BLACK LICENSE PHARMACIST FIGHT BACK PART-1: THE DEA'S RED FLAGS OF OLD JIM CROW

BY

NORMAN J CLEMENT RPH., DDS JACK FOLSON RPH

Black Pharmacy Owners, AT Cost Pharmacy, Ft. Myers Fl.,  Aaron Howard PharmD owner, Gulf Med Pharmacy  Cape Coral Fl., Ricardo Fertil PharmD owner, Pronto Pharmacy LLC, Tampa Fl, Norman J Clement RPh., DDS, owner, have joined together in suing Drug Enforcement Agency (DEA) for harassment, and malicious targeting and return of Properties unjustifiably seized. 

While, all 3 Pharmacies have been in business for more than 10 years yet suddenly  in 2019 Acting DEA Director Uttam Dhillion signed orders calling these and other Black owned Pharmacies an  “Imminent Danger to Public Health and Safety” or “Un-resolvable RED FLAGS.”

 Pharmacist, Aaron Howard, says, ” this whole issue is based on a erroneous presumption of Red Flags…..that we are improperly dispensing control medications.” “This totally  ridiculous, we check all prescriptions in my pharmacy.  I’ve been a pharmacist for more than 15 years and I am definitely not a “PILL MILL.”  

Pharmacist Ricardo Fertil states, ” this is a way of stereotyping black owned businesses whom are health professionals.” 

While, Pharmacist Norman J Clement points out they are using google maps to illegally track our patients and harassing our wholesalers. All 3 Pharmacist are graduates of Florida A&M University College of Pharmacy.

The Federal Court challenge in Florida  is lead by Attorney Dale Sisco of Tampa and based on the Oak Hill Hometown Pharmacy of Oak Hill West Virginia.  Oak Hill is Black own pharmacy, which has successfully prevailed in several Court proceeding against the DEA is lead by Attorney Issac R. Foreman.  

Jack Folson RPh.,  a Pharmacist expert an activist who has testified in Michigan Courts on behalf of several Black Pharmacy owners states, “This comes down to practicing Pharmacy while Black. In the past years alone at least 7 black owned pharmacies we know of have been attack in similar manner by the DEA, there are likely more. Black owned Pharmacies are less than 1% of all pharmacies in American but seem to be disproportionately targeted by the DEA.”

DEA’s RED FLAGS OF OLD JIM CROW

Red Flags – Distance

Due to the DEA’s aggressive policing of community pharmacies, most 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. 

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.  

Therefore, 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. 

Pharmacies, understand what need to be accomplished in treating these patients with these critical needs. The DEA agency lacks of understanding of the basics of medical care for patients in chronic pain..  

DISTRICT 6 MUSEUM, CAPE TOWN, SOUTH AFRICA

Red Flags – Cocktails, Pattern Prescribing

Pain Management is a very complex issue.  More often than not in chronic (non-acute) pain, comorbidities need to be addressed.  Therefore, when a practitioner finds a combination of medications that successfully treats chronic pain they are reluctant to stray from that protocol. 

It’s akin to other protocols that are used in medicine that address chronic conditions such as cancer protocols, ALS protocols, hypertension step-care therapy, anti-coagulation protocols and others.  

HECTOR PIETERSON: “TO PAY THE PRICE FOR FREEDOM”

Typically, there is inflammation and therefore non-steroidal anti-inflammatories are used.  Patients often experience anxiety so anti-anxiety agents such as benzodiazepines or tricyclics are used.  In nociceptive pain Gabapentin is often the first drug of choice.  In lower back pain, whose underlying causes can be quite different from each other the presentation of muscle spasm or hypersensitivity, muscle relaxers such as cyclobenzaprine, metaxolone, baclofen, carisoprodol or others represent standard therapy.

It is unreasonable to expect a Diversion Investigator to have a complete understanding of these complex issues with their 6-week course when Physicians and Pharmacists require years of training to make adequate choices in this arena.  

Red Flags – Non-resolvable red flags

As has been shown here there is no such thing as a non-resolvable red flag.  Any testimony to the contrary is either ill-informed or dishonest.  For an expert to testify that they can determine diversion without looking at the prescription, interviewing the prescriber or understanding the patient condition lacks credibility. 

As has been shown in recent cases, “suspicion of diversion does not raise to the level of actual diversion.”  This is accomplished by evisorating the physician patient relationship to establish illegitimacy and suspicion.

THE ADMINISTRATIVE COMPLAINT FILED BY STATE OF FLORIDA BOARD OF HEALTH RE: FILE NUMBER PH201705581

By Norman J Clement RPh.DDS, Norman L.Clement Pharm Tech, Jelani Z.Clement Pharm Tech

written August 10, 2017

Exactly 2 years later in August 29, 2019 DEA, investigator Richard Albert, issued an Order To Show Cause stating Pronto Pharmacy was an Imminent Danger to Public Health for illegally manufacturing on the very same issue which were resolved by the State of Florida.. This case will proceed before a Federal District Court in Tampa Florida, Dale Sisco Esq is the attorney 813-224-0555

IN THIS AGE OF FAKE NEWS AND ALTERNATIVE FACTS (BOTH WHICH HAVE ABSOLUTELY NO MERITS IN THE PROFESSION OF PHARMACY)

THERE IS ONE THING I’VE LEARNED IN LIFE from a man I didn’t like nor voter for, but have come to GREATLY respect:

PRESIDENT RONALD REAGAN;

“WE MUST TRUST AND VERIFY”

PRONTO PHARMACY LEGAL TALKING POINTS

The complaint filed by the Florida Department of Health (Case Number PH201705581) is without LEGAL MERIT, lacks ANY LEGAL FOUNDATION and lacks probable cause.

The United States Congress intent was to allow compounders to compound a batch of drugs in anticipation of receiving patient specific prescription.[i]

  1. Federal Law and Florida State Law clearly allows and has always allowed that a licensed pharmacist can compound “in limited quantities before the receipt of a valid prescription order for such individual patient.” 
  • More importantly President Donald J Trump address this issue and signed into law H.R 244 which clarifies several compounding regulation implemented in the Drug Quality and Security Act(DOSA 2013).
  • The law clarifies that Congress did not intend to redefine “distribution” to include “dispensing,” specifying Congress only intended FDA to regulate distribution– not “dispensing” to a patient over state lines.
  • The law mandates that FDA recognize that federal oversight of 503A was not the intent of Congress, and that compounding pharmacies are not drug manufactures—rather they are “state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within the state.”[ii]
  • FDA LAW 503A (a)(2) states the following examples:[iii]

a). “A compounder regularly receives valid prescription orders from a particular prescriber or prescribers, or for a particular patient or patients, for compounded drug X. The highest number of units of drug X for which the compounder has received valid patient-specific prescriptions in a 30-day period in the last year is 500 units. Compounding up to 500 units of drug X in advance of receiving prescriptions for the drug, and holding no more than that amount to fill new valid patient-specific prescriptions as the compounders receives them, would be consistent with this policy. [iv]

b). “ A compounder regularly receives valid prescription orders from a particular prescriber or prescribers, or for a particular patient or patients, for compounder drug”  {FURTHER REVIEW PG 6,7,8,9 FDA GUIDELINES}

The complaint further alleges upon a routine inspection on 03/03/2017 the pharmacy was opened without a pharmacist. On March 3, 2017 the pharmacy was open with a pharmacist. March 3rd was Norman J Clement 66th birthday.

****IN THIS ERA OF ALTERNATIVE NEWS AND FACTS. WE LEARN THAT CONCEPT HAS ABSULUTELY NO BASES IN PHARMACY. UR ATTITUDE IS BASE AROUND PRSEIDENT RONALD REGAN “TRUST AND VERIFY”

  • The Pharmacy was not opened for dispensing, on 3/30/2017.  The pharmacy was locked and secured no medications were being dispensed and the pharmacy being monitored through our security system by a Florida Licensed Pharmacist. The Pharmacy waiting room was open for guest to sit and watch television until pharmacist arrived on premise more importantly the woman observed in the window is the pharmacist wife an a owner the window is not in the filling area.  The license technician is the pharmacist son and was not dispensing, filing medications until his father arrived.
  • “THE MISSION OF THE DEPARTMENT OF HEALTH IS TO PROTECT, PROMOTE & IMPROVE THE HEALTH OF ALL PEOPLE IN FLORIDA THROUGH INTREGRATED STATE, COUNTY AND COMMUNITY EFFORTS” therefore Pronto Pharmacy LLC can fill and dispense prescription from anywhere in the State of Florida.

The complaint the Pharmacist Clement advised that he gives the customers a choice on if they want capsule or tablets…and that capsules are cheaper than the tablets.

  • Florida laws differs to and empowers the patients IN THE STATE OF FLORIDA, All Pharmacy are required to post by law visible to the public “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW
  • Cocktail: Drug Opitimization, CML: Gleeves, Cytarbine, Doxirubecine, Vincristine, Chlorambucil, Use in “cocktails”. Cocktail is prosecutorial slang, just like pill mills, in order to secure conciviction by juries and fail inform juries of drug opitimization, mechanism of action and patho-phisiology.

A) if such combination weren’t being use larger amount of the Opiate would be required.

B) Such so called prosecutorial expert testimonies are serious flawed and go unchallenged.  Ref: Edward Imwinkelreid, when science takes the Stand.

10. RED FLAG IN LIFE ARE NOT LIKES STOP SIGNS IN TRAFFIC…document, evaluate, access every case individual, (dont lie to us), distant documented same reason I go to HFH for cancer, local pharmacy areas does not fill my prescription, reject 25 times particularly minorities.. may set us up for discrimination and profiling. We simply treat peole with dignity and respect.

11. DX Codes: Question: What Purpose: we are here to render a second opinion, eg: dental ridge augmentation, sinus lift, dentist complaint patient unable to get medication filled.

A)Concern: Flip flopping if we consult with the provider charged with conspiracy, conclusion so we avoid or limit our contact.

B)Moving the Goal Post backward and forwards.

12. Insurance: Critical discussion most insurances aren’t avail to small pharmacy establishment rules for eligibility change all the time.

13. CHINESE DISIDENT: ARTIST AL WEIWEI, I cannot live in fear we must live by the law, where is the law DEA: put it in writing  miles, diagnostic codes( Costco’s, Sam’s, CVS, Walgreens, anticipatory compounding, cocktails, pill mills, insurance, cash payment

For Now You’re Within The Norms


[i] http://www.pharmacist.com/article/federal-funding-law-includes-compounding-language-apha-win

[ii] https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm496286.pdf

[iii] In this example, it would be consistent with FDA’s policy if, after distributing 200 units of drug X pursuant to valid patient-specific prescriptions, the compounder produces up to 200 additional units of drug X so that the total number of units that the compounder is holding for distribution returns to 500 units.

  1. [iv] The limited quantities policy, which relates to the amount of inventory held by the compounder, does not alter the product’s BUD. For example, if the BUD for the product is 9 days, the compounder should not produce more units than can be distributed pursuant to valid prescriptions and used within 9 days.

_______________________________________________________

BLACK OWN PHARMACIES UNDER ATTACK: "RAID ON AT COST PHARMACY" FT. MEYERS, FLORIDA

BY

WALTER R. CLEMENT B.S, MS., MBA., NORMAN J CLEMENT RPH DDS

On January 7, 2020, owner Aaron Howard PharmD of At Cost Pharmacy, Fort Meyers Florida, found himself surrounded by 7 DEA agents ordering an Immediate Suspension of his Control Substance license and seizing his property. The order was signed by Acting DEA Chief Uttam DHilllion who as in previous orders issued to other Black own pharmacies to be deem “and imminent danger to public health and safety.”

Since June 2019 we have tracked nearly 12 Black own Pharmacies being attacked in similar manner by agents of the Drug Enforcement Agency (DEA). While Black Own Pharmacies represent less than 1% of all privately own family establishments they appear to be disproportionately target by DEA and State regulators in what is said to be “Practicing Pharmacy While Black.”

The initial contact with the DEA for AT COST PHARMACY and its owner Aaron Howard PharmD, 2003 graduate of Florida A&M University, College of Pharmacy started on February 14, 2018, the Special Agent, or Task Force Officer of the Drug Enforcement Administration of the Department of Justice conducted raid based on a signed search warrant that failed to describe or define the elements of a crime. 

This search warrant was decrepitude in that it failed to illustrate and support the rudimentary descriptions defining Probable Cause.  The investigator wrote, “Application having been made, and probable cause as defined by 21 U.S.C. § 880(d)(1) having been shown by the affidavit of Diversion Investigator Norita N. Persaud, United States Drug Enforcement Administration, for an inspection of the controlled premises of Aarric, Inc., dba At Cost Rx, 16970 San Carlos Boulevard, Suite 110, Fort Myers, FL 33908, with DEA number FA2125640, it appears that said inspection is appropriate under 21 U.S.C. § 880”. 

The investigator agent clearly expressed his limited knowledge of probable cause as defined by 21 U.S.C. § 880(d)(1).  Yet, he did not, within the search warrant, describe the place to be searched and the descriptive elements to support and clearly identify any elements of a crime which would provide a reasonable officer to conclude that probable cause exist.  

The signed warrant authorized the investigating Agent “to seize from the above-described controlled premises such of the following records, information, reports, documents, files and inventories, as are appropriate and necessary to the effective accomplishment of the inspection, and for the purpose of copying or verifying their correctness, or that are used or intended to be used in violation of the Controlled Substances Act whether in electronic or printed media format as noted above”.  The Supreme Court has defined “probable cause” as an officer’s reasonable belief, based on circumstances known to that officer, that a crime has occurred or is about to occur. Carroll v. United States, 267 U.S. 132, 149 (1925).

By the fact this inspection warrant lacked sufficient levels of evidence to support probable cause. The act to inspect the premises was not based on a reasonable officer.   

As a nation we must feat the acts of this search that a law enforcement officer can obtain a baseless warrant and search a premise at will.  The act of the DEA to inspect without cause violates the “Fourth Amendment to the United States Constitution. Which protects the people’s right “to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures.” 

After the inspection, the investigating officer were further authorized to seize legally sanctioned ‘Class two, three, and four controlled substances’ from the premises; The agent wrote “Such of the following records, information, reports, documents, files and inventories, as are appropriate and necessary to the effective accomplishment of the inspection, and for the purpose of copying or verifying their correctness, or that are used or intended to be used in violation of the Controlled Substances Act whether in electronic or printed media format”.  This inspection warrant is a document to look and examine.  However, nothing in the warrant authorized the inspection to reason if a crime took place.   

The 4th amendment clearly establishing the groundwork of a search and seizure.  The agents failed to address the elements of evidence obtained through an unlawful search or seizure.  Under “Mapp v. Ohio, 367 U.S. 643 (1961). Any evidence derived from illegally obtained evidence must also be suppressed”. Thus, the courts have a fiduciary duty to safeguard the public, in as such, the criminal justice functions are there to protect the public form harm.  Such acts within this search is an assault upon every American.  If our protections are eroded, then whom shall we depend upon if the police and the courts act at will.  

Return all items taken and redress all monetary loses to the operator owner of Aarric, Inc. Rx, 16970 San Carlos Boulevard, Suite 110, Fort Myers, FL 33908, Our constitution stands on years of rulings and reforms.  

We are “One Nation Under God with Liberty and Justice for All”  

At Cost Pharmacy Ft. Myers FGlorida
Aaron Howard ACPHARM_FT_MYERS

SO WHILE WE WERE ALL FOCUSED ON IRAN, TRUMP'S DRUG ENFORCEMENT AGENCY (DEA) WAS OUT ATTACKING BLACK OWN PHARMACIES…..

by norman j clement dds., rph, AARON HOWARD PHARMD., RICARDO FERTIL PHARMD. NORMAN L CLEMENT, JELANI Z. CLEMENT, BS., MBA

BLACK HEALTHCARE UNDER ATTACK BY DEPARTMENT OF JUSTICE

My dear Brothers and Sisters, a group of black pharmacist owners, graduates of Florida A&M University College of Pharmacy, have been attacked and raided, by the DEA we need you to help expose this injustice.

THANK YOU FOR TAKING MY CALL 


My name is Norman J Clement, I am a Pharmacist and Dentist, (grad Florida A&M University Pharmacy, Dentistry University of Michigan, finishing my master FAGD University of Florida College of Dentistry).  I own Pronto Pharmacy LLc, a small family Pharmacy in Tampa Florida and we have been in Practice nearly 10 years. 

Los Suenos, Marriott Costa Rica

I’m slowly being bankrupt by the DEA who have created their own set of rules  even using GOOGLE MAPS which clearly violate the constitutions 1st amendment. YET We ARE, SCRAPPY, UNBOWED AND DETERMINE.

The DEA has attacked in a 6 month period in just Florida alone 7 black owned pharmacies and their patients and even more across the country, accusing them of drug trafficking and conspiracy. On January 7, 2020, owner Aaron Howard PharmD of At Cost Pharmacy, Fort Meyers Florida, found himself surrounded by 7 DEA agents ordering an Immediate Suspension of his Control Substance license and seizing his property. On November 19, 2019 owner Ricardo Fertil PharmD of Gulf Med Pharmacy, found himself and his wife surrounded by at least 15 agents of the DEA ordering an Immediate Suspension of his Control Substance license and seizing their property.

HUBERT HUMPHREY BLDG, WASHINGTON, DC
UNITED STATES DEPARTMENT OF HEALTH AND HUIMAN SERVICES

Now the both must go before DEA’s Court of the Kangaroo (see url., a) where justice has become an injustice to us and will cost each owner at least $150,000.00 to defend themselves. Most importantly, the Judge is hired and works for the DEA..(HELLO).
a)  https://youarewithinthenorms.com/2019/12/23/deas-kourt-of-the-kangaroo-by-norman-j-clement-rph-dds/

We need your help to bring a 1st amendment action in Federal Court or State. I’m fighting the DEA, on this very rational bases law. The DEA is using these draconian tactic to shut down Pharmacies (most whom are black and brown) by bankrupting them.  I have a website call You’re with in the Norms face book and we are fighting back and have published.


b) https://youarewithinthenorms.com/2019/12/05/pronto-pharmacy-under-attack-by-trumps-dea-the-raid-on-pronto-pharmacy-august-29-2019-by-walter-r-clement-and-norman-j-clement-rph-dds/
c) https://youarewithinthenorms.com/2019/12/10/since-when-has-it-become-the-job-or-the-role-of-law-enforcement-dea-to-dictate-and-define-medical-procedures-and-protocols-a-reflection/


Briefly:
1. My Pharmacy was raided by the DEA who claimed we were Manufacturing when in fact we are compounding.  
2. They shut me down literally further stating we were seeing Patient from more than a 30 mile limit even though there is no such rule or law.
3. I have a admin hearing Jan 28 thru 31 in Tampa Florida, before the DEA (Kangaroo Court). All Pre-hearing Statements are done.

LIBERATION MUSEUM, JOHANNESBURG, SOUTH AFRICA


My Attorney is Dale Sisco 813/224-0555

The DEA states, we need a separate license, when in fact we don’t because we are compounding.  
Also contact my Son Norman L. Clement 813 919-6005, or Jelani Z. Clement at 813 443-0970
norm dds

WHITE PAIN, BLACK AND BROWN DESTAIN IN THE SO-CALLED OPIOID CRISIS AND EPIDEMIC IN AMERICA

BY

NORMAN J. CLEMENT RPH.,DDS, JACK FOLSON RPH, WALTER R. CLEMENT BS, MS.,

Jelani Z Clement BS., MBA

THE HIDDEN FEDERAL GOVERNMENT 25 PAGE REPORT ON THE PAIN OF MEDICAL APARTHEID IN AMERICA, WHO GETS TREATED AND WHO IS SENT TO PRISON

Washington , District of Columbia, United States April 25, 2018 10:24 am, United States Surgeon General Jerome M. Adams, MD, MPH speaks attended by Jelani Z, Clement Pharm Tech., Pronto Pharmacy and Norman J Clement Rph., DDS., Conference Office of Minority Health on Opioid Overdose and Mental Health Disparities, Hubert Humphrey Bldg.

THE PAINTTHEWashington , District of Columbia, United States April 25, 2018 10:24 am, United States Surgeon General Jerome M. Adams, MD, MPH Speaks attended by Jelani Z, Clement Pharm Tech Pronto Pharmacy and Norman J Clement Rph., DDS Conference Office of Minority Health on Opioid Overdose and Mental Health DisparitiesWashington , District of Columbia, United States April 25, 2018 10:24 am, United States Surgeon General Jerome M. Adams, MD, MPH Speaks attended by Jelani Z, Clement Pharm Tech Pronto Pharmacy and Norman J Clement Rph., DDS Conference Office of Minority Health on Opioid Overdose and Mental Health Disparities.Washington , District of Columbia, United States April 25, 2018 10:24 am, United

photo by norman j clement rph., dds

Washington , District of Columbia, United States April 25, 2018 10:24 am, United States Surgeon General Jerome M. Adams, MD, MPH Speaks attended by Jelani Z, Clement Pharm Tech Pronto Pharmacy and Norman J Clement Rph., DDS., Conference video RACIAL DISPARITIES IN ACCESS TO OPIOID TREATMENT.

THE PAIN

People suffer pain and pain is real. Pain has been around and on this planet for quite sometime. Pain is a medical issue, a normal complication which exist in nearly every species on earth and beyond.  Pain and the treatment of pain, drug dependency, drug intoxication are medical public health issues and not criminal.

Yet, one cannot ignore the social economic, racial components and disparities that exist which have been mis-handled in the treatment of pain, dependency and drug intoxications. (see Video below by Norman and Jelani Clement, HHS Bldg US Surgeon General Conference on Racial Disparities Mental Opioids, “Public Health Approach)

THE CRISIS

The clear reason why there has been a classification of a “OPIOD CRISIS IN AMERICA” is more white people have gained access an are dying from  Illegally Manufactured Derivative-of Opioids Substances (IMDOS) which are mis-classified as drugs but, are in reality  poisons. These IMDOS,  when abused co-committanly with other none and unknown euphoric substance (NUES) will cause intoxication resulting in death.” 

Thus, these authors are furthered bothered by the saying Opiod Epidemic. Both the crisis and epidemic have been  driven by the increasing numbers of White People dying on illicit

manufacturing opioid derivatives that has turned on them and were traditionally allowed to be distributed in communities of colors (black and hispanic). However,  leaving intact a punitive, carceral system as the appropriate response for Black and Brown drug use.” 

THE OPIOD HOAX

Thus, the hoax  of the Opioid Epidemic and Crisis is as  nearly equivalent to that of the D.W. Griffiths, Movie Birth of a Nation, where in both are racist and “racism is racism,” as scholar William Trotter further stated “one knows it when they see it.”

Yet, little known and a very under reported is a Federal Government study called White Opioids: Pharmaceutical Race and The War on Drugs, that wasn’t , released April 2017 by The United States Department Health and Human Services (HHS) a 25 page  study (with broad foot notes) on White Opioids,(OPEN FOOT NOTE AT BOTTOM #1) which states; 

“This ‘White drug war’ has historical precedents in which predominantly White populations have used social privilege to invoke ‘medical need’ to secure or maintain access to powerful sedatives or stimulants in the mid to late twentieth century (see Herzberg, 2013). But in the case opioids, addiction treatment itself is being selectively pharmaceuticalized in ways that preserve a protected space for White opioid users, while leaving intact a punitive, carceral system as the appropriate response for Black and Brown drug use.”


  1. see url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501419/#R28/


35 AGENTS OF DEA RAID PRONTO PHARMACY AUGUST 29, 2019.

THE DOC NORM’S MANIFESTO

When you see THROUGH OUT LIFE most of your friends, colleagues and classmates who are of degree being sanctioned, terminated, harassed, arrested, jailed and imprisoned for the most minuscule violation of a regulation, or for just doing what they’ve been trained to do. Then we must stand and fight as soldiers together our die like mice. 

ENOUGH IS ENOUGH.

TO ME,  that idea that some United States Attorney is going to tell me pharmaceutical compounding is manufacturing makes it’s worth the fight.


ENOUGH IS ENOUGH.

Then at some point you are compelled to ask yourself when ENOUGH IS ENOUGH. At some point in your life you have to say and proclaim enough is enough and what are you going to do about it.


Then we must stand and fight as soldiers together our die like mice. 

 ENOUGH IS ENOUGH.


TO ME,  that idea that some United States Attorney is going to tell me pharmaceutical compounding is manufacturing makes it’s worth the fight.


ENOUGH IS ENOUGH.

FEDERAL JUDGE STOPS DEA ONCE AGAIN IN OAK HILL PHARMACY (WV) RULING

Case 2:19-cv-00716 Document 36 Filed 12/23/19 Page 1 of 12 PageID #: 2531

IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

CHARLESTON DIVISION

OAK HILL HOMETOWN PHARMACY Petitioner,

v.
UTTAM DHILLON, et al.,

Respondents.

CIVIL ACTION NO. 2:19-cv-00716

MEMORANDUM OPINION AND ORDER


On October 30, 2019, this court DISSOLVED the Order of Immediate Suspension of

Registration (“ISO”) issued by the United States Drug Enforcement Administration (“DEA”) pursuant to 21 U.S.C. § 824(d)(1) of Oak Hill Hometown Pharmacy’s (“the Pharmacy”) registration to dispense controlled substances. [ECF No. 17]. On November 27, 2019, the respondents, Uttam Dhillon and the DEA, filed a Motion to Alter or Amend that October 30, 2019 Order pursuant to Federal Rule of Civil Procedure 59(e) [ECF No. 20]. The petitioner, the Pharmacy, has responded [ECF No. 25] and the matter if ripe for adjudication. The court DENIES the respondents’ Motion to Alter or Amend the Judgment.

I. Introduction

On October 21, 2019, the Pharmacy filed what was styled as a motion for Temporary Restraining Order (“TRO”) against the ISO. [ECF No. 4]. This court held a hearing on the motion on October 23, 2019 and October 24, 2019. [ECF Nos. 9, 10]. On October 30, 2019, this court issued an order dissolving the ISO, finding that the DEA had not demonstrated that the immediate suspension of the Pharmacy’s registration was necessary to prevent an “imminent danger to public

Case 2:19-cv-00716 Document 36 Filed 12/23/19 Page 2 of 12 PageID #: 2532

health and safety.” [ECF No. 17]. In that order, the court found, based on the enabling statute, that it was more appropriate to dissolve the ISO rather than grant temporary relief. The enabling statute states, “a suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.” 21 U.S.C. § 824(d). The United States District Courts are the courts of “competent jurisdiction.” See Barry M. Schultz, M.D.; Decision and Order, 76 Fed. Reg. 78,695 (Dec. 19, 2011) (finding that an ISO is not reviewable by an administrative law judge); Novelty Distributors, Inc. v. Leonhart, 562 F. Supp. 2d 20, 27 (D.D.C. 2008); Norman Bridge Drug Co. v. Banner, 529 F.2d 822, 824 (5th Cir. 1976). Therefore, the plain language of the statute vests the United States District Courts with the power to dissolve, meaning terminate, an ISO. The October 30, 2019 Order was thus a final judgment.

On November 27, 2019, the respondents filed a Motion to Amend or Alter the October 30, 2019 Order. [ECF No. 20]. The respondents base this motion on a newly certified administrative record, which they contend constitutes evidence unavailable at the time of the dissolution hearing. The respondents ask this court to “reconsider the judgment entered on October 30, 2019, pursuant to Rule 59(e), deny OHHP’s [the Pharmacy] Motion for “TRO,” and schedule further proceedings regarding OHHP’s Petition for Injunction to Dissolve Immediate Suspension Order.” Resp’ts Mem. in Supp. of Mot. to Alter or Am., 3 [ECF No. 23].

II. Legal Standard

Federal Rule of Civil Procedure 59(e) allows for a party to motion to alter or amend a final judgment. Granting a Rule 59 motion is an extraordinary remedy that should be used sparingly. Pac. Ins. Co. v. Am. Nat. Fire Ins. Co., 148 F.3d 396, 403 (4th Cir. 1998). Although the Rule itself does not provide a standard under which a district court may grant such a motion, the Fourth Circuit

2

Case 2:19-cv-00716 Document 36 Filed 12/23/19 Page 3 of 12 PageID #: 2533

recognizes three grounds for amending or altering a final judgment: “(1) to accommodate an intervening change in controlling law; (2) to account for new evidence not available at trial; or (3) to correct a clear error of law or prevent manifest injustice.” Id. at 403; Hutchinson v. Staton, 994 F.2d 1076, 1081 (4th Cir.1993). “Rule 59(e) motions may not be used, however, to raise arguments which could have been raised prior to the issuance of the judgment,” nor may they be used to relitigate the merits of the case. Pac. Ins. Co., 148 F.3d at 403; see also Wright et al., 11 Fed. Prac. & Proc. § 2810.1 Grounds for Amendment or Alteration of Judgment (3d ed. 2019).

A party who brings a Rule 59(e) motion based on newly discovered evidence “must produce a legitimate justification for not presenting the evidence during the earlier proceeding.” Pac. Ins. Co., 148 F.3d at 403 (quoting Small v. Hunt, 98 F.3d 789, 798 (4th Cir.1996)). And must show that the new “evidence is such that is likely to produce a new outcome if the case were retried, or is such that would require the judgment to be amended.” Boryan v. United States, 884 F.2d 767, 771 (4th Cir. 1989).

III. Discussion

The respondents’ Motion to Alter or Amend turns on two primary questions: (1) whether the newly certified administrative record constitutes new evidence not available at the time of the dissolution proceeding, and (2) if it does, is the administrative record likely to produce a new outcome or require the judgment be amended. See id. For the following reasons, I find that the administrative record does constitute new evidence but that it would not produce a different judgment. Thus, the respondents’ motion is DENIED.

a. New Evidence

During the expediently scheduled dissolution proceeding it was unclear to me as to what was contained in the administrative record. At that hearing, it was argued that the administrative

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record definitely contained: (1) “the immediate suspension order itself;” (2) “the West Virginia Board of Pharmacy and prescription drug monitoring program (‘PDMP’) data;” and (3) the DEA expert’s report. TRO Hr’g Tr. 46:7–8, Oct. 23, 2019 [ECF No. 15]. The Government argued that the court’s review should be restricted to those three items. Id. At the same time, the Government admitted that the administrative record before the DEA administrator was not necessarily limited to these three sources and could include other material. See TRO Hr’g Tr. 5:25; 6:1–5, Oct. 24, 2019 [ECF No. 16].

It is apparent from the filing accompanying the Rule 59(e) motion the DEA considered more material than it previously represented to the court. For example, the Government strongly objected to—among other material—the inclusion in the record of the West Virginia Board of Pharmacy Letter; West Virginia Board of Pharmacy Inspector’s Report, and the March 2017 West Virginia Board of Pharmacy Minutes. Relying on the Government’s representation that there was no evidence that the DEA had the information from the West Virginia Board of Pharmacy when it issued the ISO, this court granted the respondents’ objection and excluded that evidence. [ECF No. 17]. Yet the Declaration of Assistant Administrator of the DEA’s Diversion Control Division, William McDermott, explicitly states that “prior to issuing the ISO, DEA was aware of material from the West Virginia Board of Pharmacy.” Decl. of William McDermott, 16 [ECF No. 30–1].

This court will not discuss here all forty-two exhibits that now make up the certified administrative record. Suffice to say, I have carefully reviewed all the exhibits. Most repackage information the that I considered in the order to dissolve the ISO—such as maps outlining distances patients traveled to fill prescriptions and specific patient prescriptions records that were reflected in the PDMP data. I will, however, outline new evidence that contains information not previously presented to the court: an excel spreadsheet of all DATA waived practitioners in West Virginia

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(Admin. Record Ex. 27); four published DEA administrative decisions and orders (Admin. Record Ex. 33–36); a list of top controlled substances filled by the Pharmacy from 2015 to 2018 (Admin. Record Ex. 39); the West Virginia DHHR, Office of Policy Services, Policy for the Coverage of Suboxone (Admin. Record Ex. 40); and a January 30, 2018 letter from the West Virginia DHHR re: Opioid Response Plan for the State of West Virginia (Admin. Record Ex. 41). Although not part of the official administrative record, the respondents also include the Declaration of the Assistant Administrator of DEA’s Diversion Control Division, William T. McDermott, as supplementary background information that helps explain the administrative record. See AT & T Info. Sys., Inc. v. Gen. Servs. Admin., 810 F.2d 1233, 1236 (D.C. Cir. 1987) (holding that reviewing background information or evidence that explain the administrative record is permitted while post- hoc rationalizations are unacceptable).

The respondents argue that although the DEA administrator obviously had the information prior to the court’s October 30, 2019 Order, they justifiably could not have organized and formally certified the administrative record because of the procedural posture of a TRO. See Resp’ts Mem. in Supp. of Mot. to Alter or Am., 4 [ECF No. 23]. I agree. A motion for TRO under Rule 65 is meant to provide temporary relief before a matter can be fully decided on the merits. See Fed. R. Civ. Pro. 65. Since the matter was presented in that procedural posture, the briefing period and hearing on the plaintiff’s motion were expedited. I find that this rushed schedule explains the DEA’s inability to produce and certify a complete administrative record. I find that the newly certified administrative record thus qualifies as new evidence not available at the time the final judgment was issued. See Pac. Ins. Co., 148 F.3d at 403.

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b. Likelihood of Producing a Different Judgment

Simply demonstrating however that the evidence qualifies as new under Rule 59(e) does not mean the motion to amend or alter should be granted. Boryan, 884 F.2d at 771. Most importantly, the movant must also show that such new evidence would be likely to result in a new outcome in the judgment. Here, the respondents have failed to do so.

1. Standard of Review

First, the respondents argue that the new administrative record changes the standard of review. Resp’ts Mem. in Supp. of Mot. to Alter or Am., 5 [ECF No. 23]. This is an odd argument. The respondents’ brief misstates my reason for reviewing the ISO de novo. I did not apply a de novo standard of review because of the lack of certified administrative record but rather applied de novo review because of the lack of administrative process in issuing an ex parte ISO and because statutory authority vest the United States District Courts with original jurisdiction to review such emergency orders. A disagreement with the court’s reasoning is not a legitimate basis for a Rule 59(e) motion. Pac. Ins. Co., 148 F.3d at 403.

2. Merits of the Case

Second, the contents of the newly certified administrative record do not produce a different outcome or require amending the judgment on the merits of the case. The administrative record filed with the Rule 59(e) motion is made up of hundreds of pages of information which largely restates the argued basis submitted to the court at the dissolution hearing. Nothing contained in the newly filed administrative record evidences a fact not previously considered by the court that supports a substantial likelihood that there exists or did exist at the time of the dissolution an “imminent threat to the public health and safety.” This newly filed record continues to rely upon unquantified suspicions. Assuming arguendo, that the behaviors characterized as red flags by the

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DEA are sometimes indicators of criminal conduct does not prove the substantial likelihood of “imminent harm to public health and safety” required by the statute. Treatment drugs such as, Subutex and Suboxone, offer the potential for diversion and abuse. After all, they are placed by prescription in the hands of drug abusers—persons addicted to opioids. But mere surmise of diversion does not equate to an “imminent danger to public health and safety.”

As the court explained in its previous order, the statute governing the ex parte emergency suspension procedure, which immediately suspends registration—without a pre-deprivation hearing—presents a high bar to the Government. 21 U.S.C. § 824(d)(1). To justify an ISO, the DEA administrator must show that the continued registration of the registrant poses an “imminent danger to the public health or safety.” Id. In 2016, Congress amended the statute, imposing an even higher threshold for issuing this emergency suspension procedure. See Ensuring Patient Access and Effective Drug Enforcement Act of 2016, Pub. L. No. 114-145, § 2, 130 Stat. 353 (codified as amended at 21 U.S.C. § 824(d)(2)). That amendment defined “imminent danger to the public health or safety” as requiring a showing of “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.” Id.

Simply demonstrating an unquantified risk of illegal drug use is not a finding of imminent danger. Here, the certified administrative record does not point to a single instance of a violation of the law. The newly filed administrative record does not contain any new evidence that any patient abused or diverted Subutex or Suboxone. The DEA yet again simply offers evidence of what it sees as a suspicious pattern of the filling of lawful prescriptions for medication designed to treat opioid addiction, which this court previously found insufficient to justify the ISO.

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Turning briefly to the four published DEA administrative decisions and orders included in the record that the respondents rely on to show that the Pharmacy’s practices present red flags for abuse and diversion, there are several reasons why these decisions are unpersuasive. Most importantly, none of the cases evaluate pharmacy practices under the standard of “imminent harm to public health and safety” because none of the cases involve a review of an ISO. See Edge Pharmacy, 81 fed. Reg. 72,092 (2016) (Admin. Ex. 33) [ECF No. 30–5]; Holiday CVS, L.L.C., 77 Fed. Reg. 62,316 (2012) (Admin. Ex. 34) [ECF No. 30–6]; Trinity Pharmacy II, 83 Fed. Reg. 7,304 (2018) (Admin. Ex. 35) [ECF No. 30–7]; Wheatland Pharmacy, 78 Fed. Reg. 69,441 (2013) (Admin. Ex. 36) [ECF No. 30–8]. All four of the cases arise under the procedure outlined in 21 U.S.C. §824(a)(4), meaning the administrative court in those cases evaluated whether the pharmacies’ registration would “be inconsistent with public interest.” Assessing whether registration would be inconsistent with the public interest is starkly different than determining whether continued registration poses “an imminent danger to public health and safety.” See John J. Mulrooney, II & Katherine E. Legel, Current Navigation Points in Drug Diversion Law: Hidden Rocks in Shallow, Murky, Drug-Infested Waters, 101 Marq. L. Rev. 333, 346 (2017).

Further, none of the four cases in the administrative record involved medications used to treat opioid addiction. Edge Pharmacy involved oxycodone and hydromorphone. Admin. Ex. 33, at 1 [ECF No. 30–5]. Holiday CVS involved alprazolam and oxycodone. Admin. Ex. 34, at 1 [ECF No. 30–6]. Trinity Pharmacy II involved benzodiazepine, fentanyl, and muscle relaxers. Admin. Ex. 35, at 1 [ECF No. 30–7]. Wheatland Pharmacy involved hydrocodone, acetaminophen, promethazine, codeine, and Xanax. Admin. Ex. 36, at 1[ECF No. 30–8]. As I emphasized in the October 30, 2019 Order, legal pain management opiates are the primary culprits in the opioid epidemic. The set of controlled substances used to medically treat pain are a far different species

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of opiate than Suboxone and Subutex—necessary to treat addiction. Evaluating “imminent danger to public health and safety” is a two-sided inquiry. Considering the “imminent danger to public health and safety” posed by shutting down access to MAT therapy was an essential part of my reasoning in the previous order. Thus, the fact that these four DEA administrative decisions do not involve treatment medication make them materially dissimilar from this case.

The Government is correct that these four cases do indicate that some of the prescriptions the Pharmacy in this case filled presented “red flags.” The courts in those cases find that traveling long distances to receive or fill a prescription, paying in cash for prescriptions, and filling prescriptions that are characteristic of “pattern prescribing” —when multiple people present prescriptions for the same drug, on the same day, issued by the same provider— are “red flags” for abuse or diversion. But none of these cases explain or even contend that these “red flags” constitute an “imminent harm to public health and safety.” These cases serve only to confirm that the Pharmacy engaged in several suspicious practices. But the statute requires more than suspicion to suspend registration without process. Therefore, these cases are unpersuasive and would not produce a different outcome in judgment from the October 30, 2019 Order.

Moreover, the new administrative record does not address the imminence requirement inherent in the statute governing the issuance of an ISO. The statute by its own terms requires the DEA factually establish that the continued operation of the Pharmacy poses an imminent danger. This standard means that there must be evidence that the Pharmacy was filling prescriptions that patients were abusing or diverting at the time the agency issued the ISO in August 2019. In the October 30, 2019 Order, this court emphasized that the Pharmacy substantially curtailed filling prescriptions that the DEA flagged as indicative of abuse and diversion after the administrative warrant was served on November 28, 2018. That fact demonstrates that any danger posed by the

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Pharmacy was not imminent. The Pharmacy accepted only three new out-of-state prescriptions for Subutex after November 28, 2018. This court previously held that the Pharmacy’s “red flag” activity since the administrative warrant appears quite limited. The Pharmacy’s practices after the administrative warrant was served in November 2018 simply do not support a finding of imminent danger almost nine-months later in August 2019, when the ISO was issued.

The DEA clearly disagrees with the court’s assessment of the continued risk the Pharmacy posed at the time the ISO was issued. But in rearguing its opinion on the imminence of harm, the Government again points to the PDMP data, evidence it acknowledges the court already considered in its October 30, 2019 Order. See Resp’ts’ Reply to Pet’r’s Resp. to Mot. to Alter or Amend the Oct. 30, 2019 J. Order, 12 [ECF No. 32]. Rule 59(e) is not a vehicle for parties to relitigate its theories of the case after a final judgment. The Government does not use the new evidence contained in the administrative record to show that the court would likely reach a different outcome on the imminence of harm issue.

I am disturbed that Mr. McDermott, in his declaration, infers that there is a correlation between patients receiving Medicaid and patients diverting or abusing controlled substances. I will not spend time here explaining the logical fallacies this surmise embraces. Suffice it to say “poverty and substance use problems operate synergistically” for a multitude of complex reasons. Nabarun Dasgupta et al., Opioid Crisis: No Easy Fix to its Social and Economic Determinants, Am. J. Pub Health 182–186 (February 2018). The suggestion, however, that an addicted patient’s qualification for Medicaid indicates in any way a propensity for diversion or substances abuse is repugnant. Service to low income communities can be no part of a government decision to suspend a pharmacy’s registration.

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Access to treatment was a focal point of this court’s October 30, 2019 Order. Evaluating the “imminent danger to public health and safety” required the court to determine whether the continued registration of the Pharmacy posed a “substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur.” Therefore, I also contemplated the dangers of further limiting the number of pharmacies in West Virginia willing to provide much needed treatment medication. The underlying reality of MAT therapy is that it requires pharmacies to fill prescriptions of controlled substances for people addicted to opiates— a group of people who frequently face a significant amount of stigma and suspicion

The DEA would suggest that filling lawful prescriptions for Subutex, when they believe that Suboxone is more appropriate, is grounds for revoking a pharmacy’s registration without process. From a perusal of all the material from the Government in this case, I conclude that they believe Subutex and Suboxone to be more a part of the problem than part of the solution to the opioid crisis. That mindset ignores the fundamental value of these medications. These treatment drugs are entirely lawful and are to be used by addicts in the treatment of opioid addiction. These drugs should be available by prescription and obtainable at any pharmacy. Discouraging the use of these drugs by revoking the registration of pharmacies who fill prescriptions without any administrative process other than a statement of law enforcement suspicion cannot be consistent with the law.

IV . Conclusion

The DEA largely appears to be using Rule 59(e) to relitigate the merits of its case. Much of its memorandum in support of its motion and its reply memorandum merely state its disagreement with the court’s findings and reargue its position based on evidence it acknowledges was presented to the court before its October 30, 2019 Order. See Resp’ts’ Reply to Pet’r’s Resp.

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to Mot. to Alter or Amend the Oct. 30, 2019 J. Order, 12 [ECF No. 32]. The respondents are of course free to appeal this court’s decision to the Fourth Circuit Court of Appeals but using Rule 59(e) as an excuse to re-present its case is inappropriate. The court therefore DENIES the respondents’ Motion to Alter or Amend the October 30, 2019 Judgement Order.

The court DIRECTS the Clerk to send a copy of this Order to the defendant and counsel, the United States Attorney, the United States Probation Office, and the United States Marshal.

ENTER: December 23, 2019