Alvin Darby, M.D.; Denial of Application, 26993-27000 [2010-11431]
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become the final determination of the
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Deborah Henderson-Norton,
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Authority: 43 CFR 2711.1–2.
[FR Doc. 2010–11483 Filed 5–12–10; 8:45 am]
BILLING CODE 4310–33–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09–6]
Alvin Darby, M.D.; Denial of
Application
On June 25, 2008, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Alvin Darby, M.D.
(Respondent), of Gretna, Louisiana. The
Show Cause Order proposed the denial
of Respondent’s pending application for
a DEA Certificate of Registration as a
practitioner on multiple grounds. ALJ
Ex. 1, at 1 (citing 21 U.S.C. 823(f) and
824(a)(1) and (2)).
First, the Government alleged that on
April 1, 1998, Respondent had pled
guilty in the Criminal Court for Orleans
Parish, Louisiana to one felony count of
possession of cocaine and one
misdemeanor county of carrying a
concealed weapon. Id. The Order
further alleged that Respondent
‘‘materially falsified’’ his application ‘‘by
failing to disclose [his] * * * felony
conviction related to controlled
substances.’’ Id. at 2.
Next, the Show Cause Order alleged
that ‘‘[o]n three separate occasions
between May 13, and June 24, 2003,
[Respondent] issued prescriptions for
hydrocodone ([a] schedule III controlled
substance) [and] alprazolam ([a]
schedule IV controlled substance),’’ to
an undercover agent in exchange for
cash, and that the prescriptions lacked
a ‘‘legitimate medical purpose’’ and were
issued outside of the ‘‘usual course of
professional practice.’’ Id. at 1. Finally,
the Show Cause Order alleged that
Respondent ‘‘committed numerous
recordkeeping violations under [his]
previous * * * registration,’’ which he
had surrendered for cause, including
that: (1) He had ‘‘fail[ed] to take a[n]
initial inventory of stocks of controlled
substances,’’ (2) he had ‘‘fail[ed] to take
and maintain a biennial inventory,’’ and
(3) he had failed to ‘‘maintain records of
controlled substances [which he]
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26993
dispensed.’’ Id. at 2 (citing 21 CFR
1304.11(b), 1304.11(c), 1304.22(c)).1
By letter of October 21, 2008,
Respondent’s counsel requested a
hearing on the allegations. ALJ Ex. 2, at
2. According to Respondent, he did not
receive the Show Cause Order ‘‘in a
timely manner because the notice was
delivered to an old address.’’ Id.
Respondent further maintained that he
‘‘was notified via facsimile on
September 22, 2008 that he has an
opportunity to show cause as to why’’
his application should not be denied
and therefore ‘‘request[ed] the
opportunity to be heard.’’ Id. The
Government did not object to granting
Respondent a hearing.2
The case was then assigned to an
agency Administrative Law Judge (ALJ),
who conducted a hearing on July 14 and
15, 2009, in New Orleans, Louisiana. At
the hearing, both parties called
witnesses and introduced documentary
evidence. After the hearing, both parties
submitted briefs containing their
proposed findings of facts, conclusions
of law, and argument.
On September 10, 2009, the ALJ
issued his Recommended Decision
(hereinafter, also ALJ). Therein, the ALJ
found that ‘‘the credible evidence clearly
establishes that Respondent prepared
and submitted an application that
falsely indicated that he had never been
convicted of a crime in connection with
a controlled substance and that he had
never had a state professional license
placed on probation.’’ ALJ at 23. The
ALJ further found that the falsification
was material as it ‘‘had the capacity to
influence DEA’s decision on the
application’’ and, second, that the
Government ‘‘ha[d] clearly established a
prima facie case for the denial of
Respondent’s application based solely
on the material falsifications contained
in [Respondent’s] application.’’ Id. at 24.
The ALJ then addressed the ‘‘the
public interest’’ factors under 21 U.S.C.
823(f). As for factor one (the
recommendation of the state licensing
board), the ALJ noted that the Board had
restored Respondent’s medical license.
ALJ at 26–27. However, he further noted
1 Moreover, in its Prehearing Statement, the
Government notified Respondent that it intended to
litigate the question of whether Respondent had
also materially falsified his March 10, 2005
application for registration by failing to disclose
that on August 18, 1999, he had entered into a
Consent Order with the Louisiana State Board of
Medical Examiners, which placed his medical
license on probation for a five year period. ALJ Ex.
4, at 3, 6–7.
2 The ALJ did not make any findings as to
whether the Government’s attempts to serve
Respondent were constitutionally adequate, the
date when service was initially attempted, and/or
whether Respondent had shown good cause for
failing to timely file.
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that under Agency precedent, a State
Board’s restoration of a medical license
is not dispositive in the public interest
inquiry because DEA has an
independent responsibility ‘‘to
determine whether a registration is in
the public interest.’’ Id. at 27 (citing
cases). The ALJ thus concluded that this
factor weighed neither for, nor against,
a determination that granting
Respondent a certificate of registration
would be in the public interest. Id.
The ALJ next addressed factor three
(the applicant’s conviction record under
Federal and State laws related to the
manufacture, distribution and
dispensing of controlled substances)
and whether Respondent’s ‘‘state felony’’
conviction for ‘‘criminal possession of
crack cocaine’’ constituted a conviction
under this factor. Id. at 27–28. While the
ALJ concluded that Respondent’s
conviction for cocaine possession was
not relevant under this factor, id. at 28,
he subsequently noted that it could be
considered under factor five as such
other conduct which may threaten
public health and safety. Id. at 34–35.
The ALJ then turned to factors two,
four and five (Respondent’s experience
in dispensing controlled substances, his
compliance with applicable State,
Federal or local laws relating to
controlled substances, and such other
conduct which may threaten the public
health and safety). With respect to the
allegation that Respondent had sold
controlled substance prescriptions to an
undercover Agent for cash, the ALJ
concluded that the Government ‘‘failed
to present evidence in sufficient[ly]
credible detail to support [the]
allegation by a preponderance of the
evidence.’’ Id. at 30. More specifically,
the ALJ noted that the Agent who had
made the undercover visits did not
testify in the proceeding and that the
Investigator who testified regarding
them ‘‘conceded’’ that the Agent’s vital
signs were taken and that he had
complained of a medical condition. Id.
The ALJ also noted that while
Respondent had diagnosed the Agent as
having a ‘‘leg-length disparity,’’ there
was ‘‘not even evidence from which it
could be inferred that [the Agent] did
not, in fact have’’ this condition. Id.
However, the ALJ also found that
Respondent had pre-signed controlled
substance prescriptions and that such
prescriptions were not ‘‘issued in the
usual course of professional practice.’’
Id. Moreover, the ALJ concluded that
when this practice was coupled with
various circumstances surrounding
Respondent’s practice (including the
late night hours he maintained, the lack
of specific appointment times, various
instances of his patients negotiating
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drug deals in his parking lot, and the
issuance of prescriptions to patients
before Respondent even saw them)
made it clear that ‘‘Respondent’s
prescribing practices were not designed
to issue prescriptions for legitimate
medical purposes in the usual course of
a professional practice.’’ Id. at 30–31. In
this regard, the ALJ further noted that
Respondent made the same diagnoses of
a leg-length discrepancy in each of the
52 patient files that the Government had
seized and that ‘‘it is patently
unreasonable to attribute [this
diagnosis] to mere coincidence.’’ Id. at
31. Finally, the ALJ noted that while
during the execution of a search
warrant, Respondent had various
controlled substances on the premises,
he did not have such required records
as an initial inventory, the biennial
inventory, and a dispensing log. Id. at
32.
The ALJ further noted that it was
‘‘remarkable that these actions took
place even after * * *. Respondent had
been through the criminal justice system
* * * and had his medical license
placed on probation.’’ Id. at 33.
Moreover, the ALJ found that
Respondent had failed to accept
responsibility for his actions and that he
‘‘flatly denied preparing and submitting
the application’’ which he materially
falsified even though his assertion ‘‘was
wholly inconsistent with the evidence
developed at the hearing.’’ Id. at 35.
The ALJ thus concluded that ‘‘the
Government has established that the
Respondent has committed acts that are
inconsistent with the public interest’’
and that Respondent has not ‘‘accepted
responsibility for his actions, expressed
remorse for his conduct at any level, or
presented evidence that could
reasonably support a finding that the
Deputy Administrator should again
entrust him with a Certificate of
Registration.’’ Id. at 36. The ALJ thus
recommended that Respondent’s
application be denied. Id.
Neither party filed exceptions to the
ALJ’s decision. Thereafter, the record
was forwarded to me for final agency
action.
Having considered the record in its
entirety, I adopt the ALJ’s findings of
fact (including his credibility findings)
except as expressly noted otherwise. I
further adopt the ALJ’s legal conclusion
that Respondent’s registration would be
inconsistent with the public interest.
Accordingly, I will adopt the ALJ’s
recommendation and deny
Respondent’s application. I make the
following findings.
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Findings
Respondent is a physician licensed by
the Louisiana State Board of Medical
Examiners who practices physical
medicine. GX 3 at 1. Respondent also
previously held a DEA Certificate of
Registration, which authorized him to
dispense controlled substances as a
practitioner at the address of 555
Holmes Boulevard, Gretna, Louisiana.
GX 1. However, on June 2, 2004,
following an investigation by DEA (the
circumstances of which are set forth
below), Respondent voluntarily
surrendered his registration. Id.; GX 6.
On March 9, 2005, Respondent
applied for a new DEA registration
using the Agency’s Web site.3 GXs 1 &
8. While Respondent denied filing this
application, Tr. 309, the Government
produced evidence showing that the
$390 application fee was charged to a
credit card account held by him. GX 13,
at 2 & 4.
On the application, Respondent was
required to answer four ‘‘liability’’
questions. The first question asked: ‘‘Has
the applicant ever been convicted of a
crime in connection with controlled
substance(s) under state or federal law,
or is any such action pending?’’ GX 1.
Respondent answered: ‘‘no.’’ Id.
The third question asked: ‘‘Has the
applicant ever had a state professional
license or controlled substance
registration revoked, suspended, denied,
restricted, or placed on probation, or is
any such action pending?’’ Id.
Respondent again answered: ‘‘no.’’ Id.
The second question asked: ‘‘Has the
applicant ever surrendered or had a
federal controlled substance registration
revoked, suspended, restricted or
denied, or is any such action pending?’’
Id. at 2. Respondent answered:
On June 02, 2004, my primary office in
Louisiana was visited by the Mississippi
Division of DEA Diversion Unit. Officers of
this unit expressed concerns regarding lack
of Mississippi State DEA Registration.
Advised to surrender Louisiana DEA
Registration to facilitate investigation of other
matters regarding patient prescription writing
[sic] habits. As of this application
submission, am uncertain of status of the
investigation.
Id. at 2.4
Based on Respondent’s ‘‘yes’’ answer
to the second question, his application
was assigned to a DEA Diversion
3 As explained below, I agree with the ALJ that
Respondent’s testimony that he did not submit the
March 10, 2005 application is not credible.
According to the affidavit of a Diversion
Investigator, while the application was submitted
via the internet on March 9, 2005, the transaction
was not posted until the following day. GX 13, at
2.
4 The fourth liability question was not applicable.
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Investigator with the New Orleans Field
Division Office.5 Tr. 189. However,
because there was an open criminal
investigation into his activities in
Mississippi, no action was taken on the
application until after the United States
Attorney for the Southern District of
Mississippi declined prosecution. Id.
During the course of its investigation,
DEA obtained a copy of a Consent Order
which Respondent entered into with the
Louisiana State Board of Medical
Examiners (hereinafter, State Board or
Board), which the latter approved on
August 18, 1999. GX 3, at 11. Therein,
Respondent admitted that on April 1,
1998, he had pled guilty to the offense
of ‘‘simple possession of cocaine,’’ a
felony under Louisiana law.6 Id. at 2; see
also GX 2(2), at 1; GX 2(3), at 1.
Respondent was given a suspended
sentence of two years in the custody of
the Louisiana Department of Correction
for this offense, two years of probation,
fined $600, and ordered to undergo drug
counseling and rehabilitation. GX 3, at
2; GX 2(5).
In the consent order, Respondent
further admitted that he had used
marijuana on a daily basis, and that he
had ‘‘used cocaine in 1982, 1985, and
1991,’’ and that during 1991, ‘‘he began
using cocaine on a more regular and
frequent basis [and] developed a
dependency on crack cocaine and
‘primo,’ a mixture of cocaine and
marijuana smoked together.’’ GX 3, at 2.
However, the State Board found that
Respondent had submitted to inpatient
treatment and ‘‘completed all four
phases of residential treatment and
made a commitment to long term
recovery by establishing a relationship
with the Physicians Health program.’’ Id.
at 2.
Based on the above, the State Board
concluded that there was ‘‘just cause’’ to
charge Respondent with various
violations of the Louisiana Medical
Practice Act. Id. at 3. However, the
Board placed Respondent on probation
for a period of five years subject to
various conditions. On May 16, 2008,
the Board terminated Respondent’s
probation and fully reinstated his
license. RX 1.
At the hearing, the Government
presented the testimony of a DEA
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5 According
to a DI, an affirmative response to
these ‘‘liability’’ questions can trigger the referral of
an application to a DEA Investigator, and the
opening of an investigation. Tr. 184. Conversely, a
negative answer to all ‘‘liability’’ questions results in
an application being forwarded to a DEA
registration technician for what is an essentially a
pro forma examination with likely approval. Id. at
184–85, 201–04.
6 In the same proceeding, Respondent pled guilty
to carrying a concealed weapon, a misdemeanor
under Louisiana law. GX 3, at 2.
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Diversion Investigator (DI) from the
Resident Office (RO) in Gulfport,
Mississippi, who was involved in the
criminal investigation of Respondent.
Tr. 21–23. According to the DI, in 2003,
his office received information from law
enforcement agencies and ‘‘concerned
citizens and parents’’ that Respondent
was operating a medical practice in
D’Iberville (a suburb of Biloxi,
Mississippi) that catered to drug-seeking
patients and which was servicing its
clientele very late at night. Id. at 28–29.
The Gulfport RO also received
information that Respondent was
charging $200.00 for a patient’s first
visit, $100.00 for subsequent visits, and
that the transactions were being
conducted in cash.7 Id. at 33. DEA also
learned that the Respondent had an
office location in Gretna, Louisiana.8 Id.
at 25, 33.
Based on this information, DEA
conducted an undercover operation
which focused on Respondent’s practice
in Mississippi. According to the DI, a
Special Agent (who has since retired),
using the name of Reggie Glorioso, made
five undercover visits to Respondent’s
D’Iberville office as well as two
undercover visits to a location in nearby
Diamondhead, Mississippi, where
Respondent eventually moved his
office.9 Id. at 50–51, 54, 124. The DI
testified that his role was to assemble
the surveillance team that would
monitor and record the progress of the
operation through audio transmitters
that the Agent wore. Id. at 47. According
to DI, he listened to the visits as they
were being conducted. Id. at 44–48.
The DI testified that the first visit was
conducted on May 14, 2003, with the
Agent arriving at Respondent’s
D’Iberville office at about 5 p.m. Id. at
57. Respondent finally arrived at
approximately 9 p.m. Id. Respondent’s
office staff weighed the Agent, took his
pulse and blood pressure, and at
approximately 10:40 p.m. led him to an
examination room. Id. at 57–58, 63. At
11:05 p.m., Respondent finally entered
the exam room. Id. at 59.
During his interaction with
Respondent, the Agent told the
7 According to the DI, in his experience a cashbased medical practice and a cash-based patient
base are unusual features of a medical practice and
raise investigatory red flags. Tr. at 34–35.
8 The DI testified that a 2003 query of DEA
databases indicates that the Respondent was
registered at locations in New Orleans, Louisiana
and Biloxi, Mississippi and that the latter
registration expired in July 2003. Tr. 24–25, 27–28.
9 According to the DI, undercover (uc) visits to
the D’Iberville office were conducted in 2003 on
May 14, May 28, June 24, July 22, and August 22;
visits to the Diamondhead office were conducted on
November 20 and December 18. Tr. at 50–51. The
Government, however, only presented evidence
about the first three uc visits. Tr. 55–89.
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Respondent that he had stiffness in his
shoulders. Id. at 147. According to the
DI, the Respondent had the Agent ‘‘place
one leg on a telephone book’’ and then
‘‘lifted’’ the Agent’s ‘‘right hand.’’ Id. at
62. Based on this examination,
Respondent told the Agent ‘‘that he had
a pelvic problem in which one foot was
3/4th of an inch lower than his right
side, which caused stress to his entire
body, [and] therefore caused him pain.’’
Id. At approximately 12:22 a.m.,
Respondent gave the Agent
prescriptions for 25 dosage units of
Xanax,10 50 dosage units of Vicodin,11
and 30 Soma (carisoprodol, a noncontrolled drug). Id. at 63–65. The
Agent paid a member of the
Respondent’s office staff $202.00 in cash
and was given a follow-up appointment
for May 28, 2003, but with no
appointment time indicated. Id. at 66.
The Government did not offer either
the transcript or a recording of the visit
(or any of the other visits for that
matter). Moreover, it did not call the
Agent to testify.
At approximately 5 p.m. on May 28,
2003, the Agent returned to
Respondent’s D’Iberville office.12 Id. at
72. The Agent signed in and was told by
Andre, a member of the office staff that
Respondent would not be in until later
in the evening. Id. at 74. The Agent and
Andre agreed that the former would call
in and check with the latter to learn
when Respondent was in the office. Id.
At 9:37 p.m., the Agent called Andre
and was told that Respondent was in.
Id. The Agent returned to the office at
9:45 p.m., where he waited until 1:05
the following morning, when he was
finally taken to an examination room.
Id. at 67, 74. While in the examination
room, the Agent was able to look
through his patient file and noted that
it contained pre-signed prescriptions for
35 dosage units of Xanax, 65 dosage
units of Vicodin, and 65 dosage units of
Soma.13 Id. at 67–68. While the record is
unclear as to what time Respondent
entered the exam room, the visit ended
at 2:15 a.m. and cost $100. Id. at 69, 75.
The Agent received the aforementioned
prescriptions as well as prescriptions for
10 A
Schedule IV controlled substance. ALJ Ex. 6,
at 1.
11 A
Schedule III controlled substance. ALJ Ex. 6,
at 1.
12 The DI testified that times were not assigned for
appointments at the Respondent’s D’Iberville office.
Patients would sign in with a staff member and wait
around the office, often in the parking lot, for
Respondent to arrive.
13 According to the DI, this combination of drugs
is highly sought after by drug abusers and is known
on the street as the ‘‘holy trinity.’’ Tr. 84. While
Soma (carisoprodol) is not controlled, it ‘‘enhances
the euphoric effect of both the hydrocodone and
* * * the Xanax.’’ Id.
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naprosyn (a non-controlled drug) and
for a modified shoe. Id. at 82–83.
According to the DI, notwithstanding
the hour, ‘‘there were still individuals
waiting in the parking lot to see’’
Respondent. Id. at 70. Moreover, the DI
testified as to the Agent’s interaction
with several of Respondent’s ‘‘patients’’
that took place in his office parking lot.
Id. at 75–79. One of these individuals,
T.B., told the Agent that he was ‘‘visiting
more than one physician in order to
obtain controlled substances.’’ Id. at 79.
The Agent asked T.B. if he was
interested in selling his Xanax; the latter
indicated that he might be interested
and the two exchanged phone numbers.
Id. at 78–79. The Agent and T.B. also
discussed the latter’s selling
hydrocodone to the former and agreed
on a price of $3 per dosage unit.14 Id. at
79–80.
The Agent also exchanged phone
numbers with another individual at the
scene, L.H., who told the former that he
was seeing multiple physicians to
obtain drugs. Id. at 80. In response to an
inquiry by the Agent, L.H. agreed to sell
him 100 Lortab 15 for $300 and some
OxyContin 80 mg.16 for $25 a tablet. Id.
at 81.
On June 24, 2003, the Agent made his
third visit to the D’Iberville office. Id. at
85. According to the DI, the Agent
arrived a little after 9 p.m. and paid
$100 for the visit. Id. at 86–87. At
approximately 10:43 p.m., while he was
still waiting to be see Respondent, a
staff member called for Reggie Glorioso
(the Agent’s assumed name) and handed
him an appointment card reflecting his
next appointment date, a receipt for
$100, and prescriptions for Vicodin,
Soma, Naprosyn, and Xanax. Id. at 88.
These prescriptions had been pre-signed
by Respondent and were given to the
Agent before his interaction with
Respondent, which commenced at 10:57
p.m. and ended five minutes later. Id. at
85–89.
Following the additional visits 17—the
details of which were not elicited from
the DI—the Investigators obtained a
warrant to search Respondent’s Gretna,
Louisiana office, which was executed on
14 A
Schedule III controlled substance. ALJ Ex. 6,
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at 1.
15 A Schedule III controlled substance which
contains hydrocodone. ALJ Ex. 6, at 1.
16 A Schedule II controlled substance. ALJ Ex. 6,
at 1.
17 On cross examination, the DI testified that at
the fifth uc visit, the Agent brought the prescribed
shoe into the Respondent’s office. Tr. 147–48. The
cross examination also revealed that during the
final uc visit, the Agent was given some exercises
to do. Id. at 149, 152. Neither the Government nor
the Respondent elicited any further details
regarding the uc visits.
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June 2, 2004.18 See GX 4 & 5. During the
search, the Government seized various
controlled substances including 22
tablets of hydrocodone 5 mg., 45 tablets
of Percocet 10/325 mg.,19 23 tablets of
Lorcet 10/650 mg., 10 full vials and one
partially full vial of diazepam 10 mg./
ml.,20 5 vials of diazepam 5 mg./ml.,
and 1 vial of Stadol 2 mg./ml.21 GX 5,
at 3.
Notwithstanding the presence of these
drugs, Respondent did not have various
records which he was required to
maintain, including an initial and/or
biennial inventories, and a dispensing
log. Tr. 113–15, 123–24, 158; see also 21
CFR 1304.11(b) & (c), id. 1304.22(c). At
the scene, the Respondent admitted to
the agents that he kept no such records.
Tr. at 115. The DI also testified that
while Respondent had issued
prescriptions at his Mississippi office,
his DEA registration for this office had
expired in July 2003. Id. at 28; see also
21 U.S.C. 822(e); 21 CFR 1301.12(a) &
(b)(3).
The DI further testified that although
he was not part of the initial entry team
that executed the warrant, he was on the
scene after the premises were secured.
18 According to the DI, the investigators sought
the warrant to search this office because it was
where Respondent kept his patient files. Tr. 90. Tr.
at 90.
19 A Schedule II controlled substance which
contains oxycodone. ALJ Ex. 6, at 1.
20 A Schedule IV controlled substance. ALJ Ex. 6,
at 1.
21 The Officers also seized a .45 caliber pistol
from his bedroom, which apparently was located
upstairs from the office. Tr. 90–103. According to
the DI, Respondent was unable to produce any
documentation for the firearm and offered no
explanation regarding its presence on the premises.
Id. at 98–99. Moreover, a serial number check with
the Bureau of Alcohol, Tobacco, Firearms and
Explosives (ATF) did not return a record showing
who owned the gun. Id. at 102.
While the DI had previous experience in a local
sheriff’s office, he was not familiar with Louisiana’s
firearms laws and did not know whether
Respondent’s possession of the gun violated either
state or federal law. Id. at 103, 160–61. The ALJ
further noted that later in the hearing, the
Government introduced a document entitled
‘‘Verification of First Offender Pardon’’ which was
addressed to the Respondent and indicated that the
pardon he was granted did not operate to restore
any rights he might have regarding receiving,
possessing or transporting a firearm. Govt. Ex. 11.
In its brief, the Government argues that
‘‘Respondent was found in violation of the First
Offender Pardon when he was found in possession
of a loaded pistol during [the] execution of [the]
search warrant.’’ Gov. Br. at 17. The Government
does not, however, cite to any judicial finding that
Respondent was in violation of either the terms of
his probation or of state law. Nor, as the ALJ noted,
does the Government cite any legal authority to
support its contention that Respondent was
permanently barred from possessing a handgun. I
further agree with the ALJ that ‘‘no valid legal
conclusion can reasonably be drawn from the
language of the letter or its issuance to the
Respondent.’’ ALJ at 8 n.23. Finally, the issue is of
tangential relevance.
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Tr. 154. According to the DI, he, along
with three or four agents and a
representative of the State Board of
Medical Licensure, met with
Respondent and interviewed him while
the search was conducted. Id. at 176.
The ALJ specifically found credible the
DI’s testimony that during the interview,
the Respondent was seated in a chair,
no threats or promises were made, and
no weapons were brandished.22 ALJ at
8; see also Tr. 130–32, 154–55. The ALJ
also found credible the DI’s testimony
that Respondent was informed that he
was not under arrest, and that following
some discussion about the status of the
investigation, Respondent voluntarily
surrendered his DEA registration and
executed a DEA Form 104 (Voluntary
Surrender of Controlled Substances
Privileges). ALJ at 8. The ALJ further
credited the DI’s testimony that before
Respondent signed the surrender form,
he read the Respondent his ‘‘surrender
rights’’ 23 from the form and Respondent
acknowledged that he understood the
significance of signing the document.
Id., see also Tr. at 132–38.
During the interview, Respondent
stated that he charged about $200.00 for
an initial office visit, $100.00 for
subsequent visits, and offered a 10–20%
discount for patients who paid in cash.
Tr. at 104, 175. Respondent also told the
DI that the Internal Revenue Service had
a judgment against him for between
$180,000.00 and $190,000.00 and that
he owed the entire amount. Id. at 105.
Pursuant to the warrant, the
Government seized fifty-two patient
files from Respondent’s Gretna,
Louisiana office. Id. at 116. According to
the DI’s review of the patient files,
Respondent had diagnosed each of the
fifty two patients (including that of the
Special Agent who used the name of
Reggie Glorioso) as having a leg-length
discrepancy.24 Id. at 116–17. Moreover,
22 The ALJ found that while the weapons may
have been drawn by other agents during the initial
entry to the premises, there is no credible evidence
to support the Respondent’s claim that weapons
were brandished during the DI’s interview of
Respondent. ALJ at 20.
23 Actually, the form contains an explanation of
the effects of the executed form, after the following
statement: ‘‘After being fully advised of my rights,
and understanding that I am not required to
surrender my controlled substances privileges, I
freely execute this document and choose to take the
actions described herein.’’ GX 6, at 1.
24 The Government elicited testimony from the DI
that during his investigation he consulted with a
physician who is an expert in pain management. Tr.
118–20. The Government, however, did not call the
expert to testify nor introduce any documentary
evidence setting forth his opinion as to the validity
of Respondent’s prescribing practices.
According to the DI, the expert told him that leglength discrepancy is a rare diagnosis, and that
there were referrals to particular specialists and
other treatment modalities that are customarily
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each file contained evidence that
Respondent had ‘‘prescribed narcotics’’
and ‘‘a modified shoe.’’ Id. at 117. While
the ALJ noted that the Government
‘‘introduced no expert testimony in this
regard,’’ he found it ‘‘striking * * * that
the same ailment and prescribed
treatment that the Respondent assigned
to SA Price would exist in all the files
seized from his practice.’’ ALJ at 9.
While this is true enough, there is no
testimony to establish how statistically
improbable the condition is in even a
single patient. Nor is there any evidence
showing the extent and duration of
Respondent’s prescribing to the other
fifty-one persons whose files were
reviewed, nor evidence establishing that
the prescriptions he issued to these
persons lacked a legitimate medical
purpose and were issued outside of the
usual course of professional practice.
The DI further testified that the
patients came from all over the
Southeastern United States and
included persons from Alabama,
Florida, and Louisiana. Tr. 121.
According to the DI, he ran a criminal
history check on each of the other
patients and found that all of them had
a history of illegal activity with regard
to controlled substances, including such
offenses as prescription fraud, offenses
based on doctor shopping, as well as
unlawful distribution apparently of both
prescription and non-prescription
controlled substances such as marijuana
and cocaine. Id.25 However, as the ALJ
noted, the Government did not offer any
evidence specific to any of these
persons such as their names, the exact
nature or recency of the criminal
activity, and most significantly, whether
any of these persons had been convicted
of criminal offenses.26 ALJ at 9 n.29.
The ALJ further noted that while the
Government initially indicated that it
intended to call the retired Agent as a
witness, it declined, without
explanation, to do so at the hearing. ALJ
at 9. The ALJ also noted that while the
DI indicated that the audio recordings
utilized during a pain practice. Id. However, there
is no evidence as to how statistically rare this
diagnosis is.
The ALJ thus considered this evidence only as
background information showing the
reasonableness of the DI’s continued investigation.
The ALJ further noted that during its examination
of the DI, the Government clarified that this was the
sole purpose for which this portion of his testimony
was being offered and that, in any event, the DI’s
testimony regarding his conversations with the
expert ‘‘w[as] vague in content and could not even
be fixed with an approximate date and time.’’ Given
the Government’s representation, I agree with the
ALJ that testimony is entitled to no weight in
determining the lawfulness of Respondent’s
prescribing practices. ALJ at 10.
25 Tr. at 169–70.
26 Tr. at 38, 40, 121.
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and transcripts of the undercover visits
to the Respondent’s offices were still in
existence, he did not bring these items
to the hearing because he was not asked
to do so. Id. at 9–10.
The ALJ further found that the DI’s
testimony concerning his recollection of
the interaction that took place between
SA Price and the Respondent was quite
vague and that on several occasions he
needed to review his case file and an
unsigned copy of an affidavit he had
prepared on previous occasion. Id. at 10.
While the ALJ generally found the DI’s
testimony to be credible, he noted that
it ‘‘would have been more helpful if it
had been preceded by a higher level of
preparation.’’ Id. Most significantly, the
ALJ found that the DI’s testimony
regarding the interaction between the
Respondent and the Special Agent
during the undercover visits ‘‘was
insufficiently precise to shed significant
light on the Respondent’s prescribing
practices as evidenced in those visits.’’
Id.
Respondent’s Evidence
In his testimony, Respondent
repeatedly denied filing the March 10,
2005 application, and insisted that
‘‘there [wa]s no way I could have left all
this incomplete.’’ Tr. 309, 313–14. He
further asserted that he submitted an
application in October or November
2005 after Hurricane Katrina and that he
told the Chicago DEA office everything
about his 1998 guilty pleas and the
probation of his state medical license.
Id. at 313–15.
As to Respondent’s assertion that he
never filed the March 10, 2005
application, the ALJ found that it ‘‘flies
in the face of much of the credible
evidence.’’ ALJ at 19. In particular, the
ALJ found it difficult to believe that an
‘‘unidentified individual would possess
[the] level of personally identifiable
information [necessary to transact the
credit card transaction] and be willing
to pay $390.00 to file an application for
a DEA Registration in secret, and to the
Respondent’s detriment.’’ Id. (see also
id. at 20: ‘‘Perhaps the least credible in
the litany of incredible assertions put
forth by the Respondent is the testimony
that he never filed the application for
the [Certificate of Registration]
containing his material falsifications,
particularly in light of the fact that his
credit card was utilized to pay the
application fee.’’).
Moreover, the nature of the
information that was provided in
response to question 2 on the
application included highly specific
information regarding the circumstances
surrounding Respondent’s surrender of
his previous registration. See GX 1, at 2.
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More specifically, the answer stated that
‘‘[o]n June 2, 2004, my primary office in
Louisiana was visited by’’ a ‘‘DEA
Diversion Unit,’’ which advised him to
surrender his Louisiana DEA
registration. Id. This, of course, was the
exact date that the warrant was executed
and on which Respondent surrendered
his registration. This begs the
question—which Respondent did not
answer—what other individual would
have known this information and used
it (as well as Respondent’s credit card)
to file the application? I thus agree with
the ALJ that Respondent completed the
application and gave false testimony
when he denied filing the March 10,
2005 application.
At the hearing, Respondent did not
deny either that he had a felony
conviction for possession of cocaine or
that his medical license had previously
been placed on probation. While
Respondent apparently admitted that
his answer to the first liability question
(which asked if he had ‘‘ever been
convicted of a crime in connection with
controlled substances under state or
federal law’’) was false, he nonetheless
insisted that his answer to the third
liability question (regarding his state
license) was ‘‘correct.’’ Tr. 341. He
further testified that in answering the
latter question, he interpreted the
question as if it asked only whether his
state prescription writing authority had
been placed on probation. Id. at 346–47.
However, as found above, the question
encompasses—in plain English—
discipline imposed against an
applicant’s professional license and not
just his state controlled substance
registration.27
Respondent also disputed that his
patients came from other States, Tr. 406,
and that he ran a cash-only practice. Id.
at 401. As for why he saw patients so
late at night as well as during the wee
hours of the morning, Respondent
testified that:
[t]he only explanation I can give you * * *
that makes sense in terms of * * * what I do
as a physiatrist, my approach is fairly unique.
We address the problems of, if you will,
physical disfunction[sic] in a manner that
typically required that type of extended, sit
down, educational, this is what we’re doing,
this is how we have to approach it, you
know, interacting with the patient to get
them to understand what was expected of
them in order to accomplish the goal.
Id. at 407.
27 The Government further showed that on an
application that Respondent submitted in June
2000, he had also provided a ‘‘no’’ answer to the
question ‘‘Has the applicant ever had a state
professional license or controlled substance
registration revoked, suspended, denied, restricted,
or placed on probation?’’ GX 12; Tr. 344.
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As for the DI’s assertion that each of
the fifty-one persons whose patient file
was seized had some criminal behavior
or drug history, Respondent testified
that he used a questionnaire which asks
various questions to identify
problematic patients such as whether
the patient had or was using illicit
drugs, whether the patient had a
psychiatric history, and that he would
also do ‘‘a general mental status
assessment’’ of each patient. Id. at 412–
13. He further maintained that he
discharged problematic patients,
including those who were seeking drugs
for self-abuse or to sell. Id. at 413–14.
Putting aside the credibility of
Respondent’s testimony regarding his
medical practices, it is notable that he
failed to address several material issues
that were proved by the Government.
More specifically, he offered no
testimony as to why he had pre-signed
prescriptions, and why he failed to
maintain inventories and a dispensing
log.
Discussion
Section 303(f) of the Controlled
Substances Act (CSA) provides that an
application for a practitioner’s
registration may be denied upon a
determination ‘‘that the issuance of such
registration would be inconsistent with
the public interest.’’ 21 U.S.C. 823(f). In
making the public interest
determination, the CSA requires the
consideration of the following factors:
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(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * 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
the public health and safety.
Id.
‘‘These factors are * * * considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). I ‘‘may
rely on any one or a combination of
factors, and may give each factor the
weight [I] deem[] appropriate in
determining whether * * * an
application for registration [should be]
denied.’’ Id. Moreover, I am not required
to make findings as to all of the factors.
Volkman v. DEA, 567 F.3d 215, 222 (6th
Cir. 2009); Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005).
Under Section 304(a)(1), a registration
may be revoked or suspended ‘‘upon a
finding that the registrant * * * has
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materially falsified any application filed
pursuant to or required by this
subchapter.’’ 21 U.S.C. 824(a)(1). Under
agency precedent, the various grounds
for revocation or suspension of an
existing registration that Congress
enumerated in section 304(a), 21 U.S.C.
824(a), are also properly considered in
deciding whether to grant or deny an
application under section 303. See The
Lawsons, Inc., 72 FR 74334, 74337
(2007); Anthony D. Funches, 64 FR
14267, 14268 (1999); Alan R.
Schankman, 63 FR 45260 (1998); Kuen
H. Chen, 58 FR 65401, 65402 (1993).
Thus, the allegation that Respondent
materially falsified his application is
properly considered in this proceeding.
See The Lawsons, 72 FR at 74337;
Samuel S. Jackson, 72 FR 23848, 23852
(2007). Moreover, just as materially
falsifying an application provides a
basis for revoking an existing
registration without proof of any other
misconduct, see 21 U.S.C. 824(a)(1), it
also provides an independent and
adequate ground for denying an
application. The Lawsons, 72 FR at
74338; cf. Bobby Watts, M.D., 58 FR
46995 (1993).
Here, the record establishes two
separate grounds for denying
Respondent’s application. First,
Respondent materially falsified his
March 2005 application for a
registration. Second, Respondent has
committed numerous acts which
demonstrate that the issuance of a
registration would be inconsistent with
the public interest. Moreover,
Respondent has failed to offer sufficient
evidence to rebut the Government’s
prima facie showing that his registration
would be inconsistent with the public
interest.
The Material Falsification Allegation
As found above, on March 9, 2005,
Respondent, who had surrendered his
DEA registration on June 2, 2004,
applied for a new registration. While on
the application Respondent
acknowledged that he had previously
surrendered his DEA registration, he
provided a ‘‘no’’ answer to the questions
of whether he had ‘‘ever been convicted
of a crime in connection with controlled
substances under state or federal law’’
and whether he had ‘‘ever had a state
professional license or controlled
substance registration’’ sanctioned.
These statements were clearly false as
Respondent had been convicted of
possession of cocaine, a felony offense
under the laws of Louisiana, and had
also had his Louisiana Medical License
placed on probation.
Both of these falsifications were
material. ‘‘The most common
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formulation’’ of the concept of
materiality ‘‘is that a concealment or
misrepresentation is material if it ‘has a
natural tendency to influence, or was
capable of influencing, the decision of’
the decisionmaking body to which it
was addressed.’’ Kungys v. United
States, 485 U.S. 759, 770 (1988) (quoting
Weinstock v. United States, 231 F.2d
699, 701 (DC Cir. 1956)) (other citation
omitted); see also United States v. Wells,
519 U.S. 482, 489 (1997) (quoting
Kungys, 485 U.S. at 770). The evidence
must be ‘‘clear, unequivocal, and
convincing.’’ Kungys, 485 U.S. at 772.
However, ‘‘the ultimate finding of
materiality turns on an interpretation of
substantive law.’’ Id. at 772 (int.
quotations and other citation omitted).
Moreover, ‘‘[i]t makes no difference
that a specific falsification did not exert
influence so long as it had the capacity
to do so.’’ United States v. Alemany
Rivera, 781 F.2d 229, 234 (1st Cir. 1985).
See also United States v. Norris, 749
F.2d 1116, 1121 (4th Cir. 1984) (‘‘There
is no requirement that the false
statement influence or effect the
decision making process of a
department of the United States
Government.’’).
DEA has previously held that ‘‘[t]he
provision of truthful information on
applications is absolutely essential to
effectuating [the] statutory purpose’’ of
determining whether the granting of an
application is consistent with the public
interest. See Peter H. Ahles, 71 FR
50097, 50098 (2006).28 As a substantive
matter, Congress has directed that the
Agency consider five factors in
determining whether the granting of an
application is consistent with the public
interest. See 21 U.S.C. 823(f). As noted
above, the Agency is required to
consider the status of the applicant’s
state authority to dispense controlled
substances,29 the applicant’s experience
28 Cf. Martha Hernandez, M.D., 62 FR 61145,
61146 (1997) (An applicant’s answers to the various
liability questions are material because this Agency
‘‘relies upon such answers to determine whether an
investigation is needed prior to granting the
application.’’). A DI explained that, as a procedural
matter, when an applicant provides ‘‘no’’ answers to
the liability questions, the application is forwarded
without further investigation to a registration
technician for approval.
It is acknowledged that Respondent truthfully
disclosed that he had previously surrendered his
registration and thus, his application would have
been subjected to an investigation in any case.
However, as the Supreme Court has explained,
whether a false statement is material depends upon
an interpretation of the substantive law. As
explained above, Respondent’s two false answers
are clearly material to several of the factors which
the Agency is charged with considering in making
the public interest determination.
29 Not only did Congress direct the Agency to
consider ‘‘[t]he recommendation of the appropriate
State licensing board or professional disciplinary
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in dispensing * * * controlled
substances,’’ his ‘‘conviction record
* * * relating to the * * * dispensing
of controlled substances,’’ his
‘‘[c]ompliance with applicable State,
Federal, or local laws relating to
controlled substances,’’ and whether he
has engaged in ‘‘such other conduct
which may threaten public health and
safety.’’ 21 U.S.C. 823(f). Moreover,
under the latter factor, DEA has
frequently denied applications and
revoked the registrations of practitioners
who have a history of abusing
controlled substances. See, e.g., Kenneth
Wayne Green, Jr., 59 FR 51453 (1994);
David E. Trawick, 53 FR 5326, 5327
(1988).
Congress has also explicitly granted
the Agency authority to revoke a
registration where a registrant ‘‘has been
convicted of a felony under [the CSA] or
any other law of the United States, or of
any State, relating to any substance
defined in [the CSA] as a controlled
substance.’’ 21 U.S.C. 824(a)(2). As
noted above, it has long been settled
that the Agency has authority to deny an
application on any of the grounds set
forth in 21 U.S.C. 824.30
Thus, even though Respondent
disclosed that he had previously
voluntarily surrendered his registration
and been the subject of an investigation
with respect to his prescribing practices,
his failure to disclose the previous state
discipline (which was based on his
abuse of various controlled substances
as well as his conviction for cocaine
possession) and this conviction, still
had the capacity to influence the
Agency’s decision as to whether his
application should be granted. It makes
no difference that the Agency did not
rely on the misrepresentations and grant
his application. See United States v.
Alemany Rivera, 781 F.2d at 234; United
States v. Norris, 749 F.2d at 1121.
Under DEA precedent, the
Government is not required to show that
the falsification was intentional but only
that the applicant ‘‘knew or should have
known that the response given to the
liability question was false.’’ The
Lawsons, 72 FR at 74339; Samuel
authority,’’ a practitioner cannot be registered
unless he ‘‘is authorized to dispense * * * under
the laws of the State in which he practices.’’ 21
U.S.C. 823(f). See also 21 U.S.C. 802(21) (defining
‘‘practitioner’’ as ‘‘a physician * * * licensed,
registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices
* * * to dispense * * * a controlled substance in
the course of professional practice’’).
30 To make clear, the Agency’s authority to deny
an application is not limited to those convictions
enumerated in 21 U.S.C. 823(f)(3), but also includes
any conviction meeting the standards of 21 U.S.C.
824(a)(2) such as a conviction for simple
possession.
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Arnold, 63 FR 8687, 8688 (1998).
Respondent obviously knew that he had
‘‘been convicted of a crime in
connection with controlled substances’’
under Louisiana law. Likewise, he knew
that his state license had previously
been placed on probation. And contrary
to his protestation that he thought the
question was only directed at the loss of
his prescription-writing authority, the
question clearly encompassed the
probationary sanction imposed on his
Louisiana medical license.
Thus, Respondent cannot credibly
claim that the falsifications were the
result of mere negligence or
misunderstanding. Indeed, that
Respondent denied having even
submitted the application—an assertion
which is patently false given the
detailed information that the
application included and the fact that
the fee was paid for with his credit
card—suggests that the falsification was
intentional.
I thus hold that Respondent
materially falsified his March 2005
application by failing to disclose his
conviction for cocaine possession and
the State Board’s imposition of
probation terms on his medical license.
I further hold that Respondent—as
evidenced by his having denied that he
submitted the application—has failed to
accept responsibility for his
misconduct. See Samuel Jackson, 72 FR
at 23853. Thus, Respondent’s material
falsification provides reason alone to
deny his application.
In addition, the evidence showed that
Respondent, when he was previously
registered, committed multiple acts
which are properly considered under
factors two and four and which render
his ‘‘registration inconsistent with the
public interest.’’ 21 U.S.C. 823(f). As
found above, Respondent issued
multiple prescriptions for controlled
substances including hydrocodone and
Xanax to an undercover Agent who
visited him at his office in D’Iberville,
Mississippi. While there is insufficient
evidence to establish that these
prescriptions lacked a legitimate
medical purpose and were issued
outside of the course of professional
practice, see 21 CFR 1306.04(a), the
evidence did show that at the
undercover Agent’s subsequent visits,
Respondent had pre-signed
prescriptions for both of the above
controlled substances, and that during
at least one of these visits, the Agent
was given the prescriptions before he
even saw Respondent.
DEA has long interpreted the CSA as
prohibiting the pre-signing of
prescriptions. See Jayam Krishna-Iyer,
71 FR 52148, 52159 & n.9 (2006)
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26999
(collecting cases), vacated on other
grounds, 249 Fed. Appx. 159 (11th Cir.
2007). See also Walter S. Gresham, 57
FR 44213, 44214 (1992); James Beale, 53
FR 15149, 15150 (1988) (‘‘It is a
violation of 21 CFR 1306.05(a) to presign prescriptions for controlled
substances.’’). Respondent’s practice of
pre-signing prescriptions is indicative of
drug dealing as he clearly had not
evaluated the undercover Agent prior to
writing the prescriptions to determine
whether they were medically necessary
to treat his purported condition.31
The evidence also showed that during
the search of Respondent’s Louisiana
office, Investigators found various
controlled substances including
Percocet (a schedule II drug containing
oxycodone), hydrocodone and Lorcet
(both schedule III drugs containing
hydrocodone), diazepam and Stadol
(both schedule IV drugs). Respondent
makes no claim that these drugs had
been lawfully prescribed to him.
Under the CSA, ‘‘every registrant
* * * shall * * * as soon * * * as
such registrant first engages in the
manufacture, distribution, or dispensing
of controlled substances, and every
second year thereafter, make a complete
and accurate record of all stocks thereof
on hand.’’ 21 U.S.C. 827(a)(1); see also
21 CFR 1304.11(b) & (c). Moreover,
‘‘every registrant * * * manufacturing,
distributing, or dispensing, a controlled
substance or substances shall maintain,
on a current basis, a complete and
accurate record of each such substance
manufactured, received, sold, delivered,
or otherwise disposed of by him.’’ 21
U.S.C. 827(a)(3); see also 21 CFR
1304.22(c) (requirement for dispensing
records). During the search, Respondent
admitted to the Investigators that he did
not have the required inventories and
was not maintaining a dispensing log. I
thus further hold that Respondent
violated Federal law and DEA
regulations by failing to maintain these
records.
Notably, Respondent offered no
testimony addressing either his presigning of prescriptions or his failure to
maintain required records. Respondent
31 The circumstantial evidence which includes
his seeing patients in the wee hours of the morning,
where the patients were coming from, the
interactions that the Agent had with other
‘‘patients,’’ and the uniformity of his diagnoses,
create a strong suspicion that Respondent was not
engaged in legitimate medical practice but rather
drug dealing. However, under the substantial
evidence test, the evidence must ‘‘do more than
create a suspicion of the existence of the fact to be
established.’’ NLRB v. Columbian Enameling &
Stamping Co., 306 U.S. 292, 300 (1939). Given the
numerous evidentiary gaps in the record, I do not
make any findings regarding the lawfulness of
Respondent’s prescribing practices with respect to
the other 51 patients whose files were seized.
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has thus failed to offer any evidence to
rebut the Government’s showing that he
has committed acts which render
granting him a registration inconsistent
with the public interest.32 See Medicine
Shoppe-Jonesborough, 73 FR 364, 387
(2008) (‘‘Where the Government has
made out its prima facie case, the
burden shifts to the Respondent to show
why [his] continued registration would
nonetheless be consistent with the
public interest.’’). Accordingly, these
violations of the CSA and DEA
regulations provide a further basis to
deny Respondent’s application.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as by 28 CFR
0.100(b) and 0.104, I hereby order that
the application of Alvin Darby, M.D., for
a DEA Certificate of Registration as a
practitioner, be, and it hereby is, denied.
This order is effective immediately.
Dated: April 16, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–11431 Filed 5–12–10; 8:45 am]
sroberts on DSKD5P82C1PROD with NOTICES
BILLING CODE 4410–09–P
32 It is acknowledged that Respondent holds a
valid state license (factor one) and has not been
convicted of an offense related to the dispensing of
controlled substances (factor three). However,
neither of these factors is dispositive. See Edmund
Chein, 72 FR 6580, 6590 (2007), aff’d Chein v. DEA,
533 F.3d 828 (DC Cir. 2008) (The authority to
decide whether to grant an application for a DEA
registration has been entrusted to the Attorney
General and ‘‘has been delegated solely to the
officials of this Agency.’’) See also id. at 6593 n.22
(absence of criminal convictions not dispositive in
public interest inquiry).
I further note the DI’s testimony that Respondent
violated Federal law because he wrote prescriptions
at his Mississippi office and did not have a
registration in this State. However, the Government
put forward no evidence that identifies specific
prescriptions that Respondent issued after the
expiration of his Mississippi registration. Moreover,
in its brief, the Government does not rely on this
conduct. Thus, I do not consider the allegation.
The Government also argues that Respondent’s
conviction for possession of cocaine can be
considered under factor three. However, the
conviction was not for an offense related to the
manufacture, distribution, or dispensing of
controlled substances and is thus not properly
considered under factor three. However, as the ALJ
reasoned, consistent with Agency precedent, the
conviction can be considered under factor five as
such other conduct which may threaten public
health and safety. See ALJ at 34–35. While there is
evidence that Respondent underwent treatment,
and the Government does not argue that
Respondent has a continuing problem with drug
abuse, when coupled with the other violations
proved on this record, it buttresses the conclusion
that Respondent is unwilling to conform to the law
and that he cannot be entrusted with a new
registration.
VerDate Mar<15>2010
15:56 May 12, 2010
Jkt 220001
307–0690 [Note: This is not a toll-free
number.]
DEPARTMENT OF JUSTICE
Office of Justice Programs
[OJP (OJP) Docket No. 1519]
Hearings of the Review Panel on
Prison Rape
AGENCY: Office of Justice Programs,
Justice.
ACTION: Notice of hearing.
SUMMARY: The Office of Justice Programs
(OJP) announces that the Review Panel
on Prison Rape (Panel) will hold
hearings in Washington, DC on June 3–
4, 2010. The hearing times and location
are noted below. The purpose of the
hearings is to assist the Bureau of Justice
Statistics (BJS) in identifying common
characteristics of victims and
perpetrators of sexual victimization in
juvenile facilities, and the common
characteristics of juvenile facilities with
the highest and lowest incidence of
rape, respectively, based on an
anonymous survey by the BJS of youth
in a representative sample of juvenile
facilities. On January 7, 2010, the BJS
issued the report Sexual Victimization
in Juvenile Facilities Reported by Youth,
2008–09. The report provides a listing of
juvenile facilities grouped according to
the prevalence of reported sexual
victimization, and formed the basis of
the Panel’s decision about which
facilities would be the subject of
testimony.
DATES: The hearing schedule is as
follows:
1. Thursday, June 3, 2010, 10 a.m. to
5:45 p.m.: Bureau of Justice Statistics;
Fort Bellefontaine, Missouri, Campus—
facility with a low prevalence of sexual
victimization; Rhode Island Training
School—facility with a low prevalence
of sexual victimization; and Pendleton,
Indiana, Juvenile Correctional Facility—
facility with a high prevalence of sexual
victimization.
2. Friday, June 4, 2010, 8:30 a.m. to
1 p.m.: Woodland Hills, Tennessee,
Youth Development Center—facility
with a high prevalence of sexual
victimization; and Corsicana, Texas,
Residential Treatment Facility—facility
with a high prevalence of sexual
victimization.
The hearings will take place
at the Office of Justice Programs
Building, Main Conference Room, Third
Floor, U.S. Department of Justice, 810
7th Street, NW., Washington, DC 20531.
FOR FURTHER INFORMATION CONTACT:
Christopher Zubowicz, Designated
Federal Official, OJP,
Christopher.Zubowicz@usdoj.gov, (202)
ADDRESSES:
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
The Panel,
which was established pursuant to the
Prison Rape Elimination Act of 2003,
Public Law 108–79, 117 Stat. 972
(codified as amended at 42 U.S.C.
15601–15609 (2006)), will hold its next
hearings to carry out the review
functions specified at 42 U.S.C.
15603(b)(3)(A). Testimony from the
hearings will assist the Panel in carrying
out its statutory obligations. The witness
list is subject to amendment; please
refer to the Review Panel on Prison
Rape Web site at https://
www.ojp.usdoj.gov/reviewpanel/
reviewpanel.htm for any updates
regarding the hearing schedule. Space is
limited at the hearing location. Special
needs requests should be made to
Christopher Zubowicz, Designated
Federal Official, OJP,
Christopher.Zubowicz@usdoj.gov or
(202) 307–0690, at least one week before
the hearings.
SUPPLEMENTARY INFORMATION:
Michael Alston,
Office of Justice Programs.
[FR Doc. 2010–11369 Filed 5–12–10; 8:45 am]
BILLING CODE 4410–18–P
DEPARTMENT OF JUSTICE
Antitrust Division
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—LiMo Foundation
Notice is hereby given that, on March
12, 2010, pursuant to Section 6(a) of the
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 8
4301 et sect. (‘‘the Act’’), LiMo
Foundation (‘‘LiMo’’) filed written
notifications simultaneously with the
Attorney General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, Else Limited, Ra’anana,
ISRAEL; Teleca Germany GmbH,
Neuremberg, GERMANY; Mobi TV, and
Emeryville, CA, have been added as
parties to this venture.
No other changes have been made in
either the membership or planned
activity of this group research project.
Membership in this group research
project remains open, and LiMo intends
to file additional written notifications
disclosing all changes in membership.
On March 1, 2007, LiMo filed its
original notification pursuant to Section
E:\FR\FM\13MYN1.SGM
13MYN1
Agencies
[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 26993-27000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11431]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-6]
Alvin Darby, M.D.; Denial of Application
On June 25, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Alvin Darby, M.D. (Respondent), of Gretna, Louisiana. The
Show Cause Order proposed the denial of Respondent's pending
application for a DEA Certificate of Registration as a practitioner on
multiple grounds. ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) and
824(a)(1) and (2)).
First, the Government alleged that on April 1, 1998, Respondent had
pled guilty in the Criminal Court for Orleans Parish, Louisiana to one
felony count of possession of cocaine and one misdemeanor county of
carrying a concealed weapon. Id. The Order further alleged that
Respondent ``materially falsified'' his application ``by failing to
disclose [his] * * * felony conviction related to controlled
substances.'' Id. at 2.
Next, the Show Cause Order alleged that ``[o]n three separate
occasions between May 13, and June 24, 2003, [Respondent] issued
prescriptions for hydrocodone ([a] schedule III controlled substance)
[and] alprazolam ([a] schedule IV controlled substance),'' to an
undercover agent in exchange for cash, and that the prescriptions
lacked a ``legitimate medical purpose'' and were issued outside of the
``usual course of professional practice.'' Id. at 1. Finally, the Show
Cause Order alleged that Respondent ``committed numerous recordkeeping
violations under [his] previous * * * registration,'' which he had
surrendered for cause, including that: (1) He had ``fail[ed] to take
a[n] initial inventory of stocks of controlled substances,'' (2) he had
``fail[ed] to take and maintain a biennial inventory,'' and (3) he had
failed to ``maintain records of controlled substances [which he]
dispensed.'' Id. at 2 (citing 21 CFR 1304.11(b), 1304.11(c),
1304.22(c)).\1\
---------------------------------------------------------------------------
\1\ Moreover, in its Prehearing Statement, the Government
notified Respondent that it intended to litigate the question of
whether Respondent had also materially falsified his March 10, 2005
application for registration by failing to disclose that on August
18, 1999, he had entered into a Consent Order with the Louisiana
State Board of Medical Examiners, which placed his medical license
on probation for a five year period. ALJ Ex. 4, at 3, 6-7.
---------------------------------------------------------------------------
By letter of October 21, 2008, Respondent's counsel requested a
hearing on the allegations. ALJ Ex. 2, at 2. According to Respondent,
he did not receive the Show Cause Order ``in a timely manner because
the notice was delivered to an old address.'' Id. Respondent further
maintained that he ``was notified via facsimile on September 22, 2008
that he has an opportunity to show cause as to why'' his application
should not be denied and therefore ``request[ed] the opportunity to be
heard.'' Id. The Government did not object to granting Respondent a
hearing.\2\
---------------------------------------------------------------------------
\2\ The ALJ did not make any findings as to whether the
Government's attempts to serve Respondent were constitutionally
adequate, the date when service was initially attempted, and/or
whether Respondent had shown good cause for failing to timely file.
---------------------------------------------------------------------------
The case was then assigned to an agency Administrative Law Judge
(ALJ), who conducted a hearing on July 14 and 15, 2009, in New Orleans,
Louisiana. At the hearing, both parties called witnesses and introduced
documentary evidence. After the hearing, both parties submitted briefs
containing their proposed findings of facts, conclusions of law, and
argument.
On September 10, 2009, the ALJ issued his Recommended Decision
(hereinafter, also ALJ). Therein, the ALJ found that ``the credible
evidence clearly establishes that Respondent prepared and submitted an
application that falsely indicated that he had never been convicted of
a crime in connection with a controlled substance and that he had never
had a state professional license placed on probation.'' ALJ at 23. The
ALJ further found that the falsification was material as it ``had the
capacity to influence DEA's decision on the application'' and, second,
that the Government ``ha[d] clearly established a prima facie case for
the denial of Respondent's application based solely on the material
falsifications contained in [Respondent's] application.'' Id. at 24.
The ALJ then addressed the ``the public interest'' factors under 21
U.S.C. 823(f). As for factor one (the recommendation of the state
licensing board), the ALJ noted that the Board had restored
Respondent's medical license. ALJ at 26-27. However, he further noted
[[Page 26994]]
that under Agency precedent, a State Board's restoration of a medical
license is not dispositive in the public interest inquiry because DEA
has an independent responsibility ``to determine whether a registration
is in the public interest.'' Id. at 27 (citing cases). The ALJ thus
concluded that this factor weighed neither for, nor against, a
determination that granting Respondent a certificate of registration
would be in the public interest. Id.
The ALJ next addressed factor three (the applicant's conviction
record under Federal and State laws related to the manufacture,
distribution and dispensing of controlled substances) and whether
Respondent's ``state felony'' conviction for ``criminal possession of
crack cocaine'' constituted a conviction under this factor. Id. at 27-
28. While the ALJ concluded that Respondent's conviction for cocaine
possession was not relevant under this factor, id. at 28, he
subsequently noted that it could be considered under factor five as
such other conduct which may threaten public health and safety. Id. at
34-35.
The ALJ then turned to factors two, four and five (Respondent's
experience in dispensing controlled substances, his compliance with
applicable State, Federal or local laws relating to controlled
substances, and such other conduct which may threaten the public health
and safety). With respect to the allegation that Respondent had sold
controlled substance prescriptions to an undercover Agent for cash, the
ALJ concluded that the Government ``failed to present evidence in
sufficient[ly] credible detail to support [the] allegation by a
preponderance of the evidence.'' Id. at 30. More specifically, the ALJ
noted that the Agent who had made the undercover visits did not testify
in the proceeding and that the Investigator who testified regarding
them ``conceded'' that the Agent's vital signs were taken and that he
had complained of a medical condition. Id. The ALJ also noted that
while Respondent had diagnosed the Agent as having a ``leg-length
disparity,'' there was ``not even evidence from which it could be
inferred that [the Agent] did not, in fact have'' this condition. Id.
However, the ALJ also found that Respondent had pre-signed
controlled substance prescriptions and that such prescriptions were not
``issued in the usual course of professional practice.'' Id. Moreover,
the ALJ concluded that when this practice was coupled with various
circumstances surrounding Respondent's practice (including the late
night hours he maintained, the lack of specific appointment times,
various instances of his patients negotiating drug deals in his parking
lot, and the issuance of prescriptions to patients before Respondent
even saw them) made it clear that ``Respondent's prescribing practices
were not designed to issue prescriptions for legitimate medical
purposes in the usual course of a professional practice.'' Id. at 30-
31. In this regard, the ALJ further noted that Respondent made the same
diagnoses of a leg-length discrepancy in each of the 52 patient files
that the Government had seized and that ``it is patently unreasonable
to attribute [this diagnosis] to mere coincidence.'' Id. at 31.
Finally, the ALJ noted that while during the execution of a search
warrant, Respondent had various controlled substances on the premises,
he did not have such required records as an initial inventory, the
biennial inventory, and a dispensing log. Id. at 32.
The ALJ further noted that it was ``remarkable that these actions
took place even after * * *. Respondent had been through the criminal
justice system * * * and had his medical license placed on probation.''
Id. at 33. Moreover, the ALJ found that Respondent had failed to accept
responsibility for his actions and that he ``flatly denied preparing
and submitting the application'' which he materially falsified even
though his assertion ``was wholly inconsistent with the evidence
developed at the hearing.'' Id. at 35.
The ALJ thus concluded that ``the Government has established that
the Respondent has committed acts that are inconsistent with the public
interest'' and that Respondent has not ``accepted responsibility for
his actions, expressed remorse for his conduct at any level, or
presented evidence that could reasonably support a finding that the
Deputy Administrator should again entrust him with a Certificate of
Registration.'' Id. at 36. The ALJ thus recommended that Respondent's
application be denied. Id.
Neither party filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to me for final agency action.
Having considered the record in its entirety, I adopt the ALJ's
findings of fact (including his credibility findings) except as
expressly noted otherwise. I further adopt the ALJ's legal conclusion
that Respondent's registration would be inconsistent with the public
interest. Accordingly, I will adopt the ALJ's recommendation and deny
Respondent's application. I make the following findings.
Findings
Respondent is a physician licensed by the Louisiana State Board of
Medical Examiners who practices physical medicine. GX 3 at 1.
Respondent also previously held a DEA Certificate of Registration,
which authorized him to dispense controlled substances as a
practitioner at the address of 555 Holmes Boulevard, Gretna, Louisiana.
GX 1. However, on June 2, 2004, following an investigation by DEA (the
circumstances of which are set forth below), Respondent voluntarily
surrendered his registration. Id.; GX 6.
On March 9, 2005, Respondent applied for a new DEA registration
using the Agency's Web site.\3\ GXs 1 & 8. While Respondent denied
filing this application, Tr. 309, the Government produced evidence
showing that the $390 application fee was charged to a credit card
account held by him. GX 13, at 2 & 4.
---------------------------------------------------------------------------
\3\ As explained below, I agree with the ALJ that Respondent's
testimony that he did not submit the March 10, 2005 application is
not credible. According to the affidavit of a Diversion
Investigator, while the application was submitted via the internet
on March 9, 2005, the transaction was not posted until the following
day. GX 13, at 2.
---------------------------------------------------------------------------
On the application, Respondent was required to answer four
``liability'' questions. The first question asked: ``Has the applicant
ever been convicted of a crime in connection with controlled
substance(s) under state or federal law, or is any such action
pending?'' GX 1. Respondent answered: ``no.'' Id.
The third question asked: ``Has the applicant ever had a state
professional license or controlled substance registration revoked,
suspended, denied, restricted, or placed on probation, or is any such
action pending?'' Id. Respondent again answered: ``no.'' Id.
The second question asked: ``Has the applicant ever surrendered or
had a federal controlled substance registration revoked, suspended,
restricted or denied, or is any such action pending?'' Id. at 2.
Respondent answered:
On June 02, 2004, my primary office in Louisiana was visited by
the Mississippi Division of DEA Diversion Unit. Officers of this
unit expressed concerns regarding lack of Mississippi State DEA
Registration. Advised to surrender Louisiana DEA Registration to
facilitate investigation of other matters regarding patient
prescription writing [sic] habits. As of this application
submission, am uncertain of status of the investigation.
Id. at 2.\4\
---------------------------------------------------------------------------
\4\ The fourth liability question was not applicable.
---------------------------------------------------------------------------
Based on Respondent's ``yes'' answer to the second question, his
application was assigned to a DEA Diversion
[[Page 26995]]
Investigator with the New Orleans Field Division Office.\5\ Tr. 189.
However, because there was an open criminal investigation into his
activities in Mississippi, no action was taken on the application until
after the United States Attorney for the Southern District of
Mississippi declined prosecution. Id.
---------------------------------------------------------------------------
\5\ According to a DI, an affirmative response to these
``liability'' questions can trigger the referral of an application
to a DEA Investigator, and the opening of an investigation. Tr. 184.
Conversely, a negative answer to all ``liability'' questions results
in an application being forwarded to a DEA registration technician
for what is an essentially a pro forma examination with likely
approval. Id. at 184-85, 201-04.
---------------------------------------------------------------------------
During the course of its investigation, DEA obtained a copy of a
Consent Order which Respondent entered into with the Louisiana State
Board of Medical Examiners (hereinafter, State Board or Board), which
the latter approved on August 18, 1999. GX 3, at 11. Therein,
Respondent admitted that on April 1, 1998, he had pled guilty to the
offense of ``simple possession of cocaine,'' a felony under Louisiana
law.\6\ Id. at 2; see also GX 2(2), at 1; GX 2(3), at 1. Respondent was
given a suspended sentence of two years in the custody of the Louisiana
Department of Correction for this offense, two years of probation,
fined $600, and ordered to undergo drug counseling and rehabilitation.
GX 3, at 2; GX 2(5).
---------------------------------------------------------------------------
\6\ In the same proceeding, Respondent pled guilty to carrying a
concealed weapon, a misdemeanor under Louisiana law. GX 3, at 2.
---------------------------------------------------------------------------
In the consent order, Respondent further admitted that he had used
marijuana on a daily basis, and that he had ``used cocaine in 1982,
1985, and 1991,'' and that during 1991, ``he began using cocaine on a
more regular and frequent basis [and] developed a dependency on crack
cocaine and `primo,' a mixture of cocaine and marijuana smoked
together.'' GX 3, at 2. However, the State Board found that Respondent
had submitted to inpatient treatment and ``completed all four phases of
residential treatment and made a commitment to long term recovery by
establishing a relationship with the Physicians Health program.'' Id.
at 2.
Based on the above, the State Board concluded that there was ``just
cause'' to charge Respondent with various violations of the Louisiana
Medical Practice Act. Id. at 3. However, the Board placed Respondent on
probation for a period of five years subject to various conditions. On
May 16, 2008, the Board terminated Respondent's probation and fully
reinstated his license. RX 1.
At the hearing, the Government presented the testimony of a DEA
Diversion Investigator (DI) from the Resident Office (RO) in Gulfport,
Mississippi, who was involved in the criminal investigation of
Respondent. Tr. 21-23. According to the DI, in 2003, his office
received information from law enforcement agencies and ``concerned
citizens and parents'' that Respondent was operating a medical practice
in D'Iberville (a suburb of Biloxi, Mississippi) that catered to drug-
seeking patients and which was servicing its clientele very late at
night. Id. at 28-29. The Gulfport RO also received information that
Respondent was charging $200.00 for a patient's first visit, $100.00
for subsequent visits, and that the transactions were being conducted
in cash.\7\ Id. at 33. DEA also learned that the Respondent had an
office location in Gretna, Louisiana.\8\ Id. at 25, 33.
---------------------------------------------------------------------------
\7\ According to the DI, in his experience a cash-based medical
practice and a cash-based patient base are unusual features of a
medical practice and raise investigatory red flags. Tr. at 34-35.
\8\ The DI testified that a 2003 query of DEA databases
indicates that the Respondent was registered at locations in New
Orleans, Louisiana and Biloxi, Mississippi and that the latter
registration expired in July 2003. Tr. 24-25, 27-28.
---------------------------------------------------------------------------
Based on this information, DEA conducted an undercover operation
which focused on Respondent's practice in Mississippi. According to the
DI, a Special Agent (who has since retired), using the name of Reggie
Glorioso, made five undercover visits to Respondent's D'Iberville
office as well as two undercover visits to a location in nearby
Diamondhead, Mississippi, where Respondent eventually moved his
office.\9\ Id. at 50-51, 54, 124. The DI testified that his role was to
assemble the surveillance team that would monitor and record the
progress of the operation through audio transmitters that the Agent
wore. Id. at 47. According to DI, he listened to the visits as they
were being conducted. Id. at 44-48.
---------------------------------------------------------------------------
\9\ According to the DI, undercover (uc) visits to the
D'Iberville office were conducted in 2003 on May 14, May 28, June
24, July 22, and August 22; visits to the Diamondhead office were
conducted on November 20 and December 18. Tr. at 50-51. The
Government, however, only presented evidence about the first three
uc visits. Tr. 55-89.
---------------------------------------------------------------------------
The DI testified that the first visit was conducted on May 14,
2003, with the Agent arriving at Respondent's D'Iberville office at
about 5 p.m. Id. at 57. Respondent finally arrived at approximately 9
p.m. Id. Respondent's office staff weighed the Agent, took his pulse
and blood pressure, and at approximately 10:40 p.m. led him to an
examination room. Id. at 57-58, 63. At 11:05 p.m., Respondent finally
entered the exam room. Id. at 59.
During his interaction with Respondent, the Agent told the
Respondent that he had stiffness in his shoulders. Id. at 147.
According to the DI, the Respondent had the Agent ``place one leg on a
telephone book'' and then ``lifted'' the Agent's ``right hand.'' Id. at
62. Based on this examination, Respondent told the Agent ``that he had
a pelvic problem in which one foot was 3/4th of an inch lower than his
right side, which caused stress to his entire body, [and] therefore
caused him pain.'' Id. At approximately 12:22 a.m., Respondent gave the
Agent prescriptions for 25 dosage units of Xanax,\10\ 50 dosage units
of Vicodin,\11\ and 30 Soma (carisoprodol, a non-controlled drug). Id.
at 63-65. The Agent paid a member of the Respondent's office staff
$202.00 in cash and was given a follow-up appointment for May 28, 2003,
but with no appointment time indicated. Id. at 66.
---------------------------------------------------------------------------
\10\ A Schedule IV controlled substance. ALJ Ex. 6, at 1.
\11\ A Schedule III controlled substance. ALJ Ex. 6, at 1.
---------------------------------------------------------------------------
The Government did not offer either the transcript or a recording
of the visit (or any of the other visits for that matter). Moreover, it
did not call the Agent to testify.
At approximately 5 p.m. on May 28, 2003, the Agent returned to
Respondent's D'Iberville office.\12\ Id. at 72. The Agent signed in and
was told by Andre, a member of the office staff that Respondent would
not be in until later in the evening. Id. at 74. The Agent and Andre
agreed that the former would call in and check with the latter to learn
when Respondent was in the office. Id.
---------------------------------------------------------------------------
\12\ The DI testified that times were not assigned for
appointments at the Respondent's D'Iberville office. Patients would
sign in with a staff member and wait around the office, often in the
parking lot, for Respondent to arrive.
---------------------------------------------------------------------------
At 9:37 p.m., the Agent called Andre and was told that Respondent
was in. Id. The Agent returned to the office at 9:45 p.m., where he
waited until 1:05 the following morning, when he was finally taken to
an examination room. Id. at 67, 74. While in the examination room, the
Agent was able to look through his patient file and noted that it
contained pre-signed prescriptions for 35 dosage units of Xanax, 65
dosage units of Vicodin, and 65 dosage units of Soma.\13\ Id. at 67-68.
While the record is unclear as to what time Respondent entered the exam
room, the visit ended at 2:15 a.m. and cost $100. Id. at 69, 75. The
Agent received the aforementioned prescriptions as well as
prescriptions for
[[Page 26996]]
naprosyn (a non-controlled drug) and for a modified shoe. Id. at 82-83.
---------------------------------------------------------------------------
\13\ According to the DI, this combination of drugs is highly
sought after by drug abusers and is known on the street as the
``holy trinity.'' Tr. 84. While Soma (carisoprodol) is not
controlled, it ``enhances the euphoric effect of both the
hydrocodone and * * * the Xanax.'' Id.
---------------------------------------------------------------------------
According to the DI, notwithstanding the hour, ``there were still
individuals waiting in the parking lot to see'' Respondent. Id. at 70.
Moreover, the DI testified as to the Agent's interaction with several
of Respondent's ``patients'' that took place in his office parking lot.
Id. at 75-79. One of these individuals, T.B., told the Agent that he
was ``visiting more than one physician in order to obtain controlled
substances.'' Id. at 79. The Agent asked T.B. if he was interested in
selling his Xanax; the latter indicated that he might be interested and
the two exchanged phone numbers. Id. at 78-79. The Agent and T.B. also
discussed the latter's selling hydrocodone to the former and agreed on
a price of $3 per dosage unit.\14\ Id. at 79-80.
---------------------------------------------------------------------------
\14\ A Schedule III controlled substance. ALJ Ex. 6, at 1.
---------------------------------------------------------------------------
The Agent also exchanged phone numbers with another individual at
the scene, L.H., who told the former that he was seeing multiple
physicians to obtain drugs. Id. at 80. In response to an inquiry by the
Agent, L.H. agreed to sell him 100 Lortab \15\ for $300 and some
OxyContin 80 mg.\16\ for $25 a tablet. Id. at 81.
---------------------------------------------------------------------------
\15\ A Schedule III controlled substance which contains
hydrocodone. ALJ Ex. 6, at 1.
\16\ A Schedule II controlled substance. ALJ Ex. 6, at 1.
---------------------------------------------------------------------------
On June 24, 2003, the Agent made his third visit to the D'Iberville
office. Id. at 85. According to the DI, the Agent arrived a little
after 9 p.m. and paid $100 for the visit. Id. at 86-87. At
approximately 10:43 p.m., while he was still waiting to be see
Respondent, a staff member called for Reggie Glorioso (the Agent's
assumed name) and handed him an appointment card reflecting his next
appointment date, a receipt for $100, and prescriptions for Vicodin,
Soma, Naprosyn, and Xanax. Id. at 88. These prescriptions had been pre-
signed by Respondent and were given to the Agent before his interaction
with Respondent, which commenced at 10:57 p.m. and ended five minutes
later. Id. at 85-89.
Following the additional visits \17\--the details of which were not
elicited from the DI--the Investigators obtained a warrant to search
Respondent's Gretna, Louisiana office, which was executed on June 2,
2004.\18\ See GX 4 & 5. During the search, the Government seized
various controlled substances including 22 tablets of hydrocodone 5
mg., 45 tablets of Percocet 10/325 mg.,\19\ 23 tablets of Lorcet 10/650
mg., 10 full vials and one partially full vial of diazepam 10 mg./
ml.,\20\ 5 vials of diazepam 5 mg./ml., and 1 vial of Stadol 2 mg./
ml.\21\ GX 5, at 3.
---------------------------------------------------------------------------
\17\ On cross examination, the DI testified that at the fifth uc
visit, the Agent brought the prescribed shoe into the Respondent's
office. Tr. 147-48. The cross examination also revealed that during
the final uc visit, the Agent was given some exercises to do. Id. at
149, 152. Neither the Government nor the Respondent elicited any
further details regarding the uc visits.
\18\ According to the DI, the investigators sought the warrant
to search this office because it was where Respondent kept his
patient files. Tr. 90. Tr. at 90.
\19\ A Schedule II controlled substance which contains
oxycodone. ALJ Ex. 6, at 1.
\20\ A Schedule IV controlled substance. ALJ Ex. 6, at 1.
\21\ The Officers also seized a .45 caliber pistol from his
bedroom, which apparently was located upstairs from the office. Tr.
90-103. According to the DI, Respondent was unable to produce any
documentation for the firearm and offered no explanation regarding
its presence on the premises. Id. at 98-99. Moreover, a serial
number check with the Bureau of Alcohol, Tobacco, Firearms and
Explosives (ATF) did not return a record showing who owned the gun.
Id. at 102.
While the DI had previous experience in a local sheriff's
office, he was not familiar with Louisiana's firearms laws and did
not know whether Respondent's possession of the gun violated either
state or federal law. Id. at 103, 160-61. The ALJ further noted that
later in the hearing, the Government introduced a document entitled
``Verification of First Offender Pardon'' which was addressed to the
Respondent and indicated that the pardon he was granted did not
operate to restore any rights he might have regarding receiving,
possessing or transporting a firearm. Govt. Ex. 11.
In its brief, the Government argues that ``Respondent was found
in violation of the First Offender Pardon when he was found in
possession of a loaded pistol during [the] execution of [the] search
warrant.'' Gov. Br. at 17. The Government does not, however, cite to
any judicial finding that Respondent was in violation of either the
terms of his probation or of state law. Nor, as the ALJ noted, does
the Government cite any legal authority to support its contention
that Respondent was permanently barred from possessing a handgun. I
further agree with the ALJ that ``no valid legal conclusion can
reasonably be drawn from the language of the letter or its issuance
to the Respondent.'' ALJ at 8 n.23. Finally, the issue is of
tangential relevance.
---------------------------------------------------------------------------
Notwithstanding the presence of these drugs, Respondent did not
have various records which he was required to maintain, including an
initial and/or biennial inventories, and a dispensing log. Tr. 113-15,
123-24, 158; see also 21 CFR 1304.11(b) & (c), id. 1304.22(c). At the
scene, the Respondent admitted to the agents that he kept no such
records. Tr. at 115. The DI also testified that while Respondent had
issued prescriptions at his Mississippi office, his DEA registration
for this office had expired in July 2003. Id. at 28; see also 21 U.S.C.
822(e); 21 CFR 1301.12(a) & (b)(3).
The DI further testified that although he was not part of the
initial entry team that executed the warrant, he was on the scene after
the premises were secured. Tr. 154. According to the DI, he, along with
three or four agents and a representative of the State Board of Medical
Licensure, met with Respondent and interviewed him while the search was
conducted. Id. at 176. The ALJ specifically found credible the DI's
testimony that during the interview, the Respondent was seated in a
chair, no threats or promises were made, and no weapons were
brandished.\22\ ALJ at 8; see also Tr. 130-32, 154-55. The ALJ also
found credible the DI's testimony that Respondent was informed that he
was not under arrest, and that following some discussion about the
status of the investigation, Respondent voluntarily surrendered his DEA
registration and executed a DEA Form 104 (Voluntary Surrender of
Controlled Substances Privileges). ALJ at 8. The ALJ further credited
the DI's testimony that before Respondent signed the surrender form, he
read the Respondent his ``surrender rights'' \23\ from the form and
Respondent acknowledged that he understood the significance of signing
the document. Id., see also Tr. at 132-38.
---------------------------------------------------------------------------
\22\ The ALJ found that while the weapons may have been drawn by
other agents during the initial entry to the premises, there is no
credible evidence to support the Respondent's claim that weapons
were brandished during the DI's interview of Respondent. ALJ at 20.
\23\ Actually, the form contains an explanation of the effects
of the executed form, after the following statement: ``After being
fully advised of my rights, and understanding that I am not required
to surrender my controlled substances privileges, I freely execute
this document and choose to take the actions described herein.'' GX
6, at 1.
---------------------------------------------------------------------------
During the interview, Respondent stated that he charged about
$200.00 for an initial office visit, $100.00 for subsequent visits, and
offered a 10-20% discount for patients who paid in cash. Tr. at 104,
175. Respondent also told the DI that the Internal Revenue Service had
a judgment against him for between $180,000.00 and $190,000.00 and that
he owed the entire amount. Id. at 105.
Pursuant to the warrant, the Government seized fifty-two patient
files from Respondent's Gretna, Louisiana office. Id. at 116. According
to the DI's review of the patient files, Respondent had diagnosed each
of the fifty two patients (including that of the Special Agent who used
the name of Reggie Glorioso) as having a leg-length discrepancy.\24\
Id. at 116-17. Moreover,
[[Page 26997]]
each file contained evidence that Respondent had ``prescribed
narcotics'' and ``a modified shoe.'' Id. at 117. While the ALJ noted
that the Government ``introduced no expert testimony in this regard,''
he found it ``striking * * * that the same ailment and prescribed
treatment that the Respondent assigned to SA Price would exist in all
the files seized from his practice.'' ALJ at 9.
---------------------------------------------------------------------------
\24\ The Government elicited testimony from the DI that during
his investigation he consulted with a physician who is an expert in
pain management. Tr. 118-20. The Government, however, did not call
the expert to testify nor introduce any documentary evidence setting
forth his opinion as to the validity of Respondent's prescribing
practices.
According to the DI, the expert told him that leg-length
discrepancy is a rare diagnosis, and that there were referrals to
particular specialists and other treatment modalities that are
customarily utilized during a pain practice. Id. However, there is
no evidence as to how statistically rare this diagnosis is.
The ALJ thus considered this evidence only as background
information showing the reasonableness of the DI's continued
investigation. The ALJ further noted that during its examination of
the DI, the Government clarified that this was the sole purpose for
which this portion of his testimony was being offered and that, in
any event, the DI's testimony regarding his conversations with the
expert ``w[as] vague in content and could not even be fixed with an
approximate date and time.'' Given the Government's representation,
I agree with the ALJ that testimony is entitled to no weight in
determining the lawfulness of Respondent's prescribing practices.
ALJ at 10.
---------------------------------------------------------------------------
While this is true enough, there is no testimony to establish how
statistically improbable the condition is in even a single patient. Nor
is there any evidence showing the extent and duration of Respondent's
prescribing to the other fifty-one persons whose files were reviewed,
nor evidence establishing that the prescriptions he issued to these
persons lacked a legitimate medical purpose and were issued outside of
the usual course of professional practice.
The DI further testified that the patients came from all over the
Southeastern United States and included persons from Alabama, Florida,
and Louisiana. Tr. 121. According to the DI, he ran a criminal history
check on each of the other patients and found that all of them had a
history of illegal activity with regard to controlled substances,
including such offenses as prescription fraud, offenses based on doctor
shopping, as well as unlawful distribution apparently of both
prescription and non-prescription controlled substances such as
marijuana and cocaine. Id.\25\ However, as the ALJ noted, the
Government did not offer any evidence specific to any of these persons
such as their names, the exact nature or recency of the criminal
activity, and most significantly, whether any of these persons had been
convicted of criminal offenses.\26\ ALJ at 9 n.29.
---------------------------------------------------------------------------
\25\ Tr. at 169-70.
\26\ Tr. at 38, 40, 121.
---------------------------------------------------------------------------
The ALJ further noted that while the Government initially indicated
that it intended to call the retired Agent as a witness, it declined,
without explanation, to do so at the hearing. ALJ at 9. The ALJ also
noted that while the DI indicated that the audio recordings and
transcripts of the undercover visits to the Respondent's offices were
still in existence, he did not bring these items to the hearing because
he was not asked to do so. Id. at 9-10.
The ALJ further found that the DI's testimony concerning his
recollection of the interaction that took place between SA Price and
the Respondent was quite vague and that on several occasions he needed
to review his case file and an unsigned copy of an affidavit he had
prepared on previous occasion. Id. at 10. While the ALJ generally found
the DI's testimony to be credible, he noted that it ``would have been
more helpful if it had been preceded by a higher level of
preparation.'' Id. Most significantly, the ALJ found that the DI's
testimony regarding the interaction between the Respondent and the
Special Agent during the undercover visits ``was insufficiently precise
to shed significant light on the Respondent's prescribing practices as
evidenced in those visits.'' Id.
Respondent's Evidence
In his testimony, Respondent repeatedly denied filing the March 10,
2005 application, and insisted that ``there [wa]s no way I could have
left all this incomplete.'' Tr. 309, 313-14. He further asserted that
he submitted an application in October or November 2005 after Hurricane
Katrina and that he told the Chicago DEA office everything about his
1998 guilty pleas and the probation of his state medical license. Id.
at 313-15.
As to Respondent's assertion that he never filed the March 10, 2005
application, the ALJ found that it ``flies in the face of much of the
credible evidence.'' ALJ at 19. In particular, the ALJ found it
difficult to believe that an ``unidentified individual would possess
[the] level of personally identifiable information [necessary to
transact the credit card transaction] and be willing to pay $390.00 to
file an application for a DEA Registration in secret, and to the
Respondent's detriment.'' Id. (see also id. at 20: ``Perhaps the least
credible in the litany of incredible assertions put forth by the
Respondent is the testimony that he never filed the application for the
[Certificate of Registration] containing his material falsifications,
particularly in light of the fact that his credit card was utilized to
pay the application fee.'').
Moreover, the nature of the information that was provided in
response to question 2 on the application included highly specific
information regarding the circumstances surrounding Respondent's
surrender of his previous registration. See GX 1, at 2. More
specifically, the answer stated that ``[o]n June 2, 2004, my primary
office in Louisiana was visited by'' a ``DEA Diversion Unit,'' which
advised him to surrender his Louisiana DEA registration. Id. This, of
course, was the exact date that the warrant was executed and on which
Respondent surrendered his registration. This begs the question--which
Respondent did not answer--what other individual would have known this
information and used it (as well as Respondent's credit card) to file
the application? I thus agree with the ALJ that Respondent completed
the application and gave false testimony when he denied filing the
March 10, 2005 application.
At the hearing, Respondent did not deny either that he had a felony
conviction for possession of cocaine or that his medical license had
previously been placed on probation. While Respondent apparently
admitted that his answer to the first liability question (which asked
if he had ``ever been convicted of a crime in connection with
controlled substances under state or federal law'') was false, he
nonetheless insisted that his answer to the third liability question
(regarding his state license) was ``correct.'' Tr. 341. He further
testified that in answering the latter question, he interpreted the
question as if it asked only whether his state prescription writing
authority had been placed on probation. Id. at 346-47. However, as
found above, the question encompasses--in plain English--discipline
imposed against an applicant's professional license and not just his
state controlled substance registration.\27\
---------------------------------------------------------------------------
\27\ The Government further showed that on an application that
Respondent submitted in June 2000, he had also provided a ``no''
answer to the question ``Has the applicant ever had a state
professional license or controlled substance registration revoked,
suspended, denied, restricted, or placed on probation?'' GX 12; Tr.
344.
---------------------------------------------------------------------------
Respondent also disputed that his patients came from other States,
Tr. 406, and that he ran a cash-only practice. Id. at 401. As for why
he saw patients so late at night as well as during the wee hours of the
morning, Respondent testified that:
[t]he only explanation I can give you * * * that makes sense in
terms of * * * what I do as a physiatrist, my approach is fairly
unique. We address the problems of, if you will, physical
disfunction[sic] in a manner that typically required that type of
extended, sit down, educational, this is what we're doing, this is
how we have to approach it, you know, interacting with the patient
to get them to understand what was expected of them in order to
accomplish the goal.
Id. at 407.
[[Page 26998]]
As for the DI's assertion that each of the fifty-one persons whose
patient file was seized had some criminal behavior or drug history,
Respondent testified that he used a questionnaire which asks various
questions to identify problematic patients such as whether the patient
had or was using illicit drugs, whether the patient had a psychiatric
history, and that he would also do ``a general mental status
assessment'' of each patient. Id. at 412-13. He further maintained that
he discharged problematic patients, including those who were seeking
drugs for self-abuse or to sell. Id. at 413-14.
Putting aside the credibility of Respondent's testimony regarding
his medical practices, it is notable that he failed to address several
material issues that were proved by the Government. More specifically,
he offered no testimony as to why he had pre-signed prescriptions, and
why he failed to maintain inventories and a dispensing log.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination ``that the issuance of such registration would be
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making
the public interest determination, the CSA requires the consideration
of the following factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * 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 the public health and
safety.
Id.
``These factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
a combination of factors, and may give each factor the weight [I]
deem[] appropriate in determining whether * * * an application for
registration [should be] denied.'' Id. Moreover, I am not required to
make findings as to all of the factors. Volkman v. DEA, 567 F.3d 215,
222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005).
Under Section 304(a)(1), a registration may be revoked or suspended
``upon a finding that the registrant * * * has materially falsified any
application filed pursuant to or required by this subchapter.'' 21
U.S.C. 824(a)(1). Under agency precedent, the various grounds for
revocation or suspension of an existing registration that Congress
enumerated in section 304(a), 21 U.S.C. 824(a), are also properly
considered in deciding whether to grant or deny an application under
section 303. See The Lawsons, Inc., 72 FR 74334, 74337 (2007); Anthony
D. Funches, 64 FR 14267, 14268 (1999); Alan R. Schankman, 63 FR 45260
(1998); Kuen H. Chen, 58 FR 65401, 65402 (1993). Thus, the allegation
that Respondent materially falsified his application is properly
considered in this proceeding. See The Lawsons, 72 FR at 74337; Samuel
S. Jackson, 72 FR 23848, 23852 (2007). Moreover, just as materially
falsifying an application provides a basis for revoking an existing
registration without proof of any other misconduct, see 21 U.S.C.
824(a)(1), it also provides an independent and adequate ground for
denying an application. The Lawsons, 72 FR at 74338; cf. Bobby Watts,
M.D., 58 FR 46995 (1993).
Here, the record establishes two separate grounds for denying
Respondent's application. First, Respondent materially falsified his
March 2005 application for a registration. Second, Respondent has
committed numerous acts which demonstrate that the issuance of a
registration would be inconsistent with the public interest. Moreover,
Respondent has failed to offer sufficient evidence to rebut the
Government's prima facie showing that his registration would be
inconsistent with the public interest.
The Material Falsification Allegation
As found above, on March 9, 2005, Respondent, who had surrendered
his DEA registration on June 2, 2004, applied for a new registration.
While on the application Respondent acknowledged that he had previously
surrendered his DEA registration, he provided a ``no'' answer to the
questions of whether he had ``ever been convicted of a crime in
connection with controlled substances under state or federal law'' and
whether he had ``ever had a state professional license or controlled
substance registration'' sanctioned. These statements were clearly
false as Respondent had been convicted of possession of cocaine, a
felony offense under the laws of Louisiana, and had also had his
Louisiana Medical License placed on probation.
Both of these falsifications were material. ``The most common
formulation'' of the concept of materiality ``is that a concealment or
misrepresentation is material if it `has a natural tendency to
influence, or was capable of influencing, the decision of' the
decisionmaking body to which it was addressed.'' Kungys v. United
States, 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States,
231 F.2d 699, 701 (DC Cir. 1956)) (other citation omitted); see also
United States v. Wells, 519 U.S. 482, 489 (1997) (quoting Kungys, 485
U.S. at 770). The evidence must be ``clear, unequivocal, and
convincing.'' Kungys, 485 U.S. at 772. However, ``the ultimate finding
of materiality turns on an interpretation of substantive law.'' Id. at
772 (int. quotations and other citation omitted).
Moreover, ``[i]t makes no difference that a specific falsification
did not exert influence so long as it had the capacity to do so.''
United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985). See
also United States v. Norris, 749 F.2d 1116, 1121 (4th Cir. 1984)
(``There is no requirement that the false statement influence or effect
the decision making process of a department of the United States
Government.'').
DEA has previously held that ``[t]he provision of truthful
information on applications is absolutely essential to effectuating
[the] statutory purpose'' of determining whether the granting of an
application is consistent with the public interest. See Peter H. Ahles,
71 FR 50097, 50098 (2006).\28\ As a substantive matter, Congress has
directed that the Agency consider five factors in determining whether
the granting of an application is consistent with the public interest.
See 21 U.S.C. 823(f). As noted above, the Agency is required to
consider the status of the applicant's state authority to dispense
controlled substances,\29\ the applicant's experience
[[Page 26999]]
in dispensing * * * controlled substances,'' his ``conviction record *
* * relating to the * * * dispensing of controlled substances,'' his
``[c]ompliance with applicable State, Federal, or local laws relating
to controlled substances,'' and whether he has engaged in ``such other
conduct which may threaten public health and safety.'' 21 U.S.C.
823(f). Moreover, under the latter factor, DEA has frequently denied
applications and revoked the registrations of practitioners who have a
history of abusing controlled substances. See, e.g., Kenneth Wayne
Green, Jr., 59 FR 51453 (1994); David E. Trawick, 53 FR 5326, 5327
(1988).
---------------------------------------------------------------------------
\28\ Cf. Martha Hernandez, M.D., 62 FR 61145, 61146 (1997) (An
applicant's answers to the various liability questions are material
because this Agency ``relies upon such answers to determine whether
an investigation is needed prior to granting the application.''). A
DI explained that, as a procedural matter, when an applicant
provides ``no'' answers to the liability questions, the application
is forwarded without further investigation to a registration
technician for approval.
It is acknowledged that Respondent truthfully disclosed that he
had previously surrendered his registration and thus, his
application would have been subjected to an investigation in any
case. However, as the Supreme Court has explained, whether a false
statement is material depends upon an interpretation of the
substantive law. As explained above, Respondent's two false answers
are clearly material to several of the factors which the Agency is
charged with considering in making the public interest
determination.
\29\ Not only did Congress direct the Agency to consider ``[t]he
recommendation of the appropriate State licensing board or
professional disciplinary authority,'' a practitioner cannot be
registered unless he ``is authorized to dispense * * * under the
laws of the State in which he practices.'' 21 U.S.C. 823(f). See
also 21 U.S.C. 802(21) (defining ``practitioner'' as ``a physician *
* * licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices * * * to dispense *
* * a controlled substance in the course of professional
practice'').
---------------------------------------------------------------------------
Congress has also explicitly granted the Agency authority to revoke
a registration where a registrant ``has been convicted of a felony
under [the CSA] or any other law of the United States, or of any State,
relating to any substance defined in [the CSA] as a controlled
substance.'' 21 U.S.C. 824(a)(2). As noted above, it has long been
settled that the Agency has authority to deny an application on any of
the grounds set forth in 21 U.S.C. 824.\30\
---------------------------------------------------------------------------
\30\ To make clear, the Agency's authority to deny an
application is not limited to those convictions enumerated in 21
U.S.C. 823(f)(3), but also includes any conviction meeting the
standards of 21 U.S.C. 824(a)(2) such as a conviction for simple
possession.
---------------------------------------------------------------------------
Thus, even though Respondent disclosed that he had previously
voluntarily surrendered his registration and been the subject of an
investigation with respect to his prescribing practices, his failure to
disclose the previous state discipline (which was based on his abuse of
various controlled substances as well as his conviction for cocaine
possession) and this conviction, still had the capacity to influence
the Agency's decision as to whether his application should be granted.
It makes no difference that the Agency did not rely on the
misrepresentations and grant his application. See United States v.
Alemany Rivera, 781 F.2d at 234; United States v. Norris, 749 F.2d at
1121.
Under DEA precedent, the Government is not required to show that
the falsification was intentional but only that the applicant ``knew or
should have known that the response given to the liability question was
false.'' The Lawsons, 72 FR at 74339; Samuel Arnold, 63 FR 8687, 8688
(1998). Respondent obviously knew that he had ``been convicted of a
crime in connection with controlled substances'' under Louisiana law.
Likewise, he knew that his state license had previously been placed on
probation. And contrary to his protestation that he thought the
question was only directed at the loss of his prescription-writing
authority, the question clearly encompassed the probationary sanction
imposed on his Louisiana medical license.
Thus, Respondent cannot credibly claim that the falsifications were
the result of mere negligence or misunderstanding. Indeed, that
Respondent denied having even submitted the application--an assertion
which is patently false given the detailed information that the
application included and the fact that the fee was paid for with his
credit card--suggests that the falsification was intentional.
I thus hold that Respondent materially falsified his March 2005
application by failing to disclose his conviction for cocaine
possession and the State Board's imposition of probation terms on his
medical license. I further hold that Respondent--as evidenced by his
having denied that he submitted the application--has failed to accept
responsibility for his misconduct. See Samuel Jackson, 72 FR at 23853.
Thus, Respondent's material falsification provides reason alone to deny
his application.
In addition, the evidence showed that Respondent, when he was
previously registered, committed multiple acts which are properly
considered under factors two and four and which render his
``registration inconsistent with the public interest.'' 21 U.S.C.
823(f). As found above, Respondent issued multiple prescriptions for
controlled substances including hydrocodone and Xanax to an undercover
Agent who visited him at his office in D'Iberville, Mississippi. While
there is insufficient evidence to establish that these prescriptions
lacked a legitimate medical purpose and were issued outside of the
course of professional practice, see 21 CFR 1306.04(a), the evidence
did show that at the undercover Agent's subsequent visits, Respondent
had pre-signed prescriptions for both of the above controlled
substances, and that during at least one of these visits, the Agent was
given the prescriptions before he even saw Respondent.
DEA has long interpreted the CSA as prohibiting the pre-signing of
prescriptions. See Jayam Krishna-Iyer, 71 FR 52148, 52159 & n.9 (2006)
(collecting cases), vacated on other grounds, 249 Fed. Appx. 159 (11th
Cir. 2007). See also Walter S. Gresham, 57 FR 44213, 44214 (1992);
James Beale, 53 FR 15149, 15150 (1988) (``It is a violation of 21 CFR
1306.05(a) to pre-sign prescriptions for controlled substances.'').
Respondent's practice of pre-signing prescriptions is indicative of
drug dealing as he clearly had not evaluated the undercover Agent prior
to writing the prescriptions to determine whether they were medically
necessary to treat his purported condition.\31\
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\31\ The circumstantial evidence which includes his seeing
patients in the wee hours of the morning, where the patients were
coming from, the interactions that the Agent had with other
``patients,'' and the uniformity of his diagnoses, create a strong
suspicion that Respondent was not engaged in legitimate medical
practice but rather drug dealing. However, under the substantial
evidence test, the evidence must ``do more than create a suspicion
of the existence of the fact to be established.'' NLRB v. Columbian
Enameling & Stamping Co., 306 U.S. 292, 300 (1939). Given the
numerous evidentiary gaps in the record, I do not make any findings
regarding the lawfulness of Respondent's prescribing practices with
respect to the other 51 patients whose files were seized.
---------------------------------------------------------------------------
The evidence also showed that during the search of Respondent's
Louisiana office, Investigators found various controlled substances
including Percocet (a schedule II drug containing oxycodone),
hydrocodone and Lorcet (both schedule III drugs containing
hydrocodone), diazepam and Stadol (both schedule IV drugs). Respondent
makes no claim that these drugs had been lawfully prescribed to him.
Under the CSA, ``every registrant * * * shall * * * as soon * * *
as such registrant first engages in the manufacture, distribution, or
dispensing of controlled substances, and every second year thereafter,
make a complete and accurate record of all stocks thereof on hand.'' 21
U.S.C. 827(a)(1); see also 21 CFR 1304.11(b) & (c). Moreover, ``every
registrant * * * manufacturing, distributing, or dispensing, a
controlled substance or substances shall maintain, on a current basis,
a complete and accurate record of each such substance manufactured,
received, sold, delivered, or otherwise disposed of by him.'' 21 U.S.C.
827(a)(3); see also 21 CFR 1304.22(c) (requirement for dispensing
records). During the search, Respondent admitted to the Investigators
that he did not have the required inventories and was not maintaining a
dispensing log. I thus further hold that Respondent violated Federal
law and DEA regulations by failing to maintain these records.
Notably, Respondent offered no testimony addressing either his pre-
signing of prescriptions or his failure to maintain required records.
Respondent
[[Page 27000]]
has thus failed to offer any evidence to rebut the Government's showing
that he has committed acts which render granting him a registration
inconsistent with the public interest.\32\ See Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (``Where the Government has made
out its prima facie case, the burden shifts to the Respondent to show
why [his] continued registration would nonetheless be consistent with
the public interest.''). Accordingly, these violations of the CSA and
DEA regulations provide a further basis to deny Respondent's
application.
---------------------------------------------------------------------------
\32\ It is acknowledged that Respondent holds a valid state
license (factor one) and has not been convicted of an offense
related to the dispensing of controlled substances (factor three).
However, neither of these factors is dispositive. See Edmund Chein,
72 FR 6580, 6590 (2007), aff'd Chein v. DEA, 533 F.3d 828 (DC Cir.
2008) (The authority to decide whether to grant an application for a
DEA registration has been entrusted to the Attorney General and
``has been delegated solely to the officials of this Agency.'') See
also id. at 6593 n.22 (absence of criminal convictions not
dispositive in public interest inquiry).
I further note the DI's testimony that Respondent violated
Federal law because he wrote prescriptions at his Mississippi office
and did not have a registration in this State. However, the
Government put forward no evidence that identifies specific
prescriptions that Respondent issued after the expiration of his
Mississippi registration. Moreover, in its brief, the Government
does not rely on this conduct. Thus, I do not consider the
allegation.
The Government also argues that Respondent's conviction for
possession of cocaine can be considered under factor three. However,
the conviction was not for an offense related to the manufacture,
distribution, or dispensing of controlled substances and is thus not
properly considered under factor three. However, as the ALJ
reasoned, consistent with Agency precedent, the conviction can be
considered under factor five as such other conduct which may
threaten public health and safety. See ALJ at 34-35. While there is
evidence that Respondent underwent treatment, and the Government
does not argue that Respondent has a continuing problem with drug
abuse, when coupled with the other violations proved on this record,
it buttresses the conclusion that Respondent is unwilling to conform
to the law and that he cannot be entrusted with a new registration.
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as by 28 CFR 0.100(b) and 0.104, I hereby order that the application of
Alvin Darby, M.D., for a DEA Certificate of Registration as a
practitioner, be, and it hereby is, denied. This order is effective
immediately.
Dated: April 16, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-11431 Filed 5-12-10; 8:45 am]
BILLING CODE 4410-09-P