testimony from the medical experts who examined and or interviewed the prescriptions and or patient.  The DEA can neither express knowledge that any patient suffered harm in any matter after an examination nor after receiving their prescription from a pharmacist. 

The DEA wrote in both ARRIC Pharmacy and Gulf Med Pharmacy administration inspection warrants,  

As discussed above, both federal and Florida law require identifying and resolving red flag of abuse and diversion. See paragraph 4, supra.  One common red flag of drug abuse or diversion is when particular prescribes “cocktail medication” Cocktail medications are combinations of controlled substances that are widely known to be abused or diverted, and when taken together create or enhance abusive or euphoric effects but also significantly increase a patient’s risk of death or overdose.  The DEA’s expert concluded that ARRIC regularly dispensed such cocktail medication without addressing or resolving this red flag.   

 Neither the State of Florida nor the Federal Government have any Red Flag Pharmaceutical laws. Nor have the DEA agents or its experts expressed a reasonable cognitive expressive knowledge of the facts of a licensee’s pharmaceutical functions and sales.     

XIULU RUAN MD 20 YEARS PRISON

The DEA agents stated, “Cocktail medications are combinations of controlled substances that are widely known to be abused or diverted, and when taken together create or enhance abusive or euphoric effects, but also significantly increase a patient’s risk of death or overdose.”  

PAIN VICTIMAND ADVOCATE

The DEA Agents and it’s experts failed to document on paper and in court the death rates and or drug overdose rates created by ARRIC, Gulf Med, Pronto’s Pharmacy, or any other licensed pharmaceutical facility.  With just a brief review of the Warrant for Inspections and Search Warrant it becomes clear that the federal government has unleashed targeted attacks upon African American owners/operators of licensed pharmaceutical facilities. 

  1306.04 Purpose of issue of prescription. 

  1. A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner.

____________________________________________________

2. Civil Rights, U.S. Attorneys Middle District of Florida   https://www.justice.gov/usao-mdfl/civil-rights

The ARCOS is used as an enforcement tool

ARCOS accumulates these transactions which are then summarized into reports, which give investigators in Federal and state government agencies information that can be used to identify the diversion of controlled substances into illicit channels of distribution. “Information on drug distribution is used throughout the United States (U.S.). by U.S. Attorneys and DEA investigators to strengthen criminal cases in the courts.”  Through their own word usage and practice ” DEA uses statistical analyzation to review to determine and identify the diversion of controlled substances into illicit channels of distribution.”  

WILMER LEON ADOCATE

The DEA agents failed articulate the elements of how Norman Clement of Pronto Pharmacy, LLC violated any aspects of the Administrator considers evidence bearing on five statutory factors. This government agency simply listed violations without articulating any elements of administrative violations or any elements that impacted the public interest.

In determining the  public interest, the Administrator considers evidence bearing on five statutory factors: 

(1)The recommendation of the appropriate state licensing board or professional disciplinary authority. 

(2)The applicant’s experience in dispensing, or conducting research with respect to controlled substances. 

(3)The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. 

(4)Compliance with applicable State, Federal, or local laws relating to 

controlled substances. 

(5)Such other conduct which may threaten public health and safety.

For any person or persons to commit a violation of the criminal statute, the officer must of a crime to develop probable cause. For a law enforcement agency to operate both as criminal justice and administrative enforcement agency, gives the DEA enormous and unrestrictive powers of authority.  The Constitution or laws of the United States. (18 U.S.C. §§ 241, 242). “Under color of law” means that the person doing the act is using power is given to him or her by a governmental agency (local, State, or Federal).

THE LATE LEWIS LADSON RPH

The DEA has failed Satisfy the constitutional Standards of the law enforcement agency.

The DEA has abided unsupported by sufficient evidence, 

The DEA has full knowledge of the Court and rarely grants summary reversal. No court would or should allow false and fabricated information to support allegations that are unwarranted. Such allowance of the DEA’s information clearly shows the corrupted attempt and coordinated efforts to subjugate the criminal justice system.

FREDDY WILLIAM MD. DIED LIFE IN PRISON 20060

ARCOS accumulates these transactions which are then summarized into reports, which give investigators in Federal and state government agencies information that can be used to identify the diversion of controlled substances into illicit channels of distribution. “Information on drug distribution is used throughout the United States (U.S.). by U.S. Attorneys and DEA investigators to strengthen criminal cases in the courts.”  Through their own word usage and practice ” DEA uses statistical analyzation to review to determine and identify the diversion of controlled substances into illicit channels of distribution.”  

What the DEA is doing is applying probability mathematics. Probability is a mathematical tool used to study randomness. It deals with the chance of an event occurring. Through this agency application of probability statistical mathematics, the DEA uses their ARCOS as an instigation tool to identify the diversion of controlled substances into illicit channels of distribution. 

What this federal agency is doing is monitoring, “the point of sales from the point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level – hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions.”   In essence, this agency is doing is monitoring and prosecutes medical professionals for performing their licenses medical fiduciary responsibilities on patients.

MICHELLE CLARK RPH (5 YEARS PROBATION)

The DEA is targeted based on probability mathematics, if a licensed medical professional is good and performs exemplary service that medical professional would be targeted despite his or her professional services. This agency’s standard of function is based on ARCOS usage to sustain their accusations

The Administrative Procedure Act sets forth the procedure for judicial review of agency action. See 5 U.S.C. § 706(2)(A).  

The DEA has shifted from considering its own actions such as relying on a computer-based law-enforcement system to determine and identify the diversion of controlled substances into illicit channels of distribution, without actual boots on the ground and or facial, investigations. The failure of the DEA to properly investigate causes to utilize the force powers of the courts to justify their inappropriate actions.

DEA TACTICS TARGETTING PHYSICIANS

Comes forth Norman J Clement, as Intervenor in United States District Court for the District of Columbia Case NO. 21-1635-CKK request MOTION TO INTERVENE BASED ON RIGHTS AND PERMISSION in joining Neil Anand, et al in seeking a number of records, including records on “data analytics algorithms used in the Pill Mill Doctor Project; all reports and work products generated by contractor Defendants Qlarant Corporation concerning the Pill Mill Doctor Project; statement of work and official contract of Qlarant Corporation; all reports from Blue Cross Blue Shield Corporation to OIG concerning improper prescribing of opiates by specific physicians.

GREGORY BELCHER MD

The Defendants aim to identify a predetermined number of Targeted Physicians. As a result, the Program identifies Targeted Persons not based on fixed criteria but rather based on a comparative analysis with other potential Physicians. A potential Targeted Physician is never advised that Defendants USDOJ, DEA, HHS, HFPP, BCBSA, or Qlarant, is considering them for classification as a Targeted Physician.  A potential Targeted Physician is not afforded any opportunity to be heard or to otherwise contest their classification as a Targeted Physician.  

Blessings all mine, with ten thousand beside!

Once a Targeted Physician is classified as such, there is no mechanism by which they can request their removal from HHS, DEA, USDOJ, HFPP, or Qlarant’s list of Targeted Physicians or otherwise contest the consequences of their classification as a Targeted Physician. Qlarant, and the factors utilized by its artificial intelligence as testified by Qlarant employee, Kevin McCash, directly violate and contradict Federal Controlled Substance Act Law as well as documentation from the Drug Enforcement Agency to physicians.  Drug Enforcement Agency Deputy Assistant Administrator Diversion Control Division, Thomas Prevoznik has sent letters to physicians including Dr. Walter Wrenn stating that “every prescription for a controlled substance must be based on a determination by an individual practitioner.” United States vs. Moore.  

WALTER WRENN MD

Furthermore, Prevoznik states that “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.”  The letter goes on to state that “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.” 71 FR 52716.  (see exhibit D)

USE OF NON-FDA APPROVED ALGORITHMS AND SOFTWARE

Furthermore, as Defendants, Qlarant, HFPP, BCBSA computer algorithms are used in medical “decision making”, they are unlawful as the artificial bits of intelligence have not been tested, evaluated or approved by the Food and Drug Administration as a Medical Device under Section 3060 of the 21st Century Cures Act which only exempts five categories of Clinical Decision Support tools.   Pertaining to software as a Medical Device, the FDA seeks a valid clinical association between the software’s output and its targeted clinical condition. The company must show that the software processes input data to generate accurate, reliable output that achieves the intended purpose in the context of clinical care for the target population.

NEIL ANAND MD

Defendants utilize data analytics through Qlarant and HFPP/GDIT which are essentially predictive policing algorithms. These agencies have not provided the public, with published studies that the computer programs can prove or indicate Mens Rea or intent during a criminal trial.   “Where the intent of the accused is an ingredient of the crime charged, its existence is a question of fact which must be submitted to the jury.” Morissette v. United States, 342 U.S. 246, 274 (1952).  

Qlarant marketing materials advertise that they present to trial courts evidence that creates “presumptive intent.”  These pre-crime predictive algorithms “conflict with the overriding presumption of innocence with which the law endows the accused, and which extends to every element of the crime. Such incriminating presumptions through data analysis of “presumptive red flags” as postulated by USDOJ, HHS, DEA experts are not to be improvised by the judiciary without U.S. Congressional legislative action.  

LEROY BAYLOR AND WALTER WRENN MD

The scientific and mathematical uncertainty surrounding the utilization of Defendants’ determinations via unproven data analytic criminal forensics as conclusory evidence to criminally indict or convict physicians violates the cannons and legal doctrines of criminal science.  In a criminal proceeding, there is unfair prejudice that can arise from the inordinate weight that a jury is likely to give to the determinations reached by a government fact-finding body. Admission of the results of conclusions produced by Qlarant data analytics programs that are programmed utilizing “secret USDOJ, DEA, HHS, HFPP or BCBSA guidelines that violate FACA” into evidence in criminal trials against physicians, risks usurping the proper role of the jury as fact finder. 

PAIN ADVOCATE

HHS, DEA, USDOJ, HFPP, BCBSA, and/or Qlarant’s algorithms are improperly designed to produce legal conclusions for the purposes of unduly and improperly influencing a jury in a criminal trial.  Ultimately the sole intent of the algorithms is to improperly influence the jury to defer to USDOJ, HHS or DEA’s conclusions. HFPP and Qlarant algorithms unlawfully supplant the jury as a fact-finder and are an unlawful form of judicial engineering.  Courts of Law and Justice are hesitant to treat as factual findings statements in a draft report or mere recommendations directed to a full agency or third party. As explained in Hines v. Brandon Steel Decks, Inc. “[c]onclusions are inadmissible because the jury would have no way of knowing whether the preparer of the report was cognizant of the requirements underlying the legal conclusion and, if not, whether the preparer might have a higher or lower standard than the law requires.” 886 F.2d 299, 303 (11th Cir. 1989). 

“TEN THOUSAND BESIDE”

Exculpatory evidence, even if it is only impeachment evidence must be disclosed whether it goes to the issue of guilt or punishment.  Qlarant has a history of creating false evidence to be utilized in the Court of Law.  See United States Court of Appeals for the Fourth Circuit No. 19-2285 Reddy Vijay Annappareddy v. Catherine Schuster Pascale et al. where materially false evidence created by NBI Medic Qlarant caused a miscarriage of justice including admission of the spreadsheets (1) was an error, (2) that was plain, (3) that affected Reddy’s substantial rights, and (4) that seriously affected the fairness, integrity, or public reputation of judicial proceedings.  

CHRIS CHRISTENS MD MONTANA, 7 YEARS PRISON

A conviction achieved through the use of false or misleading evidence violates due process because if the evidence is false, the false evidence would be material to probable cause as well as a grand jury indictment and could convert “U.S. Prosecutors” pursuing “cookie-cutter prosecutions” into “U.S. Persecutors” undermining confidence of U.S. Courts of Law.  See United States v. Zuno- Arce.

“The government cannot with its right hand say it has nothing while its left-hand holds what is of value.” United States v. Wood, 57 F.3d 733, 737 (9th Cir. 1995)(citing United States v. Endicott, 869 F.2d 452, 455 (9th Cir. 1989). Qlarant publicly advertises that it can falsely fabricate or manipulate evidence through its “custom bad actor program” that could falsely show that medical claims were knowingly submitted falsely, willfully submitted falsely and were submitted with an intent to defraud.  Qlarant’s “custom bad actor program” smacks of a Qlarant “Napue violations manufacturing factory” where US Attorney Offices are given fabricated false evidence to pursue any disfavored or targeted individual as identified by USDOJ, HFPP, BCBSA, Independence Blue Cross, or respective Blue Cross Blue Shield franchise.

HEALTH PROVIDERS SHOULD NOT BE PUNISHED MERELY FOR BEING WEALTHY

“People should not be punished merely for being wealthy, just as they should not be punished merely for being poor, but if someone profited from a crime, then the fruits of their crime is fair game to show their guilt and motive.”  

The Defendants algorithms are utilized by the USDOJ prejudicially by engaging in a continuous course of conduct designed to equate wealth with wrongdoing and to appeal to the potential bias of not-so-wealthy jurors against wealthy physician defendants.  See generally United States v Stahl, 616 F 2d 30, 31-32 (2d Cir 1980); see also United States v Holmes, 2021 WL 2044470 **5-6 (ND Cal 2021) where the Government sought to defend the tenor of remarks made in summation by stating that it “properly argued to the jury the logical inference that a man whose total life is geared to make money in real estate would also, in all likelihood, be driven by greed to pay the $10,000 bribe in order not to pay substantial monies in taxes.” “It impermissibly equates success, affluence and a single-minded occupation with one’s business affairs with greed and corruption.”

“Great is Thy faithfulness,” Lord, unto me!

These examples indicate the nature of the prosecutor’s trial strategy — a strategy that obviously included a persistent appeal to class prejudice. Because such appeals are improper and have no place in a courtroom, United States v. Socony-Vacuum Oil Co., 310 U.S. 150, 239-40, 60 S.Ct. 811, 84 L.Ed. 1129 (1940); New York Central R. Co. v. Johnson, 279 U.S. 310, 319, 49 S.Ct. 300, 73 L.Ed. 706 (1929); Koufakis v. Carvel, 425 F.2d 892, 900-905 (2d Cir. 1970); Benham v. United States, 215 F.2d 472, 473-75 (5th Cir. 1954); Drasner v. Thomson McKinnon Securities, Inc., 433 F.Supp. 485, 489-91 (S.D.N.Y. 1977)

WHEREFORE, WE REQUEST UPON THIS COURT AND PRAY:

“Great is Thy faithfulness,” O God my Father, There is no shadow turning with Thee; Thou chants not, Thy compassions, they fail not As Thou hast been Thou forever wilt be.

  1. Grant this motion and reverse these findings and decision of the Administrative Court, return and restore all privileges of the DEA Control Registration Certificates of Pronto Pharmacy LLC.

“Great is Thy faithfulness,” “Great is Thy faithfulness,”

Morning by morning new mercies I see

All Have needed Thy hand hath provided

“Great is Thy faithfulness,” Lord, unto me!

  1. Further, Dismiss the Decision of the Administrative Judge Mark Dowd in agency case No: 19-42, Federal Registry filed 1927282  on December 20, 2021with extreme prejudice.

Summer and winter, and springtime and harvest,

Sun, moon, and stars  in their course above,

Join with all nature in manifold witness

To Thy great faithfulness, mercy, and love

  1. Return all Files, Equipment, and Medications to Pronto Pharmacy Llc and its owner Norman J Clement of Tampa, Florida.

Pardon for sin and a peace that endureth,

Thine own dear presence to cheer and to guide;

Strength for today and bright hope for tomorrow,

Blessings all mine, with ten thousand beside!

  1. Reward damages and penalties to Norman J Clement and the employees of Pronto Pharmacy amounts greater than $587 million U.S. dollars, for the DEA’s actions must be stopped and has caused the deaths of many by waging a War on Pain patients, providers, and those needing help for drug addiction disease and has imprisoned both victims, families, patients and physicians, pharmacist and dentist.

“Great is Thy faithfulness,” “Great is Thy faithfulness,”

Morning by morning new mercies I see

All Have needed Thy hand hath provided

“Great is Thy faithfulness,” Lord, unto me!

RESPECTFULLY SUBMITTED

April 27, 2022

Norman J Clement

Norman J Clement, pro se

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on March 8, 2022, a true and correct copy of the foregoing was electronically filed via ECF and/or served via e-mail upon the following:

I, Norman J Clement, hereby certify that I’ve electronically filed contains 5770 words including footnotes and exhibits and agree to utilize jointly the foregoing Respondent’s Notice of Filing the Certified List of the Record with the Clerk of the Court for the United States Court of Appeals for the District of Columbia Circuit, by using the appellate CM/ECF system, on April 27, 2022. I certify further that Petitioner is pro se, and that service will is accomplished  by electronic mail to

Anita Gay, Esq United States Department of Justice 

Criminal Division/ Narcotic and Dangerous Drugs Section

156 N Street, Washington, D.C. 20032

Norman J Clement

Norman J Clement pro. see

FOR NOW, YOU ARE WITHIN

YOUAREWITHINTHENORMS.COM,(WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)

THE NORMS

1 Comment

  1. I never dreamed I’d live to see such evil rising again. My mom tried to warn me.

    I hope you have a great day Dr. Clement. I must rest a bit. I’m hurting. Thank you for the chat & the article…and for reminding me about Great Is Thy Faithfulness. 🙏🙏💗💗🐾🐾

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