from youarewithinthenorms.com
UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
Norman Clement, pro-se
Petitioner
Case: No. 21-1262
v.
Drug Enforcement Administration,
Respondent
MOTION FOR A REHEARING UNDER FEDERAL RULES OF APPELLATE PROCEDURE, RULE 35
The Appellant moves, pro se, submits this fifth (5th) supplement with exhibits to his Petition request under Rule 35 before the entire Panel for Rehearing En Banc from a May 25, 2022 decision, barring a summary reversal of the DEA Administrative court and further based on the United States Supreme Court ruling in Ruan-Khan vs. United States case: No- 20-1410.
(i)
TABLE OF CONTENT
LIST OF PROCEEDINGS Administrative Law Judge
Department of Justice,
Drug Enforcement Administration
86 FR 64714
Pronto Pharmacy LLC, Plaintiff, v. Drug Enforcement
Administration, Defendant Date Decision Issued: Nov. 11, 2021
Date Decision Effective: December 21, 2021 Department of Justice,
Drug Enforcement Administration
________________
UNITED STATES OF AMERICA, Plaintiff,
v.
ANTHONY RATTINI, et al.,
Defendants.
CASE NO. 1:19-CR-81 JUDGE McFARLAND
UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO WESTERN DIVISION
UNOPPOSED MOTION TO DISMISS THE INDICTMENT WITHOUT PREJUDICE AND STIPULATION
(iii)
APPENDIX CASE SUMMARY:
Pursuant to Rule 48(a) of the Federal Rules of Criminal Procedure, the United States of America hereby moves to dismiss the Indictment against all remaining defendants in this case without prejudice. The parties hereby agree to unconditionally release and hold harmless the United States Attorney’s Office for the Southern District of Ohio, Drug Enforcement Administration, its officers, employees and agents, and all other federal, state, and local law enforcement agencies involved in the investigation and prosecution……………………………………………..iii, 18,
Case: 1:19-cr-00081-MWM Doc #: 147 Filed: 08/02/22 Page: 1 of 2 PAGEID #: 1213
UNITED STATES OF AMERICA, Plaintiff,
v.
ANTHONY RATTINI, et al.,
Defendants.
CASE NO. 1:19-CR-81 JUDGE McFARLAND
UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO WESTERN DIVISION
UNOPPOSED MOTION TO DISMISS THE INDICTMENT WITHOUT PREJUDICE AND STIPULATION
__________________________
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TABLE OF WEBSITE REFERENCES AND AUTHORITIES
- ‘The Government Needed a Scapegoat’: 75-Year-Old Man Charged With Opioid Conspiracy Cleared: https://reason.com/2022/09/07/the-government-needed-a-scapegoat-75-year-old-man-charged-with-opioid-conspiracy-cleared/
- MY BROTHER IS DYING IN EXCRUCIATING PAIN FROM ALS, “HE ONCE WAS A HERO: ” THE TALE OF TWO MEDICAL TREATMENTS”: https://youarewithinthenorms.com/2022/09/02/my-brother-is-dying-in-excruciating-pain-from-als-he-once-was-a-hero-the-tale-of-two-medical-treatments/
- I AM HOWARD ADELGLASS, MD., A PHYSIATRIST PAIN SPECIALIST PHYSICIAN, NOT A STREET OR OFFICE DRUG DEALER OR TRAFFICKER: https://youarewithinthenorms.com/2022/08/30/i-am-howard-adelglass-md-a-physiatrist-pain-specialist-physician-not-a-street-or-office-drug-dealer-or-trafficker/
- DEA’s INTIMIDATION FORCES PHARMACIST TO VIOLATE YOUR HEALTHCARE: A COMPLEX BALANCE BETWEEN MEDICAL SCIENCE AND LAW: https://youarewithinthenorms.com/2022/08/21/deas-intimidation-forces-pharmaicst-to-violate-your-healthcare-a-complex-balance-between-medical-science-and-law/
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6. https://open.spotify.com/episode/2XcLGf4PCN0wNVLjxyAze6? si=EpDSJrvYTlCuiWwYqXUgWw…………………………….v, 5
Pronto Pharmacy, LLC; Decision and Order,
86 FR 647,14 (2021) …………………………………… v, 5, 6, 10,
Wheatland Pharmacy, 78 FR 69441, 69445 (2013)…v, 6,
7. https://www.federalregister.gov/d/2021-25133/p-87 … v, 12
8. Suntree Pharmacy and Suntree Medical Equipment, LLC; Decision and Order, 85 Fed. Reg. at 73776-77…………………….v, 12
TABLE OF LAWS
21 U.S.C. § 801(1)………………………………v, 2
United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a)….v, 2,
Ruan v. United States,
597 U.S. 20-1410 (2022) …………………………….. v ,6,7,8, 9
See id. § 811(b) (“The Attorney General shall, before initiating proceedings . . . [to schedule or reschedule a drug]…….5,
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Federal Rule of Criminal Procedure Rule 48(a),
Case 5:20-cr-00163-PRW (Document 53 Filed 07/29/22 Page 2 of 3)….
§841(a)(1) and § 1306.04(a)………………………….vi, 5, 6, 7, 9, 15
21 U.S.C. § 823(f); 21 U.S.C. 824(a); Gonzales, 546 U.S. at 262 (observing “Sections 823(f) and 824(a) explicitly grant the Attorney General the authority to register and deregister physicians…”…………………………………vi, 7, 9
See 21 U.S.C. § 903. and act as the Federal equivalent of a state medical board……………………………………..8
21 U.S.C. § 801 et seq.; Jones Total Health Care Pharmacy, LLC v. Drug Enf’t Admin., 881 F.3d 823, 827, 830 (11th Cir. 2018) (quoting Gonzales v. Raich, 545 U.S. 1, 13 (2005))……………………………………………….…vi, 9
21 U.S.C. § 871; Gonzales, 546 U.S. at 262; Final Rule: Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official, 75 Fed. Reg. 4982 (Feb. 1, 2010)……………………………………………….vi, 9
See id. § 811(b)……………………………………vi, 10
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309 of the Act (21 U.S.C. [§] 829)…………………VI, 15
EXHIBITS
(exhibits are organized by number based on supplement and number letter sequence) eg. 5=supplement and 1A,2b…sequence)
5.1A
James Barclay, springbok, oh see letter to Hon. Matthew W. McFarland, U.S. District Court Judge Southern District of Ohio……………………..….vii,
5.2B
UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO WESTERN DIvSION- CINCINNATI United States of America, Plaintiff, v. James Barclay, defendant case no. 1:19-cr-81
ORDER GRANTING MOTION TO DISMISS THE SUPERSEDING INFORMATION AND INDICTMENT AGAINST DEFENDANT JAMES BARCLAY
In the interests of justice/ the Court VACATES Defendant Barclay’s previously entered guilty plea, REJECTSDefendant Barclay’s plea agreement/ and GRANTS the unopposed motion to dismiss the charging documents against Defendant Barclay. Accordingly, the Court DISMISSES WITH PREJUDICE the Indictment and Superseding Information againstDefendant Barclay. ……………………vii, 4,
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5.3C
Congresswoman Grace Meng, Member of Congress, Sixty District of New York, December 18, 2019)………. vii, 4,
5.4D
Letter dated November 04 2019, from: Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, to: Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and Regulatory Affairs National Association of Chain Drng Stores1776 Wilson Boulevard Suite 200 Arlington, Virginia 22209………………………………………3, 4,
5.5E
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO WESTERN DIVISION, MIAMI-LUKEN, INC., Plaintiff, v. UNITED STATES DEPARTMENT OF JUSTICE, DRUG ENFORCEMENT ADMINISTRATION., Defendant.
REPORT AND RECOMMENDATION
Pursuant to custom and practice, this miscellaneous action was referred to the undersigned magistrate judge. Currently pending is the DEA’s Rule 60(b)(5) motion to set aside the prior decision of this Court. I now recommend that the DEA’s motion be DENIED……………………………………….viii, 8,
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5.6F
Letter dated February 12, 2021, from: Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, to:
Richard A. Lawhern, Ph.D. 3691 Nestling Lane Fort Mill, South Carolina 29708 lawhern@hotmail.com …………..viii, 2,3(2)
STATEMENT
The question here is the Rule of Law. The most fundamental concept of our country, without which our society crumbles. That, then allows for an agency to take anything they want unchecked based on their own manufactured rules and misinterpretation of laws, medical procedures guidelines, creating their own science and facts.
The great fear at this moment here is the United States Drug Enforcement Administration (DEA) has operated unchecked as a rogue sub-agency of government operating outside the rule of law. Creating their own medical science (Auer deference) seizing property using omnipotent authority of ill-gotten gain over the field of medicine and medical science.
Specifically, misidentifying the dosages and purposes of legally and medically prescribed FDA approved Narcotic Analgesic medications, “having useful and legitimate medical purposes,” to be re-defined as “illegitimate.” mislabeling all as “opioids.”
Congress determined 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).
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: Richard A. Lawhern, Ph.D. DATED FEBRUARY 12, 2021
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“ 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 practitioners are 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.
While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”(1) ————————————
1. (See exhibit 5-6F, Letter dated February 12, 2021, from: Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, to: Richard A. Lawhern, Ph.D. 3691 Nestling Lane Fort Mill, South Carolina 29708 lawhern@hotmail.com )
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: KEVIN NICHOLSON, RPH. DATED NOVEMBER 04, 2019
“The DEA lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine. The DEA has not promulgated 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
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medication that may be prescribed on a single prescription on the duration of treatment intended with the prescribed controlled substance. The 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. This is outlined in the 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. {A copy is enclosed for your convenience.}” (2)(3)(4)
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2. (See exhibit 5-4D, letter dated November 04, 2019, from: Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control Division, to: Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and Regulatory Affairs National Association of Chain Drng Stores1776 Wilson Boulevard Suite 200 Arlington, Virginia 22209)
DEA LETTER TO Congresswoman Grace Meng, Member of Congress Sixty District of New York, DATED DECEMBER 18, 2021
“As a Law Enforcement agency, DEA is not a position to authorize or dictate what a doctor prescribes to a patient. DEA cannot grant waivers of any kind when it comes to the practice of medicine because no such wavier exists. As the United States’ component body charged with the management of controlled substances and chemicals for scientific, medical research, and industrial applications; DEA regulates the flow of control substances, not the practice of medicine. The changing prescribing practices of practitioners are derived by a shift to prescribe medicine consistent with guidance issued by the Center for Disease Control and Prevention, along with guidance and recommendations of state boards of medicine.”(3)
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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 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.”).
However, Pharmacists and pharmacies also get contradictory guidance from federal health agencies and even the DEA that often disagrees with the Appellants licensing that pharmacists should interfere with a doctor’s individualized medical judgment.(ibid 4)(5)
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3. (See exhibit 5-3c Congresswoman Grace Meng, Member of Congress Sixty District of New York, December 18, 2019).
5. https://open.spotify.com/episode/2XcLGf4PCN0wNVLjxyAze6? si=EpDSJrvYTlCuiWwYqXUgWw
FACTUAL BACKGROUND
The Appellant is a Pharmacist Not a Street Drug Dealer. On August 29, 2019, in the city of Tampa, Florida, Hillsborough County, Pronto Pharmacy 86 FR 647,14 (2021) was raided by DEA agents. Norman Clement was acting in the capacity of a licensed’s pharmacist and authorized . Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drugs. This definition and is a statue within the Florida Administrative Code & Florida Administrative Register.
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In this and other cases DEA Diversion Investigator using a subjective standard rather than an objective standard of proof “beyond the reasonable doubt,” and who is “authorized” established by Supreme Court 9-0 in Ruan-Khan vs United States. DEA Administrator could not be met to establish criminal negligence and thus falsely established diversion solely based on subjective standards using of googles maps, red flags 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 medications filled by pharmacist from Pronto Pharmacy LLC (see Decision and Order, Fed. Reg.86 FR 64714 (2021).
Importantly, in Ruan v. United States holding that “§841(a)(1) and § 1306.04(a) require the government to provide that a practitioner-defendant either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.”
1. UNITED STATES DISMISSED INDICTMENT CASE NO. 1:19-CR-81 JUDGE McFARLAND
This matter is before the Court on the Unopposed Motion to Dismiss the Superseding Information and OriginalIndictment (Doc.150),as against Defendant James Barclay. Also before the Court is a letter submitted by Defendant Barclay(see exhibit 5.1A). Prosecutors had alleged in a 2019 indictment that Springboro, Ohio-based Miami- Luken, James Barclay and others failed to guard against illegal diversion of opioid pills in five states including West Virginia.
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Prosecutors in this case elected to dismiss all defendants(s) charges in this case as they felt the standard of proof “beyond the reasonable doubt,” who is “authorized” established Supreme Court 9-0 Ruan-Khan vs United States could not be met to establish criminal negligence. It is based upon a fundamentally untenable procedure, whereby “the DEA Administrator created its own “changed circumstance” by “quashing” an Order that already had been determined by this Court to be valid and enforceable, rather than either choosing to comply with this Court’s Order or to file a further appeal. (see exhibit 5-5E page 8 thru 10), Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice.
Further, Prosecutors feared an Appeal to a higher Court and therefore left open the fact the DEA Administrator acted beyond the authority to develop regulations to monitor and control provider registration for prescribing and dispensing controlled substances. 21 U.S.C. § 823(f); 21 U.S.C. 824(a); Gonzales, 546 U.S. at 262 (observing “Sections 823(f) and 824(a) explicitly grant the Attorney General the authority to register and deregister physicians…”).
“It is entirely possible that an appellate court would view the issues differently than previously determined by this Court. However, the key here is that review of this Court’s Orders is appropriate only by an appellate court. An agency that has been directed to comply with a district court’s order has no authority to simply disregard it through use of a procedural end-run.” (see exhibit 5-5E page 8 thru 10)
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Thus we have nexus this argument to Pronto Pharmacy LLC based here that the DEA Administrator has attained “omnipotent powers” not granted by Congress and has been wrongfully exercising the use of their ill-attained authority to regulate the practice of medicine by criminalizing good faith medical mistakes being freely able to flip-flop, moving the goal post backward and forward generate rules policy and law without proper notice or hearing required by Congress See 21 U.S.C. § 903., and further act as the Federal equivalent of a state medical board overseeing the general practice of medicine while they have lacked the authority to issue guidelines that constitute advice relating to the general practice of medicine.”…dictating what a doctor prescribes to a patient, promulgating regulations regarding the treatment of pain, imposing specific quantitative minimum or maximum limit such as 90MME on the amount of medication that may be prescribed on a single prescription on the duration of treatment intended with the prescribed controlled substance, simply “The DEA lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”ibid (2)
RULE
The Controlled Substances Act (CSA) is a closed regulatory system enacted by Congress, making it unlawful to manufacture, distribute, dispense, or possess any controlled substance, except in a manner authorized by the Act. 21 U.S.C. § 801 et seq.; Jones Total Health Care Pharmacy, LLC v. Drug
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Enf’t Admin., 881 F.3d 823, 827, 830 (11th Cir. 2018) (quoting Gonzales v. Raich, 545 U.S. 1, 13 (2005)). The Act entrusts the Attorney General with the authority to develop regulations to monitor and control provider registration for prescribing and dispensing controlled substances. 21 U.S.C. § 823(f); 21 U.S.C. 824(a); Gonzales, 546 U.S. at 262 (observing “Sections 823(f) and 824(a) explicitly grant the Attorney General the authority to register and deregister physicians . . . ”). The Attorney General has delegated this authority to the Drug Enforcement Administration (DEA) Administrator, under which the Administrator has developed regulations to oversee provider registration. 21 U.S.C. § 871; Gonzales, 546 U.S. at 262; Final Rule: Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official, 75 Fed. Reg. 4982 (Feb. 1, 2010).
CSA Section 841(a)(1) cannot be interpreted as criminalizing negligent prescribing because the statute is bereft of any indication—clear or otherwise— that Congress intended to grant a federal law enforce- ment agency such sweeping authority over the practice of medicine. (8)
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7. (See exhibit 5-4D , letter dated November 04, 2019, from: Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control Division, to: Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and Regulatory Affairs National Association of Chain Drng Stores). 8. https://www.supremecourt.gov/DocketPDF 20/20-1410/178631/20210507164642254_Ruan%20Amici%20Brief%20-%20Final%20for%20Filing%20-%205-7-21.pdf
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ANALYSIS
Congress, therefore, did not even leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances—without healthcare agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before 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.”).
Pronto Pharmacy LLC; nexus this argument, see Decision and Order, Fed. Reg.86 FR 64714 (2021) the discretion of the DEA Administrative Court was not justified by the evidence and based exclusively on speculation. No finding of actual drug diversion was proven or found. No manufacturing of drugs occurred or proved beyond the reasonable doubt that both Pronto Pharmacy, it’s owner Norman J Clement subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.”
CONCLUSION
Doctors and Pharmacist are not Street Drug Dealers in White Coats.
- Illegal street drugs are not of identical, fungible, potency, or carry equivalent degrees of fatal diversion and addiction risks to DEA-Scheduled, FDA- supervised, and controlled prescriptions drugs. The purity, doses, chemical structure, bioequivalence and /or means of intake of illegal street drugs versus DEA – scheduled / FDA- supervised medications are different. Street drugs and prescription drugs are not equivalent.
- Illegal street drugs and DEA-Scheduled, FDA- supervised medications require different registered users. Doctors and pharmacist register with the DEA. Street drug dealers register with the Mexican / Columbian / or Russian Drug Cartels.
- Illegal Street Drugs Dealer and the DEA Registrant doctor are not equivalent. The doctors prescribe DEA-Scheduled, FDA- Supervised medications, with “intent to treat”. On the other hand, street drug dealers act in furtherance of supremacy in the international illicit drug market.
- Doctors and pharmacist receive formal education from accredited schools of graduate education. Illegal street drug dealers receive informal education from the jails, the streets, and the Mexican / Columbian / Russian Drug Cartels.
- Doctors and pharmacist settle disputes with patients in the court system. On the other hand, drug dealers settle disputes via gang fights while using deadly weapons. The weapons are used with intent to kill, intent to cause grievous body harm, or felony murder.
- In conclusion, the education, experience, conduct, and registration of DEA registered doctors and street drug dealers are not the same.
- Doctors and pharmacists are not drug dealers in white coats.
2. THE DEA ADMINISTRATIVE COURTS AND ADMINISTRATOR ARE NOT INTEREST IN FINDING THE TRUTH
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An Administrative Law Judge has the power to receive evidence and to issue subpoenas to compel the attendance of witnesses and the production of materials “necessary” for the hearing. See 21 C.F.R. §1316.52(d). However, DEA administrative revocation hearings do not include the type of discovery process that is available to civil litigants in this Court and are prevented from presenting witnesses such as the prescribing practitioners. As is found in Suntree Phar- macy and Suntree Medical Equipment, LLC; Decision and Order, 85 Fed. Reg. at 73776-77. On Petition for a Writ of Certiorari to the US Supreme Court at no point did the Acting Administrator determine the legitimacy of the underlying controlled substance prescriptions that Suntree Pharmacy filled, nor did any qualified healthcare professional comment on whether the prescriptions were issued for a legitimate medical purpose. Id. at 73774-75.
The Acting Administrator also never heard testimony from any patients and prevented testimony from the physicians who prescribed the controlled substances Suntree Pharmacy filled. Id. at 73754. Instead, the Acting Administrator simply relied on “red flags” identified by Dr. Gordon, a clinical hospice pharmacist for ProCare RX, working from home as a consultant (i.e., not a retail pharmacist), and used these “red flags” as a proxy to conclude the prescriptions were illegitimate. Id. at 73754, 73774-75; R. 6 at 21; See Br. at 15-20 (describing in detail Dr. Gordon’s testimony). To this day, the DEA has never followed-up with or penalized the medical providers who prescribed these so-called “illegitimate” controlled substances that Sun- tree Pharmacy filled. (9)
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In both the cases of Pronto Pharmacy LLC and James Barclay et al., are similarly situated and nexus that Dr. Donald Sullivan professors at the Ohio State University College of Pharmacy working from home was used in both cases as the Pharmacy Expert consultant and used “red flags” as a proxy to conclude the prescriptions were ‘illegitimate.’ (See Decision and Order, Fed. Reg.86 FR 64714 (2021) id. at https://www.federalregister.gov/d/2021-25133/p-87)
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9. The owner of Suntree Pharmacy is both a pharmacist and licensed practicing Attorney. Suntree Medical LLC was a separate closed-door pharmacy that did not dispense retail prescriptions. Suntree Medical had a separate DEA registration and was not in any way engaged in the conduct in the Order to Show Cause.
JAMES BARCLAY’S LETTER TO THE COURT
In a letter (see exhibit 5-1A) to the court, Honorble James McFarland, Mr. Barclay said he had;
“ repeatedly contacted the U.S. Drug Enforcement Administration for guidance about opioid orders, and either received no response or was told that whether to fill an order was purely a “business decision.” He also said;
“ the DEA had proof from the beginning of its investigation that Barclay lacked any authority to cancel orders personally. “I was indicted because the DEA failed to do their job, and the government needed a scapegoat after the publicity of the opioid problems in West Virginia,”
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Plaintiff Miami-Luken is a Dayton Ohio, pharmaceutical wholesaler with a DEA registration that permits it to operate its business. For nearly a decade, 3 Plaintiff has been under DEA scrutiny for “facilitat[ing] the diversion of significant quantities of the highly addictive pain killers, oxycodone and hydrocodone.” The Court took judicial notice of the fact that the referenced prescription drugs are among a class of opioids that have been commonly recognized as contributing to an ongoing opioid crisis in the United States. Over the course of its investigation, the DEA has issued numerous investigatory subpoenas to Miami-Luken, requiring the production of documents to DEA investigators, primarily in the Cincinnati, Ohio office.
RULE
Supreme Court 9-0 Ruan-Khan vs United States could not be met to establish criminal negligence. and falsely established diversion based solely on the use of googles maps and performed absolutely no investigation in Ruan v. United States holding that “§841(a)(1) and § 1306.04(a) require the government to provide that a practitioner-defendant either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.” Going strictly by “pill,” numbers is not enough to support a prosecution. The government must prove that a doctor prescribed controlled substances for no “legitimate medical reason” to impose criminal liability as a violation of Section 841(a) of the Controlled Substances Act. United States v. Outler, 659 F.2d
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1306, 1309 (5th Cir. 1981). The “lack of a legitimate medical reason is as essential to the offense charged against [a doctor] as the requisite mens rea.” Id. (emphasis added). This Court should reinforce that requirement here.
ANALYSIS
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).
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The DEA agreed with these comments and changed the legal standard in the final regulations, noting the “language [was] revised to require knowledge.”(10)
CONCLUSION
The “DEA failed to do their job, and the government needed a scapegoat after the publicity of the opioid problems.” As in Pronto Pharmacy LLC, Tampa, Florida, Sun Tree Pharmacy, and Jame Barclay et al. (see exhibit 5-1A James Barclays’ letter) all control medications ordered were legitimate, compounded, distributed, or dispensed by 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. This is outlined in the 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.
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9. The owner of Suntree Pharmacy is both a pharmacist and licensed practicing Attorney. Suntree Medical LLC was a separate closed-door pharmacy that did not dispense retail prescriptions. Suntree Medical had a separate DEA registration and was not in any way engaged in the conduct in Order to Show Cause.
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The regulation at the heart of this case, 21 C.F.R. § 1306.04(a), provides: “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.”
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.
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.
“Numbers alone can’t determine whether a crime has been committed: The ‘normal’ amount of opioid prescribing for a physician treating pain or addiction will inevitably be much higher than the average for all doctors or the typical amount in most other specialties.”
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APPENDIX
Case: 1:19-cr-00081-MWM Doc #: 147 Filed: 08/02/22 Page: 1 of 2 PAGEID #: 1213
UNITED STATES OF AMERICA, Plaintiff,
v.
ANTHONY RATTINI, et al.,
Defendants.
CASE NO. 1:19-CR-81 JUDGE McFARLAND
UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO WESTERN DIVISION
UNOPPOSED MOTION TO DISMISS THE INDICTMENT WITHOUT PREJUDICE AND STIPULATION
Pursuant to Rule 48(a) of the Federal Rules of Criminal Procedure, the United States of America hereby moves to dismiss the Indictment against all remaining defendants in this case, without prejudice. The parties hereby agree to unconditionally release and hold harmless the United States Attorney’s Office for the Southern District of Ohio, Drug Enforcement Administration, its officers, employees and agents, and all other federal, state, and local law
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enforcement agencies involved in the investigation and prosecution of the above-captioned case from any and all claims, demands, causes of actions or suits, of whatever kind and description, and wheresoever situated, that might now exist or hereafter exist by reason of or growing out of or affecting, directly or indirectly from this investigation and prosecution.
Respectfully submitted,
KENNETH L. PARKER
United States Attorney
s/ Nicole Pakiz
NICOLE PAKIZ (0096242)
Case: 1:19-cr-00081-MWM Doc #: 147 Filed: 08/02/22 Page: 2 of 2 PAGEID #: 1214
s/ Sheila G. Lafferty
SHEILA G. LAFFERTY (0042554)
s/ Timothy D. Oakley
TIMOTHY D. OAKLEY (0039965)
Assistant United States Attorneys
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221 East Fourth Street, Suite 400
Columbus, Ohio 45202
(513) 684-3711
Fax: (513) 684-2047
Nicole.Pakiz@usdoj.gov
Sheila.Lafferty@usdoj.gov
Tim.Oakley@usdoj.gov
Approved by Email Authorization:
s/ Richard H. Blake
RICHARD H. BLAKE, ESQ.
Counsel for Miami Luken
rblake@mcdonaldhopkins.com
s/ Bradley Davis Barbin
BRADLEY DAVIS BARBIN, ESQ.
Counsel for Devonna Miller-West
bbarbin@BarbinLaw.com
s/ S. Benjamin Bryant
S. BENJAMIN BRYANT, ESQ.
Counsel for Samuel R. Ballengee
sbbryant@csdlawfirm.com
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CERTIFICATE OF SERVICE
I hereby certify that on this 2nd day of August 2022, a copy of the foregoing Unopposed Motion to Dismiss the Indictment Without Prejudice and Stipulation was filed electronically. Notice of this filing will be sent to all parties by operation of the Court’s electronic filing system.
s/ Nicole Pakiz
NICOLE PAKIZ (0096242) Assistant United States Attorney
________________________________________________
CONCLUSION
The Appellant is a licensed pharmacist engaged in the practice of practice of pharmacy filing prescriptions for legitimate medical use authorized by medical/dental providers license and authorized to treat patients. 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.”
Thus demands that the Court vacates the Order of Revocation of Pronto’s Pharmacy DEA registration. In the alternative, remand the case back to the trial court for adjudication under the proper
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evidentiary standard. The decision in this case by the United States Court of Appeals for the District of Columbia will have far-reaching effects on the professions of Medicine, Dentistry, Nursing, and other Mid-Level Practitioners and pharmacists. The Appellant is a Pharmacist, Not a Street Drug Dealer.
WHEREFORE, WE DEMAND UPON THIS COURT:
- 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.
- Further, Dismiss the Decision of Administrative Judge Mark Dowd in agency case No: 19-42, Federal Registry filed 1927282 on December 20, 2021with extreme prejudice.
- Return all Files, Equipment, and Medication to Pronto Pharmacy Llc and its owner Norman J Clement of Tampa, Florida.
- The Court must send a clear and strong message in its final order to the deliberately misguided actions of the DEA. We, therefore, Amend the Reward damages and penalties of amounts greater than $8.7 billion U.S. dollars TAX-FREE, equivalent, and based on the Purdue Pharma agreed DEA “RED FLAG” settlement of 8.3 billion dollars.
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September 14 , 2022, RESPECTFULLY SUBMITTED Norman J Clement, pro se
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that on September 14, 2022, a true and correct copy of the foregoing was filed through US MAIL EXPRESS upon the following:
I, Norman J Clement, hereby certify that I 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 US MAIL on September 14, 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 145 N Street, NE, Room 2E-404 Washington, D.C. 20002 (202) 353-7629 anita.gay2@usdoj.gov
Norman J Clement
Norman J Clement pro. se prontopharmacy@aol.com
exhibit
5-1A EXHIBIT
5-1A5-2b
EXHIBIT
5-3C
EXHIBIT
5-4D
EXHIBIT
5-4D
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5-5E
5-5E
5-5E
EXHIBIT
5-5E
EXHIBIT
5-5E
EXHIBIT
5-5E
EXHIBIT
5-5E
EXHIBIT
5-5E EXHIBIT
5-5E EXHIBIT
5-5E EXHIBIT
5-5E
EXHIBIT
5-5E EXHIBIT
5-5E EXHIBIT
5-5E EXHIBIT
5-5E
EXHIBIT
5-5E
EXHIBIT
5-5E
Exhibit 5-6F
Exhibit 5-6F
PETITION DENIED
What relevance does that data have?
Reviewing the data I obtained from a FOIA request by another doctor. It has become abundantly clear that insurance companies, attempt to cut their costs, has created Analytics to target doctors inappropriately.
It appears that the analytics insurance companies used created red flags that had no medical relevance to inappropriately target doctors’ race, religion, country of origin, and economic status. This is not only anti-American; it is illegal.
The insurance companies release this data to the DEA, who’s that targets physician. Apparently, the DEA cherry-picks doctors in private practice with over 60 foreign graduates, blacks, Asians, Hispanics, and Jews. I have read forms that are collected by the insurance companies that include such information as a percentage of brand medicine ordered and several antivirals ordered.
This information clearly does not indicate that a physician is doing anything wrong. But they are indicators of physicians, which may be costing the insurance company more money. Forms also have how many cars the physician has, how close to the water their house is, how rich their neighbors are, how far the physician’s office is from the pharmacy, how far the patients have to travel to the pharmacy, how far the patients travel to the physician.
Each of these questions is assigned a numerical score. If a physician’s analytic # is above a certain score, he’s referred to the DEA, who then picks out physicians to target based on their race, religion, age, color their economic status.
The government cannot obtain this data independently, so they partner with the insurance co. The ins. company gets rid of Drs who cost them too much money, and the DEA takes the doctor’s assets. This is the way things happen in a third-world country. On my indictment, I was given a—— score which is the percentage of opioids to non-opioids that I prescribed.
What studies have been done to support the relevance of that number? This data is being used to save insurance companies $ by discriminating against doctors in a biased manner. Dr”s are being charged criminally for prescribing appropriate medicine that the ins. Companies do want to pay for it.
There are many more Analytics that are used to target physicians. I would like to see this information to help defend myself for my upcoming case in October.
Thank you.
FOR NOW, YOU ARE WITHIN
THE NORMS
